Rapid exchange folded balloon catheter and stent delivery system

• US 6,071,285 A
• Filed: 03/25/1996
• Issued: 06/06/2000
• Est. Priority Date: 03/25/1996
• Status: Expired due to Term

• Current Assignee: Medtronic Ave Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Ave Incorporated (Medtronic Plc)
• Inventors: Orth, Geoffrey A., Haarstad, Philip J., Lashinski, Robert D., Brooks, Dennis L.
• Primary Examiner(s): Dawson, Glenn K.
• Application Number:
  US08/624,692
• Time in Patent Office: 1,534 Days
• Field of Search: 604/96, 604/102, 604/104, 604/264, 604/283, 606/108, 606/192, 606/194, 606/198, 606/191, 623/1, 623/11, 623/12
• US Class Current: 623/1.11
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2002/9583 Means for holding the stent on the balloon, e.g. using protrusions, adhesives or an outer sleeve
• CPC Class Codes: A61M 2025/0183 Rapid exchange or monorail catheters

Abstract

The balloon portion of a balloon catheter for implanting a stent structure is at least initially retained laterally to a guide wire by passing the guide wire axially along the balloon inside the stent structure but not through the interior of the balloon or any permanent guide wire lumen at the location of the balloon. The initially deflated balloon may be folded laterally into a plurality of folds, and the guide wire may pass between the folds or outside the folds as desired. Guide wire lumens may be provided distally and/or proximally of the balloon. An elastic sleeve may be provided around the balloon to help keep the balloon folded prior to inflation and to help refold the balloon during and after deflation. If an elastic sleeve is provided, the guide wire may pass along the balloon inside the sleeve.

Claims

1. A balloon catheter system comprising:

an initially deflated inflatable balloon;

a guidewire; and

a stent structure disposed on said balloon and forming an annulus around said balloon, said guidewire padding axially along said balloon inside the annulus formed by said stent structure but outside said balloon.

2. The catheter system defined in claim 1 wherein said stent structure is substantially the sole structure at the location of said balloon for positively maintaining said balloon adjacent to said guide wire.

3. The catheter system defined in claim 2 wherein, in its initially deflated condition, said balloon is folded laterally on itself in a plurality of folds between which said guide wire can pass, and wherein said stent structure maintains said folds in said balloon until said balloon is inflated.

4. The catheter system defined in claim 1 wherein, in its initially deflated condition, said balloon is folded laterally on itself in a plurality of folds, between which said guide wire can pass, and wherein said stent structure maintains said folds in said balloon until said balloon is inflated.

5. The catheter system defined in claim 4 wherein said balloon is folded so that an axial clearance is left between folds of the balloon, through which clearance said guide wire can pass axially along said balloon and wherein a portion of said balloon is intermediate said guide wire and said stent structure.

6. The catheter system defined in claim 5 wherein said clearance is produced by folding said balloon around a mandrel at the desired location of said clearance, heat setting the folded balloon, and withdrawing said mandrel to leave said clearance.

7. The catheter system defined in claim 6 wherein said balloon has axially opposite proximal and distal ends from which proximal and distal lumens respectively extend, and wherein said mandrel presses radially inwardly on portions of said lumens adjacent to said proximal and distal ends so that heat setting the folded balloon also heat sets the portions of said lumens that are pressed radially inwardly to help promote refolding of the balloon after use of the catheter system to implant the stent structure.

8. The catheter system defined in claim 5 wherein said balloon has axially opposite proximal and distal ends, and wherein said catheter system further comprises:

a distal guide wire lumen extending distally of said distal end of said balloon for allowing a guide wire portion which is distal of said balloon to pass through said distal guide wire lumen, said distal guide wire lumen having a proximal extension which extends into a distal portion of said clearance.

9. The catheter system defined in claim 8 wherein said extension of said distal guide wire lumen has a proximal end which is distal of a distal end of said stent structure.

10. The catheter system defined in claim 5 wherein said balloon has axially opposite proximal and distal ends, and wherein said catheter system further comprises:

a proximal guide wire lumen extending proximally of said proximal end of said balloon for allowing a guide wire portion which is proximal of said balloon to pass through said proximal guide wire lumen, said proximal guide wire lumen having a distal extension which extends into a proximal portion of said clearance.

11. The catheter system defined in claim 10 wherein said extension of said proximal guide wire lumen has a distal end which is proximal of a proximal end of said stent structure.

12. The catheter system defined in claim 1 wherein said stent structure is circumferentially expandable in response to inflation of said balloon.

