U.S. patent application number 10/866617 was filed with the patent office on 2005-02-10 for device and method for staged implantation of a graft for vascular repair.
Invention is credited to Chuter, Timothy A.M..
Application Number | 20050033400 10/866617 |
Document ID | / |
Family ID | 34082623 |
Filed Date | 2005-02-10 |
United States Patent
Application |
20050033400 |
Kind Code |
A1 |
Chuter, Timothy A.M. |
February 10, 2005 |
Device and method for staged implantation of a graft for vascular
repair
Abstract
A graft for repairing defects in arteries is formed from a
flexible graft and at least one attachment system. A device and
method is disclosed for implanting a graft within the vasculature
of a patient, in which the graft is inserted into the patient at a
different stage than the attachment systems, and which allows for
direct percutaneous insertion of the graft and attachment systems.
The method permits control over the position of the graft in the
vasculature during the course of deployment of the graft and
attachment systems by providing for traction forces to be applied
to opposing ends of the graft.
Inventors: |
Chuter, Timothy A.M.;
(Atherton, CA) |
Correspondence
Address: |
William G. Lane
William G. Lane, Inc., P.C.
16485 Laguna Canyon Road, Suite 250
Irvine
CA
92618
US
|
Family ID: |
34082623 |
Appl. No.: |
10/866617 |
Filed: |
June 12, 2004 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10866617 |
Jun 12, 2004 |
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09684008 |
Oct 6, 2000 |
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60157985 |
Oct 6, 1999 |
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Current U.S.
Class: |
623/1.11 ;
623/1.16; 623/1.35 |
Current CPC
Class: |
A61F 2002/065 20130101;
A61F 2/07 20130101; A61F 2/89 20130101; A61F 2220/0016 20130101;
Y10S 623/903 20130101; A61F 2220/0008 20130101; A61F 2/95 20130101;
A61F 2/848 20130101; A61F 2002/075 20130101 |
Class at
Publication: |
623/001.11 ;
623/001.16; 623/001.35 |
International
Class: |
A61F 002/06 |
Claims
I claim:
1. A method for the percutaneous insertion of a graft supported by
at least one attachment system within the vascular system of a
patient, the graft capable of assuming a compressed condition and
an uncompressed condition, and the at least one attachment system
being compressible radially between a compressed and an expanded
condition, the method comprising: percutaneously inserting the
graft into the vascular system; positioning the graft adjacent a
diseased portion of the vascular system; subsequently inserting at
least one attachment system into the graft; and implanting the
attachment system in the graft to form a seal between the graft and
the vascular wall.
2. The method of claim 1, wherein the feeding step includes:
feeding the graft into the vascular system by direct percutaneous
insertion; and thereafter, feeding the at least one attachment
system into the vascular system by direct percutaneous
insertion.
3. The method of claim 2, wherein the graft feeding step includes:
inserting the graft in compressed condition by direct percutaneous
insertion into a point of access to the vascular system over a
prepositioned guidewire; applying a traction force to opposing ends
of the graft to control the position of the graft within the
vasculature; and activating the graft from its compressed condition
to its uncompressed condition.
4. The method of claim 2, wherein the attachment system feeding
step includes: applying a traction force to opposing ends of the
graft to control the position of the graft within the vasculature;
inserting the at least one attachment system in compressed
condition by direct percutaneous insertion into a point of access
to the vascular system over a prepositioned guidewire; positioning
the at least one attachment system within the bore of the graft;
activating the at least one attachment system from its compressed
condition to its expanded condition.
5. The method of claim 4, wherein the traction force applying step
is carried out using a plurality of catheters, each catheter
configured to exert a force on the graft from a different point
outside the vasculature.
6. The method of claim 5, wherein the graft is configured to have a
substantially cylindrical profile having an superior end and a
inferior end, and wherein a first catheter having a first end and a
second end is releasably connected by the first end to the superior
end of the graft and configured so that the second end thereof
extends through a point of access to the vasculature located in the
left axillary artery, and wherein a second catheter having a first
end and a second end is releasably connected by the first end to
the inferior end of the graft and configured so that the second end
thereof extends through a point of access to the vasculature
located in an iliac artery.
7. The method of claim 5, wherein the graft is configured to have a
bifurcated profile having an superior trunk with an superior end
and first and second inferior legs each with an inferior end, and
wherein a first catheter having a first end and a second end is
releasably connected by the first end to the superior end of the
graft and configured so that the second end thereof extends through
a point of access to the vasculature in the left axillary artery, a
second catheter having a first end and a second end is releasably
connected by the first end to the inferior end pf the first leg and
configured so that the second end thereof extends through a point
of access to the vasculature in a first iliac artery, and a third
catheter having a first and second end is releasably connected by
the first end to the second leg's inferior end and configured so
that the second end thereof extends through a point of access to
the vasculature in a second iliac artery.
