STENT/GRAFT ASSEMBLY
A stent/graft assembly includes a tubular graft connected in substantially end-to-end relationship with a generally tubular stent. Free ends of the stent and graft extend in opposite directions from the end-to-end connection during a pre-deployment orientation of the assembly. However, the graft is inverted during deployment so that free ends of the graft and the stent extend in substantially the same direction from the end-to-end connection in a post-deployment orientation. Thus, at least a portion of the stent is disposed within at least a portion of the graft in a post-deployment orientation of the assembly.
1 . An endovascular stent graft assembly for repairing a section of a blood vessel that has an aneurysm, the assembly comprising:
a tubular stent configured to contact a first relatively healthy section of the blood vessel, the stent having opposite first and second axial ends; and
a tubular graft having a first axial end and at least a portion adjacent the first axial end configured to contact the first relatively healthy section of the blood vessel,
a discrete annular element affixed to the graft in proximity to the first axial end of the graft,
the annular element being connected with the second axial end of the stent at a plurality of circumferentially spaced apart locations to achieve a substantially fixed connection between the stent and the graft without overlap between the stent and the graft,
whereby the substantially fixed connection without overlap enables a smaller cross-section than a connection with overlap so that the assembly can be introduced more easily into the blood vessel.
2 . The endovascular stent graft assembly of claim 1 , wherein the substantially fixed connection without overlap is substantially end to end connection between the stent and the graft.
3 . The endovascular stent graft assembly of claim 1 , wherein the substantially fixed connection without overlap is a non-abutting connection between the stent and the graft.
4 . The endovascular stent graft assembly of claim 3 , wherein the non-abutting connection comprises a small axial gap between the stent and the graft.
5 . The endovascular stent graft assembly of claim 4 , wherein the annular element is connected to the second axial end of the stent through a plurality of circumferentially spaced apart curved or angled fasteners configured to secure the graft to the stent while maintaining the axial gap between the stent and graft.
6 . The endovascular stent graft assembly of claim 1 , wherein the annular element is connected with the second axial end of the stent at a plurality of circumferentially spaced apart locations on the stent through a plurality of axially projecting extensions mounted to the stent.
7 . The endovascular stent graft assembly of claim 1 , wherein the annular element is connected with the second axial end of the stent at a plurality of circumferentially spaced apart locations on the annular element through a plurality of axially projecting extensions mounted to the annular element.
8 . The endovascular stent graft assembly of claim 7 , wherein each of the plurality of axially projecting extensions extends beyond the periphery of the graft.
9 . The endovascular stent graft assembly of claim 6 , wherein each of the plurality of axially projecting extensions from the stent further comprises a radially extending surface remote from the stent.
10 . The endovascular stent graft assembly of claim 7 , wherein each of the plurality of axially projecting extensions from annular element further comprises a radially extending surface remote from the annular element.
11 . The endovascular stent graft assembly of claim 9 , wherein at least one of the radially extending surfaces comprises a barb or a hook.
12 . The endovascular stent graft assembly of claim 10 , wherein at least one of the radially extending surfaces comprises a barb or a hook.
13 . The endovascular stent graft assembly of claim 1 , wherein the annular element and the second axial end of the stent are secured by bonding, adhesion, fusing, or welds at a plurality of circumferentially spaced apart locations.
14 . The endovascular stent graft assembly of claim 13 , wherein the plurality of circumferentially spaced apart structures connect the stent to the graft pre-operatively.
15 . The endovascular stent graft assembly of claim 13 , wherein the plurality of circumferentially spaced apart structures are releasable.
16 . The endovascular stent graft assembly of claim 13 , wherein plurality of circumferentially spaced apart structures comprise a plurality of wires, stitches, or sutures disposed in the axial gap between the stent and the graft.
17 . The endovascular stent graft assembly of claim 6 , wherein each of the plurality of axially projecting extensions is mounted to the stent by a fuse, adhesive, or weld.
18 . The endovascular stent graft assembly of claim 7 , wherein each of the plurality of axially projecting extensions is mounted to the annular element by a fuse, adhesive, or weld.
19 . The endovascular stent graft assembly of claim 1 , wherein the annular element and the second axial end of the stent are affixed at a plurality of circumferentially spaced apart locations by wires or hooks.
