PTFE layers and methods of manufacturing
View Patent ↗Single, continuous PTFE layers having lateral zones of varied characteristics are described. Some of the lateral zone embodiments may include PTFE material having little or no nodal and fibril microstructure. Methods of manufacturing PTFE layers allow for controllable permeability and porosity of the layers, in addition to other characteristics. The characteristics may vary from one lateral zone of a PTFE layer to a second lateral zone of a PTFE layer. In some embodiments, the PTFE layers may act as a barrier layer in an endovascular graft or other medical device.
1. A method of processing PTFE, 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 planar layer of PTFE having an upper 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;
selectively applying an isoparaffinic stretching agent to the layer of PTFE in a predetermined pattern comprising a plurality of first lateral zones within the layer of PTFE being substantially saturated with the applied isoparaffinic stretching agent and a plurality of second lateral zones within the layer of PTFE with substantially none of the applied isoparaffinic stretching agent;
providing a tentering machine; and
stretching the layer of PTFE in the tentering machine in the transverse direction to the machine direction while the plurality of the first lateral zones of the layer of PTFE are fully saturated with the stretching agent throughout their thicknesses during stretching;
wherein the plurality of the first lateral zones have a shape selected from the group consisting of squares, rectangles, circles and ellipses;
wherein, after stretching, the plurality of the first lateral zones of the PTFE layer have 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; and
wherein, after stretching, the plurality of the second lateral zones of the PTFE layer have substantial fluid permeability with a Gurley Number of less than about 15 seconds for 100 cc of air at a pressure of 12.4 cm of water.
2. The method of claim 1 wherein stretching the layer of PTFE comprises stretching the layer of PTFE by a stretch ratio of about 2:1 to about 20:1.
3. The method of claim 1 wherein the isoparaffinic stretching agent content of the layer of PTFE prior to selective application of the stretching agent is about 0 percent by weight to about 22 percent by weight.
4. The method of claim 1 further comprising stretching the stretched layer of PTFE a second time.
5. A method of processing PTFE, comprising:
extruding a compounded PTFE resin with an isoparaffinic stretching agent 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 planar layer of PTFE having an upper 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;
optionally, applying additional isoparaffinic stretching agent onto the planar layer of PTFE having a stretching agent content level;
selectively removing the isoparaffinic stretching agent from at least a portion of the layer of PTFE to provide a predetermined pattern comprising a plurality of first lateral zones within the layer of PTFE being substantially saturated with the applied isoparaffinic stretching agent and a plurality of second lateral zones within the layer of PTFE with substantially none of the applied isoparaffinic stretching agent;
providing a tentering machine; and
stretching the layer of PTFE in the tentering machine;
wherein the plurality of the first lateral zones have a shape selected from the group consisting of squares, rectangles, circles and ellipses;
wherein, after stretching, the plurality of the first lateral zones of the PTFE layer have 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; and
wherein, after stretching, the plurality of the second lateral zones of the PTFE layer have substantial fluid permeability with a Gurley Number of less than about 15 seconds for 100 cc of air at a pressure of 12.4 cm of water.
6. The method of claim 5 wherein stretching the layer of PTFE comprises stretching the layer of PTFE by a stretch ratio of about 2:1 to about 20:1.
7. The method of claim 5 further comprising applying the additional isoparaffinic stretching agent to the layer of PTFE prior to selective removal of the isoparaffinic stretching agent.
8. The method of claim 7 wherein the isoparaffinic stretching agent content of the layer of PTFE prior to application of the additional isoparaffinic stretching agent is about 3 percent by weight to about 22 percent by weight.
9. The method of claim 7 further comprising spreading the isoparaffinic stretching agent after application to the layer of PTFE with a skimming member disposed adjacent the layer of PTFE.
10. The method of claim 5 further comprising stretching the stretched layer of PTFE a second time.