(Ð United States Patent
`Bailey et al.
`
`Iilll ilil]tilt1ilililll 1ilillllllllltillililt1ilil lilil iltillllllt
`us00ó45815381
`lro¡ Patent No.: US 6,458,153 B1
`1+s¡ Date of Patent: Oct. 1,2002
`
`(54) BNDOLUMIN,{.L CARDIAC AND VENOUS
`VALVB I'IìOSTHBSI'S AND T,{EI'HODS OII
`MANUFACTURB AND DELIVBRY THEREOF
`(75) Inventors: Steven R. Bailey; Christopher T.
`Boyle, both of San A¡tonio, 1X (US)
`(73) Assignee: Á,BPS Venture One, Ltd., San Antonio,
`rx (us)
`( " ) Noticc: Subjccl to any disclaimcr, thc tcrm of this
`patent is extended or adjustcd under 35
`U.S.C- 154(b) by 0 days.
`
`(21) Appl. No.: 091477,120
`(22) Filed: Dec.31, 1999
`(5r) Int. Cl.?
`(s2) U.S. Cl.
`(58) Field of Search ...........
`
`(s6)
`
`References Cited
`
`.. Á6Iß 2106
`62311.24; 6231.26
`62317.24, 1.25,
`623I.26
`
`U.S. PAIENT DOCUMENTS
`A
`9,¡1980 Boretos et al. ................. 3/1.5
`A
`2/1991 Dol¡l¡en....,....................62312
`A
`4/1992 Marks ........................606213
`7117992 Vtnce
`A
`.... 62312
`A
`7/1994 TeitcIbaw....................623/2
`A
`8/1994 Das
`... 6061213
`A
`12l1994 Stevens ..-...............,...... 6232
`A
`3/1995 PaveniketaI. ...............623111
`A
`8/1996 Stevens.........................62312
`A
`2/1998 Vaìlana eral. ........,-.,.-... 623/2
`A
`3/1998 Kotula et al. ............... 606i213
`A
`4/1998 Simon ........................ 6061213
`A
`10/1998 Cox
`..... 62312
`A
`10/1998 Tahe¡i
`... 62312
`11/1998 Ände¡senetal. .............. 62312
`^
`A
`1211998 Kotula .......................6062L3
`A
`1/1999 Jayaramat..........-..........623 1
`A
`1,/1999 Bessle¡eta]. ................. 62312
`A
`411999 Tweden efã1. .............-.. 62312
`A
`71999 Thompsonetal. ............ 6231
`
`4 ))) 1)Á
`1,994,077
`5,"108,420
`5,163,953
`5,332,402
`5,334,217
`5,370,635
`5,397 ,351.
`5,545,214
`5,713,953
`5 7?i SS?
`5,741,297
`5,824.0ó3
`5,824,064
`5.840,081
`5,846,26r
`5,855,597
`5,855,601
`5,895,419
`5 0ro ??4
`
`EP
`F-P
`
`A67Fl2l24
`/\61F2!06
`
`5,925,063 A
`7/1999 Khos¡avi .............-...... 6061200
`5.954,766 A
`911999 Tadno-Azvi .................. 6232
`5,957,949 A
`9/1999 Leonha¡dt et al. .......... 606/194
`10/1999 Lafontaine et al. ......... 6061273
`5,964,782 A
`12l1999 Quijano et al. ................ 6ã11
`5.997.5'73 A
`FOREI GN PATENT DOCUMENTS
`0850607 12/t996
`0808614 5i1997
`OTI-IER PUBLICATIONS
`"MASA Heart Valves", http:/l'u'rnv.heart-surgeons.com/
`valvedesign.htm, pp. 1-3.
`"Aortic Valve Replacement", SIS Patienf lnfornnrion,
`http : //wwrv.sts.org/doc/3620, pp. 1-5.
`"Minimally Invasive Aortic Valve Surgery," CT'SNIiT'
`Experts' Tech ní.ques, http:,/,/wwv,.ctsnet.org.org/doc.3358,
`pp 1-4
`"Heartport Announces Launch of Ileartpof InSite AVR
`Systcm for Le ss Invasivc Aortic Valvc Rcplacemcnt" IIea11-
`porL Inc. Contpany Press Release, pp 1-2.
`"ATS Medical Inc. Annual Report", pp. 1-7.
`"St. Jude Medical Heart Valve Division Expanding the
`Focus", wÌvrá.sum.comrstj deiworld.htm/expand.htm.
