Electrosurgical apparatus having digestion electrode and methods related thereto

• US 6,896,674 B1
• Filed: 11/08/2000
• Issued: 05/24/2005
• Est. Priority Date: 05/10/1993
• Status: Expired due to Fees

• Current Assignee: ArthroCare Corporation (Smith & Nephew PLC)
• Original Assignee: ArthroCare Corporation (Smith & Nephew PLC)
• Inventors: Davison, Terry S., Woloszko, Jean, Eggers, Philip E., Hovda, David C., Thapliyal, Hira V.
• Primary Examiner(s): Cohen, Lee S.
• Application Number:
  US09/709,035
• Time in Patent Office: 1,658 Days
• Field of Search: 606/32, 606/41, 606/45, 606/48, 606/49, 606/50, 604/114, 604/35, 607/99, 607/105, 607/113
• US Class Current: 606/41
• CPC Class Codes: A61B 18/1206 Generators therefor
• CPC Class Codes: A61B 18/14 Probes or electrodes 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 2018/00095 high, i.e. heat conducting
• CPC Class Codes: A61B 2018/00119 with metal oxide nitride
• 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 2018/00267 having a basket shaped structure
• CPC Class Codes: A61B 2018/00327 Ear, nose or throat
• CPC Class Codes: A61B 2018/00392 : Transmyocardial revascularisation
• CPC Class Codes: A61B 2018/00434 : Neural system
• CPC Class Codes: A61B 2018/0044 : Spinal cord
• 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 2018/00589 : Coagulation
• CPC Class Codes: A61B 2018/00601 : Cutting
• CPC Class Codes: A61B 2018/00666 : using a threshold value
• CPC Class Codes: A61B 2018/00678 : upper
• CPC Class Codes: A61B 2018/00702 : Power or energy
• CPC Class Codes: A61B 2018/0072 : Current
• CPC Class Codes: A61B 2018/00726 : Duty cycle
• CPC Class Codes: A61B 2018/00779 : Power or energy
• CPC Class Codes: A61B 2018/00791 : Temperature
• CPC Class Codes: A61B 2018/00827 : Current
• CPC Class Codes: A61B 2018/00875 : Resistance or impedance
• CPC Class Codes: A61B 2018/00982 : combined with or comprising means for visual or photographic inspections inside the body, e.g. endoscopes
• CPC Class Codes: A61B 2018/00988 : Means for storing information, e.g. calibration constants, or for preventing excessive use, e.g. usage, service life counter
• 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 2018/1467 : 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 2218/007 : Aspiration
• CPC Class Codes: A61F 2/2493 : Transmyocardial revascularisation [TMR] devices

Abstract

Methods and apparatus for resecting and ablating tissue at a target site of a patient, the apparatus including a probe having an elongate shaft. The shaft includes a shaft distal end portion and a shaft proximal end portion, and a resection unit located at the shaft distal end portion. The resection unit includes a resection electrode support and at least one resection electrode arranged on the resection electrode support. The at least one resection electrode includes a resection electrode head. The probe and resection electrode head are adapted for concurrent electrical ablation and mechanical resection of target tissue. The shaft may include at least one digestion electrode capable of aggressively ablating resected tissue fragments. At least one fluid delivery port on the shaft distal end portion may provide an electrically conductive fluid to the resection unit or to the target site. The shaft may include at least one aspiration port, located proximal to the resection unit, for aspirating excess or unwanted fluids and resected tissue fragments from the target site. The at least one aspiration port is coupled to an aspiration lumen. The at least one digestion electrode may be arranged within the aspiration lumen for ablation of tissue fragments therein. In use, the digestion and resection electrodes of the probe are coupled to a high frequency power supply. A surgical kit comprising the probe is also disclosed, together with a method of making the probe.

Claims

1. An electrosurgical apparatus for resecting and ablating tissue at a target site, comprising:

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

at least one aspiration port coupled to an aspiration lumen, the aspiration lumen disposed within the shaft;

at least one digestion electrode arranged within the aspiration lumen, the at least one digestion electrode being coupled to a high frequency power supply and serving as an active electrode, and the at least one digestion electrode being capable of ablation of tissue fragments; and

a resection unit located at the shaft distal end portion, the resection unit including a resection electrode support arranged on said distal end portion and at least one resection electrode arranged on the resection electrode support, wherein the at least one resection electrode includes a cutting edge extending away from the resection electrode support and is capable of ablating and mechanically resecting the tissue at the target site.

2. The electrosurgical apparatus of claim 1, wherein each of the at least one resection electrodes comprises a resection electrode head.

3. The electrosurgical apparatus of claim 2, wherein the resection electrode support protrudes from an external surface of the shaft.

