`Goicoechea et al.
`
`‘
`
`USO05716365A ‘
`
`[11] Patent Number:
`[45] Date of Patent:
`
`5,716,365
`Feb. 10, 1998
`
`[54] BIFURCATED ENDOLUMINAL PROSTHFSIS
`
`[75] Inventors: George Goicoechea. Grand Bahama.
`
`2678508 4/l99l France .
`2678508Al
`1/ 1993 France .
`2106190 4/1933 Unit/ed Kingdom A
`
`Bahamas; John Hudson. Clearwater. Fla; Claude Mlalhc. Draguignan.
`
`Frame’ Andrew H‘ Cragg‘ Edma~
`Minn.; Michael D. Dake. Stanford.
`Calif.
`
`[73] Assignee: Boston Scienti?c Technologies, Inc.
`Maple Grove_ Minn
`
`.
`[21] APPI' N°" 461’513‘
`[22] Filed:
`Jun. 5, 1995
`
`Related US. Application Data
`
`[60] Division of Set NO- 317,763, Oct 4, 1994, Pat NO- 5.609,
`627, which is a continuation-in-part of Ser. No. 312,881,
`Se"- 27’ ‘994'
`Foreign Application Priority Data
`
`[30]
`
`European Pat O?'. ............ .. 9440(Y284
`Feb. 9, 1994 [EP]
`‘m
`’ 994 [EP] Empe’” '" Off
`94401306
`Pa
`. ............ ..
`J . 10 1
`[51] Int. Cl.’5 .................................................... .. A61F 11/00
`[5 ] US Cl
`606/108. 606/195 606/ 198
`[58] Field of Search ................................... .. 6061198. 191.
`606,194 108 19g 195_ 623/9 11 12
`‘
`‘
`‘
`’
`'
`‘
`1‘
`
`..
`
`'
`
`;
`
`2
`
`. .
`
`. ........... ..
`
`[56]
`
`References Cited
`
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`
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`
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`
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`
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`
`1,1992 WIPO
`wogzxc I3
`wo9313s25 7/1993 wn>0
`
`OTHER PUBLICATIONS
`
`Dom? ct a1" fTfansluminal Expandable Ni?nol Coil Stem
`Grafnng: Preliminary Report .Techmcal Developments and
`Instrumentation, Radiology. vol. 147. pp. 259-260 (Apr.
`1983).
`Schetky. “Shape-Memory Alloys”. pp. 74-32.
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`T. W. Duen'g et al.. “An Engineer's Perspective of Pseu
`doelasticity". pp. 369-393.
`.
`.
`,,
`“
`Cragg et al.. Stems/Vascular Stents . Intervennonal Rad:
`ology, pp. 686-692 (1990).
`Search Report.
`P?mmy Exan?ner_kobe? A. Hafer
`.
`.
`.
`Assistant Exanuner-Justme R. Yu
`Attorney, Agent, or Firm—Ratner & Prestia
`
`[57]
`
`ABSTRACT
`
`An introducer for delivering into the vasculature a straight or
`bifurcated stent or prosthesis; a method for delivering into
`the vasculamfc a straight or bifurcatcd 519m 01' Prosthcsis; a
`method of treating and angeological disease using a bifur
`cared stent; an endoluminal stent having pm'pendicular hoop
`members. each hoop member formed of wire in a sinuous
`con?guration. at least some of juxtaposed apices in neigh
`boring hoops being secured to one another. such stents also
`forming axially aligned segments in straight stents. and
`segments of bifurcated stents in particular embodiments.
`Certain embodiments of such stents also include barbs.
`fabric covering and radiopaque markers.
`
`24 Claims, 23 Drawing Sheets
`
`W.L. Gore & Associates, Inc.
`Exhibit 1001-1
`
`
`
`US. PATENT DOCUMENTS
`
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`
`Wilson .
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`
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`
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`
`Kreamer .
`
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`
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`
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`
`Palmaz .
`
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`
`Palmaz ,
`
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`Hillstead .
