throbber
.PCT!USO~Vl 4 liiil
`
`!NVOLFT.KD ENHO'VASCtJLA.R VAJ, VJ!'. ANn )W:El'HOD OF
`C'ONSTRVCTlOj~·
`
`5
`
`10
`
`L:5
`
`FJELD Of THE fNVENTION
`
`The prts~11t itrvenfa:.n relates to a pn:.,sthetic valve with nn involutetl stnidnre,.
`·rhe pre-senJ invention ahm rnlates to mdh{ids and nppm:ah1s Jbr c(inRtrncting
`an in voh:rth:m v1th'e,
`
`20 HACKJJROtTND OF THE INVENTION
`
`Sh1C() the imphmt of the :first cardiac vaivnfor prostliesis in tfa .. ~ amttmni.c
`pt)sition in 196{\ n)nre fha:n 50 diHbrtnt c;-mHac valves have hien intrvdtHX~l
`over th(~ last 6x:ty ytxtrs .. Unihrttmatdy, ail:er y1:.~ai:s of developm.enJ of
`n1t-ehm:iical m1d tissue vah's}S th(~re remain signit:kaut probki:ns ,~ssociakid
`\vHh both typt:s of valves.
`
`25
`
`Edwards Lifesciences Corporation, et al. Exhibit 1017, p. 801 of 2319
`
`

`

`PCT/ti SOJ! l 4 l (,{}
`
`l\'iecha.nka1 vaJves are durnbk~
`ln, patients hut 1~{Ju1re long-term anti(cid:173)
`coagnlation therapy. Tissue valve,'> nffor fret'.dorn fron:) anticoagnlatfon therapy
`and the prohlem.s (rf bleedinK hut tend to degt:nerate tapidly, particularly in
`
`or porcine vahres), The p:reservation, sterilizatinn, and fixation processes
`cnn-e:nHy used in tissne valve preparatkm a:re believed to c.ontribnte to the lack
`
`l O Ross procedu.t-z~
`
`R.cJss prn{:ed:ure freeti the patient fro.m anti-
`
`vaJv(~ is a valve (amtk or p:nhnonic) derived from a caduver {"homogn-rfr''}_
`
`-pnlm.o.nary valve \:\'ith a homograft is ass.ociated ,.vith inun1mofogfoa1ly--
`
`lVfonoeusrr Procedure
`
`25 Altenmtivdy, a single fiap nf ifasue from the p1ihm111,try tn:mk has bten used
`to create 11 pulm()H.aty '':mn110<:it~p'" valve in pedfotdc pafo:~nts mi.,kwgoin,.~ the
`Ross prut:ezh,1re. Long"tenn function of the n1onoctt9 valve has yet to be
`
`less et1foient 1:."1osure than a td--leaJld valve. The subopthnal fan.ctimJ of a
`30 mmtocmip VR1ve may adversely impact fong~term resuH:s. It is ~1 drnwback thitt
`
`2
`
`Edwards Lifesciences Corporation, et al. Exhibit 1017, p. 802 of 2319
`
`

`

`WO llJ/092%4
`PCT!USO~V14Hiil
`the tfasne flap is created. The monocusp pn:icedure doe:~ not provide a iotut~t
`
`same individual- In !his px1:)ctidnre, ,i t1ibe of tls:nie 'wa,s htffvestzxl from. tfo:_~
`PliJ•1·,,·,1HJ1"U l""'l1'.lh· .,,vl ·r,,,,.,q,'<f,g·•1r>";{ ir>t,·1 " trifou!l-"t V""'tv" rfl l)r>·f,w t'3 {'»"!«te- «
`
`.):._ .. ~ :t-s._,.,,., .... ~ ... , ....... , ... ~:-. :;..
`
`.. ~ ~ ~., ...
`
`.>i. .. A-.. ,. :,.,:..
`
`-~
`
`'
`
`'
`
`·X --~··
`
`u., ,,. ;.,,_h
`
`.. , ... ,
`
`,, i ~ .. H;.,•>,
`
`"'
`
`•.O:. \,,:~'<,
`
`Q
`
`... ,:. _{•~-
`
`- (:
`
`.,l
`
`,li. ....
`
`insutJidency .fo hvo patient~. The faih.:tre of tliis valve n~pfa.cernl'.mt pmccdure
`resulted,, ln part~ fr<.n.n the extrenw tech:nk:aJ dmUengc for th~ surgem:L fo this
`
`tubular stnwture. This invention is tl nestlng of tubes dependent. on mi,1tip1e
`·rt ,:,; .,
`~ntr1.rz~ Fn"'~ '11' npht,,, tP ·•0111 >'11'~ +uf,q"<:( fri ,~;•~''"1''~ ., v•1·!vt'l,.,r ~•··•"(;''tll>~"
`.r· .•. :...~' ....
`. -· )' --~-'.
`
`:t-l, .,.
`
`.... - -.~ ,;,..•~~
`
`li:,i\,.
`
`',.:} w-..il:. :,W
`
`(,).,
`
`I!,:..
`
`-~lV-,\
`
`-.. ~ ',.i;- (..., ............. ~.{ ·~-_,
`
`....
`
`~:,._
`
`tl.
`
`... , .• ••
`
`~ •
`
`- l.-
`
`.y .. ,
`
`,.
`
`design~ H v{o11hi \v~ inefficient ii.nd diffi.r.u.lt to use this mdhod to reconfigure
`
`Edwards Lifesciences Corporation, et al. Exhibit 1017, p. 803 of 2319
`
`

`

`WO!lJ/092%4
`1:1trncture. to create ii thudkmal thret'-·dimmrnfontll
`
`.PCT!USO~Vl 4 liiil
`
`in a catheter for dq:iJZ1yn1cnt.
`
`'Lhis .is dfathi.guished _frnm othe:r braided
`
`PCT/USQ2/4034~\
`
`filed Decernber 16, 2002, entitled
`
`'"lJYNA?vilC
`
`entirety),
`
`SO~-il\JAR\' OF THE fNVENTION
`
`a prostlwt:tc valve by a technique reforred to inforclumgeably as the '"inv(iluted
`cylirn::.lel' or "invo1utin.n" rnz~thzxL The invofotkm valve may be S::\)l1Structed of
`synthetic, fseru.i-~s11thetic, organk m· hiofogical mak:d,=~J or 111ixtu1~:s or
`cornbbahons thereof The valvs.: is efifoient to con~trnz~t, .n:my be derived .thm1
`
`15
`
`20
`
`Edwards Lifesciences Corporation, et al. Exhibit 1017, p. 804 of 2319
`
`

