CA2264514A1 - Improved bifurcated multicapsule intraluminal grafting system and method - Google Patents
Improved bifurcated multicapsule intraluminal grafting system and method Download PDFInfo
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- CA2264514A1 CA2264514A1 CA002264514A CA2264514A CA2264514A1 CA 2264514 A1 CA2264514 A1 CA 2264514A1 CA 002264514 A CA002264514 A CA 002264514A CA 2264514 A CA2264514 A CA 2264514A CA 2264514 A1 CA2264514 A1 CA 2264514A1
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- Prior art keywords
- capsule
- assembly
- graft
- distal
- ipsilateral
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
- A61F2/06—Blood vessels
- A61F2/07—Stent-grafts
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
- A61F2/954—Instruments specially adapted for placement or removal of stents or stent-grafts for placing stents or stent-grafts in a bifurcation
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
- A61F2/958—Inflatable balloons for placing stents or stent-grafts
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
- A61B90/39—Markers, e.g. radio-opaque or breast lesions markers
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
- A61F2/88—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure the wire-like elements formed as helical or spiral coils
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
- A61F2/89—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure the wire-like elements comprising two or more adjacent rings flexibly connected by separate members
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
- A61F2/9517—Instruments specially adapted for placement or removal of stents or stent-grafts handle assemblies therefor
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
- A61F2/06—Blood vessels
- A61F2002/065—Y-shaped blood vessels
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
- A61F2/06—Blood vessels
- A61F2/07—Stent-grafts
- A61F2002/075—Stent-grafts the stent being loosely attached to the graft material, e.g. by stitching
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/848—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents having means for fixation to the vessel wall, e.g. barbs
- A61F2002/8483—Barbs
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/848—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents having means for fixation to the vessel wall, e.g. barbs
- A61F2002/8486—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents having means for fixation to the vessel wall, e.g. barbs provided on at least one of the ends
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
- A61F2250/0096—Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers
- A61F2250/0098—Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers radio-opaque, e.g. radio-opaque markers
Abstract
An improved intraluminal grafting system incorporating novel structural features for enhancing the effective and efficient deployment of a bifurcated prosthesis having a plurality of attachment systems, in the vessel of an animal body, the system including a balloon catheter assembly, an ipsilateral capsule catheter assembly, distal and contralateral capsule assemblies and means interacting therewith, and a capsule jacket assembly. The capsule assemblies include an ipsilateral capsule assembly, a contralateral capsule assembly and a distal capsule assembly, wherein the attachment systems of the bifurcated prosthesis are disposed within the three capsule assemblies. The capsule jacket assembly includes a removable sheath that covers the bifurcated prosthesis and capsule assemblies to provide a smooth transition along the length of the deployment catheters. The bifurcated prosthesis is comprised of a main tubular member and two tubular legs, having attachment systems secured to the superior end of the main tubular member and the inferior ends of the tubular legs. An inflatable membrane configured on the balloon catheter is used to firmly implant the attachment systems within the vessel. The bifurcated prosthesis and attachment systems are configured to remain in the vessel after the deployment catheters are withdrawn. A novel method of use of the present intraluminal grafting system is also disclosed, for example, for deploying a bifurcated prosthesis proximate the abdominal aortic bifurcation.
Description
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TITLE
IMPROVED BIFURCATED MULTI CAPSULE INTRALUMINAL GRAFTING SYSTEM
AND METHOD
CROSS-REFERENCES TO RELATED APPLICATIONS
This application isa1continuationâinâpart of application
Ser. No. 08/241,476, filed May 12, 1994. The contents of
this application.is hereby incorporated.herein.by reference.
BACKGROUND OF THE INVENTION
This invention relates to an improved 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 or 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-obstructed section.of the natural vessel. Known
procedures include surgically bypassing the damaged or
diseased portion of the vessel and inserting an artificial
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or donor graft attached to the native vessel by an
anastomosis.
It is also 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 addition,
prior systems having a<:apsule catheter assembly were usually
configured such that the prosthesis was disposed within a
unitaryâ capsule. Further, the prior prostheses were
sometimes ill suited toxuithstand the high pressures existing
in the vessels and, consequently, experienced structural
failures.
Generally speaking, intraluminal repair of vessels or
body lumens,
where it is a viable alternative, can be
performed with less threat to a patient. Moreover, since
intraluminal repair does not require major surgery, the
recovery time from such a procedure is usually shorter.
However, in order to fully take advantage of the benefits
of an intraluminal repair procedure, the system for
accomplishing the same must be optimized to efficiently and
effectively place a prosthesis within the vessel or lumen.
Furthermore, itself must be
the prosthesis optimally
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configured so that it can withstand and adapt to the
environment in which it is placed. Accordingly, there is
a need for the systen1to be configured such that advancement
and deployment of the prosthesis can be accomplished in an
efficient manner and such that the prosthesis can be
accurately'placed.so that the attempted.repair is effective.
Additionally, there is a need for a prosthesis which itself
is specifically configured for the environment existing
within the vessel or lumen in which it is placed. The
present invention addresses these needs.
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 to parts of the system, such as catheters,
capsules and wires, which are closest to the user and closest
to the portion of the system outside or exterior of the
patient. Distal refers to the point farthest from the user
and typically most 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
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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
contralateral attachment systenxresides in.the contralateral
iliac artery which is on the opposite side of the aorta from
which the capsule catheter enters the aorta.
SUMMARY OF THE INVENTION
Briefly, and in general terms, the present invention
provides a new and improved intraluminal delivery system
for securing a prosthesis within or between vessels or
corporeal lumens of EH1 animal, such as ea human. The
preferred embodiment of the placement system is configured
for introducing a into a
graft corporeal lumen and
positioning the graft in.the area of the aortic bifurcation.
Basically, the present invention.is directed to a system
and method for implanting a prosthesis or graft utilizing
a catheter assembly having a multiplicity of capsules. The
delivery system includes a guide wire, a balloon catheter
assemblyg a distal capsule assembly, an ipsilateral capsule
catheter assembly, a contralateral capsule assembly, and
a capsule jacket assembly. The systentalso includes control
wire, locking wire and guiding tube assemblies. Also
provided are a torque catheter and a stub nose balloon
catheter.
The prosthesis comprises a wye shaped bifurcated graft
having a selfâexpanding attachment system at each of its
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three orifices. Each attachment systen1is contained within
its own compact capsule assembly during deployment. The
capsule assemblies are movable relative to each other to
allow the graft to be emplaced at the desired location in
the corporeal lumen. The graft and capsules are deployed
by a catheter assembly designed for traversing the femoral,
iliac and aortic vessels of a human anatomy.
The present systen1has several advantages over prior art
systems.
In particular, the present system incorporates
various_ novel structural features which enhance the
efficiency of the systen1as well as facilitates the effective
deployment of the prosthesis within a vessel or body lumen.
Moreover, the present system embodies a design which is
optimized for ease of operation and nmnufacturability.
Additionally, the prosthesis includes various advancements
which also enhance the overall effectiveness of the system.
More particularly, the ipsilateral capsule catheter
assembly includes a handle embodying a rack and pinion device
which is configured coaxially with the ipsilateral capsule
catheter tubular member in order to provide precise control
as well as includes a conveniently assessable collet lock
for engaging the balloon.catheter shaft. The capsule jacket
assembly includes a capsule jacket having a more easily
manufacturable oneâpiece
design and in a preferred
embodiment, it is constructed from LDPE material.
The new and improved distal or superior capsule assembly
includes a superior end configured with a nose cone for
improvedrnaneuverability of the intraluminal delivery system
within'vessels or corporeal lumens, as well as for providing
a gradual transition of the overall profile of the delivery
system. The control wire assembly also includes a handle
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having a more manufacturable single piece design and embodies
a rack and pinion device which is configured coaxially with
the control wire for more precise control.
The lock wire assembly is provided with an ipsilateral
lock spacedâapart from a pusher button which can be
manipulated such that a limb of the prosthesis can be
deployed in tension or compression. Also, the inferior end
of the locking wire assembly includes a handle shaped so
that it can be manipulated more conveniently. The pull wire
assembly includes a slidable pusher button and a lock which
cooperate in order to provide the system with the capability
of deploying another limb in
prosthesis tension or
compression. The guiding tube assembly also includes
additional marking bands for providing an enhanced view of
the guiding tube assembly under fluoroscopy. The guiding
tube assembly also includes nonâradiopaque marker bands for
conveniently identifying the chronological sequence in which
portions of the guiding tube assembly are removed during
the deployment process.
The torque catheter includes a detachable inferior
extension to fully expose the superior end of the guiding
tube assembly, which is necessary when deploying a prosthesis
limb in compression or in tension. The superior end of the
stub nose balloon catheter is configured so that it
effectively engages the slidable pusher button.
The improved prosthesis includes additional radiopaque
members positioned along its length for the purpose of better
identifying the configuration of the prosthesis under
fluoroscopy. The improved prothesis also includes additional
means for insuring an enhanced ingrowth and sealing effect
within the vessel or corporeal lumen. Furthermore, the
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superior end of the prosthesis is provided with a superior
attachment system embodying Vâshaped members with hooked
terminal ends which cooperate with a generally sinusoided
frame to seat the superior end of the prosthesis within a
vessel or lumen. This
improved attachment system is
optimally configured to be effective even in harsh
environments wherein significant stresses are placed upon
the members comprising the attachment systenu Significantly,
the number of connecting points among the various members
of the superior attachment have been minimized.
The new and improved procedure for manipulating the
intraluminal delivery systen1to thereby deploy the prosthesis
or graft withirxa vessel or lumen.necessarily'takes advantage
of the various novel structural features incorporated into
the delivery system. In particular, additional steps are
contemplated to accomplish deploying the limbs of the
prosthesis either in tension or compression. Moreover,
additional steps are included to more optimally maintain
a sterile well as
operating field as ensure
proper
orientation of the prosthesis within the vessel or lumen.
