United States Patent [19]
`Thornton et al.
`
`US006015431A
`[11] Patent Number:
`[45] Date of Patent:
`
`6,015,431
`Jan. 18, 2000
`
`[54] ENDOLUMENAL STENT-GRAFT WITH
`LEAK-RESISTANT SEAL
`
`[75] Inventors: Troy Thornton, San Francisco; Lilip
`Lau, Sunnyvale, both of Calif.
`
`[73] Assignee: Prograft Medical, Inc., Palo Alto,
`Calif.
`
`[21] Appl. No.: 08/773,479
`[22]
`Filed:
`Dec. 23, 1996
`
`[51] Int. Cl.7 ...................................................... .. A61F 2/06
`[52] US. Cl. ................ ..
`. 623/1; 623/12; 606/194
`[58] Field of Search ........................ .. 623/1, 12; 606/108,
`606/192, 194, 195
`
`[56]
`
`References Cited
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`KatZen, B. et al.; “Initial Experience Performing Combined
`Surgical/Interventional Procedures in the Interventional
`Suite”; Journal Of Endovascular Surgery—The Official
`Journal Of The International Society For Endovascular
`Surgery; 1996; p. 467.
`
`Chuter et al.; “Bifurcated stent—grafts for AAA: 3 year
`folloW—up”; Abstracts from the Seventh International
`Course on Peripheral Vascular Intervention; J. Endovas.
`Surg. (1996) p. 458.
`Dereume, JP et al.; “Endoluminal Treatment Of Abdominal
`Aortic Aneurysm With the Corvita Endovascular Graft,
`Results of a Single—Center, Prospective Feasibility Study of
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`Surgery; 1996; pp. 460—461.
`Blum, U. et al.; “Dacron Endografts for Infrarenal Abdomi
`nal Aortic Aneurysms: 2 Year FolloW—Up”; Springer, vol.
`20, No. 1; Jan/Feb. 1997.
`(List continued on neXt page.)
`Primary Examiner—Bruce E. SnoW
`Attorney, Agent, or Firm—Morgan & Finnegan LLP
`[57]
`ABSTRACT
`
`An implantable medical device has a tubular member and a
`sealing member secured to an outer surface of the tubular
`member. The tubular member is expandable to engage an
`endolumenal Wall and has a lumen for providing an arti?cial
`conduit for How through an endolumenal space de?ned by
`that Wall. The seal member occludes ?oW around the tubular
`member betWeen the outer surface and the endolumenal
`Wall. One suitable tubular member for use in the present
`invention is a stent-graft Which may be bifurcated for use in
`protecting vascular Wall malformations adjacent to vascular
`bifurcations against endolumenal pressure and 110W. The seal
`member may be a ?ange that is oriented on the outer surface
`at one end of the tubular member as a one-Way valve against
`?oW. Multiple seal members may be used, either on opposite
`ends of the tubular member or in series at one end thereof.
`Where anchors are used to secure the tubular member to the
`endolumenal Wall, the seal member is positioned to protect
`against ?oW through leakage paths formed at localized areas
`of deformation in the tubular Wall adjacent to the anchors.
`One or more seal members may also be used With tWo or
`more tubular members to prevent ?oW through endolumenal
`spaces that remain open to How due to gaps betWeen the
`multiple, parallel tubular members.
`
`23 Claims, 29 Drawing Sheets
`
`956
`
`716
`
`952
`
`Edwards Lifesciences Corporation, et al. Exhibit 1119, Page 1 of 48
`
`