`

`PCf/USO:J.il .-j l Ml
`The valve rnay be a scafi\lld, 1nufrix., or other stn1cture faat undergoes a
`nwturatinn process of living mitofogmw ct.1H deposition thereon, For the
`purposes of the present dfa.dosu.re, the tenn scaffold wiH be reforreJ to in m1
`1:.,xempla:ry, hut mmexx::.lusive, mmmt:L An exaniple of u poh:\ntially suitih!e
`
`scaffold eou1d provide signaling to cells to organize as an aut<llogom, valve,
`
`JO
`
`renmddlng, ln this nu1nner, frw valve W'iJt1ld, when imphmte<l and the _pstthmt
`
`The present invention provides a rnethod of formi\1g a valve or valve scaffold,
`comprising, in mm exemp.hny embodiment: ( 1) pmv1ding a tubti of material,
`
`15
`
`Aceording1y, it ls <'i Jeati:ire of thti presi:;nt :inved:inn. to provide a vafv~ that ha--;
`mLnhna1 imnnmogenic strnctnr(:\
`
`20
`
`Other foatutes
`
`BRIEF DESCRIPTION OF THE DRA '\\-1NGS
`
`shnihn: parts thrnugbnut the figurns, and in which:
`
`5
`
`Edwards Lifesciences Corporation, et al. Exhibit 1017, p. 805 of 2319
`
`

`

`\VO 03/{!92$5-1
`PCf/USO:J.il-llMl
`Fig. 2 is a cuta:way vfo\V ~howing the involutinn valve hnphl:nted as :~
`
`Fig. 3 Bhows 1natetia1 in a brnkk"d cnn.tlgurntinn.;
`
`Fig. 4 Kho\vs rnatcdal in knitted l:'.OnJigurntio11;
`
`1-.ig, 11 shov-is a persp{l,;)tlve ,,·k~w' ofa ,.}yhrtder ·with thn:; .. ~ equidistm.it indsinrrn
`tn cti.::'.ate 11ups: nr "1ea.fkts";
`
`fig, L2 shows a persped.ive vk~\v of involution of the ffaps inside the cylinder
`to create foa.tkt1:1;
`
`of the mitcnnost ..,,vaU to allov\'· thr t,uhcoronm:y im:phmtatkm a1Ki preservation
`
`6
`
`Edwards Lifesciences Corporation, et al. Exhibit 1017, p. 806 of 2319
`
`

`

`.PCT!USO~Vl 4 liiil
`
`opens under pressure;
`
`5
`
`cuff of material tit either end;
`
`attachment of the im1cr and nutet tu.he by WGaving them together in an
`
`F1g. 22 shmvs .a top view of the itrvoJuHnn y.,ilv,~ depicting e.xces.~ kwtlet
`nuiterial hl the tarl:htl and circ.11.mforentiaJ directiorn.t
`
`Fig, 25 sho\v~ a pernpt~dive vinv of the invoh.ttion valve depkting the <)uter
`
`7
`
`Edwards Lifesciences Corporation, et al. Exhibit 1017, p. 807 of 2319
`
`

`

`PCf/USO:J.il .-j l Ml
`Fig, 26 shotvs a perspedive vfo\v nf the involuHrm vilve as cofbpsibie braid
`depicting tlie abHity of the strncture 1o assunw ,a rtversibk nm-ro\v
`endovagcular insertion profile,
`
`DE:SCRIPT'!.0-N OF THE INVENTION
`
`in.volut:lug ,l tubular structure in.side Hsdf, The pn:sent invention also provides
`
`Jn on~ exemplary mnhodhnent of the present invention an invohit1on valvri is
`.fonnod of synfhdic or pro,:,~essed organic materii.ti. -J1w material cnn he any of
`
`10
`
`set forth hy W<W offllustrntion onl'f and am nut intcnded·to be exchisi.ve,
`
`15
`
`Pdyglycolfo acids (PGA) eiH1 he usd as non•·woven mesh, having higli
`porosity, good cd1 u:Hm::hrnent, good grmvtb and extnwd1uhr mutrix
`it:mnatim1, rapid bhxibsorpti~,n, and hiocrimpaHhilHy, Exm:npfos of n:ia.terfo1s
`include, but are not HmHed to, pdyhydn:JX}'a1kanotes (.PHA or PHO); poly-4.y
`hyd1'l..,xyhutyrate~~ {P4HB) {?HA and P4HB hav1,.~ the properties of efastidty,
`
`P4HB hyhrid in the form of Hli:n PGA coated vvith P4HH it) reduce stltfoess
`
`25
`
`n1etals 1 or nihn0!s (pa.itk:ufady bfodegra<sfabk nlfrnols); n:,ixtur!;;Js and/o:r
`comhinutfons HJtWC(if nn<l tfo.'.'. hke,
`
`Tile v,11ve may ah:,s:i be constnJct~d of poly1neryhascd substance:,,; exm:op1es
`include, but m-e nGt Ji.mrtcd tt\ pnlypn:_ipy'knc, polyester, sffk, nylon, pfastics,
`
`Edwards Lifesciences Corporation, et al. Exhibit 1017, p. 808 of 2319
`
`

`

`polytetrafiunroethy1 enes
`
`(PTFE 1s),
`
`.PCT!USO~Vl 4 liiil
`
`and/ot
`
`eeHs pnpu!affo.g a sctdtbkl). Tht) Hv.ing materfrtl can conti.imuns1y bfffatxl :in,
`fur exRrnpk, ,::ell c\Uture rrn.¾:htt-rn <Jr B:an.k's solution so as to retain ·vfahilHy.
`
`LS
`
`A .. n exatnple of a rk<.xMu1arizatfon. ptr,cess hi in.cuba.tfrm i::rf in t1:yp~b/EDTA\
`frx48 hrs tn extnwt endotJwlfal cdis and :n1ynfibrnh!a,~ts,
`
`20
`
`fa <me exern.pfory enibodimenJ, the scaflbki is de<:}eUuktdzt:d pordn<:.! s.trwH
`1ntestim~J s1ilnnri.cosa wh:h:i1 is reconflgnr.::d iuHJ a \'tdvulaT sin1d1,u·i.:\ impktnted
`
`pufaat:ilc. eel! cu.Hu.re "biQ1\-~actnr'~) <.K inside {he hody (~tg,, {bHowfog
`irnpltmtation), Exposing the ceH--popnlated t.caffn1d to nledian:.kal stresses lws
`
`25
`
`Edwards Lifesciences Corporation, et al. Exhibit 1017, p. 809 of 2319
`
`

