CA2229537A1 - Covered endoluminal stent and method of assembly - Google Patents
Covered endoluminal stent and method of assembly Download PDFInfo
- Publication number
- CA2229537A1 CA2229537A1 CA002229537A CA2229537A CA2229537A1 CA 2229537 A1 CA2229537 A1 CA 2229537A1 CA 002229537 A CA002229537 A CA 002229537A CA 2229537 A CA2229537 A CA 2229537A CA 2229537 A1 CA2229537 A1 CA 2229537A1
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- CA
- Canada
- Prior art keywords
- stent
- graft
- mandrel
- radially
- expandable
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Abandoned
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
- A61F2/06—Blood vessels
- A61F2/07—Stent-grafts
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
- A61F2/89—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure the wire-like elements comprising two or more adjacent rings flexibly connected by separate members
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
- A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
- A61F2/06—Blood vessels
- A61F2/07—Stent-grafts
- A61F2002/075—Stent-grafts the stent being loosely attached to the graft material, e.g. by stitching
Abstract
A radially expandable endoluminal stent-graft assembly (10) and a method and apparatus for making the same are described. The stent-graft assembly (10) includes a tubular radially expandable stent (12) circumferentially covered by a tubular graft (14) which is retained about the stent (12) by inherent radial recoil forces of the tubular graft (12) and without the need for adhesives or sutures to retain the graft (14) on the stent (12). The assembly apparatus (44) for making the expandable stent-graft assembly (10) consists generally of a tapered dilation mandrel (46), a stent retaining mandrel (52), a handle (53), and couplings (60, 71) for removably and coaxially coupling the components of the assembly apparatus mandrel (44). The method for making the expandable stent-graft assembly (10) utilizes the assembly apparatus (44) to make the stent-graft assembly (10) by dilating the graft (14) on the tapered dilation mandrel (46), sliding the dilated graft (14) over a stent (12) retained on the stent retaining mandrel (52), permitting the dilated graft (14) to radially recoil over the stent (12), circumferentially cutting unsupported areas of the graft (14) at proximal and distal ends of the stent (12) and removing the stent-graft assembly (10) from the assembly apparatus (44).
Description
CA 02229537 l998-02-l3 W O 97/07751 PCTrUS95/10752 COVERED LNDOLUMINAL STENT AND MET~OD OF ASSEMBLY
~.L~ of the T ~ lion The present invention relates generally to a radially ~ hle çn~ min~l covered stent ~.-IIJI~ and a method and apparatus for making the same. More particularly, the present S invention relates to a lo~t~lin~11y and radially PYr~n~ed polyL~ oro~ lene (ePTFE) tubular graft which is ~h~iu~.lr~.elLally f-~gs~rA about at least one balloon ~ tlAhle ' stent and retained on the stent by a radial recoil force exerted by the ePTFE tubular graft against the stent.
The covered stent may complise one or more stents circul~ lially retained within a 10 single graf'c. For ;. . '-, acco,d~-g to a first plcfellcd embodiment of the invention, a covered stent is made using a single pressure eyp~n~l~hle stent ch-;ull~l~.llially and lons~ihl~lin~lly covered with a single ePTFE tubular graf'c. In accol d&nce with a second p~ ercl I ~,d embodiment, the covered stent co.u~lises a pair of balloon eYp~n~ble stents positioned at opposing ends of a single eP l'~'~; tubular graft with each stent being ~ ;UIl~l clLally and longitll~in~lly COvCI ed 15 by the eP 1~'~ graft, with an illlCI ~ ~e~liA I e region of the ePTFE tubular graft being ullsu~pcll led.
A~ld~l~, to a third plt;r~l-~ cml~oJilllclll ofthe invention, a longitu-lin~lly artic~ tin~ covered stent is made by co-axially ~li ning a plurality of discrete stents in a longit---lin~lly eYtf~n~ling array, such that the plurality of stents are in end-to-end relationship with one another, and the entire lon~yt~ itlS I array of stents is ~h ~;ulllrerelllially and longitu-1in~11y covered with an eP l 20 tubular ePT~E graft.
The present invention is further directed to a method for making the stent-graft assembly and for mounting the stent-graft onto a delivery ~LI.~Lel . In accordance with the method of the present invention, the stent-graft is as~llll~leG' using a dilation mandrel and a stent mandrel. The inventive method inrll-des the steps of mounting the stent onto the stent Illandrel, joining the 25 stent mandrel with the dilation mandrel, positioning the graft onto the dilation mandrel and radially eyrztn~ling the graft on the dilation nland-el to an inner di~meter which is greater than the outer rli~mPter of the stent, passing the radially eYp~nded graft over the stent, llilllllling excess grafl material from the p~ lal and distal ends of the stent, decoupling the mandrel from S~J~S 111 ~JTE SHEET (RULE 26) W O 97/07751 PCT~US95/10752 the stent ..I_ .L~, and removing the cov~,led stent from the stent mandrel. In accc"d~lce wvith the method of ~u~ g the covered stent onto a d~ .y c~ ,t~, the method further incllldes the steps of ~ ng~ng a ~)rùAiU--sl section of the stent n.fil~drel, ~-ng~ng a delivery caLLclcr ~.-vith the stent ~ L cl such that a balloon section of the delively ~ is prv,.;. . .~ ~ e wvith the 5 covered stent-graft, cwnce..llically po. ~ioni~ the co~,e.ed stent-graft over the balloon section ofthe delivery ~".lt, ~e- and f~ BP ing the d~ e.y c~fh~te~ from the stent mandrel.
Radially pre~ -c ,~ hle and self c~ enti~ minstl stents, such as those c~osed by Palmaz in U.S. Patents No. 4,733,665, 4,739,762 and 5,102,417, Gi~-lu~-;o in U.S. Patents No. 4,580,568 and 4,907,336, Kreamer in U.S. Patent No. 4,740207, Wiktor in U.S.PatentsNo.4,886,062and4,969,458, Pin~h~ inU.S.PatentNo. 5,163,958andSchat7 in U. S. Patent No. 5,195,984 have been clinically invçsti~ted over the past several years in an attempt to uvt;lwlllC the 1 - of p~ S tr~n~ min~l colunaly angioplasty (PTCA), particularly restçno~i~ due to fibrocellular intimal proliferation subsequent to PTCA. More ly, ...v~l;g.~1;ol-~ have focused on baUoon ~ hle stents to anchor intralllmin~l grafts.
15 "T,~ f~ 1Intr~lllmin~l GraftT~ ;onforAbdomin~l AorticAneurysms", Ann. Vasc.
S~rg 1991, 5: 491-499; "Tr~n~lumin~l pl~c~mP!nt of a Prosthetic Graft-Stent De-vice for Tl~ -.l of Subclavian Artery Al~;uly~ll", J. Vasc. Surg, Dece.,.l)er 1993, 18: 1056-1059;
and "P~ ulal eûus Fen~olupopliteal graft pl~c~ .l", Radiolo~, June 1993, 187:643-648.
Several :~U~pUI led grafts are known in the art. For e,~alllple, Kubo, et al., U.S. Patent 2û No. 5,236,447, disclose an artificial tubular organ supported by a supporting frame made of a plastic m~tPn~l which ;nay be PTFE, and a medical prosthetic lndl~. ial disposed on at least one surface of the ~ul,po.l;ng frame wl-el~iin the prosthetic material is pl r~,dbly col"~,-;sed of ab~ e and non-abso,l,al~le macromolecular yarns which may include p ~ The medical prosthetic material is joined to the ~up~o-l;--g frame by sutures. The sutures ~ cl.;..5~ the 25 prosthetic material to the suppo, ling frame limit movement of the fabric on the frame. The Kubo, ef al. ~.l-bly is not radially ~ e and is th~- cro- t; incapable of use in endoluminal applications which require radial Pyp~n~bility~
SIJ~;~ JTE SHEET (~ULE 26) W O 97/07751 PCT~US95/10752 The Rhodes, U.S. Patent No. 5,122,154 discloses an endovascular bypass graft CC r ~ ' .3 a sleeve having a plurality of ~Lr P ~ le, ring-like stent ... ~-.he, ~ are eq~ ly spaced along the longihlAin~l length and positioned on either the outer or inner surface of the sleeve. The sleeve is formed from a highly flexible material, such as ~Yp~nAeA P 1~, and has a series of longihlAin~lly ~ , pleats. Each stent ~h"~ iS conl~evled to one or more of the l-n~t~lA;n~lly . ' ,, pleats in the sleeve and permit ~Info~i~ ofthe sleeve during radial ~'I~r ~ - ~n of the ring-like stent ~-- ...I).~ . j.
Lee, U.S. PatentNo. 5,123,917, dc~~;,il,es a radially -~ -A~l~le sup~G~l~d graft having multiple graft layers. The sul"~o~ led graft in~ lAes a flexible cylindrical inner tube having an 10 outer pe.;~JLc~y, a plurality of sep~le sc~ffo!~ rings mounted on the outer pe~;~Jhe~y along the lon~hldin~l e,Ytent of the inner tube, and a flexible cylindrical outer tube conc~ ;cally enclosing the inner tube and sc~ffol~ - -..h- ~ ~. The sç~ffolcl ~--~ bc ~ are spaced to allow for n~,Ail~iL~y of the inner and outer tubes along their longitl~Ain~l a,Yis.
Another endovascular graft for l~,~,&ilin~, aneurysms is described in U.S. Patent No.
5,211,658 issued to Clouse. The Clouse patent .licclosç$ a percut~neously delivc ,lble structural frame and an independently, perc~t~neously delivc-~ble radially ~Yp~nA~ble tubular member f-.lly placed co~ ically within the structural frame. The structural frame preferably comprises a plurality of meshed strands joined to axially spaced end rings ~,vl~elei~l both the meshed st~ands and rings are comprised of a shape ~--.,.--o- y metal. The tubular .-.w.-l~er, a thin 20 walled fiexible ...~ e, ~lere-~ly incl~lAes a means for ~ nA;..~ and holding the tubular me .ll~el against the structural frame. This means may take the form of an oulwal dly c ~ n.~ le spring coil disposed within the interior of the tubular ...e...l,t;. .
Kreamer, U.S. Patent No. 5,078,726, discloses a stent-graft asse---l~ly having stents placed inside either one or more ends of a graft. The stents are formed from a rect~n~ll~r semi-~ 25 rigid ~ t~ rolled into an open ended cylinder so that an inside longitu~lin~l edge ov~.laps anoutside longih~lAin~l edge of the material. The stents further comprise a ret~ining means which acts to restrain the inner lon~h~ l edge of the graft in the graft's ~xp~n(~ed state. In use, the synthetic graft is endolllmin~lly positioned to exclude a wç~k~ned section of the v~c~ h~re.
SlJ~a 1 l l ~ITE SHEET (RULE 26) W O 97/07751 PCT~US95/10752 A stent in its relaxed ~ ,t~ r state is posifil~ned inside the end of a graft and ~Yr~nrlecl to its ~I&~ d, larger ~ ' ~x state. The radiaUy ~ ~ G force of the stent ;~ S upon the graft and the inner wall ofthe blood vessel to pl ~e.~ p- - of the stent and graft after radial ~lthm~gh a ~-u-~lbe~ of radially ~ Asble stent-graft del;~,ly ~ --;, are particularly suitable for PnAol-lmin~l delivery and ~ Pm~nt are generally known in the art, none of the r~ G2~oillg radially ~Yp~ ' ~'~ le stent-graft A~c~mhl - s offers a co~r~y~ aLiOll which inhibits axial A; Q~P? - of the graft relative to the stent pnor to and du ing PnACl~lminAl delivery and radial -n wiLhoul the use of adhesives or sutures. Fur~er, none of the previously known stent-graft devices reduces the profile of the stent graft co~llb;llaLion thereby enal~ g the reduced French size of the introducer balloon cAth~tçr Accordingly, there is a need for a stent-graft ass~l-,bly which perrnits use of a reduced size introduction çA~h~te- to fA~ilitAte easy and safe deployment of the stent-graft a~s_l-.bly within various sizes of blood vessels and at various sites within the blood vessels. There is also 15 a need for a stent-graPL ass_.lLly which co,plises a graft which is retained upon a subsl~.l;Ally non-radially ~ nd~ stent by .nh~"~.ll radial recoil forces exerted by the graft against the stent during delivery and radial ~YpAn~ n of the stent-graft assembly.
Summanr of the I~ I;c It is a pl;ll~ ,al object of the present invention, thelGro~G, to provide an intrAl--minAI
20 stent-graft a~s_n~ly having a radially eYp~n~3~ble stent in a s~llJsl~l;Ally non-radially ~ a~ ed ~I;Fn~ e circllll,rel .,Lially which is covered, about at least a substantial portion of its longitu~1inAl axis, by a tubular gra~ which is fGl~i"ed about the stent by i"he,~ radial recoil force of the graft upon the stent.
It is a further object of the present invention to utilize a tubular graft made from a Ol)OIUUS 1~ inAlly ~yp~ntied polytetlafluoroethylene material and a balloon ~Yp~n-lAble endolun~inal stent.
S~ 111 UTE SHEET (RULE 26) W O 97/07751 PCT~US95/10752 It is a further object of the present invention to provide a method for ass_mbli--~ the inventive stent-g~ft which co,~ ;ses radially dilating a tubular graft made of a material having i,,h~.lt radial recoil m~t~i~1 plUp~.- LicS, circu",rtl~ ntially fitting the dilated tubular graft about a radially f~yrAnA~le Çn~lc~-lminAl stent, and ~e ;~ B the dilated tubular graft to recoil to a 5 reduced di~mrter about the stent The stent-graft ~ssc.,~bly of the present invention is particularly useful in many type of co~ ;o~ anatomical pAc~geways, such as the repair or ~rl--Q;~n of a~.~u,~s...s, vascular oc~ o,~c either alone or in con, rtic-n with p~ - tral~ " ~l coro.~y an~5iopla~ty (l?TCA), ocrl-~;onc obstructions or strictures of the biliary ducts, ~ ,h_. ~l v~ , ureters or the urethra.
It is a further object ofthe present invention to provide an appa~ s for assembly ofthe i"~e..li.re stent-graft which comprises a stent lel~ g "-alldlel having a first diAm~tçr and a graft dilation ~and~ cl having a second ~ which is greater than the first ~ te~ of the stent rel~ in~ ,,.and,cl, which is removably ~ngAg~hle with the stent ret~ining l-,anJ-~l It is a still further object ofthe present invention to provide an app~alus for making the 5 e r ~ ~ lF stent-graft assembly which co,..~.iscs inte~hAI~g~ble stent re~ -g ",andrcls and graft dilation mandrels for acco---l--odating dirr~-e.~l radial ~i~metçrs of tubular grafts and endo'-~minAl stents and for making dirre-e..~ meter stent-graft assemblies It is yet a further object of the present invention to provide a method and appa,~ s for deli~ -g and positioning an eYp~nd~ble stent-graft within a lumen in the body wl,~ the stent-graft is assembled and loaded from the m~mlfAct~lring asse,-ll~ly directly onto a balloon r,A,thrtf~r, Briefly, the ~ b'e stent-graft a~ ,Lly inrl~ an ~ 1e tubular graft ~-t;---ber which c ~~;u--lrt; _ ILdlly covers an exterior surface of at least a longit~ in~l section of a tubular radially ~YrAntlAhle stent The tubular graft member is p-~r~r~bly comprised of sintered, lon~itll-linAlly rYr~ntled polytetrafluoroethylene More specifically, the radially ~YpAn~lAhle stent-graft assembly incllldes a tubular radially ~Yp~ntlAhle stent having an interior or luminal surface and an eYterior or abluminal surface and a tubular graft ....~.,.l,~. having an interior or SlJ~ 111 UTE SHEET (RULE 26) luminal surface and an exterior or r''uminAI s~l-fAr~, ~ller~. the luminal surface of the tubular graft m~mh~r contacts the Ab!~-minol surface of the radially ~ cl~dAhle stent and the tubular graft ...-.n~b. ~ iS r~ i..ed about the radially ~ dAhlc stent, in its sul~s~ ;Ally l~npyrAntled tlismPtçr~ by inher~nl radial recoil forces exerted by the tubular gra~ ,n~n~l~e~ graft upon the 5 radially ~ I-z~ ctlle stent.
The method for mal~ng the; , ~ ' ' e stent-graf'c a~llJly inrludes the steps of radially dilating the tubular graft ~~ . ically placing the dilated tubular graft ~~ lber about at least a longit~-lino1 section of a radially ~ b'~ stent in its S ~ I;AIIY radially -I-A--~Ie~ ,le~, removing the dilation force thereby ptlIIIillillg the dilated tubular graft 10 .I~,.llbel to diametrically recoil, and pelllliui,-~ the radial recoil propel lies of the tubular graft .IG l-~.,r to il.lpillge upon the abluminal surface of the radially r~l~AIldAhle stent, thereby co--c~ .ically fitting the tubular graft .Il~,..l~el about the radially ~ ~I.An~Al-le stent.
