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

Abstract

A system for denervation of the renal sympathetic nerve and iontophoresis drug delivery includes an iontophoresis catheter fitted with a drug coated balloon. The balloon contacts the vessel wall 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 the patient's body. The drug-delivery catheter produces an electric potential gradient within adjacent tissue, that, facilitates iontophoresis delivery of a drug. The catheter can also include a store of one or more drugs to be delivered to the targeted tissue.

1 . An iontophoresis drug delivery system, comprising:
 an energy source;   a catheter;   a balloon disposed at a distal end of the catheter;   at least one electrode disposed on a surface of the balloon and operably coupled to the energy source; and   a drug supply operatively associated with the balloon.   
     
     
         2 . The iontophoresis drug delivery system in accordance with  claim 1 , wherein the drug supply is configured to selectively release a drug. 
     
     
         3 . The iontophoresis drug delivery system in accordance with  claim 1 , wherein the drug supply includes at least one drug. 
     
     
         4 . The iontophoresis drug delivery system in accordance with  claim 3 , wherein the at least one drug is selected from the group consisting of guanethidine, epinephrine, dimethyl sulfoxide (DMSO), and combinations thereof. 
     
     
         5 . The iontophoresis drug delivery system in accordance with  claim 1 , wherein the energy source is configured to deliver direct current to the at least one electrode. 
     
     
         6 . The iontophoresis drug delivery system in accordance with  claim 1 , wherein an outer surface of the balloon includes at least one well for storing the drug supply. 
     
     
         7 . The iontophoresis drug delivery system in accordance with  claim 6 , wherein the at least one well includes a covering layer configured for being disrupted. 
     
     
         8 . The iontophoresis drug delivery system in accordance with  claim 1 , wherein the balloon includes a plurality of perforations in fluid communication with an interior of the balloon. 
     
     
         9 . The iontophoresis drug delivery system in accordance with  claim 1 , wherein the drug supply is a coating provided on an outer surface of the balloon. 
     
     
         10 . An iontophoresis drug delivery system, comprising:
 an energy source;   a catheter;   an expandable member disposed at a distal end of the catheter;   at least one electrode disposed on the expandable member and operably coupled to the energy source; and   a drug supply operatively associated with the expandable member.   
     
     
         11 . The iontophoresis drug delivery system in accordance with  claim 10 , wherein the drug supply is configured to selectively release the drug. 
     
     
         12 . The iontophoresis drug delivery system in accordance with  claim 10 , wherein the drug supply includes at least one drug. 
     
     
         13 . The iontophoresis drug delivery system in accordance with  claim 12 , wherein the at least one drug is selected from the group consisting of guanethidine, epinephrine, dimethyl sulfoxide (DMSO), and combinations thereof. 
     
     
         14 . The iontophoresis drug delivery system in accordance with  claim 10 , wherein the energy source is configured to deliver direct current to the at least one electrode. 
     
     
         15 . The iontophoresis drug delivery system in accordance with  claim 10 , wherein the expandable member is selected from the group consisting of a balloon and a frame. 
     
     
         16 . The iontophoresis drug delivery system in accordance with  claim 15 , wherein an outer surface of the balloon includes at least one well for storing the drug supply. 
     
     
         17 . The iontophoresis drug delivery system in accordance with  claim 16 , wherein the at least one well includes a covering layer configured for being disrupted. 
     
     
         18 . The iontophoresis drug delivery system in accordance with  claim 15 , wherein the balloon includes a plurality of perforations in fluid communication with an interior of the balloon. 
     
     
         19 . The iontophoresis drug delivery system in accordance with  claim 15 , wherein the drug supply is a coating provided on an outer surface of the balloon. 
     
     
         20 . An iontophoresis drug delivery catheter, comprising:
 a balloon disposed at a distal end of the catheter;   at least one electrode disposed on a surface of the balloon and operably coupled to an energy source; and   a drug supply operatively associated with the balloon.   
     
     
         21 . The iontophoresis drug delivery catheter in accordance with  claim 20 , wherein the drug supply is configured to selectively release the drug. 
     
     
         22 . The iontophoresis drug delivery catheter in accordance with  claim 20 , wherein the drug supply includes at least one drug. 
     
     
         23 . The iontophoresis drug delivery catheter in accordance with  claim 22 , wherein the at least one drug is selected from the group consisting of guanethidine, epinephrine, dimethyl sulfoxide (DMSO), and combinations thereof. 
     
     
         24 . The iontophoresis drug delivery catheter in accordance with  claim 20 , wherein an outer surface of the balloon includes at least one well for storing the drug supply. 
     
     
         25 . The iontophoresis drug delivery catheter in accordance with  claim 24 , wherein the at least one well includes a covering layer configured for being disrupted. 
     
     
         26 . The iontophoresis drug delivery catheter in accordance with  claim 20 , wherein the balloon includes a plurality of perforations in fluid communication with an interior of the balloon. 
     
     
         27 . The iontophoresis drug delivery catheter in accordance with  claim 20 , wherein the drug supply is a coating provided on an outer surface of the balloon. 
     
     
         28 . A method for the treatment of renal hypertension, comprising:
 placing a drug-delivery catheter in to the lumen of the renal artery;   producing an electric potential between the catheter and the nerves adjacent to the renal artery wall; and   administering a drug to said nerves via said electric potential to attenuate the activity of said nerves.   
     
     
         29 . A method to determine if a hypertensive patient may benefit from a renal denervation procedure, comprising:
 measuring the blood pressure of a hypertensive patient;   administering guanethidine to the hypertensive patient;   determining whether the blood pressure of the hypertensive patient changed subsequent to guanethidine administration;   comparing a change in blood pressure to a predetermined value; and   performing a renal denervation procedure on the hypertensive patient if the change in blood pressure exceeds the predetermined value.   
     
     
         30 . A method for treating hypertension comprising:
 placing a drug delivery catheter into a lumen of the renal artery;   producing an electric potential between the catheter and nerves adjacent a wall of the renal artery; and   administering a drug to the nerves via the electric potential, thereby attenuating the activity of the nerves.