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`
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`
`‘Mktor .
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`Hillstead .
`
`Pinchuk .
`
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`Harada et a1. .
`Gianmrco .
`Arpemi '
`
`5 ,047 ,050
`
`5,7 16,365
`Page 2
`
`5,057,092
`5,064,435
`5,067,957
`5,078,726
`5,078,736
`5,085,635
`5,104,399
`5,104,404
`5,123,917
`5,133,732
`5,135,536
`5,151 ,105
`5,161 r547
`5,183,085
`5,192,297
`5,201,901
`5,207,695
`5,236,446
`5,275,622
`5,282,824
`5,290,305
`5,292,331
`5,304,200
`5,314,472
`5,330,500
`5,342,337
`5,354,309
`5,360,443
`5,366,504
`5,370,683
`5,383,928
`5,387 ,235
`5,389,106
`5,397,345
`5,405,377
`5,415,664
`5,429,144
`5,443,496
`5,443,498
`5,456,713
`5,464,449
`5,507,767
`5,507,771
`5,562,724
`5,562,727
`5,562,728
`5,571,170
`5,575,817
`
`10/1991
`11/1991
`11/1991
`1/1992
`1/1992
`2/1992
`411992
`4/1992
`6/1992
`7/1992
`8/1992
`9/1992
`11/1992
`2/1993
`3/1993
`4/1993
`5/1993
`8/1993
`1/1994
`2/1994
`3/1994
`3/1994
`4/1994
`5/1994
`7/1994
`8/1994
`10/1994
`11/1994
`11/1994
`12/1994
`1/1995
`2/1995
`2/1995
`3/1995
`4/1995
`5/1995
`7/1995
`8/1995
`8/1995
`10/1995
`11/1995
`4/1996
`
`10/1996
`10/1996
`10/1996
`11/1996
`11/1996
`
`Webster, Jr, .
`Porter .................................... .. 606/198
`
`Jervis .
`
`Kreamer .
`
`Behl .
`Cragg .
`
`Lazarus .
`
`Wolff .
`
`Lee .
`
`Hillstead .
`
`Kwan-Gen .
`
`Tower .
`
`Timmermans .
`
`Hull .
`Hamda et a1. ,
`Trout .
`
`Dumon .
`
`Lazarus ,
`
`Gianlnrco .
`
`Inone .
`
`Boneau .
`Spaulding .
`Fomaine .
`Song ..................................... .. 606/198
`Summers .............................. .. 606/198
`Schnepp-Pesch et a1.
`623/12
`Bel-one et a1. ........................ .. 606/195
`Anderson et a1. .
`Fontaine .
`Scott et a1. .
`Chuter .
`
`Tower ,
`
`Lazarus .
`Cragg .
`Pinchuk .
`
`Schwartz .
`
`Fontaine .
`
`Chuter .
`Ryan et a1. ,
`Maeda ,
`
`Gdantumo .
`Vorwerk et a]. ...................... .. 6061195
`Turk et a1.
`623/12
`Lazarus et a1.
`.. 6061194
`Palmaz et a1. ....... ..
`.. 6061108
`
`Martin ....................................... .. 623/1
`
`W.L. Gore & Associates, Inc.
`Exhibit 1001-2
`
`
`
`US. Patent
`
`Feb. 10, 1998
`
`Sheet 1 0f 23
`
`5,716,365
`
`FIG. M
`
`W
`
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`
`14*
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`43
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`
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`
`W.L. Gore & Associates, Inc.
`Exhibit 1001-3
`
`
`
`US. Patent
`
`Feb. 10, 1998
`
`Sheet 2 0f 23
`
`5,716,365
`
`FIG. 2A
`
`20a
`
`20!] P’
`
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`
`20
`
`W.L. Gore & Associates, Inc.
`Exhibit 1001-4
`
`
`
`
`
`W.L. Gore & Associates, Inc.
