WORLD INTELLECTUAL PROPERTY ORGANIZATION
`International Bureau
`
`PCT
`INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT)
`(51) International Patent Classification6 :
`(11) International Publication Number:
`WO 98/53761
`.
`a
`AGIF 2/06, AGIM 29/00
`(43) International Publication Date: 3 December 1998 (03.12.98)
`
`
`
`
`(21) International Application Number:
`(22) International Filing Date:
`
`PCT/AU98/00383
`
`25 May 1998 (25.05.98)
`
`(30) Priority Data:
`PO 7008
`
`26 May 1997 (26.05.97)
`
`AU
`
`(71) Applicant (forall designated States except US); WILLIAM A,
`COOK AUSTRALIA PTY. LTD. (AU/AU}; 12 Electronics
`Street, Brisbane Technology Park, Eight Mile Plains, QLD
`4113 (AU).
`
`(72) Inventors; and
`(75) Inventors/Applicants (for US only}: WARTLEY, David
`2 View Street, Subiaco, W.A. 6008 (AU).
`[AU/AU];
`36 Shann
`LAWRENCE-BROWN, Michael
`[AU/AU];
`Street, Floreat, W.A. 6014 (AU).
`
`(74) Agent: COLLISON & CO.; 117 King William Street, Adelaide,
`S.A, 5000 (AU).
`
`(81) Designated States: AL, AM, AT, AU, AZ, BA, BB, BG, BR,
`BY, CA, CH, CN, CU, CZ, DE, DK, EE, ES, FI, GB, GE,
`GH, GM, GW, HU,ID, IL, IS, JP, KE, KG, KP, KR, KZ,
`LC, LK, LR, LS, LT, LU, LV, MD, MG, MK, MN, Mw,
`MX, NO, NZ, PL, PT, RO, RU, SD, SE, SG, SI, SK, SL,
`TJ, TM, TR, TT, UA, UG, US, UZ, VN, YU, ZW, ARIPO
`patent (GH, GM, KE, LS, MW,SD, SZ, UG, ZW), Eurasian
`patent (AM, AZ, BY, KG, KZ, MD, RU, TJ, TM), European
`patent (AT, BE, CH, CY, DE, DK, ES, FI, FR, GB, GR,
`TE, IT, LU, MC, NL, PT, SE), OAPI patent (BF, BJ, CF,
`CG, CI, CM, GA, GN, ML, MR, NE, SN, TD, TG).
`
`Published
`With international search report.
`
`(54) Title: A PROSTHESIS AND A METHOD AND MEANS OF DEPLOYING A PROSTHESIS
`
`
`
`
`
` (57) Abstract
`
`
`self-expanding endovascularprosthesis (20) in a lumen of a
`Anintroducer(1) adapted for the introduction of a
`patient. The introducer
`so that each can be moved independently. An end ovascularprosthestis
`has attachment devices (10, 30) to hold each end of the prosthesis
`(20) is also claimed with stents at the proximal and distal ends being within the graft. The rermainder of the stents are
`onthe
`positioned
`outside of the graft body,
`
`
`MEDTRONIC 1027
`
`
`
`MEDTRONIC 1027
`
`

`

`
`
`FOR THE PURPOSES OF INFORMATION ONLY
`
`Codes used to identify States party to the PCT on the front pages of pamphlets publishing international applications under the PCT,
`Albania
`ES
`SI
`LS
`Lesotho
`Slovenia
`FI
`LT
`Armenia
`Lithuania
`SK
`Slovakia
`FR
`SN
`LU
`Austria
`Senegal
`Luxembourg
`Australia
`Latvia
`LV
`GA
`SZ
`Swaziland
`GB
`TD
`Chad
`MC
`Monaco
`Azerbaijan
`MD
`GE
`Republic of Moldova
`Bosnia and Herzegovina
`TG
`Togo
`Barbados
`MG
`GH
`Ty
`Madagascar
`Tajikistan
`GN
`MK
`The former Yugoslav
`Turkmenistan
`Belgium
`Burkina Faso
`GR
`Republic of Macedonia
`Turkey
`HU
`Mali
`Trinidad and Tobago
`Bulgaria
`IE
`Benin
`Ukraine
`Mongolia
`Brazil
`IL
`Mauritania
`Uganda
`Belarus
`Malawi
`is
`United States of America
`iT
`Canada
`Mexico
`Uzbekistan
`Central African Republic
`Viet Nam
`JP
`Niger
`KE
`Netherlands
`Congo
`Yugoslavia
`KG
`Switzerland
`Zimbabwe
`Norway
`Cote d'Ivoire
`KP
`New Zealand
`Cameroon
`Poland
`China
`Portugal
`Romania
`Cuba
`Russian Federation
`Czech Republic
`Sudan
`Germany
`Denmark
`Sweden
`Estonia
`Singapore
`
`™T
`
`R
`ry
`UA
