CA2217606A1 - Dual supported intraluminal graft - Google Patents

Abstract

This invention is a dual supported intraluminal graft comprising a biocompatible flexible layer (16) sandwiched between two structural support layers (18, 20). The preferred embodiment comprises a first structural support (18), such as a stent, which is concentrically retained within a tubular shaped PFTE graft (16) which is concentrically retained within a second structural support (20), such as a stent. The ends of the PFTE graft may be folded back onto the outer surface of the second structural support thereby forming flaps (30, 32). Upon radial expansion of the preferred embodiment, the stent/graft/stent assembly forms inseparable layers.

Description

W 096133672 PCT~US96/04293 DUAL SUPPORTEI) INTRALI~MINAL GRAFT

FielA ~f the Tnventinn The present invention relates g~n~r~lly to an intr~ min~l graft which comrriees a polyk;~ o~oeLllylene (PIPE) m~tPri~l sandwiched bt;lw~;el~ two similar structural ~u~lL m~tPri~le such as those m~tl-ri~le which comrrie~ stents. The stent m~t~ri~le inelll~e any s~it~hle m~t~ri~l having the strength and el~eticity to permit radial eY~r~neion and resist radial collapse such as silver, ~ lh"", st~inless steel, gold, or any suitable plastic m~t~i~l having the required strength and el~eticity as previously described.
More particularly, one p~r~ ed embo lim~-nt of the present invention relates to a balloon eYp~nd~hle intr~ min:ll vascular graft which in-llld~e a PTFE tubular graft that is sandwiched bt;lw~ll two radially eyp~ntl~hle stent~e. Other emborlim~nte of the invention in~ le, but are not limited to, a tubular configuration having an un~u~?ol Led fleYible graft section bt;lw~ dual ~u~ d ends, an articulated tubular config--r~tinn, and a biru~ L~d tubular configuration. The dual su~ lLed intr~lllmin~l graft may be used in both vascular and non-vascular applications to eli",in~le obstructed areas. Ct nt~mrl~t~ non-vascular applications in~ln-le, but are not limited to, esophageal stenosis, prostatic hyperplasia and constricted fallopian tubes. The present invention is further directed to a method for producing the double stented intr~lllmin~l graft.

ne~,;pl;t)n of the Prinr Art Radially eYp~nti~hle stents are used to m~int~in an occluded anatomical passageway in an unoccluded state and are well known in the art of vascular prostheses.

W 096/33672 PCTrUS96/04293 The use of radially PYr~n-l~h1e stents in endovascular applir~tion~ is eYPmrlified in U.S.
Patent No. 4,733,665 issued to Palmaz and U.S. Patent No. 4,580,568 issued to GianluLco.
The prior art in the field of the invention inr.llldes llUllleÇùus stent/graft co,..l~ . For eY~ , the Parodi, et al. patent, U.S. Patent No. 5,219,355, discloses a balloon device for i.. ~ n~ g an aortic intr~ min~l prosthP~ for l~h ;.~g aneurysms which utilizes a c~thPtPr having two infl~t~hle balloons to expand two stents which are sutured to o~posile ends of a flexible dacron graft. The main ~ ose of the stents is to f~c.ilit~e se~unin~ and ~nrhoring the graft to the wall of the blood vessel. The Kreamer patent, U.S. Patent No. 5,078,726, describes a method and app~dius for l~i,h~g awe~kPnP~ blood vessel section which inrlu-le~ a pair of eyr~nrl~hle stents that are placed on the inside ends of a fleYihle vascular graft. The graft/stent ends of the rçsulting prosthP~i~ are positionPl1 on the we~kp-np~d sides of the blood vessel and eYr~n~e~l to frictionally secure the graft within the vessel. The purpose of the Kreamer method and apparatus is to provide structural support to the ends of the resnlting graft which further f~ceilit~tçs ~nrhoring the ends of the resulting graft to a blood vessel.
Other means for supplying structural support and stability to the ends of a flexihle vascular graft are also known in the prior art. For PY~mrle, the ~l-ghes, et al.
patent, U.S. Patent No. 4,728,328, ~ clc)ses a cuffed tubular vascular prosthesis. The prosthesis is formed by coating a mandrel with a polymer solution, air-curing the coating, removing the prosthesis from the mandrel, turning the prosthP~i~ inside out, folding back the edges of the prosthesis over itself, and bonding the turned back edges to the body of the plu~ . A double cuffed prosthesis may also be formed by sliding a suture sleeve over the prosthesis cuff, folding the sleeve back over itself, and bonding its turned over edges W 096/33672 PCTrUS96/04293 to the prosth~-ciC cuff and tubular body. This graft configuration ~ es infectif n and tissue granlllatinn at the ana~tQm~ si~, and ~ s long term stability when the ends of the blood vessel are pulled over and sutured to the prosthesis cuffs. The Patel patent, U.S.
~ Patent No. 4,769,029, 11icrl~ses ~noth~r tyye of structural ~uyyOll and al-rh~, ;.-g device S located at fhe ends of a flPYihle tubular graft. T~e Patel prosthesis describes an anrht ring device ~tt~rh~ at o~osi~e ends of a flPYih1e tube m~mher where each ~n~ o, ;--g device c~:?mrri~es a ring m~mher, a circular member spaced a predete min~ ~li.ct~nre apart from the ring ~"r-..lxl, and a C~ nn~!;n~ mP.mher which attarhPs the ring and circular members.
Each ring mPmher is conn~cte~ to, and defines an opening into, an opposite end of the fl~Yihle tube ",~.,.he~.
More rc~nlly, the field of prior art has advanced to provide structural ~7U~J~JUll to other areas of the flPYihle vascular graft, inr~ in~ mid portions and entire surface areas of the graft, in ~Mition to just the end portions of the vascular graft. For example, U.S. Patent No. 5,211,658 issued to Clouse dicclc~ses a device for lC~;,;np an~:uly~,.,s which co~ ;~s at least a ~r.;u~ eously-insertable structural frame, a flPYihle thin-walled tubular l"e"lber placed within the structural frame, and means for eYranflin~
and holding the flPYihle tubular member ~ pnt the inside of the structural frame.
Fur~er, the Song patent, U.S. Patent No. 5,330,500, discloses a radially eYp~n-l~hle stent having an outer surface wl~ed with mesh. The mesh is then coated with a silicon rubber which pl~;vell~, cancer cells from penptrating into the stent.
Finally, recent improvements have been made in the area of structllrally su~l~d grafts which include grafts that comprise overlapping stents or similar types of structuIal supports. For in~t~n. e, U.S. Patent No. 5,064,435 issued to Porter discloses a W 096/33672 PCTrUS96/04293 self-eYr~n-ling prosthe-ci.c comrri.cing two or more generally tubular, coaxial and slidably c~nnPcte~l stent sP.gm~P-nt.C. The axially uulw~d and non-overlapping portions of the stent may be used to fprilit~tç fiY~*on of the prc,sll.P.~ic to the blood vessel. ~ ;vely~
reinforcing segmPnt.c may be poci*onPd near the ol)l osilG ends of the stent in order to S IIIAinl;lin the axial length of the ~ro:ilh~;.c during PYp~n.cion.
Also, the MorgPn patent, U.S. Patent No. 5,380,328, ~li.c- l~sPs a co~llpo~iLe pe- r~ l~ implant :iLIu~ G which comprices at least one biologically and chP-mic~lly inert microporous membrane which is ~u~u,led by at least one layer of pelru,dLGd, hi~..-~ il-le mPt~llic sheet m~tPri~l The micr~,uus mP.mhr~nP is ~erGldbly comrri.ced of randomly tlicI~prsecl PTFE fibers, ~ lulGs of cp~ lose acetate and cP~ lnse nitrate fibers, or polyvinylidine ~ifl~lori-lç fibers. The Morgan patent also discloses an impl~nt structure which in~ ldes two layers of ~. î...,,l~, bioco,..l~l;hle mPt~llic sheet m~t-ri~l wherein one layer is affixed to each side of the biologically and chPmic~lly inert miclupo~uus membrane.
Although the prior art addresses some of the spPrific problems ~ccoci~tP~
with flexible vascular grafts such as the need for minim~lly invasive pf~,cedulGs and devices for re~aLllg blood vessels, the need for structural support of the graft particularly at its ends in order to f~ it~tP ~n~.h.., ;-~g the graft to the blood vessel, and the desire to m~int~in the axial length of the graft, the prior art does not address the need for the continuous uniform eYp~n.ciQn of the graft during ~ t~*t~n of the graft for endovascular orintr~l--min~l applic~*on. Further, the prior art does not disclose a monolithic device for endovascular or intr~lnmin~l applir~ti~n which comrricPc il~sep~dble co",ponent layers that serve to mimic the function of a blood vessel in vivo. The prior art also fails to disclose W O 96/33672 PCT~US96/04293 a vascul~r graft having a structural co~ o~ilion which allows the final eYr~n~ion ~ mett-,r of the graft to increase without increasing the introducer sheath size.
Acco~ingly, there is a need for a vascular graft having a structural ~ configuration which provides for all of the previously described .~ os in order to provide a comr~t, durable and easily i.. lpl~ hle vascular graft.

