n
`
`
`
`
`Ari-A‘Ji-e"'1"...ell.
`
`:tl.
`
`.\..'.n‘neki.’
`
`TransluminaUy-placed Coilspring
`- Endanerial Tube Grafts
`
`Technique for Penmtaneons, momma '
`Placement of Tubes within Arteries
`
`Long-term Potency in Canine Poplt’teal
`Artery
`‘
`Quail—£3.12 Dan-m, MD
`
`msumrmu. comm nun-nonf- 3 arm: A
`simple. rational and efiedtive (90% lasting
`patency) alternative to conventional .vascular sur-
`gery in the relief of primary atheromatoue narrow-
`ing. Unfortunately.
`secondary lamina!
`throm-
`botis often complicates the disease,
`leaving no
`lumen to dilate. The results of transluminal re-
`anallzation (catheter creation of a neolumeu
`through a completely occluded segment) under-
`atandably are not in a. class with those of dilata-
`tlon. While tpectaeular and lasting sumeasee have
`been adtieved by atheter teauallndon. vein
`grafting remains the treatment 0! choice {or long-
`segment femompopllzeal occlusion. In a contin-
`uing etiort to improve matters, a method for the
`perwtaneous introduction and transluminal phoe-
`ment of tubular prosthaee was developed and
`tinted in dogs. The prompt thrombosis of all in»
`pervlous tube: so placed led to the fabrication and
`trial 0! collspring equivalents. .
`_...~__.__.._..
`Work done in the Stella and Charles Gunman Insti-
`tute {or Vascular lie-earth through Radiology at the
`vulva-xi
`of Oregon Medical School. Portland. Oregon,
`wasaldc gmuhom USPHSJIEDSZ” andHE
`06536. the
`Heart Auodatiun and the George
`Alfred Cook finned“.
`Much work by other: it mwmplaued in this brief
`report. S
`'11 thank: ere due:
`. Anzac. N. Day.
`G. Flue
`J. Heat-n. '1‘. Hutddns. W. Massey. J. Pegg.
`J. Penningto M. Quart). M. Robinson.
`'1‘. Sexual
`and J. Sdtenk.
`
`Using a suitable remote entry site and_oonven-
`tlonal techniques, a guideathetcr is first placed
`so that in tip traverses the intended graft tile.
`The tubular prosthetic graft and pusher-catheter
`at similar comedian are then slipped on and
`advanced over the guldeiutheter until the graft
`'has been seated as desired. Withdnwal of inner
`gulde'and pusher-'uthctert completes the proce-
`dure' (Fig. 1).:Cana should be taken to avoid
`trauma and arterial spasm. Though it is yet to
`he done, tranxlumlnal graft placement at a site or
`arterial disease all: for preliminary preparation
`through dilatttlonor rccenalintion of the nar-
`rowed o_r occluded lumen. The leading end of the
`gait should be smoothly rounded to as to mini-
`mize any tendency to ploughup an atherotnatous
`mus-oz.
`-
`
`. To date, the above technique has been med to
`.plaoe grafts in the normal {moral or popliteal
`arteries of 25 dogs. The usual site of entry was
`the left carotid artery; though it was not essential,
`arterlotomy generally was used for catheter intro-
`duction The tubular prostheses used varied hum
`one to ten centimeters in length and one to three
`millimeters
`in outer diameter. Regardless of
`whether they were made of polyethylene,. poly-
`amlde, Silastic or Teflon, no impervious plastic
`tube graft remained patent longer than 24 hours.
`Since graft patenq was not an initial objective
`of the work, anticoagulants were not. used in con-
`junction with the_placement of a total of 19 plastic
`tubular prostheses. follow-upeogiogmphy showed
`that occlusion was usually within thefim twenty-
`four hours and pathologt'e examination revealed it
`due to thrombosis.
`-
`
`329
`
`pre-
`
`
`
`Edwards Lifesciences Corporation, et a]. Exhibit 1112, Page 1 of 4
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`Edwards Lifesciences Corporation, et al. Exhibit 1112, Page 1 of 4
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`

