IONTOPHORESIS DRUG DELIVERY SYSTEM AND METHOD FOR DENERVATION OF THE RENAL SYMPATHETIC NERVE AND IONTOPHORETIC DRUG DELIVERY
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.