of th~ Tnventinn It is a prin~ir~l object of the present invention to provide a in~lllmin~l graft having dual ~u~pOl~ m~mhPr.~.
It is a further object of the present invention to provide an eyr~nrl~hle intr~lllmin~l graft that can be used with any collve~.l;on~l balloon c~lh~el and which easily ~let~hes from the balloon ~-~lhrl~ upon ~lefl~tion of the balloon without eYhihiting recoil of the graft onto the balloon.
It is still a further object of the present invention to provide a one-piece eYr~n~hle intr~ min~l graft which comrri.~es a poly~ lluoroethylene layer and dual support layers which are il-~e~ hle both in vitro and in vivo.
It is yet a further object of the present invention to provide an ~Yr~n-l~hle intr~ll-min~l graft which can ~lrullll ul~irc~llll radial eYr~n~ion upon infl~tion of the eYr~n-l~hle intr~ min:~l graft with any convei.l;Qn~l balloon c~thpt~-r.
It is a still further object of the present invention to provide an intr~ min~l graft that has increased durability over prior art intr~lllmin~l grafts.

W 096/33672 PCT~US96/04293 It is yet another object of the present invention to provide an eYr~nd~hle intr~lllmin~l graft which produces ~nl.hnring points at its ends upon eYr~n~ n of the graft in vivo for secllrin~ the graft to a blood vessel wall.
It is still another object of the present invention to provide an intr~lllmin~l graft having increased radiopacity Ih~l~y en~hting its position to be easily loc~li7~
It is another object of the present invention to provide an eYr~n~lahle intr~hlmin~l graft whose final PYr~n~ n rli~m~t~o.r can be increased without increasing the si7.e of the introducer sheath.
It is yet another object of the present illv~lll.~n to provide an PYr~n~hle duals.l~pollt;d intr~ min~l graft having a tubular shaped polylel., ll-.o.~lllylene graft sandwiched between two stents wherein the stents and polyl~;l,i,ll~lo,oell.ylene graft form in~ep~r~hle layers.
It is yet another object of the present invention to provide an ~Yr~ntl~hle dualsupported intr~lllmin~l graft whose final eYr~n~ic)n length eYhihit~ no foreshortening or co---l~ression of the graft away from the ends.
Briefly, the present invention generally comrri~es an eYr~ntl~hle dual supported intr~lumin~l graft which comrri~çs a first layer of support m~tPri~l, a second layer of support m~tP.ri~l directly ovell~ g the first layer of support m~ttori~l, and a biocompatible fleYihle layer sandwiched between the first and second layers of support m~teri~l wherein at least a portion of the bioco.. ~ ;hle flexible layer is folded back onto at least one of the support layers. The support layers are preferably comprised of a strong m~tt-.ri~l which resists radial collapse such as silver, lil;.ni~ , st~inles.~ steel, gold, or any suitable plastic m~teri~l having the ntoces~ry strength and el~cticity to enable uniform W 096/33672 PCTrUS96/04293 eYr~n~ion without coll~pse The bioco..-~ hle fleYible layer is preferably compri~ of eYp~nr1PA polyl~l ~ n, ~ n;lhylene.
A ~.~rr~ embo~imrnt of the eYp~n-l~hle dual su~ ~d endovascular or ~ in~lnmin~1 graft inr1lldlPS a first tubular shaped su~poll member having an inner surface S and an outer snr~r~, a second tubular shaped s.l~lL member having an inner surface and an outer surface whlr~in the first tubular shaped support member is conr~ntrir~11y po~iti~nPd within the second tubular shaped ~u~ member, and a bioco.,.p .l~hlP fleYihle tubular ",c;",b~r sandwiched b~lwee~l the first and second tubular shaped members such that the outer surface of the bioco ..p~;hle flexible tubular m~mber lies ~ ~nt to the inner surface of the second tubular shaped suppoll member and the inner surface of the bioco -l~l;ll'~ fleY~ible tubular r- 1-e lies ~ c~nt to the outer surface of the first tubular shaped ~u~pcll member.
The second tubular shaped support . ..~ . .he~ in the ~lcrc~ d embodiment may comprise first and second cylin-lrir~l shaped ~u~?oll m~mhPrs which are (le~ipn~ to be ~o~ ;. n~l so that each ~iy1i~ 1 support .. ~ .lh~ overlaps the first tubular shaped support member at one of its ends. This configuration of the second tubular shaped support member results in a in~ lmin~1 graft having a first tubular support member, a fl~Yihle biocol"patible tubular member positi~ ned over the first tubular support member which is at least as long as the first tubular support member, and two shorter cylin-lrir~l shaped support members po~ition~l over the flexible bioco"lpatible tubular member near ach of its ends, respectively. Accordingly, there is no dual support at the center of the intr~lllmin~l graft. Tn~te~ only one support member, namely the first tubular shaped W 096/33672 PCTrUS96/04293 support Illr~llhe~ provides support to the flexible bioo~ ;hle member at the center of the graft.
In ~(1rlition~ the first tubular shaped support member in the ~ler~llcd embodiment may also comprise a set of two shorter cylin-~ric~l shaped Su~)~)Ol~ members wh;ch are ~eeignP~ to be positi~n~ such that the two shorter cylin~lri~l shaped support members which comprise the second tubular shaped support member d.le~lly overlap the two cylinflric~l shaped SU~ members which comprise the first tubular shaped support member. In the ~lc;r~ ;d emb~limpnt~ the tubular shaped support members preferably comprise stents like those previously described in reference to Palmaz, U.S. Patent No.
4,733,665, and Ci~llulco, U.S. Patent No. 4,580,568. Further, the use of a spring or spring-like structure for the tubular shaped Su~)~lllllelllb~l~iS also cc nle...l l~t~l . The fle.ihle bioco...r~l;hle tubular mPmher is preferably comrri~ecl of e~p~n-lecl polyW~ o~ lylene. When the first tubular shaped support member also compri~s twoshorter cylin-lri~l shaped ~U~ like the second tubular shaped support member described above, the res--lting configuration is a vascular graft compri~ing a PTFE tube having double stents located at each end of the tube, one stent on the outside of the PTFE
tube and one stent on the inside of the Pl~E tube, thereby leaving the center section of the PTFE tube un~.l)polled. The present invention also cf-l.lr ..l l~t~s an intr~l~-min~l graft having double stents sandwiching a PTFE tube wh~le-.~ the double stents are located at only one end of the intr~ min~l graft.
Further, the ends of the biocomr~tihle flexible tubular layer in the above described pl~;r~ d embodh~lent may be folded back against the outer surface of the second tubular shaped support member so that the ends of the second tubular shaped support W 096133672 PCTnUS96/04293 ...~...l~ are enrz~d within the biocolllpalible fl~Yihle tubular mPmhPr. Where the second tubular shaped ~U~IUIl m~mber comrri~es first and second shorter cylintlrit-~1 shaped ~7ulJ~?oll members, the ends of the flexible biocol,l~lible tubular member may be folded back onto the shorter cylin~lrit~l shaped support members such that at least one end of each of the shorter cytintlrir~l mPmbers is Pnt~PA within the ffexibIe biocol"paLibIe tubular member. This ad~litit n~l structural Pl~mPnt of the device creates a vascular prosthP~i~
having a stent/graft co...l-h~ t)n which enables u~ ... radial PYr~n~ion from the center uulw~l with any cull~e~ l balloon c~th-~ter without ~ui-ing suhlring of the graft and stent co"l~ ents to one another.
Also, both the first and second tubular shaped ~u~)oll members in the p t;r~ d t ...horli...t~ may each cc~ ;~ a series of shortened cylin-lric~l sup~ll members which thereby form multiple pairs of directly uv~l~ing cylintlrir~l ~u~pc,ll mPmhPr.~ with gaps belw~n each uv~l~p~ing pair to allow fl~-Yihility along the length of the graft. Each pair of ov~ ing cylin-lrir~l suppo l members contains a portion of the bioco...l~t;hle flPYihle tubular layer sandwiched between them. The resulting configuration is an intr~lllmin~l graft having double stents at each end of the graft for ~nehnrinp, with ~1l~. ..~I;.~p areas of dual support mPmhPrs for increased durability, and ~ltPrn~tinp areas of un~u~ led graft for flexibility in both delivery and deployment of the graft.
The present invention is also directed to a process for making an PYp~nfl~hle dual su~olled intr~ min~l graft which inclll-les the steps of:
a) positioning a biocolllpalible flexible tubular member having an inner surface and an outer surface over a first tubular shaped support member having an inner surface and an outer surface such that the inner surface of said biocolll~aLible flexible W 096/33672 PCT~US96/04293 tubular member lies ~ e~nt to the outer surface of said first tubular shaped support memher;
b) positioning a second tubular shaped support member having an inner surface and an outer surface dilc illy over the outer surface of said bioco..-r~l;hle ffeYI~le tubular member such that the outer surface of said biocGlllpalibIe fleYI~Ie tubuIar member is ~ Pnt the inner surface of said second tubular shaped support member and said bioco..,p~l;hle fleYihl~ tubular member is sandwiched bclw~ll said first and second tubular shaped support memhers; and c) applying a yO~ilive plC~i~UlC to said bioco,~r~ ihle flexible tubular member and said first and second tubular shaped support members such that all of said memhers are in~ep~r~hle.
The process may further include the step of folding the ends of the biocolllpalible fl-oYihle tubular member back over the ends of the second tubular shaped support member and onto the outer surface of the second tubular shaped support member lS thereby en~ing the ends of the second tubular shaped support member within the biocolll~Lible flexible tubular memher.
These and other objects, features and advantages of the present invention will become more a~clll to those skilled in the art when taken with reference to the following more detailed description of the ~ crcl-cd emb~li"~ of the invention in conjunction with the accol~ anying drawings.