13. The catheter system defined in claim 1 wherein said balloon has axially opposite proximal and distal ends, and wherein said catheter system further comprises:

a distal guide wire lumen extending distally of said distal end of said balloon for allowing a guide wire portion which is distal of said balloon to pass through said distal guide wire lumen.

14. The catheter system defined in claim 1 wherein said balloon has axially opposite proximal and distal ends, and wherein said catheter system further comprises:

a proximal guide wire lumen extending proximally of said proximal end of said balloon for allowing a guide wire portion which is proximal of said balloon to pass through said proximal guide wire lumen.

15. The catheter system defined in claim 1 wherein said balloon has axially opposite proximal and distal ends, and wherein said catheter system further comprises:

an inflation lumen extending proximally from the proximal end of said balloon, said inflation lumen being in fluid communication with the interior of said balloon for supplying pressurized inflation fluid to said balloon for inflating said balloon.

16. The catheter system defined in claim 15 further comprising:

a proximal guide wire lumen extending along said inflation lumen for allowing a guide wire portion which is proximal of said balloon to pass through said proximal guide wire lumen.

17. The catheter system defined in claim 16 wherein said proximal guide wire lumen extends along only a portion of said inflation lumen that is relatively close to said balloon.

18. The catheter system defined in claim 1 further comprising:

a radio-opaque marker adjacent to said balloon.

19. The catheter system defined in claim 1 wherein said balloon has axially opposite proximal and distal ends, and wherein said catheter system further comprises:

a pusher wire attached to the catheter at a location which is adjacent the distal end of said balloon and extending proximally from said location and from the proximal end of said balloon.

20. The catheter system defined in claim 19 wherein said pusher wire is made of nitinol.

21. The catheter system defined in claim 19 wherein said pusher wire has a distal portion which is distal of the distal end of said balloon, said distal portion being formed into an axially extending coil through which a portion of the guide wire distal of said balloon can pass.

22. The catheter system defined in claim 19 wherein said pusher wire passes axially through the interior of said balloon, and wherein said catheter system further comprises:

a radio-opaque marker on said pusher wire.

23. The catheter system defined in claim 22 wherein said radio-opaque marker is axially adjacent to an axial end of said stent structure.

24. The catheter system defined in claim 23 further comprising:

a second radio-opaque marker on said pusher wire axially adjacent to a second axial end of said stent structure.

25. The catheter system defined in claim 1 wherein said balloon and said stent structure are formed to provide a clearance through which said guide wire can pass axially along said balloon inside the annulus formed by said stent structure but outside said balloon and wherein a portion of said balloon is intermediate said guide wire and said stent structure.

26. The catheter system defined in claim 25 wherein said clearance is produced by heat setting said balloon in contact with a mandrel disposed at the desired location of said clearance, and then withdrawing said mandrel to leave said clearance.

27. The catheter system defined in claim 1 wherein said balloon has axially opposite proximal and distal ends from which proximal and distal lumens respectively extend, wherein in its initially deflated condition said balloon is folded laterally on itself in a plurality of folds, and wherein at least one of said lumens has an axially extending valley-like ramp in its wall which forms an axial continuation of a fold in said balloon.

28. A balloon catheter system comprising:

an initially deflated inflatable balloon;

a guidewire;

an annular elastic sleeve structure disposed around said balloon for resiliently circumferentially compressing said balloon; and

a stent structure disposed on said balloon and forming an annulus around said balloon, said guidewire passing axially along said balloon inside the annulus formed by said stent structure but outside said balloon.

29. The catheter system defined in claim 28 wherein said guide wire passes axially along said balloon outside of said sleeve structure, and wherein said stent structure is substantially the sole structure at the location of said balloon for positively maintaining said balloon adjacent to said guide wire.

30. The catheter system defined in claim 28 wherein said guide wire passes axially along said balloon inside said sleeve structure.

31. The catheter system defined in claim 30 wherein, in its initially deflated condition, said balloon is folded laterally on itself in a plurality of folds, between which said guide wire can pass, and wherein said sleeve structure and said stent structure maintain said folds in said balloon until said balloon is inflated.

32. The catheter system defined in claim 28 wherein, in its initially deflated condition, said balloon is folded laterally on itself in a plurality of folds, between which said guide wire can pass, and wherein said sleeve structure and said stent structure maintain said folds in said balloon until said balloon is inflated.

33. The catheter system defined in claim 28 wherein said sleeve structure and said stent structure are circumferentially expandable in response to inflation of said balloon.

