Methods and systems for treating fatty tissue sites using electroporation

• US 20060293725A1
• Filed: 06/24/2005
• Published: 12/28/2006
• Est. Priority Date: 06/24/2005
• Status: Abandoned Application

• Current Assignee: AngioDynamics, Inc.
• Original Assignee: AngioDynamics, Inc.
• Inventors: Mikus, Paul, Rubinsky, Boris, Onik, Gary
• Application Number:
  US11/165,908
• Publication Number:
  US 20060293725A1
• Time in Patent Office: Days
• US Class Current: 607/72
• CPC Class Codes: A61B 2018/00613 Irreversible electroporation
• CPC Class Codes: A61N 1/0412 Specially adapted for transcutaneous electroporation, e.g. including drug reservoirs
• CPC Class Codes: A61N 1/0476 Array electrodes (including any electrode arrangement with more than one electrode for at least one of the polarities)
• CPC Class Codes: A61N 1/327 for enhancing the absorption properties of tissue, e.g. by electroporation

Abstract

A system is provided for treating fatty tissue sites of a patient. At least first and second mono-polar electrodes are configured to be introduced at or near the fatty tissue site of the patient. A voltage pulse generator is coupled to the first and second mono-polar electrodes. The voltage pulse generator is configured to apply sufficient electrical pulses between the first and second mono-polar electrodes to induce electroporation of cells in the fatty tissue site, to create necrosis of cells of the fatty tissue site, but insufficient to create a thermal damaging effect to a majority of the fatty tissue site. The system can be incorporated into standard liposuction devices or used simultaneously to treat and remove the tissue.

Claims

1. A system for reduction of fat of a patient, comprising:

at least first and second mono-polar electrodes configured to be introduced at or near a fatty tissue site of the patient;

a voltage pulse generator coupled to the first and second mono-polar electrodes and configured to applying electrical pulses between the first and second mono-polar electrodes in an amount to induce electroporation of cells in the fatty tissue site to create cell necrosis of fat cells without creating a thermal effect to a majority of the fatty tissue site.

2. The system of claim 1, further comprising:

a monitoring electrode configured to measure a test voltage delivered to cells in the fatty tissue site.

3. The system of claim 1, wherein the test voltage is insufficient to create irreversible electroporation.

4. The system of claim 1, further comprising:

at least a third mono-polar electrode, the at least first, second and third mono-polar electrodes forming an array of mono-polar electrodes.

5. The system of claim 4, wherein the array is configured to be positioned in a surrounding relationship relative to the fatty tissue site.

6. The system of claim 1, further comprising:

a liposuction probe coupled to a vacuum source.

7. The system of claim 1, further comprising:

a tumescent probe configured to introduce a tumescent agent into the fatty tissue.

8. The system of claim 1, wherein the electroporation is performed in a controlled manner with real time monitoring.

9. The system of claim 1, wherein the electroporation is performed in a controlled manner to provide for controlled pore formation in cell membranes.

10. The system of claim 1, wherein the electroporation is performed in a controlled manner to create a tissue effect in the cells at the fatty tissue site while preserving surrounding tissue.

11. The system of claim 1, wherein the electroporation is performed in a controlled manner with monitoring of electrical impedance;

12. The system of claim 1, further comprising:

detecting an onset of electroporation of cells at the fatty tissue site.

13. The system of claim 1, wherein the electroporation is performed in a controlled manner with controlled intensity and duration of voltage.

14. The system of claim 1, wherein the electroporation is performed in a controlled manner with real time control.

15. The system of claim 1, wherein the electroporation is performed in a manner to for modification and control of mass transfer across cell membranes.

16. The system of claim 1, wherein the electroporation is performed in a controlled manner with a proper selection of voltage magnitude.

17. The system of claim 1, wherein the electroporation is performed in a controlled manner with a proper selection of voltage application time.

18. The system of claim 1, wherein the voltage pulse generator is configured to provide that each pulse is applied for a duration of about 5 microseconds to about 62 seconds.

19. The system of claim 1, wherein the voltage pulse generator is configured to provide that each pulse is applied for a duration of about 90 to 110 microseconds.

