Electrosurgical systems and methods for removing and modifying tissue

• US 20030130655A1
• Filed: 01/09/2003
• Published: 07/10/2003
• Est. Priority Date: 06/07/1995
• Status: Active Grant

• Current Assignee: ArthroCare Corporation (Smith & Nephew PLC)
• Original Assignee: ArthroCare Corporation (Smith & Nephew PLC)
• Inventors: Woloszko, Jean, Eggers, Philip E., Tsuji, Craig, Thapliyal, Hira V.
• Granted Patent: US 7,824,398 B2
• Time in Patent Office: Days
• US Class Current: 606/45
• CPC Class Codes: A61B 18/042 using additional gas becoming plasma
• CPC Class Codes: A61B 18/1206 Generators therefor
• CPC Class Codes: A61B 18/1402 Probes for open surgery
• CPC Class Codes: A61B 18/148 having a short, rigid shaft for accessing the inner body transcutaneously, e.g. for neurosurgery or arthroscopy
• CPC Class Codes: A61B 18/1482 having a long rigid shaft for accessing the inner body transcutaneously in minimal invasive surgery, e.g. laparoscopy
• CPC Class Codes: A61B 18/1485 having a short rigid shaft for accessing the inner body through natural openings
• CPC Class Codes: A61B 18/149 bow shaped or with rotatable body at cantilever end, e.g. for resectoscopes, or coagulating rollers
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 2017/00026 Conductivity or impedance, e.g. of tissue
• CPC Class Codes: A61B 2017/00084 Temperature
• CPC Class Codes: A61B 2017/00101 using an array of thermosensors
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2018/00029 open
• CPC Class Codes: A61B 2018/00083 low, i.e. electrically insulating
• CPC Class Codes: A61B 2018/00119 with metal oxide nitride
• CPC Class Codes: A61B 2018/00148 with metal
• CPC Class Codes: A61B 2018/0016 Energy applicators arranged in a two- or three dimensional array
• CPC Class Codes: A61B 2018/00178 Electrical connectors
• CPC Class Codes: A61B 2018/00327 Ear, nose or throat
• CPC Class Codes: A61B 2018/00392 Transmyocardial revascularisation
• CPC Class Codes: A61B 2018/00404 : Blood vessels other than those in or around the heart
• CPC Class Codes: A61B 2018/0047 : Upper parts of the skin, e.g. skin peeling or treatment of wrinkles
• CPC Class Codes: A61B 2018/00476 : Hair follicles
• CPC Class Codes: A61B 2018/00505 : Urinary tract
• CPC Class Codes: A61B 2018/00577 : Ablation
• CPC Class Codes: A61B 2018/00583 : Coblation, i.e. ablation using a cold plasma
• CPC Class Codes: A61B 2018/00601 : Cutting
• CPC Class Codes: A61B 2018/00625 : Vaporization
• CPC Class Codes: A61B 2018/00678 : upper
• CPC Class Codes: A61B 2018/00702 : Power or energy
• CPC Class Codes: A61B 2018/00726 : Duty cycle
• CPC Class Codes: A61B 2018/00791 : Temperature
• CPC Class Codes: A61B 2018/00797 : measured by multiple temperature sensors
• CPC Class Codes: A61B 2018/00815 : measured by a thermistor
• CPC Class Codes: A61B 2018/00821 : measured by a thermocouple
• CPC Class Codes: A61B 2018/00827 : Current
• CPC Class Codes: A61B 2018/00875 : Resistance or impedance
• CPC Class Codes: A61B 2018/1213 : creating an arc
• CPC Class Codes: A61B 2018/124 : switching the output to different electrodes, e.g. sequentially
• CPC Class Codes: A61B 2018/1253 : monopolar
• CPC Class Codes: A61B 2018/126 : bipolar
• CPC Class Codes: A61B 2018/1273 : including multiple generators in one device
• CPC Class Codes: A61B 2018/1407 : Loop
• CPC Class Codes: A61B 2018/1412 : Blade
• CPC Class Codes: A61B 2018/1422 : Hook
• CPC Class Codes: A61B 2018/1467 : using more than two electrodes on a single probe
• CPC Class Codes: A61B 2018/1472 : for use with liquid electrolyte, e.g. virtual electrodes
• CPC Class Codes: A61B 2018/162 : located on the probe body
• CPC Class Codes: A61B 2018/165 : Multiple indifferent electrodes
• CPC Class Codes: A61B 2218/002 : Irrigation
• CPC Class Codes: A61B 2218/003 : using a spray or a foam
• CPC Class Codes: A61B 2218/007 : Aspiration
• CPC Class Codes: A61F 2/2493 : Transmyocardial revascularisation [TMR] devices

