Rapid exchange catheters usable with embolic protection devices

• US 20030233117A1
• Filed: 06/14/2002
• Published: 12/18/2003
• Est. Priority Date: 06/14/2002
• Status: Active Grant

• Current Assignee: Covidien LP (Medtronic Plc)
• Original Assignee: ev3, Inc. (Medtronic Plc)
• Inventors: von Lehe, Cathleen M., Berrada, Marwane, Kusleika, Richard S., Adams, Daniel O.
• Granted Patent: US 7,717,934 B2
• Time in Patent Office: Days
• US Class Current: 606/200
• CPC Class Codes: A61F 2/01 Filters implantable into blood vessels
• CPC Class Codes: A61F 2/011 Instruments for their placement or removal
• CPC Class Codes: A61F 2002/018 made from tubes or sheets of material, e.g. by etching or laser-cutting
• CPC Class Codes: A61F 2230/0008 elliptical or oval
• CPC Class Codes: A61F 2230/008 paraboloidal

Abstract

Catheters, assemblies, and methods for delivering and recovering embolic protection devices. Catheters are provided that can be advanced over single length guide wires and which can be retracted over single length wire shafts of distal embolic protection devices. One catheter is a two-port catheter having two sidewall ports, a distal end port, and a proximal end port. The two-port catheter can be advanced over a guide wire threaded between the distal end port and the distal sidewall port. An embolic protection device wire shaft can be back loaded into the distal end port and out the proximal sidewall port. A three-port catheter includes a distal end port, and distal, intermediate, and proximal sidewall ports. The distal sidewall port can be dimensioned to accept passage of a filter body through the port. The distal end port can be dimensioned to accept only a guide wire to provide a smooth transition from the guide wire to the small profile distal end. The guide wire can extend between the distal end port and the intermediate port while the filter body shaft can extend through the proximal port, to be distally urged through the distal sidewall port. Another catheter embodiment is a slotted catheter, including a biased, normally open slot over most of its length. The slot can be sufficiently small to resist unwanted transverse movement of a wire through the slot. The slotted catheter can be retracted over a wire by forcing the wire through the resilient slot.

Claims

1. A catheter for delivering a distal embolic protection device having a shaft coupled to a distal emboli protection element selected from the group consisting of emboli filters and occlusive elements, the catheter comprising:

an elongate tubular body having a distal region, a distal tip, a proximal region, a lumen extending through the elongate tubular body distal region, and a tube wall disposed about the lumen;

a distal port dimensioned to receive a guide wire therethrough, the distal port being formed through the tube wall;

a proximal port adapted to receive the distal embolic protection device shaft, the proximal port being formed through the tube wall; and

a distal most port disposed in the catheter distal tip dimensioned to receive a guide wire and the distal protection element therethrough.

2. A catheter as in claim 1, wherein the distal port is disposed between about 5 and 30 centimeters from the catheter distal tip.

3. A catheter as in claim 1, wherein the proximal port is disposed between about 15 and 50 centimeters from the catheter distal tip.

4. A catheter as in claim 1, wherein the proximal port is disposed between about 5 and 20 centimeters proximal of the distal port.

5. A catheter as in claim 1, wherein the catheter further comprises a collapsible tube having a proximal end, a distal end, and a lumen therethrough, wherein the proximal end is secured near the catheter distal port, and is in fluid communication with the catheter distal port, and wherein the collapsible tube distal end is disposed near the catheter distal tip, such that a guide wire passed through the catheter distal port extends distally through the collapsible tube and past the catheter distal tip, and wherein the collapsible tube is sufficiently radially pliant so as to be substantially radially collapsed when approached by a distally advancing object pressing against the collapsible tube.

6. A catheter as in claim 5, wherein the collapsible tube is bonded to the catheter tube inner wall over at least about one-tenth of its circumference.

7. A catheter as in claim 1, further comprising a flap having a first region bonded proximal of and near to the distal port and having a second region opposite the first region, wherein the second region is sufficiently pliant so as to allow a distally advancing object to urge the flap aside and allow distal passage of the object distally past the flap second region, and wherein the flap is configured to urge a proximally traveling shaft abutting the flap to distally exit through the distal port.

8. A catheter as in claim 1, wherein the distal port has a maximum dimension of less than about 0.040 inch.

9. A catheter as in claim 1, wherein the distal port has a maximum dimension of less than about 0.020 inch.

10. A catheter as in claim 1, wherein the distal port has a distally and inwardly slanted proximal side wall slanted at an angle of less than about 10 degrees from the catheter longitudinal axis.

