Catheter having highly radiopaque, flexible tip

• US 5,045,072 A
• Filed: 06/13/1989
• Issued: 09/03/1991
• Est. Priority Date: 06/13/1989
• Status: Expired due to Term

• Current Assignee: Cordis Corporation (Cardinal Health, Inc.)
• Original Assignee: Cordis Corporation (Cardinal Health, Inc.)
• Inventors: Castaneda, Javier E., Castillo, Miguel A., Glemser, Eric
• Primary Examiner(s): Pellegrino, Stephen C.
• Assistant Examiner(s): Lewis, Ralph A.
• Application Number:
  US07/365,477
• Time in Patent Office: 812 Days
• Field of Search: 604/264, 604/280, 604/281, 604/282, 128/658
• US Class Current: 604/529
• CPC Class Codes: A61M 2025/0081 Soft tip
• CPC Class Codes: A61M 2205/32 with radio-opaque indicia
• CPC Class Codes: A61M 25/0054 with regions for increasing flexibility
• CPC Class Codes: A61M 25/008 Strength or flexibility characteristics of the catheter tip
• CPC Class Codes: A61M 25/0108 using radio-opaque or ultrasound markers

Abstract

A flexible plastic catheter defines a flexible, distal tip. In accordance with this invention, the distal tip comprises a plastic formulation containing sufficient radiopaque agent to be substantially more radiopaque and preferably softer than portions of the catheter proximal to the tip. Thus, the distal tip area of the catheter can be flexible to avoid possible tissue damage as the catheter is advanced, but is still readily visible by x-ray. At the same time, the majority of the catheter may be of normal flexibility and strength.

Claims

1. A flexible plastic arteriovenous catheter which defines a radiopaque catheter shaft and flexible, distal tip, said distal tip comprising a plastic formulation containing from 40 to 75 weight percent of radiopaque agent to be substantially more radiopaque than portions of said catheter proximal to said tip, said distal tip being softer than said portions of said catheter proximal to said tip.

2. The catheter of claim 1 in which said plastic formulation of the distal tip comprises a higher weight percent of radiopaque agent than the plastic formulation of said portions proximal to said tip.

3. The catheter of claim 1 in which the plastic of the distal tip comprises essentially 50 to 70 weight percent of radiopaque agent.

4. The catheter of claim 3 in which said radiopaque agent is bismuth trioxide.

5. The catheter of claim 3 in which portions proximal to said tip comprise from 25 to 38 weight percent of radiopaque agent.

6. The catheter of claim 1 which is free of any metallic radiomarker member positioned on or adjacent said distal tip.

7. The catheter of claim 1 in which the plastic formulation comprises polyurethane as a structural binder.

8. The catheter of claim 1 in which at least the majority of said distal tip is free of overlapping relation with the catheter portion proximal to said tip.

9. In a flexible plastic arteriovenous catheter which defines a catheter shaft having a bonded, flexible, distal tip, the improvement comprising, in combination:

said distal tip comprising a plastic formulation which contains from 40 to 75 weight percent of radiopaque agent, the catheter shaft proximal to said tip containing from 25 to 38 weight percent of radiopaque agent, whereby the flexible, distal tip is substantially more radiopaque than said catheter shaft proximal to said tip, said distal tip being softer than the proximal catheter shaft, said catheter being free of any metallic radiomarker member positioned in or adjacent said distal tip.

10. The catheter of claim 9 in which the plastic of the distal tip comprises 50-70 weight percent of radiopaque agent.

11. The catheter of claim 10 in which said radiopaque agent is bismuth trioxide.

12. The catheter of claim 11 in which the plastic formulation of the distal tip comprises polyurethane as a structural binder.

13. The catheter of claim 12 in which said catheter shaft also comprises polyurethane as a structural binder.

14. The catheter of claim 9 in which said radiopaque agent is bismuth trioxide.

15. The catheter of claim 9 in which at least the majority of said distal tip is free of overlapping relation with the catheter portion proximal to said tip.

16. The flexible plastic catheter of claim 9 in which said distal tip portion has a length which is not substantially more than its width, and the distal end of said tip is substantially perpendicular to the axis thereof.

17. A catheter which comprises a distal tip portion which contains from 25 to 60 weight percent of thermoplastic resin, which resin in unfilled form has a durometer of 75A to 85A, and from 40 to 75 weight percent of bismuth trioxide as a radiopaque filler mixed in said resin, whereby said distal tip portion exhibits improved radiopaque characteristics while remaining soft, said distal tip portion having a length which is not substantially more than its width, the remainder of said catheter being made of a stiffer radiopaque plastic material containing less radiopaque filler than said distal tip portion.

