Methods and systems for treating tumors using electroporation

• US 20080015571A1
• Filed: 09/28/2007
• Published: 01/17/2008
• Est. Priority Date: 06/24/2005
• Status: Abandoned Application

• Current Assignee: AngioDynamics, Inc.
• Original Assignee: AngioDynamics, Inc.
• Inventors: Onik, Gary, Mikus, Paul, Rubinsky, Boris
• Application Number:
  US11/864,217
• Publication Number:
  US 20080015571A1
• Time in Patent Office: Days
• US Class Current: 606/42
• CPC Class Codes: A61B 18/1477 Needle-like probes
• CPC Class Codes: A61B 2018/0016 Energy applicators arranged in a two- or three dimensional array
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/00613 Irreversible electroporation reversible electroporation A61N1/327
• CPC Class Codes: A61B 2018/00797 measured by multiple temperature sensors
• CPC Class Codes: A61B 2018/143 multiple needles

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

1. 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.

2. The method of claim 1 further comprising:

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

3. The method of claim 2 wherein the test voltage is insufficient to create irreversible electroporation.

4. The method of claim 1 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.

5. The system of claim 4 herein the array is positioned in a surrounding relationship relative to the tumor tissue site.

6. The method of claim 1 further comprising:

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

7. The method of claim 1 further comprising:

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

8. The method of claim 1 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.

9. The method of claim 1 further comprising:

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

10. The method of claim 1 further comprising:

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

11. The method of claim 1 further comprising:

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

12. The method of claim 1 further comprising:

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

13. The method of claim 1 further comprising:

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

14. The method of claim 1 further comprising:

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

15. The method of claim 1 wherein the electroporation is performed in a controlled manner with a proper selection of voltage magnitude.

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

17. The method of claim 1 wherein the duration of each pulse is about 5 microseconds to about 62 seconds.

18. The method of claim 1 wherein the duration of each pulse is about 90 to 110 microseconds.

19. The method of claim 1 wherein pulses are applied for a period of about 100 microseconds.

20. The method of claim 18, wherein about 1 to 15 pulses are applied.

21. The method of claim 18, wherein about eight pulses of about 100 microseconds each in duration are applied.

22. The method of claim 1 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.

23. The method of claim 1 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.

24. The method of claim 1 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.

25. The method of claim 1 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.

26. The method of claim 1 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.

27. The method of claim 1 further comprising:

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

28. The method of claim 1 further comprising:

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

29. The method of claim 1 further comprising:

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

30. The method of claim 1 further comprising:

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

31. The method of claim 1 wherein the pulses applied are of sufficient duration and magnitude to permanently disrupt cell membranes of cells at the tumor tissue site.

32. The method 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.

33. The method of claim 1 wherein the tumor is a prostate tumor.

34. The method of claim 1 wherein the tumor is a breast tumor.

35. The method of claim 1 wherein the tumor is a kidney tumor.

36. The method of claim 1 wherein the tumor is a colo-rectal tumor.

37. The method of claim 1 wherein the tumor is a brain tumor.

38. The method of claim 1 wherein the tumor is a lung tumor.

39. The method of claim 1 wherein the tumor is a liver tumor.

40. The method of claim 1 wherein the tumor is a adrenal gland tumor.

41. The method of claim 1 wherein the tumor is a skin tumor.

42. The method of claim 1 wherein the tumor is a pancreas tumor.

43. The method of claim 1 wherein the tumor is a uterine fibroid.

44. The method of claim 1 wherein the tumor is a breast fibroid.

55. The method of claim 44, wherein the test voltage is insufficient to create irreversible electroporation.

45. 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.

46. The method of claim 45, wherein a monitoring electrode is provided.

47. The method of claim 46, wherein the monitoring electrode is placed distal or proximal to the bipolar electrode.

48. The method of claim 46, wherein the monitoring electrode is placed at a fixed distance form the bipolar electrode.

49. The method of claim 46, wherein the monitoring electrode is mounted on a sheath through which the bipolar electrode is placed.

50. The method of claim 49, 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.

51. The method of claim 46, wherein the monitoring electrode is positioned at a biopsy guide coupled to the RF electrode.

52. The method of claim 51, wherein the RF electrode is configured to be placed through the biopsy guide.

53. The method of claim 52, wherein the monitoring electrode is placed at a tip of the biopsy guide and rests against tissue when the bipolar electrode is placed.

54. The method of claim 45, further comprising:

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

56. The method of claim 45, 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.

57. The system of claim 56, wherein the array is positioned in a surrounding relationship relative to the tumor tissue site.

58. The method of claim 45, further comprising:

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

59. The method of claim 45, further comprising:

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

60. The method of claim 45, 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.

61. The method of claim 45, further comprising:

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

62. The method of claim 45, further comprising:

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

63. The method of claim 45, further comprising:

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

64. The method of claim 45, further comprising:

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

65. The method of claim 45, further comprising:

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

66. The method of claim 45, further comprising:

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

67. The method of claim 45, wherein the electroporation is performed in a controlled manner with a proper selection of voltage magnitude.

68. The method of claim 45, wherein the electroporation is performed in a controlled manner with a proper selection of voltage application time.

69. The method of claim 45, wherein the duration of each pulse is about 5 microseconds to about 62 seconds.

70. The method of claim 45, wherein the duration of each pulse is about 90 to 110 microseconds.

71. The method of claim 45, wherein pulses are applied for a period of about 100 microseconds.

72. The method of claim 60, wherein about 1 to 15 pulses are applied.

73. The method of claim 60, wherein about eight pulses of about 100 microseconds each in duration are applied.

74. The method of claim 45, 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.

75. The method of claim 45, 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.

76. The method of claim 45, 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.

77. The method of claim 45, 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.

78. The method of claim 45, 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.

79. The method of claim 45, further comprising:

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

80. The method of claim 45, further comprising:

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

81. The method of claim 45, further comprising:

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

82. The method of claim 45, further comprising:

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

83. The method of claim 45, wherein the pulses applied are of sufficient duration and magnitude to permanently disrupt cell membranes of cells at the tumor tissue site.

84. The method of claim 45, 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.

85. The method of claim 45, wherein the tumor is a prostate tumor.

86. The method of claim 45, wherein the tumor is a breast tumor.

87. The method of claim 45, wherein the tumor is a kidney tumor.

88. The method of claim 45, wherein the tumor is a colo-rectal tumor.

89. The method of claim 45, wherein the tumor is a brain tumor.

90. The method of claim 45, wherein the tumor is a lung tumor.

91. The method of claim 45, wherein the tumor is a liver tumor.

92. The method of claim 45, wherein the tumor is a adrenal gland tumor.

93. The method of claim 45, wherein the tumor is a skin tumor.

94. The method of claim 45, wherein the tumor is a pancreas tumor.

95. The method of claim 45, wherein the tumor is a uterine fibroid.

96. The method of claim 45, wherein the tumor is a breast fibroid.