US008192482B2
`
`(12) United States Patent
`Goicoechea et a].
`
`(10) Patent N0.:
`(45) Date of Patent:
`
`US 8,192,482 B2
`*Jun. 5, 2012
`
`(54) ENDOLUMINAL STENT
`
`(75) Inventors: George Goicoechea, Grand Bahama
`(BS); John Hudson, Glen?eld (GB);
`Andrew H. Cragg, Edina, MN (U S);
`Claude Mialhe, Draguignan (FR);
`Michael D. Dake, Stanford, CA (US)
`
`(73) Assignee: Scimed Life Systems, Inc., Maple
`Grove, MN (US)
`
`( * ) Notice:
`
`Subject to any disclaimer, the term of this
`patent is extended or adjusted under 35
`U.S.C. 154(b) by 1263 days.
`This patent is subject to a terminal dis
`claimer.
`
`(21) Appl.No.: 09/977,826
`
`(22) Filed:
`
`Oct. 15, 2001
`
`(65)
`
`Prior Publication Data
`US 2002/0019659 A1
`Feb. 14, 2002
`
`Related US. Application Data
`
`(52) US. Cl. .................................................... .. 623/116
`
`(58) Field of Classi?cation Search ................. .. 623/1.1,
`623/1.11,1.13,1.15,1.16,1.22,1.34,1.35
`See application ?le for complete search history.
`
`(56)
`
`References Cited
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`(30)
`
`Foreign Application Priority Data
`
`Feb. 9, 1994
`Jun. 10, 1994
`
`(EP) ................................... .. 94400284
`(EP) ................................... .. 94401306
`
`(51) Int. Cl.
`A61F 2/06
`
`(2006.01)
`
`Primary Examiner * William H. Matthews
`(74) Attorney, Agent, or Firm * Brooks, Cameron &
`Huebsch, PLLC
`
`ABSTRACT
`(57)
`A stent is provided comprising a plurality of hoops aligned
`along a common axis, Wherein each of the hoops is oriented in
`a plane substantially perpendicular to the longitudinal axis of
`the stent. Each of the hoops includes a plurality of elongate
`elements joined to one another and forming apices that point
`in a direction along the axis of the stent. The stent also
`comprises means for securing an apex of one hoop to a jux
`taposed apex of a neighboring hoop.
`
`35 Claims, 23 Drawing Sheets
`
`001
`
`

`
`US 8,192,482 B2
`
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`US 8,192,482 B2
`Page 3
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`
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`
`

`
`US 8,192,482 B2
`Page 4
`
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`
`* cited by examiner
`
`004
`
`

`
`US. Patent
`
`Jun. 5, 2012
`
`Sheet 1 0f23
`
`US 8,192,482 B2
`
`FIG. 1A
`
`124
`
`141
`
`FIG. 1B
`
`,--m
`
`42
`
`18
`
`005
`
`

`
`US. Patent
`
`Jun. 5, 2012
`
`Sheet 2 0f23
`
`US 8,192,482 B2
`
`FIG. 2A
`
`Mr
`1 NH WW
`“*0 A 20
`
`006
`
`

`
`007
`
`

`
`US. Patent
`
`Jun. 5, 2012
`
`Sheet 4 0f23
`
`US 8,192,482 B2
`
`.mv 6.: mv .wHm Qv .mHm uv .mHm mv .2...‘
`
`WA WA WA WA WA
`
`008
`
`

`
`US. Patent
`
`Jun. 5, 2012
`
`Sheet 5 M23
`
`US 8,192,482 B2
`
`009
`
`

`
`US. Patent
`
`Jun. 5, 2012
`
`Sheet 6 0f 23
`
`US 8,192,482 B2
`
`Illllllll
`Ell‘ ?ououooooovouooéooooooooooooomomomomn.0
`
`
`010
`
`