Abstract

The present invention provides systems, apparatus and methods for selectively applying electrical energy to body tissue in order to, ablate, contract, coagulate, or otherwise modify a tissue or organ of a patients. An electrosurgical apparatus includes an electrode support bearing an active electrode in the form of a plasma blade or hook having an active edge and first and second blade sides. The active edge is adapted for severing a target tissue via localized molecular dissociation of tissue components. The first and second blade sides are adapted for engaging against, and coagulating, the severed tissue. s. A method of the present invention comprises positioning an electrosurgical probe adjacent to the target tissue so that a blade- or hook-like active electrode is brought into at least close proximity to the target tissue in the presence of an electrically conductive fluid. A high frequency voltage is applied between the active electrode and a return electrode to effect cool ablation or other modification of the target tissue. During application of the high frequency voltage, the electrosurgical apparatus may be translated, reciprocated, or otherwise manipulated such that the active edge is moved with respect to the tissue. The present invention volumetrically ablates or otherwise modifies the target tissue with minimal or no damage to surrounding, non-target tissue.

Claims

1. An electrosurgical probe, comprising:

a shaft having a shaft distal end portion and a shaft proximal end portion;

at least one electrode support affixed to the shaft distal end portion; and

a blade electrode affixed to the at least one electrode support, wherein the blade electrode comprises a metal blade having at least one active edge, a first blade side and a second blade side, wherein the at least one active edge of the blade electrode is adapted for severing tissue via molecular dissociation of tissue components, and at least one of the first blade side and the second blade side is adapted for engaging and coagulating severed tissue.

2. The probe of claim 1, further comprising a return electrode arranged on the shaft distal end portion proximal to the at least one electrode support.

3. The electrosurgical probe of claim 1, wherein the blade electrode comprises a hook.

4. The electrosurgical probe of claim 3, wherein the hook comprises a first axial portion and a second portion substantially orthogonal to the first axial portion.

5. The electrosurgical probe of claim 3, wherein the hook is curved.

6. The electrosurgical probe of claim 3, wherein the hook has at least one serrated edge.

7. The electrosurgical probe of claim 3, wherein the hook comprises a substantially flat metal blade having a distal active edge and a proximal active edge.

8. The electrosurgical probe of claim 3, wherein the hook comprises a first axial portion and a second portion, the second portion being curved and having a concave distal active edge.

9. The electrosurgical probe of claim 1, wherein the blade electrode comprises a first electrode arm, a second electrode arm, and a crosspiece.

10. The electrosurgical probe of claim 9, wherein the at least one electrode support comprises a first electrode support and a second electrode support, and wherein the first electrode arm and the second electrode arm are affixed to the first electrode support and the second electrode support, respectively.

11. The electrosurgical probe of claim 9, wherein the crosspiece comprises a substantially flat metal blade having a distal active edge and a proximal active edge.

12. The probe of claim 1, wherein the crosspiece is substantially orthogonal to the first electrode arm and to the second electrode arm.

13. The probe of claim 1, wherein the first blade side and the second blade side are substantially parallel to each other.

14. The probe of claim 1, wherein the blade electrode has a maximum width between the first blade side and the second blade side ranging from about 0.1 mm to about 2 mm.

