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`
`US 20030093145A1
`
`(19) United States
`(12) Patent Application Publication (10) Pub. No.: US 2003/0093145 A1
`Lawrence-Brown et al.
`(43) Pub. Date:
`May 15, 2003
`
`(54) ENDOLUMINAL GRAFT
`
`(30)
`
`Foreign Application Priority Data
`
`(75) Inventors: Michael Lawrence-Brown, Western
`Australia (AU); Kurt Li?'man, Victoria
`(AU); David Ernest Hartley, Western
`Australia (AU)
`
`Correspondence Address;
`COOK GROUP PATENT OFFICE
`PO. BOX 2269
`BLOOMINGTON, IN 47402
`
`(73) Assignee; Cook Incorporated, Bloomington, IN
`
`(21) Appl, N()_j
`
`10/279,446
`
`(22) Filed:
`
`Oct. 24, 2002
`
`Oct. 26, 2001 (AU) ............................................ .. PR8472
`
`Publication Classi?cation
`
`(51) Int. Cl.7 ...................................................... ..A61F 2/06
`(52) US. Cl. .................... .. 623/121; 623/123; 623/125;
`623/ 1.35; 623/ 1.36
`
`_
`_ _ABSTRACT
`_
`(57)
`A graft (1) WhlCh is in the form of an in?atable member
`adapted to be formed into a predetermined and/or selected
`shape When deployed in situ by ?lling With a ?ller material
`(6) Which can be made rigid in situ and deployed on a
`balloon catheter (12). The deployment balloon (13) is
`formed from a non-compliant material.
`
`Edwards Lifesciences Corporation, et al. Exhibit 1149, Page 1 of 20
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`17
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`14 15
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`i
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`ENDOLUMINAL GRAFT
`
`CROSS-REFERENCE TO RELATED
`APPLICATIONS
`
`[0001] This application claims priority of Australian Pro
`visional Application Serial No. PR 8472 ?led Oct. 26, 2001.
`
`TECHNICAL FIELD
`
`[0002] This invention relates to a medical device and in
`particular to an endoluminal graft.
`
`BACKGROUND OF THE INVENTION
`
`[0003] Abdominal aortic aneurysms and problems in other
`body lumens have been treated by the use of stent grafts or
`prostheses of a variety of constructions, but due to their
`essentially rigid construction, even in a collapsed state, there
`are problems inserting such grafts into an aorta or other body
`lumen.
`
`SUMMARY OF THE INVENTION
`
`[0004] It is the object of this invention to provide a graft,
`Which is of a minimal siZe for insertion, but can carry out
`essentially the same function as existing stent grafts.
`
`[0005] Also, When treating occlusive disease in arteries, it
`is desirable to have a delivery system, Which is as small as
`possible during delivery, but can be eXpanded in situ to a
`selected siZe to treat the occlusive disease.
`[0006] With imaging techniques using Magnetic Reso
`nance Imaging (MRI), it is desirable to have grafts, Which do
`not include metallic stents as these cause ?aring With MRI.
`It is a further object of this invention to provide such a
`grafting system.
`[0007] In one form therefore the invention is said to reside
`in a graft for maintenance or repair of a lumen of the body,
`the graft including an in?atable member having a selected
`in?ated shape When deployed in situ by ?lling With a settable
`or ?ller material Which can be set and become rigid in situ.
`
`[0008] Preferably the graft is deployed on a deployment
`balloon, the deployment balloon being formed from a non
`compliant material.
`
`[0009] In an alternative form, the invention is said to
`reside in a method of deployment of a graft Within a body
`lumen, the graft being of a type to be formed in its ?nal
`shape in situ and set into that shape, the method including
`the steps of:
`
`[0010] mounting the graft in a contracted state onto a
`deployment balloon on a delivery device, inserting
`the delivery device so that the graft is positioned at
`the desired position in the body lumen, in?ating the
`deployment balloon to place the graft adjacent the
`Wall of the body lumen, placing a settable or ?ller
`material that can be set into the graft to form the graft
`into its desired ?nal shape, setting the graft into its
`?nal shape by rigidising the settable or ?ller mate
`rial, as hereinafter de?ned, de?ating the deployment
`balloon, and removing the delivery device.
`
`[0011] Preferably the deployment balloon is formed from
`a non-compliant material as hereinafter de?ned.