4. The electrosurgical apparatus of claim 2, wherein the resection electrode head protrudes from an external surface of the shaft by a distance in the range of from about 0.1 to about 20 mm.

5. The electrosurgical apparatus of claim 2, wherein the resection electrode head comprises a wire or a blade.

6. The electrosurgical apparatus of claim 2, wherein the resection electrode head comprises a wire having a cross-sectional shape selected from the group consisting of substantially round, substantially square, and substantially triangular.

7. The electrosurgical apparatus of claim 2, wherein the resection electrode head comprises a wire having a cross-sectional shape including at least one cusp.

8. The electrosurgical apparatus of claim 2, wherein the resection electrode head comprises a serrated wire.

9. The electrosurgical apparatus of claim 2, wherein the cutting edge comprises a wire having a cutting edge.

10. The electrosurgical apparatus of claim 9, wherein the cutting edge is serrated.

11. The electrosurgical apparatus of claim 9, wherein the resection electrode head comprises a wire having an insulating layer disposed on a covered portion of the wire, wherein the covered portion of the wire excludes the cutting edge.

12. The electrosurgical apparatus of claim 2, wherein the resection electrode head 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.

13. The electrosurgical apparatus of claim 1, wherein the resection unit includes a plurality of resection electrode heads.

14. The electrosurgical apparatus of claim 13, wherein the plurality of resection electrode heads are capable of mechanically resecting tissue to provide a plurality of resected tissue fragments, and the plurality of resection electrode heads are further capable of electrically ablating the resected tissue fragments.

15. The electrosurgical apparatus of claim 13, wherein the plurality of resection electrode heads comprise at least one resection electrode array.

16. The electrosurgical apparatus of claim 15, wherein the at least one resection electrode array comprises a plurality of resection electrode heads arranged substantially parallel to each other.

17. The electrosurgical apparatus of claim 13, wherein the plurality of resection electrode heads comprise a first resection electrode head array and a second resection electrode head array, wherein the first resection electrode head array is arranged at an angle to a longitudinal axis of the resection unit in the range of from about 105°

to about 165°

, and the second resection electrode head array is arranged at an angle to the longitudinal axis of the resection unit in the range of from about 15°

to about 75°

.

18. The electrosurgical apparatus of claim 2, further comprising a return electrode coupled to the shaft, wherein the at least one resection electrode head is coupled to a high frequency power supply for applying a high frequency voltage to the at least one resection electrode head, and the at least one resection electrode head is adapted to provide a high current density in the vicinity of the at least one resection electrode head upon application of a high frequency voltage between the at least one resection electrode head and the return electrode.

19. The electrosurgical apparatus of claim 18, wherein the high frequency voltage is characterized as having a peak-to-peak voltage in the range of from about 10 to 2000 volts, a RMS voltage in the range of from about 5 to 1000 volts, and a frequency in the range of from about 5 KHz to 20 MHz.

20. The electrosurgical apparatus of claim 2, further comprising a return electrode coupled to the shaft, wherein the resection electrode head is adapted to promote generation of a plasma in the vicinity of the resection electrode head upon application of a high frequency voltage between the at least one resection electrode and the return electrode, and the plasma causes molecular dissociation of high molecular weight tissue components to yield low molecular weight ablation by-products.

21. The electrosurgical apparatus of claim 1, wherein the shaft distal end portion includes a cavity, and the resection electrode support is arranged in the cavity.

22. The electrosurgical apparatus of claim 1, wherein the shaft distal end portion includes a curve.

23. The electrosurgical apparatus of claim 1, wherein the resection electrode support is disposed on a return electrode, and the resection electrode support electrically insulates the at least one resection electrode from the return electrode.

24. The electrosurgical apparatus of claim 1, further comprising at least one fluid delivery port exiting the shaft distal portion for delivering an electrically conductive fluid to the resection unit or to the target site.

25. The electrosurgical apparatus of claim 24, wherein the at least one fluid delivery port delivers an electrically conductive fluid in a plurality of directions such that the electrically conductive fluid immerses the at least one resection electrode.

26. The electrosurgical apparatus of claim 1, further comprising a plurality of aspiration ports, each aspiration port being coupled to the aspiration lumen.

27. The electrosurgical apparatus of claim 1, wherein the at least one aspiration port is located on an external surface of the shaft at a distance of from about 5 mm to about 50 mm proximal to the resection electrode support.

28. The electrosurgical apparatus of claim 1, wherein the at least one digestion electrode comprises a plurality of digestion electrodes.

29. The electrosurgical apparatus of claim 28, wherein the plurality of digestion electrodes at least partially interweave with each other.

30. The electrosurgical apparatus of claim 1, wherein the at least one resection electrode is coupled to a high frequency power supply for delivering a high frequency voltage between the at least one resection electrode and a return electrode, wherein the high frequency voltage is sufficient to ablate at least a portion of the tissue at the target site, and the tissue ablated at the target site is exposed to a temperature in the range of from about 45°

to 90°

C.

