US 20l7/0095646 Al
`
`g
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`Mo~ ll-p~lficsilly,. lfa.-se compnnems can dil\.~tly ittlfo1.>nce
`th~ ton:ional t:<1i,1rliai-Ke ~ham,i{'.risiics. of the devit:e. !t ii
`uoo~.s-s.tood th.it frir pUfP{~~1.~ of shi~ applleatkin, ''torg:imd
`eomplbr1ce" ls lntend~i !o mc,m the arigu!ar or rot,slimml
`fie.1<ibifoy of the shafl isloi,g it~ hmgsh. As ,m example, .i
`i.lmfi whh high !nrni.<inal comp!iancc wm 1.rm1smit less
`torque or romtio.;:i from <me end to Uw olh~ i.'!x!, whlfo a
`shall.: wlth low !Ofsiona1 compllarK~ will transmit more
`lOR1Ue from one t.>:iid io lhe ether. A ~hu:ft -.vhh klw torsional
`~)mplbnce will have higher lorque tran$m\sskm dmrac!~·
`lsfo::s than <me with Mgh tm-sinnal cornp!l.mce. As dh~..;tlssed
`above, C{'.rlak, known exien$ion cathe1er1> foive high tm:que
`imn,sn:ii$;,ion dl.3.r-.R:teristici; ( an,,.1 1lw~ !1)'8 torsional ~o.npll(cid:173)
`ance characlerisiks) thm can rullse is,1.flkk:n! ~tres.1 nn tbe
`ccmnection betweim the pro;<lm,1! shaft <lfl<l distal tube 10
`caiige fallti.'C or scparalion at the corn:ioc,i<m point Nmi·
`liruhing e):ampl~ of exten~ion c,iilietes-s. having [ow tor(cid:173)
`sional compliance cM include catlie;:ers lmving a proxim.a!
`sha!l c:rnnpri~~1 ~fa slngle ekmgilte mernoor having a solid
`square or t<:-'l.':tang·ular cro:s,;.-sectioii, a oolkl munci cm~,
`$~!km, m a round cmss-sec1k~n wl1h a lumen (such iis a
`hyporube}.
`10139]
`ln ctmtrast, the IJSe oHwti or more elongate mei1:i·
`hers in combi!IBtioo wi!h di!fonmt sheiitl1 ~~m~nl ~:~mtl£U•
`rations ~.an produce higher i.<:.lrsiori.i.l oomp!imice {and :thus
`lower toque lt11.tmmfask'll) l1mn pro~lrtml s1mfts mal are im!
`cQnfigut,;i,:l. as suck More spi..',d!ica!!y; withmit hdng !lmited
`hy thoocy, me ca~hility of the !'>,vo or more doogaic
`members to move L-ii:furenden!ly in relation 10 each o!l~r
`helps lo lnc:re11se to.raim,al t.'tHnpliancelreduce !t)fil;\W tr»ns•
`ml~~m when lhe manipnfotion s:ru1ft is: t1.1med at hs pr<.1:<:l·
`ma! encl hv the ut>er to ciiure mt,tion of !he dis:Wl ll.lbe <ir
`wlwn torsion ls induced ln the :shtifl .is: u restih of pus:hlng (or
`pulling) thl$ catlmter 1hr1:mgh .a gl.lidi..1g calhctef and thmugh
`a tortuous: vessel, ln a ,'elated faihion, ii !<heath s...,~,1:mnt th.al
`c,,_we~, Qi:tly & portiim ,:Jftfi~ fongth of the efonga!e members
`{lnstood of ilie emire leiigth ilict~ot) airo maintains: s.omc
`ifl.iiep~n4enl m~wemen! of !:he elongJ3te membem, iheteby
`maiiltaining tower tos-que tt,uismis:s:ios) ln comparison to an)"
`c-;}nlhwrailm1 ,hat indudes a shealh t!ml covers the 1cmtire
`knglh of the ekmgii1e members, fo wntr,l~t, in 1h<-1se situ·
`a1k1i:\$ in 'Nhlch it is ~irnhfo, the addiiiou of a filler m~tetial
`fua1 acti. as a bonding agent in one ot more Ju.i-oons of the
`s:heaili s~men! can (}ecrn,3:se the lornional compliam,e ehat·
`acteristlc:s (-\'\t.d thus hlcrcaw the torque !rnm,mis:s:ion char,·
`a..;terfatks ), while a tll!er m.al~rfa! t!ml c<lns!iBltt.~ a !ubticam
`Cl3.ll inctease torstOll{il Compliance d:1urncterislics. !~s: !ha:n ll
`bo:ndlng ngenl, Ai cfo;cus::red ,ib<y,·e, the amount offi!kr can
`a!~o ii1fh,ence ilie torsiomil C-O,l1pliance chai<lt'l.eria:lks,
`incfo:ding whether the !ll!er fi!ll> th{?. entire lertgfu of a s.healll
`~'Tlmlt~ a ~miN1 of the ~gf!Jl~ll, more1han ooo r,mkm t)f
`ln~ segment, or more thM m1e segment
`!01-iOJ Thus,. sl ii. umktStood that torsfon;il coinpfom.ce (3f
`i,1ny given de'lice or shail cm, oo determined b,1sed Ot) a
`n\ln.1l'lel' of fo1"tOn., .inchidmg the m1mbt.'t' a!ld fongth ,)f illl:)'
`sheath segmeats, the lltlll1btt and lcng1h of ,my ufi~be.itli~
`~menls:, the amaunt <lf fl!ler, the type of mier, lhe cm?.~(cid:173)
`i~tional shapt of the P~'o or imme dongate mt~l,~l'S, t.1-ie
`number of elongale ttmmhetll, and other knClwn fac:!o~.
