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`111111111111 l;IIIIIIIIII Ill lllllll llllllll llllll 1111111111111:!llllll llll:11 llllllllllll lllllllllll lllllllllll'l lllllll 11111111111111111111
`US005713950A
`[ll] I1'ail:1E~l[l1il: Nillll[lllltlier::
`Dat1E~ of Pa1tent ::
`[45Ji
`
`·1r1·11·11"1·1t·1c1•1(ll 1'•'11l~'1ll 11· [lit,"
`. l. ,'I,•
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`L. •
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`]l:Ji,,,,111· 1-•]1r11·lt·
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`[19]1
`
`[54]
`
`MlETJUIOlD OF litlEC,PLACl[NG lll[KART '\IAll)i'lECS
`USING FLU:ll:Um.JfC '11'1Jl11IECS
`
`[76]
`
`Inventor:
`
`J:emu:s: I[,. Cox, 7 Dro:mara Rd.,. La1due,,
`Mo .. 63Jl24
`
`[21]
`
`Appl. No.:: 4:!i!►,in!I
`
`[22]
`
`Pilled:
`
`RelJllll1edl l[J.S .. A1i1p,JLiic:111tio1[1 lD11J:11
`
`Dii·1(is:iim1 of S,:r. No. 1-l<:i,.938, Nov. L, ll993,. Pat. No.
`:s;,480,4:!4.
`bit Cl.6
`......................................................................... A 1filllF '.U24
`U.S.. Cl ........................................... ,1,2:ln; 623/'l; 623/66::
`623/900; 623/901; 435/238
`.............................. 62111., 2., 66, 900.,
`623/901; 435/238
`
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`
`lf62]
`
`1[51]
`1[52]
`
`1[58]
`
`1[56]
`
`U.S. lE!ll:l'ENT DOCUMENTS
`
`3,966,4()]1
`4,10!:,16ll
`4;2lll ,32'.i
`4,470,]57
`4;~•I2,47ll
`4,6(H,7llll
`4,801,299
`4,83!1,Wll
`4,960,424
`5,031,762
`5,163,955
`5,344,442
`5,460,962
`5,S00,015
`
`6.11976 Hllll()OC:k c:t :aL .................................. 1523/2:
`8/I97l! S:mm1i1ells ell :ii. .......................... 206/43l! X
`7.lll9ll0 Wli:1Jbt1t
`.............................................. 20151'4:3::1:
`9.lll9ll4 Lov•e ......................................................... 1523/2:
`4lll9ll5 Kas1bE,1r et :aul.
`................................ 2061'43:!:
`7/ll9ll6 P,cmris d al. .................................... 6:13/1
`llll9ll9 Brendel ,e11 :ii. ................................. 6:13/l
`6/ll9l!9 W1i:gJbt1t et :1L ............................... 134/llO
`l0/ll990 Gmotern ................................................. 6(13/l!
`7lll99ll Hc:ac:ox .............................................. 2061':2:IO
`llllll992 Love: 1:t :aL ...................................... 6:13/l!
`9.lll994 Deac ........................................................... 15:13/l!
`10lll995 Kcmip .................................................. 435n38
`3/ll996 Dc:ac ............................................................. 151.13/21
`
`FOREIGN lP11:rENT' DOCUMENTS:
`
`OZ76975
`0Sllll233
`
`611988 E1uopmm P:1t. Off ....................... 15(13/Z
`Ull994 E1uopmm P:it. Off. ........ ............... 15(13/,i
`
`Ol['H[ER PUlEllU[C/l,l[1[0NS
`
`·wheallley, D ... , ·''l,'.aLlve 1=1ros1lt1eses.," pp .. 415--422 :in Rob ,&
`S1m':il1 's q11a1i1\ivc: S1u15i,i,t)~ Yo!. 7 (]ramciieson & s:1tmnway,
`eds., M[oshy--:1:11111te1wcmth,. St. Louis, l.986)1 ..
`
`Roe,. B .. B .. , "Extinct Cardliac '\i11lve Flrostheses," pp. 307••J32
`:in Rciplacement Ca.ri,r,iac ·11.c1lves (Bodnar and I<l:ater., eds.,.
`Pergamon 1i1ress, New "lfoirk, 1991).
`Love, C .. S. a1□1d Love,, J.'W., "The aulbogenous: ltissue he,airt
`valve: Cmn:nt Sta1us:.,"'' J. GniUac S1u11e·irJ' 6:: 499---507 ..
`Mlicldeborough, L .. L .. , et al., "A si:mpllil11ed conc1::i11t for a
`bilie.alllet alirioveutdcular valve Utat: :m.,a□in1aius iumu.lm0•-p,aip-(cid:173)
`:i!Laary muscle co1□11tinuity,,"'' J. Car1liiac Sw15~1:1'.)' 4: 58·-·68
`(1989).
`]l:ail1::y, C.I''.,. ,,:1t al.. ""Use of aulbologou:s tissues frt mitral v,,(1111::
`:reconstmct:iion,.'·'' G1i·da.t1'.ics 25:: 119-·129 (1970),.
`Da11id, T.E.,. et: :,(l, "·'Aortic vaJlve rnpllacement wiilll1 :stentles:s
`porcine ,fortic valv1:: bio][►ro:sth1::sis,." J .. Zl\ioraclc CtmUovasc.
`S1ug. 99: ll3--•lll8 (1990).