11. A catheter as in claim 1, wherein the distal port has a distally and inwardly slanted proximal side wall slanted at an angle of less than about 5 degrees from the catheter longitudinal axis.

12. A catheter as in claim 1, wherein the distal port is adapted to receive a guide wire extending distally and inwardly into the catheter lumen at an angle of less than about 10 degrees from the catheter sidewall and has a maximum dimension of less than about 0.040 inch.

13. A catheter as in claim 1, wherein the catheter has an outer diameter of less than about 0.040 inch.

14. A catheter for delivering a distal embolic protection device having a shaft coupled to a distal emboli protection element selected from the group consisting of emboli filters and occlusive elements, the catheter comprising:

an elongate shaft having a proximal region, a distal region, and a tubular body disposed over at least part of the shaft distal region, wherein the tubular body has a distal end having a distal end port, a distal sidewall port disposed through the tubular body sidewall and a proximal sidewall port disposed through the tubular body sidewall proximal of the distal port, wherein the tubular body has a lumen therethrough, extending between the distal end port, the distal sidewall port, and the proximal sidewall port.

15. A catheter as in claim 14, wherein the lumen further extends through the tubular body proximal region to exit at a tubular body proximal most port.

16. A catheter as in claim 14, wherein the distal sidewall port is adapted to receive a guide wire therethrough.

17. An assembly for delivering a distal embolic protection device, the assembly comprising:

a distal embolic protection device comprising an elongate shaft having a distal region and a proximal region, a distal emboli protection element disposed near the distal embolic protection device shaft distal region;

a guide wire having an elongate shaft including a distal region and a proximal region; and

an elongate catheter having a sidewall, a lumen extending therethrough, a distal tip having a distal end port, a distal port disposed through the catheter sidewall and in communication with the catheter lumen, and a proximal port disposed through the catheter sidewall and in communication with the catheter lumen, wherein the catheter distal end port is dimensioned to receive the guide wire and the distal protection element, wherein the catheter distal port is dimensioned to receive the guide wire, and wherein the catheter proximal port is dimensioned to receive the distal embolic protection device elongate shaft.

18. An assembly as in claim 17, wherein the catheter distal port is dimensioned and shaped to receive the guide wire at a distally and inwardly extending angle of less than about 10 degrees to the catheter wall.

19. An assembly as in claim 17, wherein the catheter distal port has a maximum dimension of less than about 0.040 inch.

20. An assembly as in claim 17, wherein the catheter has an outer diameter of less than about 0.040 inch.

21. An assembly as in claim 17, further comprising a tubular guide catheter dimensioned to slidably receive the catheter therethrough.

22. An assembly as in claim 17, wherein the distal embolic protection element includes an emboli filter.

23. An assembly as in claim 17, wherein the distal embolic protection element includes an occlusive element.

24. A method for positioning a distal embolic protection device within a patient'"'"'s blood vessel, the method comprising:

providing a guide wire;

providing a distal embolic protection device including an elongate shaft having a proximal region, a distal region, and a filter secured to the shaft distal region;

providing a catheter having a distal region, a proximal region, and a lumen disposed within a tubular sidewall through the distal region, wherein the distal region includes a distal end port, a distal sidewall port, and a proximal sidewall port;

disposing the distal embolic protection element within the catheter such that the distal embolic protection device shaft extends outwardly through the proximal sidewall port;

advancing the guide wire to a target site to be filtered or protected;

advancing the catheter over the guide wire by inserting the guide wire through the catheter lumen between the distal end port and the distal sidewall port;

proximally retracting the guide wire such that the guide wire distal region exits proximally from the catheter lumen through the catheter distal port;

advancing the distal embolic protection device filter distally from the catheter distal end port; and

proximally retracting the catheter from the distal embolic protection shaft such that the distal embolic protection shaft proximal end is drawn into the catheter distal region and exits the catheter distal end port.

25. A method as in claim 24, wherein the catheter and distal embolic protection device are advanced together to the target region.

26. A method as in claim 24, wherein the guide wire is advanced distally to the target region, followed by advancing the catheter over the guide wire to the target region.

