Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
  • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
  • A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
  • A61L31/18—Materials at least partially X-ray or laser opaque

Definitions

• HiD-wever they may require additional mesas fdr aacho ⁇ »g,f.he graft ⁇ within.
• li.e blood vessel such as mmi e ⁇ , clampfe s or similarly ftit!i6tiOnl ' n ' g : eiea, ⁇ !nts to overcome retracti ⁇ rs
• PTFE has prqven uausus ⁇ fy advaiitage ⁇ ws ss : a material: fr ⁇ m- which ⁇ p iabrlcaie blood- vessel grails or other knplmtabteprostltss.es,..bet v a. «se PTFB is c'xiremely biQcompaiible,- causing iitd.e:cir..tid-ktmkmogeRld reaction v ⁇ ss ⁇ placed within -the humajils
• I0OO.S] lmplaniatkm of a graft into tlie vasculature ofa patient Involves very precise ieelmkfyes.
• .the device is guided io-th ⁇ diseased or damaged portion of a lilo ⁇ d vessel ⁇ via .an implantation apparatus tliat depioys-. ' the graft attlie. desired locationo ⁇ l in order to pinpoint the ' location daring deployment;, the.
• the radfopacity is pfeferably iiicorporated into tlife device or the-e ⁇ r ⁇ traHu»g r ⁇ e ⁇ iberto A, problem can arise in delivering a grail via a slveafh.. Inpai ⁇ cul ⁇ if ⁇ ere is any ijiterfereuce. betweejft tbs gratVandthe ⁇ heatli, the.
• the ⁇ n wall m ⁇ ⁇ m& ⁇ & ⁇ Q&s- of tte implant ⁇ feyke provides flexibility to the lmplmit wliMi assists' m ⁇ wmpylMj ⁇ ? of Che Implaiitakmmd tissue during impUratatioit Use/of a tki ⁇ w ⁇ l ⁇ gm ⁇ icmi pe ⁇ h ' it the maa ⁇ lacture of smaller devices>vhich ' could :be del ⁇ Fered.BS ⁇ g smM! -sizeicsiheter b&s&ta cieliv ⁇ ry system.
• Iiowevar feat, fei I'hese.thiii wail devices may be-siibject to structural ' degradafi ⁇ .a such as y kii ⁇ king s diiri ⁇ g impknMios,
• Stents have Been used in c ⁇ nlbkatioii wMi vascuIar.rgr stis ⁇ i.c. "stent gra& f " t ⁇ provide e ⁇ d ⁇ vascufatr • pr6sth.eses-whkli ar# capable of nfainfaiBiTig tii ⁇ if ⁇ : t : against Mood, ⁇ essel walls, lite use;bf gfsfb along wlili.
• ste ⁇ ts also serves to oyercome & px ⁇ b ⁇ &m found with stents where smooifi i ⁇ uscle ce ⁇ s and-other tissues ⁇ an grow Jackpot ⁇ ugb ⁇ h ⁇ . stent's .mesh-IIke- openings,, res ⁇ liipg - ⁇ n restenosis of the y$n$&L Stent grafts -ate a prosthetk- de-vice- designed t ⁇ maintain the pateaey of various vessels. M the body ?
• imh ⁇ img tl ⁇ e tracheobtoncMal- tree.; l-he dsvlce .r ⁇ include u balloon axpmidable stent encapsulated: witM ⁇ ePTFE or alterhativ ⁇ ij s $d f-expfmd ⁇ ig Nifm ⁇ l.
• JP iue ⁇ cy ⁇ /' ⁇ vMch is marketed by C-R- Bard Peripheral Vascular Im, Examples o; ⁇ -sueh.
• tMt deploys thij: ⁇ ncaps ⁇
• In ⁇ rder t ⁇ pinpoint tin l ⁇ ci ⁇ ion ⁇ ng ⁇ tfyloymoni the- operator will ge ⁇ mlly oixl ⁇ ze a
• visnalizati ⁇ of the k ⁇ iamed device is essential for itnglantation * ' follow-up i ⁇ s ⁇ >eetidd and treatom ⁇ t; ⁇ coMingiy; m ot ⁇ et to impJabt the encapsulated " stent issmg
• the radiopacity can bs incorporated, irao ihs device or the constraining member to facilitate the correct placement wuhin the vessel.
• Dhciosure of invcftti&n f ⁇ $llj A preferred ⁇ mbodimont provides a graft device with a layer ⁇ fsjmh ⁇ t Ic noii-
• mcullic muteriai huvtng a first surface and a second surface spaced apan twin thtf fuvst surface f hs grail eevlce further bcludes a beading coupled to the laver and a radiopaque agent em ⁇ lcd to tiu beadfog. ⁇ 'lofctahiy, the beading provides kuik resistance. 3D ⁇ i the coupling of the radiopaque sgsrst to ihe beading prosldex a radiopaque beading.
• the radiopaque beading prefojably dof ⁇ nes a ⁇ ibsiantialty rectangular cross-sectional area.
• the radiopaque beading includes a radiopaque material embedded in a p ⁇ lyurethane material
• the radiopaque beading meludcs s radiopaque core deposed withia a pol ⁇ tctr ⁇ fiuoroeth ⁇ lene shell.
