Intraparietal aortic valve reinforcement device and a reinforced biological aortic valve

Abstract

A reinforcement device for a biological valve includes an arrangement of supports configured to establish a double-trigone geometry in the valve and coupled to a base upon which the valve may be mounted. A plurality of commissural supports establish the geometry of a commissural trigone, and a plurality of intercommissural supports establish the geometry of an intercommissural trigone. A method for reinforcing a biological valve includes using commissural supports in conjunction with intercommissural supports, both sets of supports coupled to a base upon which the valve is mounted.

1 . A method of reinforcing a biological valve, the valve comprising leaflets attached to an external wall at commissures, the method comprising:
 securing a commissural support to the external wall approximately at each commissure;   coupling the commissural supports to a base;   securing an intercommissural support to the external wall between each pair of commissural supports; and   coupling the intercommissural supports to a base.   
     
     
         2 . The method of  claim 1 , wherein the securing of the commissural supports to the external wall comprises inserting the commissural supports into the external wall in a generally longitudinal direction. 
     
     
         3 . The method of  claim 1 , wherein the securing of the commissural supports to the external wall comprises suturing the commissural supports to the external wall. 
     
     
         4 . The method of  claim 1 , further comprising the step of adjusting tension in the biological valve by adjusting the location of the commissural supports with respect to the base. 
     
     
         5 . The method of  claim 1 , wherein the base is provided with a first plurality of holes configured to receive the commissural supports and a second plurality of holes configured to receive the intercommissural supports. 
     
     
         6 . The method of  claim 5 , wherein the first plurality of holes includes five holes configured to allow adjustable placement of the commissural supports. 
     
     
         7 . The method of  claim 5 , wherein the coupling of the commissural supports to the base comprises crimping the commissural supports to the base. 
     
     
         8 . The method of  claim 5 , wherein the coupling of the intercommissural supports to the base comprises crimping the intercommissural supports to the base. 
     
     
         9 . A method of making a reinforced biological valve, the method comprising:
 providing a biological valve comprising biological tissue, the biological tissue having been fixed in a physically unconstrained state, the biological valve having a valve wall and a plurality of commissures;   securing a commissural support to the valve wall near each commissure; and   securing an intercommissural support to the valve wall between each pair of commissural supports.   
     
     
         10 . The method of  claim 9 , further comprising:
 providing a base configured to couple with the commissural supports and intercommissural supports; and   adjusting tension in the biological valve by adjusting the location of the commissural supports with respect to the base.   
     
     
         11 . The method of  claim 9 , wherein the biological valve has an inflow region and an outflow region, and the commissural supports and the intercommissural supports are discontinuous around the biological valve in the outflow region. 
     
     
         12 . The method of  claim 9 , wherein the securing of the commissural supports to the valve wall comprises inserting the commissural supports into the valve wall in a generally longitudinal direction. 
     
     
         13 . A method of making a reinforced biological valve, the method comprising:
 fixing biological tissue in a physically unconstrained state;   forming a biological valve from the biological tissue, the biological valve having a valve wall, a plurality of commissures, an inflow region, and an outflow region;   attaching a commissural support to the valve wall near each commissure; and   attaching an intercommissural support to the valve wall between each pair of commissural supports.   
     
     
         14 . The method of  claim 13 , wherein the commissural supports and the intercommissural supports do not continuously surround the biological valve in the outflow region. 
     
     
         15 . The method of  claim 14 , wherein the attaching of the commissural supports to the valve wall comprises placing the commissural supports substantially within the valve wall. 
     
     
         16 . A method of replacing a malfunctioning valve in a subject, the method comprising:
 removing the malfunctioning valve from said subject;   providing a reinforced biological valve comprising a plurality of commissural supports and a plurality of intercommissural supports, each commissural support being configured to stabilize a commissure of the biological valve, each intercommissural support being configured stabilize a wall of the biological valve between each pair of commissural supports, the commissural supports and intercommissural supports being disposed at discrete locations about an outflow region of the biological valve; and   implanting said reinforced biological valve in said subject in place of said malfunctioning valve.