Note: Descriptions are shown in the official language in which they were submitted.
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1
SUPPORT DEVICE FOR A GRAFT ASSEMBLY
This is a divisional application of application
serial number 2,257,663 which is a divisional application of
Canadian Patent Application serial number 2,130,138 filed
S August 15, 1994.
BACKGROUND OF THE INVENTION
This invention relates to a system and method for
emplacing a prosthesis and, more particularly, to a delivery
catheter and method of use for placement within a corporeal
lumen of a bifurcated graft having attachment systems.
It is well established that various fluid conducting
body or corporeal lumens, such as veins and arteries, may
deteriorate of suffer trauma so that repair is necessary. For
example, various types of aneurysms or other deteriorative
diseases may affect the ability of the lumen to conduct fluids
and in turn may be life-threatening. In some cases, the damaged
lumen is repairable only with the use of prosthesis such as an
artificial vessel or graft.
For repair of vital vessels such as the aorta,
surgical repair is significantly life-threatening. Surgical
techniques known in the art involve major surgery in which a
graft resembling the natural vessel is spliced into the
diseased or
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-2-
obstructed section of the natural vessel. Known procedures
include surgically bypassing the damaged or diseased portion of
the vessel and inserting an artificial or donor graft attached
to the native vessel by an anastomosis.
It is known within the art to provide a prosthesis for
intraluminal repair of a vessel, such as an abdominal aorta
having an aneurysm. The art has taught to provide a prosthesis
positioned in a vessel then securing the prosthesis within the
vessel with hooks or staples that are mechanically extended by
the user. The early prior art devices were large in diameter,
mechanically complex and in turn were susceptible to mechanical
failure. Prior intraluminal grafting systems have embodied
capsule catheters or balloon catheters, but were relatively stiff
and of a relatively high profile. Similarly, the prior art
systems were configured in such a way that the graft was
relatively difficult to deploy in the correct position. In
addi tion, pri or sys terns having a capsule ca theter assembly wer a
usually conf igur ed such that the pros thesis was disposed wi thin
a unitary capsule.
In recent years, several devices have been developed to
attempt to treat an aortic aneurysm through intraluminal repair.
For example, U. S. Pat. No. 4, 140, 126 (Feb. 20, 1979) , Choudhury,
discloses a method and article for performing an aneurysm repair,
wherein a prosthetic graft is utilized to replace the damaged
segment of the blood vessel. A plurality of radially spaced
anchoring pins are located adjacent each end of the graft and
provide means for securing the graft to the wall of the vessel.
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An assembly is provided for moving the graft within the vessel
and permanently anchoring the graft to the wall of the vessel.
U.S. Pat. No. 4, 562, 596 (Jan. 7, 1986) , Kornberg, discloses
a bifurcated aortic graft constructed for intraluminal insertion
having a plu=ality of struts having angled hooks with barbs at
their superior ends. An assembly for inserting the graft and
imp=anting the hcoks l:ltJ the vessel lume.~. is also disclosed.
U.S. Pat. No. 4, 737,899 (Nov. 29, 1903), Lazarus, discloses
an intraluminal grafting system including a hollow graft having
an attachment means located at one end of the graft. The system
includes positioning means for moving the graft within the
vessel, the positioning means having a capsule positioned at one
end for covering the graft attachment means. The disclosed
positioning means further includes an inflatable member for
I5 securing the attachment means within the lumen.
EPO Pub. No. 0 461 791 A1 (Dec. 18, 1991), Barone et al.
discloses an aortic graft and apparatus for repairing an
aneurysm. The disclosed system includes a tube graft secured
within the aorta and an attachment means at each end of the
graft. Intraluminal delivery is accomplished using a catheter
having a balloon for expanding and securing the attachment means.
The graft and attachment means are preferably enclosed by a
sheath which covers the entire graft and attachment means.
U.S. Patent No. 5,104,399 (Apr. 14, 1992), Lazarus,
discloses an intraluminal grafting system including a tubular
graft having attachment means positioned at both ends. The
system includes a positioning means for transporting the graft
through a vessel lumen and for deploying the graft within the
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lumen. The positioning means includes an inflatable member, a capsule and
means for removing the graft from the capsule. The capsule is disclosed as a
rigid cylindrical member covering the entire graft.
EPO Pub. No. 0 508 473 A2 (Oct. 14, 1992), Piplani et al., discloses
an intraluminal grafting system including a catheter having a capsule formed
of a
helical wrap of metal ribbon. A bifurcated gr aft having attachment means is
removably disposed within the capsule. Nleans is provided .or moving the craft
from the capsule, and an inflatable member is provided for securing the
attachment means within a vessel lumen.
U.S. Patent Nc. 5,256,150 (Oct. 26, 1993), Quiachon et al., discloses
a large diameter sheath for use in introducing a catheter in the body of a
patient.
T he sheath includes an flexible elongate sheath tube and a backflow adapter
having a hemostatic valve secured to the proximal extremity of the sheath
tube.
The sheath may be used for introducing a large-diameter deployment catheter
into
a femoral artery of the patient.
U.S. Patent No. 5,275,622 (Jan. 4, 1994), Lazarus et al., discloses
an intraluminal grafting system including a catheter having a capsule formed
of a
helical wrap of metal ribbon. A tubular graft having attachment means at both
ends is removably disposed within the capsule. Means is provided far moving
the
graft from the capsule, and an intlatabie member is provided for securing the
attachment means within a vessel lumen.
-4-
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To provide consistency with the common usage of terms used
in the medical surgical arts in the United States, the terms
"proximal, distal, inferior and superior" are used with a certain
regularity within the present specification. Proximal refers
S to parts of t'.-ie s;rstam, such as cat:~eters, carsules and wires,
which are closest to the user and closest to the portion of the
system outside or extericr of the patient. Distal refers to the
point farthest from the user and typically mast interior to the
corporeal lumen. The term superior refers to a location situated
above and is used herein in description of the graft and
attachment system. Inferior refers to the point situated below
and again is used herein with the graft and attachment system.
Thus, for applications in the abdominal aorta which use a femoral
approach, the superior end of the graft resides within the most
distal portion of the delivery catheter. Likewise, the inferior
end of the graft resides within the proximal capsule which is
on the most distal portion of the capsule catheter.
The term "ipsilateral" typically refers to a vessel or
part of a device which resides on the same side in which a device
enters a lumen. For example, the ipsilateral tubular leg of a
graft would be the tubular leg which resides in the iliac artery
in which the capsule catheter enters the aorta. Similarly, the
term "contralateral" refers to a vessel or device residing on
the opposite side of which the main device enters the aorta.
For example, the contra lateral attachment system resides in the
contralateral iliac artery which is on the opposite side of the
aorta from which the capsule catheter enters the aorta.
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SUMMARY OF THE INVENTION
The present invention comprises an intraluminal delivery
system for securing a prosthesis within or between vessels or
corporeal lumens of an animal, such as a human. The preferred
S embodiment of the placement system is ccnfigured for introducing
a graft into a corporeal lumen and positioning the graft in the
ar=a ef the aortic bi'urcstion. The deliver.n system includes
a ballocn catheter, a capsule ca~heter and a capsule jacket.
In general, it is an object of the present invention to
provide an intraluminal graf ring system and method which overcome
the disadvantages of the prior art systems. The present
invention comprises a system and method for implanting a
prosthesis utilizing a catheter assembly having a multiplicity
of capsules. The prosthesis comprises a wye shaped bifurcated
graft having a self-expanding attachment system at each of its
three orifices. Each attachment system is contained within its
own compact capsule during deployment. The graft and capsules
are deployed by a catheter assembly designed for traversing the
femoral, iliac and aortic vessels of a human anatomy.
2o The present system has several advantages over prior art
systems. Far example, the over the wire configuration of the
balloon catheter enables traversing the aneurysm with a guide
wire. Using a guide wire in this manner minimizes the risk of
dislodging thrombus in the aneurysm, since the delivery system
follows the guide wire, thereby preventing the distal tip from
perforating the vessel wall. In addition, using a guide wire
allows for traversing more difficult anatomy. Also, the guide
wire lumen may function as a through lumen for real time
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__
angiograms during the emplacement procedure or to insert
intravascular probes such as intravascular ultrasound systems.
As another advantage, the smaller diameter of the capsule
assemblies of the present invention permit use of the invention
in a larger patient popula~ion because the variances in iliac
vessel diameter . Similarly, the smaller device diameter relative
t~ ,...e i'_iac da.:~2te= -ay al'_ow for easier navigation i.~.side t:~e
corporeal lumen especially with more difficult anatomv.
Likewise, the two capsule segments of the present invention
permit a wider range of graft lengths than available with a
single capsule design. The single capsule systems also require
capsules slightly longer than the graft, which imposes certain
manufacturing and deployment problems. Moreover, the shorter
capsule segments provide a more flexible device, thereby allowing
traversing more difficult anatomy.
In the preferred embodiment, the balloon catheter and the
capsule catheter include capsule assemblies for retaining the
attachment systems, including a distal capsule assembly for
retaining the super for attachment system and a proximal capsule
assembly for retaining the ipsilateral attachment system. Also
included within the delivery system is a contralateral capsule
assembly for retaining the contralateral attachment system. The
capsule assemblies are movable relative to each other to allow
the graft to be emplaced at the desired location in the corporeal
lumen.
Preferably, the delivery system includes a balloon catheter
having a multilumen hollow tube or shaft having a proximal end
provided with an assembly for accepting a guide wire and with
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_g_
an assembly for inflating a balloon or similar inflatable member.
The balloon catheter shaft is of sufficient length that the
proximal end remains exterior the corporeal lumen while the
distal end of the balloon catheter shaft may be positioned
proximate the portion of the corporeal lumen to be repaired.
The balloon catheter further has an assembly for inflating and
deflating the ba=loon. In add'_tion, the balloon ca~:~e~~r is
coupled to a control assembly and a distal capsule for retaining
and releasing the superior end of the graft. In the preferred
embodiment, the control assembly includes a control wire and
handle mechanism which provides movement of the distal capsule
relative to the balloon catheter shaft.
The delivery system also includes a capsule catheter shaped
and sized for positioning within the corporeal lumen. The
capsule catheter comprises a hollow tube or shaft slidably
mounted on the balloon catheter shaft, having a proximal end
exterior the corporeal lumen for manipulation by the user. The
capsule catheter includes a proximal (ipsilateral) capsule
secured to the distal end of the capsule catheter shaft for
retaining the ipsilateralattachment system. The delivery system
is conf figured to provide relative movement between the proximal
capsule of the capsule catheter and the distal capsule of the
balloon catheter for removing the graft from the capsule
assemblies and for subsequently urging the attachment systems
into engagement with the wall of the corporeal lumen.
The placement assembly further includes a capsule jacket
for providing a smooth transition between the parts of the
balloon catheter and capsule catheter. The capsule jacket
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comprises a singled walled jacket or sheath covering the length
of the prosthesis and a double walled section over the capsule
catheter tubular member. The capsule jacket is configured
coaxially with the balloon catheter and capsule catheter, having
a proximal end exterior the corporeal lumen for manipulation by
the user. The distal end of the capsule jacket is single walled
and fla=es cutN3r :ly to a size which is slidably retained cver
the distal capsule when the placement assembl y in deployed in;.o
the corporeal lumen. The capsule jacket distal tip has a
radiopaque marker to facilitate positioning using fluoroscopy
or x-ray techniques.
