Ulllted States Patent [19]
`Lazarus
`
`[54] INTRALUMINAL VASCULAR GRAFT AND
`METHOD
`
`[76] Inventor: Harrison M. Lazarus, 853 Thirteenth
`Ave" Salt Lake Clty’ Utah 84103
`
`-
`
`USOO5871536A
`[11] Patent Number:
`[45] Date of Patent:
`
`5,871,536
`*Feb. 16, 1999
`
`3/1986 Kreamer .
`4,577,631
`4,617,932 10/1986 Kornberg .................................. .. 623/1
`5,104,399
`4/1992 Lazarus.
`623/1
`lice - G n
`3/1994 Inoue ........................................ .. 623/1
`
`Wan- e ................................ ..
`
`,
`
`,
`
`5,290,305
`
`[*1 Notice:
`
`This patent issued on a Continued pros_
`ecunon apph-CanOII ?led under 37 CFR
`1.53(d), and 1s subJect to the tWenty year
`-
`-
`patent term prov1s1ons of 35 U.S.C.
`154(a)(2)-
`
`5,330,500
`7/1994 Song ......................................... .. 623/1
`Primary Examiner—] )ebra S. Brittingham
`.
`.
`Attorney, Agent, or Ftrm—Trask, Britt & Rossa
`[57]
`ABSTRACT
`
`[21] APPL No, 568,559
`
`[22] Filed:
`
`Dec. 7, 1995
`
`Related US. Application Data
`
`[63] Continuation of Sen NO- 1491040: N°V~ 8: 1993: abandoned
`[51]
`Int. Cl? ...................................................... .. A61F 2/06
`[52] US. Cl. ................................................. .. 623/1' 623/ 12
`[58] Field of Search
`600/36 606/157
`6064 195 ’623 /1 11’
`’
`’
`’
`’
`’
`’ 12’
`
`[56]
`
`References Cited
`
`US. PATENT DOCUMENTS
`604/175
`2/1979 Choudhury
`4 140 126
`4,355,426 10/1982 MacGregor ............................... .. 623/1
`4,562,596
`1/1986 Kornberg .
`
`An intraluminal vascular graft structure is disclosed Which is
`structured to be deployable Within a vessel Without use of
`hooks or barbs. The intraluminal vascular graft structure
`comprises a tubular body formed of a biocompatible mate
`rial and a frame structure, having both circumferential
`support and longitudinal support structures, Which support
`the graft at a distal end thereof and upWardly from the distal
`@1191- The vascular graft may also include attachment means
`which initiate an in?ammatory response With the inner Wall
`of the vessel to promote attachment of the device to the
`vessel Wall. The intraluminal vascular graft may include one
`or more leg portions suitable for repairing bifurcated vessels
`Which, in conjunction With the circumferential and longitu
`dinal support structures, assure positioning and support of
`the vascular graft Within the vessel and against the crotch of
`the bifurcation. Also disclosed is a method of deployment of
`the vascular graft Within the vessel.
`
`33 Claims, 5 Drawing Sheets
`
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`W.L. Gore & Associates, Inc.
`Exhibit 1004-1
`
`

`

`U.S. Patent
`
`Feb. 16,1999
`
`Sheet 1 0f 5
`
`5,871,536
`
`W.L. Gore & Associates, Inc.
`Exhibit 1004-2
`
`

`

`U.S. Patent
`
`Feb. 16, 1999
`
`Sheet 2 0f 5
`
`5,871,536
`
`26
`
`100
`
`102
`
`Fig. 10
`
`o 2
`
`a m
`
`ig. 11
`
`W.L. Gore & Associates, Inc.
`Exhibit 1004-3
`
`

`

`U.S. Patent
`
`Feb. 16, 1999
`
`Sheet 3 0f 5
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`5,871,536
`
`w
`
`20
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`110
`
`120 -/
`‘Wu * A
`
`8 1 1
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`116
`
`f 122
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`Fig.- 12
`
`W.L. Gore & Associates, Inc.
`Exhibit 1004-4
`
`

`

`U.S. Patent
`
`Feb. 16, 1999
`
`Sheet 4 0f 5
`
`5,871,536
`
`W.L. Gore & Associates, Inc.
`Exhibit 1004-5
`
`