`
`Prima,ry Emmh1e1•---,John G .. W'eilss
`.Assf.s·1\m1t Exam,i,1,:1"••-Fran,[:.is K. Cud.1lLllhy
`.Auom1,e_)1, Agent, or Finn>•·-;Boyd D. Cm:;; Patrick D. Kellly
`
`[57]i
`
`Alll81DIACT
`
`Tttis inve111tio1□1 c011orpliise:s . .ai :me1thod of using tubull:air mateJiall
`to replace a heact vaJlve during ,::mliiac surgei:y. 'l[b create .ai
`:n::p.lacement a1rioven1ricular (miitr:aul OJ 1tdc11sp:[d) v:allve., the
`tult►e iukt is sutured to a valve :amnulus from wlttich the native
`kaJclets h:aive been n::m.oved .. , and the tube outlet .is su1ured to
`pap:ilh□ry rnu1scll,,::s 1[11 1fa: ventricle.. 'J[b create a semilunar
`(m1mtic or p1u(lmonary) v,aLlve,, the tube i1□fot: is s:utwred. to an
`1m1□1ulus from. wbr[ch the native cusps have been ren1ovedl.,
`and the tube is either "tacked'.'' at 1jt1re1:: poilnts distilly inside
`the mrt:ei:y, or :m1tun:d lo1□1gitudLlinallly .,(long t]ucc lines; !his
`allows the ll.:air>s of tissue between Ute tlm:e forn1tio1□1 points ,alt
`the valve outlet to 1f111□1ction as :movable cu:sp:s.. These
`ap][iroachcs g,,,m:ralbe: lliow Jpa1Jbern:s: :that closely dupllicate !he
`ll.ow patwm:s: of n:a11tive vallvcs. One preferr,,,d 1tuliular mate-(cid:173)
`dal. ,,:1[1mpds:es :subnu1cosal tissue. from a smalll iu1tes1tiim,::,
`from Ute same pa.ltient who i.:s. umll,eirgoiug !he carcli,a,i:: opEirn-(cid:173)
`Hon :; !this elimfrtates the risk of immune r,e,je1::1tio11 ,utd 1be
`ne1:d to tn:at: the tissue to reduce anltigenidity. Intes:tin:aLl
`tissue from. human ,,:adav,,irn or animals such as gene1iicall.y
`engi11ei::ired. hypoallerge1□Lic p:igs can also be u:s1::d, if propE:dy
`1ireakd, or a bfocornpaltihle syn1the1ic tul:1111:.u mate:riall can be:
`used ..
`
`Medtronic Exhibit 1021
`Medtronic Corevalve v. Colibri Heart Valve
`IPR2020-01454
`Page 00001
`
`

`

`U.S. Patent
`
`Ny
`
`Feb. 3, 1998
`
`a,
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`IPR2020-01454 Page 00002
`
`IPR2020-01454 Page 00002
`
`

`

`U.S. Patent
`l.J .. S~ .. ]Pateirnt
`
`Feb.3,1998
`
`Sheet 2 of 4
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`IPR2020-01454 Page 00003
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`IPR2020-01454 Page 00003
`
`

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`lJ .. ,;S .. 1F1':mte1111t
`U.S. Patent
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`Feb. 3, 1998
`
`Sheet 3 of 4
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`IPR2020-01454 Page 00004
`
`

`

`U.S. Patent
`
`Feb, 3, 1998
`
`‘Sheet 4 of4
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`IPR2020-01454 Page 00005
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`IPR2020-01454 Page 00005
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`

`

`5,7ll3,950
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`l
`MJEC'l['lll[OD (ff 11rn:PIACIING HIE'./UltT ·w1.1;vu:s
`USING :FL:E:XHU,11: 'l[Tmm:s
`
`RELA:l'ED Al"JE>Ll:CA:noN
`This is: a diYis.ioimal ,atppHcation,. base1ll on pdor U.,S.
`appllication S,:ar. No. 08/146.,938., IUed 011 Nov. :I., 1993,,
`issued OIDL Jan .. 2 .. 1996 U.S. Pat. No. 5,480,A'.(4 ..
`
`BACKGROUND OF THE lNVJElNTRlN
`
`This inve1□11tiou is .in the field of h1:,,a□rt: surg,my amid relai,es
`to l"IEJ[llacernelll1t of diseased or it\jrnredl he.a□rt: valves.
`Ana1tomy of Nonnal Heart ·1,'iallves
`The:re are four 11,lllves in 1fa: heait that s1:.rve. to diirect the
`ll.ow of blood tluough the 1wo sides of the heart in a fmwanll
`diirec:t:lcm. 0101 the kft (systemic) side of the heart ,m::: ll) the
`mitral v,aulvc, located betw,,:,,:n tlu: left atrium aud the lldt
`11em1tdcle,, and 2), th,: ao1tic valve, lloca1t,ed betwe:eu the kit
`vemLtticle and. the amlta. These itwo vallves dilre:i:t oxygenated
`blood com,ing from the llungs,, through the left sidle of the
`hemrt:.. iu1to Ute aorta :for clllstdbution to the body. Oimt the right
`(J[ml:rnomacy) sidLe of the he1urt ,m:: 1.), lthe tricus:pidl valv,,:,
`locartedl between 1the rig)111t atirium ,aund. the right ventriclle, and
`2) 1lrte pulm01□1,uy valve, lloca1J::d betw1:,,::mt the right ventirick
`and the pulm.on,aury artery. These two valve,:s direct
`ck:--oxygenated blood corning from. the body, through the
`right side of the heart iulbo the pullmona1y artery for distri-(cid:173)
`bution to the hmgs, when: ill again l:11,:come:s n:-oxygenated
`to begin 1ltte circuit: anew.
