Catheter assembly

• US 7,625,337 B2
• Filed: 08/07/2006
• Issued: 12/01/2009
• Est. Priority Date: 01/17/2003
• Status: Expired due to Term

• Current Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Original Assignee: Gore Enterprise Holdings Incorporated (W.L. Gore and Associates)
• Inventors: Cully, Edward H., Campbell, Carey V., Vonesh, Michael J., Trapp, Benjamin M., Roeber, Peter J., Eskaros, Sherif, Mann, James William, Foutrakis, George N.
• Primary Examiner(s): Sirmons; Kevin C
• Assistant Examiner(s): WITCZAK, CATHERINE
• Application Number:
  US11/500,836
• Publication Number:
  US 20070088323A1
• Time in Patent Office: 1,212 Days
• Field of Search: 604/524, 604/526, 604/527, 604/43, 604/510, 604/96.01, 604/97.01, 604/102.02, 604/102.03, 604/103.04, 604/103.09, 604/160, 604/164.03, 604/166.01, 604/264, 604/525, 604/921, 600/156, 600/104, 600/128, 600/124, 600/153, 600/116
• US Class Current: 600/156
• 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
• 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. Catheter comprising:

a first longitudinally extending hollow polymer tube having a proximal end, a distal end, a wall having an inner surface and an outer surface, and a centrally located lumen extending from the proximal end to the distal end;

a channel located in the wall forming an opening in the outer surface of the wall and extending from the proximal end to the distal end;

polymer film helically wrapped about the outer surface, covering the channel from the proximal end to the distal end, thus covering the opening in the outer surface and forming a first wall inflation lumen extending from the proximal end to the distal end; and

an inflatable member located on the distal end the catheter, the inflatable member selected from the group consisting of an occlusion balloon and a dilation balloon and being in fluid communication with the inflation lumen.

2. The catheter of claim 1 further comprising a second longitudinally extending hollow tube having a proximal end and a distal end, a wall having an inner surface and an outer surface, and a centrally located lumen extending from the proximal end to the distal end, wherein the second longitudinally extending hollow tube is located inside the first longitudinally extending hollow tube with the inner surface of the first tube being in contact with the outer surface of the second tube.

3. The catheter of claim 2, wherein the first polymer tube encapsulates a metal braid material.

4. The catheter of claim 3, wherein the first polymer tube comprises polyamide.

5. The catheter of claim 2, wherein the second tube comprises polytetrafluoroethylene.

6. The catheter of claim 5, wherein the polytetrafluoroethylene is extruded polytetrafluoroethylene.

7. The catheter of claim 2, wherein the catheter is sized to be capable of being advanced into a patient'"'"'s cerebral vasculature.

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

9. The catheter of claim 1, wherein the polymer film comprises polytetrafluoroethylene.

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

11. The catheter of claim 10, wherein the expanded polytetrafluoroethylene is provided with a thermoplastic coating.

12. The catheter of claim 11, wherein the thermoplastic coating is a non-porous coating.

13. The catheter of claim 12, wherein the thermoplastic coating comprises fluorinated ethylene propylene.

14. The catheter of claim 10, wherein the expanded polytetrafluoroethylene is imbibed with at least one filler material.

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

16. The catheter of claim 1, wherein the channel is formed by a laser.

17. The catheter of claim 1, wherein the polymer film is helically wrapper about the outer surface of the first longitudinally extending hollow tube.

18. The catheter of claim 1, wherein the channel is a longitudinally extending channel.

19. The catheter of claim 1, wherein a guidewire is in sliding relationship with the centrally located lumen of the first longitudinally extending hollow tube.

20. The catheter of claim 1, wherein the catheter is sized to be capable of being advanced into a patient'"'"'s cerebral vasculature.

21. The catheter of claim 1, wherein the inflatable member is an occlusion balloon.

22. The catheter of claim 1, wherein the inflatabled member is a dilatation balloon.

23. The catheter of claim 1, wherein a stent is mounted on the dilatation balloon.

24. The catheter of claim 1, further comprising at least a second channel located in the wall forming at least a second opening in the outer surface of the wall.

25. The catheter of claim 24, wherein the second channel extends from the proximal end to the distal end of the catheter.

26. The catheter of claim 24, wherein the polymer film covers the at least second opening in the outer surface of the wall, forming at least a second wall lumen.