The present invention includes a bifurcated prosthesis
or bifurcated graft for intraluminal placement in a fluid
conducting corporeal lumen. For most applications the prosthesis
is a hollow bifurcated graft of preselected cross-section and
length. The bifurcated graft is deformable to conform
substantially to the interior surface of the corporeal lumen or
other body part to be repaired. Pr eferably, the bifurcated graf t
is made of a material suitable for permanent placement in the
body such as polytetrafluroethylene or a polyester. The tubular
legs and/or the main tubular member of the graft may be crimped
to resist kinking during and after deployment. During
emplacement, the superior and inferior ends of the bifurcated
graft are positioned within the corporeal lumen and the graft
is configured such that the graft traverses the diseased or
damaged portion of the vessel. To anchor the graft to the wall
of the corporeal lumen, attachment systems are secured to the
superior and inferior ends of the graft.
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The attachment systems for the ipsilateral and contra-
lateral legs of the bifurcated graft are somewhat smaller than
the attachment system used for the main tubular member. The
attachment systems for the legs are sized for emplacement within
the iliac arteries. During deployment, the ipsilateral leg
attachment system resides within the proximal capsule and the
cont=a~a~aral l eg attach:~en~ sys;._:~
y° resides within the
contralateral capsule. The smaller profile of the leg attachment
systems allow them to fit within the smaller capsules which are
configured to fit together within the capsule jacket. Having
the leg attachment system within each capsule allows the
attachment systems to be secured to the tubular legs prior to
deployment. In addition, the encapsulation prevents entanglement
of the attachment systems.
The preferred attachment system has wall engaging members.
The wall engaging members of the superior attachment system are
angled toward the inferior end of the graf t. Similarly, the wall
engaging members of the inferior attachment system are angled
slightly toward the superior end of the graft. The wall engaging
members of both attachment system have sharp tips for engaging
the corporeal lumen wall. The preferred attachment system are
formed into a V-shaped lattice or framework. The frame of the
attachment system allows for elastic radial deformation resulting
in a spring-like effect when a compressed attachment system is
allowed to expand as the graft is released from the capsule
assembly. In addition, radiopaque markers are secured to the
longitudinal axis of the graft to facilitate orientation of the
graft using fluoroscopy or x-ray techniques.
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The delivery -system further includes a contralateral
capsule system for retaining the contralateral leg of the
bifurcated graft. The contralateral capsule system comprises
a retaining capsule, guiding tube and a pull wire. A segment
of the contralateral capsule guiding tube is configured to reside
in the capsule jacket, and the remainder of the guiding tube and
pu~_ w===_ a eye.~.d cut of t:~e distal e_-.d of the capsul a j
ack..
assembly. In addition, a radiopaque marker coil on the guiding
tube coincides with the distal capsule of the balloon catheter
assembly to facilitate orientation, i.e. relative twist, between
the contralateral capsule assembly and the ipsilateral capsule
assembly.
During deployment, the contralateral capsule resides within
the capsule jacket and adjacent to the proximal capsule assembly.
I5 The contralateral capsule guiding tube is traversed through the
contralateral iliac artery in a conventional manner such that
the contralateral leg of the bifurcated graft can be secured
within the contralateral iliac artery. The contralateral capsule
is configured to retain the inferior attachment system secured
to the contralateral tubular leg. Similarly, the contralateral
guiding tube and capsule are conf figured such that the attachment
system will remain within the capsule until such time when the
clinician wishes to remove the capsule and free the attachment
system within the contralateral iliac artery. The contralateral
pull wire is disposed within the capsule jacket and along the
distal capsule assembly and extends out the distal end of the
capsule jacket.
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Deployment of the graft comprises a series of steps which
begins with introducing the main guide wire into the ipsilateral
side of the corporeal lumen using well known surgical techniques.
The contralateral guide wire and guiding tube are then inserted
into the ipsilateral cutdown and are traversed through the
contralateral cutdown using standard transfemoral techniques.
Those t'chniq::es include use of a snare cr Guiding catheter
traversed through the contralateral cutdown to assist in
transferring the contralateral guide wire from the ipsilateral
side of the corporeal lumen to the contralateral side. Next-
as a single deployment catheter assembly, the balloon catheter,
capsule catheter and capsule jacket are manipulated over the
guide wire to position the capsules containing the bifurcated
graft and attachment systems to a desired location within the
corporeal lumen.
Once the graft is in the desired location, the capsule
jacket is withdrawn to expose the entire graft and capsules
containing the attachment systems. As the capsule jacket is
retracted, tension is applied on the contralateral capsule
assembly from the contralateral side of the corporeal lumen,
thereby pulling the guiding tube out of the capsule jacket and
into the contralateral lumen. The attachment systems are then
simultaneously positioned at the desired locations. The distal
capsule is then moved relative to the balloon catheter shaft and
capsule catheter to expose the superior attachment system.
After the superior portion of the graft is removed from
the distal capsule assembly, the inflatable member is moved to
within the circumference of the superior attachment system and
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inflated to urge wall--engaging members into the wall of the
corporeal lumen. The contralateral capsule assembly is then
withdrawn to expose the inferior attachment system of the
contralateral tubular leg. An auxiliary balloon catheter is
then positioned in tre contralateral tubular leg to firmly
secure the contralateral attachment system.
Once t'.~.e coat=aiateral tubular ieg is secured, the
proximal capsule assembly is withdrawn from the ipsilateral
tubular leg, exposing the attachment system secured thereto.
The deployment catheter is then moved to position the inflatable
member proximate the ipsilateral inferior attachment system.
The inflatable member is then expanded to seat the wall engaging
members of the inferior attachment system. The deployment
catheter is then removed from the corporeal lumen. An auxiliary
balloon catheter is then positioned in the ipsilateral tubular
leg to firmly secure the ipsilateral attachment system. All
catheters and guide wires are then removed and the access to the
corporeal lumens closed.
In summary, the invention provides, according to one
aspect, a prothesis having a bifurcation for repairing an aortic
aneurysm close to or involving the aortic bifurcation having an
arterial wall and comprising the aorta and the first and second
iliac arteries extending therefrom and in fluid communication
therewith in a patient, the prosthesis comprising: a main tubular
body; first and second tubular legs joined to said main tubular
body in a bifurcation, said main tubular body and said first and
13
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second tubular legs being formed of a flexible surgically
implantable material, said main tubular body and said first and
second tubular legs having respectively first, second and third
openings therein in fluid communication with each other; first
expandable attachment means for anchoring said main tubular body,
said first attachment means being secured to said main tubular
body adjacent the first opening; second expandable attachment
meara fcr anc:~oring said first tubular lsg, said second
attachment means being secured to said first tubular leg adjacent
the second opening; and third expandable attachment means for
anchoring said second tubular leg, said third attachment means
being secured to said second tubular leg adjacent the third
opening, wherein said prosthesis is capable of intraluminal
implantation by a catheter into the aortic bifurcation through
the first iliac artery such that said main tubular body can be
anchored by said first attachment means in the aorta, said first
tubular leg can be anchored by said second attachment means in
the first iliac artery, and said second tubular leg can be
anchored by said third attachment means in the second iliac
artery.
According to another aspect, the invention provides the
intraluminal graft for permanent implantation in a patient's
vasculature for repairing the vasculature proximate to a
bifurcation in the vasculature, the intraluminal graft being
intraluminally deployed into the vasculature using a catheter,
the intraluminal graft comprising: a main tubular body having a
superior end and configured to reside proximate a bifurcation in
13a
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a vasculature of a patient, the bifurcation forming a first
vessel and a second vessel; a first tubular member having an
inferior end and joined to and in fluid communication with said
main tubular body, said first tubular member configured to
extend into the first vessel; a second tubular member having an
inferior end and joined to and in fluid communication with said
ma_a tubular bcdy, said second tubular member configured to
extend distally into the second vessel; a first attachment
system secured to the superior end of said main tubular body; a
second attachment system secured to the inferior end of said
first tubular member; and a third attachment system secured to
the inferior end of said second tubular member.
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.
13b
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-14
BRIEF DESCRIPTION OF THE DRAWINGS
FIGURE 1 is a top plan view of an intraluminal grafting
apparatus and system incorporating the present invention.
FIG. 2 is a top plan view of a guide wire to be used with
the endovascular grafting system of the present invention.
FIG. 3 is a top plan view of the balloon catheter and
irs_la=a>al lccving ~,~ire c_-' the prese.~.t inve::ticn.
FIG. 4 is a top plan view of the distal cap, control wire,
hypotube and control wire handle assembly of the present
invention.
FIG. 5 is a top plan view of the proximal capsule and
capsule catheter assembly of the present invention.
FIG. 6 is a top plan view of the capsule jacket assembly
of the present invention.
FIG. 7 is a top plan view of a bifurcated graft and
contralateral capsule assembly of the present invention.
FIG. 8 is a partial cross-sectional view of the distal
end of the balloon catheter, capsule catheter and capsule jacket
assemblies taken along the line 8-8 of FIG.1.
FIG. 9 is an enlarged perspective view showing an
embodiment of the distal capsule, distal end of the control wire
and distal cap insert.
FIG. 10 is an enlarged cross-sectional view of the distal
- capsule assembly of the balloon catheter.
FIG. 11 is a cross-sectional view taken along the line
11-11 of FIG. 10.
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FIG. 12 is a partial cross-sectional view of the control
wire and control handle mechanism taken along the line 12-12 of
FIG . 1.
Fig. 13 partial_is a cross-sectional view taken along the
line I3-13 of FIG. 12.
FIG. 14 is a cross-sectional view taken along the line
4-i4 cf _I'. __.
FIG. 15 is a cross-sectional view taken along the line
15-15 of FIG. 12.
IO FIG. 15 is a cross-sectional view taken along the Line
I6-16 of FIG. 12.
FIG. 17 is an enlarged perspective view of the bifurcated
graft and attachment systems of the present invention.
FIG. 18 is an top plan view showing a super for attachment
system as sewn into the main tubular member of the graft.
FIG. 19 is an top plan view showing a inferior attachment
system as sewn into a tubular leg of the graft.
FIG. 20 is an enlarged side plan view showing a superior
attachment system.
2~ FIG. 21 is an enlarged side plan view showing an attachment
system having a supplemental helix torsion spring at the apices.
FIG. 22 is a top plan view showing a piece of yarn sewn
into the main tubular member of a graft adjacent to the vee of
an attachment system.
FIG. 23 is a side plan view of FIG 22. showing a piece
of yarn sewn into the main tubular member of a graft adjacent
to the vee of an attachment system.
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- -16-
FIG. 24 is a top plan view of a torque catheter disposed
over the guiding tube of the contralateral capsule assembly of
the present invention.
FIG. 25 is a cross-sectional view taken along the line
25-25 of FIG. 1.
FIG. 26 is a cross-sectional view taken along the line
?c-~5 c~ r_TG. 1.
FIG. 27 is a partial cross-sectional view of the contra-
lateral tubular leg and attachment system positioned in the
contralateral capsule assembly.
FIG. 28 is a cross-sectional view taken along the line
28-28 of FIG. 8.
FIG. 29 is a partial cross-sectional view of the intra-
luminal grafting system shown positioned within the corporeal
lumen.
FIG. 30 is a partial cross-sectional view of the intra-
luminal grafting system, wherein the capsule jacket has been
withdrawn from the graft.
FIG. 3I is a partial cross-sectional view of the intra-
luminal grafting system, wherein the contralateral tubular leg
and contralateral capsule assembly have been pulled into the
contralateral iliac artery.
FIG. 32 is a partial cross-section view of the intraluminal
grafting system, wherein the distal capsule has been removed from
the superior end of the main tubular member and the inflatable
member has been expanded to seat the superior attachment system.
FIG. 33 is a partial cross-sectional view of the intra-
luminal grafting system, wherein the contralateral capsule has
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been removed from the inferior end of the contralateral tubular leg and an
auxiliary
balloon catheter has been positioned and inflated to seat the inferior
attachment
system.
