`
`Director of Experimental Cardiology
`
`David Meerkin
`
`Shaare Zedek Medical Center
`
`Jerusalem
`
`Teleflex Ex. 2149
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`Medtronic v. Teleflex
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`of procedural failure
`
`Factors
`
`Poor back up i force before guide
`
`displacement
`
`Failure to deliver a stent is a frequent cause
`
`
`
`Tortuousity J, distal transmission of force
`
`Friction between rigid stent and vessel wall
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`SVG PCI accounts for between 540% of PCI
`
`procedures
`
`technically more
`procedures
`PCI
`SVG
`challenging than native coronary arteries
`
`
`
`Previous CABG shown to increase failure rate of
`
`trans radial PCI procedures 7-fold.
`2(11):1057-1UB4.
`
`JACC |ntv,2ii{19;
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`SVG—PCI include:
`
`' Inadequate Guide Catheter Support
`
`- Inability to reach ostium and cannulate SVG
`
`- Difficulties encountered during
`
`
`
`- Competitive Flow
`
`- Achieving deep seating of guide catheter in
`
`SVG
`
`- Extreme Tcrtucsity
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`Support guide - T force before
`
`displacement
`
`Support I buddy wire
`
`- reduce
`
`tortuousity
`
`
`
`Lesion preparation I lower profile stent
`
`- i friction
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`Distal anchor balloon
`
`T backup support by locking guide
`
`
`
`may increase friction (2 catheters in
`lesion)
`
`requires 2 7F to accommodate inflated
`
`balloon + stent
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`\ Guide looked in
`position allowing
`
`Stentoatheter
`advanced through
`
`proximal obstruotion
`
`1-—_
`
`Balloon inflated in distal
`
`vessel
`
`Distal anchor
`
`balloon — JR4
`
`9 U ide
`
`increased foroe on
`
`stent before
`
`displacement
`
`Need :2 ?F
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`Guide catheter extension
`
`Greatly increases back-up support
`
`. Shape modification ‘Amplatzing' T contact in aorta
`
`- Deep intubation increases contact within the coronary
`artery
`
`
`
`Can be advanced through proximally deployed
`stents
`
`May traverse proximal obstruction
`
`- more flexible than a stent
`
`Can be advanced using distal anchor balloon
`
`- Requires only 6F without need for 2 catheters in lesion
`
`- Permits proximal to distal stenting
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`JR4 guide
`
`limited support
`
`from contact with
`
`Support from conventional JR4 guide
`
`
`
`H
`
`opposite aortic
`wall
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`resistance to stent passage
`
`causes guide to back out —
`
`backup is lest as guide
`comes away from coronary
`
`Guide catheter backing out
`
`
`
`esteum & aortic wall
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`“Mother and Child”
`
`5F through standard 6F
`(CordislMedtroniclBoston etc) guide
`
`
`
`Classically used
`
`Terumo Heartrail 125cm guide
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`Mechanisms of increasing backup with guide
`catheter extension
`
`Shape change of guide
`
`Deep intubation of coronary
`
`
`
`Deep intubation
`
`adds greatly
`
`increases contact
`
`within coronary
`
`artery greatly
`
`increasing support
`
`\
`
`'1
`
`If
`
`Shape change of JR4 into
`
`‘Arnplatz Left' shape increases
`
`contact aorta increasing support
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`Coaxial
`
`“mother and child”
`
`
`
`guide extension
`
`with
`
`rapid exchange
`
`convenience
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`3' 20cm guide extension connected to
`
`
`
`-" Guidewires, balloons and stents
`
`enter the GuideLiner’s collar within
`
`the guide catheter
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`Teleflex Ex. 2149
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`IPR2020-00135
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`a push-rod with a “collar”
`
`= Flexible GuideLiner extension can
`
`be deep seated for mother-and-child
`
`back-up support
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`3 3 3
`
`
`
`Guide catheter
`
`Tip of GaideLiaer
`
`GaideLiaer
`
`positioned at ostiam
`
`deployed into
`
`advanced diataiiy up
`
`off? CA
`
`RCA
`
`to I Oem into vessel
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`Distal anchor to insert Guideliner,
`staged stent insertion
`
`Guidelineradvanced1;' t
`through proximal
`_
`2
`'
`[H
`obstructionrn
`\
`Anchor balloon
`
`I
`
`i.
`'\
`
`Guide locked in position allowing
`
`increased force on Guideliner
`
`before displacement 6F
`
`removed after
`
`Guideliner crossing
`
`
`
`Balloon inflated in distal
`
`vessel
`
`Stent advanced without
`
`resistance within Guideliner
`
`catheter
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`Severe proximal
`
`disease causes
`
`pressure damping E‘s!-
`
`prevents serenary
`
`intubatien
`
`Severe proximal and distal disease
`
`
`
`Distal disease eann
`
`be reached
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`Guideliner assisted proximal then
`distal stenting
`
`stent undeployed
`
`stent expanded opens
`.
`proXImal vessel
`
`Guideliner advanced
`
`through deployed stent
`allowing access to distal
`h
`iKt: vessel
`
`“a.
