Layered spectroscopic sample element with microporous membrane

• US 6,983,177 B2
• Filed: 01/06/2003
• Issued: 01/03/2006
• Est. Priority Date: 01/06/2003
• Status: Expired due to Fees

• Current Assignee: OptiScan Biomedical Corporation
• Original Assignee: OptiScan Biomedical Corporation
• Inventors: Braig, James R., Hartstein, Philip C., Rule, Peter
• Primary Examiner(s): WINAKUR, ERIC FRANK
• Application Number:
  US10/337,226
• Publication Number:
  US 20040133084A1
• Time in Patent Office: 1,093 Days
• Field of Search: 600/310, 600/573, 600/583, 600/584, 436/164, 436/171, 250/339.07, 250/576, 422/58, 422/102, 422/82.09, 356/38, 356/244, 356/246, 356/300, 356/319, 356/326, 356/440
• US Class Current: 600/310
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/1455 using optical sensors, e.g. spectral photometrical oximeters
• CPC Class Codes: A61B 5/1491 Heated applicators
• CPC Class Codes: B01L 2200/027 for microfluidic devices
• CPC Class Codes: B01L 2300/0654 Lenses; Optical fibres
• CPC Class Codes: B01L 2300/069 Absorbents; Gels to retain a fluid
• CPC Class Codes: B01L 2300/0825 Test strips
• CPC Class Codes: B01L 2300/0887 Laminated structure
• CPC Class Codes: B01L 2400/0406 capillary forces
• CPC Class Codes: B01L 3/5023 with a sample being transported to, and subsequently stored in an absorbent for analysis
• CPC Class Codes: B01L 3/5027 by integrated microfluidic structures, i.e. dimensions of channels and chambers are such that surface tension forces are important, e.g. lab-on-a-chip B01L3/5023 takes precedence; micromixers B01F33/30; microreactors for synthesis B01J19/0093; microcapillary devices in general B81B1/00
• CPC Class Codes: B01L 3/508 rigid containers not provided for above
• CPC Class Codes: G01N 2021/0346 Capillary cells; Microcells
• CPC Class Codes: G01N 21/03 Cuvette constructions
• CPC Class Codes: G01N 21/8483 Investigating reagent band test-element handling not specific to a test method G01N33/4875; analytical elements specific to chemical analysis of biological material G01N33/52; autometer with reagent band G01N35/04

Abstract

A spectroscopic sample holder comprises a microporous sheet. The microporous sheet has a top surface, a bottom surface substantially parallel to the top surface, and at least one side surface oriented substantially perpendicular to the top and bottom surfaces. The side surface forms an exposed transit opening configured to contact a material sample and distribute the contacted material sample into the microporous sheet. The spectroscopic sample holder further comprises a first planar support member positioned on, and substantially parallel to, the top surface of the microporous sheet. The spectroscopic sample holder further comprises a second planar support member positioned on the bottom surface of the microporous sheet, and oriented substantially parallel to the first planar support member.

Claims

1. A spectroscopic sample holder comprising:

a microporous sheet having a top surface, a bottom surface substantially parallel to the top surface, and at least one side surface oriented substantially perpendicular to the top and bottom surfaces, the side surface forming an exposed transit opening configured to contact a material sample and distribute the contacted material sample into the microporous sheet,

a first planar support member positioned on, and substantially parallel to, the top surface of the microporous sheet;

a skin-piercing structure having a passageway that connects a distal portion of the skin-piercing structure with the exposed transit opening; and

a second planar support member positioned on the bottom surface of the microporous sheet, and oriented substantially parallel to the first planar support member.

2. The spectroscopic sample holder of claim 1, wherein the exposed transit opening comprises an entry region through which the material sample can enter the microporous sheet.

3. The spectroscopic sample holder of claim 1, wherein the first and second planar support members comprise members having a structural rigidity greater than or equal to a structural rigidity of the microporous sheet.

