Embolic protection system

• US 20030212431A1
• Filed: 05/13/2003
• Published: 11/13/2003
• Est. Priority Date: 05/13/2002
• Status: Active Grant

• Current Assignee: Salviac Ltd. (Abbott Laboratories Incorporated)
• Original Assignee: Salviac Ltd. (Abbott Laboratories Incorporated)
• Inventors: Brady, Eamon, Gilson, Paul, OʼShaughnessy, John, Vale, David, Casey, Brendan, Taylor, Charles, Griffin, Patrick
• Granted Patent: US 8,303,617 B2
• Time in Patent Office: Days
• US Class Current: 606/200
• CPC Class Codes: A61F 2/011 Instruments for their placement or removal
• CPC Class Codes: A61F 2/013 Distal protection devices, i.e. devices placed distally in combination with another endovascular procedure, e.g. angioplasty or stenting
• CPC Class Codes: A61F 2/014 Retrograde blood flow filters, i.e. device inserted against the blood flow direction
• CPC Class Codes: A61F 2/844 folded prior to deployment
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/9522 Means for mounting a stent or stent-graft onto or into a placement instrument
• CPC Class Codes: A61F 2/966 with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
• CPC Class Codes: A61F 2002/018 made from tubes or sheets of material, e.g. by etching or laser-cutting
• CPC Class Codes: A61F 2210/0057 stretchable
• CPC Class Codes: A61F 2230/0006 circular
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0084 cubical
• CPC Class Codes: A61F 2250/0019 differing in hardness, e.g. Vickers, Shore, Brinell

Abstract

A catheter system 1 has an internal reception space for an embolic protection filter 10 to enable the filter 10 to be transported through a vasculature 20 and a treatment means such as a stent 15 to facilitate treatment. The catheter system may, in some configurations be used for retrieval of a filter 10 and stenting of a lesion with a stent 15. The procedure may also involve post dilitation using an on-board balloon 16.

Claims

1. A catheter having an internal reception space for receiving an embolic protection filter for transporting the filter through a vasculature;

and

the catheter comprising a treatment device to facilitate treatment of a site in a vasculature.

2. A catheter as claimed in claim 1 wherein the catheter comprises a delivery catheter.

3. A catheter as claimed in claim 2 wherein the catheter has an outer tubular body and an inner member extending at least partially through the outer body, the inner member being movable distally relative to the outer body to deploy an embolic protection filter from within the reception space.

4. A catheter as claimed in claim 1 wherein the catheter comprises a retrieval catheter.

5. A catheter as claimed in claim 4 wherein the catheter has an outer tubular body and an inner member extending at least partially through the outer body, the inner member being movable proximally relative to the outer body from an introduction configuration to a retrieval configuration to facilitate retrieval of an embolic protection filter into the reception space.

6. A catheter as claimed in claim 5 wherein in the introduction configuration, the inner member protrudes from a distal end of the outer body.

7. A catheter as claimed in claim 5 wherein a distal tip of the inner member tapers distally inwardly.

8. A catheter as claimed in claim 5 wherein a distal tip of the outer body tapers distally inwardly.

9. A catheter as claimed in claim 7 wherein the distal tip is expansible.

10. A catheter as claimed in claim 5 wherein the inner member is at least partially inflatable.

11. A catheter as claimed in claim 10 wherein the inner member comprises a balloon.

12. A catheter as claimed in claim 1 wherein the catheter defines a guidewire lumen extending at least partially therethrough for passing the catheter over a guidewire.

13. A catheter as claimed in claim 12 wherein the guidewire lumen extends only partially through the catheter to facilitate passing the catheter over a guidewire in a rapid exchange manner.

14. A catheter as claimed in claim 3 wherein the means to facilitate treatment is at least partially provided on the inner member.

15. A catheter as claimed in claim 3 wherein in the introduction configuration, the means to facilitate treatment protrudes from a distal end of the outer body.

16. A catheter as claimed in claim 3 wherein the means to facilitate treatment is at least partially provided on the outer tubular body.

17. A catheter as claimed in claim 16 wherein the means to facilitate treatment is provided at a necked down portion of the outer tubular body.

18. A catheter as claimed in claim 16 wherein the catheter comprises a cover around the means to facilitate treatment in the introduction configuration.

19. A catheter as claimed in claim 18 wherein the cover is moveable proximally to uncover the means to facilitate treatment.

20. A catheter as claimed in claim 18 wherein the cover comprises a sheath.

21. A catheter as claimed in claim 20 wherein the sheath extends along the full length of the outer tubular body.

22. A catheter as claimed in claim 20 wherein a distal end of the sheath tapers distally inwardly.

23. A catheter as claimed in claim 3 wherein the outer tubular body extends along substantially the full length of the inner member.

