Electrosurgical systems and methods with temperature control

• US 6,557,559 B1
• Filed: 02/20/1998
• Issued: 05/06/2003
• Est. Priority Date: 01/07/1992
• Status: Expired due to Fees

• Current Assignee: ArthroCare Corporation (Smith & Nephew PLC)
• Original Assignee: ArthroCare Corporation (Smith & Nephew PLC)
• Inventors: Eggers, Philip E., Thapliyal, Hira V
• Primary Examiner(s): PEFFLEY, MICHAEL F
• Application Number:
  US09/026,852
• Time in Patent Office: 1,901 Days
• Field of Search: 606/31-34, 606/41, 606/42, 606/45-50, 607/100-105, 604/22, 604/114
• US Class Current: 128/898
• CPC Class Codes: A61B 18/12 by passing a current through the tissue to be heated, e.g. high-frequency current
• 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 2017/00097 one of the thermometric elements being an electrode or the heating element
• 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 2017/00292 mounted on or guided by flexible, e.g. catheter-like, means
• CPC Class Codes: A61B 2017/003 Steerable
• CPC Class Codes: A61B 2017/22001 Angioplasty, e.g. PCTA
• CPC Class Codes: A61B 2017/22038 with a guide wire
• CPC Class Codes: A61B 2018/00029 open
• 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 2018/00196 : reciprocating lengthwise
• CPC Class Codes: A61B 2018/00392 : Transmyocardial revascularisation
• 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 2018/00642 : with feedback, i.e. closed loop control
• CPC Class Codes: A61B 2018/0066 : without feedback, i.e. open loop control
• CPC Class Codes: A61B 2018/00678 : upper
• CPC Class Codes: A61B 2018/00726 : Duty cycle
• CPC Class Codes: A61B 2018/00761 : Duration
• CPC Class Codes: A61B 2018/00791 : Temperature
• CPC Class Codes: A61B 2018/00797 : measured by multiple temperature sensors
• 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 2018/00886 : Duration
• 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 2018/126 : 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 2090/378 : using ultrasound
• CPC Class Codes: A61B 2218/002 : Irrigation
• CPC Class Codes: A61B 2218/007 : Aspiration
• CPC Class Codes: A61F 2/2493 : Transmyocardial revascularisation [TMR] devices
• CPC Class Codes: A61M 25/0133 : Tip steering devices
• CPC Class Codes: A61M 25/0147 : with movable mechanical means, e.g. pull wires
• CPC Class Codes: A61M 25/0158 : with magnetic or electrical means, e.g. by using piezo materials, electroactive polymers, magnetic materials or by heating of shape memory materials
• CPC Class Codes: A61N 1/05 : for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence
• CPC Class Codes: A61N 1/403 : for thermotherapy, e.g. hyperthermia

Abstract

Vascular catheter comprises a catheter body having a proximal end, a distal end, and an electrode array disposed near the distal end. The electrode array is located proximally of a common electrode, typically located on a movable guidewire, and includes a plurality of isolated electrode terminals. By positioning the common electrode within a stenotic region and contacting a leading surface of the stenotic region with the electrode array, the stenotic material can be heated by applying a high frequency voltage between the electrode array and the common electrode. The stenotic region can thus be recannalized by advancing the distal end of the catheter body through the heated stenotic material.

Claims

1. A method for treating tissue at a target site comprising:

delivering an electrically conductive fluid to a target site in a patient'"'"'s body;

positioning an electrode terminal adjacent to or in contact with an irregular surface of a body structure at the target site in the presence of the electrically conductive fluid;

applying a high frequency voltage between the electrode terminal and a return electrode, the voltage being sufficient to recontour the irregular surface of the body structure; and

controlling the voltage applied between the electrode terminal and the return electrode based on a temperature at the target site.

2. The method of claim 1 wherein the electrically conductive fluid generates a conductive path between the electrode terminal and the body structure.

3. The method of claim 1 wherein the return electrode is located on a surface of a patient'"'"'s body.

4. The method of claim 1 further comprising sensing a temperature at the target site.

5. The method of claim 4 wherein the temperature measurement step is carried out with a temperature sensor adjacent the electrode terminal, the method further comprising interrupting or limiting power delivery to the electrode terminal if the measured temperature exceeds a threshold value.

6. The method of claim 5 wherein the temperature sensor is integral with the electrode terminal.

7. The method of claim 1 wherein the electrode terminal and the return electrode are both located on an instrument shaft.

8. The method of claim 1 wherein the target site is in the knee, shoulder, hip, ankle, elbow, wrist, hand, foot or spine.

9. The method of claim 1 further comprising maintaining a surface temperature of the tissue within a selected temperature range.

10. The method of claim 9 wherein the selected temperature range is between about 50°

C. to about 300°

C.

11. The method of claim 1 wherein the voltage is sufficient to remove the body structure at the target site.

12. The method of claim 1, wherein the target tissue comprises connective tissue located in or around a joint.

18. The method of claims 1 or 13 wherein the body structure comprises articular cartilage on the surface of a condyle, the method comprising smoothing an irregular surface of the articular cartilage.