`101411 Th~ concepts are oos:l 1.-uptured in P!G, 6A, Which
`<J~lct~ ts. ~lmfl 80 coi1fig,ii.nion with ml.lnd rods. 82, 84
`having a sfu~alh s~ellt lM Md an ll.m,he~thi,d s.eginenl a:7,
`Tlle 1 .. mshe.iHmd. segment S1 allow& for ilit inderv-~nd~l
`movement nf two rni.uid ek,ngiitc members 81:, 84, lhcteby
`
`irs.:reasin:g t(irs:ioiJ«! compfoul"~, ns described above .. Toil ls,
`as '>!1(1wn by !he fa:cl that the proxim,d p1Jrtio1s~. of the
`eloag2te mem~rl> m~ womm together, !:he l:\.'>'O elong.ite
`rnemben. ~n move lnd~pen<ktltly in relation to ead:t
`Nhcr--foch1di..1g being in s!idfog and ro!Jsng conmci akmg
`tfa:lr len:gth;;-----lhe~by lncn..-.,;sing 1he lornlmwl ~)mpfomce
`of the isiiafi 80, ln contmst, uon~Ji.ittd ekmgat.s memberi.
`wo\i!d 1101 he ci1p.1hl~ of roUing <ir rota1lng ln retal~)n 11) ('..a.ch
`other as c~sily, lh~r,-hy t-cstil!ing in ~t:ei1sed torsioi:.al
`cmnpliance m, a reslill of the <:r,n~c! be!w~n {':ft)ng.ste
`members bdng merely slidaMe in n.aM:e (ratht.s' lmm bClth:
`sliding and rol!inJy"ri..1ta!fo&\ Fmiher, lhe smmrhe<l segment
`S6 reduces tht amo,mt of relative mow..nwnt of the twQ r<id.>.
`S.2, S4 sud1 th.it lhdr lncii::pemknt fSlO\>"ellltltlt in ref.atfon t~
`each other is mo,'C lhniled in comP<frison. to 1he length of
`!'00$ 82, 84 in ihe mi..skmihe<l i,:egmen:t S7, thereby resulfiog
`ln dect<:ilwd l.<:.lrsiomll compll:ancc, Of course,. l! is uru:!er"
`,;iood lh,it ihe 1wo rods 8:2, S4 in ihe shc.iilied segment 8~ can
`ijlso he in s:Hding and rolling contai;1 3fong !heir lengths, but
`ii is . .a!s:o undern!mx! tlmt the rods 82, 8-i in the sh<:'\\'l!h 8!S are
`nol "iipahfo of rolling or ro!;i.ling lf! refa1liml 10 each oiher ai;
`eai,lly a~ rod$ 82. 84 of im un.sheailied. segment (such .i~
`segm~nl 81), And a filler injec:1ed \I1to lh~ .segment 86 cas1
`for!her infiuent.'e the tat-sion.iil compliance as expl13in!:lcl
`.ab..1ve,
`f0t42l Fll..cther, FIGS. 6H•tW depi~t varlo,is dsffotcnt addi,
`ik1:11a1 manipulation shaft impkm~-01.i!foni, wherein imch of
`!he dHforunl. cmifigurntions iiai, a dilfot~nl L'li~,;t on lhe
`torque tran:sn:iissl<:.ln ~harocteiistics of the resu!llr,g device,
`1\-fure s~«;tlka!ly, t~tch of lh/$C figmw shows a ciifforeiSl
`embodim,:m! of a manlpulat1mi ~ba.fi S{f lm\1ing hYO dongme
`membern R'l, 84, '<'>'ilh each embodiment having a dilforenl
`sheath si..~enl conftgu;,3Hnn,
`j614lJ For e;<umple, flG, im oopid1, a maiilpi1lation sk'lft
`8(l wl!h lhe two dongale m1.~nbers 82, S4, but having fill
`sheath segment As descdboo above, tjtls shaft SO wou!d
`ex.hibi! high t(1rsiona! complfonce (or low lo~t,e lmmnis(cid:173)
`sion) for the reas.oni, s.el forlh above.
`{01441 FIG, 6C s.bows ., manipulation shaft SO with !wo
`e~mgtsle nwmbes;s .8.2, &'3 and n 5hea.th ~gm~nt Sl'i Ulat is
`disposed nronnd foe i:wo ekmgme members S'2:, S4 for a
`i.uhstiml ia! ;.mnuni. ofthelength of!h{': memhem 82, 84. That
`ls, th,~ ~heath ~4,gment H:6 ei-;ten& from a proxi.mal portkin of
`the members St, 84 10 a di~ml portion of me members Sl,
`$4, fo this i;-,mbooi.ment, !he shafi 00 exhibil, lower torsloaal
`compliance chamcteri:stkl> !han any of lhe othe-r ~mbodi,,
`menlt in FIGS. 6A,6I;', ~use the sheath 86 i,. disposed
`aromi<l i:;, greatet length (If the 1wo memb~ 82, 84 than any
`(lthe:r ernbt><iim<:'..nt, thereby Hmhing the fre,:.mom ;Jf the iwo
`rnemb;,,~-s 82, 84 to move in refo!km to ~ch <ithe.r. Alterrn.·
`Hveiy, lhe sheath st.>grr!ent 8<'i can be <lb-posed fil'OUncl the
`elo!lgate membe,rs 82, 84 for ,my fongih of those ro{':mbers
`82, 84, induiliag the cmire l~ngil1 tnerol)C Further~ as is 1rne
`with anv of !he embooimc!lts shown in FIGS, tiA4F and
`dsewhere in !his arpli!-'.stloo, a bon<lln_i agen1 fi!!er in~'¢t<m
`fo!.o t1v.s segm:eni Sn \,..,m c,mse e<;-ei1 lower tQtskmai i::<lm•
`p!la,nc~ dmrat:teris,ics {whik 2. hihri!-'.sni !'Hk-s' wmi!d have
`lotsional °''>nt.r!iance tha.r-actcris.tk.s !hn! ,$re not as k,w m,
`!ho~~ cre.l!d by a boncllng agent) ..
`[{H4SJ The munipu.lml.on sh.sf! 8~ embQdli:11:ents in FIGS.