The present h.~lLion is also directed toward an app~ s for assembling the hlvenlivt;
radially ~Ar ~ ~~~ le stent-graft assembly. The appalal~ls generally inrl~ldçs a) a tapered dilation 15 Il~ co---l--; -~, a first end having a first r~iAmeter and a second end having a second, larger ,1;5 "~1 for radially t .I.~n~ a vascular graft to a larger rliAmP~ter by sliding the vascular graft from the first end to the second end of the tapered Illanil ~1; b) a stent ~ p Illalndl ~I having a ~~iAmçter less than the second, larger ,li~ of the tapered dilation Illandrt;l; and c) means for ~~leasLbly co.~ç-,l ;.~g the second end of the tapered mandrel to the stent retAining .lland-~l 20 to permit removal ofthe rçsl~ltAnt stent-graft assembly.
The objects and advantages of the invention will appear more fully from the following more detAiled description ofthe plerelled embotlimPntc ofthe invention made in conjunction with the accolllpallyil~g drawings.
Brief Df s ~ ;vlic~ of the D. ,... i. ~ .
Figure 1 is a pel~ecli~e view of the stent cover embodiment of the PYpAn~lAble endovascular stent-graft assembly of the present invention.
SUBSTITUTE SHEET (RULE 26) Figure 2 is a cross-se~i~ n-l view taken along line 2-2 of Figure 1.
Figure 3 is a p~ e view of the stent-graft embo~lim--nt of the ~Yr~nll_hle endovascular stent-graft ~.-II>Iy of the present invention with the underlying stents located at the ends of the stent-graft shown partially in ph~ Q,,, S Figure 4 is a side e1ev_l;on&l view of the inventive ~ --hly app~alus for making the wLr ,~ ntlc~ ~ -' stent-graft s~.,ll,ly of the present invention showing plr~P.mf~nt of the ndecl stent prior to ass_."l,l;--~ the stent-graft ~ ly app~alus.
Figure S is a side elevational view, partially shown in lon~ n~l section, of thes~.,Lly apparatus for making the ~Yr~ntl~hle ~ntiolllmin~l stent-graft assembly of the present invention imme~ tely prior to placing the graft onto the mandrel portion of the assembly app&,alus.
Figure 6 is a side elevational view, partially shown in longitllrlin_l section, of the ly ~palaluS for making the ~ n~1~hle endo!l~min~l stent-graft assembly ofthe present invention showing the sll~lclfing of the graft over the dilation ..-andlel of the assembly &~)pal al~lS.
Figure 7 is a side elevational view, partially shown in longih~rlin~l section, of the Ei~m~ al)p~h ~lUS for making the eYr~nrl~hle endoluminal stent-graft assembly of the present invention showing sliding of the graft over the larger end of the dilation ~ d~c;l and over the d stent beyond the end of the stent mandrel.
Figure 8 is a side elevational view, partially shown in longihl~in~l section, of the as~t;nLly apparatus for making the ~Yr-ntl~hle endol lmin~l stent-graft assembly of the present invention showing circu--~l e--lial cutting of the graft near the ends of the lln~Yr~n~led stent.
- Figure 9 is a side elevational view, partially shown in longih~lin~l section, of the assc;nll,l~ apparatus for making the ~xr~nt~hle endoluminal stent-graft assembly ofthe present SUD~ 111 UTE SHEET ~RULE 26) W O 97/07751 PCTAUS9~/10752 invention sl-uwi~ A~mhlY of the &~ss~ l)ly ~p&lalus by sep&l~Lil,g the stent mandrel ...I,= -~;.,p the cc - . Ieted stent-graft assembly frorn the stent mandrel and the handle .~
Fig. 10 is a side elevational view ofthe &ss_.l~ly app~alus for making the ~ AAhle ' stent-graP~ a~n~l~ly and ~ q?, the stent-graft &~ lbly onto a delivery c~theter 5 of the present invention showing pl~ çm~nt of the ~n.,.l~A~ ed stent prior to asselllbling the as~elllbly app&l~lus.
Fig. 11 is a side ~ ~iul~l view, partiatly shown in lon~t~ l section of the assembly app~lus for making the eYrAntl~Able endol~minAl stent-graft assembly and l-lounlillg it onto a delive.y ~lllelel ofthe present invention ;~ .rJ;~ y priorto placing the graft onto the Illandlel 10 portion ofthe assembled assembly appali,lus.
Fig. 12 is a side elevationl vie~,v, p~La~l~ shown in longit-~lin~l section, ofthe assembly a~p&ldl~Js for making the t~YrAn~Able en~lo11~minAI stent-graft assembly and mollnting it onto a d~;~ .y C~ LeleL~llvwlllg the slrelclllllg of the graft over the dilation mandrel of the asse.llbl~ d assembly appal ~tus.
Fig. 13 is a side elevational view, partially shown in longit~l~lin~l section, of the assembly app~u~us for making the ~Yp~n-l~A~le entlo!l~min~l stent-graft assembly and mounting it onto a del;vely c~thet~r, showing sliding of the graft over the larger end of the mandrel, over the A~ ed stent, and beyond the end of the stent mandrel.
Fig. 14 is a side elevational view, partially shown in longitl-llin~l section, of the assembly 20 appa-dlus for making the çYr~ntlAhle endo' ~min~l stent-graft asselllbly and mollntinp it onto a delivery cAtheter showing the ch.iull~elel-lial cutting of the graft near the ends of the un~ e~l stent.
Fig. 15 is a side elevational view, partially shown in longit~ in~l section, of the assembly &I,p&,~lus for making the ~pAntlAhle endoluminal stent-graft assembly and mounting it onto a SU~ 1 l l UTE SHEET (RULE 26) W O 97/07751 PCT~US95110752 delivery csthP~tpr showing removal of the handle ..~ b~ bar from the stent mandrel and the positiQning the balloon ~ tel relative to the stent mu1d.~,1.
Fig. 16 is a side ~ v~lional view, partially shown in longif~ ins-l section of the &ss~ bly 4,p~1us for making the ~ h'e ~n-iol~lminQl stent-graft asse.-~l~ly and ...~ g it onto a S delivery ~ t ,r of the present invention sl-ow-ng the insertion of the bal1oon r-s-thet~ ~ into the lumen of the stent ,..~drel.
Fig. 17 is a side el.~ -' view, partially shown in lon~t~ insl secti~n of the assembly appa-~Lus for making the eYpsn-l~sble endolumina1 stent-graft assemb1y and Illoulllillg it onto a de1ivery ~~lllGlel of the present invention ~IIU .. ~lg removal of the PYpsn~sh1e PndQlllminsl stent-10 graft assembly mounted onto a de1ivery c-sthPtPr from the stent mandrel after positioning the stent-graft cover over the center of the ba1100n on the balloon csthete .
DetAiled Dcs ;~: - of the Preferred Embo;' ~ ~
Turning now to the -s-~co. ~ y..lg Figures, the inventive radia11y ~ sb1e endoluminal stent-graft assG.--1~1y 10 is i11ustrated general1y in Figure 1. Stent-graft assemb1y 10 general1y consists of a radia11y ~.,~ n-1Ab1e stent l.. ~l.. bel 12, in a sul,s~ slly radia11y lln~Ypsnfled , ciralll-rel~ ia11y covered by a radia11y eYrsnflsh1e tubu1ar graft member 14, which is pl~ o---l-l;~d of lor~tllfl;nsl1y PYp~nfled mi-;lopolvus po1ytetrafluoroethy1ene (ePTFE).
It wi11 be understood by those skilled in the art that ePTFE materia1s have a characteristic microstructure con.~ ~l;uP of nodes and fibri1s, with the fibril oriçntstion being sub~ ;slly 20 paral1el to the axis of k)ngi~ in-sl c,~ s;on. F~p-sn~led polytetrafluoroethylene mstf risl~ are made by ram extruding a co---l,lGssed billet of particu1ate po1ytetrafluoroethylene and extrusion lubricant through an extrusion die to form sheet or tubular extrudates. The extrudate is then lon~t~flinslly ~Ypsntled to form the node-fibril microstructure and heated to a temperature at or above the crysta11ine melt point of polylGLl~luoroethylene, i.e., 327 ~C for a period of time 25 sl-fficiçnt to sinter the ePTFE material. The tubular graft member 14 of the present invention is preferably made by ram extruding a PTFE-lubricant billet around a mandrel and through an ~llu;.;ol- die to form a tubu1ar ~l~ud~Le. The tubular extrudate is longitll-linslly ~Ypsnded and Sl,~;~ 111 IJTE SHEET (RULE 26) sintered, then cut to a desired length as lc~l~ to ~iuwn~.c~Li lly cover a longit~l~1in~1 section ofthe stent ...- -..b~l 12.
The tubular graft ...~ 14 cc,~ ,-ises an interior or luminal wall surface 16 and an exterior or abluminal wall surface 18. The stent member 12 is also tubular and comprises an 5 interior or luminal surface 20 and an exterior or ~l lminAl surface ~, as illustrated in Figure 2.
When ~ ulllrel~lLially ~ osed about the stent mRrnh-or, the luminal surface 16 of the graft ..,c...l,er 14 resides ~Aj~c~nt the abluminal surface 22 ofthe radially ~-~ .An~ed stent m~rnher 12 to form the eYp~n~l-b!.~ stent-graft ~cc ....1~ 10 and l ~ tai~-cd thereupon by inherent radial recoil p~upc lies ofthe ePTFE tubular graft member 14 acting against the abluminal surface 22 10 ofthe stent ...c...l~e. which imp~ts an i~lc~rc~ ce fit bcl~een the stent mf~-nh~.r 12 and the gr_ft ~,lc .lbel 14. It has been found that all tubular eP 1~ ~. graft members exhibit between about 10-30~/0 recoil from the radially ~ '' -, with the median recoil falling bt;Lween 15-25%
of the radially ~Yp~n-led ~ m~ten The radial recoil property of the radially ~yp~nl1ed tubular ePTFE material, appcal~ to be a consLalll plupc~ly and not dependent upon degree of radial 15 e"~allsiol~. Moleover, the radial recoil p~upc~Ly does not seem ~ffectecl by other material p,u~,e.LicsofanePI'~ 'graft suchasinternodalr~ nc~ wallth:~Ln~c~ degreeof lon it~-~lin~l ~l,Al.~'Ol~, etc.
Once assembled, the radially eYp~n~Ahle stent-graft assembly 10 may be placed on a balloon ç~thetP!~, such as a conventional angioplasty balloon çAthet~ delivered through an 20 ~ ' ' passageway to a desired delivery site, and placed endohlmin~lly by pressure dilating the balloon thereby radially I l.~...l;..f~ the stent-graft assembly to a desired rii~meter based upon pres~lected ~Yp~n~ed ~ m~ters of the stent member 12 and the graft member 14.
Radi~ dilation ofthe tubular graft ",e".ber 14, from a pre-eYp~n-led rliAmetçr which is less than the ~ A~-ded outer ~ elel of the stent member 12, to a radially eYpan~e~l inner 25 d;-- . .e~ ~- which is greater than the outer ~ meter of the stent member 12, imparts a recoil force to the tubular graft ...enll)el 14. The radial recoil of the radially dilated tubular graft ~ll~ bel 14 reduces the inner ~ metrr of the tubular graft member 14 such that the luminal surface 16 of the tubular graft member 14 impinges upon and resides ~dj~c~nt the abluminal wall surface 22 SU_5 111 ~JTE SHEET (RULE 26) ofthe stent l-w~ cl 12, as shown in Figure 2. In this manner the inventive stent-graft assel"bly 10 affords a more strean~ined ~nd~ minAl prosthPQ;C than the cu,,c -lly known ;~ 5~1k which require suture ~ < ~ ,n a radially ~...P ~ APd stent ...- ...he~ and a larger .1i5.".~P.
~ ~ d -' -' gra~. Further, because the inventive stent-graft asse"~bly 10 has a reduced profile, 5 the French size of the introducer set for intro~ rir~g the inventive stent-graft a;,se."l)ly 10, may be cc",c~ ' ,1y reduced, further fiA.~ g pere~ FollQ~ delivery of the ~Yp n~l ble stent-graft ass_."bly 10.
Once the stent-graft ass_.~ ly 10 is del;~cl~d Pn~n~ Im;~_lly to a desired position in an ~ ' p&. ~cw~y, the inventive stent-graft as~uLly 10 is radially eYran-led by application 10 of a radially e Al.u,s;ve plcs~ure~ such as that provided by an angioplasty balloon, against the luminal wall surface 20 ofthe stent lllcull)cl 14. Both the stent mc ~bel 12 and the graft "~c"~bel 14 radially expand to an ~YrAn~led ~ mPter as desired. During radial ~YpAnQion~ the tubular stent ,.,c",bcl 12 and the tubular graft m.omher 14 are radially dcro""ed under the inflll~nce of a positive l"c~u, c exerted against the luminal wall surface 20 of the tubular stent member. The 15 material of the tubular graft "l~ ."ber 14 iS ~1, el~;l,ed or eYp--n~led with the result that the wall : ofthe radially n .~ ed B ~c~ c~ 14 iS typically thicker than that of the radia11y A~d graft ~ lw 14 due to radial stretching of the graft member 14. Where the tubular B lllclnl~el 14 iS made of sintered ePTFE, it will be understood, by those in the art, that radial 1~ ofthe ePTFE tubular graft ~c~ber 14 deforms the node-fibril microstructure of the 20 ePTFE material. Where the ePl~ tubular graft member 14 employed has an axis of k~ngitll~in_l eAI ansion parallel to the axis of radial PYpanQ~ion of the tubular graft member 14, radial expansion of the stent-graft assembly 10 will result in elongation of the fibrils. Where, however, the ePl~l~ tubular B ~clllllel ~ ycd has an axis of ion~it--rlin-l expansion which is PCl~ to the axis of radial expansion of the tubular graft member 14, radial PYpanQit-n 25 ofthe stent-graft assembly 10 results in elongation ofthe nodes.
O The radial recoil force ofthe tubular graft member 14 against the abluminal wall surface 22 of the stent member aids in prcvenl.,,g axial migration of the graft member 14 on the stent - l"c",ber 12 during radial expansion ofthe stent-graft assembly 10.
SU~ 1 1 1 UTE SHEET (RULE 26) O 97/07751 PCTtUS95tlO752 Figure 3 illustrates second and third embo~im~nts of the inventive radially eYp~n-l~ble stent-graft aSSG~ ly 30, which each coln~l;s~ at least two stent ...~-..he- ~ 38 and 40, a single graft ~ l~r 32, W1I~.~I each ofthe stent II~ G1~j 38, 40 are po~ ;tion-od at opposing ends 34, 36 ofthe graft ...- .,.l,f ~ 32 and l-,t~led therein by the radial recoil force of the graft member 32 Lly;n~ g upon abl-~min~l wall surfaces of the at least two stent ~.,~.,.I.-..:, 38, 40. These ~mho~' -nt~ ofthe inventive stent-graft ~...bly 30 are particularly well adapted for ~Yf ~ ion of abdominal aortic al..,u-y~-l-s or other trauma to an ~n~tom:-~l passageway, such as by a gunshot, because it has an ,..L~ e longJt~ in~l section ofthe graft ,~.,,hçl 32 which is unsupyol led by any lo~t~din~l section of stent ~ e~ ~ 38, 40. Where two or more stent ~IGIIII~GI:j 38, 40 are used, the intel...~ e ~lnsul)pol led sections of graft member 32 permit articulation of the stents 38, 40 relative to one another, with the unsupported sections of graft member 32 acting as articulation joints.
Figures 4-17 generally i11ustrate an a~cn~bly apparatus 44 and the method of making the inventive stent-graft a~GIlll~ly 10, as d ~ 1 in Figure 1. Figure 4 is a partially exploded view ofthe ~Gm~IYa~)~alUS 44 used for making the inventive stent-graft assembly. The inventive as~.lll)l~ a}pa~al~ls 44 cclllylises generally a tapered dilation mandrel 46 having a first end 48 and a second end 50 wherein the ~ m~t~or of the second end 50 is greater than the di~mPt~or of the first end 48, a stent le~ lg "lanJlG152 which is removably çng~s~e~hle with the second end S0 of the tapered dilation mandrel to retains and supports the stent member 12 in a given position on the stent l~lh;l~lg .nal-dlel, and a handle m~mher 53 which is removably coupled to the stent IGl~;n;ng nIaIIdIeI 52 at one end thereof. The stent ret~ining mandrel 52 has a generally tubular shape and a circulartransverse se~ion~l shape. The stent ,.,l~;";~g mandrel should have an outside ~ ~PI which is less than the inner tli~met~r of the stent member 12 to f~cilit~te loading the stent member onto the stent ~e~ ;llg mandrel, and the combined outside ~ m.o~t~r ofthe stent ret~inin~ mandrel 52 and the outside d;h~l~e~ ofthe stent m~mh-?r 12 is less than the outside ~li~meter of the second end 50 of the tapered dilation mandrel 56.