8. A system for delivering a graft within the vasculature of a
patient, comprising: a graft capable of assuming a compressed
condition and an uncompressed condition, wherein the graft does not
include an expandable frame attached thereto; and a plurality of
catheters having first ends and second ends, each the first end
being releasably connected to the graft, and each the second end
configured to extend through a separate point of access to the
vasculature.
9. The system of claim 8, wherein the graft is configured to have a
substantially cylindrical profile having an superior end and a
inferior end, and wherein the plurality of catheters comprises: a
first catheter having a first end and a second end releasably
connected by the first end to the graft's superior end and
configured for the second end thereof to extend through a point of
access to the vasculature located in the left axillary artery; and
a second catheter having a first end and a second end releasably
connected by the first end to the graft's inferior end and
configured for the second end thereof to extend through a point of
access to the vasculature located in an iliac artery.
10. The system of claim 8, wherein the graft is configured to have
a bifurcated profile having an superior trunk with an superior end
and first and second inferior legs each with an inferior end, and
wherein the plurality of catheters comprises: a first catheter
having a first end and a second end, wherein the first catheter is
releasably connected by the first end to the graft's superior end
and is configured for the second end thereof to extend through a
point of access to the vasculature in the left axillary artery; a
second catheter having a first end and a second end, wherein the
second catheter is releasably connected by the first end to the
first leg's inferior end and is configured for the second end
thereof to extend through a point of access to the vasculature in a
first iliac artery; and a third catheter having a first and second
end, wherein the third catheter is releasably connected by the
first end to the second leg's inferior end and is configured for
the second end thereof to extend through a point of access to the
vasculature in a second iliac artery.
Description
[0001] This application is a continuation-in-part of U.S.
Provisional Application No. 60/157,985 filed Oct. 6, 1999.
FIELD OF THE INVENTION
[0002] The present invention relates to intraluminal grafts and
their attachment systems which are used for repairing defects in
vessels and other lumens within the body. More particularly, the
present invention relates to systems for forming linear and
bifurcated grafts and to methods for delivering such grafts and
their attachment systems to the correct position within the
defective body lumen by staged implantation.
BACKGROUND OF THE INVENTION
[0003] Aneurysms are discrete dilations of the arterial wall. One
of the most common, and among the most life threatening, is an
aneurysm of the abdominal aorta between the renal and iliac
arteries. If untreated, the aneurysm dilates progressively with an
ever increasing risk of rupture and hemorrhagic death.
[0004] One method of treatment is provided by direct surgical
intervention, in which the defective vessel may be bypassed or
replaced using a prosthetic device such as a synthetic graft. The
risks involved in direct surgical intervention of this magnitude
are great, and include an extensive recovery period.
[0005] In recent years a less invasive method of treatment has
evolved through a series of inventions. The details vary, but,
conventionally, a resilient tubular conduit (herein referred to as
a "graft") is introduced into the defective vessel by means of
catheters introduced into the femoral artery, and is attached to
the non-dilated arteries above and below the aneurysm using
expandable metallic or plastic cylinders (herein referred to as
"attachment systems").
[0006] However, the use of generally cylindrical grafts to
reinforce vascular walls in a patient is not without problems. The
known methods for delivering grafts to the required location within
a patient's vascular system conventionally require that an
attachment system be delivered simultaneously with the graft,
axially overlapping the graft and located either on the interior or
the exterior of the graft's lumen, so that upon deployment of the
graft the attachment system is expanded to attach the graft to the
vascular wall. In the prior art, the attachment system is typically
connected to the graft before implantation in the patient by means
such as stitching. Because grafts are conventionally required to be
compressed into a capsule or sheath before being implanted in final
position within the patient's vascular system, delivery capsules or
sheaths must be sufficiently small to enable insertion into the
patient's vessel, and, once inserted, must be sufficiently flexible
to allow bending around corners and branches of the patient's
vascular tree. Yet, as a consequence of the practice of delivering
the attachment system simultaneously with and axially overlapping
the graft, the outer diameter of the delivery capsule or sheath
containing the compressed graft in such cases is increased by the
presence of the compressed attachment system.
[0007] One of the problems encountered in the art of delivering
grafts to the vascular system of a patient is that complications
may be encountered in maneuvering the compressed graft and its
delivery system around the bends and branches of the patient's
vascular system. It will be appreciated that the greater the outer
dimension of the capsule containing the compressed graft to be
delivered, the more inflexible it will be, making delivery to the
final destination more difficult and perhaps even impossible in
some patients.
[0008] Another problem encountered in the art of graft delivery is
that, in the majority of cases, the patient must be subject to
surgery in which the appropriate vessel is surgically exposed and
opened by incision to allow entry of the graft. Significantly, it
is this surgical procedure on the vessel which gives rise to the
most serious complications known in the art of minimally invasive
graft delivery, with complications taking the form of infection,
patient discomfort, and necrosis of the vessel itself. However, if
the outside dimension of the delivery capsule were sufficiently
small, it might be possible, depending on the size and condition of
the patient, to insert the capsule into the patient's vessel by
applying sufficient force to the skin and artery of the patient
with a sharpened end of the graft's delivery capsule, similar to
the commonly known method of inserting a needle directly into the
vein or artery of a patient.