Other features and advantages of the present invention
will become apparent fron1the following detailed description,
taken in conjunction with the accompanying drawings, which
illustrate,
byâ way of example, the principles of the
invention.
BRIEF DESCRIPTION OF THE DRAWINGS
FIGURE 1 is a side plan view of an intraluminal grafting
apparatus and system incorporating the present invention.
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FIG. 2 is a side plan view of a guide wire to be used
with the endovascular grafting system of the present
invention.
FIG. 3 is a side plan view of the balloon catheter and
ipsilateral locking wire of the present invention.
FIG. 4 is a side plan'view of the distal capsule, control
wire, hypotube and control wire handle assembly of the
present invention.
FIG. 5 is a side plan View of the proximal capsule and
ipsilateral capsule catheter assembly of the present
invention.
FIG. 6 is a side 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 crossâsectional view of the distal
end of the intraluminal grafting apparatus and systentalong
the line 8-8 of FIG.1.
FIG. 9 is the partial crossâsectional view of FIG. 8,
with the distal capsule and control wire moved proximally
within the balloon catheter.
FIG. 10 is a crossâsectional view taken along the line
10-10 of FIG. 9.
FIG. 11 is a partial crossâsectional view of the control
wire and control handle mechanism shown in FIG. 4.
FIG. 12 is an enlarged side perspective view of the
ipsilateral capsule handle.
FIG. 13 is a crossâsectional view of FIG. 12 taken along
line 13-13 of FIG. 12.
FIG.
14 is an enlarged top plan view of a bifurcated
graft of the present invention having crimped tubular legs.
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FIG. 15 is a contralateral side view of the bifurcated
graft of FIG. 14.
FIG. 16 is an ipsilateral side view of the bifurcated
graft of FIG. 14.
FIG. 17 is a plan View of the inside of the graft cut
longitudinally, showingeisuperior attachment systen1as sewn
into the main tubular member of the graft.
FIG. 18 is a plan View of the outside of the graft cut
longitudinally, showing in partial hidden'view the wire frame
and separate lumen engaging members and further showing the
tufts attached to the graft.
FIG. 19 is a plan View of the inside of the graft cut
longitudinally, showing an alternative embodiment of the
wire frame, lumen penetrating members and stitching of the
attachment system.
FIG. 20 is an.top plan view showing a inferior attachment
system as sewn into a tubular leg of the graft.
FIG. 21 is an.enlarged side plan view showing an inferior
attachment system.
FIG. 22 is an enlarged side plan View showing an
attachment systenihavingeasupplemental helix torsion.spring
at the apices.
FIG. 23 is a crossâsectional View taken along the line
23-23 of FIG. 1.
FIG. 23âA shows an alternate embodiment of the view
depicted in FIG. 23.
FIG. 24 is a crossâsectional View taken along the line
24-24 of FIG. 1.
FIG. 24-A shows an alternate embodiment of the view
depicted in FIG 24.
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FIG. 25 is a crossâsectional view taken along the line
25-25 of FIG. 8.
FIG. 25âA shows an alternate embodiment of the view
depicted in FIG. 25.
FIG. 26 is a partial cross-sectional view of the contra-
lateral tubular leg and attachment systen1positioned in the
contralateral capsule assembly.
FIG. 26-A.is an alternate embodiment of the viemzdepicted
in FIG. 26.
FIG. 27 is a top plan view of a torque catheter disposed
over the guiding tube of the contralateral capsule assembly
of the present invention.
FIG. 28 is a partial crossâsectional view of the intra-
luminal grafting systen1shouw1positioned\uithin.the corporeal
lumen.
FIG. 29 is a partial crossâsectional view of the intra-
luminal grafting systenn wherein.the capsule jacket has been
withdrawn from the graft.
FIG. 30 is a partial crossâsectional view of the intra-
luminal grafting system, wherein the contralateral and
ipsilateral tubular leg and contralateral and ipsilateral
capsule assembly have been pulled.into the respective iliac
artery.
FIG. 31 is a partial crossâsection View of the intra-
luminal grafting systenn 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. 32 is a partial cross-sectional View of the intra-
luminal grafting system, wherein the contralateral capsule
has been removed from the inferior end of the contralateral
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tubular leg and an auxiliary balloon catheter has been
positioned and inflated to seat the inferior attachment
system.
FIG. 33 is a partial cross-sectional view of the intra~
luminal grafting system, wherein the ipsilateral capsule
has been removed from the inferior end of the ipsilateral
tubular leg, releasing the ipsilateral inferior attachment
system into the ipsilateral iliac artery.
FIG. 34 is a partial crossâsectional view of the intra~
luminal_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. 35 is a partial crossâsectional view of the intra-
luminal grafting system, wherein the balloon catheter,
capsule catheter and capsule jacket have been placed in a
position for withdrawal from the corporeal lumen.
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
assembly, an ipsilateral capsule catheter assembly,
contralateral and distal capsule assemblies and means
interacting therewith, and a protective sleeve or capsule
jacket. The novel features of the present system are
directed towards enhancing the efficiency'of the intraluminal
grafting system, facilitating the effective deployment of
a prosthesis within a vessel or body lumen and providing
a prosthesis well suited.for effectively repairing the vessel
or lumen.
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In the present system, the prosthesis or graft is
comprised of a bifurcated tubular body 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. Pu1attachment systenxis secured.to the superior
end of the main tubular member 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/ipsilateral, distal and
contralateral capsule assemblies. The balloon catheter,
capsule catheterâand.capsule jacket are configured.coaxially
relative
so that movement between them provides for
deployment of the graft. The inflatable member of the
balloon catheter is used 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. 1-8. The system includes a balloon catheter
assembly 51, which.is coaxially disposed.within ipsilateral
capsule catheter assembly 52, which is coaxially disposed
within capsule jacket assembly 53. As shown in FIG. 8, the
ipsilateral or 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 systenlis used.as an overâtheâ
wire device, such that the balloon catheter is further
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configured with a lumen for a guide wire 56. It is
contemplated, however, that the systen1can.also be usedwuith
well known fixed wire delivery system configurations.
As shown in FIGS. 1 and 3, the intraluminal grafting
systen150 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. 23 , the balloon catheter shaft is preferably
configured with four lumens; however, the balloon catheter
may be configured with a single, dual or triple as in FIG.
23âA, 24âA AND 25âA, 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, wherein.an inflation port (not shown), is provided
to allow inflation fluid to enter and exit the inflatable
member. The third lumen 65 is provided for a control wire
91. A fourth lumen 78 is provided for an antiâelongation
reinforcement wire 79 made from kevlar fiber or equivalent
material. In the preferred embodiment, the reinforcement
wire 79 extends the length of the balloon catheter shaft.
The flexible elongate element or balloon catheter shaft
61 is preferably formed of a material suitable for
intraluminal use, such as irradiated polyethylene tubing.
The four 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 wire lumen 65
have identical inner diameters of 0.022 inches (0.56 mm).
The reinforcement wire lumen 78 is .009 inches. However,
the lumen.inside diameter may range fron\0.006 to 0.06 inches
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(0.381-1.52 mm) and.the outside diameter may range from 0.035
to 0.1 inches (O.889â2.54 mm) for a multilumen balloon
catheter shaft. The balloon catheter may vary in length
to suit the application, for example, from fifty to one
hundredâfifty centimeters.
Referring 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 fronlinflation 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 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. The reinforcement wire 79 is disposed and attached in
the reinforcement wire lumen.78 between the splitting adapter
and the control handle assembly 110 at the proximal end,
and at its distal end near the distal extremity 80 of the
balloon catheter shaft 61.
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 graft 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 formed of suitable material such as polyethylene.
The polyethylene utilized for the balloon is irradiated to
achieve an appropriate balloon size. For larger diameter
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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 (0.0254â0.l27 mm). The
preferred balloon made in accordance with the present
invention has an outside diameter of 20 to 26 millimeters,
a diameter equal to the inner diameter of the graft, and
has a wall thickness of approximately 0.003 inches (0.076
mm). The range may be 18 to 28 millimeters. 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 hereinafter described. the deflated
Further,
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
balloon 60. The inflation lumen is used to inflate and
deflate the balloon 60 by introducing and withdrawing a gas
or liquid through the inflation port. The balloon proximal
stem 81 and balloon distal stem 82 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.
A radiopaque marker 84 is embedded in the balloon
catheter shaft approximately two millimeters distal the
balloon inflation port. 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 . Preferably two radiopaque platinum marker
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bands, 8 millimeters apart, with an outer diameter of .080
are positioned over the balloon catheter shaft 61 and are
located proximate the center of the balloon 60. A strain
relief or support wire may be disposed in the inflation lumen
64 between the distal end 80 of the balloon catheter shaft
and the balloon distal stem 82 if a three lumen balloon
catheter is used.
It should be appreciated that although a separate
inflatable member has been described, 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 in the art, by using an additional radiation dose
for the balloon region of the shaft.
The balloon 60 can also be observed under xârays 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. increased
In addition,
visibility of the balloon can be obtained by inflating the
balloon widn a diluted radiopaque contrast solution.
Moreover, radiopaque bands of a suitable material such as
platinum, gold 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.
As shown in FIGS. 1, 3 and 8, the ipsilateral locking
wire 85 runs parallel to the balloon catheter 61 within the
ipsilateral capsule catheter assembly 52. The distal end
of the ipsilateral locking wire may be configured with a
proximal pusher button 86 and a distal/ipsilateral lock
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button 87 secured approximately twelve millimeters apart.
The radiopaque buttons are oblong shaped and include thru-
holes 89 which slideably receive balloon catheter shaft 61.
The buttons are disposed within the distal end of the
ipsilateral 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.
