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1001 817_ElJ28_TAF’60_Fiao 30/06/10 18:85 PageZY7
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`lnterventinn
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`The Guidetinerm “child” catheter
`
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`
`
`Introduetion
`Deseite the advancement n percutanecus rnzerventional
`
`pr.
`.edttres including newer stehts and better e eiivery systems, the
`failure to deliver a sterit tr; the target lesion, especially in arteries
`wth complex anatomy,
`remains a common probem, Various
`techniqtcs have been LSCd to solve 0r
`retfln’ help with this
`dilemma including straightening the aver; with a second “budcy”
`W‘le
`or “huec‘y” balloon,
`larger anc were supportive guiding
`catheters, er deep intuhat-ur' with tie guiding catheter for haul. up
`supper; The Heartraii
`Zl ('ierumo.
`logo, Japan} “Five in six
`catheter syetmr” also called "mother and child",
`involving the
`insertion at a tiexible tinned extra length (120 cm} 5 tr catheter tar
`deeper intuaazsn with extra bachetp Stpnort, has been described
`in the literature, arid is an accepted technique lur
`improving
`support and deliverin stents in difficult case??? More recertly. a
`new “Child”
`support catheter has been introduced the
`Guide-Jnerml {Vascular Selutioris, Minneapolis, MN, USA}, The
`devrce received CE marking in September 23:39.
`
`Device and teehrticat detaiis
`The CI..,deLinerTM caineter is a coaxial guide extension with the
`cunveriienee if rapid exchange.
`in elilieult and c’ialleriging
`interventions guide catheters have a tendency to back out of the
`artery whereas the GuidtetirierTM allows guide extens or into the
`vessel tar deep seat ng. Th 5 simplitiec “nil-NSF and child technique
`is useful in challang rig interventiens and tar rapid exchange
`it is composer: Ci a ‘lexible 20 3th straight guice extensini’i for deep
`seating, connected to a etainlees s:eel hush tuee win a “collar”
`waict can be jnplaynd il’erLgh the cxrsting Y'arlapte' TSY rapid
`exmeige delivery (Figure 1} Urlike the Heartrail catheter.
`the
`Guide-.inr‘erlM dues not ircreaee the overall guiding caiaeter length
`or require a sewnd haerriustatii; valve. arid due to LB rriurrerail
`desgn is simp'er tr: use than the Heartra it The Gaidejnerm can be
`
`
`delivered through stai‘derd guide 0 5 resulting in an ir‘rer
`
`Clia
`r that is approximately one trench size smaller than tie
`guide. The Cu detiner"M is Ct rrently available in three. sizes: 57in76
`(0.056” internal diameter), e, r:-? (0.062 ' internal diarrieter) and 7,
`in~8 (0071" interna: c arreterir
`The axiom on is 20 crr tang, but a maximum cxtnrsim ht cnly 10 cm
`is recommended and has a silicon coaxing tar" lubricity. The extensicrn
`sect-0n is
`a component built
`tube composed Cit an inner
`pd ytelrailuuruethylere (PTFE: Teiluri) irrer, a middle etairrless sleet coii
`(which UlOViCieS maxrmum flexibility while retaining radial Strength}
`and an miter mlyefincr block amide {Pohax‘i palymcr oxtrusinn tag me
`material as a gu ee catheter. and flees not eoiten at body temperaturel,
`There S a radrcecpaque marker located 0.185" (2.85 mm) from the tip
`(Figure l}. The guiee exte'ision i5 wi‘r‘ected it) the push tube wtl‘ a
`"collar": geidewires. ballocns anc‘ stems enter the collar within he guide
`catheter (Figures 1 and 2) The delivery through the guide is eeeigned to
`
`e tight in order to prevent slppage wiinir ire guide cattle.
`, There are
`white positioring markers on the push tube at 95 cm (single) are 105
`an {dauhle} tn age at 2n placement through the guide (figure i).
`
`{néieatiens far use
`:4 Deep seating lur added track—w guide saaporl i'l challenging
`coronary cases to taciiitate device deliverv.
`2.30axial alignment when irregular coronary nstiim take (1ft
`ar'everts guide placement.
`Lise of the Gtiicleljnerl'r“ cathete’ is :ont’aindicated n vessels wth
`less than a 2.5 mm diarieter.
`
`Tips and tricks for aptimat perfermance
`it
`the GuizleLiner‘M should be inserted rte ire guide catheter ever
`a 0.011;" urinary gildewire t0 a n‘aximum 0t 10 cm beycr‘c fie
`guide tip tride' lluuruscupy and n Tit} eaee more than 20 CH to
`prevent the rretal collar from ex’tii‘g the geiding catheter.
`
`‘ Cerresmnding author» fist and North Hartfordshire NHS mist, Card/84: Suzie 194. ti'ster Hospital, Stevenage 36] MR, Hartfordsme. United
`rifi'rigdvrri
`t—mall: nee/ilekukr ‘
`
`‘biintemetcom
`
` Pi)v.3vex;
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`Page 1
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`Teleflex Ex. 2067
`Medtronic v. Teleflex
`IPR2020-00131
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`1001 817_E|J28_TAP60_Ra0 30/06/10 18:35 PageZYB
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`200m rapid exchange section
`Fwfi
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`’i
`,
`-
`.
