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1. (WO1997018006) FLOW DIRECTED PLACEMENT OF AN INTRALUMINAL GUIDEWIRE
Note: Text based on automatic Optical Character Recognition processes. Please use the PDF version for legal matters

CLAIMS:
1. A longitudinal member that can be positioned in a blood vessel having at or adjacent a free end an inflatable or otherwise expandable flow impedance device that may be actuated externally of the lumen of the blood vessel into which that free end has been positioned and which is of such a size and shape that the flow impedance device will cause the longitudinal member lo be drawn downstream through the vessel by blood flow
therethrough.
2. The longitudinal member of claim 1 wherein the flow impedance device comprises a balloon that may be inflated to a size so that it will be guided by the blood flow without being large enough to catch between the walls of the vessel through wliich it is passing.
3. The longitudinal member of claim 1 wherein the flow impedance device has the form of a small umbrella which may be at least partially opened to catch the flow of blood through the vessel and be guided and/or carried by that flow.
4. The longitudinal member of claim 1 wherein the inflatable or otherwise expandable flow impedance device is further expandable so that it can engage with the wall of the vessel and hold the longitudinal member at a desired position.
5. The longitudinal member of claim 2 wherein the balloon may be expanded by a fluid directed down a lumen in the longitudinal member.

6. The longitudinal member of claim 5 wherein the fluid is isotonic saline.
7. The longitudinal member of claim 5 wherein the fluid is a gas.
8. The longitudinal member of claim 3 wherein the umbrella is opened by actuation of a fine wire extending down a lumen in the longitudinal member.
9. The longitudinal member of claim 1 wherein the expansion of the flow impedance device is effected extracorporeally.
10. The longitudinal member of claim 1 wherein the width of the flow impedance device on expansion is between 1 and lϋmm.
11. The longitudinal member of claim 1 wherein the longitudinal member is a catheter or guidewire.
12. An assembly comprising a catheter and guidewire that can be positioned in a blood vessel, the guidewire having at or adjacent its free end an inflatable or otherwise expandable flow impedance device that may be actuated externally of the lumen of the blood vessel into which the free end has been positioned and which is of such a size and shape that the flow impedance device will cause the guidewire to be drawn downstream through the vessel by blood flow therethrough.
13. The assembly of claim 12 wherein the flow impedance device comprises a balloon that may be inflated to a size so that it will be guided by the blood flow without being large enough to catch between the walls of the vessel through which it is passing.
14. The assembly of claim 12 wherein the flow impedance device has the form of a small umbrella which may be at least partially opened to catch the flow of blood through the vessel and be guided and/or carried by that flow. 15. The assembly of claim 12 wherein the catheter has at or adjacent its free end an inflatable or otherwise expandable flow impedance device.
16. The assembly of claim 15 wherein the inflatable or otherwise expandable flow impedance device on the catheter is expandable so that it can engage with the wall of the vessel and hold the catheter at a desired position.
17. The assembly of claim 13 wherein the balloon may be expanded by a fluid directed down a lumen in the catheter.
18. The assembly of claim 14 wherein the umbrella is opened by actuation of a fine wire extending down a lumen in the catheter.
19. The assembly of claim 12 wherein the expansion of the flow impedance device is effected extracorporeally.
20. The assembly of claim 12 wherein the width of the flow impedance device on expansion is between 1 and 10mm.
21. The assembly of claim 12 wherein the inflatable or otherwise expandable flow impedance device at or adjacent the free end of the guidewire is replaced by a solid bead.
22. The assembly of claim 21 wherein the bead may comprise a bead of epoxy resin or titanium attached to the guidewire.
23. A delivery catheter for placement in a blood vessel comprising:
(a) an elongate catheter having a first end and a second end;
(b) an intraluminal graft having a body disposed about the elongate catheter, the body having at a first end, disposed adjacent lo the first end of the elongate catheter, a tubular portion, and at a second end a bifurcation into first and second tubular graft extensions, the
elongate catheter extending up the first tubular graft extension and
into the tubular portion; and
(c) a supplementary guidewire extending in a first direction
through the first tubular graft extension and projecting in a second
different direction into the second of the tubular graft extensions, the guidewire having at or adjacent its free end an inflatable or otherwise expandable flow impedance device that may be actuated externally of the lumen of the blood vessel into which the free end has been
positioned and which is of such a size and shape that the flow
impedance device will cause the guidewire to be drawn downstream
through the vessel by blood flow therethrough.
24. The delivery catheter of claim 23 wherein the supplementary guidewire extends through a channel in the graft body.
25. The delivery catheter of claim 23 wherein a supplementary catheter extends in the first direction through the first tubular graft extension and in the second direction into the second tubular graft extension, the
supplementary catheter containing the supplementary guidewire.
26. The delivery catheter of claim 23 wherein the elongate catheter has an inflatable balloon at or adjacent one end and the intraluminal graft is disposed about the balloon.
27. The delivery catheter of claim 23 wherein a portion of the
intraluminal graft proximate the first end is self-expandable.
28. The delivery catheter of claim 23 wherein each of the tubular graft extensions are adapted to engage with a further tubular intraluminal graft.