[0009] There therefore exists a need to reduce the outside
dimension of the capsule or sheath containing a compressed graft to
be delivered to the patient's vascular system. This invention
addresses these needs.
SUMMARY OF THE INVENTION
[0010] The present invention provides a device and a method for
delivering a graft to a desired location within a patient's
vascular system, and then, while maintaining the graft's position
by applying traction forces to the ends of the graft, to deliver at
least one attachment system for attaching the graft to the vascular
wall. By delivering the graft and the attachment system in separate
stages, the outside dimensions of the delivery capsules or sheaths
containing the graft and the attachment system separately may be
substantially less than that of a capsule or sheath containing the
graft and the attachment system together. This reduction in outside
dimension of the delivery capsule or sheath facilitates delivery of
the graft and may allow for the direct percutaneous insertion of
the graft and its attachment system, depending on the condition of
the patient.
[0011] One aspect of the present invention provides a device and a
method for repairing a linear vascular structure. A method in
accordance with this aspect of the present invention includes the
use of a linear graft compressible between an uncompressed
condition and a compressed condition, a guide-wire, an upstream
traction catheter and a downstream traction catheter, and at least
one attachment system compressible radially between an expanded
condition and a compressed condition. The guidewire may be placed
to run between a first access point in the vascular structure
located superior to the defective portion of the vessel to be
repaired, and a second access point located inferior to the
defective portion of the vessel. By using the traction catheters
releasably connected to the graft, the graft in a compressed
condition is fed over the guidewire to a desired position within
the vascular structure, whereupon the graft is released from its
compressed condition to revert toward its uncompressed condition.
While maintaining the graft in a desired position by applying
traction forces through the traction catheters to both ends of the
graft, at least one attachment system in compressed condition is
fed over the guidewire to a desired position within the graft,
whereupon the attachment system is expanded to its expanded
condition. In the preferred embodiment, all elements of the repair
are introduced into the vascular system by direct percutaneous
insertion. When the required number of attachment systems have been
inserted and expanded within the graft, the traction catheters are
released from the graft and are withdrawn from the vascular system
together with the guidewire, leaving the graft attached to the
vascular wall.
[0012] Another aspect of the present invention provides a device
and a method for repairing, by direct percutaneous delivery of the
graft and attachment system, a bifurcated vascular structure having
an aortic branch and left and right iliac branches projecting from
the aortic branch at a point of bifurcation. A method in accordance
with this aspect of the present invention includes the use of a
bifurcated graft foldable between an uncompressed condition and a
compressed condition and having a superior trunk and left and right
inferior legs or leg portions projecting from the superior trunk at
a point of bifurcation, a first and a second guidewire, an upstream
traction catheter, a left downstream and a right downstream
traction catheter, and at least one attachment system, compressible
radially between an expanded condition and a compressed condition.
The first guidewire is configured to run between a first access
point superior to the aortic branch of the vascular structure and a
second access point inferior to one of the iliac branches of the
vascular structure. The second guide wire is configured to run
between the second access point and a third access point inferior
to the other iliac branch of the vascular structure. By using the
upstream traction catheter releasably connected to the graft, the
graft in a compressed condition is fed over the first guidewire to
a desired position within the vascular structure. By using the left
and right downstream traction catheters releasably connected to the
left and right inferior legs of the graft respectively, the left
and right inferior legs of the graft may be pulled into the left
and right iliac branches of the vascular structure. Once located at
the desired position within the vascular system, the graft may be
released from its compressed condition. While maintaining the graft
in its desired position by applying appropriate tension to at least
one traction catheter, at least one attachment system in compressed
condition may be fed over one of the guidewires to a desired
position within the graft, whereupon the attachment system may be
expanded or allowed to expand. When the required number of
attachment systems have been inserted and expanded within the
graft, the traction catheters are released from the graft and are
withdrawn from the vascular system together with the guidewires,
leaving the bifurcated graft attached to the vascular wall. In the
preferred embodiment, all elements of the repair are introduced
into the vascular system by direct percutaneous insertion.
[0013] By allowing the graft to be delivered at a different stage
than the attachment system (or attachment systems), the diameter of
the capsule or sheath delivering the graft may be reduced.
Furthermore, it will be appreciated that, because the graft of the
present invention may be pulled, rather than pushed, into position,
the delivery capsule does not suffer adversely from the reduced
resistance to kinking which otherwise follows from its reduced
diameter. On the contrary, the reduction in diameter of the
delivery capsule, combined with its placement by a traction force,
allows greater flexibility which has the advantage of facilitating
delivery of the graft through the branches of the vascular system.
It also has the advantage, in suitable cases, of permitting
delivery of the graft by a direct percutaneous insertion, without
the need for a further surgical procedure to provide access into
the vascular system of the patient. If such a surgical procedure
can be avoided, it may be possible to use the procedure of
minimally invasive luminal repair in a wider range of situations by
a wider range of medical personnel. For example, it may be used as
an outpatient procedure in which the patient is not hospitalized.