19. The method of claims 1 or 13 further comprising positioning the return electrode within the electrically conductive fluid to generate a current flow path between the electrode terminal and the return electrode.

20. The method of claims 1 or 13 wherein electric current flows substantially through the electrically conductive fluid while minimizing electric current flow passing through the body structure.

21. The method of claims 1 or 13 wherein at least a portion of the electric current passes through the body structure.

22. The method of claims 1 or 13 wherein the electrode terminal comprises a single electrode disposed near the distal end of an instrument shaft.

23. The method of claims 1 or 13 wherein the electrode terminal includes an array of electrically isolated electrode terminals disposed near the distal end of an instrument shaft.

24. The method of claims 1 or 13 further comprising delivering the electrically conductive fluid to the body structure from an external source outside of the patient'"'"'s body.

25. The method of claim 24 wherein the electrically conductive fluid comprises isotonic saline.

26. The method of claim 23 including independently controlling current flow from at least two of the electrode terminals based on electrical impedance between each electrode terminal and the return electrode.

27. The method of claims 1 or 13 wherein the return electrode is spaced from the electrode terminal such that when the electrode terminal is brought adjacent a tissue structure immersed in electrically conductive fluid, the return electrode is spaced from the tissue structure and the electrically conductive fluid completes a conduction path between the electrode terminal and the return electrode.

28. The method as in claims 1 or 13 further including maintaining a space between the electrode terminal and the body structure during the applying step.

29. The method of claim 18 further comprising providing sufficient voltage to the electrode terminal to ablate at least a portion of the cartilage strands on the irregular surface of the articular cartilage to smooth said surface.

30. The method of claim 18 further comprising providing sufficient voltage to the electrode terminal to heat at least a portion of cartilage strands on the irregular surface of the articular cartilage to smooth said surface.

31. The method of claim 18 further comprising providing sufficient voltage to the electrode terminal to thermally soften at least a portion of the irregular surface of the articular cartilage to smooth said surface.

32. The method of claim 28 wherein the maintaining step comprises moving the electrode terminal transversely across the body structure.

13. A method for treating tissue at a target site comprising:

positioning an electrode terminal adjacent to or in contact with an irregular surface of a body structure at the target site in the presence of electrically conductive fluid;

applying a high frequency voltage between the electrode terminal and a return electrode, the voltage being sufficient to recontour the irregular surface of the body structure;

sensing a temperature at the target site; and

controlling the voltage applied to the electrode terminal and the return electrode based on said temperature.

14. The method of claim 13 wherein the high frequency voltage is applied from a high frequency power supply, and the method further comprises adjusting the output voltage of the power supply in response to a temperature set point and the temperature value sensed at the target site.

15. The method of claim 13, further comprising limiting or interrupting current flow to the electrode terminal when the temperature at the target site reaches a threshold value.

16. The method of claim 13 further comprising maintaining a surface temperature of the body structure within a selected temperature range.

17. The method of claim 16 wherein the selected temperature range is between about 50°

C. to about 300°

C.

33. A method for reshaping a target tissue using an electrosurgical system, the method comprising:

positioning an electrode array adjacent to or in contact with a surface of the target tissue, wherein the electrosurgical system includes a temperature sensor, and a high frequency power supply coupled to the electrode array and to the temperature sensor, the electrode array including a plurality of electrode terminals;

applying a high frequency voltage between the electrode array and a return electrode, the high frequency voltage being sufficient to reshape the target tissue; and

adjusting the high frequency voltage applied to at least one of the plurality of electrode terminals based on a temperature measured by the temperature sensor.

34. The method of claim 33, wherein the temperature is measured at an interface between the electrode array and the surface of the target tissue.

35. The method of claim 33, wherein each of the plurality of electrode terminals is independently coupled to the high frequency power supply.

36. The method of claim 33, wherein the high frequency power supply includes a temperature controller, and the temperature sensor is connected to the temperature controller.

37. The method of claim 33, wherein the electrosurgical system includes a probe having a distal end, and the method further comprises:

prior to the adjusting step, measuring the temperature using the temperature sensor, the temperature sensor disposed at the probe distal end.

38. The method of claim 33, wherein the high frequency power supply includes a plurality of independent current sources, each of the plurality of independent current sources independently connected to a corresponding one of the plurality of electrode terminals.

39. The method of claim 33 wherein the electrode array includes at least six electrode terminals.

40. The method of claim 33, wherein the electrode array includes at least 15 electrode terminals.

41. The method of claim 33, wherein each of the plurality of electrode terminals protrudes from an insulating matrix.

42. The method of claim 33, wherein each of the plurality of electrode terminals is flush with an insulating matrix.

43. The method of claim 33, further comprising:

delivering an electrically conductive fluid to the target tissue, and wherein said applying step effects selective heating of the target tissue while limiting heating of the electrically conductive fluid.