• ⁇ Jie radiopaque material includes 20% by weight c*f Bariom Sulfate.
• the radiopaque beading is formed from aps ⁇ te havir-g about 2C ⁇ % is ⁇ taium powder.
• the radiopaque beading is formed from a paste leaving about 20*/ « to about 40% Barium Sulfate. Moxe preferably, fee radiopaque beading k a. tzpz of 40 % ianialusn powder and 60% P ⁇ VF.
• Another embodimcut pro ⁇ ides a method of forming a graft de ⁇ Ice %vbich preferably includ ⁇ s disposing & radiopaque ageni in a polymeric shell, compressing Hit radiopaque agent and shell t ⁇ form a billet extruding the billet so as to form a radiopaque beading: and wrapping the beading about & gra ⁇ material so as to define a graft device.
• a stent graft dcv ice includes a si ⁇ nt frame having a f ⁇ &. xmtc ⁇ layer and. a second outer layer disposed about a centra! axiiu.
• the stertf grail dcvkv can further include a radiopaque agent coupled to the heading.
• the eotmUn ⁇ of the radiopaque agent to the beading provides a radiopaque beading.
• fOO 141 In yci another preferred embodiment, provided is a method of forming a .stent giarl device.
• the stent graft device is formed, at least h> ⁇ » including disposing a radiopaque agent m ii poljmcrie she!, compressing the?
• radiopaque agent and shell to form a. billet, e ⁇ lmding the billet so au to form a radiopaque beading; and wrapping the beading about a graft materca) so ⁇ s to de ⁇ i ⁇ ic a grail device,
• ⁇ ®ih Another preferred er ⁇ bodimont provides a method of observing a position of a implantable pro ⁇ thesb Ia a body, 1 lie method preferably includes disposing a implantable prosthesis having s radiopaque beading in the body and exposing the bod> t ⁇ an electromagnetic eiiergj .
• ⁇ radiopaque beading coupled to a graft or stem graft device can provide the aece ⁇ ssrj- visual cues to asslsi in the Implmit&iion, fullow-up aad treatment of the ⁇ c ⁇ ice. 'I he
• radiopaque beading can also be configured to reduce kinking m a graft b ⁇ providing structural support to the implant without significant!) reducing flexibility.
• the use of the radiopaque boading esn be preferably configtirod to minimise line contact beiweon a graft and a deliveiy sheath or between a stent gsaft a»d a delivery sheath by limiting contact to Hnc contact its the area defined be t ween the radiopaque beading and the Shaath. It is believed that
• FkJ. 1 illustrates a pieibtsd grail iievice.
• FICi ⁇ is* an X-ray view of the graft device of MG.
• HG- 3 is a crofcS-aecf ions ⁇ view of ant*didr emby ⁇ menf of a radiopaque heading.
• FIG. (> ulusirsiit.es iatx ⁇ f ⁇ fcr ehibodiment br&prefeed gMT device
• FIG; 7 illustrates -yet mipther ctnbodime»f of z ⁇ preferred gfr ' afi device, ⁇ iW2fl TlQ, S illustiaies.a pretested ste ⁇ tgraft. with- radiopaque beading. pM!28f ' FICL 91S as X-ray view of the ste ⁇ it graft with radi ⁇ paqusvbeadmg ⁇ f FI ⁇ . B;
• FIG, 10 is a citfes-s ⁇ cti ⁇ i ⁇ al- viewdf yet ano ⁇ er radiopaque beadmg.
• f 0031 J FIGS. ! 1 , 11 A, and 11 E are various perspective Md crdss-seet ⁇ oa] views of another stenigrafl having ⁇ i radiopaque bsadsiig.
• FIG. !2 is an. illustrative .fluoroscopic imagp.ofa sjent.graii ' haviBg a ' beadmg. formed by :a combkati ⁇ of jxilyi ⁇ rdliaiie and a radiopaque agent,
• the device 10 Is prel ⁇ rably a gjatl device %ti ⁇ its ouisr siiiface T2 prefcftibtly detl ⁇ es a substantially txibi ⁇ iar mepber sbo ⁇ f a ee ⁇ tral axis L-L o.f tho.dsvies 10.
• the device IO delines a substanlMly cire ⁇ iliir • perpendicular .to ills cemi-al a ⁇ js s aitliougk other eross-secttonalgeometrles are possible such as,. tor .exampie,-r ⁇ C-i& ⁇ gi ⁇ !ar or oval
• the device 10 is preferably eoafj
• the- -device 10 can be- snbstiintially s
• radiopaque agent tO ' jstovlde a vim ⁇ U indicator to an operator viewing the device- 10 ' Under ' flaor ⁇ seopis obsemtio. ⁇ as seen for example m Fl ⁇ . IA. More- spec-Mealy. t ⁇ « beading with radiopaque agent, ⁇ e. the- radiopaque beading 1.4j .provides as. operator with a Visual indicator to determine: or verify tlie.Iqcatkn a ⁇ id./or ofk ⁇ tation of the- dtn ⁇ cq IO upon implan£atio» ina.blood vessel ⁇ ? other tissue.. The radiopaque.