FIG. 34 is a partial cross-sectional view of the intrafuminal grafting
system, wherein the proximal capsule has been removed from the inferior end of
the ipsilateral tubular leg, releasing the ipsilateral inferior attachment
system into
the ipsiiaterai iliac artery.
FIG. 35 is a partial cross-sectional view of the intraluminal grafting
system, wherein the inflatable member of the balloon catheter has been moved
and inflated proximate the inferior attachment system of the ipsilateral
tubular leg.
FIG. 36 is a partial cross-sectional view of the intraluminal grafting
system, wherein the balloon catheter, capsule catheter and capsule jacket have
been placed in a position for withdrawal from the corpcreal lumen.
FIG. 37 is a top plan view of a bifurcated graft of the present
invention having c; imped tubular legs.
F1G. 38 is a contralateral side view of the bifurcated graft of FIG. 37.
FIG. 39 is an ipsiiateral side view of the bifurcated graft of FIG. 37.
FIG. 40 is an enlarged pers~:ective view of the bifurcated graft.
showing in hidden lines the additional attachment systems placed medial the
ends
of the tubular legs.
F(G. 41 is an enlarged cutaway view of a portion of one tubular leg of
the bifurcated graft of FIG. 40, showing one additional attachment system.
_17_
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-18
DESCRIPTION OF THE PREFERRED EMBODIMENTS
As shown in the drawings and for purposes of illustration,
the invention is embodied in an intraluminal grafting system of
the type having a balloon catheter, a capsule catheter, and a
protective sleeve or capsule jacket. One of the novel features
of the present system is the use of a proximal capsule, a distal
capsule and a ccr.t=alataral capsule to cover tze inferior a:,d
superior ends of a bifurcated graft to be implanted in a corporal
lumen having a bifurcation. This feature provides the capability
of deploying the inferior end of the graft before the superior
end or visa versa. Another novel feature of the present
invention is the use of a sleeve or capsule jacket to create a
smooth transition between the proximal capsule, contralateral
capsule, distal capsule and bifurcated graft. The uniqueness
of the system is accentuated by the con tr of wire and associated
handl a which provide relative movement between the distal capsule
and the balloon catheter. Providing a contralateral capsule
assembly enables including an attachment system in the
contralateral tubular leg while avoiding tangling of the tubular
legs during deployment.
In the present system, the graft is comprised of a
bifurcated tubular prosthesis having superior and inferior
extremities. The superior extremity of the graft comprises a
main tubular member which bifurcates into two tubular legs which
comprise the inferior extremity of the graft. For clarity, the
two tubular legs are referred to herein as the ipsilateral
tubular leg and the contralateral tubular leg. An attachment
system is secured to the superior end of the main tubular member
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-19-
as well as to the inferior ends of each of the tubular legs.
Each attachment system is provided with lumen piercing members
which are covered during deployment by the proximal, distal and
contralateral capsule assemblies. The balloon catheter, capsule
catheter and capsule jacket are configured coaxially so that
relative movement between them provides for deployment of the
graft. '''he inflatab_e member of the ballocn cat::eter is use3
to firmly implant the attachment systems, and thereby the graft,
in the lumen.
In more detail, the intraluminal grafting system 50 is
shown in FIGS. 1-7. As shown in FIG. 1, the system includes a
balloon catheter assembly 51, which is coaxially disposed within
capsule catheter assembly 52, which is coaxially disposed within
capsule jacket assembly 53. The proximal capsule assembly 130,
contralateral capsule assembly 200 and distal capsule assembly
90 are used to contain the bifurcated graft 55. A control wire
assembly 54 is coaxially disposed within a lumen of the balloon
catheter assembly and configured to move the distal capsule
assembly in relation to the other system components. In the
preferred embodiment, the system is used as an over-the-wire
device, such that the balloon catheter is further configured with
a lumen for a guide wire 56. It is contemplated, however, that
the system can also be used with well known fixed wire delivery
system configurations.
As shown in FIGS . 1 and 3 , the intr aluminal grafting system
50 also includes a balloon catheter assembly 51 which consists
of an inflatable member or balloon 60 secured to a flexible
elongate element or balloon catheter shaft 61. As shown in FIG.
CA 02302116 2000-03-31
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__ -20-
25, the balloon catheter shaft is preferably configured with
three lumens; however, the balloon catheter may be configured
with a single, dual or similar multilumen shaft. A guide wire
lumen 63 extends the length of the balloon catheter shaft.
Similarly, a balloon inflation lumen 64 extends from the proximal
end 70 of the balloon catheter to the inflatable member 60,
:,
wi:°.°..n an in~iaL;Cn pCa 83, F.G. F, 1S t,~CViued ~.J a~_Ovv
inflation fluid to enter and exit the inflatable member. The
third lumen 65 is provided for a control wire 91.
The flexible elongate element or balloon catheter shaft
61 is preferably formed of a material suitable far intraluminal
use, such as irradiated polyethylene tubing. The three lumen
balloon catheter shaft is preferably extruded to an outside
diameter of 0.08 inches (2.03 mm). The guide wire lumen 63 has
an inner diameter of 0.042 inches (1.07 mm) . The inflation lumen
64 and the control wir a lumen 65 have identical inner diameters
of 0.022 inches (0.56 mm). However, the lumen inside diameter
may range from 0.015 to 0.06 inches (0.381-1.52 mm) and the
outside diameter may range from 0.035 to 0.1 inches (0.889-2.54
mm) for a multilumen balloon catheter shaft. The balloon
catheter may vary in length to suit the application, for example,
from fifty to one hundred-fifty centimeters.
Referr ing to FIG. 1, the proximal extremity 70 of the
balloon catheter shaft 61 is secured to a splitting adapter 71
which splits the guide wire lumen 63 from inflation lumen 64.
The side arm 72 of the adapter 71 has a stop cock 73 mounted at
its proximal end which is movable between open and closed
positions. The stop cock is provided with a Luer fitting 74
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_ -21-
which is adapted to be secured to a syringe for injecting
inflation fluid. The side arm 75 of the splitting adapter 71
is connected to female Luer fitting 77 for distal tip injection
and to a Touhy Borst adapter 76 which is configured to- removably
and slidably receive the guide wire 56. A strain relief wire
78 is disposed in the control wire lumen 65 between the splitting
adapter and tha control handle assembly 110.
The inflatable member or balloon 60 is preferably secured
twelve centimeters from the distal extremity 80 of the balloon
catheter shaft 61. The balloon is positioned proximal of the
distal capsule assembly 90 and the superior end of the graf t 55 .
For shorter grafts of four to seven centimeters in length, the
inflatable member may be positioned distal of the distal capsule
assembly. The balloon is farmed of suitable material such as
polyethylene. The polyethylene utilized for the balloon is
irradiated to achieve an appropriate balloon size. For larger
diameter balloons, higher tensile strength materials like
polyethyleneterephthalate (PET) is desirable because thinner
walls, hence a lower profile, can be achieved.
The balloon can vary in diameter from twelve to forty-five.
millimeters in diameter and can have a wall thickness ranging
from 0.001 to 0.005 inches (0.0254-0.127 mm). The preferred
balloon made in accordance with the present invention has an
outside diameter of twenty-four millimeters, a diameter equal
to the inner diameter of the graft, and has a wall thickness of
approximately 0.003 inches (0.076 mm). In addition, the balloon
is pleated along its axis for a low profile which facilitates
its introduction into a corporeal lumen of a patient as
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_ -22-
hereinafter described. Further, the deflated balloon is heated
to provide it with a memory of its low profile configuration.
The balloon catheter shaft 61 is provided with an inflation
lumen 64 which is in fluid communication with the inflation port
74. The inflation Iumen is used to inflate and deflate the
balloon 60 by introducing and withdrawing a gas or liquid through
the inf 1 a tion pcr ;.. The ball oon is secured approx'_:na rely twelve
centimeters from the distal extremity 80 of the balloon catheter
shaft. The balloon proximal stem 81 and balloon distal stem 82
IO are heat sealed to the balloon catheter shaft to form a fluid
tight seal. The length of the proximal stem may vary from 0.5
to 1.0 centimeter.
The balloon catheter shaft 61 has an inflation port 83
located approximately ten millimeters distal the balloon proximal
stem 81. In addition, a radiopaque marker 84 is embedded in the
balloon catheter shaft approximately two millimeters distal the
balloon inflation port. Preferably, the radiopaque marker is
a platinum or tungsten coil one centimeter long with an outer
diameter of 0.02 inches (0.508 mm) and is located proximate the
center of the balloon 60. Also, a strain relief or support wire
97 is disposed in the inflation lumen 64 between the distal end
80 of the balloon catheter shaft and the balloon distal stem 82.
It should be appreciated that although a separate
inflatable member has been described in the drawing, an integral
coaxial inflatable member may be provided which is formed of the
same tubing from which the balloon catheter shaft is made. This
can be readily accomplished, as is well known to those skilled
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~w ENDOV-54396 -
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in the art, by using an additional radiation dose for the balloon
region of the shaft.
As shown in FIGS. 1, 3 and 8, the ipsilateral lacking wire
85 runs parallel to the balloon catheter 6I within the capsule
catheter assembly 52. The distal end of the ipsilateral locking
wire may be configured with a proximal locking ring 86 and a
dis to l =ock;ng r '_:~g 8 7 secured approxima =a ~ y t ae l ~.~s mi 1 i i
r..e te= s
apart. The radiopaque locking rings are disposed within the
distal end of the capsule catheter assembly during deployment
and secure the ipsilateral attachment system of the bifurcated
graft 55 within the distal end of the capsule catheter assembly.
In the preferred embodiment, however, only the distal locking
ring is used.
The proximal end of the ipsilateral locking wire 85 is
disposed in the proximal end of the capsule catheter assembly
52. The proximal extremity of the locking wire is configured
with a segment of stainless steel hypotube approximately sixty
millimeters long to form a handle 88. The ipsilateral locking
wire handle is used to laterally move the radiopaque proximal
and distal locking rings 86 and 87 which engage the ipsilateral
attachment system of the ipsilateral tubular leg of the
bifurcated graft 55. Movement of the handle in relation to the
capsule catheter assembly permits removal of the ipsilateral
attachment system from the capsule catheter assembly.
The balloon 60 can also be observed under x-rays if carbon
dioxide is used as the inflation medium, because the blood in
the patient's vessel is more opaque than the gas used for
inflating the balloon. In addition, increased visibility of the
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. ENDOV-54396
-- -24-
balloon can be obtained by inflating the balloon with a diluted
radiopaque contrast solution. In addition, radiopaque bands of
a suitable material such as platinum or a platinum-tungsten alloy
can be placed on the proximal and distal balloon stems 81 and
82 to aid in ascertaining the position of the balloon.
Similarly, radiopaque rods may be inserted in the balloon
inflation lumen.
The intraluminal grafting apparatus also includes a control
wire assembly 54, which is shown in FIGS. 1 and 4. The distal
end of the control wire assembly consists of a distal caDSUle
assembly 90. As shown in more detail in FIGS. 9-11, the distal
capsule assembly comprises a control wire 91 disposed within a
cylindrical distal cap 92 and distal cap insert 96 disposed
within the distal cap. The distal cap insert is secured to the
distal cap by means of an adhesive, solvent bonding, ultrasonic
welding or by heat shrinking. A hollow distal capsule 93 is
secured to the distal cap and coaxially surrounds the control
wire and balloon catheter shaft 61.