`

`.PCT!USO~Vl 4 liiil
`
`Layermg,
`
`e.ndothdh:atio:n period. 111~ty
`the risk i)f thrombus
`frnnwl:iun, Alt~tt1wtiv1/l.y, chemicals, d:n.1gs1 gnrw'th foctow and otht~r agents
`that prmmAe endoth.dization rmd rct-;.trd thrnmbm, fbnnat.ion mny be bound t(J
`the valve material to provl<le hxnl thwipy,
`
`25
`
`Edwards Lifesciences Corporation, et al. Exhibit 1017, p. 810 of 2319
`
`

`

`PCT/ti SOJ! l 4 l (,{}
`during the t:1.rdiac cycle. 1t appears in he advantag,imrn to have fhe v,'11-ve
`
`fmiher in Exan1ple Li\. pu1mn11ic V£tlve suhstHution \Vlth U-w ir.rvnlution wd.ve
`is shown in Fig .. 2 and des.cribed in r.mm.~ detail in Exmnpl.e 2. Th~::: involution
`'\"lhif• n><i·<-r ,,1.,,o lv> "ll1'-t,,A 1·11 n{!·'-"'l.' ''l.'''l\)1-n~,-,,.,1 nos1''"«)11"' ~1'"''1 =>:s ·1},r n~r•1nc("'"'"D'
`.:.~ h.,. -, ... A~,-~:J...t s::-
`>-"'i..l'h,....
`~•~ ..... ~-...~· ... i.
`
`·-:: :..
`
`"" .... .;.::ix. ✓ o.:,,.,._,..
`
`. ......,
`
`.._"i-
`
`"-•U
`
`. . :;.. ,.
`
`. .. ">--
`
`-.:.3..:., .... ,< ,'..),v.;.-...•iA ,;.,t,. ..
`
`i~-~
`
`treat.m~nt for aortic j11,1:mffideney with impfa.ntmfon of rhc Invulntfon valve .in
`the des<.:.cmling aorta.
`
`Non•hom.ogenootts
`
`15
`
`The matedaJ uf the involution vah,,i may also hi::: non-hon:iogenem1s, For
`
`knitted~ o.r 'brafrfod into a sheet or cyEnder};
`
`chan.it,h~rls:tk-~, For exumpk, rib knit may he usz£u1 given its property of
`ebstkity fo its \vidt.h dinx~fo;)n, Jtrsey knit is kmJ.,Yn h:.i bav1:.~ good ·wrinkle
`
`.materials and fabrica:do.n kchnig_lK~s 11my be exploited in light of the anakin) y
`of Hw native humm1 v~dvc t:o rzmstrnct a vu1ve n:~pb(:ement ivith desirnhle
`elasticity, wrinkles, and stn.~ngfa pro·perhes.
`
`30
`
`11
`
`Edwards Lifesciences Corporation, et al. Exhibit 1017, p. 811 of 2319
`
`

`

`.PCT!USO~Vl 4 liiil
`Consider that the histnfogy ofthe hui11an native scn:dlunw: valves i:,1 referred to
`
`5
`
`fibe:n~ \:vhich expand fB:::rpendkuht ti) the cuspal free rnargb (Le, radial
`dir&:'.ifon) m:id imparts a high ;;;s,:nnpliarn:;e (HJ the bafiet in this <lirectk,n, 'The
`
`is ,:l. ptedo:rnimrte load ht.iadng ek~ment, -restrietfog leaflet durl:ng fiUing and
`m1s11 d.istes1tiun Stren.Rth is 1J:roviJ1:.\d bv Qronns of ,:x:iUauen o;.1rds .radiate from
`
`t;-'
`
`....
`
`-~
`
`,J
`
`..... ~
`
`~"'
`
`... ,
`
`. ;'
`·i
`,
`u:np .Hnt~0t1011.
`
`the potential to :morn accun,tely signal the exrracdlnfa:r n:iatdx rnate.tiab a.nd
`
`12
`
`Edwards Lifesciences Corporation, et al. Exhibit 1017, p. 812 of 2319
`
`

`

`.PCT!USO~Vl 4 liiil
`
`t,xtrudcd, The fib~r may he rectanglllar, rntind, o, twisted around itsdf in a
`
`5
`
`sn:u.i.Uer diameter tlbern,
`
`30
`
`nmgf: from approxhnatdy 100---500 mforons, more prefurably in the 100 to 240
`
`1-~
`.,,
`
`Edwards Lifesciences Corporation, et al. Exhibit 1017, p. 813 of 2319
`
`

`

`.PCT(OSO~Vl 4 liiil
`
`,-f"1'1;~ P-·-Jr"'""' ••1 t·i,,,. -.,-,,~1,.,,·bl n•· f},~ ,3ri' ;~-o•1f,_,-i/n•1 nt" "fl:>r_,._-.~ 'l-''-"'"'"''~•~•1 """' T'"lf'~"",'' l«
`.t _,.-..,..: .e~ ...... ;.•t~
`
`i.1, ..
`
`• J,,V' ~•U,-.;,t.,......,,>,>,-W...
`
`,_,,,
`
`:,. •. ,:.~·
`
`·~
`
`·"' ,,~- ·~~._,q .... , .. t, ,.. ~.t'•,~ . ..., . ._.,;i.,;
`
`,,...._.l..\") .... ~Ji..
`
`t.:L,t....,,. d:.b . ._ . ..._~).:t -N9
`
`of
`
`lm1~ely arranged
`
`30
`
`s:xmkl b{:) C(cid:144)Jistru<:t.:.."£1 offoyering .material purposd\d!y mtanged. For exam.pk,
`tb~ top layer (the future info'.>\.V fiurface of valve 1~afiet) m~y be s::01npfomt in
`
`14
`
`Edwards Lifesciences Corporation, et al. Exhibit 1017, p. 814 of 2319
`
`