29. The delivery catheter of claim 23 wherein one of the tubular graft extensions is of a greater length than the other tubular graft extension.
30. The delivery catheter of claim 23 wherein the supplementary guidewire is relatively thin and kink resistant.
31. The delivery catheter of claim 25 wherein the supplementary catheter is a 3 French catheter.
32. The delivery catheter of claim 25 wherein the supplementary catheter extends in the first direction through the first tubular graft extension and in the second different direction into and through the second tubular graft extension.

33. The delivery catheter of claim 25 wherein the supplementary catheter is linked for part of its length to the balloon catheter.
34. The delivery catheter of claim 25 wherein a portion of the
supplementary catheter is connected to a portion of the intraluminal graft. 35. The delivery catheter of claim 25 wherein the supplementary catheter is incorporated into a channel in the body of the graft.
36. The delivery catheter of claim 23 wherein the graft body is
circumferentially reinforced proximate its first end by a plurality of separate, spaced-apart malleable wires, each of which has a generally closed sinusoidal shape, a first wire being located adjacent to the first end such that alternate crests or apices of the first wire projects beyond at least part of the first end.

37. The delivery catheter of claim 36 wherein the first wire has a greater amplitude than the next adjacent wire, and preferably the next two adjacent wires.
38. The delivery catheter of claim 36 wherein wires adjacent the first end of the graft are more closely spaced than wires distal the first end.
39. The delivery catheter of claim 36 wherein the wires are interwoven with the graft body.
40. The delivery catheter of claim 39 wherein the ends of each wire are twisted together on the outside of the graft body.
41. The delivery catheter of claim 36 wherein the graft body is fabricated from polyester, polytetrafluoroethylene, polyurethane or a composite thereof.

