Catheter

• US 20030093106A1
• Filed: 06/27/2002
• Published: 05/15/2003
• Est. Priority Date: 06/27/2001
• Status: Active Grant

• Current Assignee: Salviac Ltd. (Abbott Laboratories Incorporated)
• Original Assignee: Salviac Ltd. (Abbott Laboratories Incorporated)
• Inventors: Brady, Eamon, Neilan, John, Vale, David
• Granted Patent: US 7,780,693 B2
• Time in Patent Office: Days
• US Class Current: 606/194
• CPC Class Codes: A61F 2/011 Instruments for their placement or removal
• CPC Class Codes: A61F 2230/0006 circular
• CPC Class Codes: A61F 2230/0008 elliptical or oval
• CPC Class Codes: A61M 2025/0183 Rapid exchange or monorail catheters

Abstract

A delivery catheter 200 for rapid exchange delivery of an embolic protection filter 301 over a guidewire 22, and rapid exchange deployment of the filter 301 at a desired site in a vasculature. The delivery catheter 200 comprises a catheter body 2, a restraining sheath 10 and an elongate pull wire 9. The catheter body 2 comprises a proximal hypotube portion 5 and a radially offset distal spring pusher 6. The restraining sheath 10 is movable in a sliding manner relative to the catheter body 2 upon retraction of the wire 9, and the distal end of the pusher 6 is engageable with the filter 301 in a reception space 11 upon retraction of the sheath 10 to deploy the filter 301 out of the reception space 11. The pusher 6 has a guidewire lumen 16 and a proximal guidewire opening 17 for passage of the guidewire 22 through the lumen 16 and out through the proximal guidewire opening 17 in a rapid exchange manner.

Claims

1. A delivery catheter comprising:

a catheter shaft having a control lumen for an operating element;

a pod defining a reception space for an embolic protection filter, the pod being movable relative to the catheter shaft upon operation of the operating element to facilitate deployment of a filter from within the reception space; and

an engagement element for engaging a filter in the reception space upon movement of the pod relative to the catheter shaft.

2. A catheter as claimed in claim 1 wherein a distal end of the catheter shaft is disconnected from a proximal end of the pod for movement of the pod relative to the catheter shaft.

3. A catheter as claimed in claim 2 wherein the distal end of the catheter shaft is spaced proximally of the proximal end of the pod.

4. A catheter as claimed in claim 3 wherein the catheter comprises a covering sleeve extending between the distal end of the catheter shaft and the proximal end of the pod.

5. A catheter as claimed in claim 4 wherein the covering sleeve is mounted to the catheter shaft.

6. A catheter as claimed in claim 5 wherein the pod is movable relative to the covering sleeve.

7. A catheter as claimed in claim 4 wherein the covering sleeve is mounted to the pod.

8. A catheter as claimed in claim 7 wherein the covering sleeve is movable relative to the catheter shaft.

9. A catheter as claimed in any of claims 1 to 8 wherein the engagement element is attached to the catheter shaft.

10. A catheter as claimed in any of claims 1 to 9 wherein the engagement element extends distally of the catheter shaft.

11. A catheter as claimed in any of claims 1 to 10 wherein the engagement element comprises a pusher.

12. A catheter as claimed in claim 11 wherein the pusher comprises a coiled spring.

13. A catheter as claimed in claim 11 or 12 wherein the pusher is of a high modulus of elasticity polymeric material.

14. A catheter as claimed in any of claims 1 to 13 wherein the engagement element defines a guidewire lumen therethrough.

15. A catheter as claimed in claim 14 wherein the engagement element has a guidewire opening at a proximal end of the guidewire lumen.

16. A catheter as claimed in claim 15 wherein the engagement element is configured for passage of a guidewire from the guidewire lumen through the guidewire opening substantially parallel to the longitudinal axis of the catheter shaft.

17. A catheter as claimed in claim 16 wherein the longitudinal axis of the engagement element is substantially parallel to the longitudinal axis of the catheter shaft at least in the region of the guidewire opening.

18. A catheter as claimed in any of claims 15 to 17 wherein the guidewire opening faces proximally.

19. A catheter as claimed in any of claims 15 to 18 wherein the guidewire opening is located a substantial distance distally of a proximal end of the catheter for rapid exchange of the catheter over a guidewire.

20. A catheter as claimed in any of claims 1 to 19 wherein the cross-sectional area of the operating element is small relative to the cross-sectional area of the catheter shaft along at least part of the length of the operating element.

21. A catheter as claimed in claim 20 wherein the cross-sectional area of the operating element is small relative to the cross-sectional area of the catheter shaft in the region of the guidewire opening.

22. A claim as claimed in claim 21 where in the delivery configuration the cross-sectional area of the operating element is small relative to the cross-sectional area of the catheter shaft for a distance of at least 10 mm proximally of the guidewire opening.