`Exhibit 1001-5
`
`
`
`US. Patent
`
`Feb. 10, 1998
`
`Sheet 4 of 23
`
`5,716,365
`
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`W.L. Gore & Associates, Inc.
`Exhibit 1001-6
`
`
`
`US. Patent
`
`Feb. 10, 1998
`
`Sheet 5 0f 23
`
`5,716,365
`
`W.L. Gore & Associates, Inc.
`Exhibit 1001-7
`
`
`
`US. Patent
`
`Feb. 10, 1998
`
`Sheet 6 of 23
`
`5,716,365
`
`W.L. Gore & Associates, Inc.
`Exhibit 1001-8
`
`
`
`US. Patent
`
`Feb. 10, 1998
`
`Sheet 7 0f 23
`
`5,716,365
`
`114
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`W.L. Gore & Associates, Inc.
`Exhibit 1001-9
`
`
`
`US. Patent
`
`Feb. 10, 1998
`
`Sheet 8 0f 23
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`5,716,365
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`W.L. Gore & Associates, Inc.
`Exhibit 1001-10
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`
`
`US. Patent
`
`Feb. 10, 1998
`
`Sheet 9 of 23
`
`5,716,365
`
`W.L. Gore & Associates, Inc.
`Exhibit 1001-11
`
`
`
`US. Patent
`
`Feb. 10, 1998
`
`Sheet 10 of 23
`
`5,716,365
`
`FIG. 10A
`
`
`
`FIB. 10B
`
`101 i,
`
`102
`
`W.L. Gore & Associates, Inc.
`Exhibit 1001-12
`
`
`
`US. Patent
`
`Feb. 10, 1998
`
`Sheet 11 0f 23
`
`5,716,365
`
`FIG. 11
`
`W.L. Gore & Associates, Inc.
`Exhibit 1001-13
`
`
`
`US. Patent
`
`Feb. 10, 1993
`
`Sheet 12 of 23
`
`5,716,365
`
`W.L. Gore & Associates, Inc.
`Exhibit 1001-14
`
`
`
`US. Patent
`
`Feb. 10, 1998
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`Sheet 13 of 23
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`5,716,365
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`W.L. Gore & Associates, Inc.
`Exhibit 1001-15
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`US. Patent
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`Feb. 10, 1998
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`Sheet 14 of 23
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`5,716,365
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`W.L. Gore & Associates, Inc.
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`US. Patent
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`Feb. 10, 1998
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`US. Patent
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`Feb. 10, 1998
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`Sheet 16 of 23
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`5,716,365
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`W.L. Gore & Associates, Inc.
`Exhibit 1001-18
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`Feb. 10, 1998
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`Sheet 17 of 23
`
`5,716,365
`
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`W.L. Gore & Associates, Inc.
`Exhibit 1001-19
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`US. Patent
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`Feb. 10, 1998
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`Feb. 10, 1998
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`W.L. Gore & Associates, Inc.
`Exhibit 1001-21
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`W.L. Gore & Associates, Inc.
`Exhibit 1001-21
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`US. Patent
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`Feb. 10, 1998
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`W.L. Gore & Associates, Inc.
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`Feb. 10, 1998
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`W.L. Gore & Associates, Inc.
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`Feb. 10, 1998
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`W.L. Gore & Associates, Inc.
`Exhibit 1001-24
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`W.L. Gore & Associates, Inc.
`Exhibit 1001-24
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`Feb. 10, 1998
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`
`5,716,365
`
`1
`BIFURCATED ENDOLUMINAL PROSTHESIS
`
`This application is a division of application Ser. No.
`08/317.763. filed Oct. 4. 1994. now U.S. Pat. No. 5.609.627.
`which is a Continuation-in-Part of application Ser. No.
`08312.881. filed Sep. 27. 1994.
