Catheter Assembly

• US 20090198219A1
• Filed: 04/14/2009
• Published: 08/06/2009
• Est. Priority Date: 01/17/2003
• Status: Active Grant

• Current Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Original Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Inventors: Foutrakis, George N., Cully, Edward H., Campbell, Carey V., Vonesh, Michael J., Trapp, Benjamin M., Roeber, Peter J., Eskaros, Sherif, Mann, James William
• Granted Patent: US 9,884,170 B2
• Time in Patent Office: Days
• US Class Current: 604/524
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61M 2025/0034 characterized by elements which are assembled, connected or fused, e.g. splittable tubes, outer sheaths creating lumina or separate cores making of catheters A61M25/0009
• CPC Class Codes: A61M 2025/0035 characterized by a variable lumen cross-section by means of a resilient flexible septum or outer wall
• CPC Class Codes: A61M 2025/0063 having means, e.g. stylets, mandrils, rods or wires to reinforce or adjust temporarily the stiffness, column strength or pushability of catheters which are already inserted into the human body
• CPC Class Codes: A61M 2025/0183 Rapid exchange or monorail catheters
• CPC Class Codes: A61M 2025/0188 having slitted or breakaway lumens
• CPC Class Codes: A61M 2025/1056 having guide wire lumens outside the main shaft, i.e. the guide wire lumen is within or on the surface of the balloon
• CPC Class Codes: A61M 2025/1081 having sheaths or the like for covering the balloon but not forming a permanent part of the balloon, e.g. retractable, dissolvable or tearable sheaths
• CPC Class Codes: A61M 25/0023 by the form of the lumen, e.g. cross-section, variable diameter
• CPC Class Codes: A61M 25/0029 characterized by features relating to least one lumen located at the middle part of the catheter, e.g. slots, flaps, valves, cuffs, apertures, notches, grooves or rapid exchange ports catheter shaft surface irregularities A61M2025/006
• CPC Class Codes: A61M 25/0032 characterized by at least one unconventionally shaped lumen, e.g. polygons, ellipsoids, wedges or shapes comprising concave and convex parts
• CPC Class Codes: A61M 25/0043 characterised by structural features
• CPC Class Codes: A61M 25/005 with embedded materials for reinforcement, e.g. wires, coils, braids
• CPC Class Codes: A61M 25/0051 made from fenestrated or weakened tubing layer
• CPC Class Codes: A61M 25/0052 Localized reinforcement, e.g. where only a specific part of the catheter is reinforced, for rapid exchange guidewire port
• CPC Class Codes: A61M 25/0053 having a variable stiffness along the longitudinal axis, e.g. by varying the pitch of the coil or braid
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61M 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61M 25/1011 Multiple balloon catheters

Abstract

Novel catheter constructions comprising thin covering or wrapping materials such as polymer films. A catheter provided with a guidewire catheter lumen having a thin covering that is easily punctured by a guidewire at virtually any desired point along the catheter length. The thin covering may be integral with the catheter shaft, or may be a separate component that covers only the portion of the catheter shaft immediately adjacent the outer portion of the guidewire lumen, or may be a thin tubular construct that surrounds the entire catheter shaft. Moreover, polymer film can be used in combination with one or more elements to produce novel catheter constructions.

Claims

1. A catheter comprising:

a hub; and

a longitudinally extending tube having at least one physical property varied from a proximal point on the catheter to a distal point on the catheter, the at least one physical property being varied by wrapping polymer film about at least a portion of the length of the catheter.

2. The catheter of claim 1, wherein the at least one varied physical property is selected from the group consisting of flexibility, column strength, tensile strength, crush resistance, burst strength, wall thickness and lubricity.

3. The catheter of claim 1, wherein the catheter has a wall thickness that varies from a proximal point to a distal point.

4. The catheter of claim 1, wherein the longitudinally extending tube is formed by the wrapped polymer film.

5. The catheter of claim 4, wherein the longitudinally extending tube has a wall thickness that varies from a proximal point to a distal point.

6. The catheter of claim 4, wherein the catheter has a tapered outer diameter.

7. The catheter of claim 1, wherein the catheter has a tapered inner diameter.

8. The catheter of claim 1, wherein the polymer film comprises at least one material selected from the group consisting of polyethylene, including ultra-high molecular weight polyethylene, polypropylene, polyamide, polyethylene terephthalate, fluorinated ethylene propylene, perfluoro alkoxy resin, polyurethane, polyester, polyimide, and polytetrafluoroethylene.

9. The catheter of claim 1, wherein the polymer film comprises a helical wrap.

10. The catheter of claim 9, wherein the polymer film comprises porous expanded polytetrafluoroethylene.

11. (The catheter of claim 10, wherein the porous expanded polytetrafluoroethylene further comprises fluorinated ethylene propylene.

