Apparatus and method for RF lesioning

• US 6,280,441 B1
• Filed: 12/15/1997
• Issued: 08/28/2001
• Est. Priority Date: 12/15/1997
• Status: Expired due to Term

• Current Assignee: Covidien AG (Medtronic Plc)
• Original Assignee: Sherwood Services AG
• Inventors: Ryan, Thomas Patrick
• Primary Examiner(s): Lateef, Marvin M.
• Assistant Examiner(s): SHAW, SHAWNA JEANNINE
• Application Number:
  US08/990,377
• Time in Patent Office: 1,352 Days
• Field of Search: 606/45, 606/41, 606/48, 607/99, 607/101, 607/154, 600/373
• US Class Current: 606/45
• 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 2017/00026 Conductivity or impedance, e.g. of tissue
• CPC Class Codes: A61B 2018/00023 closed, i.e. without wound contact by the fluid
• CPC Class Codes: A61B 2018/00702 Power or energy
• CPC Class Codes: A61B 2018/00875 Resistance or impedance
• CPC Class Codes: A61B 2018/1435 Spiral

Abstract

To ablate target tissue a handle with proximal and distal ends connect to an interior passageway and along an axis. A semi rigid and helical effector at the distal end is along the axis and has a sharpened distal tip and a mount at its handle attachment. A source of radio frequency current supplies the effector and is insulated from the handle for delivery to bipolar and monopolar circuits. A return electrode connects between tissue and the source of radio frequency current. A sensor is carried on the handle positioned to measure target tissue ablation. A control couples the source of radio frequency current and the sensor for loop regulation of ablation. The effector is a wire bent into the helical shape with an insulating sleeve to prevent passage of radio frequency current near its mount. The sensor has a calculator to find impedance or temperature changes and the control examines for a rise. The effector is in an alternate a hollow tube bent into the helical shape and closed at its distal tip; the handle has a passage for fluid circulation. A return located on the effector insulating sleeve has a larger surface area than the distal tip. A bipolar delivery effector carries at least two electrodes supplied with current of opposite polarity between the electrodes. The effector is a framework with at least two supports for locating electrodes in spaced apart relationship about the distal tip. A plurality of electrodes are in an alternate coupled to the source of radio frequency current to receive opposite polarity from a multiplexer coupled electrically between the source of radio frequency current and the plurality of electrodes for selective delivery of radio frequency current of opposite polarity to at least two of the electrodes at the same time. An elongate shank extending from the mount to the helical shaped part of the effector for laparoscopic applications. A portal near the distal tip diverts the sensor to a position to measure target tissue. A light based system has a fiber optic for measurement of radiation of the target tissue with a meter. The control has a power modulator to maintain the impedance at approximately its low point. A method of ablating subsurface tissue includes inserting the distal tip into an entry point, rotating the effector about its axis to screw the helical shape into the tissue, and delivering controlled amounts of radio frequency current to the tissue.

Claims

1. An electrosurgical apparatus for thermally treating tissue, the apparatus comprising:

an elongate body having a proximal end and a distal end and defining a longitudinal axis;

an effector mounted to the distal end of the body and being rotatable relative to the body, the effector having a general helical shaped portion and having a sharpened distal closed tip, the effector having defining an internal lumen for circulating cooling fluid within the effector to cool the effector;

a source of cooling fluid in fluid communication with the internal lumen of the effector;

a drive member disposed within the elongate body and operatively connected to the effector, the drive member axially stationary relative to the elongate body and being rotatable to cause corresponding rotational movement of the effector;

a source of radio frequency current coupled to the effector and insulated from the body;

a sensor mounted to the distal end of the elongate body and extending within an inner boundary defined within the helical shaped portion to measure within the target tissue the extent of ablation about the effector due to the passage of radio frequency current through the target tissue;

a control coupled between the source of radio frequency current and the sensor to effect a loop regulation of the delivery of the radio frequency current for defining the extent of ablation; and

an actuator operatively connected to the effector whereby manipulation of the actuator causes corresponding rotational movement of the drive member and the effector relative to the elongate body.

2. The electrosurgical apparatus according to claim 1 wherein the effector is an RF electrode having an insulating sleeve.

3. The electrosurgical apparatus according to claim 1 wherein a calculator is associated with the sensor to find impedance changes during the delivery of radio frequency current to the target tissue and the control examines the changes for a rise in impedance calculated.