`UG
`US
`UZ
`YN
`YU
`ZW
`
`Spain
`Finland
`France
`Gabon
`United Kingdom
`Georgia
`Ghana
`Guinea
`Greece
`Hungary
`Ireland
`Israel
`Iceland
`Italy
`Japan
`Kenya
`Kyrgyzstan
`Democratic People’s
`Republic of Korea
`Republic of Korea
`Kazakstan
`Saint Lucia
`Liechtenstein
`Sri Lanka
`Liberia
`
`ML
`MN
`MR
`MW
`MX
`NE
`NL
`NO
`NZ
`PL
`PT
`RO
`RU
`SD
`SE
`8G
`
`
`
`
`KR
`KZ.
`LC
`
`WL
`
`K
`LR
`
`AL
`AM
`AT
`AU
`AZ
`BA
`BB
`BE
`BF
`BG
`BI
`BR
`RY
`CA
`CF
`cG
`CH
`ch
`CM
`CN
`cu
`CZ
`DE
`DK
`EE
`
`

`

`“WO 98/53761
`
`PCT/AU98/00383
`
`TITLE:
`
`A PROSTHESIS AND A METHOD AND MEANS OF
`DEPLOYING A PROSTHESIS
`
`FIELD OF INVENTION
`
`a
`This invention relates to a method and means for
`expandable
`introducing
`tubular or bifurcated in form
`which may be straight,
`intraluminal prosthesis
`and intended for the endovascular repair of diseased or
`damaged vessels
`prosthesis which is suitable for such a
`and to a
`procedure.
`
`are used for
`Throughout this specification the terms proximal and
`proximally
`a
`or direction towards the patient's heart and the terms distal and
`position
`or direction away the
`are used for a
`patient's heart.
`position
`
`distally
`
`BACKGROUND OF THE INVENTION
`
`15
`
`20
`
`25
`
`30
`
`into the lumen of a
`patient from a
`of intraluminal prostheses
`The deployment
`device or introducer has been
`remote location by the use of a
`deployment
`disclosed in a number of earlier patent specifications.
`
`United States Patent No. 4,562,596 in the name of Kornberg proposes the
`retention of a self expanding graft within a sieeve until it is to be
`at
`deployed
`which time the sleeve is withdrawn and the graft allowed to
`expand. After the
`graft has been released there is no
`passible control of the position of the
`can render the entire
`distal end of the graft.
`Inadequate placement
`deployment null and void.
`
`United States Patent No. 4,665,918 in the name of Garza et al proposes a
`system and method for the deployment of a
`prosthesis in a blood vessel. The
`betweena
`delivery catheter and an outer sheath and
`is
`prosthesis
`positioned
`expands outwardly upon removal of the sheath. Once again after the
`prosthesis has been released by removal of the sheath there is no
`possible
`of the either end of the prosthesis.
`control of the position
`
`United States Patent No. 4,950,227 in the name of Savia et al proposes the
`delivery of a stent by mounting
`the stent to the outside of an inflatable
`catheter and retaining the ends of an
`sleeve over
`unexpanded stentby
`
`fitting
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`“WO 98/53761
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`
`2
`
`either end of the stent. Expansion of the stent is caused by inflation of the
`catheter between the sleeves so that the ends of the stent are withdrawn from
`the respective sleeves and the stent released and expandedinto position.
`very
`contro! over the deployment procedure
`andin
`This system provides
`little
`for intraluminal deployment where accuracy
`practice would be impractical
`vital.
`
`is
`
`No. 472 731 In the name of Inoue proposes an
`European Patent specification
`to be inserted into a human organ in a folded
`artificial tube
`prosthesis
`condition retained within a catheter and released to expand within the organ.