The proximal end of the ipsilateral locking wire 85
extends_through the proximal end of the ipsilateral capsule
catheter assembly 52. The proximal extremity of the locking
wire is specially configured with a handle 88 which is
configured.for gripping. âThe ipsilateral lockingxuire handle
is used to laterally move the radiopaque proximal button
86 and distal pusher lock 87 which engage the ipsilateral
attachment system of the ipsilateral tubular leg of the
bifurcated graft 55. Rotation of the knob 113 (see FIG.
4) permits retraction of the proximal/ipsilateral Capsule
to expose the ipsilateral attachment system which is held
fixed relative to the cororeal lumen via the ipsilateral
lock 87 and pusher button 86. Movement of the ipsilateral
locking wire handle in relation to the ipsilateral capsule
catheter assembly permits removal of the ipsilateral lock
and pusher button back into the capsule catheter assembly
after the deployment of the ipsilateral attachment system.
Preferably, the pusher button will be twice as long as the
lock to allow full deployment of the ipsilateral attachment
system while keeping the pusher button partially contained
in the ipsilateral capsule.
The intraluminal grafting apparatus also includes a
control wire assembly 54, which is shown in FIGS. 1 and 4.
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The distal end of the control wire assembly consists of a
distal capsule assembly 90. As showniJ1more detail in.FIGS.
8-10, the distal capsule assembly comprises a control wire
91 disposed within a distal cap 92 and distal cap spacer
96 disposed within the distal cap. The distal cap spacer
is secured.to the distal cap.byIneans 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 superior end of the distal cap is secured to nose cone
105 which provides the delivery system with improved
maneuverability through vasculature due to its gradually
tapered profile. Preferably, the nose cone 106 is formed
of a low durometer plastic material such as polyester block
amide under the trademark "PEBAX" with Bismuth Subcarbonate
or barinon sulfate for radiopacity.
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
configured between the distal cap 92 and the distal cap
spacer 96. The control wire is formed in a Uâshaped bend
over the distal cap spacer and is configured to slide within
the slot and the control wire lumen of the balloon catheter
shaft. The distal end 95 of the control wire resides in
the portion of the control wire lumen beyond the distal end
of the slot.
The configuration shown in FIGS. 8-10 allows the distal
cap assembly to move axially along the balloon catheter
shaft. The Uâshaped bend of the control wire over the distal
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cap spacer 96, however, prevents the distal cap assembly
from rotating in relation to the balloon catheter shaft.
As described above, the distal cap spacer 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 FIG. 8, bullet 100 is secured to the balloon
catheter shaft 61 at a position distal the balloon distal
stem 82 and proximal the aperture 94. The bullet is secured
to the balloon catheter shaft by means of two retaining bumps
101 and 102 and alternatively in conjunction with adhesive.
These retaining bumps secure the bullet in place, limiting
its movement. Such a configuration provides a rounded,
atraumatic transition from edge 103 of the distal capsule
93 resting on the top surface of the bullet when the distal
capsule is its most distal position as shown in FIG. 9.
As the control wire 91j£;moved:u1a longitudinal manner,
the distal end 95 of the control wire, the distal cap spacer
96, the distal cap 92, the distal capsule 93 and the nose
cone 105 each move as a single assembly. The proximal edge
103 of the distal capsule is rolled, curved or crimped
inward, or deburred and smoothened so that the proximal cap
will provide a smooth transition along the distal capsule
assembly 90 when the distal capsule is advanced. âThe distal
movement of the distal capsule is limited by a third
retaining bump 99 positioned approximately 2.5 centimeters
distal the distal cap 92. 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
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edge of the distal capsule coincides with the top surface
of the proximal cap 100.
The distal cap 92 may be formed from polycarbonate or
other suitable material for insertion through the body lumen.
Similarly, the distal cap spacer 96 and nose cone 105 may
be formed.of the same material as the distal cap. âThe distal
cap spacer and distal cap provide a bore 104 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
of other suitable biocompatible material, such as a nickel
titanium. 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 device insertion. Similarly, the
distal cap is configured.with a cutout slot 108 and the nose
cone 105 is configured with a longitudinal recess 109 to
accept the recess in the distal capsule. The distal cap
cutout inhibits the relative rotation between the bullet
100 and ultimately the balloon capsule shaft 61.
The outside diameter of the distal cap 92 and capsule
93 may range fron14 to Sxnillimeters and is preferably 0.282
inches (7.16 mm)
in outer diameter and 0.276 inches (7.01
mm) inner diameter. Similarly, the bullet 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
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during the emplacement process. Ir1an.alternate embodiment,
the proximal cap may have a tapered profile. 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. The nose cone 105 may range from 1 to 5
centimeters and preferably is 3.8 centimeters long.
As shown in FIGS. 1 and 11, a handle assembly 110 is
secured to the proximal end of the control wire 91. The
handle assembly comprises a body 111, a control knob 113
with rotating shaft 114 and a hypotube 115. For ease of
manufacturability and simplicity of design, the handle body
has a oneâpiece design. Also, the body has a central bore
119 for receiving the balloon catheter shaft 61 as well as
a retaining screw 118 for longitudinally locking the
retaining rack relative to the handle.
The hypotube 115 is coaxially disposed over the balloon
catheter shaft 61 and extends distally fronxthe central bore
119 in the handle body 111. The proximal end of the hypotube
is secured to the balloon catheter shaft 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 formed
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 (2.21 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
112. A crimped graft is loaded into the capsule assemblies
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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.
The control wire 91 (see FIGS. 4, 23) resides in a
balloon.catheter lumen.65 and extends fronlthe distal capsule
assembly 90 to an aperture 117 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 ethyleneâpropylene (FEP). The coated
control wire is about 0.02 inches (0.508 mm) in diameter,
providing sufficient strength to move the distal capsule
assembly without buckling or kinking.
The proximal end of the control wire 91 is secured to
a retaining rack 120, whicrxis approximately 4.5 centimeters
long. The retaining rack is slidably disposed within the
central bore in the handle 111 and is in coaxial alignment
with the balloon catheter shaft 61 and control wire 91.
This coaxial design provides precise control of the relative
movement of the control wire (including the components
attached thereto), and.remaining portions of the intraluminal
grafting system 50.
The retaining rack.12O is configuredxnith teeth.123 along
a longitudinal edge which engage a pinion or gear 124. 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
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rotates the gear and in turn moves the retaining rack,
including the components attached thereto, longitudinally
within the central bore 119. 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 (including the components attached
thereto). The base of the control knob 113 is configured
with a locking gear 125 which has angled teeth. The angled
teeth engage a locking pin 126 which can be biased by a
locking spring (not shown). The configuration.of the curved
teeth allows the control knob to turn in only one direction
while the locking pin engages the locking gear. When the
locking pin is removed frontengagement with the locking«gear
125, then.the control knobrnay be turned.in either direction.
The locking gear is preferably molded as part of a plastic
control knob, but may be a separate mechanism secured to
the base of the control knob.
As shown in FIGS. 1, 5, 12 and 13, the ipsilateral
capsule catheter assembly 52 consists of a proximal (ipsi-
lateral) 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 trademark "PEBAX", available fronLAtochem
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 centimeters for the abdominal aortic-iliac
arteries and approximately ninetyâfive centimeters for the
thoracic aortic artery. The elongate tubular member has
a preferred outside diameter of 0.187 inches (4.75 mm) and
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an inside diameter of 0.125 inches (3.175 mm). âThe elongate
tubular member can be produced in a certain color such as
' blue. Preferably, the elongate tubular member can be
extruded with braided wire to improve torsional response.
To render the elongate tubular member radiopaque under xâ
rays, its material of construction.may contain a radiopaque
material, such as twenty percent by weight of bismuth
subcarbonatecn:bariun1sulfate. The elongate tubular member
may have markings or bands distal of the handle 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 ipsilateral capsule catheter elongate tubular member
131. The elongate tubular member also serves as a shaft
for advancing the proximal 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. 25). 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 semiâflexible material.
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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,
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 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 knr means of emu cyanoacrylate ester
adhesive, or other suitable means. To facilitate a
mechanical lock, the*elongate tubular member distal extremity
is molded to form a flange 137, wherein the capsule adapter
housing is configured so as to Hate with the flange.
Preferably; the capsule adapter is of polycarbonate material
insert molded to the distal extremity of the elongate tubular
member 131.
An ipsilateral capsule handle 145 is secured to the
proximal extremity of the elongate tubular member 131 of
the ipsilateral catheter
capsule assembly 52. The
ipsilateral capsule handle ease of
comprises, for
manufacturing and simplicity in design, a one-piece body
146, a control knob 147 with rotating shaft 148 and a collet
lock assembly 158 which tightens around the hypotube 115
disposed in a central bore 159 of the handle. The central
bore 159 also receives the elongate tubular member 131 of
the capsule catheter assembly. A stop cock 149 is mounted
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on the tubular member 188 extending from retaining rack 192
within the one~piece body 146 fluid
and being in
communication with the elongate tubular member 131 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 other
fluid. Air may be purged from the capsule jacket
assembly'53 by injecting fluid through.the Luer fitting 150.
The injection fluid and air will exit purge ports 151 and
152, thereby filling the capsule jacket assemblyâ 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.
The ipsilateral locking wire 85 is disposed in the
ipsilateral capsule catheter assembly 52 through a slotted
opening 184 in the collet lock assembly 158. The collet
lock assembly includes a rotating arm 186, shaft 187 and
opposing members 188. The slotted opening is formed in one
ofthetwwnopposingnenbers. Additionally,opposingnmmbers
provide a throughway for the balloon catheter shaft 61
containedxnithin.hydrotube 115. âUpon.activation.of rotating
arm 186, the balloon catheter shaft can be locked and
unlocked via the hypotube 115.
