Abstract: The invention relates to a catheter and method for controlling tissue remodeling or proliferation. The catheter includes an outer balloon located on a distal end of the catheter, a first lumen in fluid communication with the outer balloon and fluidly connected to a source of liquid for expanding the outer balloon with liquid to contact the tissue site, and a second lumen fluidly connected to a source of coolant fluid at a proximal end for transporting the coolant fluid to a distal end of the second lumen to cool the liquid in the outer balloon and thereby the tissue site to a cryo-therapeutic temperature. The second lumen includes an orifice configured and dimensioned to allow the coolant fluid to expand as it passes therethrough to reduce coolant fluid temperature. In another embodiment, the outer balloon is coated or expanded with a media.

Abstract: A system and method for percutaneous access to a blood vessel is disclosed. The system according to the present invention includes a flexible guide wire for guiding the system to a desired position in a blood vessel; a tubular member having a lumen sized to slidingly receive the guide wire; an introducer having a lumen sized to slidingly receive the tubular member and a distal section including a S-shaped curve for assisting in positioning the system in the blood vessel; and a sheath having a lumen sized to slidingly receive the introducer, wherein the sheath provides access to the blood vessel after the system has been advanced to the desired position in the blood vessel.