`Alll four of these h,::.aart valves ,ue p;a1s::sl've stmctures iutt that 30
`tfa:y do not themsellves expend mmy enctg)r ,amd. do 1101t
`'J[1ttey cou:siLs:t of
`p::irfonn ,amy a,c:tiv,:: coimtrnctile function ..
`mov,::alble "k:.1rllet:s:''" ttmt are desigm:d. simply to open and
`close fa :re:s11011se Ibo diJBfor,::ntii,aLl pre:ssrnres on e.i1he:r sidle of
`1fa: v,aLlve .. The mi1tral. mull tricusp:id valv,,:s al'I:: :r,::fened to as ,15
`''·a.1triio11c:llltdc11h□: valves'''' bc:i:aimse of thefr being :siitua1)E:d
`b,:tw1:,1::.11 ,rn a1triium and v,e:ntrick: on each siide of tJtte hemt
`The rnitr.ail vailve has: two kaJkts and th,: tricusp:id. valve has
`'J[1tte acmtic and pulmo1ttaty valves ,ue referred to as
`1lrtree ..
`'·"se.milunar valves" b::,,:ause of the m□Lique appearnnce of '~D
`lttteir lleafk:1ts, wlttich are more ap1tly tenn1::d "cus:ps·•·• and ,a□re
`sh,mped som,:what like a half-moon. The: aoirtk amtd p11Jlme►-
`n.ar1y v,aLlve:s eadt hav,:, three cusps.
`S:im::,,: the physiological s1irw:iture.s: of natiive_ mi1rnl ,auttd
`ltricuspid v,aulves and lliimtiv1:: acmtk: and. pulmonmy v,aLlve:s ,a□rc 45
`ll,
`Impcmtant to 1this fonve1J11tion, they are d.ep.ic1J::d in FIG ..
`which cont11itts: a <:Jross--s1:,1::tion,aLI cutaw,aiy depiction of a
`nonnal h1,Lmm□1 heart UIO (shown next to heart :um .is a
`:s.e:gment of itubular ti::ssue :!OIOI which willl bi:: usedl to :r1::place
`lthc miiltr,aul Y,aulve, as dcscdb1:d below). 'J[1tLE: k:ft: slide of heairt 50
`llHI o:mti,ins left ,atltdum 110, left ven1tdc11lair chambc:r U:!:
`posi1iio1□1ed be1t1vee11 llell: ven1iriculm: walll U4 and septum lUi,.
`amtic valve lUI, ,amd. miiltrnl v,aulve as:s:ernblly l,!O .. Thi:: com(cid:173)
`ponents of the mitrnl valve assernubly U:O im:lu:de 1fo: mi1rnl
`val.v,e: m□mullus 1:lrn, whik:h will. remain as a roughly dJrcuular 55
`open ring aJftc:r 1Jtte Ieall.1::1ts of ,a1 cHs,,:as,::d or damaged v,aLlve
`have be,::n IC11ctov1::dl; antc:rioir kafl.elt ll:!,:l: (so.1111,:1times c::.alllcdl
`the aoir1ic: leaflet, since it ii:s: adljacent Ibo the ac1r1ic re:g:ion)::
`ll:!,c6, and ll.!13:
`postedo:r ll,eafk:t ll'.MI; two pap:ilbury :r111i1:s.dles:
`wl1kh am atJ,mched. alt theibr b.aises to the :iut,:dor smfac:e of the 60
`left v1::1rttdcuJl.arr wall 114;. al□t(I mul.ltiplle chcir<fae ten&ine,at1,:
`ll:l,l, which coupk the miltrnl vailve lcaJfots: 1,!:2: and l,!4 to
`the papilJLmy muscles ll:!16, and l,!ll-. There fa 11.0 one--to--olll1,:
`cho:r<fal coi□mectiion be1twee1□t the. k:alk:1ts ,aund 1Jtte pa1r1illlacy
`m1rtsck:s:; iu:s.teadl., mmu:rous. 1::hord.ae :arre p.r,:::s,::nt, and 65
`cho:r<fa,,: fro:m each pap:ill.aary mrn:clc Uif, and ll:!l!i attach t:o
`boltl1 of the valve: leadElets ll:?.'.? and l:?4 ..
`
`5
`
`'][he odtcr side of th,: h1,:,a□rt: cou1latins the rig/ttt ,a11ttiium ll!SiO,
`a .dght ven1iriic:ular chamber llSil bounded by right ventdcuLa□r
`wall ll!MI and septum lUi, andl a t1ricus111:id. valve as:s:e:mblly
`UiO. 'Ute tricusp:id valve ass,,:mblly U,1□1 comir,dses a valve
`ammulus Hi:!,. thre:e: k:allets H,4, paJ1:iUarty nmsck:s 170
`attached. to the i1D1terior smrf.m,ce of the rig/ttt ventiricular will
`ll!Si4, and. .multiple: chonbe te:ndineae :UU) which couple ilhe
`tricm:pid vaJlv1:: lleaJl.ets H,4 to the 1r1apillary :mu1scles
`ll'l'0--17il.