24. A catheter as claimed in claim 3 wherein the outer tubular body extends along part of the inner member.

25. A catheter as claimed in claim 1 wherein the treatment device comprises an angioplasty balloon.

26. A catheter as claimed in claim 1 wherein the treatment device comprises a stent deployment balloon.

27. A catheter as claimed in claim 1 wherein the catheter comprises a sheath movable from a delivery configuration, in which a treatment device is restrainable by the sheath in a collapsed configuration, to a deployment configuration, in which the treatment device is uncovered.

28. A catheter as claimed in claim 27 wherein the treatment device is a self-expanding stent.

29. A catheter as claimed in claim 27 when dependent on claim 3 or 5 wherein the sheath is provided by the outer body.

44. A catheter system as claimed in claim 1 wherein the filter has a carrier with a guide olive mounted at the distal end thereof, the guide olive being configured to engage with the distal end of the catheter section in the collapsed configuration of the filter body to provide a smooth transition between the catheter section and the guidewire tip.

45. A catheter system as claimed in claim 1 wherein the filter has a proximal and a distal end, inlet openings being positioned at the proximal end and outlet holes being positioned at the distal end.

46. A catheter system as claimed in claim 1 wherein the filter element has a proximal and a distal end, inlet openings being positioned at the distal end and outlet holes being positioned at the proximal end.

30. A delivery and deployment catheter system comprising:

—

a filter catheter section;

a filter mounted in the filter catheter section, the filter being movable on release from the filter catheter section from a collapsed delivery configuration to an expanded deployment configuration,

a stent catheter section;

a stent mounted in the stent catheter section, the stent being movable on release from the stent catheter section from a retracted delivery configuration to an expanded deployment configuration; and

having a guidewire lumen for receiving a guidewire through the catheter sections;

the stent catheter section and associated stent being movable along the guidewire independently of the deployed filter for sequential deployment of the filter and stent.

31. A catheter system as claimed in claim 30 including at least one stop for limiting longitudinal movement of the filter and/or the stent relative to the guidewire.

32. A catheter system as claimed in claim 31 wherein the stop is a filter stop for limiting movement of the filter in the proximal direction.

33. A catheter system as claimed in claim 31 wherein the stop is a stent stop for limiting movement of the stent in the proximal direction.

34. A catheter system as claimed in claim 30 wherein the stent catheter section is located proximal to the filter catheter section.

35. A catheter system as claimed in claim 34 wherein an outer sheath comprises the filter catheter section and the stent catheter section.

36. A catheter system as claimed in claim 35 wherein an inner tube extends axially through the outer sheath.

37. A catheter system as claimed in claim 36 wherein the guidewire extends through the inner tube.

38. A catheter system as claimed in claim 36 wherein a distal end of the inner tube provides a proximal stop for the filter.

39. A catheter system as claimed in claim 36 wherein the inner tube has an abutment to provide a proximal stop for the stent.

40. A catheter system as claimed in claim 30 wherein the stent catheter section is located distal to the filter catheter section.

41. A catheter system as claimed in claim 40 wherein the stent catheter section comprises an outer stent retaining sheath for the stent and the filter catheter section comprises an outer filter retaining sheath for the filter.

42. A catheter system as claimed in claim 41 wherein a first ring is mounted on the guidewire intermediate the stent and the filter to provide a proximal stop for the stent.

43. A catheter system as claimed in claim 41 wherein a second ring is mounted on the stent retaining sheath proximal of the filter to provide a proximal stop for the filter.

47. A catheter system as claimed in claim 30 wherein the filter is a self-expanding filter.

48. A catheter system as claimed in claim 30 wherein the stent is a self-expanding stent.

49. A catheter system as claimed in claim 30 wherein the stent is a balloon expandable stent.

50. A catheter system comprising a filter delivery catheter and a treatment device delivery catheter, the filter delivery catheter comprising a filter retaining sheath and a shaft extending from the sheath, the treatment device delivery catheter comprising a treatment device retaining sheath and a shaft extending from the sheath, the treatment device delivery catheter shaft being extendable through the filter delivery catheter.

51. A catheter system as claimed in claim 50 wherein the treatment device is a stent.

52. A method for carrying out a procedure at a treatment site in a vasculature comprising the steps of:

—

providing an embolic protection device;

deploying the embolic protection device distal of the treatment site;

providing a procedural catheter comprising a tubular member having a distal space housing a medical device;

advancing the procedural catheter to the treatment site;

deploying the medical device from the procedural catheter at the treatment site; and

retrieving the embolic protection device into the procedural catheter.

53. A method as claimed in claim 52 wherein

the medical device is a stent;

the procedural catheter is a stent delivery catheter having a distal reception space housing a stent; and

the method comprises deploying the stent from the stent delivery catheter; and

retrieving the embolic protection device at least partially into the reception space in the stent delivery catheter.