34. The catheter system defined in claim 28 wherein said sleeve structure is axially spaced from said stent structure.

35. The catheter system defined in claim 34 wherein said sleeve structure comprises:

a proximal portion which is proximal of a proximal end of said stent structure; and

a distal portion which is distal of a distal end of said stent structure.

36. The catheter system defined in claim 28 wherein said stent structure axially overlaps said sleeve structure.

37. The catheter system defined in claim 36 wherein said stent structure surrounds at least a portion of said sleeve structure.

38. The catheter system defined in claim 28 wherein said balloon has axially opposite proximal and distal ends from which proximal and distal lumens respectively extend, wherein at least one of said lumens has a port in its wall adjacent said balloon for emergence of said guide wire from the at least one lumen in a direction toward said balloon, and wherein said sleeve extends axially from said balloon to a point which is axially beyond said port.

39. A balloon catheter system and guide wire system comprising:

an initially deflated inflatable balloon;

a guide wire passing axially along said balloon without traversing the interior of said balloon; and

an annular stent structure disposed around said balloon and said guide wire at the location of said balloon for keeping said balloon adjacent to said guide wire at the location of the balloon.

40. The system defined in claim 39 wherein said balloon and said stent structure are movable together axially relative to said guide wire.

41. The system defined in claim 39 wherein said guide wire passes between said balloon and said stent structure.

42. The system defined in claim 39 wherein, in its initially deflated condition, said balloon is folded laterally into a plurality of folds, and wherein said guide wire passes along said balloon between said folds.

43. The system defined in claim 42 wherein said stent structure maintains said folds in said balloon until said balloon is inflated.

44. The system defined in claim 42 wherein said balloon is folded so that an axial clearance is left between folds of the balloon, through which clearance said guide wire can pass axially along said balloon and wherein a portion of said balloon is intermediate said guide wire and said stent structure.

45. The system defined in claim 44 wherein said clearance is produced by folding said balloon around a mandrel at the desired location of said clearance, heat setting the folded balloon, and withdrawing said mandrel to leave said clearance.

46. The system defined in claim 45 wherein said balloon has axially opposite proximal and distal ends from which proximal and distal lumens respectively extend, and wherein said mandrel presses radially inwardly on portions of said lumens adjacent to said proximal and distal ends so that heat setting the folded balloon also heat sets the portions of said lumens that are pressed radially inwardly to help promote refolding of the balloon after use of the catheter to implant the stent structure.

47. The system defined in claim 44 wherein said balloon has axially opposite proximal and distal ends, and wherein the catheter further comprises:

a distal guide wire lumen extending distally of said distal end of said balloon for allowing a guide wire portion which is distal of said balloon to pass through said distal guide wire lumen, said distal guide wire lumen having a proximal extension which extends into a distal portion of said clearance.

48. The system defined in claim 47 wherein said extension of said distal guide wire lumen has a proximal end which is distal of a distal end of said stent structure.

49. The system defined in claim 44 wherein said balloon has axially opposite proximal and distal ends, and wherein the catheter further comprises:

a proximal guide wire lumen extending proximally of said proximal end of said balloon for allowing a guide wire portion which is proximal of said balloon to pass through said proximal guide wire lumen, said proximal guide wire lumen having a distal extension which extends into a proximal portion of said clearance.

50. The system defined in claim 49 wherein said extension of said proximal guide wire lumen has a distal end which is proximal of a proximal end of said stent structure.

51. The system defined in claim 39 wherein said stent structure is circumferentially expandable in response to inflation of said balloon.

52. The system defined in claim 39 wherein said balloon has axially opposite proximal and distal ends, and wherein the catheter further comprises:

a distal guide wire lumen extending distally of said distal end of said balloon for allowing a guide wire portion which is distal of said balloon to pass through said distal guide wire lumen.

53. The system defined in claim 39 wherein said balloon has axially opposite proximal and distal ends, and wherein the catheter further comprises:

a proximal guide wire lumen extending proximally of said proximal end of said balloon for allowing a guide wire portion which is proximal of said balloon to pass through said proximal guide wire lumen.

54. The system defined in claim 39 wherein said balloon has axially opposite proximal and distal ends, and wherein the catheter further comprises:

an inflation lumen extending proximally from the proximal end of said balloon, said inflation lumen being in fluid communication with the interior of said balloon for supplying pressurized inflation fluid to said balloon for inflating said balloon.

55. The system defined in claim 54 further comprising:

a proximal guide wire lumen extending along said inflation lumen for allowing a guide wire portion which is proximal of said balloon to pass through said proximal guide wire lumen.