`
`[0012] Throughout this speci?cation the term “non-com
`pliant”, With respect to the balloon, is intended to mean that
`the balloon is constructed from a material, Which at normal
`intended in?ation pressures, is essentially non-elastic,
`Whereby upon in?ation, a selected siZe and shape of balloon
`is provided. The use of such a non-compliant balloon as the
`deployment balloon Will help to ensure that a ?nally placed
`graft has a lumen of a selected siZe and shape.
`
`[0013] Throughout this speci?cation the term “non-com
`pliant or semi-compliant”, With respect to the graft material,
`is intended to mean that the graft is constructed from a
`material, Which at normal intended in?ation pressures, is
`non elastic or only slightly elastic so that it can conform to
`the Walls of a lumen into Which it is placed but Will not
`signi?cantly distort during in?ation.
`
`[0014] Throughout this speci?cation, the term “rigidised”
`is intended to mean that the material for in?ation or ?lling
`of the graft is able to be made more rigid but does not
`eXclude a ?nal form in Which the material is ?eXible.
`
`[0015] In a preferred form of the invention, the graft is of
`a type having an internal lumen, being a lumen that is not
`open to the body lumen, and the step of setting the graft into
`its ?nal shape includes the step of inserting a suitable liquid
`into that internal lumen to thereby in?ate it to the predeter
`mined or selected shape.
`
`[0016] In one embodiment, the graft is generally of an
`elongate torroidal or annular shape When in the in?ated
`condition to de?ne a lumen therethrough that provides an
`arti?cial ?oWpath for the body lumen.
`
`[0017] The graft can be formed from a double Walled
`plastic tube thereby providing an inner Wall and an outer
`Wall and Wherein the settable or ?ller material or in?ation
`material is provided betWeen the inner Wall and the outer
`Wall to in?ate the graft to form it into its ?nal shape.
`Preferably, the graft is evacuated before being inserted into
`the body lumen so that during in?ation there are no air
`pockets in the ?nal shape When in?ated.
`
`[0018] The graft has an in?oW tube for the supply of
`settable or ?ller material to the graft and can also have an
`out?oW tube so that complete ?lling of the graft can be
`determined by eXcess ?oWing out of the graft through the
`out?oW tube. The in?oW and out?oW tubes can be connected
`in use to tubes or associated With the lumens delivery device
`that eXtend to outside the body of a patient so that the
`settable or ?ller material can be supplied and the eXcess
`material ?oWing out of the graft can be observed.
`
`[0019] Webs or baf?es can be provided betWeen the inner
`and outer Walls of the graft to ensure that the graft thor
`oughly in?ates to a predetermined or selected shape. The
`Webs or baf?es can be provided by joining of the inner and
`outer Walls at intervals or can be provided by Webs of
`material joined to each Wall.
`
`[0020] The material of construction of the Walls of the
`tube can be any biocompatible ?lm and in a preferred
`embodiment of the invention, the biocompatible ?lm is
`made from a non-compliant or semi-compliant material as
`hereinbefore discussed so that When in?ated, it forms a
`selected siZe and does not in?ate too much or in a distorted
`manner but is able to conform to the Wall of a vessel.
`
`Edwards Lifesciences Corporation, et al. Exhibit 1149, Page 15 of 20
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`[0021] The liquid Which is inserted into the graft to in?ate
`it to the selected shape is preferably a bio-compatible
`material and can be a monomer, a liquid pre-polymer or an
`un-crosslinked polymer. The setting or rigidising of the
`liquid or ?ller material inserted into the graft can be by
`polymerisation of the monomer or pre-polymer or by
`crosslinking of the liquid polymer. The polymerisation can
`be by irradiation such as With UV, IR or visible light
`radiation to initiate the polymerisation or cross-linking.
`Such irradiation can be provided into the lumen by means of
`a ?bre optic cable inserted through a lumen of the delivery
`device.
`
`[0022] Where the polymerisation or rigidising is achieved
`by the use of radiation such as UV, IR or visible radiation
`and the graft is formed from a double Walled plastic tube
`thereby providing an inner Wall and an outer Wall, the outer
`Wall is preferably a radiation opaque material and its inner
`Wall is a radiation transparent material.