15. The probe of claim 1, further comprising a handle affixed to the shaft proximal end portion, the handle accommodating a connection block, the blade electrode coupled to the connection block via at least one electrode connector, wherein the connection block is adapted for coupling the blade electrode to a high frequency power supply.

16. The probe of claim 1, further comprising an insulating sleeve partially encasing the shaft, the insulating sleeve terminating in a sleeve distal end at a location proximal to the electrode support and defining an exposed portion of the shaft, and the exposed portion comprising a return electrode.

17. The probe of claim 1, further comprising an aspiration element including an aspiration lumen in communication with a distal aspiration port.

18. The probe of claim 17, wherein the blade electrode includes a crosspiece, the aspiration port is located proximal to the crosspiece, and the crosspiece spans the aspiration port.

19. The probe of claim 17, wherein the blade electrode extends distally from the electrode support by a distance in the range of from about 0.1 mm to about 10 mm.

20. The probe of claim 1, further comprising a fluid delivery unit.

21. The probe of claim 20, wherein the fluid delivery unit includes an outer sheath situated external to the shaft and defining an annular fluid delivery lumen between the outer sheath and the shaft, the annular fluid delivery lumen terminating in an annular fluid delivery port located at the shaft distal end portion proximal to the at least one electrode support.

22. The probe of claim 1, wherein the at least one electrode support is disposed at the distal terminus of the shaft, and the blade electrode is affixed to the distal end of the at least one electrode support.

23. The probe of claim 1, wherein the blade electrode is arranged laterally on the at least one electrode support.

24. The probe of claim 1, wherein the shaft distal end portion is curved.

25. The probe of claim 1, wherein the shaft distal end portion terminates in a beveled edge and the at least one electrode support is disposed on the beveled edge.

26. The probe of claim 1, wherein the shaft distal end portion includes a laterally compressed region adapted for accommodating the at least one electrode support.

27. The probe of claim 1, wherein the at least one electrode support comprises a silicone rubber.

28. The probe of claim 1, wherein the blade electrode comprises a material selected from the group consisting of platinum, tungsten, palladium, iridium, and titanium.

29. An electrosurgical probe, comprising:

a shaft having a shaft distal end portion and a shaft proximal end portion;

an electrode support affixed to the shaft distal end portion; and

a blade electrode affixed to the electrode support, wherein the blade electrode comprises a hook having at least one active edge, a first blade side and a second blade side, wherein the at least one active edge is adapted for severing tissue via molecular dissociation of tissue components.

30. The electrosurgical probe of claim 29, wherein the hook comprises a substantially flat metal blade having a first axial portion and a second portion extending in a direction substantially orthogonal to the first axial portion.

31. The electrosurgical probe of claim 29, wherein the hook is curved.

32. The electrosurgical probe of claim 29, wherein the hook has at least one serrated edge.

33. The electrosurgical probe of claim 29, wherein the hook includes a distal active edge and a proximal active edge.

34. The electrosurgical probe of claim 33, wherein the hook is curved and the distal active edge is concave.

35. The electrosurgical probe of claim 29, wherein the hook is adapted for severing tissue by drawing the probe towards an operator of the probe.

36. The electrosurgical probe of claim 29, wherein each of the first blade side and the second blade side are adapted for engaging a severed tissue and for coagulating the severed tissue.

37. The probe of claim 29, further comprising an insulating sleeve covering a portion of the shaft, the insulating sleeve terminating distally in a sleeve distal end at a location proximal to the electrode support to define an exposed portion of the shaft distal end portion, and the exposed portion defining a return electrode.

38. The probe of claim 29, further comprising an aspiration element including an aspiration lumen and an aspiration port.

39. The probe of claim 38, wherein the blade electrode includes a crosspiece, the aspiration port is located proximal to the crosspiece, and the crosspiece spans the aspiration port.

40. The probe of claim 38, wherein the aspiration lumen in internal to the shaft.

41. The probe of claim 29, further comprising a fluid delivery unit.

42. The probe of claim 41, wherein the fluid delivery unit includes an outer sheath situated external to the shaft and forming an annular fluid delivery lumen between the outer sheath and the shaft, the annular fluid delivery lumen terminating in an annular fluid delivery port.

