U.S. patent application number 10/653401 was filed with the patent office on 2004-05-20 for branch grafting device and method.
This patent application is currently assigned to Cook Incorporated. Invention is credited to Hartley, David Ernest, Lawrence-Brown, Michael, Stelter, Wolf.
Application Number | 20040098084 10/653401 |
Document ID | / |
Family ID | 27671473 |
Filed Date | 2004-05-20 |
United States Patent
Application |
20040098084 |
Kind Code |
A1 |
Hartley, David Ernest ; et
al. |
May 20, 2004 |
Branch grafting device and method
Abstract
An endoluminal stent graft deployment system useful for
deployment of a limb of a branched stent graft (16) into a blind
vessel. The branched stent graft has a main body (16) and a limb
(19) extending from the body. The branched stent graft is mounted
on a deployment device which has a separate deflecting guide wire
(14) extending into the limb. The method of deploying the branched
stent graft into a blind vessel in a human or animal body includes
the step of releasing the limb from the deployment device,
extending the guide wire from the limb into the blind vessel,
manipulating the deployment device by withdrawing the deployment
device slightly to cause the limb to enter the blind vessel
assisted by the guide wire and releasing the stent graft from the
deployment device.
Inventors: |
Hartley, David Ernest;
(Subiaco, AU) ; Stelter, Wolf; (Bad Soden, DE)
; Lawrence-Brown, Michael; (City Beach, AU) |
Correspondence
Address: |
COOK GROUP PATENT OFFICE
P.O. BOX 2269
BLOOMINGTON
IN
47402
|
Assignee: |
Cook Incorporated
Bloomington
IN
William A. Cook Australia PTY LTD
Eight Mile Plains
|
Family ID: |
27671473 |
Appl. No.: |
10/653401 |
Filed: |
September 2, 2003 |
Current U.S.
Class: |
623/1.11 ;
623/1.35 |
Current CPC
Class: |
A61F 2/954 20130101;
A61F 2002/9511 20130101; A61F 2/962 20130101; A61F 2002/065
20130101 |
Class at
Publication: |
623/001.11 ;
623/001.35 |
International
Class: |
A61F 002/06 |
Foreign Application Data
Date |
Code |
Application Number |
Sep 2, 2002 |
AU |
2002951147 |
Claims
What is claimed is:
1. An endoluminal stent graft deployment system adapted for
deployment of a limb of a branched stent graft into a blind vessel,
the deployment system comprising a deployment device having a
distal end and a proximal end and including the branched stent
graft releasably retained thereon at the proximal end thereof; an
inner sheath slidably and coaxially mounted on the deployment
device, the branched stent graft having a main body and a limb
extending therefrom, the limb extending distally from a bifurcation
in the main body, the branched stent graft being mounted on the
deployment device with a deployment catheter passing through the
main body, the inner sheath enclosing the main body up to distally
of the bifurcation, and a separate deflecting wire guide extending
into the limb from the distal end.
2. An endoluminal stent graft deployment system as in claim 1
further including an outer sheath slidably and coaxially mounted on
the inner sheath and enclosing the entire stent graft.
3. An endoluminal stent graft deployment system as in claim 2
further including an anchor wire arrangement extending between the
inner and outer sheaths and extending to and fastened to the main
body of the stent graft adjacent to the bifurcation.
4. An endoluminal stent graft deployment system as in claim 1
wherein the separate deflecting wire guide includes a guide wire
arrangement extending through the limb and extending distally
therefrom to assist with directing the limb into the blind
vessel.
5. An endoluminal stent graft deployment system as in claim 1
wherein the deployment device includes a guide wire catheter
mounted coaxially and movably within a deployment catheter, the
guide wire catheter extending to a nose cone and the branched stent
graft releasably retained distally of the nose cone.
6. An endoluminal stent graft deployment system as in claim 1
further including a diameter reducing arrangement on at least part
of the main body of the stent graft.
7. An endoluminal stent graft deployment system as in claim 1
further including a diameter reducing arrangement on the limb of
the stent graft.
