Device and Method for Treating Cardiac Disorders by Modulating Autonomic Response

Abstract

A method and device for modulating the autonomic nervous system adjacent a pericardial space to treat cardiac arrhythmia includes a treatment source arranged to supply a treatment medium, a catheter having an end sized for insertion into the pericardial space, a medium delivery assembly having a distal end arranged to be positioned by the catheter into the pericardium, with the distal end of the delivery assembly comprising a delivery tip arranged to extend away from the distal end of the catheter into the pericardial space. A connector operatively couples the delivery tip of the medium delivery assembly to the treatment source, and the delivery tip of the medium delivery assembly including a plurality of delivery points for delivering the treatment medium at a plurality of treatment areas within the pericardial space. The device performs modulation or ablation of the autonomic nervous system at selected treatment areas within the pericardium.

1 . (canceled) 
     
     
         2 . A catheter device for modulating autonomic nervous tissue, the catheter device comprising:
 a catheter shaft including a distal end portion;   a cryogenic element disposed at the distal end portion, the cryogenic element operable for cooling tissue that the cryogenic element contacts; and   a plurality of electrodes disposed at the distal end portion, the plurality of electrodes operable for delivering energy for modulating the autonomic nervous tissue.   
     
     
         3 . The catheter device of  claim 2 , wherein the electrodes are located on an opposite side of the distal end portion in relation to the cryogenic element. 
     
     
         4 . The catheter device of  claim 2 , wherein the cryogenic element is carried on an expandable element. 
     
     
         5 . The catheter device of  claim 4 , wherein the expandable element comprises a balloon. 
     
     
         6 . The catheter device of  claim 5 , wherein the balloon has a flat cross-sectional shape. 
     
     
         7 . The catheter device of  claim 4 , wherein the expandable element comprises a metallic framework. 
     
     
         8 . The catheter device of  claim 2 , wherein the distal end portion is curved. 
     
     
         9 . The catheter device of  claim 2 , further comprising an insulative covering disposed on portions of the catheter shaft other than on the cryogenic element and the plurality of electrodes. 
     
     
         10 . The catheter device of  claim 2 , wherein the distal end portion is deflectable. 
     
     
         11 . A method of modulating autonomic nervous tissue residing within a pericardial space to treat cardiac disorders, the method comprising the steps of:
 positioning a distal end portion of a treatment delivery assembly at a location within the pericardial space, the distal end portion comprising one or more electrodes and a cryogenic element;   activating the cryogenic element such that the cryogenic element cools tissue in contact with the cryogenic element; and   energizing the one or more electrodes with electrical energy such that at least some of the autonomic nervous tissue is modulated by the electrical energy.   
     
     
         12 . The method of  claim 11 , wherein said activating the cryogenic element includes anchoring the distal end portion to the tissue in contact with the cryogenic element. 
     
     
         13 . The method of  claim 11 , wherein the one or more electrodes comprises a plurality of spaced apart electrodes. 
     
     
         14 . The method of  claim 11 , wherein the distal end portion comprises an expandable element shiftable between a collapsed state and an expanded state, and the method further comprising expanding the expandable element after placement of the distal end portion at the location within the pericardial space. 
     
     
         15 . The method of  claim 11 , wherein the expandable element comprises a balloon. 
     
     
         16 . The method of  claim 11 , wherein the distal end portion is curved. 
     
     
         17 . A catheter device for modulating autonomic nervous tissue, the catheter device comprising:
 a catheter shaft including an expandable distal end portion, the expandable distal end portion comprising a frame of multiple wire strands that form a rectilinear array; and   a plurality of electrodes disposed on the expandable distal end portion, the plurality of electrodes operable for delivering energy for modulating the autonomic nervous tissue.   
     
     
         18 . The catheter device of  claim 17 , further comprising a cryogenic element disposed at the expandable distal end portion. 
     
     
         19 . The catheter device of  claim 17 , further comprising one or more infusion ports for infusing a fluid. 
     
     
         20 . The catheter device of  claim 17 , wherein the frame comprises nitinol. 
     
     
         21 . The catheter device of  claim 17 , wherein the expandable distal end portion is deflectable.