`

`6,015,431
`Page 2
`
`9/1997 Igarashi .
`5,669,930
`5,693,088 12/1997 Lazarus ..................................... .. 623/1
`5,769,882
`6/1998 Fogarty et al. ........................... .. 623/1
`
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`
`,
`
`,
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`3/1988 Hughes et al. .......................... .. 623/12
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`7/1990 Okada et al. .
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`3/1992 Sinofsky et a1~ -
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`3/1993 Jessen-
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`573427387
`8/1994 summers _
`5,348,537
`9/1994 Wiesner et a1- -
`5,360,443 11/1994 Bafone et a1~ -
`5,370,691 12/1994 Samson '
`5,425,739
`6/1995 Jessen ................................... .. 606/151
`5,489,295
`2/1996 Piplani et al. .
`575077769
`4/1996 Marin et aL _
`575227880
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`5,522,961
`6/1996 Leonhardt.
`5,554,182
`9/1996 Dinh et a1- -
`5’562’724 10/1996 Vorwerk ct a1~~
`5’562’727 10/1996 Tllrk et a1‘ '
`5,571,166 11/1996 Dmh et al. .
`575757815 11/1996 slepian et a1_ _
`576287784
`5/1997 Smoker _
`5,653,748
`8/1997 strecker _
`5,667,523
`9/1997 Bynon et al. ......................... .. 606/198
`
`.
`
`.
`
`.
`
`.
`
`KatZen et al., “Endovascular therapy of thoracic and
`abdominal aortic aneurysms” Abstracts from the Seventh
`International Course on Peripheral Vascular Intervention J.
`Endovasc. Surg. (1996) 3:467—468.
`White et al., “Endoleak following endoluminal repair of
`AAA: Diagnosis, signi?cance, and management Abstracts
`from the Seventh International Course on Peripheral Vas
`cular Intervention J. Endovasc. Surg. (1996) 3:339—340.
`Parodi et al., “Long—term folloW—up of AAA endoluminal
`repair” Abstracts from the Seventh International Course on
`Peripheral Vascular Intervention J. Endovasc. Surg. (1996)
`3335'
`
`,,
`
`“
`.
`.
`Moore et al., Transfemoral endovascular repair of abdomi
`nal aortic aneurysm: Result of the North American EVT
`phase 1 trial” J. Vasc. Surg. (1996) 23:543—552.
`Chuter et al., “Bifurcated stent—grafts for AAA: 3 year
`folloW—up” Fifth International and Interdisciplinary Sym
`posium on Endoluminal Stents and Grafts (Oct. 10—13,
`1996) Washinton, DC, 2 pages total.
`.
`.
`.
`World Medical News, World Medical Manufacturing C'or
`porat1on, 13794 NW 4th Street, Bldgs. 210 & 211, Sunrise,
`Florida, 33325, USA, vol. 5, Issue 3, (Jul. 1996) 3 pages
`total.
`
`Edwards Lifesciences Corporation, et al. Exhibit 1119, Page 2 of 48
`
`

`

`U.S. Patent
`
`Jan. 18,2000
`
`Sheet 1 0f 29
`
`6,015,431
`
`56
`
`Edwards Lifesciences Corporation, et al. Exhibit 1119, Page 3 of 48
`
`

`

`U.S. Patent
`
`Jan. 18,2000
`
`Sheet 2 0f 29
`
`6,015,431
`
`Edwards Lifesciences Corporation, et al. Exhibit 1119, Page 4 of 48
`
`

`

`U.S. Patent
`
`Jan. 18,2000
`
`Sheet 3 0f 29
`
`6,015,431
`
`Edwards Lifesciences Corporation, et al. Exhibit 1119, Page 5 of 48
`
`

`

`U.S. Patent
`
`Jan. 18,2000
`
`Sheet 4 0f 29
`
`6,015,431
`
`0
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`
`FIG.7B
`
`Edwards Lifesciences Corporation, et al. Exhibit 1119, Page 6 of 48
`
`

`

`U.S. Patent
`
`Jan. 18,2000
`
`Sheet 5 0f 29
`
`6,015,431
`
`126 340
`
`126
`
`348
`
`342
`
`344-
`
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`
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`
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`
`Edwards Lifesciences Corporation, et al. Exhibit 1119, Page 7 of 48
`
`

`

`U.S. Patent
`
`Jan. 18,2000
`
`Sheet 6 0f 29
`
`6,015,431
`
`Edwards Lifesciences Corporation, et al. Exhibit 1119, Page 8 of 48
`
`