`Deployment is achieved by retention of the proximal end of the prosthesis by
`a tube through the middle of the prosthesis while
`wires passing through
`withdrawing the catheter. A balloon is then used to
`expand the prosthesis.
`has been released by removal of the catheter
`Once again after the prosthesis
`there is no
`possible control of the position of the distal end of the prosthesis.
`
`United States Patent No. 5,071,407 in the name of Termin et al proposes the
`delivery of a stent by retaining the stent in an
`elastically deformed condition
`between a catheter and a sheath. The
`proximal end of the stent is retained at
`the catheter. The stent is allowed to expand by removal of the sheath and
`No indication is given of any method for release
`optional balloon expansion.
`of the stent from the catheter or how the distal end of the stent can be
`
`positioned accurately.
`
`Australian Patent Application No. 669,338 in the name of Chuter proposes
`a
`prosthesis at a
`delivery arrangementfor transluminally positioning
`on an internal wall of a lumen. The
`delivery arrangement
`particular position
`has an outer sheath to surround the prosthesis and a retention arrangement
`in a selected position during removal of the sheath
`to hold the prosthesis
`before final release.
`
`a
`
`No. 671,910 in the name of Endovascular
`Australian Patent Application
`Technologies, Inc. proposes a
`a
`delivery arrangementfor
`positioning
`prosthesis within a lumen.
`It has capsules which retain each end of the
`prosthesis and a balloon arrangement to
`expand the prosthesis when the
`capsules have been retracted to release the prosthesis. A sheath is used to
`protect the prosthesis during insertion. Once the capsules have been
`withdrawn there is no method provided
`to ensure that the ends of the
`
`10
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`“WO 98/5376}
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`PCT/AU98/00383
`
`prosthesis
`
`are
`
`correctly positioned.
`
`3
`
`graft and a method and apparatus
`it is the object of this invention to
`provide
`which will overcome at least some of the
`to
`deploy the
`graft prosthesis
`an alternative arrangement to
`problems discussed aboveor at least provide
`art systems described above.
`the prior
`
`a
`
`BRIEF DESCRIPTION OF THE INVENTION
`
`an
`to one aspectof the present invention there is provided
`According
`an
`expandable endovascular prosthesis In a lumen
`introducer for positioning
`a
`proximal portion and a distal portion, the
`of a
`patient, the prosthesis having
`a
`prosthesis positioning mechanism selectively
`introducer comprising
`at a desired
`when the
`prosthesis is positioned
`releasable from the
`prosthesis
`a first control member
`site in the lumen of a
`at least the
`patient,
`controlling
`longitudinal position of the proximal portion of the prosthesis; and a second
`control member controlling at least the longitudinal position of the distal
`The prosthesis positioning mechanism can include
`portion of the
`prosthesis.
`a distal attachment region and/or a
`proximal attachment region. The distal
`can include a distal attachment device. The proximal
`attachment region
`can include a
`proximal attachment device. The prosthesis
`attachment region
`preferably include a control arrangementfor
`positioning mechanism can
`the length of the prosthesis. The prosthesis positioning
`controlling
`include a rotational arrangement by which
`mechanism can also
`preferably
`the relative angular orientation of the proximal and distal portions of the
`This prosthesis positioning mechanism can
`can be adjusted.
`prosthesis
`or in combination also
`the
`angular orientation of the prosthesis
`adjust
`singly
`an
`The introducer can also preferably comprise
`expansion control
`of the
`prosthesis when the prosthesis is
`mechanism for controlling expansion
`positioned at the desired sits in the lumen of the
`
`patient.