20. The system of claim 1, wherein the voltage pulse generator is configured to provide that each pulse is applied for a duration of about about 100 microseconds.

21. The system of claim 19, wherein the voltage pulse generator is configured to apply from about 1 to 15 pulses.

22. The system of claim 19, wherein the voltage pulse generator is configured to apply about eight pulses of about 100 microseconds each in duration.

23. The system of claim 1, wherein the voltage pulse generator is configured to provide for pulse application to produce a voltage gradient at the fatty tissue site in a range of from about 50 volt/cm to about 8000 volt/cm.

24. The system of claim 1, wherein a temperature of the fatty tissue site is monitored and the pulses are adjusted to maintain a temperature of 100 degrees C. or less at the fatty tissue site.

25. The system of claim 1, wherein a temperature of the fatty tissue site is monitored and the pulses are adjusted to maintain a temperature of 75 degrees C. or less at the fatty tissue site.

26. The system of claim 1, wherein a temperature of the fatty tissue site is monitored and the pulses are adjusted to maintain a temperature of 60 degrees C. or less at the fatty tissue site.

27. The system of claim 26, wherein the temperature is maintained at 50 degrees C. or less.

28. The system of claim 1, wherein a current-to-voltage ratio is adjusted based on temperature to maintain the fatty tissue site temperature at 100 degrees C. or less.

29. The system of claim 1, wherein a current-to-voltage ratio is adjusted based on temperature to maintain the fatty tissue site temperature at 75 degrees C. or less.

30. The system of claim 1, wherein a current-to-voltage ratio is adjusted based on temperature to maintain the fatty tissue site temperature at 60 degrees C. or less.

31. The system of claim 1, wherein a current-to-voltage ratio is adjusted based on temperature to maintain the fatty tissue site temperature at 50 degrees C. or less.

32. The system of claim 1, wherein the first electrode is placed at about 5 mm to 10 cm from the second electrode.

33. The system of claim 1, wherein the first and second mono-polar electrodes are circular in shape.

34. The system of claim 1, wherein the voltage pulse generator is configured to provide for pulse application of sufficient duration and magnitude to permanently disrupt cell membranes of cells at the fatty tissue site.

35. The system of claim 1, wherein a ratio of electric current through cells at the fatty tissue site to voltage across the cells is detected and a magnitude of applied voltage to the fatty tissue site is adjusted in accordance with changes in the ratio of current to voltage.

36. A system for reduction of fat of a patient, comprising:

a bi-polar electrode configured to be introduced at or near a fatty tissue site of the patient;

a voltage pulse generator coupled to the first and second electrodes and configured to applying electrical pulses to the bi-polar electrode to induce electroporation of cells in the fatty tissue site to create cell necrosis of fat cells without creating a thermal effect to a majority of the fatty tissue site.

37. The system of claim 36, further comprising:

a monitoring electrode configured to measure a test voltage delivered to cells in the fatty tissue site.

38. The system of claim 36, wherein the test voltage is insufficient to create irreversible electroporation.

39. The system of claim 36, further comprising:

at least a second and a third bipolar electrodes, the at least first, second and third bipolar electrodes forming an array of electrodes.

40. The system of claim 39, wherein the array is configured to be positioned in a surrounding relationship relative to the fatty tissue site.

41. The system of claim 36, further comprising:

a liposuction probe coupled to a vacuum source.

42. The system of claim 36, further comprising:

a tumescent probe configured to introduce a tumescent agent into the tatty tissue. tissue.

43. The system of claim 36, wherein the electroporation is performed in a controlled manner with real time monitoring.

44. The system of claim 36, wherein the electroporation is performed in a controlled manner to provide for controlled pore formation in cell membranes.

45. The system of claim 36, wherein the electroporation is performed in a controlled manner to create a tissue effect in the cells at the fatty tissue site while preserving surrounding tissue.

46. The system of claim 36, wherein the electroporation is performed in a controlled manner with monitoring of electrical impedance;

47. The system of claim 36, further comprising:

detecting an onset of electroporation of cells at the fatty tissue site.

48. The system of claim 36, wherein the electroporation is performed in a controlled manner with controlled intensity and duration of voltage.