Figures 5-7 leple3~L sequ~nti~l views ofthe graft member 12 being loaded onto the tapered dilation ,ll~u,L~,152 and being ~n~ ically ~g~d about the stent member 12. It can be appreciated that by confi~l~ing the outside ~lih~elpr ofthe second end 50 ofthe tapered SUBSTITUTE SHEET (RULE 26) dilation "~,d-~1 to be greater than the outside ~I;c....-te- ofthe stent ~ c 12 mounted onto the stent n,~ drtl 52, the graft ~ 14 is radially dilated as it is pulled over the tapered dilation ~ I 46 or as the a~ ly appara~us 44 is pushed 72 into the lumen of graft ,ml~el 14. a section ofthe grafc r.. ~ 14 passes over the stent member 12 mr-llnted on the 5 stent ~ l,~,Lel 52 and is conc~ ically po~ition~d about the stent ",e.,.ber 12. As the nl~c~ 14 is passed over the stent ~--- ..l~l-er 12, it ~ u~ no le~ to radial recoil and radially recoils until the luminal surface ofthe graft ..- . ..l~el 14 imringl~s upon the a~!~lmin-o-l wall surface ofthe stent ~F-..I~ 12, at which point the graft ~ 14 Cl ntimles to exert a positive radial recoil force against the stent .. 1~, 12, which is resisted radially il,colll~ ;,il,ility ofthe stent member 12.
As noted above, the tapered dilation mandrel 46, the stent l~l~i";"g mandrel 52 and the handle Ill~,.nl~el 53 each have means for removably intclco~ e~ g the tapered dilation mandrel 46, the stent ~ dlel 52 and the handle Illelnber 53 to one another along a collllllon k)l~ 7l axis. As illustrated in Figures 4-9, the second end 50 oftapered dilation l-,andlel 52 incl~ld~ an axially positioned female coupling 58 which receives a mating male coupling 60 on a first end of the stent retoining mandrel 52. While the Figures depict threaded female couplillg 58 and male coupling 60, it will be understood by those in the art that the couplings are il.lel~l-Ange~oble and may be any of a wide variety of suitable couplings, For example, the coupling associated with the tapered dilation ~-.a~ldlt;l 46 may be a male c~,u~ling 60, with a 20 mating female co~ g 58 being o-~o~;o~e~ with the stent IG~ g mandrel 52, or the cou~lings may be threaded, or non-threaded, such as being an inte.rt;-N,ce fit coupling. The stent retoining ll~l~l-el 52 is also removably coupled to the handle ll~ml)c;l 53 by a male coupling 56 projecting from a second end 62 of the stent lcl~iOi~, mandrel 52. The male coupling 56 removably engages with a female coupling 69 associated with the handle member 53. Again, while the 25 Figures depict a non-threaded coupling between the stent ret~ining mandrel 52 and the handle Ill~;ml t;l 53, those in the art will understand that the couplings are intel~ g~ble and may be ,, any of a wide variety of suitable co~ ~p~inp;~, For ~llple, the coupling associated with the stent ;"g Illan.llel 52 may be a female coupling 69, with a mating male coupling 56 being - o.~so~i-oted with the handle member 53, and the coupl;llgs may be threaded, or non-threaded, 30 such as being an inlelrelence fit or friction fit coupling.
SUBSTITUTE SHEET (RULE 26) In acco-dance with the plerel-ed embo~im~nt ofthe ~csçmhlya~p~ualus44~ the stenti"i,~ d~,l 52 has a generally .;~lin.l~ic~l body portion 54 which le ...;l.~les in shcn-l~er sectionc62 at opposing ends ofthe cylindrical body portion 54 ~ c~nt CO~IPI;~OJC S0 and 66. r When the a~ ~ly ~F Ic 44is in its fillly co~ d state, shoulders 62 serve as pru~l,lal and 5distal dd,~liolls for p,u~"al and distal annular detents 67 bcl~ en the second end 50 of the tapered dilation l~&ndl~l44 and one end of stent mPmhPr 12 and between the handle member 53 and a second end of stent nl~ cll2. The length ofthe "y1; ~ ;c~l body portion 54 beL~ ell shoulder sectionc 62 pl~f~.ably coll~ Ol~c to the length of stent member 14. As used in ~C, 1~ ~on with the asse.~,~ly app~a~us 44, "distal" refers to a direction corresponding to the 10relative position of the tapered dilation ,llalldlcl 46, while "prc,~l"al" refers to a direction corresponding to the relative position of the handle ",c~"bcr 53.
Figures 4-9 also illustrate the method for making the inventive stent-graft lO zlccçn~hly using the &~."I,ly appa.~us 44. Tapered dilation mandrel 46is coupled to the stent, c1 ~.;..;np ",a.~dlel 52 by ~~ng~ging cc,u~ling 60 in second end S0 ofthe tapered dilation mandrel 46 with coupling 60 of the stent ret~inin~ ",al~d,el 52 A stent m~mhçr 12, in its subst~nti~lly radially une~p~nded ~ m~oter~ is ~n~ged about the stent ret~inin~ mandrel 52 by concentrically pocitioning the stent "le",l,el 12 about the stent ret~ining mandrel 52. The handle member 53 is then coupled to the stent rc~ g ",and~el 52 by ~ng~ging coupling 56 ofthe stent lclAi~ g ~"al~ cl 52 with cu~ 69 of the handle ",c"ll)el 53 . As shown in Figure 5, the stent me",l,er 12 is positioned ~ ;ulllrelclllially about the stent ret~inin~ mandrel 52, and the stent r~l~;--;-.
mandrel is positioned inte....e.l;i.le bcl~cell the tapered dilation mandrel 46 and the handle 53.
Figure 6 illustrates the step of .~np~ in~ the graft member 14 onto the tapered dilation ~ d~ ~1 44 by applying an a~al force 72 to the ~cmbly appa~ ~ s 44 which causes the tapered dilation mandrel to pass into and through the lumen of graft member 14. The assembly a~l.~a~s 44 is passed into and through the lumen of graft member until the first end ofthe graft member 14 is in close p~ux~llliLy to a terminal portion 54 of handle member 53. As the graft ...~...1..~1 14 passes over the second end 50 of the tapered dilation mandrel 44, the graft member 30 14 radially e~r~nded so that the inner ~ met~r of graft member 14 is radially e~ran(led to the S~,~S 111 ~JTE SHEET (RULE 26) WO 97/07751 PCT/US9~,/10752 outer dismP~ter of the second end 50 of the tapered dilation mandrel 44. At the point of the distal annular detent 67, the inner tlismeter ofthe graft mPmhPr 14 is greater than the outside ;smPtPr ofthe stent ~ .nl,~,~ 12. As the gra~ ..hP,I 14 moved axially over the stent nlcll-l~cl 12 and to a pos.Liol- 9~ ~ the handle ll~ l,er 53, the graft "wllll~cl 14 undergoes radial recoil 5 so that the inner .~ le~ ofthe graft llwllll~el 14 reduces until it meets with n ~ - -e to further recoil. As illustrated in Figure 7, the graft .--~ f-~ 12 has r. dially recoiled onto the stent ,l~,.,l1~. 12, and has also recoiled into annular detents 67 at the p,~,~,lal and distal ends ofthe stent ...~...hf.l 12.
F~ng~sgf~mpnt ofthe graft member 14 over the tapered dilation mandrel 46 is fs-.ilitstP~d by forming tabs on the first end of the graft ............ 1.~ . by cutting longitudinal slits (not shown) along d;~Llllcllically opposed sides of the graft ,. .~.. bçl . The tabs can then be used to retain the graft mclllber 14 while an axial force 72 is applied to the assembly appa-~lus, or the tabs may be used to m~ml~lly pull the graft member 14 over the tapered dilation mandrel 46, the stent ll.~,.llber 14 and to the handle member 53. To prevent formation of seams or wrinkles, is important to avoid applying torsional forces to the graft ",cn,b~,r by twisting the graft during PngslgPmPnt of the graft member onto the assembly api)a, ~ s 44.
Figures 8 and 9 illustrate the steps for removing the stent-graft assembly from the assembly apph-~ s 44. Cutting blades 74 are used make ci~;u~lrerc~lial cuts in the graft ~c~ el 14 at the position ofthe annular detents 67, which is slightly, i.e. about 1-2 mm, longer 20 than the longit~tlin~l length of the stent member 12. The 1 e~ il .;g section of material of the graft member 14 which projects beyond the opposing ends of stent mP.mbP~r 12 allows for the axial rore:il,o,lening of the graft 14 in relation to the stent 12 during Pn~1olllmin~1 radial e~l,ans;on ofthe stent-graft assembly 10.
After making the ~ ;ulllrc-c -Li~l cuts at the position of the annular detents 67, the stent-graft as~c.nl,ly 10 is sep~ ed from the rP.m~in.1çr ofthe graft member 14. The stent ret~ininp mandrel 52 may be decoupled from the tapered dilation ~I-anli. cl 46 and the handle member 53 by disens~ ng the stent ret~ining mandrel coupling 60 from the tapered dilation mandrel .71 and ~ eng~ging the stent ret~inin~ coupling 66 from handle member coupling 69.
SlJ~ 1 1 1 UTE SHEET (RULE 26) WO 97/07751 PCT/US9~;/10752 The stent-graft ass_.l~l)ly 10 is then removed from the stent ,~ g ~ drel 52 by axially ~ ~- pl ~ the stent-gr~ft asw..-l,ly 10 relative to the stent ~ g mandrel 52. a waste portion of the graft ... -..l-- - 14 resident on the handle ~ t~l 53 may be discarded. The as~_..-bl.~
~p~_~ 44 is then in c -- ' ~ 5n to reload another ~ tled stent n,~,.sla)el 12 onto the stent 5 l~ ~ ~ ~ y~ lllan~,l to reinitiate the inventive method by le~ g the above-described steps and produce a~ldition~l stent-graft a~c~ ,!ies 10.
It will be ~/a.~lt to those skilled in the art that a m~ltit~de of sizes, both in length and in outer ~ 7 of the stent n -_- - -l~e- 12, the graft r ~ 14 and the assembly a~"~&- ~us 44 may be employed to make a stent-graft assembly 10 having pre-determined dimensions.
1 0 ~,.. "~
A 2.8 mm internal .l;~...el~ (ID) eP'l'~ tubular graft was radially stretched over a tapered dilation mandrel having a 3.7 mm external ~IiAmPter at its largest end. The eP~ ' graft was then ;.. ediAl~ly passed over a 3.4 mm ~ ed stent ~,;lcull~èlenlially mounted on a stent r~t~ .g .l.andlcl which was removably co"~te~ to the tapered dilation mandrel. After 15 being passed over the ~ n-l~d stent, the eP'l~ 1~ graft exhibited imme~iAte recoil against the outer surface ofthe stent and ~ d a 3.4 mm ID. The graft appeared to be fit tightly about the stent and was le;,;sl~llL to manual displAcçm~ont along the longit~l-iinAl axis of the stent.
Subsequent radial t ~~lA-- o.~ ofthe res~llt~nt stent-graft assembly was accomplished by loading the stent-g~ft ~sellltul.~ onto an angioplasty balloon CAth~PtPr~ applying a positive fluid pressure 20 to the angioplasty balloon to radially expand the stent-graft assembly to 10 rnm OD. At its expanded ~i~mP~tPr~ the graft rçmAined tightly fit about the circumference of the stent and ~,,.I~;Ied recietAnce to axial disp!acçmPnt upon manual manipulation.
Figures 10-17 depict the inventive method and assembly app&-~ s 75 for making and mounting the ~ n~lAhle endoluminal stent-graft asse..lbly onto a delivery çAthetçr More specifically, Figures 10-14 are repli~tes of Figures 4-8 with the exception that the stent l~;; ~ ~ ~g l.l~dlel 52 in~ ldes a central closed-end longituflinAl bore 76, in Fig. 15, which opens tow_rd the ~lu~llal end ofthe assembly app&l~ s 75 Adj~cçnt the handle member 53.
S~ JTE SHEET (RULE 26) W O 97/07751 PCTrUS95/10752 The procedure for making the stent-graft assembly 10 follows the same steps in Figures 10-14 ~ il,ed above with .~f~ nce to Figures 4-8. II~ _., as illu~ ed in Figure 15, after the circ~-lrc ~.-l;al cuts in the graft .. ,.l-~ 14 are made at the position ofthe annular detents 67,thehandle.~.,,,l~Pr53is~ f ~8~fromthestent.~ ;-.;u~~--andlelS2. adistaltipofaS balloon c~thPtçr~ having an infl-t~le balloon 80, is then passed into the longihl~inAl bore 76 such that the balloon 80 is positioned in p[o~l--ly to the stent-graft assembly 10 as illustrated in Figure 16. The stent-graft a~.nl,ly 10 is then ~ ~F'- ~ed from the stent ret~inir~ .-.~-dlt;l 52 and c~ ~ -~ "y po ;~i~ nPIl about the ~ n ' ~ ~ balloon 80 of the balloon cn~ ei 78. Finally, as shown in Figure 17, the balloon 4~.l1,-,t~ 78 is removed from the k-n~~ 1in~ bore 76 in the 10 stent rc;~ g mandrel 52, thereby providing an pre-mounted stent-graft delivery system.
The resulting radially .~l~An~l~blc endoluminal stent-graft assembly has an added advantage of luw~-i--g the c-l~Ar~;on pressure required to radially expand the stent-graft ass_...1~1y due to the pre-c~ ion of the eP 1 bk graft during the inventive process.
In acco-dance with the p.~rwlt;d embo-lim~nte ofthe present invention, it is plert:lled 15 that a PALMAZ stent (Johnson & Johnson Interventional Systems, Inc., Warren, N.J.), as des-;lil.ed by Palma~ in U.S. Patent No. 4,733,665, or balloon eYr~n-i~hle PALMAZ-type stents be used. However, other dirr~ L types of pressure ~oYp~n-~ble stents known in the art may be used, with the only limit~qtion being that the exhibit sufficient radial strength to resist the radial recoil of a radially ~xpAntle~l ePl~iE tubular graft. It is also pl~reltlble that the assembly 20 appa.~us 44 be made of a material which is resistant to burr formation, such as st~inl~e.e steel, and which provides smooth surfaces which do not ~m~ge the graft member while it is being manipulated on the asse--ll)ly app~l~lus. The inventivê process may be carried out at room léllll~,.aLul~, or may be carried out at elevated t~lll~c;l~L-Ires which are below the crystalline melt point ~P 1 bk. I~ f~his m._..n~.er, there is proYided a ~OV. ered ste-nt in which t~he coYer is ret~ined 25 by an illlelrc;lellce fit bcLween the cover and the stent and no adhesives or sutures are le~uhed to positionally affix the cover onto the stent.
While plGrt;.~d embotlim~nt~ ofthe invention have been shown and described, it will be app~:lll to those skilled in the art that various mo-lifi~ti--ns may be made in these embo~lim~nte SU~a 1 l l UTE SHEET (RULE 26) WO 97/077SI PCTnUS95/10752 without d~li,~ from the spirit ofthe present invention. The.erort, all s~lit~le moflifiç~tit-ns and equivalents fall within the scope of the invention.
S~ ~S 111 ~JTE SHEET ~RULE 26)
~.L~ of the T ~ lion The present invention relates generally to a radially ~ hle çn~ min~l covered stent ~.-IIJI~ and a method and apparatus for making the same. More particularly, the present S invention relates to a lo~t~lin~11y and radially PYr~n~ed polyL~ oro~ lene (ePTFE) tubular graft which is ~h~iu~.lr~.elLally f-~gs~rA about at least one balloon ~ tlAhle ' stent and retained on the stent by a radial recoil force exerted by the ePTFE tubular graft against the stent.
The covered stent may complise one or more stents circul~ lially retained within a 10 single graf'c. For ;. . '-, acco,d~-g to a first plcfellcd embodiment of the invention, a covered stent is made using a single pressure eyp~n~l~hle stent ch-;ull~l~.llially and lons~ihl~lin~lly covered with a single ePTFE tubular graf'c. In accol d&nce with a second p~ ercl I ~,d embodiment, the covered stent co.u~lises a pair of balloon eYp~n~ble stents positioned at opposing ends of a single eP l'~'~; tubular graft with each stent being ~ ;UIl~l clLally and longitll~in~lly COvCI ed 15 by the eP 1~'~ graft, with an illlCI ~ ~e~liA I e region of the ePTFE tubular graft being ullsu~pcll led.
A~ld~l~, to a third plt;r~l-~ cml~oJilllclll ofthe invention, a longitu-lin~lly artic~ tin~ covered stent is made by co-axially ~li ning a plurality of discrete stents in a longit---lin~lly eYtf~n~ling array, such that the plurality of stents are in end-to-end relationship with one another, and the entire lon~yt~ itlS I array of stents is ~h ~;ulllrerelllially and longitu-1in~11y covered with an eP l 20 tubular ePT~E graft.
The present invention is further directed to a method for making the stent-graft assembly and for mounting the stent-graft onto a delivery ~LI.~Lel . In accordance with the method of the present invention, the stent-graft is as~llll~leG' using a dilation mandrel and a stent mandrel. The inventive method inrll-des the steps of mounting the stent onto the stent Illandrel, joining the 25 stent mandrel with the dilation mandrel, positioning the graft onto the dilation mandrel and radially eyrztn~ling the graft on the dilation nland-el to an inner di~meter which is greater than the outer rli~mPter of the stent, passing the radially eYp~nded graft over the stent, llilllllling excess grafl material from the p~ lal and distal ends of the stent, decoupling the mandrel from S~J~S 111 ~JTE SHEET (RULE 26) W O 97/07751 PCT~US95/10752 the stent ..I_ .L~, and removing the cov~,led stent from the stent mandrel. In accc"d~lce wvith the method of ~u~ g the covered stent onto a d~ .y c~ ,t~, the method further incllldes the steps of ~ ng~ng a ~)rùAiU--sl section of the stent n.fil~drel, ~-ng~ng a delivery caLLclcr ~.-vith the stent ~ L cl such that a balloon section of the delively ~ is prv,.;. . .~ ~ e wvith the 5 covered stent-graft, cwnce..llically po. ~ioni~ the co~,e.ed stent-graft over the balloon section ofthe delivery ~".lt, ~e- and f~ BP ing the d~ e.y c~fh~te~ from the stent mandrel.