`"St. Jude Medical Fleart Valve Division The Mechical I{eart
`Valve Evolution", vnrrv.sjm.com/stjude/*'orld/hlm.evo-
`lut.hfm.
`"Heartport z\nnounces I-aunch of Heartport lnSitc AVR
`System for Less Invasive Aortic Valve Replacement",
`Heartport, Inc. Illtat's New Release, \ "ww.pddnet.com/
`Pddneq's/O8Oct.9903.htm, pp. 1-2.
`P rì nt a ry E xa n t í.ner-lorrine McDermolt
`A ssista nt Exantiner--A1vin Stewart
`(74) Attorney, Agenr, or Firnr-Ðwicl G. Rosenbaum;
`Rosenbaum & Associates, PC.
`(57)
`ABSTRACT
`'I'hìs inventicln rclates to prosthetic cardiac and vcnous
`valves and a single câlheter clevice and minimally invasivc
`techniques fbr percutaneous and lransluminal valvuloplasty
`and prosthetic vaive implantation.
`
`25 Clairns, 6 Drawing Sheets
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`NORRED EXHIBIT 2340 - Page 1
`Medtronic, Inc., Medtronic Vascular, Inc.,
`& Medtronic Corevalve, LLC
`v. Troy R. Norred, MD
`Case IPR2014-00395
`
`

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`I-I.S. Patent
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`Oct.L,2002
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`Sheet 1- of 6
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`us 6,458,153 B1
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`U.S. Patent
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`Oct. 1,2002
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`NORRED EXHIBIT 2340 - Page 3
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`Oct.L,2002
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`Oct. 1,2002
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`NORRED EXHIBIT 2340 - Page 5
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`LJ.S. Patent
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`Oct. L,2002
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`NORRED EXHIBIT 2340 - Page 6
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`Oct.1,2002
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`NORRED EXHIBIT 2340 - Page 7
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`

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`us 6,458,153 B1
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`1
`BNDOLUI{INAL CARDIAC AND VBNOUS
`VALVE PROSTHBSES AND METHODS OF
`I\,TANUFACTURB AND DBLIVERY THEREOF
`
`BACKGROUND OF THE II.WENTION
`The present invention relates generally to implantable
`prosthetic cardiac and venous valves. More particularly, the
`present invention pertains to prclsthetic cardiac ancl venous
`valr'e implants which are capable of being delivered using
`cndovascular tcchniqucs and bcing implantcd at an intrac-
`ardiac or intravenous sitc without thc nccd for anatomic
`valr,e removal. The prosthetic valves of the present inven-
`tion are rvell-suited for cardiac delivery via a femoral or
`subclavian artery approach using a delivery catheter, and,
`depending upon the specific configuration selected, may be
`deployed withiû the heart to repair valve defects or disease
`or septal defects or disease. According to one embodiment
`oI the invention, there is provicled a chamber-to-vessel (CV)
`confìguration which is particularly rvell-suited as an aortic
`valr'e prosthesis to facilitate bloocl flou'from the 1eft ven-
`trìcle to the aorta. In a second embocliment, there is providecl
`a prostbetic valve in a chamber-to-chamber (CC) conflgu-
`ration rvhich is particularl¡, wcll-adaptcd for mitral valvc
`replacement or repair of septal clefects. Finally, a third
`embodiment is provided in a vessel-to-vessel (VV)
`confìguralion, which is well suitcd for vcnous valve exclu-
`sion and replacement.
`Common to each of the CV CC and W embodiments of
`the present invention are a stent support mcmbcr, a graft
`member which covers at lea.st a porticx of either or both the
`lumenal and ablumenal surfaces of the stenl, valve llaps
`which are fbrmed either by biological xenografl valves,
`synthetic valr'es tbrmed from either the same material or a
`diffcrcnt matcriai as thc graft mcmbcr, the vaive flaps being
`couplcd to the stent in a manner which biases thc valvc flaps
`so they close upon a zero pressure differential across the
`valve region.
`It is important for the present invention to provide orien-
`tationaÌ definitions. For purposes of the present invention,
`references to positional aspects of the present invention wìll
`be defìned relative to the directional llorv veckrr of lrkrod
`flow through the implantable clevice. Thus. the term "proxi-
`mal" is intended to mean on the inflorv or upstream flou'side
`of the clevice, rvhiie "clistal" is intenclecl 1o mean on the
`outflow or dorvnstream flow side of the device. With respect
`to the catheter delivery system described herein, the term
`"proximal" is intended to mean loward the operator end of
`the catheter, whiie the term "distal" is intended to mean
`torvard the terminai encl or device-carrying end of the
`catheter.
