Systems and methods for obtaining desired lesion characteristics while ablating body tissue

• US 6,056,745 A
• Filed: 10/27/1997
• Issued: 05/02/2000
• Est. Priority Date: 06/27/1994
• Status: Expired due to Term

• Current Assignee: EP Technology (Boston Scientific Corporation)
• Original Assignee: EP Technology (Boston Scientific Corporation)
• Inventors: Panescu, Dorin, Swanson, David K., Fleischman, Sidney D.
• Primary Examiner(s): PEFFLEY, MICHAEL F
• Application Number:
  US08/962,918
• Time in Patent Office: 918 Days
• Field of Search: 606/27-31, 606/41, 606/42, 606/45-50, 607/96, 607/100-102, 607/104, 607/105, 607/115, 607/116, 607/122, 604/21, 604/22
• US Class Current: 606/42
• CPC Class Codes: A61B 18/00 Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body eye surgery A61F9/007; ear surgery A61F11/00
• 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 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 2017/00017 Electrical control of surgical instruments
• CPC Class Codes: A61B 2017/00084 Temperature
• CPC Class Codes: A61B 2018/00011 with fluids
• CPC Class Codes: A61B 2018/00023 closed, i.e. without wound contact by the fluid
• CPC Class Codes: A61B 2018/00029 open
• CPC Class Codes: A61B 2018/00047 using Peltier effect
• 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 2018/00208 actively driven, e.g. by a motor
• CPC Class Codes: A61B 2018/00351 Heart
• CPC Class Codes: A61B 2018/00577 Ablation
• 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 2018/00666 using a threshold value
• CPC Class Codes: A61B 2018/00684 using lookup tables
• CPC Class Codes: A61B 2018/00702 Power or energy
• CPC Class Codes: A61B 2018/00744 : Fluid flow
• CPC Class Codes: A61B 2018/00761 : Duration
• CPC Class Codes: A61B 2018/00791 : Temperature
• CPC Class Codes: A61B 2018/00815 : measured by a thermistor
• CPC Class Codes: A61B 2018/00886 : Duration
• 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 2018/1425 : Needle
• CPC Class Codes: A61B 2018/1435 : Spiral
• CPC Class Codes: A61B 2018/1861 : with an instrument inserted into a body lumen or cavity, e.g. a catheter
• CPC Class Codes: A61B 2218/002 : Irrigation
• CPC Class Codes: A61M 2230/50 : Temperature

Abstract

Systems and methods for ablating body tissue use an electrode for contacting tissue to form a tissue-electrode interface. The electrode is coupled to a source of ablation energy for transmitting ablation energy at a prescribed ablation power level into tissue to form, over a prescribed ablation time period, a therapeutic result. The therapeutic result includes a lesion that extends beneath the tissue-electrode interface to a boundary depth between viable and nonviable tissue and a maximum tissue temperature developed within the lesion between the tissue-electrode interface and the boundary depth. The systems and methods include an element to cool the electrode. An input element inputs a desired therapeutic result including at least a targeted lesion boundary depth. The systems and methods employ a processing element that retains a function correlating an observed relationship among lesion boundary depth, ablation power level, ablation time, actual or predicted sub-surface tissue temperature, and electrode temperature. The processing element compares the desired therapeutic result to the function. The processing element selects an operating condition based upon the comparison to achieve the desired therapeutic result without exceeding a prescribed actual or predicted sub-surface tissue temperature, at least in part by cooling the electrode to control electrode temperature while the electrode transmits ablation energy.

Claims

1. A system for ablating body tissue comprising

an electrode adapted to contact tissue to form a tissue-electrode interface, the electrode being coupled to a source of ablation energy for transmitting ablation energy at a determinable ablation power level into tissue to form, over a prescribed ablation time period, a therapeutic result including a lesion that extends beneath the tissue-electrode interface to a boundary depth between viable and nonviable tissue and a maximum tissue temperature developed within the lesion between the tissue-electrode interface and the boundary depth,

a heat removal element in thermal conductive contact with the electrode and operable to remove heat from the electrode at a determinable heat removal rate,

a temperature sensing element in thermal conductive contact with the electrode to sense temperature of the electrode, and

a controller coupled to the electrode, the heat removal element, and the temperature sensing element and including

an input element for inputting a desired therapeutic result including at least a targeted lesion boundary depth, and

a processing element coupled to the input element for retaining a function that correlates an observed relationship among lesion boundary depth, ablation power level, ablation time, tissue temperature beneath the tissue-electrode interface, and electrode temperature;

for sampling an actual operating condition including the ablation power level at which the electrode transmits ablation energy, the heat removal rate, and the temperature of the electrode sensed by the temperature sensing element, without sampling an actual tissue temperature beneath the tissue-electrode interface;

for comparing the actual operating condition to the function to derive a prediction of the maximum tissue temperature condition beneath the tissue-electrode interface based upon the desired therapeutic result; and

for controlling the ablation power level transmitted by the electrode, or the heat removal rate, or both, at least in part, upon the prediction of the maximum tissue temperature and without sampling an actual tissue temperature beneath the tissue-electrode interface.

2. A system according to claim 1

wherein the desired therapeutic result further includes a targeted ablation time, and

wherein the processing element is also operative for limiting the ablation time to the targeted ablation time.