`

`WO llJ/092%4
`PCT!USO~V14Hiil
`the radial tHrecdo.n and the :mt)si hotfon1 byer cuuld ha:ve ,J di1xx1tinm\iily
`
`:>
`
`Irrve;;.tigntors have exp:rt:i;;:i,,¾J
`;:;11rn.x~m that the use nf laytidng, a1td. m
`particuJe::r1 lmnination of porcine small .lntt5stina1 subrnuco:s,:i., n:my ddurnimJ.te
`imi_pp:top:riatc,ly fo}kr\ving impla:ntatfon" frn,) way to O'Verz.'ome this ,.vzmld bi:: to
`\veave1 knit, 0r 'braid foe J:ni1te-da1 to prevent ddm:ni:nation, A specific exarnple
`
`finnness and sh:-engfo to the materfo1 and pn~v-ents slippage aud tlispfo.cen:ient
`
`number of ti:X~hnique::; ktHJ\Vn to thost~ s:kHled in the art m1d ap_proprbt(• to the
`materlil beit1g used, such iis, hut rmt hmih:{J to, wea\.'lng~ intedaeh:tg, braiding,
`
`W\1V'(>,f1, or braided Jh:n11 strands of ma:h.~rhc.iL /t tuhular {rr cyGn<.lrkill stn.1tturn
`ca:n he cn},1td by sleevfog t<:.~chn.iques using brnfr:ling, knitting, ivt'Jl.Ving nr
`combiimtkin of these :i:nethods, The i:<tructure t~an ·bt: n prn_per i:yibdc,r (tho
`term cylinder and tube being used 1nk:rchangeably fo the prs.:sent discfosntc) <.)r
`
`25
`
`15
`
`Edwards Lifesciences Corporation, et al. Exhibit 1017, p. 815 of 2319
`
`

`

`.PCT!USO~Vl 4 liiil
`
`Involution
`
`<.)rfated prior to irrnertinn., H <«111 hi:l h}Sttxl prior to use and the vaJ:vf\ fi.mcfarn is
`twt wholly· dependent on m1rgicaJ hnµfonhitkm techniques,
`
`20
`
`to sinotubular junction dishmce ver~es iinrmht':I dimnz~ter in s.u1w patknt~ .Lt.!.,
`hdght of <.\):n:rtnism:.u,es is apprnxinw.tdy half the amnihrn: dfa.rnefoL
`'fhz~
`tnaterfoJ ha~ a thickm.\ss "'t",
`
`16
`
`Edwards Lifesciences Corporation, et al. Exhibit 1017, p. 816 of 2319
`
`

`

`.PCT!USO~Vl 4 liiil
`and frrn m1termost ,vaU hccnmt.~.s the sht nt' ,,ttadunent to the im:phmtatkm sik.
`The leafiets are setttred to the inner sltle of thr <)11tennost 'Wtill (Fig, 13). If the
`
`fbp1, fo be m.1.si1y invofoted and s(~iured to the hmer \Vall (_rf the cylinder,
`A1th,mgh, the ini:_:faions: are not 1:11::.~e,-;sa.ry, ff.wy all{J\Y eadt ffap to he s,x:ur(~d to
`
`(Fig, 15}-
`
`In mmfoe.r e1nboditn.ent, a hwided tube is in:volutcd inside ifae,Jf a:nd foe inner
`
`tltw to the :fotce~ created hv th(~ hrvolu.tion ofth1:.'. hraided t1.ibefF:i 0 , 16)_,.
`
`\
`
`0
`
`V
`
`H}
`
`20
`
`t1ibi:1 (Fig. 17}, ln the prnvkms .. Hsf-ll"!Sion of th0 present invt~ntlzm, the
`outtinrmst tube is fohfod int,ide. itself In this cnnfo.{tn·ation, there can cxfat an
`
`-
`
`'
`
`......
`
`Edwards Lifesciences Corporation, et al. Exhibit 1017, p. 817 of 2319
`
`

`

`\VO 03/{!9255-1
`Atttu:-J.1mi;mt
`
`PCf/USO:J.il-llMl
`
`previ(cid:144)usly), Other techniques of attaching the 1nm~r t.o the otit,::ir ·waU of the
`valve hidude, btit a:re not btdk:d tt\ i11terhcing, intednckfog, sfaplll\g,
`
`5
`
`c:omhinatkms thereof and the like,
`
`15
`
`/\. mathematica.! stress analysis nf the fovoluiion valve cotmtrncted of hmrrnu
`blond vi;:i;.tid~ indicated that m1 m:ta of high stress v.'ouid octur in a disc.rek~
`area. at ea.z:h com1uissu:re {att.:K:b1nent area of the in:ner lea±letS to the mrtem1nst
`
`25
`
`vi!ve.
`
`Intedeafkt _T'tfaim.lM
`
`e-reatcd b_y the angled attachment of the each le1lHet !\) the 1,vaU. ln the 1Jresent
`invention, an amdogous stn1di:.1rc can be in1posed in t11e invofotion niJve by
`
`30
`
`Edwards Lifesciences Corporation, et al. Exhibit 1017, p. 818 of 2319
`
`

