Energy delivery device and methods of use

Abstract

An energy delivery system for delivering electrical energy to tissue, includes an elongate catheter member defining a longitudinal axis and dimensioned for passage within a body vessel and an expandable treatment member mounted to the catheter member. The treatment member includes an inflatable element adapted to transition between an initial condition and an at least partially expanded condition upon introduction of an anesthetic solution within the inflatable element, an electrode for delivering electrical energy to at least the nerve tissue associated with the body vessel to cause at least partial denervation thereof and at least one aperture dimensioned to permit passage of the anesthetic solution from the inflatable element to contact the body vessel whereby the solution at least enters the body vessel to at least partially anesthetize the nerve tissue therewithin. The electrode may be mounted to at least the inflatable element of the treatment member and may be generally helical.

What is claimed is: 
     
         1 . An energy delivery system for delivering electrical energy to tissue, the energy delivery system comprising:
 an elongate catheter member defining a longitudinal axis and dimensioned for passage within a body vessel; and   an expandable treatment member mounted to the catheter member, the treatment member including:
 an inflatable element adapted to transition between an initial condition and an at least partially expanded condition upon introduction of an anesthetic solution within the inflatable element; 
 an electrode for delivering electrical energy to at least nerve tissue associated with the body vessel to cause at least partial denervation thereof; and 
 at least one aperture dimensioned to permit passage of the anesthetic solution from the inflatable element to contact the body vessel whereby the solution enters a wall of the body vessel to at least partially anesthetize nerve tissue therewithin. 
   
     
     
         2 . The energy delivery system according to  claim 1  wherein the electrode is mounted to at least the inflatable element of the treatment member. 
     
     
         3 . The energy delivery system according to  claim 2  wherein the electrode is generally helical. 
     
     
         4 . The energy delivery system accoiding to  claim 1  wherein the at least one aperture is dimensioned to deliver the anesthetic solution at a pressure sufficient to facilitate passage of the anesthetic solution at least within the wall of the body vessel. 
     
     
         5 . The energy delivery system according to  claim 4  wherein at least one of the inflatable element and the electrode includes a plurality of apertures dimensioned to deliver the anesthetic solution at the pressure sufficient to cause passage of the anesthetic solution at least within the wall of the body vessel. 
     
     
         6 . The energy delivery system according to  claim 4  wherein the apertures are each dimensioned to deliver the anesthetic solution at a pressure ranging from about 1 atm to about 4 atm. 
     
     
         7 . The energy delivery system according to  claim 6  wherein the apertures are each dimensioned to deliver the anesthetic solution at a pressure ranging from about 1 atm to about 4 atm and over a flow range of about 1 to about 20 mL/min. 
     
     
         8 . The energy delivery system according to  claim 7  wherein each aperture defines a pore size ranging from about 0.5 mil to about 10 mil. 
     
     
         9 . The energy delivery system according to  claim 6  wherein the catheter member defines a fluid lumen for delivering the anesthetic solution to the inflatable element of the treatment member. 
     
     
         10 . The energy delivery system according to  claim 9  further comprising a source of anesthetic solution in fluid communication with the fluid lumen of the catheter member and the inflatable element of the treatment member. 
     
     
         11 . The energy delivery system according to  claim 10  farther comprising a pump couplable to the fluid lumen of the catheter member, the pump dimensioned to deliver the anesthetic solution from the source to the fluid lumen of the catheter member at a pump pressure sufficient to convey the anesthetic through the fluid lumen and out the apertures at the pressure to enhance passage of the anesthetic solution at least within the wall of the body vessel. 
     
     
         12 . The energy delivery system according to  claim 11  including a sensor in fluid communication with at least the fluid lumen of the catheter member. 
     
     
         13 . The energy delivery system according to  claim 12  wherein the sensor is a pressure sensor adapted to sense pressure corresponding to pressure within the inflatable element. 
     
     
         14 . The energy delivery system according to  claim 11  wherein the sensor is a flow rate sensor adapted to detect flow rate associated with passage of the anesthetic solution through the fluid lumen. 
     
     
         15 . The energy delivery system according to  claim 12  further comprising a controller for controlling operation of the pump. 
     
     
         16 . The energy delivery system according to  claim 15  wherein the controller includes logic responsive to a parameter detected by the sensor to vary operation of the pump. 
     
     
         17 . The energy delivery system according to  claim 9  further comprising a source of irrigation fluid in fluid communication with the inflatable element of the treatment member for passage through the apertures. 
     
     
         18 . The energy delivery system according to  claim 17  further comprising a valve in fluid communication with the source of anesthetic solution and the source of irrigation fluid, the valve being actuable between an anesthetic mode to permit the delivery of the anesthetic solution to the fluid lumen of the catheter member and an irrigation mode to permit the delivery of the irrigation fluid to the fluid lumen of the catheter member. 
     
