Assemblies of a transcatheter valve within a bioprosthetic cardiac structure

Abstract

A spacer for creating a docking station for a transcatheter heart valve is provided. The spacer changes an effective diameter and/or a shape of an implanted bioprosthetic structure such as a bioprosthetic heart valve or annuloplasty ring, providing a supporting structure into which the transcatheter valve expands without over expanding. The spacer may be deployed through an interventional technique either through transseptal access, transfemoral access, or transapical access and is typically deployed at least in part on an inflow portion of the implanted bioprosthetic structure.

What is claimed is: 
     
         1 . An assembly of a transcatheter heart valve secured within an annuloplasty ring defining a D-shaped inner space and a central flow axis defining an upstream direction and a downstream direction, the assembly comprising:
 a collapsible spacer ring having an inner shaft adapted to receive the transcatheter heart valve, the spacer ring defining a central flow axis having an upstream direction and a downstream direction, the downstream direction corresponding to the direction of blood flow from an upstream portion through a downstream portion of the annuloplasty ring when the spacer ring is implanted within the annuloplasty ring, the spacer ring having a D-shaped outer periphery when expanded while the inner shaft is cylindrical,   wherein the spacer ring is collapsible to a reduced diameter smaller than the D-shaped inner space of the annuloplasty ring to enable advancement of the spacer ring into the D-shaped inner space, and wherein the spacer ring is expandable within the D-shaped inner space of the annuloplasty ring such that the D-shaped outer periphery registers with the D-shaped inner space, the spacer ring inner shaft being sized to provide a cylindrical engagement surface for expanding and securing the transcatheter heart valve therein.   
     
     
         2 . The assembly of  claim 1 , wherein the spacer ring is made of a metal that is close in the galvanic series to both a metal in the transcatheter heart valve and a metal in the annuloplasty ring. 
     
     
         3 . The assembly of  claim 1 , wherein the spacer ring comprises anchors extending therefrom sized to embed into the annuloplasty ring as the spacer ring is expanded within the D-shaped inner space to maintain the spacer ring in position within the annuloplasty ring. 
     
     
         4 . The assembly of  claim 3 , wherein the D-shaped inner space of the annuloplasty ring is covered with a fabric, and the anchors secure into the fabric. 
     
     
         5 . The assembly of  claim 1 , further comprising snares coupled to the spacer ring for controlling expansion of the spacer ring. 
     
     
         6 . The assembly of  claim 1 , wherein the spacer ring is self-expandable. 
     
     
         7 . The assembly of  claim 1 , wherein the spacer ring is at least partially balloon-expandable. 
     
     
         8 . The assembly of  claim 7 , further including a pressure sensor built-in to the spacer ring for detecting an outward pressure exerted by a balloon. 
     
     
         9 . The assembly of  claim 1 , wherein the spacer ring is formed of expandable struts and has an expandable upstream flange and an expandable downstream flange, wherein the struts of the flanges have varying lengths chosen to form the D-shaped outer periphery. 
     
     
         10 . The assembly of  claim 1 , wherein the spacer ring inner shaft is provided with a soft compressible docking inner surface selected from the group consisting of foam, a resilient polymer, a hydrogel, and a fabric covering. 
     
     
         11 . The assembly of  claim 1 , wherein the spacer ring inner shaft is spring-loaded to provide an inward reaction force against the transcatheter heart valve expanded therein. 
     
     
         12 . An assembly of a transcatheter heart valve secured within a bioprosthetic heart valve with leaflets, the bioprosthetic heart valve having an inner space with an inside diameter and a central flow axis defining an upstream direction and a downstream direction, the assembly comprising:
 a collapsible spacer ring having an inner shaft adapted to receive the transcatheter heart valve, the spacer ring defining a central flow axis having an upstream direction and a downstream direction, the downstream direction corresponding to the direction of blood flow from an upstream portion through a downstream portion of the bioprosthetic heart valve when the spacer ring is implanted within the bioprosthetic heart valve, the spacer ring having an expandable upstream spacer flange, and the spacer ring inner shaft being sized to provide a cylindrical engagement surface for securing the transcatheter heart valve therein,   wherein the spacer ring is collapsible to a reduced diameter smaller than an inner space of the bioprosthetic heart valve to enable advancement of the spacer ring into the inner space, and wherein the spacer ring is expandable within the inner space with the upstream spacer flange configured to flip or rotate from a longitudinal orientation to a generally horizontal or radial position in contact with an upstream end of the inner space of the bioprosthetic heart valve, and an outside dimension of the upstream spacer flange is greater than the inside diameter of inner space, and the spacer ring is expandable such that a downstream end thereof is positioned upstream from the leaflets of the bioprosthetic heart valve and the spacer ring has external structure to engage and anchor to the inner space of the bioprosthetic heart valve, the spacer ring inner shaft thus providing the cylindrical engagement surface for expanding and securing the transcatheter heart valve therein.   
     
     
         13 . The assembly of  claim 12 , wherein the spacer ring is made of a metal that is close in the galvanic series to both a metal in the transcatheter heart valve and a metal in the bioprosthetic heart valve. 
     
     
         14 . The assembly of  claim 12 , wherein the inner space of the bioprosthetic heart valve is covered with a fabric, and wherein the external structure anchors to the fabric. 
     
     
         15 . The assembly of  claim 14 , wherein the external structure comprises an expandable upstream spacer flange. 
     
     
         16 . The assembly of  claim 14 , wherein the external structure comprises an array of barbs. 
     
     
         17 . The assembly of  claim 12 , further comprising snares coupled to the spacer ring for controlling expansion of the spacer ring. 
     
     
         18 . The assembly of  claim 12 , wherein the spacer ring inner shaft is spring-loaded to provide an inward reaction force against the transcatheter heart valve. 
     
     
         19 . The assembly of  claim 12 , wherein the spacer ring inner shaft is provided with a soft compressible docking inner surface selected from the group consisting of foam, a resilient polymer, a hydrogel, and a fabric covering. 
     
     
         20 . The assembly of  claim 12 , wherein the spacer ring is at least partially balloon-expandable, and wherein the spacer ring has a pressure sensor built-in for limiting an outward pressure exerted by a balloon. 
     
     
         21 . The assembly of  claim 12 , wherein the upstream spacer flange has a radial dimension greater than the downstream spacer flange. 
     
     
         22 . The assembly of  claim 12 , wherein the spacer ring is formed of self-expandable struts made of a shape memory material.