18. The catheter of claim 17 in which the portions of said catheter other than said distal tip comprise 25 to 38 weight percent of radiopaque agent.

19. The catheter of claim 18 in which said distal tip and portions of said catheter other than said distal tip comprise polyurethane as a structural binder.

20. The catheter of claim 17 in which the durometer of said thermoplastic without filler is at least 80A.

21. In a flexible plastic catheter which defines a radiopaque catheter shaft and flexible, distal tip, the improvement comprising, in combination:

said distal tip comprising a plastic formulation, which, in turn, comprises a thermoplastic structural binder mixed with powdered bismuth trioxide as a radiopaque agent, from 50 to 70 weight percent of radiopaque agent being present in the distal tip, to be more radiopaque than said catheter shaft, the thermoplastic structural binder in unfilled form having a durometer of 75A to 85A, said distal tip being softer than proximal plastic portions of said catheter.

22. The plastic catheter of claim 21 in which said proximal plastic portions of the catheter comprise from 25 to 38 weight percent of radiopaque agent.

23. The flexible plastic catheter of claim 22 which is free of any metallic radiomarker member positioned on or adjacent said distal tip.

24. The plastic catheter of claim 23 in which the plastic formulation of the distal tip comprises polyurethane as a structural binder.

25. An arteriovenous catheter which comprises a distal tip portion which contains from 25 to 60 weight percent of polyurethane resin, which resin in unfilled form has a durometer of 75and from 40 to 75 weight percent of bismuth trioxide radiopaque filler mixed in said resin, whereby said distal tip portion exhibits improved radiopaque characteristics while remaining soft, said distal tip portion having a length which is not substantially more than its width, the remainder of said catheter being made of a stiffer radiopaque plastic material containing less radiopaque agent than said distal tip portion.

26. A flexible plastic arteriovenous catheter which defines a radiopaque catheter shaft and a flexible, distal tip, said distal tip comprising a plastic formulation containing from 40 to 75 weight percent of radiopaque agent to be substantially more radiopaque than portions of said catheter proximal to said tip, said flexible, distal tip comprising a thermoplastic resin as part of said plastic formulation, mixed with said radiopaque agent, said thermoplastic resin in unfilled form having a durometer of 75A to 85A, whereby said plastic formulation exhibits improved radiopaque characteristics while remaining softer than the plastic formulation of the rest of said catheter proximal to said distal tip.

27. A flexible plastic arteriovenous catheter which defines a catheter shaft having a bonded, flexible, distal tip, said distal tip comprising a plastic formulation which contains from 40 to 75 weight percent of a radiopaque agent, the catheter shaft proximal to said tip containing from 25 to 38 weight percent of radiopaque agent, whereby the flexible, distal tip is substantially more radiopaque than said catheter shaft proximal to said tip, said distal tip comprising a thermoplastic resin as part of said plastic formulation, mixed with said radiopaque agent, the thermoplastic resin in unfilled form having a durometer of 75A to 85A, said distal tip being softer than the proximal catheter shaft, said catheter being free of any metallic radiomarker member positioned in or adjacent said distal tip, whereby said plastic formulation exhibits improved radiopaque characteristics while remaining soft.

28. A flexible plastic catheter which defines a radiopaque catheter shaft and flexible, distal tip, said distal tip comprising a plastic formulation which, in turn, comprises a polyurethane thermoplastic structural binder mixed with powdered bismuth trioxide as a radiopaque agent, from 50 to 70 weight percent of said radiopaque agent being present in the distal tip to be more radiopaque than said catheter shaft, the polyurethane thermoplastic structural binder in unfilled form having a durometer of 75A to 85A, said distal tip being softer than proximal plastic portions of said catheter.

29. A flexible plastic arteriovenous catheter which defines a radiopaque catheter shaft and a flexible distal tip, said distal tip comprising a plastic formulation containing from 40 to 75 weight percent of bismuth trioxide, to be substantially more radiopaque than portions of said catheter proximal to said tip, said distal tip being softer than said portions of said catheter proximal to said tip, said distal tip having a length which is not substantially more than its width.

30. The flexible plastic catheter of claim 29 in which said flexible distal tip defines a flat end substantially perpendicular to its axis.