IP Library Patent Application 11165961
Patent Application
App. No. 11/165,961

Methods and systems for treating tumors using electroporation

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Quick Facts
Patent No.
US None
App. No.
11/165,961
Abstract

A system is provided for treating tumor tissue sites of a patient. At least first and second mono-polar electrodes are configured to be introduced at or near the tumor 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 tumor tissue site, to create necrosis of cells of the tumor tissue site, but insufficient to create a thermal damaging effect to a majority of the tumor tissue site.

Claims (222)

1 . A system for treating a tumor of a patient, comprising:

at least first and second mono-polar electrodes configured to be introduced at or near a tumor 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 tumor tissue site to create cell necrosis of tumor cells without creating a thermal damage effect to a majority of the tumor tissue site.

2 . The system of claim 1 , further comprising:

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

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

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

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

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

10 . The system of claim 1 , further comprising:

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

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

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

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

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

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

16 . The system of claim 15 , wherein voltage pulse generator is configured to provide that each pulse is applied for a duration of about 5 microseconds to about 62 seconds.

17 . 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.

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 100 microseconds.

19 . The system of claim 17 , wherein the voltage pulse generator is configured to apply from about 1 to 15 pulses.

20 . The system of claim 17 , wherein the voltage pulse generator is configured to apply about eight pulses of about 100 microseconds each in duration.

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

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

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

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

25 . The system of claim 22 , wherein the temperature is maintained at 50 degrees C. or less.

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

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

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

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

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

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

32 . 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 tumor tissue site.

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

34 . A system for treating a tumor of a patient, comprising:

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

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

35 . The system of claim 34 , wherein the electroporation is performed in a controlled manner with real time monitoring.

36 . The system of claim 34 , further comprising:

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

37 . The system of claim 34 , wherein the test voltage is insufficient to create irreversible electroporation.

38 . The system of claim 34 , 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.

39 . The system of claim 38 , wherein the array is configured to be positioned in a surrounding relationship relative to the tumor tissue site.

40 . The system of claim 34 , wherein the electroporation is performed in a controlled manner to provide for controlled pore formation in cell membranes.

41 . The system of claim 34 , wherein the electroporation is performed in a controlled manner to create a tissue effect in the cells at the tumor tissue site while preserving surrounding tissue.

42 . The system of claim 34 , wherein the electroporation is performed in a controlled manner with monitoring of electrical impedance;

43 . The system of claim 34 , further comprising:

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

44 . The system of claim 34 , wherein the electroporation is performed in a controlled manner with controlled intensity and duration of voltage.

45 . The system of claim 34 , wherein the electroporation is performed in a controlled manner with real time control.

46 . The system of claim 34 , wherein the electroporation is performed in a manner to for modification and control of mass transfer across cell membranes.

47 . The system of claim 34 , wherein the electroporation is performed in a controlled manner with a proper selection of voltage magnitude.

48 . The system of claim 34 , wherein the electroporation is performed in a controlled manner with a proper selection of voltage application time.

49 . The system of claim 34 , 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.

50 . The system of claim 34 , wherein the voltage pulse generator is configured to provide that each pulse is applied for a duration of about 90 to 110 microseconds.

51 . The system of claim 34 , wherein the voltage pulse generator is configured to provide that each pulse is applied for a duration of about 100 microseconds.

52 . The system of claim 50 , wherein the voltage pulse generator is configured to apply from about 1 to 15 pulses.

53 . The system of claim 50 , wherein the voltage pulse generator is configured to apply about eight pulses of about 100 microseconds each in duration.

54 . The system of claim 34 , wherein the voltage pulse generator is configured to provide for pulse application to produce a voltage gradient at the tumor tissue site in a range of from about 50 volt/cm to about 8000 volt/cm.

55 . The system of claim 34 , wherein a temperature of the tumor tissue site is monitored and the pulses are adjusted to maintain a temperature of 100 degrees C. or less at the tumor tissue site.

56 . The system of claim 34 , wherein a temperature of the tumor tissue site is monitored and the pulses are adjusted to maintain a temperature of 75 degrees C. or less at the tumor tissue site.

57 . The system of claim 34 , wherein a temperature of the tumor tissue site is monitored and the pulses are adjusted to maintain a temperature of 60 degrees C. or less at the tumor tissue site.

58 . The system of claim 55 , wherein the temperature is maintained at 50 degrees C. or less.

59 . The system of claim 34 , wherein a current-to-voltage ratio is adjusted based on temperature to maintain the tumor tissue site temperature at 100 degrees C. or less.