8. An endoluminal stent graft deployment system as in claim 6 or 7
wherein the diameter reducing arrangement includes ties around the
main body or limb of the stent graft to reduce the diameter of the
stent graft or limb from a deployed diameter to a compressed
diameter and a trigger wire arrangement to release the ties to
allow the main body or limb of the stent graft to expand to the
deployed diameter.
9. An endoluminal stent graft deployment system as in claim 8
wherein the trigger wire arrangement includes a trigger wire
release arrangement at the distal end of the deployment device and
adapted to remain outside the patient during deployment.
10. An endoluminal stent graft deployment system as in claim 1
wherein the branched stent graft comprises a tubular body and self
expanding stents at at least the proximal and distal ends of the
main body and at the distal end of the limb.
11. An endoluminal stent graft deployment system as in claim 1
wherein the separate deflecting guide wire catheter extending to
the limb includes a guide wire and a guide wire sheath, the guide
wire being movable within the guide wire sheath from outside the
patient during deployment.
12. An endoluminal stent graft deployment system as in claim 1
wherein the limb includes on an outer surface thereof fibres
extending therefrom to improve adhesion to the vessel wall.
13. An endoluminal stent graft deployment system as in claim 3
wherein the anchor wire arrangement includes an anchor wire and an
anchor release wire and the anchor release wire extending to an
anchor wire release arrangement at the distal end of the deployment
device that is adapted to remain outside the patient during
deployment.
14. A method of deploying a limb of a branched stent graft into a
blind vessel in a human or animal body, the branched stent graft
being mounted on a deployment device, the branched stent graft
having a main body and a limb extending therefrom, the limb
extending distally from a bifurcation in the main body, the method
including the steps of: deploying the deployment device into a
vessel from which the blind vessel extends; releasing a limb of the
main body of the branched stent graft from the deployment device
such that the limb extends laterally and distally; extending a
guide wire from the limb into the blind vessel; manipulating the
deployment device by withdrawing the deployment device slightly to
cause the limb to enter the blind vessel assisted by the guide
wire, and releasing the branched stent graft from the deployment
device.
15. An endoluminal stent graft deployment system adapted for
deployment of a limb of a branched stent graft into a blind vessel,
the deployment system comprising a deployment device having a
distal end and a proximal end and including the branched stent
graft releasably retained thereto at the proximal end thereof; an
inner sheath slidably and coaxially mounted on the deployment
device, an outer sheath slidably and coaxially mounted on the inner
sheath, the branched stent graft having a main body and a limb
extending therefrom, the limb extending distally from a bifurcation
in the main body, the branched stent graft being mounted on the
deployment device in an annular recess thereon, with a deployment
catheter passing through the main body, the inner sheath enclosing
the main body up to distally of the bifurcation, the outer sheath
enclosing the entire stent graft and extending proximally of the
annular recess, and an anchor wire arrangement extending between
the inner and outer sheaths and extending to and fastened to the
main body adjacent to the bifurcation.
16. An endoluminal stent graft deployment system as in claim 15
further including a guide wire arrangement extending through the
limb and extending distally therefrom to assist with directing the
limb into the blind vessel.
17. An endoluminal stent graft deployment system as in claim 15
wherein the deployment device includes a guide wire catheter
mounted coaxially within a deployment catheter, the guide wire
catheter extending to a nose cone and the annular recess being
between the nose cone and the deployment catheter.
18. An endoluminal stent graft deployment system as in claim 15
further including a diameter reducing arrangement on at least part
of the main body of the stent graft.
19. An endoluminal stent graft deployment system as in claim 15
further including a diameter reducing arrangement on the limb of
the stent graft.
20. An endoluminal stent graft deployment system as in claim 18
wherein the diameter reducing arrangement includes ties around the
stent graft to reduce the diameter of the stent graft from a
deployed diameter to a compressed diameter and a trigger wire
arrangement to release the ties to allow the stent graft to expand
to the deployed diameter.
