PCT
`INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT)
`(51) International Patent Classification 6;
`(11) International Publication Number:
`AGIF 2/06
`
`WORLD INTELLECTUAL PROPERTY ORGANIZATION
`International Bureau
`
`
`
`(43) International Publication Date:
`
`17 June 1999 (17.06.99)
`
`WO 99/29262
`
`(81) Designated States: AL, AM, AT, AU, AZ, BA, BB, BG, BR,
`BY, CA, CH, CN, CU, CZ, DE, DK, EE, ES, FI, GB, GD,
`GE, GH, GM, HR, HU, ID,IL,IN, 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,IE, IT, LU, MC, NL, PT, SE), OAPI patent
`(BF, BJ, CF, CG, CI, CM, GA, GN, GW, ML, MR, NE,
`SN, TD, TG).
`
`Published
`With international search report.
`
`(21) International Application Number:
`(22) International Filing Date:
`
`PCT/AU98/01019
`
`9 December1998 (09.12.98)
`
`(30) Priority Data:
`PP 0835
`
`10 December 1997 (10.12.97)
`
`AU
`
`(71) Applicant(for ail 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): HARTLEY, David, Emest
`2 View Street, Subiaco, W.A. 6008 (AU).
`[AU/AU];
`BROWNE,Thomas, Francis [IE/GB]; 29 Oak Lodge Tye,
`Springfield, Chelmsford, Essex CM1 6GY (GB).
`
`(74) Agent: COLLISON & CO.; 117 King William Street, Adelaide,
`S.A. 5000 (AU).
`
`(54) Title: ENDOLUMINAL AORTIC STENTS
`
`(57) Abstract
`A prosthesis comprises Z stents (7, 8) sutured to a
`bio-compatible material tube such as
`a
`graft (5) comprising
`dacron, The Z stents are attachedto the inside surface of the
`dacron tube and there is at least one fenestration (10) in the
`dacron tube corresponding to an
`intersecting artery opening.
`A further Z stent (1) extends proximally and they may
`have caudally facing barbs (2). Each fenestration includes
`a
`one or more
`radiopaque markers defining
`periphery of
`the fenestration. A release mechanism for said prosthesis
`includes trigger wires stitched into a fold on the dacron to
`retain the prosthesis in a
`partially compressed state
`during
`deployment. A delivery device has a sheath to hold the
`compressed prosthesis during insertion and a top cap to
`retain the top stent.
`
` MEDTRONIC 1105
`
`MEDTRONIC 1105
`
`

`

`Codesused to
`
`FOR THE PURPOSES OF INFORMATION ONLY
`
`Albania
`Armenia
`Austria
`Australia
`Azerbaijan
`Bosnia and Herzegovina
`Barbados
`Belgium
`Burkina Faso
`Bulgaria
`Benin
`Brazil
`Belarus
`Canada
`Central African Republic
`Congo
`Switzerland
`Céte d’Ivoire
`Cameroon
`China
`Cuba
`Czech Republic
`Germany
`Denmark
`Estonia
`
`GE
`GH
`GN
`GR
`HU
`IE
`IL
`IS
`IT
`JP
`KE
`KG
`KP
`
`KR
`KZ
`LC
`LI
`LK
`LR
`
`identify States party to the PCT on the front pages of pamphlets publishing international applications under the PCT.
`ES
`LS
`Lesotho
`SI
`Slovenia
`Spain
`FI
`Finland
`LT
`SK
`Lithuania
`Slovakia
`FR
`France
`LU
`SN
`Luxembourg
`Senegal
`GA
`Gabon
`LV
`Latvia
`SZ
`Swaziland
`United Kingdom
`MC
`Monaco
`TD
`Chad
`MD
`Republic of Moldova
`TG
`Georgia
`Togo
`MG
`Ghana
`TJ
`Madagascar
`Tajikistan
`Guinea
`MK
`The former Yugoslav
`Turkmenistan
`Greece
`Republic of Macedonia
`Turkey
`Mali
`Trinidad and Tobago
`Hungary
`Treland
`Ukraine
`Mongolia
`Israel
`Mauritania
`Uganda
`Iceland.
`Malawi
`United States of America
`Mexico
`Uzbekistan
`Italy
`Viet Nam
`Japan
`Niger
`Netherlands
`Kenya
`Yugoslavia
`Kyrgyzstan
`Norway
`Democratic People’s
`New Zealand
`Republic of Korea
`Poland
`Republic of Korea
`Portugal
`Kazakstan
`Romania
`Saint Lucia
`Russian Federation
`Liechtenstein
`Sudan
`Sri Lanka
`Sweden
`Liberia
`Singapore
`
`Zimbabwe
`
`™T
`
`R
`TT
`UA
`UG
`us
`UZ
`VN
`YU
`ZW
`
`ML
`MN
`MR
`MW
`MX
`NE
`NL
`NO
`NZ
`PL
`PT
`RO
`RU
`SD
`SE
`SG
`
`

