Personalized aortic valve prosthesis

Abstract

A personalized prosthetic valve for implantation at a native valve treatment site includes a self-expanding mesh and a plurality of valve leaflets coupled to the mesh. The mesh may be delivered to the native valve in a collapsed configuration, and in an expanded configuration the mesh engages the native valve. The mesh in the expanded configuration is also personalized to match the treatment site, such that the outer mesh surface substantially matches the treatment site shape and size. The self-expanding mesh forms a central lumen configured to allow blood or other body fluids to pass therethrough. In the open configuration, blood passes through the prosthetic valve, and in the closed configuration, the plurality of leaflets are closer together and blood is prevented from flowing upstream through the prosthetic valve.

1 . (canceled) 
     
     
         2 . (canceled) 
     
     
         3 . A personalized prosthetic valve for implantation at a native valve treatment site, said prosthetic valve comprising:
 a self-expanding mesh having one or more apertures extending through a sidewall thereof, a collapsed configuration and an expanded configuration, the collapsed configuration adapted for delivery to the treatment site, and the expanded configuration adapted for engagement with the treatment site,   wherein the mesh is personalized prior to implantation such that in the expanded configuration an outer surface of the self-expanding mesh substantially matches a size and a shape of the native valve treatment site, and   wherein the one or more apertures are personalized prior to implantation such that in the expanded configuration the one or more apertures align with an anatomical location of one or more coronary ostia at the treatment site to permit substantially unobstructed blood flow between the one or more apertures and the one or more coronary ostia; and   a plurality of prosthetic valve leaflets coupled to the self-expanding mesh, the plurality of prosthetic valve leaflets having an open configuration and a closed configuration, wherein in the open configuration the plurality of prosthetic valve leaflets are disposed away from one another such that blood can flow therepast, and wherein in the closed configuration the plurality of prosthetic valve leaflets are disposed closer to one another than in the open configuration and blood is prevented from flowing upstream through the prosthetic valve.   
     
     
         4 . The prosthetic valve of  claim 3 , wherein the self-expanding mesh comprises nitinol. 
     
     
         5 . The prosthetic valve of  claim 3 , wherein the self-expanding mesh comprises one or more filaments woven together. 
     
     
         6 . The prosthetic valve of  claim 5 , wherein the one or more filaments are woven together to form overlapping regions. 
     
     
         7 . The prosthetic valve of  claim 3 , further comprising a membrane disposed over the self-expanding mesh, wherein the membrane conforms to the self-expanding mesh. 
     
     
         8 . The prosthetic valve of  claim 3 , further comprising one or more radiopaque markers coupled to the self-expanding mesh for facilitating visualization of the prosthetic valve during implantation. 
     
     
         9 . The prosthetic valve of  claim 3 , wherein the native valve is an aortic valve. 
     
     
         10 . The prosthetic valve of  claim 3 , wherein the self-expanding mesh comprises a proximal end, a distal end and a central lumen extending therebetween. 
     
     
         11 . The prosthetic valve of  claim 10 , wherein the central lumen has a shape substantially matching the shape of the native valve treatment site. 
     
     
         12 . A method for manufacturing a personalized prosthetic valve, said method comprising:
 providing one or more images of a native valve having a shape, a size, and one or more native coronary ostia;   creating a digital data set characterizing a shape and a size of the native valve based on the one or more images;   transforming the digital data set into fabrication instructions;   using the fabrication instructions to form a mandrel with a shape and a size substantially matching the shape and size of the native valve;   applying a mesh to the mandrel; and   heat treating the mesh so the mesh is biased to return to a shape and a size that substantially matches the shape and the size of the native valve.   
     
     
         13 . The method of  claim 12 , further comprising:
 wherein creating the digital data set comprises characterizing a location of the one or more native coronary ostia based on the one or more images; and   forming one or more apertures in a sidewall of the mesh such that the one or more apertures are aligned with the anatomical location of the one or more coronary ostia prior to implantation;   
     
     
         14 . The method of  claim 12 , wherein providing the one or more images comprises providing one or more images obtained with computerized tomography (CT), magnetic resonance imaging (MRI), x-ray, ultrasound, or angiography. 
     
     
         15 . The method of  claim 12 , wherein transforming the digital data set comprises transferring the digital data set into a computer aided design or computer aided manufacturing (CAD/CAM) system. 
     
     
         16 . The method of  claim 12 , wherein forming the mandrel comprises machining a piece of metal. 
     
     
         17 . The method of  claim 12 , wherein forming the mandrel comprises 3D printing the mandrel. 
     
     
         18 . The method of  claim 12 , wherein applying the mesh to the mandrel comprises slidably disposing the mesh over the mandrel. 
     
     
         19 . The method of  claim 12 , wherein the mesh is a self-expanding mesh. 
     
     
         20 . The method of  claim 12  further comprising forming a membrane over the mesh thereby forming a cover over the personalized prosthetic valve. 
     
     
         21 . The method of  claim 12 , wherein the native valve is an aortic valve. 
     
     
         22 . The method of  claim 12  further comprising mounting the personalized prosthetic valve onto a delivery catheter.