`BACKGROUND OF THE INVENTION
`
`The present invention relates to a bifurcated endoluminal
`prosthesis for use in a bifurcated blood vessel such. for
`example. as the infrarenal portion of a mammalian aortic
`artery where it bifurcates to the common iliac arteries. The
`present invention also embraces a stent connecting means
`for connecting a stent (e.g. a stent which forms part of an
`endoluminal prosthesis) to another stent. as well as appara-
`tus and method for introducing prostheses to the vasculature
`and methods of treating angeological diseases.
`A stent is used to provide a prosthetic intraluminal wall
`e.g. in the case of a stenosis to provide an unobstructed
`conduit for blood in the area of the stenosis. An endoluminal
`prosthesis comprises a stent which carries a prosthetic graft
`layer of fabric and is used e.g. to treat an aneurysm by
`removing the pressure on a weakened part of an artery so as
`to reduce the risk of embolism. or of the natural artery wall
`bursting. Typically. a stent or endoluminal prosthesis is
`implanted in a blood vessel at the site of a stenosis or
`aneurysm by so-called “minimally invasive techniques” in
`which the stent
`is compressed radially inwards and is
`delivered by a catheter to the site where it is required
`through the patient’s sldn or by a “cut down” technique in
`which the blood vessel concerned is exposed by minor
`surgical means. When the stent is positioned at the correct
`location. the catheter is withdrawn and the stent is caused or
`allowed to re—expand to a predetermined diameter in the
`vessel.
`
`U.S. Pat. No. 4.886.062 discloses a vascular stent which
`comprises a length of sinuous or “zig-zag” wire formed into
`a helix; the helix defines a generally cylindrical wall which.
`in use. constitutes a prosthetic intraluminal wall. The sinu—
`ous configuration of the wire permits radial expansion and
`compression of the stent; U.S. Pat. No. 4.886.062 discloses
`that the stent can be delivered percutaneously and expanded
`in situ using a balloon catheter.
`U.S. Pat. No. 4.733.665 discloses an expandable intralu-
`minal graft which is constituted by a tubular member formed
`from a plurality of intersecting elongate members which
`permit radial expansion and compression of the stent.
`EP-A—0556850 discloses an intraluminal stent which is
`constituted by a sinuous wire formed into a helix; juxtaposed
`apices of the wire are secured to one another so that each
`hoop of the helix is supported by its neighboring hoops to
`increase the overall strength of the stent and to minimize the
`risk of plaque herniation; in some embodiments the stent of
`EBA-0556850 further comprises a tubular graft member to
`form an endoluminal prosthesis.
`The prior art stents and prostheses mentioned above are
`generally satisfactory for the treatment of aneurysms.
`stenoses and other angeological diseases at sites in continu—
`ous unbifurcated portions of arteries or veins.
`However.
`the prior art stents and prostheses are not
`wholly satisfactory for use where the site of desired appli-
`cation of the stent or prosthesis is juxtaposed or extends
`across a bifurcation in an artery or vein such. for example.
`as the bifurcation in the mammalian aortic artery into the
`common iliac arteries. For example.
`in the case of an
`abdominal aortic aneurysm (“AAA") in the infrarenal por-
`
`2
`tion of the aorta which extends into one of the common iliac
`arteries. the use of one of the prior art prosthesis referred to
`above across the bifurcation into the one iliac artery will
`result in obstruction of the proximal end of the other
`common iliac artery; by-pass surgery is therefore required to
`connect the one iliac artery in juxtaposition with the distal
`end of the prosthesis to the other blocked iliac artery. It will
`be appreciated by a person skilled in the art that it is
`desirable to avoid surgery wherever possible; the require-
`ment for by-pass surgery associated with the use of the prior
`art prosthesis in juxtaposition with a bifurcation in an artery
`therefore constitutes a significant disadvantage.
`
`SUMMARY OF THE INVENTION
`
`Throughout this specification. the term “proximal” shall
`mean “nearest to the heart.” and the term “distal" shall mean
`“furthest from the heart."