4. The spectroscopic sample holder of claim 1, wherein the microporous sheet further comprises a non-solid material having a network of voids through which the material sample can propagate.

5. The spectroscopic sample holder of claim 1, wherein information bearing media is disposed on at least one of the planar support members.

6. The spectroscopic sample holder of claim 1, further comprising a shield forming an aperture.

7. The spectroscopic sample holder of claim 6, wherein the shield is substantially opaque to electromagnetic radiation.

8. The spectroscopic sample holder of claim 1, wherein the microporous sheet has four side surfaces, and the first and second planar support members are substantially coextensive with at least two of the side surfaces of the microporous sheet.

9. The spectroscopic sample holder of claim 8, wherein the first and second planar support members are substantially coextensive with all four of the side surfaces of the microporous sheet.

10. The spectroscopic sample holder of claim 1, further comprising an open mesh at least partially covering the exposed transit opening.

11. The spectroscopic sample holder of claim 1, wherein the spectroscopic sample holder has an average baseline transmittance of at least 1 percent.

12. The spectroscopic sample holder of claim 1, wherein the spectroscopic sample holder has an average baseline transmittance of at least 10 percent.

13. The spectroscopic sample holder of claim 1, wherein the spectroscopic sample holder has an average baseline transmittance of at least 50 percent.

14. The spectroscopic sample holder of claim 1, wherein the microporous sheet consists essentially of a polyolefin film.

15. The spectroscopic sample holder of claim 1, wherein the microporous sheet consists essentially of one or more of the following:

polyethylene, polypropylene, ethylene/propylene copolymers, polytetrafluoroethylene, chlorotrifluoroethylene polymers and copolymers, polyvinylidene fluoride, polyester, or nylon.

16. The spectroscopic sample holder of claim 1, wherein the microporous sheet is hydrophilic.

17. The spectroscopic sample holder of claim 1, wherein the microporous sheet is hydrophobic.

18. The spectroscopic sample holder of claim 1, wherein the microporous sheet has an electrostatic charge on opposing sides.

19. The spectroscopic sample holder of claim 1, wherein the microporous sheet further comprises azlactone material.

20. The spectroscopic sample holder of claim 19, wherein a polymer material is grafted to the azlactone material.

21. The spectroscopic sample holder of claim 1, wherein the microporous sheet comprises a polymeric, non-woven material.

22. The spectroscopic sample holder of claim 1, wherein the microporous sheet has a void volume greater than about 20 percent.

23. The spectroscopic sample holder of claim 1, wherein the microporous sheet has a void volume of between about 50 percent and about 98 percent.

24. The spectroscopic sample holder of claim 1, wherein the microporous sheet has a void volume of between about 70 percent and about 85 percent.

25. The spectroscopic sample holder of claim 1, wherein the microporous sheet has pores ranging from about 0.1 μ

m to about 50 μ

m in their average characteristic width.

26. The spectroscopic sample holder of claim 1, wherein the exposed transit opening has a structured surface.

27. The spectroscopic sample holder of claim 1, wherein the microporous sheet has a thickness between about 2.5 μ

m and about 25 μ

m.

28. The spectroscopic sample holder of claim 1, wherein the microporous sheet transmittance variability is less than 25 percent.

29. The spectroscopic sample holder of claim 1, wherein the microporous sheet transmittance variability is less than 10 percent.

30. The spectroscopic sample holder of claim 1, wherein the microporous sheet has an area between about 1 cm² and about 6 cm².

31. An apparatus comprising:

a microporous sheet positioned between first and second support members, wherein at least a portion of the microporous sheet is an exposed transit opening configured to receive and distribute a material sample into the microporous sheet; and

a skin-piercing structure having a passageway that connects a distal portion of the skin-piercing structure with the exposed transit opening.

32. The apparatus of claim 31, wherein the exposed transit opening comprises art entry region through which the material sample can enter the microporous sheet.

