Apparatus and method for treating tumors near the surface of an organ

• US 6,337,998 B1
• Filed: 07/14/1999
• Issued: 01/08/2002
• Est. Priority Date: 07/28/1998
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Radio Therapeutics Corporation (Boston Scientific Corporation)
• Inventors: Behl, Robert S., Kermit, Eben L.
• Primary Examiner(s): Dvorak, Linda C. M.
• Assistant Examiner(s): ROLLINS, ROSILAND STACIE
• Application Number:
  US09/354,379
• Time in Patent Office: 909 Days
• Field of Search: 607/98, 607/101, 607/113, 607/115, 607/116, 606/32, 606/41, 606/45, 606/46, 606/47, 606/48, 606/49, 606/50, 128/898
• US Class Current: 607/101
• CPC Class Codes: A61B 18/1477 Needle-like probes
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/143 multiple needles
• CPC Class Codes: A61B 2018/1432 curved

Abstract

A system for treating a target region in tissue beneath a tissue surface comprises a probe for deploying an electrode array within the tissue and a surface electrode for engaging the tissue surface above the treatment site. Preferably, surface electrode includes a plurality of tissue-penetrating elements which advance into the tissue, and the surface electrode is removably attachable to the probe. The tissue may be treated in a monopolar fashion where the electrode array and surface electrode are attached to a common pole on an electrode surgical power supply and powered simultaneously or successively, or in a bipolar fashion where the electrode array and surface electrode are attached to opposite poles of the power supply. The systems are particularly useful for treating tumors and other tissue treatment regions which lie near the surface.

Claims

1. A method for treating a target region in tissue at or beneath a tissue surface, said method comprising:

deploying a first array of electrodes in the tissue beneath the tissue surface at the target region;

deploying a second electrode on the tissue surface over the target region; and

applying electrical current to the tissue through the electrodes.

2. A method as in claim 1, wherein the high frequency current is applied successively from the electrodes in a monopolar mode.

3. A method as in claim 1, wherein high frequency current is applied with one pole attached to the array electrodes and another pole attached to the second electrode in a bipolar fashion.

4. A method as in claim 1, wherein deploying the second electrode comprises engaging a plate electrode against the tissue surface.

5. A method as in claim 4, wherein the plate electrode has an area in the range from 2 cm² to 10 cm².

6. A method as in claim 1, wherein deploying the second electrode comprises penetrating a plurality of tissue-penetrating electrode elements through the tissue surface.

7. A method as in claim 6, wherein the plurality of tissue-penetrating electrode elements are penetrated over an area in the range from 2 cm² to 10 cm².

8. A method as in claim 7, wherein the electrode elements are penetrated to a depth in the range from 3 mm to 10 mm.

9. A method as in claim 1, wherein high frequency current is applied simultaneously through both the array electrodes and the second electrode attached to a common pole of a power supply in a monopolar mode.

10. A method as in claim 6, wherein the tissue-penetrating electrode elements are pins having a diameter in the range from 1 mm to 3 mm and a depth from the electrode face in the range from 3 mm to 10 mm.

12. A method as in any of claims 1, 2, or 11, wherein deploying the first 2 array of electrodes comprises:

positioning a probe so that a portion of the probe is near the target region in the tissue; and

advancing a plurality of at least three array electrodes radially outwardly from the probe to define the first electrode array.

13. A method as in claim 12, wherein the probe is advanced directly into tissue with the array electrodes retracted within the probe.

14. A method as in claim 12, wherein a combination of probe and stylet is initially advanced into the tissue, and wherein the stylet is withdrawn from the probe prior to advancing the array electrodes through the probe.

15. A method as in claim 12, wherein advancing the array electrodes comprises advancing them forwardly from a distal end of the probe so that the electrodes evert outwardly as they are advanced into the tissue.

16. A method as in claim 12, wherein the array electrodes deploy outwardly to a radius from 0.5 cm to 3 cm when fully distally extended.

17. A method as in claim 12, further comprising removably attaching the second electrode to the probe after the array electrodes have been advanced.

18. A method as in any of claims 1, 2, or 3, wherein the first array electrodes are deployed at a depth below the tissue surface in the range from 2 cm to 10 cm.

