Shape changing ablation balloon

Abstract

A device, method, and system for thermally affecting tissue. The device may generally include an elongate body, an actuation element slidably disposed within the elongate body, a balloon defining an interior chamber, a proximal neck, and a distal neck, the first neck being coupled to the distal portion of the elongate body and the second neck being coupled to the distal portion of the actuation element, retraction of the actuation element within the elongate body causing the treatment element to transition from a first configuration to a second configuration. The distal neck may be located external to the interior chamber in the first configuration and within the interior chamber in the second configuration. The device may also include a fluid injection element that is transitionable to an expanded configuration when the balloon is inflated, thereby enhancing the cooling capacity of the balloon.

What is claimed is: 
     
         1 . A method for ablating an area of tissue, the method comprising:
 positioning an inflatable treatment element proximate the area of tissue, the inflatable treatment element defining a distal neck and an interior chamber, the inflatable treatment element being in a first configuration in which the distal neck of the inflatable treatment element is everted to extend distally from the interior chamber;   retracting an actuation element to transition the inflatable treatment element from the first configuration in which the distal neck of the inflatable treatment element is inverted to extend proximally within the interior chamber of the inflatable treatment element, a fluid injection element being disposed within the interior chamber, at least a portion of the fluid injection element being coiled around and substantially in contact with a portion of the actuation element; and   circulating cryogenic fluid within the interior chamber of the inflatable treatment element.   
     
     
         2 . The method of  claim 1 , wherein the inflatable treatment element is at a distal end of an elongate body of a medical device. 
     
     
         3 . The method of  claim 2 , wherein retraction of the actuation element causes the fluid injection element to expand away from the actuation element when the inflatable treatment element is in a second configuration. 
     
     
         4 . The method of  claim 3 , wherein at least a portion of the fluid injection element is coiled around and is substantially in contact with a portion of the actuation element when the inflatable treatment element is in the first configuration. 
     
     
         5 . The method of  claim 4 , wherein the fluid injection element includes a plurality of ports, at least some of the plurality of ports being proximate an inner wall of the inflatable treatment element when the inflatable treatment element is in the second configuration. 
     
     
         6 . The method of  claim 5 , wherein the area of tissue is a pulmonary vein, positioning an inflatable treatment element proximate the area of tissue including positioning the inflatable treatment element in contact with the pulmonary vein such that at least a portion of the distal neck is located within the pulmonary vein. 
     
     
         7 . The method of  claim 6 , wherein retracting the actuation element to transition the inflatable treatment element from the first configuration includes retracting the actuation element such that the inflatable treatment element defines a distal face and the at least a portion of the distal neck is not located within the pulmonary vein. 
     
     
         8 . The method of  claim 7 , further comprising initiating a flow of cryogenic fluid within the interior chamber before retracting the actuation element to transition the inflatable treatment element from the first configuration to the second configuration. 
     
     
         9 . The method of  claim 7 , further comprising initiating a flow of cryogenic fluid within the interior chamber after retracting the actuation element to transition the inflatable treatment element from the first configuration to the second configuration. 
     
     
         10 . A method for ablating an area of tissue, the method comprising:
 positioning an inflatable treatment element proximate the area of tissue, the inflatable treatment element being disposed at a distal end of an elongate body of a medical device, the inflatable treatment element defining a distal neck and an interior chamber, the inflatable treatment element being in a first configuration in which the distal neck of the inflatable treatment element is everted to extend distally from the interior chamber of the inflatable treatment element;   retracting an actuation element to transition the inflatable treatment element from the first configuration in which the distal neck of the inflatable treatment element is inverted to extend proximally within the interior chamber of the inflatable treatment element, a fluid injection element being disposed within the interior chamber, at least a portion of the fluid injection element being coiled around and substantially in contact with a portion of the actuation element at when the inflatable treatment element is in the first configuration; and   circulating cryogenic fluid within the interior chamber of the inflatable treatment element.   
     
     
         11 . The method of  claim 10 , wherein retraction of the actuation element causes the fluid injection element to expand away from the actuation element when the inflatable treatment element is in a second configuration. 
     
     
         12 . The method of  claim 11 , wherein the fluid injection element includes a plurality of ports, at least some of the plurality of ports being proximate an inner wall of the inflatable treatment element when the inflatable treatment element is in the second configuration. 
     
     
         13 . The method of  claim 12 , wherein the area of tissue is a pulmonary vein, positioning an inflatable treatment element proximate the area of tissue including positioning the inflatable treatment element in contact with the pulmonary vein such that at least a portion of the distal neck is located within the pulmonary vein. 
     
     
         14 . The method of  claim 13 , wherein retracting the actuation element to transition the inflatable treatment element from the first configuration includes retracting the actuation element such that the inflatable treatment element defines a distal face and the at least a portion of the distal neck is not located within the pulmonary vein. 
     
     
         15 . The method of  claim 14 , further comprising initiating a flow of cryogenic fluid within the interior chamber before retracting the actuation element to transition the inflatable treatment element from the first configuration to the second configuration. 
     
     
         16 . The method of  claim 15 , further comprising initiating a flow of cryogenic fluid within the interior chamber after retracting the actuation element to transition the inflatable treatment element from the first configuration to the second configuration. 
     
     
         17 . The method of  claim 11 , wherein the actuation element includes a distal tip, the distal neck of the inflatable treatment element being coupled to the distal tip of the actuation element. 
     
     
         18 . A method for minimizing blood contact with a cryoballoon during an ablation procedure, the method comprising:
 positioning a medical device having the cryoballoon in contact with an ostium of a pulmonary vein such that a distal neck of the cryoballoon is located external to a cryoballoon interior chamber and within the pulmonary vein; and   retracting an actuation element in mechanical communication with the cryoballoon to cause the distal neck to invert and become located within the cryoballoon interior chamber.   
     
     
         19 . The method of  claim 18 , wherein the medical device includes a fluid injection element within the cryoballoon, retraction of the actuation element causing the fluid injection element to expand within the cryoballoon. 
     
     
         20 . The method of  claim 18 , wherein the cryoballoon includes a distal neck and the actuation element includes a distal tip, the distal neck of the cryoballoon being coupled to the distal tip of the actuation element.