W 096/33672 PCTrUS96/04293 Rrief n~ inn nfthe nr~wing.c Figure 1 is a perspective view of a first ~cr~llcd embodiment of the dual ~u~polled intr~lllmin~l graft of the present invention comTri.cing a tubular shaped configuration which in~ de,$ a configuration of the su~ m.~mherc.
S Figure 2 is another p~-r~I~ective view of a first ~ ertill~ e~ o~Iilllt;lll of ~e dual :jU~ ed intr~lnmin~l graft of the present invention comrricing a tubular shaped configuration which in~llldes a second configuration of the ~u~lL members.
Figure 3 is a ~ ~iLiVt; view of the first ~lc;r~lled embodiment of the pleselll invention shown in Figure 2 com~ricing the tubular ch~pecl, dual ~u~poll~d intralllmin~l graft shown par~ally cut away to expose the underlying bioco",p~l;hle member and underlying ~u~J?oll member which comprise part of the intr~hlmin~l graft.
Figure 4 is a cross-section~l view of the tubular sh~re~, dual su~pol~d in~lllmin~l graft shown in Figure 2 taken along line 4-4 of Figure 2.
Figure 5 is a cross-sectinn~l view of the tubular ch~ped, dual ~u~lled inh~lllmin~l graft shown in Figure 2 taken along line 5-5 of Figure 2.
Figure 6 is a lon~itn-lin~l cross-section of a first ~rer~ d embodiment of the dual su~polled intr~lllmin~l graft of the present invention in an lm~Yr~n-1ed state.
Figure 7 is a lnngit~ in~l cross-section of a first ~l~r~lred embodiment of the dual ~u~l?olled intr~lllmin~l graft of the present invention shown after eYp~ncic)n Figure 8 is a ~ re view of a second embodiment of the tubular shaped, dual sup~lled intr~lumin~l graft configuration of the present invention with areas shown partially cut away to expose the underlying layers which comprise the intr~lllmin~l graft.

W 096/33672 PCTrUS96/04293 Figure 9 is a cross-se~tion~l view of the tubular shaped, dual su~ ~lled intr~lllmin~l graft shown in Figure 8 taken along line 9-9 of Figure 8.
Figure 10 is a cross-section~1 view of the tubular shaped, dual ~u~,Led intr~lllmin~l graft shown in Figure 8 taken along line 10-10 of Figure 8.
Figure 11 is a pe~ e view of a th~rd e,~ of the tubular .~h~pe~, dual ~u~JulLed intralllmin~l graft configuration of the present invention shown partially cut away to expose the underlying layers which comprise the intr~lllmin~l graft.
Figure 12 is a cross-sectional view of the tubular shaped, dual suL~ulLed intr~lllmin~l graft shown in Figure 11 taken along line 12-12 of Figure 11.
Figure 13 is a cross-se~ti~ n~l view of the tubular shaped, dual su.~lled intr~lllmin~l graft shown in Figure 11 taken along line 13-13 of Figure 11.
Figure 14 is a cross-se~ti~-n~l view of the tubular shaped, dual ~u~?~ll~d intr~lllmin~l graft shown in Figure 11 taken along line 14-14 of Figure 11.
Figure lS is a pP-r~ tive view of a fourth embodiment of the tubular shaped, dual ~u~?pol~d intr~lllmin~l graft of the present invention shown partially cut away to expose the underlying layers which comprise the graft.
Figure 16 is a cross-section~l view of the tubular-shaped, dual su~lled intr~ min~l graft shown in Figure 15 taken along line 16-16 of Figure 15.
Figure 17 is a cross-sectional view of the tubular-shaped, dual ~u~lLed intr~ min~l graft shown in Figure lS taken along line 17-17 of Figure lS.
Figure 18 is a cross-sectional view of the tubular-shaped, dual ~u~olled intrAlllmin~l graft shown in Figure lS taken along line 18-18 of Figure lS.

Figure 19 is a cross-sectional view of the tubular-shaped, dual supported intr~lllminAl graft shown in Figure 15 taken along line 19-19 of Figure 15.