`
`to another aspect of the present invention therein provides
`According
`an
`expandable prosthesis at a
`endovascular arrangement for positioning
`desired location in a lumen of a
`a
`said arrangement comprising
`patient,
`control section to be maintained external to the patient, and a
`prosthesis
`positioning mechanism controllable by the control section for moving and
`to a desired location in the lumen, wherein
`manipulating the prosthesis
`first
`member extends from the control section to a
`proximal region of the
`
`an
`
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`
`4
`
`positioning mechanism, the proximal region of the
`positioning mechanism
`means for controiling the proximal end of the prosthesis, wherein a
`having
`second member extends from the control section to a distal region of the
`meansfor controlling the
`positioning mechanism, the distal region having
`in cooperation with the second member. The
`distal end of the prosthesis
`arrangementfurther preferably comprises contraction means for containing
`stents of the prosthesis during insertion of the prosthesis
`self-expanding
`meansfor
`positioning mechanism into the lumen and/or expansion
`stents of the prosthesis when the prosthesis is
`expanding expandable
`at the desired site in the lumen of the patient. The contraction
`positioned
`preferably includes tubular means that extends from the contro!
`means
`section to the positioning mechanism and serves to contain the prosthesis
`mechanism into the lumen and to control
`during insertion of the
`positioning
`when the tubular means has been moved in a
`the distal end of the
`prosthesis
`distal direction relative to the first and second members, relative movement
`between the first and second members enabling manipulation of the
`means includesat least radial
`prosthesis whenin the lumen. The expansion
`means such as
`an inflatable balloon for radially expandable stents
`preferably
`at the desired locationin
`when the
`is positioned
`of the
`prosthesis
`prosthesis
`the lumen. The first and second members can be contained within the said
`tubular means. Means can be
`for clamping the first and second
`provided
`insertion of the prosthesis and for releasing the first
`members together during
`to the manipulation. Expansion of a non self
`and second membersprior
`can be performed by expansion of a balloon located
`expanding prosthesis
`around the first member and within the
`said balloon being
`prosthesis,
`of the attachment
`inflatable from the control section. The
`proximal region
`mechanism can contain tubular means for containing
`the proximal end of the
`to final
`positioning thereof, and release of the prosthesis from
`prosthesis prior
`the tubular means can be achieved by proximal
`movementofthe first
`member The second member has means for controlling
`the distal end of the
`stent whilst the latter is inside tubular means. The arrangement
`can further
`comprise release mechanisms in the contro! section for
`controlling wires
`to
`stents of the prosthesis, The prosthesis positioning
`extending
`respective
`mechanism can
`include a control arrangement for
`the
`preferably
`controlling
`prosthesis positioning mechanism can also
`The
`length of the prosthesis,
`preferably include a rotational arrangement by which the relative angular
`can be
`orientation of the proximal and distal portions of the prosthesis
`adjusted. This prosthesis positioning mechanism can
`or in
`
`singly
`
`10
`
`15
`
`20)
`
`25
`
`30
`
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`

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`“WO98/53761
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`
`5
`
`angular orientation of the prosthesis. The
`combination also adjust the
`an
`introducer can also preferably comprise
`expansion control mechanism for
`controlling expansion of the prosthesis when the prosthesis is positioned at
`the desired site in the lumen of the
`patient.
`
`can be used to locate expandable
`The above introducer and/or arrangement
`self-expandable prosthesis. If the former are
`used, then one or
`or
`prosthesis
`more balloons, inflatable from a control section or external the patient,
`can be
`used.
`
`can either be fixed to an
`The first member in the endovascular arrangement
`extension or the member can
`actually be shaped into the form of the
`.
`
`extension
`
`The first and second control members of the introducer can
`or in
`singly
`include a
`at the proximal
`trigger wire positioned
`combination preferably
`can
`The trigger wire(s)
`extend
`and/or distal ends of the prosthesis.
`preferably
`to one or more release mechanisms external to
`for
`releasing the
`patient
`mechanism when the prosthesis is positioned
`prosthesis from the positioning
`at the lumen site in the
`
`patient.
`
`Some form of container or
`
`expansion
`is
`contain that end while the remainder of the
`prosthesis
`being manipulated
`It is after the manipulation has been executed that
`in the lumen of the
`patient
`of the various control members.
`the container is removed by operation
`
`control mechanism can be used to
`
`In another aspect of the invention, the introducer or endovascular
`a control arrangement
`arrangementof the invention can also comprise
`for
`the manipulation in the patient.
`of the
`the
`prosthesis during
`length
`controlling
`or members can
`in one
`aspect, the control arrangement
`preferably include
`coaxial tubes which are connected to the respective ends of the prosthesis
`for rotation thereof When the control members are locked together, the entire
`can be rotated in the lumen of the patient. Alternatively, the control
`prosthesis
`arrangement and/or members can be
`the
`individually controlled for
`rotating
`relative ends of the prosthesis with respect to each other In the same or
`opposite directions.