49. The system of claim 36, wherein the electroporation is performed in a controlled manner with real time control.

50. The system of claim 36, wherein the electroporation is performed in a manner to for modification and control of mass transfer across cell membranes.

51. The system of claim 36, wherein the electroporation is performed in a controlled manner with a proper selection of voltage magnitude.

52. The system of claim 36, wherein the electroporation is performed in a controlled manner with a proper selection of voltage application time.

53. The system of claim 36, wherein the voltage pulse generator is configured-to provide that each pulse is applied for a duration of about 5 microseconds to about 62 seconds.

54. The system of claim 36, wherein the voltage pulse generator is configured to provide that each pulse is applied for a duration of about 90 to 110 microseconds.

55. The system of claim 36, wherein the voltage pulse generator is configured to provide that each pulse is applied for a duration of about 100 microseconds.

56. The system of claim 54, wherein the voltage pulse generator is configured to apply from about 1 to 15 pulses.

57. The system of claim 54, wherein the voltage pulse generator is configured to apply about eight pulses of about 100 microseconds each in duration.

58. The system of claim 36, wherein the voltage pulse generator is configured to provide for pulse application to produce a voltage gradient at the fatty tissue site in a range of from about 50 volt/cm to about 8000 volt/cm.

59. The system of claim 36, wherein a temperature of the fatty tissue site is monitored and the pulses are adjusted to maintain a temperature of 100 degrees C. or less at the fatty tissue site.

60. The system of claim 36, wherein a temperature of the fatty tissue site is monitored and the pulses are adjusted to maintain a temperature of 75 degrees C. or less at the fatty tissue site.

61. The system of claim 36, wherein a temperature of the fatty tissue site is monitored and the pulses are adjusted to maintain a temperature of 60 degrees C. or less at the fatty tissue site.

62. The system of claim 59, wherein the temperature is maintained at 50 degrees C. or less.

63. The system of claim 36, wherein a current-to-voltage ratio is adjusted based on temperature to maintain the fatty tissue site temperature at 100 degrees C. or less.

64. The system of claim 36, wherein a current-to-voltage ratio is adjusted based on temperature to maintain the fatty tissue site temperature at 75 degrees C. or less.

65. The system of claim 36, wherein a current-to-voltage ratio is adjusted based on temperature to maintain the fatty tissue site temperature at 60 degrees C. or less.

66. The system of claim 36, wherein a current-to-voltage ratio is adjusted based on temperature to maintain the fatty tissue site temperature at 50 degrees C. or less.

67. The system of claim 36, wherein the voltage pulse generator is configured to provide for pulse application of sufficient duration and magnitude to permanently disrupt cell membranes of cells at the fatty tissue site.

68. The system of claim 36, wherein a ratio of electric current through cells at the fatty tissue site to voltage across the cells is detected and a magnitude of applied voltage to the fatty tissue site is adjusted in accordance with changes in the ratio of current to voltage.

69. A method for reduction of fat of a patient, comprising:

introducing at least first and second electrodes to a fatty tissue site of the patient;

positioning the at least first and second electrodes at or near the fatty tissue site;

applying an electric field in a controlled manner to the fatty tissue site in an amount sufficient to produce electroporation of cells at the fatty tissue site and below an amount that causes thermal damage to a majority of the fatty tissue site.

70. The method of claim 69, further comprising:

using a monitoring electrode to measure a test voltage delivered to cells in the fatty tissue site.

71. The method of claim 70, wherein the test voltage is insufficient to create irreversible electroporation.

72. The method of claim 69, further comprising:

introducing at least a third mono-polar electrode to the fatty tissue site, the first, second and third mono-polar electrodes forming an array of electrodes.

73. The system of claim 100.3, wherein the array is positioned in a surrounding relationship relative to the fattty tissue site.

74. The method of claim 69, further comprising:

removing the electroporation of cells from the patient with a liposuction probe during the electroporation.

75. The method of claim 69, further comprising:

removing the electroporation of cells from the patient with a liposuction probe after the electroporation.

76. The method of claim 69, further comprising:

introducing a tumescent agent into the fatty tissue. tissue.

