Catheters with high-purity fluoropolymer additives

Patent metadata

Field	Value
Publication number	US-9731049-B2
Application number	US-201414519589-A
Country	US
Kind code	B2
Filing date	Oct 21, 2014
Priority date	Mar 15, 2013
Publication date	Aug 15, 2017
Grant date	Aug 15, 2017

Abstract

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.

First claim

What is claimed is:

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.

Assignees

• Angiodynamics Inc
• Angio Dynamics Inc

Inventors

• Lareau Raymond
• Bell Benjamin
• Santerre J Paul
• Ho Jeannette

Classifications

• A61L29/041 Primary

  obtained by reactions only involving carbon-to-carbon unsaturated bonds · CPC title

• A61M2025/0056

  provided with an antibacterial agent, e.g. by coating, residing in the polymer matrix or releasing an agent out of a reservoir · CPC title

• A61M25/0017

  specially adapted for long-term hygiene care, e.g. urethral or indwelling catheters to prevent infections · CPC title

• C08L75/04

  Polyurethanes · CPC title

• A61M25/0021

  characterised by the form of the tubing (A61M25/0054 takes precedence) · CPC title