Devices for physiological fluid sampling and methods of using the same

• US 6,939,310 B2
• Filed: 10/10/2001
• Issued: 09/06/2005
• Est. Priority Date: 10/10/2001
• Status: Expired due to Term

• Current Assignee: Cilag Gmbh International (Johnson & Johnson)
• Original Assignee: Lifescan Incorporated (Duv Holding Corporation)
• Inventors: Matzinger, David, Quraishi, Khalid R.
• Primary Examiner(s): Nasser, Robert L.
• Assistant Examiner(s): MALLARI, PATRICIA C
• Application Number:
  US09/974,654
• Publication Number:
  US 20030069509A1
• Time in Patent Office: 1,427 Days
• Field of Search: 600300-301, 600/306, 600309-344, 600345-347, 600/363, 600/365, 600/366, 600/368, 600/419, 600/423, 600/437, 600/438, 600443-480, 600500-507, 600/583, 600/584, 600/573, 600/576
• US Class Current: 600/573
• 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 the suitability of a site for sampling physiological fluid for use in an analyte concentration determination test, said device comprising:

at least one physiological fluid flow rate characterization element for measuring the flow rate of physiological fluid at said site;

at least one skin-piercing element for accessing said physiological fluid at said site; and

means for determining whether said site is suitable for sampling physiological fluid for use in said analyte concentration determination test based on said measured flow rate of physiological fluid at said site.

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

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

4. The device according to claim 1, wherein said at least one physiological fluid flow rate characterization element comprises at least one light so 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 so 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 at least one physiological fluid sample type 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 fluid.

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

13. The device according to claim 7, wherein said at least one physiological fluid sample type characterization element comprises a hemoglobin characterization element.

14. The device according to claim 7, wherein said a least one physiological fluid sample type characterization element comprises a pulse characterization element.

22. The device according to claim 6, wherein said a least one physiological fluid sample type characterization element comprises an element capable of determining the hemoglobin character of said physiological fluid at said site.

62. 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. a device according to claim 1,

ii. a device according to claim 15, and

iii. a device according to claim 34, and

(b) instructions for using said device.

63. The kit according to claim 62, further comprising at least on skin-piercing element.

64. The kit according to claim 62, further comprising at least one fluid stimulating element.

65. The kit according to claim 62, further comprising at least on analyte concentration characterization reagent test strip.

66. The kit according to claim 62, further comprising at least one meter for automatically determining the concentration of an analyte in said physiological sample.

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

a plurality of devices selected from the group consisting of;

a plurality of devices according to claim 1,

ii. a plurality of devices according to claim 15, and

iii. a plurality of devices according to claim 34.

15. A device for determining the suitability of a site for sampling physiological fluid for use in an analyte concentration determination test, said device comprising:

at least one physiological fluid sample type characterization element for determining whether a site comprises arterial fluid, venous fluid or interstitial fluid;

at least one skin-piercing element for accessing said physiological fluid at said site; and

means for determining whether said site is suitable for sampling physiological fluid for use in said analyte concentration determination test, based on said determined fluid type.

16. The device according to claim 15, further comprising at least one physiological fluid flow rate characterization element.

17. The device according to claim 15, wherein said a least one physiological fluid 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 15, wherein said a least one physiological fluid sample type characterization element comprises an element capable of determining the pulse character of said site.

23. The device according to claim 15, wherein said a least one physiological fluid sample type characterization element comprises an element capable of determining the hemoglobin concentration of said physiological fluid at said site.

24. The device according to claim 15, wherein said a least one physiological fluid sample type characterization element comprises an element capable of determining the concentration of oxygenated hemoglobin and deoxygenated hemoglobin of said physiological fluid at said site.

25. The device according to claim 15, wherein said a least one physiological fluid sample type characterization element comprises an element capable of determining the concentration of total hemoglobin of said physiological fluid at said site.