`

`
`
`
`,”a.4—h-huk...“‘2.
`
`
`‘..31
`
`
`
`
`
`translumimzl placement 0]. Iubular firmlhuit within
`{summon-c,
`fro. I. Technique for
`
`
`Hood #5214: Abovuguldc introduced lhxough entry needle. Cartier; guide moss nmowlng,
`catheter puahc: misc graft toward Intended site. Below: withdrawal on guide and whom- have:
`
`graft- ip. place.
`
`
`; poilspring truism-aw presumes
`In the six final experiments, Instead of impel-r
`Mica: pia'sticvtubing, the grammar: in the folrm
`~91 whom; qfich-Qenlercd coilspxings wound from
`N0. 5 stainless steel wine. win: an auger dinmczer
`o! ”0.14 indxa and.’ ranging in length from 1
`to
`10 cin (Fig. 2). ngarin was given u'mi) occlusion
`occurred, m- for Tour days after grahihg. A )O-cm.
`a 3mm and-a l-tm silimnwomcd giaf! were found .
`occluded the following day. Two out at three Inn
`09339:! l—cm milsprings rennin patent at, two and
`‘a half years} and mm and a quarter ycnrs follow-
`ing in‘scnion..35 show'n on serial follow-u? angiw
`-grzms (Fig; 3.‘ i). '
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`..
`,. .,.
`._,_
`.
`,,
`. Tubular tempting mufowuculdr pmxllnasis.
`31c.
`I! 0.! 9‘.
`.
`v.
`‘
`..
`'
`-
`.
`
`glam: w¢r¢§°$.1;;glw "ed “in Suwasfu) Sm
`
`.
`7. ED'isCussiox'x-
`' This “1’9" mafia“; n 5mple, basic technique
`fox the .lmfls‘lm‘lfinal pincement of tubular endo-
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Edwards Lifesciences Corporation, et a]. Exhibit 1112, Page 2 of 4
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`Edwards Lifesciences Corporation, et al. Exhibit 1112, Page 2 of 4
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`

`

`
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`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`. I‘4
`l ‘t
`
`l5
`
`‘i,-
`0.‘r.1‘
`
`we,
`ell carotid artery _
`FIG‘ 3. Meyenf'pn-li‘ni‘)‘.¢:7f_7:cnr collspgingjgrm 91,954 .w'g¢'g¢m [mm .1
`in 49-90mm 119507.531 Dls‘t’al tnlgmtlon tool; 'plzoe on day of implantation (relate o! @2311?) .
`but there was no~tbbsequmt change ln posltlon-or.patcncy.
`«
`
`
`
`5
`
`«mania—'3-
`
`"anus—ea:>..-.».:
`
`vascular ptosthcsee and point: to possible mlvitm
`tags of open eoilspring' construction. Any. prob-
`.thesls capable of long-term pateney in the amine
`femoralsystem warrants attention; though. a: Kin-
`mouth. 3R_ob a‘ntl‘ Simeone point out,
`'f1t appears
`that thesueceispr failure of an arterial substitutgc
`-in dogs bears’no direct relationship to-tlre results
`one wfll-obtaln (when -a aslmila; substitute 1: used
`clinically [or the pefiplieral arteries?!
`Th'e‘suctcsafdt catheters’ lnjhe matingemem oi.
`atheromntous narrowing sliows— t'lle' feisibflltroi
`at tramlumlnal attack:
`their. shortcoming: .ln the»
`ptesenee ol’ complete occlusion jun/e anphuslzed
`the need for J’unher improvement, a..long-ung‘c
`objective of the present investigation. Porstmsmn's
`Succes‘sl’ul uafisluxninal plugging,“ 25 consecutive
`patent ductl= wlthout thoncotbmy'"~ntld§- dmtimt‘lt'
`confirmation. to the basic thesis that what can be
`better accomplished without operative exposure
`should be.
`
`Theoretic advantages or translumlnally-plnced
`coilsprlug vascular line: prostheses include:
`the
`Internally-gutted ~segment of vessel
`is not
`re-
`moved,
`incised or even exposed,
`thus avoiding
`trauma to 'an already diseased vessel. Blood‘ loss
`at
`the treatedyite, perivascular hemaroma and
`sutures or: not- likely to cause difiiculty. Open“
`coil construction permits prompt fibroblattlc en-
`velopment and the-rapid formation cl a new.
`firmly andtor’cd, autoge'nous-lining surface, thereby
`favoring continuing patcncy. Pi‘omtype models
`have shown thit-‘coiltptings, either wretched out
`or wound up and hooked ton conu'olling man-
`drel; an be‘reduced in diametex. favoring their
`easy Introduction and placement. Upon their
`cattemallyelfected~trelease from the man‘drelpthey
`automatically ekpand for a bigger
`lumen and
`betteranchorlng at the site of placement. Should
`progresssnnd hmh’er experimental work ever lead
`to a .cllnlcal role'l’or transluminal gutting. it Scents
`
`Edwards Lifesciences Corporation, et a]. Exhibit 1112, Page 3 of 4
`
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`
`
`.-.-rI-kvurhfu.w....--
`
`Edwards Lifesciences Corporation, et al. Exhibit 1112, Page 3 of 4
`
`