54. A method as claimed in claim 53 wherein the stent is a self expanding stent.

55. A method as claimed in claim 53 wherein the stent is a balloon expandable stent.

56. A method as claimed in claim 52 wherein the procedural catheter comprises a balloon catheter and the method comprises deploying the balloon at the treatment site.

57. A method as claimed in claim 56 wherein the balloon is a post dilitation balloon.

58. A method as claimed in claim 56 wherein the balloon is a stent expanding balloon.

59. A method as claimed in claim 52 wherein the embolic protection device is retrieved into the procedural catheter by engaging the embolic protection device.

60. A method as claimed in claim 52 wherein the procedural catheter has an inner member.

61. A method as claimed in claim 60 wherein the inner member is a centering member which projects distally of the distal end of the procedural catheter.

62. A method as claimed in claim 60 wherein the inner member comprises an engagement element for engagement with an embolic protection device.

63. A method as claimed in claim 52 comprising advancing a guidewire through the vasculature so that a distal tip of the guidewire is located distal of the treatment location, and then advancing the catheter over the guidewire.

64. A method as claimed in claim 63 wherein the guidewire has a distal stop and the embolic protection device is retrieved by engaging the distal stop of the guidewire with the embolic protection device.

65. A method for carrying out a procedure at a treatment site in a vasculature comprising the steps of:

—

providing a catheter comprising a tubular member having a distal space, the distal space comprising a first portion and a second portion, the first portion being adjacent to and distal of the second portion;

providing a treatment device loaded into the second portion of the distal space of the catheter;

providing an embolic protection device loaded into the first portion of the distal space of the catheter;

the embolic protection device having a collapsed configuration for transport through the vasculature and an expanded deployed configuration for collecting emboli released during a procedure;

advancing the catheter to a treatment site in the vasculature;

deploying the embolic protection device from the first portion of the distal space in the catheter, the deployed filter taking up an expanded emboli-collecting configuration distal to the treatment location; and

deploying the treatment device from the second portion of the distal space in the catheter to carry out a procedure at the treatment site.

66. A method as claimed in claim 65 comprising retrieving the embolic protection device into the reception space of the catheter after completion of the procedure.

67. A method as claimed in claim 65 comprising advancing a guidewire through the vasculature so that a distal tip of the guidewire is located distal of the treatment location, and then advancing the catheter over the guidewire.

68. A method as claimed in claim 65 wherein the treatment device comprises a balloon.

69. A method as claimed in claim 68 wherein the balloon is an angioplasty balloon.

70. A method as claimed in claim 65 wherein the treatment device comprises a stent.

71. A method as claimed in claim 70 wherein the stent is a self expanding stent.

72. A method as claimed in claim 70 wherein the stent is a balloon expandable stent.

73. A method as claimed in claim 65 wherein the treatment device is mounted on an inner member.

74. A method as claimed in claim 73 comprising engaging the embolic protection device with the inner member to deploy the embolic protection device.

75. A method as claimed in claim 73 wherein the inner member defines a centring member.

76. A method for carrying out a procedure at a treatment site in a vasculature comprising the steps of:

—

providing a catheter system comprising a filter delivery catheter and a treatment device delivery catheter, the filter delivery catheter comprising a filter retaining sheath and a shaft extending from the sheath, the treatment device delivery catheter comprising a treatment device retaining sheath and a shaft extending from the sheath, the treatment device delivery catheter shaft extending through the filter delivery catheter sheath and shaft;

providing a treatment device loaded into the treatment device delivery sheath;

providing an embolic protection device loaded into the filter sheath, the embolic protection device having a collapsed configuration for transport through the vasculature and an expanded deployed configuration for collecting emboli released curing a procedure;

advancing the catheter system to a treatment site in the vasculature;

deploying the embolic protection device from the filter sheath, the deployed filter taking up an expanded emboli-collecting configuration; and

deploying the treatment device from the sheath of the treatment device delivery catheter.

77. A method as claimed in claim 76 comprising retrieving the embolic protection device into the reception space of the catheter after completion of the procedure.

78. A method as claimed in claim 76 comprising advancing a guidewire through the vasculature so that a distal tip of the guidewire is located distal of the treatment location, and then advancing the catheter over the guidewire.

79. A method as claimed in claim 76 wherein the treatment device comprises a balloon.

80. A method as claimed in claim 79 wherein the balloon is an angioplasty balloon.

81. A method as claimed in claim 76 wherein the treatment device comprises a stent.

82. A method as claimed in claim 81 wherein the stent is a self expanding stent.

83. A method as claimed in claim 81 wherein the stent is a balloon expandable stent.

84. A method as claimed in claim 76 wherein the treatment device is mounted on an inner member.

85. A method as claimed in claim 84 comprising engaging the embolic protection device with the inner member to deploy the embolic protection device.