42. The delivery catheter of claim 23 wherein the tubular graft body is circumferentially supported along its length by a plurality of separate, spaced-apart wires, with a first wire being located adjacent the first end of the graft body such that portions of the first wire project beyond at least part of the first end.
43. The delivery catheter of claim 42 wherein each wire has a closed substantially sinusoidal continuously curved configuration having alternate apices, and wherein alternate apices of the first wire project beyond at least part of the first end.
44. The delivery catheter of claim 42 in which each end of the graft body is provided with a wire which has alternate crests or apices extending beyond the adjacent end of the graft body.
45. The delivery catheter of claim 42 wherein each of the wires is interwoven with the graft body such that alternate portions of each wire are outside of the graft body with the remaining portions of each wire inside the graft body.
46. The delivery catheter of claim 42 wherein the graft body comprises a plurality of holes and wherein each of the wires are threaded through the holes such that alternate portions of the wire are outside of the graft body with the remaining portions of the wire inside the graft body.
47. The delivery catheter of claim 42 wherein the wires are sutured to the graft body.
48. The delivery catheter of claim 43 wherein the first wire has a greater amplitude than the wire adjacent to it.
49. The delivery catheter of claim 44 wherein the wires adjacent the upstream end of the graft body are more closely spaced apart from each other than the wires intermediate the two ends of the graft body.
50. The delivery catheter of claim 49 wherein the first wire has a greater amplitude and a smaller wavelength than a majority of the other wires in the graft body.
51. The delivery catheter of claim 43 wherein the wavelength of the wires is substantially constant along the length of the graft body.
52. The delivery catheter of claim 42 wherein each wire comprises two opposing ends, and wherein both ends of each wire are joined together on the outside of the graft body.
53. The delivery catheter of claim 52 wherein both ends of each wire are twisted or crimped together.
54. The delivery catheter of claim 52 wherein the joined ends of adjacent wires project in opposite directions along the graft body.
55. The delivery catheter of claim 42 wherein the upstream end of the graft body comprises an edge, and wherein the edge of the first end is scalloped between each projecting apex of the first wire.
56. The delivery catheter of claim 23 wherein the tubular graft body is circumferentially supported along its length by a plurality of separate, spaced-apart wires each having a closed substantially sinusoidal
continuously curved configuration having alternate apices.
57. The delivery catheter of claim 23 wherein the tubular graft body is circumferentially supported along its length by a plurality of separate.
spaced-apart wires, wherein each of the wires is interwoven with the graft body such that alternate portions of the wire are outside of the graft body with the remaining portions of the wire inside the graft body.
58. The delivery catheter of claim 28 wherein the further tubular intraluminal graft varies in outside diameter along its length.
59. The delivery catheter of claim 58 wherein the variation in outside diameter is provided by a taper of the graft along a portion of its length.
60. The delivery catheter of claim 58 wherein a first portion of the further tubular intraluminal graft has a first outside diameter and a second portion has a different outside diameter.
61. The delivery catheter of claim 23 wherein the flow impedance device comprises a balloon that may be inflated to a size so that it will be guided by the blood flow without being large enough to catch between the walls of the vessel through which it is passing.
62. The delivery catheter of claim 23 wherein the flow impedance device has the form of a small umbrella which may be at least partially opened to catch the flow of blood through the vessel and be guided by that flow.
63. The delivery catheter of claim 25 wherein the supplementary catheter has at or adjacent its free end an inflatable or otherwise expandable flow impedance device.
64. The delivery catheter of claim 63 wherein the inflatable or otherwise expandable flow impedance device on the catheter is expandable so that it can engage with the wall of the vessel and hold the catheter at a desired position.
65. The delivery catheter of claim 61 wherein the balloon may be expanded by a fluid directed down a lumen in the catheter.
66. The delivery catheter of claim 62 wherein the umbrella is opened by actuation of a fine wire extending down a lumen in the catheter.
67. The delivery catheter of claim 23 wherein the expansion of the flow impedance device is effected extracorporeally.
68. The delivery catheter of claim 23 wherein the width of the flow impedance device on expansion is between 1 and 10mm.
69. The delivery catheter of claim 23 wherein the expandable flow impedance device at or adjacent the free end of the guidewire is replaced by a solid bead.
70. The delivery catheter of claim 69 wherein the bead may comprise a bead of epoxy resin or titanium attached to the guidewire.

71. A method for positioning a longitudinal member having a free end within a blood vessel or other bodily vessel, comprising the steps of introducing the longitudinal member into the blood or other bodily vessel upstream of where the free end of the longitudinal member is to be
positioned, inflating or otherwise expanding a flow impedance device positioned at or adjacent a free end of the longitudinal member within the vessel and allowing the flow of blood through the vessel to draw the flow impedance device downstream through the vessel.
72. The method of claim 71 wherein the longitudinal member is a catheter or guidewire.
73. A method for positioning an assembly comprising a catheter and guidewire each having a free end within a blood vessel or other bodily vessel, comprising the steps of introducing the assembly into the blood or other bodily vessel upstream of where the free ends of the catheter and guidewire are to be positioned, inflating or otherwise expanding a flow impedance device positioned at or adjacent the free end of the guidewire within the vessel and allowing the flow of blood through the vessel to draw the flow impedance device downstream through the vessel.
74. A method for positioning an intraluminal graft into a branching vessel within a patient's body, the vessel comprising a single pre-branching vessel branching into a pair of post-branching vessels, the method
comprising:
(a) introducing into one of the post-branching vessels a first
inlraluniinal graft having a body having at a first end a tubular
portion and a second end that is bifurcated into first and second
tubular graft extensions, there being positioned within the first
intraluminal graft a guidewire that extends in a first direction
through the first tubular graft extension and projects in a second
different direction into the second tubular graft extension, the
guidewire having at or adjacent its free end an inflatable or otherwise expandable flow impedance device that may be actuated externally of the lumen of the post-branching vessel into which the free end has been positioned and which is of such a size and shape that the flow impedance device will cause the guidewire to be drawn downstream tlirough the vessel by blood flow therethrough;