Slideably disposed within central bore 159 is a retaining
rack 192 which.is in coaxial alignment with.elongate tubular
member 131. Also disposed within the central bore is a
spring 233 which.operates to bias the retaining rack.distally
and to support the ipsilateral lock wire when subjected to
compressive loads during the deployment of the ipsilateral
attachment system preventing wire buckling, kinking or
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bowing. The proximal end of the elongate tubular member
is secured to the retaining rack. The coaxial design of
the rack and.elongate tubular member provides precise control
of the relative movement of the elongate tubular member,
the components attached.thereto, and the remaining portions
of the intraluminal grafting system 50. The retaining rack
is configuredsnith teeth.20l along a longitudinal edge which
engage a pinion or gear 224 fix to the lower end of a shaft
227. The upper end of the shaft is secured to control knob
147 such that rotation of the central knob rotates the gear
and in turn moves the retaining rack longitudinally within
the central bore. Longitudinal movement of the rack causes
longitudinal movement of the elongate tubular member and
of the capsule 132 (including the components attached
thereto). The control knob is configured with a locking
gear 234 which has angled teeth for releasably engaging a
locking pin 237. The locking pin can be biased by a locking
spring (not shown).
Referring to FIGS. 1,
6 and 8, the capsule jacket
assembly 53 is slidably disposed coaxially over the
ipsilateral capsule catheter assembly 52 and the balloon
catheter assembly 51 (FIG. 24). The capsule jacket assembly
is comprised of a main sheath 160, a locking connector 162
and a locking ring/adapter 164. The sheath has a one piece
design for ease of manufacturability and simplicity in design
and is preferably made fron1HOPE or equivalent material such
as LDPE, FEP, PET. At the distal extremity of the sheath,
it flares to a larger diameter covering the proximal
(ipsilateral) 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)
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at its proximal end and about 0.3 inches (7.62 mm) at the
distal end 163.
The proximal end of the sheath 160 is secured to the
ring/adapter 164 and locking connector 162 by mechanical
means and.by adhesive. Ir1addition, a length.of polyethylene
tubing 167 is adhered over the sheath adapter and over the
proximal ends of the sheath to secure the parts from
separating. The distal end of the sheath of the capsule
jacket is provided with radiopaque marker 166 about five
millimetersixilongitudinal length. The preferred.embodiment
is an "L" shaped marker of 3 mm LEG x 5 mm LEG x 2 mm WIDTH
gold.radiopaque foil laminated 2rmnfron1the distal extremity
163 of capsule jacket assembly 53.
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/adapter 164 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/adapter 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
exposedâ At its furthermost proximal position, the locking
connector is
positioned
adjacent the distal of the
ipsilateral capsule handle 145. The distal end of the
ipsilateral capsule handle is configured with a male
component 154 and.mates with the proximal end of the locking
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connector. The locking ring/adapter may be tightened at
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 14-16, the intraluminal
grafting apparatus 50 also includes an expandable,
collapsible and flexible intraluminal vascular bifurcated
prosthesis or graft 55 for implanting in a body vessel or
corporeal lumen. Referring to FIG. 14, the graft consists
of a deformable main tubular member 170 which bifurcates
into an ipsilateral tubular leg 171 and a contralateral
tubular leg 172. The main tubular member and tubular legs
each are formed.of a substantially 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 6.5 centimeters is
suitable for most patients. The main tubular member may
have a maximum expandable diameter ranging from fourteen
to forty millimeters and a minimum diameter in a collapsed
conditicwlof 0.175 to 0.3 inches (4.44â7.62 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 implantabletmaterial 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 material at the
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ends, the ends can be melted with heat to provide a small
melted bead of material on each end. Alternatively, the
prosthesis may be of PTFE material, knitted polyester or
any surgical implantable material.
As shown in FIGS. 14-17, crimps 251 are configured in
the ipsilateral and contralateral tubular legs 171, 172 to
resist kinking of the graft when deployed in a corporeal
lumen. However, it is to be recognized that, where crimping
is not desired, they can be omitted from the structure of
the graft. The crimps begin just superior to the bifurcation
from the main tubular member 170 and are evenly spaced along
the tubular leg. The crimps discontinue approximately 7
(seven) 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. standard. size crinm> mayâ be Iised, it is
preferred to make the crimps 251 radially deeper and less
numerous than produced from standard crimping techniques.
Having sparsely crimped tubular legs 171, 172 reduces the
elongation properties of the bifurcated graft 55. 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 withlnarker bands on the hypotube of the balloon
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catheter to adjust for the inâvivo length of the crimped
graft which is the graft length with the crimps subjected
to physiologic pressures in the corporeal lumen.
Whereas the standard crimp have peak widths of about two
times the graft wall thickness, the crimps 251 of the bifur-
cated graft 55 may be of sufficient width, preferably 1.5
millimeters, so as to sew in radiopaque markers 255 in the
valleys between selected crimps. Alternatively, the
radiopaque markers can be sewn on the face of selected
crimps.â The radiopaque markers are preferably 5 mm long
platinum coils sewn on the outerseam of the tubular legs
in a cross-wise orientation that appear "C" shaped, allowing
for twist detection under fluoroscopy. Similarly, long
radiopaque markers 256 and short radiopaque markers 257 are
secured to the edge of the main tubular member 170 to ensure
proper alignment of the graft 55 in line with the outseam
of the tubular legs and aligned with the markers on the
tubular legs Also, in the preferred embodiment, one or
more radiopaque markers are secured to the graft at the point
of bifurcation.
The distance between the crimps 251, or crimp pitch, is
preferably less than the diameter of the tubular legs 171,
172, so as to resist kinking. The crimp pitch is preferably
3.25 millimeters. The crimped graft 55 of the present
invention is configured with crimps having peaks that are
preferably 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 FIGS. 14-19, a self-expanding superior
attachment system 175 is secured adjacent the superior end
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of the tubular member 170. As shown in FIGS. 14-16 and 20,
a first selfâexpanding inferior attachment system 176 is
secured.adjacent the inferior end.of the ipsilateral tubular
leg 171. Similarly, a second. selfâexpanding inferior
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 position and
provides a fluid tight seal between the graft and corporeal
lumen wall.
As shown in FIGS. 17-19, the superior attachment system
175 includes a sinusoidal frame 302 that has longitudinally
inwardly directed base apices that are affixed to the graft
longitudinally inward from the outer
extremity.
Alternatively spaced between the sinusoidal frame are
outwardly directed protruding apices that extend outward
from the end of the graft. As shown in the embodiment
illustrated.in FIG. 17, the wire frame has a first end strut
308 and a second end strut 310. In the prefered embodiment,
the first and second end struts of the single piece of wire
frame are welded together to provide a continuous spring
like attachment systenL The wire frame is wound into helical
coils or helices with one and a half rotations and include
apices A1 through A8.
In the prefered embodiment, the sinusoidal wire frame
302 is formed with eight outward.protruding apices numbered
A1 through.A8 respectively beginning at the protruding apex
A1 closest to the first end. Each of the apices are wound
into a helical spring coil 370. The alternating base apices
are numbered for reference B1 through B8 beginning with the
base apices closest to apex A1.
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Each of the protruding apices Al through A8 are
integrally connected to adjacent base apices B1 through B8
by struts 378. As observed in FIG. 17, not all of the struts
are of equal length. Rather, the length of the struts are
configured.to stagger the apices along different planes that
are spaced longitudinally apart and are perpendicular to
the axis of the graft 55 according to the pattern described
below. It isauiimportant objective of the present invention
to create a narrow profile for the attachment system 175
when the attachment system is constricted radially. Since
the helical apices tend to have a greater radial width than
the struts, staggering the apices serves the purpose of
creating a narrow profile for insertion into a capsule.
The helixes 370 located at outward protruding apices Al
through.A8 are aligned slightly outward from the end of the
graft. Furthermore, the diameter of the helices 370 at apice
A1 through.A8 are .042" inches which is smaller in diameter
than helices 376 and 382. This accomplishes the purpose
of minimizing the radial profile of the graft in collapsed
position. The graft provides considerable bulk to the
attachment system 175 and positioning the apices A1 through
A8 beyond the end of the graft distributes longitudinally
the bulk of the graft and helices.
The helixes 370 located at the base apices B1 through
B8 are staggered considerably. Apices B1, B3, B5, and B7
are configured with slightly larger diameter helices 376
to accommodate the lumen.piercing1nembers 374 which.are bent
into the shape of a vee. V-shaped lumen piercing members
374 will fit between the struts 378 adjacent to apices B1,
B3, B5 and B7 in a close proximal relationship. The
lengthened struts that connect the apices are sufficiently
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long to orient the apices B1, B3, B5 and B7 0.550" inches
longitudinally inward from the
protruding apices.
Furthermore, the diameter of the enlarged helices 376 at
apices B1, B3, B5, B7 are 0.050 inches (1.2 mm), which is
considerably larger than the diameter of remaining smaller
helices 382 formed in the wire frame 302. The smaller
helices 382 have a diameter of 0.047 inches (1.1 mm) at
apices B2, B4, B6 and B8. The enlarged helices 376, in
combination with the lengthened struts 378, create a space
between the struts 378 that extend longitudinally outward
from the enlarged helices 376 formed in apices B1, B3, B5
and B7 that conform in shape to the Vâshaped lumen piercing
members 374 such that the lumen piercing members can fit
into the attachment systenl in close proximity" to the
and the
lengthened struts
enlarged helices, without
contacting or rubbing against the same.
18 apices B2 and B6 may be further staggered with respect
to apices B4 and B8. Apices B2 and B6 are oriented 0.46
inches longitudinally inward from the protruding apices.
Apices B4 and B8 are oriented 0.36 inches longitudinally
inward from the protruding apices.
As shown in FIG. 19, it may not be necessary or desirable
under some circumstances to stagger apices B2 and.B6 relative
to B4 and B8. For example, the profile of the protruding
apices Al through A8 of the attachment system 175 might be
sufficiently large that even if the staggering of helices
B2 and B6 relative to B4 and B8 occurred it would not serve
to reduce the diameter of the overall capsule. When
staggering apices B2 and B6 relative to B4 and B8 would not
serve to facilitate the use of a narrower capsule or delivery
system, then aligning such apices may be desired.