`oD-oF 2,H have it! leMt i:wts sheath ?.egn,en1s disrosed around
`two donga\e memhi:-,rs Sl, 8,t More ~redikaUy, flG. 6D
`depio::l5 ~ fa"St or dis.u1l she.:1ih segment SSA, and a sll>CQmi or
`pro1dmlll sbeaih ~tgffi'<1l11 8:38, with asl unsh.ea!h{':d .segment
`
`Page 361
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`Medtronic Exhibit 1003
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`Page 361
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`Teleflex Ex. 2251
`Medtronic v. Teleflex
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`

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`US 2017/0095646 AI
`
`Apr, 6, 2017
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`~O hetw-.·tm the i:wo ~egim:m'is S8A, 88:Et The skdl: SU ii1 FKL
`6E has four shtmth sei;me111s 92.A, 92'.H, 92C, 'nD wii.>t !htce
`unshe--a!he<l segmenti. 94A, 94B, 94C dis;,ose<l therdie·
`t,.v~n. Furth1..~·, FlG. 6F hils l'N<l ?>h.eath seg.n~m!1 %A. %B
`with an unsh~1hed segme111 ~S betw~~!'i llw t>,w,:i segm.erits
`%A, 96B. Tiie unshf'.athed seg...'tsenl 9S ill FJO. 6f h11!1 ,i
`greater lenglh than the unsh~ihed se11mem 90 in PIG, fiD,
`whkh meai"lS tha! the shllfi SG iu FJG, fiF exhibits !owecr
`10fqi.!e lrnmmi«sion than ,he shaft 81} in PlG. 60, 1n a f1.uil1et
`i!ltenuifrve, th1.1 shaft 80 o.1Jl have ,i sheat.>t thm h, dl!1posed
`arotmtl the two e!ongale members 82, 84 and exten<ls :for lhe
`~\!1tlre fongth of !hf! sbd't BG, tlM, eon!1!HuHng ,~ unitmy or
`llOU•segmented >lhe,ith. Fur!het, ii il uooersrooo thm the
`sht!atl1 nr ~>grr1entsc can hi:lve mw length and cover ,mv
`portion ofthc length oftlie shi:tts.'h is ;loo 1m&:-r!>t,Xld t!Ji
`there can be any rM11ber of sheiiili !mg.men!,. or \tmhe.ath~:l
`segmenis. hl addition, cert<l'in em!xidi..-1ien1s can haVtl ai leas!
`two segmems that are ili.spo;;.ed around the .at lea~t lW<"!
`clongM~ members and oojacent in <.'<ieh 01he:r such tl-mt t.h;1>y
`in contm;:t ·with ea~h other such th.at 1here am 110 timh!1",itlmcl
`se~1lerns beiwoon the at least !\Vo ·~<:."gjlwnts~
`fIGS. 7/1/'IC <lepict m:i..'l!h.:r emhl,'<:lim,mt of ,1
`ftl146f
`catheter H!U with a nmJtipul.atim:i sha!l lM !hat is coupled !o
`ilie distal ruoo l 01 iit m, eccentric rrmmwr, rather man .,i
`conwn1rk mam:i.er. Th.it is, the shall 1{)4 is iolned K1 the
`dhiial ilioe 102 !li one roint or i11 one z,.me t1f i.he perip11et)'
`~r drt:l4'Ufoten<:e of the disial mb<'l 1(12 onilong an e>a.ension
`142 i)f tlw diswl tube 102 w ;facusw.d in further deuiil
`below, Fo.r ei·mmpk, in m1e im~lemm1111k'>n .as shown in
`FIGS. 7A-"!C, tlie manipt1latlo11 shaft 1M is cntipkd to tht:
`disc!al tube l 02 .at a poiril or ate,i of !he w;il! .! {lfi d' the tuhe
`102.
`J0141! The shafl HU ln this emboolment is m.mie 1.1p of
`tw~) mds 108, HO ptl!1ltim:wd within lhe himen H4 of th~
`sheath U2 dispo!itl<l around !he rods 100, HO, a;. he:,t shciwri
`h:i FlG. 7C. fo this emb..·,dirnent, the rods 108; no .ate solid
`(that is, thtJy do !K1t have lumeus), Alternalin~ly, as di«~!.l1ii'i&.<tl
`above, !he rods 100, HO c;m b~ ltypoiu~ !OS, HO; with
`each having :a lumen denmid th~rein, and/ix ran have 11
`shap~ ot Iler th,m round,
`i0148l As best shown in FIGS, 7A nnd 1B, !hi« spe(:i!k:
`implementati<"!n !m., a ills.ta! po:rlfon of the sl:ml't 104 !lmt is
`slntifor !<1 the configm.11ion of FlG. JA ns dlscussoo {$hove,
`b--."Cau~e 1he shaft l M is roupfud to ami folegra! with ihe wan
`106 of the dist::1! tube 102 at the eoml\."Ctk">tl zoue 116.
`fun.her, as best sfanvu iri r!G, 7 A, lite the devk~ 10 in
`FlGS. 3A,JC the r,>,·.o s\1d?> 108, 110 cJuend from the distal
`P,.'lrtion of the 'shalt 104 sud1 th.at !he diinai t•Jrtion~ 118, no
`nf thf' rods llJS, no extend into lli.e distal tube 102. r-.foro
`sp..,,s;Hh .. <;ll1; !he distal portions 118, UO are pnsitl,)ned in ihe
`wiill 1 M contrafotem!ly sn rdaikm to eadi 1>thi.>r. Timi is, the
`dis1<1l ponion 1.18 is dispm,ed in the wan Hll'ic on one sidt: of
`foe c!lsia! t1.1be 1in whlle the disia! portk1n HO ill <fopose<l
`in !he wall l 06 on the otl~r side of tlw tube 102 sut:h sha!
`ihe p-ortinns Hff, 120 are pusiikme<l across the lum~n 122
`from ~..ach other, .As with e9ery emlmcli..<u~1! lmving -.'.Qnlnll~
`llt,-ral dist.II portio11s, ibe distal p<.."">rtiom trn, 110 can he
`directly <"!flp..'l>tile each other acrnss the ltin~n l2l, hut in
`nther l:mplemcntatkim,, ,hey are nol directly llppo:;it.: ~,ch
`oilier,
`j0149J Further, a:; be~t ;;h,)wn in FKL 7B, bosh distal
`mmions 118, Utl (onlv 120 is visible iu FlG. '!B because .of
`the kxatiori tif dist,il p<1rtion HS behlnd distal porliM 120
`in ih~ ligm-e} have angld p<..)rtkms 124, 126 i.hni ext,:md al ,m
`
`angle in rd.a\ion t.i) the !tmgitudirml mds oHhe tube 102 <100
`nxfo! p1.1riiom, U:8:, DO that exw·.nd axially nlong that posi(cid:173)
`lk1n for some dlstan ... -e as -.vell <1s shown, A!!ern.atively, the
`distal porlions 118, 110 can haw oruy angled !)OJtsons
`(similar t<"! pmtio.ns 114., -126) and no stmigM or axi:l.ll
`portions. In nccordam:e wtth one impiemenmtion, !he posi(cid:173)
`tioning BXld e:onfigurntfan t}f the distal pwtion,; .U I, l::W Qf
`the sud~ 108, 1Hl h1 ihe wall 1% of ilw distal mbe 102
`enhance the kiitk resisc!mlce of tlmt p<m:iou of Ille rnbe 102
`ijS well .;s ~ssisting in nll..'>re {":Vi;n!y tr;msmitthig an .axi<1i
`fot1..~ !t) the distal tube 102 in a m,,:ire evoo fashii.:in during uw
`of ihe catheter !00, while maintaining .i !ow torque tmns~
`missimi.