net~ile1 nP.~-~..;p1it~n l~fthPPrefPrr~l F.mh~l;....~
l2f~r ~ g now to the figures, where the l~r~ ce mlmP~t~ ~e~lcsent various elemPnt~ of the present invention, a first p~cr~lled embo~limPnt of the dual ~u~llcd intrAlllminAl graft 10 is ill-.~;l.,.led in Figures 1 and 2. The first ~lcr~lled embodiment of the dual s~ d intr~lllmin~l graft 10 of the present invention generally compri~P~ a tubular shape having a first end 12 and a second end 14. The tubular shaped, dual ol~d intr~lllmin~l graft co...l). ;~s a flPYihle tubular member 16, preferably comrri~P~
of a bioc4.. l~l;hlP m~tPriA1 such as polyl~ n~u~ ylene ~l~), which is loaded over a first tubular shaped s.~ member 18, which ~lcr~ldbly ct)mrri~es a stent like that des~nbe~ in U.S. Patent No. 4,733,665 issued to PaLm-~z. A second tubular shaped support mPmber 20 is then loaded over the stent/graft combin~tion~ and the first and second ends 22,24 of the flexible tubular member 16 are folded back over the first and second ends 26,28 (not shown) of the second tubular shaped support .. ,~.. ,he 20 to form first and second flaps 30,32 ~cs~e~;liv~ly.
Like the first tubular shaped support member 18, the second tubular shaped support member 20, preferably comI~rises a Palmaz stent. The first and second tubular shaped support members 18,20 may be compri~e~ of any m~tPri~l having the strength and elasticity to permit radial PYp~n~ion and resist radial collapse. Examples of such m~tPri~
incll1cle silver, ~ l, st~inlp~ steel, gold, and strong suitable plastics. Fig. 1 also AI~S barbs 21 which are formed from the first tubular shaped support member. The W 096/33672 PCTrUS96/04293 barbs 21 assist in se~uring and ~n~horin~ the dual suL~l~ed intr~ min~l graft within a blood vessel.
After loading the tubular shaped m~.mhl-.r.c onto one another and folding back the ends of the Pl~ tube, the tubular stent/graft/stent ~cc.o.mhly is loaded onto a standard S baIIoon c~thPt~-r for eYr~nC;on in vivo. The tubuIar shap~d, dual ;~ul)pol~ed intr~tllmin~
graft 10 of the present invention is ~eci~n~l to be used with any convention~l balloon on a balloon c~theter making the delivery system for the device simple and cost effici~.nt Figure 3 depicts a ~r.. ~ ;ve view of the first plt;;r~ d embodiment of the present invention comrricing the tubular .ch~re~, dual s.~?polled intr~lllmin~l graft illllctr~t~ in Figure 2 shown partially cut away to expose the underlying mt-.mhers which comprise part of the intr~lllmin~l graft. The tubular shaped, dual su~"x~ d intr~lllmin~l graft 10 in~.llldes a bioco...~ ihle flPYihle tubular member 16, p~reldbly comrricecl of PTFE, which is sandwiched be~w~n two tubular shaped support members 18,20, which preferably compric~- Palmaz stents, all of which are capable of being radially PYp~n-lecl The hi~co.. l~l;hlP. flexible tubular Illr.. li~., 16 is greater in length than the first and second tubular shaped support Illr.lllhr.l.~i 18,20. This allows the first and second ends 22,24 of the bioco",p~lihle flexible tubular member 16 to be folded back onto the outer surface of the second tubular shaped support member 20, thereby en~cing the first and second ends 26,28 (not shown) of the second tubular shaped support member 20 within the bioco~ lihle flexible tubular member 16, and forming flaps 30,32 on the outer surface of the second tubular shaped support m.o.mher 20.
The second tubular shaped support member 20 is cut away to reveal the underlying biocompatible tubular flexible member 16, which is further cut away to reveal W 096/33672 PCTrUS96/04293 the first tubular shaped SU~ member 18. The first and second tubular shaped support ~l.el-lb~ ~ 18,20 may be of the same length. When the first and second tubular shaped support .,-~...lx~. ~ 18,20 are of the same length, the second tubular shaped support member 20 ~llul~ls lon~itu(linAlly as the center of the tubular shaped, dual ~u~)~ L~d in~1nmin~l graft 10 eYr~n~ during inflation of the ba~[oon. The shortening of the secon~ tubular shaped ~u~ L member 20 allows the ends of the first tubular shaped ~u~ll member 18 to flare oulw~ beyond the first and second ends 26,28 (See Figs. 6-7) of the second tubular shaped ~u~ulL member 20 and thereby function to assist in anrhoring the tubular shaped, dual ~up~lL~d intrAlllminAl g~aft 10 to the wall of a blood vessel. If flaring of the ends of the first tubular shaped ~u~poll memher 18 is l-ndP~irAhle, the flaring can be c<~ d by using a first tubular shaped support member 18 that is shorter in length than ~e second tubular shaped su~ L mPmber 20 when constructing the tubular ~h~pecl, dual ~u~ L~;d intrAlllmin~l graft 10.
The first and second flaps 30,32 of the bioco.~ hle tubular flPYihle lS member 16 and the first tubular shaped su~lL member 18 of the tubular ~hAred, dual ~u~olled intr~hlminAl graft 10 function to L~cvell~ the biocolllral;hle tubular fleYihle Ille,lll~r 16 from ~ho.L~ning away from the first and second ends 26,28 (See Figs. 6-7) of the second tubular shaped support member 20. As a result, the biocollll)~t;hle fleYihlP
member 16 does not CO111~1~SS to its center during exp~n~ion of the tubular ~hapP~, dual ~u~ Lt;d intr~lllminAl graft. The tubular shaped, dual ~u~ Led intralllminal graft 10 of the present invention functions to solve several problems associated with PYi~fing tubular shaped vascular grafts inchl(linE n~lull~;ro~ eYpAn~inn of the graft, graft shortening upon W 096/33672 PCTrUS96/04293 c ~ A;Oi-, and suture tears or holes if sutures are needed to ~tt~h~l the graft to the support member.
A cross-sectional view taken along line 4-4 at the center of the tubular shaped, dual ~u~polt~d intr~1umin~l graft 10 of the present invention illll~tr~t~A in Figure

2 is shown in Figure 4. The first tubular shaped support .. ~.. hel 18, preferably comrri~ing a Palmaz stent or ~imil~rly constructed structure, forms the inn~rmost layer of the tubular shaped, dual su~ ed intr~ min~l graft 10 and surrounds the lumen 34 of the tubular, shaped dual su~vlLed intr~lllmin~l graft 10. The bioco."l~ hle fl~Yihle tubular layer 16, ~lc~r~ldl)ly comrri~ed of PT~E, forms the middle layer located at the center of the tubular shaped, dual ~uppolled intr~lumin~l graft 10. Finally, the second tubular shaped support member 20, which also ~er~ldbly comrri~es a Palmaz stent or ~imil~rly constructed structure, forms the out~rmost layer located at the center of the tubular shaped, dual ~u~wlLed intr~hlmin~l graft 10.
Figure S illustrates a cross-section~l view of the tubular shaped, dual ~u~clL~d intrAlllmin~l graft 10 shown in Figure 2 taken along line S-S of Figure 2 near the first end 12 of the intr~lllmin~l graft 10. The innPrmost layer is formed by the first tubular shaped support lllc;ll~ 18 which sulluunds the lumen 34 of the intr~lnmin~l graft 10. The next innermost layer is formed by the bioco",r.~l;hle flexible tubular member 16 which is covered by a support layer which is formed from the second tubular shaped support member 20. The outermost layer comrri~es a biocompatible layer which is formed by folding the first and second ends 22,24 of the biocompatible flexible tubular member over the first and second ends 26,28 (See Figs. 6-7) of the second tubular shaped support member 20. As previously described, the tubular support members 18,20 preferably comprise Palmaz W 096/33672 PCT~US96/04293 stents, or similarly constructed ~L~UC~U1CS~ but may be comr~ri~e~ of any m~tPri~l having the strength and e~ city to permit radial PYr~n~inn and resist radial coll~rse A longitl~tlin~l cross section of a first ~lcr~llcd embodiment of the tubular - ~h~pe~, dual ~uLJI?ollt;d intr~lllmin~l graft prior to eYr~n~ion is shown in Figure 6. Prior S to PYr~n~ion, the flPYihle tubular mPmhPr 16 is sandwiched ~ ,Weell the first and second tubular ~u~poll mPmbers 18,20 which are concPntri~lly aligned with one another. The first and second ends 22,24 of the fleYible tubular member 16 are folded back onto the outer surface of the second tubular support ...~...h~. 20 to form first and second flaps 30,32.
Figure 7 ill~ 5 the lnngit~lrlin~l cross section of the intr~lllmin~1 graft shown in Figure 6 after PYr~n~inn During eYr~n~inn with a balloon c~thpter~ the dual su~llt;d intr~ min~l graft radially PYp~nrl~ to form an eYr~n~lP~d dual su~olled graft having ~n~horing means which are formed by the first and second ends 36,38 of the first tubular -r 18.
The following eY~mplP-s describe the ~ ;nn of various tubular shaped, dual ~u~ d intr~lllmin~l grafts in an attempt to detprminp the optimum length of the ~fIPE flaps and infl~tinn ~res~ul~; required to produce a tubular shaped, dual su~lled intr~lllmin~l graft which exhibits ul~irullll eyr~n~ion that results in in~ep~r~hle layers. The PY~mrlPs are meant to be purely illn~tr~tive and nonlimiting.
All of the following PY~mrles were ~epa.~d by: (1) lo~tling a 3 to 4 inch segmPnt of graft m~tPri~l over the outside surface of a Palmaz stent; (2) loading the stent/graft configuration over a 3.18 millimetPr (mm) outer ~ mpter (OD) mandrel; (3) loading a second Palmaz stent over the outer surface of the graft m~tPri~l and ~ ning the ends with the first stent; (4) folding one end of the graft back over the outer surface of the second stent while applying enough l~lCS~iUl'e to remove any lnngit~lrlin~l slack or c~ ..rx~;nl- from the graft m~tPri~l; (5) cutting the first flap so that it is no longer than lt2 the length of the stent; (6) folding the second end of the graft m~tPri~l back over the outer surface of the second stent and applying enough ~lCS~ulc to remove any longitu-lin~l slack or co,l,pl~on from the graft m~tPri~l; (7) cutting the second flap so that it abuts the first flap; (8) ...~.ki.~ each flap at a predt;~ Pd length from the end of the device; (9) cutting the flaps at the length m~rk~d (10) gently removing the device from the mandrel; and (11) loading the device on a tapered ç~thPtPr balloon and ce~ ;.-g the device between the two radiopaque . .~ . kt~. j Fur~er, all of the following examples were eyp~n~lp~ in a 37 degrees Celcius (~C) water bath using an ACS Tn~irll~, Plus infl~tion device; OD and length measurements were taken using a Mitutoyo Digital Caliper; intPrn~ mp-tpr (ID) measurements were taken using pin gauges and reflect Ill;nil",--.. ~ mPtPr; water ~ c was m~int~ined with a Cole-Parmer Polystet 12002 Series Immersion Heater and verified with a Fisher ThermomPtPr; all of the stent devices used were Palmaz P394 stents (composed of 3166I, s~inlP~ steel with a nominal length of 39mm, a wall thicknPs~
of .0055 inches, and a nomin~l OD of 2.5mm); the c~thPt~Pr balloons used were Medi-tech P_MT DC/1~3/8/100 in ~ ion PY~mrlPs and Fx~m~ 1 through 3, and MeAitPrh P~IT DC/1~8/8/606 in FY~mrlPs 4 and 5. A M~n.~fielcl 20-55 balloon was also used in FY~mrle 5.
In FY~mrle 3, a 5.0mm tapered mandrel was used prior to c, ~
the device on a 3.18mm mandrel. Dirr~,lces in graft m~tPri~l used and final length of the folded flaps are inr~ tP11 in the descriptions for each eY~mple. Any other deviations from W 096/33672 PCTrUS96/04293 the above procedure, along with individual results, are do~ ed in the ~Y~mr1e descriptions as they occurred. Preconception eY~mrles consist of a single stent press-fit eYtPrn~l to the graft m~t~ l on a 3.18mm mandrel.