`
`The sleeve can be independently located relative to the control
`
`arrangement
`
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`“WO 98/53761
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`
`6
`
`and/or the first and second control members. The control arrangement
`members can also be contained within the sleeve. The sleeve can
`or can be a tube with wire therein. The
`be a tube, wraps of wire,
`or release wires can also be contained in the sleeve
`aforementioned trigger
`tube or in the wall of the tube.
`
`preferably
`
`or
`
`means for expanding
`With respect to expandable prosthesis, the expansion
`can
`preferably include one or more
`expandable stents of the prosthesis
`for advantageously and
`three balloons)
`balloons (more preferably
`independently expanding the proximal and distal portions of the prosthesis
`as well as the mid section thereof.
`
`In an alternate form the invention may be said to reside in an introducer
`adapted for the introduction of a self expanding endovascular prosthesis into
`a
`proximal end and a distal end,
`a lumen of a
`the
`prosthesis having
`patient,
`a
`to be
`proximal attachment device adapted
`the introducer comprising,
`a distal attachment device
`attached to the proximal! end of the prosthesis,
`each of the
`to be attachedto the distal end of the prosthesis,
`adapted
`to the prosthesis in such a
`proximal and distal attachment devices attaching
`can be held in tension therebetween and that
`manner that the prosthesis
`can be individually moved in proximal and distal
`each end of the prosthesis
`means associated with the
`directions and be rotated, and proximal releasing
`means associated with the
`proximal attachment device and distal releasing
`distal attachment device to enable selective releasing
`distal ends of the prosthesis.
`
`of the proximal and
`
`attachment means has a
`In a
`preferred form of the invention the proximal
`long tapering flexible extension on its proximal end to facilitate insertion of
`the introducer into a
`body lumen and its advancement along the lumen.
`
`The proximal attachment device may be mounted on
`flexible thin walled
`tube which extends in a distal direction from the proximal attachment device
`to an external manipulation section of the introducer which is adapted to
`remain external of the patient.
`
`fluid connection means external of the
`The thin wal! metal tube may
`include
`patient to enable the introduction of a medical reagent therethrough.
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`WO 98/5376]
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`
`7
`
`The long flexible extension may include a hollow tube therethrough in fluid
`communication with the thin wall metal tube and a
`of side holes to
`plurality
`enable dispersion of the medical reagent proximal of the prosthesis.
`
`In a
`preferred form of the invention the distal attachment device is mounted
`on a flexible thick walled tubing and coaxial on the thin walled tube and
`extending in a distal direction to the external manipulation section and
`or
`mounted such that the respective tubes can be moved together
`
`independently.
`
`There may be further included a haemostatic seal between the thin walled
`tube and the thick walled tube in the manipulation section.
`
`There may be further included means to introduce a medical reagent into an
`annular space defined between the thin walled tube and the thick walled
`tube.
`
`15
`
`20
`
`preferred form of the invention there may be a
`in a
`proximal trigger wire
`extending from the proximally attachment device to the manipulation section,
`the proximal trigger wire being adapted to activate the proximal releasing
`means and a distal trigger wire extending from the distal attachment device to
`to activate the
`the manipulation section, the distal trigger wire being adapted
`means.
`distal releasing
`
`In a
`
`preferred form of the invention there may be included an external release
`wire and distal trigger wire, the
`mechanism for each of the proximal trigger
`to prevent accidental release of the
`external release mechanism adapted
`means
`trigger wires and to allow release of the distal releasing
`only after
`means.
`release of the proximal releasing
`
`25
`
`Preferably there is a haemostatic seal around the respective trigger wires in
`section.
`the manipulation
`
`The introducer may
`also include an external sheath extending from external
`to cover and compressthe prosthesis during insertion of the
`of the patient
`introducer into a
`patient and movable longitudinally from outside the patient
`to expose the prosthesis.
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`“WO 98/5376]
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`8
`sliding fit on the thick walled
`The external sheath may be coaxial with and a
`tube. The external sheath may have a
`proximal end which is tapered and
`a low resistance to advancementof the introducer
`smoothed to
`present
`end of the external sheath may also be
`during insertion. The proximal
`to have a
`fit on to the proximal attachment device.
