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`Edwards Lifesciences Corporation, et al. Exhibit 1011, p. 801 of 2039
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`Edwards Lifesciences Corporation, et al. Exhibit 1011, p. 802 of 2039
`
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`Edwards Lifesciences Corporation, et al. Exhibit 1011, p. 803 of 2039
`
`

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`
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`Edwards Lifesciences Corporation, et al. Exhibit 1011, p. 804 of 2039
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`Edwards Lifesciences Corporation, et al. Exhibit 1011, p. 806 of 2039
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`Edwards Lifesciences Corporation, et al. Exhibit 1011, p. 808 of 2039
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`Edwards Lifesciences Corporation, et al. Exhibit 1011, p. 811 of 2039
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`

`

`INTERNATIONAL SEARCH REPORT
`
`International application No.
`
`PCT/US02/32588
`
`A.
`CLASSIFICATION OF SUBJECT MATTER
`IPC(7)
`: A61F 2/24
`USCL
`623/2.17
`:
`According to International Patent Classification (IPC) or to both national classification and IPC
`B.
`FIELDS SEARCHED
`Minimum documentation searched {classification system followed by classification symbols)
`U.S. : 623/2.17, 2.12
`
`Documentation searched other than minimum documentation io the extent that such documents are included in the fields searched
`
`Electronic data base consulted during the international search (name of data base and, where practicable, search terms used)
`
`c.
`DOCUMENTS CONSIDERED TO BE RELEVANT
`Category*
`Citation of document, with indication, where appropriate, of the relevant passages
`X,P
`US 6,454,799 Bl (SCHRECK) 24 September 2002 (24.09.2002), see Figures, see entire
`document.
`US 5,840,081 A (ANDERSEN et al.) 24 November 1998 (24.11.1998), see entire
`document.
`US 6,458,153 Bl (BAILEY et al.) 01 October 2002 (01.10.2002), see entire document.
`
`A,P
`
`A
`
`Relevant to claim No.
`1-74
`
`1-74
`
`1-74
`
`□ Further documents are listed in the continuation cf Box C. □ See patent family annex.
`
`*
`"A"
`
`Special categories of cited documents:
`
`document defining the general state of the art which is not considered to be
`of particular relevance
`
`"E"
`
`earlier application or patent published on or after the international filing date
`
`"L"
`
`document which may throw doubts on priority claim(s) or which is cited to
`establish the publication date of another citation or other special reason (as
`specified)
`
`"O"
`
`document referring to an oral disclosure, use, exhibition or other means
`
`"P"
`
`document published prior to the international filing date but later than the
`priority date claimed
`Date of the actual completion of the international search
`
`14 Januarv 2003 (14.01.2003)
`Name and mailing address of the ISA/US
`Commissioner of Patents and Trademarks
`Box PCT
`Washington, D.C. 20231
`Facsimile No. (703)305-3230
`Form PCT/ISA/210 (second sheet) (July 1998)
`
`"
`
`r G. Blanco
`
`Telephone No. 703-605-4259
`
`"T"
`
`later document published after the international filing date or priority
`date and not in conflict with the application but cited to understand the
`principle or theory underlying the invention
`
`"X"
`
`"Y"
`
`document of particular relevance; the claimed invention cannot be
`considered novel or cannot be considered to involve an inventive step
`when the document is taken alone
`
`document of particular relevance; the claimed invention cannot be
`considered to involve an inventive step when the docwnent is
`combined with one or more other such documents, such combination
`being obvious to a person skilled in the art
`
`"&"
`
`document member of the same patent family
`
`Date of mailing of the international search report
`,...,,.."I'll
`
`•
`
`ft .- .- n
`
`,
`
`~~J; CD WUJ
`
`Edwards Lifesciences Corporation, et al. Exhibit 1011, p. 837 of 2039
`
`