`
`[0023] The graft can have on its outer surface at one or
`both ends one or more blood ?oW prevention rings or sealing
`ridges or ?anges circumferentially around each end. These
`can be provided so that once in place, ?oW of blood cannot
`go outside the graft. The ridges, ?anges or rings can also
`assist With prevention of longitudinal movement of the graft
`Within the body lumen under the in?uence of, for instance,
`blood ?oW.
`
`[0024] The graft can be fenestrated or bifurcated as
`required for particular applications.
`[0025] There can be means provided to enable detachment
`of the tubes through Which the setting or ?ller material is
`supplied to the graft and excess material removed before
`de?ation of the deployment balloon. Such a detachment
`means can utilise a fusible or separable link, a severing
`mechanism or some other arrangement.
`
`[0026] In a preferred embodiment of the invention, the
`in?ation pressure of the graft’s settable or ?ller material can
`be selected to be slightly higher than the in?ation pressure
`of the deployment balloon. For instance, the deployment
`balloon can be in?ated at perhaps ?ve atmospheres and the
`graft in?ated With the settable material at 8 to 10 atmo
`spheres. By this arrangement, thin or thick spots in the Wall
`of the graft can be avoided.
`[0027] A delivery device for deployment of the graft
`according to this invention can be a multi-lumen catheter.
`Lumens can be provided for a guide Wire, in?ation material
`such as brine for the deployment balloon, supply and return
`lumens for the settable or ?ller material for the graft and a
`lumen for the ?bre-optic cable for the setting stage.
`[0028] Alternatively, tubes for the supply and optionally
`return of settable or ?ller material can be provided external
`to the delivery catheter.
`[0029] Preferably, the multi-lumen catheter of the delivery
`device includes a soft conical distal tip, an annular recess
`along the body of the delivery device into Which the deploy
`ment balloon and graft is inserted and a sheath Which is
`adapted for covering the deployment balloon region during
`initial insertion.
`
`[0030] In a further form, the invention can be said to reside
`in a deployment device for an in?atable graft, the deploy
`ment device having a delivery catheter, an in?atable balloon
`
`at or near the distal end of the delivery catheter, the catheter
`having at least a guide Wire lumen and a lumen to supply
`in?ation ?uid for the balloon, a tube to supply settable or
`?ller material extending from a proximal end of the delivery
`catheter to an in?atable graft mounted on to the balloon.
`
`[0031] Preferably the balloon is formed from a non
`compliant material.
`[0032] Preferably, the delivery catheter is a balloon cath
`eter.
`
`[0033] Preferably, the delivery catheter, the balloon, the
`tube and the graft are covered by a sleeve coaxial With the
`balloon catheter.
`
`[0034] There can be further included a second tube
`extending along the delivery catheter from the graft so that
`excess settable or ?ller material can be carried aWay from
`the graft.
`
`[0035] There can be further included a lumen in the
`delivery catheter to extend a ?bre optic cable to the graft to
`provide radiation to set the settable or ?ller material in the
`graft.
`[0036] There can be further included means to enable
`detachment of the tubes through Which the setting material
`is supplied to the graft. The means to enable detachment of
`the tubes can utiliZe a fusible or separable link or a severing
`mechanism.
`
`[0037] Hence, according to one embodiment of this inven
`tion, it is proposed that the graft be a synthetic material tube
`Where the Walls of the tube contain a ribbed or Webbed inner
`cavity that runs the length of the graft. The graft has little
`structural strength and, by itself, cannot act as a channel for
`the blood ?oWing through the AAA. HoWever, When the
`cavity Wall of the graft is ?lled With radiation-activated
`liquid polymer, the graft Will obtain the appropriate struc
`tural strength (and ?exibility) once the system has been
`exposed to suitable radiation.
`
`[0038] Due to the drag force of blood ?oWing through the
`graft, it is preferable that it has some means of keeping itself
`in place Within the lumen. For this purpose, external counter
`?oW ridges can be built into the outer Wall of the graft.
`
`[0039] The graft is preferably delivered to the body lumen
`via a balloon catheter surrounded by a restraining sleeve.
`The graft, in a collapsed/compressed state, surrounds the
`balloon While the graft is being delivered to the aneurysm
`via an easily accessible, remote artery. Once the tube is in
`the optimal position, the sleeve is WithdraWn, the balloon is
`expanded and the tube is ?lled With the polymer via a
`separate delivery tube. When the cavity Wall is ?lled With the
`polymer, a UV or light source is introduced via an optical
`?bre. Appropriate exposure to the light causes the polymer
`to set. The polymer and the containment graft Will noW have
`obtained the required rigidity. The balloon is subsequently
`de?ated and the catheter WithdraWn. Finally the UV polymer
`inlet tube is cut and the graft is secured in place by the
`strategically placed “counter-?ow” ridges, Which imbed
`themselves into the arterial Wall.