Radially pre~ -c ,~ hle and self c~ enti~ minstl stents, such as those c~osed by Palmaz in U.S. Patents No. 4,733,665, 4,739,762 and 5,102,417, Gi~-lu~-;o in U.S. Patents No. 4,580,568 and 4,907,336, Kreamer in U.S. Patent No. 4,740207, Wiktor in U.S.PatentsNo.4,886,062and4,969,458, Pin~h~ inU.S.PatentNo. 5,163,958andSchat7 in U. S. Patent No. 5,195,984 have been clinically invçsti~ted over the past several years in an attempt to uvt;lwlllC the 1 - of p~ S tr~n~ min~l colunaly angioplasty (PTCA), particularly restçno~i~ due to fibrocellular intimal proliferation subsequent to PTCA. More ly, ...v~l;g.~1;ol-~ have focused on baUoon ~ hle stents to anchor intralllmin~l grafts.
15 "T,~ f~ 1Intr~lllmin~l GraftT~ ;onforAbdomin~l AorticAneurysms", Ann. Vasc.
S~rg 1991, 5: 491-499; "Tr~n~lumin~l pl~c~mP!nt of a Prosthetic Graft-Stent De-vice for Tl~ -.l of Subclavian Artery Al~;uly~ll", J. Vasc. Surg, Dece.,.l)er 1993, 18: 1056-1059;
and "P~ ulal eûus Fen~olupopliteal graft pl~c~ .l", Radiolo~, June 1993, 187:643-648.
Several :~U~pUI led grafts are known in the art. For e,~alllple, Kubo, et al., U.S. Patent 2û No. 5,236,447, disclose an artificial tubular organ supported by a supporting frame made of a plastic m~tPn~l which ;nay be PTFE, and a medical prosthetic lndl~. ial disposed on at least one surface of the ~ul,po.l;ng frame wl-el~iin the prosthetic material is pl r~,dbly col"~,-;sed of ab~ e and non-abso,l,al~le macromolecular yarns which may include p ~ The medical prosthetic material is joined to the ~up~o-l;--g frame by sutures. The sutures ~ cl.;..5~ the 25 prosthetic material to the suppo, ling frame limit movement of the fabric on the frame. The Kubo, ef al. ~.l-bly is not radially ~ e and is th~- cro- t; incapable of use in endoluminal applications which require radial Pyp~n~bility~
SIJ~;~ JTE SHEET (~ULE 26) W O 97/07751 PCT~US95/10752 The Rhodes, U.S. Patent No. 5,122,154 discloses an endovascular bypass graft CC r ~ ' .3 a sleeve having a plurality of ~Lr P ~ le, ring-like stent ... ~-.he, ~ are eq~ ly spaced along the longihlAin~l length and positioned on either the outer or inner surface of the sleeve. The sleeve is formed from a highly flexible material, such as ~Yp~nAeA P 1~, and has a series of longihlAin~lly ~ , pleats. Each stent ~h"~ iS conl~evled to one or more of the l-n~t~lA;n~lly . ' ,, pleats in the sleeve and permit ~Info~i~ ofthe sleeve during radial ~'I~r ~ - ~n of the ring-like stent ~-- ...I).~ . j.
Lee, U.S. PatentNo. 5,123,917, dc~~;,il,es a radially -~ -A~l~le sup~G~l~d graft having multiple graft layers. The sul"~o~ led graft in~ lAes a flexible cylindrical inner tube having an 10 outer pe.;~JLc~y, a plurality of sep~le sc~ffo!~ rings mounted on the outer pe~;~Jhe~y along the lon~hldin~l e,Ytent of the inner tube, and a flexible cylindrical outer tube conc~ ;cally enclosing the inner tube and sc~ffol~ - -..h- ~ ~. The sç~ffolcl ~--~ bc ~ are spaced to allow for n~,Ail~iL~y of the inner and outer tubes along their longitl~Ain~l a,Yis.
Another endovascular graft for l~,~,&ilin~, aneurysms is described in U.S. Patent No.
5,211,658 issued to Clouse. The Clouse patent .licclosç$ a percut~neously delivc ,lble structural frame and an independently, perc~t~neously delivc-~ble radially ~Yp~nA~ble tubular member f-.lly placed co~ ically within the structural frame. The structural frame preferably comprises a plurality of meshed strands joined to axially spaced end rings ~,vl~elei~l both the meshed st~ands and rings are comprised of a shape ~--.,.--o- y metal. The tubular .-.w.-l~er, a thin 20 walled fiexible ...~ e, ~lere-~ly incl~lAes a means for ~ nA;..~ and holding the tubular me .ll~el against the structural frame. This means may take the form of an oulwal dly c ~ n.~ le spring coil disposed within the interior of the tubular ...e...l,t;. .
Kreamer, U.S. Patent No. 5,078,726, discloses a stent-graft asse---l~ly having stents placed inside either one or more ends of a graft. The stents are formed from a rect~n~ll~r semi-~ 25 rigid ~ t~ rolled into an open ended cylinder so that an inside longitu~lin~l edge ov~.laps anoutside longih~lAin~l edge of the material. The stents further comprise a ret~ining means which acts to restrain the inner lon~h~ l edge of the graft in the graft's ~xp~n(~ed state. In use, the synthetic graft is endolllmin~lly positioned to exclude a wç~k~ned section of the v~c~ h~re.
SlJ~a 1 l l ~ITE SHEET (RULE 26) W O 97/07751 PCT~US95/10752 A stent in its relaxed ~ ,t~ r state is posifil~ned inside the end of a graft and ~Yr~nrlecl to its ~I&~ d, larger ~ ' ~x state. The radiaUy ~ ~ G force of the stent ;~ S upon the graft and the inner wall ofthe blood vessel to pl ~e.~ p- - of the stent and graft after radial ~lthm~gh a ~-u-~lbe~ of radially ~ Asble stent-graft del;~,ly ~ --;, are particularly suitable for PnAol-lmin~l delivery and ~ Pm~nt are generally known in the art, none of the r~ G2~oillg radially ~Yp~ ' ~'~ le stent-graft A~c~mhl - s offers a co~r~y~ aLiOll which inhibits axial A; Q~P? - of the graft relative to the stent pnor to and du ing PnACl~lminAl delivery and radial -n wiLhoul the use of adhesives or sutures. Fur~er, none of the previously known stent-graft devices reduces the profile of the stent graft co~llb;llaLion thereby enal~ g the reduced French size of the introducer balloon cAth~tçr Accordingly, there is a need for a stent-graft ass~l-,bly which perrnits use of a reduced size introduction çA~h~te- to fA~ilitAte easy and safe deployment of the stent-graft a~s_l-.bly within various sizes of blood vessels and at various sites within the blood vessels. There is also 15 a need for a stent-graPL ass_.lLly which co,plises a graft which is retained upon a subsl~.l;Ally non-radially ~ nd~ stent by .nh~"~.ll radial recoil forces exerted by the graft against the stent during delivery and radial ~YpAn~ n of the stent-graft assembly.
Summanr of the I~ I;c It is a pl;ll~ ,al object of the present invention, thelGro~G, to provide an intrAl--minAI
20 stent-graft a~s_n~ly having a radially eYp~n~3~ble stent in a s~llJsl~l;Ally non-radially ~ a~ ed ~I;Fn~ e circllll,rel .,Lially which is covered, about at least a substantial portion of its longitu~1inAl axis, by a tubular gra~ which is fGl~i"ed about the stent by i"he,~ radial recoil force of the graft upon the stent.
It is a further object of the present invention to utilize a tubular graft made from a Ol)OIUUS 1~ inAlly ~yp~ntied polytetlafluoroethylene material and a balloon ~Yp~n-lAble endolun~inal stent.
S~ 111 UTE SHEET (RULE 26) W O 97/07751 PCT~US95/10752 It is a further object of the present invention to provide a method for ass_mbli--~ the inventive stent-g~ft which co,~ ;ses radially dilating a tubular graft made of a material having i,,h~.lt radial recoil m~t~i~1 plUp~.- LicS, circu",rtl~ ntially fitting the dilated tubular graft about a radially f~yrAnA~le Çn~lc~-lminAl stent, and ~e ;~ B the dilated tubular graft to recoil to a 5 reduced di~mrter about the stent The stent-graft ~ssc.,~bly of the present invention is particularly useful in many type of co~ ;o~ anatomical pAc~geways, such as the repair or ~rl--Q;~n of a~.~u,~s...s, vascular oc~ o,~c either alone or in con, rtic-n with p~ - tral~ " ~l coro.~y an~5iopla~ty (l?TCA), ocrl-~;onc obstructions or strictures of the biliary ducts, ~ ,h_. ~l v~ , ureters or the urethra.
It is a further object ofthe present invention to provide an appa~ s for assembly ofthe i"~e..li.re stent-graft which comprises a stent lel~ g "-alldlel having a first diAm~tçr and a graft dilation ~and~ cl having a second ~ which is greater than the first ~ te~ of the stent rel~ in~ ,,.and,cl, which is removably ~ngAg~hle with the stent ret~ining l-,anJ-~l It is a still further object ofthe present invention to provide an app~alus for making the 5 e r ~ ~ lF stent-graft assembly which co,..~.iscs inte~hAI~g~ble stent re~ -g ",andrcls and graft dilation mandrels for acco---l--odating dirr~-e.~l radial ~i~metçrs of tubular grafts and endo'-~minAl stents and for making dirre-e..~ meter stent-graft assemblies It is yet a further object of the present invention to provide a method and appa,~ s for deli~ -g and positioning an eYp~nd~ble stent-graft within a lumen in the body wl,~ the stent-graft is assembled and loaded from the m~mlfAct~lring asse,-ll~ly directly onto a balloon r,A,thrtf~r, Briefly, the ~ b'e stent-graft a~ ,Lly inrl~ an ~ 1e tubular graft ~-t;---ber which c ~~;u--lrt; _ ILdlly covers an exterior surface of at least a longit~ in~l section of a tubular radially ~YrAntlAhle stent The tubular graft member is p-~r~r~bly comprised of sintered, lon~itll-linAlly rYr~ntled polytetrafluoroethylene More specifically, the radially ~YpAn~lAhle stent-graft assembly incllldes a tubular radially ~Yp~ntlAhle stent having an interior or luminal surface and an eYterior or abluminal surface and a tubular graft ....~.,.l,~. having an interior or SlJ~ 111 UTE SHEET (RULE 26) luminal surface and an exterior or r''uminAI s~l-fAr~, ~ller~. the luminal surface of the tubular graft m~mh~r contacts the Ab!~-minol surface of the radially ~ cl~dAhle stent and the tubular graft ...-.n~b. ~ iS r~ i..ed about the radially ~ dAhlc stent, in its sul~s~ ;Ally l~npyrAntled tlismPtçr~ by inher~nl radial recoil forces exerted by the tubular gra~ ,n~n~l~e~ graft upon the 5 radially ~ I-z~ ctlle stent.
The method for mal~ng the; , ~ ' ' e stent-graf'c a~llJly inrludes the steps of radially dilating the tubular graft ~~ . ically placing the dilated tubular graft ~~ lber about at least a longit~-lino1 section of a radially ~ b'~ stent in its S ~ I;AIIY radially -I-A--~Ie~ ,le~, removing the dilation force thereby ptlIIIillillg the dilated tubular graft 10 .I~,.llbel to diametrically recoil, and pelllliui,-~ the radial recoil propel lies of the tubular graft .IG l-~.,r to il.lpillge upon the abluminal surface of the radially r~l~AIldAhle stent, thereby co--c~ .ically fitting the tubular graft .Il~,..l~el about the radially ~ ~I.An~Al-le stent.
The present h.~lLion is also directed toward an app~ s for assembling the hlvenlivt;
radially ~Ar ~ ~~~ le stent-graft assembly. The appalal~ls generally inrl~ldçs a) a tapered dilation 15 Il~ co---l--; -~, a first end having a first r~iAmeter and a second end having a second, larger ,1;5 "~1 for radially t .I.~n~ a vascular graft to a larger rliAmP~ter by sliding the vascular graft from the first end to the second end of the tapered Illanil ~1; b) a stent ~ p Illalndl ~I having a ~~iAmçter less than the second, larger ,li~ of the tapered dilation Illandrt;l; and c) means for ~~leasLbly co.~ç-,l ;.~g the second end of the tapered mandrel to the stent retAining .lland-~l 20 to permit removal ofthe rçsl~ltAnt stent-graft assembly.
The objects and advantages of the invention will appear more fully from the following more detAiled description ofthe plerelled embotlimPntc ofthe invention made in conjunction with the accolllpallyil~g drawings.
Brief Df s ~ ;vlic~ of the D. ,... i. ~ .
Figure 1 is a pel~ecli~e view of the stent cover embodiment of the PYpAn~lAble endovascular stent-graft assembly of the present invention.
SUBSTITUTE SHEET (RULE 26) Figure 2 is a cross-se~i~ n-l view taken along line 2-2 of Figure 1.
Figure 3 is a p~ e view of the stent-graft embo~lim--nt of the ~Yr~nll_hle endovascular stent-graft ~.-II>Iy of the present invention with the underlying stents located at the ends of the stent-graft shown partially in ph~ Q,,, S Figure 4 is a side e1ev_l;on&l view of the inventive ~ --hly app~alus for making the wLr ,~ ntlc~ ~ -' stent-graft s~.,ll,ly of the present invention showing plr~P.mf~nt of the ndecl stent prior to ass_."l,l;--~ the stent-graft ~ ly app~alus.
Figure S is a side elevational view, partially shown in lon~ n~l section, of thes~.,Lly apparatus for making the ~Yr~ntl~hle ~ntiolllmin~l stent-graft assembly of the present invention imme~ tely prior to placing the graft onto the mandrel portion of the assembly app&,alus.
Figure 6 is a side elevational view, partially shown in longitllrlin_l section, of the ly ~palaluS for making the ~ n~1~hle endo!l~min~l stent-graft assembly ofthe present invention showing the sll~lclfing of the graft over the dilation ..-andlel of the assembly &~)pal al~lS.
Figure 7 is a side elevational view, partially shown in longih~rlin~l section, of the Ei~m~ al)p~h ~lUS for making the eYr~nrl~hle endoluminal stent-graft assembly of the present invention showing sliding of the graft over the larger end of the dilation ~ d~c;l and over the d stent beyond the end of the stent mandrel.
Figure 8 is a side elevational view, partially shown in longihl~in~l section, of the as~t;nLly apparatus for making the ~Yr-ntl~hle endol lmin~l stent-graft assembly of the present invention showing circu--~l e--lial cutting of the graft near the ends of the lln~Yr~n~led stent.
- Figure 9 is a side elevational view, partially shown in longih~lin~l section, of the assc;nll,l~ apparatus for making the ~xr~nt~hle endoluminal stent-graft assembly ofthe present SUD~ 111 UTE SHEET ~RULE 26) W O 97/07751 PCTAUS9~/10752 invention sl-uwi~ A~mhlY of the &~ss~ l)ly ~p&lalus by sep&l~Lil,g the stent mandrel ...I,= -~;.,p the cc - . Ieted stent-graft assembly frorn the stent mandrel and the handle .~
Fig. 10 is a side elevational view ofthe &ss_.l~ly app~alus for making the ~ AAhle ' stent-graP~ a~n~l~ly and ~ q?, the stent-graft &~ lbly onto a delivery c~theter 5 of the present invention showing pl~ çm~nt of the ~n.,.l~A~ ed stent prior to asselllbling the as~elllbly app&l~lus.
Fig. 11 is a side ~ ~iul~l view, partiatly shown in lon~t~ l section of the assembly app~lus for making the eYrAntl~Able endol~minAl stent-graft assembly and l-lounlillg it onto a delive.y ~lllelel ofthe present invention ;~ .rJ;~ y priorto placing the graft onto the Illandlel 10 portion ofthe assembled assembly appali,lus.
Fig. 12 is a side elevationl vie~,v, p~La~l~ shown in longit-~lin~l section, ofthe assembly a~p&ldl~Js for making the t~YrAn~Able en~lo11~minAI stent-graft assembly and mollnting it onto a d~;~ .y C~ LeleL~llvwlllg the slrelclllllg of the graft over the dilation mandrel of the asse.llbl~ d assembly appal ~tus.
Fig. 13 is a side elevational view, partially shown in longit~l~lin~l section, of the assembly app~u~us for making the ~Yp~n-l~A~le entlo!l~min~l stent-graft assembly and mounting it onto a del;vely c~thet~r, showing sliding of the graft over the larger end of the mandrel, over the A~ ed stent, and beyond the end of the stent mandrel.