`_
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`Rapid; exchahgej
`a
`transition ,9
`‘x
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`figure 2‘ The GifidéL/nerm camefer. This consists nr’ a flembi'e 2:") am straight guide extension connecfea’ m a stainless sfeei’ push tube,
`* radiopaque marker 2.66 mm from tip. Arrows; White positioning markers at 94 cm (sing’e arrow) and 505 cm {double arrowsl
`
`
`
`
`i;,..erti0r2 of {he GuideLmer’M, The monorail Suidamer
`‘g re 2;
`Canister is inserted 217:0 a guiding caifiefer over a guiaewire (OW) (i).
`we 'dv'na‘
`in!
`n
`‘
`i m C' h fen ii” “ i’eLin r H ‘h f
`i
`:71: b: ajfan::d iijiijsfiijéjflggthiGi/ in fogguj}. Th:- gLifieLiW:
`can be advanced up to 3.0 cm Leyona {he guidihg cai’ireter' M) (iii).
`Bal’oons or stems (5; can be advanced along {he guidewire mi,
`through the GuideL/nerio the iaigei.‘ iesion (it)
`
`
`
`
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`PC)
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`5‘
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`. On initial insert‘on a? the Guiceuner‘“, the flat push—rod shouid
`3: oriented in a {atrial pesiiinh within the guiding cathicr and
`shcuici 3e a ~«anceci within the guiding catheter without reiation
`to avoid manning the gaidewire around it
`3. Deep sewing, of iiie GuideLi’m‘M in the wror‘ary entry can be
`f'aCiiitated by usmg afi uneim‘iaied baiioon catheter over the
`arimary ware min dista! vessei
`i heneasary this cm than he
`ihi a‘ted a’i the iarget iesiori to 8L2 as an ancher, foficwed by gentle
`advancement of the GuideL hermi
`4, Simie Shnim be advanced (we? the (vi-”nary guidhwim ?hrnugh
`the GLideLiher \" as secondary wires may wrap ammd the
`GuideLinerw pusn tube. obstructing s:er~: irsertionv
`
`in case 0i resi " ' ce whiie insertir‘g a guidewre or sieni ;iir0ugh
`the GuideLinerW, the ioca‘iior 0" the wire or meet n relaticnship
`to the motai collar of the Guidceinerm should :0 theme: and
`m
`the
`ieni inspectej f0" 5 gns oi damage prior to reeadvancement.
`To correct any assistance tho, scours at (or proximai to; 218 cellar:
`a Ensure {he combinaiion mi [he wire ai d sierii is compatibie
`wih me mernai diameter 0" the GuideLinei’“M.
`3‘ if e :hmndary wire is in L30, check for wirc w’rahp rg 37' the
`secordary wire around {he GuiceLinerTM. If so CUflSidei’ either
`puiiihg back the seccndery wire or vie-advancing i. or if the
`winery wire (pieced Sabre Ge: cem’neim ii'seiiion} e eiili
`in
`piece consader advancing the sient over the primary wire.
`if a sient cor-times ta encounter resistance at the metai :ciiar,
`puii the stent and guidew-ie aack together 34:3 cm and :i} e
`advancing the stem and guidewire Eagether through fihe rhetal
`coliar.
`if resistance is again encountered, Check the men: for
`Signs of damage and either choose a iswer praiiie stem or
`Change the guifiewire.
`c
`.
`.
`CETE’IEQB! EXBBflQnCE
`
`A 74 yo;
`‘id paiimi With WWDUS coronary Mary bypass grafiing in
`EGGS was admittec mm a FCI‘HSi eievatier- myosard-ai
`i-iiarciion
`(NSTEMU ahc n‘emiatera! ST segment Changes. His ecgiagram
`shuwed c moderate iescri i'i lize pro): ma! Iefl afllS'C!’ deeceiidirigariery
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`Page 2
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`Medtronic v. Teleflex
`IPR2020-00131
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`

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`1001 817_ElJ28_TAP60_Fla0 30/06/10 18:35 Page279
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`(LAO) and a tignt steriosis in the circumflex astiurn. The grait ta trie LAD
`was occluded but there was a patent jump graft to an Cihthe mar; i‘al
`and posterior descending aviary The right cornnary anew {RCA} was
`tortuii-Js and calcified with tights‘renases in the Dl’Oleal and mid vessel
`(Figures Ba and 3t). Percu’iaheous interver‘tioh t6 the native RCA was
`performed trahsfomuraily rising a 6 Fr Sheath ihscrtcd i’l ih: right
`femoral artery. initially a hockey stick guiding cat'iezer was used which
`was Changed tC an Ampla’iz Left {AL} 1 guide for belter ehgagamerl. The
`RCA was .lliill w red usu’ig a BMW wire (.‘ibbullVastular, Rejwwd City,
`CA, USA 1 and pi'evclilatecl will“ a 2.5 x iii Mai/aria balloon (Boston
`
`Scierlific, Narihlr MA USA) (Figures 3c and 33}. However Clue to a
`umihhaiiun cl calcil'icaliei“ and tow
`eliiaeiedi
`
`
`lip, a gem soul: m
`After Hither dilatim will a 3.0x15 mm Maverick ballxn, it was still
`
`impossible in arirancr} a slant. Therefore. 5 Giiidel inerTM Ckfl‘fiifir was
`deployed though the A a guide and advanced into the mid RCA to aid
`alert delivery (Figure Se). This enabled the easy depbymeriz of four
`overlapping d'ug’elulirig saris from the mid/vessel
`lo the usiiurri
`(3.5x15 mm. 3.5x18mm, SEXZE mm and 35.18 mm: all Fromm;
`Bastian Scicnt lie, \laljck, MA, USA). The Cir-snaps were, aostrjiatod with
`a 3.5x8 irm noncor‘hpliant bal can (Quantum Maverick; Beston
`Sclertifiq \laticlr, MA. USA) whilst the osturr or RC wag pest—dialed
`arid flared Will'- a 43x8 rrirri riuri-corriplarii ballwii (Quariluiii Mailer Ck;
`Boston Scientific. Naticla MA, JSA). A good angiographic result was
`
`am.