`As mei□Ltionedl ,atbove., th1:, mi1iral v,aLlve: lleaflelt.s: 1.;u: and
`l1l Jl:U, and. tiricuspidl v,,Llv1:, le:,auflet:s Hill ,allrc all. p,aL:s:siive sltriu:-(cid:173)
`tures;. they do not th1::mselve:s: expernd auy energy and do 1mot
`peirfmm ,my active con1rnctille fu1D1ction. They ,a□re desig:1D1ed
`t:o :s:iimJ1ly open a1D1d dose :in n:spcmse to diJEforentii,d pressures
`on either side: of the leaJElet ltissue. 'When the lcJJt v,,:1D1tric11llar
`15 w;alll U4 irc:lm;es so thm1t the vemtirkular chamber 112 enl::aurge:s
`and dr.atws :in blood, tlbte :mii:tr,a/l valve l:?.t□1 opens (i.e .. , the
`le:,dlcts :u;i anci Jl:MI sc:parate). Oxygern,aite)d blood ill,ows iln a
`downward din:ctiion tluough a~e valv,:, :U!O,, to :till the
`expandilng ventidc:ular cavity. On,:i:: tlte left ventdcufaor cavity
`20 h,ms :filkd, lthe kh ve1□L1tdcle contrnct.s, ,::am::ing a r.aipi1ll :dse: in
`tltte k::Et venltriiculmr c,a,v.itm:y pres:mre. Thiis causes 1fa: mi1rnl
`l:!:l: and JL:ll4
`valve lllO Ito clos:e (:i.e.,, the k:aJliet:s
`re-apprmtilrnate) whJfo 1Jhe ,mm1tic v,dve llllll- opem:, allowing
`title oxygenated blood. to be ,:jectedl from. the k::lt ventricle:
`25 into the aoir1Jai. 'Ute chorcfae te:11tdine:lle J.:!:l: oflthe miJrnl v.iLlve:
`pirevent Ute mitral le,alElets 12:!: ,au□td 1:M from. prolapsin11: back
`into 1Jtte Icfit ,a1t1ium 110 when ltl11: left venltriicular dttamlber
`114 contrncts ..
`The three leaJllets, chordae tem1di1□1eae, aud papiilh□ry
`1□m1sdes of the ti:icuspid v.aLLve foumc:tion fo a simiJar :mmmner.,
`iin irespom:,:: to lthe llllling of the: .tiight ventricle and its
`:mlbsequent oontm.ctio111 ..
`The cusps of the ao:rt:k valve alls.o irespQnd passively to
`p:t'l::ssure diJEforentials between Ute lefit ven1ttiicle and the ao:rt.at ..
`'\Vhen 1lhe left: ventricle con1rncts,. litte ao1:tk: v.iLlve: cm:ps open
`1to allow the Jllow of oxygenat,::d blood. from the lefr ventriclle
`ilnto the: ao1ta. When the: left 111::1□11ttiicle relaxes,. 1the aC]l]rt:iic
`valve cusp:s. n:appro:dmaite 1to prevent the: blocd whk:h has
`entered the aorta from I.eaking (ircgmtrgiltatilttg) baie:k iinto the
`llellt ve1111tdcle. The puulmonmy v:ailve cu:sp.s. :respond. pas:s:ively
`1l11 1fa: s,alme mm1rn:r in r,:::spcmse to reLar,;ation and con1tr,utio1D1
`of 1ltte iright ve:ntricle: in moving de:-oxyge,natcdi blood :into
`to the llllngs for
`th,:111::e
`the pulmonary arilery a111ll
`ire--rn1ygcna1tion, N,,::ith1:ar of these semilumar valves has asso-(cid:173)
`c:iated chordae tendlineae, or papilJlacy muscles.
`In smmm11ry, wii1th relaxatio1□1 and eiipamsio1□1 of the ven-(cid:173)
`tdcles (diastok), tJm,e: llllitr,,Ll mul tricusp:id v,aLlves open,, whik
`the acmtic ,amdl _puulmonmy v.aLlv1:,s close. 'When the ven1ttiicles
`contract (:sys:tol.e), 1the. mciitral a□□td tricrn:pidl valves cllose aimd
`the ,untie and pulmouary v,,Llves open. In this mim1□1,e:r, blood
`:is Jiropelled 1throu11/tt both sidl,e:s of the ltteact.
`The anat011Jl)' of 1lhe lttei111t allld 1he structure and. termiittol-(cid:173)
`ogy of hi::aart: valves are described and illustrated .in detail[ in
`numerous ref,,:reimce wo:rks on .amato:my and camlliac srnrgery,
`indlucUng sta1ttdanl texts :mdtt ,ats: Su1;5(el'.)' ,t{ 1i\1,i, Chest
`(Sabii:slton and Sp,::Jttccr,. eds .. , Sauude:rs 1'1,tbL., lE'hiuladc:lphi.at)
`and Gu1ilifac .Sunr,i•;ry by KJbrldin and Bm:reH--Boyes.
`P,atlthollogy and Abnoimalities of Hea11t Valves
`Hei111t valves may e,dtibit al:morm.il anatomy ancll fo:nction
`as a result: of oongenitaLI oir acqlllin:d v.illve ilLllseas:e .. Co1□1geni­
`tiil. valve albummalilties ma1y be so sev1::n: that em,:1rg1::ncy
`sm11:e1y is rnquin)cl w:itlllln 11tte flrst fe.w hours of life, oir they
`1n1l)' be welJ!.-1:okratedl foir many years only to develop a
`life--tlureatemriug p:rolbkm in an eldedy _pat[m1t:.. Acquired.