It will be appreciated that outpatient treatment in this context
will be considerably less costly than inpatient treatment to
achieve the same result, and will be substantially more convenient
for the patient.
[0014] Other features and advantages of the present invention will
become apparent from the following detailed description, taken in
conjunction with the accompanying drawings, which illustrate, by
way of example, the principles of the invention.
BRIEF DESCRIPTION OF THE DRAWINGS
[0015] FIG. 1 is a sectional schematic view of the vascular system
of a patient, showing the relationship of the aorta to the renal,
axillary, iliac and femoral arteries, and also showing a guidewire
configured to run between access points in the left axillary and
the right femoral arteries;
[0016] FIG. 2 is a perspective view of the repair assembly, showing
the graft compressed by a sheath; also shown are the relative
positions of the upstream and downstream traction catheters and
guidewire, prior to insertion into the vascular system;
[0017] FIG. 2a is a section through the upstream catheter, sheath
and guidewire of FIG. 2;
[0018] FIG. 3 is a schematic view showing the guidewire of FIG. 1
threaded downwards through an upstream traction catheter, through
the bore of a tubular graft, and exiting the graft at its inferior
end; a collection catheter is also shown, threaded over the
guidewire from the first access point;
[0019] FIG. 3a is a sectional view of the releasable connection
between the collection catheter and the upstream traction
catheter;
[0020] FIG. 4 is a perspective view of the repair assembly after it
has been pulled superiorly by the upstream traction catheter until
the graft is located in the aorta, shown here in section;
[0021] FIG. 5 is a perspective view showing the graft in an
uncompressed condition within the aorta after the sheath has been
withdrawn, while held in position by the upstream and downstream
traction catheters;
[0022] FIG. 6 is a perspective view of the graft (shown cut away)
of FIG. 5, with a delivery assembly being introduced over the
guidewire;
[0023] FIG. 6a is a cross-sectional view of the delivery assembly
of FIG. 6, showing an attachment system contained in a compressed
condition by a sheath, and releasably connected to a pushrod;
[0024] FIG. 7 is a perspective view of the graft of FIG. 6, in
which the attachment system is shown in its expanded condition;
[0025] FIG. 7a is a perspective view of the embodiment of the
attachment system shown in FIGS. 7, 14 and 15.
[0026] FIG. 7b is a perspective view of an alternative embodiment
of an attachment system suitable for use with the present
invention.
[0027] FIG. 8 is a sectional schematic view of the vascular system
of a patient, showing the relationship of the aorta to the renal,
axillary, iliac and femoral arteries, and also showing a first
guidewire and a second guidewire configured to run between access
points in the arteries;
[0028] FIG. 9 is a schematic view showing the first and second
guidewires of FIG. 8 and their relationship to a bifurcated graft
and upstream and downstream traction catheters, before they are
introduced into the vascular system; a relay catheter is also
shown, threaded over the second guidewire entering the vascular
system from the third access point and exiting at the second access
point;
[0029] FIG. 9a is a sectional view through the relay catheter of
FIG. 9 after it has been passed over the second-guidewire, and
showing an empty lumen ready to receive the left downstream
traction catheter;
[0030] FIG. 10 is a schematic view of the assembly shown in FIG. 9,
after the left downstream traction catheter has been configured to
run between the second and third access points;
[0031] FIG. 11 is a perspective view of the bifurcated graft shown
in FIGS. 9 and 10, after it has been enclosed by a sheath confining
the graft in a compressed condition;
[0032] FIG. 11a is a sectional view of the right downstream
traction catheter, showing the second guidewire threaded through a
lumen;
[0033] FIG. 12 is a perspective view of the graft in compressed
condition within the aorta (shown cut away) before the graft is
finally positioned, and showing the relationship between the graft,
the sheath, the traction catheters and the guidewires;
[0034] FIG. 13 is a perspective view of the bifurcated graft of
FIG. 12, after the graft has been pulled inferiorly to allow the
left and right inferior legs of the graft to enter the left and
right iliac arteries respectively; a sheath is also shown,
partially removed, confining the graft in a compressed
condition;
[0035] FIG. 14 is a perspective view (cut away) of the bifurcated
graft of FIG. 13 after the sheath has been removed and after an
attachment system has been deployed within the bore of the graft;
and
[0036] FIG. 15 is a perspective view (cut away) of the bifurcated
graft of FIG. 14 with attachment systems deployed within the bore
of the graft's superior trunk, and within the left and the right
inferior legs.
[0037] FIG. 16 is a schematic view (cut away) of the bifurcated
graft of FIG. 15 shown in combination with the embodiment of the
attachment system shown in FIG. 7b.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0038] The device and method disclosed by the present invention may
be used to deliver to a patient's vascular system a flexible
tubular graft which may be straight, tapered, or bifurcated. In the
preferred embodiment of this invention, the graft may be delivered
to the patient's vascular system without performing surgery on the
patient to open the vessel prior to insertion of the graft; rather,
insertion is achieved percutaneously over a guidewire using the
Saldinger technique or with a small diameter introducer sheath.