`

`WO 99/29262
`
`PCT/AU98/01019
`
`TITLE
`
`ENDOLUMINAL AORTIC STENTS
`
`INTRODUCTION
`
`The present invention relates
`to the field of the treatment of aortic
`generally
`disease andin particular to endoluminal aortic stents and a methodof
`of a covered
`of such stents which allows accurate
`deployment
`placement
`stent in the aorta.
`In particular it is capable of being deployed and
`positioned accurately abovethe renal arteries in the treatmentof infra-renal
`aortic aneurysmal disease.
`
`10
`
`BACKGROUND OF THE INVENTION
`
`to the prior art, aortic disease is often treated by surgical
`According
`techniquesinvolving the use of stents and grafts. For example, it is well
`a
`interpose, within the stenotic portion of an
`knownin the art to
`stent,
`artery,
`whether madeof stainless steel or other materials, capable of being
`or occluded
`strengthening the walls of a
`balloon-expandable for
`stepotic
`In addition, it is well knownin the prior art to use a
`to
`artery.
`graft
`repair
`highly damagedportions of, for example, the aorta or other arteries thereby
`ensuring blood flow and reducing the risk of aneurisms or
`ruptures. The
`grafts, hollow tubes comprised of material such as dacron, are
`normally
`inserted within the walls of a
`damaged artery and can be sewninto position
`or
`expanded through the use of a stented balloon catheter.
`
`occurs when it is necessary to use a
`A more severe
`at or
`problem
`graft
`around the intersection of a
`major artery (eg. the aorta) with intersecting
`(eg. the renal arteries, carotid or
`arteries
`brachycephalic artery). While the
`graft is clearly required to strengthen and ensure the flow of blood through,
`for example, the aorta, the use of a
`graft effectively seals or blocksoff the
`or cerebral circulation. Accordingly,it is often
`blood flow to the kidneys
`or
`graft to treat aortic disease at or around
`impractical to use a
`impossible
`Instead a surgeon must
`the intersection of the aorta and other arteries.
`attempt to
`repair the weakened walls of such artery using other surgical
`
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`2
`techniques having high failure rates and limited success. For example,
`although several centres around the world have been routinely deploying
`as many
`endoluminal
`grafts for the treatment of infra-renal aortic aneurisms,
`as 30% of abdominal aortic aneurisms are unsuitable for this method of
`treatment due to an insufficient length
`infra-renal aorta
`of
`or stent.
`to
`firmly anchorthe graft
`
`aneurysmal-free
`
`The present invention solves the problem in the priorart by utilising the
`for an aortic
`whilst at
`supra-renal aorta to
`provide adequate anchorage
`graft
`the same time employing extremely accurate placementof a fenestrated
`covered stent which correspondsto the exactsites of
`of the
`origin
`intersecting arteries.
`
`BRIEF DESCRIPTION OF THE INVENTION
`
`general relates to a fenestrated endoluminal aortic
`The presentinvention in
`two or more stainless
`stent which is a
`single component device comprising
`steel or nitinol Z stents which may have caudal
`barbs sutured to a
`facing
`bio-compatible material tube in which the Z stents are
`length of a
`variable
`attached to the inside surface of the bio-compatible material tube and,
`on the geometry of the intersecting arteries to be covered,
`depending
`customised fenestrations accurately placed in the bio-compatible material
`tube
`to the
`intersecting artery openings.
`corresponding
`
`In one
`
`form, therefore, the invention may be said to reside in a
`prosthesis
`a bio-
`two or more Z stents sutured to a
`graft comprising
`comprising
`compatible material tube, wherein the two or more Z stents are attachedto
`the inside surface of the bio-compatible material tube and at least one
`to an
`fenestration in the bio-compatible material tube corresponding
`intersecting artery opening.
`
`Preferably there are more than two Z stents attached to the bio-compatible
`material tube.
`
`10
`
`15
`
`20
`
`25
`
`There may be a further Z stent fastened to the bio-compatible material tube
`and
`extending proximally from the bio-compatible material tube.
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`3
`At least one of the Z stents may have caudally facing barbs thereonto assist
`with accurate retention of the prosthesis when completely inserted.
`
`The proximally extending
`facing barbs thereon.
`
`Z stent may be the stent which has the caudally
`
`The bio-compatible material tube may in one embodiment be a dacron
`material tube.
`
`There may be two or more fenestrations according to the number of
`arteries.
`intersecting
`
`The or each fenestration may include one or more
`a
`periphery of the fenestration.
`
`defining
`
`10
`
`radiopaque markers
`
`The distal most of the Z stents may include a
`
`loop extending distally of the
`
`graft.
`
`The prosthesis may further include a release mechanism for said prosthesis
`trigger wires wherein a
`one or more
`portion of the
`including
`bio-compatible
`material tube is folded longitudinally with the one or more
`trigger wires
`respectively threaded
`longitudinally through the bio-compatible material
`tube at the fold to retain the prosthesis in a