The control wire 91 is slidably disposed in the control
wire lumen 65. A longitudinal slot 94 is cut out of the balloon
catheter shaft 61 to expose the control wire lumen and the
control wire. To secure the control wire within the distal
capsule assembly 90, the control wire is threaded through an
opening 98 in the distal cap insert 96. The control wire is
formed in a U-shaped bend over the opening in the distal cap
insert and is configured to slide within the slot and the control
wire lumen of the balloon catheter shaft. The distal end 95 of
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-25-
the control wire resides in the portion of the control wire lumen
beyond the distal end of the slot.
The configuration shown in FIGS. 9-11 allows the distal
cap assembly to move axially along the balloon catheter shaft.
The U-shaped bend of the control wire through the distal cap
insert, however, prevents the distal cap assembly from rotating
in relation to the balloon catheter shat. As desc-~hP~ ah~,~o
the distal cap insert is firmly secured within the distal cap
92. To prevent rotation of the distal cap, a three centimeter
length of the control wire extends distal of the distal cap and
is slidably disposed in the control wire lumen 65 of the balloon
catheter shaft 61.
As shown in FT_G. I0, balloon catheter proximal cap 100
is secured to the balloon catheter shaft 61 at a position distal
the balloon distal stem 82 and proximal the aperture 94. The
proximal cap is secured to the balloon catheter shaft by adhesive
and by means of two reta i ping bumps 101 and 102 . These retaining
bumps secure the proximal cap in place, limiting its movement.
Such a configuration provides a rounded, atramatic transition
from edge I03 of the distal capsule 93 resting on the top surface
of the proximal cap when the distal capsule is its most distal
position.
As the control wire 91 is moved in a longitudinal manner,
the distal end 95 of the control wire, the distal cap insert 90,
the distal cap 92 and the distal capsule 93 each move as a single
assembly. The proximal edge 103 of the distal capsule is rol led,
curved or crimped inward, or deburred and smoothened so that the
proximal cap will provide a smooth transition along the distal
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._ -26-
capsule assembly 90 when the distal capsule is advanced. The
distal movement of the distal capsule is limited by a third
retaining bump 99 positioned approximately 2.5 centimeters distal
the balloon distal stem 82. The third retaining bump limits the
amount of distal movement of the distal capsule assembly so that
when the assembly is fully advanced the proximal edge of the
distal capsule coincides with the top surface of the prexi~al
cap 100.
Referring to FIG. 9, the distal cap 92 may be formed from
polycarbonate or other suitable material for insertion through
the body lumen. The distal cap is formed with a bare 1oa
approximately the same diameter as the outer diameter of balloon
catheter shaft 61. Similarly, the distal cap insert 96 may be
farmed of the same material as the distal cap, wherein the distal
cap insert is provided with a bore 105 for receiving the balloon
catheter shaft. The distal cap is further provided with a recess
106 or other means for receiving the distal end of the distal
capsule 93. The distal capsule is preferably formed of stainless
steel, but may be formed cf other suitable biocompatible
material, such as a nickel titanium.
Each of the pieces of the distal capsule assembly 90 fit
snugly in a coaxial configuration. The distal cap recess 106
is angled to allow crimping of the distal capsule 93 to the
distal cap 92. In addition, the distal capsule is configured
with a longitudinal semicircular recess 107 in which the guiding
tube 206 resides during deployment. Similarly, the distal cap
is configured with a cutout slot 108 and the distal cap insert
96 is configured with a longitudinal recess 109 to accept the
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-27-
recess in the distal capsule. The distal cap cutout inhibits
the relative rotation between the distal capsule proximal cap
100 and ultimately the balloon capsule shaft 6I.
The proximal-cap 100 is configured with two concentric
alignment holes 140 in its walls. The alignment holes may range
from 1.5 to 2.5 millimeters (preferably 2.5) in diameter and are
i~r.i~ed ~.~ ~"?.~ny~rS fr th d~ -i
m __ ~ om a =seal e,.ge of the p=oxi.~.,al ca5.
The alignment holes, which are not radiopaque, are used under
fluoroscopy during the deployment of the graft 55 to indicate
the optimal orientation of the main tubular member 170 as the
superior attachment system 175 is released from the distal
capsule assembly 90.
The outside diameter of the distal cap 92 and capsule 93
may range from 4 to 9 millimeters and is preferably 0.282 inches
(7.16 mm) in outer diameter and 0.276 inches (7.01 mm) inner
diameter. Similarly, the balloon catheter proximal cap 100 is
comprised of stainless steel and has an outside diameter slightly
less that of the distal capsule so as to provide a smooth
transition. The proximal end of the proximal cap is preferably
rounded to minimize trauma in the vessel and to facilitate
balloon retraction into the bifurcated graft 55 during the
emplacement process. The distal capsule may range in length from
one to five centimeters, and preferably is 3.5 centimeters long
so as to adequately retain the superior extremity of the main
tubular member of the graft.
As shown in FIGS. 12-16, a handle assembly lI0 is secured
to the proximal end of the control wire 91. The handle assembly
comprises a proximal body 111, a distal body 112, a control knob
CA 02302116 2000-03-31
.
ENDOV-54396
__ -28-
113 with rotating shaft 114 and a hypotube 115. The two handle
body parts have a central bore 119 for receiving the balloon
catheter shaft 61. A retaining pin 129 may be used to secure
the two pieces of thehandle body together.
The hypotube 115 is coaxially disposed over the balloon
catheter shaf t 61 and extends distally from the central bore 119
in the d=seal handle body 112. The proximal end of the hypotube
is secured to the balloon catheter shaft approximately one
centimeter proximal from the distal end of the distal handle bodv
by means of a polyethylene sealing tube 116 which is heat shrunk
over the proximal end of the hypotube. An adhesive may be used
to fix the distal handle body to the hypotube.
Hypotube 115 consists of a rigid thin wall tube for:aed
of a suitable material such as stainless steel. The hypotube
has a length of about 55 centimeters and has an outside diameter
of 0.095 inches (2.41 mm) and an inside diameter of 0.087 inches
(2.2I mm). When a crimped graft 55 is used, the hypotube may
have marker bands (not shown) at predetermined positions distal
of the control handle body II2. A crimped graft is loaded into
the capsule assemblies in its most stretched configuration.
After the capsule jacket assembly 53 is retracted, then
adjustments need to be made to the position of the hypotube
relative to the capsule catheter assembly 52 for the graft to
resume its crimped length under physiological pressure. The
marker bands facilitate the correct positioning of the inferior
end of the graft.
Referring to FIG. 12, the control wire 91 resides in a
balloon catheter lumen 65 and extends from the distal capsule
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-29-
assembly 90 to an aperture I17 located in the lumen just proximal
of the proximal end of the hypotube 115. The control wire
preferably consists of an elongate solid flexible stainless steel
wire having a lubricating coating, such as fluorinated ethylene-
propylene (FEP). The coated control wire is about 0.02 inches
(0.508 mm) in diameter, providing sufficient strength to move
t:e dicta; capsulA asse:~J'_y withou= buck;_..~.g cr k'_-::c'_ng.
The prcximal end of the cants of wir a 91 is disposed wi thin
a retaining rack 120, approximately six centimeters long and
having a central bore to secure the control wire. The retaining
racks's proximal end is slidably disposed within a 1 ongitudinal
guiding slot 121 in the proximal handle III. Similarly, the
retaining rack's distal end is slidably disposed within an
longitudinal slot 122 in the distal handle body 112.
The retaining rack 120 is configured with teeth 123 along
a longitudinal edge which engage a pinion or gear I24. The
pinion is attached to a lower end of the rotating shaft 114.
The upper end of the rotating shaft is secured within the control
knob 113 such that rotation of the control knob rotates the gear
and in turn moves the retaining rack longitudinally within the
guiding slots. Longitudinal movement of the retaining rack
causes longitudinal movement of the proximal end of the control
wire 91, causing like longitudinal movement of the distal end
95 of the control wire and of the distal capsule 93. As shown
in FIGS . 13 and 15 , a locking screw I18 is conf figured to f ix the
retaining rack in place. The locking screw ensures that the
control wire and distal capsule will not move even if torque is
applied to the control knob.
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. ENDOV-54396
-30-
At the base of the control knob 113 is a locking gear 125
which has curved teeth. The curved teeth engage a locking pin
126 biased by a locking spring 127 disposed within a recess 128
in the upper surface of the proximal body 111 of the control
handle 110. The configuration of the curved teeth allows the
control knob to turn in only one direction while the locking pin
e:,gages tze locki, _ C°a= . rNi:e.~, =a lcc:~;~ . p;.-. i -,~ ~ to
s ~....~: a..
compress the locking spring, then the control knob may be turned
in either direction. The locking gear is preferably molded as
par t of a plastic control knob, but may be a separate mechanism
secured to the base of the control knob.
As shown in FIGS. 1 and 5, the capsule catheter assembly
52 consists of a proximal (ipsilateral) capsule catheter assembly
130 secured to the distal end of a flexible elongate tubular
member 131 formed of a suitable plastic material such as
polyether block amide available under the tr ademar k "PE3AX" ,
available from Atochem Polymers, Glen Rock, N.J. The capsule
catheter elongate tubular member is of a suitable length as, for
example, forty to one hundred centimeters and preferably
approximately seventy-five centimetersfor the abdominal aortic-
iliac arteries and approximately ninety-f ive centimeter s for the
thoracic aortic artery. The elongate tubular member has a
preferred outside diameter of 0.187 inches (4.75 mm) and an
inside diameter of 0.125 inches (3.175 mm) . The elongate tubular
member can be produced in a certai n color such as blue. To
render the elongate tubular member radiopaque under x-rays, its
material of construction may contain a radiopaque material, such
as twenty percent by weight of bismuth subcarbonate or barium
CA 02302116 2000-03-31
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-31-
sulfate. The elongate tubular member may have markings or bands
distal of the wye adapter 145 at predetermined positions to
indicate capsule jacket retraction and locking points.
The proximal catheter assembly 130 includes a proximal
(ipsilateral) capsule 132 mounted on the distal extremity of the
capsule catheter elongate tubular member 131. The elongate
~~yu~?= :1E.'.::.~= 3.S S2:'J25 dS a Sh3_'= f~= ~G~Vd2~.c~:17 th°_
~~~:Xi:.,c'=
capsule, as hereinafter described. Thus, the elongate tubular
member should have a diameter which is less than that of the
proximal capsule, preferably having an outside diameter ranging
from three to seven millimeters.
The proximal capsule 132 is configured to approximately
match the size of the distal capsule assembly 90. The proximal
capsule is somewhat oval in shape, having opposite concave and
convex outer surfaces, resembling a crescent moon (FIG. 28).
The proximal capsule has a preferred diameter ranging from four
to nine millimeters, which may be configured to accommodate
different size grafts. The proximal capsule is preferably made
of stainless steel or similar impermeable and rigid, or semi
flexible material.
Referring to FIG. 8, the proximal (ipsilateral) capsule
132 is secured to the distal extremity of the elongate tubular
member 131 by means of a capsule adapter assembly 133. The
capsule adapter assembly comprises a housing 134 and an inner
sleeve 135, which may be constructed from polycarbonate. The
capsule adapter housing distal extremity 136 is secured in the
proximal extremity of the capsule, for example, by crimping, by
using a press fit swaging or an adhesive such as a cyanoacrylate
CA 02302116 2000-03-31
ENDOV-54396
-32-
ester. The capsule adapter housing distal extremity may be
angled to facilitate securing the housing to the proximal
capsule.