`

`\VO 03/{!92$5-1
`PCf/USO:J.il-llMl
`constmct This can he crea:hx1 by interlocking n:r iuterl.a\..ing the 111a.t~~,dsJ \vith
`,vcaving, braidh:lg or knitting techniques (Fig, 20),
`
`·i,, .q,,, ""'lt·1'v,, }1' 1!''""') '""'1·11'l<1•'1•:q· ,.•,il\,P·~· t1w> ·=-nni:1u~' n~,1·><)1'1·•·~·.-,,- ''')'""f<!"l''i ,,ir,,1,~
`,,.....,·.s.
`. .. ,.. ~ u....i
`\.:X). {~b. 1,.v..s..J v..._ i
`
`.{.\ S.d.,., L(.}_,o;_._.
`
`, ~ .
`
`. 11.,U >....b-Ut ...
`
`•x,d.. ~c»
`
`,..;:.),~' ~ ....... ~.;1..,. •~
`
`....
`
`U..S.. V,->......,
`
`..._..
`
`to the vva11 or sinus) during the t~ardfac cycle, During diastnh\ tht~ a1muhls
`
`sinctulm.far junction incR.1ases dimrwter. This motion may he important ±cir
`i O valve 1ong,?vhy and the shming of stn.-~~s beh:-veen the foaHct m1d \.Vn11 chlri.ng
`the cyde. foserting inteds~afiet triangles into Hie involution valve constnwt
`
`(~;:instruct inter1eatfot triangles nury pc:nnit indepenck:11t rnove:ment of leaflets
`
`sutures to rdleve the point stress at the foatlet comrnis:rnre!:1, Angling. of tht~
`
`Sinuses
`
`is kno\vn to incn::'-,t'>e tbc effidem~y of valve function by providing an eddy
`cvrrent of cfrcufating hlood W'hich :foncfa.ms, in part, fo n1aintain the separn:tfon
`<Yf the katl(~t from the wall d:m:in.g foe opening of the valvt:'.,
`
`In the present invt)ntkm, the ont.ernmst \iiaH of th~ invoh1ted cy·1inder vo:{ve
`;:;onstruct cHn bt:: pu11msd\1Uy enfarged at lhe base of the valve to nx;;retlte a
`
`19
`
`Edwards Lifesciences Corporation, et al. Exhibit 1017, p. 819 of 2319
`
`

`

`·
`
`·
`
`·?• '
`
`PCf/USO:J.il .-j l Ml
`±'
`1
`·1
`· '1
`'l
`'I' 1
`t mt i:i.ie outen:nost wan JS a arger t lfH"neter tti;u1 tn.c mne-nno~t \;<,'al \~yrml'. er, .,J:
`T. ,,
`the 8hui.ing material is a tube~ one \-vay to achieve this is to use a conica'l shape
`oft'b:: nmte:riaI sm:Ji that trH:.1 s:mdler diameter of the cnne wiU be ir.rvduted into
`the b.rger di,1J11eter of the comi,
`
`•·!,._
`
`.,
`
`,
`
`5
`
`In mo.r<.:) complicated :methods of forming an involution vt1tve, such as
`,veaving, the s.in11&es can he integrated intn foe final geometry by crea.iing
`
`technique,-:; of ·weaving~ knitting, and braiding ;::an form pouches, pnckets,
`
`:Sc,i11oping tn preserve a potential spm::e (the native Sinus of \\dsa1va) to exist
`between the leaflet and the mrtive ai.rrHc wail (Fig, 21),
`
`As desc.dbed previously,
`
`tht) native
`
`l:.n.unan semib:nar va!.ve
`
`leai'k~t
`
`direction which in.rptirt :dgn:ifkant C(.)ITlpl:b:n.c.e in this orit':mtafa)n, fo the
`drcnnifo:rentlai direction~ fhe fihrosa layer has a crhn_plng c~f co1fagwi that
`provides a count\wforc(" to overexten::;ion of Uie teufid during d1e perfod of
`nl(lfe extreme 1omiing-bmm.n.g (dfost.oJe). fo order to n:ion.~ cfo::K~1y tnodd foe
`
`present invention m.a.y be constructed ,vith excess material ln the leaflet in the
`
`,. , 1
`l
`. •
`,
`J
`, ,,
`.. ,
`,
`t
`m.arena.t or _pouc,ies cour..1 )e p m·'1.ln1 ounng va1.'-le c<.mstrw::non, pa11lCl..HUt y :rt
`
`.
`
`.,
`
`..•
`
`. •
`
`·i
`
`dire,:.:tion (Fig, 23}
`
`20
`
`Edwards Lifesciences Corporation, et al. Exhibit 1017, p. 820 of 2319
`
`

`

`PCf/USO:J.il .-j l Ml
`other). Such nlt1;..•:rnntive ~hape of kaJJei:s include si.'.'al1opi11g or rotm.diug off tk.~
`
`fonnadon .nf a. 6.mtrnl rmdufo by ournoseth11v impartiu1.~ a 1K.ide shane at the
`
`..
`
`·"-
`
`:,._
`
`...
`
`...
`
`......
`
`·t
`
`5
`
`anatomy and help v,1lve .fl.mctkm.
`
`\Vith a rigid or se1ni~dgid fbmc ("ste-nt.") to cre:;1te a valve. The stent can
`
`10
`
`in1.phmtation. In another ernhodirrwnt, a sheet of '>'<'oven porcine (or other
`
`St(m1 (fig. 24).
`
`15
`
`imd nmteriaJs is odentated such that .foHo-wing hnpla:ntation, the nKist viable
`
`21
`
`Edwards Lifesciences Corporation, et al. Exhibit 1017, p. 821 of 2319
`
`

`

`PCf/USO:J.il .-j l Ml
`One advm1.tage of a ll,hular braid configurnt.ion is the possibility of c1~,;-1tin.g u
`tubub:r V<~lvr: that is colfapsfoJe (Fig. 26), Braided tubes can be con~trncted
`
`5
`
`f('.duced iu <.fomwter by ex1:.:r.ting a longitudinal tbn::e hy tt trocar on the inside
`of foe tuhe, introduced into the endovascuhir spac.e in n1idmruly invasive
`maimer, and fa deployed as a hrrger dian1etz~r structurt: at the valve
`
`Apparatus: ;;md methods fhr ibrming, inserting and using
`
`' H!1G
`
`PCT/US{J2/40349,
`
`fikxi December
`
`2002.,
`
`entitled
`
`"DYNA.Tvnc
`
`15
`
`CANNUL/\.'1
`
`..
`
`A mo.id nf tK'-aJfdd can be ct1~ahx1 by "~ t1fotrnpid '\c•entrict.)1ar" and "aortic"'
`stamp (e.g., ri sHicqni:::--c<)ak:d ah..,mh.rmn mold).. Themmp1astic st.\1.ffdding
`
`20
`
`ao:rtk toot and valve ..
`
`Cornputer-aided rnok:'.c.nhr deposition of scaUbld material rmtenti.ally he used
`
`zweate a valve ..
`
`22
`
`Edwards Lifesciences Corporation, et al. Exhibit 1017, p. 822 of 2319
`
`