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`H9} \.\-'MM fok!!edua! Pt>:1p~rty Organi:t.dim'.!
`lntt:tnationtd Bun.:'-<~H
`
`(43) §nternatl!mill Puh!irnti,m lhk
`U N-0cv.emher 2(H.13 {LUL2{}03)
`
`PCT
`
`A6!F 2./24
`
`f'i!} Applkmst {ii;," ul! d,,,,ign,~;,x! S'f.~t<,,,, ,-..,y.,,., .. pt I/Sr T!Hi
`Gf.~NKRM. l'"H.)SPfTAL COR!>OKATH}N !
`Y:.
`
`f72) fo.·eM<)r; ,md
`{75) h!~'~'!.lt•:>r/.-'>pplbmt (iiw US ,_;,,~(;:.i: \HHT.C, Jeirnifai; K
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`f74J Agi~ni.: mi:RNST'f.:tN, J;l.'i!m, A ..
`:P(>Wti! .. (fok!,krn ..
`f-'r::ll(:f & :~·1arphy· 1.LV~ 16~±; f},;}()l\ t91 }\.~;5;,.~htt':::.t s~rt,~t
`Atb::.i::i. Ct·\ Jtt)OJ~l736 (US}.
`
`(~f} ne"lgmsti:d Stl.lt;:~ 1:,1,11f,:mdh AE. AG, AL, A:\l AT AI1,
`J\J:~ H/~c. HH .. B(f .B.R .. H:{. }3:/.~ CA~ CtL (·:"f'.J~ ('.fl: CR.; Ct\
`CZ, DE. DK, UM, DZ, EC, EL LS, fl, Git GD, CW, GH,
`UM. HR. HU.!!.\ lL. IN. rn. JV, KC Kn. KV KR. Kl .. LC.
`LK LR LB. LT, U!, LV, ;V!A. MD, :\K,, 1-,-lK t,!N, \:t\.\'
`?,,rx·, ~,tz, .N(). ·:<tt. PH. "PL~ PT .. Rf\ nu., ~;;J), SE. S(:,:._, .SK,
`.SL ·n, TM, TN, TR, TL TZ, tA UG, US, UZ, VN '\'U,
`J.\./\( z·~ .. t ·z\'t
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`{M} Ut~lgn~1ted Sh,w" ("tg,mw/.!: i\.RWO p;it,'ni (GH, Gt>·l,
`Kl\ LS, MW, MZ, sn, SL sz, TZ, UG, Zn-1, Z\V).
`t~u-.-i~t:i·s p;3t~:nt V\.~.:°l; .:\'l .. . BY. K(i. K./ .. 1'•H:\ RU< 1".f. l~·l).
`E;_ff:)JV;.".ii!l JX~krn {:\T. EI:, B.(J: (Jt CY .. (\?., r~E. l)K~ EE~
`ES. fl. FR. UH. GH .. HU. Hi, !T. LU. MC. NL. PT. RO.
`SE. S!, SK, TRr O,\P1 p,\t,~n, tBr. HJ. Cf, CG, Cl, CM.
`(~A~(?~'. (H). (}\\\ \.-tL. ~/1Rr ·r--:n~. SNr Ti). T(I).
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`(Utl·t ?i:)tts: o...-.:: (:·)d.-es anr.iA/-ri>.1·ti-:s/(;l{rvr·2 .. ' apr::1-::f:;Pi.~1 .. g ~l.~ th-:.-: fx:g{n:··
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`Edwards Lifesciences Corporation, et al. Exhibit 1011, p. 838 of 2039
`
`

`

`5
`
`fNVOLUT.ED ENHUVA.SCt.ll.-,<\R VAJ, VJ; ANH \l:El'HOD OF
`f:'ONSTRVCTlON
`
`10
`
`15
`
`FJELD Of THE fNVENTION
`
`The prtsent itrve:nhm1 reiates to ti pn:.,sthetic va.lve with nn involuted i::trudure ..
`
`The pre.sent iuve:nfam als:n rnlates to mdhtJtfa ttnd appai:-ah1s Jbr 1.}(ln.Rtrnctfog
`an in vdtrtkm vah'e,
`
`20 HACKJ.:HZOtTND OF THE INVENTION
`
`Sh:l.C() the frnphmt of the :first cardiac vaivufor prosthesis in tb,~ amitomi.c
`position in 196{\ n;nre tha:n 50 d:iHbrt:ni t~mfo-1.c -valves have bt}en introductx}
`over thz1 fasl f.Kty ytxu-s. Unihrhmi:ltdy, ail:er y{.~at·s of devdopm.ent of
`n1f.cht.-mical m1d tis~m.e w1h't~s there remain signit:k~aut probkrns ,1ssociakid
`\vHh both ty_pt:s of valves.
`
`25
`
`Edwards Lifesciences Corporation, et al. Exhibit 1011, p. 839 of 2039
`
`

`

`and the prnhlel:m, of b!.eedingt- hnt tend to degt:nerate rapidly, particularly in
`
`5
`
`younger patients. 'l11e 1nZlst con1nlo:n1y irnphm:ted fonme v~ilw.s are constn1ded
`
`or pordne vahres). The p:reservatio11, s:teorihzatinn, and .fixation protxisses
`
`cnrrenily used in tissu.e valve pn~paratkm are believed to <.:.ontribnk to the la(~k
`
`l O Ross procedure
`
`tissue valves, A disadva:.ntagt; of ·using the pulmm1Rry valve k3 rq:iace t.ht)
`amtie valve in foe same patienl: is that H.w puln1m:ittry valw.~ n-HJS! also be
`
`20
`
`Prohkms arise fimn fai;;k of donor iwaihbifay a11d. size misrnatch.eH hetween
`
`-pulmo.nary valve ·with a. homog-raft is ass.ociated ,vith frnn:n.mologicaHy--
`
`25 Alternativdy, :, single fiap nf Hs~ue from the puhnnnary tn:mk has been used
`to create a pulmt)n.aty ''n1n11o"citw" valve in _pedfotdc pattcnts 1.m.1:kirgob.,.~ the
`Ross p:rut:ez.h1re, LongAenn function of the n1onocusp valve has yet to be
`
`les& efl:foient 1.,fosure than a td--leaflct v,lh'c, The suoopthna1 function of a
`30 monocusp va1ve may adversely impact kmg~tcrm msdts. It is a d.mwback th.at
`
`2
`
`Edwards Lifesciences Corporation, et al. Exhibit 1011, p. 840 of 2039
`
`