The proximal extremity of the capsule adapter housing 134
is secured to the distal extremity of the elongate tubular member
131 by means of an cyanoacrylate ester adhesive, or other
suitable mea:.s. '='o fscil.tate a mecZa.~.ical lock, the elongate
tubular member distal extremity is molded to form a flange I3?,
wherein the capsule adapter housing is conf igur ed so as to cl ose
around the flange. The capsule adapter housing is further
provided with a recess for receiving the capsule adapter inner
sleeve 135. The inner sleeve is provided with a bore of a
suitable diameter so as to allow the balloon catheter shaft 61
to reside therein. The inner sleeve may further be provided with
radiopaque marker rods or flat ribbons 138 for detection of the
capsule adapter assembly 130 during fluoroscopy. In the
preferred embodiment, the flange is bonded to the capsule adapter
134 without using the inner sleeve.
A female Luer adapter with barb (not shown) is secured
to the proximal extremity of the elongate tubular member 131 of
the capsule catheter assembly 52 and a wye adapter 145 is secured
to the female Luer adapter. The central arm 146 of the wye
adapter is connected to a Touhy Borst adapter 147 which tightens
around the hypotube 115 disposed in the central arm of the wye
adapter. The side arm 148 of the wye adapter has a stop cock
149 mounted therein which is movable between open and closed
positions. The stop cock is provided with a Luer fitting 150
which is configured to accept a syringe for injecting a dye or
CA 02302116 2000-03-31
ENDOV-54396
-33-
other fluid. The side arm is also configured with a Touhy Borst
adapter 153 which tightens around the ipsilateral locking wire
85 or preferably with a collet lock mechanism and O-ring (not
shown) Which tightens around the ipsilateral locking wire for
hemostasis. The ipsilateral locking wire is disposed in the
capsule catheter assembly 52 through the side arm of the wye
h ~, , w ~- ~. ~, ~ ~ 61 and
ad~D d..~.d b'~rJe_.. ~_ a ba_~OOn Ca_:le _8_ s..d_
elongate tubular member 131.
Air may be purged from the capsule jacket assembly 53 by
inj ec ring fluid thr ough the Luer f it ring 150 in the s ide arm 14 s .
The injection fluid and air will exit purge ports 151 and 152,
thereby filling the capsule jacket assembly with injection fluid.
The Luer fitting also may be attached to a saline drip line
during the operative procedure and may be used for contrast hand
syringe injections for real time angiograms. In addition, a
length of polyethylene tubing 154 is adhered over and distal the
proximal end of the elongate tubular member 131 and over the
distal end of the wye adapter 145 or female Luer adapter to
provide strain relief.
Referring to FIGS. 1, 6 and 8, the capsule jacket assembly
53 is slidably disposed coaxially over the capsule catheter
assembly 52 and the balloon catheter assembly 51 (FIG. 26) . The
capsule jacket assembly is comprised of a main sheath 160, a
support shea th 161, a locking connector 16 2 and a shea th adapter
164. The main and support sheaths are coaxial from their
proximal end, to a point approximately twelve to twenty-five
centimeters from the distal end 163 of the main sheath, depending
on the length of the graft. At the distal extremity of the
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-34-
support sheath, the main sheath flares to a larger diameter
covering the proximal capsule 132, the contralateral capsule 202,
the bifurcated graft 55 and the distal capsule 93. The diameter
of the main sheath is about 0.263 inches (6.68 mm) at its
proximal end and about 0.3 inches (7.62 mm) at the distal end
163.
The pr oxima 1 ends of the shea the =60 and 161 may be secur ed
to the sheath adapter 164 of the locki:.g connector by mechanical
means and by adhesive. In addition, a length of polyethylene
tubing 167 is adhered over the sheath adapter and over the
proximal ends of the sheaths to secure the parts from separating.
The distal end of the main sheath of the capsule jacket is
provided with radiopaque marker 166 about five millimeters in
longitudinal length.
When the capsule jacket assembly 53 is in its most distal
position, the distal end 163 of the capsule jacket main sheath
160 extends to cover at least a portion of the distal capsule
assembly 90. Similarly, the capsule jacket locking connector
162 is thereby positioned just proximal the proximal capsule
catheter purge port 151. Prior to insertion into the lumen, the
locking ring 165 is turned down to hold the capsule jacket
assembly firmly in place, thereby maintaining a smooth transition
surface along the length of the intraluminal grafting system 50.
When the locking ring is released, the capsule jacket assembly
may be moved to a furthermost proximal position, wherein at least
a portion of the proximal capsule catheter assembly is exposed.
Thus, the locking connector is positioned just distal the capsule
catheter wye adapter 145. The locking ring may be tightened at
CA 02302116 2000-03-31
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-35-
any intermediate position to firmly secure the capsule jacket
assembly at the desired location. In addition, a radiopaque
marker 166 is provided at the distal end of the main sheath to
facilitate proper linear positioning of the main sheath.
As shown in FIGS. 1, 7 and 17, the intraluminal grafting
apparatus 50 also includes an expandable, collapsible and
C 1 ' 1 s ~ i. T 1 .w1 i ~ , ~ 1
ir.e:C_;:la ~ w_=3_~1... :,a_ 'J SC,..'_3Z' ~;_''.i~C,=t°_'~
Cr~S~~"?°S_S C~ ,=3==
55 for implanting in a body vessel or corporeal lumen. Referring
to FIG. 17, the graft consists of a deformable main tubular
member 170 which bifurcates into an ipsilateral tubul ar 1 eg 171
and a contralateral tubular leg 172. The main tubular member
and tubular legs each are formed of a cylindrical or continuous
wall 173 allowing fluid communication between the superior and
inferior ends of the bifurcated graft.
The main tubular member 170 may have a length in the range
of two to ten centimeters, where 7.5 centimeters is suitable for
most patients. The main tubular member may have a maximum
expandable diameter ranging from four teen to forty millimeter s
and a minimum diameter in a collapsed condition of 0.175 to 0.3
inches (4.44-7.62 mm). The tubular legs 171 and 172 may have
a length in the range of three to ten centimeters, where five
centimeters is suitable for most patients. The graft wall 173
can be woven of any surgical implantable material such as
polytetrafluroethylene or a polyester fiber made from
polyethylene terephthalate (PET), such as "DACRON" (Type 56).
One material found to be satisfactory is "DEBAKEY" soft woven
"DACRON" vascular prosthesis (uncrimped) sold by C.R. Bard of
Billerica, Mass. In order to prevent unraveling of the woven
CA 02302116 2000-03-31
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-36-
material at the ends, the ends can be melted with heat to provide
a small melted bead of material on each end.
FIGS. 37-39 discloses an alternate embodiment of a bifur-
Gated graft 250. Crimps 251 are configured in the ipsilateral
and contralateral tubular legs 252 to resist kinking of the graft
when deployed in a corporeal lumen. The crimps begin just
supericr to the bi'urca4ion from the main tubular Tembe= 253 a..~.d
ara evenly spaced along the tubular leg. The crimps discontinue
approximately five millimeters superior the inferior ends 254
of the tubular legs so as to provide sufficient space for the
inferior attachment systems (not shown) to be sewn into the
inferior ends of the tubular legs. The crimps may be annularly
or helically spaced along the tubular leg. Similarly, crimps
may also be provided in the main tubular member of the graft.
Although a s tandar d size crimp may be used, i t is pref er r ed
to make the crimps 251 radially deeper and less numerous than
produced from standard crimping techniques. Having sparsely
crimped tubular legs 252 reduces the elongation properties of
the bifurcated graft 250. Also, a sparsely crimped graft is
easier to pack into the capsule jacket than a standard crimped
graft. The low bulk and low elongation of the crimped graft
further allows that the inferior ends of the graft may be packed
into smaller diameter capsules. Similarly, the low crimp
elongation factor allows for a higher degree of placement
accuracy in conjunction with marker bands on the hypotube of the
balloon catheter to adjust for the physiologic length of the
crimped graft.
CA 02302116 2000-03-31
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-37-
Whereas the standard crimp have peak widths of about two
times the graf t wall thickness, the crimps 25I of the bifurcated
graft 250 may be of sufficient width, preferably two millimeters,
so as to sew in radiopaque markers 255 on the face of selected
crimps. The radiopaque markers are preferably "C" shaped and
are secured to the edge of the crimp, allowing for twist
detection under fluoroscopy. Similarly, long radiopaque markers
256 and short radiopaque markers 257 are secured to the edoe of
the main tubular member 253 to ensure proper alignment of the
graft 250.
The distance between the crimps 251, or crimp pitch, is
preferably less than the diameter of the tubular legs 252, so
as to resist kinking. The crimp pitch is preferably 3.25
millimeters. The crimped graft 250 of the present invention is
I5 configured wi th cr imps having peaks that are prefer ably one
millimeter deep. So configured, the graft will maintain its high
flexibility even under arterial pressures of over one hundred
mm Hg within the corporeal lumen.
Referring to FIG. 18, a self-expanding superior attachment
system 175 is secured adjacent the superior end 171 of the
tubular member I70. As shown in FIG. 19, a first self-expanding
inferior attachment system 176 is secured adjacent the infer for
end of the ipsilateral tubular leg 171. Similarly, a second
self-expanding infer for attachment system 176 is secured adjacent
the inferior end of the contralateral tubular leg 172. Each
attachment system serves to yieldably urge the graft 55 from a
first compressed or collapsed position to a second expanded
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., -38-
position and provides a fluid tight seal between the graft and
corporeal lumen wall.
Each attachment system is formed of a plurality of vees
177 with the outer apices 178 and inner apices 179 of the vees
being formed with helical torsion springs 180. The attachment
system may be comprised of apices numbering from four to twenty-
four. The springs vieldably urge the legs of each of the vees
outwardly at a direction approximately at right angles to the
plane in which each of the vees lie. The superior attachment
system 175 has both leng legs 181 and short legs 1032 which
stagger the apices along the superior end of the graft 55. The
legs 183 of the infer for attachment system 176, however , ar a of
equal length.
As shown in more detail in FIG. 20, the superior attachment
system 1?5 is comprised of a single piece of wire which is formed
to provide the vees 177 and also to define.the helical torsion
springs 180 between the legs i81 and 132. The two ends of the
single piece of wire can be welded together in one of the legs
to provide a continuous spring-like attachment system. In the
construction shown in FIGS. 17 and 18, it can be seen that the
attachment systems have twelve apices lying in three
longitudinally spaced-apart parallel planes which are spaced with
respect to the longitudinal axis of the main tubular member 170.
. The outer apices 178 residing external of the graft are
staggered; whereas, the inner apices 179 residing within the
graft lie in the same plane. Similarly, the apices will lie in
four planes if the inner apices are also staggered.
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The superior and inferior attachment systems 175 and 176
are secured to the wall 173 of the graft 55 by suitable means
such as a polyester suture material. As shown in FIGS. 18 and
19, sutures or knots 190 are used for sewing the inner apices
179 onto the wall of the main tubul ar member 170 and each tubular
leg 171 and 172. Additional sutures 191 are preferably formed
cn each of the super for lAgs 181 a..~.d 182 to f'_r:~?y sec~.:_--s each
leg to the graat. The legs may be secured so that the apices
lying in each plane are staggered to provide for the minimum
profile when the attachment system is placed in its collapsed
condition.
As shown in FIG. 20, wall engaging members 193 are
preferably secured to the legs 131 and 132 of the attachment
systems 175 and 176 in the vicinity of the outer apices 178 by
suitable means such as a weld 194. The wall engaging members
have a diameter ranging from 0.007 to 0.018. inches (0.254-0.457
mm) and a length frcm 0.5 to 5.0 millimeters. The wall engaging
members are preferably sharpened to provide conical tips 195,
and should have a length which is sufficient for the tip to
penetrate into and perhaps through the corporeal lumen wall.
The wall engaging members of the inferior attachment system 176
are configured in a similar manner.
