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.

1 - 20 . (canceled) 
     
     
         21 . A prosthetic device comprising a tubular frame having a luminal surface and an abluminal surface, and a coating disposed on the tubular frame, the coating comprising a layer of electrospun PTFE present on the luminal surface. 
     
     
         22 . The prosthetic device of  claim 21 , wherein the prosthetic device is a tubular vascular prosthesis. 
     
     
         23 . The prosthetic device of  claim 21 , 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. 
     
     
         24 . The prosthetic device of  claim 23 , 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. 
     
     
         25 . The prosthetic device of  claim 23 , wherein one or more of the electrospun layers has a porosity to enhance cellular ingrowth or attachment. 
     
     
         26 . The prosthetic device of  claim 23 , wherein one or more of the electrospun layers has a porosity to inhibit cellular ingrowth or attachment. 
     
     
         27 . The prosthetic device of  claim 21 , further comprising a self sealing thermoplastic component. 
     
     
         28 . The prosthetic device of  claim 27 , wherein the thermoplastic polymer comprises a polymer selected from the group consisting of nylons, polyurethanes, polyesters, and fluorinated ethylene propylene. 
     
     
         29 . The prosthetic device of  claim 21 , wherein the layer of electrospun PTFE has been spun from an aqueous dispersion comprising polytetrafluoroethylene and polyethylene oxide. 
     
     
         30 . The prosthetic device of  claim 21 , wherein the layer of electrospun PTFE comprises PTFE that has been spun onto a rotating assembly. 
     
     
         31 . The prosthetic device of  claim 21 , wherein the spun PTFE is electrospun PTFE. 
     
     
         32 . A prosthetic device-having a luminal surface and an abluminal surface, wherein the luminal surface comprises a layer of electrospun fibers, and the electrospun fibers comprise polytetrafluoroethylene. 
     
     
         33 . The prosthetic device of  claim 32 , further comprising a tubular frame. 
     
     
         34 . The prosthetic device of  claim 32 , wherein the spun PTFE is electrospun PTFE. 
     
     
         35 . The prosthetic device of  claim 32 , wherein the diameter of fibers in the layer of electrospun fibers ranges from about 10 nm to 2000 nm in size. 
     
     
         36 . A prosthetic device comprising a plurality of polymer layers, at least one of said polymer layers defining a luminal surface of the device and a second of said polymer layers defining an abluminal surface of the device, wherein the polymer layer defining the abluminal surface is comprised primarily of micron and sub-micron sized electrostatically spun polytetrafluoroethylene (PTFE) fibers in a random orientation. 
     
     
         37 . The prosthetic device of  claim 36 , wherein at least one layer of the plurality of polymer layers defines pore structures and sizes that are substantially different from the pore structures and sizes of at least another layer of the plurality of polymer layers. 
     
     
         38 . The prosthetic device of  claim 36 , wherein the polymer layer defining the luminal surface of the device is defined by a porosity that enhances cellular ingrowth and wherein the polymer layer defining the abluminal surface of the device is defined by a porosity that inhibits cellular ingrowth.