Device and method for electroporation based treatment of stenosis of a tubular body part

Abstract

The present invention relates to medical devices and methods for treating a lesion such as a vascular stenosis using non-thermal irreversible electroporation (NTIRE). Embodiments of the present invention provide a balloon catheter type NTIRE device for treating a target lesion comprising a plurality of electrodes positioned along the balloon that are electrically independent from each other so as to be individually selectable in order to more precisely treat an asymmetrical lesion in which the lesion extends only partially around the vessel.

1 . A method of treating a stenosis of a tubular body part by non-thermal irreversible electroporation comprising:
 inserting, through the tubular body part, a balloon catheter having at least three electrodes positioned and spaced apart along the balloon, the electrodes being electrically independent from each other;   expanding the balloon to bring the electrodes near a stenosis to be treated;   determining which electrodes are near the stenosis;   applying electrical pulses to the electrodes according to the determination of which electrodes are near the stenosis, the applied pulses being in an amount which is sufficient to induce irreversible electroporation of cells of the stenosis, but which is insufficient to induce thermal damage to substantially all of the cells of the stenosis such that substantially all stenosis cells are killed by non-thermal irreversible electroporation.   
     
     
         2 . The method of  claim 1 , wherein the step of applying electrical pulses includes selecting at least one electrode to which the electrical pulses are not to be applied. 
     
     
         3 . The method of  claim 1 , wherein the step of applying electrical pulses includes connecting through a switch a pulse generator output to any pair of the electrodes independent of the other electrodes. 
     
     
         4 . The method of  claim 3 , wherein the step of applying electrical pulses includes control the switch to output the electrical pulses to only those electrodes that have been selected based on a determination of which electrodes are near the stenosis. 
     
     
         5 . The method of  claim 1 , further comprising determining at least one individualized electrical parameter for each pair of electrodes based on the determination of which electrodes are near the stenosis. 
     
     
         6 . The method of  claim 5 , wherein the at least one electrical parameter includes Voltage or pulse duration. 
     
     
         7 . The method of  claim 1 , further comprising determining at last one individualized electrical parameter for each pair of electrodes based on the depth and proximity of the stenosis in relation to the electrode positions. 
     
     
         8 . The method of  claim 7 , wherein the step of determining at least one individualized electrical parameter includes determining an individualized voltage level to use for each pair of electrodes based on the depth of the restenosis near the each pair. 
     
     
         9 . The method of  claim 1 , wherein which electrodes are near the stenosis is determined by one or more imaging markers disposed near the electrodes. 
     
     
         10 . The method of  claim 9 , wherein the one or more imaging markers include a radiopaque marker. 
     
     
         11 . The method of  claim 1 , wherein which electrodes are near the stenosis is determined by applying test pulses to different pairs of the electrodes and measuring at least one electrical characteristic of the stenosis cells for the different pairs of electrodes. 
     
     
         12 . The method of  claim 11 , wherein the step of determining includes measuring an electrical resistance as the at least one electrical characteristic of tissue cells. 
     
     
         13 . The method of  claim 12 , further comprising displaying a graphical representation and identification of the electrodes in positional relationship to the stenosis. 
     
     
         14 . The method of  claim 12 , further comprising displaying a graphical representation of the stenosis and a graphical representation and identification of the electrodes in positional relationship to the stenosis. 
     
     
         15 . A medical device for treating a stenosis of a tubular body part by non-thermal irreversible electroporation comprising:
 a pulse generator adapted to generate electrical pulses in an amount which is sufficient to induce irreversible electroporation of cells of a stenosis to be treated, but which is insufficient to induce thermal damage to substantially all of the cells of the stenosis;   a catheter;   a balloon attached to a distal portion of the catheter;   at least three electrodes positioned and spaced apart along the balloon, and electrically independent from each other, the electrodes adapted to receive the electrical pulses from the pulse generator such that substantially all of the cells of the stenosis are killed by non-thermal irreversible electroporation.   
     
     
         16 . The medical device of  claim 15 , further comprising a switch connected between a pulse generator and the electrodes, and adapted to connect the pulse generator output to any pair of the electrodes independent of the other electrodes. 
     
     
         17 . The medical device of  claim 16 , further comprising a treatment control module adapted to control the switch to output the electrical pulses to those electrodes that have been selected based on a determination of which electrodes are near the stenosis. 
     
     
         18 . The medical device of  claim 15 , wherein the treatment control module is adapted to determine at least one individualized electrical parameter for each pair of electrodes based on a determination of which electrodes are near the stenosis. 
     
     
         19 . The medical device of  claim 18 , wherein the at least one electrical parameter includes Voltage or pulse duration. 
     
     
         20 - 27 . (canceled) 
     
     
         28 . A method for treating a lesion of a tubular body part by non-thermal irreversible electroporation comprising:
 inserting into the tubular body part a plurality of elongated electrodes disposed lengthwise and circumferentially spaced a selected distance from one another;   positioning the electrodes within the tubular body part to provide one or more of the electrodes in position to deliver a plurality of electrical pulse to a target lesion;   selecting electrodes among the plurality of electrodes for administering the electrical pulses;   administering the electrical pulses through only the selected electrodes to the target lesion in an amount which is sufficient to induce irreversible electroporation of cells of the target lesion, but which is insufficient to induce thermal damage to substantially all of the cells of the target lesion such that substantially all cells of the target lesion are killed by non-thermal irreversible electroporation.   
     
     
         29 - 34 . (canceled)