31. The electrosurgical apparatus of claim 1, wherein the resection electrode support electrically insulates the at least one resection electrode from a return electrode coupled to the shaft.

32. The electrosurgical apparatus of claim 1, wherein the resection electrode support comprises a material selected from the group consisting of a glass, a ceramic, a silicone, a urethane, a polyurethane, a polyimide, silicon nitride, polytetrafluoroethylene, and alumina.

33. The electrosurgical apparatus of claim 1, wherein said at least one resection electrode support is arranged laterally on said distal end portion.

34. An electrosurgical instrument for resecting and ablating tissue at a target site, comprising:

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

a resection unit located at the shaft distal end portion, the resection unit including a resection electrode support and a plurality of resection electrode heads arranged on the resection electrode support where the resection electrodes include a cutting edge extending away from the resection electrode support and capable of mechanically resecting the tissue at the target site;

an aspiration device including at least one aspiration port proximal to the resection unit and an aspiration lumen coupled to the at least one aspiration port; and

at least one digestion electrode arranged on the aspiration device, said at least one digestion electrode adapted to provide high current density upon application of a high frequency voltage.

35. The electrosurgical instrument of claim 34, wherein each of the plurality of resection electrode heads comprises a wire loop or a blade.

36. The electrosurgical instrument of claim 34, wherein the aspiration device accommodates an aspiration stream including excess fluids and resected tissue fragments, the at least one digestion electrode arranged within the aspiration lumen and coupled to a high frequency power supply, and the at least one digestion electrode adapted for aggressive ablation of the resected tissue fragments.

37. The electrosurgical instrument of claim 34, further comprising an electrically insulating sleeve covering the shaft to a position proximal of the resection unit.

38. The electrosurgical instrument of claim 34, further comprising a return electrode disposed on the shaft distal end portion, wherein at least one fluid delivery port delivers an electrically conductive fluid to provide a current flow path between the return electrode and the plurality of resection electrode heads.

39. The electrosurgical instrument of claim 38, wherein each of the at least one fluid delivery port delivers the electrically conductive fluid towards the plurality of resection electrode heads, and the plurality of resection electrode heads generate a plasma from the electrically conductive fluid upon application of a high frequency voltage to the plurality of resection electrode heads, and the plasma causes molecular dissociation of the tissue at a temperature in the range of from about 45°

to 90°

C.

40. The electrosurgical instrument of claim 34, wherein each of the plurality of resection electrode heads includes a surface geometry configured to promote substantially high electric field intensities in the vicinity of the plurality of resection electrode heads when a high frequency voltage is applied to the plurality of resection electrode heads, wherein the high frequency voltage is characterized by a peak-to-peak voltage in the range of from about 10 to 2000 volts, a RMS voltage in the range of from about 5 to 1000 volts, and a frequency in the range of from about 5 KHz to 20 MHz, and the electric field intensities are sufficient to vaporize an electrically conductive fluid in contact with the plurality of resection electrode heads.

41. A method of removing tissue at a target site of a patient, comprising:

a) advancing a shaft distal end portion of an electrosurgical probe towards the target site, the shaft distal end portion having a resection unit disposed thereon, the resection unit including at least one resection electrode head extending laterally away from the resection unit and adapted for ablating and mechanically resecting body tissue components; and

b) applying a high frequency voltage between the at least one resection electrode head and a return electrode wherein the target site is aspirated by a vacuum source coupled to at least one aspiration port, wherein the at least one aspiration port is located a distance of from about 5 mm to about 50 mm proximal to the resection unit.

42. The method of claim 41, further comprising:

c) contacting the tissue at the target site with the at least one resection electrode head, such that the tissue at the target site is removed by at least one mechanism selected from the group consisting of mechanical resection and molecular dissociation.

43. The method of claim 42, further comprising:

d) concurrently with said step c), exerting a mechanical force on the at least one resection electrode head such that pressure is exerted by the at least one resection electrode head on the tissue at the target site, wherein the mechanical force exerted results in resection of at least a portion of the tissue at the target site to form resected tissue fragments.

44. The method of claim 43, wherein at least a portion of the resected tissue fragments undergo molecular dissociation as a result of said step b) to yield low molecular weight ablation by-products.

45. The method of claim 43, further comprising:

e) during said steps b), c), and d), moving the at least one resection electrode head with respect to the tissue at the target site.

46. The method of claim 45, wherein said step e) comprises moving the at least one resection electrode head in a direction substantially perpendicular to a direction of the mechanical force exerted.

47. The method of claim 45, wherein said step e) comprises moving the at least one resection electrode head in a direction substantially parallel to a surface of the tissue at the target site.