23. A catheter as claimed in claim 22 wherein in the delivery configuration the cross-sectional area of the operating element is small relative to the cross-sectional area of the catheter shaft for a distance of at least 20 mm proximally of the guidewire opening.

24. A catheter as claimed in claim 23 wherein in the delivery configuration the cross-sectional area of the operating element is small relative to the cross sectional area of the catheter shaft for a distance of at least 30 mm proximally of the guidewire opening.

25. A catheter as claimed in claim 24 wherein in the delivery configuration the cross sectional area of the operating element is small relative to the cross-sectional area of the catheter shaft for a distance of at least 40 mm proximally of the guidewire opening.

26. A catheter as claimed in any of claims 1 to 25 wherein the diameter of the operating element is in the range of from 0.008″

to 0.015″

.

27. A catheter as claimed in claim 26 wherein the diameter of the operating element is in the range of from 0.01″

to 0.012″

.

28. A catheter as claimed in any of claims 1 to 27 wherein the operating element comprises a control wire.

29. A catheter as claimed in claim 28 wherein the operating element comprises a pull wire.

30. A catheter as claimed in any of claims 1 to 29 wherein the operating element exits the control lumen at a location distally of the guidewire opening.

31. A catheter as claimed in any of claims 1 to 29 wherein the operating element exits the control lumen at a location proximally of the guidewire opening.

32. A catheter as claimed in any of claims 1 to 29 wherein the operating element exits the control lumen at a location adjacent the guidewire opening.

33. A catheter as claimed in any of claims 1 to 32 wherein the catheter comprises means to guide passage of a guidewire through the guidewire opening.

34. A catheter as claimed in claim 33 wherein the means to guide passage comprises a guide tube.

35. A catheter as claimed in claim 34 wherein the guide tube is located at the guidewire opening.

36. A catheter as claimed in claim 34 or 35 wherein the guide tube is mounted to the engagement element.

37. A catheter as claimed in any of claims 1 to 36 wherein the guidewire lumen of the engagement element is offset radially from the control lumen of the catheter shaft.

38. A catheter as claimed in any of claims 1 to 37 wherein the catheter shaft comprises a mounting piece for attaching the engagement element to the catheter shaft.

39. A catheter as claimed in claim 38 wherein the distal end of the catheter shaft is located distally of the proximal end of the engagement element.

40. A catheter as claimed in claim 39 wherein the mounting piece is more flexible than the catheter shaft and the engagement element.

41. A catheter as claimed in claim 38 or 39 wherein the mounting piece is more stiff than the catheter shaft and the engagement element.

42. A catheter as claimed in any of claims 38 to 41 wherein the mounting piece tapers proximally inwardly.

43. A catheter as claimed in any of claims 38 to 42 wherein the mounting piece tapers distally inwardly.

44. A catheter as claimed in any of claims 38 to 43 wherein the guidewire opening is provided by an opening in the mounting piece.

45. A catheter as claimed in any of claims 1 to 44 wherein the engagement element comprises an engagement surface for engaging a filter in the reception space.

46. A catheter as claimed in claim 45 wherein the engagement surface is provided by a distal end face of the engagement element.

47. A catheter as claimed in claim 45 or 46 wherein the engagement surface extends circumferentially around the engagement element to define an “

O”

-shape.

48. A catheter as claimed in claim 45 or 46 wherein the engagement surface extends partially circumferentially around the engagement element to define an “

U”

-shape.

49. A catheter as claimed in any of claims 45 to 48 wherein the engagement surface is configured to engage a tubular member of a filter.

50. A catheter as claimed in claim 49 wherein the tubular member defines a guidewire lumen therethrough.

51. A catheter as claimed in any of claims 1 to 50 wherein the operating element is attached to the pod.

52. A catheter as claimed in claim 51 wherein the operating element is attached to an exterior surface of the pod.

53. A catheter as claimed in any of claims 1 to 52 wherein the pod comprises a proximal portion and a distal portion, the distal portion defining the reception space.

54. A catheter as claimed in claim 53 wherein the operating element is attached to the proximal portion.

55. A catheter as claimed in claim 53 or 54 wherein the proximal portion and the distal portion are fixed together by means of a marker band.

56. A catheter as claimed in any of claims 1 to 55 wherein the operating element is a control wire.

57. A catheter as claimed in claim 56 wherein the operating element is a pull wire.

58. A catheter as claimed in claim 56 or 57 wherein the operating element comprises a plurality of wires.

59. A catheter as claimed in claim 58 wherein the wires are braided together along at least part of the length of the operating element.

60. A catheter as claimed in any of claims 1 to 59 wherein the stiffness of the catheter shaft decreases distally.

61. A catheter as claimed in claim 60 wherein the stiffness of the catheter shaft decreases from a point proximally of the guidewire opening to a point distally of the guidewire opening.

62. A catheter as claimed in claim 60 or 61 wherein the stiffness decreases in a gradual manner.

63. A catheter as claimed in any of claims 60 to 62 wherein the catheter shaft includes at least one slot in the catheter shaft.