• beading 14 is prelbfab!y : ⁇ .und about the outer s ⁇ «.f ace- .12 so as U) gttb ' sumiMiy -drt ⁇ umcribe- ihe ; cefeai.ax ⁇ s of- tile device 10.
• Aker ⁇ ati.vely i ,-tiie radiopaque Beading; can be disposed on ih&- oixmt ' smfm® .12 sq as to be substantial iy t ⁇ one side of the central axis.
• "Hie radiopaq e beading foitlier preferably forms aconti ⁇ no . us wrapping about the.
• tiie.radiopaque beading 14 can fee formed by a.serles of ⁇ egmenls aligned about the outer surface- 12 * Furtherlft fee aHtmatlvei the r adi ⁇ .paqise -.bbading 14 am be formed by wp1tirdit> s of individual rings.
• jl ⁇ , & tmg of beading . may be siibstaniiallj :r ⁇ eiasignlar or circular ⁇ so long as ⁇ ns ring -sMsnes a.s ⁇ fiicleM lntemytlal space to be disp ⁇ sed about, the device 10.
• Ersferabiy, the radlo- ⁇ paq ⁇ e ' beSdmg..14 is fceii.cftl.3y wrapped about the oirier s ⁇ r&ce •
• the device .10 can fee a tubaiar member :macle from, a graft. materia! which caa .be a ⁇ tJ-m ⁇ talKe.Bi&te ⁇ aL Frefembly, tiie graft .material is expanded pol ⁇ tetraOuoroetIiyle ⁇ e ⁇ ePTFE) 5 but alternative n ⁇ -metdHc:.mate ⁇ als are : possib!e.for1briiiing the ⁇ mke W such as, for example:, .Dsesro ⁇ v, p ⁇ lyes ⁇ r, poIytetraOu ⁇ roethyleae ⁇ P ' rFE ⁇ ., ePTFB;, potyurethimfe; p ⁇ ljurethiHKt- ⁇ rea, slbxase, and. combinations thereof..
• the ip.almal can fncl ⁇ d.e
• tlienoii-meta.lllc mate ⁇ al is preferably fomiulated mt ⁇ :&
• f ⁇ r sample 'circular, oval or polygonal
• beaming 14 Is diii) ⁇ nsi ⁇ e ⁇ i so as to have : a: le ⁇ gtir of abbiit 1 -millimeter a ⁇ d a width of about ' 500 microns, Ppenab!>% ih.& -elongated ⁇ e of the-
• the radidpaqoe beading ⁇ 4 is pr ⁇ feralilv mads of & Bioc ⁇ ipatible poiyufeliiauo ⁇ M ⁇ ria! siith. ' as, for exat ⁇ gl ⁇ , Ca ⁇ ' thaae ⁇ PC-3575 by Novb ⁇ n, Ino, .(Th ⁇ rmedics l>ivisk>:n ⁇
• the Carbofcme preferably ' has a .72 Shore ⁇ hardness aiicl.ihe Barmm i$. pjr ⁇ .s ⁇ nt : at 20% by weight Sulfate -greater than Jib%:.is :' ⁇ «fe ⁇ eai' ' to- provide : radiopsdl ⁇ .
• tJie conc ⁇ tratioi ⁇ of Barium Sutfafceus ⁇ .e. beading :14 ranges fmi ⁇ j. about 20% to about 40% tc prdvicie tile tMi ⁇ padty.
• The- radiopaque beading .14 is preferably forMed by extru ⁇ ioa.
• &e Cartethasie PC-3575 Material and 20% by Barium Sulfate are combined in a &)ntpos ⁇ i ⁇ : resi ⁇ or paste in which the Bjir ⁇ um Sulfate is preferably dispersed réellep-ugbout/the p ⁇ lyurelhaue material.
• the ⁇ composite paste . is preferably loaded In a press device to .compress
• a:- billet.. Tie Billet is then preferably extxu ⁇ ed iq.lomi the radiopaque po.h'uretha ⁇ .e beading i4.
• fe a preferred me ⁇ oS-of coupling, the beading 14 ' to ibs-Outer surface 1.2 ⁇ fths.
• the device .IQ, fJie. beading 14 is preloaded oslo the outer sur ⁇ aes 12, More specilically,. the beadmg 14 is placed under, tension,- preferably about 500 grams of farce, abi ⁇ ' the outer surface 12..oFthe grail vthicl ⁇ omi betemporarily mounted to a.maad ⁇ i ⁇ L Preferably, the spacing between adjacent windings of the beading 14 is aboiti I mllHi ⁇ ietsr to abcmt 2- millimeters, As previously sxea of. die beadipg ls. engaged 6r coupled to. the.outer.su?facie 12.
• the solvent is preferably applied fey spj'ayisg or coating and preferably :by pulling die " beading, through a solvent, bath.
• FlO. IA shows # fluoroscopic ox X-my view of the xtevkts 10 with radiopaque
• the .beaded.gr# assembly is removed from tlie- solvent ajad &e ..solvent evaporated b
• the beaded g ⁇ ftassembly is preferably dried in oven at- ⁇ 0 °C for rn ⁇ elve hours to mmove tlie solvent completely.