`
`According to one aspect of the present invention there is
`provided a stent connecting means for connecting two
`intraluminal stents one to the other to define a continuous
`lumen through the two stents. the stent connecting means
`including a first stent including a male engaging portion
`which can be compressed radially inwardly. and a second
`stent including a female cooperating portion. The male
`engaging portion may be entered into the female cooperating
`portion in a radially compressed state and thereafter caused
`or allowed to expand in the female cooperating portion; the
`arrangement being such that in service the interengagement
`of the male engaging portion and the female cooperating
`portion serves to resist longitudinal separation of the two
`stents one from the other.
`
`Typically. the first stent may include a proximal male
`engaging portion; the second stent may include a distal
`female cooperation portion. The male engaging portion may
`be flared radially outwardly towards its extremity. and the
`female cooperating portion may be tapered radially inwardly
`towards its extremity.
`In some embodiments.
`the male
`engaging portion may comprise a frustoconical wall which
`flares outwardly towards its longitudinal extremity;
`the
`female engaging portion may comprise a frustoconical wall
`which tapers radially inwardly towards its longitudinal
`extremity.
`Alternatively. said male engaging and female cooperating
`portions may be substantially untapered; they may be sub-
`stantially cylindrical.
`The male engaging portion of the first stent may be
`resiliently compressible in a radially inwards direction such
`that in the radially compressed state it is capable of self-
`reexpansion to engage in the female cooperating portion.
`Typically. each of said first and second stents may be
`resiliently compressible.
`In use therefore the second stent may be delivered in a
`radially compressed state by using a catheter; when the
`second stent is located at the site of use. the catheter may be
`withdrawn thereby allowing the second stent to re-expand to
`engage the endoluminal surface of the blood vessel.
`The first stent may then be delivered percutaneously or by
`a “cut down” technique to a site distal of the second stent
`such that the mate engaging portion of the first stent in the
`radially compressed state is entered into the expanded
`female cooperating portion of the second stent; the catheter
`may then be withdrawn allowing the first stent to re-expand
`such that the male engaging portion engages in the female
`cooperating portion of the second stent.
`In some embodiments of the present invention the second
`stent may have two transversely spaced distal female coop-
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`65
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`W.L. Gore & Associates, Inc.
`Exhibit 1001-26
`
`W.L. Gore & Associates, Inc.
`Exhibit 1001-26
`
`
`
`3
`
`4
`
`5.716365
`
`crating portions; the second stent may therefore constitute a
`bifurcated stent for use in juxtaposition with a bifurcation in
`a blood vessel.
`
`Each of the two transversely spaced distal female coop-
`erating portions may be adapted for connection to a first
`male stent which. in use. extends across the bifurcation into
`a respective one of the branched blood vessels.
`In a particular aspect of the present invention there is
`provided a bifurcated intraluminal stent for use in juxtapo—
`sition with an angeological bifurcation;
`the bifurcated
`intraluminal stent comprising a proximal portion adapted to
`be positioned in service in a blood vessel in juxtaposition
`with a bifurcation. a first distal stent portion adapted to
`extend across the bifurcation into one of the branched blood
`vessels and a second distal stent portion adapted to allow
`blood to flow from the proximal portion into the other
`branched vessel. The first distal stent portion may be formed
`integrally with the proximal portion.
`In some embodiments the second distal stent portion may
`comprise a female cooperating portion which is adapted to
`engage a male engaging portion of a another stent adapted
`to extend in the other branched blood vessel such that. in
`use. the bifurcated stent can be connected in situ to the other
`stent. The bifurcated intraluminal stent may therefore con-
`stitute a second stent in accordance with the present inven—
`tion comprising a distal female cooperating portion disposed
`intermediate the proximal and distal extremities of the stent;
`the other stent may constitute a first stent in accordance with
`the present invention.
`Typically. the proximal end of said second stent may be
`flared radially outwardly towards its extremity to engage the
`endoluminal surface of the artery thereby to resist longitu-
`dinal movement of the second stent in service.