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`\VO l\3/092~54
`PCT!USO~Vl 4 Hii}
`the tfasne fbp is created. The monocusp pn:icedtire does not pn_ivide a &Olll'(~t
`
`same individual- In !his p1"Z)(.X1dt1rt\ a t1ibe of tissue w;:is htffvest(:d from. th\.~
`fr1 l)'"Asw t'"3 <'t'"<!"te. «
`n_ 1iJ-i,·>,-}1l'J1"U i""'J:nh· s,,~il ·r,,,,.,q,'<f,g·•ir,:,,{ ·ir1t--1 'l trifou!l,,.t V""lv;,
`~ \. "1:-.'(,~ ~-s._,..,,, .... ~ ... ,--:..·,~ .,:-. >.
`.·.t"
`... }_{•~-
`- {
`.. ~ ~ ~ ........ x..
`....... ~.
`-~-'
`' -~ _.<c,.•"
`
`"'
`
`......
`
`\,,:(,.,\,
`
`Q
`
`.,l
`
`{~.;e.. ';/' ;.,,_h
`
`,,. ... ,
`
`,, i ~ .. H;,•>,.
`
`insufficiency .fo hvo patients, The faiktre of tliis vilve n~pfa.zx:ment pKiccdure
`resulted~ ln part~ 11:{n.n the extm:ne ted1.J1k:aJ clmlkwige for th~ su.rgenrt fo this
`proci:idure, the surgeon must simultaneously co:nstrnd and irnpfa:nt the YR1ve
`
`:rdiab1y constrnd a fi.mdiniml and durnblc tissue vHlve, It wrmld he desfra.hle
`
`20
`
`of cellular
`
`s.fo-sign~ H vrouhi \v~ irntffident Rnzl diffitu.lt to use this meihnd to reconfigm:e
`
`3
`
`Edwards Lifesciences Corporation, et al. Exhibit 1011, p. 841 of 2039
`
`

`

`\VO l\3/092~$4
`~trt:i:dure. to create 1:1 thndkmal thret'-·dimem;iont.ll
`
`in a Gatbeter for dq:ifoyrn.cnt. 'l~his is distinguished _frum otlw:r braided
`
`entirety),
`
`SOfvU\-1AitY OF THE rNVENTION
`
`15
`
`cylindcl' or "invo1utinn"' nwfood, The invofotkn valve may be ({)11Strncted of
`synthetic, 8en:1i-~j11thetic, organk m· hiofogical mak:d,=~.1
`(Jr mixt1.mt> or
`con1hinahQns thereof The valve is efifoient to con~trm.~t, n-i:ay be derived frmn
`
`20
`
`Edwards Lifesciences Corporation, et al. Exhibit 1011, p. 842 of 2039
`
`

`

`The valve rnay be a scaH\ild, 1nafrix., or other stn1cture Huit undergoes a
`maturation prnces& of living a1itofognus ct1U deposition thcnxrn., for the
`purposes of the present disclosure, the te.nn s.caffdd wiH be reforred to in an
`
`scatfold zx:n.dd provide signaling to cells to organize as an autologmrn valve,
`
`comprising, fo one exemp.hny embodiment: ( 1) providing ;1 tube of material,
`(2) .h.1vti1uting the ttitw inside itseU~ (3) selectively attaching pzwtiom of foe
`
`15
`
`mLni.miI1 ilmnunogenic structure,
`
`It ts ,1nothe:l' .foatiire iJf tfo:~ p:n:~sSent invenfam to provitk a vfoJvc !hat is capable
`of cdlulm- regeneration and repair and that i2 fi.rnctio.n.al mid i:.hu-abk,
`
`20
`
`Other foatutes
`
`invention. when taken in cm1,_juuction <,-v.Hh the iippend.ed daims,
`
`BRIEF DESCRIPTION OF THE DRA "\\1NGS
`
`5
`
`Edwards Lifesciences Corporation, et al. Exhibit 1011, p. 843 of 2039
`
`

`

`WO 03/092$54
`PCf/USOJ/14160
`Fig. 2 is a cuhrway view showing the involutinn valve hnphrnted as :~
`
`Fig. 3 Bhows 111atetial in a brnkk"d cnn.figuratinn;
`
`Fig. 4 BhO\.VS n:u.ttcdal in knitted l:'.OnJigurnt1011;
`
`Fig, 7 sho:\.v~ a perspectiw vie'N ofnwhi-direc::hrmal layering nfn-rnteri,1.ls;
`
`1-.ig, 11 dKiVls a perspective ,,·k~\\' <)fa o:.,iyHrtder v,dth thn:.-'e equid:isfaut incfa"inrrn
`
`tn Ct!.::'.ate flaps nr "ka.fkts";
`
`Fig, 12 shows a persped.ive vkt\v of involution of the ffaps inside the cyHnder
`to create 1ea.tfot;c.;
`
`6
`
`Edwards Lifesciences Corporation, et al. Exhibit 1011, p. 844 of 2039
`
`

