SYSTEM AND METHOD FOR PREDICTING LESION SIZE SHORTLY AFTER ONSET OF RF ENERGY DELIVERY

• US 20110066147A1
• Filed: 09/15/2010
• Published: 03/17/2011
• Est. Priority Date: 09/15/2009
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation), Arizona Board of Regents (University of Arizona)
• Original Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Inventors: Bosnos, Michael, Marcus, Frank I., Guillén-Rodríguez, José M., He, Ding Sheng
• Granted Patent: US 9,326,814 B2
• Time in Patent Office: Days
• US Class Current: 606/33
• 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 2017/00084 Temperature
• CPC Class Codes: A61B 2018/00357 Endocardium
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/00702 Power or energy
• CPC Class Codes: A61B 2018/00869 Phase
• CPC Class Codes: A61B 2018/00875 Resistance or impedance
• CPC Class Codes: A61B 2034/104 Modelling the effect of the tool, e.g. the effect of an implanted prosthesis or for predicting the effect of ablation or burring

Abstract

Lesion size or volume prediction shortly after the onset of an ablation procedure can inform or control the ablation procedure. The prediction and/or control is made without regard to an actual detected temperature in the vicinity of the ablation electrodes. As a consequence, the system has utility with irrigated catheter constructions and other situations in which local irrigation in the vicinity of an ablation site would otherwise interfere with a prediction or control scheme that solely relies upon temperature measurements.

Claims

1. A computer-implemented control system adapted to predict a lesion size in tissue shortly after the onset of an RF ablation procedure, the procedure being conducted using an RF generator output to drive at least one ablation electrode supported on the distal section of a catheter, the catheter further having at least one temperature sensor, comprising:

a computer having a processor;

a data acquisition system having multiple channels that provide data, including at least one channel providing data from the at least one ablation electrode;

a plurality of modules each executing in the processor of the computer, including;

a temperature determining module comprising a detection of a temperature from the at least one temperature sensor and a control loop operatively responsive to the detected temperature to control a rise time to a target temperature;

an RF control module operative to vary the RF generator output so as to maintain the target temperature for a duration of the RF ablation procedure;

a regression algorithm operative to apply a formula and compute the prediction of the lesion size in the tissue, shortly after the onset of the RF ablation procedure, independent of the detected temperature from the at least one temperature sensor; and

a user-interface module operative to provide from the computer onto a display at least the prediction of the lesion size to inform the RF ablation procedure.

2. The control system of claim 1, wherein the formula used by the regression algorithm comprises a weighted combination of impedance, resistance, capacitive reactance, power and an average difference between a maximum and a minimum electrode temperature detection over pulsed cycles centered about a particular prediction time.

3. The control system of claim 2, wherein the weighted combination in the formula used by the regression algorithm further comprises an offset.

4. The control system of claim 3, wherein the weighted combination in the formula used by the regression algorithm further comprises a weighting of a time to peak power.

5. The control system of claim 3, wherein the formula comprises solely the weighted combination of impedance, resistance, capacitive reactance, power, the offset, and the average difference between the maximum and the minimum electrode temperature over pulsed cycles centered about the particular prediction time.

6. The control system of claim 1, wherein the control loop of the temperature determining module comprises a proportional, integral and differential (PID) control loop.

7. The control system of claim 6, wherein the PID control loop has coefficients selected to hasten a time to peak-power delivery while concurrently minimizing overshoot of the target temperature.

8. The control system of claim 1, wherein the RF generator output is in a range of about 300 to about 500 KHz.

9. The control system of claim 1, wherein the regression algorithm is further operative so as to arrive at the prediction of the lesion size within five seconds of the onset of the RF ablation procedure.

10. The control system of claim 1, further comprising a phase angle circuit or module, wherein the phase angle circuit or module computes a phase angle between an RF voltage and an RF current from which a capacitive reactance and a resistance can be derived.

11. The control system of claim 1, wherein the RF control module is responsive to the regression algorithm to automatically control RF energy delivery so as to achieve a target lesion size in view of the tissue response after the first few seconds of energy delivery after the onset of the RF ablation procedure.

