Expandable implantable conduit

Abstract

An expandable valved conduit for pediatric right ventricular outflow tract (RVOT) reconstruction is disclosed. The valved conduit may provide long-term patency and resistance to thrombosis and stenosis. The valved conduit may enlarge radially and/or longitudinally to accommodate the growing anatomy of the patient. Further, a method is disclosed for the manufacture of the valved conduit based in part on a plastically deformable biocompatible polymer and a computer-optimized valve design developed for such an expandable valved conduit.

1 .- 22 . (canceled) 
     
     
         23 . A method of replacing a first valved conduit comprising a plastically deformable material implanted in an animal, the method comprising:
 contacting an inner surface of the first valved conduit with an expansion device;   causing the expansion device to expand, thereby radially increasing at least a portion of the first valved conduit;   introducing a second valved conduit within at least a portion of the first valved conduit; and   causing the second valved conduit to expand within the at least portion of the first valved conduit,   wherein the plastically deformable material has a yield strength of about 0.1 MPa to about 4 MPa and an ultimate tensile strength greater than about 4 MPa.   
     
     
         24 . An implantable device for implantation into a human or animal, the implantable device comprising:
 a fluoropolymer conduit having radial expandability in a range from 20% to 400% above an initial conduit radius, wherein the fluoropolymer conduit is configured to expand upon exertion of a balloon catheter, the balloon catheter having a pressure greater than about 0.05 MPa.   
     
     
         25 . The implantable device of  claim 24 , wherein the fluoropolymer conduits further comprises a valve structure. 
     
     
         26 . The implantable device of  claim 24 , wherein the fluoropolymer conduit comprises at least a first layer and a second layer. 
     
     
         27 . The implantable device of  claim 24 , where the fluoropolymer conduit has an ultimate tensile strength greater than 4 MPa and an internode distance of 10 microns to 60 microns. 
     
     
         28 . A valved conduit for implantation into a human or animal, the valved conduit comprising:
 a fluoropolymer conduit having radial expandability in a range from 20% to 400% above an initial conduit radius; and   a valve structure disposed therein,   wherein the fluoropolymer conduit expands upon exertion of a balloon catheter, the balloon catheter having a pressure greater than about 0.05 MPa.   
     
     
         29 . The valved conduit of  claim 28 , wherein the fluoropolymer conduit comprises at least a first layer and a second layer. 
     
     
         30 . The valved conduit of  claim 29 , wherein the second conduit layer comprises a stent. 
     
     
         31 . The valved conduit of  claim 28 , wherein the valve structure comprises one or more leaflets. 
     
     
         32 . A method of expanding a device implanted in a human or animal, the method comprising:
 contacting an inner surface of a fluoropolymer conduit with an expansion device;   causing the expansion device to expand to a pressure greater than about 0.05 MPa, thereby radially increasing at least a portion of the conduit;   increasing the radial expandability in a range from 20% to 400% above an initial conduit radius,   wherein the conduit has a yield strength of 0.1 MPa to 4 MPa.   
     
     
         33 . The method of  claim 32 , wherein the fluoropolymer conduits further comprises a valve structure.