`

`opens under pressure;
`
`attachment. of the im1t:r and nutet tuhe by weaving them together in an
`
`F1g. 22 shffW$ .a top vie'N of the itrvoJnHnn valve depicting ~xces.~ foafiet
`rniiterial In the tarihi1 and circn:.mfarentia1 directio11i.t
`
`Ieafid materfal in foe .kmgihidfrm{ pfanz~;
`
`7
`
`Edwards Lifesciences Corporation, et al. Exhibit 1011, p. 845 of 2039
`
`

`

`Fig, 26 sho~NS a pen"pedive v:inv nf the involuHrm vu"lve as cofbpsibie brnid
`
`depicting foe abHity of the strnctu:re
`endovagcular insertion profile,
`
`fo assmne ,a
`
`.revexsibk~ na.rro\v
`
`DESCRIPT'!.0-N OF THE INVBNTJ.ON
`
`methods of .fi.lm1ing t·Ul invo1utioH valve,
`
`Jn one exemplary mnhodhrwnt of the present invention an h.ivohit1on valvti is
`.fonned of synfhdic nr processed organic rn.aterii.ti. ··n.lf material t,:m he any f•f
`
`W
`
`set forth by way offlh.-istrntion only and are not intended·to be exch.is:i.ve,
`
`PdyglycoUc acidt, (PGA) can he ustd as non•1voven mesh; having high
`porosity, good cd1 aHm::hment, good gtx-nvtb and extracel1uhr mutrix
`
`15
`
`fr.°imsafam, rapid bhwbsorptfo-n, am1 hiocompaHhilHy, Exutnpfos of Jna.terfo1s
`include, but are not limited t:n, prJyhydn::JX.}'alkanotes (.PHA or PHO); poly-A ....
`hyd:n .. ,xybutyrate~"l {P4HH) {?HA and P4HB hav1,.~ the properties of efastidty,
`
`P4HB hyhrid in the form of thin PGA coated vvith P4HH fa reduce sbtfoess
`
`The v,1lv~ may ahKi be ctmstn.ic-t~d of polyn:ier•lmst!d substttnce~; exm:op1es
`inc!mk, but ,u-e not h.mfted tt\ pnlypropy'Ier1e, polyester, sHk, nylon, pfa.stics,
`
`Edwards Lifesciences Corporation, et al. Exhibit 1011, p. 846 of 2039
`
`

`

`polytetrafiunroethy1 enes
`
`1nixtures
`
`and/ot
`
`eeUs pnpu!affag a sctdfold). The Hv.ing 1n.akrkll can rontinuz.msly bffth.txl :in,
`fur exRrnpk, ,:;dl c1.Uture mz.ltfo.1tn <Jr B:an.k\, s<llution so as to retain viability.
`
`thi:.ise inch .. uJe r.k,i.::dh..tfarized porcine smaU inkstine sub1mwosa ("S1W') and
`seg1ntufa. of a deceHulariz.t:"co.i aorta, or V(ma cava tissiw from cadave:r donors.
`
`/\n exa.tnple o:f J dt)Ct::Mularizatfon prrn:.'.e~s is incuba.ti0:t1 i::rf in t1:ypB'h1/E.DTA\
`Ibr48 hrs tn extract endothelial ccHs and :i:nynfihrnh!a,':itS,
`
`20
`
`fa <JJ.K~ exernpim:y enibodiment, the seaHbki is de<:}eUuktdzt:d pordtK! trrwH
`
`1nkstirn~J ~.mbmucosa wh:it\h is reeonflgnred iut1:J a \'tdvu1;;w stn:.tdu!'i,;\ inrpfanted
`
`t'.u.ltu.rc "biQ1\:~acfar'~) <.K inskl.e the hody (z.: .. g,, {bllowfog
`puhn.ttik eel!
`irnp"h.mtation), Exposing the ceH--popnlated :i<caffn1d to nwchankal stresses has
`
`2.5
`
`Edwards Lifesciences Corporation, et al. Exhibit 1011, p. 847 of 2039
`
`

`

`invent.ion, The valve fa then itnphmtz'td into th1:1 body~ am.i depending u:pOll the
`to nu.lture by
`m:aterial
`and
`endothdializatfon, aut<.ilngous cd1 seding, and. e-::.tn1.cellubr matrix
`
`fonnal:ion, A1t(.tt1wlivdy, chemicals, d111gs1 gnrivth foctorn and. ntl'wr .agents
`that pn:.ii:.note end.othdjzatlon. and nit'i-trd thrn:rnlms :Kmnation may be bound tQ
`the valve material to 1novkle locul ther.:.tpy,
`
`25
`
`rn
`
`Edwards Lifesciences Corporation, et al. Exhibit 1011, p. 848 of 2039
`
`