`

`U.S. Patent
`
`Jan. 18,2000
`
`Sheet 7 0f 29
`
`6,015,431
`
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`
`Edwards Lifesciences Corporation, et al. Exhibit 1119, Page 9 of 48
`
`

`

`US. Patent
`
`Jan. 18,2000
`
`Sheet 8 0f 29
`
`6,015,431
`
`102
`
`502
`
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`
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`
`504
`
`Edwards Lifesciences Corporation, et 31. Exhibit 1119, Page 10 of 48
`
`Edwards Lifesciences Corporation, et al. Exhibit 1119, Page 10 of 48
`
`

`

`U.S. Patent
`
`Jan. 18, 2000
`
`Sheet 9 0f 29
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`6,015,431
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`Edwards Lifesciences Corporation, et al. Exhibit 1119, Page 11 of 48
`
`

`

`U.S. Patent
`
`Jan. 18,2000
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`Edwards Lifesciences Corporation, et al. Exhibit 1119, Page 12 of 48
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`

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`Jan. 18, 2000
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`Edwards Lifesciences Corporation, et 31. Exhibit 1119, Page 13 of 48
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`Edwards Lifesciences Corporation, et al. Exhibit 1119, Page 13 of 48
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`

`

`US. Patent
`
`Jan. 18, 2000
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`Edwards Lifesciences Corporation, et al. Exhibit 1119, Page 14 of 48
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`

`

`US. Patent
`
`Jan. 18,2000
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`Edwards Lifesciences Corporation, et 31. Exhibit 1119, Page 15 of 48
`
`Edwards Lifesciences Corporation, et al. Exhibit 1119, Page 15 of 48
`
`

`

`U.S. Patent
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`Edwards Lifesciences Corporation, et al. Exhibit 1119, Page 16 of 48
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`

`U.S. Patent
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`Jan. 18,2000
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`Sheet 15 0f 29
`
`6,015,431
`
`Edwards Lifesciences Corporation, et al. Exhibit 1119, Page 17 of 48
`
`

`

`U.S. Patent
`
`Jan. 18,2000
`
`Sheet 16 0f 29
`
`6,015,431
`
`Edwards Lifesciences Corporation, et al. Exhibit 1119, Page 18 of 48
`
`

`

`U.S. Patent
`
`Jan. 18,2000
`
`Sheet 17 0f 29
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`6,015,431
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`Edwards Lifesciences Corporation, et al. Exhibit 1119, Page 19 of 48
`
`

`

`US. Patent
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`Jan. 18, 2000
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`Edwards Lifesciences Corporation, et al. Exhibit 1119, Page 20 of 48
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`Edwards Lifesciences Corporation, et 31. Exhibit 1119, Page 21 of 48
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`Edwards Lifesciences Corporation, et al. Exhibit 1119, Page 21 of 48
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`Jan. 18, 2000
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`Edwards Lifesciences Corporation, et 31. Exhibit 1119, Page 22 of 48
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`Edwards Lifesciences Corporation, et al. Exhibit 1119, Page 22 of 48
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`Jan. 18,2000
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`Edwards Lifesciences Corporation, et 31. Exhibit 1119, Page 23 of 48
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`Edwards Lifesciences Corporation, et al. Exhibit 1119, Page 23 of 48
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`

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`US. Patent
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`Jan. 18,2000
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`Edwards Lifesciences Corporation, et 31. Exhibit 1119, Page 24 of 48
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`Edwards Lifesciences Corporation, et al. Exhibit 1119, Page 24 of 48
`
`

`

`US. Patent
`
`Jan. 18,2000
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`Edwards Lifesciences Corporation, et 31. Exhibit 1119, Page 25 of 48
`
`Edwards Lifesciences Corporation, et al. Exhibit 1119, Page 25 of 48
`
`

`

`US. Patent
`
`Jan. 18, 2000
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`Edwards Lifesciences Corporation, et 31. Exhibit 1119, Page 26 of 48
`
`Edwards Lifesciences Corporation, et al. Exhibit 1119, Page 26 of 48
`
`

