Method for Making a Bicuspid Pulmonary Heart Valve

Abstract

A heart valve constructed from a synthetic resin that is designed to be surgically implanted in the right ventricular outflow tract of the heart comprising a plurality of flexible members, and an orifice.

1 . A method of making an implantable valve, the method comprising: 
 forming a sheet of flexible synthetic resin having an elliptical shape having a minor axis, the sheet including an incision along the minor axis and an outer edge region having no frame structure;    wherein the sheet is sufficiently flexible to allow the sheet to bend along the minor axis to form a valve in which the incision is movable between open and closed positions.    
   
   
       2 . The method of  claim 1 , further comprising suturing the outer edge region to an anatomical site.  
   
   
       3 . The method of  claim 1 , further comprising suturing the outer edge region to the anterior and posterior wall of the infundibular septum of the right ventricular outflow tract of a patient.  
   
   
       4 . The method of  claim 3 , wherein the length of the incision or the minor axis is equal to about 1.5 times the diameter of the right ventricular outflow tract.  
   
   
       5 . A method of forming an implantable valve, the method comprising: 
 forming an elliptical sheet from a flexible synthetic resin, the elliptical sheet including an incision along the minor axis of the elliptical sheet; and    bending the elliptical sheet along the minor axis to form a valve in which the incision is movable between open and closed positions, the valve including an outer edge region having no frame structure.