`v,illve cllisease 1mry result from causes such as :cheumatk
`f,,:ver., dege:ne:r.mtive disorders of the v.aLLve !tissue, bacterial or
`fungal infections, and trami□L,L
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`5,,713,,950
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`10
`
`4
`tiitauilum. Alll of these vallves an: a1tadu:d to a doth (usually
`Since heact valves an: passive s1tructu□res that simpliy op,:n
`D:a,(Ton1r1,l) s,,:wing ring :so that the v:ailve prosthe:sil:s. cmm be
`and close in response Ito diffen:nti:aLl p][essures on eitltfer silde
`su1JLu:ed to llhe pii.1tieut's na.ltive tissue to hold the artiJfid,aLl
`o,f the particular v,dve,, the problems Hmt can devellop wilth
`v:BLlve: in place postoper:a11livelly; All of these rnech:amk:.aLl
`vaulves can be dassHied :into two categories: 1) stenosis, :in
`5 valves can be used Io impll.a,c,,: any of the heart's four valves.
`which :a, valve dloes nolt opi::J[L propedy, OJ[ 2) :insuJEEidency
`Nlo other 1m:ch:amic:3Jl v,aLlves ,aire cunc1□11tly approvecl :fo1r use
`(also calll,,:d Ieguig.itation),,, i1□1 which a valve does not close
`by the FDA in the U.S.A ..
`pr<i1r•erlly. Stenos.is and im:ulllLc:.iency may oecur ccmcoml(cid:173)
`The mai11 adv:amta11:e of .medtaaniical valves: is theilr long,(cid:173)
`ta1111Jly ii[t 1Jtte same: valve or in (lliffe:reimt v:aLlve:s. Hoth of the:se
`ltmm dlur:a:bility. Theiur mail□l clisa.dvaut111:c is 1lhat: they :re:qufre
`abn<irn□LaLlities iiuirease the workload pla,::ed 01□1 lthe he.atrt, and.
`the p:a11lie:mrt to titke systemic aJmticoaguOlation drugs for 1lhe. rest
`llt1e sev1,irity of 1his i111,cireased sltress on the heart and the
`of his oI her Hf'e .. , b::c:aum,e of the piopensily of m.edtaanical
`pattient, arull the heart."s ability Ito adapt to it, dete][mine
`valves: to c,m:s1,, blood clots to form on th,:m. U such Mood
`whctfa:r the abn.ounal vallve willl hav1:, to be :mrgk::2Llly
`clots: fonn on the: vallve, they may preclude the valve fro:m
`][epllaced (or,. il□l some catse:s, repafred) or not.
`opening or closing com:c1Jly m, more impoJtantly,, the:. blood
`lln addlition to stenos.is :amd in:m:Eli.1::km:y of heimt valv,,:s:.,
`c:lots :m,a.y clisengage from. tfa: valve and emholiize to the
`'I'he anticoagulant drugs that are
`:s.urg,,:][y may also be: requfred foJ certaiict types of bact:1,iriail or
`15 brai11~, causi1mg a stroke ..
`,2ure expens.ive and pc>temtti:aJlly
`:himgali infei::1tions in which 1fa: v.aLlve maiy ,::ontlnue. to fonc-(cid:173)
`necessary to prevent 1Jttis
`cla1□1gerou:s in th:a,1t 1hey may ,:::muse ab10Lom1al bleeding wbLlch,,
`tion no:cmalliy, but nevm1tt1ele:ss harbors an overgrowth of
`i1□1 .it5el[ can cause ,ac stroke ff Ute bleeding occurs. wi1Jt1i1m the
`bact,::rfa (a, so-•catlled "w:geta1tio1i"') on the leall:e:ts of 1he
`valve that may Jfake off l("emh◄:ilize") and lodge dlowrn:s1,ream
`brain.
`fo1 ad1lition to the rnech:amical valves: availlitble: !for impllan--
`in a vitali a11te1y .. If sudh vegetatiom: are on the valves of 1fa: 2:0
`1ia.tion today,, a mi1111be::r of o1fa:r vallve ,JLE:s::[gns ,am: desc1.:ibed
`left side (i.e .• the systemic circulatiom1 side) of th,:: heait,
`and .iUustrated iJ□L a chaplter callled. ''·Extin,:t Ca1diac Valve
`emboliza1ilon results iln sudden llos:s of the bllood supply to 1fo:
`Pro:slthescs," :a1t pages 307,--332 of Rep-lacem,in.t Cwidi'ac
`affected body oirgan al□L(I :inuncdilatc m:allfonc1ion of 1lurt
`Ifalv,i·s (Bo1luc11tr and Frater, cited above), .. Two oflltte "ex1tinc1t"
`oi:gan .. 'l[he mg.am :mo:s:1t ,c:ommonly aJfocted by such embo(cid:173)
`25 v,aLlves which dles:,,irv,e: :auttelliltion as: pdor :a□rt in th,: :subj1e:ct
`Hzattion il:s: the br.atin., in wlilich c:3,:se th,:: patient: :suffern a
`ii1111cm1tion an: 1he l\/kGoon: valve (pp .. 319--320) and 1Jt1e
`stroke .. Thus,. :mJrgJ:caLl rcpl:a,oe:m.en11t oJf either the mi1rnl (!r
`Roe-,M:oore vallve (pp. 32(}-,321.), .. JEloth of these: involve
`aoitilc valve (ldt--silded heait v.dves) may be neo,::ssairy for
`JEle:dbk: k::auElets :made of an dast:o:m.1,Jr or doltl1 coated wi.lth
`1Jhis Jrl.I'Oblem. ,e:ven thoug/r1 neither steno:sils nor :insuJEEide:.ncy
`polyte1iraJll11oroethyl1,:1□1e (:PTPE,, widely :sold mufor 1he trndle•-
`of either valve is present. Likewise, bacte:cii:aLl OI fougal
`.mommted :in:side a cyliindldcal :s1teut.
