United States Patent [19J
`Goicoechea et al.
`
`[54] ENDOLUMINAL PROSTHESIS AND SYSTEM
`FOR JOINING
`
`[75]
`
`Inventors: George Goicoechea, Freeport,
`Bahamas; John Hudson, Glenfield,
`United Kingdom; Claude Mialhe,
`Draguignan, France; Andrew H.
`Cragg, Edina, Minn.; Michael D.
`Dake, Stanford, Calif.
`[73] Assignee: Boston Scientific Technology, Inc.,
`Maple Grove, Minn.
`
`[21] Appl. No.: 09/020,749
`Feb. 9, 1998
`[22] Filed:
`Related U.S. Application Data
`
`[63] Continuation of application No. 08/461,513, Jun. 5, 1995,
`Pat. No. 5,716,365, and a division of application No. 08/317,
`763, Oct. 4, 1994, Pat. No. 5,609,627, which is a continu-
`ation-in-part of application No. 08/312,881, Sep. 27, 1994.
`Foreign Application Priority Data
`[30]
`Feb. 9, 1994
`[EP]
`European Pat. Off. . ... ... .... ... 94400284
`Jun. 10, 1994
`[EP]
`European Pat. Off. .............. 94401306
`Int. Cl? ........................................................ A61F 2/00
`[51]
`[52] U.S. Cl. ............................................................. 623/1.16
`[58] Field of Search .................................... 623/1, 11, 12,
`623/1.16
`
`[56]
`
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`1111111111111111111111111111111111111111111111111111111111111
`US006117167A
`6,117,167
`[11] Patent Number:
`Sep.12,2000
`[45] Date of Patent:
`
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`OTHER PUBLICATIONS
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`1983).
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`ology, pp. 686-692 (1990.
`Primary Examiner-Michael 1. Milano
`Attorney, Agent, or Firm---Ratner & Prestia
`ABSTRACT
`[57]
`A stent joining means is provided for joining a first endolu-
`minal stent to a second endoluminal stent to define a
`continuous lumen through the first and second endoluminal
`stents. The stent joining means includes two transversely
`spaced female portions on the first endoluminal stent. The
`stent joining means also includes a male engaging portion of
`the second endoluminal stent. The male engaging portion is
`configured to be entered into one of the female portions in
`a radially compressed state and thereafter expanded in the
`female portion such that an outer surface of the male
`engaging portion and an inner surface of the female portion
`are interengaged to resist longitudinal movement to prevent
`separation of the first and second endoluminal stents in
`service.
`
`82 Claims, 23 Drawing Sheets
`
`W.L. Gore & Associates, Inc.
`Exhibit 1001-1
`
`