4. The electrosurgical apparatus according to claim 3 wherein the control includes a radio frequency power modulator to maintain the impedance at approximately the low point before it begins to rise.

5. The electrosurgical apparatus according to claim 3 wherein a user setting is provided to set a predetermined value of impedance and the control includes a radio frequency power modulator to maintain the impedance at the predetermined value.

6. The electrosurgical apparatus according to claim 1 wherein the effector is a hollow tube bent into the helical shape and the elongate body includes a passage for fluid circulation within the hollow tube.

7. The electrosurgical apparatus according to claim 6 wherein the hollow tube includes a portal near the distal tip for diverting the sensor to a position to measure within the target tissue the extent of ablation about the effector due to the passage of radio frequency current through the target tissue.

8. The electrosurgical apparatus according to claim 1 wherein the sensor includes a fiber optic to quantify target tissue ablation measurement by changes in the radiation of the target tissue with a radiation sensitive meter.

9. The electrosurgical apparatus according to claim 1 wherein the sensor includes a probe to find target tissue temperature changes during the delivery of radio frequency current to the target tissue and the control examines the changes for a rise in temperature from a preset value.

10. The electrosurgical apparatus according to claim 9 wherein a look up table is provided to supply at least one preset value of temperature as a function of measured impedance and the control includes a radio frequency power modulator to maintain the temperature at the preset value.

11. The electrosurgical apparatus according to claim 9 wherein the preset value of temperature is in the range of about 60 to 105 degrees Celsius.

12. The electrosurgical apparatus according to claim 1 wherein the actuator is rotatable.

13. The electrosurgical apparatus according to claim 1 wherein the effector includes an outer wall which defines the internal lumen, the outer wall being devoid of openings.

14. A method of ablating subsurface target tissue without ablating surface tissue where the surface is about an initial entry point, the method comprising the steps of:

providing an electrosurgical apparatus, the apparatus including an elongate body defining a longitudinal axis, a drive member disposed within the elongate body and rotatable therewithin, and an effector mounted to the body and operatively connected to the drive member, the effector being rotatable upon rotational movement of the drive member, the effector having a general helical shaped portion and a sharpened distal tip and a source of radio frequency current coupled to the effector;

inserting the distal tip of the effector into the initial entry point;

rotating the drive member to cause rotational movement of the effector relative to the body such that the effector penetrates the subsurface target tissue without longitudinally moving the drive member relative to the elongate body; and

delivering controlled amount of radio frequency current to the subsurface target tissue while sparing the surface tissue from ablation.

15. The method of claim 14 wherein the step of delivering controlled amounts of radiofrequency current includes measuring impedance changes in the subsurface target tissue about the subsurface target tissue about the distal tip with a sensor.

16. The method of claim 14 with the step of delivering controlled amounts of radio frequency current by measuring the temperature changes in the subsurface target tissue about the distal tip with a sensor set to adjust the radio frequency current to a preset temperature.

17. An electrosurgical apparatus for thermally treating tissue, the apparatus comprising:

an elongate body having a proximal end and a distal end and defining a longitudinal axis;

an electrode mounted to the elongate body and extending from the distal end of the body, the electrode having a generally helical configuration along at least a portion of its length and being rotatable relative to the elongate body, the electrode having an outer insulating sleeve mounted thereto and arranged to define at least two spaced exposed conductive portions of the electrode;

a source of radio frequency (RF) energy in electrical communication with the effector and being electrically insulated from the elongate body; and

a handle mounted to the elongated body, the handle including a frame and an actuator pivotally mounted to the frame, the actuator operatively connected to the effector such that pivotal movement of the actuator causes corresponding rotational movement of the effector.

18. The apparatus according to claim 17, wherein the electrode has a sharpened tip at a distal end thereof for penetrating tissue.

19. The apparatus according to claim 18, wherein the electrode includes a monopolar RF electrode.

20. The apparatus according to claim 18, wherein the first-mentioned electrode is an active RF electrode and further including a second return electrode.

21. The apparatus according to claim 18, further comprising a sensor mounted to the elongate body and extending from the distal end of the elongate body to measure the extent of thermal treatment of the tissue.

22. The apparatus according to claim 21, wherein the sensor is adapted to measure an impedance value of the tissue during treatment, and further including a control to compare the measured impedance value to a preset impedance value whereby the control cooperates with the source of RF energy to maintain the measured impedance value of the tissue at the preset impedance value.