20 . The endovascular stent graft assembly of claim 19 , wherein the annular element and the second axial end of the stent are anchored by a plurality of wires at circumferentially spaced apart locations.
21 . The endovascular stent graft assembly of claim 6 , wherein each of the plurality of axially projecting extensions from stent further comprises a curved surface remote from the stent.
22 . The endovascular stent graft assembly of claim 7 , wherein each of the plurality of axially projecting extensions from annular element further comprises a curved surface remote from the annular element.
23 . The endovascular stent graft assembly of claim 7 , wherein each of the plurality of axially projecting extensions from annular element further comprises an angular surface remote from annular element.
24 . The endovascular stent graft assembly of claim 6 , wherein each of the plurality of axially projecting extensions from stent further comprises an angular surface remote from stent.
25 . The endovascular stent graft assembly of claim 6 , wherein each of the plurality of axially projecting extensions from the stent comprises a fastener having a radially extending surface and a wire.
26 . The endovascular stent graft assembly of claim 7 , wherein each of the plurality of axially projecting extensions from annular element further comprises a fastener having a radially extending surface and a wire.
27 . The endovascular stent graft assembly of claim 5 , wherein the axial gap is bridged by the plurality of circumferentially spaced apart curved or angled fasteners.
28 . The endovascular stent graft assembly of claim 1 , wherein the annular element comprises a ring embedded within the graft.
29 . The endovascular stent graft assembly of claim 1 , wherein the annular element is configured to keep the graft open during insertion into the blood vessel without encircling the stent.
30 . The endovascular stent graft assembly of claim 1 , wherein the graft comprises a bifurcated graft having two free ends remote from the stent.
31 . The endovascular stent graft assembly of claim 30 , further comprising second and third grafts configured to be connected to the free ends subsequent to deployment of the first graft in the blood vessel.
32 . The endovascular stent graft assembly of claim 31 , wherein each of the second and third grafts comprises an associated second and third stent.
33 . The endovascular stent graft assembly of claim 32 , wherein the first bifurcated graft comprises a flexible wall substantially unsupported by any underlying framework prior to deployment of the second and third grafts and associated stents.
34 . The endovascular stent graft assembly of claim 31 , wherein the second and third grafts are configured to be deployed internal to the free ends of the first graft after the first graft is inserted in the blood vessel.
35 . An endovascular stent graft assembly for repairing a section of a blood vessel that has an aneurysm, the blood vessel having first and second relatively healthy sections adjacent and on opposite ends of the aneurysm, the assembly comprising:
a stent having opposite first and second axial ends;
a graft having first and second axial ends and a flexible wall portion disposed between the axial ends of the graft, substantially the entirety of the flexible wall being unsupported by any underlying metallic framework;
a discrete ring affixed to the graft in proximity to the first axial end of the graft and configured to keep the graft open when in the blood vessel and without encircling the stent;
and a plurality of hooking devices configured to connect the stent to the ring and achieve a non-abutting connection with a gap between the first axial end of the graft with the second axial end of the stent, wherein the stent is connected to the graft via the hooking devices;
wherein the hooking devices comprise a plurality of circumferentially spaced axially projecting extensions from mounting points on at least one of the ring or the stent, each axially projecting extension further comprising a radially projecting surface remote from the mounting point, and wherein the radially projecting extensions are configured to securely maintain the gap between the stent and the graft
36 . The endovascular stent/graft assembly of claim 35 , wherein the each hooking device comprises a wire, stitch, suture, fuse, or weld disposed between the stent and the ring.
37 . The endovascular stent graft assembly of claim 35 , wherein the each hooking device comprises a wire or stitch configured to secure the stent to the ring.
38 . The endovascular stent graft assembly of claim 35 , wherein each of the axial projections comprises a barb configured to securely maintain the gap between the stent and the graft.
39 . The endovascular stent graft assembly of claim 35 , wherein a plurality of wires connects the ring to the stent at a plurality of circumferentially spaced apart locations.
40 . The endovascular stent graft assembly of claim 35 , wherein the connection of the stent and the graft is achieved pre-operatively.
41 . The endovascular stent graft assembly of claim 35 , wherein the graft is a one piece bifurcated graft having two free ends remote from the ring.