43. The probe of claim 42, wherein the fluid delivery port is located at the shaft distal end portion proximal to a return electrode.

44. The probe of claim 29, wherein the blade electrode comprises a material selected from the group consisting of platinum, tungsten, palladium, iridium, and titanium.

45. A plasma blade electrosurgical probe, comprising:

a shaft having a shaft distal end portion and a shaft proximal end portion;

at least one electrode support disposed on the shaft distal end portion; and

a blade electrode affixed to the at least one electrode support, wherein the blade electrode comprises a metal blade having a first arm, a second arm, and a crosspiece extending between the first arm and the second arm, the first arm and the second arm disposed on the at least one electrode support, and the blade electrode adapted for severing tissue via molecular dissociation of tissue components.

46. The electrosurgical probe of claim 45, further comprising a return electrode disposed on the shaft distal end portion at a location proximal to the at least one electrode support.

47. The electrosurgical probe of claim 45, wherein the blade electrode comprises a substantially flat metal blade having at least one active edge.

48. The electrosurgical probe of claim 47, wherein the at least one active edge is located on the crosspiece.

49. The electrosurgical probe of claim 45, wherein the blade electrode includes a proximal active edge and a distal active edge.

50. The electrosurgical probe of claim 45, wherein the blade electrode includes a first blade side and a second blade side, each of the first blade side and the second blade side adapted for engaging a severed tissue and for coagulating the severed tissue.

51. The electrosurgical probe of claim 45, wherein the at least one electrode support comprises a first electrode support and a second electrode support, and wherein the first arm and the second arm are affixed to the first electrode support and the second electrode support, respectively.

52. The probe of claim 45, further comprising an aspiration element including an aspiration lumen and an aspiration port.

53. The probe of claim 52, wherein the crosspiece is distal to the aspiration port, and the crosspiece spans the aspiration port.

54. The probe of claim 45, further comprising a fluid delivery unit, the fluid delivery unit including an outer sheath located external to the shaft and defining an annular fluid delivery lumen between the outer sheath and the shaft, the annular fluid delivery lumen terminating at the shaft distal end portion in an annular fluid delivery port.

55. An electrosurgical probe, comprising:

a shaft having a shaft distal end portion and a shaft proximal end portion, the shaft distal end portion including a laterally compressed region;

at least one electrode support affixed to the laterally compressed region;

a blade electrode disposed on the at least one electrode support, the blade electrode adapted for modifying tissue at a target site; and

an insulating sleeve covering a portion of the shaft, the insulating sleeve terminating distally in a sleeve distal end at a position proximal to the electrode support to define an exposed portion of the shaft distal end portion, and the exposed portion comprising a return electrode.

56. The probe of claim 55, wherein the blade electrode comprises a substantially flat metal blade having at least one active edge adapted for severing tissue via localized molecular dissociation of tissue components.

57. The probe of claim 55, wherein the blade electrode comprises a hook.

58. The probe of claim 55, wherein the blade electrode comprises a first arm, a second arm, and a crosspiece extending between the first arm and the second arm.

59. An electrosurgical apparatus, comprising:

a shaft having a shaft distal end portion and a shaft proximal end portion;

an electrode support arranged terminally on the shaft distal end portion;

a blade electrode disposed on the distal terminus of the electrode support, the blade electrode including an active edge and first and second blade sides, the active edge capable of localized ablation of tissue to form a first-modified tissue, the blade electrode adapted for engaging the first-modified tissue against at least one of the first and second blade sides, and the first and second blade sides capable of effecting hemostasis of the first-modified tissue; and

a return electrode arranged on the shaft distal end portion proximal to the electrode support.

60. The apparatus of claim 59, wherein the blade electrode consists essentially of at least one electrode arm in communication with a crosspiece, the at least one electrode arm arranged orthogonal to the crosspiece.

