Transcatheter Stent-Valves and Methods, Systems and Devices for Addressing Para-Valve Leakage

Abstract

Some embodiments of the present disclosure provide a stent-valve for transcatheter implantation to replace a cardiac valve. In some embodiments, the stent valve being compressible to a compressed state for delivery, and expandable to an operative state for implantation. In some embodiments, the stent-valve comprises a stent, a plurality of leaflets for defining a prosthetic valve, an inner skirt, an outer skirt, and a paravalve seal for sealing against surrounding tissue. In some embodiments, the paravalve seal comprising material that swells in response to contact with blood or components thereof.

What is claimed is: 
     
         1 . A stent-valve for transcatheter implantation to replace a cardiac valve, the stent valve being compressible to a compressed state for delivery, and expandable to an operative state for implantation, the stent-valve comprising a stent, a plurality of leaflets for defining a prosthetic valve, an inner skirt, an outer skirt, and a paravalve seal for sealing against surrounding tissue, the paravalve seal comprising material that swells in response to contact with blood. 
     
     
         2 . The stent-valve of  claim 1 , wherein at least one of the skirts comprises the swellable material. 
     
     
         3 . The stent-valve of  claim 1 , wherein the stent comprises at least one of: a lower tubular portion; an upper crown portion; a plurality of upstanding commissural supports; a plurality of stabilization arches. 
     
     
         4 . The stent-valve of  claim 3 , wherein the stent comprises the lower tubular portion, the upper crown portion, the plurality of upstanding commissural supports, and the plurality of stabilization arches. 
     
     
         5 . The stent-valve of  claim 4 , wherein the lower tubular portion communicates with the upper crown and the commissural supports, wherein the commissural supports upstand relative to the upper crown portion, and wherein the stabilization arches communicate with the commissural supports. 
     
     
         6 . The stent-valve of  claim 4 , wherein the swellable material is positioned between and spaced from respective extremities of both a free edge of the upper crown, and a free edge of the lower tubular portion. 
     
     
         7 . The stent-valve of  claim 4 , wherein the lower tubular portion is configured for deployment after at least partial deployment of the upper crown portion, the commissural supports and the stabilization arches. 
     
     
         8 . The stent-valve of  claim 1 , wherein the outer skirt comprises fabric comprising fibers of the swellable material. 
     
     
         9 . The stent-valve of  claim 1 , wherein the swellable material is captive within a containing chamber, the containing chamber carried by the outer skirt. 
     
     
         10 . A stent-valve for transcatheter implantation to replace a cardiac valve, the stent valve being compressible to a compressed state for delivery, and expandable to an operative state for implantation, the stent-valve comprising a stent, a plurality of leaflets for defining a prosthetic valve, and a paravalve seal for sealing against surrounding tissue, the paravalve seal comprising material that swells in response to contact with blood, the paravalve seal being positioned towards one extremity of the stent, and spaced from said one extremity. 
     
     
         11 . The stent-valve of  claim 10 , wherein said one extremity of the stent comprises a zig-zag edge, the zig-zag edge including first apexes alternating with second apexes, wherein the paravalve seal is positioned such that it does not extend in the region between the apexes.