21. An endoluminal stent graft deployment system as in claim 20
wherein the trigger wire arrangement includes a trigger wire
release arrangement at the distal end of the deployment device that
is adapted to remain outside the patient during deployment.
22. An endoluminal stent graft deployment system as in claim 15
wherein the branched stent graft comprises a tubular body and self
expanding stents at at least the proximal and distal ends of the
main body and at the distal end of the limb.
23. An endoluminal stent graft deployment system as in claim 16
wherein the guide wire arrangement extending to the limb includes a
guide wire and a guide wire catheter, the guide wire being movable
within the guide wire catheter from outside the patient during
deployment.
24. An endoluminal stent graft deployment system as in claim 15
wherein the branched stent graft comprises a tubular body and self
expanding stents at at least the proximal and distal ends of the
main body and at the distal end of the limb.
25. An endoluminal stent graft deployment system as in claim 16
wherein the guide wire arrangement extending to the limb includes a
guide wire and a guide wire catheter, the guide wire being movable
within the guide wire catheter from outside the patient during
deployment.
26. An endoluminal stent graft deployment system as in claim 15
wherein the anchor wire arrangement includes an anchor wire and an
anchor release wire and the anchor release wire extending to an
anchor wire release arrangement at the distal end of the deployment
device that is adapted to remain outside the patient during
deployment.
27. An endoluminal stent graft deployment system adapted for
endoluminal deployment of a stent graft, the deployment system
including a deployment device having a distal end and a proximal
end and including the stent graft releasably retained thereon at
the proximal end thereof, characterized by a releasable anchor wire
arrangement extending from the distal end of the deployment device
and engaging the stent graft to thereby anchor the stent graft
during manipulation of the deployment device or another deployment
device through the stent graft.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application claims priority to Australian Provisional
Patent Application No. 2002951147, filed Sep. 2, 2002.
TECHNICAL FIELD
[0002] This invention relates to a bifurcated or branched stent
graft and to a deployment device for deploying a branched stent
graft and a method of deploying such a device as well as to a
temporary stent graft anchoring system.
BACKGROUND OF THE INVENTION
[0003] The invention will be generally discussed with reference to
deploying a branched stent graft into an internal iliac artery from
the common iliac but is not so limited and may be used with
deployment into any branched vessel but is particularly applicable
where the vessel into which the device is deployed is a blind
vessel, that is, access is not available from an end of the vessel
remote from the bifurcation from a main vessel.
[0004] Throughout this specification the term `distal` with respect
to a portion of the vasculature of a patient, a deployment device
or a prosthesis is the end of the vasculature, deployment device or
prosthesis furthest away in the direction of blood flow from the
heart and the term `proximal` means the portion of the vasculature,
deployment device or end of the prosthesis nearer to the heart. For
other lumens within the human or animal body the terms caudal and
cranial respectively should be understood.
SUMMARY OF THE INVENTION
[0005] In one form therefore the invention is said to reside in an
endoluminal stent graft deployment system adapted for deployment of
a limb of a branched stent graft into a blind vessel, the
deployment system including, a deployment device having a distal
end and a proximal end and including the branched stent graft
releasably retained thereon at the proximal end thereof, an inner
sheath slidably and coaxially mounted on the deployment device, the
branched stent graft having a main body and a limb extending
therefrom, the limb extending distally from a bifurcation in the
main body, the branched stent graft being mounted on the deployment
device with the deployment catheter passing through the main body,
the inner sheath enclosing the main body up to distally of the
bifurcation, and a separate deflecting wire guide extending into
the limb from the distal end of the deployment device.
[0006] Preferably the endoluminal stent graft deployment device
further includes an outer sheath slidably and coaxially mounted on
the inner sheath and adapted to enclose the entire stent graft.
[0007] Preferably the endoluminal stent graft deployment system
further includes an anchor wire arrangement extending between the
inner and outer sheaths and extending to and fastened to the main
body of the stent graft adjacent to the bifurcation.
[0008] The anchor wire arrangement may include an anchor wire and
an anchor release wire and the anchor release wire extending to an
anchor wire release arrangement at the distal end of the deployment
device and adapted to remain outside the patient during
deployment.