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The wire frame 302 of the
attachment system 175
illustrated in FIGS. 17 through 19 is designed to fit inside
a graft 55 that has a diameter of 20 to 26 millimeters but
may range from 18 to 28 mm. When affixing the frame to the
tubularâ graft, the wire frame is preferably" partially
compressed to maintain a constant outward bias against the
wall of the graft. The two ends of the wire frame, 308 and
310, overlap and are welded to each other.
The attachment system 175 including the wire frame 302
and the V-shaped lumen piercing members 374 are sutured to
the graft 55 at various points throughout the graft. The
sewing pattern can best be viewed with reference to FIGS.
17 or 19 showing the stitching from the perspective of the
inside of the graft.
In the embodiment illustrated in of FIGS. 14, 17-19, the
V-shaped lumen piercing members 374 are not welded to the
wire frame 302, but rather are sewn into the graft 55 in
close proximity to the sinusoidal wire frame and are
responsive to the compression and expansion of the wire
frame. To provide stability and flexibility, the lumen
piercing members are formed from a single strand of wire
with two ends. The wire is bent into a V-shape having an
apex 394 and two outwardly protruding arms 396 and 398 that
form an acute angle when in relaxed position. The two ends
of the wire are bent radially outward.to fornlhooks 399 that,
when mounted to the graft, are designed to pierce into the
wall of the blood'vessel. As shown in FIGS. 18-20, the hooks
are shown.to point tangential to the graft perimeterz These
illustrations are merely to show what the hooks look like.
In actuality, the hooks would be directed at an angle
perpendicular to the paper. At such an angle, the hooks
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would be difficult to illustrate. By incorporating this
weldless design, the superior attachment system is better
suited to withstand the pressures applied thereto when placed
within a body lumen such as an aorta. There are no welds
which, under repeated compression and expansion cycles,
become fatigued and/or eventually break, thereby resulting
in failures. Accordingly, being better suited for the
environment in which it is placed allows the attachment
systenltotnore effectively anchor the graft within.the lumen.
Each hook forms an angle with its respective arm ranging
from ninety degrees to forty five degrees, but preferably
seventy (70) degrees. The wire of each Vâshaped lumen
piercing member is wound at the apex to form a helical coil
400. Such a helical coil contributes to the outward bias
and spring of the entire attachment system. Absent such
a design feature, the Vâshaped lumen piercing members would
not be as responsive to the contractions of the graft.
Moreover, the fatigue life of the hooks are extended because
the helical design distributes the tension of the wire over
the helix when the arms of the lumen piercing member are
subject to continual contractions caused by the pulsing of
the blood vessel during the cardiac cycle. The diameter
of the apices in the embodiment illustrated in FIG. 17, 18
and 19 should have an outside diameter ranging between 0.025
inches and 0.060 inches and preferably 0.047 inches.
There are four pairs of Vâshaped lumen piercing members
374 in the embodiment illustrated in FIGS. 17, 18 and 19.
The number of V-shaped lumen piercinglnembers mounted.depends
upon the number of pairs of protruding apices and base
apices. The Vâshaped lumen piercing members are placed
around the graft equally spaced.apart. They are fitted into
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the space between the elongated struts 378 and are mounted
adjacent to apices B1, B3, B5, and B7. The arms of the V-
shaped lumen piercing members extend parallel to adjacent
elongated struts. The Vâshaped lumen piercing members of
the embodiment illustrated in FIG. 17 has a length of 13.5
mm and.a helical diameter of 0.047 inches but may range from
10-20 mm.
The hooks 399 have a length of two to three millimeters
and are sharpened at the tips 405. The hooks may be
sharpened with a conical tip as shown in FIGS. 17 through
19 or with a duck billed tip (not shown).
A conical tip
is formed when the wire tip is held at an angle against the
sharpening tool (not shown) and rotated. The duck bill tip
is formed by holding one side of the tip of the hook 399
against the sharpening surface (not shown) at an angle.
Not rotating the wire results in an oblong flat surface and
a sharpened curved cutting edge that cuts into the blood
vessel wall when.the hookzis pressed against the vessel wall.
One possible method of attaching the Vâshaped lumen
piercing members 374 to the frame can be observed with
reference to FIGS. 17, 18 and 19.
As can readily be
observed, the helices of the Vâshaped lumen piercing members
are located on the outside of the graft 55 while the arms
396 and 398 extend parallel to the struts along the inside
of the graft 55. The frame is positioned within the interior
of the graft wall apexes AlâA8 extending just beyond the
end of the graft. By mounting the Vâshaped lumen piercing
members directly through the fabric of the graft, the V-
shaped lumen piercing members will be mounted more firmly.
Furthermore, the fabric of the graft separates the helix
400 of the Vâshaped lumerxpiercingxnember fron1the respective
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adjacent enlarged helices 376 and thereby prevents the
helices of the Vâshaped lumen piercing member from rubbing
against the adjacent base helices.
The Vâshaped lumen.piercing members 374 are mounted into
the graft by pressing together the two arms 396 and 398 of
the Vâshaped lumen piercing members until the hooks are
separated by a distance approximately equal to the outer
diameter of the helices. The hooks are then punctured
through the fibers of the graft from the outside of the graft
wall to the inside of the graft. The entry holes made by
the Vâshaped lumen piercing members are spaced longitudinally
outward by more than the outer diameter of the helices 400
of the Vâshaped lumen piercing members. The spacing apart
of helices 400 of the Vâshaped lumen piercing members
prevents them from radially overlapping the enlarged base
helices 376. This longitudinal spacing also furthers the
goal of distributing the bulk of the attachment system
thereby narrowing the radial profile of the graft when in
a compressed.state. âThe apices of the lumerxpiercinglnember,
prior to insertion of the hooks through the graft, point
outward towards the end of the graft. The two hooks should
preferably be laterally aligned so that the entry holes 410
through the graft wall created by the hooks are laterally
aligned. The Vâshaped lumen piercing members are pressed
through the puncture holes and slid inward along the arms
until the helix 400 contacts the outer wall of the graft.
The Vâshaped lumen piercing members are inverted to an
upright position.thereby orienting the hooks radially outward
to engage the wall of the blood vessel.
The arms 396, 398 of the Vâshaped lumen piercing members
374 are compressed before being sewn to the graft 55 to
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maintairithe outward.bias of the graft. âThe distance between
the arms at the edge of the graft is preferably four to six
millimeters but may range from 3~8 millimeters. The arms
are sutured to the graft parallel to and in close proximal
relationship to the struts 378 adjacent to the'Vâshaped lumen
piercing members. The arms of the Vâshaped lumen piercing
members are generally not sutured directly to the adjacent
struts. The arms of the V-shaped lumen piercing members
and the adjacent struts are sutured separately in order to
prevent them from rubbing together.
Referring to FIGS. 14-16 and 20, the inferior attachment
systems 176 are 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 inferior
attachment systems may be comprised of apices numbering from
four to twentyâfour. The springs yieldably 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 inferior attachment system 176 has legs 181, each being
of equal length.
As shown in. more detail in FIG. 20, the inferior
attachment systems 176 are 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 181.
The two ends of the single piece of wire can be welded
together to provide a continuous spring-like attachment
system. In the construction shown in FIGS. 14 and 21, it
can be seen that the attachment systems have twelve apices
lying in two longitudinally spaced-apart parallel planes
which are spaced with respect to the longitudinal axis of
the tubular legs 171,
172. Accordingly, the outer apices
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178 residing external of the graft are spreadâapart from
the inner apices 179 residing within the graft lie in the
same plane. The apices, however, can lie in three or four
spacedâapart planes if the inner and outer apices are
staggered. As can also be seen, each of inferior attachment
systems includes three wall engaging members 193 which are
welded to the legs, and spaced uniformly about the attachment
systems.
With respect to the ipsilateral leg of the graft 55, the
attachment system 176 may be sewn to the graft such that
the inner apices 179 are positioned 2.5 - 3 centimeters
within the interior of the graft. As to the contralateral
legs 172, the inner apices 179 may be attached to the end
of the leg. The inferior attachment systems 176 are secured
to the wall 173 of the graft 55 by suitable means such as
a polyester suture material. As shown in FIG. 20, sutures
or knots 190 are used for sewing the inner apices 179 onto
the wall of each tubular leg 171 and 172.
As shown in FIG. 21, wall engaging members 193 are
preferably secured to the legs 181 of the attachment systems
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 from 0.5 to 5.0 millimeters. The wall
engaging members are preferably sharpened to provide conical
tips 196, 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.
In the preferred embodiment, in order to provide additional
structural support to the wall engaging members, the suture
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material used to sew the attachment system to the graft is
wrapped around the legs of the attachment system to which
the wall engaging members are welded, through the adjacent
apices and is anchored to the graft.
The attachment system 175, inferior attachment systems
176 and the wall engaging members 193, 374 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 Elgiloy of
Elgin, Illinois. The wire can have a diameter ranging from
0.008 to 0.025" inches (0.203âO.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 twentyâeight millimeters
diameter, and 0.008 to 0.012 inch (0.203â0.305 mm) diameter
wire may be used in the smaller grafts being eight to sixteen
millimeters in diameter. 9
It has been found that the spring force created by the
helical torsion springs at the apices is largely determined
by the diameter of the wire. The greater the diameter of
the wire, the greater the spring force applied. 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
eighteen millimeters between the outer extremities of the
legs of the superior attachment system 175. Similarly, a
spacing of approximately ten millimeters between the outer
extremities of the legs of the inferior attachment system
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176 is preferable, although smaller or larger distances may
be utilized.
FIG. 22 shows a low stress configuration of an attachment
system. An additional helical torsion apex 185 is added
along the legs of the attachment system. The additional
apices are located adjacent the apices at the vees formed
by the legs. Such a configuration improves the fatigue
characteristics of the attachment systenn In addition, the
weld location for the welded attachment systenxmay be moved
down the attachment system leg to improve fatigue life.