`partially compressedstate.
`
`At least one of the Z stents may include one or more shortened loops to
`enable location of the fenestrations as
`required.
`
`Accurate siting of the branches of the aorta may be achieved from
`andthe invention is
`Computerised Axial Tomograms (CT) and angiography
`customised to each patient in relation to the sites corresponding with the
`CT. The fenestrations are marked with radiopaque beadsto facilitate their
`positioning under X-ray control before deployment.
`
`In an alternative form the invention may be said to reside in a method for
`treating arterial disease at an intersection of two arteries, including the
`stepsof:
`X-raying arteries to be treated so as to
`
`accurately determine the position of
`
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`
`4
`one or more fenestrations to a
`the intersection of the arteries, customising
`a selected length of a
`bio-compatible material tube,
`prosthesis comprising
`attaching radiopaque markers around the or each fenestrations, placing two
`or more Z stents into said bio-compatible material tube, bends in the Z
`shortenedif necessary in such a way so as notto coverthe
`stents
`being
`a
`top Z stent, covering the top Z stent with
`fenestrations, manually gathering
`a
`the Z stent in place in the top cap with a
`top cap and
`trigger wire,
`holding
`stitching the trigger wire or another trigger wire through
`a
`longitudinal fold in
`bio-compatible material tube to narrow the diameter of said prosthesis
`the
`a customised fenestrated covered graft
`to be inserted into
`thereby providing
`an
`to be treated.
`
`artery
`
`The method may
`
`a further Z stents to top
`further include the step of sewing
`ring of said bio-compatible material tube, such that the further Z stent
`extends
`proximally from the bio-compatible material tube.
`
`There may be morethan twosaid Z stents attached to the bio-compatible
`material tube and two or more than two fenestrations according
`to the
`numberof
`intersecting arteries.
`
`The processofinsertion of the graft may include the steps of; compressing
`the graft and placingit into a sheath which fits
`snugly around said top cap,
`a femoral
`said prosthesis, the Z stents and an
`obturator, inserting through
`artery in a
`a
`groin said prosthesis using
`delivery device which includes said
`top cap, said sheath, said obturator and guide wires, withdrawing said
`sheath to reveal said graft in
`semi-deployed position, positioning the
`prosthesis, partially withdrawing said sheath and obturator to enable
`insertion of angiography catheters and guide wires, inserting said
`a contralateral groin into
`angiography catheters and guide wires through
`the artery to be treated to provide manoeuvrability, and accurate positioning
`of the graft by positioning right and left angiography catheters and guide
`wires through the fenestrations into the
`intersecting arteries, releasing the
`trigger wire to provide full deployment of the said graft, withdrawing said
`angiography catheters and pushing up said sheath and obturator through
`said stent and docking with said top cap and
`fully withdrawing said delivery
`device, whereby the said fully deployed stent ensures the flow of blood at
`the intersection of the arteries to be treated.
`
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`
`15
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`
`5
`The method by whichthe prosthesis of the present invention may be
`manoeuvredinto place prior to full deployment is by way of the right
`angiography catheters and guide wires.
`
`andleft
`
`or any other bio-compatible material
`The radiopaque markers may be gold
`or other methods.
`which enables the marker to be visualised by X-ray
`
`This generally describes the invention but to assist with understanding of
`the invention reference will now be madeto preferred embodiments of the
`invention with the assistance of the
`following drawings.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`10
`
`One embodimentof the present invention will now be described with
`reference to the
`drawingsin which:
`
`15
`
`20
`
`25
`
`FIG. 1
`
`is an outside view of one embodimentof the present invention
`illustrating the top Z stents, bio-compatible material tube with
`at the base of
`fenestrations and small radiopaque beads and metal
`loop
`the
`bio-compatible material tube;
`
`FIG. 2 is an inside view of the embodiment of the present invention
`illustrating the internal Z stents and their relationship with the
`fenestrations for the
`intersecting arteries;
`
`FIG. 3 is an outside perspective view of the embodimentof the present
`inventionillustrating how the material of the bio-compatible material tube
`a threaded trigger wire. The Z
`may be folded back and held in place by
`stents attached to the inside surface of the material of the bio-compatible
`material tube are
`to allow a section of the material
`incomplete posteriorly
`bio-compatible material tube to be folded and held with a
`of the
`wire threaded through the material;
`
`trigger
`
`FIG. 4 is a cross-section view of the embodimentof the present invention
`before release of the
`trigger wire;
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`