[0009] The separate deflecting wire guide may include a guide wire
arrangement extending through the limb and extending distally
therefrom to assist with directing the limb into the blind
vessel.
[0010] Preferably the separate deflecting wire guide extending to
the limb includes a guide wire and a guide wire sheath, the guide
wire being movable within the guide wire sheath from outside the
patient during deployment.
[0011] The deployment device may include a guide wire catheter
mounted coaxially and movably within a deployment catheter, the
guide wire catheter extending to a nose cone and the branched stent
graft releasably retained distally of the nose cone.
[0012] Preferably the endoluminal stent graft deployment system
further includes a diameter reducing arrangement on at least part
of the main body of the stent graft and a diameter reducing
arrangement on the limb of the stent graft.
[0013] The diameter reducing arrangements may each include ties
around the main body or limb to reduce the diameter of the main
body or limb from a deployed diameter to a compressed diameter and
a trigger wire arrangement to release the ties to allow the main
body or limb to expand to the deployed diameter. Generally it is
intended that the released ties remain associated with the stent
graft.
[0014] The trigger wire arrangement may include a trigger wire
release arrangement at the distal end of the deployment device that
is adapted to remain outside the patient during deployment.
[0015] In one form the branched stent graft comprises a tubular
body and self expanding stents at, at least the proximal and distal
ends of the main body and at the distal end of the limb. Further
self expand stents may be provided on the main body and limb. The
stents may be zig-zag Z stents made from Nitinol or stainless
steel.
[0016] Preferably the limb includes on an outer surface thereof
fibres extending therefrom to improve adhesion to the vessel
wall.
[0017] The anchor wire arrangement may include an anchor wire and
an anchor wire release wire and the anchor wire release wire
extending to an anchor wire release arrangement at the distal end
of the deployment device and adapted to remain outside the patient
during deployment. The anchor wire and anchor wire release wire
extend through an anchor wire catheter which is positioned between
the inner and outer sheaths.
[0018] In an alternative form the invention resides in a method of
deploying a limb of a branched stent graft into a blind vessel in a
human or animal body, the branched stent graft being mounted on a
deployment device, the branched stent graft having a main body and
a limb extending therefrom, the limb extending distally from a
bifurcation in the main body, the method including the steps
of:
[0019] deploying the deployment device into a vessel from which the
blind vessel extends;
[0020] releasing a limb of the main body of the branched stent
graft from the deployment device such that the limb extends
laterally and distally adjacent the blind vessel;
[0021] extending a guide wire from the limb into the blind
vessel;
[0022] manipulating the deployment device by withdrawing the
deployment device slightly to cause the limb to enter the blind
vessel assisted by the guide wire, and
[0023] releasing the branched stent graft from the deployment
device.
[0024] The step of manipulating by withdrawing the deployment
device slightly may include the step of retaining the main body of
the branched stent graft on the deployment device by means of an
anchor wire and the step of releasing the branched stent graft may
include the step of releasing the anchor wire.
[0025] The step of releasing the branched stent graft may include
the step of releasing diameter reducing ties on the limb and main
body of the branched stent graft using a trigger wire system.
[0026] The step of deploying the deployment device may include the
step of releasably retaining the branched stent graft on the
deployment device by means of an inner and outer coaxial sheath,
the outer sheath retaining the whole of the branched stent graft
and the inner sheath retaining a portion of the main body of the
branched stent graft distal of the bifurcation.
[0027] In an alternative form the invention is said to reside in an
endoluminal stent graft deployment system adapted for deployment of
a limb of a branched stent graft into a blind vessel, the
deployment system including, a deployment device having a distal
end and a proximal end and including the branched stent graft
releasably retained thereto at the proximal end thereof; an inner
sheath slidably and coaxially mounted on the deployment device, an
outer sheath slidably and coaxially mounted on the inner sheath,
the branched stent graft having a main body and a limb extending
therefrom, the limb extending distally from a bifurcation in the
main body, the branched stent graft being mounted on the deployment
device in an annular recess thereon with the deployment catheter
passing through the main body, the inner sheath enclosing the main
body up to distally of the bifurcation, the outer sheath enclosing
the entire stent graft and extending proximally of the annular
recess, and an anchor wire arrangement extending between the inner
and outer sheaths and extending to and fastened to the main body
adjacent to the bifurcation.
