Apparatus and method for creating, maintaining, and controlling a virtual electrode used for the ablation of tissue

• US 6,409,722 B1
• Filed: 07/06/1999
• Issued: 06/25/2002
• Est. Priority Date: 07/07/1998
• Status: Expired due to Term

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Goetz, Steven M., Christopherson, Mark A., Hoey, Michael F.
• Primary Examiner(s): PEFFLEY, MICHAEL F
• Application Number:
  US09/347,635
• Time in Patent Office: 1,085 Days
• Field of Search: 606/27-34, 606/41, 606/42, 607/101-105
• US Class Current: 606/34
• CPC Class Codes: A61B 18/1206 Generators therefor
• CPC Class Codes: A61B 18/1233 with circuits for assuring patient safety
• CPC Class Codes: A61B 18/14 Probes or electrodes therefor
• CPC Class Codes: A61B 18/1402 Probes for open surgery
• CPC Class Codes: A61B 18/18 by applying electromagnetic radiation, e.g. microwaves radiation therapy A61N5/00
• CPC Class Codes: A61B 18/1815 using microwaves
• CPC Class Codes: A61B 2018/00029 open
• CPC Class Codes: A61B 2018/00196 reciprocating lengthwise
• 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 2018/00708 switching the power on or off
• CPC Class Codes: A61B 2018/00779 Power or energy
• 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 2018/00875 Resistance or impedance
• CPC Class Codes: A61B 2018/1213 creating an arc
• CPC Class Codes: A61B 2018/1253 monopolar
• CPC Class Codes: A61B 2018/1417 Ball
• CPC Class Codes: A61B 2018/1472 : for use with liquid electrolyte, e.g. virtual electrodes
• CPC Class Codes: A61B 2018/1475 : Electrodes retractable in or deployable from a housing
• CPC Class Codes: A61B 2218/002 : Irrigation
• CPC Class Codes: A61B 2218/007 : Aspiration

Abstract

The present invention provides an apparatus and a method for producing a virtual electrode within or upon a tissue to be treated with radio frequency alternating electric current. An apparatus in accordance with the present invention includes a supply of a conductive or electrolytic fluid to be provided to the patient, an alternative current generator, and a processor for creating, maintaining and controlling the ablation process by the interstitial or surficial delivery of the fluid to a tissue and the delivery of electric power to the tissue via the virtual electrode. The method in accordance with the invention includes the steps of delivering a conductive fluid to a predetermined tissue ablation site for a predetermined time period, applying a predetermined power level of radio frequency current to the tissue, monitoring at least one of several parameters and adjusting either the applied power and/or the fluid flow in response to the measured parameters.

Claims

1. An apparatus for producing, maintaining, and controlling a virtual electrode for a provision of RF current therapy through the virtual electrode to a target tissue of a body of a patient, the apparatus providing a conductive fluid and an RF current via at least one surgical instrument to the target tissue to create the virtual electrode, the apparatus comprises:

a generator of RF current, the generator supplying the RF current to the virtual electrode via the surgical instrument;

means for detecting an electrical arc;

means for measuring the impedance of the body of the patient to the passage of the RF current;

at least one primary temperature sensor for sensing the temperature at least a first predetermined location in the body of the patient;

at least one source of conductive fluid selectively providing conductive fluid to the target tissue; and

means for controlling a rate of application of the conductive fluid to the target tissue and for controlling a power level of the RF current, the means for controlling receiving arc detection signals from the arc detection means, impedance measurement signals from the impedance measuring means, and temperature measurement signals from the at least one temperature sensor, the power level of the RF current and the rate of conductive fluid flow controlled by the controlling means in response to changes in the measured impedance and the sensed temperature, the means for controlling discontinuing the application of RF current for a predetermined period of time upon receiving signals indicating a detection of an electrical arc.

2. The apparatus of claim 1 wherein said predetermined time for discontinuing the RF power in response to the detection of an electrical arc is at least two seconds.

3. The apparatus of claim 1 and further including means for determining time and means for counting the number of arcs detected by the arc detection means, the means for controlling discontinuing the application of the RF current to the patient upon counting a predetermined number of arcs within a predetermined time period.

4. The apparatus of claim 1 and further including a clock, said clock providing time indicating signals to said means for controlling, wherein said means for controlling determining the time interval between successive changes in the maximum RF power based upon said time indicating signals.

5. The apparatus of claim 4 wherein the means for controlling maintains the current maximum RF power if a predetermined time interval has not elapsed since the most recent change to RF power.

6. The apparatus of claim 1 wherein the means for controlling determines a rate of change of the measured impedance and compares it with a predetermined impedance threshold, the means for controlling reducing the maximum RF power by a predetermined amount if such predetermined impedance threshold is exceeded.