`
`SUMMARY OF PRIOR ART
`The prior art discloses certain common device segments
`inherently required by a percutaneous prosthetic valve: an
`expandablc stent segment, an anchoring segment and a
`llow-regulation segment.
`Prior art percutaneous prosthelic valve devices include the
`Dobben valve, U.S. Pat. No. 4994!17, the Vince valve,
`U.S. Pat. No. 5,163,953, tbe Teitelbaum valve, U.S. Pat. No.
`5,332,402, the Stevens valr'e, U.S. Pat. No. 5,370,685, the
`Pavcnik valve, U.S. Pat. No. 5,397,351, the Taheri valve,
`U.S. Pat. No. 5,824,064, the Ànderson valves, U.S. Pat. Nos,
`5,417,552 & -5,840,081, the Jayaraman vah'e, U.S. Pat. No.
`5,855,597, the Bcsselcr valvc, U.S. Pat. No. 5,355,601, thc
`Khosravi valvc, U.S. Pat. No. 5,925,063, the Zadano-Azizi
`valve, U.S. Pat. No. 5,954,766, and the l-eonharclt valve,
`
`2
`U.S. Pat. No. 5,957,949. Each of these pre-existing slent
`valve designs has certain disadvantages which are resolved
`by the present invention.
`'I'he Dobben valve has a disk shaped flap threaded on a
`5 wire bent lìke a safety pin to cngage thr: vessel wall and
`anchor the valve. A second embocliment uses a stent of a
`cylindrical or crown shape that is made by bending rvire into
`a zigzag shape to anchor the device and altach Ïhe flow
`regulator flap. The device presents signifìcant
`10 hemodynamic, deliver¡ fatigue and stability disadvantages.
`The Vince valve has a stent comprised of a toroidal body
`formed of a flexibÌe coil of wire and a florv-regulation
`me chanism consisting of a flap of biologic material. Nume¡-
`. _ ous longitudinal extensions within the stent are provicled as
`rr attachnrcnt posls to nìount ltìe fìow-regulation mechanism.
`The device requires balloon expansion to deliver to the body
`orifice. The main shortcoming of this clesign is <lelivery
`proflle. Speciflcally, the device and methocl put forth will
`rcquirc a 20+ Frcnch sizc cathclcr (approximatcly 9 Frcnch
`^^
`-u sücs to accommodatc thc balloon and 14+ Frcnch sizes to
`accommoclate tbe compressed device) maliing the device
`clinicaily ineffective as a minimally invasive technique.
`Additionally, the device does not adequately address
`-- hemod¡'namic, stability and anchoring concerns.
`The Teitelbaum valve is made of shape memory nitinol
`and consists of two components. 'Ihe first component is
`stentlike and comprised of a meshu'ork or braiding of
`nitinol itire similar to that described by Wallsten, U.S. Pat.
`.n No. 4,655,771, with trumpet iike clistal a proximal flares.
`-- The purpose of the stent is to maintain a semi-ridgecl patent
`channel through the cliseascd carcliac valvc afic¡ ìnitial
`balloon dilation. The fla¡ed ends are intended to maintain the
`position of the stent component across the valve thereby
`^- anchoring the device. Embodiments for the florv-regulation
`' ' mechanism include a sliding obturator and a caged ball both
`which are delivered seconclary to the stent portion. The
`disadvantages of the device are the flow regtlators reduce
`the ellective valve orifice ancl generate sub-optimal hemo-
`,n dynamic characteristics; fatigue concems arise fiom the
`separate nature of the stent and flow-regulation components;
`the high metal and exposed melal content raises
`thrombogenesis, valvular stenosis ancl chronic anticoagula-
`tion concerns; and the separate delivery rcquircmcnts
`,. (althoueh acldrcssing thc nccd fo¡ small dclivcry profile) in
`" acldition to any initial valvuloplasty performe<l increases the
`time, costs, risks, difficulty and trauma associated with the
`percutaneous procedure.
`Ihe Pavcnik valve is a solf-expanding percutaneous
`59 device comprised of a pc4lpe1, a stent and a restraining
`element. -l'he valve stent has barbed means to anchor to lhe
`internal passageway. The clevice inclucles a self-expanding
`stent of a zigzag configuration in conjunction rl'ith a cage
`mechanism comprised of a multiplicit¡, of crisscrossed wires
`55 ancl a valve seat. The disadvantages of the device include
`large delivery proûle, recluced effective valvular orifice,
`possible perivalr'ular leakage, trauma-índucing turbulent
`flow generatecl b.v the cage occlusive apparatus and valve
`seat, thrombogenesis, valvular stenosis, chronic
`66 anticoagulation, problematic physiological and procedural
`concerns due to the barl¡ anchors and complex delivery
`procedure that includes inllation oI occlusive membe r after
`initial implantation.