[0028] Preferably the endoluminal stent graft deployment system
further includes a guide wire arrangement extending through the
limb and extending distally therefrom to assist with directing the
limb into the blind vessel.
[0029] The deployment device may include a guide wire catheter
mounted coaxially within a deployment catheter, the guide wire
catheter extending to a nose cone and the annular recess being
between the nose cone and the deployment catheter.
[0030] Preferably the endoluminal stent graft deployment system
further includes a diameter reducing arrangement on at least part
of the main body of the stent graft.
[0031] Preferably the endoluminal stent graft deployment system
further includes a diameter reducing arrangement on the limb of the
stent graft.
[0032] The diameter reducing arrangement may include ties around
the stent graft to reduce the diameter of the stent graft from a
deployed diameter to a compressed diameter and a trigger wire
arrangement to release the ties to allow the stent graft to expand
to the deployed diameter.
[0033] The trigger wire arrangement may include a trigger wire
release arrangement at the distal end of the deployment device and
adapted to remain outside the patient during deployment.
[0034] Preferably the branched stent graft comprises a tubular body
and self expanding stents at at least the proximal and distal ends
of the main body and at the distal end of the limb.
[0035] The guide wire arrangement extending to the limb may include
a guide wire and a guide wire catheter extending to the distal end
of the deployment device, the guide wire being movable within the
guide wire catheter from outside the patient during deployment.
[0036] The anchor wire arrangement may include an anchor wire and
an anchor release wire and the anchor release wire extending to an
anchor wire release arrangement at the distal end of the deployment
device and adapted to remain outside the patient during
deployment.
[0037] In an alternative form the invention is said to reside in an
endoluminal stent graft deployment system adapted for endoluminal
deployment of a stent graft, the deployment system including a
deployment device having a distal end and a proximal end and
including the stent graft releasably retained thereon at the
proximal end thereof, characterized by an anchor wire arrangement
extending from the distal end of the deployment device and engaging
the stent graft to thereby anchor the stent graft during
manipulation of the deployment device or other deployment devices
through the stent graft.
[0038] Preferably the anchor wire arrangement includes an anchor
wire and an anchor release wire and the anchor release wire
extending to an anchor wire release arrangement at the distal end
of the deployment device and adapted to remain outside the patient
during deployment.
[0039] The deployment device may include an inner sheath and an
outer sheath and the anchor wire and an anchor release wire extend
between the inner and outer sheaths in an anchor wire catheter.
BRIEF DESCRIPTION OF THE DRAWING
[0040] This generally describes the invention but to assist with
understanding the invention will now be exemplified with the
assistance of the accompanying drawings.
[0041] In the drawings:
[0042] FIG. 1 shows a deployment device according to one embodiment
of the invention; and
[0043] FIG. 2A to 2I show various stages of deployment using the
device shown in FIG. 1.
DETAILED DESCRIPTION
[0044] U.S. Pat. No. 5,387,235 entitled "Endovascular Transluminal
Prosthesis For Repair Of Aneurysms" discloses apparatus and methods
of retaining grafts onto deployment devices. These features and
other features disclosed in U.S. Pat. No. 5,387,235 could be used
with the present invention and the disclosure of U.S. Pat. No.
5,387,235 is herewith incorporated in its entirety into this
specification.
[0045] U.S. Pat. No. 5,720,776 entitled "Stent Barb" discloses
improved barbs with various forms of mechanical attachment to a
stent. These features and other features disclosed in U.S. Pat. No.
5,720,776 could be used with the present invention and the
disclosure of U.S. Pat. No. 5,720,776 is herewith incorporated in
its entirety into this specification.