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`
`6
`FIG. 5 is a cross-section view of the embodimentof the present invention
`after release ofthe trigger wire. The trigger wire has been withdrawn and
`the folded bio-compatible material unfurled, allowing
`the stent to
`expand
`to its full extent, holding it against the aortic wall with a radial force;
`
`FIG. 6 is a view of the aorta and renalarteries with the prosthesis of this
`embodimentof the present invention within the delivery
`device The top
`Z stents of the present invention have been manually pulled together and
`covered with a
`top cap whilst the lower part of the present invention sits
`snugly above the obturator and within the sheath which are all threaded
`over a
`guide wire which mounts the present invention to the correct
`
`position;
`
`FIG. 7 is a view of the prosthesis of this embodimentof the present
`inventionafter its release from the sheath in a
`semi-deployed position
`opposite the renal arteries, that is before release of the trigger wire;
`
`FIG. 8 is a view of the prosthesis of this embodiment of the present
`invention in a
`semi-deployed position where the fenestrations of the
`a
`present invention have been canulated by
`guide wire from the
`over which two
`contralateral groin
`catheters have been
`angiography
`passedin orderto fix the stent firmly in the correct positionsprior tofull
`deployment, that is prior to release of the triggerwire;
`
`FIG. 9 is a view ofthe prosthesis of this embodimentof the present
`invention in full deployment, that is after release of the trigger wire with
`cap
`the
`angiography catheters and top
`still in place;
`
`FIG. 10 is a view of the prosthesis of this embodimentof the present
`inventionin full deployment with the angiography catheters and their
`guide wires withdrawn, and the sheath and obturatorof the delivery
`device pushed up to dock with the top cap in preparation for withdrawal
`of the
`delivery device; and
`
`FIG. 11 is a view of the prosthesis of this embodimentof the present
`invention in full deployment preserving flow to the renal arteries with the
`sheath, obturator and top cap withdrawn.
`
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`
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`
`PCT/AU98/01019
`
`DESCRIPTION OF A PREFERRED EMBODIMENTOF THE INVENTION
`
`7
`
`to the field of the treatment of aortic
`The present invention relates
`generally
`disease and in particular to endoluminal aortic stents which allow accurate
`placementof a fenestrated covered stent in the aorta.
`In particularit is
`capable of being deployed and positioned accurately above the renal
`arteries in the treatmentof infra-renal aortic aneurysmal disease.
`
`the method as well
`The drawing figuresillustrate the basic steps comprising
`as
`illustrating the features of one embodiment of the present invention.
`
`FIGS. 1 and 2 show an outside view of one embodimentof the present
`invention. A proximal stainless steel or nitinol Z stent 1 with caudal facing
`is stitched to a
`4 of a
`barbs
`bio-compatible material tube 5. The
`top ring
`proximal Z stent 1 extends proximally from the bio-compatible material tube
`5. Two further stainless steel or nitinol Z stents 7 and 8 are fitted within the
`bio-compatible material tube 5. The Z stents are stitched at intervals to the
`bio-compatible material tube but in part of the bio-compatible material tube
`stitching is omitted to enable a
`longitudinal fold to be made in the bio-
`compatible material tube as will be discussed later. Fenestrations 10 are
`a
`provided in the bio-compatible material tube 5 providing
`aperture in the
`tube whichwill in use
`align with the renal or other arteries. The
`fenestrations 10 are customised in size and position for the renal arteries
`following computer tomography and angiography and their peripheral
`are marked with small gold radiopaque beads 11 which help to
`edges
`identify the fenestrations with X-rays. There is a
`long loop 12 in one of the
`crownsof the Z stent 8 which extends
`distally of the bio-compatible material
`tube 5 and which holds the anterior of the stent within the delivery device as
`will be discussedlater.
`
`As can be
`seen in FIG. 2, which showsthe inside view of the
`particularly
`prosthesis, there is a shortened loop 13 of one of the crownsof the top inner
`Z stent 7 which permits placementof the fenestrations for the renal arteries
`at the desired position.
`
`FIG. 3 is an
`crowns
`perspective view of the prosthesis where the proximal
`14 of the Z stent 1 have been drawn together manually to facilitate their
`
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`PCT/AU98/01019
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`8
`insertion into a
`wire 17 is used to
`proximal capsule (not shown). A
`trigger
`retain the crowns within the capsule. The same