27. The catheter of claim 26, wherein the second wall lumen extends from the proximal end to the distal end of the catheter.

28. The catheter of claim 24, wherein the at least second channel is a longitudinally extending channel.

29. The catheter of claim 1, wherein the polymer film is provided with an adhesive material to at least a portion of at least one side of the polymer film.

30. The catheter of claim 29, wherein the adhesive comprises a UV-curable adhesive.

31. Catheter comprising:

a first longitudinally extending hollow polymer tube having a proximal end, a distal end, a wall having an inner surface and an outer surface, and a centrally located lumen extending from the proximal end to the distal end;

a channel located in the wall forming an opening in the outer surface of the wall and extending from the proximal end to near the distal end;

polymer film helically wrapped about the outer surface, covering the channel from the proximal end to near the distal end, thus covering the opening in the outer surface and forming a first wall inflation lumen extending from the proximal end to near the distal end; and

an inflatable member located on the distal end of the catheter, the inflatable member selected from the group consisting of an occlusion balloon and a dilation balloon and being in fluid communication with the inflation lumen.

32. The catheter of claim 31, further comprising a second longitudinally extending hollow tube having a proximal end and a distal end, a wall having an inner surface and an outer surface, and a centrally located lumen extending from the proximal end to the distal end, wherein the second longitudinally extending hollow tube is located inside the first longitudinally extending hollow tube with the inner surface of the first tube being in contact with the outer surface of the second tube.

33. The catheter of claim 32, wherein the first polymer tube encapsulates a metal braid material.

34. The catheter of claim 33, wherein the first polymer tube comprises polyamide.

35. The catheter of claim 32, wherein the second tube comprises polytetrafluoroethylene.

36. The catheter of claim 35, wherein the polytetrafluoroethylene is extruded polytetrafluoroethylene.

37. The catheter of claim 32, wherein the catheter is sized to be capable of being advanced into a patients cerebral vasculature.

38. The catheter of claim 31, wherein the polymer film comprises a material selected from the group consisting of ultra-high molecular weight polyethylene, polypropylene, polyamide, polyethylene terephthalate, fluorinated ethylene propylene, perfluoro alkoxy resin, polyurethane, polyester, and polyimide.

39. The catheter of claim 31, wherein the polymer film comprises polytetrafluoroethylene.

40. The catheter of claim 39, wherein the polymer film comprises expanded polytetrafluoroethylene.

41. The catheter of claim 40, wherein the expanded polytetrafluoroethylene is provided with a thermoplastic coating.

42. The catheter of claim 41, wherein the thermoplastic coating is a non-porous coating.

43. The catheter of claim 42, wherein the thermoplastic coating comprises fluorinated ethylene propylene.

44. The catheter of claim 40, wherein the expanded polytetrafluoroethylene is imbibed with at least one filler material.

45. The catheter of claim 44, wherein the at least one filler material comprises a radiopaque material.

46. The catheter of claim 31, wherein the channel is a formed by a laser.

47. The catheter of claim 31, wherein the polymer film is helically wrapped about the outer surface of the first longitudinally extending hollow tube.

48. The catheter of claim 31, wherein the channel is a longitudinally extending channel.

49. The catheter of claim 31, wherein a guidewire is in sliding relationship with the centrally located lumen of the first longitudinally extending hollow tube.

50. The catheter of claim 31, wherein the catheter is sized to be capable of being advanced into a patient'"'"'s cerebral vasculature.

51. The catheter of claim 31, wherein the inflatable member is an occlusion balloon.

52. The catheter of claim 31, wherein the inflatable member is a dilatation balloon.

53. The catheter of claim 31, wherein a stent is mounted on the dilatation balloon.

54. The catheter of claim 31, further comprising at least a second channel located in the wall forming at least a second opening in the outer surface of the wall.

55. The catheter of claim 54, wherein the second channel extends from the proximal end to the distal end of the catheter.

56. The catheter of claim 54, wherein the polymer film covers the at least second opening in the outer surface of the wall, forming at least a second wall lumen.

57. The catheter of claim 56, wherein the second wall lumen extends from the proximal end to the distal end of the catheter.

58. The catheter of claim 54, wherein the at least second channel is a longitudinally extending channel.

59. The catheter of claim 31, wherein the polymer film is provided with an adhesive material to at least a portion of at least one side of the polymer film.

60. The catheter of claim 59, wherein the adhesive comprises a UV-curable adhesive.