`

`US. Patent
`
`Jan. 18,2000
`
`Sheet 25 0f 29
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`6,015,431
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`Edwards Lifesciences Corporation, et 31. Exhibit 1119, Page 27 of 48
`
`Edwards Lifesciences Corporation, et al. Exhibit 1119, Page 27 of 48
`
`

`

`US. Patent
`
`Jan. 18,2000
`
`Sheet 26 0f 29
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`Edwards Lifesciences Corporation, et 31. Exhibit 1119, Page 28 of 48
`
`Edwards Lifesciences Corporation, et al. Exhibit 1119, Page 28 of 48
`
`

`

`US. Patent
`
`Jan. 18, 2000
`
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`Edwards Lifesciences Corporation, et al. Exhibit 1119, Page 29 of 48
`
`

`

`US. Patent
`
`Jan. 18,2000
`
`Sheet 28 0f 29
`
`6,015,431
`
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`
`Edwards Lifesciences Corporation, et 31. Exhibit 1119, Page 30 of 48
`
`Edwards Lifesciences Corporation, et al. Exhibit 1119, Page 30 of 48
`
`

`

`US. Patent
`
`Jan. 18, 2000
`
`Sheet 29 0f 29
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`Edwards Lifesciences Corporation, et al. Exhibit 1119, Page 31 of 48
`
`