Fig. 14 is a side elevational view, partially shown in longitl-llin~l section, of the assembly 20 appa-dlus for making the çYr~ntlAhle endo' ~min~l stent-graft asselllbly and mollntinp it onto a delivery cAtheter showing the ch.iull~elel-lial cutting of the graft near the ends of the un~ e~l stent.
Fig. 15 is a side elevational view, partially shown in longit~ in~l section, of the assembly &I,p&,~lus for making the ~pAntlAhle endoluminal stent-graft assembly and mounting it onto a SU~ 1 l l UTE SHEET (RULE 26) W O 97/07751 PCT~US95110752 delivery csthP~tpr showing removal of the handle ..~ b~ bar from the stent mandrel and the positiQning the balloon ~ tel relative to the stent mu1d.~,1.
Fig. 16 is a side ~ v~lional view, partially shown in longif~ ins-l section of the &ss~ bly 4,p~1us for making the ~ h'e ~n-iol~lminQl stent-graft asse.-~l~ly and ...~ g it onto a S delivery ~ t ,r of the present invention sl-ow-ng the insertion of the bal1oon r-s-thet~ ~ into the lumen of the stent ,..~drel.
Fig. 17 is a side el.~ -' view, partially shown in lon~t~ insl secti~n of the assembly appa-~Lus for making the eYpsn-l~sble endolumina1 stent-graft assemb1y and Illoulllillg it onto a de1ivery ~~lllGlel of the present invention ~IIU .. ~lg removal of the PYpsn~sh1e PndQlllminsl stent-10 graft assembly mounted onto a de1ivery c-sthPtPr from the stent mandrel after positioning the stent-graft cover over the center of the ba1100n on the balloon csthete .
DetAiled Dcs ;~: - of the Preferred Embo;' ~ ~
Turning now to the -s-~co. ~ y..lg Figures, the inventive radia11y ~ sb1e endoluminal stent-graft assG.--1~1y 10 is i11ustrated general1y in Figure 1. Stent-graft assemb1y 10 general1y consists of a radia11y ~.,~ n-1Ab1e stent l.. ~l.. bel 12, in a sul,s~ slly radia11y lln~Ypsnfled , ciralll-rel~ ia11y covered by a radia11y eYrsnflsh1e tubu1ar graft member 14, which is pl~ o---l-l;~d of lor~tllfl;nsl1y PYp~nfled mi-;lopolvus po1ytetrafluoroethy1ene (ePTFE).
It wi11 be understood by those skilled in the art that ePTFE materia1s have a characteristic microstructure con.~ ~l;uP of nodes and fibri1s, with the fibril oriçntstion being sub~ ;slly 20 paral1el to the axis of k)ngi~ in-sl c,~ s;on. F~p-sn~led polytetrafluoroethylene mstf risl~ are made by ram extruding a co---l,lGssed billet of particu1ate po1ytetrafluoroethylene and extrusion lubricant through an extrusion die to form sheet or tubular extrudates. The extrudate is then lon~t~flinslly ~Ypsntled to form the node-fibril microstructure and heated to a temperature at or above the crysta11ine melt point of polylGLl~luoroethylene, i.e., 327 ~C for a period of time 25 sl-fficiçnt to sinter the ePTFE material. The tubular graft member 14 of the present invention is preferably made by ram extruding a PTFE-lubricant billet around a mandrel and through an ~llu;.;ol- die to form a tubu1ar ~l~ud~Le. The tubular extrudate is longitll-linslly ~Ypsnded and Sl,~;~ 111 IJTE SHEET (RULE 26) sintered, then cut to a desired length as lc~l~ to ~iuwn~.c~Li lly cover a longit~l~1in~1 section ofthe stent ...- -..b~l 12.
The tubular graft ...~ 14 cc,~ ,-ises an interior or luminal wall surface 16 and an exterior or abluminal wall surface 18. The stent member 12 is also tubular and comprises an 5 interior or luminal surface 20 and an exterior or ~l lminAl surface ~, as illustrated in Figure 2.
When ~ ulllrel~lLially ~ osed about the stent mRrnh-or, the luminal surface 16 of the graft ..,c...l,er 14 resides ~Aj~c~nt the abluminal surface 22 ofthe radially ~-~ .An~ed stent m~rnher 12 to form the eYp~n~l-b!.~ stent-graft ~cc ....1~ 10 and l ~ tai~-cd thereupon by inherent radial recoil p~upc lies ofthe ePTFE tubular graft member 14 acting against the abluminal surface 22 10 ofthe stent ...c...l~e. which imp~ts an i~lc~rc~ ce fit bcl~een the stent mf~-nh~.r 12 and the gr_ft ~,lc .lbel 14. It has been found that all tubular eP 1~ ~. graft members exhibit between about 10-30~/0 recoil from the radially ~ '' -, with the median recoil falling bt;Lween 15-25%
of the radially ~Yp~n-led ~ m~ten The radial recoil property of the radially ~yp~nl1ed tubular ePTFE material, appcal~ to be a consLalll plupc~ly and not dependent upon degree of radial 15 e"~allsiol~. Moleover, the radial recoil p~upc~Ly does not seem ~ffectecl by other material p,u~,e.LicsofanePI'~ 'graft suchasinternodalr~ nc~ wallth:~Ln~c~ degreeof lon it~-~lin~l ~l,Al.~'Ol~, etc.
Once assembled, the radially eYp~n~Ahle stent-graft assembly 10 may be placed on a balloon ç~thetP!~, such as a conventional angioplasty balloon çAthet~ delivered through an 20 ~ ' ' passageway to a desired delivery site, and placed endohlmin~lly by pressure dilating the balloon thereby radially I l.~...l;..f~ the stent-graft assembly to a desired rii~meter based upon pres~lected ~Yp~n~ed ~ m~ters of the stent member 12 and the graft member 14.
Radi~ dilation ofthe tubular graft ",e".ber 14, from a pre-eYp~n-led rliAmetçr which is less than the ~ A~-ded outer ~ elel of the stent member 12, to a radially eYpan~e~l inner 25 d;-- . .e~ ~- which is greater than the outer ~ meter of the stent member 12, imparts a recoil force to the tubular graft ...enll)el 14. The radial recoil of the radially dilated tubular graft ~ll~ bel 14 reduces the inner ~ metrr of the tubular graft member 14 such that the luminal surface 16 of the tubular graft member 14 impinges upon and resides ~dj~c~nt the abluminal wall surface 22 SU_5 111 ~JTE SHEET (RULE 26) ofthe stent l-w~ cl 12, as shown in Figure 2. In this manner the inventive stent-graft assel"bly 10 affords a more strean~ined ~nd~ minAl prosthPQ;C than the cu,,c -lly known ;~ 5~1k which require suture ~ < ~ ,n a radially ~...P ~ APd stent ...- ...he~ and a larger .1i5.".~P.
~ ~ d -' -' gra~. Further, because the inventive stent-graft asse"~bly 10 has a reduced profile, 5 the French size of the introducer set for intro~ rir~g the inventive stent-graft a;,se."l)ly 10, may be cc",c~ ' ,1y reduced, further fiA.~ g pere~ FollQ~ delivery of the ~Yp n~l ble stent-graft ass_."bly 10.
Once the stent-graft ass_.~ ly 10 is del;~cl~d Pn~n~ Im;~_lly to a desired position in an ~ ' p&. ~cw~y, the inventive stent-graft as~uLly 10 is radially eYran-led by application 10 of a radially e Al.u,s;ve plcs~ure~ such as that provided by an angioplasty balloon, against the luminal wall surface 20 ofthe stent lllcull)cl 14. Both the stent mc ~bel 12 and the graft "~c"~bel 14 radially expand to an ~YrAn~led ~ mPter as desired. During radial ~YpAnQion~ the tubular stent ,.,c",bcl 12 and the tubular graft m.omher 14 are radially dcro""ed under the inflll~nce of a positive l"c~u, c exerted against the luminal wall surface 20 of the tubular stent member. The 15 material of the tubular graft "l~ ."ber 14 iS ~1, el~;l,ed or eYp--n~led with the result that the wall : ofthe radially n .~ ed B ~c~ c~ 14 iS typically thicker than that of the radia11y A~d graft ~ lw 14 due to radial stretching of the graft member 14. Where the tubular B lllclnl~el 14 iS made of sintered ePTFE, it will be understood, by those in the art, that radial 1~ ofthe ePTFE tubular graft ~c~ber 14 deforms the node-fibril microstructure of the 20 ePTFE material. Where the ePl~ tubular graft member 14 employed has an axis of k~ngitll~in_l eAI ansion parallel to the axis of radial PYpanQ~ion of the tubular graft member 14, radial expansion of the stent-graft assembly 10 will result in elongation of the fibrils. Where, however, the ePl~l~ tubular B ~clllllel ~ ycd has an axis of ion~it--rlin-l expansion which is PCl~ to the axis of radial expansion of the tubular graft member 14, radial PYpanQit-n 25 ofthe stent-graft assembly 10 results in elongation ofthe nodes.
O The radial recoil force ofthe tubular graft member 14 against the abluminal wall surface 22 of the stent member aids in prcvenl.,,g axial migration of the graft member 14 on the stent - l"c",ber 12 during radial expansion ofthe stent-graft assembly 10.
SU~ 1 1 1 UTE SHEET (RULE 26) O 97/07751 PCTtUS95tlO752 Figure 3 illustrates second and third embo~im~nts of the inventive radially eYp~n-l~ble stent-graft aSSG~ ly 30, which each coln~l;s~ at least two stent ...~-..he- ~ 38 and 40, a single graft ~ l~r 32, W1I~.~I each ofthe stent II~ G1~j 38, 40 are po~ ;tion-od at opposing ends 34, 36 ofthe graft ...- .,.l,f ~ 32 and l-,t~led therein by the radial recoil force of the graft member 32 Lly;n~ g upon abl-~min~l wall surfaces of the at least two stent ~.,~.,.I.-..:, 38, 40. These ~mho~' -nt~ ofthe inventive stent-graft ~...bly 30 are particularly well adapted for ~Yf ~ ion of abdominal aortic al..,u-y~-l-s or other trauma to an ~n~tom:-~l passageway, such as by a gunshot, because it has an ,..L~ e longJt~ in~l section ofthe graft ,~.,,hçl 32 which is unsupyol led by any lo~t~din~l section of stent ~ e~ ~ 38, 40. Where two or more stent ~IGIIII~GI:j 38, 40 are used, the intel...~ e ~lnsul)pol led sections of graft member 32 permit articulation of the stents 38, 40 relative to one another, with the unsupported sections of graft member 32 acting as articulation joints.
Figures 4-17 generally i11ustrate an a~cn~bly apparatus 44 and the method of making the inventive stent-graft a~GIlll~ly 10, as d ~ 1 in Figure 1. Figure 4 is a partially exploded view ofthe ~Gm~IYa~)~alUS 44 used for making the inventive stent-graft assembly. The inventive as~.lll)l~ a}pa~al~ls 44 cclllylises generally a tapered dilation mandrel 46 having a first end 48 and a second end 50 wherein the ~ m~t~or of the second end 50 is greater than the di~mPt~or of the first end 48, a stent le~ lg "lanJlG152 which is removably çng~s~e~hle with the second end S0 of the tapered dilation mandrel to retains and supports the stent member 12 in a given position on the stent l~lh;l~lg .nal-dlel, and a handle m~mher 53 which is removably coupled to the stent IGl~;n;ng nIaIIdIeI 52 at one end thereof. The stent ret~ining mandrel 52 has a generally tubular shape and a circulartransverse se~ion~l shape. The stent ,.,l~;";~g mandrel should have an outside ~ ~PI which is less than the inner tli~met~r of the stent member 12 to f~cilit~te loading the stent member onto the stent ~e~ ;llg mandrel, and the combined outside ~ m.o~t~r ofthe stent ret~inin~ mandrel 52 and the outside d;h~l~e~ ofthe stent m~mh-?r 12 is less than the outside ~li~meter of the second end 50 of the tapered dilation mandrel 56.
Figures 5-7 leple3~L sequ~nti~l views ofthe graft member 12 being loaded onto the tapered dilation ,ll~u,L~,152 and being ~n~ ically ~g~d about the stent member 12. It can be appreciated that by confi~l~ing the outside ~lih~elpr ofthe second end 50 ofthe tapered SUBSTITUTE SHEET (RULE 26) dilation "~,d-~1 to be greater than the outside ~I;c....-te- ofthe stent ~ c 12 mounted onto the stent n,~ drtl 52, the graft ~ 14 is radially dilated as it is pulled over the tapered dilation ~ I 46 or as the a~ ly appara~us 44 is pushed 72 into the lumen of graft ,ml~el 14. a section ofthe grafc r.. ~ 14 passes over the stent member 12 mr-llnted on the 5 stent ~ l,~,Lel 52 and is conc~ ically po~ition~d about the stent ",e.,.ber 12. As the nl~c~ 14 is passed over the stent ~--- ..l~l-er 12, it ~ u~ no le~ to radial recoil and radially recoils until the luminal surface ofthe graft ..- . ..l~el 14 imringl~s upon the a~!~lmin-o-l wall surface ofthe stent ~F-..I~ 12, at which point the graft ~ 14 Cl ntimles to exert a positive radial recoil force against the stent .. 1~, 12, which is resisted radially il,colll~ ;,il,ility ofthe stent member 12.
As noted above, the tapered dilation mandrel 46, the stent l~l~i";"g mandrel 52 and the handle Ill~,.nl~el 53 each have means for removably intclco~ e~ g the tapered dilation mandrel 46, the stent ~ dlel 52 and the handle Illelnber 53 to one another along a collllllon k)l~ 7l axis. As illustrated in Figures 4-9, the second end 50 oftapered dilation l-,andlel 52 incl~ld~ an axially positioned female coupling 58 which receives a mating male coupling 60 on a first end of the stent retoining mandrel 52. While the Figures depict threaded female couplillg 58 and male coupling 60, it will be understood by those in the art that the couplings are il.lel~l-Ange~oble and may be any of a wide variety of suitable couplings, For example, the coupling associated with the tapered dilation ~-.a~ldlt;l 46 may be a male c~,u~ling 60, with a 20 mating female co~ g 58 being o-~o~;o~e~ with the stent IG~ g mandrel 52, or the cou~lings may be threaded, or non-threaded, such as being an inte.rt;-N,ce fit coupling. The stent retoining ll~l~l-el 52 is also removably coupled to the handle ll~ml)c;l 53 by a male coupling 56 projecting from a second end 62 of the stent lcl~iOi~, mandrel 52. The male coupling 56 removably engages with a female coupling 69 associated with the handle member 53. Again, while the 25 Figures depict a non-threaded coupling between the stent ret~ining mandrel 52 and the handle Ill~;ml t;l 53, those in the art will understand that the couplings are intel~ g~ble and may be ,, any of a wide variety of suitable co~ ~p~inp;~, For ~llple, the coupling associated with the stent ;"g Illan.llel 52 may be a female coupling 69, with a mating male coupling 56 being - o.~so~i-oted with the handle member 53, and the coupl;llgs may be threaded, or non-threaded, 30 such as being an inlelrelence fit or friction fit coupling.
SUBSTITUTE SHEET (RULE 26) In acco-dance with the plerel-ed embo~im~nt ofthe ~csçmhlya~p~ualus44~ the stenti"i,~ d~,l 52 has a generally .;~lin.l~ic~l body portion 54 which le ...;l.~les in shcn-l~er sectionc62 at opposing ends ofthe cylindrical body portion 54 ~ c~nt CO~IPI;~OJC S0 and 66. r When the a~ ~ly ~F Ic 44is in its fillly co~ d state, shoulders 62 serve as pru~l,lal and 5distal dd,~liolls for p,u~"al and distal annular detents 67 bcl~ en the second end 50 of the tapered dilation l~&ndl~l44 and one end of stent mPmhPr 12 and between the handle member 53 and a second end of stent nl~ cll2. The length ofthe "y1; ~ ;c~l body portion 54 beL~ ell shoulder sectionc 62 pl~f~.ably coll~ Ol~c to the length of stent member 14. As used in ~C, 1~ ~on with the asse.~,~ly app~a~us 44, "distal" refers to a direction corresponding to the 10relative position of the tapered dilation ,llalldlcl 46, while "prc,~l"al" refers to a direction corresponding to the relative position of the handle ",c~"bcr 53.
Figures 4-9 also illustrate the method for making the inventive stent-graft lO zlccçn~hly using the &~."I,ly appa.~us 44. Tapered dilation mandrel 46is coupled to the stent, c1 ~.;..;np ",a.~dlel 52 by ~~ng~ging cc,u~ling 60 in second end S0 ofthe tapered dilation mandrel 46 with coupling 60 of the stent ret~inin~ ",al~d,el 52 A stent m~mhçr 12, in its subst~nti~lly radially une~p~nded ~ m~oter~ is ~n~ged about the stent ret~inin~ mandrel 52 by concentrically pocitioning the stent "le",l,el 12 about the stent ret~ining mandrel 52. The handle member 53 is then coupled to the stent rc~ g ",and~el 52 by ~ng~ging coupling 56 ofthe stent lclAi~ g ~"al~ cl 52 with cu~ 69 of the handle ",c"ll)el 53 . As shown in Figure 5, the stent me",l,er 12 is positioned ~ ;ulllrelclllially about the stent ret~inin~ mandrel 52, and the stent r~l~;--;-.
mandrel is positioned inte....e.l;i.le bcl~cell the tapered dilation mandrel 46 and the handle 53.