S Pr~r m~P.rtinn FY~mple A
A 3mm ID Ultra Thin wall stMi~ht graft was used, and the flaps were cut to a length of 17mm at one end and 10mm at the other. At 6 atmospheres, the uncuv~lc;d section of the stent eYp~n~ed fully, and at 8 ~tmoslJhe.cs the end of the device with the 10mm long flap eYr~n~ed fully. The ~l~;;s~ule was increased to 10 a~l-,os~heres,~hcleu~)on, the ba11oon lu~u~KI without fully ~Yr~nrlin~ the 17mm flap. After removing the device from the balloon, the following mea~ulc",~llls were taken: (1) length was 30.65mm; (2) OD was 9.57mm; (3) length of the 10mm flap was 3.89mm; and (4) length of the 17mm flap was 7.32mm. Upon visual in~rection of the device, ridges had formed in the lumen under the small flap, and the graft had recoiled away from the inner surface lS of the stent.

Pr~rnnceI~tinn FY~mrle R
The same graft was used as in E~ l ;nll F~ A, but both flaps were cut to a length of Smm. Again, the initial eYr~n~inn occurred in the uncovered section of the stent. Full ~Yr~n~ion of the device occurred at 7 atmospheres. However, the graft pulled away from the internal surface of the stent and stuck to the balloon when the balloon was d~fl~ted and migr~tion of the graft again caused ridges along the lumen. Upon defl~tinn of the balloon, it was difficult to sep~ e the graft from the balloon. An W O 96133672 PCTrUS96/04293 litinn~l stent internal to the graft was ~,.~esl~l to prevent the graft from recoiling during ~efl~tion The lC~ i,.g eY~mplPs incol~,~le this suggestion.

F.Y~mr~le 1 In order to offset the pl~i~lllC re~llire~ to expand 2 con~entric stents, a 3mm Thinwall High Porosity Straight 50 micron graft was used and both flaps were cut to a length of 5mm. The balloon was rapidly infl~tPcl to 7 atmospheres and the device fully eYp~n-1Pd However, it was felt that full PYr~n~ion of the device could have been achieved at a lower lJlCS:jU~C if the balloon had been infl~tP~ more slowly. Visual in~rectinn of the device after removal from the balloon revealed a tear in the graft m~teri~l sandwiched beLw~n the two stents. It is felt that this was due to an unseen flaw in the graft and not due to the eYr~n~inn ~l~S~lc.

FY~mrlP '' The same graft m~tPri~l in FY~mrle 1 was used for FY~mI~le 2, but was visibly ;..~il~l prior to loading, and both flaps were cut to a length of 8mm. The device was fully eYr~n-led at 5.5 ~tmosphPres. After removal from the balloon, the ID was 7.75mm. This example was ~ee-mP~ a SUCCf~

Fx~mple ?s It was clecid~P~ to use a larger ID graft to determine if the device could be succes~fully crimped on a P394 stent and fully eYr~n-led. A 4mm High Porosity micron graft was used and both flaps were cut to a length of 8mm. Due to the larger ~ mPtPr Of W 096/33672 PCTrUS96/04293 the graft m~t~.ri~ , a 5.0mm tapered mandrel was used to pre-dilate ~e second stent. The second stent was loaded over the 4mm graft; the outer stent and graft were loaded on the 5.0mm tapered mandrel; the end of the graft over the larger mandrel ~ m~otpr was folded back over the outside surface of the second stent; the stent/graft was lcllluved, ~vt;l~ed, S and re11~de~ on the 5.0mm tapered mandrel; ~e end of the graft now over ffle Iarger mandrel ~ . was folded back over the outer surface of the second stent and removed, and both flaps were cut to the length of 8mm. This par~al assembly had an OD of 5.89mm, an ID of 5. lmm, and an overaU length of 37. 81mm. The first stent was loaded inside the stent graft and the whole configuration was loaded on the 5.0mm tapered mandrel to press-fit the inner stent to the graft m~t~ri~l in order to ~evel~ m~ge to, or mi~r~*on of, the graft during çrimping The device was ~h~ l down on a 3.18mm mandrel by gently g and rolling in a l~n~;l...l;.~lly slit piece of tygon tubing. After ç~ h~ , the flaps were loose. The profile of the device after 10~1ing the device on balloon was 4.3mm OD.
Initial eyp~n~ion was seen in the center at 3.5 atmospheres. At 5 atmospheres, the flaps were tight, and at 8 ~tmr~rh~res the distal OD was 9.3mm but the p u~illlal OD was 6.3mm due to device pl~ mPnt on the baUoon being slightly off center towards theAill~l end. The balloon was defl~ted and the device was repositi-)n~A toward the distal end. At 8 ~tmosph~-res, the baUoon luytur~d during reinfl~tion After removal from baUoon, the OD was 8.9mm, the ID was 7.24mm, and the overall length was 34.08mm.The device was relo~-led on the same type of balloon and the balloon was infl~tPd to 8 atmospheres with a res-llting OD of 9.3mm. The balloon was then infl~t~1 to 9 .t s with a resnlting OD of 9.4mm. After removal from the balloon, the ID was 7.54mm; the OD was 8.99mm; the length was 32.63mm; but the device c~nt~in~d a slight bottle neck at the pn,~il-lal end.