11. A method for treating a target region in tissue at or beneath a tissue surface, said method comprising:

deploying a first array of electrodes in the tissue beneath the tissue surface at the target region;

deploying a cover over the tissue surface over the target region, wherein the cover is configured to electrically and thermally isolate the target region and first electrode array from external tissue structures adjacent to the target region; and

applying electrical current to tissue in the target region through the first array of electrodes.

21. A method as in claim 19 or 11, wherein the cover comprises a rigid plate.

22. A method as in claim 19 or 11, wherein the cover comprises a conformable surface.

23. A method as in claim 19 or 11, wherein the cover is composed of an electrically non-conductive material.

24. A method as in claim 19 or 11, wherein the cover and first electrode array are drawn together with a force of at least 0.5 psi.

25. A method as in claim 19 or 11, wherein deploying the first electrode array comprises positioning a probe so that a portion of the probe lies near the target region and deploying the cover comprises securing the cover to the probe after the probe has been deployed.

19. A method for treating a target region in tissue at or beneath a tissue surface, said method comprising:

deploying a first array of electrodes in the tissue beneath the tissue surface at the target region;

deploying a cover over the tissue surface over the target region, wherein the first array and cover are drawn together to apply compression on tissue in the target region; and

applying electrical current to tissue in the target region through the first array of electrodes.

20. A method as in claim 19, wherein the electrical current is applied first through the first array of electrodes to necrose tissue at or near a boundary of the target region to inhibit blood flow into the target region.

26. A method for treating a target region in tissue at or beneath a tissue surface, said method comprising:

deploying a first array of electrodes in the tissue at the target region;

penetrating a plurality of tissue-penetrating electrodes comprising a second electrode array through the tissue surface;

applying electrical current to the tissue through the electrodes.

27. A method as in claim 26, wherein deploying the first array of electrodes comprises:

positioning a probe so that a portion of the probe is near the target region in the tissue; and

advancing a plurality of at least three array electrodes radially outwardly from the probe to define the first electrode array.

28. A method as in claim 27, wherein the probe is advanced directly into tissue with the array electrodes retracted within the probe.

29. A method as in claim 27, wherein a combination of probe and stylet is initially advanced into the tissue, and wherein the stylet is withdrawn from the probe prior to advancing the array electrodes through the probe.

30. A method as in claim 27, wherein advancing the array electrodes comprises advancing them forwardly from a distal end of the probe so that the electrodes evert outwardly as they are advanced into the tissue.

31. A method as in claim 27, wherein the array electrodes deploy outwardly to a radius from 0.5 cm to 3 cm wherein fully distally extended.

32. A method as in claim 27, further comprising removably attaching the second electrode to the probe after the array electrodes have been advanced.

33. A method as in claim 26, wherein the first array electrodes are deployed at a depth below the tissue surface in the range from 2 cm to 10 cm.

34. A method as in claim 26, wherein penetrating the second electrode comprises engaging a plate electrode against the tissue surface.

35. A method as in claim 34, wherein the plate electrode has an area in the range from 2 cm² to 10 cm².

36. A method as in claim 26, wherein the plurality of tissue-penetrating electrode elements are penetrated over an area in the range from 2 cm² to 10 cm².

37. A method as in claim 26, wherein the electrode elements are penetrated to a depth in the range from 3 mm to 10 mm.

38. A method as in claim 26, wherein the tissue-penetrating electrode elements are pins having a diameter in the range from 1 mm to 3 mm and a depth from an electrode face in the range from 3 mm to 10 mm.

39. A method as in claim 26, wherein high frequency current is applied simultaneously through both the array electrodes and the second electrode attached to a common pole of a power supply in a monopolar mode.

40. A method as in claim 26, wherein high frequency current is applied with one pole attached to the array electrodes and another pole attached to the second electrode in a bipolar fashion.

41. A method as in claim 26, wherein the high frequency current is applied successively from the electrodes in a monopolar mode.

42. A method for treating a target region in tissue at or beneath a tissue surface, said method comprising:

positioning a probe so that a portion of the probe is near the target region in tissue;

advancing a plurality of at least three array electrodes radially outwardly from the probe to define a first electrode array;

deploying a second electrode on the tissue surface over the target region;

removably attaching the second electrode to the probe after the first array electrodes have been advanced; and

applying electrical current to the tissue through the electrodes.

45. A method as in any of claims 42, 43, and 44, wherein the probe is advanced directly into tissue with the array electrodes retracted within the probe.