56. The system defined in claim 55 wherein said proximal guide wire lumen extends along only a portion of said inflation lumen that is relatively close to said balloon.

57. The system defined in claim 39 further comprising:

a radio-opaque marker adjacent to said balloon.

58. The system defined in claim 39 wherein said balloon has axially opposite proximal and distal ends, and wherein the catheter further comprises:

a pusher wire attached to said catheter at a location which is adjacent the distal end of said balloon and extending proximally from said location and from the proximal end of said balloon.

59. The system defined in claim 58 wherein said pusher wire is made of nitinol.

60. The system defined in claim 58 wherein said pusher wire has a distal portion which is distal of the distal end of said balloon, said distal portion being formed into an axially extending coil through which a portion of the guide wire distal of said balloon can pass.

61. The system defined in claim 58 wherein said pusher wire passes axially through the interior of said balloon, and wherein said catheter further comprises:

a radio-opaque marker on said pusher wire.

62. The system defined in claim 61 wherein said radio-opaque marker is axially adjacent an axial end of said stent structure.

63. The system defined in claim 62 further comprising:

a second radio-opaque marker on said pusher wire axially adjacent a second axial end of said stent structure.

64. The system defined in claim 39 wherein said balloon and said stent structure are formed to provide a clearance through which said guide wire can pass axially along said balloon inside the annulus formed by said stent structure but outside said balloon and wherein a portion of said balloon is intermediate said guide wire and said stent structure.

65. The system defined in claim 64 wherein said clearance is produced by heat setting said balloon in contact with a mandrel disposed at the desired location of said clearance, and then withdrawing said mandrel to leave said clearance.

66. The system defined in claim 39 wherein said balloon has axially opposite proximal and distal ends from which proximal and distal lumens respectively extend, wherein in its initially deflated condition said balloon is folded laterally on itself in a plurality of folds, and wherein at least one of said lumens has an axially extending valley-like ramp in its wall which forms an axial continuation of a fold in said balloon.

67. The system defined in claim 39 further comprising:

an annular elastic sleeve structure around said balloon for resiliently circumferentially compressing said balloon.

68. The system defined in claim 67 wherein said sleeve structure is axially spaced from said stent structure.

69. The system defined in claim 68 wherein said sleeve structure comprises:

a proximal portion which is proximal of a proximal end of said stent structure; and

a distal portion which is distal of a distal end of said stent structure.

70. The system defined in claim 67 wherein said stent structure surrounds said sleeve structure.

71. The system defined in claim 70 wherein said guide wire passes between said sleeve structure and said stent structure.

72. The system defined in claim 67 wherein said balloon has axially opposite proximal and distal ends from which proximal and distal lumens respectively extend, wherein at least one of said lumens has a port in its wall adjacent said balloon for emergence of said guide wire from said lumen in a direction toward said balloon, and wherein said sleeve extends axially from said balloon to a point which is axially beyond said port.

73. A stent delivery catheter system comprising:

an annular stent structure;

a balloon having an interior, proximal and distal ends, and an initially deflated configuration wherein the balloon is laterally folded in on itself in a plurality of folds, the annular stent structure retaining the balloon in the initially deflated configuration;

a guidewire;

a proximal lumen communicating with the interior of the balloon; and

a guidewire lumen having a distal end disposed proximally of the proximal end of the balloon member, the guidewire disposed for translation through the guidewire lumen so as to exit the distal end of the guidewire lumen and pass between the plurality of folds of the balloon.

74. The delivery catheter system as defined in claim 73 further comprising a distal guide wire lumen disposed from the distal end of the balloon.

75. The delivery catheter system as defined in claim 73 wherein the balloon maintains the initially deflated configuration until said balloon is inflated.

76. A balloon catheter system comprising:

a balloon having an interior, proximal and distal ends, and an initially deflated configuration wherein the balloon is laterally folded in on itself in a plurality of folds;

an elastic annular member disposed around the balloon to retain the balloon in the initially deflated configuration;

a proximal lumen communicating with the interior of the balloon;

a guidewire; and

a guidewire lumen having a distal end disposed proximally of the proximal end of the balloon, the guidewire disposed for translation through the guidewire lumen so as to exit the distal end of the guidewire lumen and pass between the plurality of folds of the balloon.

77. The balloon catheter system as defined in claim 76 further comprising a distal guide wire lumen disposed from the distal end of the balloon.

78. The balloon catheter system as defined in claim 76 wherein the balloon maintains the initially deflated configuration until said balloon is inflated.