Catheter apparatus, and compositions useful for producing same

• US 4,990,138 A
• Filed: 07/18/1989
• Issued: 02/05/1991
• Est. Priority Date: 07/18/1989
• Status: Expired due to Term

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Baxter International Inc.
• Inventors: Jabba, Ronald J., Miraki, Manouchehr, Wilcox, Robert L., Seiler, Louis Jr., Skribiski, Robert, Bacich, Steven R.
• Primary Examiner(s): Yasko, John D.
• Application Number:
  US07/381,895
• Time in Patent Office: 567 Days
• Field of Search: 604/103, 604/102, 604/101, 604/96, 604/280, 604/264, 604/271, 604/273, 128/344
• US Class Current: 604/103.1
• CPC Class Codes: A61M 2205/32 with radio-opaque indicia
• CPC Class Codes: A61M 25/0119 Eversible catheters

Abstract

An everting balloon catheter having a distal end opening defined by a beveled rim is disclosed. The distal end portion of a catheter, e.g., an everting balloon catheter, can be made radioopaque by bonding a distal end portion comprising a polymeric material doped with a major amount of radioopaque metals onto a catheter body. Alternately, a composition comprising polymeric adhesives, and/or precursors of polymeric adhesives, and a major amount of radioopaque metal components can be placed, e.g., painted on the distal end portion of a catheter body to provide the desired degree of radioopacity.

Claims

1. An apparatus for insertion into the body of a patient comprising:

a flexible catheter tube sized and adapted to be inserted into the body of a patient;

said catheter tube having a distal end portion and a body portion located proximally of said distal end portion;

said catheter tube including a distal end opening defined by a rim which is beveled; and

balloon means attached to said catheter tube and capable of being inverted in said catheter tube and of being everted therefrom.

2. The apparatus of claim 1 wherein said distal end portion has increased flexibility relative to said body portion.

3. The apparatus of claim 1 wherein said catheter tube further includes a lumen and said distal end opening is the distal termination of said lumen.

4. The apparatus of claim 1 wherein said distal end portion has a substantial degree of radioopacity.

5. The apparatus of claim 1 wherein said beveled rim facilitates the folding of said balloon means as said balloon means is inverted into said catheter tube.

6. The apparatus of claim 1 wherein said balloon means is folded into a clamshell configuration as said balloon means is inverted into said catheter tube.

7. The catheter of claim 1 wherein the beveling of said rim has a curved axial profile.

8. The catheter of claim 1 wherein the beveling of said rim has a substantially symmetrical curved axial profile.

9. The catheter of claim 1 which further includes an elongated member located at least partially within said catheter body, said member includes an open ended tubular element and said balloon means is secured to said tubular element.

31. The catheter of claim 1 and wherein the beveling of the rim has a linear axial profile which defines an angle from the catheter axis.

32. The catheter of claim 31 and wherein the angle is about 5 to about 45 degrees.

33. The catheter of claim 32 and wherein the angle is about 17 degrees.

10. An apparatus for insertion into the body of a patient comprising:

a catheter tube sized and adapted to be inserted in the body of a patient;

said catheter tube having a distal end portion and a body portion located proximally of said and distal end portion, and a lumen; and

a composition comprising a minor amount of polymeric material, and a major amount of radioopaque substance selected from the group consisting of radioopaque metal components and mixtures thereof, said composition being located on at least a portion of said distal end portion and being present in an amount effective to provide a substantial degree of radioopacity to at least a portion of said distal end portion.

11. The apparatus of claim 10 herein said composition is present as an intimate admixture of said polymeric material and said radioopaque substance.

12. The apparatus of claim 10 wherein said radioopaque substance is selected from the group consisting of elemental radioopaque metals and mixtures thereof.

13. The apparatus of claim 10 wherein said distal end portion has an exterior surface and said composition is located on at least a portion of said exterior surface.

14. The apparatus of claim 10 wherein said composition is adhesively bonded to said distal end portion.

15. The apparatus of claim 10 wherein said radioopaque substance is selected from the qroup consisting of gold, the platinum group metals, tungsten, molybdenum, rhenium, tantalum and mixtures thereof.

16. An apparatus for insertion into the body of a patient comprising:

a flexible catheter tube sized and adapted to be inserted into the body of a patient;

a distal end element located distally of said catheter tube and made of a combination comprising a polymeric material and a radiopaque substance present in said combination in an amount effective to provide a substantial degree of radiopacity to said distal end element, said distal end element including a distal end opening defined by a rim which is beveled; and

balloon means attached to said catheter tube and capable of being inverted in said catheter tube and of being everted therefrom.

17. The apparatus of claim 16 wherein said radioopaque substance is selected from the group consisting of radioopaque metal components and mixtures thereof,

18. The apparatus of claim 16 wherein said distal end element is bonded to said catheter tube.

19. The apparatus of claim 16 wherein said distal end element is formed by extrusion.

20. The apparatus of claim 16 wherein said polymeric material is selected from the group consisting of ethylene vinyl acetate copolymers and mixtures thereof, and said radioopaque substance is tantalum in the form of particles.

21. The apparatus of claim 16 wherein said distal end element has increased flexibility relative to said catheter tube.

22. The apparatus of claim 16 wherein said beveled rim facilitates the folding of said balloon means as said balloon means is inverted into said catheter tube and said distal end element.

23. An apparatus for insertion into the body of a patient comprising:

a catheter tube sized and adapted to be inserted into the body of a patient;

a composition comprising a polymeric material and a radioopaque substance present in said composition in an amount effective to provide a substantial degree of radioopacity adhesively bonded to said tube; and

balloon means attached to said tube and capable of being inverted in said catheter tube, and of being everted therefrom.

24. The apparatus of claim 23 wherein said radioopaque substance is selected from the group consisting of elemental radioopaque metals and mixtures thereof.

25. The apparatus of claim 23 wherein said radioopaque substance is present in the form of elemental metal particles.

26. The apparatus of claim 24 wherein said radioopaque substance is selected from the group consisting of gold, the platinum group metals, tungsten, molybdenum, rhenium, tantalum and mixtures thereof.

27. The apparatus of claim 23 and wherein the composition is applied in the form of a liquid-solid slurry.

28. The apparatus of claim 23 wherein said polymeric materials are selected from the group consisting of polyurethanes, epoxy resins, polycyanoacrylates, ethylene vinyl acetate copolymers and mixtures thereof.

29. The apparatus of claim 23 wherein said catheter tube includes at its distal end a beveled tip and said composition is adhesively bonded to said tip.

30. Apparatus according to claim 23 and wherein said balloon means is adhesively attached to said tube using said composition.

34. An apparatus for insertion into the body of a patient comprising:

a first flexible catheter tube sized and adapted to be inserted into the body of a patient, said first flexible catheter tube having a distal end portion and a body portion located proximally of said distal end portion, said first flexible catheter tube including a distal end opening defined by a rim which is beveled;

a second flexible catheter tube sized and adapted to slide in said first flexible catheter tube, said second flexible catheter tube having a distal end portion and a body portion located proximally of said distal end portion and a body portion located proximally of said distal end portion; and

balloon means attached to said distal end portions of said first and second catheter tubes and capable of being inverted in said first catheter tube and of being everted therefrom.

35. The apparatus of claim 34 wherein said distal end of said first flexible catheter tube includes a composition comprising a polymeric material and a radiopaque substance present in said combination in an amount effective to provide a substantial degree of radiopacity to sid distal end.

36. The apparatus of claim 35 wherein said composition forms a separate element fitted to said distal end.

37. The apparatus of claim 36 wherein said element has increased flexibility relative to said catheter tube.