`

`fmiher in Exan1ple L 1\ pu1mnnic Villve suhstHution wlth Uw ir:rvnlutitm val.ve
`
`treatm\".nt for aortic fo,1:mffidt;ney with impla.ntathm of rh.e Jnv.uluti.nn valve .in
`the des<x.:mling aorta,
`
`chan.itterlstk-~, For exumpk, rib knit may he usz£u1 given its p:mperty of
`ebstidty ill its \:vidt.h dinx~tlort Jeri:iey knit is kno,:1m t<.i bavli~ good '"irinkle
`
`.materials and f:ihrica:tion techniqlR~s nmy be rxpfoited in light of the mwtorny
`of the native hnrnm1 v~1h,e to rzmstrnct a va1ve r<:~plaGement ivith desfrnble
`clasddty, wrfokks, and stn.~ngfo properties.
`
`30
`
`11
`
`Edwards Lifesciences Corporation, et al. Exhibit 1011, p. 849 of 2039
`
`

`

`Consider that the histnfogy ofthe human native s:cn:dlunw: v.:1Jve$ is refon:wi to
`:'<> J:vi,,hh, ,,.,;~,·\tr,,,,;,., n ,~ "qt ·t'h"· ,;:-,~"'"'' ''" s- 11 ,.J;.,.,~~N,·,n~) 1·t +,1Jkl'\,V"1 i'tN1' nw
`•• ~. -.. 1 ..... .....,..
`
`~..:r
`
`.,;.~..,_~.,..:,,.,. .... r
`
`.:: .. -..;......_~ ..... 1>.._,
`
`\ :;... .......... _,o ...... :;,..
`
`. ...... ~.
`
`.,,(4.1.~il v
`
`.);.<J...
`
`,t:-o,.J;
`
`,:,.,;.i.._,;,,,.
`
`• -.-J,,.½•,.,._._,.., ;, J
`
`~-"--
`
`•
`
`•
`
`•, sh
`
`---~
`
`.1_. "' "· ... _.
`
`5
`
`fibe:n~ \:vhich expand JK:rpendkuht ti) the \::us:pal free rnargb (Le, radial
`d:iredfon) and inrparts a high conlpUanx::e i)n the foafiet in this <lirec.fo::.n, T'lw
`
`is ;:l. predominate load heating ekrnent, -restddhlg leaflet duri:ng fining and
`cm;,l1 d_istes1tiun Stren_gth is 1RoviJ1:.\d bv e:rouns of 1x:i1lauen (X.\rds radbt{~ fron1
`
`S'
`
`._,_
`
`-~
`
`,J
`
`..... ~
`
`~"'
`
`,._,
`
`lO
`
`cardfa('. fi.lHng (di:asofo).
`
`rih knit or jersey knit e1>.nf1gurn.tion of tlw makriu..l along the :radml or
`circumtere.ntfa.1 din:.xtion of nw valve constnwt in or<for to fanpart t::i!ast.kiiy or
`
`i111plM1fatio11.
`
`the potential to :more accun,tely signal the exrracz{!Jufa:r n:iat.dx rnaf.c..tials m1d
`
`ctn1 vary fo the smne or in diffonmt fihern cornposing thl~ mat.eriaL One study
`
`12
`
`Edwards Lifesciences Corporation, et al. Exhibit 1011, p. 850 of 2039
`
`

`

`5
`
`Hn:H.i.Uer dianJrn'er fibern,
`
`introduct\1 into the materhl by a variety of dH1'excnt tedmicrues, hldu.d:lng, but
`
`30
`
`rnngf: from approximately 100---500 mkrons, more prcfurab1y i11 the 100 to 240
`
`Edwards Lifesciences Corporation, et al. Exhibit 1011, p. 851 of 2039
`
`

`

`.1:.1rientattxt
`
`,mch
`
`that
`
`the directio.nahty nf
`
`fh(:. materials
`
`is pi.trn11d,
`
`-paral1e1 lo th(~ f\:ec e<lge of the kwtfot \Vith this in mind, the _pre:;;ent invention
`
`14
`
`Edwards Lifesciences Corporation, et al. Exhibit 1011, p. 852 of 2039
`
`

