Methods and apparatus for multi-catheter tissue ablation

Abstract

Catheter systems, tools and methods are disclosed for the selective and rapid application of DC voltage to drive irreversible electroporation, with the system controller configurable to apply voltages to an independently selected subsets of electrodes, such that voltages of one polarity are applied to a multiplicity of electrodes on a first medical device and voltages of the opposite polarity to a multiplicity of electrodes on a second medical device. The first and second medical devices can be epicardial catheters positioned such that their opposing distal tips are approximately aligned and whose segments with electrodes collectively wrap around the pulmonary veins.

1 . An apparatus, comprising:
 a voltage pulse generator configured to produce a pulsed voltage waveform; and   an electrode controller configured to be operably coupled to the voltage pulse generator, the electrode controller including a first output port and a second output port, the first output port configured to be operatively coupled to a first medical device including a first plurality of electrodes, the second output port configured to be operatively coupled to a second medical device including a second plurality of electrodes, the electrode controller including a selection module and a pulse delivery module,   the selection module configured to select at least a first electrode from the first plurality of electrodes and identify at least the first electrode as an anode, the selection module configured to select at least a second electrode from the second plurality of electrodes and identify at least the second electrode as a cathode,   the pulse delivery module configured to deliver a first output signal having a first polarity and being associated with the pulsed voltage waveform to the first output port for application to the first electrode, the pulse delivery module configured to deliver a second output signal having a second polarity opposite the first polarity and being associated with the pulsed voltage waveform to the second output port for application to the second electrode.   
     
     
         2 . The apparatus of  claim 1 , wherein the pulse delivery module is configured to deliver the first output signal to the first plurality of electrodes in a sequential pattern and the second output signal to the second plurality of electrodes in the sequential pattern. 
     
     
         3 . The apparatus of  claim 1 , wherein the pulse delivery module is configured to deliver the first output signal to the first plurality of electrodes and the second output signal to the second plurality of electrodes such that the first medical device receives only the first output signal having the first polarity and the second medical device receives only the second output signal having the second polarity. 
     
     
         4 . The apparatus of  claim 1 , wherein the electrode controller includes an input/output module, the selection module configured to select the first electrode and the second electrode based on input received from the input/output module. 
     
     
         5 . The apparatus of  claim 1 , wherein the electrode controller includes an input/output module, the pulse delivery module configured to deliver at least one of the first output signal or the second output signal having a voltage pulse amplitude based on input received from the input/output module. 
     
     
         6 . The apparatus of  claim 1 , wherein the selection module is configured to select the first electrode and the second electrode based on a predetermined schedule of the plurality of electrodes. 
     
     
         7 . The apparatus of  claim 1 , wherein the selection module is configured to select the first electrode and the second electrode automatically based on at least one of an impedance associated with the first electrode and the second electrode, a distance between the first electrode and the second electrode, and a characteristic associated with a target tissue. 
     
     
         8 . The apparatus of  claim 1 , wherein the electrode controller includes a feedback module configured to determine an impedance between the first electrode and the second electrode, the selection module configured to select the first electrode and the second electrode based the impedance. 
     
     
         9 . The apparatus of  claim 1 , wherein the electrode controller includes a feedback module configured to determine an impedance map associated with the first plurality of electrodes and the second plurality of electrodes, the selection module configured to select the first electrode and the second electrode automatically based on the impedance map. 
     
     
         10 . The apparatus of  claim 1 , wherein:
 the electrode controller is configured to be operably coupled to a pacing lead; and   the electrode controller is configured to be operatively coupled to a pacing module and a feedback module, the pacing module configured to produce a pacing signal to the pacing lead to electrically pace a heart, the feedback module configured to receive an electrocardiograph signal associated with a function of the heart, the pulse delivery module configured to deliver the first output signal and the second output signal during a time window associated with at least one of the pacing signal or the electrocardiograph signal.   
     
     
         11 . An apparatus, comprising:
 a voltage pulse generator configured to produce a pulsed voltage waveform; and   an electrode controller configured to be operably coupled to the voltage pulse generator, the electrode controller including a first output port and a second output port, the first output port configured to be operatively coupled to a first medical device including a first plurality of electrodes, the second output port configured to be operatively coupled to a second medical device including a second plurality of electrodes, the electrode controller including a selection module and a pulse delivery module,   the selection module configured to select a plurality of anode/cathode pairs, each anode selected in the plurality of anode/cathode pairs being only in the first plurality of electrodes, each cathode selected in the plurality of anode/cathode pairs being only in the second plurality of electrodes,   the pulse delivery module configured to deliver a first output signal having a first polarity and associated with the pulsed voltage waveform to the first output port for application to each anode selected, the pulse delivery module configured to deliver a second output signal having a second polarity opposite the first polarity and associated with the pulsed voltage waveform to the second output port for application to each cathode selected, the pulse delivery module configured to deliver the first output signal and the second output signal to the plurality of anode/cathode pairs according to a sequential pattern.   
     
     
         12 . The apparatus of  claim 11 , wherein the electrode controller includes an input/output module, the selection module configured to select the plurality of anode/cathode pairs based on input received from the input/output module. 
     
     
         13 . The apparatus of  claim 11 , wherein the selection module is configured to select the sequential pattern based on a predetermined schedule of the plurality of electrode of anode/cathode pairs. 
     