`

`6,015,431
`
`1
`ENDOLUMENAL STENT—GRAFT WITH
`LEAK-RESISTANT SEAL
`
`TECHNICAL FIELD
`
`This invention is a surgical device assembly. More
`specifically, it is an implantable medical device for provid-
`ing an artificial conduit for physiological flow through an
`endolumenal body space that is defined by an endolumenal
`wall, and also for substantially isolating that flow from the
`endolumenal wall.
`
`BACKGROUND ART
`
`Treatment or isolation of vascular aneurysms or of vessel
`walls which have been thickened by disease has traditionally
`been performed via surgical bypassing with vascular grafts.
`Shortcomings of this invasive procedure include the mor-
`bidity and mortality associated with major surgery,
`long
`patient recovery times, and the high incidence of repeat
`intervention needed due to limitations of the graft or of the
`procedure.
`Minimally invasive alternatives involving stents or stent-
`grafts are generally known and widely used in certain types
`of treatments. Intralumenal stents, for example, are particu-
`larly useful for treatment of vascular or arterial occlusion or
`stenosis typically associated with vessels thickened by dis-
`ease.
`Intralumenal stents function to mechanically hold
`these vessels open. In some instances, stents may be used
`subsequent to or as an adjunct to a balloon angioplasty
`procedure.
`Stent-grafts, which include a graft layer either inside or
`outside of a stent structure, are particularly useful for the
`treatment of aneurysms. An aneurysm may be characterized
`as a sac formed by the dilatation of the wall of an artery,
`vein, or vessel. Typically the aneurysm is filled with fluid or
`clotted blood. The stent-graft provides a graft
`layer to
`reestablish a flow lumen through the aneurysm as well as a
`stent structure to support the graft and to resist occlusion or
`restenosis.
`Treatment of a bifurcation site afflicted with such defects
`
`as an occlusion, stenosis, or aneurysm is a particularly
`demanding application for either stents or stent-grafts. A
`bifurcation site is generally where a single lumen or artery
`(often called the trunk) splits into two lumen or arteries
`(often called branches), such as in a “Y” configuration. For
`example, one such bifurcation site is found within the human
`body at
`the location where the abdominal aortic artery
`branches into the left and right
`(or
`ipsalateral and
`contralateral) iliac arteries.
`When a defect, such as an aneurysm, is located very close
`to the bifurcation of a trunk lumen into two branch lumens,
`treatment becomes especially difficult. One reason for this
`difficulty is because neither the trunk lumen nor either of the
`branch lumens provides a sufficient portion of healthy,
`lumen wall on both sides of the defect to which a straight
`section of single lumen stent or stent-graft can be secured.
`The stent or stent-graft must span the bifurcation site and yet
`allow undisturbed flow through each of the branch and trunk
`lumens.
`
`What is required then is a stent or stent-graft which may
`be secured to each of the lumen wall a sufficient distance
`
`away from the defect and yet is capable of allowing undis-
`turbed flow into each of the branch and trunk lumen. Such
`
`a configuration, at least after implantation, generally must
`have the same Y—shape as described for the bifurcation site.
`Prior to implantation, the stent or stent-graft may have a
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`Y—shape or may have a modular construction which is
`assembled into the desired shape as it is implanted.
`As we shall see, deployment of implants adapted to meet
`these needs is also problematic in that they must be deployed
`and secured in three different lumen which are impossible to
`access from a single direction. Further, to facilitate intralu-
`menal delivery through a body’s tortuous vasculature, the
`implant must be capable of being compressed into a very
`small diameter or profile and then expand to a predetermined
`geometry adapted to engage the vessel wall. However,
`sometimes this expanded condition is insufficient to com-
`pletely occlude flow over the device and into the endolu-
`menal defect.
`Prior devices that deal with treatment at a bifurcation site
`
`within the body generally include grafts, stents, and stent-
`grafts in either a single-piece or modular configuration.
`The use of tubular grafts for treating defects at bifurcation
`sites has been known for some time. For example, in US.
`Pat. No. 3,029,819 to Starks, US. Pat. No. 3,096,560 to
`Liebig, US. Pat. No. 3,142,067 to Liebig, and US. Pat. No.
`3,805,301 to Liebig. These grafts are typically made of
`woven fabric or other synthetic material and, because they
`have no supporting stent structure, typically involve excis-
`ing the defected segment and suturing the fabric graft in
`place using common surgical procedures.
`A number of bifurcated graft implants have been devel-
`oped which use some limited means of supporting the