`
`6,117,167
`Page 2
`
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`7/1991 Gianturco.
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`5,041,126
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`5,047,050
`9/1991 Arpesani.
`5,057,092 10/1991 Webster, Jr ..
`5,064,435 11/1991 Porter ...................................... 606/198
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`5,085,635
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`5,104,399
`4/1992 Lazarus .
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`7/1992 Wiktor.
`5,133,732
`5,135,536
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`5,151,105
`5,161,547 11/1992 Tower.
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`
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`5,275,622
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`5,282,824
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`5,292,331
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`5,314,472
`7/1994 Song ....................................... 606/198
`5,330,500
`8/1994 Summers ................................ 606/198
`5,342,387
`5,354,309 10/1994 Schnepp-Pesch ......................... 623/12
`5,360,443 11/1994 Barone et a!.
`.......................... 606/195
`5,366,504 11/1994 Anderson et a!. .
`5,370,683 12/1994 Fontaine.
`5,383,928
`1!1995 Scott eta!. .
`5,387,235
`2/1995 Chuter.
`5,389,106
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`5,397,345
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`5,405,377
`5,415,664
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`5,443,498
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`5,507,767
`4/1996 Maeda.
`5,507,771
`4/1996 Gianturco.
`5,562,724 10/1996 Vorwerk ...................................... 623/1
`5,562,727 10/1996 Turk et a!.
`................................ 623/12
`5,562,728 10/1996 Lazarus et a!.
`......................... 606/194
`5,571,170 11/1996 Palmaz et a!. .......................... 606/108
`5,575,817 11/1996 Martin ......................................... 623/1
`5,662,675
`9/1997 Polanskyj-Stockert ..................... 623/1
`5,676,697 10/1997 McDonald .................................. 623/1
`
`FOREIGN PATENT DOCUMENTS
`0508473 A2 10/1992 European Pat. Off ..
`0 540 290 A2
`5/1993 European Pat. Off ..
`0551179A1
`7/1993 European Pat. Off ..
`0556850A1
`8/1993 European Pat. Off ..
`0579523A1
`1!1994 European Pat. Off ..
`0 536 164 B1
`3/1994 European Pat. Off ..
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`6/1994 European Pat. Off ..
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`0 646 365 A1
`4/1995 European Pat. Off ..
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`6/1995 European Pat. Off ..
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`6/1995 European Pat. Off ..
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`7/1995 European Pat. Off ..
`2678508
`4/1991 France .
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`1!1993 France .
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`8/1994 Germany.
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`4/1983 United Kingdom .
`W089/08433
`9/1989 WIPO.
`W091!07928
`6/1991 WIPO.
`92/00043
`1!1992 WIPO ........................................ 623/1
`W093/13825
`7/1993 WIPO.
`W094/17754
`8/1994 WIPO.
`W095/01761
`1!1995 WIPO.
`
`W.L. Gore & Associates, Inc.
`Exhibit 1001-2
`
`

`
`U.S. Patent
`
`Sep.12,2000
`
`Sheet 1 of 23
`
`6,117,167
`
`FIG. 1A
`
`10
`
`jB
`
`FIG.
`43
`
`12
`
`16
`
`W.L. Gore & Associates, Inc.
`Exhibit 1001-3
`
`

`
`U.S. Patent
`
`Sep.12,2000
`
`Sheet 2 of 23
`
`6,117,167
`
`FIG. 2A
`
`26,
`
`22
`
`25a
`
`FIG. 28
`20a
`
`25
`
`W.L. Gore & Associates, Inc.
`Exhibit 1001-4
`
`

`
`U.S. Patent
`
`Sep.12,2000
`
`Sheet 3 of 23
`
`6,117,167
`
`FIG. 3
`
`FIG.
`22
`
`20
`
`17
`
`W.L. Gore & Associates, Inc.
`Exhibit 1001-5
`
`

`
`U.S. Patent
`
`Sep.12,2000
`
`Sheet 4 of 23
`
`6,117,167
`
`•
`
`(.!) t
`
`W.L. Gore & Associates, Inc.
`Exhibit 1001-6
`
`

`
`U.S. Patent
`
`Sep.12,2000
`
`Sheet 5 of 23
`
`6,117,167
`
`FIG. 5
`
`58
`
`54
`
`FIG. 7
`
`96
`
`W.L. Gore & Associates, Inc.
`Exhibit 1001-7
`
`

`
`U.S. Patent
`
`Sep.12,2000
`
`Sheet 6 of 23
`
`6,117,167
`
`-:!;../( n l
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`- :: II
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`II
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`W.L. Gore & Associates, Inc.
`Exhibit 1001-8
`
`

`
`U.S. Patent
`
`Sep.12,2000
`
`Sheet 7 of 23
`
`6,117,167
`
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`W.L. Gore & Associates, Inc.
`Exhibit 1001-9
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`

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`U.S. Patent
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`Sep.12,2000
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`Sheet 8 of 23
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`6,117,167
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`W.L. Gore & Associates, Inc.
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`Sep.12,2000
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`6,117,167
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`W.L. Gore & Associates, Inc.
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`Sep.12,2000
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`U.S. Patent
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`Sep.12,2000
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`W.L. Gore & Associates, Inc.
`Exhibit 1001-13
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`