27. A method as in claim 24, wherein the catheter is advanced distally across a lesion while carrying the distal embolic protection device filter within, such that the distal embolic protection device filter and catheter are advanced together across the lesion.

28. A method as in claim 24, wherein the catheter is advanced distally to the target site, followed by distally advancing the distal embolic protection device through the catheter lumen until the distal embolic protection device filter distally exits the catheter distal end port to reach the target site.

29. A catheter for delivering a distal embolic protection device having an elongate shaft including a distal region and a proximal region, the distal embolic protection device having a distal filter disposed near and secured to the distal embolic protection device shaft distal region, the catheter comprising:

an elongate body having a distal region, a proximal region, a lumen having a sidewall in the distal region, a distal end port for receiving a guide wire, a proximal port disposed through the catheter sidewall and in communication with the catheter lumen for receiving the distal embolic protection device shaft, and an intermediate port disposed through the catheter tube sidewall dimensioned to receive the guide wire, and a distal port disposed through the catheter tube sidewall, wherein the distal port is dimensioned to receive the distal embolic protection device filter therethrough.

30. A catheter as in claim 29, wherein the proximal port is disposed between about 15 and 50 centimeters from the catheter distal tip.

31. A catheter as in claim 29, wherein the distal port is disposed between about 2 and 50 millimeters from the catheter distal end.

32. A catheter as in claim 29, wherein the intermediate port is disposed between about 5 and 30 centimeters proximal of the catheter distal end.

33. A catheter as in claim 29, wherein the distal port is dimensioned to receive the distal embolic protection device filter therethrough when the filter is in a collapsed state, and wherein the distal port has an elongate shape.

34. A catheter as in claim 33, wherein the catheter distal port includes a tapered distal end wall portion curved away from the catheter sidewall and the distal port is formed in the catheter distal end wall.

35. A catheter as in claim 29, wherein the distal port has an elongate, slit, normally closed shape.

36. A catheter as in claim 29, wherein the catheter distal port includes a region of preferential tearing such that a filter pressed against the catheter preferential tearing region will distally extend through the torn region to form the distal port.

37. A catheter as in claim 29, wherein the intermediate port has a maximum transverse dimension of less than about 0.040 inch.

38. A catheter as in claim 29, wherein the intermediate port has a maximum transverse dimension of less than about 0.020 inch.

39. A catheter as in claim 29, wherein the intermediate port has a distally and inwardly slanted proximal side wall slanted at an angle of less than about 10 degrees from the catheter longitudinal axis.

40. A catheter as in claim 29, wherein the intermediate port has a distally and inwardly slanted proximal side wall slanted at an angle of less than about 5 degrees from the catheter longitudinal axis.

41. A catheter as in claim 29, wherein the intermediate port is adapted to receive a guide wire extending distally and inwardly into the catheter lumen at an angle of less than about 10 degrees from the catheter sidewall and has a maximum transverse dimension of less than about 0.040 inch.

42. A catheter as in claim 29, wherein the catheter has an outer diameter of less than about 0.040 inch.

43. An assembly for delivering a distal embolic protection device, the assembly comprising:

a distal embolic protection device comprising an elongate shaft having a distal region and a proximal region, a distal embolic protection element disposed near the distal embolic protection device shaft distal region;

a guide wire having an elongate shaft including a distal region and a proximal region; and

an elongate catheter shaft having a distal region, a proximal region, a lumen disposed within a tubular sidewall in the distal region, a distal end port for receiving a guide wire, a proximal port disposed through the catheter sidewall and in communication with the catheter lumen for receiving the distal embolic protection device shaft, and an intermediate port disposed through the catheter tube sidewall dimensioned to receive the guide wire, and a distal port disposed through the delivery catheter sidewall, wherein the distal port is dimensioned to receive the distal embolic protection device element therethrough.

44. An assembly as in claim 43, wherein the catheter intermediate port is dimensioned and shaped to receive the guide wire at a distally and inwardly extending angle of less than about 10 degrees to the catheter wall.

45. An assembly as in claim 43, wherein the catheter intermediate port has a maximum transverse dimension of less than about 0.040 inch.

46. An assembly as in claim 43, wherein the catheter has an outer diameter of less than about 0.040 inch.

47. An assembly as in claim 43, further comprising a tubular guide catheter dimensioned to slidably receive the catheter therethrough.