Alternatively, insertion is achieved by applying force to the skin
and vessel of the patient with the tapered end of the repair
assembly sufficient to gain direct entry into the vessel. This
method of insertion is referred to herein as the "direct
percutaneous" method of insertion.
[0039] The terms "superior" and "inferior" shall be used herein to
have the same meaning as the terms "up" and "down" respectively and
shall signify ends or directions which are towards and away from
the patient's head, respectively. The terms "right" and "left"
shall be used herein to signify ends or directions which are toward
the patient's right and left sides, respectively. It should be
noted that in the anatomical drawings provided herein, the patient
faces the reader.
[0040] As exemplified in FIG. 1, implantation of a straight or
tapered graft according to the preferred embodiment of the present
invention includes the use of a guidewire 30 with an superior end
32 an inferior end 34, which is configured to run between two
access points of the patient's vascular system. In the preferred
embodiment, if the vascular structure to be repaired is the aorta
40, the first access point 36 is in the left axillary artery 42 and
the second access point 38 is in the right femoral artery 44.
Additionally, the insertion of all elements of repair is
accomplished by percutaneous or direct percutaneous insertion in
the preferred embodiment. In other embodiments, the right axillary
or the left femoral artery may be used, or alternatively any points
of access on opposite sides of the defective vascular structure may
be used.
[0041] As exemplified in FIGS. 2, 2a and 3, in the preferred
embodiment of the present invention, a repair assembly 46 is
provided, comprising an upstream traction catheter 48 with an
superior end 50 and an inferior end 52 and having a plurality of
internal lumens; a downstream traction catheter 54 with an superior
end 56 and an inferior end 58 and having a plurality of lumens,
and; a graft 60 foldable radially between a compressed condition
and an uncompressed condition and having an superior end 62 and an
inferior end 64. In addition, the repair assembly includes a sheath
74, although it is also contemplated that the sheath can be omitted
when it is desirable to do so.
[0042] Grafts are preferably formed from a biocompatible material
having sufficient strength to withstand the implantation procedure
described herein, and to endure the biomechanical forces that will
be imposed on the graft. Such materials may include polyester
materials such as DACRON, polytetrafluoroethylene, polyester
materials, and silicone. Grafts are preferably made from material
formed into woven fabric. The inferior end of the upstream traction
catheter is releasably connected to the superior end of the graft.
The superior end of the downstream traction catheter is releasably
connected to the inferior end of the graft. There are numerous
releasable connections known in the art.
[0043] The repair assembly 46 shown in FIG. 2 is assembled as
follows. As exemplified in FIG. 3, when the guidewire 30 has been
configured within the vascular system as described, protruding from
the access points 36, 38, its inferior end 34 is threaded downwards
first through a lumen of the upstream traction catheter 48 and then
through the bore of the tubular graft 60. A tubular sheath 74,
shown in FIG. 2, is configured to enclose and confine the graft 60
in a compressed condition, and to slidably disengage from the
graft. (For the sake of clarity, the tubular sheath 74 is not shown
in FIG. 3, but, if it had been shown at the stage of assembly
exemplified in FIG. 3, it would be shown having been pulled upwards
over the upstream traction catheter 48 prior to being pulled
downwards over the graft 60 to hold the graft in compressed
condition, as exemplified in FIG. 2.) In a preferred embodiment of
the sheath, the sheath also slidably encloses the upstream traction
catheter 48. In another embodiment, the sheath may enclose the
downstream catheter 54 rather than the upstream catheter. In the
preferred embodiment, the diameter of the sheath varies, having
substantially one diameter extending over that portion of the
sheath surrounding the graft, and having another smaller diameter
extending over that portion of the sheath surrounding the traction
catheter. In a further embodiment, the sheath may have a uniform
diameter. Typical materials for forming the sheath include, for
example, nylon, teflon, polytetrafluoroethylene, polythene and like
materials. Before the graft is inserted in the vascular system, a
portion of the sheath surrounding the upstream traction catheter is
connected to the upstream traction catheter, thereby preventing
relative axial movement between sheath and graft and preventing
premature release of the graft.
[0044] The upstream traction catheter 48 is then moved in an
superior direction over the guidewire 30, eventually exiting
through the first access point 36. This movement may be achieved by
pushing the upstream traction catheter over the guide wire from the
second access point 38 into the vascular system of the patient,
until it protrudes from the first access point 36. Alternatively,
as exemplified in FIG. 3, a collection catheter 66 with superior
end 68 and inferior end 70 may be passed over the guidewire from
the first access point until the collection catheter protrudes from
the second access point. The inferior end of the collection
catheter is then releasably connected to the superior end 50 of the
upstream traction catheter 48 using any means of connection which
is known in the art. A preferred means of releasable connection is
to screw the inferior end 70 of the collection catheter to threads
72 provided on the superior end of the upstream traction catheter,
as exemplified in FIG. 3a. The collection catheter is then
withdrawn superiorly through the first access point 36, thereby
pulling the upstream traction catheter into the patient's vascular
system, until it eventually protrudes from the first access point,
whereupon the collection catheter is disconnected from the upstream
traction catheter. Once either method described above has been used
to advance the upstream traction catheter superiorly over the
guidewire until its superior end protrudes from the first access
point, differential tension may be applied to the upstream and the
downstream traction catheters 48, 54 in order to introduce the
graft into the desired position in the aorta 40, as exemplified in
FIG. 4.