33. The apparatus of claim 31, wherein the first and second planar support members comprise members having a structural rigidity greater than or equal to a structural rigidity of the microporous sheet.

34. The apparatus of claim 31, wherein the microporous sheet comprises a non-solid material having a network of voids through which the material sample can propagate.

35. The apparatus of claim 31, wherein information bearing media is disposed on at least one of the support members.

36. The apparatus of claim 31, further comprising a shield forming an aperture.

37. The apparatus of claim 36, wherein the shield is substantially opaque to electromagnetic radiation.

38. The apparatus of claim 31, wherein the microporous sheet has four side surfaces, and the first and second support members are substantially coextensive with at least two of the side surfaces of the microporous sheet.

39. The apparatus of claim 38, wherein the first and second support members are substantially coextensive with all four of the side surfaces of the microporous sheet.

40. The apparatus of claim 31, further comprising an open mesh at least partially covering the exposed transit opening.

41. The apparatus of claim 31, wherein the exposed transit opening has a structured surface.

42. The apparatus of claim 31, wherein the apparatus has an average baseline transmittance of at least 1 percent.

43. The apparatus of claim 31, wherein the apparatus has an average baseline transmittance of at least 10 percent.

44. The apparatus of claim 31, wherein the apparatus has an average baseline transmittance of at least 50 percent.

45. The apparatus of claim 31, wherein the microporous sheet consists essentially of a polyolefin film.

46. The apparatus of claim 31, wherein the microporous sheet consists essentially of one or more of the following:

polyethylene, polypropylene, ethylene/propylene copolymers, polytetrafluoroethylene, chlorotrifluoroethylene polymers and copolymers, polyvinylidene fluoride, polyester, or nylon.

47. The apparatus of claim 31, wherein the microporous sheet is hydrophilic.

48. The apparatus of claim 31, wherein the microporous sheet is hydrophobic.

49. The apparatus of claim 31, wherein the microporous sheet has an electrostatic charge on opposing sides.

50. The apparatus of claim 31, wherein the microporous sheet further comprises azlactone material.

51. The apparatus of claim 50, wherein a polymer material is grafted to the azlactone material.

52. The apparatus of claim 31, wherein the microporous sheet comprises a polymeric, non-woven material.

53. The apparatus of claim 31, wherein the microporous sheet has a void volume greater than about 20 percent.

54. The apparatus of claim 31, wherein the microporous sheet has a void volume between about 50 percent and about 98 percent.

55. The apparatus of claim 31, wherein the microporous sheet has a void volume between about 70 percent and about 85 percent.

56. The apparatus of claim 31, wherein the microporous sheet has pores ranging from about 0.1 μ

m to about 50 μ

m in their average characteristic width.

57. The apparatus of claim 31, wherein the microporous sheet has a thickness between about 2.5 μ

m and about 25 μ

m.

58. The apparatus of claim 31, wherein the microporous sheet transmittance variability is less than 25 percent.

59. The apparatus of claim 31, wherein the microporous sheet transmittance variability is less than 10 percent.

60. The apparatus of claim 31, wherein the microporous sheet has an area between about 1 cm² and about 6 cm².

61. A method comprising:

providing a microporous sheet disposed between first and second support members, such that at least a portion of the microporous sheet is left exposed;

contacting the exposed portion of the microporous sheet with a material sample such that at least a portion of the material sample is drawn into the microporous sheet;

transmitting electromagnetic radiation through the material sample in the microporous sheet;

piercing a patient'"'"'s skin with a skin-piercing structure, the skin-piercing structure having a passageway that connects a distal portion of the skin-piercing structure with the exposed portion of the microporous sheet; and

analyzing the electromagnetic radiation transmitted through the material sample in a spectral region of interest.

62. The method of claim 61, wherein the exposed portion of the microporous sheet comprises an entry region through which the material sample can enter the microporous sheet.