Alternativelyy a.nonâroundcn:nonâcircular 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 facilitate securing the graft 55 in the corporeal
lumen, the tips 405 of the wall engaging members 374 on the
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 inferior end of the graft by 55° to 90° and
preferably about 85°. Likewise, the tips 195 of the wall
engaging members 193 on the inferior attachment system 176
may be inclined towards the superior end of the graft by
30° to 90° and preferably 85°. By angling the conical tips
of the wall engaging members so that they resist the force
of the blood flow, the implantednwall engaginglnembers oppose
migration of the graft.
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The helical torsion springs 180, 370, 400 placed at the
apices of the attachment systems serve to facilitate
compression of the graft 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.
Placing the apices in.different planes and.staggering
or offsetting the wall engaging members 193, 374
significantly reduces the minimum compressed size of the
graft. Having the tips 196, 399 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 graft to
its expanded position as soon as the attachment system is
free of the capsules.
The graft 55 preferably contains a radiopaque marker
systen1for locating the graft and for detecting any twisting
of the graft during deployment. As shown in FIGS. 14-16,
the preferred radiopaque marking system for a bifurcated
graft 55 includes short and long radiopaque markers 256,
257 located longitudinally on the wall 173 of the graft in
a line parallel to the longitudinal axis of the main tubular
member 170 and located on opposite sides thereof. By having
the short radiopaque markers on the side of the graft from
which the contralateral leg extends and the long markers
on the side of the graft from which the ipsilateral leg
extends, for example, under
flouroscopy, the proper
orientation of the graft can be ensured. Elongate tubular
legrnarker coils 255 are sewn laterally withir1preâdetermined
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valleys between crimps
of the legs and on the
same
longitudinal axis as the long and short radiopaque markers
256 and 257. When detecting twist of the graft under
fluoroscopy, the tubular leg markers appear with varying
widths may appear lateral and medial to the guide wire in
the leg.. The tubular leg markers, however, appear uniform
in size and lateral to the guide wire in the leg for a
tubular leg that is not twisted.
Additionally, radiopaque markers are positioned at the
point of bifurcation of the graft. These two aid in
determining whether the graft is 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. The tubular legs 172 and
171 are approximately of the same length in the preferred
embodiment but may be staggered from .1 to 6 centimeters
if configured on.a patient by patient basis. For the repair
of an aortic aneurysm, the hook to hook length of the
prosthesis is selected so to span approximately one and.oneâ
half centimeter superior and two centimeters inferior of
the aneurysnu wherein the wall engaging members of the 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 aneurysnxbeing 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 arteries 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
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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 and tubular legs 171 and 172 having a
diameter at least .1 or oneâtenth millimeter larger than
that measured. In the preferred embodiment, the diameter
of the tubular legs is half the diameter of the main.tubular
member which is available in two millimeter increments of
18 mm,
20 mm, 22 mm, 24 mm, 26 mm and 28 mm.
As shown in FIGS. 14-16 and 18, segments or tufts of
polyester yarn 418 or similar material are sewn about the
circumference of the graft 55. The segments or tufts 418
are 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 increase
the embolization area. The yarn segment is sutured to the
wall 173 of the graft between the vees 177 of the superior
attachment system 175.
Similarly, yarn segments may be attached to the graft
wall adjacent the inferior 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 graft wall may be made to accomplish
the same result.
FIGS. 1, 7, 8, 26 and 27 show the contralateral capsule
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
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secured to the contralateral tubular leg 172. The guiding
tube assembly is used to pull the contralateral capsule into
the contralateral artery, e.g., iliac,
to deploy the inferior attachment system when the contra-
and is configured
lateral 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
contralateral tubular leg.
As shown in FIG. 26, 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 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 or similar biocompatible material. The
contralateral capsule is typically 2 centimeters long with
a internal diameter of 0.3 centimeters. The contralateral
capsule is preferably circular shaped so as to fit within
the indentation of the proximal capsule 132, as shown in
FIG. 25, and is open at 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
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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. The barbed adapter is further
configured with a bore in which the guiding tube resides.
Furthermore, the barbed adapter is secured to the guiding
tube with adhesive.
A distal lock set 208 is fixed at the distal end of a
pull wire 207 spaced apart from a proximal sliding pusher
button 209, each of which reside within the contralateral
capsule.. The distal lock set 208 is configured with a .028"
outer diameter, stainless steel fixed<guidewire which extends
into the trunk or main tubular member 170 preferably 1.2
centimeters distal of the graft bifurcation marker 255.
The length of the lead wire may range from 4 centimeters
to 15 centimeters
depending on the length of the
contralateral tubular leg 172. Proximal to the sliding
pusher button 209 is a stop 199 which limits the proximal
motion.of the pusher button The hypotube stop 199 is crimped
to the pull wire 207. Prior to deployment of the contra-
lateral tubular leg 172 into the contralateral iliac artery,
the inferior attachment system 176 resides in the contra-
lateral capsule between the distal lock set and proximal
pusher button.
The guiding tube assembly 205 comprises the pull wire
207 disposed within the distal guiding tube 206 and a
proximal guiding tube 213. Approximately a distance equal
to the length of the graft 55 frontthe contralateral capsule
202, or distal end of the guiding tube, a six centimeter
segment of the guiding tube is configured with a radiopaque
material,
such as a platinum coil 210. As shown in FIGS.
1, 7 and 8, the radiopaque material marks the point where
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the guiding tube exits the distal end 163 of the capsule
jacket 160. Moreover, a pre-determined number of spaced-
apart platinum radiopaque markers 420 (preferrably ten in
number) are positioned on the guiding tube assembly 205
proximally relative to the platinunlcoil 210. Suchlnarkings
allow fluoroscopic determination.of whether the guiding tube
has been twisted, kinked, or wrapped around the capsule
jacket or distal capsule assembly 90 as well as the
longitudinal position. of the guiding tube within the
vasculature.
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
213. The tapered proximal end of the distal guiding tube
nests inside the flared distal end of the proximal guiding
tube. Both guiding tubes are 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 "Jâtipped" 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 proximal the proximal end of the proximal
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 correspondingxnovement of the contra-
lateral capsule. If,
however, the guiding tube assembly
205 is cut at specific points between the tapered joint 211
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and the contralateral guide 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 over the pull wire. Black or
colored marker bands 214 formed from PET shrink tubing are
positionedem:predeterminedlocationscxitheproximalguiding
tube 213 to indicate the chronological order in which the
sections of the guiding tube assembly is removed during the
deployment process. In the preferred embodiment, the guiding
tube assembly has a single marker, a marker group with two
marks and.a1narker group with three marks. The single marker
is cut away to remove the "Jâtipped" guide wire whereas the
marker group with two marks is cut away to enable relative
movement between.the contralateral capsule and the pull wire.
A torque catheter assembly 215 for use with the contra-
lateral capsule assembly 200 is shown.in.FIG. 27. 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 or percutaneous 12 French
introducer sheath to the position:u1the contralateral iliac
artery where the contralateral attachment system 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.
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
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securing the distal end of the torque catheter to the barb
adapter. Alternatively, the distal end of the shaft may
be configured with a radiopaque adapter configured to mate
with the barb adapter. The distal end of 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 a
hemostatic seal 240 and a Touhy Borst adapter 241 separated
by a single lumen polyethylene tube 242. Distal to the stop
lock, the torque catheter is configured with a male luer
adapter 410 which mates with a distal female luer fitting
411.
The hemostatic seal 240 locks on and seals the distal
guiding tube 206 with the barb adapter 203 engaging the
distal end 217 of the torque catheter shaft 216. The
proximal Touhy Borst adapter 241 engages the proximal guiding
tube 213 and ultimately the pull wire 207 which secures the
contralateral attachment system 176 within the contralateral
capsule. The tapered joint 211 between the distal guiding
tube and the proximal guiding tube resides between the
hemostatic seal and the Touhy Borst adapter. This engagement
allows safe torque ability of the contralateral capsule 202
and adjustment of the position and orientation of the
contralateral limb.
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The ends of the polyethylene tube are configured with
barbed male Luer fitting 243 on the distal end and a barbed
female luer fitting on the proximal end 244 on which the
hemostatic seal and.Touhy Borst adapter 240, 241 are secured.
To allow longitudinal movement of the contralateral limb,
the guiding tubes 206 and 213 should have the hemostatic
seal and Touhy Borst adapter locked.
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 100. 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 lever
lock on the capsule catheter assembly.
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 systen1176 are removably retainedwuithin
the proximal capsule 132. the inferior end of
Likewise,
the contralateral tubular leg 172 and inferior attachment
system 176 are removably retained within the contralateral
capsule 202.
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 100
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is positioned just proximal the distal cap 92 and is disposed
within the distal capsule 93. In addition, proximal pusher
button 86 and distal lock 87 are disposed on either side
of the ipsilateral attachment systen1176 within.the proximal
capsule 132. Similarly, proximal sliding pusher button 209
and distal lock set 208 are disposed on either side of the
contralateral attachment systen1l76 within.the contralateral
capsule 202. In the preferred embodiment, distal pusher
button 87 and distal set 208 are disposed just distal of
the respective attachment systems 176. Also, the capsule
jacket assembly 53 is longitudinally locked and 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 145, the entire
apparatus 501noves as a single unit. It is also contemplated
that the handle assemblies 145 and 110 have socket head
shoulder screws 246 opposite the knobs for an.elastic vessel
loop (not shown). The loop mounted on the posts function
as a counting element to the quantity and direction of
rotations made between the two handles in the correction
for graft twist between the main tubular member and the
tubular legs.