[0045] The position of the repair assembly 46 and graft 60 within
the vascular system may be ascertained by using flouroscopic
methods that are known in the art. For example, a radio-opaque
marker 78 may be attached to the inferior end of the sheath 74, as
exemplified in FIG. 4. The marker may take the form of an annular
ring formed from a metal, such as stainless steel or
platinum-iridium, or may consist of any radio-opaque material. Once
located in the desired position, the sheath is withdrawn by sliding
it superiorly, over the upstream traction catheter and over the
graft, thereby releasing the graft from its compressed condition
and allowing it to revert to its uncompressed condition, as
exemplified in FIG. 5. The graft may contain further radio markers
to facilitate its final positioning.
[0046] Next, one or more attachment systems, compressible radially
between a compressed condition and an uncompressed condition, are
introduced into the bore of the uncompressed graft in order to
engage the graft with the vascular wall. There are many types of
attachment systems, or anchors, known in the art that will achieve
the result of fixing the graft to the vascular wall. Such
attachment systems may be self-expanding, may be manufactured from
shape memory alloy such as Nitinol, and may include hooks or barbs.
Alternatively, the attachment systems or anchors may be expandable
by a balloon catheter.
[0047] As exemplified in FIGS. 6 and 6a, the step of introducing an
attachment system into the bore of the graft is achieved by
inserting the attachment system into a delivery assembly 80 which
is then introduced into the bore of the graft over the guidewire
30. As exemplified in FIG. 6a, the delivery assembly includes a
pushrod 82 having superior end 83 and an inferior end 85 and at
least one lumen, and a sheath or jacket 84 surrounding the pushrod
and extending superiorly to provide a cover which applies a
radially compressive force (If the attachment system is
self-expanding) to the attachment system 76 which is releasably
connected to the superior end of the push rod. In the preferred
embodiment the diameter of the sheath varies, having substantially
one diameter extending over that portion of the sheath surrounding
the attachment system, and having another smaller diameter
extending over that portion of the sheath surrounding the pushrod.
The sheath may be manufactured from the same material as the graft
sheath 74, and operates to first confine the attachment system in a
compressed condition and then to release the attachment system when
the sheath is slidably removed inferiorly over the pushrod 82. The
attachment system 76 is delivered to the correct position within
the bore of the graft by applying an superior force to the pushrod,
which slides over the guidewire 30 to the enter the bore of the
graft 60.
[0048] During insertion of the attachment system into the bore of
the graft, the graft may be held in a fixed position by applying
the appropriate tension forces to the two traction catheters 48,
54. When the delivery assembly 80 is being pushed over the
guidewire 30, the sheath and the pushrod are connected to each
other to prevent relative axial movement between the attachment
system and the sheath, thereby avoiding premature expansion of the
attachment system. The position of the attachment system in
relation to the vascular structure may be determined by using
flouroscopic methods such as those described above in relation to
positioning the graft. When the attachment system has reached the
desired position, the sheath is withdrawn by sliding it inferiorly
over the pushrod while holding the pushrod in place. As exemplified
in FIG. 7, withdrawing the sheath allows the attachment system 76
to expand radially (either as a self-expanding or balloon expanded
attachment system) to an expanded condition in which it exerts an
outward radial force on the graft 60 sufficient to attach the graft
to the vascular wall 40. Such attachment may be either frictional
or by means of barbs connected to the attachment system which
penetrate the graft fabric and the vascular wall.
[0049] In one embodiment of a self expanding attachment system
suitable for use with the present invention, an attachment system
may be used which is made from a piece of wire which is bent in a
generally undulating form and configured to have a generally
cylindrical profile. This embodiment of self-expanding attachment
system 76 is exemplified in a deployed state in FIG. 7 (and also as
attachment system 76' in FIGS. 14 and 15), and is exemplified in
full perspective in greater detail in FIG. 7a. The wire undulates
between proximal apices 86 and distal apices 87 which are joined by
connecting legs 88. At each apex, the wire may include a helical
loop 89, to provide a greater range of expansion within the elastic
range of the wire. Hooks 90 may be connected to each proximal apex
by welding or gluing or other suitable connecting means, to enhance
the ability of the attachment system to attach to the vascular
wall.
[0050] In another embodiment, an attachment system 92 suitable for
using with the present invention, exemplified in FIG. 7b, may be
manufactured from a continuous cylinder into which a pattern may be
cut by a laser or by chemical etching to produce slits in the wall
of the cylinder. The resulting structure may thereafter be heat set
to give it a desired final configuration. The preferred final
configuration includes a shape which undulates between proximal
apices 93 and distal apices 94 which are joined by connecting legs
95. Hooks 96 may be added, either by shaping them from the
continuous cylinder, or by welding or gluing them on.