• Th& short dippiag time is pR ⁇ erably designed to boiidthe beading to
• acetainiide may also be alternatively ⁇ sed, Sblvonts.that evappnuer.rapidiy tm most
• the outer layer 16' is ; preferably ⁇ PTPB so as to provide a ⁇ . ⁇ eFl'Fl ⁇ beadr ⁇ g .14' with desired.- peeling properties, as is provideeHn fenowjB/ beaded products s ⁇ ch as, Ibr.exsBiptej CEi ⁇ rrERFLEX® graft, by Bard Periphem!
• the P FFl ⁇ reslr s can be- further mixed and healed, with other sniiable bic- aeine- maie ⁇ al as part ⁇ faii optional compounding process, bor example, the FTHv sesin uui be compounded with a suitable hydruxyapatiie (HA) material to produce a beading materia! for uiereased Hocomp ⁇ tibilJiy ⁇ ind HoactH ity is order to, for example promoie endothelial cell growth far the reduction of intlmal hsperplasia.
• HA hydruxyapatiie
• the resin can be poured into an inner barrel ofapresomier b) directing Ii through ⁇ funnel which is fit to the outside of the itmor barrel,
• FiG. 4 illustrates a preferred cmbodmien? of a divided preform barrel 40 -which can be used in preforming a resin into a co ⁇ iptessed cylinder.
• the divided prsform barrel 40 preferably includes an outer holknv c>Kndiicai inemher 42. on optional inner hollow eyliiidrieal member 44.
• the inner hollow cy ⁇ nd ⁇ cal member 44 can be coftce ⁇ tiicali) cosst ⁇ hed uithin the outer holkm cylindrical member 42. Details of a similar process are shown and
• the PTFO resb can be p ⁇ arsai within a First area 52 located between the oote? hallow cylifidric ⁇ member 42 and a solid cylindrical member 46, Tii£ first ares 5 ⁇ can be
• radiopaque materia! such a?., for example, a 20% by -weight Barium Sulfate compound to form ihc radiopaque core 1 S*.
• ⁇ MUS] b one ⁇ >f the preferred embodiments, (he outer hollow cylindrical member 42 has it radius greater than the radius ⁇ f the inner huil ⁇ m cylindrical member 44.
• a preferred embodiment of the preform barrel 40 can have a radius ⁇ >r approximately 1 ,5 inches, lhe secondary area 48 between the inner hollow cylindrical member 44 arid ⁇ he central solid cylindrical member 46 can ba%e s radium of approximate!) 0,38 inches dit' :nticr hollow cylindrical member 44 can liuve a 0.0?
• a radiopaque paste or resin can be partial! ⁇ or fully embedded in a portion of the inner surface of lhe PTM" rssin w iihout the use of mi inner divider merahe? 44.
• I. he radiopaque paste can be formed from a tantalum powder.
• thm radiopaque pasre can be formed ixom a skt ⁇ percent (t?0%) tantalum paste eomblned witli a» eP'I i/K paste.
• ⁇ ddtioaal ⁇ y other suitable maltinal? caii be utilised to (br ⁇ the radiopaque paste, for example, gold or titaa ⁇ um.
• file radiopaque paste can be formed from a Baiium S ⁇ liaic mixtiiro.
• the radiopaque paste can he include an eP ' I Fh pasts mixed WUh twenty to foriy pcrceni (20-40%) Barium Sultaie. 1 « a preferred ymbodimexU, tbs i& ⁇ h ⁇ que paste i# formed into an elongated strip that can be disposed along the length of the inner s ⁇ rtaee of the- ITFB resin.
• the radiopaque paste cau form a plurality of radiopaque elements that e-an be aligned along the inner s ⁇ iriaee of the PTM: resb along Its
• The. radiopaque: paste can be formed into any shape ⁇ r ' fb ⁇ n.
• the paste can be fote ⁇ ecba ' S sutures,. ilireacls aftd.-other small pieces such as- ⁇ i ⁇ s- disposed, anywii&t- within !hi > PlTErsskt
• the e ⁇ tjM ⁇ i ⁇ s or d ⁇ iigated strip of . radiopaque material embedded in the iiftier surface of ⁇ e FfFE fe ⁇ aim provide the radiopaque core l8 f to the. operator viewing the
• the. preform, bmx ⁇ 40, the..inner eylindt ⁇ cal member 44 (if ysed ⁇ , ' the outer cylindrical member 42 ? -and the center solid cylindrical mei»b ⁇ r 46 of the divided pre fccm bsTjfej 40 are. removed to. ⁇ btaiu a compressed.eyliader or billet of material.
• the dividers witMn.th-e preform barrel may be remoVed : prior to oompressioft s without .disturbing- the interface between tile dif ferejit « ⁇ r ⁇ oads ?
• The-c ⁇ ftlpmsss&l eylinder or h ⁇ ' h ⁇ i having an oiitcr FTFE layer arid radiopaque 1 core is preferably co-ex
• the compressed cylinder of. material is plae ⁇ d wltlim an extrusion barrd.