`

`U.S. Patent
`
`Feb. 16, 1999
`
`Sheet 5 0f 5
`
`5,871,536
`
`104
`
`106
`37
`
`112
`
`/
`
`Fig. 14
`
`W.L. Gore & Associates, Inc.
`Exhibit 1004-6
`
`

`

`1
`INTRALUMINAL VASCULAR GRAFT AND
`METHOD
`
`This application is a continuation of application Ser. No.
`08/149,040, ?led Nov. 8, 1993, noW abandoned.
`BACKGROUND OF THE INVENTION
`1. Technical Field
`This invention relates to medical devices in general, and
`speci?cally to grafts positionable intraluminally for repair
`ing aneurysms or other vascular defects in humans and
`animals.
`2. Background
`Aneurysms are caused by Weakening of a vessel Wall
`Which results in the outWard ballooning of the Wall under the
`pressure of ?oWing blood. Aneurysms are more prevalent in
`men than in Women, and are more common With advancing
`age. Prior to the development of technology to repair the
`bulging blood vessel, aneurysms posed a fatal threat to those
`Who developed them. Even With the early development of
`repair procedures, signi?cantly invasive surgery Was
`required to access the aneurysm. Today, graft structures have
`been developed Which alloW insertion and delivery of the
`graft to the point of the aneurysm using less invasive
`procedures.
`KnoWn intraluminal graft structures generally comprise a
`tubular graft, expansion means for deploying and position
`ing the graft in the vessel and anchoring or attachment
`means for keeping the graft in place Within the vessel. Many
`varying types of expansion means have been disclosed,
`including those described in US. Pat. No. 4,140,126 to
`Choudhury (expandable ring positioned at open end of
`graft); US. Pat. No. 4,776,337 to PalmaZ (a mesh-like tube);
`US. Pat. No. 5,123,917 to Lee (Zig-Zagged expandable
`ring); and US. Pat. No. 5,151,105 to KWan-Gett (helically
`coiled spring). Means have also been described for provid
`ing longitudinal support to the graft, including those means
`described in US. Pat. No. 4,562,596 to Kornberg (a plurality
`of steel struts) and US. Pat. No. 5,151,105 to KWan-Gett
`(diametrically spaced adjustable ribs).
`Additionally, various means for attaching the graft to the
`vessel have been disclosed. Most frequently, hook, barb or
`pin means are described and used, including the means
`described in US. Pat. No. 4,140,126 to Choudhury (a
`plurality of pins); US. Pat. No. 4,562,596 to Kornberg (a
`plurality of barbs; and US. Pat. No. 5,151,105 to KWan-Gett
`(staples). In some instances, the hook or barb means are
`attached to the expandable means as described in US. Pat.
`No. 4,140,126 to Choudhury and US. Pat. No. 5,104,399 to
`LaZarus. US. Pat. No. 4,577,631 to Kreamer discloses use
`of an adhesive covering the entire outside of the graft to
`provide adherence of the luminal intima to the graft.
`The most commonly used intraluminal graft structures
`have hooks or barbs Which pierce into or through the Wall of
`the vessel to anchor the graft to the vessel above the
`aneurysm. That is, most, if not all, currently used intralu
`minal grafts are supported in the vessel upstream from or
`above the disease condition. HoWever, hooks or barbs may
`damage the vessel, particularly Where the vessel is Weakened
`already by an aneurysm or other disease condition.
`Additionally, there are instances When the condition of the
`vessel may make it impossible or imprudent to use a graft
`device having hooks or pins, such as the existence of
`calcium deposits. Such conditions may also limit the use
`fulness of adhesives.
`Thus, it Would be advantageous to provide an intraluminal
`graft Which is adapted for use in vascular repair under any
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`2
`conditions, but particularly under conditions Which limit or
`prevent the use of intraluminal grafts having hook, pin, barb