7. The apparatus of claim 1 and further comprising:

at least one secondary temperature sensor being disposed at a predetermined location in the body of the patient, wherein the at least one secondary temperature sensor provides temperature indicating signals to the means for controlling; and

wherein the means for controlling compares the secondary temperature measurements with a predetermined secondary temperature threshold and discontinues the application of RF power if the predetermined secondary temperature threshold is exceeded.

8. The apparatus of claim 7, wherein said virtual electrode substantially defines a volume of tissue to be ablated and the at least one secondary temperature sensor is placed in tissue surrounding the volume of tissue to be ablated.

9. A method of treating tissue by ablation with a virtual electrode, the method comprising:

placing an RF power delivery electrode within the tissue;

providing the tissue with a conductive fluid to create the virtual electrode;

applying RF current power to the tissue through the virtual electrode while continuing to provide conductive fluid to the tissue;

monitoring an impedance of the tissue;

determining a rate of change of the tissue impedance within a predetermined time interval; and

increasing a size of the virtual electrode when the determined rate of change of the tissue impedance exceeds a predetermined value by increasing a flow rate of the conductive fluid.

10. The method of claim 9 and further including:

determining a maximum impedance for the tissue to be ablated;

determining an actual impedance at a specified time;

comparing the maximum impedance with the actual impedance to determine if the actual impedance is greater than the maximum impedance; and

reducing the applied power when the actual impedance is greater than the maximum impedance.

11. The method of claim 9 and further including adjusting the applied RF current power in response to the measured impedance change.

12. The method of claim 9 and further comprising:

the step of monitoring the voltage to detect the occurrence of an electrical arc; and

the step of reducing the power upon the detection of an arc.

13. The method of claim 12 and further including turning off the applied power upon the detection of an arc for a predetermined period of time.

14. The method of claim 9, and further including:

determining a maximum impedance Z_max for the tissue to be ablated;

determining the impedance Z₁ at a time t₁;

comparing Z_max with Z₁ to determine if Z₁ is greater or less than Z_max; and

increasing the applied power when Z₁ is less than Z_max.

15. The method of claim 13, and further including counting the number of detected arcs.

16. A system for producing, maintaining, and controlling a virtual electrode for a provision of RF current therapy through the virtual electrode to a target tissue of a body of a patient, the apparatus providing a conductive fluid and an RF current via at least one surgical instrument to the target tissue to create the virtual electrode, the apparatus comprises:

a surgical instrument including an electrode for delivery of the RF current to the virtual electrode;

a generator of RF current, the generator supplying the RF current to the virtual electrode via the surgical instrument;

means for detecting an electrical arc;

means for measuring the impedance of the body of the patient to the passage of the RF current;

at least one primary temperature sensor for sensing the temperature at at least a first predetermined location in the body of the patient;

at least one source of conductive fluid selectively providing conductive fluid to the target tissue; and

means for controlling a rate of application of the conductive fluid to the target tissue and for controlling a power level of the RF current, the means for controlling receiving arc detection signals from the arc detection means, impedance measurement signals from the impedance measuring means, and temperature measurement signals from the at least one temperature sensor, the power level of the RF current and the rate of conductive fluid flow controlled by the controlling means in response to changes in the measured impedance and the sensed temperature, the means for controlling discontinuing the application of RF current for a predetermined period of time upon receiving signals indicating a detection of an electrical arc.

17. The system of claim 16 wherein said predetermined time for discontinuing the RF power in response to the detection of an electrical arc is at least two seconds.

18. The system of claim 16 and further including means for determining time and means for counting the number of arcs detected by the arc detection means, the means for controlling discontinuing the application of the RF current to the patient upon counting a predetermined number of arcs within a predetermined time period.

19. The system of claim 16 and further including a clock, said clock providing time indicating signals to said means for controlling, wherein said means for controlling determining the time interval between successive changes in the maximum RF power based upon said time indicating signals.

20. The system of claim 19 wherein the means for controlling maintains the current maximum RF power if a predetermined time interval has not elapsed since the most recent change to RF power.

21. The system of claim 16 wherein the means for controlling determines a rate of change of the measured impedance and compares it with a predetermined impedance threshold, the means for controlling reducing the maximum RF power by a predetermined amount if such predetermined impedance threshold is exceeded.

22. The system of claim 16 and further comprising:

at least one secondary temperature sensor being disposed at a predetermined location in the body of the patient, wherein the at least one secondary temperature sensor provides temperature indicating signals to the means for controlling; and

wherein the means for controlling compares the secondary temperature measurements with a predetermined secondary temperature threshold and discontinues the application of RF power if the predetermined secondary temperature threshold is exceeded.

23. The system of claim 22, wherein said virtual electrode substantially defines a volume of tissue to be ablated and the at least one secondary temperature sensor is placed in tissue surrounding the volume of tissue to be ablated.