Systems for treating tissue sites using electroporation

• US 20080132884A1
• Filed: 11/27/2007
• Published: 06/05/2008
• Est. Priority Date: 12/01/2006
• Status: Abandoned Application

• Current Assignee: AngioDynamics, Inc.
• Original Assignee: AngioDynamics, Inc.
• Inventors: Mikus, Paul, Rubinsky, Boris, Onik, Gary
• Application Number:
  US11/945,772
• Publication Number:
  US 20080132884A1
• Time in Patent Office: Days
• US Class Current: 606/34
• CPC Class Codes: A61B 18/1477 Needle-like probes
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/00613 Irreversible electroporation
• CPC Class Codes: A61B 2018/143 multiple needles
• CPC Class Codes: A61N 1/327 for enhancing the absorption properties of tissue, e.g. by electroporation

Abstract

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

Claims

1. A system for treating a tissue site, comprising:

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

a voltage pulse generator coupled to the first and second mono-polar electrodes and configured to apply sufficient electrical pulses between the first and second mono-polar electrodes to induce electroporation of cells in the tissue site to create necrosis of cells of the tissue site but insufficient to create a thermal damaging effect to a majority of the tissue site.

2. The system of claim 1, further comprising:

a monitoring electrode configured to measure a test voltage delivered to cells in the 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 electrodes.

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

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 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, wherein the electroporation is monitored using an tissue imaging modality.

11. The system of claim 1, further comprising:

a device for detecting an onset of electroporation of cells at the tissue site.

12. The system of claim 11, further comprising:

a device for monitoring the effects of electroporation on cell membranes of cells at the tissue site.

13. The system of claim 11, further comprising:

a device for detecting that the effects of electroporation on cell membranes of cells at the tissue site continues.

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

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

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

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

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

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 5 microseconds to about 62 seconds.

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 90 to 110 microseconds.

21. 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.

22. The system of claim 20, wherein the voltage pulse generator is configured to apply from about 1 to 15 pulses.

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

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

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

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

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

28. The system of claim 1, wherein a temperature of the tissue site is monitored and the pulses are adjusted to maintain a temperature of 50 degrees C. or less at the tissue site.

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

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

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

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

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

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

35. 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 tissue site.

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

37. A system for treating a tissue site, comprising:

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

a voltage pulse generator coupled to the first and second electrodes and configured to apply sufficient electrical pulses to the bi-polar electrode to induce electroporation of cells in the tissue site to create necrosis of cells of the tissue site, but insufficient to create a thermal damaging effect to a majority of the tissue site.

38. The system of claim 37, further comprising:

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

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

40. The system of claim 37, 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.

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

42. The system of claim 37, wherein the electroporation is performed in a controlled manner with real time monitoring.

43. The system of claim 37, wherein the electroporation is performed in a controlled manner to provide for controlled pore formation in cell membranes.

44. The system of claim 37, wherein the electroporation is performed in a controlled manner to create a tissue effect in the cells at the tissue site while preserving surrounding tissue.

45. The system of claim 37, wherein the electroporation is performed in a controlled manner with monitoring of electrical impedance.

46. The system of claim 37, further comprising:

a device for detecting an onset of electroporation of cells at the tissue site.

47. The system of claim 37, wherein the electroporation is performed in a controlled manner with controlled intensity and duration of voltage.

48. The system of claim 37, wherein the electroporation is performed in a controlled manner with real time control.

49. The system of claim 37, wherein the electroporation is performed in a manner to for modification and control of mass transfer across cell membranes.

50. The system of claim 37, wherein the electroporation is performed in a controlled manner with a proper selection of voltage magnitude.

51. The system of claim 37, wherein the electroporation is performed in a controlled manner with a proper selection of voltage application time.

52. The system of claim 37, 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.

53. The system of claim 37, wherein the voltage pulse generator is configured to provide that each pulse is applied for a duration of about 90 to 110 microseconds.

54. The system of claim 37, wherein the voltage pulse generator is configured to provide that each pulse is applied for a duration of about 100 microseconds.

55. The system of claim 37, wherein the voltage pulse generator is configured to apply from about 1 to 15 pulses.

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

57. The system of claim 37, wherein the voltage pulse generator is configured to provide for pulse application to produce a voltage gradient at the tissue site in a range of from about 50 volt/cm to about 8000 volt/cm.

58. The system of claim 37, wherein a temperature of the tissue site is monitored and the pulses are adjusted to maintain a temperature of 100 degrees C. or less at the tissue site.

59. The system of claim 37, wherein a temperature of the tissue site is monitored and the pulses are adjusted to maintain a temperature of 75 degrees C. or less at the tissue site.

60. The system of claim 37, wherein a temperature of the tissue site is monitored and the pulses are adjusted to maintain a temperature of 60 degrees C. or less at the tissue site.

61. The system of claim 37, wherein a temperature of the tissue site is monitored and the pulses are adjusted to maintain a temperature of 50 degrees C. or less at the tissue site.

62. The system of claim 37, wherein a current-to-voltage ratio is adjusted based on temperature to maintain the tissue site temperature at 100 degrees C. or less.

63. The system of claim 37, wherein a current-to-voltage ratio is adjusted based on temperature to maintain the tissue site temperature at 75 degrees C. or less.

64. The system of claim 37, wherein a current-to-voltage ratio is adjusted based on temperature to maintain the tissue site temperature at 60 degrees C. or less.

65. The system of claim 37, wherein a current-to-voltage ratio is adjusted based on temperature to maintain the tissue site temperature at 50 degrees C. or less.

66. The system of claim 37, 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 tissue site.

67. The system of claim 37, wherein a ratio of electric current through cells at the tissue site to voltage across the cells is detected and a magnitude of applied voltage to the tissue site is adjusted in accordance with changes in the ratio of current to voltage.