`
`[0040] The example of a graft in the form of a simple tube
`has been used to illustrate the concept, hoWever, the graft
`can have a more complex structure. For example, it can have
`the shape of a bifurcated endoluminal graft, i.e., a single tube
`
`Edwards Lifesciences Corporation, et al. Exhibit 1149, Page 16 of 20
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`that bifurcates into tWo tubes. The graft can also have this
`shape or indeed another shape Where any number of tubes
`are joined together in a manner that is appropriate for the
`physiology of the patient and/or the desired medical appli
`cation.
`
`[0041] In other embodiments, there can be more than one
`internal lumen and there can be more than one type of
`settable or ?ller material for the different internal lumens or
`the settable or ?ller material can be supplied to the different
`lumens at different pressures. Alternatively, a ?rst internal
`lumen can be in?ated With settable material and rigidised
`and then a further internal lumen in?ated With settable
`material and rigidised.
`
`[0042] Current endoluminal grafts can also have fenestra
`tion holes or tubes in the Wall of the graft. These holes or
`tubes act as entrance points for separate tubes, often referred
`to as extension legs. The graft of the present invention can
`also be adapted to this practice.
`
`BRIEF DESCRIPTION OF THE DRAWING
`
`[0043] This then generally describes the invention but to
`assist With understanding, reference Will noW be made to
`preferred embodiments of the invention. In the draWings:
`
`[0044] FIG. 1 shoWs a schematic vieW of a graft of one
`embodiment of the invention;
`
`[0045] FIG. 2 shoWs an enlarged longitudinal cross sec
`tional vieW of the graft of FIG. 1;
`
`[0046] FIG. 3 a schematic vieW of a graft of FIG. 1 in
`cross section;
`[0047] FIG. 4 shoWs the ?rst stage of a deployment
`procedure for a graft of one embodiment of the present
`invention in an abdominal aortic aneurysm;
`
`[0048] FIG. 5 shoWs a second stage of a deployment;
`
`[0049] FIG. 6 shoWs a third stage of a deployment pro
`cedure;
`[0050] FIG. 7 shoWs a ?nal stage of a deployment pro
`cedure;
`[0051] FIG. 8 shoWs an alternative embodiment of a graft
`of the present invention;
`[0052] FIG. 9 shoWs an alternative embodiment of a graft
`of the present invention and the process of delivering an
`extension to a branch artery via a guide Wire threaded
`through a fenestrated graft;
`
`[0053] FIGS. 10A and B shoW an embodiment of a
`double ?ange extension leg graft for connecting a fenes
`trated graft to a branch artery of the type as shoWn in FIG.
`8 or 9;
`
`[0054] FIG. 11 shoWs an embodiment of a single ?ange
`extension leg graft of the present invention;
`
`[0055] FIGS. 12a and b shoW an embodiment of a bifur
`cated graft With an extension leg of the present invention;
`
`[0056] FIG. 13 shoWs one form of delivery device for a
`graft of the present invention With the graft mounted thereon
`in the de?ated state With a sheath covering the graft;
`
`[0057] FIG. 14 shoWs a second stage in the deployment of
`the embodiment of FIG. 13;
`
`[0058] FIG. 15 shoWs a third stage in the deployment of
`the embodiment of FIG. 13;
`
`[0059] FIG. 16 shoWs a ?nal stage in the deployment of
`the embodiment of FIG. 13;
`
`[0060] FIG. 17 shoWs a further embodiment of the deliv
`ery device of the present invention in the form of a balloon
`catheter;
`[0061] FIG. 18 shoWs the embodiment of FIG. 17 With
`the sleeve WithdraWn;
`[0062] FIG. 19 shoWs the embodiment of FIG. 18 With
`the balloon in?ated;
`[0063]
`FIG. 20 shoWs the next stage in Which the graft is
`in?ated;
`[0064] FIG. 21 shoWs the next stage in Which the balloon
`is de?ated; and
`[0065] FIG. 22 shoWs the ?nal stage in Which the delivery
`device is WithdraWn and the graft is left in place.