3. A system according to claim 1

wherein the desired therapeutic result further includes a prescribed maximum ablation power level, and

wherein the processing element is also operative for controlling the ablation power level subject to the prescribed maximum ablation power level.

4. A system according to claim 3

wherein the desired therapeutic result further includes a targeted ablation time, and

wherein the processing element is also operative for limiting the ablation time to the targeted ablation time.

5. A system according to claim 1

wherein the ablation energy comprises radio frequency energy.

6. A system according to claim 1

wherein the system is free of an element that senses actual tissue temperature beneath the tissue-electrode interface.

7. An apparatus for supplying energy to an electrode for ablating tissue comprising

a generator coupled to an electrode in contact with tissue to supply energy to the electrode at a prescribed ablation power level to form, over a prescribed ablation time period, a therapeutic result including a lesion that extends into tissue beneath the electrode to a boundary depth between viable and nonviable tissue and a maximum tissue temperature developed within the lesion between the electrode and the boundary depth,

a heat removal element in thermal conductive contact with the electrode and operable to remove heat from the electrode at a determinable heat removal rate,

a temperature sensing element in thermal conductive contact with the electrode to sense temperature of the electrode, and

a controller coupled to the heat removal element, the temperature sensing element and the generator comprising

an input element for inputting a desired therapeutic result including at least a targeted lesion boundary depth, and

a processing element coupled to the input element for retaining a function that correlates an observed relationship among lesion boundary depth, ablation power level, ablation time, tissue temperature beneath the tissue-electrode interface, and electrode temperature;

for sampling an actual operating condition including the ablation power level at which the electrode transmits ablation energy, the heat removal rate, and the temperature of the electrode sensed by the temperature sensing element, without sampling an actual tissue temperature beneath the tissue-electrode interface;

for comparing the actual operating condition to the function to derive a prediction of the maximum tissue temperature condition beneath the tissue-electrode interface based upon the desired therapeutic result; and

for controlling the ablation power level transmitted by the electrode, or the heat removal rate, or both, at least in part, upon the prediction of the maximum tissue temperature and without sampling an actual tissue temperature beneath the tissue-electrode interface.

8. A system according to claim 7

wherein the desired therapeutic result further includes a targeted ablation time, and

wherein the the processing element is also operative for limiting the ablation time to the targeted ablation time.

9. A system according to claim 7

wherein the desired therapeutic result includes a prescribed maximum ablation power level,

and further including a second sensing element coupled to the controller to measure the ablation power level, and

wherein the processing element is also operable for controlling the ablation power level sensed by the second sensing element subject to the prescribed maximum ablation power level.

10. A system according to claim 9

wherein the desired therapeutic result further includes a targeted ablation time, and

wherein the processing element is also operative for limiting the ablation time to the targeted ablation time.

11. A system according to claim 7

wherein the ablation energy comprises radio frequency energy.

12. A system according to claim 7

wherein the system is free of an element that senses actual tissue temperature beneath the tissue-electrode interface.

13. A method for ablating heart tissue comprising the steps of

locating an electrode in contact with heart tissue to form a tissue-electrode interface, the electrode being adapted to transmit ablation energy at a determinable ablation power level into heart tissue to form, over a prescribed ablation time period, a therapeutic result including a lesion that extends beneath the tissue-electrode interface to a boundary depth between viable and nonviable tissue and a maximum tissue temperature developed within the lesion between the tissue-electrode interface and the boundary depth,

receiving from a user a desired therapeutic result including at least a targeted lesion boundary depth,

conducting heat from the electrode at a determinable heat conduction rate,

sensing temperature of the electrode,

sensing the power level transmitted by the electrode,

sampling an actual operating condition including the ablation power level at which the electrode transmits ablation energy, the heat conduction rate, and the temperature sensed at the electrode and without sampling an actual tissue temperature beneath the tissue-electrode interface;

comparing the actual operating condition to a function that correlates an observed relationship among lesion boundary depth, ablation power level, ablation time, tissue temperature beneath the tissue-electrode interface, and electrode temperature to derive a prediction of the maximum tissue temperature condition beneath the tissue-electrode interface based upon the desired therapeutic result, and

controlling the ablation power level transmitted by the electrode, or the heat conduction rate, or both, at least in part, upon the prediction of the maximum tissue temperature and without sampling an actual tissue temperature beneath the tissue-electrode interface.

14. A method according to claim 13

wherein the step of receiving the desired therapeutic result further includes receiving from the user a targeted ablation time, and

wherein, in the controlling step limits the ablation time to the targeted ablation time.

15. A method according to claim 13

wherein the step of receiving the desired therapeutic result includes receiving from the user a prescribed maximum ablation power level, and

wherein the controlling step controls the ablation power level subject to the prescribed maximum ablation power level.

16. A method according to claim 15

wherein the step of receiving the desired therapeutic result further includes receiving from the user a targeted ablation time, and

wherein the controlling step limits the ablation time to the targeted ablation time.

17. A method according to claim 13

wherein the controlling step supplies radio frequency energy as the ablation energy.

18. A method according to claim 13

wherein the step of conducting heat from electrode includes directing a cooling medium into thermal conductive contact with the electrode.

19. A method according to claim 13

wherein the step of sensing temperature of the electrode includes sensing the electrode temperature by a sensing element in thermal conductive contact with the electrode.