     
         14 . The apparatus of  claim 11 , wherein the selection module is configured to select the plurality of anode/cathode pairs automatically based on at least one of an impedance associated with each anode/cathode pair, a distance between each anode/cathode pair, and a characteristic associated with a target tissue. 
     
     
         15 . The apparatus of  claim 11 , wherein the electrode controller is configured to be operatively coupled to a feedback module configured to determine an impedance between an electrode from the first plurality of electrodes and an electrode from the second plurality of electrodes, the selection module configured to select the plurality of anode/cathode pairs based in part on the impedance. 
     
     
         16 . The apparatus of  claim 11 , wherein:
 the electrode controller is configured to be operably coupled to a pacing lead; and   the electrode controller is configured to be operatively coupled to a pacing module and a feedback module, the pacing module configured to produce a pacing signal to the pacing lead to electrically pace a heart, the feedback module configured to receive an electrocardiograph signal associated with a function of the heart, the pulse delivery module configured to deliver the first output signal and the second output signal during a time window associated with at least one of the pacing signal or the electrocardiograph signal.   
     
     
         17 . A method, comprising:
 identifying, via a selection module of an electrode controller, a plurality of anode/cathode pairs, each anode selected in the plurality of anode/cathode pairs being only in a first plurality of electrodes of a first multi-electrode catheter, each cathode selected in the plurality of anode/cathode pairs being only in a second plurality of electrodes of a second multi-electrode catheter, the first multi-electrode catheter and the second multi-electrode catheter configured to collectively surround a portion of a heart;   conveying a pacing signal to a pacing lead configured to be operatively coupled to the heart;   receiving, at a feedback module, an electrocardiograph signal associated with a function of the heart;   delivering, via a pulse delivery module of the electrode controller, a first output signal having a first polarity to each anode selected; and   delivering, via the pulse delivery module, a second output signal having a second polarity opposite the first polarity to each cathode selected, the first output signal and the second output signal being delivered according to a sequential pattern.   
     
     
         18 . The method of  claim 17 , wherein the identifying is based on an input received from an input/output module of the electrode controller. 
     
     
         19 . The method of  claim 17 , further comprising:
 determining an impedance between at least one anode electrode in the first plurality of electrodes and at least one cathode electrode in the second plurality of electrodes,   the identifying being performed automatically by the selection module based at least in part on the impedance.   
     
     
         20 . The method of  claim 17 , further comprising:
 determining the sequential pattern based on at least one of an impedance associated with the plurality of anode/cathode pairs, a distance between the plurality of anode/cathode pairs, and a characteristic associated with the heart.   
     
     
         21 . The method of  claim 17 , wherein the first multi-electrode catheter is electrically isolated from the second multi-electrode catheter. 
     
     
         22 . The method of  claim 17 , wherein the portion of the heart includes the pulmonary veins. 
     
     
         23 . A non-transitory processor readable medium storing code representing instructions to be executed by a processor, the code comprising code to cause the processor to:
 identify a plurality of anode/cathode pairs, each anode in the plurality of anode/cathode pairs being only in a first plurality of electrodes of a first multi-electrode catheter, each cathode in the plurality of anode/cathode pairs being only in a second plurality of electrodes of a second multi-electrode catheter, the first multi-electrode catheter and the second multi-electrode catheter configured to collectively surround a portion of a heart;   convey a pacing signal to a pacing lead configured to be operatively coupled to the heart;   receive an electrocardiograph signal associated with a function of the heart; and   deliver, according to a sequential pattern, a first output signal having a first polarity to each anode selected and a second output signal having a second polarity opposite the first polarity to each cathode selected.   
     
     
         24 . A system, comprising:
 a first flexible catheter including a first plurality of electrodes; and   a second flexible catheter including a second plurality of electrodes;   a distal end portion of the first flexible catheter configured to be coupled to a distal end portion of the second catheter to form a continuous length including the first plurality of electrodes and the second plurality of electrodes, the first flexible catheter and the second flexible catheter configured to deliver a bipolar voltage signal to a target tissue such that a first portion of the bipolar voltage signal having a first polarity is delivered only to the first plurality of electrodes and a second portion of the bipolar voltage signal having second polarity opposite the first polarity is delivered only to the second plurality of electrodes.   
     
     
         25 . The system of  claim 24 , wherein the first flexible catheter is electrically isolated from the second flexible catheter when the distal end portion of the first flexible catheter is coupled to the distal end portion of the second catheter. 
     
     
         26 . The system of  claim 24 , wherein an amplitude of the bipolar voltage signal is up to 5 kV. 
     
     
         27 . The system of  claim 24 , wherein:
 an amplitude of the bipolar voltage signal is up to 5 kV; and   the first flexible catheter includes a plurality of leads, each lead of the plurality of leads coupled to an electrode from the first plurality of electrodes, each lead from the plurality of leads including an outer insulating layer having a thickness of less than about 0.05 mm.   
     
     
         28 . The system of  claim 24 , wherein:
 an amplitude of the bipolar voltage signal is up to 5 kV;   the first plurality of electrodes includes at least eight electrodes; and   the first flexible catheter includes a plurality of leads, each lead of the plurality of leads coupled to an electrode from the first plurality of electrodes, the first flexible catheter having a diameter of less than about 3 mm.