`
`'5.
`~. K:—
`Halon—r"
`
`
`
`Guideliner increases
`
`support to allow stent
`
`advancement into
`
`proximal lesion
`
`I
`
`.
`
`J
`
`‘1 all.
`
`I.
`I“.
`"my
`$3173.;—
`
`Teleflex Ex. 2149
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`r"
`
`*5
`_.?-:
`
`.I--' 'L .
`1 HUI-2y My)
`WHQIEIfimuPCIENEW] — unramed
`
`
`
`Irrage S'ze: 5|? :x'SIE
`View SiZE‘Z 506 :x: EIUE-
`
`W; 102 W'III’: 202
`
`13—15% fing'e- F]
`Fmr‘r'
`Irr: 1336
`
`Uncompfiessed
`
`EEQUIUQ
`14
`
`ESHUEII’EUUQ 39:54:25
`
`Made In DSifiH
`
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`INEQESZEZS123512
`View SiZE‘Z 506 :x: «EOE
`
`W; 91 WW: 13:1
`
`,
`
`..
`
`-
`
`_
`
`ME T9233! "My?
`Angiografl-PCIIINENZI — mrarred
`
`EEQUIUQ
`15
`
`
`
`Fmrr: Fifi fing'e: [‘1
`Irr: 1342
`
`Uncompfiessed
`
`.5
`
`-
`
`_
`
`-
`
`+
`
`"
`
`-_
`
`.
`
`.
`
`'
`
`ESIUEIEUDQ 10:10:47“
`
`Made In DSPiH
`
`Teleflex Ex. 2149
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`Medtronic v. Teleflex
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`IPR2020-00135
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`Page 22
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`
`Irrageaize:512 36.512
`View Size: EOE: 3: E06
`W; 92 WW 15:3
`
`|"1| 723“ My]
`Angiogram-PCIHEW] — unnarred
`EEHUNJH
`
`.m Ewfifl
`
`
`
`me7‘1'fifia'fiwgh-F '
`Irr: 13??
`
`Uncompreased
`
`253’ 36:20:19 10:21:23
`
`Fade In DSHH
`
`Teleflex Ex. 2149
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`
`
`Imagesize:5|2::512
`View EiZE‘Z 5L“) :4 jUD
`WL: 90 WW:
`17”}?!
`
`VIII ?2y,?1y3
`Angogram-JLIHHF] — urnamed
`2200500
`
`-- u.
`
`- :‘24
`
`
`
`x .L- ,i... If§:iir'-‘I;
`EUIJIII. 15 :53 Allglt‘i C'
`Ir'r'l' 1I4lfil
`
`Uncom-resaed
`
`:Efffifi'fiflq Hl'fJ'fi'fifi
`
`Made In DSiPiH
`
`Teleflex Ex. 2149
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`In'agr} aim: Eiii .3: 36.51.36
`View size: 805 3: E06
`W;
`iUE’J WW: 21L]
`
`'.-"='.1-
`
`..
`
`"H y J
`J
`151?. 3;
`ii I
`Angiogram-PCH‘JEW] ------ Lirmarred
`EEULJIU'Q
`
`._..
`
`,I
`
`..
`
`‘1; i
`
`
`
`?r‘r'1r‘r‘r 1'31??? Afigip- I”
`Irr: NEE
`
`Uncompreased
`
`25f JEJIEUUQ 10:43:52
`
`Fade In DSiiH
`
`Teleflex Ex. 2149
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`11.1.I_1_:_;_:rgi_1;: {53.311111133331131
`
`-;":f'-.;-1;:'111.111111HE =|;|]||11.‘g;—;:-
`
`1111.1 L111-211
`'-
`..—-x
`_-.
`_.__.-'.
`I
`| 3'
`
`5571
`
`(SF (5-in-6)
`
`6F II). E 0.0?0”
`
`0.056”
`
`(1.78111111)
`
`(1.42111111)
`
`
`
`5572
`
`113 (6-in—1)
`
`7F ID. 3 GETS“
`
`0.062”
`
`(138111111)
`
`(1.5?111111)
`
`5573
`
`8F (1-in—3)
`
`8F ID. 1“: {1088”
`
`0.0T1”
`
`(224111111)
`
`(130111111)
`
`Teleflex Ex. 2149
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`Conclusions
`
`
`
`The Guideliner offers the ability to
`“change course midstream” due to its
`rapid exchange nature as well as allow
`for staged anchoring and extremely
`safe deep cannulation
`
`Multiple techniques can be used in
`isolation or in combination to maximize
`
`and optimize guide catheter support to
`deal with most limitations
`
`Teleflex Ex. 2149
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`IPR2020-00135
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`Conclusions
`
`
`
`the expansion of the transradial
`approach to almost every scenario
`faced in daily coronary practice
`
`The combination of Sheathless
`
`catheters (6.5F and 7.5F) and 5 in 6
`and 6 in 7 Guideliners allows for
`
`Teleflex Ex. 2149
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