`trigger wire or another
`trigger wire 15 is also used to retain a
`tuck in the bio-
`longitudinal
`a fold
`compatible material tube 5 thus narrowing the diameter and leaving
`16 of excess material to the side of the prosthesis. The trigger wire 17 also
`12 to assist with retaining the distal end of the
`passes through the loop
`prosthesis after withdrawal of the sheath aswill be discussed later. This
`enables rotation of the prosthesis within the artery to accurately positionit
`before final release. The trigger
`wire 15 is inserted through
`the surface of
`the dacron or other material intermittently to create a series of stitches to
`form the seam-like fold of material 16 as more
`in FIG. 4.
`clearly depicted
`
`FIG. 4 showsa cross section view of the prosthesis before release of the
`trigger wire 15 from the fold 16 of material. The seam-like fold 16 , held in
`place by the stitched-on trigger wire 15 ,
`a diameter which is
`provides
`narrower than the diameter of the aorta
`the prosthesis to
`thereby enabling
`be manoeuvred both up and downand
`on release
`rotationally 360 degrees,
`sheath, and after catheterisation as will be
`of the present invention from a
`discussed in reference to FIG. 8, to ensure accurate placementof the
`fenestrations in relation to the renal arteries.
`
`10
`
`15
`
`20
`
`FIG. 5 showsa cross section view of the prosthesis after release of the
`ie. in full deployment.
`trigger wire.
`
`25
`
`30
`
`FIG. 6 is a view of the aorta 30, renal arteries 32 and 34 extending
`to the
`kidneys 35 and femoral arteries 36 and 38 and the delivery device which
`introduces the prosthesis 18 of the present invention to the aorta 30 via a
`groin incision to one of the femoralarteries 36.
`
`The delivery device generally shown as 20is inserted overa
`plastic
`a stainless steel proximal cap
`covered metal
`wire 22 and comprises
`guide
`24 mounted ona flexible steel tube 23. The proximal cap 24 covers the top
`part of the proximal Z stent and a sheath 26
`covering the prosthesis
`including bio-compatible material tube 5 and the remainderof the Z stents
`and extends over
`insertion. The sheath
`part of the proximal cap 24
`during
`26 is fitted over a
`plastic obturator 28 whichis sufficiently long to protrude
`from the femoral artery and
`incision to enable manual movement
`groin
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`9
`thereof. The plastic obturator 28 is a
`sliding fit on the flexible steel tube 23.
`The obturator 28 sits snugly under the sheath and holds the prosthesis in
`position both on insertion and later when the sheath is drawn back over the
`obturator as
`depicted in FIG. 7
`thereby exposing the fenestrated stent in the
`semi-deployed positionillustrated in FIGS. 3.
`
`In FIG. 7 the sheath 26 has been withdrawnonto the obturator 28 while
`leaving the obturator 28 and the proximal capsule 24 in place by preventing
`relative movement between the flexible steel tube 23 and the obturator 28.
`movementof the flexible tube
`The prosthesis 18 is then free to be rotated by
`until the fenestrations 10 and 11 are
`23 and moved
`longitudinally
`positioned correctly with respect to the renal arteries 32 and 34.
`
`FIG. 8 is a view of the aorta 30, renal arteries 32 and 34 extending to the
`kidneys 35 and femoral arteries 36 and 38 and the delivery device 20
`where the obturator 28 and sheath 24 have been withdrawn back to oneof
`the femoral arteries 36. This is achieved by holding the flexible steel tube
`23
`and
`moving the sheath 26 and obturator 28 relative to it. The
`stationary
`trigger wire 15 remains in place. This allows room for the introduction of the
`guide wires 40 and 42 and angiography catheters 44 and 46 that have
`been inserted via an incision in the contralateral groin (not shown) and up
`through the contralateral femoral artery 38 and placed in the renal arteries
`as directed by the right and left angiography catheters 44 and 46. These
`angiography catheters 44 and 46 are
`designed with right and left bended
`so. as to
`necks
`guide the wire from the aorta 30 in to the
`respectively
`appropriate renal artery 32 and 34. The guide wires 40 and 42 and
`angiography catheters 44 and 46are inserted into the renal arteries 32 and
`34 so as to
`safely and accurately position the fenestrations 10 and 11 of the
`prosthesis of this embodiment of the present invention.
`
`FIG. 9 is a view of the present invention in full deploymentafter release of
`the trigger wires 15 and 17 or the single trigger wire carrying out the
`functions of both trigger wires with the guide wires 40 and 42, angiography
`catheters 44 and 46 and
`delivery device 20still in place. At this stage the
`proximal Z stent 1 expands out to the wall of the aorta 30 and the barbs 2
`engagein to the wall of the aorta to retain the prosthesis 18 in the correct
`position.
`
`10
`
`15
`
`20
`
`25
`
`30
`
`