44. The method of claim 33, wherein the target tissue comprises connective tissue in or around a joint.

45. The method of claim 33, wherein the target tissue comprises articular cartilage or an articular meniscus.

46. A method for reshaping a target tissue using an electrosurgical system, the method comprising:

positioning an electrode array adjacent to or in contact with a surface of the target tissue, wherein the electrosurgical system includes a high frequency power supply coupled to a probe, the probe including the electrode array, and the electrode array having a plurality of electrode terminals;

applying a high frequency voltage between the electrode array and a return electrode, the high frequency voltage being sufficient to reshape the target tissue; and

independently limiting current flow to selected ones of the plurality of electrode terminals when a low resistance path exists between the selected ones of the plurality of electrode terminals and the return electrode.

47. The method of claim 46, wherein said step of independently limiting current flow is enacted via a plurality of current limiting circuit structures, each of the plurality of current limiting circuit structures coupled to a corresponding one of the plurality of electrode terminals.

48. The method of claim 47, wherein the plurality of current limiting circuit structures are integral with the high frequency power supply.

49. The method of claim 47, wherein each of the plurality of current limiting circuit structures comprises a passive current limiting circuit structure selected from the group consisting of inductors, capacitors, and resistors.

50. The method of claim 47, wherein each of the plurality of current limiting circuit structures comprises an active current limiting circuit structure.

51. The method of claim 50, wherein each active current limiting circuit structure comprises a switching element.

52. The method of claim 51, wherein each switching element switches off current flow to a corresponding one of the plurality of electrode terminals when the corresponding one of the plurality of electrode terminals is in contact with a low impedance return path to the return electrode.

53. The method of claim 50, wherein the active current limiting circuit structure comprises a relay, a silicon controlled rectifier, or a silicon controlled switch.

54. The method of claim 46, wherein the low resistance path comprises an electrically conductive fluid between at least one of the plurality of electrode terminals and the return electrode.

55. The method of claim 46, wherein the return electrode comprises a band of electrically conductive material located proximal to the electrode array.

56. The method of claim 46, wherein said applying step comprises sequentially energizing various sub-sets of the plurality of electrode terminals.

57. The method of claim 46, wherein the high frequency power supply includes a plurality of independent current sources, each of the plurality of independent current sources connected to a corresponding one of the plurality of electrode terminals.

58. The method of claim 57, wherein the high frequency power current sources are in parallel with each other, and each of the plurality of independent current sources are in series with the common voltage source.

59. The method of claim 46, further comprising:

manipulating the electrode array with respect to the target tissue, whereby the target tissue is reshaped.

60. The method of claim 46, further comprising:

during said applying step, exerting pressure on the target tissue via the probe.

61. The method of claim 46, wherein each of the plurality of electrode terminals are electrically insulated from each other.

62. The method of claim 46, wherein the electrosurgical system further includes a resistance measurement means for measuring an electrical resistance of a medium in contact with each of the plurality of electrode terminals, and wherein the resistance measurement means prevents application of the high frequency voltage if the measured electrical resistance exceeds a pre-selected level.

63. The method of claim 46, wherein the probe includes a shaft, and the electrode array is disposed at the shaft distal end.

64. The method of claim 63, wherein the electrode array is planar, disc-shaped, or hemispherical.

65. The method of claim 63, wherein the electrode array is linear.

66. The method of claim 46, wherein the target tissue comprises connective tissue.

67. The method of claim 46, wherein the target tissue is in or around a joint.

68. The method of claim 46, wherein the target tissue comprises articular cartilage or an articular meniscus.

69. A method for reshaping tissue at a target site, comprising:

positioning at least one electrode terminal adjacent to or in contact with a surface of the tissue at the target site in the presence of an electrically conductive fluid;

applying a high frequency voltage between the at least one electrode terminal and a return electrode, the voltage being sufficient to recontour the surface of the tissue; and

controlling the voltage applied between the at least one electrode terminal and the return electrode based on a temperature of the tissue at the target site.

70. The method of claim 69, further comprising:

delivering the electrically conductive fluid to the target site or to the at least one electrode terminal.

71. The method of claim 69, wherein the electrically conductive fluid comprises normal saline irrigant.

72. The method of claim 69, wherein the tissue has an electrical resistivity about four times as high as an electrical resistivity of the electrically conductive fluid.

73. The method of claim 72, wherein the high frequency voltage has a frequency of about 50 KHz or greater.

74. The method of claim 69, further comprising measuring the temperature of the tissue at the target site using a temperature sensor.

75. The method of claim 69, wherein the at least one electrode terminal comprises a plurality of electrode terminals, each of the plurality of electrode terminals independently coupled to a high frequency power supply.

76. The method of claim 69, wherein the high frequency power supply is further coupled to a temperature sensor.

77. The method of claim 69, wherein the target tissue comprises connective tissue in or around a joint.

78. The method of claim 69, wherein the target tissue comprises articular cartilage or an articular meniscus.