46. A method as in any of claims 42, 43, and 44, wherein a combination of probe and stylet is initially advanced into the tissue, and wherein the stylet is withdrawn from the probe prior to advancing the array electrodes through the probe.

47. A method as in any of claims 42, 43, and 44, wherein advancing the array electrodes comprises advancing them forwardly from a distal end of the probe so that the electrodes evert outwardly as they are advanced into the tissue.

48. A method as in any of claims 42, 43, and 44, wherein the array electrodes deploy outwardly to a radius from 0.5 cm to 3 cm wherein fully distally extended.

49. A method as in any of claims 42, 43, and 44, wherein the first array electrodes are deployed at a depth below the tissue surface in the range from 2 cm to 10 cm.

50. A method as in claim 42, wherein deploying the second electrode comprises engaging a plate electrode against the tissue surface.

51. A method as in claim 42, wherein the plate electrode has an area in the range from 2 cm² to 10 cm².

52. A method as in claim 42, wherein deploying the second electrode comprises penetrating a plurality of tissue-penetrating electrode elements through the tissue surface.

53. A method as in claim 52, wherein the plurality of tissue-penetrating electrode elements are penetrated over an area in the range from 2 cm² to 10 cm².

54. A method as in claim 53, wherein the electrode elements are penetrated to a depth in the range from 3 mm to 10 mm.

55. A method as in claim 52, wherein the tissue-penetrating electrode elements are pins having a diameter in the range from 1 mm to 3 mm and a depth from an electrode face in the range from 3 mm to 10 mm.

56. A method as in claim 42, wherein high frequency current is applied simultaneously through both the array electrodes and the second electrode attached to a common pole of a power supply in a monopolar mode.

57. A method as in claim 42, wherein high frequency current is applied with one pole attached to the array electrodes and another pole attached to the second electrode in a bipolar fashion.

58. A method as in claim 42, wherein the high frequency current is applied successively from the electrodes in a monopolar mode.

43. A method for treating a target region in tissue at or beneath a tissue surface, said method comprising:

positioning a probe so that a portion of the probe is near the target region in tissue;

advancing a plurality of at least three array electrodes radially outwardly from the probe to define a first electrode array;

deploying a cover over the tissue surface over the target region, wherein the first array and cover are drawn together to apply compression on tissue in the target region;

removably attaching the second electrode to the probe after the first array electrodes have been advanced; and

applying electrical current to tissue in the target region through the first array of electrodes.

59. A method as in claim 43, wherein the high frequency current is applied first through the first array of electrodes to necrose tissue at or near a boundary of the target region to inhibit blood flow into the target region.

60. A method as in claim 43 or 44, wherein the cover comprises a rigid plate.

61. A method as in claim 43 or 44, wherein the cover comprises a conformable surface.

62. A method as in claim 43 or 44, wherein the cover is composed of an electrically non-conductive material.

63. A method as in claim 43 or 44, wherein the cover and first electrode array are drawn together with a force of at least 0.5 psi.

64. A method as in claim 43 or 44, wherein deploying the first electrode array comprises positioning a probe so that a portion of the probe lies near the target region and deploying the cover comprises securing the cover to the probe after the probe has been deployed.

44. A method for treating a target region in tissue at or beneath a tissue surface, said method comprising:

positioning a probe so that a portion of the probe is near the target region in tissue;

advancing a plurality of at least three array electrodes radially outwardly from the probe to define a first electrode array;

deploying a cover over the tissue surface over the target region, wherein the cover is configured to electrically and thermally isolate the target region and first electrode array from external tissue structures adjacent to the target region;

removably attaching the second electrode to the probe after the first array electrodes have been advanced; and

applying electrical current to tissue in the target region through the first array of electrodes.

65. A method for treating a target region in tissue at or beneath a tissue surface, said method comprising:

deploying a first array of electrodes in the tissue at the target region;

deploying a cover composed of an electrically non-conductive material over the tissue surface over the target region, wherein the first array and cover are drawn together to apply compression on tissue in the target region; and

applying electrical current to tissue in the target region through the first array of electrodes.

67. A method as in claim 65 or 66, wherein deploying the first array of electrodes comprises:

positioning a probe so that a portion of the probe is near the target region in the tissue; and

advancing a plurality of at least three array electrodes radially outwardly from the probe to define the first electrode array.

68. A method as in claim 67, wherein the probe is advanced directly into tissue with the array electrodes retracted within the probe.