`
`DETAILED DESCRIPTION
`
`[0066] NoW looking more closely at the draWings and, in
`particular, FIGS. 1 to 3 Which shoW a ?rst embodiment of
`the graft according to this invention, it Will be seen that the
`graft comprises an annular tubular holloW body 1, Which is
`formed from an outer Wall 2 and an inner Wall 3. BetWeen
`the inner and outer Walls are Webs 4, Which do not extend the
`full length of the graft. The annular holloW body has an end
`Wall 5 betWeen the inner Wall 3 and the outer Wall 2. The
`Walls 2, 3 and 5 de?ne a holloW space 6 into Which can be
`inserted a settable or ?ller material under slight pressure to
`in?ate the graft to a predetermined or selected tubular shape
`as shoWn in FIG. 1 and then after setting of the settable or
`?ller material, the graft remains in that shape. The graft has
`an in?oW tube 6 at one end through Which can be supplied
`the settable or ?ller material. There is also a further return or
`out?oW tube 8 for return of excess settable or ?ller material.
`The out?oW tube 8 could extend from the opposite side of
`the graft 1 as in?oW tube 6 The return or out?oW tube 8
`could also extend from the opposite end of the graft 1 and
`extend back through the annular opening and co-extend
`along With in?oW tube 6 to assure that settable or ?ller
`material has been caused to ?oW completely through the
`graft for thorough in?ation.
`[0067] It is preferred that the graft, When in its de?ated
`state, is evacuated so that no air is inside the graft When it
`is inserted into a lumen of a body.
`
`[0068] At each end of the graft are a series of annular
`?anges or ridges 7 Which are in effect continuations of the
`outer Wall 2 and When the body is in?ated With the settable
`or ?ller material, the annular ?anges or ridges 7 are also
`in?ated. In use these annular ?anges, When in?ated, engage
`against the Walls of the body lumen to provide a seal so that
`blood ?oW Will not occur on the outside of the graft. These
`?anges or ridges help to ensure that the drag force from the
`blood ?oWing through the graft does not displace the graft
`from its optimal position.
`[0069] In FIG. 2 shoWing a longitudinal cross section of
`the UV graft, it can be seen that an approximately 5 mm
`thick cavity exists in the Wall of the tubular graft and, When
`in?ated, the total internal Width of the inner tube of the graft
`
`Edwards Lifesciences Corporation, et al. Exhibit 1149, Page 17 of 20
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`is in the range of 10 to 20 mm. The internal structure of the
`stability ?anges or ridges 7 is also shown at either end of the
`graft.
`[0070] The cavity 6 Within the graft has a Webbed or a
`ribbed internal structure. The Webs or ribs 4 are designed to
`limit the expansion of the cavity during the polymer injec
`tion phase. This ensures that the UV graft does not balloon
`at points Where the external Wall of the graft is not con
`strained by an arterial Wall or by laminated thrombus. The
`ribs can have a non-continuous longitudinal or helical shape.
`Gaps in the longitudinal or helical structure alloW the
`settable or ?ller material such as a UV polymer to ?oW freely
`through the entire cavity. The ribs 4 do not necessarily
`extend to the ends of the graft. Of course, other rib shapes
`are possible.
`
`[0071] It Will be realiZed that the graft, as shoWn in FIGS.
`1 to 3, can have a different shape than an essentially
`cylindrical shape depending upon the form of the lumen into
`Which the graft is to be supplied. For instance, the graft can
`have an arcuate shape if it is to be placed in a spot such as
`the thoracic arch or can have constrictions in diameter if it
`is to be placed, for instance, in the aorta and extend doWn
`one of the iliac arteries. As Well be discussed With further
`embodiments, the graft can have apertures or bifurcations.
`[0072] The graft of the present invention is preferably
`made from a biocompatible plastics material that is trans
`parent to UV and/or visible light and non-compliant to
`stretch. As discussed above, the outer layer of the biocom
`patible plastics material can be opaque to UV and/or visible
`light.
`[0073] FIGS. 4 to 7 shoW the various stages of deployment
`of a graft according to this invention into a body lumen.
`
`[0074] In this case, the body lumen is an aorta 10 With an
`aneurysm 11. The deployment device 12 such as a catheter
`With a deployment balloon 13 and the graft 14 mounted onto
`it is introduced on a guide Wire 9. Introduction by the
`deployment device including a tapered tip 16 to assist With
`introduction into the aorta.
