Iontophoresis drug delivery system and method for denervation of the renal sympathetic nerve and iontophoretic drug delivery

Abstract

An iontophoresis drug delivery system and method for denervation of the renal sympathetic nerve and iontophoresis drug delivery. The system includes an iontophoresis catheter fitted with a drug coated balloon. The iontophoresis catheter includes a balloon near its distal tip or end that contacts the vessel wall circumferentially when inflated. One or more electrodes are associated with a surface of the balloon, and may be disposed on an outer surface of the balloon. The electrodes are operably coupled to an energy source configured to produce a bipolar or monopolar electric field between two balloon electrodes and/or between one balloon electrode and another electrode placed in contact with a part of the patient's body. During use, the disclosed drug-delivery catheter produces an electric potential gradient within adjacent tissue, that, in turn, facilitates iontophoresis delivery of a drug. The disclosed catheter can also include a store of one or more drugs to be delivered to the targeted tissue.

1 - 30 . (canceled) 
     
     
         31 . An iontophoresis drug delivery system for treatment of a human patient, the drug delivery system comprising:
 a catheter shaped and sized for intravascular delivery to a renal blood vessel of the patient;   an expandable member at a distal region of the catheter;   one or more electrodes disposed on the expandable member, wherein the one or more electrodes are configured to be coupled to an energy source external to the patient; and   a drug supply operatively associated with the balloon and configured to selectively release a drug, wherein the drug is selected from a group including guanethidine, epinephrine, dimethyl sulfoxide (DMSO), and combinations thereof.   
     
     
         32 . The iontophoresis drug delivery system of  claim 31  wherein the catheter is shaped and sized for intravascular delivery within a lumen of a renal artery of the patient between the descending aorta and one or more renal artery branches adjacent to a kidney of the patient. 
     
     
         33 . The iontophoresis drug delivery system of  claim 31  wherein the expandable member comprises a frame. 
     
     
         34 . The iontophoresis drug delivery system of  claim 31  wherein the expandable member comprises a balloon. 
     
     
         35 . The iontophoresis drug delivery system of  claim 34  wherein an outer surface of the balloon includes a plurality of wells for storing the drug supply. 
     
     
         36 . The iontophoresis drug delivery system of  claim 35 , further comprising a covering layer over the wells, and wherein the covering layer is configured to be disrupted as the balloon transforms between a low-profile delivery configuration and an expanded treatment configuration. 
     
     
         37 . The iontophoresis drug delivery system of  claim 34  wherein the drug supply comprises a coating on an outer surface of the balloon. 
     
     
         38 . The iontophoresis drug delivery system of  claim 34  wherein the balloon comprises one or more lumens to allow blood to flow therethrough. 
     
     
         39 . The iontophoresis drug delivery system of  claim 34  wherein, when inflated, the balloon is sized and shaped to circumferentially engage an inner vessel wall of the renal blood vessel. 
     
     
         40 . The iontophoresis drug delivery system of  claim 34  wherein the balloon comprises a weeping balloon a plurality of perforations positioned to deliver the drug therethrough. 
     
     
         41 . The iontophoresis drug delivery system of  claim 31  wherein the drug is in ionic form. 
     
     
         42 . The iontophoresis drug delivery system of  claim 31  wherein the one or more electrodes disposed on the expandable member comprises two electrodes adapted for delivery of a bipolar electric field to target tissue to facilitate delivery of the drug via iontophoresis. 
     
     
         43 . The iontophoresis drug delivery system of  claim 31  wherein the one or more electrodes are adapted for delivery of a monopolar electric field to target tissue to facilitate delivery of the drug via iontophoresis.