Balloon catheter method for reducing restenosis via irreversible electroporation

A balloon catheter device for insertion into a vessel and reducing neointima, comprising:

• a flexible elongated shaft comprising a distal end portion for insertion into a vessel;
• a balloon positioned at the distal end portion;
• a first electrode positioned at the distal end portion of the shaft, the first electrode being comprised of a conductive material which is flexible and generally conforms to an outer surface of the balloon during expansion of the balloon;
• a second electrode positioned at a point relative to the first electrode so as to allow electrical current to flow between the electrodes and through vascular tissue to the first electrode, the second electrode being comprised of a conductive material which is flexible and conforms to an outer surface of the balloon during expansion of the balloon;
• wherein the first electrode and second electrode are positioned in an overlapping relationship on a single longitudinal axis to form a double helix spanning an entire length of the balloon, and comprising multiple helical t urns around the balloon, and wherein the first and second electrodes are positioned to generate an electric field encompassing substantially the entire outer balloon surface;
• an electrical power source which provides electrical pulses to the electrodes for durations and in amounts sufficient to subject substantially all vascular cells in a target area of the vessel to non-thermal irreversible electroporation (NTIRE).