`
`[0075] Once the graft is in the correct position, as ascer
`tained by MRI or X-ray ?uoroscopy or some other visual
`iZation technique, the balloon 13 is in?ated as shoWn in FIG.
`5. The balloon 13 is manufactured from a non-compliant
`material. This means that the balloon Will expand to a
`predetermined and/or selected siZe and shape but not go
`beyond that shape under normal in?ation. Expansion con
`tinues until the unin?ated graft 14 has engaged the Walls of
`the aorta 10 beyond the aneurysmal region 11.
`
`[0076] The balloon 13 is then held in?ated and settable or
`?ller material is then inserted into the graft 14 until it, too,
`is in?ated, and the sealing ?anges or ridges 15 at each end
`of the graft 14 engage into the Walls of the aorta 10 to engage
`the graft Within the aorta. Preferably, the pressure of the
`settable or ?ller material in the graft 14 is slightly greater
`than the pressure in the balloon 13 so that the balloon does
`not distort the ?nal shape of the graft 14. Settable or ?ller
`material is supplied to the graft 14 by means of in?oW tube
`17.
`
`[0077] After the tube has been ?lled, a ?bre optic cable 19,
`Which is either present in the delivery device or is inserted
`through the delivery device 12, is used and UV radiation 20
`
`is supplied in the region of the graft 14 to set the settable or
`?ller material in the graft. See FIG. 6.
`
`[0078] After the settable or ?ller material has set in both
`the graft and the delivery tube 17, a mechanical means or
`other means (not shoWn) is used to separate the tube 17 from
`the graft 14 and the balloon 13 is de?ated as shoWn in FIG.
`7. The delivery device 12 can then be removed to leave the
`graft 14 in place bridging the aortic aneurysm 11.
`
`[0079] FIGS. 8 to 11 shoW the use of the graft of the
`present invention as a fenestrated graft and hoW a side arm
`is inserted through such a fenestration. The graft 30 has at
`least one fenestration or aperture 31 along its length. The
`fenestration is designed to enable a side arm to extend
`through the fenestration into a branch of the body lumen
`such as occurs Where the renal arteries leave the aorta.
`
`[0080] As can be seen in FIG. 9, an aneurysm 35 has
`occurred in an aorta and the renal artery 36 is incorporated
`in the aneurysm. In such a situation, the graft is placed so
`that it extends across the aneurysm and the sealing ?anges
`or ridges 37 engage into non-aneurismal material of the
`aorta 38. Placement can be by the method discussed With
`respect to FIGS. 4 to 7.
`
`[0081] The graft 30 is designed so that once installed, the
`fenestration 31 is immediately opposite the renal artery.
`Suitable radiopaque markers 32 such as gold or MRI opaque
`markers can be used to con?rm the positioning of the
`fenestration. As shoWn in FIG. 9, a catheter 40 With a
`cranked portion 41 at its end is used to place a guide Wire 42
`extending into the renal artery 36.
`
`[0082] An arrangement, as shoWn in FIGS. 4 to 7, can be
`used to insert a branch graft through the fenestration 31.
`
`[0083] One embodiment of the branch graft is shoWn in
`FIG. 10A and the installation of the branch graft is shoWn
`in FIG. 10B. The graft has a pair of ?anges 50 and 51 at one
`end of an elongate body 52. A tube 53 is used for insertion
`of the settable or ?ller material.
`
`[0084] In use, the branched graft is positioned that When
`in?ated, the gap 54 betWeen the ?ange 50 and the ?ange 51
`?ts around the fenestration 31 in the Wall 55 of the graft 30.
`The end 56 of the branch graft can have sealing ridges (not
`shoWn) Which are used for sealing into the branch artery.
`
`[0085] FIG. 11 shoWs an alternative embodiment of a
`branch graft. Due to variations in vascular anatomy, it is
`sometimes impossible to have a ?ange on the outside of the
`main fenestrated graft. For example, if the primary graft is
`in contact With the main artery Wall, there can be no room
`to expand a ?ange on the outside of the graft. In such
`circumstances, a single ?ange graft as shoWn in FIG. 11 can
`be used Where the ?ange 57 resides inside the primary graft
`tube and the body 58 is passed through the fenestration 51
`before being in?ated. Once again, the terminal end 59 can
`have one or more sealing ?anges or ridges.
