Serially expanding an artificial heart valve within a pediatric patient

Abstract

Some embodiments are directed to methods for serially expanding an artificial heart valve within a pediatric patient. For example, the artificial heart valve can be implanted into the pediatric patient during a first procedure, and then expanded during a second procedure to accommodate for the pediatric patient’s growth. Some embodiments include introducing an expander into the implanted valve when the frame is expanded to a first working diameter, and then actuating the expander to expand the frame to a second working diameter greater than the first working diameter, to accommodate for the pediatric patient’s growth.

1 - 21 . (canceled) 
     
     
         22 . A catheter insertable and re-expandable artificial growth heart valve for implantation, comprising:
 an expandable stent frame having a compressed, delivery configuration, in which the valve is deliverable to a patient via a catheter, and an expanded, deployed configuration, in which the valve is implantable within the patient, the valve having a first working condition when the expandable stent frame is in the deployed configuration and expanded to a first diameter and a second working condition when the expandable stent frame is in the deployed configuration and re-expanded after initial implantation and initial expansion to a second diameter that is greater than the first diameter to accommodate growth of the patient; and   a plurality of leaflets disposed within and coupled to the expandable stent frame, each leaflet from the plurality of leaflets extending from the expandable stent frame and terminating at a free edge, the plurality of leaflets being configured to provide competent valvular function when the valve is expanded to the first diameter and when the valve is re-expanded to the second diameter.   
     
     
         23 . The artificial growth heart valve of  claim 22 , wherein each free edge has a length that is greater than the first diameter. 
     
     
         24 . The artificial growth heart valve of  claim 22 , wherein the expandable stent frame has a diameter between about 2 mm and 6 mm when in the compressed, delivery configuration, and a diameter between about 5 mm and about 30 mm when in the expanded, deployed configuration. 
     
     
         25 . The artificial growth heart valve of  claim 22 , wherein: the expandable stent frame has a first open end, a second open end, and a longitudinal axis extending therebetween, the longitudinal axis defining a flow path through the valve, the frame being formed by a plurality of struts each extending continuously from the first open end to the second open end, the plurality of struts defining a plurality of cells therebetween. 
     
     
         26 . The artificial growth heart valve of  claim 25 , wherein at least a portion of the plurality of cells are covered. 
     
     
         27 . The artificial growth heart valve of  claim 25 , wherein at least a portion of the plurality of cells are coated with a polymer. 
     
     
         28 . The artificial growth heart valve of  claim 25 , wherein the expandable stent frame further defines a plurality of vertical posts, at least two of the vertical posts having different widths. 
     
     
         29 . The artificial growth heart valve of  claim 22 , wherein: each leaflet from the plurality of leaflets has a center spaced apart from the leaflet free edge, each free edge of each leaflet having a thickness greater than a thickness of each center of each leaflet from the plurality of leaflets. 
     
     
         30 . The artificial growth heart valve of  claim 22 , wherein the expandable stent frame has a first open end, a second open end, and a longitudinal axis defined therebetween, the longitudinal axis defining a flow path through the valve, the free edge of each leaflet varying along the longitudinal axis of the frame when the frame is in the deployed configuration. 
     
     
         31 . The artificial growth heart valve of  claim 22 , wherein the plurality of leaflets is formed of a polymer. 
     
     
         32 . The artificial growth heart valve of  claim 22 , wherein the expandable stent frame is configured to be expanded to the first diameter and re-expanded to the second diameter via a catheter insertable expander. 
     
     
         33 . The artificial growth heart valve of  claim 32 , wherein the expander is a balloon catheter. 
     
     
         34 . An artificial expandable heart valve, comprising:
 an expandable stent frame having a compressed, delivery configuration, in which the valve is deliverable to a patient via a catheter, and an expanded, deployed configuration, in which the valve is implantable within the patient; and   a plurality of leaflets disposed within and coupled to the frame, each leaflet from the plurality of leaflets extending from the frame and terminating at a free edge, the frame being formed by a plurality of struts defining a plurality of cells therebetween, each leaflet from the plurality of leaflets being coupled to the frame along a leaflet attachment line, each leaflet attachment line traversing the cells while remaining within about 3 mm of a strut from the plurality of struts.   
     
     
         35 . The artificial expandable heart valve of  claim 34 , wherein:
 each leaflet attachment line includes a curved portion and a linear portion, the curved portion terminating at the linear portion and the linear portion terminating at the free edge of the leaflet, each linear portion extending parallel to a longitudinal axis of the valve.   
     
     
         36 . The artificial expandable heart valve of  claim 35 , wherein the expandable stent includes a plurality of vertical posts, each linear portion of each leaflet attachment line traversing a vertical post from the plurality of vertical posts. 
     
     
         37 . The artificial expandable heart valve of  claim 36 , wherein a first vertical post from the plurality of vertical posts is disposed at a junction between two leaflets from the plurality of leaflets. 
     
     
         38 . The artificial expandable heart valve of  claim 37 , wherein the first vertical post defines a window covered by a polymer, the two leaflets being cohesively coupled to the polymer. 
     
     
         39 . The artificial expandable heart valve of  claim 35 , wherein the expandable stent frame is dip-coated in a polymer. 
     
     
         40 . A method of manufacturing an implantable heart valve, comprising:
 dipping an expandable stent in a polymer, the expandable stent defining a plurality of vertical posts;   dipping a mandrel in a polymer to form polymer leaflets, the mandrel having a cylindrical profile and defining a plurality of recesses configured to define the polymer leaflets, each of the recesses terminating at a commissure line;   placing the dipped expandable stent about the dipped mandrel and aligning the dipped expandable stent such that the polymer leaflets bond to the plurality of vertical posts of the expandable stent; and   after the placing, separating the mandrel from the dipped stent, leaving the manufactured heart valve for implantation.   
     
     
         41 . The method of  claim 40 , wherein each of the plurality of vertical posts define one or more windows, the dipping the expandable stent including filling the one or more windows with polymer, and the placing the dipped expandable stent including bonding the polymer leaflets to the polymer disposed within the one or more windows. 
     
     
         42 . The method of  claim 40 , wherein the mandrel defines a reinforcing zone to allow for additional thickness in certain regions of the leaflets. 
     
     
         43 . The method of  claim 42 , wherein the reinforcing zone is defined along a perimeter of the plurality of recesses. 
     
     
         44 . The method of  claim 42 , wherein the mandrel defines a gap portion between each plurality of recesses such that the polymer leaflets formed on the mandrel during the dipping the mandrel are separated by the gap portion.