`or staple attachment means. That is, it Would be advanta
`geous to provide an intraluminal graft Which is structured to
`be supportable from a position doWnstream or beloW the
`disease condition to thereby eliminate the need for hook,
`pin, barb or staple anchoring means. Such structure Would
`alloW the placement and positioning of a graft Within a
`diseased vessel When the condition or morphology of the
`vessel prevents use of barbtype attachment means. It Would
`also be advantageous to provide an intraluminal graft struc
`tured to be ?exible and adjustable to thereby facilitate
`insertion and placement of the graft Within a vessel Which
`displays abnormal morphology.
`DISCLOSURE OF THE INVENTION
`In accordance With the present invention, an intraluminal
`vascular graft is structured to be supported Within a vessel
`from a position doWnstream from, or beloW, a disease
`condition existing in the vessel and includes a biocompatible
`tube supportable Within a vessel by adjustable circumferen
`tial and longitudinal support structures. The circumferential
`and longitudinal support structures provide means for sup
`porting the biocompatible tube Within the vessel, and further
`provide means for limiting movement of the intraluminal
`graft Within the vessel. Movement inhibitor structures may
`further be associated With the longitudinal and/or circum
`ferential support structures to limit movement of the graft
`tube Within the vessel and to enhance attachment of the graft
`to the vessel. The intraluminal vascular graft may be struc
`tured With one or more caudal leg portions positionable
`Within one or tWo bifurcations extending from the vessel in
`Which the graft is placed. Alternatively, the intraluminal
`graft may be a single tube having no extending leg portions.
`The intraluminal vascular graft may be secured to the intima
`of the vessel by attachment means induced by an in?am
`matory response betWeen the graft and the inner Wall of the
`vessel. While the intraluminal vascular graft of the invention
`may be used in any number of various vascular repairs, it is
`particularly suitable in the repair of aneurysms of the
`abdominal aorta, Which is one of the most common types of
`aneurysm.
`The intraluminal vascular graft includes a tube of bio
`compatible material, such as Dacron® or
`polytetra?uoroethylene, Which is capable of being com
`pressed to provide a graft having a reduced circumferential
`dimension to permit insertion of the graft into a vessel (e.g.,
`femoral artery) for transportation to the disease site. The
`tube is thereafter capable of expanding radially outWardly
`from a central longitudinal axis to provide a close ?t
`betWeen the tube structure and the inner vessel Wall. The
`tube has at least tWo open ends- one Which may be termed
`a proximal end, and one Which may be termed a distal end.
`As used herein, “proximal” refers to the end of the graft
`Which is positioned upstream or Which is oriented toWard the
`cranium of the patient. As used herein, “distal” refers to the
`end of the graft Which is positioned doWnstream or Which is
`oriented toWard the caudal end of the patient.
`When used in vessels Which bifurcate, such as the
`abdominal aorta, the tube may include leg portions Which
`extend into one or more branching vessels resulting from the
`bifurcation. The tube may have a single leg portion extend
`able into a single branching vessel. More suitably, hoWever,
`the tube has tWo leg portions extendable into both branching
`vessels. The relative lengths of the tWo leg portions may be
`equal, or one may be longer than the other as dictated by the
`particular condition of the vessel. The leg portions facilitate
`
`W.L. Gore & Associates, Inc.
`Exhibit 1004-7
`
`