(b) positioning the first end of the first intraluminal graft and the
second tubular graft extension within the pre-branching vessel and
expanding that graft until at least the first end thereof expands into
contact with a circumferential wall of the pre-branching vessel;
(c) inflating or otherwise expanding the flow impedance device
positioned at or adjacent the free end of the guidewire and allowing the flow of blood through the vessel to draw the guidewire
downstream to a desired position in the other of the post-branching vessels and then deflating the flow impedance device;
(d) introducing a second intraluminal graft, having an upstream end and a downstream end. into the other of the post-branching vessels
and, utilising the guidewire, or another guide positioned in its place, moving the second intraluminal graft until its upstream end is within or surrounds the second tubular graft extension and its downstream
end is within the other of the post-branching vessels and causing the upstream end of the second intraluminal graft to form fluid
conveying engagement with the second tubular graft extension.
75. The method of claim 74 wherein a supplementary catheter extends in the first direction through the first tubular graft extension and in the second different direction into the second tubular graft extension, the supplementary catheter containing the supplementary guidewire.
76. The method of claim 75 wherein the catheter has at or adjacent its free end an inflatable or otherwise expandable flow impedance device and wherein prior to step (c) the flow impedance device on the catheter is inflated or otherwise expanded to allow the flow of blood through the vessel to draw the catheter downstream to a desired position in the other of the post-branching vessels and then, once the catheter is in the desired position, the flow impedance device is deflated.
77. The method of claim 76 wherein once the catheter is in the desired position in the other of the post-branching vessels, the flow impedance device is further expanded so that it can engage with the wall of the other of the post-branching vessels and hold the catheter at the desired position.

78. The method of claim 74 further comprising the step of:
(e) introducing a third intraluminal graft, having an upstream end and a downstream end, into the one post-branching vessel and
moving the third graft until its upstream end is within or surrounds the first tubular graft extension and its downstream end is within the one post-branching vessel and causing the upstream end of the third intraluminal graft to form fluid conveying engagement with the first tubular graft extension.
79. The method of claim 74 wherein the steps of introducing the first intraluminal graft into one of the post-branching vessels and positioning the upstream end and the second tubular graft extension within the pre-branching vessel comprise:
(a) guiding a delivery catheter, which has a uninflated balloon
adjacent one end with the first end of the first intraluminal graft
disposed about the balloon, over a smaller diameter guidewire and
within a larger diameter catheter sheath pre-positioned in the one
post-branching vessel and pre-branching vessel:
(b) partially withdrawing the catheter sheath lo free the first
intraluminal graft;
(c) inflating the balloon and so expanding the first end of the first intraluminal graft until it engages against the pre-branching vessel wall; and
(d) deflating the balloon.
80. The method of claim 74 wherein the steps of introducing the second intraluminal graft into the other of the post-branching vessels and moving it until its upstream end is within the second tubular graft extension comprise:

(a) guiding a second delivery catheter, which has an uninflated balloon adjacent one end with the upstream end of the second
intraluminal graft disposed about the balloon, over a guidewire and within a larger diameter catheter sheath pre-positioned in the other post-branching vessel and the pre-branching vessel;
(b) partially withdrawing the catheter sheath to free the second intraluminal graft;
(c) inflating the balloon and so expanding the upstream end of the second intraluminal graft until it engages against the second tubular graft extension:
(d) maintaining the inflation of the balloon while withdrawing the first delivery catheter from the one post-branching vessel; and
(c) once the first delivery catheter is removed from the one post- branching vessel deflating the balloon.

81. The method of claim 78 wherein the steps of introducing the third intraluminal graft into the one post-branching vessel and moving it until its upstream end is within the first tubular graft extension comprise:
(a) guiding a third delivery catheter, which has an uninflated
balloon adjacent one end with the upstream end of the third
intraluminal graft disposed about the balloon, over a smaller
diameter guidewire and within a larger diameter catheter sheath pre- positioned in the one post-branching vessel and the pre-branching
vessel;
(b) partially withdrawing the catheter sheath to free the third
intraluminal graft;
(c) inflating the balloon and so expanding the upstream end of the third intraluminal graft until it engages against the first tubular graft extension: and
(d) deflating the balloon.
82. A method for positioning an intraluminal graft across an aneurysm which extends from the aorta into one iliac artery within a patient's body, the method comprising the steps of:
(a) making an incision or puncture to expose one of the patient's femoral arteries;
(b) inserting a first guidewire through the exposed femoral artery, the corresponding iliac artery and the aorta such that it traverses the aneurysm;
(c) guiding a first catheter sheath over the first guidewire until it traverses the aneurysm;
(d) withdrawing the first guidewire;
(e) inserting a second relatively stiff guidewire through the first catheter sheath until it traverses the aneurysm;
(f) withdrawing the first catheter sheath;
(g) guiding a second relatively larger diameter catheter sheath over the second guidewire until it traverses the aneurysm;
(h) guiding a first delivery catheter, which has an uninflated
balloon adjacent one end with a first intraluminal graft disposed
about the balloon, over the second guidewire and within the second larger diameter catheter sheath, the first intraluminal graft having a body having at a first end a tubular portion and a second end that is bifurcated into first and second tubular graft extensions, there being positioned within the first graft a third catheter containing a third guidewire which extends in a first direction through the first tubular graft extension and in a second different direction into the second tubular graft extension, the third guidewire having at or adjacent its free end an inflatable or otherwise expandable flow impedance device that may be actuated externally of the lumen of the other iliac artery into which the free end has been positioned and which is of such a size and shape that the flow impedance device will cause the third guidewire to be drawn downstream through the other iliac artery by blood flow therethrough;
(i) positioning the first delivery catheter so that the first end of the first graft is upstream of the aneurysm;
(j) partially withdrawing the second larger diameter catheter sheath to free the first intraluminal graft;
(k) inflating the balloon and so expanding the first end of the first intraluminal graft until it engages against the wall of the aorta above the aneurysm;
(1) deflating the balloon which allows blood to flow down the first graft distending the first and second tubular graft extensions;
(in) inflating or otherwise expanding the flow impedance device positioned at or adjacent the free end of the third guidewire and allowing the flow of blood through the other iliac and femoral arteries lo draw the third guidewire downstream to a desired position in the other femoral artery and then deflating the flow impedance device;