`

`l
`,.f"
`.
`,
`,
`1 tit~ present. :mvention u .so
`
`PCf/USO:J.il .-j l Ml
`
`stnu::ti ... n-e of a heart vaJve, The ceHs are atiadH.'.d to the s~ailbld while keeping
`
`cdJs frm1) extracellular matrix, the biodegnd.ahle p-olyrner scaffold st.arts to
`
`10
`
`degrade, The scaffold and the attached cells are imphmted into tbe body wh&Te
`
`wee.ks),
`
`25
`
`The involnti<.m valve can he <xmslructed frorn a wide n.mge of materials, The
`
`Edwards Lifesciences Corporation, et al. Exhibit 1017, p. 823 of 2319
`
`

`

`.PCT!USO~Vl 4 liiil
`
`1f the va1vt retains its gro',Nlh pntentfa1, it may h,1 particularly useful .fix·
`pu1n:Kn1k valve st1hstitution in tlw Ross ptot:'.edure or in pediatric pahenfa with
`
`20
`
`·-.iq
`.,._. ~-·
`
`construcuxJ fr<:.lt:n a wide .range of materials, The ,,·alvt~ fa potentfoUy .;i:ffk:font
`
`24
`
`Edwards Lifesciences Corporation, et al. Exhibit 1017, p. 824 of 2319
`
`

`

`.PCT!USO~Vl 4 liiil
`
`EXAtvf PLES
`
`:5
`
`10 An involuted cyHnder valve constructed frnrn pul.nKn:tfu-y artery tissue and
`
`15
`
`rec.ipietrt t~nrtic annnhw diru:neter (1:nrn), h '" tissue cyhnd(~\' height (1nn1) 1 ::ind d
`= tisstH.~ cylinder diamder (mm). Exct'SS fatt •.v~~s trimmed from the s_pecitnen
`,1nd adventitfal hryet wus c:,gJefhUy veded off as a single ~ihed nf tissue and
`discarded, The tissue cylinder '>Yns indsed vr.ith thrtX! hJngituclhial. incisiorn;
`
`thickness (rmn} (see fig. 1).
`
`25
`
`flaps \Vern involut.ed jnto the tissue cytimfor and suJnred to the cylinder ,vaU at
`
`in:ipfantaiion of the valve in:fodor to the coromuy arteries (see 'Pig. 4), ln an
`
`25
`
`Edwards Lifesciences Corporation, et al. Exhibit 1017, p. 825 of 2319
`
`

`

`,,
`sa.tmt\
`
`.PCT!USO~Vl 4 liiil
`
`5
`
`given by direct ostbJ cn.nnubtion, The ascending: aorta \Vas transverndy
`
`tnobiUt:y 'Was observed throughout the c;.wrliac cycle in frnrr-chm.nber apk'-<-11
`
`n1c.ithmi und itnphrn:tt.~1 into foe sub{xn-on1:H}' poshinn h1 1bur sheep, Jn he\'\:)
`C<.)n,:;irncts the .ka±lets \Ven:1 modifaxl, Ctfuting cuncave lea11et free-e(Jgt~s .. The
`
`30
`
`-::~onstrm:,ts the <.";{;:ntrn1 wgkm of the katfots was not support<:x1 ad<:-.YJUatdy
`\\=hkh retrnlted in leatJet prdapse under diastolic lowL The constructs without
`
`26
`
`Edwards Lifesciences Corporation, et al. Exhibit 1017, p. 826 of 2319
`
`

`

`rounded :leaflets assumed a more cup<•like config11rahrm and e.ihlbited no
`
`the :frr.e-edge, It nw.y also be sig11ifica:nt that the longitudinal axis of the
`pu.lmonary artery wal1 beco1n.es the radfal mds of th;": vaJw:i ka.Het Incni,:sed
`ext~nsibifay of the kafait in tfa~ rad:ial direction rn::ry a.ct tD 1e.ssen the central
`
`5
`
`Exmrrple 2
`
`The involufam method described above is used to form a f11nctiomil t.lu;ec-
`
`0:mstm;;::ted of Pnrdne Sm.an Intestinal Su:brnncosa
`
`15
`
`i\Jaterials< and<Jvfothods
`
`A sheet of 4,-p]y porcint~ srnall i.ntestin,J.l subtrmcusa "SIS'" (Cm)k, foe.) of
`iiimern~ions 68.2 mm long x 20 nnn wide was prepared. Tvvo equidistant 8mn1
`
`20
`
`svith the filnor.,t:her smf,1ce on the inside., A cy'limkr v.;as ibrnwd hy suturing
`
`st--cun:.~ in a perpen.cHcnlm~ m,umei- to the kn,,r wan of th.ti cylinder hy '"U"
`m.1tures, 'hvo miditimm1 sheet~ of SJS were s1-ini:n:xi to dthtr <:)Ud of foe valve,
`
`instituted in a rec.ipitn:t sheep, Cokl high potassimn cry.'sfalioid mm:liop1egla
`
`Edwards Lifesciences Corporation, et al. Exhibit 1017, p. 827 of 2319
`
`

