Medical devices utilizing melt-processible poly(tetrafluoroethylene)
View Patent ↗This invention relates to medical devices containing melt-processible polytetrafluoro-ethylene (PTFE) and methods of making same.
1. A medical tube for inserting into the human body, comprising:
a tube comprising first, second, and third layers, in which the first layer is formed between the second and third layers, wherein the first layer is formed of a first material comprising a thermoplastic polymer comprising a co-polymer, wherein the copolymer is a fluoro copolymer chosen from the group consisting of a copolymer of tetrafluoroethylene with a perfluoroalkyl vinyl ether, a copolymerization of tetrafluoroethylene and perfluoromethylvinylether and a fluorinated ethylene-propylene resin, and a second layer is formed of a second material having a melt temperature, wherein the second material is a melt-processible poly(tetrafluoroethylene) composition, the melt-processible poly(tetrafluoroethylene) composition having a melt flow index value greater than 0 and less than 2.5 g/10minutes, and a third layer is formed of a third material having a melt temperature, wherein the third material is a melt-processible poly(tetrafluoroethylene) composition, the melt-processible poly(tetrafluoroethylene) composition having a melt flow index value greater than 0 and less than 2.5 g/10minutes, wherein the third layer is in direct contact with the first layer and wherein the first layer, the second layer, and the third layer are co-extruded at a temperature at or above the melt temperatures of the second and the third materials.
2. The medical tube of claim 1 , wherein the medical tube is a catheter tube.
3. The medical tube of claim 2 , the first layer having an inner and outer side, wherein the second layer is in contact with the inner side of the first layer.
4. The medical tube of claim 2 , wherein the melt temperature of the second material exceeds 320° C.
5. The medical tube of claim 4 , wherein the second material has an elongation to break of at least 10%.
6. The medical tube of claim 4 , wherein the second material has a crystallinity of 1-55%.
7. The medical tube of claim 6 , the third layer being tractable and having a peak melting temperature of at least 320 degrees C., an elongation to break of at least 10% and a crystallinity of 1-55%.
8. The medical tube of claim 1 , wherein the three layers are thermally co-extruded above their melt temperatures.
9. The medical tube of claim 1 , the first layer having an inner and outer side, wherein the second layer is in contact with the outer side of the first layer.
10. The medical tube of claim 1 , wherein the tube is an inner catheter shaft.
11. The medical tube of claim 1 , wherein the tube is an outer catheter shaft.
12. The medical tube of claim 1 , wherein the tube is a catheter balloon.
13. The medical tube of claim 1 , the second layer being tractable.