`

`WO 99/29262
`
`PCT/AU98/01019
`
`10
`In FIG. 10 the angiography catheters 44 and 46 and guide wires 40 and 42
`have been withdrawn through the contralateral femoral artery 38 and the
`obturator 28 and sheath 24 have been pushed up to dock with the proximal
`capsule 24 in preparation for removal of the complete delivery device 20.
`This is achieved by holding the flexible steel tube 23 stationery and moving
`the obturator 28 and sheath 24 relative to it and towards the proximal
`
`capsule.
`
`FIG. 11 is a view of the prosthesis 18 of the present invention in full
`deployment, with the delivery device 20 withdrawn, enabling free flow of
`through the aorta 30 andinto the renal arteries 32 and 34 via the
`blood
`fenestrations 10 and 11.
`
`10
`
`Post-deployment angiography should be carried out to confirm correct
`deploymentand
`positioning of the fenestrations.
`
`Modifications which can be made which may be advantageous
`follows.
`
`15
`
`are as
`
`There may be more than two Z stents attached to, and within, the bio-
`compatible material tube. More than two Z stents would be usedif
`elongation of the graft of the present invention is required.
`
`The release mechanism may befoldedinternally either (a) posteriorly
`anteriorly and posteriorly with one or two
`trigger wires respectively.
`
`or
`
`(b)
`
`20
`
`There may be more than two fenestrations in the bio-compatible material
`tube where there are more than twointersecting arteries.
`
`25
`
`Throughout this specification and the claims that follow unless the context
`requires otherwise, the words ‘comprise' and ‘include' and variations such
`as
`and
`imply the inclusion of a
`‘including’ will be understood to
`‘comprising’
`or group of integers but not the exclusion of any other
`Stated
`integer
`integer
`group of integers.
`
`or
`
`