12. The catheter of claim 11, wherein the fluorinated ethylene propylene is provided as a non-porous coating on a surface of the expanded polytetrafluoroethylene film.

13. The catheter of claim 11, wherein the fluorinated ethylene propylene is provided as a porous coating on a surface of the expanded polytetrafluoroethylene film.

14. The catheter of claim 10, wherein the porous expanded polytetrafluoroethylene further comprises at least one filler.

15. The catheter of claim 14, wherein the at least one filler comprises at least one material selected from the group consisting of ceramics, metals, metalloids, and carbon.

16. The catheter of claim 14, wherein the at least one filler comprises a radiopaque material.

17. The catheter of claim 10, wherein the at least one physical property is selected from the group consisting of flexibility, column strength, tensile strength, crush resistance, burst strength, wall thickness and lubricity.

18. The catheter of claim 1, wherein the catheter comprises a relatively stiff proximal region transitioning to a relatively flexible distal region.

19. The catheter of claim 18, wherein the catheter further comprises an intermediately stiff transition region between the proximal region and the distal region.

20. A catheter comprising:

a longitudinally extending tube formed from polymer film wrap, wherein at least one physical property varies from a proximal point on the catheter to a distal point on the catheter.

21. The catheter of claim 20, wherein the at least one varied physical property is selected from the group consisting of flexibility, column strength, tensile strength, crush resistance, burst strength, wall thickness and lubricity.

22. The catheter of claim 20, wherein the catheter has a wall thickness that varies from a proximal point to a distal point.

23. The catheter of claim 20, wherein the catheter has a tapered outer diameter.

24. The catheter of claim 20, wherein the catheter has a tapered inner diameter.

25. The catheter of claim 20, wherein the polymer film comprises at least one material selected from the group consisting of polyethylene, including ultra-high molecular weight polyethylene, polypropylene, polyamide, polyethylene terephthalate, fluorinated ethylene propylene, perfluoro alkoxy resin, polyurethane, polyester, polyimide, and polytetrafluoroethylene.

26. The catheter of claim 25, wherein the polymer film comprises a helical wrap.

27. The catheter of claim 26, wherein the polymer film comprises porous expanded polytetrafluoroethylene.

28. The catheter of claim 27, wherein the porous expanded polytetrafluoroethylene further comprises fluorinated ethylene propylene.

29. The catheter of claim 28, wherein the fluorinated ethylene propylene is provided as a non-porous coating on a surface of the porous expanded polytetrafluoroethylene film.

30. The catheter of claim 28, wherein the fluorinated ethylene propylene is provided as a porous coating on a surface of the porous expanded polytetrafluoroethylene film.

31. The catheter of claim 28, wherein the porous expanded polytetrafluoroethylene further comprises at least one filler.

32. The catheter of claim 31, wherein the at least one filler comprises at least one material selected from the group consisting of ceramics, metals, metalloids, and carbon.

33. The catheter of claim 31, wherein the at least one filler comprises a radiopaque material.

34. The catheter of claim 27, wherein the at least one physical property is selected from the group consisting of flexibility, column strength, tensile strength, crush resistance, burst strength, wall thickness and lubricity.

35. The catheter of claim 20, wherein the catheter comprises a relatively stiff proximal region transitioning to a relatively flexible distal region.

36. The catheter of claim 35 wherein the catheter further comprises an intermediately stiff transition region between the proximal region and the distal region.

37. A tubular catheter body consisting essentially of a hub and a longitudinally extending tube formed by a helically wrapped polymer film.

38. The catheter of claim 37, wherein at least one physical property of the tube is varied.

39. The catheter of claim 38, wherein the at least one physical property is selected from the group consisting of flexibility, column strength, tensile strength, crush resistance, burst strength, wall thickness, and lubricity.

40. The catheter of claim 38, wherein the catheter has a wall thickness that varies from a proximal point to at distal point.

41. The catheter of claim 37, wherein the polymer film comprises at least one material selected from the group consisting of polyethylene, polypropylene, polyamide, polyethylene terephthalate, fluorinated ethylene propylene, perfluoro alkoxy resin, polyurethane, polyester, polyimide, and polytetrafluoroethylene.

42. The catheter of claim 41, wherein the polymer film comprises porous expanded polytetrafluoroethylene.

43. The catheter of claim 42, wherein the porous expanded polytetrafluoroethylene further comprise fluorinated ethylene propylene.

44. The catheter of claim 43, wherein the fluorinated ethylene propylene is provided as a non-porous coating on a surface of the expanded polytetrafluoroethylene film.

45. The catheter of claim 42, wherein the porous expanded polytetrafluoroethylene further comprises at least one filler.

46. The catheter of claim 42, wherein the at least one filler comprises at least one material selected from the group consisting of ceramics, metals, metalloids, and carbon.