Artificial valved conduits for cardiac reconstructive procedures and methods for their production

Abstract

Artificial heart valve structures and methods of their fabrication are disclosed. The heart valve structures may be fabricated from a biocompatible polymer and include one or more heart valve leaflet structures incorporated within a conduit. The valve structures may incorporate one or more conduit sinuses, as well as a gap between the lower margin of the valve leaflets and the interior of the conduit. In addition, the valve structures may include one or more valve sinuses created in a space between the valve leaflets and the conduit inner surface. Computational fluid dynamics and mechanical modeling may be used to design the valve leaflets with optimal characteristics. A heart valve structure may also incorporate a biodegradable component to which cells may adhere. The incorporated cells may arise from patient cells migrating to the biodegradable component, or the component may be pre-seeded with cells prior to implantation in a patient.

What is claimed is: 
     
         1 . A conduit comprising:
 one or more conduit breaches, wherein each conduit breach comprises at least one conduit breach edge; and   a conduit wall;   wherein the at least one conduit breach edge is affixed to the conduit wall.   
     
     
         2 . The conduit of  claim 1 , wherein the one or more conduit breaches comprise one or more of a biocompatible polymer and a hemocompatible polymer. 
     
     
         3 . The conduit of  claim 1 , wherein the one or more conduit breaches are disposed along a longitudinal axis, along a circumferential axis, or at one or more angles with respect to the longitudinal axis of the conduit. 
     
     
         4 . The conduit of  claim 1 , wherein the one or more conduit breaches are disposed along a circumferential axis of the conduit. 
     
     
         5 . The conduit of  claim 1 , wherein the one or more conduit breaches overlap one or more circumferential portions of the conduit wall. 
     
     
         6 . The conduit of  claim 1 , wherein the one or more conduit breaches do not overlap along one or more circumferential portions of the conduit wall. 
     
     
         7 . The conduit of  claim 1 , wherein the one or more conduit breaches are disposed along the conduit wall to form a helical curve along a longitudinal axis of the conduit. 
     
     
         8 . The conduit of  claim 1 , wherein the one or more conduit breaches extend along at least a portion of a longitudinal length of the conduit. 
     
     
         9 . The conduit of  claim 1 , wherein the one or more conduit breaches are arranged in one or more straight line segments, one or more curved line segments, or one or more serrated line segments. 
     
     
         10 . The conduit of  claim 1 , wherein a biodegradable structure is affixed to the at least one conduit breach edge. 
     
     
         11 . A conduit comprising:
 an inner conduit surface;   an outer conduit surface;   a diameter;   at least one conduit breach having a first conduit breach edge and a second conduit breach edge;   a heart valve multi-leaflet structure; and   at least one biodegradable structure having a first side affixed to the first conduit breach edge and a second side affixed to the second conduit breach edge.   
     
     
         12 . A conduit comprising:
 a conduit breach along a longitudinal axis of the conduit, the conduit breach having a first conduit breach edge and a second conduit breach edge; and   a biodegradable structure having a first side affixed to the first conduit breach edge and a second side affixed to the second conduit breach edge.   
     
     
         13 . The conduit of  claim 12 , wherein the conduit comprises one or more of a biocompatible polymer and a hemocompatible polymer. 
     
     
         14 . The conduit of  claim 12 , wherein the biodegradable structure is a composite material. 
     
     
         15 . The conduit of  claim 12 , wherein the biodegradable structure comprises collagen fibers. 
     
     
         16 . The conduit of  claim 12 , further comprising one or more cells seeded onto the biodegradable structure. 
     
     
         17 . The conduit of  claim 16 , wherein the cells comprise CD34 cells, mesenchymal cells, myocytes, smooth muscle cells, endothelial cells, or cardiac stem cells. 
     
     
         18 . The conduit of  claim 12 , further comprising a valve disposed on an inner surface of the conduit.