The superior attachment system 175, inferior attachment
system 176 and the wall engaging members 193 secured then eto are
formed of a corrosion resistant material which has good spring
and fatigue characteristics. One such material found to be
particularly satisfactory is "ELGILOY" which is a cobalt-
chromium-nickel alloy manufactured and sold by Elgil oy of Elgin,
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Illinois. The wire can have a diameter ranging from 0.008 to
0.016 inches (0.203-0.406 mm) , with a smaller diameter wire being
utilized for the smaller diameter grafts. For example, 0.012
to 0.016 inch (0.305-0.406 mm) diameter wire for the frame and
wall engaging members may be used in the larger grafts of
eighteen to twenty-eight millimeters diameter , and 0. 008 to 0. 012
inch (v.2V3 0.305 mm) diameter wire may be used in the s:ialle=
grafts being eight to sixteen millimeters in diameter.
It has been found that the spring force created by the
helical torsion spr'_ngs 180 at the apices 178 and 179 is largel y
determined by the diameter of the wire. The greater the diameter
of the wire, the greater the spring force applied to the legs
181 and 182 of the vees. Also, the longer the distances are
between the apices, the smaller the spring force that is applied
to the Legs. It therefore has been desirable to provide a
spacing of approximately fifteen millimeters between the outer
extremities of the legs 181 of the superior attachment system
175. Similarly, a spacing of approximately ten millimeters
between the outer extremities of the legs 183 of the inferior
attachment system 176 is preferable, although smaller or larger
distances may be utilized.
FIG. 21 shows a low stress configuration of an superior
attachment system 175 or inferior attachment system 176. An
additional helical torsion apex 185 is added along the legs 181,
182 or 183 of the attachment system. The additional apices are
located adjacent the apices at the vees 177 formed by the legs.
Such a conf iguration improves the fatigue characteristics of the
attachment system. In addition, the weld 194 for the wall
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engaging members 193 may be moved down the attachment system leg
181 or 182 to improve fatigue life. Alternatively, a non-round
or non-circular wire, for example, a rectangular, conical or
rounded ribbon wire, may be used to reduce the amount of stress
in the attachment system and still maintain the spring force of
the attachment system.
To foci l irate securing the graft 55 in the ccrporea= lumen,
the conical tips 195 of the wall engaging members 193 on t:.e
superior attachment system 175 may be angled with respect to
longitudinal axis of the main tubular member 170. The wall
engaging members face outwardly from the main tubular member to
facilitate holding the graft in place. Preferably, the conical
tips of the wall engaging members on the superior attachment
system are inclined from the longitudinal axis and toward the
I5 inferior end of the graf t by 55 ° to 90 ° and preferably
about 8 5 ° .
Likewise, the conical tips 196 of the wall engaging members on
the inferior attachment system 176 may be inclined towards the
superior end of the graf t by 30 ° to 90 ° and prefer ably 85
° . gy
angling the conical tips of the wall engaging members so that
they resist the force of the blood flow, the implanted wall
engaging members oppose migration of the graft.
The helical torsion springs 180 placed at the apices 178
and 179 serve to facilitate compression of the graf t 55 to place
the superior and inferior attachment system 175 and 176 within
the capsule assemblies 90, 130 and 200, as hereinafter described.
The compression of the graft is accomplished by deformation of
the helical torsion springs to just outside their elastic limit,
thereby having a small component within the plastic range.
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Placing the apices in different planes and staggering or
offsetting the wall engaging members 193 significantly reduces
the minimum compressed size of the graft. Having the conical
tips 195 and 196 in different planes also helps to prevent the
wall engaging members from becoming entangled with each other.
The natural spring forces of the helical torsion springs serves
to expand the graf t to its expanded position as soon as the
attachment system is f=ee of the capsules.
The graft 55 preferably contains a radiopaque marker system
for locating the graft and for detecting any twisting of the
graft during deployment. As shown in FIG. 17, the radiopaque
marker system is comprised of two sets of relatively long
radiopaque markers I97 and two sets of relatively short
radiopaque markers 198. The radiopaque markers are made of a
suitable material such as a platinum tungsten alloy wire of a
suitable diameter such as 0 . 004 inches ( 0 . 102 mm) which is wound
into a spring coil having a diameter of 0.4 inches (1.0 mm).
The radiopaque markers are secured to the wall 173 by sutures,
using the same material used to secure the attachment system to
the graft.
As shown in FIG. 17, the long radiopaque markers 197 are
located on the wall 173 of the graft 55 in a line parallel to
the longitudinal axis of the main tubular member 170 and extend
along the outside of the tubular legs 171 and 172. The first
marker is positioned 0.5 centimeters from the superior attachment
system 175. Additional markers are positioned intermittently
thereafter for the length of the graft. The last marker in each
set is 0.6 centimeters away from the inferior attachment system
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176. Each long marker has a preferred length of three
millimeters. Thus, the total number of markers in each set
depends upon the length of the graft.
Each of the second set of radiopaque markers 198 preferably
has a smaller length, for example two millimeters, and are
positioned along the longitudinal axis of the inside of the
tubular legs at a positicn 180° from the first set of markers
197. By placi.~.g markers of different lengths along the axis cf
the graft 55, it is possible to ascertain the position of the
l0 graft and to determine whether the ipsilateral and contralateral
tubular legs have twisted between their superior and inferior
ends. Under fluoroscopy, the two sets markers will be exhibited
as two relatively straight lines for an untwisted graft, wherein
a twisted graft will be revealed by a non-linear pattern of
markers. By placing the markers at equal increments apart, it
is possible to use fluoroscopy to ascertain longitudinal
compression or tension on the graft.
As shown in FIGS . 3 7-3 9 , the prefer r ed r adiopague mar king
system for a bifurcated graft 250 having crimped tubular legs
252 includes one millimeter wide by five millimeter long marker
coils 255 sewn to the tubular legs. The tubular leg marker coils
are sewn horizontally every one centimeter on the same
longitudinal axis as the long and short radiopaque markers 256
and 257 sewn on the main tubular member. The radiopaque marker
configuration for the main tubular member remains the same as
described above (FIG. 17). When detecting twist of the graft
under fluoroscopy, the tubular leg markers appear with varying
widths, ranging from one to five millimeters. The tubular leg
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markers, however, appear uniform in size for a tubular leg that
is not twisted.
The sizing of the graft 55 may be performed on a patient-
by-patient basis, or a series of sizes may be manufactured to
adapt to most patient needs. For the repair 'of an aortic
aneurysm, the length of the graft is selected so to span
apnrcximatel,~ c;:e cent'_meter superior and one centimeter inferier
of the aneurysm, w'.~.erein the wall engaging members 193 of t:.e
graft can seat within normal tissue of the vessel on both sides
of the aneurysm. Thus, the graft should be about two centimeters
longer than the aneurysm being repaired. During the preimplant
fluoroscopy procedure, a conventional pigtail angiography
catheter is used to determine the locations of the renal arteries
to ensure the renal ar reties will not be covered by the implanted
graft. Likewise, on the inferior end of the corporeal lumen,
determining the location of the internal iliac arteries ensures
that they will not be covered by the implanted graft. Also, the
diameter of the main tubular member 170 is selected by measuring
the corporeal lumen which will receive the graft by conventional
radiographic techniques and then selecting a graft with a main
tubular member having a diameter at least one millimeter larger
than that measured.
FIGS. 22 and 23 show an alternative embodiment of the
intraluminal graft 55. A segment of polyester yarn 199 or
similar material is used to produce a ~~fuzzy" thrombogenic
surface to reduce blood leakage and improve blood clotting and
coagulation along the superior end of the main tubular member
170. The filaments of the yarn segment are teased apart to
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increase the embolization area. The yarn segment is sutured to
,., the wall 173 of the graft between one or more of the vees 177
of the superior attachment system 175.
FIG. 22 shows the yarn segment 199 positioned on the graft
wall 173 inside an outer apex 178; however, the yarn segment may
also be positioned within the vee of an inner apex I79.
S imi lar ly , yar n seg:,ients may be at Cached to the gr a f t wa ~ 1
adjacent the infer for attachment systems 176 on the ipsilateral
and contralateral tubular legs 171 and 172. Alternatively, the
graft may be made of velour or terry to similarly occlude blood
flow through the ends of the graft adjacent the attachment
system. Likewise, other modifications to the graf t wall may be
made to accomplish the same result.
FIGS. 1, 7, 8, 24 and 27 show the contralateral capsule
Z5 assembly 200 comprising a contralateral capsule 202 and a guiding
tube assembly 205. The purpose of the contralateral capsule is
to retain the inferior attachment system 176 secured to the
contralateral tubular leg 172. The guiding tube assembly is used
to pull the contralater al capsule into the contralater al artery,
e.g., iliac, and is configured to deploy the inferior attachment
system when the contralateral tubular leg is properly positioned.
The contralateral capsule is also configured to connect with a
torque catheter 215 to aid in proper deployment of the contra-
lateral tubular leg.
As shown in FIG. 27, the contralateral capsule 202 is of
sufficient length to contain the contralateral inferior
attachment system 176 secured to the contralateral tubular leg
172. The contralateral capsule prevents the conical tips 196
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of the wall engaging members 193 from contacting the wall of the
body lumen prior_to deployment of the attachment system. The
contralateral capsule is~made from stainless steel ar similar
biocompatible material. The contralateral capsule is typically
1. 5 centimeters long with a internal diameter of 0 . 3 centimeter s .
The contralateral capsule is preferably circular shaped so as
to fit within the i~dentation of the prexi:~al capsule 132, as
Shawn in FIG. 28, and is open a~ its distal end to receive the
inferior attachment system. In addition, the contralateral
capsule may be configured with an indentation (not shown) to
prevent the inferior attachment system from rotating within the
contralateral capsule.
A barbed adapter 203 is fitted within the proximal end
of the contralateral capsule 202 to couple to the distal end of
the torque catheter 215. The barbed adapter is formed around
a polyethylene guiding tube 206 which comprises the distal length
of the guiding tube assembly 205. The distal end of the guiding
tube is flared and expanded just distal of the barbed adapter.
A retaining bump 204 may be formed on the guiding tube just
proximal of the barbed adapter to secure the adapter in place.
As shown in FIG. 8, the barbed adapter is further configured with
a bore in which the guiding tube resides.
A distal locking ball 208 and a proximal locking ball 209
are fixed at the distal end of a pull wire 207 about 1.2
centimeters apart and reside within the contralateral capsule.
Prior to deployment of the contralateral tubular leg 172 into
the contralateral iliac artery, the inferior attachment system
I76 resides in the contra lateral capsule between the distal and
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proximal locking balls. As shown in FIG. 27, the contralateral
capsule assembly may be configured with only the distal locking
ball, when the inferior attachment system does not need to be
pushed from the contralateral capsule.
The guiding tube assembly 205 comprises the pull wire 207
disposed within the distal guiding tube 206 and a proximal
guiding tube 213 . Appr ;ximat=ly a distance equal to the length
of the graft SS from the centralateral capsule 202, or dis~al
end of the guiding tube, a six centimeter segment of the guiding
tube is configured with a radiopaque mater ial, such as a platinum
coil 210. As shown in FIGS. 1 and 8, the radiopaque material
marks the point where the guiding tube exits the distal end 163
of the capsule jacket 160. Such a marking allows fluoroscopic
determination of whether the guiding tube has been twisted or
wrapped around the capsule jacket or distal capsule assembly 90.
The guiding tube assembly 205 is further configured with
a tapered joint 211 approximately fifty centimeters from the
contralateral capsule 202. The tapered joint connects the distal
guiding tube 206 with a proximal guiding tube 2I3. The tapered
proximal end of the distal guiding tube nests inside the flared
distal end of the proximal guiding tube. Both guiding tubes ar a
preferably made from polyethylene tubing or similar material.
