Non-Thermal Ablation System for Treating BPH and Other Growths

Abstract

Systems and methods for non-thermal ablation of tissue are provided. A non-implantable minimally invasive system for treatment of tissue in a body via direct current ablation is provided including a catheter, a plurality of electrodes for deployment through the catheter, a power source for applying power to the electrodes, and a fixation element for maintaining the catheter in a treatment position during treatment of the tissue. A minimally invasive method for treating tissue in a body via direct current ablation is provided including inserting a catheter into the body such that a portion of the catheter remains outside of the body, deploying a fixation element to fix the catheter in a treatment position, deploying a plurality of electrodes through the catheter, applying power to the plurality of electrodes, using the electrodes to apply a current to the tissue, and removing the catheter from the body.

1 . A minimally invasive method for treating prostate tissue via direct current ablation comprising:
 inserting a catheter into the urethra, wherein a portion of the catheter remains outside of the body when the catheter is in a treatment position proximate the prostate;   deploying a fixation element associated with the catheter to fix the catheter in the treatment position;   deploying a plurality of electrodes through the catheter into the prostate;   determining treatment parameters;   inputting treatment parameters into at least one of a power source and a processor;   applying between approximately 10 and 50 mA of direct current and less than 3200 mW of power to deliver a charge to the electrodes using a power source, wherein the direct current applied is based on the treatment parameters; wherein at least one of a high pH and a low pH is imparted by at least one of the electrodes upon application of the direct current such that a necrotic zone in the treatment zone is created and wherein application of the direct current is substantially non-thermal; and   stopping the application of direct current to the treatment area once the treatment parameters are reached, wherein the application of current to the electrodes is done in between approximately 15 and 45 minutes with the catheter in a single treatment position.   
     
     
         2 . The method of  claim 1 , wherein the electrodes are the fixation element and deploying the fixation element and deploying the electrodes comprises one step of deploying the electrodes. 
     
     
         3 - 13 . (canceled) 
     
     
         14 . The method of  claim 1 , wherein the electrodes are deployed into both lateral posterior quadrants, and both lateral anterior quadrants or both lateral quadrants, of tissue relative to the urethra. 
     
     
         15 . (canceled) 
     
     
         16 . The method of  claim 1 , further comprising increasing or decreasing the direct current delivered by the electrodes at a controlled ramp rate. 
     
     
         17 . The method of  claim 16 , wherein the ramp rate is between approximately 0.1 mA/sec and 10 mA/sec. 
     
     
         18 . The method of  claim 1 , wherein the current is kept constant throughout the treatment by using voltage compliance to adjust for changing impedance between the electrodes during treatment. 
     
     
         19 - 26 . (canceled) 
     
     
         27 . The method of  claim 1 , further comprising testing impedance of the electrodes in prostate tissue to verify adequate contact. 
     
     
         28 - 54 . (canceled)