PROSTHETIC DEVICE INCLUDING ELECTROSTATICALLY SPUN FIBROUS LAYER & METHOD FOR MAKING THE SAME
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 . 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.