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.

What is claimed is: 
     
         1 . An implantable device for implantation into a human or animal, the implantable device comprising:
 a fluoropolymer conduit having an inner layer and an outer layer;   wherein the fluoropolymer conduit has a radial expandability in a range from 20% to 200% above an initial conduit radius,   wherein the outer layer has a yield strength of about 0.05 MPa to about 4 MPa, and wherein the outer layer has an ultimate tensile strength of greater than about 4 MPa.   
     
     
         2 . The implantable device of  claim 1 , wherein the outer layer has a wall thickness of about 0.2 mm to about 2.0 mm. 
     
     
         3 . The implantable device of  claim 1 , wherein the outer layer has a density of about 0.2 mg/mm 3  to about 0.8 mg/mm 3 . 
     
     
         4 . The implantable device of  claim 1 , wherein the inner layer has a density of about 1.0 mg/mm 3  to about 2 mg/mm 3 . 
     
     
         5 . The implantable device of  claim 1 , wherein the fluoropolymer conduit is configured to be implanted into a cardiovascular structure using sutures, and wherein the fluoropolymer conduit has a suture retention strength greater than or about equal to 0.5 N. 
     
     
         6 . The implantable device of  claim 1 , wherein the fluoropolymer conduit further comprises a valve structure. 
     
     
         7 . The implantable device of  claim 1 , wherein the fluoropolymer conduit comprises nodes having an internode distance of about 10 microns to about 40 microns. 
     
     
         8 . A valved conduit for implantation into a human or animal, the valved conduit comprising:
 a fluoropolymer conduit having an initial radius, the fluoropolymer conduit configured to be expanded from an unexpanded state to an expanded state; and   a valve structure disposed within the fluoropolymer conduit, the valve structure comprising two leaflets and having a closed state and an open state;   wherein the fluoropolymer conduit has a radial expandability in a range from 20% to 200% above the initial radius,   wherein the fluoropolymer conduit has a yield strength of about 0.05 MPa to about 4 MPa and an ultimate tensile strength of greater than about 4 MPa,   wherein, when the fluoropolymer conduit is in the unexpanded state and the valve structure is in the closed state, the leaflets overlap, and   wherein, when the fluoropolymer conduit is in the expanded state and the valve structure is in the closed state, the leaflets do not overlap.   
     
     
         9 . The valved conduit of  claim 8 , wherein the valve structure comprises three leaflets. 
     
     
         10 . The valved conduit of  claim 8 , wherein the leaflets are at least partially domed in the unexpanded state. 
     
     
         11 . The valved conduit of  claim 8 , wherein the valved conduit has a regurgitation fraction less than or equal to about 30%. 
     
     
         12 . The valved conduit of  claim 8 , wherein the fluoropolymer conduit comprises nodes having an internode distance of about 10 microns to about 40 microns. 
     
     
         13 . A valved conduit for implantation into a human or animal, the valved conduit consisting of:
 a fluoropolymer conduit having radial expandability in a range from 20% to 200% above an initial conduit radius; and   a valve structure disposed therein;   wherein the fluoropolymer conduit has a yield strength of about 0.05 MPa to about 4 MPa, and   wherein the fluoropolymer conduit has a suture retention strength greater than or about equal to 0.5 N.   
     
     
         14 . The valved conduit of  claim 13 , wherein the fluoropolymer conduit comprises a first conduit layer and a second conduit layer, and wherein the second conduit layer comprises a stent. 
     
     
         15 . The valved conduit of  claim 13 , wherein the valve structure comprises from one leaflet to three leaflets. 
     
     
         16 . The valved conduit of  claim 13 , wherein the valved conduit is configured to be implanted into a vascular structure using sutures, and wherein the valved conduit has a suture retention strength greater than or about equal to 0.8 N. 
     
     
         17 . An implantable device for implantation into a human or animal, the implantable device consisting of:
 a fluoropolymer conduit having radial expandability in a range from 20% to 200% above an initial conduit radius, wherein the fluoropolymer conduit has a yield strength from about 0.05 MPa to about 4 MPa, and   wherein the fluoropolymer conduit has a suture retention strength greater than or about equal to 0.5 N.   
     
     
         18 . The implantable device of  claim 17 , wherein the implantable device is configured to be implanted into a cardiovascular structure using sutures, and wherein the fluoropolymer conduit has a suture retention strength greater than or about equal to 0.8 N.