`

`PCT!USO~Vl 4 Hii}
`\VO ll.3/092$54
`the radial direction and the :m~:ist hotfon1 byer cl'..mkl have ,J dirtxitinmiHly
`
`cir.:.'.tm1ll":ren.tfal dires::tinn.. A middle hytr could bl~ s:ar1dwiched .in betv;,-ee_n
`vdfrch h.~s Hn 111nHi,-dln:-:ctiona\ ohfap(\ or 1nosdy itrra:ngt'<l rniiteriaL
`
`finnw;,css and sh:;engfh to the materfo1 and prevents shppage aud tlisp.facernent
`
`20
`
`numher of t~x~hniques hHYWTl to those s:k.Hled in H-w art m1d ap_pxoprbt(• to foe
`material beit1g used, such *ts, hut not limited to, wea,..-lng~ intedadxig, braiding,
`knitting, 1rt'1:nehing, t..rfting, Ia .. mim,Hng, sutttdng, stapling) g!.ufog, welding,
`frL'ling. ,,omhirw.tions thenx,f aw:.1 fhe 1iki:.~ {Pig .. 9). T1w t~heet can he knitkld,
`W\1\-'\',fl, or braided frtun strands of n-1a:h}rh1L /t tub-ular Dr cyfrn&rk~!l stn.Ktme
`ca:n he c1\~,1ted by sleeving t<:.~chniques using hr:aiding, knitting, ivtmv_ing nr
`combi1mtkin of these :methods, The i:<trncture ,~an ·bt: a prn_per t:yibdc,r (tho
`
`ttibuhr valve that is coUapsibfo (Fig. 10), ..Braided tubes cnn be e-unstructed
`
`15
`
`Edwards Lifesciences Corporation, et al. Exhibit 1011, p. 853 of 2039
`
`

`

`Involution
`
`Creaifog lea.fieis by invofotkm, aUmvs th,\) n-mt(~in1 at the site of fr.e infokling
`
`p
`
`is approxirnately
`
`20
`
`hdght of ,\):11rtnis::Ktres is aµprnxin1r:1t<.dy half the armubs: diarneteL 'Ih1._~
`tnatedaJ ha~ a thickness "'t",
`
`than haLf tlK height "1:t' of f!w cylinder in on:ler 'h:1 eliminate a potentfoJ tK)k in
`
`16
`
`Edwards Lifesciences Corporation, et al. Exhibit 1011, p. 854 of 2039
`
`

`

`\VO l\3/092$$4
`PCT!USO~Vl 4 Hii}
`and frrn m1termost ,vaH hec:i>mt.~sS tht~ sht nt' ,,ttadnnent to the im:phmtatkm sih~-
`The leafiets are setured to th,~ ir:mer sltle of the <Ji.rtennost ··wil1 (Fig, .i3). 1.f the
`
`indsh:ms in HK~ \:.:yHnder rt!foase the corrntrnints on the material and a1krw the
`
`H}
`
`20
`
`t1ibi:1 (Fig. 17}, In the prtivious dfact1s;sion of the present in\•'t~itkm, the
`out;;.inrmst bbe is fohfod inside itself fo th.fa cnnfig1..H"atfon, then.i can cxhlt an
`
`imphm.ti1tion nf the valve by de1.::.reasi.ng the risk of distorting the leaflefa
`
`Edwards Lifesciences Corporation, et al. Exhibit 1011, p. 855 of 2039
`
`

`

`WO 03/092$54
`A ttad.uni;mt
`
`previ(msly), Ofoer techniques nf ati.a.ch.ing the inxmr t.o the o-i.it,::;r ·waU of the
`
`5
`
`valve include, but a:re not fadk:d h\ interbcing, interindd.ng~ sfapl11)g,
`
`c:omhinatlom; ther~of and the like,
`
`/\ mathematica.! stress ,malysis nf Hw h1vi;_)luiion valve constructed of hmmm
`
`25
`
`vi!ve.
`
`Intedeafkt _Ttfa\ig.ks
`
`csreate<l by the angled attachml::'.nt of the i;:~ach }e;U.Het ll) the ·walL ln the present
`
`30
`
`invention, ;:m vnalogous stn.n:t1.1re can be imposed fo th~ il1vofotion v.:1.lve by
`
`18
`
`Edwards Lifesciences Corporation, et al. Exhibit 1011, p. 856 of 2039
`
`

`

`WO 03/092$54
`PCf/USOJ/14160
`co:iwtmct This cnn he cre<:~te,d by interlocking o:r interl.acfog the n1a.t{~1fal with
`
`·weaving, braiding or knitting ted:miques (Fig, 20),
`
`representing the base of the va!Vt)) movr:s itl oppos.itkm to the sinotuln.ihlt
`
`to the vvaH o:r sinus) duri.ng the (~ardiac cyde, During diastnh\ the anm.t1us
`increases dimneter as the s:hwtubuJar junc:tion dt~1:m::.~.ases diar:nd.'t!L Dmi1ig
`systci}e, tht: reven:;e is tnw, tm .. u1dy~ the mmutus redn<:.X!S dfomete:r and the
`s.inotulm.far jur.wt'io.n incR.1ases dirurwter. This motion rnay he important ±cir
`l O valve 1ong,-:Nity wld the sharing r,f strt~~s bd,;-veen the k:aJ!.ct ru1d \van chlri.i1g
`
`the cycle. foserting infodsJafiet triangles into H1e ittvolution valve construct
`
`.:xmstmct i,1terleaflet triangles umy pi::nrdt indepew:k:nt tnove:ment d' k~.dfots
`
`20
`
`Sinuses
`
`19
`
`Edwards Lifesciences Corporation, et al. Exhibit 1011, p. 857 of 2039
`
`