`30 :mark TIIJJFLON),.,
`veget:a11tions on the 1irkm:pid valve :may embollize to the llung:s
`Al1Jt1orngh bo1Jt1 w1,:re tested. in .lmman:s,, they wen: nev,::r
`(re:5lJLltiing :in a lung abscess), :amd 1therefore. may n:quuire
`0011JlmeicfaJlized and. app:m:ntly are: not being .afctively stud(cid:173)
`repllacmm:nt of the tdcusp:id valve eve:mt 1Jt1ough m10 1irk:usJ>idi
`ied m· devcl.uped today.
`\\alve .s.Ienosils or insuJElidency :is present. "Wi1h the: e:xcepticm
`A11titiciall Tissue 'lli1lives
`of ,c:ongenital pulmcm:a□ry valve stenosis oI imuffic.iency., .it is
`!Most tissue v:dves :m: cons1rm:ted by :;ew:ing the le::acEle1t.s.
`umi,:s.u1al :fol[ a p:aitienlt Ito devellop an almoumali1ty of the 35
`of pilg :a1rn1tic v.atlve:s to a sten1t (to ho1cl lthe lleafl.e1ts in pioper
`pulimonmy v.ailve that is :silgncillicant enou:gh 1to Ieqlllire surgi-•
`po:sitio:n)i., or by cons1imclting valve l,,:dkts. from the p(:ric,u-•
`e,BLI rc:paLir or rc:placement.
`di:all sac (which :mirrrnmds the he:att1;) of cows oir pigs and
`Omn:ntly, smgkal rep:acilr of :miitr.aul and 1iric:m:pid valves :is
`sewiJctg them Ito :a, ste:mut. Tb,: s1emrts may be :tigid or sHghitly
`pref1::Jn:d over ltotJil vallve r,eplacem.,::nt when pos.s.iblle,
`fl.,::xiblc :atncl an: covered with doth (rns:ually a s:yn1Jt1etiic
`altln1cmgh o:lten 1he valves are too diseased Io rcpi1ilr and .must 40
`material :mild 1mder lthe 1rndemark D,3.1:JronlM) and. alttach,e:d to
`be :ri:placcd. M:ost ,3Jt,n1)1J[malii1ties of the aorHc v:ailve require
`a :se:wi1i11ir ring for :fix:a:tion to the p:adtienlt's native t:is:s:ue. The
`rep.lacern.c:111t, :ailthoug)i some elfo11ts an: now being :m.:a,dle to
`porcine <u bovine 1ils:su,: is chemciicallly treartedl to allevialbe
`repair insu:Eli.cknt aortic valves :in sele:c:ted pialticnt:s .. "li11llve
`any antigenlci1y t(i..e., to reduce the: risk that the patient's
`n,:pair and v:atlve replacement surgt:ry is descdlbed :amd illims:,.
`body w:ill rej,,:ct the fo1re:iigu tissue). 'J[hese 11ri--kaJllet valves
`1ratedl :ln 111J1111eiro1J1:s books: :md a11ticle:s., ilncluding the texts 45
`may be used. to :re:Jr•lace any of 1fo: heait's :four valves. 1[1ite
`cited herein ..
`only tissue valv,e::s ciuren1Jly .arpprn,ved by 1he PDA fo,r
`CURRENT OJE'J['.[ONS FOR IllEAlltll' 'I/A])11lEl REPLACE(cid:173)
`irni;ilantation in the U .. S.A. are 1ltte Cai,pc1□1itier-lEld.wards Por•(cid:173)
`MIBNT
`cilne 'li'.aJlve,. ithe Il[ancod: IE'orcim,: 11':dve,, and the Cm1r1en1iier•-
`llf a heart valve rn.1J1st be re:placed, 1h,:re are cum:1i:Uy
`severnl opltiom: availlabll,,:, and the choilce of a pa1t.icul.a□r 1;)1pe 50 Edlwards Pedcardial V1Llv1:: ..
`The main advantJ.ge of ti:s.:me v:dves :is that they do not
`of prostJt1esis (i.e ... artiJfidial valve) dcpe:111ds cm factors such as
`cause blood clots to frncm a:s .readily as. dlo the m1::chankal
`1dhe locatio1c1 of the valve, the age and. other specifics of the
`valvm:, and llt1cr,,:forc, 1Jt1ey do not :a:bsolu11tely Iequire sys(cid:173)
`pati,e:nt,. aJJ1d the surgeon's ei,pmie:nces and preforeni::e::s.,
`temic anticoagufa,1tiom1. Nev>E:c1fa:less, many su□rgeons do anti(cid:173)
`,11,vailabk pio:stt1cses :indludle three catego:de.s of v,ilves or
`coagulalte pa1font:s who have any 1;)rpc of :ut:iilid:aLl mi1rnl
`:mate:cfals: mechanicall valves, tissue valves., and aoitic 55
`valve, inclmlling Hss:ue valves: .. 1[he: :major ,fa:adv,3J□ttagie of
`houc1ogirnJft valves. ·n1ese :ue brietlly di:scm::sedl be.low; they
`tissm:: valves is 1Jtmt they lad1: the long•-li:1:m dm:,a1billity of
`:amd dc::scrib,)d in detatil in t,1:Kts such as
`are illlu s1ira1J,:d
`nu:chmiuical valves .. Tissue valves have a signiJflcant failure
`R,i)t>L,1c,i!nwn.t Cal'dtac \,hlves, edillecl by E, :Bod1□1:air and R.