`tight
`adapted
`
`and is
`Preferably the distal attachment device is of a streamlined shape
`to be advanced to the proximal attachment device wherebyto allow
`adapted
`smooth retrieval through the released prosthesis and into the external
`sheath for removal from a
`
`patient.
`
`The introducer according
`self expanding prosthesis
`bifurcated prosthesis.
`
`to this invention may be used with a
`straight tubular
`or it may be used wherethe prosthesis is a
`
`The introducer according to this invention may be used where the lumen of
`an aortic
`the patient is an aorta and the prosthesis
`to repair
`is
`adapted
`aneurism.
`
`In an alternative form the invention is said to reside in a method of
`placing
`means of an insertion assembly the
`prosthesis into an internal lumen by
`the insertion assembly including the
`the steps of;
`method including
`inserting
`a sheath from the insertion
`prosthesis into the internal lumen, withdrawing
`assembly to expose the prosthesis, releasing the prosthesis from the
`the sheath onto the insertion
`assembly, and
`insertion assembly, replacing
`the insertion assembly.
`
`retracting
`
`a
`
`proximal end and a distal end and the
`Preferably the prosthesis has a
`proximal attachment device and a distal
`includes a
`insertion assembly
`to retain the proximal and distal ends of the
`attachment device adapted
`prosthesis respectively and the step of releasing the prosthesis includes the
`steps of releasing the proximal end and then the distal end.
`
`the sheath onto the insertion assembly may include the
`The step of
`replacing
`advancing the distal attachment device up to the proximal attachment
`step of
`device and withdrawing the two devices together.
`
`Between steps (b) and (c)
`
`the prosthesis may be manipulated byrespective
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`9
`
`movements longitudinally and rotationally of the proximal attachment device
`the prosthesis.
`and distal attachment device to
`correctly position
`
`is a bifurcated prosthesis the step of withdrawing the
`Wherethe prosthesis
`sheath may include the steps of withdrawing the sheathto a first position in
`is exposed, insertion of an extension
`which a side arm of the prosthesis
`into the side arm and then full removal of the sheath from the
`prosthesis
`
`prosthesis.
`
`the step of insertion of the extension prosthesis into the side arm
`Preferably
`an extension insertion assembly into the
`comprises the steps of, inserting
`a
`top guide mounted on
`side arm, the extension insertion assembly including
`on the catheter and a sheath retaining the
`a
`an extension prosthesis
`catheter,
`over the top guide, withdrawing the
`and extending
`extension prosthesis
`sheath to expose and deploy the extension prosthesis, withdrawing the
`sheath, top guide and catheter together.
`
`nose extension and the catheter
`The top guide may include a
`long proximal
`may include a distal stop with the extension prosthesis being mounted
`between the distal stop and the top guide.
`
`In an alternative form the prosthesis is a bifurcated prosthesis and the step of
`withdrawing the sheath includes the steps of withdrawing the sheath to a first
`position in which a first side arm of the prosthesis is exposed, insertion of a
`into the first side arm, then full removal of the sheath
`first extension prosthesis
`to expose a second side arm and then insertion of a
`from the prosthesis
`second extension prosthesis into the second side arm.
`
`10
`
`15
`
`20
`
`The steps of insertion of the first and second extension prosthesis into the first
`as discussed above.
`comprises the same
`and second side arms
`steps
`
`25
`
`In a further form the invention is said to reside in an intraluminal prosthesis
`and a_
`a tubular graft
`stents along the
`plurality of self expanding
`having
`a
`proximal end and a distal end, the
`length of the graft the
`prosthesis having
`the stents at the proximal end and at the
`prosthesis being characterised by
`distal end being inside the tubular graft and the remainder of the stents being
`on the outside of the graft.
`
`30
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`
`10
`There may be further included a further self expanding stent mounted to the
`the said proximal end. The
`and extending beyond
`proximal end of the graft
`further stent may include attachment devices. The attachment devices may
`comprise barbs extending towards the distal end of the prosthesis.
`
`a shorter
`The prosthesis may bebifurcated at its distal end to
`provide
`prosthesis leg and a
`longer prosthesis leg. The shorter leg may have a
`terminal stent on the outside of the prosthesis
`and the longer leg have the
`internal distal stent.
