Devices for physiological fluid sampling and methods of using the same

• US 20030069509A1
• Filed: 10/10/2001
• Published: 04/10/2003
• Est. Priority Date: 10/10/2001
• Status: Active Grant

• Current Assignee: Cilag Gmbh International (Johnson & Johnson)
• Original Assignee: Lifescan Incorporated (Duv Holding Corporation)
• Inventors: Matzinger, David, Quraishi, Khalid R.
• Granted Patent: US 6,939,310 B2
• Time in Patent Office: Days
• US Class Current: 600/504
• CPC Class Codes: A61B 10/0045 Devices for taking samples of body liquids devices for taking blood samples A61B5/15
• CPC Class Codes: A61B 2010/008 Interstitial fluid
• CPC Class Codes: A61B 2017/00057 Light
• CPC Class Codes: A61B 5/0059 using light, e.g. diagnosis by transillumination, diascopy, fluorescence A61B5/0093, A61B5/1455, A61B5/02416 and A61B5/0261 take precedence
• CPC Class Codes: A61B 5/0261 using optical means, e.g. infrared light
• CPC Class Codes: A61B 5/14514 using means for aiding extraction of interstitial fluid, e.g. microneedles or suction
• 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 5/14551 for measuring blood gases
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/15003 for venous or arterial blood
• CPC Class Codes: A61B 5/150076 by heating
• CPC Class Codes: A61B 5/150083 by vibration, e.g. ultrasound
• CPC Class Codes: A61B 5/150305 Packages specially adapted for piercing devices or blood sampling devices kits for diabetes A61M5/003; packaging in general B65D
• 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 5/150503 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 5/150748 Having means for aiding positioning of the piercing device at a location where the body is to be pierced means for aiding positioning of devices for bringing media into the body A61M5/427, locating blood vessels A61B5/489
• CPC Class Codes: A61B 5/150954 Means for the detection of operative contact with patient, e.g. by temperature sensitive sensor
• CPC Class Codes: A61B 5/15107 : Piercing being assisted by a triggering mechanism
• CPC Class Codes: A61B 5/15109 : Fully automatically triggered, i.e. the triggering does not require a deliberate action by the user, e.g. by contact with the patient's skin
• CPC Class Codes: A61B 5/15113 : Manually triggered, i.e. the triggering requires a deliberate action by the user such as pressing a drive button
• CPC Class Codes: A61B 5/15117 : comprising biased elements, resilient elements or a spring, e.g. a helical spring, leaf spring, or elastic strap
• CPC Class Codes: A61B 5/1519 : comprising driving means, e.g. a spring, for propelling the piercing unit
• CPC Class Codes: A61B 5/157 : Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: A61B 5/441 : Skin evaluation, e.g. for skin disorder diagnosis
• CPC Class Codes: A61B 5/489 : Blood vessels
• CPC Class Codes: G01N 33/49 : Blood chemical methods for determining blood cell populations G01N33/5094; chemical analysis of blood groups or blood types G01N33/80
• CPC Class Codes: G01N 33/80 : involving blood groups or blood types or red blood cells white blood cells G01N33/56972

Abstract

Methods and devices are provided for determining a suitable site for sampling physiological fluid. In the subject methods, a potentially suitable physiological sampling site is selected, the fluid flow of the site is characterized and the site is then determined to be suitable based on the whether the site has high or low flow. Suitability may also be determined based on the type of sample obtainable from the site, where the order of the above-described steps may be altered. The subject devices include at least one site flow characterization element for determining the flow characteristics of a potential physiological sampling site and/or at least one sample type characterization element for determining whether the vasculature is arterial, venous or neither, i.e., an interstitial fluid sampling site. The subject methods and devices are particularly suited for use in the detection of physiological sampling sites in the fingers, arms, legs, earlobes, heels, feet, nose and toes. Also provided are kits that include the subject devices for use in practicing the subject methods.

Claims

1. A device for determining a suitable site for sampling physiological fluid, said device comprising:

(a) at least one flow characterization element for determining the flow of said site; and

(b) at least one skin-piercing element for accessing said physiological fluid at said site.

2. The device according to claim 1, wherein said at least one flow characterization element comprises an element capable of determining the temperature of said site.