63. The method of claim 61, wherein the first and second planar support members comprise members having a structural rigidity greater than or equal to a structural rigidity of the microporous sheet.

64. The method of claim 61, wherein the microporous sheet comprises a non-solid material having a network of voids through which the material sample can propagate.

65. The method of claim 61, wherein the material sample is allowed to dry before electromagnetic radiation is transmitted through the microporous sheet.

66. The method of claim 61, further comprising determining the baseline transmittance of the microporous sheet before contacting the material sample to the microporous sheet.

67. The method of claim 61, wherein the material sample is a solvent soluble material, and further comprising dissolving the sample in solvent before contacting the material sample to the microporous sheet.

68. The method of claim 61, wherein information bearing media is disposed on at least one of the support members.

69. The method of claim 61, wherein the microporous sheet further comprises a shield forming an aperture.

70. The method of claim 69, wherein the shield is substantially opaque to electromagnetic radiation.

71. The method of claim 61, wherein the microporous sheet has four side surfaces, and the first and second support members are substantially coextensive with at least two of the side surfaces of the microporous sheet.

72. The method of claim 71, wherein the first and second support members are substantially coextensive with all four of the side surfaces of the microporous sheet.

73. The method of claim 61, further comprising an open mesh at least partially covering the exposed portion of the microporous sheet.

74. The method of claim 61, wherein the exposed portion of the microporous sheet has a structured surface.

75. The method of claim 61, wherein the microporous sheet has an average baseline transmittance of at least 1 percent.

76. The method of claim 61, wherein the microporous sheet has an average baseline transmittance of at least 10 percent.

77. The method of claim 61, wherein the microporous sheet has an average baseline transmittance of at least 50 percent.

78. The method of claim 61, wherein the microporous sheet consists essentially of a polyolefin film.

79. The method of claim 61, wherein the microporous sheet consists essentially of one or more of the following:

polyethylene, polypropylene, ethylene/propylene copolymers, polytetrafluoroethylene, chlorotrifluoroethylene polymers and copolymers, polyvinylidene fluoride, polyester, or nylon.

80. The method of claim 61, wherein the microporous sheet is hydrophilic.

81. The method of claim 61, wherein the microporous sheet is hydrophobic.

82. The method of claim 61, wherein the microporous sheet has an electrostatic charge on opposing sides.

83. The method of claim 61, wherein the microporous sheet further comprises azlactone material.

84. The method of claim 83, wherein a polymer material is grafted to the azlactone material.

85. The method of claim 61, wherein the microporous sheet comprises a polymeric, non-woven material.

86. The method of claim 61, wherein the microporous sheet has a void volume greater than about 20 percent.

87. The method of claim 61, wherein the microporous sheet has a void volume between about 50 percent and about 98 percent.

88. The method of claim 61, wherein the microporous sheet has a void volume between about 70 percent and about 85 percent.

89. The method of claim 61, wherein the microporous sheet has pores ranging from about 0.1 μ

m to about 50 μ

m in their average characteristic width.

90. The method of claim 61, wherein the microporous sheet has a thickness between about 2.5 μ

m and about 25 μ

m.

91. The method of claim 61, wherein the microporous sheet transmittance variability is less than 25 percent.

92. The method of claim 61, wherein the microporous sheet transmittance variability is less than 10 percent.

93. The method of claim 61, wherein the microporous sheet has an area between about 1 cm² and about 6 cm².

94. An analyte detection system for determining the concentration of analyte in a biological fluid sample drawn from a patient, the system comprising:

a near patient optical detection system comprising;

a source configured to emit electromagnetic radiation; and

a detector positioned in an optical path of the radiation;

a sample element configured for removable engagement with the optical detection system, the sample element comprising;

a sample cell configured to hold the biological fluid sample, the sample cell being located in the optical path upon engagement of the sample cell with the optical detection system, the sample cell being defined by at least one window which is highly transmissive of infrared radiation; and

a sample supply passage extending from and in fluid communication with the sample cell and including a pierceable portion; and

a sample extractor comprising a skin piercing member, the skin piercing member configured to create a passageway that connects a distal portion of the skin-piercing structure with the pierceable portion of the sample supply passage of the sample element;

wherein the detection system performs optical analysis on the material sample to assess the concentration of at least one constituent of the material sample.