`{Figure 3f). The patient was discharged the iallowirig day with
`no con’iplications.
`
`Discassiun
`in this case, stent delivery was impossible despite the use of a
`highly sumytive gulG rg catheter. By using the GiiicleLherW the
`stent was daployec eaSily anc successfully because of the extra
`back up support and deep Museum” without an; cispiacemeir of
`ihe guidc catheter or the wire. 3’ any vessel ham;
`
`The Cuidelinerm provides a new alternative for performing
`simplex interventiona Benefits 'nclude:
`1. Deep seating Witl" a straight. highly flexrble guide extension.
`7 Unlike deer) ihlLibatiOn of a gilding catheter, there is nn Grimary
`curve lo urilerilia ly darriaga ar‘d \j‘SSBLLl. vie vessel.
`7 Cal backbone pi’cvidea superior llexia lily while retaining radial
`strength.
`
`. The Gavin. TIT-ll] rediicns 1hr»: 1.2mm by approximately are Frmrzh
`
`Size, 30
`hast all dramas will still tit through a b H GurdeLinar’m
`(lrtema: diameter 0.056“),
`ax sting
`through hr:
`3. Rapid excharga aid?» deployment
`haemostalic valve without extending the guiding catheter length»
`and so does no: :imit the Lsable length at helicoris and wires.
`
`'\)
`
`References
`1,
`ja’ary Fl—i. When are avail i110 ii, use lwuduub 8 ”way" W ririg lu
`
`laciltale sleril advariceriieiil a
`‘5 a Eilg‘ily Lalilllieil artery. Caz/Her
`Cardiovasc Me: v 200657.721
`
`
`E. Taraliabiil 8, Sailu S) Tariaka S. Migrashila ‘i‘, SHOW} T, Ara: F.
`
`Domae H. Sataire S, ltoh T New me: dt
`lease a backup support of
`a 6 French guidirg mmhary :atl‘iete“ Catheter Cardi’avasc Jittery
`21)U£:63:4E;2-b.
`
`E» Shaukat A. Al-Buetam‘ iv, Orig PJ. Chronic total occluaicn-«use of
`a b Hench guiding catheter in a 6 Hench guiding catheter. J Invasixe
`Cardin 200820. :1 7—8
`9’ Fraser D. Successrli use of the
`4, Mamas MA. Fath-Crcoubad.
`Headrail ill catheier as a stem Celi‘iieiy cathete’ to lowing failure of cah-
`ventiaral techniques. Catheter Cardiwasc mew 2008;71:358-633.
`5. Mamas MA, Echho‘i’erJ, Elendry C, El-Omar M? Carke D, Nevses Li
`
`Fair—Ordained E Fraser D. Use at “ r3 lleartrad ‘l catheter a3 a distal
`Slant Claiivery Cl,
`. an extan. ,d
`Ftrroi‘nrervsnimn
`
`
`
`
`
`
`
`9
`
`a.
`
`is} Using an Ampzarz Left 1 gurde, the
`Figure 3. Clinical use 3% the GuideL/ner'“. fa) and ([3) Diagnostic angiogram of the right caz‘anary artery.
`lestons were crossed With a BMW Wire {d} We fastens were pre—dtlafed but a slant could not be advanced. {e} i'ne GmdsLmerW (arrow) was
`advanced up to the 195mm to allow dealoymsnf of the stenr (anal/mead}, {fl Final angicgraphrc result.
`
`
`
`EX)v.3
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`rill?
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`VSIQXM_EOOO44477
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`Page 3
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`Teleflex Ex. 2067
`Medtronic v. Teleflex
`IPR2020-00131
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`Teleflex Ex. 2067
`Medtronic v. Teleflex
`IPR2020-00131
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