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`U.S. Patent
`
`Sep.12,2000
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`6,117,167
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`W.L. Gore & Associates, Inc.
`Exhibit 1001-14
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`U.S. Patent
`
`Sep.12,2000
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`6,117,167
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`W.L. Gore & Associates, Inc.
`Exhibit 1001-15
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`

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`Sep.12,2000
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`Sep.12,2000
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`Sep.12,2000
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`
`Sep.12,2000
`
`Sheet 19 of 23
`
`6,117,167
`
`W.L. Gore & Associates, Inc.
`Exhibit 1001-21
`
`

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`
`Sep.12,2000
`
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`W.L. Gore & Associates, Inc.
`Exhibit 1001-23
`
`

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`U.S. Patent
`
`Sep.12,2000
`
`Sheet 22 of 23
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`
`Sep.12,2000
`
`Sheet 23 of 23
`
`6,117,167
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`Exhibit 1001-25
`
`

`
`1
`ENDOLUMINAL PROSTHESIS AND SYSTEM
`FOR JOINING
`
`This is a Continuation of U.S. patent application Ser. No.
`08/461,513, filed Jun. 5, 1995 (status: allowed), which is a
`Divisional of U.S. patent application Ser. No. 08/317,763,
`filed Oct. 4, 1994 (status: issued), which in turn is a
`Continuation-In-Part of U.S. patent application Ser. No.
`08/312,881, filed Sep. 27, 1994 (status: pending).
`This is a continuation-in-part application of the applica-
`tion of common assignment herewith of inventors George
`Goicoechea, Claude Mialhe, John Hudson and Andrew
`Cragg, entitled BIFURCATED ENDOLUMINAL
`PROSTHESIS, filed on Sep. 27, 1994, for which application
`a serial number had not yet been assigned as of the date of 15
`filing this continuation-in-part application.
`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 30
`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 skin or by a "cut down" technique in 40
`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 50
`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 55
`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
`EP-A-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,
`
`6,117,167
`
`2
`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-
`5 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-
`10 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
`20 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
`25 "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
`35 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
`45 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
`60 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
`65 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
`
`W.L. Gore & Associates, Inc.
`Exhibit 1001-26
`
`

`
`6,117,167
`
`3
`such that the male 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 5
`cooperating portion of the second stent.
`In some embodiments of the present invention the second
`stent may have two transversely spaced distal female coop-
`erating 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
`
`4
`"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 EP-A-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
`10 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
`15 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
`20 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
`25 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
`30 used.
`Typically, the stents of this invention whether of the
`helical or perpendicular variety, also comprise a securing
`means for securing an apex of the sinuous wire in one hoop
`to a juxtaposed apex of a neighboring hoop so that each hoop
`35 is supported by its neighbors. The securing means may
`comprise a loop element of a suture material, for example,
`to tie 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
`40 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
`45 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
`50 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
`55 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 secured to the
`distal end of the proximal stent portion in juxtaposition with
`60 the first frustoconical 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
`65 generally cylindrical stent portion secured to said proximal
`stent portion in transversely spaced relation to the distal
`portion.
`
`W.L. Gore & Associates, Inc.
`Exhibit 1001-27
`
`

`
`6,117,167
`
`25
`
`30
`
`5
`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 in juxtaposition with the
`stent; the combined stent and graft layer constituting an
`endoluminal prosthesis. Typically the graft layer may be 5
`disposed externally of the stent; it will be appreciated
`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- 10
`patible fabric may be a polyester fabric or a polytetrafiuo-
`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 20
`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 40
`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 45
`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- 50
`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- 55
`ment or slippage of the stent in use. Typically the barbs or
`hooks 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 60
`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.
`The male engaging portion for the first stent may be
`provided with circumferentially spaced hooks or barbs on its
`
`6
`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.
`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 positioned in an artery in
`15 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 vasculature 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 vasculature at an