95. The system of claim 94, further comprising a filter positioned in the sample supply passage, the filter configured to filter the material sample passing therethrough.

96. The system of claim 94, further comprising a microporous sheet situated in the optical path of the radiation, wherein the microporous sheet is positioned within the sample cell.

97. The system of claim 96, wherein the microporous sheet comprises a non-solid material having a network of voids through which the material sample can propagate.

98. A method comprising:

providing a microporous sheet disposed between first and second support members, such that at least a portion of the microporous sheet is left exposed;

contacting the exposed portion of the microporous sheet with a material sample such that at least a portion of the material sample is drawn into the microporous sheet;

transmitting electromagnetic radiation emitted from the material sample in the microporous sheet to a detector;

piercing a patient'"'"'s skin with a skin-piercing structure, the skin-piercing structure having a passageway that connects a distal portion of the skin-piercing structure with the exposed portion of the microporous sheet; and

analyzing the electromagnetic radiation emitted from the material sample in a spectral region of interest.

99. The method of claim 98, wherein the exposed portion of the microporous sheet comprises an entry region through which the material sample can enter the microporous sheet.

100. The method of claim 98, wherein the first and second planar support members comprise members having a structural rigidity greater than or equal to a structural rigidity of the microporous sheet.

101. The method of claim 98, wherein the microporous sheet comprises a non-solid material having a network of voids through which the material sample can propagate.

102. The method of claim 98, further comprising determining the baseline transmittance of the microporous sheet before contacting the material sample to the microporous sheet.

103. The method of claim 98, wherein the material sample is a biological fluid.

104. The method of claim 98, wherein the microporous sheet has four side surfaces, and the first and second support members are substantially coextensive with at least two of the side surfaces of the microporous sheet.

105. The method of claim 104, wherein the first and second support members are substantially coextensive with all four of the side surfaces of the microporous sheet.

106. The method of claim 98, wherein the exposed portion of the microporous sheet has a structured surface.

107. The method of claim 98, wherein the microporous sheet comprises a polymeric, non-woven material.

108. An analyte detection system for determining the concentration of analyte in a biological fluid sample drawn from a patient, the system comprising:

a source configured to emit electromagnetic radiation;

a detector positioned to receive at least a portion of the electromagnetic radiation emitted from the source;

a sample element configured to hold the biological fluid sample in a sample cell that is defined by a window, wherein the window is highly transmissive of infrared radiation, and a microporous sheet positioned in the sample cell wherein at least a portion of the sheet is an exposed transit opening configured to receive and distribute the biological fluid sample;

a sample supply passage extending from a skin-piercing structure to the exposed transit opening; and

a filter positioned in the sample supply passage to filter the biological sample;

wherein the detection system performs optical analysis on the biological sample to assess the concentration of at least one constituent of the biological sample.

109. The system of claim 108, wherein the microporous sheet comprises a non-solid material having a network of voids through which the material sample can propagate.

110. The system of claim 108, wherein the microporous sheet has a void volume of greater than about 20%.

111. The system of claim 108, wherein the microporous sheet has an average baseline transmittance of at least 1 percent.

112. The system of claim 108, wherein the sample element is configured to be removably positioned within an optical path extending from the source to the detector.

113. The system of claim 108, wherein the sample cell is reagentless.

114. The system of claim 108, wherein the skin-piercing structure forms a part of the sample element.

115. The system of claim 108, further comprising an optical filtering system that allows at least one wavelength between about 3.5 μ

m and about 14 μ

m to pass through the sample cell.