     
         19 . The energy delivery system according to  claim 1  wherein the at least one aperture is dimensioned to permit passage of the anesthetic solution at a pressure whereby the anesthetic solution slowly diffuses through the wall of the body vessel and migrates to the nerve tissue associated with the body vessel. 
     
     
         20 . The energy delivery system according to  claim 19  wherein the inflatable element of the treatment member is dimensioned to establish a reservoir between the inflatable element and the wall of the body vessel when in the at least partially expanded condition thereof, the reservoir for receiving the anesthetic solution for diffusion through the wall of the body vessel. 
     
     
         21 . The energy delivery system according to  claim 20  wherein the treatment member includes at least one occluding element, the at least one occluding element defining a dimension greater than a corresponding dimension of the inflatable element when the at least one inflatable clement is in an at least partially expanded condition thereof, the at least one occluding element dimensioned to at least partially occlude the body vessel to at least partially enclose the reservoir. 
     
     
         22 . The energy delivery system according to  claim 21  wherein the inflatable element is a balloon member, the balloon member including first and second axially spaced occluding segments and a central segment between the first and second occluding segments, each of the first and second occluding segments having a transverse dimension greater than a corresponding transverse dimension of the central segment when the balloon member is in a first inflated condition, and being dimensioned to substantially occlude the body vessel to enclose the reservoir. 
     
     
         23 . The energy delivery system according to  claim 22  wherein the balloon member is adapted to transition between the first inflated condition and a second inflated condition where the central segment defines a greater transverse dimension to position the electrode in apposition with the body vessel to deliver electrical energy to the nerve tissue surrounding the body vessel. 
     
     
         24 . The energy delivery system according to  claim 23  wherein the catheter member defines a fluid lumen for delivering the anesthetic solution to the balloon member. 
     
     
         25 . The energy delivery system according to  claim 20  wherein the catheter member includes first and second occluding elements mounted adjacent opposed ends of the inflation element, the first and second occluding elements adapted to expand to occlude the body vessel and enclose the reservoir established between the inflatable element and the wall of the body vessel, the first and second occluding elements adapted for expansion independent of expansion of the inflatable element. 
     
     
         26 . The energy delivery system according to  claim 25  wherein the first and second occluding elements are first and second occluding balloon members and the inflation element is a treatment balloon member. 
     
     
         27 . The energy delivery system according to  claim 26  wherein the catheter member defines a second fluid lumen for delivering fluid to the first and second occluding balloon members. 
     
     
         28 . The energy delivery system according to  claim 26  wherein the first and second occluding balloon members are inflatable independent of each other. 
     
     
         29 . The energy delivery system according to  claim 19  wherein the treatment member includes a first balloon member and a second balloon member coaxially mounted about the first balloon member, the first and second balloon members establishing a reservoir between the first and second balloon members when in the at least partially inflated condition thereof, the reservoir for receiving the anesthetic solution, the second balloon member including the at least one aperture dimensioned to permit passage of the anesthetic solution and having the electrode mounted thereto. 
     
     
         30 . The energy delivery system according to  claim 29  wherein the first and second balloon members are inflatable independent of each other. 
     
     
         31 . The energy delivery system according to  claim 30  wherein the elongate member defines a second lumen for supplying fluids to the first balloon member to inflate the first balloon member. 
     
     
         32 . A method for treating hypertension, comprising:
 positioning a treatment member including an inflatable segment and an electrode segment within a renal artery;   delivering an anesthetic solution into the inflatable segment such that the anesthetic solution is released from at least one aperture of the treatment member to contact a wall of the renal artery whereby the anesthetic solution at least enters the wall of the renal artery and migrates to nerve tissue associated with the renal artery; and   emitting RF energy from the electrode segment to disrupt renal nerve transmission to treat hypertension.   
     
     
         33 . The method according to  claim 32  wherein delivering the anesthetic solution includes directing the anesthetic solution at a pressure sufficient to enter the wall of the renal artery and contact the renal nerve tissue. 
     
     
         34 . The method according to  claim 33  wherein delivering the anesthetic solution includes directing the anesthetic solution through a plurality of apertures in the treatment member. 
     
     
         35 . The method according to  claim 34  wherein delivering the anesthetic solution includes directing the anesthetic solution through a plurality of apertures in the treatment member at a pressure ranging from about 1 atm to about 4 atm. 
     
     
         36 . The method according to  claim 32  wherein delivering the anesthetic solution includes permitting passage of the anesthetic solution at a pressure whereby the anesthetic solution slowly diffuses through the wall of the renal artery and migrates to the renal nerve tissue surrounding the renal artery. 
     
     
         37 . The method according to  claim 36  wherein delivering the anesthetic solution includes distributing the anesthetic solution within a reservoir defined between the inflatable segment and the wall of the renal artery. 
     
     
         38 . The method according to  claim 37  wherein the treatment member includes occluding segments adjacent each end of the inflation segment and further including expanding the occluding segments to contact the wall of the renal artery to occlude the artery and substantially enclose the reservoir.