FY~mrle 4 A 3mm Th~n Wall Straight graft m~tPri~t frsm the third eY~mpte descn~ed above, with a low eYr~n~icm plC:i~Ul'C was used for FY~mrle 4; both flaps were cut to a length of 3mm and a 10mm X 8cm balloon was used. At 1 ~tmosph~re, the tapered ends of the balloon infl~ted and the balloon hot-dogged; at 4 atmospheres, both ends of the device eyr~n~le-d; at S atmos~hclcs, the center of the device eyr~ntl~l; at 6 atmospheres, the OD was 8.3mm; at 7 atmfisphP~es~ the OD was 8.8mm; and at 8 atmos~h~lcs, theballoon ruptured. After removing the device from the balloon, the OD was 9.06mm.

F.Y~mrle ';
A 3mm Thin Wall Straight graft was used; both flaps were cut to a length of 2.33mm; and the device was loaded on a 10mm X 4cm balloon. At 8 atmospheres, the OD was 8.13mm, but at 10 ~tmosphPres, the balloon burst. The device was loaded on a 10mm X 8cm balloon which ruptured at 8 atmospheres. After removal from the balloon the OD was 8.51mm and eYhihitffl a hotdog shaped profile. The device was loaded on a 20mm balloon, but attempt to remove the hotdogging was un~ucce-s~ful. After removal from the balloon, the OD was 9.2mm.
As noted from the above eY~mplP~, a 3 mm ID thin walled High Porosity PTFE graft sandwiched be~een two P-394 "PALMAZ" stents and eYp~nde~7 at 5.5 atmospheres, at 37 degrees Celsius, results in a uniformly eYr~n~1 tubular shaped, dual W 096133672 PCTrUS96/04293 ~u~po-led intr~lllmin~l graft having stent and graft and stent layers that are i~ ep~.~hle.
The stent and graft design may be m~lifiP~ to decrease the eYr~n~inn ~resi~c;.
A second embo~lim~-.nt of the tubular shaped, dual ~u~ led int~lllmin~l graft 40 of the present invention is illu~t~ted in Figures 8-10. The tubular ~h~red, dual S su~ulled intr~lllmin~l graft 40 compri~es a first elnnE~t~ tuburar ~U~l~ lllt;llllJC;l 4 which is c.,v~ cd by a flPYihl~. tubular member 44. The first elc-nEat~d tubular support member 42 prer~.dbly comI)ri~es a Palmaz stent but may comprise other structuralconfigllr~ti( n~ which are compri~-A of any m~tt-.ri~l having the strength and el~icity to permit radial PYr~n.~inn and resist radial collapse. The fl~Yihle tubular member 44 is ~l~rrli1hly c~mpri~l of a l~inco.. -l~lihlc m~t~.ri~l such as PT~FE. The tubular .~h~re~ dual ~U~)p~llt;d intr~lllmin~l graft 40 further co-..l.. ;.~rs a pair of first and second short cylin-lric~l ~iUpl~Oll mPmbers 46,48 which are loaded over the fll-Yihle tubular member 44 and po~iti-n~l at op~osile ends of the flPYihle tubular member 44. The ends of the flPYihle tubular member 44 are folded back over the outer surface of the first and second short cylin~lri~ U~J~)l ~ mPmh~rs 46,48 thereby fnrminE first and second flaps 50,52, e~ ly, which encase at least the outermost ends of each of the first and second short cylin~lric~l ~u~oll me.mhers 46,48 within the fleYihle tubular member 44. Further, as illll~tr~t~l in Figure 8, the entire first and second short cylintlr~ l support members 46,48 may be covered by the first and second flaps 50,52 of the fleYible tubular member 44.
As shown in the cross-sectional view depicted in Figure 9, which is taken along line 9-9 of Figure 8, the center portion of the second embodiment of the tubular shaped, dual ~u~l~d intr~lllmin~l graft 40 int.llldes the elongated tubular support member 42, preferably compri~ing a Palmaz stent, which surrounds the lumen 54 of the tubular W O 96/33672 PCT~US96104293 shaped, dual sup~ L~d intr~lllmin~l graft 40 of the present invention. The fl~Yihle tubular m~.mher 44, preferably compri.~ed of P~FE, ~ulluunds the elongated tubular support member 42 and forms the out~rmost layer of the tubular shaped, dual su~polLtd intr~lllmin~l graft 40.
S Figure 10 illu~ .S a cross-se~ti--n~l view of the tubular shaped, dual SU~)IX~ d intrAlllmin:ll graft 40 shown in Figure 8 taken along line 10-10 of Figure 8 near an end of the intr~lllmin~l graft 40. The i~ l layer is formed by the elc)ng~t~l tubular support member 42 which sulluunds the lumen 54 of the intr~lllmin~l graft 40. The next sl layer is formed by the flexible tubular member 44 which is cuv~;lcd by a support layer which is formed from the first short cylin~lri~l support member 46. The out~-rm- st layer comprises a biocû...~ ;hle layer which is formed by folding an end of the flexible tubular m.o.mher 44 over the out~rmost end of the first short cylin~1ri~l shaped support member 46 and back over the outer surface of the first short tubular shaped cylin-lri~
member 46.
A third e nbo l;.. r-.l of the tubular shaped, dual ~ul)~lLed intr~ min~l graft 60 of the present invention is illustrated in Figures 11-14. The tubular shaped, dual su~ led intr~lllmin~l graft 60 comrri~es a biocûlllpalible flexible tubular member 62, preferably compri~ed of Pl~E, having a first end 64 and a second end 66, a pair of first and second shortened cylin~lric~l support members 68,70, and a pair of third and fourth shortened cylin(1ric~l support members 72,74. The pair of third and fourth shortened cylin-lri~l support members 72,74 are located near opposite ends of the biocol.,~aLible tubular flexible Illrlllhel 62, ~ .;Lively, and are con~ntri~lly retained within the interior of the bioco-ll~atible flexible tubular member 62. The pair of first and second shortened W 096/33672 PCTrUS96/04293 cylin~lrir~l support ...~ ~-, 68,70 are also located near opposiLe ends of the hinco...L~I;hlP
fl.-Yihle tubular ,I.elllbcL 62, lc;s~ecLively, but are conrçntric~lly positionPA about the ~;~Lc;li~Jl surface of the bioc~...p~l;hle fleYihle tubular member 62 such that the pair of first and second ;,h~ elled cylin~lric~l support mPmhers 68,70 dil~Lly overlap the pair of third and four~ shortened cylin~lric~l su~ll memhers 72,74, respectiveIy, wi~h onIy the bioco...p~lihle fle ible tubular mPmher 62 cont~inrA between them. The first cylinrlrir~l ~u~?oll member 68 is not shown in Fig. 11 in that it is comrlptply e-nr~l within the bioco...l~l;ble flPYihle tubular mPmhPr 62.
Thepairs of slwlLt;lled cylin~lrir~l support ...~...l~..~i 68,70 72,74 preferably comprise short Palmaz stents or similarly structured configllr~tion~ which are comrri~Pd of a s~it~hle m~tPri~l having sllffiriont strength and elasticity to permit radial eYr~n~ion and resist radial coll~rse. Further, the first and second ends 64,66 of the bioco-..l..1l;l)1e flPYihle tubular member 62 may be folded back over the outside surface of the pair of first and second shortened cylin-lrir,~l Sup~)OlL members 68,70 to form first and second flaps 76,78, as illustrated in Figure 11, thereby enr~ing the outerm-st ends of the first and second shortened cylin~lrir~l support members 68,70 within the biocol-lpalible flexible tubular member 62. Also, as illl-~l...ted in Figure 11, the first and second shortened cylin-lrir~l suEtport ~ llb~l~ 68,70 may be entirely covered by the first and second flaps 76,78 of the bioco..~p~l;hle fleYible tubular member 62.
As shown in the cross-sectional view depicted in Figure 12 which is taken along line 12-12 of Figure 11, the center portion of the third embodiment of the tubular shaped, dual supported intr~l--min~l graft 60 simply compri~es a lumen 80 which is ~ulruLulded by the hi~l,.l)AI;hle flexible tubular member 62. Figure 13 illll~tr~tçs a cross-W 096/33672 PCTrUS96/04293 sectir n~l view of the tubular shaped, dual su~polLed intr~ min~l graft 60 shown in Figure 11 taken along line 13-13 of Figure 11 near an end of the intr~lllmin~l graft 60. The innermost layer is formed by the third shortened cylin~1ric~1 support member 72 which ~u~ unds the lumen 80 of the intr~lllmin~l graft 60. The next innPrmost layer is formed by the bioco.. ~ t~- flexibIe tubular ",~."lhe. 6Z which is C~Vtil~ by a su~lL Iayer which is formed from the first shortened cylintlric~l support memher 68. The outermost layer comprises a bioco",p~lihle layer which is formed by folding the first end 64 of the biocol"~?aLible flexible tubular member 62 over the outermost end of the first shortened cylindrical SU~Ol~ member 68 and back over the outer surface of the first shortened cylintlrir~l support member 68.