`rate, usu,3J[ly app,,::a□ring at appro,dm,iltely 8 years foHowing
`l'i:ate1: (Pmgamon Pres:s:., New "lfo:ck, 1991).
`,m implianta,tio1m, ailthough prelimi1c1atry results wiU1 lthe new
`Artifa:i;aJl M:,,:chaniical ·11\dve::s
`conum:r,:::ial p::ricanlii.aLl vallves sug:i:est that the:y 1nay llas:t
`Mlechanical valves faclude ,,:mged--balll valves {such as
`long,,:r. One cause of 1fa:se faillures is believed to be 1Jr.1e
`S:t,mr-•!Eklwanls vallves),., bi--le:acElet: "\'.,ilve::s ![such as: St Jude
`di1e:miical 1brea1ment of th1:, :amimal tlss:mi that prnven1ts: .it from
`11,1Jlves)i, and tiltillg disk vallvcs (such as Mcd1ironic--Halll oI
`being an1ilgenic Ibo the patient In adlditllon., the piesence of1Jtte
`Oirmiis:cieno,: valve:s). Caged balll valv,e:s: m:ually .aure 11cL1fcle
`65 st:ent a1□1d sewiimg :Iilng prevents the .arct:ifi.c:ial 1ils:me valv,,: from.
`with a balll m,3,de of a silticon,e irubber (S.Jilasticn1) ilt1side a
`being aua1tomically accurate fa comparis<m 1to a m10.m1al hcm1
`1itmiium cage., whille b:i-•lk:alk:1t andl 1tilliting dil:s:k valves .arre
`valve., even :in the: aortic vallve position.
`mad.e: of various: co:m.bina1tiom: of py1rolly1ic c:airbon and.
`
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`5,713,.950
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`HoI11ogr,a(El: Valves
`Homogiraft v,aLlves ar,:: harvested from hmnam cadlivt:rs.
`'Utey ,a□re most ,c:omamomLly a.o:ctic vallves but also cx:casicm,aully
`'l[1h1es,,: valves .am: :specially pre(cid:173)
`:indludle pullmoni.c valve:s: ..
`pan:d and frm:,,:n in lliquid nitmgen, wh,e.rn 1bey m1,: slton:d for
`late1r use :ln adults for ,a1rntic V,3Llve replac,::m.ent, or :in chilcln:n
`for putm.omuy vaJlve repll.a1c,:::m.e,m1t. A v:altfamt cx:cas:ion:aully
`emqr1loyed. fo,r aortic valve r,::plac:1:,ment Is to use the pati,::nt''s
`own 1mllmonary valve {mm ,u1to:1;rnJft) Ito r1::place a diseased.
`aortic valve, combin,::d wiJth inseirtiion of ,autt ao11tic (or llO
`pulmonairy) homogr,3Jft: fro.111 ;m ,;:aidav1:,r to repface thi:: ,f:xcised.
`_pulmonary valve (tl1is is commonly called a "Ros::s
`prnce,fani''), ..
`'l[fa: acllvan1ta1ge of a.or1ic ho:tn.ogrnuft. valves is that they
`apJ[•car 1to be as durnb].1:: as 1m.echamic,aJl valves ,aind y,::t th::y do I5
`not pro:m.ote blood cJl.ot: fo:tmation ,aund ther,,:fore, do not:
`r,::qufre anticoa.gulaticm.. The main disadva1□1tage. of 1hes,::
`valves is: tlrn11t tfa:y :a□re not availitbl.e in :s:ulliic:ient: nmmbers to
`sati:s:Jfy tfa: needs of patients who need new aortic or pul-(cid:173)
`mcma□ry v,aulves. 'Utey also cannot: be. used. to replac,:: either 20
`the mitral valv,,: or 1tnicuspild v,ailve. In ,mddition, they m:,::
`extn::m.elly exJ1ensive ;aind much more diJElictilt. to :lmqpllm1t tha1□1
`ei1ther mechanical. or ti.:ssue valves. The diJlEicul.ty in implan-•
`ta,1tion meau:s that the operative :d:s:k wiith a hcrmogrn(fl. valve
`i:s gin:aJ:,e:r in a gji-ven pa11tient tlrn.1□1 :it i:s with either a In.e1:h.2mic,aJI 25
`m tissue valve. An adLUtilonal problem is Utat :in .June 1992.,
`1fa: :FDA n:--clas:s:lfied homograll: vaLl11es :a,:s an exp1:iriment:,aJI
`dL::vk:e., so they are no longer ,a,vail..3,ble on a rorntine basis.
`lE'RlNCl[l"lUElS OF AIU'.IFl:CIAL HEAHJI' V,11LVE CON-(cid:173)
`SlrRUCDON
`i1Jll mtifrcial hemrt vallves arc desig111ed to optimize 1three
`maji:1r phys.iollogji,c: characltt:d:s.tics and one practical cons.id.-·
`1:rntilon,. The tll□ree ma[ior plt1ysiollo111ic dt1ara,:t,e:1iisdcs mre Cl)
`hemodynamic pei1fom1mmoe, (2) tluombogenk::ity, .. amd. 1(3)
`durabilli1y .. The Jprn,dical. com:ildcration ittvollves ease of SUI'·
`gical. impllanta11tion.
