Apparatus and methods for making leaflets and valve prostheses including such leaflets

Abstract

A method for making a bioprosthetic heart valve includes providing a non-contact cutting apparatus and a layer of tissue. The non-contact cutting apparatus may include a laser cutting system or high pressure water jet system. A leaflet is cut from the layer of tissue using a predefined template, and a plurality of alignment holes in the leaflet are created in the leaflet, e.g., along a peripheral edge. A support structure is provided having a plurality of alignment holes corresponding to alignment holes in the leaflet. The leaflet is secured to the support structure by securing one or more sutures through corresponding alignment holes in the leaflet and the support structure to provide a leaflet subassembly. A bioprosthetic heart valve is made by securing a set of leaflet subassemblies to a frame.

1 . A method for making a bioprosthetic heart valve, comprising: 
 creating a leaflet from a sheet of target material;    creating a plurality of alignment holes in the leaflet along at least one peripheral edge of the leaflet;    providing a support structure having a plurality of alignment holes corresponding to at least some of the alignment holes in the leaflet; and    directing one or more sutures through the corresponding alignment holes in the leaflet and the support structure to secure the leaflet to the support structure.    
     
     
         2 . The method of  claim 1 , wherein the leaflet and alignment holes are created using a non-contact cutting apparatus.  
     
     
         3 . The method of  claim 2 , wherein the non-contact cutting apparatus comprises at least one of a laser cutting system and a high-pressure water jet system.  
     
     
         4 . The method of  claim 2 , wherein the alignment holes in the leaflet are located within about 0.025 inch of the at least one peripheral edge of the leaflet.  
     
     
         5 . The method of  claim 2 , wherein the alignment holes in the leaflet have a diameter between about 0.006-0.012 inch.  
     
     
         6 . The method of  claim 2 , wherein the target material comprises biological tissue.  
     
     
         7 . The method of  claim 6 , wherein the biological tissue comprises pericardium.  
     
     
         8 . The method of  claim 6 , wherein the biological tissue has a thickness between about 0.015-0.024 inch.  
     
     
         9 . The method of  claim 1 , wherein the alignment holes in the leaflet are symmetrically arranged about an apex of the leaflet.  
     
     
         10 . The method of  claim 1 , further comprising directing one or more additional sutures through alignment holes in the leaflet and a fabric covering on the support structure.  
     
     
         11 . The method of  claim 1 , securing the support structure to a valve frame.  
     
     
         12 . The method of  claim 11 , wherein the support structure is secured to the valve frame by a spacer.  
     
     
         13 . A bioprosthetic heart valve, comprising: 
 a frame;    a support structure secured to the frame, the leaflet support structure including a plurality of alignment holes; and    a leaflet secured to the support structure such that the leaflet may open and close relative to the frame, the leaflet having a plurality of alignment holes corresponding to the alignment holes in the support structure, the leaflet being secured to the leaflet support structure by one or more sutures passing through the respective alignment holes in the leaflet and the support structure.    
     
     
         14 . The bioprosthetic heart valve of  claim 13 , wherein the plurality of alignment holes are laser-cut in the leaflet.  
     
     
         15 . The bioprosthetic heart valve of  claim 13 , wherein the support structure comprises a laminated, crescent-shaped strut, the strut having an alignment hole located at its base and a an alignment holes located at each end of the strut.  
     
     
         16 . The bioprosthetic heart valve of  claim 13 , wherein the support structure is secured to the frame by a spacer secured to a base of the support structure such that ends of the support structure are free to move relative to the frame.  
     
     
         17 . The bioprosthetic heart valve of  claim 13 , wherein the support structure is at least partially covered by fabric.  
     
     
         18 . The bioprosthetic heart valve of  claim 17 , further comprising a plurality of sutures secured through holes in the leaflet and the fabric.  
     
     
         19 . The bioprosthetic heart valve of  claim 13 , wherein the alignment holes in the leaflet are arranged symmetrically about an axis of the leaflet.  
     
     
         20 . The bioprosthetic heart valve of  claim 13 , wherein the alignment holes in the leaflet are located within about 0.025 inches of a peripheral edge of the leaflet.  
     
     
         21 . The bioprosthetic heart valve of  claim 13 , further comprising a plurality of support structures secured to the frame, each support structure carrying a leaflet such that the leaflets open and close together to allow fluid flow through the valve.  
     
     
         22 . The bioprosthetic heart valve of  claim 21 , wherein the plurality of support structures comprises three support structures disposed substantially symmetrically about a periphery of the frame.  
     
     
         23 . A bioprosthetic heart valve, produced by the steps of: 
 providing a laser cutting apparatus;    providing a target material;    cutting a leaflet from the target material using a template, wherein cutting includes forming a plurality of alignment holes in the leaflet;    providing a support structure having a plurality of alignment holes corresponding to at least some of the alignment holes in the leaflet; and    attaching the leaflet to the support structure by securing one or more sutures through corresponding alignment holes in the leaflet and the support structure.    
     
     
         24 . The bioprosthetic heart valve of  claim 23 , further including the step of securing a base of the support structure to a frame such that ends of the support structure are free to move to open and close the leaflet.