48. The method of claim 45, further comprising:

successively repeating said step e) until an appropriate volume of tissue has been removed from the target site.

49. The method of claim 43, wherein the shaft further includes an aspiration lumen having at least one digestion electrode disposed therein, and the method farther comprises:

f) aspirating the resected tissue fragments into the aspiration lumen; and

g) applying a high frequency voltage to the at least one digestion electrode such that components of the resected tissue fragments undergo molecular dissociation within the aspiration lumen.

50. The method of claim 41, further comprising:

delivering an electrically conductive fluid to the target site.

51. The method of claim 50, wherein said step of delivering comprises delivering the electrically conductive fluid via at least one fluid delivery port.

52. The method of claim 50, wherein said step of delivering comprises immersing the at least one resection electrode head in the electrically conductive fluid.

53. The method of claim 41, wherein the at least one resection electrode head comprises a plurality of resection electrode heads arranged on the resection unit as a resection electrode head array.

54. The method of claim 41, wherein the at least one resection electrode head is coupled to a power supply, the power supply applies a high frequency voltage to the at least one resection electrode head, the at least one resection electrode head promotes a high current density thereat in response to the applied high frequency voltage, the at least one resection electrode head is in contact with an electrically conductive fluid, and application of the high frequency voltage generates a plasma from the electrically conductive fluid.

55. The method of claim 54, wherein the plasma causes molecular dissociation of tissue components at the target site, and the molecular dissociation of the tissue components results in ablation of the tissue at the target site.

56. The method of claim 41, wherein said step b) comprises applying sufficient voltage to the at least one resection electrode head in the presence of an electrically conductive fluid to vaporize at least a portion of the electrically conductive fluid between the at least one resection electrode head and the tissue at the target site.

57. The method of claim 56, further comprising accelerating charged particles from the vaporized fluid to the tissue to cause molecular dissociation of tissue components at the target site.

58. A method of making an electrosurgical resection and ablation probe, comprising:

a) providing a shaft including a shaft distal end and a shaft proximal end, the shaft distal end having at least one resection unit thereon, the at least one resection unit including a resection electrode support arranged laterally on said shaft distal end and at least one resection electrode head, wherein the shaft comprises at least one aspiration port coupled to an aspiration lumen, and the aspiration lumen is disposed within the shaft and wherein said probe further comprises at least one digestion electrode arranged within said aspiration lumen, said at least one digestion electrode having a positive connection with a voltage supply and serving as an active electrode;

b) providing a handle; and

c) affixing the handle to the shaft.

59. The method of claim 58, wherein said step b) comprises providing a handle having a connection block, the at least one digestion electrode and the at least one resection electrode head are coupled to the connection block, and the connection block is adapted for coupling the at least one digestion electrode and the at least one resection electrode head to a high frequency power supply.

60. The method of claim 58, wherein the shaft includes a plurality of digestion electrodes arranged within the aspiration lumen.

61. The method of claim 58, further comprising the step of:

d) encasing a proximal portion of the shaft within an insulating sleeve to provide a distal exposed portion of the shaft, wherein the distal exposed portion of the shaft defines a return electrode.

62. The method of claim 61, wherein said step a) comprises providing a shaft having the at least one resection unit disposed on the return electrode.

63. The method of claim 58, wherein said step a) comprises providing a shaft having at least one fluid delivery port coupled to a fluid delivery lumen, wherein the at least one fluid delivery port at least partially surrounds the at least one resection unit.

64. The method of claim 58, wherein said step a) comprises providing a shaft wherein the at least one resection unit includes a resection electrode support and the at least one resection electrode head comprises a plurality of resection electrode heads arranged on the resection electrode support, wherein each of the plurality of resection electrode heads comprises a wire or a blade.

65. The method of claim 58, wherein the handle includes a connection block for coupling the probe to a high frequency power supply, and the method further comprises:

e) coupling the at least one resection electrode head to the connection block; and

f) coupling the at least one digestion electrode to the connection block.

66. The method of claim 58, wherein the at least one resection electrode head includes a cutting edge and a covered portion, the covered portion having an insulating layer disposed thereon.

67. A method for resecting tissue comprising:

a) inserting a distal end of an electrosurgical apparatus into a target tissue space;

b) resecting target tissue with at least one resection head arranged at said distal end of said electrosurgical apparatus;

c) aspirating tissue fragments arising from said step b) through a lumen extending through said electrosurgical apparatus; and

d) ablating said tissue fragments within said aspiration lumen with at least one digestion electrode arranged within said aspiration lumen wherein said at least one digestion electrode is an active electrode having a positive connection to a voltage supply.

68. The method of claim 67 wherein said step b) comprises ablating tissue.