`one-piece bifurcated graft structure. Examples of such bifur-
`cated grafts include US. Pat. No. 4,562,596 to Kornberg;
`US. Pat. No. 5,489,295 to Piplani et al.; and US. Pat. Nos.
`5,360,443, and 5,522,880, both to Barone et al.
`As with all such one-piece devices, the delivery of the
`graft implant is complicated by the fact that each of the trunk
`and two legs of the graft must be positioned into their
`respective lumen and then secured into place. This requires
`the branch legs to be compressed together for delivery
`through one of the lumen and requires difficult maneuvering
`of the branch legs to get them unfolded and untwisted into
`place within their respective branch lumen. This type of
`delivery requires the graft sections to be highly flexible so
`that its components may be manipulated as required and
`requires a larger profile. This demand for high flexibility
`often results in unsupported graft sections that may be
`subject to kinking, folding, collapse or the like.
`Bifurcated stent devices have also been disclosed, such as
`in US. Pat. No. 4,994,071 to MacGregor, for example,
`which discloses a single-piece bifurcated stent for insertion
`into a bifurcating vessel, or in US. Pat. No. 5,342,387 to
`Summers.
`
`Some implant devices have further used a modular
`approach, primarily for purposes of enhancing delivery.
`Examples of modular implants such as stents or grafts
`include FR 2 678 508 A1; US. Pat. No. 5,507,769 to Marin
`et al; EP 0 (551) (179) A1 to Palmaz et al.; WO 95/(215)92
`(International Application number PCT/US95/(014)66); EP
`(068)6 (379) A2; EP 0 (696) (447) A2; and US. Pat. No.
`5,562,724 to Vorwerk et al. While these modular devices
`tend to offer a measure of improved delivery, continuing
`problems may include a certain amount of leakage around
`the openings of the device or at the modular connection, as
`well as increased compressed profiles, and inoptimal
`flexibility, kink-resistance, and axial stiffness.
`Another problem associated with the endovascular repair
`of aneurysms is postprocedural leakage into the aneurysm
`sac. Katzen et al., Initial Experience Performing Combined
`Surgical/Interventional Procedures in the Interventional
`
`Edwards Lifesciences Corporation, et al. Exhibit 1119, Page 32 of 48
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`Edwards Lifesciences Corporation, et al. Exhibit 1119, Page 32 of 48
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`6,015,431
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`3
`
`Suite (1996) J. Endovasc. Surg. 3: 467—468, discloses the
`treatment of patients for abdominal aortic aneurysms
`(AAAs) using covered (Dacron or polytetrafluoroethylene)
`multisegment Z-stents; approximately one third of the
`patients experienced postprocedural leakage. Repair cases of
`AAAs using the White-Yu endovascular graft were
`described in White et al., Endoleak Following Endoluminal
`Repair of AAA: Diagnosis, Significance, and Management
`(1996) J. Endovasc. Surg. 3: 339—340;
`this technique
`resulted in leakage around the graft 7.8% of the time. Chuter
`et al., Bifurcated Stent-Grafts for AAA: 3-Year Follow-Up
`(1996) J. Endovasc. Surg. 3:453, describes the observation
`of persistent perigraft leakage 12% of the time in a late
`portion of patients treated for an AAA using a bifucated
`stent-graft. Parodi et al. Long-term Follow-up of AAA
`Endoluminal Repair (1996) J. Endovasc. Surg. 3:335, cites
`leakage as one of the primary factors causing early failures
`of aortic tube graft replacement treatment of AAAs, employ-
`ing either proximal stent fixation or aortoiliac stent grafts;
`perigraft leakage is the only cited cause in late failures.
`The postprocedural leakage problem has persisted in more
`recently developed systems forAAAtreatment. Moore et al.,
`in Transfemoral Endovascular Repair ofAbdominal Aortic
`Aneurysm: Results of the NorthAmerican EVTPhase 1 Trial
`(April 1996) J. Vasc. Surg., 543—552, disclose an endovas-
`cular grafting system (EGS) consisting of an endovascular
`prosthesis, an endovascular deployment assembly, and an
`expandable introducer sheath developed by Endovascular
`Technologies for the treatment of AAAs. Moore et al.
`discloses postprocedural leakage for this device, as initially
`detected, in 44% of the patients; persistent leakage was
`observed in greater than 20% of the patients.
`An endovascular grafting system is further described in
`Dereume et al. Endoluminal Treatment ofAbdominal Aortic
`Aneurysm with the Corvita Endovascular Graft. Results of a
`Single-Center; Prospective Feasibility Study of 90 Patients
`(1996) J. Endovasc. Surg. 3:453—483. Dereume et al.
`describe a system composed of a metallic self-expanding
`braided wire stent and an inner liner comprised of polycar-
`bonate urethane microfibers. Among patients treated with
`this graft, 38% presented some postprocedural
`leakage,
`according to the Dereume et al. disclosure.
`In short, the prior art does not disclose a system for the