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 access both ipsilateral and contralateral femoral
arteries or vessels of the patient. In the preferred
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procedure, a super stiff .035" guidewire is used. 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 228 into the
aorta. By conventional means, a gooseneck snare catheter,
basket catheter or similar device is fed through an
introducer sheath emplaced in the contralateral femoral
artery over a contralateral guidewire
(not shown) to the
contralateral iliac artery 229. The contralateral guidewire
is then removed. Thereafter, the snare or basket catheter
is used to snare or capture the J-tipped proximal end of
the guiding tube assembly. The guiding tube 206 is then
pulled through the contralateral iliac artery and out the
cutdown or introducer sheath in the contralateral femoral
artery.
The distal end of the intraluminal grafting apparatus
50 is then inserted into the sheath over the super stiff
.035" guide wire, which has previously been placed in the
femoral artery. In the preferred embodiment of the present
invention, balloon catheter lumen 63 is provided for
receiving the guide wire 56 that was previously traversed
across 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 ipsilateral
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. 28, the main guide
wire is introduced by the physician into an arteriotomy or
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introducer sheath 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, the nose cone 105 facilitating
advancement about arduous turns, while maintaining slight
tension on the guiding tube assembly 205 from the access
site in the contralateral femoral 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 millimeter inferior
to the lower renal artery.
The inferior attachment systems
176 should be positioned superior the internal iliac
arteries. Alternatively, the attachment system may be
deployed.in the common iliac below the internal iliac artery
for one leg without additional surgical intervention or if
both attachment systems are in the common iliac, additional
surgical intervention is necessary to provide blood flow
into the internal iliac. However, prior to removing the
contralateral tubular leg 172 from the capsule jacket
assembly 53, the proximal capsule assembly 130 and contra-
lateral capsule assembly 200 must be positioned superior
the bifurcation of the abdominal aorta to the ipsilateral
iliac artery 228 and contralateral iliac artery 229, as shown
in FIG. 28. Fluoroscopy is used to inspect the position
of the radiopaque section 210 of the guiding tube assembly
205 to identify its longitudinal position within the
vasculature as well as to ensure that the distal end of the
guiding tube 206 is not wrapped.or twisted around the distal
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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,
the Jâtipped end of the guiding tube assembly is discarded
by cutting away the first marker 214 and for the purpose
of maintaining a sterile field. Thereafter, 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
ipsilateral capsule catheter assembly 52 and hold it
stationary, the physiciar1grasps 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 contralateral side as
it is removed fronlthe capsule jacket assembly. 'The capsule
jacket assembly is gradually retracted.to sufficiently expose
the proximal capsule 132 to free the contralateral capsule
202. The capsule jacket assembly is then moved to its most
proximal position and its proximal end 162 is locked to the
male component 154 of the ipsilateral capsule handle 145.
The locking ring is then.tightened.to hold.the capsule jacket
assembly in place, as shown in FIG. 29. The radiopaque
marker 166 at the distal end of the capsule jacket main
sheath may be used to position the capsule jacket as desired.
Moreover, 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 adjust the graft 55 length to
physiologic length.
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At this point in.the procedure, the contralateral tubular
leg 172 of the graft 55iJsmoved into the contralateral iliac
artery 229 by pulling the guiding tube 206 in a proximal
direction, as shown in FIG. 30. At the same time and with
concurrent motion, the superior end of the main tubular
memberâ170, disposed in the distal capsule 93, is moved into
the desired location of the aorta 225 by moving the control
handle 145, and thereby the intraluminal grafting assembly
50, in a proximal direction. By 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
retainedxuith.in.the contralateral capsule 202, is positioned
for deployment of the contralateral attachment system. In
order to insure proper orientation of the graft, the balloon
catheter shaft lock can be disengaged and the superior
capsule handle 110 rotated relative to the ipsilateral
capsule catheter assembly 52 to maximize the lateral
radiopaque marking on the graft. Once these steps are
performed, each of the attachment systems should be in
position for deployment.
The retaining screw 118 is loosened and the control knob
113 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 distal cap 92, nose cone 105, and distal capsule
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93 are secured to the control wire 91, and since the handle
incorporates the coaxial design, they move in a precise
manner and in corresponding relationship with the rotation
of the control knob. As the distal capsule is moved from
engagement with the superior attachment system, the balloon
catheter proximal cap 100 locates at the proximal end of
the distal capsule. The distal capsule is continued to be
advanced so that a smooth profile of the superior capsule
and the cap is achieved. As soon as the distal capsule has
cleared the superior attachment system 175, the superior
extremity of theInain.tubular member expands outwardly under
the force of the selfâexpanding attachment system which
springs into engagement with the vessel wall 230. The
locking pin 126 holds the control knob, and thus the control
wire and distal capsule, fixed in place.
Once the superior attachment systen1l75 is exposed, steps
are taken to firmly seat or urge the wall engaging members
374 in the vessel wall. First, the collet lock assembly
158 on the ipsilateral capsule handle is loosened to permit
relative movement between the ipsilateral capsule catheter
assembly 52 and the balloon catheter assembly 51. While
the physician uses one hand to hold the ipsilateral 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
of the main tubular member 170. The radiopaque marker 84
is used to align the main balloon and superior attachment
system. The balloon shaft 61 is then locked again by
activation of the collet lock assembly.
Thereafter, a conventional hand operated syringe or
inflation assembly (not shown) is attached to the balloon
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catheter inflation port 74. As depicted in FIG. 31, the
main balloon 60 is then expanded by introducing a suitable
gas such as carbon dioxide or a dilute radiopaque liquid
from 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 175.
However, the main balloon may be deflated and reinflated
during the following steps to allow the tubular legs 171
and 172 to fill with blood to facilitate detecting any
twisting of the bifurcated graft 55.
As shown in FIG. 32, the next step is to implant or
anchor the inferior attachment system 176 of the contra-
lateral tubular leg 172. Then, the torque catheter assembly
215 is passed over the remaining guiding tube assembly 205
so as to engage the distal connector 217 of the torque
catheter with the barb adapter 203 of the contralateral
capsule assembly 200, as depicted.in FIG. 24. The hemostatic
seal 240 and Touhy Borst 241 is then tightened around the
guiding tube assembly, thereby locking it in place and
providing a seal. Thereafter, 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
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hemostatic seal 240 and Touhy Borst adapters 241 locked to
the distal and proximal guiding tubes 206 and 213.
Next, the guiding tube assembly 205 is cut to disconnect
the group containing two marker bands 214 to allow relative
movement between the distal section.of the guiding tube 206
and the pull wire 207. The Touhy Borst adapter 241 of the
torque catheter assembly 215, which is locked to the proximal
guiding tube, is disengaged by removing the Luer fitting
243 from the hemostatic seal 240 thereby exposing the pull
wire 207. Thus, the proximal guiding tube 213 having the
triple marker band is also removed. At this point, the
contralateral leg 172 can be affixed within the iliac in
either compression or in tension. To deploy the limb in
compression, the contralateral lock wire is held.fixedâwhile
the torque catheter is retracted over it. The contralateral
pusher button 209 supports the attachment system 176 while
the torque catheter is retracted keeping the attachment
system fixed relative to the implantation site. To deploy
the limb in tension, the torque catheter is retracted to
release the attachment system attempting to keep the
contralateral look within the graft limb.
Once the inferior extremity of the contralateral tubular
leg is free of the contralateral capsule, the inferior
attachment system will 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 contralateral capsule 202 are removed through the
contralateral femoral artery access. The pull wire 207 may
be moved distally so that the locking ball 208 is disposed
near the superior end of the contralateral tubular leg 172.
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A conventional (contralateral) small nose balloon catheter
235 (FIG. 32) is then moved into the contralateral iliac
artery 229 over the pull wire 207 and advanced until its
tip engages the slidable pusher button 209 and causes it
to abut the distal lock set 208. The stub nose balloon
catheter is configured with a radiopaque marker in order
to position the tip as desired using fluoroscopy. Then,
the tip of the stub nose balloon catheter is positioned
within.the inferior attachment system 176. A contralateral
balloon.236 configuredcnithe contralateral balloon.catheter
is then inflated to firmly seat the 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 with the contralateral
balloon.inflated.during the next sequence of steps; however,
the contralateral balloon catheter and pull wire may be
removed once the contralateral attachment system is firmly
implanted.
As shown in FIG. 33, the next step is to deploy the
inferior attachment system 176 of the ipsilateral tubular
leg 171 into the ipsilateral iliac artery 228. The retaining
pin 126 is removed from the ipsilateral capsule handle 145.
The collet locking assembly 158 of the ipsilateral capsule
handle 145 is locked to the balloon catheter. Then the
control knob 147 is turned in order to effect longitudinal
movement of the ipsilateral capsule 132 and.rack 192, precise
control of which is achieved by way of the coaxial design
of the handle. The ipsilateral tubular leg 171 can be
affixed within the vessel either in compression or tension.
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To deploy the limb in compression, the pusher button 86 and
lock 87 remain locked longitudinally to the ipsilateral
handle 145. The handle assembly 110 is also longitudinally
locked to the ipsilateral handle 145 with the balloon 60
inflated to secure the superior attachment system, while
the capsule catheter rack 192 is moved proximally when the
knob 147 is rotated until the inferior attachment system
and inferior end of the ipsilateral tubular leg are
completely clear of the proximal capsule 132 while its
position is held fixed relative to the corporeal lumen.
To deploy the limb in tension, both the ipsilateral locking
wire 87 and pusher button 86 and the capsule catheter
assembly 52 are moved proximally until the leg 171 is held
in tension. Thereafter, the capsule catheter assembly is
moved further proximally while keeping the lock and pusher
button stationary.