[0051] It will be appreciated by one of skill in the art that, in
the configurations of these previously described two embodiments,
when the attachment system is compressed, its legs and apices are
urged radially outward in a direction generally at right angles to
its axis. Preferably, the self-expanding attachment systems of both
described embodiments are made from a material having highly
elastic properties such as nickel-titanium alloys, including
Nitinol, since the same allows a great amount of expansion and
compression of structures without permanent deformation.
Implantable stainless steel is also known to be satisfactory for
the purpose. An additional material from which such attachment
system may be manufactured is Elgiloy.TM. which is a
chromium-cobalt-nickel alloy manufactured and sold by Elgiloy of
Elgin, Ill.
[0052] It will be appreciated that, as long as the guidewire 30
protrudes from the second access point 38 and runs within the bore
of the uncompressed graft 60, and the traction catheters 48, 54
remain releasably connected to the graft, a plurality of attachment
systems may be sequentially inserted within the bore of the
uncompressed graft in the manner described above.
[0053] Once the required number of attachment systems have been
deployed within the graft, the traction catheters are released from
their connection to the graft and are removed together with the
guidewire, leaving the graft fixedly supported by the attachment
systems within the vascular system.
[0054] Although the description of the aspect of the present
invention set forth above relates to the staged implantation of a
tubular or tapered graft, another aspect of the invention includes
a device and method for the staged implantation of a bifurcated
graft into a bifurcated vascular structure. As exemplified in FIG.
8, the method of implanting a bifurcated graft commences with
placing within the vascular system a first guidewire 30' with an
superior end 32' and an inferior end 34' and a second guidewire 100
with a right end 102 and a left end 104. In the preferred
embodiment, if the vascular structure to be repaired is the aorta,
the first access point 36' is in the left axillary artery and the
second access point 38' is in the right femoral artery. In
alternative embodiments, the right axillary or the left femoral
artery may be used, or any points of access superior and inferior
to the defective vascular structure may be used. In alternative
embodiments, the steps set out below will have to be modified to
accommodate the changes from left to right, and right to left, as
may be necessary. In the preferred embodiment, the second guidewire
is configured to run between the second access point and a third
access point 106 in the left femoral artery.
[0055] Then, as exemplified in FIGS. 9, 10 and 11, a repair
assembly 46' is provided and assembled, comprising an upstream
traction catheter 48' with an superior end 50' and inferior end
52', and a bifurcated graft 108 having an superior trunk 110 with
an superior 112 end, a right inferior leg 114 and a left inferior
leg 118 each with inferior ends 116, 120. Additionally, a right
downstream traction catheter 54' and a left downstream traction
catheter 122 are provided, each with superior ends 56', 124 and
inferior ends 58', 126 and having a plurality of lumens. The repair
assembly also includes a sheath 74', although it is contemplated
that the sheath may be omitted when it is desirable to do so. (For
the sake of clarity, the sheath 74' is not shown in FIGS. 9 and 10,
but, if it had been shown at the stage of assembly exemplified in
FIGS. 9 and 10, it would be shown having been pulled upwards over
the upstream traction catheter 48' prior to being pulled downwards
over the graft 108 to hold the graft in compressed condition.) As
exemplified in FIG. 9, the following steps are undertaken outside
the patient's body to assemble the repair assembly: The inferior
end 52' of the upstream traction catheter 48' is releasably
connected to the superior end 112 of the graft's superior trunk
110. The superior end 56' of the right downstream traction catheter
54' is releasably connected to the inferior end 116 of the graft's
right inferior leg 114. The superior end 124 of the left downstream
traction catheter 122 is releasably connected to the inferior end
120 of the graft's left inferior leg 118. Then, still proceeding
outside the patient's body, the inferior end 34' of the first guide
wire 30', which at this stage is protruding from the second access
point 38', is threaded downward first through a lumen of the
upstream traction catheter, then downward through the bore of the
graft 108, entering the graft at the superior trunk 110 and passing
out of the graft through the right inferior leg 114. Next, the
right end 102 of the second guidewire 100 is threaded first through
the bore of the graft, entering the graft through the graft's left
inferior leg 118 and exiting at the end of the right inferior leg
114, from where it may be threaded into a lumen of the right
downstream traction catheter 54'. It is not essential that the
second guidewire be threaded into a lumen of the right downstream
traction catheter, but doing so helps prevent the guidewire from
subsequently becoming twisted around the traction catheter.