48. An assembly as in claim 43, wherein the distal embolic protection element includes an emboli filter.

49. An assembly as in claim 43, wherein the distal embolic protection element includes an occlusive element.

50. A method for advancing a distal embolic protection device into the vasculature of a patient to a target site, the distal embolic protection device having a shaft having a proximal region and a distal region, the shaft distal region being coupled to a emboli protection element selected from the group consisting of emboli filters and occlusive elements, the method comprising:

providing a guide wire;

providing a catheter having a distal region, a proximal region, and a lumen extending within a tubular sidewall through the distal region, wherein the distal region includes a distal end port, a distal sidewall port, a proximal sidewall port, and an intermediate sidewall port disposed between the distal and proximal sidewall ports, wherein the lumen terminates in a proximal end port,

advancing the guide wire through the vasculature to near the target site;

disposing the distal embolic protection device filter within the catheter lumen and disposing the distal embolic protection device shaft outwardly through the proximal port to extend outside of the catheter body;

disposing the guide wire distal end within the catheter lumen with the guide wire extending outwardly through the intermediate sidewall port and extending the guide wire shaft proximal region external to the catheter;

advancing the catheter and distal embolic protection device over the guide wire to the target site within the vasculature;

retracting the guide wire proximally from the catheter lumen, causing the guide wire distal region to be pulled proximally through the intermediate port;

forcing the distal embolic protection device distal element through the distal sidewall port and into the vasculature; and

proximally retracting the catheter from the vasculature while maintaining the distal embolic protection device shaft in a substantially constant position.

51. A method as in claim 50, further comprising:

proximally retracting the catheter over the distal embolic protection device elongate shaft until the elongate shaft is visible past the catheter distal end; and

grasping the distal embolic protection device elongate shaft distal of the catheter distal end and fully proximally retracting the catheter from the distal embolic protection device elongate shaft.

52. A method as in claim 50, wherein the distal embolic protection device and the catheter are advanced together to the target region.

53. A catheter for delivering a distal embolic protection device having an elongate shaft including a distal region, a proximal region, and an embolic protection element selected from the group consisting of emboli filters and occlusive elements disposed near the elongate shaft distal region, the catheter comprising:

an elongate tubular body having a tube side wall, a proximal port, and a lumen therethrough; and

a slot extending longitudinally along the tubular sidewall and through the sidewall to the lumen, wherein the slot has an unconstrained open width of between about 0.001 inch and 0.032 inch.

54. A catheter as in claim 53, wherein the slot has an unconstrained open width of between about 0.001 inch and 0.010 inch.

55. A catheter as in claim 53, wherein the catheter has a distal unslotted region having a length of at least about 2 centimeters.

56. A catheter as in claim 53, wherein the catheter distal region has a widened, open region disposed in the catheter distal region forming a distal sidewall port for receiving a guide wire therethrough.

57. A catheter as in claim 53, further comprising a proximal handle, wherein the proximal handle is longitudinally offset to allow unimpeded longitudinal access to the catheter proximal port.

58. A catheter as in claim 53, wherein the distal end port is at least about 0.010 inch in diameter.

59. An assembly for delivering a distal embolic protection device, the assembly comprising:

a distal embolic protection device comprising an elongate shaft having a distal region and a proximal region, an emboli filter body disposed near the distal embolic protection device shaft distal region;

a guide wire having an elongate shaft including a distal region and a proximal region; and

a catheter comprising an elongate tubular body having a tube side wall, a proximal port, and a lumen therethrough and a slot extending longitudinally along the tubular sidewall and through the sidewall to the lumen, wherein the slot has an unconstrained open width of between about 0.001 inch and 0.032 inch.

60. An assembly as in claim 59, wherein the catheter has an outer diameter of less than about 0.040 inch.

61. An assembly as in claim 59, further comprising a tubular guide catheter dimensioned to sidably receive the catheter therethrough.

62. A method for delivering a distal embolic protection device to a target region within a patient'"'"'s vasculature, wherein the distal embolic protection device includes a shaft having a proximal region and a distal region and having a filter secured to the distal region, the method comprising:

providing a guide wire;

providing a catheter having a proximal region, a distal region, a distal end, a lumen disposed within a tubular wall, a normally open slot extending through the tubular wall to the lumen over a majority of the catheter length, the catheter having a distal sidewall port disposed in the slot in the distal region, and a distal end port disposed in the distal end and in communication with the lumen;

distally advancing the guide wire to near the target region;

distally advancing the catheter and distal embolic protection device to the target region over the guide wire;

proximally retracting the guide wire from the target region and from the catheter;

proximally retracting the catheter over the distal embolic protection device elongate shaft by forcing the distal embolic protection device shaft through the catheter slot; and

proximally retracting the catheter from the patient while maintaining the distal embolic protection device elongate shaft position.