[0046] U.S. Pat. No. 6,206,931 entitled "Graft Prosthesis
Materials" discloses graft prosthesis materials and a method for
implanting, transplanting replacing and repairing a part of a
patient and particularly the manufacture and use of a purified,
collagen based matrix structure removed from a submucosa tissue
source. These features and other features disclosed in U.S. Pat.
No. 6,206,931 could be used with the present invention and the
disclosure of U.S. Pat. No. 6,206,931 is herewith incorporated in
its entirety into this specification.
[0047] PCT Patent Publication Number No. WO98/53761 entitled "A
Prosthesis and a Method of Deploying a Prosthesis" discloses an
introducer for a prosthesis which retains the prosthesis so that
each end can be moved independently. These features and other
features disclosed in PCT Patent Publication No. WO98/53761 could
be used with the present invention and the disclosure of PCT Patent
Publication No. WO98/53761 is herewith incorporated in its entirety
into this specification.
[0048] PCT Patent Publication No. WO99/29262 entitled "Endoluminal
Aortic Stents" discloses a fenestrated prosthesis for placement
where there are intersecting arteries. This feature and other
features disclosed in PCT Patent Publication No. WO99/29262 could
be used with the present invention and the disclosure of PCT Patent
Publication No. WO99/29262 is herewith incorporated in its entirety
into this specification.
[0049] PCT Patent Publication No. WO03/034948 entitled "Prostheses
for Curved Lumens" discloses prostheses with arrangements for
bending the prosthesis for placement into curved lumens. This
feature and other features disclosed in PCT Patent Publication No.
WO03/034948 could be used with the present invention and the
disclosure of PCT Patent Publication No. WO03/034948 is herewith
incorporated in its entirety into this specification.
[0050] Australian Provisional Patent Serial No. 60/392,682 entitled
"Trigger Wires" discloses release wire systems for the release of
stent grafts retained on introducer devices. This feature and other
features disclosed in Australian Provisional Patent Serial No.
60/392,682 could be used with the present invention and the
disclosure of Australian Provisional Patent Serial No. 60/392,682
is herewith incorporated in its entirety into this
specification.
[0051] Australian Provisional Patent Serial No. 10/609,846 entitled
"Thoracic Deployment Device" discloses introducer devices adapted
for deployment of stent grafts particularly in the thoracic arch.
This feature and other features disclosed in Australian Provisional
Patent Serial No. 10/609,846 could be used with the present
invention and the disclosure of Australian Provisional Patent
Serial No. 10/609,846 is herewith incorporated in its entirety into
this specification.
[0052] Australian Provisional Patent Serial No. 60/391,737 entitled
"A Stent-Graft Fastening Arrangement" discloses arrangements for
fastening stents onto grafts particularly for exposed stents. This
feature and other features disclosed in Australian Provisional
Patent Serial No. 60/391,737 could be used with the present
invention and the disclosure of Australian Provisional Patent
Serial No. 60/391,737 is herewith incorporated in its entirety into
this specification.
[0053] PCT Patent Publication No. WO03/053287 entitled "Improving
Graft Adhesion" discloses arrangements on stent grafts for
enhancing the adhesion of such stent grafts into walls of vessels
in which they are deployed. This feature and other features
disclosed in PCT Patent Publication No. WO03/053287 could be used
with the present invention and the disclosure of PCT Patent
Publication No. WO03/053287 is herewith incorporated in its
entirety into this specification.
[0054] Australian Provisional Patent Application No. 2002950950
entitled "Composite Prostheses" discloses prostheses or stent
grafts suitable for endoluminal deployment. These prostheses and
other features disclosed in Australian Provisional Patent
Application No. 2002950950 could be used with the present invention
and the disclosure of Australian Provisional Patent Application No.
2002950950 is herewith incorporated in its entirety into this
specification.