60 . The system of claim 34 , wherein a current-to-voltage ratio is adjusted based on temperature to maintain the tumor tissue site temperature at 75 degrees C. or less.

61 . The system of claim 34 , wherein a current-to-voltage ratio is adjusted based on temperature to maintain the tumor tissue site temperature at 60 degrees C. or less.

62 . The system of claim 34 , wherein a current-to-voltage ratio is adjusted based on temperature to maintain the tumor tissue site temperature at 50 degrees C. or less.

63 . The system of claim 34 , 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 tumor tissue site.

64 . The system of claim 34 , wherein a ratio of electric current through cells at the tumor tissue site to voltage across the cells is detected and a magnitude of applied voltage to the tumor tissue site is adjusted in accordance with changes in the ratio of current to voltage.

65 . A method for treating a tumor of a patient, comprising:

introducing at least first and second mono-polar electrodes to a tumor tissue site of the patient;

positioning the at least first and second mono-polar electrodes at or near the tumor tissue site;

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

66 . The method of claim 65 , further comprising:

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

67 . The method of claim 66 , wherein the test voltage is insufficient to create irreversible electroporation.

68 . The method of claim 65 , further comprising:

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

69 . The system of claim 68 , wherein the array is positioned in a surrounding relationship relative to the tumor tissue site.

70 . The method of claim 65 , further comprising:

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

71 . The method of claim 65 , further comprising:

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

72 . The method of claim 65 , further comprising:

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

73 . The method of claim 65 , further comprising:

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

74 . The method of claim 65 , further comprising:

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

75 . The method of claim 65 , further comprising:

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

76 . The method of claim 65 , further comprising:

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

77 . The method of claim 65 , further comprising:

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

78 . The method of claim 65 , further comprising:

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

79 . The method of claim 65 , wherein the electroporation is performed in a controlled manner with a proper selection of voltage magnitude.

80 . The method of claim 65 , wherein the electroporation is performed in a controlled manner with a proper selection of voltage application time.

81 . The method of claim 65 , wherein the duration of each pulse is about 5 microseconds to about 62 seconds.

82 . The method of claim 65 , wherein the duration of each pulse is about 90 to 110 microseconds.

83 . The method of claim 65 , wherein pulses are applied for a period of about 100 microseconds.

84 . The method of claim 82 , wherein about 1 to 15 pulses are applied.

85 . The method of claim 82 , wherein about eight pulses of about 100 microseconds each in duration are applied.

86 . The method of claim 65 , wherein pulses are applied to produce a voltage gradient at the tumor tissue site in a range of from about 50 volt/cm to about 8000 volt/cm.

87 . The method of claim 65 , further comprising:

monitoring a temperature of the tumor tissue site; and

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

88 . The method of claim 65 , further comprising:

monitoring a temperature of the tumor tissue site; and

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

89 . The method of claim 65 , further comprising:

monitoring a temperature of the tumor tissue site; and

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

90 . The method of claim 65 , further comprising:

monitoring a temperature of the tumor tissue site; and

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

91 . The method of claim 65 , further comprising:

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

92 . The method of claim 65 , further comprising:

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

93 . The method of claim 65 , further comprising:

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

94 . The method of claim 65 , further comprising:

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

95 . The method of claim 65 , wherein the pulses applied are of sufficient duration and magnitude to permanently disrupt cell membranes of cells at the tumor tissue site.

96 . The method of claim 65 , wherein a ratio of electric current through cells at the tumor tissue site to voltage across the cells is detected and a magnitude of applied voltage to the tumor tissue site is adjusted in accordance with changes in the ratio of current to voltage.

97 . The method of claim 65 , wherein the tumor is a prostate tumor.

98 . The method of claim 65 , wherein the tumor is a breast tumor.

99 . The method of claim 65 , wherein the tumor is a kidney tumor.

100 . The method of claim 65 , wherein the tumor is a colo-rectal tumor.

101 . The method of claim 65 , wherein the tumor is a brain tumor.

102 . The method of claim 65 , wherein the tumor is a lung tumor.

103 . The method of claim 65 , wherein the tumor is a liver tumor.

104 . The method of claim 65 , wherein the tumor is a adrenal gland tumor.

105 . The method of claim 65 , wherein the tumor is a skin tumor.

106 . The method of claim 65 , wherein the tumor is a pancreas tumor.

107 . The method of claim 65 , wherein the tumor is a uterine fibroid.

108 . The method of claim 65 , wherein the tumor is a breast fibroid.

109 . A method for treating a tumor of a patient, comprising:

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

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

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

110 . The method of claim 109 , wherein a monitoring electrode is provided.

111 . The method of claim 110 , wherein the monitoring electrode is placed distal or proximal to the bipolar electrode.