`

`3
`positioning and support of the device in bifurcated vessels
`by providing a crotch area betWeen the tWo leg portions
`Which straddle the crotch betWeen the vessels of the bifur
`cation.
`In an alternative embodiment, the tube may have a single
`leg portion With a hole formed in the tube opposite the leg
`portion to alloW ?uid ?oW into the other branching vessel.
`In another alternative embodiment, the tube may have a
`single leg portion With no corresponding opening in oppos
`ing position, or the tube may have a ?rst leg portion and a
`second, the shorter leg portion having no opening therein to
`alloW blood ?oW therethrough. An intraluminal vascular
`graft of such construction Would be useful in repairing
`bifurcated vessels (such as an iliac artery) Where the surgeon
`speci?cally desires to restrict blood ?oW to a single branch
`ing vessel of the bifurcation.
`The tube of the intraluminal vascular graft may also
`comprise a single tube, having no extending leg portions,
`Which is suitable for repairing less complex vessel structures
`or disease conditions. In a single tube con?guration, the
`intraluminal vascular graft includes only a proximal opening
`and a distal opening to alloW movement of blood through the
`graft.
`The intraluminal vascular graft further includes expand
`able circumferential support structures secured at the proxi
`mal end of the tube and at the distal end of the tube. The
`expandable circumferential support structure positioned at
`the distal end of the graft tube, also referred to herein as the
`expandable caudal ring, provides a means for positioning the
`graft tube Within the vessel and for supporting the graft
`Within the vessel at a point distal to the disease condition. In
`bifurcated vessels, the expandable caudal ring is particularly
`structured to provide support and seating of the graft tube at
`the point Where the vessel bifurcates, or on What is otherWise
`termed the cusp of the bifurcation.
`The expandable circumferential support structures may be
`constructed of any material, or may take any form, Which
`provides the ability of reducing the circumferential dimen
`sion of the circumferential support structures prior to
`deployment of the intraluminal graft, and Which alloWs the
`structures to expand once the graft is deployed. The expand
`able circumferential support structures may be expandable
`by unrelated means, such as an angioplasty balloon intro
`duced folloWing insertion of the graft, or may be self
`expanding, such as a tensioned ring of ?exible material
`Which unWinds or decompresses upon release of a compres
`sion force.
`The intraluminal vascular graft also includes at least tWo
`adjustable longitudinal support structures oriented along the
`length of the biocompatible graft tube and positioned at
`about sixty to one hundred and tWenty degrees to the
`expandable circumferential support structures. The longitu
`dinal support structures maintain the tube in its full, prede
`termined length folloWing deployment Within the vessel. By
`“predetermined” is meant that the length of the longitudinal
`support structures and graft tube Which is required to repair
`the vessel is determined by knoWn x-ray or ?uoroscopic
`techniques, and prior to insertion, the surgeon may modify
`or adjust the longitudinal support structures and graft tube to
`?t the vessel. The longitudinal support structures support the
`graft longitudinally Within the vessel and act in tandem With
`the expandable caudal ring to support the graft in the vessel
`from the distal end of the graft upWard. The longitudinal
`support structures also maintain the graft in place and
`function to keep the graft from moving back and forth
`longitudinally Within the vessel.
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`The longitudinal support structures are most suitably
`?exible so that they may bend in a direction transverse the