[0056] It is desired that the left downstream traction catheter 122
and the second guidewire 100 be configured to enter the second
access point 38', as exemplified in FIG. 10, and to protrude from
the third access point 106 without being twisted around each other
within the vascular system. In the preferred method of achieving
this configuration, a relay catheter 128 (shown in FIG. 9) with a
plurality of lumens 129 may be passed over the second guidewire, so
that it protrudes from both second and third access points 38',
106. A sectional view of the relay catheter at this stage of the
procedure is exemplified by FIG. 9a. The left end 126 of the left
downstream traction catheter 122 is then passed from right to left
through one of the open lumens 129 of the relay catheter, until the
left downstream traction catheter emerges from the third access
point 106, whereupon the relay catheter may be withdrawn leftwards
from the vascular system to expose both the second guidewire 100
and the left downstream traction catheter 122 passing between the
second and third access points 38', 106 as desired, without
twisting, as exemplified in FIG. 10.
[0057] Before introducing the graft into the vascular system, the
graft is enclosed in a sheath 74', which extends superiorly to
slidably surround the upstream traction catheter 48', as
exemplified in FIG. 11. As in the case of the sheath 74 used to
deliver the straight or tapered graft, the sheath 74' used to
deliver a bifurcated graft may have a varying diameter, and may be
constructed from the same materials.
[0058] Having thus fully assembled the repair assembly 46', the
upstream traction catheter 48', surrounded by the sheath 74', is
then introduced into the vascular system at the second access point
38' until it protrudes from the first access point 36'. This result
may be achieved in the same manner used to introduce the upstream
catheter 48 in the case of the straight or tapered graft, that is,
either by threading the upstream traction catheter upwards over the
first guidewire or by passing a collection catheter downwards over
the first guidewire, and releasably connecting the upstream
catheter to the collection catheter before withdrawing the
collection catheter upwards until the upstream traction catheter
emerges from the first access point.
[0059] As exemplified in FIG. 12, the next step is to draw the
repair assembly 46' into the vascular system of the patient. This
may be achieved by applying an superiorly directed traction force
to the upstream traction catheter 48' until the bifurcated graft
108 in compressed condition is situated in the aorta with the
inferior ends of the graft's inferior legs 114, 118 superior to the
point of bifurcation of the aorta. Inferior traction forces may
then be applied to the left and right downstream traction catheters
48', 122 until the graft is located in the desired position within
the vascular system, as exemplified in FIG. 13.
[0060] Once the bifurcated graft is located in a desired position
within the aorta, the sheath 74' may be slidably removed by
withdrawing it superiorly over the upstream traction catheter 48',
allowing the graft to revert to its uncompressed condition, as
exemplified in FIG. 14. Then, following a technique similar to that
disclosed in the case of the straight or tapered graft above, at
least one attachment system compressible radially between a
compressed condition and an uncompressed condition is provided, and
is fed into the vascular system in a compressed condition over the
first or the second guidewire within a delivery assembly which
includes a sheath or jacket to confine the attachment system in a
compressed condition. Using the same flouroscopic technique as
disclosed above, the attachment system is located at a desired
position within the bore of the graft, and is then expanded or
allowed to expand by removing the sheath. As exemplified in FIGS.
14 and 15, attachment systems 76', 130, 132 maybe inserted over the
first or the second guidewires into the bore of the graft 108. The
graft may be maintained in a fixed position during delivery of the
attachment systems by applying appropriate traction forces to at
least two of the traction catheters, 48', 54', 122. Once the
desired number of attachment systems have been positioned within
the graft, the traction catheters are removed together with the
guidewires, leaving the graft attached to the vascular wall. FIG.
16 exemplifies the graft 108 of FIG. 15, and shows the second
embodiment of the attachment system 92 in deployed position in the
superior trunk and further embodiments of attachment systems 134,
136 in the inferior legs of the graft.
[0061] It will be apparent from the foregoing that, while
particular forms of the invention have been illustrated and
described, various modifications can be made without departing from
the spirit and scope of the invention. For example, at the stage
when an attachment system is fed into the vascular system over a
guidewire, it is not essential to the invention that the guidewire
protrude from the access point opposite to the access point into
which the attachment system is fed. What is essential is that the
guidewire should run into the bore of the graft through the
appropriate inferior leg 114 or 118 (in the case of the bifurcated
graft), and should extend upward into the bore of the graft as far
as is necessary to implant the attachment system within the graft.
For instance, the second-guide wire 100 may be repositioned by
withdrawing it leftwards until its right end 102 is positioned in
the left inferior leg 118 of the bifurcated graft, and by then
pushing the guidewire upwards until its right end is positioned
within the graft's superior trunk 110, or beyond. Such
repositioning may assist in placing attachment systems within the
left inferior branch of the bifurcated graft. Moreover, it is not
essential to the invention that the graft be introduced through the
second access point, but may equally be introduced through the
third access point if the necessary changes are made to the points
of entry/exit of the guidewires and traction catheters.
Furthermore, while the preferred embodiment described above is used
to implant a graft in the aorta, alternative embodiments may be
used to implant a graft in any lumen of the body.
[0062] Furthermore, instead of using self-expanding attachment
systems, balloon expanded attachment systems may be used.
[0063] Accordingly, it is not intended that the invention be
limited, except as by the appended claims.
* * * * *