Methods and systems for treating BPH using electroporation

• US 8,114,070 B2
• Filed: 06/24/2005
• Issued: 02/14/2012
• Est. Priority Date: 06/24/2005
• Status: Active Grant

• Current Assignee: AngioDynamics, Inc.
• Original Assignee: AngioDynamics, Inc.
• Inventors: Rubinsky, Boris, Onik, Gary, Mikus, Paul
• Primary Examiner(s): PEFFLEY, MICHAEL F
• Application Number:
  US11/166,974
• Publication Number:
  US 20060293713A1
• Time in Patent Office: 2,426 Days
• Field of Search: 606 27- 31, 606/42, 607/2, 607/3, 607/72, 607/101, 607/102, 607/115, 607/116, 604 20- 22, 435/173.6, 435/285.2
• US Class Current: 606/32
• CPC Class Codes: A61B 2018/00613 Irreversible electroporation reversible electroporation A61N1/327
• 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 for treating benign prostate hyperplasia (BPH) of a prostate. At least first and second mono-polar electrodes are configured to be introduced at or near a BPH tissue site of the prostate gland 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 BPH tissue site, to create necrosis of cells of the BPH tissue site, but insufficient to create a thermal damaging effect to a majority of the BPH tissue site.

Claims

1. A method for treating benign prostate hyperplasia (BPH) of a prostate, comprising:

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

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

using a programmed control circuit to treat the BPH tissue and to control the temperature of the BPH tissue site by applying an electric field to the BPH tissue site in an amount sufficient to produce irreversible electroporation of cells at the BPH tissue site and below an amount that causes thermal damage to a majority of the BPH tissue site.

2. The method of claim 1, further comprising:

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

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

4. The method of claim 1, wherein the bipolar electrode is introduced through a rectal wall of a patient.

5. The method of claim 4, wherein a monitoring electrode is provided.

6. The method of claim 5, wherein the monitoring electrode is placed distal or proximal to the bipolar electrode.

7. The method of claim 5, wherein the monitoring electrode is placed at a fixed distance form the bipolar electrode.

8. The method of claim 5, wherein the monitoring electrode is mounted on a sheath through which the bipolar electrode is placed.

9. The method of claim 8, 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.

10. The method of claim 9, wherein the monitored tissue site is a rectal mucosa tissue site.

11. The method of claim 10, wherein the monitoring electrode is positioned at a biopsy guide coupled to the bipolar electrode.

12. The method of claim 11, wherein the bipolar electrode is configured to be placed through the biopsy guide.

13. The method of claim 12, wherein the monitoring electrode is placed at a tip of the biopsy guide and rests against the rectal mucosa when the bipolar electrode is placed.

14. The method of claim 1, wherein the bipolar electrode is introduced through a peritoneum of the patient.

15. The method of claim 1, further comprising:

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

16. The method of claim 1, further comprising:

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

17. The method of claim 1, further comprising:

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

18. The method of claim 1, further comprising:

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

19. The method of claim 1, further comprising:

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

20. The method of claim 1, further comprising:

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

21. The method of claim 1, further comprising:

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

22. The method of claim 1, further comprising:

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

23. The method of claim 1, further comprising:

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

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

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

26. The method of claim 1, wherein the step of applying an electric field includes applying at least one pulse and the duration of each pulse is about 5 microseconds to about 62 seconds.

27. The method of claim 1, wherein the step of applying an electric field includes applying at least one pulse and the duration of each pulse is about 90 to 110 microseconds.

28. The method of claim 1, wherein the step of applying an electric field includes applying at least one pulse and the duration of each pulse is about 100 microseconds.

29. The method of claim 27, wherein about 1 to 15 pulses are applied.

30. The method of claim 27, wherein about eight pulses of about 100 microseconds each in duration are applied.

31. The method of claim 1, wherein pulses are applied to produce a voltage gradient at the BPH tissue site in a range of from about 50 volt/cm to about 8000 volt/cm.

32. The method of claim 1, further comprising:

monitoring a temperature of the BPH tissue site; and

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

33. The method of claim 1, further comprising:

monitoring a temperature of the BPH tissue site; and

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

34. The method of claim 1, further comprising:

monitoring a temperature of the BPH tissue site; and

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

35. The method of claim 1, further comprising:

monitoring a temperature of the BPH tissue site; and

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

36. The method of claim 1, further comprising:

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

37. The method of claim 1, further comprising:

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

38. The method of claim 1, further comprising:

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

39. The method of claim 1, further comprising:

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

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

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

42. A method for treating benign prostate hyperplasia (BPH) of a prostate, comprising:

positioning at least one treatment electrode at or near a BPH tissue site of a patient; and

using a programmed control circuit to treat the BPH tissue and to control the temperature of the BPH tissue site by applying, through the treatment electrode, an electric field to the BPH tissue site in an amount sufficient to produce irreversible electroporation of cells at the BPH tissue site and below an amount that causes thermal damage to a majority of the BPH tissue site.

43. The method of claim 42, further comprising using a monitoring electrode to measure a test voltage delivered to cells in the BPH tissue site.

44. The method of claim 43, wherein the test voltage is insufficient to create irreversible electroporation of the cells in the BPH tissue site.

45. The method of claim 43, wherein the monitoring electrode is mounted on a sheath through which the treatment electrode is placed.

46. The method of claim 45, wherein a distance of the monitoring electrode from the treatment electrode is varied and positioned in response to an imaging of a monitored tissue site.

47. The method of claim 46, wherein:

the monitoring tissue site is a rectal mucosa tissue site; and

the monitoring electrode is positioned at a biopsy guide coupled to the treatment electrode.

