Medtronicv. Teleflex
`
`David Meerkin
`Director of Experimental Cardiology
`Shaare Zedek Medical Center
`
`Jerusalem
`
`Teleflex Ex. 2149
`
`
`Page 1
`
`Teleflex Ex. 2149
`Medtronic v. Teleflex
`
`
`
`David Meerkin
`Director of Experimental Cardiology
`Shaare Zedek Medical Center
`
`Jerusalem
`
`Teleflex Ex. 2149
`
`
`Page 1
`
`Teleflex Ex. 2149
`Medtronic v. Teleflex
`
`
`
`Failure to deliver a stent is a frequent cause
`of procedural failure
`
`Medtronicv. Teleflex
`
`Factors
`
`Poor back up J force before guide
`displacement
`
`Tortuousity J distal transmission of force
`
`Friction between rigid stent and vessel wall
`
`Teleflex Ex. 2149
`
`
`Page 2
`
`Teleflex Ex. 2149
`Medtronic v. Teleflex
`
`
`
`SVG PCI accounts for between 5-10% of PCI
`procedures
`
`technically more
`procedures’
`PCI’
`SVG
`challenging than native coronaryarteries
`
`Medtronicv. Teleflex
`
`Previous CABG shown to increase failure rate of
`trans radial PCI procedures /7-fold. sacc inty, 2009:
`2(11):1057-1064.
`
`Teleflex Ex. 2149
`
`
`Page 3
`
`Teleflex Ex. 2149
`Medtronic v. Teleflex
`
`
`
`Difficulties encountered during
`SVG-PCI include:
`
`Medtronicv. Teleflex
`
`¢ Extreme Tortuosity
`
`Teleflex Ex. 2149
`
`¢- Inadequate Guide Catheter Support
`
`¢ Inability to reach ostium and cannulate SVG
`
`* Competitive Flow
`
`¢ Achieving deep seating of guide catheter in
`SMe
`
`
`Page 4
`
`Teleflex Ex. 2149
`Medtronic v. Teleflex
`
`
`
`Support guide - T force before
`displacement
`
`Support / buddy wire
`
`-reduce
`
`Medtronicv. Teleflex
`
`Lesion preparation / lower profile stent
`mA fatesttels
`
`tortuousity
`
`Teleflex Ex. 2149
`
`
`Page 5
`
`Teleflex Ex. 2149
`Medtronic v. Teleflex
`
`
`
`Distal anchor balloon
`
`T backup support by locking guide
`
`lesion) Teleflex Ex. 2149
`
`requires = 7F to accommodateinflated
`balloon + stent
`
`may increasefriction (2 cathetersin
`
`Medtronicv. Teleflex
`
`
`Page 6
`
`Teleflex Ex. 2149
`Medtronic v. Teleflex
`
`
`
`Stent catheter
`advanced through
`proximal obstruction
`
`ae
`
`Distal anchor
`balloon — JR4
`guide
`
`Medtronicv. Teleflex
`
`ee
`position allowing
`increased force on
`ICs] 1M l=10) k=
`displacement
`
`Need > 7F
`
`Balloon inflated in distal
`
`vessel
`
`Teleflex Ex. 2149
`
`
`Page 7
`
`Teleflex Ex. 2149
`Medtronic v. Teleflex
`
`
`
`Guide catheter extension
`
`Medtronicv. Teleflex
`
`Greatly increases back-up support
`* Shape modification ‘Amplatzing’ T contact in aorta
`- Deep intubation increases contact within the coronary
`acl at
`May traverse proximal obstruction
`¢ more flexible than a stent
`Can be advanced usingdistal anchor balloon
`¢ Requires only 6F without need for 2 catheters in lesion
`Can be advanced through proximally deployed
`STisy at
`
`¢ Permits proximal to distal stenting
`
`Teleflex Ex. 2149
`
`
`Page 8
`
`Teleflex Ex. 2149
`Medtronic v. Teleflex
`
`
`
`JR4 guide
`
`limited support
`from contact with
`*~opposite aortic
`wall
`
`Support from conventional JR4 guide
`
`Medtronicv. Teleflex
`
`Quebec 2010
`
`Teleflex Ex. 2149
`
`
`Page 9
`