• radiopaque beading P' can be bonded or coupled to a graft cbvke 10. in a preferred method Jot- bonding the uFIF ⁇ . radiopaque beading 14' to & grail device H), ePTKF
• the graft 10 and beading 14" can ⁇ e sintered at a temperature to f ⁇ so ihe beading 14' with the grail surfaces 12.
• Use siniermg temperatures can range from about 340 6 C to aboiu 380 0 C and preferably from about 355 °C to
• Hie tape can be formed with a preferred composite resin of about 60% tantalum as a radiopaque agent and 40% FTFE of polymeric material. Alternatively, otter polymeric and radiopaque agents can be used.
• the tantalxais m ⁇ PTFE composite is preferably extruded ami expanded three iimQn to form the radiopaque tape 14". Further in the alternatives an «rtexpan>Jed tape can be employed.
• the tinexpanded tape can provide more radi ⁇ -opacit) as compyrcd to ⁇ p ⁇ i ⁇ dcd tsp ⁇ pre_ajmabL> due to reduction of density ofradio-opaque r ⁇ atc ⁇ aL
• the tapd 14 * ' is preierably homid or coupled io s graft device 10 by wrapping the tape i 4" about a grau vtevicc 10 a «d s ⁇ attjruig tlis assembly to fuse the radiopaque tape 14'' to the device 10.
• Ihe tape 14" is prefefubiy bound to the device i ⁇ by sintering the assembly at 340-380 ft C preferabh at 355 N X' to 365 0 C for 0.5 ro 5 minutes, and preferably for 1-2 minutes.
• 10 e&ix be preferably formed by extruded ' .
• ePTF E materia! along -with a ⁇ adiopaq ⁇ e beading:204, 304, 1 ' hatiS; a radiopaque beading can-, be. bonded by sintering -or solvent bonding to at kast ⁇ ne of the luminal and abkaviihai sui-feces of the- grafts: (2 " 00 or 300). Additional examples of various; grails.,
• IS ⁇ WSS ⁇ Bh ⁇ fwxi Ip P ' ⁇ gnre 8 is ⁇ preferred, -es ⁇ b ⁇ dr ⁇ ent of an iiBplantabte prosthesis deyfc-s, ⁇ iior ⁇ pre&rably.
• T.h ⁇ device .100 is preferably eoMfgured for migrdtion t& ⁇ ugh a- Mood vessel to engage., .for dsampb f aMenosb, (0056)
• the stent grail 10(5 probably has a beading 104 to provide structural rigidity to ⁇ ® .stent 100. More preferably, the beading 104 includes oris coupled io a radiopaque a.gmt io form ⁇ radiopaque beading 104 to provide an operator with a visual locution or ⁇ cntatiou indicaior during aad following implantation of the implant 100 in ⁇ blood v ⁇ -ssel.
• the 5 radiopaque heading ! 04 is disposed within tlic stent grail ! 00 so as Uv substantially circumscribe the central axis.
• the radiopaque beading is preferably disposed between the inner aisd outer layers of the stent gral ⁇ to define the contours of the device 100,
• the radiopaque beading 104 further preferabh forms a coathuious wrapping aboat the cental axis of the device 100 so as t ⁇ form a continuous contour line on the outer surface 102 of the device 100.
• the radiopaque beading further preferabh forms a coathuious wrapping aboat the cental axis of the device 100 so as t ⁇ form a continuous contour line on the outer surface 102 of the device 100.
• radiopaque beadmg 104 can be formed by a series of segments aligned abom the outer surface 102. Further in the alternai ⁇ e. the radiopaque beading 104 cm be formed by « piarsliu of Individual rings dimensioned cmd coul ⁇ gur ⁇ d to be disposed about the device 100 and ⁇ space apart along the centra! axis. Each of the plurality of rings can define its own geometric shape. for example, a ring of bcadmg may be substantiai ⁇ y reeta ⁇ gular or circular so long as the ring
• the radiopaque beaiing 104 is preferably helically ound about ihc stent graft
• the helical wrapping of tlic radiopaque beading 104 can maximize coverage oi ' tho surface 12 ⁇ hIk r ⁇ hiimmng the overall surface area of the beading 104 t ⁇ ierohy minimi/'itig the contact between the device 100 and any sheath used to install the deuce 100,
• AB cxur ⁇ plary delivery sheath includes FLUEK €Y# by Bard Peripheral Vascular, Tempe, AZ- The contact between the device 100 and ⁇ it deliver ⁇ ' sheath can minimize the force required io pull the sheath over die device 100 during
• contour lines that provide additional visual cues to the user during and after implantation.
• m untwisted implanted dtruce 100 with preferred radiopaque beading 104 optimaHy appcars as a series of parallel along ihti central axis of the device 100.
• ConvmeK, am i-vvJMitig or bencU ⁇ g in tlie device 100 wou ⁇ i appear as converging line? m the ladlopaquc beading 104.
• radiopaque beading 104 can be employed such as, for example, forming distinct circular radi.opa.que beading about the outer surface 102 along axial length >-n"the dexiee 100.
• the circular radiopaque beading 104 caft be substantially
• the beading 104 can be elongated strips of radiopaque hiding radially spaced about the central axis of the device 100.