77. The method of claim 69, further comprising:

performing the electroporation in a controlled manner with real time monitoring.

78. The method of claim 69, further comprising:

performing the electroporation in a controlled manner to provide for controlled pore formation in cell membranes.

79. The method of claim 69, further comprising:

performing the electroporation in a controlled manner to create a tissue effect of cells at the fatty tissue site while preserving surrounding tissue.

80. The method of claim 69, further comprising:

performing the electroporation in a controlled manner with monitoring of electrical impedance;

81. The method of claim 69, further comprising:

detecting an onset of electroporation of cells at the fatty tissue site.

82. The method of claim 69, further comprising:

performing the electroporation in a controlled manner with controlled intensity and duration of voltage.

83. The method of claim 69, further comprising:

performing the electroporation in a controlled manner with real time control.

84. The method of claim 69, further comprising:

performing the electroporation in a manner for modification and control of mass transfer across cell membranes.

85. The method of claim 69, further comprising:

performing the electroporation in a controlled manner with a proper selection of voltage magnitude.

86. The method of claim 69, wherein the electroporation is performed in a controlled manner with a proper selection of voltage application time.

87. The method of claim 69, wherein the duration of each pulse is about 5 microseconds to about 62 seconds.

88. The method of claim 69, wherein the duration of each pulse is about 90 to 110 microseconds.

89. The method of claim 69, wherein pulses are applied for a period of about 100 microseconds.

90. The method of claim 88, wherein about 1 to 15 pulses are applied.

91. The method of claim 88, wherein about eight pulses of about 100 microseconds each in duration are applied.

92. The method of claim 69, wherein pulses are applied to produce a voltage gradient at the fatty tissue site in a range of from about 50 volt/cm to about 8000 volt/cm.

93. The method of claim 69, further comprising:

monitoring a temperature of the fatty tissue site; and

adjusting the pulses to maintain a temperature of 100 degrees C. or less at the fatty tissue site.

94. The method of claim 69, further comprising:

monitoring a temperature of the fatty tissue site; and

adjusting the pulses to maintain a temperature of 75 degrees C. or less at the fatty tissue site.

95. The method of claim 69, further comprising:

monitoring a temperature of the fatty tissue site; and

adjusting the pulses to maintain a temperature of 60 degrees C. or less at the fatty tissue site.

96. The method of claim 69, further comprising:

monitoring a temperature of the fatty tissue site; and

adjusting the pulses to maintain a temperature of 50 degrees C. or less at the fatty tissue site.

97. The method of claim 69, further comprising:

adjusting a current-to-voltage ratio based on temperature to maintain the fatty tissue site temperature at 100 degrees C. or less.

98. The method of claim 69, further comprising:

adjusting a current-to-voltage ratio based on temperature to maintain the fatty tissue site temperature at 75 degrees C. or less.

99. The method of claim 69, further comprising:

adjusting a current-to-voltage ratio based on temperature to maintain the fatty tissue site temperature at 60 degrees C. or less.

100. The method of claim 69, further comprising:

adjusting a current-to-voltage ratio based on temperature to maintain the fatty tissue site temperature at 50 degrees C. or less.

101. The method of claim 69, wherein the pulses applied are of sufficient duration and magnitude to permanently disrupt cell membranes of cells at the fatty tissue site.

102. The method of claim 69, wherein a ratio of electric current through cells at the fatty tissue site to voltage across the cells is detected and a magnitude of applied voltage to the fatty tissue site is adjusted in accordance with changes in the ratio of current to voltage.

103. A method for reduction of fat of a patient, comprising:

introducing a bi-polar electrode to a fatty tissue site of the patient;

positioning the bi-polar electrode at or near the fatty tissue site;

applying an electric field in a controlled manner to the fatty tissue site in an amount sufficient to produce electroporation of cells at the fatty tissue site and below an amount that causes thermal damage to a majority of the fatty tissue site.

104. The method of claim 103, further comprising:

using a monitoring electrode to measure a test voltage delivered to cells in the fatty tissue site.

105. The method of claim 104, wherein the test voltage is insufficient to create irreversible electroporation.

106. The method of claim 103, further comprising:

introducing at least a second and a third bipolar electrode to the fatty tissue site, the first, second and third bipolar electrodes forming an array of electrodes.