`Multiple. fact,in: Lmpac1t on eac:h of tfo:se potential. prnb(cid:173)
`kms :in 1the developmcnlt of arti1ficfal valves. As a IcsulLt, lthe
`:atdv,iic1tage of arti1ficial valve A over m1tiJic:ial. valve Hin one
`:a□rea :is typicallly crn1mte1'bal.iamced. by valv,:: B's advantage Jin
`:amo1□hcr area. If cme a11tificial. heart valve were cl.e:a□tl.y supi,:•(cid:173)
`do:r in alll aispects to :aJLI otlmr m1iilidal valve,:s .in alll four 01E
`1these areas .. , ii1t would be ithe only :a□rtilidaLl vitlve used. ..
`A11tiJiciali l\/le:i::hank:.aLl 'lli1lvcs
`Tiu: hemody111m1k pt:dorni,amce of :111.echanicaLl heart 45
`valves has been sati.sfactoiy but not optimal.., e:sp,::dallly :in
`th1:, s:nrnlller sizes. All previously constructed 1mlchanical
`heart v,lilves h:a,ve had :s:ome 1t)IJJi:: of obstmctiimg stn1ctun:
`wi1Jhin the Jllow orifi.ce of tltte v:8Llve: when the valve is :in du:
`op,::n position. FoJr e;1;a□mpk, bii-k:.adklt valves., such ,m:s 1the St.
`]lmk: valve, h.arve two bars :a1.c110:ss the 01tiJficc m□cd in ad.&it.iion,
`the Iedlet.:s thcms:,,:lves arc wit11iin 1fo: orifa:e when ldhc v:8Llve
`is ilDl the opc:1□1 po:siltion. S::ingile-leall.e1t disc v:8Llves, sudn1 as the
`Mcd.ltronk:--lfl:iaJll valve, have a c,entrnl biaJ: :aind. s1trnt mei::ltta(cid:173)
`ni:sm that keep the le:aJElct: in plac,:: .. The llljork-:Shiky valv,,::s
`have e1ith<::r on,,: cu two stmt::s th,a,1t :spim ithe valve o:tiifice in
`ad.&itiion 1bo the _parti.aJlly--opened. &isc itJsdL Thi:. O:tm□Liscien.::e:
`vallvc has the pmrti.,aully ope:1□1e)d cfo:k itsdf in 1the viilve ,cmilk:e
`when open .. :aind. 1it1e Stanr--llidwards caged--biaull valve h,a,:s both
`the b:aLll .imdl the cage wi1thiun tfa: JBlow oriJlioe of 1lt1e valv,:: in
`the ope1□1 position.. Alli of 1it1cse s:tm,citures decn:ase the
`hen1odyn:am1ic pei1fo1:mmmo,: of the m,::ic:hanik::aLI valv,::s.
`Such obstmcltions also :lnt:,:i,fi:::te with the nrn111cLiLI JElow
`p,a1tteim.:s within and aroum1d the n1edh1ani.ic::8LI valve and
`tlt1ere1fore,, promote, thrombo:sii:s: .. Meire :img;1cmta111Jly, ,3Jll ,a□rtili-­
`d.ail smrf:a1ces are thiro1n11bogenk: ( ,:Iot:-'.promotiic1g) to a greater
`m k:s::mr cll,e:gn:e. The only complie1tely non-tluornbogenic
`
`( non--dlot--promotiing) smface that. e.;ds1ts is the layer of viable
`1::nd.othelii.atl oc:lls that: lhtt: the :int:c:irioI of alJI the body's
`vascufar surfaces,. :including the iusiide of 1.b:: heart chambers
`,aind. the 1m:a11tiv,,: valve l.eaElet:s. Tlu:r1::fore, aimy metal or pllasltic
`5 mat,eirfall, no matter how ltighly polished, w:ill have some
`level of 1□t1rombog,::nid1ty m1l.e:s:s the smface of 1fo: :utifi.cial
`1rnat,,1rfall ca1□1 be: cove1red. with endothelial cells. It is :for 1thiis
`:2□11iilicilal m,,,:idumiic1il he,a□rt:
`reaso1□1 1Jta1. alJI pati.i::mrts witlt1
`val.v,,::s mm:1t be J•e1mauemrtly a1□11tico,aigul.:ai1tcd.
`The nuijm a,ilvallitage of me)c:harnical v:aLlves over !tissue
`valves is fomg--tcrm. d.1i□rab:ilitjr. M:echai□Lical valve co1□1:s:1tmc­
`ltion lu1:s been based on sopllListi.calbed engiI1eedng pdnc:lpl.1:::s:
`1tha1, hav,e: prn,v,,:n Ibo be soumd. :in tcmrn of :providing devk:1:::s:
`1thalt ,a□re extiremcly resistanlt 1to we,a□r and :stiructunil failure ..
`Nev,:irthi,:kss., :s:1truct11rnl f:alilrnre of 1111::dttanii(al valves do,:s:
`occmr and it is the :majio:r .n:::ai:son foI the rncent withdr.arwal.
`from th,: mmb:t of two commu,::rcfally available mechanical.
`valves: (the Bjmk-S:hil.ey Concavo--Convex1rMI single dii:s.c
`valve amid the Du□ramedics1nir b:i-.Jlealk:1t valve:).
`ArtiJficial. Tissue 'lii1llvcs
`Uncfor 1tt1e best of drcumstamces (i.e ... , replaoem.ent of the
`aortic valve)., the com:1tmction of mtifi.cial. tissue valives has
`bee1□1 based. 01□1 1lu: concept: th:a11t if the ,aLttllk::ial valve c,a