Whether deploying the ipsilateral tubular leg 171 in
compression or in tension, once the inferior extremity of
the limb is free of the proximal capsule 132, the ipsilateral
inferior attachment systen1176 will spring open.and.the wall
engagingxnembers 193 will engage the ipsilateral iliac vessel
wall 232. Leaving the main balloon 60 inflated while the
ipsilateral capsule catheter assembly 52 is moved ensures
that the superior attachment system 175 will remain firmly
secured in place. Thereafter, the main balloon 60 is
deflated. The ipsilateral handle 88 is rotated 90° and
retracted to release engagement with the ipsilateral handle
145 to position the lock 87 and pusher button 86 back.within
the ipsilateral capsule 132 for a smooth transition. As
shown in FIG. 34, the handle assembly 110 is moved proximally
so that the main balloon is retracted into the ipsilateral
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tubular leg 171 andmplaced.adjacent the ipsilateral inferior
attachment system 176. If the main balloon cannot be
positioned adjacent to the ipsilateral attachment system
due to limited available movement of the handle assembly,
then the collet lock assembly 158 is secured to the hypotube
115, thereby securing the ipsilateral capsule catheter
assembly to the balloon catheter assembly 51. The entire
deployment catheter 50 is then moved proximally to position
the1nair1balloon.adjacent the ipsilateral attachment system.
The main balloon.6O may be inflated and deflated through
the entire length of the main tubular member 170 and ipsi-
lateral tubular leg 171 to ensure patency 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 ipsilateral attachment system to tack
down.the wall engagingtnembers 193 into the ipsilateral iliac
artery vessel wall 232.
Thereafter, the main balloon is
finally deflated.
As shown in FIG. 35, the proximal capsule assembly 130
and balloon 60 are moved proximal the graft 55 and within
the capsule jacket assembly 53. First the collet lock
assembly 158 is loosened. Then, while holding the
ipsilateral capsule catheter'assembly'52jJ1placeknrgrasping
the handle 145 with one hand, the balloon catheter assembly
51 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 cap 100 for smooth transition.
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Finally, the capsule jacket locking ring 165 is loosened
and the proximal end of the capsule catheter 162 is
disengaged from the male member 154 and the distal end of
the ipsilateral capsule handle 145. While holding the
capsule jacket sheath adapter 164 in place, the balloon
catheter assembly 51 and capsule catheter assembly 52 are
moved proximally and in unison by gently pulling the handle
145 of the ipsilateral 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 the capsule jacket, thereby
creating a smooth transition along the entire length of the
intraluminal.grafting apparatus 50. Thereafter, the balloon
catheter assembly, ipsilateral capsule catheter assembly,
capsule jacket assembly 53 and control wire assembly 54 are
removed fronlthe aorta through the femoral arterju Theggraft
55 and attachment.systems 175 and 176 remain secured to the
vessel walls 230, 231 and 232, thereby sealing the aneurysm
226 from blood flow.
When the intraluminal grafting apparatus 50 is removed
from the ipsilateral iliac and femoral arteries, the main
guide wire 56 remains
in place in the Vessels. A
conventional (ipsilateral) auxiliary 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 auxiliary balloon
catheter is inflated 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
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inflated and deflated along the entire ipsilateral tubular
leg to ensure the tubular leg is completely open and to
remove creases which.may have set while the graft was loaded
in the capsule jacket assembly. The tubular legs may be
dilated using two balloon catheters being simultaneously
inflated while adjacent to each other introduced through
the ipsilateral and contralateral leg respectively for a
"kissing balloon" technique. Thereafter, the ipsilateral
auxiliary balloon catheter is removed. The main guide wire
is removed from the ipsilateral femoral artery after a post
implant angiogram, introducer sheaths are removed 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
mechanisms 87 and 208,
radiopaque markers 255, 256, 257
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 graft markers. 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 ipsilateral capsule catheter assembly 52 or the
contralateral capsule 205 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
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ipsilateral capsule catheter assembly and torque catheter
215.
Additional attachment systems may be placed within the
tubular legs for the purpose of further preventing kinking
of the graft material in the tubular legs. These additional
attachment systems are placed. medial the ends of the
ipsilateral and/or contralateral tubular legs. Such.medial
attachment systems may resemble the inferior or superior
attachment systems, but the medial attachment system are
preferably configured without 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 contralateral tubular leg 172 after 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 shaft.
Thereafter the sheath.cankxaremoved.fron1the femoral artery
and the femoral artery 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 graft within six months so that
no portion of the graft thereafter would be in communication
with the blood circulating in the vessel. This establishes
a complete repair of the aneurysn1which.had.occurred. While
forms
several particular 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.
For example, references to
SUBSTITUTE SHEET (RULE 26)
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materials of construction and specific dimensions are also
not intended to be limiting in any manner and other materials
and dimensions could be substituted and remain within the
spirit and scope of the invention. Accordingly, it is not
5 intended that the invention be limited, except as by the
appended claims.
SUBSTITUTE SHEET (RULE 26)
Claims (20)
1. A system for implanting a prosthesis in a corporeal lumen having a wall, said system comprising:
a graft having a plurality of ends;
a plurality of capsule assemblies, each said capsule assembly having an elongate tubular member having proximal and distal ends and each being configured to releasably retain one end of said graft; and at least one handle assembly, said handle assembly including a rack and pinion configured in a coaxial arrangement with one said elongate tubular member.
a graft having a plurality of ends;
a plurality of capsule assemblies, each said capsule assembly having an elongate tubular member having proximal and distal ends and each being configured to releasably retain one end of said graft; and at least one handle assembly, said handle assembly including a rack and pinion configured in a coaxial arrangement with one said elongate tubular member.
2. The system of claim 1, further comprising a one-piece capsule jacket assembly that is configured to substantially cover said capsule assemblies and said graft.
3. The system of claim 1, further comprising a lock wire assembly disposed in a lumen of one said elongate tubular member of said capsule assemblies, said pull wire assembly including a lock spaced-apart from a pusher button and a handle spaced from said lock and said pusher button.
4. The system of claim 1, further comprising a pull wire slidably disposed in a lumen of one said elongate tubular member of said capsule assemblies, said pull wire including a slidable pusher button and a locking device.
5. The system of claim 1, wherein at least one capsule assembly includes a nose cone.
6. The system of claim 1, wherein said graft includes an attachment system secured to each of its ends, at least one attachment system including V-shaped members with hooked terminal ends.
7. The system of claim 1, wherein said system includes a plurality of handle assemblies, at least one said handle assembly includes a collet lock.
8. The system of claim 1, further comprising a balloon catheter, said balloon catheter including a shaft having at least one lumen formed therethrough and an inflatable member.
9. The system of claim 8, further comprising an anti-elongation reinforcement wire disposed in one lumen of said balloon catheter shaft.
10. The system of claim 1, wherein at least one of said elongate tubular members include braided wire.
11. The system of claim 1, wherein said graft is wye-shaped and includes a radiopaque marker at its bifurcation.
12. The system of claim 1, wherein said handle assembly includes a rotating knob, said rotating knob being configured with a locking gear having angled teeth.
13. The system of claim 12, wherein said handle assembly includes a locking screw which cooperates with said control knob to limit the rotation of said knob to one direction.
14. The system of claim 1, wherein one of said elongate tubular members comprises a guiding tube configured with a barb adapter.
15. The system of claim 14, further comprising a torque catheter, said torque catheter including a radiopaque adapter configured to mate with said barb adapter.
16. The system of claim 1, wherein said system includes a plurality of handle assemblies, each said handle assembly includes a counting system that tracks the relative rotational positions of one handle assembly with respect to another handle assembly.
17. The system of claim 16, wherein said counting system includes spaced-apart posts connected to each other by an elastic vessel loop.
18. The system of claim 1, wherein one of said elongate tubular members includes markers for identifying specific portions of said elongate tubular member.
19. The system of claim 18, wherein said markers include a first single marker band spaced-apart from a group of two marker bands spaced-apart from a group of three marker bands.
20. The system of claim 1, wherein one of said handle assemblies include a locking pin for longitudinally locking said handle assembly.
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US08/707,179 US5824044A (en) | 1994-05-12 | 1996-09-03 | Bifurcated multicapsule intraluminal grafting system |
US08/707,179 | 1996-09-03 | ||
PCT/US1997/015441 WO1998009584A1 (en) | 1996-09-03 | 1997-09-03 | Improved bifurcated multicapsule intraluminal grafting system and method |
Publications (1)
Publication Number | Publication Date |
---|---|
CA2264514A1 true CA2264514A1 (en) | 1998-03-12 |
Family
ID=24840671
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CA002264514A Abandoned CA2264514A1 (en) | 1996-09-03 | 1997-09-03 | Improved bifurcated multicapsule intraluminal grafting system and method |
Country Status (6)
Country | Link |
---|---|
US (6) | US5824044A (en) |
EP (1) | EP0932378A1 (en) |
JP (1) | JP2001500403A (en) |
AU (1) | AU4246397A (en) |
CA (1) | CA2264514A1 (en) |
WO (1) | WO1998009584A1 (en) |
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-
1996
- 1996-09-03 US US08/707,179 patent/US5824044A/en not_active Expired - Lifetime
-
1997
- 1997-09-03 WO PCT/US1997/015441 patent/WO1998009584A1/en not_active Application Discontinuation
- 1997-09-03 CA CA002264514A patent/CA2264514A1/en not_active Abandoned
- 1997-09-03 JP JP10512816A patent/JP2001500403A/en active Pending
- 1997-09-03 AU AU42463/97A patent/AU4246397A/en not_active Abandoned
- 1997-09-03 EP EP97940760A patent/EP0932378A1/en not_active Withdrawn
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2000
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2001
- 2001-05-22 US US09/864,822 patent/US6663666B1/en not_active Expired - Fee Related
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2004
- 2004-09-28 US US10/700,795 patent/US7118594B2/en not_active Expired - Fee Related
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US6039758A (en) | 2000-03-21 |
US6287330B1 (en) | 2001-09-11 |
EP0932378A1 (en) | 1999-08-04 |
US7118594B2 (en) | 2006-10-10 |
US20050015141A1 (en) | 2005-01-20 |
AU4246397A (en) | 1998-03-26 |
WO1998009584A1 (en) | 1998-03-12 |
US6663666B1 (en) | 2003-12-16 |
JP2001500403A (en) | 2001-01-16 |
US6235050B1 (en) | 2001-05-22 |
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