Catheters with high-purity fluoropolymer additives
View Patent ↗The present invention provides catheter compositions that provide anti-thrombogenic properties while not adversely impacting mechanical properties. All embodiments of the present invention comprise a catheter that comprises a fluoropolymer additive with specific compositions and/or purity levels.
1. A catheter comprising:
an elongated tubular structure comprising:
a polymeric material;
an outer surface, a proximal end, a distal end, and a lumen, wherein said outer surface and said lumen extend between said proximal and distal ends; and
a wall thickness between said outer surface and said lumen, said wall thickness being within the range of 0.005 inches to 0.050 inches;
wherein said polymeric material comprises polyurethane and additives, said additives comprising a fluoropolymer comprising terminal polyfluoro-oligomeric groups;
wherein said polymeric material is comprised of a positive amount of up to about 44 weight percent of said additives;
wherein the fluoropolymer comprises a trimer in an amount greater than 0 and less than 5.0 percent by weight of the fluoropolymer, wherein the trimer is formed by a reaction of one equivalent of a diisocyanate with two equivalents of a perfluorinated alcohol to form a low molecular weight fluoropolymer component containing no soft segment, and
wherein said fluoropolymer comprising terminal polyfluoro-oligomeric groups is characterized by a polystyrene equivalent weight average molecular weight (M w ) of 14 kDa to 26 kDa.
2. The catheter of claim 1 , wherein said fluoropolymer comprising terminal polyfluoro-oligomeric groups is characterized by a polystyrene equivalent number average molecular weight (M n ) of 10 kDa to 26 kDa.
3. The catheter of claim 1 , wherein said fluoropolymer comprising terminal polyfluoro-oligomeric groups has a polydispersity index of between 1.0 and 2.0.
4. The catheter of claim 1 , wherein said fluoropolymer comprising terminal polyfluoro-oligomeric groups has a polydispersity index of between 1.0 and 1.5.
5. The catheter of claim 1 , wherein said polymeric material comprises about 1.5 weight percent to about 2.5 weight percent of said fluoropolymer comprising terminal polyfluoro-oligomeric groups.
6. The catheter of claim 1 , wherein said additives comprise a radiopaque material.
7. The catheter of claim 6 , wherein said polymeric material is comprised of about 20 weight percent to about 35 weight percent of said radiopaque material.
8. The catheter of claim 7 , wherein said radiopaque material comprises barium sulfate.
9. A catheter comprising:
an elongated tubular structure comprising:
a polymeric material;
an outer surface, a proximal end, a distal end, and at least two lumens, wherein said outer surface and said lumen extend between said proximal and distal ends; and
a wall thickness between said outer surface and any of said at least two lumens, said wall thickness being within the range of 0.0075 inches to 0.0110 inches;
wherein said polymeric material comprises polyurethane and additives, said additives comprising a fluoropolymer comprising terminal polyfluoro-oligomeric groups;
wherein said polymeric material is comprised of a positive amount of up to about 40 weight percent of said additives;
wherein the fluoropolymer comprises a trimer in an amount greater than 0 and less than 5.0 percent by weight of the fluoropolymer, wherein the trimer is formed by a reaction of one equivalent of a diisocyanate with two equivalents of a perfluorinated alcohol to form a low molecular weight fluoropolymer component containing no soft segment, and
wherein said fluoropolymer comprising terminal polyfluoro-oligomeric groups is characterized by a polystyrene equivalent weight average molecular weight (M w ) of 14 kDa to 26 kDa.
10. The catheter of claim 9 , wherein said fluoropolymer comprising terminal polyfluoro-oligomeric groups is characterized by a polystyrene equivalent number average molecular weight (Mn) of 10 kDa to 26 kDa.
11. The catheter of claim 9 , wherein said fluoropolymer comprising terminal polyfluoro-oligomeric groups has a polydispersity index of between 1.0 and 2.0.
12. The catheter of claim 9 , wherein said fluoropolymer comprising terminal polyfluoro-oligomeric groups has a polydispersity index of between 1.0 and 1.5.
13. The catheter of claim 9 , wherein said polymeric material comprises about 1.5 weight percent to about 2.5 weight percent of said fluoropolymer comprising terminal polyfluoro-oligomeric groups.
14. The catheter of claim 9 , wherein said additives comprise a radiopaque material.
15. The catheter of claim 14 , wherein said polymeric material is comprised of about 20 weight percent to about 35 weight percent of said radiopaque material.
16. The catheter of claim 15 , wherein said radiopaque material comprises barium sulfate.
17. The catheter of claim 9 , wherein said polyurethane comprises a polycarbonate-based polyurethane.
18. The catheter of claim 9 , wherein said polymeric material is comprised of a positive amount of up to about 33 weight percent of said additives.