`lri 1hls spcecinc lmpfomer1tati011, both of the dist-ll
`f0ISOJ
`portions 118, 12(1 of the mds 10S, HO have a :murid
`C{inflgura1ion, .Altemtiiivcly, they could h.;ve n f!tti configu,
`l'tllion, thereby reducing !hek f.>,'\'}fi!es wit!tiri the dfatal nib~
`Hl2.
`fo uddltim.1, in this implementation, as oo~t shown
`!{llS1]
`in PIG, 18, the di~tnl woo 102 has a tapered proxirtial
`op,:,mfog Ull and .a proximal exte11sinn 1<12 !hat ls oonfigu,.~'l
`10 m-:eive ihe marupulation e;i',.afi 1ll4 as shown. fo one
`impler!leiitation, the u1pen.>d prmtim.a! opening 140 provides
`e.isi.ir .icces..'> .and inser11on !hf any device belJs& positiOJled
`thr<mgh the !llm!:'..Jl 122 of ilie <llstul ~be 102, while the
`proximal ei,:lensi,m VU pmvides enhaHced f,!rength 10 the
`~"mmt'>:.>!kin betw-.>t-~1 the manipula1icn sh.;ft 104 and !he
`dlstii! tube 1 tl.
`jtl152:l Accotdin& so ,i further embodimer1t cl&,:tic1~:xi in
`flGS. SA and 8B, the <lev:ke 150 has a manlpul.itiori i;!J;rl't
`154 1ha1 is mmie u~ of two rmls lSl'i, l:58 and .a robe 160
`i:,osh.ion-.>tl bt:1wcen the tv..,·1) rods 156. 158 {as bes! shown in
`FIG, SB), F!G. SA it, a :side ·vk.">v, wkHe F!O. 8B is.; top
`vl<:w, ln ihls implemeniath:m, the shalt 1§4 has a polymeric
`s!ie&th segment 162 S\tt:h 13:; p<ilyes!et and/or PET ihat ls
`dispos~>d arni.md the two rods J 56., lSS and tube 160. A distal
`pMion of i.he shal) .154 ill coupled to <md irne,wal wiih .m
`ouJer waU 1 M of th~ <lfaml robe 152 as the coim&-ctiml 1.(sne
`164, :imd more specsl:kaHy is %!lj.)kd i<1 a proximal ~iden,
`sit.111 186 of the t11be 152, Fui:thet, ihe tw{i rods 156, 158
`ei,:t~ncl <!ism.Uy <lt.'i..i1 that the distal Pi)tl1>.'1ms 16S, .17tl nf the
`rods 1%, 158 ei,:tend irl;!O the <li;;mi tube 151. The ,.fatal
`p(lrtions 158, I10 are positioned in the wa!l 166 comr.illat~
`em!ly in relation 10 eat:h other. T11.at is, me distal ixmion l 58
`il1 ilisp{~!1l'ti :in ihe wa!l 16{\ on one side of the Mie 152 whil!.!
`the ilistai por!k)U l '10 ls di«p<.J.SOO in the \',o';\1!l 16{i on theother
`-side of the tube 152 su,:;h that !he p1>.ctfons .lfi.8, 170 ~re
`positioned ~ro;;s U1e fo.m;.:-n 180 fi~m !,;'$.Ch other. Fttf1her. ::1s:
`hest *<howii fa PfG. BA, both di~i.al p<..1rtions 168, 1'10 {oo.ly
`170 is: vfa,ibfo fo f1G. S:A h'l..'.intse of !he klcClltion of diswl
`portkw1 168 hehimi distal p..'lrtioo no in the flg,tre) hav~
`angled portfons 1 n, 1'14 tbai extend al an ang.l~ m re!.il!fon
`10 ttie long.ltudimtl axi;. of the tube 152 a.tJd llXl{$l portroHs
`1 W, 178 l.li<i! extetid axially akmg tllllt posi!ion for some
`d.istan,~e as ,,vell as :,.lmwn. ln !:hi?> sp~ifa, impkment.i!1.'1n,
`!Kith oflhe diJStal portions l~8, 110 ofilie r<"!d:.156., .l58h.iv11>
`a roi.md configurotioo, Altemafrnly; th~y cmtld Jmve a !'mt
`c(mfigu.raik>n, tlum~by ~ka::fog their profik~ within the
`(fo,ial iltb!l u:t
`In ll<lditiou, in th.ls implementatiM, the Mie JM
`[0153!
