Prosthesis Seals and Methods for Sealing an Expandable Prosthesis

Abstract

Embodiments of the present disclosure are related to devices and techniques for para-valve sealing of an expandable stent-valve implanted using a catheter. In some embodiments, a stent-valve is provided which comprises a seal sleeve/cuff containing material that swells when contacted by blood. A piercing tool may be included and used to permit a user to puncture the sleeve/cuff prior to introduction into a patient's body. In some embodiments, the sleeve/cuff has an integral tubular structure configured to withstand balloon expansion of the stent-valve during or after implantation.

1 - 84 . (canceled) 
     
     
         85 . A stent-valve for transcatheter implantation to replace a cardiac valve, the stent-valve being compressible to a compressed configuration for delivery, and expandable to an operative state for implantation, the stent-valve comprising a stent, a plurality of leaflets defining a prosthetic valve, and a seal for sealing against surrounding tissue, wherein the seal comprises:
 a hollow sleeve/cuff arranged to extend in a circumferential direction substantially around the stent and containing swellable material that swells when contacted by blood to distend the hollow cuff, the hollow sleeve/cuff comprising an integral tubular structure.   
     
     
         86 . The stent-valve of  claim 85 , wherein the hollow sleeve/cuff comprises a tubular extrusion or blow molded tubing. 
     
     
         87 . The stent-valve of  claim 85 , wherein the hollow sleeve/cuff defines a hollow toroid shape around the stent, the toroid shape being closed-loop or split or helical. 
     
     
         88 . The stent-valve of  claim 87 , wherein the hollow sleeve/cuff comprises an elongate tubular member bent to define the toroid shape. 
     
     
         89 . The stent-valve of  claim 88 , wherein the ends of the elongate tubular member are joined together to define a closed-loop toroid shape. 
     
     
         90 . The stent-valve of  claim 85 , wherein the hollow sleeve/cuff comprises a tubular segment from a valvuloplasty balloon. 
     
     
         91 . The stent-valve of  claim 85 , wherein the hollow sleeve/cuff comprises a laminate of (i) plastics film and (ii) a diffusion barrier layer to obstruct diffusion of liquids from outside the hollow sleeve/cuff to the hollow interior, the diffusion barrier layer comprising metal or a metal compound. 
     
     
         92 . A stent-valve for transcatheter implantation to replace a cardiac valve, the stent valve being compressible to a compressed configuration for delivery, and expandable to an operative state for implantation, the stent-valve comprising a stent, a plurality of leaflets defining a prosthetic valve, and a seal for sealing against surrounding tissue, wherein the external seal comprises:
 a hollow sleeve/cuff arranged to extend in a circumferential direction substantially around the stent and containing swellable material that swells when contacted by blood to distend the hollow cuff, comprising a laminate of (i) plastics film and (ii) a diffusion barrier layer to obstruct diffusion of liquids from outside the hollow sleeve/cuff to the hollow interior, the diffusion barrier layer comprising a layer comprising metal or a metal compound.   
     
     
         93 . The stent-valve of  claim 92 , wherein the diffusion barrier layer is a plasma vapor deposited layer. 
     
     
         94 . The stent-valve of  claim 92 , wherein the diffusion barrier player is formed (i) on an interior face of the cuff, or (ii) as a non-surface layer of the laminate. 
     
     
         95 . The stent-valve of  claim 92 , wherein the diffusion barrier layer has a thickness of less than 100 nm, optionally less than 50 nm, optionally less than 10 nm. 
     
     
         96 . The stent-valve of  claim 92 , wherein the diffusion barrier layer remains in position on the stent-valve when the valve is implanted. 
     
     
         97 . The stent-valve of  claim 92 , wherein the hollow sleeve/cuff is configured to withstand post-implantation balloon expansion of the stent-valve against a calcified anatomy without substantial loss of structural integrity of the hollow cuff. 
     
     
         98 . A stent-valve for transcatheter implantation to replace a cardiac valve, the stent valve being compressible to a compressed configuration for delivery, and expandable to an operative state for implantation, the stent-valve comprising a stent, a plurality of leaflets defining a prosthetic valve, and a seal for sealing against surrounding tissue, wherein the external seal comprises:
 a hollow sleeve/cuff arranged to extend in a circumferential direction substantially around the stent and containing swellable material that swells when contacted by blood to distend the hollow cuff, the hollow sleeve/cuff being configured to withstand post-implantation balloon expansion of the stent-valve against a calcified anatomy without substantial loss of structural integrity of the hollow cuff.   
     
     
         99 . The stent-valve of  claim 98 , wherein the sleeve/cuff is configured to be manually pierceable at one or more points to define liquid admitting punctures permitting liquid entry into the cuff. 
     
     
         100 . The stent-valve of  claim 98 , wherein the sleeve/cuff has one or more liquid admitting punctures made therein, prior to introduction of the stent-valve into the body of a patient, for admitting liquid into the seal. 
     
     
         101 . A stent-valve for transcatheter implantation to replace a cardiac valve, the stent valve being compressible to a compressed configuration for delivery, and expandable to an operative state for implantation, the stent-valve comprising a stent, a plurality of leaflets defining a prosthetic valve, and a seal for sealing against surrounding tissue, wherein the external seal comprises:
 a hollow sleeve/cuff arranged to extend in a circumferential direction substantially around the stent and containing swellable material that swells when contacted by blood to distend the hollow cuff, the hollow sleeve/cuff comprising a film made of liquid-impermeable material, the sleeve/cuff having one or more liquid admitting punctures made therein, prior to introduction of the stent-valve into the body of a patient, for admitting liquid into the seal.   
     
     
         102 . The stent-valve of  claim 101 , wherein the number of punctures is less than fifty, optionally less than forty, optionally less than thirty, optionally less than twenty, optionally less than ten. 
     
     
         103 . The stent-valve of  claim 101 , wherein the seal further comprises a skirt secured to the hollow cuff. 
     
     
         104 . The stent-valve of  claim 103 , wherein the skirt is secured to the sleeve/cuff by an attachment that does not puncture the cuff, for example, an attachment selected from: fusion; welding; adhesive. 
     
     
         105 . The stent-valve of  claim 103 , wherein the skirt is secured to the stent, thereby mounting the sleeve/cuff to the stent.