[0055] Now looking more closely at the drawings and more
particularly the embodiment shown in FIG. 1 and parts of this
embodiment shown in FIGS. 2A and 2B it will be seen that the
deployment device comprises a deployment catheter 1 having slidably
mounted over it an outer sheath 3 and an inner sheath 4. The outer
sheath 3 is manipulated from an outer sheath manipulator generally
shown as 6 and the inner sheath is manipulated from an inner sheath
manipulator 7. Extending from a nose cone 8 throughout the
deployment catheter is a guide wire catheter 9. The guide wire
catheter 9 is fixed for movement with respect to the deployment
catheter 1 by means of a pin vice 10. Release of the pin vice
allows movement of the nose cone with respect to the deployment
catheter 1.
[0056] A stent graft 16 (FIG. 2A) is retained in the region 11 of
the deployment device immediately distally of the nose cone 8 as
can be particularly seen in FIG. 2A. The stent graft 16 includes a
proximal body portion 17 enclosed and retained in a constrained
state by the outer sheath 3 and a distal body portion 18 enclosed
and retained in a constrained state by the inner sheath 4.
Extending between the proximal 16 and distal 18 body portions from
a bifurcation 15 is a limb 19. The proximal body portion 17 is
retained in a compressed state by diameter reducing ties 20 and the
limb 19 is retained in a compressed state by diameter reducing ties
21. The method of releasing these diameter reducing ties will be
discussed later.
[0057] A deflecting wire guide arrangement generally shown as 12 on
the deployment device in FIG. 1 has a guide wire catheter 13 with a
guide wire 14 within it.
[0058] The separate deflecting guide wire catheter 13 extends from
the deployment catheter 1 at a Y-piece generally shown as 40.
[0059] The deflecting guide wire catheter 13 extends from the part
of the deployment device which in use remains outside of the
patient through the inner sheath 3 and is bent and extends into the
limb 19. When the limb 1 9 is released as discussed below the
deflecting wire guide assists in causing the limb to deflect
laterally from the main body of the stent graft.
[0060] An anchor wire arrangement is mounted at 24 to the main body
of the stent graft 16 adjacent the bifurcation 15. The anchor wire
arrangement includes an anchor wire catheter 25, an anchor wire 26
which passes through the anchor wire catheter 25 and an anchor wire
release wire 27 which also passes through the anchor wire catheter
25. The anchor wire 26 includes a bead 29 at its proximal end so
that a suture 30 can be fastened through the stent graft body
adjacent to the bifurcation 15 and then around the anchor wire 26
and retained by a knot 28 which is locked by the anchor wire
release wire 27. The anchor wire catheter 25 passes between the
outer sheath 3 and the inner sheath 4 and extends out of the rear
of the outer sheath manipulator 6. The cap 32 can be removed to
enable release of the anchor wire release wire 27 and pull it
through the anchor wire catheter 25 and the cap 31 can be released
to pull the actual anchor wire 26 back. When the anchor wire
release wire 27 is withdrawn the knot 28 is unlocked and the suture
30 is released and the anchor wire 26 is released from the stent
graft body 16.
[0061] The diameter reducing ties 21 on the limb 19 are activated
by the release of the trigger wire mechanism 35 on the deployment
catheter 1. The diameter reducing ties 20 on the proximal body
portion 17 are released by means of the trigger wire release
mechanism 36. Trigger wire 38 extends from the diameter reducing
ties 20 to the release 36 and trigger wire 39 extends from the
diameter reducing ties 21 to the release 35.
[0062] This then generally describes the deployment apparatus but
to assist with understanding reference will now be made to FIGS. 2A
to 21 which show various stages of deployment of a stent graft
using the deployment device discussed in relation to FIG. 1.
[0063] In FIG. 2A it will be seen that the stent graft 16 is
retained within the outer sheath 3 and inner sheath 4 in the manner
discussed above. It will be noted that the limb 19 is outside the
inner sheath 4 but inside the outer sheath 3.
[0064] In FIG. 2B the outer sheath has been withdrawn to allow the
limb 19 to deflect laterally.
[0065] For clarity the portion of the iliac bifurcation into which
the device is deployed according to this invention is not
illustrated in FIGS. 2A and 2B but is shown in dotted lines in
later illustrations.