69. A method as in claim 67, wherein a combination of probe and stylet is initially advanced into the tissue, and wherein the stylet is withdrawn from the probe prior to advancing the array electrodes through the probe.

70. A method as in claim 67, wherein advancing the array electrodes comprises advancing them forwardly from a distal end of the probe so that the electrodes evert outwardly as they are advanced into the tissue.

71. A method as in claim 67, wherein the array electrodes deploy outwardly to a radius from 0.5 cm to 3 cm wherein fully distally extended.

73. A method as in claim 67, further comprising removably attaching the second electrode to the probe after the array electrodes have been advanced.

74. A method as in claim 65, wherein an high frequency current is applied first through the first array of electrodes to necrose tissue at or near a boundary of the target region to inhibit blood flow into the target region.

75. A method as in claim 65 or 66, wherein the cover comprises a rigid plate.

76. A method as in claim 65 or 66, wherein the cover comprises a conformable surface.

77. A method as in claim 65 or 66, wherein the cover and first electrode array are drawn together with a force of at least 0.5 psi.

78. A method as in claim 65 or 66, wherein deploying the first electrode array comprises positioning a probe so that a portion of the probe lies near the target region and deploying the cover comprises securing the cover to the probe after the probe has been deployed.

66. A method for treating a target region in tissue at or beneath a tissue surface, said method comprising:

deploying a first array of electrodes in the tissue at the target region;

deploying a cover composed of an electrically non-conductive material over the tissue surface over the target region, wherein the cover is configured to electrically and thermally isolate the target region and first electrode array from external tissue structures adjacent to the target region; and

applying electrical current to tissue in the target region through the first array of electrodes.

72. A method as in claim 66 or 67, wherein the first array electrodes are deployed at a depth below the tissue surface in the range from 2 cm to 10 cm.

79. A method for treating a target region in tissue at or beneath a tissue surface, said method comprising:

deploying a first array of electrodes from a probe in the tissue at the target region so that a portion of the probe lies near the target region;

securing a cover to the probe after the probe has been deployed so that the probe lies over the tissue surface over the target region, wherein the first array and cover are drawn together to apply compression on tissue in the target region; and

applying electrical current to tissue in the target region through the first array of electrodes.

81. A method as in claim 79 or 80, wherein deploying the first array of electrodes comprises:

positioning a probe so that a portion of the probe is near the target region in the tissue; and

advancing a plurality of at least three array electrodes radially outwardly from the probe to define the first electrode array.

82. A method as in claim 81, wherein the probe is advanced directly into tissue with the array electrodes retracted within the probe.

83. A method as in claim 81, wherein a combination of probe and stylet is initially advanced into the tissue, and wherein the stylet is withdrawn from the probe prior to advancing the array electrodes through the probe.

84. A method as in claim 81, wherein advancing the array electrodes comprises advancing them forwardly from a distal end of the probe so that the electrodes evert outwardly as they are advanced into the tissue.

85. A method as in claim 81, wherein the array electrodes deploy outwardly to a radius from 0.5 cm to 3 cm wherein fully distally extended.

86. A method as in claim 79 or 80, wherein the first array electrodes are deployed at a depth below the tissue surface in the range from 2 cm to 10 cm.

87. A method as in claim 81, further comprising removably attaching an second electrode to the probe after the array electrodes have been advanced.

88. A method as in claim 79, wherein the high frequency current is applied first through the first array of electrodes to necrose tissue at or near a boundary of the target region to inhibit blood flow into the target region.

89. A method as in claim 79 or 80, wherein the cover comprises a rigid plate.

90. A method as in claim 79 or 80, wherein the cover comprises a conformable surface.

91. A method as in claim 79 or 80, wherein the cover is composed of an electrically non-conductive material.

92. A method as in claim 79 or 80, wherein the cover and first electrode array are drawn together with a force of at least 0.5 psi.

80. A method for treating a target region in tissue at or beneath a tissue surface, said method comprising:

deploying a first array of electrodes from a probe in the tissue at the target region so that a portion of the probe lies near the target region;

securing a cover to the probe after the probe has been deployed so that the probe lies over the tissue surface over the target region, wherein the cover is configured to electrically and thermally isolate the target region and first electrode array from external tissue structures adjacent to the target region; and

applying electrical current to tissue in the target region through the first array of electrodes.