`longitudinal axis of the graft tube, such as may be necessary
`When the graft is deployed in a vessel Which bends along its
`course. The longitudinal support structures, in an alternative
`embodiment, may be further adjustable after the graft is
`placed Within the vessel. Such adjustability may be
`provided, for example, by use of longitudinal support struc
`tures having telescoping members.
`The expandable circumferential support structures and the
`adjustable longitudinal structures generally comprise What
`may be called the frame of the graft structure. The frame is
`secured to the biocompatible graft tube by any suitable
`means, such as tacking, seWing or by Weaving the graft tube
`to the frame. The frame may be positioned Within the graft
`tube material so that the frame is exposed to ?uid moving
`through the graft tube. Alternatively, and more suitably, the
`frame is disposed on the outer surface of the graft tube
`material and is, therefore, positioned betWeen the inner
`vessel Wall and the outer surface of the graft tube.
`When the frame is disposed on the outside of the graft
`tube, movement inhibiting structures may be positioned
`along the longitudinal and circumferential support structures
`and oriented toWard the vessel Wall. The movement inhib
`iting structures may be in the form of scales or graspers
`oriented in either, but preferably both, directions (cranial or
`caudal) along the longitudinal axis of the vessel, Which
`impinge against the inner Wall of the vessel. The movement
`inhibiting structures limit longitudinal movement of the
`graft tube along the length of the vessel Which may be
`caused by eddy currents or other forces in a ?oWing stream.
`The movement inhibiting structures may be located at the
`distal end of the tube, at the proximal end of the tube, along
`the length of the tube, or any combination of locations. In
`addition, or alternatively, movement inhibiting structures
`may be associated With the biocompatible tube. The move
`ment inhibiting structures may penetrate into the media
`lining the vessel Wall (e.g., clotted matter), but do not
`penetrate through the adventitia.
`Fixed attachment of the graft tube to the interior Wall, or
`the intima, of the vessel is provided by inducement of an
`in?ammatory response betWeen the outer surface of the
`intraluminal vascular graft and the inner Wall of the vessel.
`Thus, the graft tube is caused to attach to the interior Wall of
`the vessel. The in?ammatory response is caused by placing
`along the frame and/or tube structure a material knoWn to
`cause an in?ammatory response in tissues. Such materials
`knoWn to cause an in?ammatory response may include those
`Which are retained permanently in place betWeen the vessel
`Wall and the graft, or those Which are absorbed by the body.
`Materials for inducing an in?ammatory response Which may
`be used in the invention include cat gut, nylon and cellulose.
`To further attach the intraluminal vascular graft to the
`vessel, the graft tube material (e.g., Dacron® or PTFE) may
`be coated or otherWise treated With a material or substance
`Which induces an in?ammatory response, such as polylactic
`acids, polyglycolic acids or polyamino acids. The graft tube
`may also be constructed or treated in a manner Which
`encourages ingroWth of tissue on to the graft tube to enhance
`or promote incorporation of the intraluminal graft structure
`into the surrounding vascular environment. Such treatment
`may include coating or infusing the graft tube material With
`collagen. Also, the longitudinal and/or circumferential sup
`port structures may be constructed of a material Which
`inherently causes an in?ammatory response and/or Which is
`constructed of a material Which promotes ingroWth of tissue
`into the support structure. The longitudinal and/or circum
`
`W.L. Gore & Associates, Inc.
`Exhibit 1004-8
`
`