Figure 6 illustrates the step of .~np~ in~ the graft member 14 onto the tapered dilation ~ d~ ~1 44 by applying an a~al force 72 to the ~cmbly appa~ ~ s 44 which causes the tapered dilation mandrel to pass into and through the lumen of graft member 14. The assembly a~l.~a~s 44 is passed into and through the lumen of graft member until the first end ofthe graft member 14 is in close p~ux~llliLy to a terminal portion 54 of handle member 53. As the graft ...~...1..~1 14 passes over the second end 50 of the tapered dilation mandrel 44, the graft member 30 14 radially e~r~nded so that the inner ~ met~r of graft member 14 is radially e~ran(led to the S~,~S 111 ~JTE SHEET (RULE 26) WO 97/07751 PCT/US9~,/10752 outer dismP~ter of the second end 50 of the tapered dilation mandrel 44. At the point of the distal annular detent 67, the inner tlismeter ofthe graft mPmhPr 14 is greater than the outside ;smPtPr ofthe stent ~ .nl,~,~ 12. As the gra~ ..hP,I 14 moved axially over the stent nlcll-l~cl 12 and to a pos.Liol- 9~ ~ the handle ll~ l,er 53, the graft "wllll~cl 14 undergoes radial recoil 5 so that the inner .~ le~ ofthe graft llwllll~el 14 reduces until it meets with n ~ - -e to further recoil. As illustrated in Figure 7, the graft .--~ f-~ 12 has r. dially recoiled onto the stent ,l~,.,l1~. 12, and has also recoiled into annular detents 67 at the p,~,~,lal and distal ends ofthe stent ...~...hf.l 12.
F~ng~sgf~mpnt ofthe graft member 14 over the tapered dilation mandrel 46 is fs-.ilitstP~d by forming tabs on the first end of the graft ............ 1.~ . by cutting longitudinal slits (not shown) along d;~Llllcllically opposed sides of the graft ,. .~.. bçl . The tabs can then be used to retain the graft mclllber 14 while an axial force 72 is applied to the assembly appa-~lus, or the tabs may be used to m~ml~lly pull the graft member 14 over the tapered dilation mandrel 46, the stent ll.~,.llber 14 and to the handle member 53. To prevent formation of seams or wrinkles, is important to avoid applying torsional forces to the graft ",cn,b~,r by twisting the graft during PngslgPmPnt of the graft member onto the assembly api)a, ~ s 44.
Figures 8 and 9 illustrate the steps for removing the stent-graft assembly from the assembly apph-~ s 44. Cutting blades 74 are used make ci~;u~lrerc~lial cuts in the graft ~c~ el 14 at the position ofthe annular detents 67, which is slightly, i.e. about 1-2 mm, longer 20 than the longit~tlin~l length of the stent member 12. The 1 e~ il .;g section of material of the graft member 14 which projects beyond the opposing ends of stent mP.mbP~r 12 allows for the axial rore:il,o,lening of the graft 14 in relation to the stent 12 during Pn~1olllmin~1 radial e~l,ans;on ofthe stent-graft assembly 10.
After making the ~ ;ulllrc-c -Li~l cuts at the position of the annular detents 67, the stent-graft as~c.nl,ly 10 is sep~ ed from the rP.m~in.1çr ofthe graft member 14. The stent ret~ininp mandrel 52 may be decoupled from the tapered dilation ~I-anli. cl 46 and the handle member 53 by disens~ ng the stent ret~ining mandrel coupling 60 from the tapered dilation mandrel .71 and ~ eng~ging the stent ret~inin~ coupling 66 from handle member coupling 69.
SlJ~ 1 1 1 UTE SHEET (RULE 26) WO 97/07751 PCT/US9~;/10752 The stent-graft ass_.l~l)ly 10 is then removed from the stent ,~ g ~ drel 52 by axially ~ ~- pl ~ the stent-gr~ft asw..-l,ly 10 relative to the stent ~ g mandrel 52. a waste portion of the graft ... -..l-- - 14 resident on the handle ~ t~l 53 may be discarded. The as~_..-bl.~
~p~_~ 44 is then in c -- ' ~ 5n to reload another ~ tled stent n,~,.sla)el 12 onto the stent 5 l~ ~ ~ ~ y~ lllan~,l to reinitiate the inventive method by le~ g the above-described steps and produce a~ldition~l stent-graft a~c~ ,!ies 10.
It will be ~/a.~lt to those skilled in the art that a m~ltit~de of sizes, both in length and in outer ~ 7 of the stent n -_- - -l~e- 12, the graft r ~ 14 and the assembly a~"~&- ~us 44 may be employed to make a stent-graft assembly 10 having pre-determined dimensions.
1 0 ~,.. "~
A 2.8 mm internal .l;~...el~ (ID) eP'l'~ tubular graft was radially stretched over a tapered dilation mandrel having a 3.7 mm external ~IiAmPter at its largest end. The eP~ ' graft was then ;.. ediAl~ly passed over a 3.4 mm ~ ed stent ~,;lcull~èlenlially mounted on a stent r~t~ .g .l.andlcl which was removably co"~te~ to the tapered dilation mandrel. After 15 being passed over the ~ n-l~d stent, the eP'l~ 1~ graft exhibited imme~iAte recoil against the outer surface ofthe stent and ~ d a 3.4 mm ID. The graft appeared to be fit tightly about the stent and was le;,;sl~llL to manual displAcçm~ont along the longit~l-iinAl axis of the stent.
Subsequent radial t ~~lA-- o.~ ofthe res~llt~nt stent-graft assembly was accomplished by loading the stent-g~ft ~sellltul.~ onto an angioplasty balloon CAth~PtPr~ applying a positive fluid pressure 20 to the angioplasty balloon to radially expand the stent-graft assembly to 10 rnm OD. At its expanded ~i~mP~tPr~ the graft rçmAined tightly fit about the circumference of the stent and ~,,.I~;Ied recietAnce to axial disp!acçmPnt upon manual manipulation.
Figures 10-17 depict the inventive method and assembly app&-~ s 75 for making and mounting the ~ n~lAhle endoluminal stent-graft asse..lbly onto a delivery çAthetçr More specifically, Figures 10-14 are repli~tes of Figures 4-8 with the exception that the stent l~;; ~ ~ ~g l.l~dlel 52 in~ ldes a central closed-end longituflinAl bore 76, in Fig. 15, which opens tow_rd the ~lu~llal end ofthe assembly app&l~ s 75 Adj~cçnt the handle member 53.
S~ JTE SHEET (RULE 26) W O 97/07751 PCTrUS95/10752 The procedure for making the stent-graft assembly 10 follows the same steps in Figures 10-14 ~ il,ed above with .~f~ nce to Figures 4-8. II~ _., as illu~ ed in Figure 15, after the circ~-lrc ~.-l;al cuts in the graft .. ,.l-~ 14 are made at the position ofthe annular detents 67,thehandle.~.,,,l~Pr53is~ f ~8~fromthestent.~ ;-.;u~~--andlelS2. adistaltipofaS balloon c~thPtçr~ having an infl-t~le balloon 80, is then passed into the longihl~inAl bore 76 such that the balloon 80 is positioned in p[o~l--ly to the stent-graft assembly 10 as illustrated in Figure 16. The stent-graft a~.nl,ly 10 is then ~ ~F'- ~ed from the stent ret~inir~ .-.~-dlt;l 52 and c~ ~ -~ "y po ;~i~ nPIl about the ~ n ' ~ ~ balloon 80 of the balloon cn~ ei 78. Finally, as shown in Figure 17, the balloon 4~.l1,-,t~ 78 is removed from the k-n~~ 1in~ bore 76 in the 10 stent rc;~ g mandrel 52, thereby providing an pre-mounted stent-graft delivery system.
The resulting radially .~l~An~l~blc endoluminal stent-graft assembly has an added advantage of luw~-i--g the c-l~Ar~;on pressure required to radially expand the stent-graft ass_...1~1y due to the pre-c~ ion of the eP 1 bk graft during the inventive process.
In acco-dance with the p.~rwlt;d embo-lim~nte ofthe present invention, it is plert:lled 15 that a PALMAZ stent (Johnson & Johnson Interventional Systems, Inc., Warren, N.J.), as des-;lil.ed by Palma~ in U.S. Patent No. 4,733,665, or balloon eYr~n-i~hle PALMAZ-type stents be used. However, other dirr~ L types of pressure ~oYp~n-~ble stents known in the art may be used, with the only limit~qtion being that the exhibit sufficient radial strength to resist the radial recoil of a radially ~xpAntle~l ePl~iE tubular graft. It is also pl~reltlble that the assembly 20 appa.~us 44 be made of a material which is resistant to burr formation, such as st~inl~e.e steel, and which provides smooth surfaces which do not ~m~ge the graft member while it is being manipulated on the asse--ll)ly app~l~lus. The inventivê process may be carried out at room léllll~,.aLul~, or may be carried out at elevated t~lll~c;l~L-Ires which are below the crystalline melt point ~P 1 bk. I~ f~his m._..n~.er, there is proYided a ~OV. ered ste-nt in which t~he coYer is ret~ined 25 by an illlelrc;lellce fit bcLween the cover and the stent and no adhesives or sutures are le~uhed to positionally affix the cover onto the stent.
While plGrt;.~d embotlim~nt~ ofthe invention have been shown and described, it will be app~:lll to those skilled in the art that various mo-lifi~ti--ns may be made in these embo~lim~nte SU~a 1 l l UTE SHEET (RULE 26) WO 97/077SI PCTnUS95/10752 without d~li,~ from the spirit ofthe present invention. The.erort, all s~lit~le moflifiç~tit-ns and equivalents fall within the scope of the invention.
S~ ~S 111 ~JTE SHEET ~RULE 26)
Claims (25)
1. A radially expandable stent-graft assembly, comprising a tubular radially expandable stent and an tubular graft member, said graft member is circumferentially disposed about at least a portion of the longitudinal length and retained thereupon by inherent recoil pressure exerted by the tubular graft member about the tubular radially expandable stent and the graft member is radially expandable with the stent.
2. The expandable stent-graft assembly of Claim 1, wherein said expandable tubular graft member further comprises an expanded polytetrafluoroethylene material.
3. The expandable stent-graft assembly of Claim 1, wherein said expandable tubular graft circumferentially covers an entire longitudinal section of the tubular radially expandable stent.
4. The expandable stent-graft assembly of Claim 1, wherein said tubular radially expandable stent and said expandable vascular graft are substantially equal in length.
5. A radially expandable stent cover, comprising:
a tubular radially expandable stent having luminal and abluminal wall surfaces, and a tubular expanded graft member having luminal and abluminal wall surfaces, wherein the luminal wall surface of the graft member circumferentially covers at least a substantial longitudinal aspect of the tubular radially expandable stent and the graft member is retained about the stent by an interference fit between the luminal wall surface of the graft member and the abluminal wall surface of the stent.
a tubular radially expandable stent having luminal and abluminal wall surfaces, and a tubular expanded graft member having luminal and abluminal wall surfaces, wherein the luminal wall surface of the graft member circumferentially covers at least a substantial longitudinal aspect of the tubular radially expandable stent and the graft member is retained about the stent by an interference fit between the luminal wall surface of the graft member and the abluminal wall surface of the stent.
6. The expandable stent cover of Claim 5, wherein said graft member further comprises an expanded polytetrafluoroethylene material.
7. The expandable stent cover of Claim 5, wherein said graft member circumferentially at least substantially covers the abluminal wall surface of the stent.
8. The expandable stent cover of Claim 5, wherein said tubular shaped expandablestent and said expandable vascular graft are equal in length upon final radial expansion of the stent cover.
9. An expandable endovascular stent-graft, comprising:
a plurality of radially expandable endovascular stents, each having an interior and an exterior surface; and a radially expandable endovascular graft having a first end, a second end, an interior surface and an exterior surface wherein the interior surface of the vascular graft is friction fit about at least a portion of the exterior surface of each of said expandable stents prior to any expansion of the expandable stent-graft.
a plurality of radially expandable endovascular stents, each having an interior and an exterior surface; and a radially expandable endovascular graft having a first end, a second end, an interior surface and an exterior surface wherein the interior surface of the vascular graft is friction fit about at least a portion of the exterior surface of each of said expandable stents prior to any expansion of the expandable stent-graft.
10. The expandable endovascular stent-graft of Claim 9, wherein the plurality ofendovascular stent members further comprises first and second stents which are positioned and retained within the first and second ends of the radially expandable endovascular graft, respectively.
11. The expandable endovascular stent-graft of Claim 10, further comprising at least three endovascular stent members, wherein a third stent member is entirely covered by and retained within the radially expandable endovascular graft and positioned intermediate between the first and second stents along the longitudinal axis of the radially expandable endovascular graft.
12. The expandable endovascular stent-graft of Claim 9, wherein said radially expandable endovascular graft is comprised of expanded polytetrafluoroethylene.
13. The expandable endovascular stent-graft of Claim 9, wherein the expandable vascular graft covers at least a substantial longitudinal extent of each of said plurality of radially expandable endovascular stents.
14. A method for a radially expandable stent-graft assembly, comprising the steps of:
a) radially dilating a graft member, the graft member having a lumen, an inner diameter and an outer diameter;
b) concentrically engaging the graft member over a radially expandable stent member, the stent member having a first end, a second end an inner diameter and an outer diameter; the outer diameter of the stent being greater than the inner diameter of the graft member; and c) permitting the radially dilated graft member to radially recoil and circumferentially cover at least a substantial longitudinal section of the outer diameter of the radially expandable stent member.
a) radially dilating a graft member, the graft member having a lumen, an inner diameter and an outer diameter;
b) concentrically engaging the graft member over a radially expandable stent member, the stent member having a first end, a second end an inner diameter and an outer diameter; the outer diameter of the stent being greater than the inner diameter of the graft member; and c) permitting the radially dilated graft member to radially recoil and circumferentially cover at least a substantial longitudinal section of the outer diameter of the radially expandable stent member.
15. The method of Claim 14, further comprising the step of placing the radially expandable stent on a stent mandrel and connecting said stent mandrel to a dilation mandrel prior to the step of concentrically engaging the graft member over the stent member.
16. The method of Claim 15, wherein the steps of radially dilating the graft member and concentrically engaging the graft member over the stent member further comprise the steps of:
a) forming tab members on a first end of the graft member; and b) pulling the tab members over the dilation mandrel and the stent member without torsionally twisting the graft member.
a) forming tab members on a first end of the graft member; and b) pulling the tab members over the dilation mandrel and the stent member without torsionally twisting the graft member.
17. The method of Claim 15, wherein the step of concentrically engaging the graft over the radially expandable stent member further comprises the step of applying an axial force to the stent mandrel to push the dilation mandrel and the stent mandrel into and through the lumen of the graft member.
18. The method of Claim 14, further comprising the step of removing the radially expandable stent-graft assembly from the stent mandrel.
19. The method of Claim 18, wherein the step of removing the radially expandable stent-graft assembly from the stent mandrel further comprises circumferentially cutting the graft member proximate to the first and second ends of the stent member.
20. An apparatus for making a radially expandable stent-graft assembly, comprising:
a) a tapered dilation mandrel comprising a first end having a first diameter and a second end having a second, larger diameter;
b) a stent mandrel for supporting and retaining a radially expandable stent member in a predetermined position; and c) means for releasably connecting the second end of the tapered dilation mandrel to the stent mandrel, whereby a graft member may be radially dilated on the tapered dilation mandrel and concentrically engaged upon the stent member residing on the stent mandrel.
a) a tapered dilation mandrel comprising a first end having a first diameter and a second end having a second, larger diameter;
b) a stent mandrel for supporting and retaining a radially expandable stent member in a predetermined position; and c) means for releasably connecting the second end of the tapered dilation mandrel to the stent mandrel, whereby a graft member may be radially dilated on the tapered dilation mandrel and concentrically engaged upon the stent member residing on the stent mandrel.
21. The apparatus according to Claim 20, further comprising a handle member releasably connected to an end of the stent mandrel opposite the tapered dilation mandrel.
22. The apparatus according to Claim 20, wherein the stent mandrel further comprises a closed-end axial bore passing into the stent mandrel and open to an end of the stent mandrel opposite the tapered dilation mandrel.
23. The apparatus according to Claim 22, further comprising a balloon catheter insertable within the closed-end axial bore thereby permitting axial displacement of a stent-graft from the stent mandrel directly onto a balloon portion of the balloon catheter.
24. The apparatus according to Claim 20, wherein the stent mandrel, when combined with a radially expandable stent member concentrically disposed thereupon, have a combined outer diameter less than the outer diameter of the second end of the tapered dilation mandrel.
