PTFE layers and methods of manufacturing
Thin PTFE layers are described having little or no node and fibril microstructure and methods of manufacturing PTFE layers are disclosed that allow for controllable permeability and porosity of the layers. In some embodiments, the PTFE layers may act as a barrier layer in an endovascular graft or other medical device.
1. A composite film comprising:
a first layer comprising:
a material comprising polytetrafluoroethylene;
a closed cell microstructure with a plurality of interconnected high density regions of polytetrafluoroethylene having no distinct fibrils interconnecting adjacent nodes when viewed at a magnification of 20,000 under a scanning electron microscope;
a thickness from 0.00005 inch to 0.005 inch; and
a fluid permeability of substantially no fluid permeability with a Gurley Number of greater than 12 hours for 100 cc of air at a pressure of 12.4 cm of water or of a limited fluid permeability with a Gurley Number of greater than 1,500 seconds for 100 cc of air at a pressure of 12.4 cm of water;
a second layer of expanded polytetrafluoroethylene having a substantial node and fibril microstructure secured to the first layer, the first layer and the second layer defining an inflatable space therebetween.
2. The composite film of claim 1 , wherein the material further comprises a copolymer of polytetrafluoroethylene.
3. The composite film of claim 2 , wherein the copolymer of polytetrafluoroethylene is a fluorinated copolymer of polytetrafluoroethylene.
4. The composite film of claim 2 , wherein the copolymer of polytetrafluoroethylene is perfluoropropylvinylether-modified polytetrafluoroethylene.
5. The composite film of claim 2 , wherein the copolymer of polytetrafluroethylene is about 2% or less of the mass of the material.
6. A vascular graft comprising:
a composite film having a first layer and a second layer,
the first layer comprising:
a material comprising polytetrafluoroethylene;
a closed cell microstructure with a plurality of interconnected high density regions of polytetrafluoroethylene having no distinct fibrils interconnecting adjacent nodes when viewed at a magnification of 20,000 under a scanning electron microscope; and
the second layer comprising:
a material comprising expanded polytetrafluoroethylene; and
a substantial node and fibril microstructure;
wherein the second layer is secured to the first layer, and an inflatable space is defined by the space therebetween.
7. The device of claim 6 , wherein the first layer comprises a thickness from 0.00005 inch to 0.005 inch.
8. The device of claim 7 , wherein the first layer has a limited or substantially no fluid permeability.
9. The device of claim 8 , wherein the first layer has a Gurley Number of greater than 12 hours for 100 cc of air at a pressure of 12.4 cm of water.
10. The device of claim 8 , wherein the first layer has a Gurley Number of greater than 1,500 seconds for 100 cc of air at a pressure of 12.4 cm of water.
11. The vascular graft of claim 6 , wherein the material further comprises a copolymer of polytetrafluoroethylene.
12. The vascular graft of claim 11 , wherein the copolymer of polytetrafluoroethylene is a fluorinated copolymer of polytetrafluoroethylene.
13. The vascular graft of claim 12 , wherein the copolymer of polytetrafluoroethylene is perfluoropropylvinylether-modified polytetrafluoroethylene.
14. The vascular graft of claim 11 , wherein the copolymer of polytetrafluoroethylene is about 2% or less of the mass of the material.
15. A vascular graft comprising a thin polytetrafluoroethylene made by a method of processing polytetrafluoroethylene, the method comprising:
extruding a compounded PTFE resin through an extruder in a machine direction to form a PTFE ribbon extrudate;
calendering the PTFE ribbon extrudate in the machine direction to form a layer of PTFE having an upper surface, a lower surface and a longitudinal length in a machine direction of an extruder used to produce the layer of PTFE and having a width in a cross machine or transverse direction;
applying a liquid stretching agent in an excess amount to at least a portion of the upper surface or the lower surface of the layer of PTFE;
stretching the layer of PTFE in the transverse direction to the machine direction; and
maintaining the excess amount of the liquid stretching agent on the at least portion of the upper or the lower surface of the layer of PTFE during at least part of the stretching to fully saturate the layer of PTFE throughout its thickness with the liquid stretching agent during the stretching to form a stretched layer of PTFE that has:
(i) a closed cell microstructure with a plurality of interconnected high density regions of PTFE having no distinct fibrils interconnecting adjacent nodes when viewed at a magnification of 20,000 under a scanning electron microscope; and
(ii) a thickness from 0.00005 inch to 0.005 inch;
(iii) wherein the stretching is at a rate from 10 percent per second to 100 percent per second;
(iv) wherein the stretching is performed at a stretch ratio from 2:1 to 20:1; and
(v) wherein stretching of the layer of PTFE is performed at a temperature of 80° F. to 100° F.