12. A computer-implemented control system adapted to predict a lesion size in tissue shortly after the onset of an RF ablation procedure that is conducted using an RF generator output, comprising:

an irrigated catheter having a distal section that supports at least one ablation electrode and at least one temperature sensor, and a fluid lumen extending the length of the irrigated catheter sized to deliver an irrigation fluid in the vicinity of the at least one ablation electrode;

a computer having a processor;

a data acquisition system having multiple channels that provide data, including data from the at least one ablation electrode;

a plurality of modules each executing in the processor of the computer, including;

a temperature determining module comprising a detection of a temperature from the at least one temperature sensor and a control loop operatively responsive to the detected temperature to control a rise time to a target temperature;

an RF control module operative to vary the RF generator output so as to maintain the target temperature for a duration of the RF ablation procedure;

a regression algorithm operative to apply a formula and compute the prediction of the lesion size in the tissue, shortly after the onset of the RF ablation procedure, independent of the detected temperature from the at least one temperature sensor; and

a user-interface module operative to provide from the computer onto a display at least the prediction of the lesion size to inform the RF ablation procedure.

13. The control system of claim 12, wherein the formula used by the regression algorithm comprises a weighted combination of impedance, resistance, capacitive reactance, power and an average difference between a maximum and a minimum electrode temperature detection over pulsed cycles centered about a particular prediction time.

14. The control system of claim 13, wherein the weighted combination in the formula used by the regression algorithm further comprises an offset.

15. The control system of claim 14, wherein the weighted combination in the formula used by the regression algorithm further comprises a weighting of a time to peak power.

16. The control system of claim 14, wherein the formula comprises solely the weighted combination of impedance, resistance, capacitive reactance, power, the offset, and the average difference between the maximum and the minimum electrode temperature over pulsed cycles centered about the particular prediction time.

17. The control system of claim 12, wherein the control loop of the temperature determining module comprises a proportional, integral and differential (PID) control loop.

18. The control system of claim 17, wherein the PID control loop has coefficients selected to hasten a time to peak-power delivery while concurrently minimizing overshoot of the target temperature.

19. The control system of claim 12, wherein the RF generator output is in a range of about 300 KHz to about 500 KHz.

20. The control system of claim 12, wherein the regression algorithm is further operative so as to arrive at the prediction of the lesion size within five seconds of the onset of the RF ablation procedure.

21. The control system of claim 12, further comprising a phase angle circuit or module, wherein the phase angle circuit or module computes a phase angle between an RF voltage and an RF current from which a capacitive reactance and a resistance can be derived.

22. The control system of claim 12, wherein the RF control module is responsive to the regression algorithm to automatically control RF energy delivery so as to achieve a target lesion size in view of the tissue response after the first few seconds of energy delivery after the onset of the RF ablation procedure.

23. A computer-implemented prediction system adapted to predict a lesion size in tissue shortly after the onset of an ablation procedure, the procedure being conducted using an energy source to drive at least one ablation energy transducer supported on the distal section of a catheter, the catheter further having at least one electrode for impedance measurements, comprising:

a computer having a processor;

a data acquisition system having multiple channels that provide data, including at least one channel providing data from the at least one electrode;

a plurality of modules each executing in the processor of the computer, including;

a regression algorithm operative to apply a formula and compute the prediction of the lesion size in the tissue, shortly after the onset of the ablation procedure, independent of any detected temperature, wherein the formula used by the regression algorithm comprises a weighted combination of resistance, and capacitive reactance, and power; and

a user-interface module operative to provide from the computer onto a display at least the prediction of the lesion size to inform the ablation procedure.

24. The control system of claim 23, wherein the regression algorithm is operative, more than five seconds after the onset of the ablation procedure, to apply the formula and compute the prediction of the lesion size in the tissue using the weighted combination of resistance, and capacitive reactance, and power and further using the weighted combination of impedance.

25. The control system of claim 23, wherein the regression algorithm is operative, more than five seconds after the onset of the ablation procedure, to apply the formula and compute the prediction of the lesion size in the tissue using the weighted combination of resistance, and capacitive reactance, and power and further using the weighted combination of an average difference between a maximum and a minimum electrode temperature detection over pulsed cycles centered about a particular prediction time.

26. The control system of claim 23, wherein the regression algorithm is operative free of any measured temperature.