System and method for adaptive RF ablation

• US 9,504,518 B2
• Filed: 04/28/2011
• Issued: 11/29/2016
• Est. Priority Date: 11/29/2010
• Status: Expired due to Fees

• Current Assignee: Medtronic Ablation Frontiers LLC (Medtronic Plc)
• Original Assignee: Medtronic Ablation Frontiers LLC (Medtronic Plc)
• Inventors: Condie, Catherine R., Sherman, Marshall L., Kasischke, Kathryn E., Corvi, Timothy J., Strunk, Aaron R.
• Primary Examiner(s): Peffley, Michael
• Assistant Examiner(s): Ekrami, Yasamin
• Application Number:
  US13/096,255
• Publication Number:
  US 20120136346A1
• Time in Patent Office: 2,042 Days
• Field of Search: 606/41
• US Class Current: 1/1
• CPC Class Codes: A61B 18/1206 Generators therefor
• CPC Class Codes: A61B 18/14 Probes or electrodes 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 2018/0016 Energy applicators arranged in a two- or three dimensional array
• CPC Class Codes: A61B 2018/00214 Expandable means emitting energy, e.g. by elements carried thereon
• CPC Class Codes: A61B 2018/00267 having a basket shaped structure
• 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 2018/00648 using more than one sensed parameter
• CPC Class Codes: A61B 2018/00678 upper
• CPC Class Codes: A61B 2018/00702 Power or energy
• CPC Class Codes: A61B 2018/00714 Temperature
• CPC Class Codes: A61B 2018/00726 Duty cycle
• CPC Class Codes: A61B 2018/00779 Power or energy
• CPC Class Codes: A61B 2018/00791 Temperature
• CPC Class Codes: A61B 2090/065 for measuring contact or contact pressure

Abstract

A medical method, device, and system are provided, including advancing an ablation element of a medical device into contact with tissue to be treated, selecting a power level of energy to ablate the tissue, delivering energy at the selected power level to the ablation element, determining whether the ablation element is in continuous contact with the tissue, and reducing the selected power level when the ablation element ceases to be in continuous contact with the tissue.

Claims

1. A medical system for treating tissue, comprising:

a medical device;

an ablation electrode and a temperature sensor coupled to the medical device;

a source of RF energy in electrical communication with the ablation element, the source having a variable power output, the source of RF energy supplying power to the ablation electrode to ablate the tissue;

a control unit in communication with the temperature sensor and operable to receive a temperature signal from the temperature sensor, the control unit programmed to determine a state of contact between the ablation electrode and tissue based at least in part on the temperature signal, the control unit having a delay interval and being programmed to permit the power supplied to the ablation element to be increased when, after a determination that continuous contact has been lost;

the ablation element regains continuous tissue contact; and

the state of regained continuous tissue contact has continued for a time at least equal to the delay interval; and

a feedback controller in communication with the control unit, the temperature sensor, and the source of RF energy, the feedback controller being programmed to modify the power output of the source of RF energy based at least in part on the temperature signal.

2. The medical system of claim 1, wherein the source of RF energy has a duty cycle of selectable duration.

3. The medical system of claim 2, wherein the source of RF energy has a duty cycle with a base frequency of at most 10 ms.

4. The medical system of claim 1, wherein the feedback controller is a P-I-D or P-I controller, and the integration period of the feedback controller is at least the duration of a human heartbeat.

5. The medical system of claim 1, wherein the control unit is programmed to modify the power output of the source of RF energy based at least in part on the state of contact.

6. The medical system of claim 5, wherein the control unit is programmed to prevent the feedback controller from increasing the power output of the source of the RF energy based at least in part on the state of contact being no tissue contact.

7. The medical system of claim 1, wherein the tissue to be treated is cardiac tissue.

8. A medical system, comprising:

means for advancing an ablation element of a medical device into contact with tissue to be treated;

means for supplying power to the ablation element to ablate the tissue;

means for selecting a desired temperature of the ablation element;

means for monitoring a temperature of the ablation element;

means for determining a state of contact between the ablation electrode and the tissue based on signals from the means for monitoring a temperature of the ablation element;

means for reducing the supplied power to the ablation element when the monitored temperature exceeds the desired temperature; and

means for initiating an increase in the power to the ablation element when, after a determination that continuous contact has been lost;

the ablation element regains continuous tissue contact; and

the state of regained continuous tissue contact has continued for at least three seconds.

9. The medical system of claim 8, further comprising:

means for monitoring power delivered to the ablation element;

means for calculating the average power produced by the means for supplying power; and

means for limiting the average power to a preselected maximum delivered power threshold.

10. The medical system of claim 8, further comprising:

means for setting a maximum duty cycle equal to a current duty cycle value when the power is at least equal to a desired maximum power; and

means for reducing a selected power level by limiting the duty cycle value to the maximum duty cycle.

11. A medical system controller, comprising:

a power source for supplying power to an ablation element; and

a control unit programmed to monitor a temperature of the ablation element and characterize the contact between the ablation element and biological tissue based on the temperature of the ablation element, said contact characterization comprising the states of loss of continuous tissue contact and regained continuous tissue contact,

the control unit further being programmed to;

limit the power supplied to the ablation element when the contact characterization is loss of continuous tissue contact; and

permit an initiation of an increase in the power supplied to the ablation element when the contact characterization is regained continuous tissue contact for at least three seconds.

12. The medical system controller of claim 11, wherein:

the control unit has a maximum limit for the power supplied to the ablation element; and

the control unit is programmed to measure the supplied power to the ablation element;

the control unit is programmed to calculate the average power supplied to the ablation element; and

the control unit is programmed to limit the average power to the maximum limit.

13. The medical system controller of claim 11, wherein a maximum duty cycle equal to the current duty cycle value is set when the supplied power is at least equal to the maximum limit, and thereafter the duty cycle value is limited to the maximum duty cycle.

14. The medical system controller of claim 11, wherein:

the control unit is programmed to select a desired temperature and a threshold variation;

the control unit is programmed to calculate an average temperature of the ablation element, to calculate a difference between the ablation element temperature and the average ablation element temperature, and to calculate a continuity value by subtracting the difference from the desired temperature; and

the control unit is programmed to reducing the desired temperature when the continuity value exceeds the threshold variation.

15. The medical system controller of claim 14 wherein the control unit is programmed to increase the desired temperature when the continuity value falls below the threshold variation.

16. The medical system controller of claim 15 wherein the threshold variation is substantially equal to 5 degrees.