Prosthetic device including electrostatically spun fibrous layer & method for making the same

Abstract

In accordance with certain embodiments of the present disclosure, a process of forming a prosthetic device is provided. The process includes forming a dispersion of polymeric nanofibers, a fiberizing polymer, and a solvent, the dispersion having a viscosity of at least about 50,000 cPs. A tubular frame is positioned over a tubular polymeric structure. Nanofibers from the dispersion are electrospun onto the tubular frame to form a prosthetic device. The prosthetic device is heated.

What is claimed is: 
     
         1 . A prosthetic device comprising a tubular frame and a coating disposed on the tubular frame, the coating comprising a layer of electrospun PTFE. 
     
     
         2 . The prosthetic device of  claim 1 , wherein the prosthetic device is a tubular vascular prosthesis comprising a luminal and abluminal surface, and the first layer of electrospun PTFE is present on the luminal surface. 
     
     
         3 . The prosthetic device of  claim 1 , wherein the layer of electrospun PTFE is a first layer of electrospun PTFE, and the prosthetic device further comprises a second layer of electrospun PTFE. 
     
     
         4 . The prosthetic device of  claim 3 , wherein the pore structure of one or more of the electrospun layers as defined by ASTM F316 is between about 0.05 μm and about 50 μm. 
     
     
         5 . The prosthetic device of  claim 3 , wherein one or more of the electrospun layers has a porosity to enhance cellular ingrowth or attachment. 
     
     
         6 . The prosthetic device of  claim 3 , wherein one or more of the electrospun layers has a porosity to inhibit cellular ingrowth or attachment. 
     
     
         7 . The prosthetic device of  claim 1 , further comprising a self sealing thermoplastic component. 
     
     
         8 . The prosthetic device of  claim 7 , wherein the thermoplastic polymer comprises a polymer selected from the group consisting of nylons, polyurethanes, polyesters, and fluorinated ethylene propylene. 
     
     
         9 . The prosthetic device of  claim 1 , wherein the layer of electrospun PTFE has been spun from an aqueous dispersion comprising polytetrafluoroethylene and polyethylene oxide. 
     
     
         10 . The prosthetic device of  claim 1 , wherein the layer of electrospun PTFE comprises PTFE that has been spun onto a rotating assembly. 
     
     
         11 . A prosthetic device comprising a layer of electrospun fibers around a central lumen, wherein the electrospun fibers comprise polytetrafluoroethylene. 
     
     
         12 . The prosthetic device of  claim 11 , further comprising a tubular frame. 
     
     
         13 . A method of constructing a prosthetic device, comprising:
 providing a frame; and   applying an electrospun PTFE layer to the frame to form a prosthetic device.   
     
     
         14 . The method of  claim 13 , further comprising applying a fluorinated ethlyene propylene (FEP) layer to the device. 
     
     
         15 . The method of  claim 13 , further comprising heating the prosthetic device. 
     
     
         16 . The method of  claim 15 , further comprising applying a wrap to the prosthetic device and maintaining the wrap on the prosthetic device during heating. 
     
     
         17 . The method of  claim 13 , wherein the applying step comprises electrospinning PTFE onto a rotating assembly. 
     
     
         18 . The method of  claim 17 , wherein electrospinning PTFE comprises:
 providing an aqueous dispersion comprising PTFE and polyethylene oxide; and   drawing out the aqueous dispersion onto the rotating assembly.   
     
     
         19 . The method of  claim 13 , further comprising applying a thermoplastic component to the device. 
     
     
         20 . The method of  claim 19 , wherein the thermoplastic component comprises a polymer selected from the group consisting of nylons, polyurethanes, and polyesters.