`
`Each of the first and second stents may comprise a sinuous
`wire formed into a tubular configuration. The sinuous and
`tubular configurations may be imparted to the wire by
`winding it on a mandrel. Typically. each stent may be made
`from a shape memory nitinol (nickel-titanium) wire which
`may be wound on to the mandrel to form the stent in a
`tubular configuration of slightly greater diameter than the
`diameter of the blood vessel in which the stent is intended
`to be used. The stent may be annealed at an elevated
`temperature and then allowed to cool in air so that the nitinol
`wire “remembers” the configuration in which it was wound
`on the mandrel.
`
`Said nitinol wire may be type “M” nitinol wire which is
`martensitic at
`temperatures below about 13° C. and is
`austenitic at temperatures above about 25° C.; it will be
`appreciated therefore that the type “M” wire will be auste-
`nitic at body temperature of 37° C. Typically. the annealing
`may be conducted at about 500° C. or more for at least about
`60 minutes; after cooling the wire may be immersed in cold
`water to facilitate removal of the wire from the mandrel with
`the wire in its maleable martensitic form. Typically. the cold
`water may have temperature of less than about 10° C.; the
`wire may be immersed for about 5 minutes or more. An
`advantage of using nitinol wire to form the stent in accor—
`dance with the present invention is that the nitinol wire is
`“super elastic” in its austenitic state; the radial outward force
`exerted by the stent on the wall of the blood vessel in use is
`therefore substantially constant irrespective of the diameter
`of the vessel and the expanded stent.
`In some embodiments the wire may have a helical con-
`figuration as disclosed in EBA-0556850. Alternatively. the
`wire may be of an entirely novel configuration. namely one
`in which the wire forms a plurality of hoops such that the
`
`plane of the circumference of each hoop is substantially
`perpendicular to the longitudinal axis of the stent. Each hoop
`may comprise a substantially complete turn of the wire
`having a sinuous configuration; optionally. as each hoop is
`completed. the point of winding the wire may be displaced
`longitudinally with respect to the winding axis to form the
`next hoop. When the next hoop is complete. the point of
`winding is moved further longitudinally with respect to the
`winding axis to the form the next succeeding hoop and so on.
`It will appreciated that an advantage of this novel arrange-
`ment is that the planes of the hoops are not skewed with
`respect to the longitudinal axis of the stent; the longitudinal
`ends of the stent are “square” to said longitudinal axis. so
`that when the stent is caused or allowed to expand in situ
`there is substantially no twisting of the stent as it shortens in
`length. It will be appreciated that this represents a significant
`advantage. as in areas of stenosis or aneurysm it is desirable
`to minimize the movement of the stent within the blood
`vessel so as to reduce the potential trauma to the patient. A
`stent of this configuration may be used. apart from the
`bifurcated embodiment otherwise taught herein.
`in any
`application which in stents generally have heretofor been
`used.
`
`the stents of this invention whether of the
`Typically.
`helical or perpendicular variety. also comprise a securing
`means for securing an apex of the sinuous wire in one hoop
`to ajuxtaposed apex of a neighboring hoop so that each hoop
`is supported by its neighbors. The securing means may
`comprise a loop element of a suture material. for example.
`to lie the juxtaposed apices together; the loop element may
`also comprise a loop formed of a thermoplastics material
`such. for example. as polypropylene. Alternatively.
`the
`securing means may be a bead formed of a thermoplastic
`material around juxtaposed apices. Also alternatively. the
`securing means may be a loop. ring. or staple formed of wire
`such as nitinol.
`
`The male engaging portion and female cooperating
`portion. of the first and second interengaging stents of this
`invention. may be formed separately from the remainder of
`the respective non-engaging portions of these stents and then
`the engaging and non—engaging portions secured to one
`another by securing means.
`In one embodiment of the present invention. the proximal
`and distal stent portions of the bifurcated stent in accordance
`with the present invention may be formed separately; the
`distal end of the proximal stent portion may be secured to the
`wider proximal end of a first intermediate frustoconical stent
`portion; the narrower distal end of the first intermediate
`frustoconical stent portion may be secured to the proximal
`end of the distal stent portion. The female cooperating
`portion of the bifurcated stent may be constituted by a
`second frustoconical stent portion which is seemed to the
`distal end of the proximal stent portion in juxtaposition with
`the first fiustoconical portion.