(n) making an incision or puncture and retrieving the third guidewire from the other femoral artery;
(o) withdrawing the third catheter through the one femoral artery; (p) guiding a fourth catheter sheath over the third guidewire and through the other femoral and iliac arteries until it is within the first graft and reaches at least to the top of the second tubular graft extension;
(q) withdrawing the third guidewire through the one femoral artery; (r) guiding a fourth relatively large diameter guidewire through the fourth catheter sheath until the guidewire reaches at least the top of the second tubular graft extension;

(s) withdrawing the fourth catheter shealh through the other femoral artery;
(t) guiding a fifth relatively larger diameter catheter sheath over the fourth guidewire until the fifth catheter sheath reaches at least the top of the second tubular graft extension;
(u) guiding a second delivery catheter, which has a uninflated balloon adjacent one end with a second intraluminal graft, having an upstream end and a downstream end, disposed about the balloon, over the fourth guidewire and within the fifth larger diameter catheter sheath until the upstream end of the second graft is within lhe second tubular graft extension;
(v) partially withdrawing the fifth catheter sheath to free the second intraluminal graft;
(w) inflating the balloon on the second delivery catheter and so expanding the upstream end of the second intraluminal graft until it engages against the second tubular graft extension;
(x) maintaining the inflation of the balloon while withdrawing the first delivery catheter from the one femoral artery;
(y) once the first deliveiy catheter is removed from the one femoral artery deflating the balloon;
(z) fully withdrawing the fifth catheter sheath through the other femoral artery;
(aa) guiding a third delivery catheter, which has an uninflated balloon adjacent one end with a third intraluminal graft, having an upstream end and a downstream end, disposed about the balloon, over the second guidewire and within the second catheter sheath until the upstream end of the third graft is within the first tubular graft extension;
(bb) partially withdrawing the second catheter sheath to free the third intraluminal graft;
(cc) inflating the balloon on the third delivery catheter and so expanding the upstream end of the third intraluminal graft until it engages against the first tubular graft extension;
(dd) deflating the balloon on the third delivery catheter;

31

(ee) withdrawing the second delivery catheter through the other
femoral artery and the third delivery catheter through the one
femoral artery;
(ff) withdrawing the fourth guidewire and the fifth catheter sheath through the other femoral artery and suturing the incision or
puncture in that artery; and
(gg) withdrawing the second guidewire and second catheter sheath
through the one femoral artery and suturing the incision or puncture in that artery.
83. The method of claim 82 wherein the third catheter has at or adjacent its free end an inflatable or otherwise expandable flow impedance device and wherein prior to step (in) the flow impedance device on the third catheter is inflated or otherwise expanded to allow the flow of blood through the vessel to draw the third catheter downstream to a desired position in the other of the post-branching vessels and then, once the third catheter is in the desired position, the flow impedance device is deflated.
84. The method of claim 83 wherein once the third catheter is in the desired position in the other iliac artery, the flow impedance device is further expanded so that it can engage with the wall of the other iliac artery and hold the third catheter at the desired position until it is necessary to withdraw the third catheter.
85. The method of claim 82 wherein in an alternative step (1) the first and second tubular graft extensions are distended respectively by an inflatable balloon or are self-expandable.