Apparatuses and methods for extravasation detection

• US 6,408,204 B1
• Filed: 07/28/1999
• Issued: 06/18/2002
• Est. Priority Date: 07/28/1999
• Status: Active Grant

• Current Assignee: Bayer Healthcare LLC (Bayer AG)
• Original Assignee: Medrad Incorporated (Bayer AG)
• Inventors: Hirschman, Alan D.
• Primary Examiner(s): HINDENBURG, MAX F
• Application Number:
  US09/362,384
• Time in Patent Office: 1,056 Days
• Field of Search: 600/382, 600/384, 600/393, 600/547, 604/116
• US Class Current: 600/547
• CPC Class Codes: A61B 5/0537 Measuring body composition by impedance, e.g. tissue hydration or fat content
• CPC Class Codes: A61B 5/4869 Determining body composition
• CPC Class Codes: A61M 5/16836 by sensing tissue properties at the infusion site, e.g. for detecting infiltration detecting tissue temperature for diagnostic purposes A61M39/0247

Abstract

An apparatus for the detection of extravasation is positioned in a manner so that the vicinity of a site is available for palpation and is visible for visual inspection. Another embodiment of the apparatus improves the sensitivity of detection by positioning an energy source and a receiver between a first layer of a high dielectric material and a second lay of a low dielectric material. The apparatus may further include a third layer of a conductive material to shield the apparatus from stray capacitance. In addition, a system for detection of extravasation includes an array of sensors located at, adjacent to and/or remote from an injection site.

Claims

1. An apparatus for the detection of extravasation, the apparatus comprising:

at least a first energy source to supply energy to tissue in the vicinity of an injection site; and

at least a first receiver to measure a signal resulting from the energy supplied to the tissue by the first energy source, the first energy source and the first receiver being arranged to define an open area around the injection site, the open area adapted to allow for palpation or visual inspection of the vicinity of the injection site.

2. The apparatus of claim 1 wherein the first energy source and the first receiver physically contact the skin of a patient.

3. The apparatus of claim 1 wherein the first energy source and the first receiver are disposed on a base.

4. The apparatus of claim 1 wherein the at least a first energy source and the at least a first receiver comprise a transceiver.

5. The apparatus of claim 1 wherein the signal represents a change in the bulk electrical properties of the tissue.

6. The apparatus of claim 1 wherein the first energy source and the first receiver are in ohmic contact with the skin of a patient.

7. The apparatus of claim 3 wherein the base comprises two opposing portions joined together by a bridge region.

8. The apparatus of claim 7 wherein the open area is defined by the bridge region and the two opposing portions.

9. The apparatus of claim 1 wherein each of the at least a first energy source and the at least a first receiver is disposed on a base portion.

10. The apparatus of claim 9 wherein the base portions are positioned on opposing sides of the injection site.

11. The apparatus of claim 9 wherein the open area is defined by the base portions.

12. The apparatus of claim 7 wherein each opposing portion is substantially rectangular.

13. The apparatus of claim 7 wherein the bridge region is substantially rectangular.

14. The apparatus of claim 9 wherein the base portions are substantially rectangular.

15. The apparatus of claim 1 wherein the at least a first energy source comprises at least one electrode.

16. The apparatus of claim 15 wherein the at least one electrode comprises two electrodes.

17. The apparatus of claim 1 wherein the at least a first receiver comprises at least one electrode.

18. The apparatus of claim 17 wherein the at least one electrode comprises two electrodes.

27. The apparatus of claim 7 wherein each of the two opposing portions comprises an end, and the bridge is connected to the ends of the two opposing portions of the base.

28. The apparatus of claim 7 wherein the two opposing portions of the base are substantially parallel to each other.

29. The apparatus of claim 7 wherein the bridge is substantially perpendicular to the opposing portions of the base.

19. A method of detecting extravasation, the method comprising:

arranging a first energy source and a first receiver to define an open area around an injection site, the open area adapted to allow for palpation or visual inspection of the injection site;

applying energy to tissue in the vicinity of the site via the first energy source; and

measuring a signal resulting from the energy supplied to the tissue by the first energy source with the first receiver.

20. The method of claim 19, further comprising the step of palpating the vicinity of the injection site.

21. The method of claim 19, further comprising visually inspecting the vicinity of the injection site.

22. The method of claim 19, further comprising sensing swelling of tissue in the vicinity of the injection site.

23. The method of claim 19 wherein the step of arranging a first energy source and a first receiver comprises placing the first energy source and the first receiver in contact with the skin of the patient.

24. The method of claim 23 wherein the first energy source and the first receiver are placed in physical contact with the skin of a patient.