`

`5
`ferential support structures may also be treated, such as by
`coating With collagen, polylactic acids, polyglycolic acids or
`polyamino acids to promote ingroWth of the device into the
`surrounding vascular tissue.
`Support of the intraluminal vascular graft Within the
`vessel is enhanced by providing leg portions extending from
`the distal or caudal end of the biocompatible graft tube. The
`graft tube may preferably include tWo leg portions position
`able Within each vessel branching from a main bifurcating
`vessel (e.g., the iliac arteries). Providing leg portions stabi
`liZes the graft Within the main vessel, provides support for
`the graft structure Within the vessel by positioning the crotch
`betWeen the tWo leg portions over the crotch spanning
`betWeen the tWo bifurcating vessels, and facilitates seating
`of the frame on the cusp of the bifurcation. The leg portions
`may also be necessary Where the disease (e.g., aneurysm)
`extends into or along one or both of the branching vessels of
`the bifurcation. The leg portions may be the same length or
`may vary in lengths comparatively.
`The leg portions of the graft may include longitudinal
`support structures along the length of the leg portion, and
`may include expandable ring structures. Further, movement
`inhibiting structures as described previously may be posi
`tioned along the longitudinal or circumferential support
`structures of the leg portions, or along the length of tubular
`material of the leg portions, to limit or prevent movement of
`the leg portions Within the branching vessels. Attachment
`means as previously described may also be associated With
`the outer surface of either or both leg portions.
`The intraluminal vascular graft is suitable for use in
`vascular repairs Where a very short, or no, length of unaf
`fected vessel exists betWeen the beginning point of disease
`in a vessel and the location of vessels branching from the
`affected vessel. For example, in a signi?cant number of
`patients, the abdominal aortic aneurysm occurs just beloW
`the renal arteries Which branch from the abdominal aorta,
`and as a result, very little unaffected aorta exists just beloW
`the renal arteries. That area of unaffected vessel just beloW
`the renal arteries may be termed, for the sake of this
`disclosure, the “neck” of the vessel.
`In such situations as just described, the limited existence
`of a neck of the vessel makes it impossible or unlikely to
`attach a vascular graft thereto by the conventional means of
`hooks or barbs. Therefore, the present invention alloWs
`positioning of the intraluminal vascular graft Within the
`vessel and maintenance of the graft in place by virtue of the
`fact that it is supported at the distal end thereof and sup
`ported upWardly, eliminating the need for attachment by
`hooks or barbs. The present invention also alloWs deploy
`ment of the graft at the point of branching of any other
`vessels (e.g., renal arteries) Without occlusion of the branch
`ing vessels. In an embodiment suitable for the described
`condition, tWo or more of the longitudinal support structures
`may extend beyond the proximal end of the graft tube
`material and be positionable against the inner Wall of the
`vessel beyond the area of branching vessels (e.g., renal
`arteries) to facilitate positioning of the graft tube around the
`branching vessels; but neither the extending longitudinal
`support structures nor the tube occlude the branching ves
`sels. The extension of the frame alloWs the graft to be
`Well-centered in the vessel if a turn or kink exists in the
`vessel to be repaired.
`The intraluminal graft is delivered to the site of the
`diseased vessel by transport means Which are siZed and
`structured to contain the intraluminal graft therein or
`thereabout, and Which facilitate insertion of the device
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`through the arterial system. A particularly suitable transport
`means comprises a capsule Within Which the intraluminal
`graft is retained in a collapsed condition, and deployment
`means for releasing the intraluminal graft from the capsule
`and positioning it Within the vessel.
`The capsule is structured to navigate smoothly through
`the tortuous pathWay that can often be encountered in the
`arterial tree. The capsule and associated deployment
`structures, described hereafter, are inserted into a small
`incision made in an artery or vein located remotely from the
`area of diseased vessel. With respect to aortic aneurysms, for
`example, the capsule is inserted into a femoral artery and
`passed upWardly to the abdominal aorta. A guide Wire may
`be used initially to determine proper placement. The capsule
`containing the graft may then be threaded about or over the
`guide Wire to the point of deployment.
`When the capsule has reached the disease site, a deploy
`ment structure deploys the device Within the vessel. Expan
`sion actuator means may be included, such as an angioplasty
`balloon, to facilitate expansion of the device. Alternatively,
`the deployment structure may be structured With expansion
`actuator means to both deploy and facilitate expansion of the
`graft. Exemplar deployment means include a hydraulic
`force.
`In a ?rst suitable implantation method, the capsule con
`taining the collapsed graft is inserted into the diseased
`vessel. Aguide Wire may be used to insert the capsule. Once
`positioned at the site of deployment, deployment means urge
`the intraluminal vascular graft from inside the capsule by,
`for example, pushing the graft out of a hole formed in the
`end of the capsule. The capsule is then retrieved from inside
`the body. Alternatively, the capsule may be removed from
`about the graft structure, such as When the capsule is in the
`form of a tear-aWay sheath. The graft may be assisted in
`deployment from the capsule by means of a stabiliZer rod
`Which is manipulable from outside the patient’s body.
`An angioplasty balloon may be used to assist in deploying
`and expanding the graft. Alternatively, the graft may be
`deployed from the capsule by application of a hydraulic
`force provided by infusion of saline solution. Once the graft
`is released from the capsule, the compressive forces Which
`kept the frame of the graft positioned Within the capsule are
`released and the graft expands outWardly from a central axis
`of the graft. The capsule and other deployment structures are
`retrieved from inside the vessel by WithdraWing those struc
`tures over the inserted guide Wire. Use of hydraulic means
`to deploy the graft reduces the amount of deployment
`structures required for deployment, and insertion is possible
`through a smaller incision.
`When deployed in a vessel, the expandable circumferen
`tial support structures may spring open to expand the graft
`tube Within the vessel. The expansion of the graft tube may
`be full or partial, depending upon the con?guration of the
`support structures and/or the material from Which they are
`constructed. Expansion may be assisted With additional
`expansion means, such as a balloon catheter or a hydraulic
`force applied to the inner area of the graft tube.
`The longitudinal support structures maintain the graft in
`an elongated expansion Within the vessel. The expandable
`caudal ring and the longitudinal structures maintain the graft
`in position Within the vessel at the distal or caudal end of the
`vessel. When deployed in a bifurcating vessel, like the
`abdominal aorta, the expandable caudal ring comes to rest
`upon the cusp of the bifurcation to support the graft. The
`longitudinal support structures are forced radially outWardly
`from a central axis of the graft by force of the expandable
`
`W.L. Gore & Associates, Inc.
`Exhibit 1004-9
`
`