`Teleflex Ex. 2149
`Medtronic v. Teleflex
`
`
`
`Guide catheter backing out
`
`z
`
`ae se
`ae
`eat
`a
`oP
`_—_
`7 {ee z
`
`S
`
`resistance to stent passage
`causes guide to back out —
`backup is lost as guide
`comes away from coronary
`osteum & aortic wall
`
`Medtronicv. Teleflex
`
`Page 10
`
`Teleflex Ex. 2149
`
`
`Page 10
`
`Teleflex Ex. 2149
`Medtronic v. Teleflex
`
`
`
`Classically used
`Terumo Heartrail 125cm guide
`SF through standard 6F
`(Cordis/Medtronic/Boston etc) guide
`
`Medtronicv. Teleflex
`
`“Mother and Child”
`
`Teleflex Ex. 2149
`
`
`Page 11
`
`Teleflex Ex. 2149
`Medtronic v. Teleflex
`
`
`
`Mechanisms of increasing backup with guide
`catheter extension
`
`Medtronicv. Teleflex
`
`Page 12
`
`Teleflex Ex. 2149
`
`Shape change of guide
`
`Deep intubation of coronary
`
`Deep intubation
`adds greatly
`increases contact
`within coronary
`artery greatly
`increasing support
`AN
`
`a
`
`‘
`Shape change of JR4 into
`‘Amplatz Left’ shape increases
`contact aorta increasing support
`
`
`Page 12
`
`Teleflex Ex. 2149
`Medtronic v. Teleflex
`
`
`
`Medtronicv. Teleflex
`
`Teleflex Ex. 2149
`
`
`Page 13
`
`Teleflex Ex. 2149
`Medtronic v. Teleflex
`
`
`
`Medtronicv. Teleflex
`
`“mother and child”
`guide extension
`with
`rapid exchange
`convenience
`
`Coaxial
`
`Page 14
`
`Teleflex Ex. 2149
`
`
`Page 14
`
`Teleflex Ex. 2149
`Medtronic v. Teleflex
`
`
`
`Page 15 = 20cm guide extension connectedto
`
`" Guidewires, balloons andstents
`enter the GuideLiner’s collar within
`the guide catheter
`
`Teleflex Ex. 2149
`
`Medtronicv. Teleflex
`
`a push-rod with a “collar”
`
`=" Flexible GuideLiner extension can
`be deep seated for mother-and-child
`back-up support
`
`
`Page 15
`
`Teleflex Ex. 2149
`Medtronic v. Teleflex
`
`
`
`Medtronicv. Teleflex
`
`CTBTTas
`advanceddistally up
`to 10cm into vessel
`
`Teleflex Ex. 2149
`
`Guide catheter
`positioned at ostium
`ofRCA
`
`Tip of GuideLiner
`deployedinto
`eer
`
`
`Page 16
`
`Teleflex Ex. 2149
`Medtronic v. Teleflex
`
`
`
`Medtronicv. Teleflex
`
`Teleflex Ex. 2149
`
`
`Page 17
`
`Teleflex Ex. 2149
`Medtronic v. Teleflex
`
`
`
`Guideliner advanced
`through proximal
`ottolelaaw
`f
`
`i.
`
`,
`
`;
`
`Anchor balloon
`
`removed after
`Guideliner crossing
`
`Distal anchor to insert Guideliner,
`staged stent insertion
`ie
`a
`
`Medtronicv. Teleflex
`
`:
`
`Guide lockedin position allowing
`increased force on Guideliner
`before displacement 6F
`
`>
`
`Balloon inflated in distal
`
`vessel
`
`Page 18
`
`Stent advanced without
`
`resistance within Guideliner
`
`catheter
`
`Teleflex Ex. 2149
`
`
`Page 18
`
`Teleflex Ex. 2149
`Medtronic v. Teleflex
`
`
`
`Severe proximal and distal disease
`
`Medtronicv. Teleflex
`
`severe proximal
`disease causes
`pressure damping ——+
`prevents coronary
`intubation
`
`\
`
`a
`—_— |c
`hon
`A
`a
`
`| A1
`Distal disease cannot_\N™ =
`
`be reached
`
`—
`
`Page 19
`
`Teleflex Ex. 2149
`
`
`Page 19
`
`Teleflex Ex. 2149
`Medtronic v. Teleflex
`
`
`
`stent undeployed
`
`- 7
`af, * Lu
`
`stent expanded opens
`proximal vessel
`
`—- eae
`SS
`i
`
`ra
`
`.