25. The apparatus according to Claim 20, further comprising annular detents at opposing ends of the stent mandrel.
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| PCT/US1995/010752 WO1997007751A1 (en) | 1995-08-24 | 1995-08-24 | Covered endoluminal stent and method of assembly |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA2229537A1 true CA2229537A1 (en) | 1997-03-06 |
Family
ID=22249706
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA002229537A Abandoned CA2229537A1 (en) | 1995-08-24 | 1995-08-24 | Covered endoluminal stent and method of assembly |
Country Status (8)
| Country | Link |
|---|---|
| US (1) | US6214039B1 (en) |
| EP (1) | EP0850030B1 (en) |
| JP (1) | JPH11511352A (en) |
| AU (1) | AU707727B2 (en) |
| CA (1) | CA2229537A1 (en) |
| DE (1) | DE69533289T2 (en) |
| ES (1) | ES2224132T3 (en) |
| WO (1) | WO1997007751A1 (en) |
Families Citing this family (115)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US6264684B1 (en) | 1995-03-10 | 2001-07-24 | Impra, Inc., A Subsidiary Of C.R. Bard, Inc. | Helically supported graft |
| US6451047B2 (en) | 1995-03-10 | 2002-09-17 | Impra, Inc. | Encapsulated intraluminal stent-graft and methods of making same |
| US6039755A (en) * | 1997-02-05 | 2000-03-21 | Impra, Inc., A Division Of C.R. Bard, Inc. | Radially expandable tubular polytetrafluoroethylene grafts and method of making same |
| US6193745B1 (en) * | 1995-10-03 | 2001-02-27 | Medtronic, Inc. | Modular intraluminal prosteheses construction and methods |
| US5788626A (en) * | 1995-11-21 | 1998-08-04 | Schneider (Usa) Inc | Method of making a stent-graft covered with expanded polytetrafluoroethylene |
| US6576009B2 (en) | 1995-12-01 | 2003-06-10 | Medtronic Ave, Inc. | Bifurcated intraluminal prostheses construction and methods |
| US5931865A (en) * | 1997-11-24 | 1999-08-03 | Gore Enterprise Holdings, Inc. | Multiple-layered leak resistant tube |
| US6626939B1 (en) | 1997-12-18 | 2003-09-30 | Boston Scientific Scimed, Inc. | Stent-graft with bioabsorbable structural support |
| JP4057238B2 (en) * | 1998-02-02 | 2008-03-05 | バード・ペリフェラル・バスキュラー・インコーポレーテツド | Encapsulated Intraluminal Stent-Method of Manufacturing a Graft |
| US6395019B2 (en) | 1998-02-09 | 2002-05-28 | Trivascular, Inc. | Endovascular graft |
| US6623521B2 (en) | 1998-02-17 | 2003-09-23 | Md3, Inc. | Expandable stent with sliding and locking radial elements |
| US6336937B1 (en) | 1998-12-09 | 2002-01-08 | Gore Enterprise Holdings, Inc. | Multi-stage expandable stent-graft |
| US6398803B1 (en) | 1999-02-02 | 2002-06-04 | Impra, Inc., A Subsidiary Of C.R. Bard, Inc. | Partial encapsulation of stents |
| US7717961B2 (en) | 1999-08-18 | 2010-05-18 | Intrinsic Therapeutics, Inc. | Apparatus delivery in an intervertebral disc |
| US8323341B2 (en) | 2007-09-07 | 2012-12-04 | Intrinsic Therapeutics, Inc. | Impaction grafting for vertebral fusion |
| US7553329B2 (en) * | 1999-08-18 | 2009-06-30 | Intrinsic Therapeutics, Inc. | Stabilized intervertebral disc barrier |
| US7998213B2 (en) | 1999-08-18 | 2011-08-16 | Intrinsic Therapeutics, Inc. | Intervertebral disc herniation repair |
| WO2004100841A1 (en) | 1999-08-18 | 2004-11-25 | Intrinsic Therapeutics, Inc. | Devices and method for augmenting a vertebral disc nucleus |
| US6936072B2 (en) | 1999-08-18 | 2005-08-30 | Intrinsic Therapeutics, Inc. | Encapsulated intervertebral disc prosthesis and methods of manufacture |
| WO2002054978A2 (en) | 1999-08-18 | 2002-07-18 | Intrinsic Orthopedics Inc | Devices and method for nucleus pulposus augmentation and retention |
| US7972337B2 (en) | 2005-12-28 | 2011-07-05 | Intrinsic Therapeutics, Inc. | Devices and methods for bone anchoring |
| US6883520B2 (en) | 1999-08-18 | 2005-04-26 | Intrinsic Therapeutics, Inc. | Methods and apparatus for dynamically stable spinal implant |
| US6264671B1 (en) * | 1999-11-15 | 2001-07-24 | Advanced Cardiovascular Systems, Inc. | Stent delivery catheter and method of use |
| US7736687B2 (en) * | 2006-01-31 | 2010-06-15 | Advance Bio Prosthetic Surfaces, Ltd. | Methods of making medical devices |
| US20060052865A1 (en) * | 2004-09-09 | 2006-03-09 | Banas Christopher E | Stents with metallic covers and methods of making same |
| US10172730B2 (en) | 1999-11-19 | 2019-01-08 | Vactronix Scientific, Llc | Stents with metallic covers and methods of making same |
| US6537310B1 (en) | 1999-11-19 | 2003-03-25 | Advanced Bio Prosthetic Surfaces, Ltd. | Endoluminal implantable devices and method of making same |
| US6379382B1 (en) | 2000-03-13 | 2002-04-30 | Jun Yang | Stent having cover with drug delivery capability |
| US6613082B2 (en) | 2000-03-13 | 2003-09-02 | Jun Yang | Stent having cover with drug delivery capability |
| US7560006B2 (en) * | 2001-06-11 | 2009-07-14 | Boston Scientific Scimed, Inc. | Pressure lamination method for forming composite ePTFE/textile and ePTFE/stent/textile prostheses |
| US7597775B2 (en) | 2001-10-30 | 2009-10-06 | Boston Scientific Scimed, Inc. | Green fluoropolymer tube and endovascular prosthesis formed using same |
| US6814561B2 (en) | 2001-10-30 | 2004-11-09 | Scimed Life Systems, Inc. | Apparatus and method for extrusion of thin-walled tubes |
| US7125464B2 (en) | 2001-12-20 | 2006-10-24 | Boston Scientific Santa Rosa Corp. | Method for manufacturing an endovascular graft section |
| US6776604B1 (en) * | 2001-12-20 | 2004-08-17 | Trivascular, Inc. | Method and apparatus for shape forming endovascular graft material |
| US7090693B1 (en) * | 2001-12-20 | 2006-08-15 | Boston Scientific Santa Rosa Corp. | Endovascular graft joint and method for manufacture |
| US20040015224A1 (en) * | 2002-07-22 | 2004-01-22 | Armstrong Joseph R. | Endoluminal expansion system |
| AU2003256227A1 (en) * | 2002-07-30 | 2004-02-16 | Nanyang Technological University | Spherical nano-composite powder and a method of preparing the same |
| JPWO2004012743A1 (en) * | 2002-08-01 | 2006-09-21 | 中外製薬株式会社 | Psoriasis treatment |
| GB0223870D0 (en) * | 2002-10-14 | 2002-11-20 | Cathnet Science Holding As | Stent assembly |
| CA2506510C (en) * | 2002-11-22 | 2011-03-29 | Cook Incorporated | Stent tissue graft prosthesis |
| US7318836B2 (en) * | 2003-03-11 | 2008-01-15 | Boston Scientific Scimed, Inc. | Covered stent |
| GB0309616D0 (en) | 2003-04-28 | 2003-06-04 | Angiomed Gmbh & Co | Loading and delivery of self-expanding stents |
| US20040260300A1 (en) * | 2003-06-20 | 2004-12-23 | Bogomir Gorensek | Method of delivering an implant through an annular defect in an intervertebral disc |
| JP2007515988A (en) * | 2003-06-20 | 2007-06-21 | イントリンジック セラピューティックス インコーポレイテッド | Device and method for delivering an implant from an annular defect of an intervertebral disc |
| US7628806B2 (en) * | 2003-08-20 | 2009-12-08 | Boston Scientific Scimed, Inc. | Stent with improved resistance to migration |
| GB0322511D0 (en) * | 2003-09-25 | 2003-10-29 | Angiomed Ag | Lining for bodily lumen |
| US7530994B2 (en) * | 2003-12-30 | 2009-05-12 | Scimed Life Systems, Inc. | Non-porous graft with fastening elements |
| US7803178B2 (en) | 2004-01-30 | 2010-09-28 | Trivascular, Inc. | Inflatable porous implants and methods for drug delivery |
| CA2554595C (en) | 2004-02-03 | 2016-03-29 | Atria Medical Inc. | Device and method for controlling in-vivo pressure |
| US7195644B2 (en) * | 2004-03-02 | 2007-03-27 | Joint Synergy, Llc | Ball and dual socket joint |
| US20050216043A1 (en) * | 2004-03-26 | 2005-09-29 | Blatter Duane D | Stented end graft vessel device for anastomosis and related methods for percutaneous placement |
| AU2005237985B2 (en) | 2004-04-20 | 2010-10-21 | Genzyme Corporation | Surgical mesh-like implant |
| US20080132999A1 (en) * | 2004-07-09 | 2008-06-05 | Mericle Robert A | Tubular Polymer Stent Coverings |
| US7758626B2 (en) * | 2004-07-20 | 2010-07-20 | Medtronic Vascular, Inc. | Device and method for delivering an endovascular stent-graft having a longitudinally unsupported portion |
| US7763065B2 (en) | 2004-07-21 | 2010-07-27 | Reva Medical, Inc. | Balloon expandable crush-recoverable stent device |
| US20060036308A1 (en) * | 2004-08-12 | 2006-02-16 | Medtronic Vascular, Inc. | Stent with extruded covering |
| US8968390B2 (en) | 2004-09-27 | 2015-03-03 | Medinol Ltd. | Covering for an endoprosthetic device and methods of using for aneurysm treatment |
| US8292944B2 (en) | 2004-12-17 | 2012-10-23 | Reva Medical, Inc. | Slide-and-lock stent |
| US7857843B2 (en) | 2004-12-31 | 2010-12-28 | Boston Scientific Scimed, Inc. | Differentially expanded vascular graft |
| US7806922B2 (en) * | 2004-12-31 | 2010-10-05 | Boston Scientific Scimed, Inc. | Sintered ring supported vascular graft |
| US20060149366A1 (en) * | 2004-12-31 | 2006-07-06 | Jamie Henderson | Sintered structures for vascular graft |
| US7524445B2 (en) * | 2004-12-31 | 2009-04-28 | Boston Scientific Scimed, Inc. | Method for making ePTFE and structure containing such ePTFE, such as a vascular graft |
| US7914574B2 (en) | 2005-08-02 | 2011-03-29 | Reva Medical, Inc. | Axially nested slide and lock expandable device |
| US9149378B2 (en) | 2005-08-02 | 2015-10-06 | Reva Medical, Inc. | Axially nested slide and lock expandable device |
| US8187318B2 (en) * | 2005-08-31 | 2012-05-29 | Advanced Bio Prosthetic Surfaces, Ltd. | Covered stent with proximal and distal attachment, delivery catheter, and method of making same |
| WO2007083288A2 (en) | 2006-01-23 | 2007-07-26 | Atria Medical Inc. | Heart anchor device |
| CA2643720A1 (en) * | 2006-02-28 | 2007-09-07 | Debra A. Bebb | Flexible stretch stent-graft |
| WO2008042266A2 (en) * | 2006-09-28 | 2008-04-10 | Cook Incorporated | Thoracic aortic aneurysm repair apparatus and method |
| US7704275B2 (en) | 2007-01-26 | 2010-04-27 | Reva Medical, Inc. | Circumferentially nested expandable device |
| US8087923B1 (en) | 2007-05-18 | 2012-01-03 | C. R. Bard, Inc. | Extremely thin-walled ePTFE |
| US20110196492A1 (en) | 2007-09-07 | 2011-08-11 | Intrinsic Therapeutics, Inc. | Bone anchoring systems |
| GB0718187D0 (en) * | 2007-09-18 | 2007-10-31 | Angiomed Ag | Radially expansible stent |
| US8663309B2 (en) | 2007-09-26 | 2014-03-04 | Trivascular, Inc. | Asymmetric stent apparatus and method |
| US8226701B2 (en) | 2007-09-26 | 2012-07-24 | Trivascular, Inc. | Stent and delivery system for deployment thereof |
| US8066755B2 (en) | 2007-09-26 | 2011-11-29 | Trivascular, Inc. | System and method of pivoted stent deployment |
| JP2010540190A (en) | 2007-10-04 | 2010-12-24 | トリバスキュラー・インコーポレイテッド | Modular vascular graft for low profile transdermal delivery |
| US8328861B2 (en) | 2007-11-16 | 2012-12-11 | Trivascular, Inc. | Delivery system and method for bifurcated graft |
| US8083789B2 (en) | 2007-11-16 | 2011-12-27 | Trivascular, Inc. | Securement assembly and method for expandable endovascular device |
| EP2211773A4 (en) | 2007-11-30 | 2015-07-29 | Reva Medical Inc | Axially-radially nested expandable device |
| US9149358B2 (en) * | 2008-01-24 | 2015-10-06 | Medtronic, Inc. | Delivery systems for prosthetic heart valves |
| US8157853B2 (en) * | 2008-01-24 | 2012-04-17 | Medtronic, Inc. | Delivery systems and methods of implantation for prosthetic heart valves |
| US8196279B2 (en) | 2008-02-27 | 2012-06-12 | C. R. Bard, Inc. | Stent-graft covering process |
| GB0816965D0 (en) * | 2008-09-16 | 2008-10-22 | Angiomed Ag | Stent device adhesively bonded to a stent device pusher |
| EP2331014B1 (en) | 2008-10-10 | 2017-08-09 | Reva Medical, Inc. | Expandable slide and lock stent |
| US20130268062A1 (en) | 2012-04-05 | 2013-10-10 | Zeus Industrial Products, Inc. | Composite prosthetic devices |
| GB0901496D0 (en) | 2009-01-29 | 2009-03-11 | Angiomed Ag | Delivery device for delivering a stent device |
| US10076403B1 (en) | 2009-05-04 | 2018-09-18 | V-Wave Ltd. | Shunt for redistributing atrial blood volume |
| US20210161637A1 (en) | 2009-05-04 | 2021-06-03 | V-Wave Ltd. | Shunt for redistributing atrial blood volume |
| US9034034B2 (en) | 2010-12-22 | 2015-05-19 | V-Wave Ltd. | Devices for reducing left atrial pressure, and methods of making and using same |
| EP2427143B1 (en) | 2009-05-04 | 2017-08-02 | V-Wave Ltd. | Device for regulating pressure in a heart chamber |
| GB0909319D0 (en) | 2009-05-29 | 2009-07-15 | Angiomed Ag | Transluminal delivery system |
| JP5456892B2 (en) | 2009-08-07 | 2014-04-02 | ゼウス インダストリアル プロダクツ インコーポレイテッド | Multilayer composite |
| JP5809237B2 (en) | 2010-04-10 | 2015-11-10 | レヴァ メディカル、 インコーポレイテッドＲｅｖａ Ｍｅｄｉｃａｌ， Ｉｎｃ． | Expandable slide lock stent |
| US9060852B2 (en) | 2011-04-08 | 2015-06-23 | Cook Medical Technologies Llc | Method for making a flexible stent-graft |
| US11135054B2 (en) | 2011-07-28 | 2021-10-05 | V-Wave Ltd. | Interatrial shunts having biodegradable material, and methods of making and using same |
| US8992595B2 (en) | 2012-04-04 | 2015-03-31 | Trivascular, Inc. | Durable stent graft with tapered struts and stable delivery methods and devices |
| US9498363B2 (en) | 2012-04-06 | 2016-11-22 | Trivascular, Inc. | Delivery catheter for endovascular device |
| US9408732B2 (en) | 2013-03-14 | 2016-08-09 | Reva Medical, Inc. | Reduced-profile slide and lock stent |
| EP2999412B1 (en) | 2013-05-21 | 2020-05-06 | V-Wave Ltd. | Apparatus for delivering devices for reducing left atrial pressure |
| US10940296B2 (en) | 2015-05-07 | 2021-03-09 | The Medical Research, Infrastructure and Health Services Fund of the Tel Aviv Medical Center | Temporary interatrial shunts |
| US10835394B2 (en) | 2016-05-31 | 2020-11-17 | V-Wave, Ltd. | Systems and methods for making encapsulated hourglass shaped stents |
| US20170340460A1 (en) | 2016-05-31 | 2017-11-30 | V-Wave Ltd. | Systems and methods for making encapsulated hourglass shaped stents |
| WO2018012387A1 (en) * | 2016-07-12 | 2018-01-18 | 株式会社パイオラックスメディカルデバイス | Covered stent |
| US11291807B2 (en) | 2017-03-03 | 2022-04-05 | V-Wave Ltd. | Asymmetric shunt for redistributing atrial blood volume |
| AU2018228451B2 (en) | 2017-03-03 | 2022-12-08 | V-Wave Ltd. | Shunt for redistributing atrial blood volume |
| US10869747B2 (en) | 2017-05-10 | 2020-12-22 | Cook Medical Technologies Llc | Side branch aortic repair graft with wire lumen |