3. The device according to claim 1, wherein said at least one flow characterization element comprises an element capable of determining red blood cell character of said site.

4. The device according to claim 1, wherein said at least one flow characterization element comprises at least one light source for irradiating tissue with light and at least one detector for detecting the light absorbed by said tissue.

5. The device according to claim 4, wherein at least one light source is capable of emitting light at a wavelength in the range from about 400 nm to 1200 nm.

6. The device according to claim 1, wherein said at least one flow characterization element comprises an element capable of performing Doppler flowmetry.

7. The device according to claim 1, further comprising a microprocessor for processing measurements obtained by said flow characterization element.

8. The device according to claim 1, further comprising an analyte concentration determination reagent test strip.

9. The device according to claim 8, wherein said test strip is an electrochemical test strip.

10. The device according to claim 8, wherein said test strip is a colorimetric test strip.

11. The device according to claim 1, further comprising a means for automatically determining the concentration of at least one analyte in said physiological sample.

12. The device according to claim 1, further comprising at least one fluid enhancing element.

13. The device according to claim 1, further comprising at least one sample type characterization element.

14. The device according to claim 13, wherein said at least one sample type characterization element comprises a pulse characterization element.

15. The device according to claim 13, wherein said at least one sample type characterization element comprises a hemoglobin characterization element.

103. A kit for determining a site for sampling physiological fluid, said kit comprising:

(a) at least one device selected from the group consisting of;

i. at least one device according to claim 1,

ii. at least one device according to claim 16, and

iii. at least one device according to claim 36;

and

(b) instructions for using said device.

104. The kit according to claim 103, further comprising at least one skin-piercing element.

105. The kit according to claim, 103, further comprising at least one fluid stimulating element.

106. The kit according to claim 103, further comprising at least one analyte concentration characterization reagent test strip.

107. The kit according to claim 103, further comprising at least one meter for automatically determining the concentration of an analyte in said physiological sample.

108. A kit for determining the analyte concentration of a physiological sample, said kit comprising:

a plurality of devices selected from the group consisting of;

i. a plurality of devices according to claim 1,

ii. a plurality of devices according to claim 16, and

iii. a plurality of devices according to claim 36.

16. A device for determining a suitable site for sampling physiological fluid, said device comprising:

(a) at least one sample type characterization element for determining the sample type of a particular site; and

(b) at least one skin-piercing element for accessing said physiological fluid at said site.

17. The device according to claim 16, wherein said at least one sample type characterization element comprises at least one light source for irradiating tissue with light and at least one detector for detecting the light absorbed by said tissue.

18. The device according to claim 17, wherein said at least one light source is capable of emitting light at a wavelength from about 400 nm to 1200 nm.

19. The device according to claim 17, wherein said at least one light source includes at least two light sources.

20. The device according to claim 19, wherein each of said at least two light sources is capable of emitting light at a wavelength from about 400 nm to 1200 nm.

21. The device according to claim 16, wherein said at least one sample type characterization element comprises an element capable of determining the pulse character of said site.

22. The device according to claim 16, wherein said at least one sample type characterization element comprises an element capable of determining the hemoglobin character of said site.

23. The device according to claim 16, wherein said at least one sample type characterization element comprises an element capable of determining the hemoglobin concentration of said site.

24. The device according to claim 16, wherein said at least one sample type characterization element comprises an element capable of determining the concentration of oxygenated hemoglobin and deoxygenated hemoglobin of said site.

25. The device according to claim 16, wherein said at least one sample type characterization element comprises an element capable of determining the concentration of total hemoglobin of said site.

26. The device according to claim 16, wherein said at least one sample type characterization element comprises an element capable of determining the oxygenated hemoglobin to deoxygenated hemoglobin ratio of said site.

27. The device according to claim 16, further comprising a microprocessor for processing measurements obtained by said vessel characterization element.

28. The device according to claim 16, further comprising an analyte concentration determination reagent test strip.

29. The device according to claim 28, wherein said test strip is an electrochemical test strip.

30. The device according to claim 28, wherein said test strip is a colorimetric test strip.

31. The device according to claim 16, further comprising a means for automatically determining the concentration of at least one analyte in said physiological sample.