`
`10
`
`15
`
`20
`
`25
`
`30
`
`There may also be an extension prosthesis
`for insertion into the shorter
`a tubular extension
`prosthesis leg, the extension prosthesis comprising
`prosthesis and a
`plurality of self expanding stents, the extension prosthesis
`a
`proximal end and a distal end, stents at the proximal and distal ends
`having
`being inside the tubular extension prosthesis and the
`remaining stents being
`on the outside of the prosthesis.
`
`The intraluminal prosthesis may be constructed so that both the shorter leg
`have external terminal stents and extension prostheses for
`and longer leg
`a tubular extension
`each leg, each extension prosthesis comprising
`prosthesis and a
`plurality of self expanding stents, the extension prosthesis
`proximal end and a distal end, stents at the proximal and distal ends
`a
`having
`being inside the tubular extension prosthesis and the remaining stents being
`on the outside of the
`
`prosthesis.
`
`Each stent of the intraluminal prostheses according
`stent.
`
`zig-zag
`
`to this invention may be a
`
`an
`it will be seen that by this invention there is provided
`Generally
`can be compressed into a thin insertion
`arrangement by which a
`prosthesis
`a vessel such as a
`device and then the insertion device advanced through
`femoral artery until the prosthesis is substantially in the position required and
`then by careful positioning before release of the attachment means at a
`if necessary before
`proximal end of the prosthesis and then
`repositioning
`can be placed and
`release of the distal end of the prosthesis, the prosthesis
`released accurately.
`
`DETAILED DESCRIPTION OF EMBODIMENTS OF THE INVENTION
`
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`“WO 98/53761
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`PCT/AU98/00383
`
`11
`
`The construction of preferred embodiments and the method by which the
`device may be operated may be madeclearer with the aid of the
`accompanying drawings which show preferred embodiments of the invention
`which the device of the various embodiments may be
`and the method by
`used. For the purpose of clarity the lumens or vessels into which the
`prosthesis is to be inserted is not been shownin the
`drawings except in FIG
`18.
`
`In the drawings:
`
`10
`
`15
`
`FIG 1 showsa first embodiment of an introducer according to this
`view with the prosthesis partially deployed,
`invention in perspective
`
`FIG 2 showsthe first embodiment of the introducer as shown in FIG 1
`being fully loaded and ready for introduction into a
`
`patient,
`
`FIG 3 shows the embodiment of FIG 2 in the next
`
`stage of
`
`deployment
`
`of the
`
`prosthesis,
`
`4 shows the embodimentof FIG 2 with the release of the proximal
`Fig
`end stage of deployment,
`
`FIG 5 showsthe release of the distal end stage of
`
`deployment,
`
`FIG 6 shows the advancementof the distal attachment device to the
`proximal attachment device,
`
`20
`
`FIG 7 shows the withdrawal of the introducer,
`
`FIG 8 shows that part of the introducer around the distal end of the
`prosthesis in detail,
`
`FIG 8A showsanalternative embodiment of that pari of the introducer
`around the distal end of the prosthesis in detail,
`
`25
`
`FIG 8B shows the embodiment of FIG 8A with the distal attachment
`device advanced to the proximal attachment device,
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`

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`WO 98/53761
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`12
`
`FIG 9 shows that part of the introducer around the proximal end of the
`in detail,
`
`prosthesis
`
`FIG 10 showsthat part of the introducer around the haemostatic seal in
`
`detail,
`
`FIG 11 shows that part of the introducer around the
`mechanisms in detail,
`
`trigger
`
`wire release
`
`FIG 12 shows that part of the introducer around the pin vive clamp and
`the medical reagent introduction tube in detail,
`
`-
`
`13C show portions of an alternative embodiment of
`FIGS 13A
`for introduction of a
`to this invention adapted
`introducer according
`bifurcated prosthesis,
`
`FIG 14 shows an alternative embodimentof introducer according
`this invention adapted for introduction of an extension prosthesis,
`
`to
`
`FIG 15 shows an embodiment of a bifurcated prosthesis with an
`to this invention,
`extension prosthesis according
`
`FIG 16 shows an embodiment of a bifurcated prosthesis
`to this invention,
`extension prostheses according
`
`with two
`
`FIG 17 shows an embodiment of a
`
`prosthesis according to this
`invention intended for aortouni-iliac deployment, and
`
`FIG 18 shows a
`deployed prosthesis according
`an aorta with an aneurism.