`Alternatively the first and second frustoconical portions
`may be omitted; the proximal and distal stent portions may
`be secured directly one to the other.
`The female cooperating portion may be constituted by a
`generally cylindrical stent portion seemed to said proximal
`stent portion in transversely spaced relation to the distal
`portion.
`Each of the first and second stents of the bifurcated form
`of the present invention may carry a tubular graft layer
`formed from a biocompatible fabric injuxtaposition with the
`stent; the combined stent and graft layer constituting an
`endoluminal prosthesis. Typically the graft layer may be
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`65
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`W.L. Gore & Associates, Inc.
`Exhibit 1001-27
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`W.L. Gore & Associates, Inc.
`Exhibit 1001-27
`
`
`
`5
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`6
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`5.716.365
`
`it will be appreciated
`disposed externally of the stent;
`however that in some embodiments the graft layer may be
`disposed internally of the stent. In some embodiments the
`graft layer may be secured to the stent by loop elements
`such. for example. as loops of polypropylene. The biocom-
`patible fabric may be a polyester fabric or a polytetrafluo—
`roethylene fabric; typically said fabric may be woven or a
`warp knitted polyester fabric. In some embodiments the
`woven or a warp knitted fabric may be formed in a seam-free
`bifurcated configuration as a sleeve for a bifurcated stent.
`In some embodiments the male engaging portion of the
`first stent and the female cooperating portion of the second
`stent may be left uncovered. Alternatively. the fabric graft
`layer may extend to the proximal extremity on the external
`surface of the male engaging portion. and may be folded
`over the distal extremity of the female engaging portion to
`form an inner sleeve; in use the external fabric of the male
`engaging portion may butt against the folded over portion of
`the fabric internally of the female cooperating portion to
`form a substantially blood tight seal.
`The present invention in one aspect therefore includes a
`bifurcated endoluminal prosthesis comprising a bifurcated
`stent in accordance with the invention and a tubular graft
`layer.
`The first stent having the male engaging portion may also
`have a tubular graft layer. If required the first prosthesis may
`be introduced in a radially compressed state such that the
`male engaging portion of the first prosthesis is engaged in
`the intermediate female cooperating portion of the bifur-
`cated prosthesis; the first prosthesis is then caused to be
`allowed to re-expand in situ such that the male engaging
`portion engages in the female cooperating portion to resist
`longitudinal separation of the two prosthesis in service.
`The bifurcated prosthesis may be adapted for use in the
`infrarenal portion of a mammalian aorta in juxtaposition
`with the bifurcation of the common iliac arteries for the
`treatment of abdominal aortic aneurysms. In use the bifur-
`cated endoluminal prosthesis may be introduced into the
`infrarenal portion of the aorta using a catheter such that the
`first distal stent portion extends into one of the branched iliac
`arteries; the catheter may then be withdrawn allowing the
`prosthesis to re—expand in situ.
`It will be appreciated by a person skilled in the art that the
`prostheses may be introduced to the site of use percutane—
`ously or by “cut down” techniques.
`Any of the stents according to this invention may be
`provided on its external surface with circumferentially
`spaced wire barbs or hooks adapted to engage in the endolu-
`minal surface of the host artery to resist longitudinal move—
`ment or slippage of the stent in use. Typically the barbs or
`books may be disposed on part of the stent which is provided
`with a fabric graft layer such that in use the points of the
`artery which are engaged by the barbs or hooks are covered
`by the fabric graft. It will be appreciated by a person skilled
`in the art that the trauma to the artery wall caused by the
`hooks or barbs may cause emboli; the provision of the fabric
`graft over the barbs or hooks in use will therefore help to
`prevent the introduction of such emboli
`into the blood
`stream.