The proximal end of the proximal guiding tube is connected to
a 0.035 inch (0.9 mm) diameter contralateral "J" guide wire 212
made from stainless steel and having a length of about seventy
centimeters.
The pull wire 207 extends from the contralateral capsule
202 to a point just distal the proximal end of the proximal
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guiding tube 213. The pull wire is fixed at its proximal end
to the proximal guiding tube to prevent relative movement between
the parts of the guiding tube assembly 205 such that pulling on
the contralateral guide wire 212 or the proximal guiding tube
will cause corresponding movement of the contralateral capsule.
If, however, the guiding tube assembly 205 is cut somewhere
bet aeen the ta5er ed j c in t 211 and t::e contr a 1 ater a 1 cu ide wire ,
then the proximal portion of the proximal guiding tube can be
removed from the pull wire. Once the assembly is cut, the
contralateral capsule can be moved relative to the pull wire by
sliding the distal guiding tube 206 proximally aver the pull
wire. Black or colored marker bands 214 formed from PET shrink
tubing are positioned at predetermined locations on the proximal
guiding tube to indicate the chronological order in which the
sections of the guiding tube assembly is removed during the
deployment process.
A torque catheter assembly 215 for use with the contra-
lateral capsule assembly 200 is shown in FIG. 24. The torque
catheter assembly consists of a torque catheter shaft 216 made
of a flexible plastic material, such as PEBAX. The shaft is of
sufficient length to span the distance from the contralateral
femoral cutdown to the position in the contralateral iliac artery
Where the contralater al attachment sys tem 176 is to be deployed,
-: for example, forty centimeters. The torque catheter shaft is
provided with a through lumen configured to accept and pass over
the proximal and distal sections 213 and 206 of the guiding tube
assembly 205.
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The distal end 217 of the torque catheter shaft 216 is
configured to connect to the barb adapter 203 on the contra-
lateral capsule 202. The distal end of the shaft is further
configured with a radiopaque marker band 218 for use in securing
the distal end of the torque catheter to the barb adapter.
Alternatively, the distal end of the shaf t may be conf figured with
a radicpaque adapter configured to mate with the barb adapter.
The distal end o~ the torque catheter shaft is preferably
provided with one or more purge ports 219.
The proximal end 221 of the torque catheter assembly 215
is provided with a stop cock 222 having a female Luer fitting
223 for injecting a fluid for purging the torque catheter shaft
lumen 220. Likewise, a contrast fluid may be injected through
the Luer fitting and out the distal end 217 or purge ports 219
of the torque catheter shaft. The proximal end of the torque
catheter shaft is further provided with two consecutive Touhy
Borst adapters 240 and 241 separated by a single lumen
polyethylene tube 242.
The distal Touhy Horst adapter 240 locks on the distal
guiding tube 206 with the barb adapter 203 engaging the distal
end 217 of the torque catheter shaft 216. This engagement allows
torque ability of the contralateral capsule 202. The proximal
Touhy Borst adapter 241 engages the proximal guiding tube 213
and ultimately the pull wire 207 which secures the contralater al
attachment system 176 within the contralateral capsule. The
tapered joint 211 between the distal guiding tube and the
proximal guiding tube resides between the two Touhy Borst
adapters.
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The distal end of the single lumen polyethylene tube 242
is flared and secured to the cap of the distal Touhy Borst
adapter 240. The proximal end of the polyethylene tube is
configured with a barbed female Luer fitting 243 on which the
proximal Touhy Borst adapter 241 is secured for engaging the
proximal guiding tube 213. To expose the pull wire 207, the
proximal Touhfr Horst is unlocked and removed from the female
Luer, thereby r=_moving the proximal guiding tube 213 with the
proximal Touhy Borst adapter.
FIG. 8 depicts the distal end of the intraluminal grafting
system 50 assembled for deployment. The distal cap 92 is in its
retracted or proximal position adjacent to proximal cap I00.
Similarly, core wire 91 is locked via control knob 113 in its
retracted or proximal position. During initial deployment,
capsule catheter tubular member 131 is in its most distal
position in relation to balloon catheter assembly 51 and is
locked in place by the locking ring on the Touhy Borst adapter
147.
The graft 55 is disposed within the distal capsule 93,
the proximal capsule 132, the contralateral capsule 202 and the
capsule jacket main sheath 160. The superior end of the main
tubular member 170 and superior attachment system 175 are
removably retained within the distal capsule 93. The inferior
end of the ipsilateral tubular leg 171 and inferior attachment
system 176 are removably retained within the proximal capsule
132. Likewise, the inferior end of the contralateral tubular
leg 172 and inferior attachment system I76 are removably retained
within the contralateral capsule 202.
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During initial deployment, the distal end of the balloon
catheter 80 is positioned such that the distal stem 82 of the
balloon 60 resides within the main tubular member 170 of the
graft 55, as shown in FIG. 8. The proximal cap I00 is positioned
just proximal the distal cap 92 and is disposed within the distal
capsule 93. In addi=ion, proximal locking ring 86 and distal
locking ring 87 aye disposed on either side of the ipsilateral
attachment system 176. Similarly, proximal locking ball 209 and
distal locking ball 208 are disposed on either side of the
contralateral attach:~ent system 176. In the preferred
embodiment, distal locking ring 87 and distal locking ball 208
are disposed just distal of the respective attachment systems
176. Also, the capsule jacket assembly 53 is positioned such
that the distal end 163 of the capsule jacket main sheath 160
overlaps at least a portion of the distal capsule. During
deployment, capsule jacket locking connector 162 secures the main
sheath in place. Thus, when any movement or force is applied
to the handle assembly 110, the entire apparatus 50 moves as a
single unit.
By way of example, the following describes a method of
repair of an aortic aneurysm using the method comprising the
present invention for intraluminal placement of a graft in an
aorta. First, a patient is prepared in a conventional manner
by use of a guide wire 56, a dilator and sheath (not shown) to
open both ipsilateral and contralateral femoral arteries or
vessels of the patient. The contralateral guide wire 212 is then
used to feed the guiding tube assembly 205 through the cutdown
in the ipsilateral femoral artery and ipsilateral iliac artery
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228 into the aorta. By conventional means, a basket catheter
or similar device _is fed through a cutdown in the contralateral
femoral artery to the contralateral iliac artery 229 to snare
or capture the proximal end of the guiding tube assembly. The
guiding tube 206 is then pulled through the contra lateral iliac
artery and out the cutdown in the contralateral femoral artery.
The distal end of the in tr aluminal grafting appar atus 50
is then inserted into the sheath, which has previcuslf been
placed in the femoral artery. In the preferred embodiment of
the present invention, balloon catheter lumen 63 is provided fcr
receiving the guide wire 56 tha t was previously traversed acr oss
the aneurysm. However, the following procedure may also be used
when the guiding member is constructed as part of the balloon
catheter.
Next, the balloon catheter assembly 51, the capsule
catheter assembly 52, the capsule jacket assembly 53 and the
control wire assembly 54 are all configured for deployment as
shown in FIGS. 1 and 8. Thus, the assemblies may be advanced
by the physician as a single unit over the main guide wire 56.
As shown in FIG. 29, the main guide wire is introduced by the
physician into a cutdown in the ipsilateral femoral artery and
advanced through the ipsilateral iliac artery 228 to the desired
location in the abdominal aorta 225 and adjacent to the diseased
or damaged portion 226 of the vessel.
The physician advances the distal end of the intraluminal
grafting assembly 50 through the ipsilateral femoral artery over
the guide wire 56 while maintaining slight tension on the guiding
tube assembly 205 from the cutdown in the contralateral femoral
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artery. Typically, the desired position for implanting the graft
55 will be within the abdominal aorta 225 with the superior
extremity of the main tubular member 170 at least one centimeter
inferior to the lower renal artery. The inferior attachment
systems 176 should be positioned 0.5 centimeters superior the
internal iliac arteries. However, prior to removing the contra-
lateral t~.:bular leg 172 from the capsule jacket assembly 53, the
proximal capsule assembly 130 and contralateral capsule assembly
200 must be positioned superior the bifurcation of the abdominal
aorta to the ipsilateral iliac artery 228 and contralateral il iac
artery 229, as shown in FIG. 29. Fluoroscopy is used to inspect
the position of the radiopaque section 210 of the guiding tube
assembly 205 to ensure that the distal end of the guiding tube
206 is not wrapped or twisted around the distal capsule assembly
90 as the distal capsule 93 first enters the aorta.
When the proximal capsule assembly 130 and the contra-
lateral capsule assembly 200 are in the desired position, as
shown in FIG. 29, the locking ring 165 of the capsule jacket
assembly 53 is loosened to allow movement of the capsule jacket
main sheath 160. While using one hand to firmly grasp the
capsule catheter assembly 52 and hold it stationary, the
physician grasps the sheath adapter 164 with the other hand and
gently pulls the sheath adapter proximally towards the capsule
catheter wye adapter 145. Simultaneously, the physician applies
slight tension on the guiding tube assembly 205 from the contra-
lateral side as it is removed from the capsule jacket assembly.
The capsule jacket assembly is gradually retracted to
sufficiently expose the proximal capsule 132 to free the contra-
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lateral capsule 202. The locking ring is then tightened to hold
the capsule jacket assembly in place such that the distal end
I63 of the capsule jacket rests near the proximal end of the
proximal capsule, as shown in FIG. 30. The radiopaque marker
166 at the distal end of the capsule jacket main sheath may be
used to position the capsule jacket relative to the proximal
capsule. In the al ternative embodiment where the crimped graf~
250 is used, the position of the distal capsule 93 relative to
the proximal capsule 132 is adjusted by using the marker bands
on the hypotube 115 to ad just the implant length to physiologic
length.
At this point in the procedure, the contralateral tubular
leg 172 of the graft 55 is moved into the contralateral iliac
artery 229 by pulling the guiding tube 206 in a proximal
direction, as shown in FIG. 31. At the same time and with
concurrent motion, the superior end of the main tubular member
170, disposed in the distal capsule 93 , is moved into the desired
location of the aorta 225 by moving the control handle 110, and
thereby the intraluminal grafting assembly 50, in a proximal
direction. Hy this motion, the inferior end of the ipsilateral
tubular leg 171, securely retained within the proximal capsule
132, is moved to the desired location in the ipsilateral iliac
artery 228 for deploying the ipsilateral attachment system 176.
Similarly, the inferior end of the contralateral tubular leg,
securely retained with in the contralateral capsule 202, is
positioned for deployment of the contralateral~attachment system.
Thus, each of the attachment systems should be in position for
deployment.
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The control knob I13 is then rotated to cause relative
movement between the distal capsule assembly 90 and the balloon
catheter assembly 51 to release the superior end of the main
tubular member 170 and superior attachment system 175 from the
distal capsule 93. Rotating the control knob causes the
retaining rack 120 to move the control wire 91 in a distal
direction. Since the dista~ cap 92 and distal capsule 93 are
secured to the control wire 91, they ;"ove in corresponding
relationship with the rotation of the control knob. As the
distal capsule is moved from engagement with the superior
attachment sys tem, the balloon ca theter proximal cap 100 locates
at the proximal end of the distal capsule. As soon as the distal
capsule has cleared the superior attachment system 175, the
superior extremity of the main tubular member expands outwardly
under the force of the self-expanding attachment system which
springs into engagement with the vessel wall 202. The locking
pin 126 holds the control knob, and thus the control wire and
distal capsule, fixed in place.
Once the superior attachment system 175 is exposed, steps
are taken to firmly seat or urge the wall engaging members 193
in the vessel wall. First, the locking ring on the capsule
catheter Touhy Borst adapter 147 is loosened to permit relative
movement between the capsule catheter assembly 52 and the balloon
catheter assembly 5I. While the physician uses one hand to hold
the capsule catheter assembly stationary, the handle assembly
110 is grasped by the other hand and pushed distally to position
the center of the main balloon 60 into the superior extremity
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of the main tubular member 170. The radiopaque marker 84 is used
to align the main. balloon and superior attachment system.