`

`of tfa:: nmteria.I sw.:::h that ih1:1 s:ma11 et diameter of the cnne wi.U be fr.rvduted into
`
`the hrger di,1:r11eter of the comi.
`
`5
`
`In mo.n.:~ complicated :mdhods of forming an involution vtitve, such as
`,veaving, the sh1nses can he integrated info foe final geometry by creaJing
`
`teclmique~ of \Veaving~ knitting, and braiding ;::an form ponchts, pnckets,
`
`pleiits, conugations, cdrn:ps and t>im:ises.
`
`/\ltenu1tivdy; portion~ of the
`
`between the leaflet and the rmtive aortic wall (Fig. 21),
`
`15
`
`ventriciitaris layer has gross i:~on-ugitllons ffi' colhgen and dastfo in the rndfal
`direction '<Vhk:h in.rpt.ut :.d.gn:ifkant c1.)n1pLb:nc.e in this ori~':mtaHon, fo the
`drcunifo:rentlai direct.ion~ t'he fihro~a layer has a c.rhnplng c~f cdfagen that
`provides a countzwfr)rCZ" to <.iverexten::,ion of the teafiet i.hiring d1e perfod of
`
`fobrkallng the invoh.ttkm vu:lve w!.ing knitting, ,veavfog, o:r hrnidfrlg of
`
`dire;;.:tion (Fig, 23)-
`
`20
`
`Edwards Lifesciences Corporation, et al. Exhibit 1011, p. 858 of 2039
`
`

`

`WO 03/092$54
`PCf/USOJ/14160
`<Jther). Suc:h nh1;,.•:rnntive slmpe of leaflets include scaHoping or rotm.diug off th(~
`
`midpoint 1n c:e:rtain cast~s. these slmpes may better mh::nfo native valve
`auatorny and help v,1lve .fl.mctkm.
`
`5
`
`A shz~t of \V(JVt!n, knitttd.1 or braided material n:HiJ be u,.,;ed fo combination
`·with a rigid or se1n.i~rigid fr,:im,1 ("ste11f ') to cre:;1te a. va1ve. The stent can
`
`10
`
`in.1.plantatfon. In another ern1mditn.eni., a sheet nf \'<'oven porcine (or other
`
`St(mt (fig. 24).
`
`hnplcmfaHon
`
`lfthe invointlid eyfrnder valve ihrmed by m1y of the aforetn.er.famed ·m.ethods
`
`15
`
`and nmte:riafo fo odentated such that .foUo-wing frnpla:ntation, the nKist viable
`
`.As sfa.)W'li in Fig. 25 the oukr 1,w11l oftissue c_y'limfor can remain intact and cut
`
`21
`
`Edwards Lifesciences Corporation, et al. Exhibit 1011, p. 859 of 2039
`
`

`

`One advantage of a tuhular braid con.figu.rnt.ion is the possibihty of cr~ ... 1tin.g u
`tuhufa:r valvr: that is eoUapsfok (Fig. 26), Bn:dd.ed tubes can be com;trncted
`
`of foe tlibe, introduced into the en.dnvaseular sr.w.ee in 1ninimruly invasive
`mm.mer, and fa deployml as a targer diam.etz~r strncturr: at the valve
`
`Ai;iparatus ;;md methods Jhr ibrming, inserting and using expandable untl
`
`kchtu:il.ogy t~sefu1 ft:,r crrinting a scaf6)kl. capable r:d'lwving a tedn<x.:d diarneter
`
`during impb.ntation and expm.iding thereafrer am d1sdosed in. cnpendi:ng
`
`PCT/US{J2/40349,
`
`filt'\i December
`
`2002., entitled
`
`"DYNA"fvHC
`
`AJtenmt.i ve_ :3caffokling__ k~chnlques
`
`/\ n-wM nf sca .. ffbld ean be ,:.n.\1\.fd by '"~ t1:icuspid '\c•entric11far" imd "aortic"'
`stm:np (e.g., f1 sHicqni:::--c<)at,-xl ifomhmtn mold). Thenrmplastic St.'.affbkhng
`
`20
`
`ao:rtic toot and valve,
`
`22
`
`Edwards Lifesciences Corporation, et al. Exhibit 1011, p. 860 of 2039
`
`

`

`genernf!y having fae ci:mBgr.trnfo.m n)ade of ,1 sy.nthd:ic material, \'vhid1 is fo.eu
`
`cdJs frm1) extraceUular matrix, the bfodegrad.ahle poiyrner scaffcild st.arts to
`
`10
`
`degrade, The scaffold and the attached cells ltre irnph.nted into tbe body w+uxe
`
`wee.ks),
`
`25
`
`Tbe involnti<Jn valve can he crmstructed frorn a wide nmge of materials, The
`
`repair following maturation of tht) :imphmt in ifa:: '":::ircubtbn,
`
`Edwards Lifesciences Corporation, et al. Exhibit 1011, p. 861 of 2039
`
`