`

`WO 99/29262
`
`PCT/AU98/01019
`
`11
`
`CLAIMS
`
`1.
`
`A prosthesis comprising two or more Z stents sutured to a
`graft
`a
`bio-compatible material tube, wherein the two or more Z stents
`comprising
`are attached to the inside surface of the bio-compatible material tube and at
`least one fenestration in the bio-compatible material tube corresponding to
`an
`intersecting artery opening.
`
`A prosthesis according to claim 1 wherein there are more than two Z
`2.
`stents attached to the bio-compatible material tube.
`
`10
`
`3.
`a further Z stent
`A prosthesis according to claim 1 further including
`fastened to the bio-compatible material tube and extending proximally from
`the
`bio-compatible material tube.
`
`A prosthesis according to any one
`4.
`preceding claim wherein at least
`one of the Z stents has caudally facing barbs thereon.
`
`5.
`
`A prosthesis according
`to claim 3 wherein the proximally extending
`Z stent has
`caudally facing barbs thereon.
`
`15
`
`one
`preceding claim wherein there are
`6.
`A prosthesis according to.any
`two or more fenestrations according to the numberof intersecting arteries.
`
`A prosthesis according to any one
`7.
`preceding claim wherein the or
`each fenestration includes one or more
`a
`radiopaque markers defining
`
`20
`
`periphery
`
`of the fenestration.
`
`A prosthesis according to any one
`8.
`preceding claim wherein the distal
`mostof the Z stents includes a
`loop extending distally of the
`graft.
`
`

`

`WO 99/29262
`
`PCT/AU98/01019
`
`12
`
`A prosthesis according to any one
`9.
`preceding claim further including
`a release mechanism for said prosthesis including
`one or more
`trigger
`wires wherein a
`portion of the bio-compatible material tube is folded
`with the one or more
`threaded
`trigger wires respectively
`longitudinally
`longitudinally through the bio-compatible material tube at the fold to retain
`the prosthesis in a
`partially compressedstate.
`
`to any one
`10.
`claim wherein at least
`A prosthesis according
`preceding
`one of the Z stents includes one or more shortened loops to enable location
`of the fenestrations as
`required.
`
`10
`
`11.
`
`treating arterial disease at an intersection of two
`A method for
`the stepsof:
`
`arteries, including
`
`X-raying arteries to be treated so as to
`the intersection of the arteries,
`
`accurately
`
`determine the position of
`
`one or more fenestrations to a
`prosthesis comprising
`customising
`selected length of a
`bio-compatible material tube;
`
`a
`
`15
`
`attaching radiopaque markers around the or each fenestrations;
`
`placing two or more Z stents into said bio-compatible material tube, bends
`being shortened if necessary in such a way So as notto cover
`in the Z stents
`the fenestrations;
`
`20
`
`top Z stent, covering with the top Z stent with a
`a
`manually gathering
`holding the top cap in place with a
`and
`trigger wire;
`
`top cap
`
`a
`a
`longitudinal fold in the bio-compatible
`wire through
`stitching
`trigger
`material tube to narrow the diameter of said graft;
`
`a customised fenestrated covered graft
`thereby providing
`an
`artery to be treated.
`
`25
`
`to be inserted into
`
`

`

`WO 99/29262
`
`PCT/AU98/01019
`
`13
`12.
`A methodasin Claim 11 further including the step of sewing
`further Z stents to top ring of said bio-compatible material tube, such that the
`further Z stent extends
`materia! tube.
`proximally from the bio-compatibie
`
`a
`
`13.
`
`The method asin claim 11 wherein the process of insertion of the
`graft includes the stepsof;
`
`compressing the graft and placingit into a sheath which fits snugly around
`said top cap, said prosthesis, the Z stents and an obturator;
`
`a femoral artery in a
`groin said prosthesis using
`inserting through
`delivery
`device which includes said top cap, said sheath, said obturator and guide
`wires;
`
`a
`
`10
`
`withdrawing said sheath to reveal said graft in semi-deployed position;
`
`positioning the prosthesis:
`
`partially withdrawing said sheath and obturator to enable insertion of
`angiography catheters and guide wires;
`
`15
`
`inserting said angiography catheters and guide wires through
`to be treated to
`contralateral groin into the artery
`provide manoeuvrability,
`andleft
`and accurate
`positioning of the graft by positioning right
`wires
`the fenestrations into the
`catheters and guide
`angiography
`through
`intersecting arteries;
`
`a
`
`20
`
`releasing the trigger wire to provide full deploymentof the said graft;
`
`withdrawing said
`
`angiography catheters;
`
`pushing up said sheath and obturator through said stent and docking with
`said top cap and
`said
`delivery device;
`fully withdrawing
`
`whereby
`
`the said fully deployed
`intersection of the arteries to be treated.
`
`stent ensures the flow of blood at the
`
`25
`
`