32. The device according to claim 16, further comprising at least one fluid enhancing element.

33. The device according to claim 16, further comprising at least one flow characterization element.

34. The device according to claim 33, wherein said at least one flow characterization element comprises a pulse characterization element.

35. The device according to claim 33, wherein said at least one flow characterization element comprises a hemoglobin characterization element.

36. A device for determining a suitable site for sampling physiological fluid, said device comprising:

(a) at least one flow characterization element for determining the general concentration of vasculature of said site; and

(b) at least one sample type characterization element for determining whether said site comprises arterial or venous vasculature.

37. The device according to claim 36, wherein said at least one of said flow characterization element and said sample type characterization element comprises at least one light source and at least one detector.

38. The device according to claim 36, wherein said at least one flow characterization element comprises a temperature characterization element.

39. The device according to claim 36, wherein said at least one flow characterization element comprises a red blood cell characterization element.

40. The device according to claim 36, wherein said at least one sample type characterization element comprises a pulse characterization element.

41. The device according to claim 36, wherein said at least one sample type characterization element comprises a hemoglobin characterization element.

42. The device according to claim 36, further comprising a microprocessor for processing measurements obtained by said at least one flow characterization element and at least one sample type characterization element.

43. The device according to claim 36, further comprising an analyte concentration determination reagent test strip.

44. The device according to claim 43, wherein said test strip is an electrochemical test strip.

45. The device according to claim 43, wherein said test strip is a colorimetric test strip.

46. The device according to claim 36, further comprising a means for automatically determining the concentration of at least one analyte in said physiological sample.

47. The device according to claim 36, further comprising at least one skin-piercing element.

48. The device according to claim 36, further comprising at least one fluid enhancing element.

49. A method for determining a suitable site for sampling physiological fluid, said method comprising the steps of:

(a) characterizing the flow of said potentially suitable site; and

(c) determining whether said potentially suitable site is suitable based on said flow characterization.

50. The method according to claim 49, wherein said step of characterizing the flow of said potentially suitable site comprises characterizing the temperature of said potentially suitable site.

51. The method according to claim 49, wherein said step of characterizing the flow of said potentially suitable site comprises determining the red blood cell character of said potentially suitable site.

52. The method according to claim 51, wherein said step of determining the red blood cell character of said site comprises irradiating said physiologically suitable site with light and detecting the light absorbed by said physiologically suitable site.

53. The method according to claim 51, wherein said step of determining the red blood cell character of said site comprises characterizing the red blood cell flux of said site.

54. The method according to claim 49, wherein said step of characterizing the flow of said potentially suitable site comprises employing Doppler flowmetry techniques.

55. The method according to claim 49, further comprising the step of characterizing the sample type of said potentially suitable site.

56. The method according to claim 55, wherein said step of characterizing the sample type of said potentially suitable site comprises characterizing the pulse of said site.

57. The method according to claim 55, wherein said step of characterizing the sample type of said potentially suitable site comprises characterizing the hemoglobin of said site.

58. The method according to claim 49, further comprising the step of accessing said physiological fluid at said suitable sampling site.

59. The method according to claim 49, further comprising the step of stimulating the site to enhance the volume of fluid expressed from said site.

60. The method according to claim 49, further comprising the step of determining the concentration of at least one analyte in said physiological sample.

61. The method according to claim 60, wherein said concentration determination comprises transferring said physiological sample to an analyte concentration test strip.

62. The method according to claim 60, wherein said at least one analyte is glucose and said physiological sample is blood.

63. The method according to claim 60, wherein said at least one analyte is glucose and said physiological sample is interstitial fluid.

64. The method according to claim 60, wherein an automated meter performs said concentration determination automatically.

65. A method for determining a suitable site for sampling physiological fluid, said method comprising the steps of:

(a) characterizing the sample type of said potentially suitable site; and

(c) determining whether said potentially suitable site is suitable based on said flow characterization.

66. The method according to claim 65, wherein said step of characterizing the sample type of said site comprises characterizing the pulse of said site.

67. The method according to claim 66, wherein the step of characterizing the pulse of said site comprises characterizing the red blood cell character of said site.

68. The method according to claim 66, wherein the step of characterizing the red blood cell character of said site comprises characterizing the red blood cell flux of said site.

