Device and method for in vitro determination of analyte concentrations within body fluids
View Patent ↗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.
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 μL 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 μL or less in total volume.
18. The method of claim 1 , wherein said sample of body fluid is 0.3 μL 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 μL 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 μL 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 μm and 2.5 μm.
49. The method of claim 47 , wherein said wavelengths are between 2.5 μm and 20 μm.
50. The method of claim 47 , wherein said wavelengths are between 20 μm and 100 μm.
51. The method of claim 47 , wherein said wavelengths are between 3.5 μm and 14 μm.
52. The method of claim 22 , wherein said sample of body fluid is 0.5 μL or less.
53. The method of claim 22 , wherein said sample of body fluid is 0.3 μL or less.
54. The method of claim 22 , wherein said sample of body fluid is 0.1 μL 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 μL in total volume.
57. The method of claim 22 , wherein said sample element is adapted to hold no more than 1 μL 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 μL 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 μL 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 μL of body fluid.
88. The method of claim 74 , wherein said chamber is configured to hold less than 0.3 μL of body fluid.