Figure 14 shows a cross-~tion~l view of the tubular shaped, dual ~u~poll~d intr~lumin~l graft 60 shown in Figure 11 taken along line 14-14 of Figure 11 near the o~i~ end of the cross-sectinn~l view of the intr~lllmin~l graft 60. The inn~.rmost layer is formed by the fourth shortened cylin-lrit~l support member 74 which sulloullds the lumen 80 of the intr~lllmin~l graft 60. The next innPrmost layer is formed by the biocompatible flexible tubular member 62 which is covered by a support layer which is formed from the second shortened cylin-lri~l support member 70. The outermost layer comprises a bioco,,,l.~ihle layer which is formed by folding the second end 66 of the biocn".l al;l-le flexible tubular member 62 over the outermost end of the second shortened cylin-lric~ u~oll member 70 and back over the outer surface of the second shortened cylin~lric~l su~ll member 70.
A fourth embodiment of the tubular shaped, dual ~u~ d int~hlmin~l graft 90 of the present invention is illustrated in Figures 15-19. The tubular shaped, dual W 096/33672 PCTrUS96/04293 ~u~pc~ d intr~ min~l graft 90 compri~es a bioco...~ ihle fleYihle tubular member 92, r~ ly comrri.~ of PI~E, having a first end 94 and a second end 96, a first series of shortened cylin-l ir~l s.~ members which include first, second and third shortened - cylinrlrir~l .,le",bel~ 98,100,102, and a second series of shortened cylin-lri~l support S ... ~.. h~ i which incIude fourth, fifth and sib~th sLc~lLclled cytin~nr~t members lO*,r~,rO8.
The fourth and fifth shortened cylin~lri~ u~ m~.mhPr~ 104,106 are cl llre.~l.;r~lly lck~ ed within the interior of the biocc""~ ible fleYihle tubular member 92 near opposiLci ends of the biocolllpaLible flPYihle tubular member 92, respectively, while the siY~th shortened cylin-lrir~l sul~poll m~mher 108 is conrPntrir~lly retained within the interior of the bioco.. p~l;hle flPYihle tubular m~mher 92 belw~ll the fourth and fifth shortened cylin~lrir~ U~p<jl~ m~.mhers 104,106. The first and second shortened cylin~1rir~1 support ...~-..he~.e 98,100 are col~rP~ ;r~lly positi~n~A about the eYt~o.rior surface of the hi~ le fleYible tubular mP.mher 92 near oppGsile. ends of the bioco...p~l;hle fleYible tubular ...-~-..hP~ 92, ~ iv~ly, while the ~ird shortened cylintlrir~l support member 102 is coi-r~ ~lly positinn~d about the eYteri-r surface of the bioco-~p~ I ;hle fleYihle tubular 92 belW Wll the first and second shortened cylin~1rir~l support members 98,100. The first, second and third ~ho,L~lled cylinrlrir~l support mPmhrrs 98,100,102 are superimposed over the fourth, fifth, and sixth shortened cylin~lrir~l support members, respectively, with the bioco...l~l;hle fleYible tubular memh.or 92 sandwiched bc;lweell each res-lltin~ superimposed pair of shortened cylin~l!rir~l support members.
All of the shortened cylin~lrir~l su~lL members 98,100,102,104,106,108 preferably comprise short Palmaz stents or ~imil~rly stluctured configurations which are comprised of a s~it~hle m~t.o.ri~l having sllffiriPnt strength and el~ticity to permit radial W 096133672 PCT~US96/04293 eYp~n~inn and resist radial collapse. Further, the first and second ends 94,96 of the biocc,lllpatible flPYihle tubular member 92 are folded back onto the outer snrf~l~es of the firstand second shortened cylin-lric~l support members 98,100, res~Lively, to form first and second flaps 110,112 Lh~y en~ing the olltP-rmost ends of the first and second S shortened cylinllri~1 members 98,100 within the bi~co.. l ~I hle f~PYible tubular mPmher 92. Also, as illnctr~tP~ in Figure 15, the fourth and fifth shortened cylin~1ri-~1 members 104,106 may be entirely covered by the first and second flaps 110,112 of the biocomp~tih1e flexible tubular mPmher 92. This configuration of the fourth embodiment results in a tubular shaped articulating intr~1llmin~1 graft which has a series of dual stent supported s~l;- n~ which are sel~.,-'ed by entirely unsu~?olLed sections of the bioco.. l-~lihle fleYihle tubular member 92. This embodiment of the dual ~u~ Led intr~lllmin~l graft provides flexibility during pl~cPmPnt while still providing rigid support after deployment.
The cross-~tion~1 view ~1~PP -ted in Figure 16, which is taken along line 16-16 of Figure 15, i111lstr~tPs an un~u~ ed section of the articn1~ting dual supported intr~11lmin~1 graft shown in Figure 15. This section of the graft simply compri~Ps a lumen 114 which is surrounded by the bioco...p~;hle fleYihle tubular member 92.
Figures 17 and 18 ilhlstr~tP cross-se~tinn~1 views taken along line 17-17 and line 18-18 of Figure 15, leSpecLi~rely. These cross-sectinn~l views illll~tr~tP the layers which comprise the end sectiQn~ of the articulating dual ~u~ d intr~lllmin~l graft. In Figures 17 and 18, the innPrmost layer is formed by the fourth and fifth shortened cylin~lrie~l support members 104,106, respectively, which surround the lumen 114 of the art~ ting dual ~u~?~lL~d intr~lnmin~l graft. The next innermost layer in both Figures 17 and 18 is formed by the bioco",~Lible flexible tubular member 92 which is then covered W 096J33672 PCTrUS96/04293 by a support layer which is formed from the first and second sho~ ed cylinflric~l support ...~...l~..~i 98,100"~e-;L~ely. FinaUy, the ~ul~- ...ns~ layer.s in Figures 17 and 18 comprise a biocolll~aLible layer which is formed by folding the first and second ends 94,96 of the biocc,...~l;l)le flPYihl~. tubular member 92 over the c,.,l~- ...o~l ends of the first and second S shortened cylin rrlc~r ~u~.l m~-mhers 98,roo, respectively, and back over ffle outer surface of the first and second sh~ ed cylin~ric~l support members 98,100, respectively.
Figure 19 shows a cross-~titm~l view taken along line 19-19 of Figure 15.
This cross-s=Pctinn~l view ill~ S the layers which are present in the center dual su~?pol~d section of the art~ g dual ~u~l~d int~lnmin~l graft. The innP-rrnost layer is formed from the siYth shortened cylin-lri~ u~ .. he~ 108 which surrounds the lumen 114 of the articlll~ting dual su~?polled int~lllmin~l graft. The middle layer comrri.~es a biocoll~L,alible m~tPri~l which is formed from the bioco...p~l;hle flPYihle tubular mPmher 92 and the ~).,~- .... ~l layer is formed from the third sholl~ned cylintlric~l su~o,l member 102.
It should be ~~ od by those skilled in the relevant field of art that each of the previously ~P~ . ;hed elllb~l;...~ of the tubular shaped, dual su~ ed intr~lllmin~l graft may also eYist without folding back the PIF~ tubular member to form flaps on the ends of the intr~lllmin~ aft. Further, all of the previously described compositions for the members which comprise the various embotlimP-nt~ of the tubular shaped, dual ~u~polled in~lnmin~l graft are preferably eyr~n~l~hle.
While the invention has been described with reference to pler~
emborlim~-nt~ thereof, the description is for illll~tr~tive purposes only and is not to be construed as limiting the scope of the invention. Various mo~ifi~tit)n~ and changes may W 096/33672 PCT~US96/04293 be made by those sl~lled in the art wi~out de~Li.~g from the true spirit of the scope of the invention as defined by the appended claims.