61. The apparatus of claim 59, wherein the blade electrode comprises a single metal blade having a shape selected from the group consisting of:

substantially semicircular, substantially rectangular, hooked, and arcuate.

62. The apparatus of claim 59, further comprising a high frequency power supply coupled to the blade electrode and to the return electrode for applying a high frequency voltage between the blade electrode and the return electrode.

63. The apparatus of claim 59, wherein the blade electrode is serrated.

64. The apparatus of claim 59, wherein the shaft comprises a material selected from the group consisting of tungsten, stainless steel alloys, platinum or its alloys, titanium or its alloys, molybdenum or its alloys, and nickel or its alloys;

and the electrode support comprises a material selected from the group consisting of a polyimide, a fluoropolymer, and a silicone rubber.

65. A plasma blade electrosurgical probe, comprising:

a shaft having a shaft distal end portion and a shaft proximal end portion;

an electrode support affixed to the shaft distal end portion;

a blade electrode mounted on the electrode support such that a substantially flat blade protrudes from the distal end of the electrode support, the blade electrode adapted for generating high electric current densities thereon and for localized molecular dissociation of tissue components in the vicinity of the blade electrode.

66. The probe of claim 65, wherein the blade electrode includes at least one active edge and essentially parallel first and second blade sides, and wherein the blade electrode has a shape selected from the group consisting of:

substantially rectangular, substantially semicircular, hooked, and arcuate.

67. A method of modifying a tissue at a target site of a patient'"'"'s body, comprising:

a) providing an electrosurgical probe having a shaft distal end, the shaft distal end bearing an electrode support, and the electrode support having an active electrode affixed thereto, the active electrode consisting essentially of a single blade electrode, the single blade electrode including at least one active edge and first and second blade sides, the at least one active edge adapted for severing tissue via molecular dissociation of components of the tissue;

b) positioning the shaft distal end in the vicinity of the target site such that the single blade electrode is in at least close proximity to the tissue at the target site; and

c) applying a high frequency voltage between the active electrode and a return electrode, wherein at least a portion of the tissue at the target site is ablated or modified.

68. The method of claim 67, wherein the ablated or modified tissue is dissected, transected, incised, or contracted.

69. The method of claim 67, wherein the tissue at the target site is modified by electrosurgical molecular dissociation of tissue components in the vicinity of the active electrode.

70. The method of claim 67, further comprising manipulating the probe such that the active electrode moves in a direction substantially parallel to a surface of the tissue.

71. The method of claim 70, wherein manipulating the probe comprises reciprocating the active electrode with respect to the tissue.

72. The method of claim 67, wherein the single blade electrode comprises a hook.

73. The method of claim 67, wherein the single blade electrode comprises a first arm, a second arm, and a crosspiece extending between the first arm and the second arm.

74. The method of claim 67, further comprising:

moving the at least one active edge with respect to the tissue, wherein the tissue is severed due to localized molecular dissociation of tissue components in a region of movement of the active edge.

75. The method of claim 74, wherein said moving step comprises engaging the active edge against the tissue and drawing the shaft distal end towards the operator.

76. The method of claim 67, wherein each of the first and second blade sides are adapted for engaging severed tissue and for coagulating the severed tissue.

77. The method of claim 74, further comprising engaging at least one of the first and second blade sides against the severed tissue such that hemostasis of the severed tissue is effected.

78. The method of claim 67, further comprising:

prior to said step c), delivering an electrically conductive fluid to the shaft distal end or to the target site such that a current flow path is formed between the active electrode and a return electrode.

79. The method of claim 67, further comprising:

aspirating unwanted materials from the target site via an aspiration lumen.

80. The method of claim 67, wherein the high frequency voltage applied between the active electrode and the return electrode is in the range of from about 10 to 500 volts RMS.

81. The method of claim 67, wherein the tissue at the target site is exposed to a temperature in the range of from about 40°

C. to 70°

C.