`

`V,iO OJiH925~-.1
`PCliUSHJ/1-llM!
`rtw superior aspt¾it to the distil pnlmonary trunk using 5--0 prolene, The c:trff trt.
`the base of the valve \'\'as s:utured tn foe proximal re1nnant of the pulmonary
`trunk Protorr.1ine1M
`\Vas given an<l {he an:inml
`·was
`\'>lenm.:d
`from
`cardfopulrnonary by_pass~ The · m:iimal
`function and
`ethocard:iogrnphy ,vas perfon:ned to ass.t:ss valve function.
`
`5
`
`Results
`
`1 '\
`ii)
`
`i-
`
`'J'l
`
`<
`
`'
`
`•
`
`.
`
`' • t '
`
`'
`
`:replacernent
`no 1n1ln1on:i c regurgitation
`ez~hocardiogrn.phy with eontinurn.:is-wave Doppkr wring a hand~held 1c.ipfo~n:liaJ
`l1
`. 1 '
`·i
`prnl)e, ·_ ne snort-mas vww· ex.nw1terl toa:ptatmn of n. hm~ eHtiets ( nnng
`va"lve dmmre, Sym:metr:kc111eatfot movement and good :mobility 'Nas observt:d
`throughout the cardiac cyde in fom·~chambe:r ,1pical viev.-,
`
`.
`
`.
`
`. '
`
`l
`
`·::i
`
`15
`
`suhmucosa furu:-:tioned as a triieafk:t puimrm.ary artery replacement b an acute
`sheep tnodd. Chronic studies ate l\\.%.'.e~sary to determine th~ ability of the
`
`1< '.>'1,~- t' •'") 1 i'1.~·11t
`f(),_1 J ., ~5;_,.~ "t
`v!:,:ti,,h.l£; 1'.t)l\ a,,,a 1vl.
`,.,. i
`
`• ,..,.
`
`"'.
`
`l . lr 1-,.t..:> ... ~ ..... ::-.
`,le .. t' ( ~\,dl11,t.t.-
`
`·'t~~
`-~ :-.: •:>,,+~- ~"'' .< w,
`l ~ t,!)~-,U.:c,.t~S<'!
`
`• ... ~
`l,_\
`
`0., \Ue V«J<'t,
`{._.. ~-t}
`~)~ f-.:: ... -c-<;
`patients,
`
`20
`
`1 .....
`K.:.xu:mp e J
`
`l'J
`
`/\. sheet of the patient"s pericardium is harvested and. fm:n:wd into a vaive
`construd using the inv:o!ution:mdhod m'\ dest~ribed herd11above ut the surgical
`b.~wktable, The vulvz~ const.rnct fo tested, then rcim-planfod into foe same patient
`
`28
`
`Edwards Lifesciences Corporation, et al. Exhibit 1017, p. 828 of 2319
`
`

`

`WO!lJ/092%4
`J::.xm::npk~ 4
`
`Formafam of Seaffoid
`
`.PCT!USO~Vl 4 liiil
`
`.A.n umi{oVt:'.n polyglyc.ci1k acid ("PG.A'') mesh s.h~1t 24 rn111 x 75 mm and LS
`'~"'" tl,L·,Jt 1·~ !W''"l'''''''d .,~-"<1 <'q1h·>·4 ·1·i~to •:> ,,~,1hi}:>r ')''hr~<~ ;::q··,11'dlf.lt,P~t fomi;h.1diJrn}
`,.,u~,~ i·,;...;.t;.,,:u
`.. , J,:O.,;.\,,.t ~it......
`..,.,J
`..... ~'! i. ~ ....... ,.;,._ .
`
`..1:. ~·
`
`...........
`
`"'
`
`\,
`
`~...-
`
`:;.. ~"'
`
`.
`
`.{S..~-->.~.~
`
`~>,-!),,,,..,~
`
`... ,
`
`. W-
`
`Exarnp1e5
`
`10
`
`rotating, pulsatih:\ or conti.num:is flmv hinreactor .for a pedod of thne (e.g,, 4
`
`and temporarily irnphmkd in the body (e:ndovuscnbr or other site) to allow
`
`29
`
`Edwards Lifesciences Corporation, et al. Exhibit 1017, p. 829 of 2319
`
`

`

`PCf/USO:J.il-llMl
`\VO 03/{!92$5-1
`1i wiH he UtH.k1rntood. that t.he tenns "a'; and ''an" as used h(~'dn a:rn not
`intended to mean n.n1y ·\)we," but .may ahw :nxian a nurnber greater than "one,"
`All patents~ applic<.1hom, and puhEcations referred tD herd.11 are hereby
`inc()tporated by rderenct~ in thefr entirety, While the inventfon has brn~n
`
`the sc.o_pe of t.he hrventiort to !l1e partic:ular forros set forth, hul. 011 111e
`to eover such alte:cnativ,:s, mm:!itkati,,ns, and
`contrary, it is
`intended
`equivalents as may he inducled within the true spmt and scope of du.~
`invention as defined by the appended 1Jai1ns,
`
`30
`
`Edwards Lifesciences Corporation, et al. Exhibit 1017, p. 830 of 2319
`
`

`

`CL.Af~{S
`
`PCf/USO:J.il .-j l Ml
`
`CLA1Ml3D IS:
`
`L A 1nct1Hx1 ofthnning a prosthetic. valvl\ conrprising:
`
`a, providing a tobe of material having un .inner \vul1, an outer wal1, a
`
`b. cutting three 1ongitudirn.,J incisinns from one end in said rnakrial about
`
`edge, a second edgf generally paraUel to said fast edge, u:nd a bottorn
`
`edge;
`
`d. attaching each said fir::;t edge and second edge of each involut.d flap to
`said inn.1:.ir wall of said. tube,
`
`2. The .method of Claim 1, V-ilwrdn said three km.gihK1in<d incisions have a
`length "L", such that i"">'z.h--2ti \'Vh~1\~ «11°' is the cylinder height and '"t" is
`ihe thickness of said tub.:.\
`
`15
`
`3, The method of Claim .1, \Vherdn said hdght '"h;' is <lpproxirnately equa1 to
`••
`' '
`f'·<
`ti1e d.rnmetcr o _ tne recipient ao:rnc m:mlhUS uum.ietet "1-i.. · · •.
`.
`''
`'1
`
`"l·'<
`
`l
`
`1'
`
`4. The method of Claim 1, ,vherein the edges of each fiap an.1 cvt. in be
`munded off along their free dgt~ tn create concave sh.aped let1i1~ts,
`
`20
`
`5, The method of Cla.hn 1~ ,vhernin scallop shaped ,-.eg.i.1w.nts of said tub~ ,van
`
`6, The rnethod of Claim. 1, wherein said atta,::tbfog is ad1k'vcd 'by suturing,
`
`7, The :mefood of -C.foim 1~ w'hereh:1 said tube is tX}mpdses a generally
`
`v,:i.lve, co1.npri~.ing:
`
`31
`
`Edwards Lifesciences Corporation, et al. Exhibit 1017, p. 831 of 2319
`
`

