Intracardiac tools and methods for delivery of electroporation therapies

Abstract

A medical system, including a medical device having a plurality of deployable arms, and at least one electrode on at least one of the plurality of arms; and an electric signal generator in communication with the medical device, the electric signal generator programmed to deliver pulsed energy to the medical device sufficient to induce irreversible electroporation ablation.

1 . A medical system, comprising:
 a medical device having a plurality of substantially planar windings, wherein at least a portion of the plurality of substantially planar windings is electrically conductive; and   an electrical pulse generator coupled to the electrically conductive portion, the electrical pulse generator programmed to deliver pulsed, high voltage biphasic energy to the electrically conductive portion to induce irreversible electroporation of a targeted tissue region.   
     
     
         2 . The system of  claim 1 , wherein the medical device includes an intravascular catheter body coupled to the plurality of substantially planar windings. 
     
     
         3 . The system of  claim 1 , wherein the electrically conductive portion includes at least one electrode. 
     
     
         4 . The system of  claim 1 , wherein the plurality of substantially planar windings includes a substantially-continuous electrically conductive surface. 
     
     
         5 . The system of  claim 1 , wherein the pulsed, biphasic energy includes a plurality of pulses each having a cycle time of not more than 5 milliseconds. 
     
     
         6 . The system of  claim 1 , wherein the pulsed, biphasic energy includes energy at an output voltage between approximately 500 to 1000 volts at a pulse width between approximately 0.005 to 50 microseconds. 
     
     
         7 . The system of  claim 1 , wherein the pulsed, biphasic energy includes a series of pulse trains, with each train having between approximately 10 to 100 pulses. 
     
     
         8 . A medical system, comprising:
 a medical device having a plurality of deployable arms, and at least one electrode on at least one of the plurality of arms; and   an electric signal generator in communication with the medical device, the electric signal generator programmed to deliver pulsed energy to the medical device sufficient to induce irreversible electroporation ablation, including an output voltage in the range of 500 to 1000 volts, a pulse width in the range of 0.005 to 50 microseconds, and a pulse interval of approximately 20 microseconds.   
     
     
         9 . The system of  claim 8 , wherein the medical device includes a flexible catheter body. 
     
     
         10 . The system of  claim 9 , wherein the plurality of deployable arms are deployable into a substantially linear configuration. 
     
     
         11 . The system of  claim 10 , wherein the substantially linear configuration is substantially transverse to a longitudinal axis of the catheter body. 
     
     
         12 . The system of  claim 8 , wherein the medical device includes a selectively extendable needle electrode. 
     
     
         13 . The system of  claim 8 , wherein the electrode includes an electrically conductive surface and an electrically insulated surface. 
     
     
         14 . The system of  claim 8 , wherein the electrode includes at least two electrically conductive surfaces separated by an electrically insulated surface. 
     
     
         15 . The system of  claim 8 , wherein the pulse generator is further programmed to deliver the pulsed, high voltage energy as biphasic pulses. 
     
     
         16 . A method of ablating cardiac tissue, comprising:
 positioning a first electrically conductive surface adjacent an endocardial surface of a heart;   positioning a second electrically conductive surface adjacent an epicardial surface of the heart; and   conducting pulsed energy between the first and second electrically conductive surfaces to induce irreversible electroporation ablation of tissue therebetween.   
     
     
         17 . The method of  claim 16 , wherein at least one of the first and second electrically conductive surfaces includes a plurality of electrically conductive coils. 
     
     
         18 . The method of  claim 16 , wherein at least one of the first and second electrically conductive surfaces includes a plurality of electrodes disposed on a plurality of deployable arms of a catheter. 
     
     
         19 . The method of  claim 16 , wherein the pulsed energy includes a plurality of biphasic pulses each having a cycle time of not more than 500 microseconds. 
     
     
         20 . The method of  claim 16 , wherein the pulsed energy includes biphasic energy at an output voltage between approximately 500 to 1000 volts at a pulse width between approximately 0.005 to 50 microseconds. 
     
     
         21 . The method of  claim 16 , wherein the pulsed energy includes a series of biphasic pulse trains, with each train having between approximately 10 to 100 biphasic pulses. 
     
     
         22 . The method of  claim 16 , further comprising obtaining an electrocardiogram of the heart, and wherein conducting the pulsed energy includes timing conduction of the energy with at least one selected segment of the electrocardiogram. 
     
     
         23 . The method of  claim 22  wherein the selected segment is indicative of the tissue to be ablated experiencing depolarization. 
     
     
         24 . The method of  claim 22 , wherein the selected segment of the electrocardiogram is a QRS wave segment. 
     
     
         25 . The method of  claim 22 , wherein the selected segment of the electrocardiogram is a P wave segment. 
     
     
         26 . A method of ablating cardiac tissue, comprising:
 positioning a first electrically conductive surface of a first medical device adjacent an endocardial surface of a heart;   positioning a second electrically conductive surface of a second medical device spaced away from the first electrically conductive surface; and   conducting pulsed energy between the first and second electrically conductive surfaces to induce irreversible electroporation ablation of tissue therebetween.   
     
     
         27 . The method of  claim 26 , wherein at least one of the first and second electrically conductive surfaces includes a plurality of electrodes disposed on a plurality of deployable arms. 
     
     
         28 . The method of  claim 26 , wherein at least one of the first and second medical devices includes a guide wire. 
     
     
         29 . The method of  claim 26 , wherein at least one of the first and second medical devices includes an inflatable element. 
     
     
         30 . The method of  claim 26 , further comprising substantially occluding an orifice with the first medical device. 
     
     
         31 . The method of  claim 30 , wherein the second medical device is positioned within a pulmonary vein. 
     
     
         32 . The method of  claim 26 , wherein the second medical device is positioned within a coronary sinus. 
     
     
         33 . The method of  claim 26 , wherein the second medical device is positioned within a superior vena cava. 
     
     
         34 . The method of  claim 26 , wherein the first medical device is positioned adjacent a septal wall, and the second medical device is positioned in a right atrium. 
     
     
         35 . The method of  claim 26 , further comprising conducting pulsed energy between a plurality of electrically conductive surfaces on the first medical device to induce irreversible electroporation ablation of tissue therebetween.