`
`to this invention within
`
`more
`-
`
`closely at the drawings and particularly in the embodiment
`Now looking
`712 it will be seen that an endovascular arrangement such
`shown in FIGS 1
`an external
`as the introducer according
`to this invention
`comprises generally
`manipulation section 1, a distal attachment region 2 and a
`3.
`attachment region
`
`proximal
`
`The proximal attachment region
`
`3 shown in detail in FIG 9 includes a
`
`10
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`15
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`20
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`25
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`"WO 98/53761
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`PCT/AU98/00383
`
`13
`cylindrical sleeve 10 with a
`long tapered flexible extension 11 extending from
`its proximal end. The extension 11 has an internal longitudinal aperture 12
`an insertion wire 13 and to enable the
`to enable it to be advanced along
`by the use of a contrast agentto allow
`supply of medical reagents such as
`performed during placement and deployment phasesof
`to be
`angiography
`the medical procedure. A thin walled metal tube 15 is fastened to the
`extension 11 and extends through the complete introducer to the
`manipulation section and terminates in a connection means 16 for a
`syringe
`so that the medical reagent may be introduced into the metal tube and
`subsequently the extension 11 to emanate through the apertures 14. The
`thin walled metal tube 15 is flexible so that the introducer can be advanced
`relatively tortuous vessel such as the femoral artery and also to allow
`a
`along
`manipulation longitudinally and rotationally of the proximal attachment region
`3.
`
`The prosthesis 20 is of a self expanding type having resilient stents 19 to
`expand after it is released from the introducer. The prosthesis
`enable it to
`retained within the introducer includes a self expanding zigzag
`stent 21
`extending from its proximal end and in the compressed condition the zigzag
`sleeve 10 of the proximal attachment
`stent 21 is retained in the cylindrical
`means ofa trigger wire 22 which extends
`region 3 and retained in there by
`an
`aperture 23 in the side of the proximal attachment device 10 and
`through
`is received in one of the loops of the zigzag stent. The
`trigger wire 22
`extends along most of the length of the introducer and exits at the
`manipulation region at a
`proximal wire release mechanism 24.
`
`means of an
`20 is retained in its compressed condition by
`The prosthesis
`external sleeve 30 which is advanced to be received over the
`cylindrical
`sleeve 10 of the proximal attachment device 10 when the deviceis
`seen in FIG 2. The external
`assembled for insertion as can be particularly
`to external of a
`to the external manipulation
`sheath 30 extends distally
`patient
`means 35 thereof.
`section and a
`and haemostatic sealing
`
`gripping
`
`seen in FIG 8, the distal end of the prosthesis 20is
`As can be particularly
`retained in the distal attachment device 40 which is mounted onto a thick
`to external of the patient and to
`walled plastics tube 41 which extendsdistally
`1. The thick walled tube is coaxial with and
`the manipulation region
`outside the thin walled tube 15 and the sheath 30 is coaxial with and
`
`radially
`
`radially
`
`10
`
`15
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`25
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`35
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`

`

`WO 98/5376
`
`PCT/AU98/00383
`
`14
`
`outside the thick walled tube 41. The distal end 42 of the prosthesis 20 has a
`loop 43 through which a distal trigger wire 44 extends. The distal
`wire
`trigger
`aperture 45 on the distal attachment device into the
`an
`extends through
`between the thin walled tube 15 and the thick walled tube 41
`annular region
`like the proximal trigger wire which also extends through the annular space
`41 and the thin walled tubing 15 to the
`between the thick walled tubing
`manipulation device and out at a distal wire release mechanism 25 as
`in FIG 2.
`depicted
`
`In the alternative embodiment as shown in FIGS 8A and 8B, the thick walled
`tube 160 has a
`tapered end 161 through the thin walled tube 162 extends. A
`low friction lining 163 is provided between the thick walled tube 160 and the
`over the latter. The
`thin walled tube 162 so that the former slides easily
`proximal release wire 165 and the distal release