`

`l O
`
`stn.ichitel:l, the method deii<t:dbed in thi~ prnse:nt frrve:ntion enables a t:d-leaflet
`
`lf the va1vt :retains its growth pntentfal, it rnay ht: particularly usefol .fi)r
`puhtKn1k vaJvt:i substitution in tht': Ross pi:ocedure or in pediatric patient~, with
`
`20
`
`Ttu:1 hrvcntio11 may also have app1ictihiHty to non4nedfo,a1 application, The
`mivmi.fage of this design and nwthod hi the p<)knii,tl t() Gn)ate a valve with the
`
`Ci'ln pokmdaily Jhrm a Sf:af an:nn1d an irmer rod or piston- The valve can be
`
`24
`
`Edwards Lifesciences Corporation, et al. Exhibit 1011, p. 862 of 2039
`
`

`

`EXAJvf PLES
`
`:5
`
`10
`
`A:n involuted cyHnder valve constructed frnm pulmonftry artery tissue and
`
`15
`
`m.1d advrntitfa1 hryet was e;.gJefhUy veeied off as a single ~ilwd tif Hssut m1cl
`discarded, The tissue cylinder '>vns indsed. \V:.hh Umx!. h)ngHudlnal. frl.dsiorn;
`
`25
`
`Edwards Lifesciences Corporation, et al. Exhibit 1011, p. 863 of 2039
`
`

`

`,,
`sa.tme,
`
`5
`
`given by direct ostia1 cn.nnulation, Tht ascending: aurta \Vas transverndy
`
`1n.ild aortic
`
`regurgitatkm
`
`:mobility \Vas observed throughout th~ cutdiac cyde in fmrr-cfan.nber
`
`26
`
`Edwards Lifesciences Corporation, et al. Exhibit 1011, p. 864 of 2039
`
`

`

`rounded 1eatfots assumed a ni<):re i:mp<·Hke config11rahrm and e.ihfoited no
`prolapse1 rnvst likely due fo the snspenskin of the leatlefa at aH points afong
`the free-edge, 1t. nw.y also he sig11:ifica:nt that the longitudinal axis of the
`
`Exarnpk 2
`
`15
`
`i\Jaterials< and<Jvfotlmds
`
`A sheet of 4-·ply porcine srnall i.ntestimi.l subtnt.u:;nsa "SIS'" (Cook, foe.) of
`iiimensfrms 68.2 nun long x 20 nnrl 1v1de WHB prepared. '1\vo equidistant 8mm
`
`s(:cured in a perpen.dfoulm~ m,umet to the hlnfi· '.van of th,i cylinder hy '"U"
`
`sutures, 'hvo miditio.na1 ~heet~ uf SJS were stitti:r~xi to dtb.er ~)!1d of the valve,
`
`instituted in a recipknt sheep, Co1d high potasi,dmn crystalioid mm.iiop1egla
`
`Edwards Lifesciences Corporation, et al. Exhibit 1011, p. 865 of 2039
`
`

`

`foe base of the valve -.,:,,,as s:uti:ired tn foe proximal relnnant {lf the pulmonary
`
`trunk ProfornirwrM
`card.k)pulrn onary
`echocardiogrnplw ,vas performed to am.K~ss valve functkn.t
`
`\Vas given antl
`The · animal
`
`{h1:.1
`
`an:in1al
`
`·was
`
`frorn
`""''eam.:d
`fundi011 and
`
`Restilts
`
`no 1n1ln1on:ic regurgitailon on
`:replacernent
`ez~hocardfogrn.phy with continunus-wa:ve Doppler n.sing a hand~held. 1;.ipfoan:liaJ
`probe, The short-mds vie·w· exHbited coa:ptation (if nl1 nm~ katlets during
`vi:ilvl~ dmmre, Syi11me:tricc111eatfot movement and good :n:whility ·was observt~d
`
`5
`
`rn
`
`i\n involution vaive c,)rtstmdix1 .frm:n (k:cellu1arhx.~1 rm.rdne .f:s:n:uin lntestirmJ
`
`15
`
`~uhmucosa frindioned. ~~s a trikaflet puh.m1n.m:y artery replacement h an acute
`,:;heep model. Chronic gtudies ate 1w.(e8sary to ddennine tlK~ ability of the
`sc ... 1ffold tnateda.1
`to e11dofodb1ize and populate ·with mit.ofogzms cidb
`
`20
`
`patients,
`
`construct using the invu!ution:method 1.rn riest~ribed hen::inabove at the surgical
`b}wktable, The valve constrnct fo tested, then rcimplanted into the same patient
`
`28
`
`Edwards Lifesciences Corporation, et al. Exhibit 1011, p. 866 of 2039
`
`

`

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