107. The system of claim 106, wherein the array is positioned in a surrounding relationship relative to the fatty tissue site.

108. The method of claim 103, further comprising:

removing the electroporation of cells from the patient.

109. The method of claim 103, further comprising:

removing the electroporation of cells from the patient with a liposuction probe during the electroporation.

110. The method of claim 103, further comprising:

removing the electroporation of cells from the patient with a liposuction probe after the electroporation.

111. The method of claim 103, further comprising:

introducing a tumescent agent into the tatty tissue. tissue.

112. The method of claim 103, further comprising:

performing the electroporation in a controlled manner with real time monitoring.

113. The method of claim 103, further comprising:

performing the electroporation in a controlled manner to provide for controlled pore formation in cell membranes.

114. The method of claim 103, further comprising:

performing the electroporation in a controlled manner to create a tissue effect of cells at the fatty tissue site while preserving surrounding tissue.

115. The method of claim 103, further comprising:

performing the electroporation in a controlled manner with monitoring of electrical impedance.

116. The method of claim 103, further comprising:

detecting an onset of electroporation of cells at the fatty tissue site.

117. The method of claim 103, further comprising:

performing the electroporation in a controlled manner with controlled intensity and duration of voltage.

118. The method of claim 103, further comprising:

performing the electroporation in a controlled manner with real time control.

119. The method of claim 103, further comprising:

performing the electroporation in a manner for modification and control of mass transfer across cell membranes.

120. The method of claim 103, further comprising:

performing the electroporation in a controlled manner with a proper selection of voltage magnitude.

121. The method of claim 103, wherein the electroporation is performed in a controlled manner with a proper selection of voltage application time.

122. The method of claim 103, wherein the duration of each pulse is about 5 microseconds to about 62 seconds.

123. The method of claim 103, wherein the duration of each pulse is about 90 to 110 microseconds.

124. The method of claim 103, wherein pulses are applied for a period of about 100 microseconds.

125. The method of claim 123, wherein about 1 to 15 pulses are applied.

126. The method of claim 123, wherein about eight pulses of about 100 microseconds each in duration are applied.

127. The method of claim 103, wherein pulses are applied to produce a voltage gradient at the fatty tissue site in a range of from about 50 volt/cm to about 8000 volt/cm.

128. The method of claim 103, further comprising:

monitoring a temperature of the fatty tissue site; and

adjusting the pulses to maintain a temperature of 100 degrees C. or less at the fatty tissue site.

129. The method of claim 103, further comprising:

monitoring a temperature of the fatty tissue site; and

adjusting the pulses to maintain a temperature of 75 degrees C. or less at the fatty tissue site.

130. The method of claim 103, further comprising:

monitoring a temperature of the fatty tissue site; and

adjusting the pulses to maintain a temperature of 60 degrees C. or less at the fatty tissue site.

131. The method of claim 103, further comprising:

monitoring a temperature of the fatty tissue site; and

adjusting the pulses to maintain a temperature of 50 degrees C. or less at the fatty tissue site.

132. The method of claim 103, further comprising:

adjusting a current-to-voltage ratio based on temperature to maintain the fatty tissue site temperature at 100 degrees C. or less.

133. The method of claim 103, further comprising:

adjusting a current-to-voltage ratio based on temperature to maintain the fatty tissue site temperature at 75 degrees C. or less.

134. The method of claim 103, further comprising:

adjusting a current-to-voltage ratio based on temperature to maintain the fatty tissue site temperature at 60 degrees C. or less.

135. The method of claim 103, further comprising:

adjusting a current-to-voltage ratio based on temperature to maintain the fatty tissue site temperature at 50 degrees C. or less.

136. The method of claim 103, wherein the pulses applied are of sufficient duration and magnitude to permanently disrupt cell membranes of cells at the fatty tissue site.

137. The method of claim 103, wherein a ratio of electric current through cells at the fatty tissue site to voltage across the cells is detected and a magnitude of applied voltage to the fatty tissue site is adjusted in accordance with changes in the ratio of current to voltage.