Ablation device with multiple ablation modes

• US 9,463,064 B2
• Filed: 09/06/2015
• Issued: 10/11/2016
• Est. Priority Date: 09/14/2011
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Subramaniam, Raj, Koblish, Josef V., Tun, Zaya, Harvey, Guy R., Cao, Minhchau N., Sparks, Kurt D.
• Primary Examiner(s): Lavert, Nicole F
• Application Number:
  US14/846,814
• Publication Number:
  US 20150374436A1
• Time in Patent Office: 401 Days
• Field of Search: 606/41
• US Class Current: 1/1
• 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 2018/00023 closed, i.e. without wound contact by the fluid
• CPC Class Codes: A61B 2018/00065 porous
• CPC Class Codes: A61B 2018/0022 Balloons
• CPC Class Codes: A61B 2018/00232 having an irregular shape
• CPC Class Codes: A61B 2018/00238 porous
• CPC Class Codes: A61B 2018/00345 Vascular system
• CPC Class Codes: A61B 2018/00351 Heart
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/00791 Temperature
• CPC Class Codes: A61B 2018/00797 measured by multiple temperature sensors
• CPC Class Codes: A61B 2018/00815 measured by a thermistor
• CPC Class Codes: A61B 2018/00821 measured by a thermocouple
• CPC Class Codes: A61B 2018/00839 Bioelectrical parameters, e.g. ECG, EEG
• CPC Class Codes: A61B 2018/1472 for use with liquid electrolyte, e.g. virtual electrodes

Abstract

Devices, systems, and methods for performing ablation therapy on body tissue are disclosed. An example ablation device for treating body tissue includes an ionically conductive balloon and a radio-frequency electrode that delivers RF energy into a distal section of the balloon. The balloon is configured to transmit the RF energy in a direction distally towards a leading end of the ablation device. Multiple ablation electrodes on the device can be used for providing lesions of different size or shape.

Claims

1. A method for performing ablation therapy on the body of a patient, the method comprising:

advancing an ablation device to a target body tissue region, the ablation device including an inflatable balloon coupled to an elongate shaft, a first electrode disposed within an interior space of the balloon, and a second electrode located outside of the balloon;

injecting an electrically conductive fluid into the interior section of the balloon and inflating the balloon from a collapsed state to an expanded state within the body;

selectively energizing the first electrode and generating a first RF electrical field within the balloon interior;

forming at least one ablation lesion within the body tissue using the first RF electrical field;

selectively energizing the second electrode and generating a second RF electrical field; and

forming at least one ablation lesion within the body tissue using the second RF electrical field.

2. The method of claim 1, further comprising an RF generator including a switching mechanism, and wherein selectively energizing the first or second electrodes includes operating the switching mechanism between a first and second switch position.

3. The method of claim 1, wherein forming at least one ablation lesion within the body tissue using the first RF electrical field includes forming a lesion in the body tissue at a location distal to the elongate shaft.

4. The method of claim 1, wherein the at least one ablation lesion formed within the body tissue using the first RF electric field is larger than the at least one ablation lesion formed in the body tissue using the second RF electric field.

5. The method of claim 1, wherein the balloon further comprises a temperature sensor disposed within an interior space of the balloon, the method further comprising sensing a temperature of the electrically conductive fluid.

6. The method of claim 1, wherein the balloon further comprises a temperature sensor located outside the balloon, the method further comprising sensing a temperature of the target body tissue region.

7. The method of claim 1, wherein the inflatable balloon is comprised of a material that allows the electrically conductive fluid to permeate through the balloon and wherein injecting an electrically conductive fluid comprises continuously injecting an electrically conductive fluid into the balloon so that the balloon remains in the expanded state.

8. The method of claim 7, further comprising:

determining an amount of electrically conductive fluid injected into the balloon.

9. The method of claim 7, wherein the electrically conductive fluid includes a drug.

10. A method for performing ablation therapy using an ablation device, the method comprising:

advancing an ablation device to a tissue region in a body of a patient, the ablation device including an inflatable balloon coupled to a distal end of an elongate shaft, the inflatable balloon including a conductive section, a first electrode disposed within an interior space of the balloon and a second electrode located outside of the balloon;

injecting an electrically conductive fluid into the balloon to inflate the balloon to an expanded state, wherein at least one of the conductive section and the second electrode contact the tissue region; and

activating at least one of the first electrode and the second electrode to ablate at least a portion of the contacted tissue region.

11. The method of claim 10, further comprising a RF generator including a switching mechanism, wherein activating the first electrode includes operating the switching mechanism to a first switch position and wherein activating the second electrode includes operating the switching mechanism to a second switch position.

12. The method of claim 10, wherein the inflatable balloon further comprises at least one temperature sensor, the method further comprising sensing a temperature of at least one of the electrically conductive fluid and the tissue region using the temperature sensor.

13. The method of claim 12, wherein the temperature is sensed while activating at least one of the first electrode and the second electrode.

14. The method of claim 10, wherein the inflatable balloon is comprised of a material that allows the electrically conductive fluid to permeate through the balloon and wherein injecting an electrically conductive fluid comprises continuously injecting an electrically conductive fluid into the balloon so that the balloon has a substantially constant internal pressure.

15. The method of claim 14, further comprising determining an amount of electrically conductive fluid injected into the balloon.

16. The method of claim 14, wherein the electrically conductive fluid includes a drug.

17. The method of claim 10, wherein a surface area of the electrically conductive region is larger than a surface area of the second electrode.

18. A method for performing ablation therapy on the body of a patient, the method comprising:

advancing an ablation device to a target body tissue region, the ablation device including an inflatable balloon coupled to a distal end of an elongate shaft, the inflatable balloon including a conductive section and a first electrode disposed within an interior space of the balloon;

injecting an electrically conductive fluid into the balloon to inflate the balloon to an expanded state, wherein the conductive section of the balloon contacts a portion of the target body tissue region; and

generating a current through the electrically conductive fluid using the first electrode to ablate a portion of the target body tissue region.

19. The method of claim 18, the ablation device further including a second electrode located outside of the balloon, wherein a surface area of the second electrode is smaller than a surface area of the conductive section, the method further comprising:

energizing the second electrode to ablate a portion of the target body tissue region.

20. The method of claim 19, further comprising a RF generator including a switching mechanism, wherein generating a current through the electrically conductive fluid using the first electrode includes operating the switching mechanism to a first switch position and wherein energizing the second electrode includes operating the switching mechanism to a second switch position.