26. The device according to claim 15, wherein said a least one physiological fluid sample type characterization element comprises an element capable of determining the oxygenated hemoglobin to deoxygenated hemoglobin ratio of said physiological fluid at said site.

27. The device according to claim 16, wherein said a least one physiological fluid flow rate characterization element comprises a hemoglobin characterization element.

28. The device according to claim 15, 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 15, further comprising a means for automatically determining the concentration of at least one analyte in said physiological fluid.

32. The device according to claim 15, further comprising at least one fluid enhancing element.

33. The device according to claim 16, wherein said a least one physiological fluid flow rate characterization element comprises a pulse characterization element.

34. A device for determining the suitability of a site or sampling physiological fluid for use in an analyte concentration determination test, said device comprising:

at least one physiological fluid flow rate characterization element for measuring the flow rate of physiological fluid at said site;

at least one physiological fluid sample type characterization element for determining whether said site comprises arterial fluid, or venous fluid or interstitial fluid; and

means for determining whether said site is suitable for sampling physiological fluid for use in said analyte concentration determination test, based on the measured flow rate of physiological fluid at said site and based on the determined fluid type at said site.

35. The device according to claim 34, further comprising a means for automatically determining the concentration of at least one analyte in said physiological sample.

36. The device according to claim 34, further comprising at least one skin-piercing element.

37. The device according to claim 34, wherein said a least one of said physiological fluid flow rate characterization element and said physiological fluid sample type characterization element comprises at least one light source and at least one detector.

38. The device according to claim 34, wherein said a least one physiological fluid flow rate characterization element comprises a temperature characterization element.

39. The device according to claim 34, wherein said a least one physiological fluid flow rate characterization element comprises a red blood cell characterization element.

40. The device according to claim 34, wherein said at least one physiological fluid sample type characterization element comprises a pulse characterization element.

41. The device according to claim 34, wherein said at least one physiological fluid sample type characterization element comprises a hemoglobin characterization element.

42. The device according to claim 34, further comprising at least one fluid enhancing element.

43. The device according to claim 34, 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. A method for determining the suitability of a site or sampling physiological fluid for use in an analyte concentration determination test, said method comprising the steps of:

measuring the flow rate of physiological fluid at a potentially suitable site; and

determining whether said potentially suitable site is suitable for sampling physiological fluid for use in said analyte concentration determination test, based on said measured flow rate.

47. The method according to claim 46, further comprising the step of determining the concentration of at least one analyte in said physiological sample.

48. The method according to claim 47, wherein said at least one analyte is glucose and said physiological sample is blood.

49. The method according to claim 47, wherein said at least one analyte is glucose and said physiological sample is interstitial fluid.

50. The method according to claim 46, wherein said step of measuring the flow rate of said physiological fluid at said potentially suitable site comprises characterizing the temperature of said physiological fluid at said potentially suitable site.

51. The method according to claim 46, wherein said step of measuring the flow rate of said physiological fluid at 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 potentially 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 46, wherein said step of measuring the flow rate of said physiological fluid at said potentially suitable site comprises employing Doppler flowmetry techniques.

55. The method according to claim 46, further comprising the step of determining the type of physiological fluid at said potentially suitable site.

56. The method according to claim 46, wherein said step of determining the type of physiological fluid at said potentially suitable site comprises characterizing the pulse of said site.

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

58. The method according to claim 46, further comprising the step of accessing said physiological fluid at said suitable sampling site.

59. The method according to claim 46, further comprising the step of stimulating the site to enhance the volume of fluid expressed from said site.

60. The method according to claim 47, wherein an automated meter performs said concentration determination automatically.

61. The method according to claim 47, wherein said concentration determination comprises transferring said physiological sample to an analyte concentration test strip.

67. A method for determining the suitability of a site for sampling physiological fluid for use in an analyte concentration determination test, said method comprising the step of:

(a) determining the type of physiological fluid at a potentially suitable site, wherein said determining comprises characterizing the pulse of said potentially suitable site; and

(b) determining whether said potentially suitable site is suitable for sampling physiological fluid for use in said analyte concentration determination test, based on determined type of physiological fluid.