`positltll}l;.~ ocl'ween fue two .rods 1.§6, 158 hBs a pn1x1mal
`end of !he lube 160 c>:.tending pmximal!y of the distal tube
`H,2 and the distal end extending inttl tlie disrnl tube HU as
`shown, !I is \mde.is.!0>."1tit!m! the proxi.maknd of the tube .160
`
`Page 362
`
`Medtronic Exhibit 1003
`
`
`Page 362
`
`Teleflex Ex. 2251
`Medtronic v. Teleflex
`
`

`

`US 2017/0095646 Al
`
`Apr. 6; 2017
`
`can he positi:-.')nro m MY point akmg: !he lel'lg!h ,.)f rhe
`m&nipli!atim, islmfi lS4, Altemallv~ly, !he pro;,i:im,ll end nf
`the rnbe 16.fl ('JU, ~~tend lQ llie proximl:'I! en<l ofH,e masi]:pu•
`foiioiuhafl 154, According !o mieembadlmeni, ttw moo Hill
`has .i hwen (nnt shm\'l1) in fluid coinmunlcaiion with lhe
`lumen lat of lhe i;hea!h ~1-~ent 162 llnd !'i.irther in Hdd
`eomrn.tlitlcaHon with the hm1en 100 of the disial !1:ibe 152,
`Ahenlatively, the Mw HH.l cars huve a lumen (,10! 5howri)
`that i;s nol in fluid ci)mn1wJicallnn with uic lumen l 81 (ir the
`!urrMl lS{t ln ye! another alteml3tive, !he tuhe Hi!) h.i~ rm
`!mn~n, Ftirtlwr, in 11th. emh,.'Riimlt'Jlt, two m<'lrke:r hands 184
`aro poi;itione<l around !he rods l51'i; l 58:.
`f0154l As mentioned abi:1\.<e, ill lhh embodimem, the iuhc
`160 ei,;teitds dhtallv hlta !lie ,fatal tuM 1:52 ~uch ilim !he
`lurnl.l'S1 (no! shown) of lhe tube 160 !$ il1 fluid t\.',nnut.mkatinn
`witll the lumen 180 of the diism! Mie 15::t Altema!ivdv, the
`tuhe l 60 e>.tcnds dlsially out of the "Sht.'<lili l 62 such i.h;t ilic
`!fatlll ern1 of the tooo 1 nO is poi,it1oned in !he 1l3p~rm,i
`openlng tH:8 of the d1M.11 mhc 152 {dlt'scdl*''-d in fonfa}r
`detail helow), ln !hat embodimenl,. !he hmwn is in fluid
`ca:nimuniclltim.1 with an m~ll ext~rrnil to and pr<.1;<in1.1l tr, the
`fomen 180 ofilie distal tube 152, hill further ulterna1iw, the
`lube 160 ;;;3n e;,ct;:nd ifo:!lllly t,1 r,r hey(mci the dislal end of
`the distal tube 152 s~~h ihat !he lumeri (!lo! shown} of th;z
`tuhe l M h. in fhlid comnnmk.atii)fl wilh im &f{'_.i ~~;t~miil to
`and distal !o the disial tube 151. ln a futther embodiment
`llH5$J
`In oo.dilion, in !his lmpkmcntaiion (like
`tlw
`emhodimeal depki,~ in flGS. 7A m:ill 7B), as best show.a in
`flG, S.A, lhe clfatn! tube 152 has .s pmidmal ~>.tension 186
`canfigu.."'00. lo r1-<>ceivtt the mal'lipullltim.1 i,lmfi I 04 as sh,J,Vit
`and a l.a~"i'ed proximal opedng 18S, The 1.ipete<l pmxin~l
`opedng ms i,~ lhi;; emfa,aim.erti lms ie~,els of tapering as
`5hown, indudlng n shmp !a~red portion 188A, a {:mvoo
`t<'lperecl porlkm IS8B, ms aid&! p(miNl 18SC, ;m.d it ~t'cm:1.d
`s!Mrp !:?-~red portion l8St:t Thie !,i~red l)p~ming lSS pro·
`videi; (.~&let· a..::,:;ess .ssid inY.miou fot any device lx:ins
`positioned through the lun.wn 180 of the disml Mie 152,
`while the pn:ixl.mal extM~ioii 186 provides Nihm:--:Ced
`su·cngth to the coMe<:!ion be1,,veen tte m,u,1iptdn1ion 5h,ift
`l:54 and !he dis1 .. l rube 1!2,
`f0l56J As shown in FIG. 9A, according to certain lmp!e,
`meniati~)rm, a mmripllfatkm shalt 200 c.m !ermit3!>te in a
`pi\1>.lmal fiiting l:f12, ln a,;etmia.nw wlth one emrnxEmefll,..
`the fi!tirig 202 ls ad!!pted for ~":Omlection to a fluid wurce, !n
`certain embooh11.mt:s, the fisting 102: is a slamhrd i~mak
`luet eor,neeiion iha! is mmk fro11i. p!ai;iic, The foting. Ull cnn
`be !xmdcd lO the numipufotion shaft WO wilh adhesive, or it
`can he i,iserHtm!ded ovet the mmuplli<ltion £lll:'l!l 200. !n the
`embodiment 1:,~)W,1 in HG, 9A, there ls an option.a! sl.min,
`rclie.f ~egrnen! .W4 disposed between the mMipu}ation shaft
`200 and the pr<ndmn! fatlng 2:02, The ~train relief ~>£!.'i!~llt
`204 provides ;) tfoxil>le ttansiiion from 1l1c munipul.atitm
`sh.aft lllO to the ps\1>.lroal lining 202, fa this emb,.,,dimenl, ihe
`hm,en 20t'i of the shaft l(H} extcn,fs thn.'>IJSh she pm:<li:m1l
`firi.fog: 101, as ;.llowsi.
`[!Jl:57} Al!.enmtivdy, in Pm. 9B, lhe prtwima1 end t1f thie
`lwneu 206 in the "hls:U WO do.:'li nm have an opening, Thal
`i~, the m:mdm.a! eitd of ihc lumen 206 i~ i:wi! ln fluid
`C(immu~k,ifon with any opening at the in,i~lmnl end of lhc
`:s.lll:'lft lO!l.