63. A method as in claim 62, further comprising proximally retracting the catheter while forcing the distal embolic protection device elongate shaft through progressively more distal regions of the slot until the catheter distal end is retracted from the patient'"'"'s body, and grasping the distal embolic protection device elongate shaft distal of the catheter distal end;

and

fully retracting the catheter off of the distal embolic protection device elongate shaft.

64. A method for positioning a distal embolic protection device within a patient'"'"'s blood vessel, the method comprising:

providing a guide wire;

providing a distal embolic protection device including an elongate shaft having a proximal region, a distal region, and a filter secured to the shaft distal region;

providing a catheter having a distal region, a proximal region, and a lumen disposed within a tubular sidewall through the distal region, wherein the distal region includes a distal end port, a distal sidewall port, and a proximal sidewall port;

disposing the distal embolic protection element within the catheter such that the distal embolic protection device shaft extends outwardly through the proximal sidewall port;

advancing the guide wire to a target site to be filtered or protected;

advancing the catheter over the guide wire by inserting the guide wire through the catheter lumen between the distal end port and the distal sidewall port;

proximally retracting the guide wire such that the guide wire distal region exits proximally from the catheter lumen through the catheter distal sidewall port;

advancing the distal embolic protection device filter distally from the catheter distal end port;

at least partially retracting the distal embolic protection device filter into the catheter distal end port; and

proximally retracting the catheter and the distal embolic protection device from the patient.

65. A method for advancing a distal embolic protection device into the vasculature of a patient to a target site, the distal embolic protection device having a shaft having a proximal region and a distal region, the shaft distal region being coupled to a embolic protection element selected from the group consisting of emboli filters and occlusive elements, the method comprising:

providing a guide wire;

providing a catheter having a distal region, a proximal region, and a lumen extending within a tubular sidewall through the distal region, wherein the distal region includes a distal end port, a distal sidewall port, a proximal sidewall port, and an intermediate sidewall port disposed between the distal and proximal sidewall ports, wherein the lumen terminates in a proximal end port,

advancing the guide wire through the vasculature to near the target site;

disposing the distal embolic protection device filter within the catheter lumen and disposing the distal embolic protection device shaft outwardly through the proximal port to extend outside of the catheter body;

disposing the guide wire distal end within the catheter lumen with the guide wire extending outwardly through the intermediate sidewall port and extending the guide wire shaft proximal region external to the catheter;

advancing the catheter and distal embolic protection device over the guide wire to the target site within the vasculature;

retracting the guide wire proximally from the catheter lumen, causing the guide wire distal region to be pulled proximally through the intermediate port;

forcing the distal embolic protection device distal element through the distal sidewall port and into the vasculature;

at least partially retracting the distal embolic protection device into the catheter; and

proximally retracting the catheter and the distal embolic protection device from the vasculature.

66. A method for delivering a distal embolic protection device to a target region within a patient'"'"'s vasculature, wherein the distal embolic protection device includes a shaft having a proximal region and a distal region and having a filter secured to the distal region, the method comprising:

providing a guide wire;

providing a catheter having a proximal region, a distal region, a distal end, a lumen disposed within a tubular wall, a normally open slot extending through the tubular wall to the lumen over a majority of the catheter length, the catheter having a distal sidewall port disposed in the slot in the distal region, and a distal end port disposed in the distal end and in communication with the lumen;

distally advancing the guide wire to near the target region;

disposing the distal embolic protection device within the catheter lumen;

distally advancing the catheter and distal embolic protection device over the guide wire to the target region;

proximally retracting the guide wire from the target region and from the catheter;

urging the distal embolic protection device filter out of the catheter distal end port;

at least partially retracting the distal embolic protection device distal element into the catheter distal end port; and

proximally retracting the catheter and the distal embolic protection device elongate shaft.