| US11458287B2 (en) | 2018-01-20 | 2022-10-04 | V-Wave Ltd. | Devices with dimensions that can be reduced and increased in vivo, and methods of making and using the same |
| US11744589B2 (en) | 2018-01-20 | 2023-09-05 | V-Wave Ltd. | Devices and methods for providing passage between heart chambers |
| US10898698B1 (en) | 2020-05-04 | 2021-01-26 | V-Wave Ltd. | Devices with dimensions that can be reduced and increased in vivo, and methods of making and using the same |
| EP3886761A1 (en) | 2018-11-29 | 2021-10-06 | V-Wave Ltd. | Systems and methods for making encapsulated hourglass shaped stents |
| US11612385B2 (en) | 2019-04-03 | 2023-03-28 | V-Wave Ltd. | Systems and methods for delivering implantable devices across an atrial septum |
| CN114096205A (en) | 2019-05-20 | 2022-02-25 | V-波有限责任公司 | System and method for creating room shunt tubes |
| US11234702B1 (en) | 2020-11-13 | 2022-02-01 | V-Wave Ltd. | Interatrial shunt having physiologic sensor |
| WO2023199267A1 (en) | 2022-04-14 | 2023-10-19 | V-Wave Ltd. | Interatrial shunt with expanded neck region |
| CN117159219B (en) * | 2023-11-02 | 2024-03-08 | 北京华脉泰科医疗器械股份有限公司 | Vascular prosthesis connection device and vascular prosthesis connection system |
Family Cites Families (96)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US6436135B1 (en) | 1974-10-24 | 2002-08-20 | David Goldfarb | Prosthetic vascular graft |
| JPS6037733B2 (en) | 1978-10-12 | 1985-08-28 | 住友電気工業株式会社 | Tubular organ prosthesis material and its manufacturing method |
| US4300244A (en) | 1979-09-19 | 1981-11-17 | Carbomedics, Inc. | Cardiovascular grafts |
| DE3019996A1 (en) | 1980-05-24 | 1981-12-03 | Institute für Textil- und Faserforschung Stuttgart, 7410 Reutlingen | HOHLORGAN |
| US4416028A (en) | 1981-01-22 | 1983-11-22 | Ingvar Eriksson | Blood vessel prosthesis |
| US4604762A (en) | 1981-02-13 | 1986-08-12 | Thoratec Laboratories Corporation | Arterial graft prosthesis |
| US4546500A (en) | 1981-05-08 | 1985-10-15 | Massachusetts Institute Of Technology | Fabrication of living blood vessels and glandular tissues |
| US4512338A (en) | 1983-01-25 | 1985-04-23 | Balko Alexander B | Process for restoring patency to body vessels |
| US4503569A (en) | 1983-03-03 | 1985-03-12 | Dotter Charles T | Transluminally placed expandable graft prosthesis |
| US4647416A (en) | 1983-08-03 | 1987-03-03 | Shiley Incorporated | Method of preparing a vascular graft prosthesis |
| US5104399A (en) | 1986-12-10 | 1992-04-14 | Endovascular Technologies, Inc. | Artificial graft and implantation method |
| US4562596A (en) | 1984-04-25 | 1986-01-07 | Elliot Kornberg | Aortic graft, device and method for performing an intraluminal abdominal aortic aneurysm repair |
| US4580568A (en) | 1984-10-01 | 1986-04-08 | Cook, Incorporated | Percutaneous endovascular stent and method for insertion thereof |
| SE452110B (en) | 1984-11-08 | 1987-11-16 | Medinvent Sa | MULTILAYER PROTEST MATERIAL AND PROCEDURE FOR ITS MANUFACTURING |
| US5035708A (en) | 1985-06-06 | 1991-07-30 | Thomas Jefferson University | Endothelial cell procurement and deposition kit |
| US4718907A (en) | 1985-06-20 | 1988-01-12 | Atrium Medical Corporation | Vascular prosthesis having fluorinated coating with varying F/C ratio |
| US5102417A (en) | 1985-11-07 | 1992-04-07 | Expandable Grafts Partnership | Expandable intraluminal graft, and method and apparatus for implanting an expandable intraluminal graft |
| US4733665C2 (en) | 1985-11-07 | 2002-01-29 | Expandable Grafts Partnership | Expandable intraluminal graft and method and apparatus for implanting an expandable intraluminal graft |
| DE3640745A1 (en) | 1985-11-30 | 1987-06-04 | Ernst Peter Prof Dr M Strecker | Catheter for producing or extending connections to or between body cavities |
| DE3608158A1 (en) | 1986-03-12 | 1987-09-17 | Braun Melsungen Ag | VESSELED PROSTHESIS IMPREGNATED WITH CROSSLINED GELATINE AND METHOD FOR THE PRODUCTION THEREOF |
| US4749585A (en) | 1986-04-11 | 1988-06-07 | University Of Medicine And Dentistry Of New Jersey | Antibiotic bonded prosthesis and process for producing same |
| CH670759A5 (en) | 1986-06-02 | 1989-07-14 | Sulzer Ag | |
| US4743480A (en) | 1986-11-13 | 1988-05-10 | W. L. Gore & Associates, Inc. | Apparatus and method for extruding and expanding polytetrafluoroethylene tubing and the products produced thereby |
| US5061276A (en) | 1987-04-28 | 1991-10-29 | Baxter International Inc. | Multi-layered poly(tetrafluoroethylene)/elastomer materials useful for in vivo implantation |
| US4816339A (en) | 1987-04-28 | 1989-03-28 | Baxter International Inc. | Multi-layered poly(tetrafluoroethylene)/elastomer materials useful for in vivo implantation |
| US4892544A (en) | 1988-03-07 | 1990-01-09 | Dow Corning Wright Corporation | Methods for forming hollow, porous-surfaced elastomeric bodies |
| US5181903A (en) | 1988-03-25 | 1993-01-26 | Duke University | Method for improving a biomaterial's resistance to thrombosis and infection and for improving tissue ingrowth |
| US4986831A (en) | 1988-04-25 | 1991-01-22 | Angeion Corporation | Medical implant |
| US5192311A (en) | 1988-04-25 | 1993-03-09 | Angeion Corporation | Medical implant and method of making |
| CA1322628C (en) | 1988-10-04 | 1993-10-05 | Richard A. Schatz | Expandable intraluminal graft |
| US5078726A (en) | 1989-02-01 | 1992-01-07 | Kreamer Jeffry W | Graft stent and method of repairing blood vessels |
| US4969896A (en) | 1989-02-01 | 1990-11-13 | Interpore International | Vascular graft prosthesis and method of making the same |
| US4955899A (en) | 1989-05-26 | 1990-09-11 | Impra, Inc. | Longitudinally compliant vascular graft |
| US5152782A (en) | 1989-05-26 | 1992-10-06 | Impra, Inc. | Non-porous coated ptfe graft |
| US5104400A (en) | 1989-05-26 | 1992-04-14 | Impra, Inc. | Blood vessel patch |
| DE3918736C2 (en) | 1989-06-08 | 1998-05-14 | Christian Dr Vallbracht | Plastic-coated metal mesh stents |
| US5201778A (en) | 1989-07-04 | 1993-04-13 | Giovanni Brotzu | Vascular prosthesis containing in the wall microcapsules, including hormone-producing cells |
| US5084065A (en) | 1989-07-10 | 1992-01-28 | Corvita Corporation | Reinforced graft assembly |
| DE4102550A1 (en) * | 1990-02-02 | 1991-08-08 | Stephan Prof Dr Bockenheimer | Sealing blood vessel fistula - involves inserted sleeve with spiral support with turns bridged by impervious elastic material |
| US5123917A (en) | 1990-04-27 | 1992-06-23 | Lee Peter Y | Expandable intraluminal vascular graft |
| EP0461791B1 (en) | 1990-06-11 | 1997-01-02 | Hector D. Barone | Aortic graft and apparatus for repairing an abdominal aortic aneurysm |
| US5578071A (en) | 1990-06-11 | 1996-11-26 | Parodi; Juan C. | Aortic graft |
| US5360443A (en) | 1990-06-11 | 1994-11-01 | Barone Hector D | Aortic graft for repairing an abdominal aortic aneurysm |
| US5236447A (en) | 1990-06-29 | 1993-08-17 | Nissho Corporation | Artificial tubular organ |
| US5122154A (en) | 1990-08-15 | 1992-06-16 | Rhodes Valentine J | Endovascular bypass graft |
| AU659097B2 (en) | 1990-08-28 | 1995-05-11 | Meadox Medicals, Inc. | Self-supporting woven vascular graft |
| SE9102448D0 (en) | 1990-08-28 | 1991-08-26 | Meadox Medicals Inc | RAVEL RESISTANT, SELF-SUPPORTING WOVEN GRAFT |
| AR246020A1 (en) | 1990-10-03 | 1994-03-30 | Hector Daniel Barone Juan Carl | A ball device for implanting an intraluminous aortic prosthesis, for repairing aneurysms. |
| AU8850391A (en) | 1990-10-18 | 1992-05-20 | Ho Young Song | Self-expanding endovascular stent |
| US5217483A (en) | 1990-11-28 | 1993-06-08 | Numed, Inc. | Intravascular radially expandable stent |
| US5163951A (en) | 1990-12-27 | 1992-11-17 | Corvita Corporation | Mesh composite graft |
| US5156620A (en) | 1991-02-04 | 1992-10-20 | Pigott John P | Intraluminal graft/stent and balloon catheter for insertion thereof |
| CA2202800A1 (en) | 1991-04-11 | 1992-10-12 | Alec A. Piplani | Endovascular graft having bifurcation and apparatus and method for deploying the same |
| US5192310A (en) | 1991-09-16 | 1993-03-09 | Atrium Medical Corporation | Self-sealing implantable vascular graft |
| US5354309A (en) | 1991-10-11 | 1994-10-11 | Angiomed Ag | Apparatus for widening a stenosis in a body cavity |
| US5282860A (en) | 1991-10-16 | 1994-02-01 | Olympus Optical Co., Ltd. | Stent tube for medical use |
| US5456713A (en) | 1991-10-25 | 1995-10-10 | Cook Incorporated | Expandable transluminal graft prosthesis for repairs of aneurysm and method for implanting |
| US5387235A (en) | 1991-10-25 | 1995-02-07 | Cook Incorporated | Expandable transluminal graft prosthesis for repair of aneurysm |
| US5211658A (en) | 1991-11-05 | 1993-05-18 | New England Deaconess Hospital Corporation | Method and device for performing endovascular repair of aneurysms |
| US5316023A (en) | 1992-01-08 | 1994-05-31 | Expandable Grafts Partnership | Method for bilateral intra-aortic bypass |
| US5405377A (en) | 1992-02-21 | 1995-04-11 | Endotech Ltd. | Intraluminal stent |
| US5282823A (en) * | 1992-03-19 | 1994-02-01 | Medtronic, Inc. | Intravascular radially expandable stent |
| US5591224A (en) | 1992-03-19 | 1997-01-07 | Medtronic, Inc. | Bioelastomeric stent |
| US5246452A (en) | 1992-04-13 | 1993-09-21 | Impra, Inc. | Vascular graft with removable sheath |
| US5354329A (en) | 1992-04-17 | 1994-10-11 | Whalen Biomedical, Inc. | Vascular prosthesis having enhanced compatibility and compliance characteristics |
| US5540712A (en) | 1992-05-01 | 1996-07-30 | Nitinol Medical Technologies, Inc. | Stent and method and apparatus for forming and delivering the same |
| US5507771A (en) | 1992-06-15 | 1996-04-16 | Cook Incorporated | Stent assembly |
| US5382261A (en) | 1992-09-01 | 1995-01-17 | Expandable Grafts Partnership | Method and apparatus for occluding vessels |
| US5383926A (en) | 1992-11-23 | 1995-01-24 | Children's Medical Center Corporation | Re-expandable endoprosthesis |
| US5433996A (en) | 1993-02-18 | 1995-07-18 | W. L. Gore & Associates, Inc. | Laminated patch tissue repair sheet material |
| US5334201A (en) | 1993-03-12 | 1994-08-02 | Cowan Kevin P | Permanent stent made of a cross linkable material |
| US5735892A (en) | 1993-08-18 | 1998-04-07 | W. L. Gore & Associates, Inc. | Intraluminal stent graft |
| US6027779A (en) | 1993-08-18 | 2000-02-22 | W. L. Gore & Associates, Inc. | Thin-wall polytetrafluoroethylene tube |
| CA2169549C (en) * | 1993-08-18 | 2000-07-11 | James D. Lewis | A tubular intraluminal graft |
| AU6943794A (en) | 1993-08-18 | 1995-03-14 | W.L. Gore & Associates, Inc. | A thin-wall, seamless, porous polytetrafluoroethylene tube |
| US5389106A (en) | 1993-10-29 | 1995-02-14 | Numed, Inc. | Impermeable expandable intravascular stent |
| US5527353A (en) | 1993-12-02 | 1996-06-18 | Meadox Medicals, Inc. | Implantable tubular prosthesis |
| JP2703510B2 (en) | 1993-12-28 | 1998-01-26 | アドヴァンスド カーディオヴァスキュラー システムズ インコーポレーテッド | Expandable stent and method of manufacturing the same |
| US5549663A (en) * | 1994-03-09 | 1996-08-27 | Cordis Corporation | Endoprosthesis having graft member and exposed welded end junctions, method and procedure |
| US5449373A (en) | 1994-03-17 | 1995-09-12 | Medinol Ltd. | Articulated stent |
| US5527355A (en) | 1994-09-02 | 1996-06-18 | Ahn; Sam S. | Apparatus and method for performing aneurysm repair |
| US5522883A (en) | 1995-02-17 | 1996-06-04 | Meadox Medicals, Inc. | Endoprosthesis stent/graft deployment system |
| US5556414A (en) | 1995-03-08 | 1996-09-17 | Wayne State University | Composite intraluminal graft |
| US6124523A (en) | 1995-03-10 | 2000-09-26 | Impra, Inc. | Encapsulated stent |
| DE69518337T2 (en) * | 1995-03-10 | 2001-02-01 | Impra Inc | ENDOLUMINAL ENCLOSED STENT AND MANUFACTURING METHOD |
| US5591197A (en) | 1995-03-14 | 1997-01-07 | Advanced Cardiovascular Systems, Inc. | Expandable stent forming projecting barbs and method for deploying |
| US5591228A (en) | 1995-05-09 | 1997-01-07 | Edoga; John K. | Methods for treating abdominal aortic aneurysms |
| US5628786A (en) * | 1995-05-12 | 1997-05-13 | Impra, Inc. | Radially expandable vascular graft with resistance to longitudinal compression and method of making same |
| DE69635112T2 (en) * | 1995-07-07 | 2006-05-18 | W.L. Gore & Associates, Inc., Newark | INTERIOR COATING FOR TUBES AND BLOOD TUBES |
| US5788626A (en) * | 1995-11-21 | 1998-08-04 | Schneider (Usa) Inc | Method of making a stent-graft covered with expanded polytetrafluoroethylene |
| US5800512A (en) * | 1996-01-22 | 1998-09-01 | Meadox Medicals, Inc. | PTFE vascular graft |
| US5769884A (en) * | 1996-06-27 | 1998-06-23 | Cordis Corporation | Controlled porosity endovascular implant |
| US5824046A (en) * | 1996-09-27 | 1998-10-20 | Scimed Life Systems, Inc. | Covered stent |
| US6086610A (en) * | 1996-10-22 | 2000-07-11 | Nitinol Devices & Components | Composite self expanding stent device having a restraining element |
| US5858556A (en) * | 1997-01-21 | 1999-01-12 | Uti Corporation | Multilayer composite tubular structure and method of making |
| US6139573A (en) * | 1997-03-05 | 2000-10-31 | Scimed Life Systems, Inc. | Conformal laminate stent device |
-
1995
- 1995-08-24 ES ES95930267T patent/ES2224132T3/en not_active Expired - Lifetime
- 1995-08-24 WO PCT/US1995/010752 patent/WO1997007751A1/en active IP Right Grant
- 1995-08-24 CA CA002229537A patent/CA2229537A1/en not_active Abandoned
- 1995-08-24 US US09/011,846 patent/US6214039B1/en not_active Expired - Fee Related
- 1995-08-24 DE DE69533289T patent/DE69533289T2/en not_active Expired - Lifetime
- 1995-08-24 EP EP95930267A patent/EP0850030B1/en not_active Expired - Lifetime
- 1995-08-24 AU AU33718/95A patent/AU707727B2/en not_active Ceased
- 1995-08-24 JP JP9510203A patent/JPH11511352A/en active Pending
Also Published As
| Publication number | Publication date |
|---|---|
| US6214039B1 (en) | 2001-04-10 |
| JPH11511352A (en) | 1999-10-05 |
| AU3371895A (en) | 1997-03-19 |
| DE69533289T2 (en) | 2005-08-18 |
| WO1997007751A1 (en) | 1997-03-06 |
| EP0850030A4 (en) | 1999-12-08 |
| EP0850030A1 (en) | 1998-07-01 |
| EP0850030B1 (en) | 2004-07-21 |
| AU707727B2 (en) | 1999-07-15 |
| ES2224132T3 (en) | 2005-03-01 |
| DE69533289D1 (en) | 2004-08-26 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| FZDE | Discontinued |