[0066] As can be seen in FIG. 2C, the deployment device is deployed
in an iliac artery which has a common iliac artery 50 branching
into an internal iliac artery 51 and the external iliac artery 52.
The deployment device has been deployed through the external iliac
artery 52. The common iliac artery 50 is deformed into an
aneurysmal sac and to provide a good place for deployment of a leg
of an endoluminal device to bridge the aneurysm the device of the
present invention is deployed.
[0067] As can be seen in FIG. 2C, the outer sheath 3 has been
withdrawn to a position in which where the limb 19 can escape from
being retained by the outer sheath 3 and the guide wire 14 has been
advanced so that it can extend into the internal iliac artery 51.
It will be understood by those skilled in the field that
radiological techniques can be used to ensure proper alignment
before advancement of the guide wire 14 into the internal iliac
artery 51. Suitable radiopaque markers may be place as needed on
the main body and limb to assist with placement and contrast fluids
may be provided through the deployment device to assist with
visualization of the arterial structure.
[0068] As can be seen in FIG. 2D, once the guide wire 14 has been
deployed into the internal iliac artery 51, the entire device can
be manipulated from outside the patient by being withdrawn slightly
so that the limb 19 extends into the internal iliac artery 51 while
being guided by the already placed guide wire 14.
[0069] Once a sufficient amount of the limb has been deployed into
the internal iliac artery 51, which can be observed by suitable
radiological techniques, the diameter reducing ties 21 on the limb
19 are released by removal of the trigger wire release 35 and the
limb 19 expands under the effect of self expanding stents to engage
with the walls of the internal iliac 51 as particularly can be seen
in FIG. 2E. It will be noted that fibres 55 are included on the
limb 19 to improve adhesion onto the wall of the internal iliac
artery 51 by encouraging ingrowth.
[0070] As can be seen in FIG. 2F, the diameter reducing ties 20 on
the proximal body portion 19 have been released by removal of the
trigger wire release mechanism 36 so that the proximal body portion
expands under the effect of self expanding stents to its full size.
At this stage, however, the proximal body portion does not
necessarily engage with the walls of the common iliac artery 50
because of the aneurysmal sac within the vessel 50.
[0071] In the next stage, as shown in FIG. 2G, the inner sheath 4
is withdrawn to release the distal body portion 18 which expands
under the effect of self expanding stents to engage against the
walls of the external iliac artery. At this stage the deployment of
the iliac branched stent graft is essentially completed and the
nose cone 8, guide wire catheter 9 and internal sheath 4 along with
the separate guide wire catheter 13 and guide wire 14 can be
withdrawn leaving the outer sheath 3 in place for deployment of
other devices through the iliac branched stent graft 16 as
required. At this stage, however, the anchor wire arrangement may
still be maintained in place to hold the branched stent graft in
place while further deployment occurs through the device.
[0072] Deployment of subsequent devices can be carried out over
guide wire 57 which remains in place after removal of the iliac
branched stent graft deployment device.
[0073] FIG. 2H for instance shows the leg 56 of a further stent
graft deployed within the proximal end of the proximal body portion
17.
[0074] After deployment of further stent grafts as required, the
anchor wire arrangement can be withdrawn by withdrawal of the
anchor wire release wire 27 which releases the knot 28 so that the
anchor wire 26 and the anchor wire catheter 25 can be then be
withdrawn to leave the situation shown in FIG. 2I.
[0075] It will be seen generally by this invention that a stent
graft can be deployed into a blind vessel such as an internal iliac
and then that stent graft anchored while further stent grafting is
occurring.
[0076] The use of an anchoring system using an anchor wire
catheter, an anchor wire and an anchor wire release is not
restricted to this application but may be used in other situations
where a temporary anchoring of a stent graft is desirable.
[0077] Throughout this specification various indications have been
given as to the scope of the invention but the invention is not
limited to only one of these but may reside in two or more of these
combined together. The examples are given for illustration only and
not for limitation.
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