42 . The endovascular stent graft assembly of claim 41 , further comprising at least one second subsequently deployed graft configured to connect to the bifurcated graft at one of its free ends.
43 . The endovascular stent graft assembly of claim 42 , further comprising at least one second stent configured to support the second graft.
44 . The endovascular stent graft assembly of claim 42 , wherein the second stent is an internal stent disposed in an interior of the bifurcated graft post deployment with the second graft.
45 . The endovascular stent/graft assembly of claim 42 , wherein the second stent is an internal stent configured for insertion at least partly into the interior of the bifurcated graft after the first stent and the bifurcated graft are inserted into the blood vessel.
46 . The endovascular stent graft assembly of claim 42 , further comprising a third subsequently deployed graft configured to connect to the bifurcated graft at another of its free ends.
47 . The endovascular stent graft assembly of claim 35 , wherein the connection of the stent and the graft is releasable.
48 . The endovascular stent graft assembly of claim 46 , wherein the subsequently deployed grafts in association with the bifurcated graft bridge the aneurysm post insertion of the stent graft assembly and subsequently deployed grafts in the blood vessel.
49 . An endovascular stent/graft assembly for repairing a section of a blood vessel that has an aneurysm, the blood vessel having first and second relatively healthy sections adjacent and on opposite ends of the aneurysm, the assembly comprising:
a substantially tubular stent having opposite first and second axial ends,
a graft having first axial and second axial ends and a flexible wall portion there between, substantially the entirety of the flexible wall portion being unsupported by any metallic framework;
an annular member incorporated into the graft in proximity to its first axial end and configured to keep the graft open during deployment without encircling the stent;
a plurality of axial extensions projecting from at least one of the stent or the annular member toward the other at a plurality of circumferentially spaced apart locations;
and a plurality of fastening elements configured to connect the annular member and the second axial end of the stent at the plurality of circumferentially spaced-apart axial projections;
wherein the plurality of fastening elements are configured to maintain a substantially end-to-end axial non-abutting connection without overlap between the stent and the graft; and
whereby the connection without overlap enables a smaller cross-section than a connection with overlap so that the assembly can be introduced more easily into the blood vessel.
50 . The endovascular stent/graft assembly of claim 49 , wherein each of the plurality of fastening elements comprises a wire configured to securely connect the annular member and the stent.
51 . The endovascular stent/graft assembly of claim 49 , wherein each of the plurality of fastening elements comprises a hook configured to affix the stent to the annular member.
52 . The endovascular stent/graft assembly of claim 49 , wherein each of the plurality of axial projections further comprises a radially extending segment and a curved surface.
53 . The endovascular stent/graft assembly of claim 49 , wherein each of the plurality of axial projections further comprises a segment extending radially so as to releasably hook on a circumferentially disposed portion or element of the assembly.
54 . The endovascular stent/graft assembly of claim 53 , wherein the segment extending radially comprises an angled surface.
55 . The endovascular stent/graft assembly of claim 49 , each of the plurality of fastening elements further comprising at least one stitch, wire, or suture configured to secure the annular member to the stent.
56 . The endovascular stent/graft assembly of claim 49 , each of the plurality of fastening elements further comprising at least one wire configured to secure the annular member to the stent.
57 . The endovascular stent/graft assembly of claim 49 , wherein each of the plurality of axial extensions is fused, welded, adhered or bonded to the stent or to the annular member.
58 . The endovascular stent/graft assembly of claim 49 , wherein at least one of the axial extensions is fused, welded, adhered or bonded to the sent or to the annular member.
59 . The assembly of claim 49 , wherein the annular member is a discrete ring affixed to the graft.
60 . The endovascular stent/graft assembly of claim 49 , wherein the plurality of axially extending members achieves a non-abutting connection between the stent and the graft with a gap between the stent and the graft.
61 . The endovascular stent/graft assembly of claim 60 , wherein the plurality of fastening devices are disposed at plurality of circumferentially spaced apart locations in the gap between the stent and the graft.