`

`bum“.
`
`;xamn;~.u;«h...'-'
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`
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`‘
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`3541,. 1549.627 ézalmq. fifilifinai‘bilffifin‘gfigmflyloxfl' bamlufiufihlIy-jgom is]: carotid ark???
`.‘v'
`1;; 4433mm 405159411). Na change (gnawing lama! ponplz‘t'zmcma-niig'fidon. can dbes not
`obsuuct adjaunubnndaet.
`
`c1
`
`."
`
`
`
`pbéfiblc-thfir me‘ 'dgmmd for Miami mu 'may
`b'e-deiinbly Iea-th‘ariflxat now rcquimd= for. com-
`pttént 'vaSCulfl‘r surgery.
`
`Kn filo-nit: grill, nmuia- dilmdon, confining, {amoro-
`p'opfltcnl, occlusion.
`1:147“? for :mapondma: CharkLT. Dom-r,
`=MD,, Deparlmzm of Radiology, University a]
`arixan-'Mzaicqii.9cfiboz, 333131;! Sam Jack'mn
`Parfi'flohdx'l’bfflimd, 012.9720!
`.
`unwary
`‘ Linen“; c. '1'... and 'M. P. Juékins: cfvculalima
`30:6“; 1964.
`_
`_
`,
`' 2,--—-.
`. Rdsah andzM. 1’. judkin}; Stu-g. Gynu.
`0mm. 127:7 , was.
`_
`Z
`3. Monmouth. J. 8., C. 0. Rob nnd.7. .A. Simeoncz
`Vascular surgery. Balfirootchwmiaw nnd Wilkins
`figfififih
`=
`.
`. Nmmmn, Von 'WW'J. Wicmy and 5}}, Wamkc:
`Forudrr. Rmtngtr. 109;)”, 1968.:
`‘
`
`'
`
`Sn
`
`,.
`
`.
`
`.
`
`_
`
`'Ifubgjl'az pxoszhetins graltggigmo'duged N19. .mdd
`‘aitgries ch p’fqocd mns‘luminzuyfin [Cinem-
`pgplircal anm'ts in £51105: usihg gimpk c'athqzer
`technique: While wioul lmptrvigu: pmu'e: tubes
`dorm! pmgupd'y,
`th‘e adoption of an open coil-
`.spxing cpnfiguntion has made vppssible buggers:
`pancy. Advantagu qt
`this yolfiemially :35:qu
`afp'mazu indudg' madam from xii: trauma many-
`anodized: with su'igi'cui mint “construction.
`
`a.”F.f—‘*—-lv'—Mfi—3fffwfi.p_‘..
`
`
`Edwards Lifesciences Corporation, et a]. Exhibit 1112, Page 4 of 4
`
`Edwards Lifesciences Corporation, et al. Exhibit 1112, Page 4 of 4
`
`