23. The apparatus according to claim 21, wherein the sensor is adapted to measure a temperature value of the tissue during treatment, and further including a control to compare the measured temperature value to a preset temperature value whereby the control cooperates with the source of RF energy to maintain the measured temperature value of the tissue at the preset temperature value.

24. The apparatus according to claim 21, wherein the sensor extends from the distal end of the body and is located within an interior area defined by the generally helical configuration of the electrode.

25. The apparatus according to claim 21, wherein the electrode defines an internal passageway for support of the sensor therewithin, the effector further defining a portal for positioning the sensor to measure the extent of thermal treatment of the tissue.

26. The apparatus according to claim 18, wherein at least two electrodes of opposite polarity are mounted to the elongate body.

27. The apparatus according to claim 18, wherein the electrode defines an internal passageway for fluid circulation therewithin.

28. The apparatus according to claim 27, wherein the body defines a passageway in fluid communication with the internal passageway of the electrode.

29. The apparatus according to claim 18, wherein a handle is mounted to the proximal end of the body, the handle including a rotation mechanism for causing rotation of the electrode.

30. The apparatus according to claim 29, wherein the rotation mechanism includes an actuator coupled to the handle and movable relative to the body to cause rotation of the electrode.

31. The apparatus according to claim 30, wherein the actuator is coupled to a ratchet mechanism for incremental rotation of the electrode.

32. The apparatus according to claim 30, wherein the handle further includes a lever for controlling rotational direction.

33. The apparatus according to claim 18, wherein the electrode is retractable within an internal passageway defined within the body.

34. An electrosurgical apparatus for thermally treating tissue, the apparatus comprising:

an elongate body having a proximal end and a distal end and defining a longitudinal axis;

an effector mounted to the elongate body and extending from the distal end of the elongate body, and being rotatable relative to the elongate body, the effector including at least two generally helical shaped monopolar RF electrodes, each RF electrode having a sharpened tip at a distal end thereof for penetrating tissue; and

a source of radio frequency (RF) energy in electrical communication with the effector and being electrically insulated from the elongate body.

35. An electrosurgical apparatus for thermally treating tissue, the apparatus comprising:

an elongate body having a proximal end and a distal end and defining a longitudinal axis;

an articulating member mounted to the distal end of the elongate body, the articulating member adapted to pivot relative to the longitudinal axis of the body;

an effector mounted to the articulating member to pivot therewith, the effector having a generally helical configuration along at least a portion of its length and being rotatable relative to the articulating member; and

a source of radio frequency (RF) energy in electrical communication with the effector and being electrically insulated from the elongate body.

36. A method for treating prostatic tissue, the method comprising the steps of:

providing an electrosurgical apparatus, the apparatus including an elongate body and at least one effector mounted to the body and extending from the distal end of the body, the effector having a generally helical configuration along at least a portion of its length and being rotatable relative to the body;

positioning the apparatus within a prostatic urethra;

rotating the effector relative to the body to cause penetration into the prostatic tissue; and

supplying RF energy to the effector from and RF energy source to thermally treat the prostatic tissue.

37. The method according to claim 36, wherein the apparatus further includes a sensor and further including a step of measuring the extent of treatment.

38. The method according to claim 36, wherein the step of rotating includes moving a manually manipulable actuator operatively connected to the effector whereby manipulation of the actuator causes corresponding rotational movement of the effector.

39. The method according to claim 38 wherein the actuator is pivotally mounted with respect to the elongate body and wherein the step of rotating includes pivoting the actuator to cause rotational movement of the effector.

40. An electrosurgical apparatus for thermally treating tissue, which comprises:

an elongate body;

an effector mounted to the elongate body, the effector having a general helical coiled configuration along at least a portion of a length thereof, the effector having an outer wall defining an enclosed internal lumen for circulating cooling fluid through the effector; and

an electromagnetic energy source in electrical communication with the effector.

41. The electrosurgical apparatus according to claim 40 wherein the electromagnetic energy source is a radio frequency source, the effector being a radio frequency electrode.

42. An electrosurgical apparatus for thermally treating tissue, which comprises:

an elongate body;

an effector mounted to the elongate body, the effector having a general helical coiled configuration along at least a portion of a length thereof, the effector including an internal lumen and having a portal in the outer wall in communication with the internal lumen;

a sensor probe disposed within the internal lumen of the effector to measure a degree of thermal treatment of tissue adjacent the effector, the sensor probe extendable through the portal of the effector; and

an electromagnetic energy source in electrical communication with the effector.