69. The method according to claim 65, wherein said step of characterizing the sample type of said site comprises characterizing the hemoglobin character of said site.

70. The method according to claim 69, wherein the step of characterizing the hemoglobin character of said site comprises determining the hemoglobin concentration of a site.

71. The method according to claim 69, wherein the step of characterizing the hemoglobin character of said site comprises determining the concentration of the oxygenated hemoglobin and deoxygenated hemoglobin of said site.

72. The method according to claim 69, wherein the step of characterizing the hemoglobin character of said site comprises determining the oxygenated hemoglobin to deoxygenated hemoglobin ratio of said site.

73. The method according to claim 65, further comprising the step of characterizing the flow of said potentially suitable.

74. The method according to claim 73, wherein said step of characterizing the flow of said site comprises characterizing the temperature of said site.

75. The method according to claim 73, wherein said step of characterizing the flow of said site comprises characterizing the red blood cell character of said site.

76. The method according to claim 65, further comprising the step of accessing said physiological fluid at said suitable sampling site.

77. The method according to claim 65, further comprising the step of stimulating the site to enhance the volume of fluid expressed from said site.

78. The method according to claim 65, further comprising the step of determining the concentration of at least one analyte in said physiological sample.

79. The method according to claim 78, wherein said concentration determination comprises transferring said physiological sample to an analyte concentration test strip.

80. The method according to claim 78, wherein said at least one analyte is glucose and said physiological sample is blood.

81. The method according to claim 78, wherein said at least one analyte is glucose and said physiological sample is interstitial fluid.

82. The method according to claim 78, wherein an automated meter performs said concentration determination automatically.

83. A method for determining a suitable site for sampling physiological fluid, said method comprising the steps of:

(a) characterizing the flow of said potentially suitable site; and

(b) characterizing the sample type of said site.

84. The method according to claim 83, wherein said step of characterizing the flow of said potentially suitable site comprises characterizing the temperature of said potentially suitable site.

85. The method according to claim 83, wherein said step of characterizing the flow of said potentially suitable site comprises determining the red blood cell character of said potentially suitable site.

86. The method according to claim 85, wherein said step of determining the red blood cell character of said site comprises irradiating said physiologically suitable site with light and detecting the light absorbed by said physiologically suitable site.

87. The method according to claim 85, wherein said step of determining the red blood cell character of said site comprises characterizing the red blood cell flux of said site.

88. The method according to claim 83, wherein said step of characterizing the flow of said potentially suitable site comprises employing Doppler flowmetry techniques.

89. The method according to claim 83, wherein said step of characterizing the sample type of said site comprises characterizing the pulse of said site.

90. The method according to claim 89, wherein the step of characterizing the pulse of said site comprises characterizing the red blood cell character of said site.

91. The method according to claim 90, wherein the step of characterizing the red blood cell character of said site comprises characterizing the red blood cell flux of said site.

92. The method according to claim 83, wherein said step of characterizing the sample type of said site comprises characterizing the hemoglobin character of said site.

93. The method according to claim 92, wherein the step of characterizing the hemoglobin character of said site comprises determining the hemoglobin concentration of a site.

94. The method according to claim 92, wherein the step of characterizing the hemoglobin character of said site comprises determining the concentration of the oxygenated hemoglobin and deoxygenated hemoglobin of said site.

95. The method according to claim 92, wherein the step of characterizing the hemoglobin character of said site comprises determining the oxygenated hemoglobin to deoxygenated hemoglobin ratio of said site.

96. The method according to claim 83, further comprising the step of accessing said physiological fluid at said suitable sampling site.

97. The method according to claim 83, further comprising the step of stimulating the site to enhance the volume of fluid expressed from said site.

98. The method according to claim 83, further comprising the step of determining the concentration of at least one analyte in said physiological sample.

99. The method according to claim 98, wherein said concentration determination comprises transferring said physiological sample to an analyte concentration test strip.

100. The method according to claim 98, wherein said at least one analyte is glucose and said physiological sample is blood.

101. The method according to claim 98, wherein said at least one analyte is glucose and said physiological sample is interstitial fluid.

102. The method according to claim 98, wherein an automated meter performs said concentration determination automatically.