`endovascular repair of AAAs that has adequately addressed
`the problem of postprocedural leakage.
`From the foregoing discussion it is evident that it would
`be desirable to have a stent-graft device for treating vessel
`wall aneurysms by endolumenally isolating the abnormal
`aneurysmal wall from blood pressure, and which does not
`allow for substantial leakage flow around the outer periphery
`of the device.
`
`SUMMARY OF THE INVENTION
`
`The present invention is an implantable medical device
`for delivery to an endolumenal body space that is defined by
`an endolumenal wall and for providing an artificial conduit
`for flow through the endolumenal body space. The device
`preferably is adapted for delivery to an intravascular region
`of an aneurysm and provides a conduit through that region
`while protecting the aneurysm from the intralumenal pres-
`sure.
`
`4
`shape dimensioned to substantially engage at least a portion
`of the endolumenal wall. Furthermore,
`the tubular wall
`defines a lumen that extends along the length and that
`provides a conduit for flow through the endolumenal body
`space.
`The seal member is secured to the outer surface and is
`
`adapted to occlude leakage flow externally around the
`tubular wall between the outer surface and the endolumenal
`
`wall when the tubular member is deployed within the
`endolumenal body space.
`the seal member is an
`In one mode of this variation,
`occlusive cuff that forms a flange as a one-way valve over
`the conduit tubing member’s outer surface.
`In another mode,
`the tubular member has a radially
`collapsed condition such that the outer surface has a reduced
`diameter which is dimensioned to be smaller than the
`endolumenal diameter. The tubular member of this mode is
`
`adjustable to a radially expanded condition such that the
`outer surface has the first diameter and shape for engaging
`the endolumenal wall. This mode allows for delivery of the
`tubular member when in the radially collapsed condition,
`and implantation of the tubular member when in the radially
`expanded condition.
`In still another mode of this variation, the tubular member
`includes an anchor and the seal member is adjacent to that
`anchor. It is believed that the anchoring of endolumenal
`grafts may create leakage paths around the outer surface of
`the graft. The seal member is positioned to occlude such
`leakage paths.
`Another variation of the invention is an implantable
`medical device that has a tubular member, which is a
`stent-graft,
`in combination with a seal member over the
`outside surface of that stent-graft. The stent graft includes a
`flexible,
`tubular graft member, and also a stent member
`which is coupled to an outer surface of the tubular graft
`member. The stent member has at least one circumferentially
`reinforcing member that is constructed of relatively rigid
`material compared to the tubular graft member.
`In a further mode of this variation, the stent-graft which
`makes up the tubular member is bifurcated, which provides
`primary utility for implantation in lower abdominal aortic
`bifurcations which have aortic wall aneurysms. It is believed
`that leakage into aneurysms over bifurcated implants of this
`type may occur over either the main body end, or over one
`or both of the legs of the bifurcation. Therefore, the seal
`member may be positioned adjacent the distal end of the
`main body of this stent-graft, or adjacent the end of one of
`the legs of the bifurcation, or both.
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`FIG. 1 is a perspective view of an implantable medical
`device of the present invention wherein a seal member is
`secured to an outer surface of a tubular member adjacent an
`end of the tubular member.
`
`FIG. 2 is a perspective view of a further embodiment of
`the implantable medical device of FIG. 1, wherein two
`similar seal members are shown secured to outer surfaces of
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`two opposite end portions of the tubular member with one
`seal member in an expanded condition relative to the other
`seal member.
`
`In one variation of the invention, the implantable medical
`device has a tubular member and a sealing member.
`The tubular member has a tube wall with a length, two
`opposite end portions with a central portion therebetween,
`and an outer surface. The outer surface has a diameter and
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`FIG. 3 is a perspective view of the implantable medical
`device of FIG. 1, wherein the tubular member is shown in a
`radially expanded position within an intravascular region of
`an aneurysm.
`FIG. 4 is a perspective view of an implantable medical
`device that is restrained in a collapsed state.
`
`Edwards Lifesciences Corporation, et al. Exhibit 1119, Page 33 of 48
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`Edwards Lifesciences Corporation, et al. Exhibit 1119, Page 33 of 48
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`