25. The method of claim 19 wherein the signal represents a change in the bulk electrical properties of the tissue.

26. The method of claim 19 wherein the first energy source and the first receiver are in ohmic contact with the patient.

111. The method of claim 20, further comprising determining whether extravasation has occurred.

112. The method of claim 111, further comprising terminating an injection procedure if extravasation has occurred.

30. An apparatus for the detection of extravasation, comprising:

at least a first energy source to supply energy to tissue in the vicinity of an injection site; and

at least a first receiver to measure a signal resulting from the energy supplied to the tissue by the first energy source,

the at least a first energy source and the at least a first receiver being disposed on at least one base arranged to define an open area around the injection site, the open area adapted to allow for palpation or visual inspection of the injection site.

31. The apparatus of claim 30 wherein the at least one base is in contact with the skin of a patient.

32. The apparatus of claim 31 wherein the at least one base is in physical contact with the skin of the patient.

33. The apparatus of claim 30 wherein the at least one base comprises two opposing portions joined together by a bridge region.

34. The apparatus of claim 30 wherein the signal represents a change in the bulk electrical properties of the tissue.

35. The apparatus of claim 30 wherein the at least one base is substantially rectangular.

36. The apparatus of claim 30 wherein the at least one base comprises two base portions.

37. The apparatus of claim 36 wherein the at least a first energy source is disposed on one of the two base portions.

38. The apparatus of claim 36 wherein the at least a first receiver is disposed on one of the two base portions.

39. The apparatus of claim 36 wherein each of the base portions is substantially rectangular.

40. The apparatus of claim 36 wherein each of the at least a first energy source and the at least a first receiver is disposed on a respective one of the two base portions.

41. The apparatus of claim 36, further comprising a bridge disposed between the two base portions.

42. The apparatus of claim 30 wherein the at least a first energy source and the at least a first receiver comprise a transceiver.

43. The apparatus of claim 30 wherein the at least a first energy source comprises at least one electrode.

44. The apparatus of claim 43 wherein the at least one electrode comprises two electrodes.

45. The apparatus of claim 30 wherein the at least a first receiver comprises at least one electrode.

46. The apparatus of claim 45 wherein the at least one electrode comprises two electrodes.

47. A method of detecting extravasation using at least a first energy source and at least a first receiver, the method comprising:

applying energy to tissue in the vicinity of an injection site via the at least a first energy source;

measuring a signal resulting from the energy supplied to the tissue by the at least a first energy source with the at least a first receiver; and

palpating or visually inspecting an open area around the injection site defined by the at least a first energy source and the at least a first receiver.

48. The method of claim 47, further comprising sensing swelling of tissue in the vicinity of the injection site.

49. The method of claim 47 wherein the at least a first energy source and the at least a first receiver are disposed on a base.

109. The method of claim 47, further comprising determining whether extravasation has occurred.

110. The method of claim 109, further comprising terminating an injection procedure if extravasation has occurred.

50. An apparatus for the detection of extravasation, comprising:

at least a first energy source to supply energy to tissue in the vicinity of an injection site; and

at least a first receiver to measure a signal resulting from the energy supplied to the tissue by the at least a first energy source,

the first energy source and the first receiver being disposed on at least one base in contact with the skin of a patient, the at least one base arranged to define an open area around the injection site adapted to allow for palpation or visual inspection of the injection site.

51. The apparatus of claim 50 wherein the at least one base comprises two base portions.

52. The apparatus of claim 51 wherein the at least a first energy source is disposed on one of the two base portions.

53. The apparatus of claim 52 wherein the at least a first receiver is disposed on the other of the two base portions.

54. The apparatus of claim 50 wherein the at least one base comprises two opposing portions joined together by a bridge region.

55. The apparatus of claim 51 wherein each of the base portions is substantially rectangular.

56. The apparatus of claim 54 wherein each of the two opposing portions is substantially rectangular.

57. The apparatus of claim 54 wherein the bridge region is substantially rectangular.

58. The apparatus of claim 51, further comprising a bridge region adapted to connect the two base portions.

59. The apparatus of claim 58 wherein the bridge region is substantially rectangular.

60. The apparatus of claim 54 wherein the open area is substantially rectangular.

61. The apparatus of claim 58 wherein each of the two bases comprises an end, and the bridge region is connected to the ends of the bases.

62. The apparatus of claim 58 wherein the bridge region is substantially perpendicular to the bases.

63. The apparatus of claim 51 wherein the base portions are substantially parallel to each other.

64. The apparatus of claim 50 wherein the at least a first energy source and the at least a first receiver comprise a transceiver.