• a ⁇ s long as * J ⁇ ordinal observer can determine f ⁇ at ihi Jines provided by the radiopaque beading 104 in a fluoroscopic display inetliuin has a darken or higher contract image than the remainder of the device HKK tlien the ⁇ kliopaeity of the beading 104 would be deemed io be greater than a mmitm*m level needed for the beading to function a ⁇ * a radiopaque ⁇ w&or in a body.
• ⁇ lter ⁇ ath ⁇ a machine vision with the abii ⁇ tv to peeogoi?e discrete levels of contrast can be utilised to provide an objective indicator of
• ShO 1 VM in FiO. 8& is a. ⁇ ' ⁇ oss-sectional view of one e.mtx ⁇ liment of the device 1 OC) v&ih stem 101. encapsulated by Inner beading 1.04;
• the radiopaque. beading 1.04 is preferably rectangular m cro$Srsectimi.ta;proyido the maximum contact -surface &r coupling to the device.1,0.
• the.ke&ding 104 can t?$ &nj other geometry in cross-section, such ': M f fo?
• the • eio ⁇ igate ' d $ ⁇ is of the beading.104 Forms the interlace ; • between. the radibpaijue bidding 104 and the e&M ⁇ r siMsce 302 M ifee devic € .100.
• the beading 104 is substa ⁇ itialiy circular in cr ⁇ ss-se&ion, mid the diameter of ' the beading.14 lis? preferably about 0X>?
• Tfie radiopaque beading J 04 can be fomied.by variety of .techniques lacltidmg exm?sio ⁇ ,.I ⁇ jeUk>5i uioicli ⁇ g, solVerrt casting /m ⁇ the like..
• the radiopaque ' bfeaiding ' 104 can be ⁇ ade ftofn other biocompatible pQ3.ytners.such as, for- exa. ⁇ ple,,pacri>n., polyester, PTFE, e : FTEl? s polycarbonates,
• -24- cyliadei preferably containing 200 milliliters TIiF so as to expose all surfhce of the stent ⁇ raft assembly to the U lW
• the assembly can be exposed to THF for 30 seconds to 5 minuter more prefercbl) t ⁇ 1 mi g rate,
• the exposure time is controlled so tus to pornut bonding of poh-tirdkme beading io the e ⁇ VHi encapsulation layers without substantially U ⁇ cjitolvmg the beading snateicJ.
• the boack*d assembly can be takes out and air dj i «I for 30 minute* and then cried 1» c ⁇ on U y r "0 0 C tor 12 hou ⁇ s. If the eP fi'l- encapsulation material is sintereds no ⁇ dditional sintering step is needed, av ihe poly ⁇ r ⁇ thaac beading holds the encapsulation layers kjgciher- 10064J
• Another prefcrred embodiment ⁇ fihe radiopaque beading 104 is $h * )vui in FlC- 10 « ⁇ !
• radiopaque heading 104' a&vmg an outer luaicnal layer of so ⁇ -radiopaque material i I6 ! surrouiivllng a iatlioque core 118 ! -
• the o ⁇ ier layer 16' is preferably ePTPh so as to nrm Mt* an eP FFIi beading 104 With dosired f eclmg properties in knows beaded products such * ss
• S ⁇ oh polymcik materials include, for example, I )acron, polyester, polyurethane, PTFfL polvcarboBiues, polysulfonc. polyethylene, ⁇ o!ypropvk ⁇ «, p ⁇ lvuretba ⁇ c- ;uca, ⁇ iloxatfeg. ajtd eumbi ⁇ tiOBs thereof TM radiopaque core 118 * is preferah)> 2 ⁇ % by ⁇ weight of Barium Sulfas sal, material.
• the radiopaque core 118' can he m ⁇ (h from otli.ee radiopaque agents including Umtalum, tungsten, gold, stiver or oiher metallic powders or salts such as ealdum or Il ⁇ .salt
• the ePTH ⁇ beading 104' can be made b> ⁇ variety of suitable tcokmques, such as * lot example, by extrusion of elTFh and a ⁇ o ⁇ tahle radiopaque Biatcriai Q$ descflhed earlier io iorm a m ⁇ ular extrudatc or beading.
• radiopaque paste ' can ' , be ifo ⁇ nied from a ⁇ ;rii%l«m powder, '
• the radiopaque paste ⁇ can be f ⁇ ined from. &.
• the-xadiojsaque paste can be include ast-sPTFB pifete .mixed with akjut-tvventy to about fert% ! ':perce ⁇ .t (20-40.% ⁇ Bariimi Sulfate.. M. ⁇ . preferred effibtHi ⁇ iient tl-ie radiopaque, paste is f ⁇ miecl ⁇ i ⁇ mi el ⁇ agaied strip that eati.be disposed along, the length of the inner .surfaee of the PTFE t ⁇ n. Alternatively ot in : addi ⁇ ki ⁇ to ? the radiopaq tie.
• the- paste CM be formed.-as suoli as disks di$ppsed ' aiy where within ⁇ is FIFE resm.