`6,015,431
`
`5
`FIG. 5 is an end view of the restrained implant of FIG. 4.
`FIG. 6 is a perspective view of the assembly of FIG. 4
`with the restraint released and the implant in an expanded
`state.
`
`FIG. 7A is an end view of the assembly of FIG. 6.
`FIG. 7B is a bottom plan view of the restraining member
`of FIG. 7A.
`
`FIG. 8A shows a restraining member retraction mecha-
`nism where the mechanism is in an unactuated state.
`FIG. 8B shows the mechanism of FIG. 8A in an actuated
`state.
`
`FIG. 8C shows a retraining member retraction mechanism
`according to yet another variation where the mechanism is
`in an unactuated state.
`FIG. 8D shows the mechanism of FIG. SC in an actuated
`state.
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`FIG. 9A is a perspective view of another variation of the
`implant in conjunction with the restraining member of FIG.
`4.
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`FIG. 9B is a perspective view of a further variation of the
`implant in conjunction with the restraining member of FIG.
`4.
`
`FIG. 10A illustrates the restraining and coupling member
`of FIG. 4 and the pull direction for removing the coupling
`member from the restraining member.
`FIG. 10B shows the assembly of FIG. 10A with the
`coupling member loosened to illustrate the chain knots used
`according to one variation.
`FIG. 10C diagrammatically represents release of the
`assembly of FIG. 10A or 10B as the coupling member is
`pulled in the direction shown.
`FIGS. 11A, 11B, 11C, 11D, 11E and 11F diagrammati-
`cally show a procedure for loading an expandable stent-graft
`into a restraining member prior to endolumenal delivery.
`FIG. 12A diagrammatically shows delivering a restrained
`implant to a desired site in a mammalian body lumen with
`the coupling member configured as shown in FIGS.
`10A—10C.
`
`FIG. 12B is a sectional view of FIG. 12A taken along line
`12B—12B.
`
`FIG. 12C shows an alternate multiple restraining member
`arrangement for that shown in FIG. 12A.
`FIG. 13A diagrammatically shows partial deployment of
`the implant assembly illustrated in FIG. 12A showing pro-
`gressive expansion in a direction away from the distal end of
`the illustrated guidewire (i.e., toward the illustrated hub).
`FIG. 13B is a sectional view of FIG. 13A taken along line
`13B—13B.
`
`FIG. 14A diagrammatically shows full deployment of the
`implant assembly illustrated in FIG. 12A.
`FIG. 14B is a sectional view of FIG. 14A taken along the
`line 14B—14B.
`
`FIGS. 15A, 15B, 15C and 15D diagrammatically show
`deployment of a restrained implant according to another
`variation where the coupling member configuration provides
`release from the middle portion of the implant outward
`toward the implant ends.
`FIG. 16 illustrates one coupling member configuration for
`deployment as shown in FIGS. 15A—15D.
`FIG. 17A is a perspective view of a bifurcated stent-graft.
`FIG. 17B is a top plan view of the bifurcated stent-graft
`of FIG. 17A.
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`FIG. 17D is a cross-sectional view taken along section
`line 17D—17D depicted in FIG. 17A.
`FIG. 18 is a front view of the assembled bifurcated
`
`stent-graft of FIG. 17Aplaced at a bifurcation site within the
`vasculature of a body.
`FIG. 19 is a perspective break-away view showing a
`close-up of one construction of the stent anchoring apexes
`with a seal member secured adjacent thereto.
`FIG. 20A is a perspective break-away view showing a
`close-up of a an alternative construction of the stent anchor-
`ing apexes, also including a seal member secured adjacent
`thereto.
`
`FIG. 20B is a longitudinal cross-sectional view of a
`generic tubular member with anchor and seal member
`deployed within an endolumenal space.
`FIG. 21 is a cross-section view of the stent-graft tubular
`member taken along section line 21—21 depicted in FIG.
`17B.
`
`FIG. 22 is a cross-section view of the stent-graft depicted
`in FIG. 17A, taken along section line 22—22.
`FIG. 23 is an enlarged partial cross-sectional view of the
`contralateral leg connection depicted in FIG. 22.
`FIGS. 24 and 25 are enlarged partial cross-sectional views
`of alternative constructions of the receiving lumen.
`FIG. 26 is a partial perspective view of an alternate
`scalloped construction of the proximal region of the con-
`tralateral leg component.
`FIGS. 27A and 27B are cross-sectional views taken along
`section line 27A—27A as shown in FIG. 17A depicting a
`free state and a forced state respectively.
`FIGS. 28A and 28B are cross-sectional views taken along
`section line 28A—28A as shown in FIG. 26 depicting a free
`state and a forced state respectively.
`FIG. 29A is a front view of the unassembled components
`of a variation of the graft element to be combined with a
`stent member to form a tubular member variation for use
`with the current invention.
`
`FIGS. 29B and 29C are respectively the front view and
`top view of the assembled graft elements.
`FIG. 30A is a front view of the unassembled components
`of an alternate construction of the graft element.
`FIG. 30B is a front view of the assembled graft element
`according to the alternative construction of FIG. 30A.
`FIGS. 31A through 31E diagrammatically show the
`deployment of the two components of a bifurcated stent-
`graft constructed according to the principles of the present
`invention using a type of restraining member for deploy-
`ment.
`
`FIGS. 32A through 32D diagrammatically show the
`deployment of the two components of a bifurcated stent-
`graft constructed according to the principles of the present
`invention using an alternate type of restraining member
`which provides release from the middle portion of