`
`[0086] In some situations, an aortic aneurysm occurs in
`the region of the aorta betWeen the renal arteries and the iliac
`bifurcation Where the aorta divides into tWo ?oW paths. Such
`an aneurysm can be so close to the bifurcation, that it is
`impossible to place a tubular graft successfully in such
`situations. To treat this type of aneurysm, it is best to use an
`endoluminal graft that is similar in shape to the anatomy of
`this region of the aorta, thus the graft has a bifurcation in it.
`
`Edwards Lifesciences Corporation, et al. Exhibit 1149, Page 18 of 20
`
`

`

`US 2003/0093145 A1
`
`May 15,2003
`
`[0087] FIGS. 12a and b show an example of a bifurcated
`graft of the present invention. The bifurcated graft comes in
`tWo parts. A primary section 60 has a larger upper body
`portion 61 With sealing ?anges or ridges 62 and a tapered
`loWer portion 63 With sealing ?anges or ridges 64 adapted in
`use to seal into one of the iliac arteries. A short leg 65
`terminating in an aperture 66 is provided betWeen the ends
`of the graft. Into this short leg 65 can be inserted an
`extension leg graft 67 Which is shoWn in cross section in
`FIG. 12B. Once the main graft 60 has been placed, in?ated
`and set, then the extension graft 67 is inserted With its upper
`end 68 Within the short leg 65 and sealing ?anges or ridges
`69 engaging into the other iliac artery to provide a good seal.
`
`[0088] Depending upon the topography of the aorta in the
`region of the aneurysm the extension into the contralateral
`iliac artery can be by an arrangement of an extension leg of
`the type discussed above for a renal artery.
`
`[0089] FIGS. 13 to 16 shoW an alternative embodiment of
`a deployment device and a method of deploying the graft of
`the present invention. For ease of vieWing, the aorta is not
`shoWn in this embodiment.
`
`[0090] In this embodiment the deployment device com
`prises a catheter 70 Which terminates in a tapered front
`portion 71 and Which can be slid over a guide Wire 72 and
`a sheath 74 covers the catheter 70 up as far as the tapered
`portion 71.
`[0091] Near the tapered portion 71 of the catheter 70 is an
`annular region into Which is mounted as is shoWn in the
`cutaWay section of the sheath, a graft of the present inven
`tion 75 mounted on a balloon.
`
`[0092] As shoWn in FIG. 14, the sheath 74 has been
`WithdraWn so that the balloon and graft is noW exposed and
`the balloon 76 has been in?ated Whilst the graft 75 carried
`on the balloon 76 remains unin?ated With the settable and/or
`?ller material. In this embodiment there are tWo tubes 77 and
`78 leading from the catheter to the in?atable graft.
`
`[0093] As shoWn in FIG. 15, settable and/or ?ller material
`has been forced into the graft 75 through the in?oW tube 77
`so that it has expanded While being supported on the balloon
`76 and the out?oW tube 78 alloWs for return of excess
`settable and/or ?ller material so that it can be ascertained
`that the graft 75 has been completely in?ated With the
`settable and/or ?ller material. As discussed earlier, the
`pressure of settable and/or ?ller material is higher than the
`pressure applied to the balloon.
`
`[0094] The settable or ?ller material is then irradiated or
`by other means set so that it forms a substantially rigid graft
`and then, as shoWn in FIG. 16, the in?oW and out?oW tubes
`77 and 78 are disconnected by means not shoWn and the
`balloon 76 Within the graft 75 is de?ated. The sleeve 74 can
`then be slid forWard again so that it covers the balloon and
`reaches the tapered portion 71 at Which stage the entire
`deployment assembly can be WithdraWn leaving the graft in
`place.
`[0095] The alternative embodiment shoWn in FIGS. 17 to
`22 shoWs the use of the present invention With the deploy
`ment device in the form of a balloon catheter.
`
`[0096] In FIG. 17 it Will be seen that the balloon catheter
`arrangement includes a catheter 80 With a sleeve 81 over it.
`At the distal end 82 of the catheter 80 is a connection point
`
`83 for a syringe and at the proximal end 84 is a balloon and
`graft encased by the sheath 81. A tube 85 extends from a
`?uid supply port 86 to the graft as Will be discussed later.
`
`[009