`

`7
`caudal ring, and the longitudinal support structures aid in
`expansion of the graft.
`After the graft has been deployed and extended radially
`outWardly to ?t the vessel, attachment means Which may be
`associated With the device contact the inner Wall of the
`vessel and immediately an in?ammatory response is initi
`ated. Attachment of the graft to the vessel Wall may be
`completed Within a feW days to Weeks after insertion of the
`graft. While the in?ammatory response continues and the
`vascular graft becomes more attached to the vessel Wall, the
`frame structure of the graft keeps the graft in place and fully
`supported Within the vessel.
`When the graft tube is structured With leg portions, the leg
`portions are deployed in generally the same manner as
`described previously. If one leg portion is used, that leg
`portion is typically deployed Within the iliac artery through
`Which the deployment structures are passed. When tWo leg
`portions are used, the deployment of the second leg may be
`accomplished in different Ways. For example, the second leg
`portion, When structured Without longitudinal supports, may
`be folded up against the outer surface of the graft prior to
`deployment. With proper positioning of the graft, the second
`leg portion Will naturally extend into the appropriate vessel
`bifurcation.
`In alternative deployment means, a catheter or guide Wire
`may be inserted into the other femoral artery (Which Was not
`used for insertion of the vascular graft) prior to insertion of
`the device into the femoral artery. The guide Wire or catheter
`may be inserted until the distal end (the end inserted into the
`vessel) reaches the point of bifurcation. The distal end can
`then be passed across the bifurcation and doWn through the
`other artery (through Which deployment of the device Will
`take place) until the distal end of the guide Wire or catheter
`can be retrieved from the other artery to outside the patient’s
`body. The distal end of the guide Wire or catheter may then
`be sutured to the leg portion of the device Which Will
`ultimately be positioned in the other iliac artery. The entire
`intraluminal vascular graft is then inserted into the femoral
`artery and through the iliac artery until positioned Within the
`aorta. FolloWing deployment of the entire graft tube Within
`the aorta, the guide Wire, catheter or suture attached to the
`second leg portion is retrieved from the other femoral artery.
`As a result, the second leg is brought over to the other iliac
`artery and into position. The guide Wire, catheter or suture
`is then removed from the other artery.
`In an alternative procedure, the guide Wire or catheter
`passed through the other femoral artery may be passed
`across the bifurcation and manipulated until the distal end of
`the guide Wire or catheter encounters the second leg portion
`of the graft tube. The distal end of the guide Wire or catheter
`may be con?gured With a hook or other similar device for
`attaching the second leg portion thereto. Once the second leg
`portion is engaged by the distal tip, the guide Wire or catheter
`may be retrieved from the vessel thereby causing the second
`leg portion to be brought over to the other branching vessel.
`The guide Wire or catheter may then be removed from the
`artery.
`BRIEF DESCRIPTION OF THE DRAWINGS
`In the draWings, Which illustrate What is currently con
`sidered to be the best mode for carrying out the invention,
`FIG. 1 is a vieW in elevation of a ?rst embodiment of the
`intraluminal vascular graft;
`FIG. 2 is a vieW in elevation of an exemplar circumfer
`ential support structure in a compressed state;
`FIG. 3 is a vieW in elevation of the circumferential
`support structure shoWn in FIG. 2 in an uncompressed state;
`
`10
`
`15
`
`25
`
`35
`
`45
`
`55
`
`65
`
`5,871,536
`
`8
`FIG. 4 is a vieW in elevation of an alternative embodiment
`of the circumferential support structure in a compressed
`state;
`FIG. 5 is a vieW in elevation of the circumferential
`support structure shoWn in FIG. 4 in an expanded state;
`FIG. 6 is a vieW in elevation of another alternative
`embodiment of the circumferential support structure;
`FIG. 7 is a vieW in elevation of an alternative embodiment
`of the vascular graft illustrating an alternative embodiment
`of the longitudinal support structures;
`FIG. 8 is a vieW in elevation of another alternative
`embodiment of the vascular graft illustrating extended lon
`gitudinal support structures;
`FIG. 9 is an enlarged perspective vieW of a longitudinal
`support structure illustrating positioning of attachment
`means and grasping means thereto;
`FIG. 10 is a vieW in elevation of another alternative
`embodiment of the vascular graft illustrating the inclusion of
`a single leg portion;
`FIG. 11 is a vieW in elevation of another alternative
`embodiment of the vascular graft, having tWo leg portions,
`positioned Within an abdominal aorta and bifurcating iliac
`arteries;
`FIG. 12 is a vieW in cross section of a transporting and
`deployment structure for positioning the vascular graft into
`a vessel;
`FIG. 13a—f illustrates deployment of a vascular graft
`Within a diseased vessel; and
`FIG. 14 illustrates an alternative implantation procedure
`for a vascular graft embodied With tWo leg portions.
`
`DETAILED DESCRIPTION OF THE DRAWINGS
`FIG. 1 illustrates a simpli?ed version of the intraluminal
`vascular graft 20 Which generally comprises a tubular body
`22 and a frame 24. Attachment means 26 are also illustrated.
`The tubular body 22 is made from a biocompatible material
`Which has the ability to be manipulated into a tube of smaller
`circumferential dimension relative to a longitudinal axis 28
`formed through the tubular body 22. The ability to be
`manipulated to a circumferentially smaller dimension alloWs
`the tubular body 22 to be positioned Within a transportation
`means siZed to ?t Within a vessel lumen. The tubular body
`22 is open at either end, providing a passageWay 30 for ?uid
`therethrough. One end of the tubular body 22 may be
`denoted as the proximal or cranial end 32, and the opposite
`