Assembly of heart valves and intermediate adapter stent

Abstract

A prosthetic heart valve configured to replace a native heart valve and having a support frame configured to be reshaped into an expanded form in order to receive and/or support an expandable prosthetic heart valve therein is disclosed, together with methods of using same. The prosthetic heart valve may be configured to have a generally rigid and/or expansion-resistant configuration when initially implanted to replace a native valve (or other prosthetic heart valve), but to assume a generally expanded form when subjected to an outward force such as that provided by a dilation balloon or other mechanical expander.

What is claimed is: 
     
         1 . A surgical prosthetic heart valve adapted for post-implant expansion and having an inflow end and an outflow end, comprising:
 a fabric-covered stent surrounding a flow axis and having three upstanding commissure posts, the stent defining a substantially circular base at an inflow end with an implant circumference that is substantially non-compressible from a first diameter prior to implant and in normal physiological use, wherein a portion of the base includes free ends connected by a suture to provide at least one point of weakness configured to permit expansion of the base from the first diameter to a second diameter larger than the first diameter upon application of an outward dilatory force from within the stent substantially larger than forces associated with normal physiological use; and   a plurality of flexible leaflets supported by the stent and configured to close toward the flow axis and ensure one-way blood flow through the heart valve.   
     
     
         2 . The prosthetic heart valve of  claim 1 , wherein the stent is a single polymer band. 
     
     
         3 . The prosthetic heart valve of  claim 1 , wherein the free ends are made of stainless steel. 
     
     
         4 . The prosthetic heart valve of  claim 1 , wherein the free ends overlap, one radially sliding inside the other. 
     
     
         5 . The prosthetic heart valve of  claim 1 , wherein the stent is a single metallic band. 
     
     
         6 . The prosthetic heart valve of  claim 1 , wherein there is a single point of weakness located circumferentially mid-way between two of the commissure posts. 
     
     
         7 . The prosthetic heart valve of  claim 1 , wherein the s suture that provides the point of weakness has a breaking pressure of between 2.25 to 3 atm. 
     
     
         8 . The prosthetic heart valve of  claim 1 , further including a unique identifier on the stent visible from outside the body after implant that identifies the stent as being expandable. 
     
     
         9 . The prosthetic heart valve of  claim 1 , wherein the stent is a dual band structure with an inner polymer band concentrically disposed within and in contact with an outer metallic band, the inner band defining the commissure posts while the outer band has truncated peaks coinciding with the commissure posts of the inner band. 
     
     
         10 . The prosthetic heart valve of  claim 9 , wherein there are a plurality of points of weakness formed around the base that permit expansion of the base from the first diameter to the second diameter. 
     
     
         11 . A surgical prosthetic heart valve adapted for post-implant expansion and having an inflow end and an outflow end, comprising:
 a fabric-covered stent surrounding a flow axis and having three upstanding commissure posts, the stent defining a substantially circular base at an inflow end with an implant circumference that is substantially non-compressible from a first diameter prior to implant and in normal physiological use, wherein a portion of the base includes a break point held together by a suture to provide at least one point of weakness configured to permit expansion of the base from the first diameter to a second diameter larger than the first diameter upon application of an outward dilatory force from within the stent substantially larger than forces associated with normal physiological use;   a radiopaque marker on the base that identifies the stent as being expandable; and   a plurality of flexible leaflets supported by the stent and configured to close toward the flow axis and ensure one-way blood flow through the heart valve.   
     
     
         12 . The prosthetic heart valve of  claim 11 , wherein the stent is a single polymer band. 
     
     
         13 . The prosthetic heart valve of  claim 11 , wherein the base includes free ends connected by the suture. 
     
     
         14 . The prosthetic heart valve of  claim 13 , wherein the free ends are made of stainless steel. 
     
     
         15 . The prosthetic heart valve of  claim 13 , wherein the free ends overlap, one radially sliding inside the other. 
     
     
         16 . The prosthetic heart valve of  claim 11 , wherein there is a single point of weakness located circumferentially mid-way between two of the commissure posts. 
     
     
         17 . The prosthetic heart valve of  claim 11 , wherein the suture that provides the point of weakness has a breaking pressure of between 2.25 to 3 atm. 
     
     
         18 . The prosthetic heart valve of  claim 11 , wherein the radiopaque marker comprises a valve size identifier. 
     
     
         19 . The prosthetic heart valve of  claim 11 , wherein the radiopaque marker comprises a wire. 
     
     
         20 . The prosthetic heart valve of  claim 11 , wherein the stent is a dual band structure with an inner polymer band concentrically disposed within and in contact with an outer metallic band, the inner band defining the commissure posts while the outer band has truncated peaks coinciding with the commissure posts of the inner band.