• e ⁇ ibedded in the ⁇ xitm surface of the ⁇ TFE resin can provide- the radiopaque qr ⁇ e..1 !. ⁇ ' i ⁇ - the operator viewing the bsa ⁇ mg: 104' uB ef iiaorosc ⁇ py,
• A- second bio ⁇ 5ompatible ' flexible tubular member 25. is thes preferably loaded o.ver t ⁇ e -first
• the tubidar shaped s ⁇ pp ⁇ ri memfe ⁇ ?r,23 preferably includes a ⁇ t ⁇ u skailm to that desq ⁇ bet! In 0.3, Fat Nos, 4,733,665; 40 ⁇ a,941 ; 6 S 053 J43; SJm ⁇ $6; 6,572,641 is mcQrporatediiiits.enlimty by .reference Th ⁇ stent utilized ibr the memte 22 can. bea IMkro ⁇ e&pandabkvsienlv seli-e ⁇ panding stem ' or mem ⁇ ty ⁇ k ⁇ $ ⁇ plasticstejit.
• the tubular Hse ⁇ «fes 24, 26-nm ptakmhly. fu ⁇ together.. ⁇ eB ⁇ apsuIat ⁇ the supdortniembet* 22>
• the iob.uksy members 24 3 26 of stsnt-grsph, 100 are: prefeabiy formed by extrnd ⁇ ig a biOei.of expanded the -first sm& second biocompatible flexible tubukr members 24 s. 26 ' .iimy also .-be made. ⁇ f unexpaiided.
• the tabular members 24. 26 cmi further aife ⁇ iatively be- femed frbhi 0-l ⁇ .r 1 jio ⁇ -inetaliic iisaleriais g ' iJd ⁇ as,. for example. I3acr6.&.
• FI0 ⁇ 1 IB is a,c ⁇ oss ⁇ eetiom ⁇ l view ⁇ t -the . ' stent graft 100 OfFIG, 11 prior to fusing -the: grail or tubular members 24, 26 " to tie expansion membe ⁇ 22 to form the device 100; ' The.
• ⁇ he;t ⁇ h ⁇ lar siipp ⁇ rt member 22 preferably, a stent,- stent ft ame or similarly constructed stactus-ev forays- the Middle layer j ocated.at the centerof th ⁇ slant g ⁇ a ⁇ 100.
• O ⁇ e location can be tte cMter s ⁇ $rla.e ⁇ ::of the:- inner-member .?4.-
• Another location can be osr.the outer suriace of the stent 22, - ⁇ ?.- shown, in F1G ⁇ I l A.
• Yet another location can be .oa the outer surface of the .outer member 26, Ixi each of these locations, -the heading 1.04 is spirally wrapped about a : to ⁇ gitt ⁇ 1i ⁇ ia! axis ⁇ gtf-e ⁇ ctends tkm ⁇
• the feading 10.4 ' is • wrapped and bonded to the ⁇ uter surlaee of the
• tubular 22 is a sfe ⁇ t fraimvihie -fetiaiidisecond ePTPE- 0 iiibuiarmambsrs 24 S 26 fire fused, tp one aiiptlier tiirp ⁇ ig ⁇ i ' the openi ⁇ gi?;b.etwsei ⁇ iii.e struts tif the steal m ⁇ between &e ⁇ pi ⁇ pes of winding- of fke ' b ⁇ adihg ⁇ 04, f!3fO70j
• the : preferred teehi ⁇ gues fer fosing the radiopaque beadlng-betwee ⁇ the itsb ⁇ lar members 14.26 maj vary depending upon, the .configuration aad/br materials !b.riiili%; the-
• h ⁇ i other aprotk solvents : ⁇ nn be used.
• the other solvents or soj:ve»t Biktures ihM cai ⁇ be used include, ac-e.to.ne.. dloxtms, dmleiky! scetami ⁇ le,.diippthyi ' sulfoxide, ⁇ -
• IB ose embodibent a 10.0 Mi ⁇ il tiiick 6 millimeter diameter, graft ⁇ vhll 60% lantalt ⁇ m Um -(2 millimeter wide and 50-90..t ⁇ Scr-o.n iiikk) -ivsts extr ⁇ d ⁇ l
• smtace. 1 he filament and gr ⁇ il are preferably sintered to produce ⁇ mtahim marking on the gMT ⁇ surface ihai Ls visible in x-ray imaging.
• the i ⁇ lametn mcrv also be spiral) wound on a *>te ⁇ U graO sufi ⁇ ice.
• piefembh fo ⁇ «sc tlio radiopaque beading 14 * has an outer ePTFH fhc gra ' J i3eading/styj «/gra ⁇ ⁇ sse ⁇ bly Is healed at sinte ⁇ ag tempetatutes to form a phjhica! bond between the layers.
• the sintering temperatures can iange fiom abn ⁇ t j 00 0 C to abcn ⁇ 300 °C ⁇ aid orelexably lrom about I Ot ) 0 C to about 200 0 C.
• tlie prosthesis can Include hydsanyapst ⁇ te oa both its luminal and ahiur ⁇ mal surfaces Further, the cP 1 FH layers ma> a!st> be or jiOincd together around the ends of the u ⁇ ar ⁇ ied stem (hereby e ⁇ tirelx encasing tlits stem b hoth tlie radial mid longitudinal directions.