`!-01581 As di${o\.1;,sro ahove, certl3b pmi<:lmal sh.ill impk·
`mentatk'\11« have a st1.<a~1th defining a hin-wn in which two
`sepamte hmer dm1gale members arc l)O$Hisxiecl, For
`ei,;m:npk, the mi1r1ipulafo:m shall 2211 showii i!t PKL 10 has
`
`a ,.!,,:mih 226 ddhting .a lumen 218 with two iM.m· efot~w.'tte
`r@moors in, 224 po.~ltio~cl 1h.e.rui!l, whe.rnln e$;C:h or lh~
`eloiigale members 21,l, 224 have fomcns, hi. t~is !.lmbo&·
`ment, both nfth~ ekmg,sle meroooflS 222,124 h<'lve .t1:.'ifocoo
`di.imeier potti@s 222A, 224A as shown. ll1 this exemplm-y
`e.mb!..1dlm~nt, ;: .. i~h elo~g,31-e snembet 1:l2, ·124 has a ~":Ortt.i.'eA
`tknt see!son 2l2B, l24B ociwcen the full dimuc!m- s~ti(m
`22:?C, :?l4C mid the n..>rlu~li diameter se'°!km 112A, ll4A
`tliai iiwdve!> ri natrowh)g or ri~k nrmm.d 1l~ fall circmn,
`foren(;'.,:. of ,lie nrembw.s ·121, 21"4 3.S $hewn,
`!0159) Al.teml:'ltive!y, the munipulution shaft 240 ~tmwn in
`FK'i, U hti" ~he3th 241'i defrniil£ a hlmert 248 'Nilh Mo inner
`dong,3lc inembtmi. 242, 244 positinnoo. ihcreio, The s.bt'<l!h
`UO lms 3 !~pewi set:!ion .246 in whkh both oftlle dong,.<1te
`me~Jibet-s l4l, 244 l~ve uiperoo sectfons 142B, :l44B ais
`islmwii. ln 1his exempfaty emboclimci,l, each dong.a.ti: mi:m-·
`ber 141, 144 h."\l.l ,sn e>.tcnoocl mper f~im !he fuH dimooier
`seeiimi 24lC, 244C 10 ihe rL•,:focoo diameter sectk,n 242A,
`144A.
`101601 A~~h,JWn in F!DS, tlA-UC,cerwin k'-,nbodi.m~ts
`of <1 di~ml tuhe WO cars ll.3:v.e fur~ segments or more of
`dilfodng f!e~ibifaks.: !ow ftexibilily <1.t tlw proximal end 264
`oflhe iiibe 160, medlurn fle);.ibifa;y in lh~ middk 266 (.of the
`mbe U.iO, and Jiigji fk:xihifoy n1 the cll:~ta! ~nd 268, More
`sey-tn<.'\.nt;ofv·,in'l;1g llexihilhles c;m. tdoo be U%l:d, 1n fact, the
`eoruK'l.::tion. mrte 11-0 (the n-re<1 of overlap in -.·vhlch tile
`manlpula.tiou shaft 262 is ooup!ed 10 the !assger nioo 26.fl) has
`v.irying flcidbi!ity in 1hnt wnc l'i'{t The differing: fiexibili!ics
`cars I-it;, a{:,t}inplfahoo lhrough combinmfons of difi'i:ring
`i:miterials, eonfigumtion-s, or geomeai~-----&s fa known hi the
`,m {e,g. m1-o;;h or ooU rei,i.forcing, clilf~-cnt PEB.t\.-"\ varleti~,
`e!c} Mo~Vet', dHfo,~nt lengths can he ~cle<:ted for the
`s.egme.nli, 264, lou, ln8 and tM CO!)Jl~tion wne 270 ac:tord,(cid:173)
`ing tl;} design ~"'>nslder;i1\1).,.')-S. Thi~ perml:1s .ttiore fle1<il>llity
`2lorig: a greater fong,th of the de'lice 2:>8 as needed lo cleat
`with nntidpllted ttirvu,ure in the p.sih !he cathele:t 258 mti-st
`follow. tn ani}l:hef' impkmenimion, the at l~st th~ seg,·
`m~nl-s have differing f!e:-.lbiHtles at, follows: low fki,;ibUity
`,it the pm~imal end 264, h.lgh flcxlbifoy ln ilii: middle 2Mi,
`ai~ !ow Ue.1dbJ!ity .il the dist«! ertd 168. Any oth{'.t ct,mhi~
`imlfon of f!eit1bill!i..::-s fa; ri!oo po-sslb!e,
`[01 ()l j As mentioned .»hove,. the flei,;ibk tube 260 ~n have
`r.3diopaque i:n.srkers emoodded in lh~ lu~ 2fi!l 3-rtd/or placed
`nk1s)g lhe length 1)f !he llibe ·?Mt fot various purpos~, for
`example, ll.'l.<'ltt:cr 274 can be used at pr near the dfaial lip WO
`of the tube 2Ml to hdp !he doctor locnte the positi1)n of the
`lip 28(L Anolhcr imid,!$t' 276 could be llSed at or n.C<'lr the
`pro:-.html end 2:R"l d the mbe 260 to as~l:.! thie dt1c1or m
`ki1-.sifrlg !lll:'lt end 182 of the !uble 260 relative to the encl of
`the guidfog calheler ot to assist in vlsuaHz.iiig the fo1-.iiio:m. of
`1.he proximal Op<1'-ning of 1he lube 26-0, ln MC emhodlrnen!,
`1he miirker b.snd 276 <'.an bi: loclltetl near the ~soxlm.~l encl
`28'1 of the ttihe bµt as ,i position on lile nibc 260 th,ii fa dislal
`t(i 1he end 182, us stio'<'•'fi in flGS. UA-UC.
`l\irther, in e,main embodiment..,;, ~ rudiopaque
`jOH:l:!
`Irti.rkt~ {not sh{lwn) cars 1:w kl1-cat(..J anywh!t"-t~ in or ise3r the
`connection zone 210 {c.g, on the mooiptllatfon shaft Z62 fo
`or ll<'.'<1r the ~mnm;tlon ,mne 27-0 O.' lu the <lii,!l31 luhe 2M ill
`she ~-cmii:.-ctlon u:onc 170}. Fisrlher, MY of lhe lW3.r};er,; 274,
`216, 278 rnn be tlOn--qHndtkal. F1..'r example, oiw Qt' mo,e
`<if the markers 274, 27n, 21S cM he strips {Jr other kn.own
`cmiflgu.ral io.1s,
`(lll t.iJl Os)e or mare {if 11iese mnrkers 214, 116, 118 ~an be
`hdplhl 10 lndkate ti.'• the doctor or surp,ec<1i the locution of the
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`Page 363
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`Teleflex Ex. 2251
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`US 2017/0095646 At
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`Apr. 6, 2017
`
`proxim»I .end 2.82 of 1he rube :um in refotii.)n to tlw guiding
`caiheier (not :;hown) !><,} !ha! !hey do not insert <.\, pusti the
`proximal end 282 past fue distal end of the guiding c&!lml.er.