`Ths=
`aed
`
`Guideliner assisted proximal then
`distal stenting
`
`Medtronicv. Teleflex
`
`Guideliner advanced
`through deployed stent
`allowing access to distal
`,
`aWhyecer
`i=—_
`
`4i
`
`Guideliner increases
`support to allow stent
`advancement into
`proximal lesion
`
`Page 20
`
`Teleflex Ex. 2149
`
`
`Page 20
`
`Teleflex Ex. 2149
`Medtronic v. Teleflex
`
`
`
`Image sze 512x512
`View size 606 x $06
`
`ba ea eee
`
`“it
`C
`
`|
`
`¥
`
`DIS Aae
`ie
`
`| ee aeTl Sie
`
`Medtronicv. Teleflex
`
`fiaegn eni ns)ane
`lagen aaa)
`airerejag) aig=s=i=]=16)
`
`Page 21
`
`voay/ Oley PAO) es oa
`WeerelS lay Geirtas
`
`Teleflex Ex. 2149
`
`
`Page 21
`
`Teleflex Ex. 2149
`Medtronic v. Teleflex
`
`
`
`FAA area ase
`| as
`Image sze 512x512
`
`ia =a =| dees Le ae OL F608] lege Oh|ok Rea] =e
`eae |e env bee
`"
`peel AOLS)
`ae
`hs
`
`Medtronicv. Teleflex
`
`Faateag: esis 2m) 0
`roa45/08/2000 101047 Quebec 2010
`Uncompressed
`ha =e=a (= Pas
`
`Teleflex Ex. 2149
`
`
`Page 22
`
`Teleflex Ex. 2149
`Medtronic v. Teleflex
`
`
`
`Le a
`Angiogram-PCIINEW) — unnamed
`2290/09
`
`Medtronicv. Teleflex
`
`25/06/2009 10:21:23
`Made In Osirix
`
`Teleflex Ex. 2149
`
`Image size S12 e512
`View size: G06 » G06
`
`a
`
`‘
`Py
`a
`en eeoi
`peeraae ick: oe—
`
`In aaa)
`Lncompressed
`
`
`Page 23
`
`Teleflex Ex. 2149
`Medtronic v. Teleflex
`
`
`
`Mt ?72y, 7ly)
`AngiogrmamPCINEW) — unnamed
`2290/09
`
`Medtronicv. Teleflex
`
`Sera llcr eee OL end aw Ola)
`
`Made In Osirix
`
`Teleflex Ex. 2149
`
`Image size 512 x512
`View size: 605 « 60D
`WL: SO Ww: 1?9
`
`a .
`
`fl =
`
`aeSsee
`Zoom. Torre ental a,
`
`
`Page 24
`
`Teleflex Ex. 2149
`Medtronic v. Teleflex
`
`
`
`Image size. Sle xole
`a ated eat eo eee ae,
`
`WL TUE wow: 210)
`
`ree
`
`‘
`
`“Spel a call
`
`=
`
`Pape Sere el
`Angiogram-PCINEW ) — unnamed
`fara Orabe)
`
`Made In Osirix Teleflex Ex. 2149
`
`FateoA Sale|Sa
`liga eee
`|
`Mafetefa] i=y=t=i=16
`
`'
`
`,
`
`|
`
`25/06/2009 10-4352, Quebec 2070
`
`Medtronicv. Teleflex
`
`
`Page 25
`
`Teleflex Ex. 2149
`Medtronic v. Teleflex
`
`
`
`Medtronicv. Teleflex
`
`ole UD eae UA ta
`(2.24mm)
`
`Model
`
`Size
`
`(suide Catheter
`Compatibility
`
`GuideLinet
`ID
`
`ength
`
`Working
`eet aelic ia ole
`T a — =
`Lenet i
`a oth
`-
`‘ te
`
`6F (5-in-6)
`
`el PEF ie Ai
`CBee site)
`
`0.056"
`(1.42mm)
`
`20
`
`te
`
`135 cm
`
`Cee
`
`poe O07 s"
`GRsrt)
`
`0.062”
`CR wey
`
`Ge
`
`0.071”
`GRU
`
`135 cm
`
`Teleflex Ex. 2149
`
`
`Page 26
`
`Teleflex Ex. 2149
`Medtronic v. Teleflex
`
`
`
`Conclusions
`
`Multiple techniques can be used in
`isolation or in combination to maximize
`and optimize guide catheter support to
`deal with most limitations
`
`Medtronicv. Teleflex
`
`The Guideliner offers the ability to
`“change course midstream”due toits
`rapid exchange nature as well as allow
`for staged anchoring and extremely
`safe deep cannulation
`
`Teleflex Ex. 2149
`
`
`Page 27
`
`Teleflex Ex. 2149
`Medtronic v. Teleflex
`
`
`
`The combination of Sheathless
`catheters (6.5F and 7.5F) and 5 in 6
`and 6 in 7 Guideliners allows for
`the expansion ofthe transradial
`approach to almost every scenario
`
`faced in daily coronary practice Teleflex Ex. 2149
`
`Conclusions
`
`Medtronicv. Teleflex
`
`
`Page 28
`
`Teleflex Ex. 2149
`Medtronic v. Teleflex
`
`
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