`
`US. Patent
`
`Jun. 5, 2012
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`
`1
`ENDOLUMINAL STENT
`
`US 8,192,482 B2
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`2
`
`This application is a continuation of Ser. No. 09/313,593,
`filed May 18, 1999, now U.S. Pat. No. 6,302,906, which is a
`continuation of Ser. No. 08/662,484, filed Jun. 13, 1996, now
`U.S. Pat. No. 5,916,263, which is a continuation of Ser. No.
`08/317,763, filed Oct. 4, 1994, now U.S. Pat. No. 5,609,627,
`which is a continuation-in-part of Ser. No. 08/312,881, filed
`Sep. 27, 1994, now pending. This application is also a con-
`tinuation-in-part of Ser. No. 08/312,881.
`
`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 endolu-
`minal prosthesis) to another stent, as well as apparatus 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 ofa 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. Typi-
`cally, 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 com-
`pressed 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 which the blood vessel concerned is
`exposed by minor surgical means. When the stent is posi-
`tioned 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 sinuous
`configuration of the wire permits radial expansion and com-
`pression 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 per-
`mit 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 ofthe 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,
`stenoses and other angeological diseases at sites in continu-
`ous un-biurcated portions of arteries or veins.
`However, the prior art stents and prostheses are not wholly
`satisfactory foruse where the site of desired application ofthe
`stent or prosthesis is juxtaposed or extends across a bifurca-
`tion 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 portion 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 proxi-
`mal end of the other common iliac artery; by-pass surgery is
`therefore required to connect the one iliac artery in juxtapo-
`sition with the distal end ofthe 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
`requirement for by-pass surgery associated with the use ofthe
`prior art prosthesis in juxtaposition with a bifurcation in an
`artery therefore constitutes a significant disadvantage.
`
`SUMMARY OF THE INVENTION
`
`10
`
`15
`
`Throughout this specification, the term “proximal” shall
`mean “nearest to the heart,” and the term “distal” shall mean
`“furthest from the heart.”
`
`20
`
`According to one aspect of the present invention there is
`provided a stent connecting means for connecting two intralu-
`minal 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 ofthe 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 engag-
`ing 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 resil-
`iently 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 compress-
`ible.
`
`In use therefore the second stent may be delivered in a
`radially compressed state by using a catheter; when the sec-
`ond 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 ofthe second stent such
`that the male engaging portion of the first stent in the radially
`compressed state is entered into the expanded female coop-
`erating 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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`US 8,192,482 B2
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`3
`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 cooper-
`ating 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 pro-
`vided a bifurcated intraluminal stent for use in juxtaposition
`with an angeological bifurcation; the bifurcated intraluminal
`stent comprising a proximal portion adapted to be positioned
`in service in a blood vessel injuxtaposition with a bifurcation,
`a first distal stent portion adapted to extend across the bifur-
`cation into one of the branched blood vessels and a second
`
`distal stent portion adapted to allow blood to is flow from the
`proximal portion into the other branched vessel. The first
`distal stent portion may be formed integrally with the proxi-
`mal 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 constitute a sec-
`ond stent in accordance with the present invention 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 longitudi-
`nal 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 wind-
`ing 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 con-
`
`figuration of slightly greater diameter than the diameter ofthe
`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
`martersitic at temperatures below about 13° C. and is auste-
`nitic at temperatures above about 25° C.; it will be appreciated
`therefore that the type “M” wire will be austenitic at body
`temperature of 37° C. Typically, the annealing may be con-
`ducted 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 accordance 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 sub-
`
`stantially constant irrespective of the diameter of the vessel
`and the expanded stent.
`In some embodiments the wire may have a helical configu-
`ration 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 perpen-
`dicular to the longitudinal axis of the scent. Each hoop may
`
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`comprise a substantially complete turn of the wire having a
`sinuous configuration; optionally, as each hoop is completed,
`the point ofwinding 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 axes 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”0 to said longitudinal axis, so
`that when the stent is caused or allowed to expand in situ there
`is substantially no twisting ofthe stent as it shortens in length.
`It will be appreciated that this represents a significant advan-
`tage, 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.
`Typically, the stents ofthis invention whether ofthe helical
`or perpendicular variety, also comprise a securing means for
`securing an apex of the sinuous wire in one hoop to a juxta-
`posed apex of a neighboring hoop so that each hoop is sup-
`ported 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 com-
`prise 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 por-
`tion, ofthe first and second interengaging stents of this inven-
`tion, may be formed separately from the remainder of the
`respective nonengaging 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 frustocomcal stent
`portion; the narrower distal end of the first intermediate frus-
`toconical stent portion may be secured to the proximal end of
`the distal stent portion. The female cooperating portion ofthe
`bifurcated stent may be constituted by a second frustoconical
`stent portion which is secured to the distal end ofthe proximal
`stent portion in juxtaposition with the first frustoconical por-
`tion.
`
`Alternatively the first and second frustocomcal 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 secured to said proximal
`stent portion in transversely spaced relation to the distal por-
`tion.
`Each ofthe first and second stents ofthe 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 endolumi-
`nal prosthesis. Typically the graft layer may be 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 biocompatible fabric may be a
`
`029
`
`029
`
`

`
`US 8,192,482 B2
`
`5
`polyester fabric or a polytetrafluoroethylene 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 ofthe male engaging portion, and may be folded over
`the distal extremity ofthe 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 sub-
`stantially 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
`m