`

`WO 03/H91554
`9. A.11 <ti 1hl1"<l\'<'!'11~ v-~Ive "hrn:1ed h•t p l1l'i_)•'~"SS cnr"t)f<~1·r,,,,
`,._,., ,..{5~
`<<-- \
`'-•~ ---•.;::·-,.:.·-,-....:•
`,;. •.•~
`.... •·
`
`1 . • •·
`
`,.
`
`\.,"'l
`
`❖ .{··
`
`,....,...._._,
`
`,
`
`~- >-~x·
`
`a. p.rovidin.g a tub(~ of .rnate:dd having .an inner wall, an outer waU, a
`
`b.
`
`(~utting rl:n:-et~ kmgitmlina1 irn:::isiorrn froi.n one end in said 1rmtexia1 about
`120 degrees apart to fom1 three flaps, each said .flap having a first
`
`5
`
`edge;
`
`d, atfaching each said first et'ige and secrmd t'.!dge of each lnvolut(xi flap to
`
`diameter "a", a height "b'• and a \Vall thicknt'.$S 'i'';
`
`15
`
`120 degrees a1-mrt to frmn thrne tb_ps, e;:tch suid flap having a first
`
`edge;
`
`:invo1uting e,ad1 said Hap \Vithin said tnbt; and,
`
`d. attaching each said firnt edge and sewnd \...>t:lge of each involuted Hap tu
`
`32
`
`Edwards Lifesciences Corporation, et al. Exhibit 1017, p. 832 of 2319
`
`

`

`b, a pluraHty of leaflets frmm::d frorn a portion o.f said fi.rnt end by making
`
`and :ai;;cond edge nf each fiap to said in.nerwaH of said tube
`
`33
`
`Edwards Lifesciences Corporation, et al. Exhibit 1017, p. 833 of 2319
`
`

`

`Wi) GOARISS 4
`
`POVUSOa/1Shed
`
`
`
`EdwardsLifesciences Corporation,et al. Exhibit 1017, p. 834 of 2319
`
`Edwards Lifesciences Corporation, et al. Exhibit 1017, p. 834 of 2319
`
`

`

`Wi) GOARISS 4
`
`POVUSOa/1Shed
`
`a
`
`EdwardsLifesciences Corporation,et al. Exhibit 1017, p. 835 of 2319
`
`Edwards Lifesciences Corporation, et al. Exhibit 1017, p. 835 of 2319
`
`

`

`PCf/USO:J.il .-j l Ml
`
`FIG .. 3
`
`Edwards Lifesciences Corporation, et al. Exhibit 1017, p. 836 of 2319
`
`

`

`FIG.,4
`
`Edwards Lifesciences Corporation, et al. Exhibit 1017, p. 837 of 2319
`
`

`

`Wi) GOARISS 4
`
`POVUSOa/1Shed
`
`
`
`FIG. 5
`
`EdwardsLifesciences Corporation,et al. Exhibit 1017, p. 838 of 2319
`
`Edwards Lifesciences Corporation, et al. Exhibit 1017, p. 838 of 2319
`
`

`

`Wi) GOARISS 4
`
`POVUSOa/1Shed
`
`
`
`FIG. 6
`
`EdwardsLifesciences Corporation,et al. Exhibit 1017, p. 839 of 2319
`
`Edwards Lifesciences Corporation, et al. Exhibit 1017, p. 839 of 2319
`
`

`

`Wi) GOARISS 4
`
`POVUSOa/1Shed
`
`X
`
`i
`
`FIG,7
`
`(!) -
`
`u..
`
`EdwardsLifesciences Corporation,et al. Exhibit 1017, p. 840 of 2319
`
`Edwards Lifesciences Corporation, et al. Exhibit 1017, p. 840 of 2319
`
`

`

`FIG~ 8
`
`Edwards Lifesciences Corporation, et al. Exhibit 1017, p. 841 of 2319
`
`

`

`WO GANISS
`
`POVIUSOS Tot
`
`
`
`
`i Hy
`
`r
`
`FIG.9
`
`EdwardsLifesciences Corporation,et al. Exhibit 1017, p. 842 of 2319
`
`Edwards Lifesciences Corporation, et al. Exhibit 1017, p. 842 of 2319
`
`

`

`Wi) GOARISS 4
`
`POVUSOa/1Shed
`
`
`
`FIG.10
`
`i
`
`
`EdwardsLifesciences Corporation,et al. Exhibit 1017, p. 843 of 2319
`
`Edwards Lifesciences Corporation, et al. Exhibit 1017, p. 843 of 2319
`
`

`

`FIG~ 11
`
`Edwards Lifesciences Corporation, et al. Exhibit 1017, p. 844 of 2319
`
`

`

`FIG~ 12
`
`Edwards Lifesciences Corporation, et al. Exhibit 1017, p. 845 of 2319
`
`

`

`FIG~ 13
`
`Edwards Lifesciences Corporation, et al. Exhibit 1017, p. 846 of 2319
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`Edwards Lifesciences Corporation, et al. Exhibit 1017, p. 847 of 2319
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`Edwards Lifesciences Corporation, et al. Exhibit 1017, p. 848 of 2319
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`EdwardsLifesciences Corporation,et al. Exhibit 1017, p. 849 of 2319
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`Edwards Lifesciences Corporation, et al. Exhibit 1017, p. 849 of 2319
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`Edwards Lifesciences Corporation, et al. Exhibit 1017, p. 850 of 2319
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`Edwards Lifesciences Corporation, et al. Exhibit 1017, p. 851 of 2319
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`Edwards Lifesciences Corporation, et al. Exhibit 1017, p. 852 of 2319
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`FIG. 20
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`Edwards Lifesciences Corporation, et al. Exhibit 1017, p. 853 of 2319
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`EdwardsLifesciences Corporation,et al. Exhibit 1017, p. 854 of 2319
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`Edwards Lifesciences Corporation, et al. Exhibit 1017, p. 854 of 2319
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`Edwards Lifesciences Corporation, et al. Exhibit 1017, p. 855 of 2319
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`EdwardsLifesciences Corporation,et al. Exhibit 1017, p. 856 of 2319
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`Edwards Lifesciences Corporation, et al. Exhibit 1017, p. 856 of 2319
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`Edwards Lifesciences Corporation, et al. Exhibit 1017, p. 857 of 2319
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`Edwards Lifesciences Corporation, et al. Exhibit 1017, p. 858 of 2319
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