`fo !his regard, certain i.-rnbodime.m;; in""fode ,1 third m.irh~
`278 lncBtc.-ci ,ll .smne opiirnal point .ik;ns the lube 250 in
`be,w~tl the other two inarl<:~.rs 274 mid 1.16, as shown hi
`FIGS, ;m, UB, and UC A$ t<C$l shown in FKi. ;m, Hie
`(foc!or or sur,gro11 c:an use this third nmrker 178 to lr;i~~ how
`fa, lhe tube 2#0 is exlending beyond the guiding ,,iilwler 12,
`That is, the third mm:ker 2.18 can be· usd ln .:-er!.iin dtt:tim·
`stances ,3:i a limit iml.foaiw. For example, in .i spedfa:
`embooh:nem having a lube 2Ml Hm! ii; 15 cm in l,mgth, the
`third marker b,md 218 mcy be kcmed 15 cm from the distal
`end WO of the tube ~MO in order to indic;ite tiss !)redeter·
`m.lflcl: distam:e to ihc d~tor, ~.id1 that !he dt)ctor know,; lhe
`dlsiam:ce that the ilista! end 280 ext,md& beyo.nd 1h"~ guide
`(:.lt!wler U, ~pending on Hie specific configurnt§.:m of lhe
`catheier lS.~, the 1hkd n1arkl't' band 27S c;in lm dispt'>Secl in
`the low fkx:ibifay s~~me!lt 264, 111e middle fki,;i.bilhy &l<g·
`mtmt 2.6~. m pnl>-~il:>!y even io 1he high flc>:ibility segment
`2.68,
`{01641 h i;; um:l~rnloorl tlla! !he di51;il 111be 260 can 11,ive
`one, t<.•m, thn,e, or n10.re markt~·s as tfu:scrsl.'{.'<l abnve, h i:s
`Ji.tr1her i.mderst()l;d ltmt ai:iy marker nmmg~meni. of one or
`mm~ markers, im~h··,fat& IJie illR-e mMker a:crMgeimmt, ~.m
`be ui,.oo in cottne<.~li!.\\1 ,vi!Ji a Vllfie~ of c.1fut~e.- c~)nfigun,(cid:173)
`tl.ons, i.i:w!.udhlg m..1se having a :solid mil (e,g, ,l llat or mund
`wire} ~)r B hnlfow mil (31' pm:>:lma! w~!i<m wish a lmmsn,. six:h
`as ll t\ibe, ln other il11pkmes1tmionii, oru: or nmr-e mark1:n t.!11
`be pos:iilon:ed tin the ma11ipu!atkin ~!mfi 16.Z,
`fo further emhodini.enl:s, the pmximal t,hafl 262 l,111
`!016SJ
`have gre,,1iel' longiruclinat ffuxibiH!y IJian the dbial wbe 160
`or rmy p<irtlon ths.~e(lf.
`jOlMl Accordh~g to c.eiiain implemema.tkms, the pmxi(cid:173)
`mal &h,ifl .M2 t:,,n hllw a hi.men in thllt e»ternl:s a!nng th~
`length of the proximal shafl 261, As. shown, the !1.unen 272
`ha:s m, ds:,ial ope.ning 1'7.l !h<1t is in !Md i::mn,"tli.miM,fioii wi1h
`mt ill'~ external t{) artd pmximal to ihc distal tlibe 160. hi
`<1!teni.1fi,,e ~mbodimetll.s,. foe shall 262 (:;m ex!end di~t,,Hy
`ii110 the dlsial tuhe 2M :mch that the !um.en 211 is. in fluid
`wmmimk:atlon wilh the lumen of the di,;la1 1ube 260 vfo ,he(cid:173)
`apei,ing 113, !n a funher alternative, the shaft :Ut? c,m
`e;.:1end d.fa!~Hy lhrou3h !he dista! uitie .ZM stit:h th«! the
`lumen i~ in fluid eonllI!un:il'lllttm with an area ex!ernal to nnd
`cl.is.ta! to l~ di!it2l tube 260, l.a J(..'t atR)!her a!lem,3t1ve, ihe
`Jiro1.ti.aml i;h,3fi 262 has m h.iir1t.•.n.
`{0161! Olher embodiment!> imJude additional :rnpport
`siri.icmn: fo the dhsl»l Mre tll.at can pr~)vide med1&1kal
`adv,mtage similar to IJial pRwided hy the s.upp......,rt roil. FIG.
`BA &pk!;; a dtvke J!lO bvfog a dis-!al tube .!02 witti a
`s\ipp~1rt memh1:r 304 p<isirkmoo !:n the cmu1eciion rone 366
`ttmt is coill'igmx:<l to assimw at least some of!Jle med,m:u,al
`load.'>, Ailemative.ly, flQ, UB depicts another embo,::Hmem
`of a stipp<,.1rl member :l08 pooitkme<l l.n the er11uiection mne
`J{lS of a dii.sa.J tube 302, ,vhHe FIG .. t3C shows n furiher
`implerrue11tatkin of a support member J. Ht In a farther
`atlenmtiw, i.he iub~ .3Ul ca11 haw ~'O or m(m~ supp,..-1rt
`membet-s.. hi cersam embooimenls, ilw :SllpfR)f1 member
`(inclmiing fhe slipp~,rt i111:~nbers 304, :H.m, :HO ,::kplcted in
`F!OS. BA-BC) (:.1n be the distal portion of then.,){{ or ti.ibe
`ei,;temlitlg. dis.tally fwm the sh.an ,l u.