64. A catheter as claimed in claim 63 wherein the slot extends along the catheter shaft in a spiral.

65. A catheter as claimed in claim 64 wherein the pitch of the spiral varies along the catheter shaft.

66. A catheter as claimed in any of claims 1 to 65 wherein the pod is thin-walled.

67. A catheter as claimed in claim 66 wherein the pod has a wall thickness in the range of from 0.0005″

to 0.00075″

.

68. A catheter as claimed in any of claims 1 to 67 wherein the pod is of the material polyethyleneterephthalate or polytetrafluoroethylene.

69. A catheter comprising a proximal shaft portion and a distal shaft portion attached to the proximal shaft portion, and means to stiffen the catheter at the junction between the proximal shaft portion and the distal shaft portion.

70. A catheter as claimed in claim 69 wherein the catheter comprises a mounting piece for attaching the distal shaft portion to the proximal shaft portion.

71. A catheter as claimed in claim 69 or 70 wherein the distal end of the proximal shaft portion is located distally of the proximal end of the distal shaft portion to stiffen the junction.

72. A catheter as claimed in claim 71 wherein the mounting piece is more flexible than the proximal shaft portion and the distal shaft portion.

73. A catheter as claimed in claim 70 or 71 wherein the mounting piece is more stiff than the proximal shaft portion and the distal shaft portion to stiffen the junction.

74. A catheter as claimed in any of claims 69 to 73 wherein the catheter comprises strain relief means.

75. A catheter as claimed in claim 72 wherein the mounting piece tapers distally inwardly.

76. A catheter as claimed in claim 72 or 73 wherein the mounting piece tapers proximally inwardly.

77. A catheter as claimed in any of claims 69 to 75 wherein a guidewire opening is provided in the catheter, the guidewire opening being located a substantial distance distally of a proximal end of the catheter for rapid exchange of the catheter over a guidewire.

78. A catheter as claimed in claim 77 wherein the guidewire opening is provided by an opening in the mounting piece.

79. A catheter as claimed in claim 77 or 78 wherein the guidewire opening faces in a direction substantially parallel to the longitudinal axis of the catheter.

80. A catheter as claimed in any of claims 77 to 79 wherein the catheter comprises means to guide passage of a guidewire through the guidewire opening in the catheter.

81. A catheter as claimed in claim 80 wherein the means to guide passage is provided by the mounting piece.

82. A delivery catheter comprising:

a catheter shaft;

a pod defining a reception space for an embolic protection filter; and

an operating element coupled to the pod;

the pod being movable relative to the catheter shaft upon operation of the operating element to facilitate deployment of a filter from within the reception space;

the operating element being coupled to the exterior surface of the pod.

83. A catheter as claimed in claim 82 wherein the operating element extends internally through a control lumen in the catheter shaft, exits the control lumen and extends externally along the pod.

84. A catheter as claimed in claim 82 or 83 wherein the operating element is fixedly attached to the pod.

85. A catheter as claimed in any of claims 82 to 84 wherein the operating element is a control wire.

86. A catheter as claimed in claim 85 wherein the operating element is a pull wire.

87. A catheter as claimed in any of claims 82 to 86 wherein the pod comprises a proximal portion and a distal portion, the operating element being coupled to the proximal portion.

88. A catheter as claimed in any of claims 82 to 87 wherein a guidewire opening is provided in the catheter located a substantial distance distally of a proximal end of the catheter for rapid exchange of the catheter over a guidewire.

89. A catheter as claimed in any of claims 82 to 88 wherein the catheter comprises an engagement element for engaging a filter in the reception space upon movement of the pod relative to the catheter shaft.

90. A delivery catheter comprising:

a catheter shaft;

a pod defining a reception space for an embolic protection filter, the pod being movable relative to the catheter shaft to facilitate deployment of a filter from within the reception space; and

an engagement element for engaging a filter in the reception space upon movement of the pod relative to the catheter shaft;

the engagement element being offset in the radial direction from the catheter shaft.

91. A catheter as claimed in claim 90 wherein the engagement element is attached to the catheter shaft.

92. A catheter as claimed in claim 90 or 91 wherein the engagement element extends distally of the catheter shaft.

93. A catheter as claimed in any of claims 90 to 92 wherein the distal end of the catheter shaft is located distally of the proximal end of the engagement element.

94. A catheter as claimed in any of claims 90 to 93 wherein the catheter comprises a mounting piece for attaching the engagement element to the catheter shaft.

95. A catheter as claimed in any of claims 90 to 94 wherein the catheter comprises an operating element coupled to the pod for moving the pod relative to the catheter shaft.

96. A catheter as claimed in any of claims 90 to 95 wherein a guidewire opening is provided in the catheter located a substantial distance distally of a proximal end of the catheter for rapid exchange of the catheter over a guidewire.

97. A catheter substantially as hereinbefore described with reference to the accompanying drawings.