112 . The method of claim 110 , wherein the monitoring electrode is placed at a fixed distance form the bipolar electrode.

113 . The method of claim 110 , wherein the monitoring electrode is mounted on a sheath through which the bipolar electrode is placed.

114 . The method of claim 113 , wherein a distance of the monitoring electrode from the bipolar electrode is varied and positioned in response to an imaging of a monitored tissue site.

115 . The method of claim 110 , wherein the monitoring electrode is positioned at a biopsy guide coupled to the RF electrode.

116 . The method of claim 115 , wherein the RF electrode is configured to be placed through the biopsy guide.

117 . The method of claim 116 , wherein the monitoring electrode is placed at a tip of the biopsy guide and rests against tissue when the bipolar electrode is placed.

118 . The method of claim 109 , further comprising:

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

119 . The method of claim 108 , wherein the test voltage is insufficient to create irreversible electroporation.

120 . The method of claim 109 , further comprising:

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

121 . The system of claim 120 , wherein the array is positioned in a surrounding relationship relative to the tumor tissue site.

122 . The method of claim 109 , further comprising:

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

123 . The method of claim 109 , further comprising:

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

134 . The method of claim 109 , further comprising:

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

125 . The method of claim 109 , further comprising:

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

126 . The method of claim 109 , further comprising:

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

127 . The method of claim 109 , further comprising:

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

128 . The method of claim 109 , further comprising:

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

129 . The method of claim 109 , further comprising:

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

130 . The method of claim 109 , further comprising:

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

131 . The method of claim 109 , wherein the electroporation is performed in a controlled manner with a proper selection of voltage magnitude.

132 . The method of claim 109 , wherein the electroporation is performed in a controlled manner with a proper selection of voltage application time.

133 . The method of claim 109 , wherein the duration of each pulse is about 5 microseconds to about 62 seconds.

134 . The method of claim 109 , wherein the duration of each pulse is about 90 to 110 microseconds.

135 . The method of claim 109 , wherein pulses are applied for a period of about 100 microseconds.

136 . The method of claim 134 , wherein about 1 to 15 pulses are applied.

137 . The method of claim 134 , wherein about eight pulses of about 100 microseconds each in duration are applied.

138 . The method of claim 109 , wherein pulses are applied to produce a voltage gradient at the tumor tissue site in a range of from about 50 volt/cm to about 8000 volt/cm.

139 . The method of claim 109 , further comprising:

monitoring a temperature of the tumor tissue site; and

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

140 . The method of claim 109 , further comprising:

monitoring a temperature of the tumor tissue site; and

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

141 . The method of claim 109 , further comprising:

monitoring a temperature of the tumor tissue site; and

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

142 . The method of claim 109 , further comprising:

monitoring a temperature of the tumor tissue site; and

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

143 . The method of claim 109 , further comprising:

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

144 . The method of claim 109 , further comprising:

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

145 . The method of claim 109 , further comprising:

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

146 . The method of claim 109 , further comprising:

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

147 . The method of claim 109 , wherein the pulses applied are of sufficient duration and magnitude to permanently disrupt cell membranes of cells at the tumor tissue site.

148 . The method of claim 109 , wherein a ratio of electric current through cells at the tumor tissue site to voltage across the cells is detected and a magnitude of applied voltage to the tumor tissue site is adjusted in accordance with changes in the ratio of current to voltage.

149 . The method of claim 109 , wherein the tumor is a prostate tumor.

150 . The method of claim 109 , wherein the tumor is a breast tumor.

151 . The method of claim 109 , wherein the tumor is a kidney tumor.

152 . The method of claim 109 , wherein the tumor is a colo-rectal tumor.

153 . The method of claim 109 , wherein the tumor is a brain tumor.

154 . The method of claim 109 , wherein the tumor is a lung tumor.

155 . The method of claim 109 , wherein the tumor is a liver tumor.

156 . The method of claim 109 , wherein the tumor is a adrenal gland tumor.

157 . The method of claim 109 , wherein the tumor is a skin tumor.

158 . The method of claim 109 , wherein the tumor is a pancreas tumor.

159 . The method of claim 109 , wherein the tumor is a uterine fibroid.

160 . The method of claim 109 , wherein the tumor is a breast fibroid.

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 24, 2008
From: ONCOBIONIC, INC.
To: ANGIODYNAMICS INCORPORATED
Reel/Frame 021144/0963 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 24, 2005
From: RUBINSKY, BORIS; ONIK, GARY; MIKUS, PAUL
To: ONCOBONIC, INC.
Reel/Frame 016732/0113 →