`!01681 As rtientioned abl)Ve, certain add.l!iNml embm.li·
`meui;s as di!idosoo an<l eontempliitd henifo reillle B) ml
`improvd !,':,11:hcier tip that cBti he incorpo.taloo !nt,1 mw
`
`K!lliwn mt.lli,layer calhe!er, incfadin9.; any catheter disclosed
`hei'ein or any o1het cathet~r for use in a hunmn pati.mt. As
`wrn be exp!ained in forth~. dizl'Bil below, the vatiou~ ~!he!er
`iip emhodimei:1:ti; disck\.'N!d herein lnwe '° p.mtective wrap
`dlsp;.)iled at the lip of !he e~tiiett-"r that climhlaie:s any
`e>.p(!sed. ends of the mbu!ar layers,
`[ll169J One e~i1hodimem (Jf catheter !uoe 340 with an
`improved cBlheler lip 34l i& <k1')kUi.:1 in F!(l 15, Th~ ti.she
`340 ha;; .i fast !ayer {whidi, in this e:<:iuuple, ii. al.so an inner
`layetJ 344 and a sec<im1 laye:r {wlridi, in !his example, t!i ali..i
`M omer l2yer} 3M. ·J11e two layers 344, 345 are pi}Eitioned
`adjacent !u each mher and are .idhered, s.~Uf!led, tJ, olher-(cid:173)
`wis<: a,u1dit~ 10 each oth1:,~ along a suh~t,mtla.l length of
`1:»dt The ln.m:-~ fayer :M4 also has a pmtecfrve wrnp (a!.ro
`refom:d la a& an "extended p{mion.," "e1ue11sic.'lfl," "distal
`wrap," or "prntc<efr>!e Hp") 348 that e.xteiids beyond loo
`!eittth of th.~ ouier fayer .:Ml'i a.'ld, hi this hnpleme11tation, ls
`wrapped Rrouud !he distal end of th(: outer fayer .l.46 iui::h
`that the e~tenml portk'lll (alw retinn'Xl io as "outer porfron"
`nr "distal pmtli.:.n") of the el'iletided i,'0!11011 348 exteiids
`tmvaro i.be prt)Xitmil end of the nibe 340 and is pcsilioned
`agal.nsl or adjocen! to the ei,.,c:rior surface of the outer layer
`346c, This e<rnflgwatlon et<:.lte:s a fo!d 3SO (nlsi.) referred to
`herein <ls a "disM fold") t)fthe extended portion :M.8 at too
`catheter tip 342 that fuciliiates. prot~tl.oo of the Mi~ foyers
`a! fue lip 342., tn<itherw<irds, tiiepo:slti.orili1:g of me extended
`portloii 348 as g}iown emmes. th;it the ..mds of ihe /.isye.r,; J:44,
`346 ,ire 11ot ~i,;JX!&ed at Hie dili!Bl ead of !he tube 340, !hereby
`R~U<=ing th<.:~ risk of defomin.1fam and the pml:>k-ms related
`thereto.
`In this particular emoodimeni., 1hc P.'<>tet:tive wrap
`{0170{
`HS is i~legrn.l with tmd i:s an e:<lendw. p~1rtlon of the fo,1cr
`foyl;)~ 344. Altemati.·vely,. in any of the catheter ii;µ emhm:ll(cid:173)
`meoi.s disdos(!d or c1m!empfaK<:d htc-reis1, the proi.<:.~tive wrap
`{sm:;h i1:s pml~'le!ive wrnp 348} ~n be a ~a.r-.sle &'O!Ilf.'OMnt
`that is t:miplerl io the disla! eri<ls of the iruwr l.ayt~r {in thfa
`examp!e, '!Ile inner lay1,ir 344} mcl lhe a1.1ter lay~.r (in this
`(:,lse, lhe outer layer 346) .. hi a fal'llltt ah{'.rnatlve, in imy of
`!he t1lll:wier iip embodiments disclrn,e:1 or c<mtemplated
`herein, the prutecfrve wmp {such as prote(:tive wrnp 34SJ ean
`he im<.:1;ral \\'Ith and an extended p,)fifon of the 01..aer la~r
`{~a.di ,m omer fayer 346\
`[iH 711 FlG, 16 shows ~nothcr emh.xfanem of n c,11hcter
`M~e %0 wilh M iisipK·wed <:athelcr tip 362, 11l~ tuhe .3@
`hils a fin.! (or "fo.m~r") !ttye.r 3M ,md 2 S{."COl1d (omer) fayer
`J66 th,it are ix,s:hkmed adjacenl. lo eac.h oilier and are
`o.tiachc<l to ~ch asher a!m,g a subsumtial lengih fuereof, kt
`thii. i.mplememati!}n, the prou.>ctiv~ wrap 368 fo an extei1doo
`ponion 368 of !he inner faiye.r 164 dial exse11d& b..~'tmd the
`length of 1he m.H~r !ayer 366 and,. in !h.ls imple.mei1Mion, is
`fol<li.«i such th,il ihe e-:<!em.il pos1ion or ou!e.r r-,m-tion (also
`~,fen~d io here\11 as th~ "distal portion") 368:,<\ of the
`<Ii<H.mdt.<tl pos1lon J6S is pnsi1k1aoo against ur adjncen! to lne
`inlernal ixirtion N' il'l..tiesr portion (also refam~ lo herein S$l>
`!he "j)Kl:<imiil f)QI'li-."-n") 3~SB .and the &st&! (..'tln 370 (lf lhe
`e»tema! ponion JMA ls po~i!iomxl awiiu~t or att;iched lo !lre
`distal end :rn nf ,he mner fayer 366, 1fa!l. txinfigm11tion
`ereat~'l! n fold 374 {also refom .. >d to herein a& is '\fo,,al fold"}
`af the ei<te11di.:,J ~)t''t!on 368 at l'.he t.~thet~r tip 362 ilia!
`fociliilltes pmte~lion <~f the rooo !,syef!i al the tip :l~l. Like
`the embi>dimenl depk!~ in FIG, l~, l.h~ ct.'nfigu:ration ofilie
`pmtectiw wrnp )6'8 a.s sho">vti ensures ihat th.e end& of the
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`Page 364
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`Teleflex Ex. 2251
`Medtronic v. Teleflex
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`

`

`t.JS 2017 /0095646 A 1
`
`Apr, 6. 2017
`
`12
`
`byeta JM, 36-6 ,ire not exposed til th~ dis!al end or the tube
`3M, there&~, reducing the risk ~if defamfrliilfon imd lhe
`problem~ re1att-x'! ther;io.
`10171} A funher l.mplcmemaifon of a catheter tube J80
`with ai1 imptow.<:d e:ifoelet Hr JS2 is ®{lli:ted in FKt 11. The
`mhe 180 ha8 11 first {hm1,n') layer 384 and a seetmd (ouh:.>r)
`!.rya- l8ii th.ii are positlor~ adjacent !<.) e.~h