82. The method of claim 67, wherein the tissue comprises connective tissue.

83. The method of claim 82, wherein the connective tissue is selected from the group consisting of adipose tissue, cartilage, and bone.

84. A method of harvesting tissue or an organ from a patient using an electrosurgical probe, comprising:

accessing a tissue to be harvested; and

using the electrosurgical probe, dissecting the tissue to be harvested from connective tissue, the connective tissue located adjacent to the tissue to be harvested, the probe including a shaft having a shaft distal end, the shaft distal end bearing an electrically insulating electrode support, the electrode support having an active electrode affixed thereto, the active electrode consisting essentially of a single blade electrode, and the single blade electrode adapted, inter alia, for highly localized ablation of connective tissue via molecular dissociation of components of the connective tissue.

85. The method of claim 84, wherein accessing the tissue to be harvested comprises:

positioning the single blade electrode in at least close proximity to an overlying tissue, wherein the overlying tissue conceals the tissue to be harvested;

delivering an electrically conductive fluid to the single blade electrode such that a current flow path is formed between the single blade electrode and a return electrode; and

applying a high frequency voltage to the single blade electrode sufficient to sever the overlying tissue via localized molecular dissociation of components of the overlying tissue.

86. The method of claim 84, wherein the single blade electrode includes an active edge adapted for severing tissue via localized molecular dissociation of tissue components juxtaposed with the active edge of the single blade electrode.

87. The method of claim 84, wherein the single blade electrode comprises a hook.

88. The method of claim 84, wherein the single blade electrode further includes first and second blade sides adapted for engaging and coagulating severed tissue upon application of a high frequency voltage to the single blade electrode, and wherein accessing the tissue to be harvested includes engaging the severed tissue against at least one of the first and second blade sides such that hemostasis of the severed tissue is effected.

89. The method of claim 84, wherein dissecting the tissue to be harvested comprises:

positioning the single blade electrode in at least close proximity to the tissue to be harvested;

delivering an electrically conductive fluid to the single blade electrode such that a current flow path is formed between the single blade electrode and a return electrode; and

applying a high frequency voltage to the single blade electrode sufficient to ablate the connective tissue adjacent to the tissue to be harvested via molecular dissociation of connective tissue components, wherein at least a portion of the connective tissue is removed from the tissue to be harvested.

90. The method of claim 84, wherein the tissue to be harvested comprises at least a portion of an organ.

91. The method of claim 84, wherein dissecting the target tissue comprises applying to the single blade electrode a high frequency voltage in the range of from about 10 volts RMS to about 500 volts RMS.

92. A method of modifying a tissue at a target site of a patient, comprising:

a) providing an electrosurgical probe having a shaft distal end, the shaft distal end bearing at least one electrically insulating electrode support, and the at least one electrode support having an active electrode affixed thereto, the active electrode consisting essentially of a hook having at least one active edge, the at least one active edge adapted for severing tissue via molecular dissociation of components of the tissue;

b) positioning the shaft distal end in the vicinity of the target site such that the hook is in at least close proximity to the tissue at the target site; and

c) applying a high frequency voltage between the active electrode and a return electrode, the high frequency voltage sufficient to ablate or modify at least a portion of the tissue at the target site.

93. The method of claim 92, wherein the hook comprises a metal blade having first and second blade sides, the first and second blade sides adapted for engaging severed tissue and for coagulating the severed tissue.

94. The method of claim 92, wherein said step c) effects localized molecular dissociation of tissue components at the target site.

95. The method of claim 94, further comprising:

d) during said step c), moving the hook with respect to the tissue at the target site, wherein the tissue is severed at the target site.

96. The method of claim 95, wherein the tissue is severed during movement of the shaft distal end portion towards an operator of the probe.

97. The method of claim 95, wherein said step d) comprises engaging the at least one active edge with the tissue at the target site and reciprocating the at least one active edge with respect to the tissue at the target site.

98. The method of claim 95, further comprising:

e) during said step c), engaging severed tissue against at least one of the first and second blade sides, and coagulating the severed tissue thus engaged.