`

`WO 99/29262
`
`PCT/AU98/01019
`
`13.
`
`14
`to claim 11 wherein there are more than two
`|The method according
`said Z stents attached to the bio-compatible material tube.
`
`to claim 11 wherein there are two or more
`14.
`The method according
`to the number of
`than two fenestrations according
`intersecting arteries.
`
`15.
`
`are
`
`to claim 11 wherein the
`|The method
`markers
`according
`radiopaque
`or any other bio-compatible material which enables the markerto
`gold
`or other methods.
`be visualised
`by X-ray
`
`

`

`
`
`

`

`O 99/29262
`
` FIG 5
`
`

`

`WO 99/29262
`
`PCT/AU98/01019
`
`3/8
`
`22
`
` wa
`
`FIG 6
`
`

`

`WO 99/29262
`
`PCT/AU98/01019
`
`4/8
`
`|
`1ASL
`
`N
`
`Ui)
`1)
`WT
`
`FIG 7
`
`
`
`

`

`WO 99/29262
`
`PCT/AU98/01019
`
`5/8
`
`22
`
`
`
`

`

`6/8
`
`22
`
`WO 99/29262
`
`PCT/AU98/01019
`
`
`
`
`cA
`
`

`

`PCT/AU98/01019
`
`7/8
`
`=CLLLLLLILLLollaahielaihe
`94
`—
`====aOS
`=|
`;
`KITEneipbald
`ahahallePLDa{
`Freacit
`as,1
`nileTbhOTs
`dphpleigbei
`=2
`aS,
`ae
`aeea=Pe4
`SRP
`
`al
`,aa
`STEEee
`
`|2
`
`WO 99/29262
`
`Xeef
`™Wayhg
`
`©o)
`
`=
`
`5609
`
`<5
`
`FIG 10
`
`
`
`
`
`

`

`WO 99/29262
`
`PCT/AU98/01019
`
`8/8
`
`
`hakaIgNSTSO
`
`
`11
`
`

`

`INTERNATIONAL SEARCH REPORT
`
`International application No.
`
`A.
`
`B.
`
`CLASSIFICATION OF SUBJECT MATTER
`
`AGI1F 2/06
`
`FIELDS SEARCHED
`
`or to both nationalclassification and IPC
`
` PCT/AU 98/01019
` Int 16:
` According to International Patent Classification (IPC)
` Minimum documentation searched (classification system followedby classification symbols)
`
`IC’ A6lLF2/- A6IM 29/-
`
`Documentation searched other than minimum documentationto the extent that such documents are included in thefields searched
`
`Electronic data base consulted during the international search (nameof data base and, wherepracticable, search terms used)
`WPAT & JAPIO with junct: intersect: branch: aort: arter: vessel stent# z-stent#
`
`Cc
`
`DOCUMENTS CONSIDERED TO BE RELEVANT
`
`Category*
`A
`
`Citation of document, with indication, where appropriate, of the relevant passages
`WO,A, 98/36709 (SCIMED LIFE SYSTEMSINC) 27 August 1998
`
`Relevant to claim No.
`
`A
`
`A
`
`WO,A, 97/45073 (BARD GALWAY LIMITED) 4 December 1997
`
`US, A, 5617878 (TAHER]) 8 April 1997
`
` See patent family
`
`Further documentsare listed in the
`continuation of Box C
`
`
`annex
`
`*
`
`"A"
`
`"E"
`
`“LL
`
`ie
`
`"p"
`
`Special categories of cited documents:
`document defining the general state of the art whichis
`not considered to be ofparticular relevance
`on or after
`or
`patent but published
`earlier application
`the internationalfiling date
`document which may throw doubts on
`priority claim(s)
`or which is cited to establish the publication date of
`reason
`another citation or other special
`(as specified)
`documentreferring to an oral disclosure, use,
`exhibition or other means
`to the international filing
`document published prior
`date but later than the priority date claimed
`
`ope
`
`"x
`
`wy
`
`"a"
`
`later document publishedafter the internationalfiling date or
`priority date and not in conflict with the application but cited to
`or
`understandthe principle
`theory underlying the invention
`documentof
`particular relevance; the claimed invention cannot
`be considered novel or cannot be considered to involve an
`inventive step when the documentis taken alone
`documentofparticular relevance; the claimed invention cannot
`be considered to involve an inventive step when the documentis
`combined with one or more other such documents, such
`combination being obviousto a person skilled in the art
`document memberof the same patent family
`
`Date of the actual completion of the international sear