48. The method of claim 47, wherein the treatment electrode is configured to be placed through the biopsy guide.

49. The method of claim 48, wherein the monitoring electrode is placed at a tip of the biopsy guide and rests against the rectal mucosa when the treatment electrode is placed.

50. The method of claim 42, wherein the treatment electrode is introduced through a peritoneum of the patient.

51. The method of claim 42, wherein the step of applying an electric field includes performing the electroporation in a controlled manner with monitoring of electrical impedance at the BPH tissue site.

52. The method of claim 42, further comprising detecting an onset of electroporation of cells at the BPH tissue site.

53. The method of claim 42, wherein the step of applying an electric field includes performing the electroporation in a controlled manner with controlled voltage intensity, controlled voltage duration or both.

54. The method of claim 42, wherein the step of applying an electric field includes applying one or more electrical pulses, and the duration of each pulse is about 5 microseconds to about 62 seconds.

55. The method of claim 42, wherein the step of applying an electric field includes applying one or more electrical pulses, and the duration of each pulse is about 90 to 110 microseconds.

56. The method of claim 42, wherein the step of applying an electric field includes applying a set of about 1 to 15 pulses.

57. The method of claim 56, wherein each pulse has a duration of about 90 to 110 microseconds.

58. The method of claim 42, wherein the step of applying an electric field includes applying a plurality of electrical pulses to produce a voltage gradient at the BPH tissue site in a range of from about 50 volt/cm to about 8000 volt/cm.

59. The method of claim 42, further comprising:

monitoring a temperature of the BPH tissue site; and

adjusting the electric field to maintain a temperature of 100 degrees C. or less at the BPH tissue site.

60. The method of claim 42, further comprising:

monitoring a temperature of the BPH tissue site; and

adjusting the electric field to maintain a temperature of 75 degrees C. or less at the BPH tissue site.

61. The method of claim 42, further comprising:

monitoring a temperature of the BPH tissue site; and

adjusting the electric field to maintain a temperature of 60 degrees C. or less at the BPH tissue site.

62. The method of claim 42, further comprising:

monitoring a temperature of the BPH tissue site; and

adjusting the electric field to maintain a temperature of 50 degrees C. or less at the BPH tissue site.

63. The method of claim 42, wherein the step of applying an electric field includes applying a plurality of electrical pulses that are of sufficient duration and magnitude to permanently electroporate the cells at the BPH tissue site.

64. The method of claim 42, further comprising:

detecting a ratio of voltage across cells at the BPH tissue site to electric current through the cells; and

adjusting a magnitude of applied voltage to the BPH tissue site in accordance with changes in the ratio of voltage to current.

65. A method for treating benign prostate hyperplasia (BPH) of a prostate, comprising:

positioning at least one treatment electrode at or near a BPH tissue site of a patient; and

using a programmed control circuit to treat the BPH tissue site and to control the temperature of the BPH tissue site by applying, through the treatment electrode, an electric field to the BPH tissue site in an amount sufficient to produce irreversible electroporation of cells at the BPH tissue site and in an amount insufficient to cause the temperature to exceed 50 degrees C. at the BPH tissue site to prevent thermal damage to a majority of the BPH tissue site.

66. The method of claim 65, further comprising using a monitoring electrode to measure a test voltage delivered to cells in the BPH tissue site.

67. The method of claim 66, wherein the test voltage is insufficient to create irreversible electroporation of the cells in the BPH tissue site.

68. The method of claim 66, wherein the monitoring electrode is mounted on a sheath through which the treatment electrode is placed.

69. The method of claim 68, wherein a distance of the monitoring electrode from the treatment electrode is varied and positioned in response to an imaging of a monitored tissue site.

70. The method of claim 69, wherein:

the monitoring tissue site is a rectal mucosa tissue site; and

the monitoring electrode is positioned at a biopsy guide coupled to the treatment electrode.

71. The method of claim 70, wherein the treatment electrode is configured to be placed through the biopsy guide.

72. The method of claim 71, wherein the monitoring electrode is placed at a tip of the biopsy guide and rests against the rectal mucosa when the treatment electrode is placed.

73. The method of claim 65, wherein the treatment electrode is introduced through a peritoneum of the patient.

74. The method of claim 65, wherein the step of applying an electric field includes performing the electroporation in a controlled manner with monitoring of electrical impedance at the BPH tissue site.

75. The method of claim 65, further comprising detecting an onset of electroporation of cells at the BPH tissue site.

76. The method of claim 65, wherein the step of applying an electric field includes performing the electroporation in a controlled manner with controlled voltage intensity, controlled voltage duration or both.

77. The method of claim 65, wherein the step of applying an electric field includes applying one or more electrical pulses, and the duration of each pulse is about 5 microseconds to about 62 seconds.

78. The method of claim 65, wherein the step of applying an electric field includes applying one or more electrical pulses, and the duration of each pulse is about 90 to 110 microseconds.

79. The method of claim 65, wherein the step of applying an electric field includes applying a set of about 1 to 15 pulses.

80. The method of claim 79, wherein each pulse has a duration of about 90 to 110 microseconds.

81. The method of claim 65, wherein the step of applying an electric field includes applying a plurality of electrical pulses to produce a voltage gradient at the BPH tissue site in a range of from about 50 volt/cm to about 8000 volt/cm.

82. The method of claim 65, further comprising:

monitoring a temperature of the BPH tissue site; and

adjusting the electric field to maintain a temperature of 50 degrees C. or less at the BPH tissue site.

83. The method of claim 65, further comprising:

detecting a ratio of voltage across cells at the BPH tissue site to electric current through the cells; and

adjusting a magnitude of applied voltage to the BPH tissue site in accordance with changes in the ratio of voltage to current.

84. The method of claim 65, wherein the step of applying includes applying a plurality of electrical pulses through a switching device to activate treatment electrodes in a selected pattern.