• the resulting stent grail I Od and mdiopaque h&almg ean he loaded oni ⁇ a suitable dcliveiy ⁇ c ⁇ ke such as, for example, I N S Patent Ko.
• Patent - Application- Publfcati ⁇ JxNo, 2004-0015228 which w mcorpotaied ifr Ifex ⁇ ntiiety by reference.
• mi ordinary observer can ⁇ 1ete : rn ⁇ uie thai the. Hn.es provMM by the ; rai3iopac
• Suchtimt ⁇ he tape is about 2 mi ⁇ im ' etisrs wide witii-s-thicl ⁇ iess ranging, from about IDO microns to- about . ⁇ 50..m ⁇ cro ' ns,
• the (ape can be f ⁇ ' mled with a preferred c ⁇ n ⁇ posii& resin - ⁇ f about .60% ' tauJalum as a radiopa ⁇ te.&gent. ancl:4 ⁇ % FTFE of polymeric ipateiiaL Alteitiatiwly, ⁇ thsr poiyperic 1 and .
• the stsnt grafi of this ⁇ .mfo.otfmie ⁇ t has the appearance of -about h&if ' of the sterft being encapsulated, by members 24 and 2(> ⁇ with about half ol " the stent being ⁇ xpds ⁇ d m'.b ' aie,- Tfcuse of the ra ⁇ iiopai
• hybrid st ⁇ Bt-graft allows for a-generaily precise piacenie ⁇ t ⁇ f the hybrid- sicat graft
• radiopaque beading allows applicant to we ' re ptMiously Unavailabie; For example, the. beading -allows for JoM/cr loading "slid deployr ⁇ e ⁇ t
• bioaclive agents include, (kit are not limited, to) pharmaceuti ⁇ -.ag ⁇ its such &%ihf example, iiftii-iJr ⁇ l ⁇ feMiye ⁇ miimuotic age.ats - m ⁇ diiig natural products swk m vines a&ak ⁇ ds (i.e
• .5 m ⁇ deprives cells which do not.have the capacity to syn&esize their O ⁇ V: ⁇ asparagme); .antiplatelet agents ...such as . G(GP) iyiJ ⁇ a mhihi'tors a ⁇ i ⁇ vitrotiecda receptor antagonists;- alkylating.
• agents suck as nitrogen, .mustards (a ⁇ eeMoreihami ⁇ e, cyclophossphafaid ⁇ atjd aiiaiogSy. ⁇ ieipMil ⁇ . ⁇ , chlorambucil), et ⁇ iyknimmes and ⁇ ieth ⁇ 3 hiidam!nea(liexamethylmelamirie mid thioteps), alkyl . sBifoiiafes-
• Birtdsoureas (cammstiae (BCNU) ⁇ iid aaSi(>gs R strepfe>zoc?H), trazones - CDTIG); aati-prblilferai-ve/ani ⁇ aitotic antimetabolite such as IbIIc add analogs (methotrexate);, py ⁇ mkliite analogs (ituoromwL fl ⁇ suridine, and cytarabka), purine: ⁇ malogs.
• acetic acids (iid ⁇ metk ⁇ cin, sull ⁇ dac, mid etodalae), fieteroarj'! acetic acids •• ⁇ t ⁇ lmetm, diclofenac s - and keiwolac), axylpmpi ⁇ mc. aeids. ⁇ lfeupf ojfea. m ⁇ . derivatives), : aalhtamlte acids, (jiiafeitjjjniio
• radiopaque beading ste»l ffaxne ⁇ ork, w ⁇ other design parameters e$ ⁇ - he atilized w.ith the : g.rat ⁇ device 100.
• Furthe ⁇ re. tlie radiopaque beading provides additional.
• .tnodHkaiioHS are wlthm the vMatioBs oltlie described er ⁇ kxliments; Accordingly, ii.k. iute ⁇ ded ' that the .present.mvention not be llniitedto tfee described; embodiments, but that ⁇ i hiw ⁇ the full seope defined by the., iatigyage-.of tlie foilowirig claims,- .and eqm ⁇ ale-nts.-thereol " .

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• Health & Medical Sciences (AREA)
• Epidemiology (AREA)
• Animal Behavior & Ethology (AREA)
• Heart & Thoracic Surgery (AREA)
• Surgery (AREA)
• Vascular Medicine (AREA)
• Physics & Mathematics (AREA)
• Life Sciences & Earth Sciences (AREA)
• Optics & Photonics (AREA)
• General Health & Medical Sciences (AREA)
• Public Health (AREA)
• Veterinary Medicine (AREA)
• Prostheses (AREA)
• Materials For Medical Uses (AREA)
• Media Introduction/Drainage Providing Device (AREA)

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• 2006
  • 2006-11-09 US US12/092,561 patent/US20090171436A1/en not_active Abandoned
  • 2006-11-09 WO PCT/US2006/060704 patent/WO2007056762A2/en not_active Ceased
  • 2006-11-09 EP EP06839788A patent/EP1945139A4/en not_active Withdrawn
  • 2006-11-09 CA CA002626601A patent/CA2626601A1/en not_active Abandoned
  • 2006-11-09 JP JP2008540338A patent/JP2009514656A/ja not_active Withdrawn
• 2012
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