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`The male engaging portion for the first stent may be
`provided with circumferentially spaced hooks or barbs on its
`external surface to engage the internal surface of said female
`cooperating means.
`thereby to reinforce the connecting
`means against longitudinal separation of the stents one from
`the other in the service.
`
`65
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`The present invention therefore provides a connecting
`means for connecting two stents longitudinally one to the
`
`other. It will be appreciated that this represents a significant
`step forward in the art as it allows the provision of a
`bifurcated endoluminal prosthesis for use in juxtaposition
`e.g. with arterial bifurcations without requiring by-pass
`surgery to connect one of the branched arteries to the other
`branched artery.
`In particular. the invention provides a bifurcated endolu-
`minal prosthesis which can be posiu'oned in an artery in
`juxtaposition with a bifurcation to extend into one of the
`branched arteries; the bifurcated prosthesis can be connected
`to another prosthesis which extends into the other branched
`artery. The prosthesis can be delivered percutaneously or by
`“cut down” methods and connected together in situ thereby
`to provide effective treatment of an angeological disease
`such. for example. as an aneurysm or a stenosis which
`extends across a bifurcation in a blood vessel without the
`need for by—pass surgery.
`In another aspect. this invention provides an introducer
`for delivering. into the vasculanrre at an angeological bifur-
`cation where a blood vessel branches into two branched
`vessels. a bifurcated endoluminal stent or prosthesis having
`a proximal portion adapted to be disposed in the blood vessel
`and a distal portion adapted to be disposed at least partially
`in one of the two branched vessels. The introducer com—
`prises a tubular outer sheath. a proximal portion pusher
`disposed at least partially within the outer sheath. and a
`distal portion pusher disposed at least partially within the
`proximal portion pusher.
`The present invention further provides an introducer for
`delivering into the vasculanrre at an angeological bifurcation
`where a blood vessel branches into two branched vessels. an
`endoluminal prosthesis having a proximal stent portion and
`a distal stent portion. The introducer comprises a tubular
`outer sheath. a proximal portion pusher disposed at least
`partially within the outer sheath and having a proximal end
`adapted to contact the proximal stent portion. a distal portion
`pusher disposed at leant partially within the proximal por—
`tion pusher and having a proximal end adapted to contact the
`distal stent portion; and a balloon catheter. having a balloon
`attached thereto. disposed at least partially within the distal
`portion pusher.
`This invention in another aspect provides a method for
`delivering a bifurcated endoluminal stent or prosthesis hav-
`ing a proximal portion and a first distal portion into the
`vasculature at an angeological bifurcation where a blood
`vessel branches into a first branched vessel and a second
`branched vessel. The method comprises insuring a first
`introducer containing the stent or prosthesis into the vascu-
`lature to a predetermined delivery location. the first intro-
`ducer comprising an outer sheath. a proximal portion pusher.
`and a distal portion pusher; withdrawing the outer sheath of
`the first introducer while maintaining the proximal portion
`pusher in a fixed position until the proximal portion of the
`stent or prosthesis is deployed from the first introducer into
`the blood vessel; withdrawing the outer sheath and the
`proximal portion pusher while maintaining the distal portion
`pusher in a fixed position until the first distal portion of the
`stent or prosthesis is deployed from the first introducer at
`least partially into the first branched vessel; and withdrawing
`the first introducer from the vasculature.
`
`This invention further provides a method for delivering.
`into the vasculature at an angeological bifurcation where a
`blood vessel branches into two branched vessels. an endolu—
`minal prosthesis having a proximal stent portion. and a distal
`stent portion. The method comprises the steps of inserting an
`introducer containing the prosthesis into the vasculature to a
`
`W.L. Gore & Associates, Inc.
`Exhibit 1001-28
`
`W.L. Gore & Associates, Inc.
`Exhibit 1001-28
`
`
`
`7
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`8
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`5.716.365
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`predetermined delivery location. the introducer comprising
`an outer sheath. a pr