67. A catheter for delivering a distal embolic protection device having a shaft coupled to a distal emboli protection element selected from the group consisting of emboli filters and occlusive elements, the catheter comprising:

an elongate shaft body having a distal region, a distal tip, a proximal region, a lumen extending through the elongate shaft body distal region, and having a tube wall disposed about the lumen;

a first port dimensioned to receive a guide wire therethrough, the first port being formed through the tube wall; and

a distal most port disposed in the catheter distal tip in fluid communication with the first port and dimensioned to receive a guide wire therethrough.

68. A catheter as in claim 67, wherein the first port is disposed within about 30 centimeters from the catheter distal tip.

69. A catheter as in claim 67, wherein the first port has a maximum transverse dimension of less than about 0.040 inch.

70. A catheter as in claim 67, wherein the first port has a distally and inwardly slanted proximal side wall slanted at an angle of less than about 10 degrees from the catheter longitudinal axis.

71. A catheter as in claim 67, wherein the first port is adapted to receive a guide wire extending distally and inwardly into the catheter lumen at an angle of less than about 10 degrees from the catheter sidewall and has a maximum dimension of less than about 0.040 inch.

72. A catheter as in claim 67, further comprising a second port adapted to receive the distal embolic protection device shaft, the second port being formed through the tube wall.

73. A catheter as in claim 72, further comprising a third port disposed through the catheter sidewall and in communication with the catheter lumen for receiving the distal emboli protection element.

74. A catheter as in claim 67, wherein the proximal shaft comprises a tube having a proximal lumen and proximal sidewall over a majority of its length, further comprising:

a slot extending longitudinally along the proximal tubular sidewall and through the sidewall to the proximal lumen, wherein the slot has an unconstrained open width of between about 0.001 inch and 0.032 inch, wherein the slot is contiguous with the first port.

75. An assembly for delivering a distal embolic protection device, the assembly comprising:

a catheter comprising an elongate shaft body having a distal region, a distal tip, a proximal region, a lumen extending through the elongate shaft body distal region, and having a tube wall disposed about the lumen;

a first port dimensioned to receive a guide wire therethrough, the first port being formed through the tube wall;

a distal most port disposed in the catheter distal tip in fluid communication with the first port and dimensioned to receive a guide wire therethrough; and

a distal embolic protection device comprising an elongate shaft having a distal region and a proximal region, an emboli filter body disposed near the distal embolic protection device shaft distal region, wherein the emboli filter body is dimensioned to be disposed within the catheter distal region lumen.

76. An assembly as in claim 75, further comprising a second port formed through the tube wall dimensioned to accept passage of the distal embolic protection device shaft therethrough.

77. An assembly as in claim 76, further comprising a third port disposed through the catheter sidewall and in communication with the catheter lumen for receiving the distal emboli protection element.

78. An assembly as in claim 75, wherein the proximal shaft comprises a tube having a proximal lumen and proximal sidewall over a majority of its length, the assembly further comprising:

a slot extending longitudinally along the proximal tubular sidewall and through the sidewall to the proximal lumen, wherein the slot has an unconstrained open width of between about 0.001 inch and 0.032 inch, wherein the slot is contiguous with the first port.

79. A method for advancing a distal embolic protection device into the vasculature of a patient to a target site, the distal embolic protection device having a shaft having a proximal region and a distal region, the shaft distal region being coupled to an emboli protection element selected from the group consisting of emboli filters and occlusive elements, the vasculature having a guidewire disposed within and including an externally accessible proximal guide wire portion, the method comprising:

providing a catheter comprising an elongate shaft body having a distal region, a distal tip, a proximal region, a lumen extending through the elongate shaft body distal region, and having a tube wall disposed about the lumen;

a first port dimensioned to receive a guide wire therethrough, the first port being formed through the tube wall;

a distal most port disposed in the catheter distal tip in fluid communication with the first port and dimensioned to receive a guide wire therethrough;

wherein the emboli protection element is disposed within the catheter distal region lumen and the distal embolic protection device shaft extends along the length of the catheter;

inserting the proximal guide wire portion into the catheter distal most port, through the lumen, and exiting the lumen through the catheter first port; and

advancing the catheter over the guide wire through the vasculature.

80. A method as in claim 79, further comprising retracting the guide wire from the catheter after the advancing step.

81. A method as in claim 79, further comprising urging the emboli protection element to exit from the catheter lumen.

82. A method as in claim 81, the catheter further comprising a second port formed through the tube wall and having the distal embolic protection device shaft extending therethrough, the method further comprising retracting the catheter from the vasculature while substantially maintaining the position of the distal embolic protection device shaft.