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

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

70. The method according to claim 67, further comprising the step of determining the concentration of at least one analyte in said physiological sample.

71. The method according to claim 70, wherein said concentration determination comprises transferring said physiological sample to an analyte concentration test strip.

72. The method according to claim 70, wherein said at least one analyte is glucose and said physiological sample is blood.

73. The method according to claim 70, wherein said at least one analyte is glucose and said physiological sample is interstitial fluid.

74. The method according to claim 70, wherein an automated meter performs said concentration determination automatically.

75. The method according to claim 67, further comprising the step of stimulating the site to enhance the volume of fluid expressed from said site.

76. The method according to claim 67, further comprising the step of accessing said physiological fluid at said suitable sampling site.

77. A method for determining the suitability of a site for sampling physiological fluid for use in an analyte concentration determination test, said method comprising the steps of:

(a) determining the type of physiological fluid at a potentially suitable site, wherein said determining comprises characterizing the hemoglobin character of physiological fluid said potentially site; and

(b) determining whether said potentially suitable site is suitable for sampling physiological fluid for use in said analyte concentration determination test based on said determined type of physiological fluid.

78. The method according to claim 77, wherein the step of characterizing the hemoglobin character of said physiological fluid at said site comprises determining the hemoglobin concentration of said physiological fluid at said site.

79. The method according to claim 77, wherein the step of characterizing the hemoglobin character of said physiological fluid at said site comprises determining the concentration of the oxygenated hemoglobin and deoxygenated hemoglobin of said physiological fluid at said site.

80. The method according to claim 77, wherein the step of characterizing the hemoglobin character of said physiological fluid at said site comprises determining the oxygenated hemoglobin to deoxygenated hemoglobin ration of said physiological fluid at said site.

81. A method for determining the suitability of a site for sampling physiological fluid for use in an analyte concentration determination test, said method comprising the steps of:

(a) determining the type of physiological fluid at a potentially suitable site;

(b) measuring the flow rate of physiological fluid at said potentially suitable site; and

(c) determining whether said potentially suitable site is suitable for sampling physiological fluid for use in said analyte concentration determination test, based on said determined type and flow rate of physiological fluid.

82. The method according to claim 81, wherein said step of measuring the flow rate of said physiological fluid at said site comprises characterizing the temperature of said physiological fluid at said site.

83. The method according to claim 81, wherein said step of measuring the flow rate of said physiological fluid at said site comprises characterizing the red blood cell character of said site.

84. A method for determining the suitability of a site for sampling physiological fluid for use in an analyte concentration determination test, said method comprising the steps of:

measuring the flow rate of physiological fluid at a potentially suitable site;

determining the type of physiological fluid of said potentially suitable site; and

determining whether said potentially suitable site is suitable for sampling physiological fluid for use in said analyte concentration determination test, based on said measured flow rate of physiological fluid and based on said determined fluid type at said site.

85. The method according to claim 84, wherein said step of measuring the flow rate of said physiological fluid at 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 physiological suitable site the 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 84, wherein said step of measuring the flow rate of said physiological fluid at said potentially suitable site comprises employing Doppler flowmetry techniques.

89. The method according to claim 84,wherein said step of determining the type of physiological fluid at 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 84, wherein said step of determining the type of physiological fluid at said site comprises characterizing the hemoglobin character of said physiological fluid at said site.

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

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

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

96. The method according to claim 84, further comprising the step of accessing said physiological fluid at said suitable sampling site.

97. The method according to claim 84, further comprising the step of stimulating the site to enhance the volume of fluid expressed from said site.

98. The method according to claim 84, 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.

103. The method according to claim 84, wherein said step of measuring the flow rate of said physiological fluid at said potentially suitable site comprises characterizing the temperature of said physiological fluid at said potentially suitable site.