Thereafter, a conventional hand operated syringe or
inflation assembly (not shown) is attached to the balloon
catheter inflation port 74, As depicted in FIG. 32, the main
_. balloon 60 is then expanded by introducing a suitable gas such
as ca=bc:, dioxide or a dilute radiopaque liquid 'rom the syringe
to urge the wall engaging members 193 outwardly to firmly emplace
the superior conical tips 195 into the vessel wall 230. The main
balloon may be deflated and inflated repeatedly to ensure the
superior attachment system is firmly implanted in the vessel.
The main balloon 60 normally remains in an inflated
position during the next steps of the procedure. During the
actual retraction of the contralateral capsule 202 and proximal
capsule 132, the main balloon should be inflated, further
securing the superior attachment system I75. However, the main
balloon may be def la red and reinf fated during the following s reps
to allow the tubul ar legs 171 and 172 to fill with blood to
facilitate detecting any twisting of the bifurcated graft 55.
As shown in FIG. 33, the next step is to implant or anchor
the inferior attachment system 176 of the contralateral tubular
-; leg 172. Initially; the proximal guiding tube 213 is cut between
the single and double marker bands 214. Next, the portion of
the guiding tube containing the single marker band is removed.
- Then, the torque catheter assembly 215 is passed over the
- remaining guiding tube assembly 205 so as to engage the distal
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connector 217 of the torque catheter with the barb adapter 203
of the contralateral capsule assembly 200, as depicted in FIG.
24. The torque catheter is used to straighten any twists in the
guiding tube and can be used to adjust the placement of the
contralateral capsule 202. The torque catheter may remain
secured to the contralateral capsule assembly during the
following procedure with the two Tcuhy Borst adapters 240 and
241 locked to the distal and proximal guiding tubes 206 and 213.
Next, the proximal guiding tube 213 is cut proximal of
the tapered joint 211 between the double and triple marker bands
214 to allow relative movement between the distal section of the
guiding tube 206 and the pull wire 207. Then, the portion of
the guiding tube containing the double marker band is removed.
The proximal Touhy Borst adapter 241 of the torque catheter
assembly 215, which is locked to the proximal guiding tube, is
disengaged from the Luer fitting 243 exposing the pull wire 207.
Thus, the proximal guiding tube having the triple marker band
is also removed. The pull wire and locking ball 208 are then
advanced into the contralateral tubular leg 172 by moving the
pull wire distally.
The torque catheter assembly 215 and distal guiding tube
206 are then moved in a proximal direction to remove the contra-
lateral capsule 202 from the inferior attachment system 176 while
the pull wire 207 is held f fixed relative to the torque ca theter
assembly. The distal end of the pull wire and locking ball 208
remain in place inside the contralateral tubular leg 172. Once
the inferior extremity of the contra lateral tubular leg is free
of the contralateral capsule, the inferior attachment system will
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spring open and the wall engaging members 193 will engage the
contralateral iliac artery wall 231.
Thereafter, the torque catheter 215 and/or guiding tube
206 and contra lateral capsule 202 are removed through the contra
lateral femoral artery cutdown. The pull wire 207 is moved
distally so that the locking ball 208 is disposed near the
superior end cf the contralaterai tubular leg 1"~.
conventional (contralateral) ball oon catheter 235 is then moved
into the contralateral iliac artery 229 over the pull wire and
positioned within the inferior attachment system I76. A contra-
lateral balloon 236 configured on the contralateral balloon
catheter is then inflated to firmly seat the conical tips 196
of the inferior attachment system into the contralateral iliac
artery wall 231. The contralateral balloon may be deflated and
reinflated throughout the contralateral tubular leg to open the
entire length of the tubular leg. The contralateral balloon
catheter remains in place wi th the contralateral balloon inf fated
during the next sequence of steps; however, the contralateral
balloon catheter, pull wire and locking ball may be removed once
the contralateral attachment system is firmly implanted.
As shown in FIG. 34, the next step is to deploy the
inferior attachment system 176 of the ipsilateral tubular leg
171 into the ipsilateral iliac artery 228. First, the
ipsilateral lock adapter 153 is loosened to release the
ipsilateral locking wire 85. The ipsilateral locking wire
proximal handle 88 is then moved distally to advance the locking
rings 87 into the superior portion of the ipsilateral tubular
leg. Next, the locking mechanism 147 of the capsule catheter
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wye adapter is loosened. With the handle assembly 110 of the
balloon catheter assembly 51 held firmly in place, the capsule
catheter assembly 52 is moved proximally until the inferior
attachment system and inferior end of the ipsilateral tubular
leg are completely clear of the proximal capsule 132.
Once the inferior extremity of the ipsilateral tubular
leg 171 is free of the proximal capsule 132, the ipsilaterai
inferior attachment system I76 will spring open and the wall
engaging members I93 will engage the ipsilateral iliac vessel
wall 232. Leaving the main balloon 60 inflated while the capsule
catheter assembly 52 is moved ensures r~,ar t~,o ~"...,_. _
attachment system 175 will remain firmly secured i~ place.
Thereafter, the ipsilateral locking wire 85 is moved proximally
to its original position and is secured by tightening the locking
wire adapter 153.
Next, the main balloon 60 is deflated. As shown in FIG.
35, the handle assembly 110 is moved proximall y so that the main
balloon is retracted into the ipsilateral tubular leg 171 and
placed adjacent the ipsilateral inferior attachment system 176.
If the main balloon cannot be positioned adjacent to the ipsi-
lateral attachment system due to limited available movement of
the handle assembly, then the capsule catheter locking ring 147
is secured to the hypotube 115, thereby securing the capsule
catheter assembly to the balloon catheter assembly 51. The
entire deployment catheter 50 is then moved proximally to
position the main balloon adjacent the ipsilateral attachment
system.
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The main balloon 60 may be inflated and deflated through
the entire length of the main tubular member 170 and ipsilateral
tubular Ieg 171 to ensure potency of the bifurcated graft 55.
Again, the balloon radiopaque marker 84 is used to align the
center of the main balloon with the ipsilateral attachment system
176. The balloon is then inflated just enough to expand the
ps i la ter a_ a t =ac;:.:,e:~ t s1 s tem to t3Ck down t~:e wa 11 enga ; i:,g
members 193 into the ipsilateral iliac artery vessel wall 232.
Thereafter, the main ballocn is finally deflated.
As shown in FIG. 36, the proximal capsule assembly 130
and balloon 60 are moved proximal the graft 55. First the
locking ring 147 is loosened. Then. wt,; iA h~~,~;,.,. ~~._ ____.,
catheter assembly 52 in place by grasping the wye adapter 145
with one hand, the balloon catheter assembly 5I is moved
proximally by gently pulling the handle assembly 110 with the
other hand. Thus, the capsule catheter assembly and balloon
catheter are in the same relative position as they were just
prior to deployment (FIG. 8) . Also, the proximal end 103 of the
distal capsule 93 has been mated with the proximal can 100 for
smooth transition.
Finally, the capsule jacket locking ring 165 is loosened.
While holding the capsule jacket sheath adapter I64 in place,
the balloon catheter assembly 51 and capsule catheter assembly
52 are moved proximally and in unison by gently pulling the wye
145 of the capsule catheter assembly. The catheter assemblies
are moved until the distal end 163 of the capsule jacket main
sheath 160 covers the proximal cap 100 or until the proximal
capsule adapter housing 134 mates with the flared transition of
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the capsule jacket, thereby creating a smooth transition along
the entire length of the intraluminal grafting apparatus 50.
Thereafter, the balloon catheter assembly, capsule catheter
assembly, capsule jacket assembly 53 and control wire assembly
54 are removed from the aorta through the femoral artery. The
graft 55 and attachment systems 175 and 176 remain secured to
the vessel walls 230, 231 and 232, thereby seal ing the a:,eurys:~
226 from blood flow.
When the intraluminal grafting apparatus 50 is removed
from the ipsilateral iliac and femoral aster ies, the main guide
wire 56 remains in place in the vessels. A conventional (ipsi-
lateral) auxil iary balloon catheter (not shown) is traversed over
the main guide wire and positioned at the inferior end of the
ipsilateral tubular leg 171 and within the ipsilateral attachment
system 176. An ipsilateral auxiliary balloon on the ipsilateral
auxi 1 iary balloon ca theter is ~ of la ted to firmly implant the
conical tips 196 of the wall engaging members 193 into the
ipsilateral iliac artery wall 232. The ipsilateral auxiliary
balloon may be inflated and deflated along the entire ipsilateral
tubular leg to ensue a the tubular leg is completely open and to
remove creases which may have set while the graft was loaded in
the capsule jacket assembly. Thereafter, the ipsilateral
auxiliary balloon catheter and main guide wi re are removed from
the ipsilateral femoral artery and the cutdowns are closed.
The entire procedure described herein can be observed under
fluoroscopy. The relative positioning of the graft 55 and the
balloon 60 can be readily ascertained by the radiopaque
attachment systems 175 and 176, radiopaque locking mechanisa;,s
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87 and 208, radiopaque markers 197 and 198 provided on the graft, the
radiopaque marker 84 on the balloon shaft 61 and the proximal cap 100. If any
twisting of the graft has occurred between placement of the superior
attachment
system and the inferior attachment system, then the twisting can be readily
ascertained by observing the series of markers 197 and 198. Adjustments to
eliminate any twisting which may have occurred can be made before exposing the
attachment systems by rotation of the balloon catheter 51, the capsule
catheter
assembly 52 or the contralateral capsule 132 via the torque catheter 215. Any
excessive graft compression can be ascertained by observing the radiopaque
markers under fluoroscopy. Adjustments to eliminate graft compression can be
made before exposing the inferior extremity of the graft by applying tension
on the
capsule catheter assembly and torque catheter 215.
If crimping of the tubular legs of the graft is not employed, then
additional attachment systems may be placed within the tubular legs to prevent
kinking of the graft material in the tubular legs. As shown in FIGS. 40 and
41,
these additional attachment systems 275 are placed medial the ends of the
ipsiiateral andlor contralateral tubular legs. Such medial attachment systems
275
resemble the inferior attachment systems 176 used to secure the ipsilateral
171
and contrafateral 172 tubular legs, but the medial attachment systems are
preferably configured without our wall engaging members. The medial attachment
systems are deployed using an auxiliary capsule catheter traversed over the
main
guide wire 56 and the contralateral pull wire 207 or another guide wire
inserted in
the
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contra lateral tubular leg 172 aster the contralateral attachment
system 176 is firmly seated.
Post implant fluoroscopy procedures can be utilized to
confirm the proper implantation of the device by the use of a
conventional pigtail catheter or by injecting dye into the guide
wire lumen of the balloon catheter sha°t. Thereafter the sheath
can be removed from the femoral artery and the femoral ar~ery~
closed with conventional suturing techniques. Tissues should
begin to grow into the graft within two to four weeks with tissue
completely covering the interior side of the gra°t within six
months so that no portion of the graft thereafter would be in
communication with the blocd circulating in the vessel. This
establishes a complete repair of the aneurysm which had occurred.
While several particular forms of the invention have been
illustrated and described, it will be apparent that various
modifications can be made without departing from the spirit and
scope of the invention. Far example, references to materials
of construction and specific dimensions are also not intended
to be limiting in anv manner and other materials and dimensions
could be substituted and remain within the spirit and scope of
the invention. Accordingly, it is not intended that the
invention be limited, except as by the appended claims.