Claims (31)

WE CLAIM:

1. A radially expandable dual supported intraluminal graft comprising:
a first radially expandable tubular support member;
a second radially expandable tubular support member having first and second opposing ends and concentrically positioned about the first radially expandable tubular support member; and an expanded polytetrafluoroethylene tubular member, interdisposed between the first and second radially expandable tubular support members, having first and second opposing ends coupled to the first and second opposing ends of the second radially expandable tubular support member.

2. The radially expandable dual supported intraluminal graft of Claim 1 wherein the first and second radially expandable tubular support members are made of a biocompatible material selected from the group of silver, titanium, stainless steel, and gold.

3. Canceled.

4. The radially expandable dual supported intraluminal graft of Claim 1 wherein expanded polytetrafluoroethylene is characterized by a microporous microstructure having an average internodal distance within the range of 10 to 90 microns.

5. Canceled.

6. The radially expandable dual supported intraluminal graft of Claim 1 wherein the at least one of the first and second opposing ends of the expanded polytetrafluoroethylene tubular member are evertedly folded over the first and second ends of the second radially expandable tubular shaped support member such that the first and second opposing ends of the second radially expandable tubular support member are annularly covered by the expanded polytetrafluoroethylene tubular member and the first and second ends of the expanded polytetrafluoroethylene tubular member are supported about the first and second ends of the second radially expandable tubular support member.

7. The radially expandable dual supported intraluminal graft of Claim 6 wherein the at least one folded back first and second end of the expanded polytetrafluoroethylene tubular member comprises a length of up to one-half a length of the second tubular shaped support member.

8. The radially expandable dual supported intraluminal graft of Claim 1 wherein the second tubular support member further comprises first and second radially expandable ring members positioned in spaced apart relationship to one another at the first and second ends, respectively, of the first tubular shaped support member.

9. The radially expandable dual supported intraluminal graft of Claim 8 wherein the first and second ends of the expanded polytetrafluoroethylene tubular member are evertedly folded onto outer surfaces of the first and second radially expandable ring members which are thereby at least partially enclosed by the evertedly folded first and second ends of the expanded polytetrafluoroethylene tubular material.

10. The radially expandable dual supported intraluminal graft of Claim 9 whereinthe evertedly folded first and second ends of the expanded polytetrafluoroethylene tubular member each comprise a length of up to one-half a length of first and second radially expandable ring members.

11. The radially expandable dual supported intraluminal graft of Claim 8 whereinthe first radially expandable tubular shaped support member comprises first and second radially expandable ring members concentrically positioned about the first and second radially expandable ring members comprising the second radially expandable tubular support member and the expanded polytetrafluoroethylene tubular member further comprises an intermediate region along a longitudinal axis of the intraluminal graft which is unsupported by any of the first and second radially expandable ring members comprising each of the first and second radially expandable tubular support members.

12. The radially expandable dual supported intraluminal graft of Claim 11 wherein the expanded polytetrafluoroethylene tubular member are evertedly folded the first and second radially expandable ring members comprising the second radially expandable tubular support member.

13. Canceled.

14. The radially expandable dual supported intraluminal graft of Claim 11 further comprising at least one pair of concentrically positioned radially expandable cylindrical support members positioned intermediate the first and second radially expandable ring members comprising each of the first and second radially expandable tubular support members and in spaced apart relationship thereto, the expanded polytetrafluoroethylene tubular member being interdisposed between the pair of concentrically positioned radially expandable cylindrical support members.

15. The radially expandable dual supported intraluminal graft of Claim 14 wherein the first and second ends of expanded polytetrafluoroethylene tubular member are evertedly coupled to the first and second ring members of each of the first and second radially expandable tubular support members.

16. Canceled.

17. The radially expandable dual supported intraluminal graft of Claim 1 whereinthe first and second radially expandable tubular support members are each comprised of a plurality of concentric pairs of support members co-axially aligned and in spaced apart relationship with one another along a longitudinal axis of the intraluminal graft and the expanded polytetrafluoroethylene tubular member is interdisposed and retained between the plurality of concentric pairs of support members thereby imparting flexibility along the longitudinal axis of the intraluminal graft.

18. The radially expandable dual supported intraluminal graft of Claim 17 wherein the first and second ends of polytetrafluoroethylene tubular member are evertedly folded first and second ends of opposing end pairs of the plurality of concentric pairs of support members comprising each of the first and second cylindrical shaped support members.

19. Canceled.

20. Canceled.

21. Canceled.

22. Canceled.

23. Canceled.

24. A process for making a tubular radially expandable dual supported intraluminal graft comprising the steps of:
a) positioning an expanded polytetrafluoroethylene tubular member having a microporous microstructure of nodes interconnected by fibrils concentrically over and in intimate contact with a first radially expandable stent member;
b) concentrically positioning a second radially expandable stent member over and in intimate contact with the expanded polytetrafluoroethylene tubular member; and c) applying a positive pressure to the biocompatible flexible tubular member and the first and second tubular shaped support members such that the expanded polytetrafluoroethylene tubular member, the first radially expandable stent member and the second radially expandable stent member are inseparable from one another under physiological conditions.

25. The process of Claim 24, further including the step of everting at least one end of the expanded polytetrafluoroethylene tubular member over and onto an outer end surface of at least one end of the second tubular shaped support member thereby covering the at least one end of the second tubular shaped support with the everted at least one end of the expanded polytetrafluoroethylene tubular member.

26. The radially expandable dual supported intraluminal graft of Claim 1 wherein the first and second radially expandable tubular support members are made of a biocompatible plastic having the sufficient hoop strength and radial elasticity to enable uniform radial expansion without radial collapse under physiological conditions.

27. A radially expandable dual supported intraluminal graft comprising:
a biocompatible flexible tubular member having a first end a second end an inner surface and an outer surface;
a first tubular shaped support assembly comprising at least two cylindrical shaped support members concentrically positioned relative to one another at a first end of the biocompatible flexible tubular member, one of the at least two cylindrical shaped support members being in intimate contact with an inner surface of the biocompatible flexible tubular member and a second of the at least two cylindrical shaped support members being in intimate contact with the outer surface of the biocompatible flexible tubular member;
a second tubular shaped support assembly comprising at least two cylindrical shaped support members concentrically positioned relative to one another at the second end of the biocompatible flexible tubular member, one of the at least two cylindrical shaped support members being in intimate contact with an inner surface of the biocompatible flexible tubular member and a second of the at least two cylindrical shaped support members being in intimate contact with the outer surface of the biocompatible flexible tubular member; and a third tubular shaped support assembly comprising at least two cylindrical shaped support members concentrically positioned relative to one another intermediate the first and second ends of the biocompatible flexible tubular member, one of the at least two cylindrical shaped support members being in intimate contact with an inner surface of the biocompatible flexible tubular member and a second of the at least two cylindrical shaped support members being in intimate contact with the outer surface of the biocompatible flexible tubular member.

28. The radially expandable dual supported intraluminal graft of Claim 27, wherein the at least a portion of the first and second ends of the biocompatible flexible tubular member arc evertedly folded over the first and second cylindrical shaped support assemblies such that one of the at least two cylindrical shaped support members comprising each of the first and second cylindrical shaped support assemblies is at least partially covered by the everted portions of the biocompatible flexible tubular member.

29. The radially expandable dual supported intraluminal graft of Claim 28, wherein the everted portions of the biocompatible flexible tubular member each comprise a length of less than or equal to about one-half longitudinal length of the first and second cylindrical shaped support assemblies.

30. The radially expandable dual supported intraluminal graft of Claim 29 wherein each of the first, second and third cylindrical support assemblies are positioned substantially equidistantly along a longitudinal axis of the biocompatible flexible tubular member.

31. The radially expandable dual supported intraluminal graft of Claim 30, wherein one of the first and second cylindrical members of each of the first and second cylindrical support assemblies substantially encased within the everted first and second ends of the biocompatible flexible tubular member.