65. The apparatus of claim 50 wherein the at least a first energy source comprises at least one electrode.

66. The apparatus of claim 65 wherein the at least one electrode comprises two electrodes.

67. The apparatus of claim 50 wherein the at least a first receiver comprises at least one electrode.

68. The apparatus of claim 67 wherein the at least one electrode comprises two electrodes.

69. The apparatus of claim 50 wherein the signal represents a change in the bulk electrical properties of the tissue.

70. The apparatus of claim 50 wherein the open area is substantially rectangular.

71. An apparatus for the detection of extravasation, comprising:

a base comprising two opposing portions joined together by a bridge region, the opposing portions and the bridge portion arranged to define an open area around the injection site;

at least a first energy source to supply energy to tissue in the vicinity of an injection site, the at least a first energy source disposed on at least one of the two opposing portions; and

at least a first receiver to measure a signal resulting from the energy supplied to the tissue by the first energy source, the at least a first receiver disposed on at least one of the two opposing portions;

wherein the open area is adapted to allow for palpation or visual inspection of the injection site.

72. The apparatus of claim 71 wherein each of the opposing portions comprises an end, and the bridge region is disposed between the ends of the opposing portions.

73. The apparatus of claim 71 wherein the bridge region is substantially perpendicular to the opposing portions.

74. The apparatus of claim 71 wherein each of the opposing portions is substantially perpendicular to the bridge region.

75. The apparatus of claim 71 wherein at least one of the two opposing portions is substantially perpendicular to the bridge region.

76. The apparatus of claim 71 wherein the two opposing portions are substantially parallel to each other.

77. The apparatus of claim 71 wherein the opposing portions are positioned on opposing sides of the injection site.

78. The apparatus of claim 71 wherein each of the opposing portions is substantially rectangular.

79. The apparatus of claim 71 wherein the bridge region is substantially rectangular.

80. The apparatus of claim 71 wherein at least one of the opposing portions is substantially rectangular.

81. The apparatus of claim 71 wherein the at least a first energy source comprises at least one electrode.

82. The apparatus of claim 81 wherein the at least one electrode comprises two electrodes.

83. The apparatus of claim 71 wherein the at least a first receiver comprises at least one electrode.

84. The apparatus of claim 83 wherein the at least one electrode comprises two electrodes.

85. The apparatus of claim 71 wherein the base contacts the skin of a patient.

86. The apparatus of claim 85 wherein the base physically contacts the skin of the patient.

87. The apparatus of claim 71 wherein the at least a first energy source and the at least a first receiver comprise a transceiver.

88. An apparatus for the detection of extravasation, comprising:

at least a first energy source to supply energy to tissue in the vicinity of an injection site, the at least a first energy source disposed on a first portion of a base; and

at least a first receiver to measure a signal resulting from the energy supplied to the tissue by the first energy source, the at least a first receiver disposed on a second portion of the base;

the first and second portions of the base arranged to define an open area around the injection site, the open area adapted to allow for palpation or visual inspection of the injection site.

89. The apparatus of claim 88, further comprising a bridge region disposed between the first and second portions of the base.

90. The apparatus of claim 89 wherein each of the first and second portions comprises an end, and the bridge region is disposed between the ends of the first and second portions.

91. The apparatus of claim 88 wherein the first and second portions of the base are substantially rectangular.

92. The apparatus of claim 88 wherein at least one of the first and second portions of the base is substantially rectangular.

93. The apparatus of claim 89 wherein the bridge region is substantially rectangular.

94. The apparatus of claim 88 wherein the first and second portions of the base are substantially parallel to each other.

95. The apparatus of claim 88 wherein the first and second portions of the base are disposed on opposite sides of the injection site.

96. The apparatus of claim 89 wherein the first portion, the second portion and the bridge region cooperate to define the open area around the injection site.

97. The apparatus of claim 89 wherein the bridge region is substantially perpendicular to the first and second portions.

98. The apparatus of claim 89 wherein the first and second portions are substantially perpendicular to the bridge region.

99. The apparatus of claim 89 wherein the first and second portions are substantially parallel to each other.

100. The apparatus of claim 89 wherein the base is substantially U-shaped.

101. The apparatus of claim 88 wherein the open area is substantially rectangular.

102. The apparatus of claim 88 wherein the at least a first energy source and the at least a first receiver comprise a transceiver.

103. The apparatus of claim 88 wherein the at least a first energy source comprises at least one electrode.

104. The apparatus of claim 103 wherein the at least one electrode comprises two electrodes.

105. The apparatus of claim 88 wherein the at least a first receiver comprises at least one electrode.

106. The apparatus of claim 105 wherein the at least one electrode comprises two electrodes.

107. The apparatus of claim 88 wherein the first and second portions of the base are in contact with the skin of a patient.

108. The apparatus of claim 88 wherein the signal represents a change in the bulk electrical properties of the tissue.