62 . A method for repairing a section of a blood vessel that has an aneurysm, the method comprising:
inserting a stent graft assembly into the blood vessel, the assembly comprising:
a tubular stent configured to contact a first relatively healthy section of the blood vessel, the stent having opposite first and second axial ends;
a tubular graft having a first axial end, the tubular graft having a flexible wall at least a portion of which is adjacent the first axial end and configured to contact the first relatively healthy section of the blood vessel;
a discrete annular element affixed to the graft in proximity to the first axial end of the graft, the annular element being connected by a plurality of circumferentially spaced apart hooking devices to the second axial end of the stent to achieve a substantially end-to-end non-abutting connection between the stent and the graft without overlap; and
whereby the substantially end-to-end connection without overlap enables a smaller cross-section than a connection with overlap so that the assembly can be introduced more easily into the blood vessel.
63 . The method of claim 62 , wherein the stent and the graft are connected pre-operatively.
64 . The method of claim 62 , wherein the graft comprises a one-piece bifurcated graft having two free ends remote from the annular member.
65 . The method of claim 64 , further comprising inserting at least one second subsequently deployed graft configured to contact the flexible wall of the bifurcated graft at one of its free ends.
66 . The method of claim 65 , further comprising inserting at least a third subsequently deployed graft configured to contact the flexible wall of the bifurcated graft at another one of its free ends.
67 . The endovascular stent graft assembly of claim 65 , wherein the at least one second graft is inserted in association with a second stent.
68 . The method of claim 67 , wherein the second stent is an internal stent disposed in an interior of the second graft.
69 . The method of claim 68 , wherein the second graft is configured for insertion at least partly into the interior of the graft after the first stent and the graft are inserted into a patient.
70 . The method of claim 69 , wherein the flexible wall of the graft is substantially unsupported by any metallic framework at least until the second graft is deployed.
71 . The method of claim 62 , wherein the annular element is configured to hold the graft open during insertion in the blood vessel.
72 . The method of claim 62 , wherein the stent graft assembly has a substantially end-to-end connection between the stent and the graft with an axial gap between the stent and the graft, and the plurality of circumferentially spaced apart hooking devices are disposed within the gap between the stent and the graft.
73 . The method of claim 72 , wherein the each hooking device comprises a wire, stitch or suture.
74 . The method of claim 62 , wherein each hooking device comprises a member extending axially from the annular member toward the stent and beyond the periphery of the graft.
75 . The method of claim 62 , wherein each hooking device comprises a member extending axially from the stent toward the graft.
76 . The method of claim 74 , wherein each member extending axially from the annular member toward the stent and beyond the periphery of the graft comprises a radially projecting surface.
77 . The method of claim 75 , wherein each member extending axially from the stent toward the graft comprises a radially projecting surface.
78 . The method of claim 76 , wherein each radially projecting surface is configured to catch on a transverse surface.
79 . The method of claim 77 , wherein each radially projecting surface is configured to catch on a transverse surface.
80 . The method of claim 62 , wherein each hooking device is releasable.
81 . The method of claim 74 , wherein each member extending axially from the annular member toward the stent and beyond the periphery of the graft is fixedly mounted to the annular member by a weld, fuse, or adhesive.
82 . The method of claim 75 , wherein each member extending axially from the stent toward the graft is fixedly mounted to the stent by a weld, fuse, or adhesive.
83 . The method of claim 62 , wherein the stent graft assembly has a substantially end-to-end connection between the stent and the graft with an axial gap between the stent and the graft, and the plurality of circumferentially spaced apart hooking devices securely maintains the gap between the stent and the graft without overlap to enable a smaller cross-section than a connection with overlap so that the assembly can be introduced more easily into the blood vessel.
84 . The endovascular stent graft assembly of claim 1 , wherein the annular element and the second axial end of the stent are secured by a plurality of circumferentially spaced apart wires.
85 . The endovascular stent graft assembly of claim 1 , wherein the annular element and the second axial end of the stent are secured by a plurality of circumferentially spaced apart hooks or barbs
86 . The endovascular stent graft assembly of claim 1 , wherein the annular element and the second axial end of the stent are secured by a plurality of circumferentially spaced apart sutures.
87 . The endovascular stent graft assembly of claim 1 , wherein the annular element and the second axial end of the stent are secured by fusing at a plurality of circumferentially spaced locations.
88 . The endovascular stent graft assembly of claim 1 , wherein the annular element and the second axial end of the stent are secured by adhesive at a plurality of circumferentially spaced apart locations.