`Stevens cliscloses â percutaneous valve replacement sys-
`65 lcm for thc cnclovascular rcmoval of a malfunctioning valvc
`followcd by rcplaccmcnt rvith a prosthclic vah,e. 'Ihe valvc
`replacemenl system may include a prosthetic valve device
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`NORRED EXHIBIT 2340 - Page 8
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`comprisod of a stent and cusps for florv-regulation such as a
`txed porcine aortic valve, a valve introducer, an intralumi-
`nal proccdure device, a proccdure devicc capsule and a
`lissüe cutter. The devices clisclosed indicate a long and
`complex procedure requiring large diameter catheters. The í
`valve device disclosed rvill require a large delivery catbeter
`and does not address the key mechanisms required of a
`functioning va1ve. Additionally, the device requires
`intraluminal-sccuring mcans such as suturing to anchor the
`devicc at the dcsired location.
`The Taheri valve describes an aortic valve replacement
`comlrined i¡'ith an aortic arch graft. The devices and percu-
`laneous methods descrit¡ed require puncture of the chest
`cavity.
`Anclerson has disclosed various balloon expanclable per- 15
`cutàneous prosthetìc valves. I'he latest discloses a valve
`prosthesis comprisecl of a stent macle fìom an expancìabie
`cylindrical slructure macle of several spaced apices and an
`elaslically collapsible valve mounted to the stent q'ith the
`commissural points of the valve mounted to Ïhe apices. The 16
`devicc is placcd at the dcsircd location by balloon cxpanding
`fhe stenl ancl valve. The main disadvantage to this design is
`the 20+ French size delivery requirement. Other problems
`include anchoring stability, perivalvular lealiage, difficuit
`rnanufacture and suspect valve performance.
`The Jayaraman valvc ìncludcs a star-shapcd stent and a
`replacement valve and/or replacement graft for use in repair-
`ing a damaged cardiac valve. the device is comprised of a
`chain of interconnecled star-shaped stent segrnents in the
`center of which sits a replacement valve. The flow- 36
`regulation mechanism consists of three flaps cut into a flat
`piece of graft material that is rolled to form a conduit ìn
`which the three l1aps may be foided inwardly in an over-
`lapping manner. A¡ additional florv-regulation mechanism is
`clisclosed in rvhich a patch (or multiple palches) is suturecl to :5
`the outside of a conduit which is then pulled inside out or
`inverted such that the patch(s) reside on the filly inverted
`conduit. A balloon cathctcr is rcquired to assist cxpansion
`during cielivcry. The disadvantages of this dcsign include
`lack of suflicient anchoring mechanism; problematic inter- ¿o
`ference concerns rvith adjacent tissues and anatomical struc-
`lures; fatigue concerns associated *'ith the muitiplicity of
`segments, comections and sutures; lack of an adequately
`controlled and biased flow-regulation mechanism; uncertain
`cffective valve orilìce, dillicult manufacture; baìlocln dila- +s
`lion requirement; complex, clilllcult and inaccurate delivery
`and large delivery prof,le.
`The Besseler valve discloses methods and devices for the
`endovascular removal of a defective heart valve ancl lhe
`replacement with a percutaneous cardiac valr'e . 'l-he device so
`is com¡rrised of a self'-expanding stent member with a
`llexible valve disposed within. The stent meml¡er is of a
`self-expancìing cylindrical shape macìe from a closecl wire in
`formed in a zigzag conflguration that can be a single piece,
`stampcd or extruded or formcd by welding thc frcc cnds 5s
`togcthcr. Thc flow-rcgulation mcchanism is compriscd of an
`arcuate portion u,hich confains a slit (or slits) to form leaflets
`and a cuff portion which is sutured to and encloses the stent.
`The preferred flow regulalor is a porcine pericardiun with
`three cusps. An additional florr' regulator is described in oo
`whicb the grafl materìal that comprìses the leafìets (no
`aclditional mechanisms lor fìorv-regulation) cxtends 1o form
`the outcr cull'portion and is attached to the stcnt portion with
`sutures. The anchoring segment is provicled Lry a plurality of
`barbs carricd by thc stcnt (and thcrcfor pcnctrating the o,s
`cuff-graft segment). f)clivcry rcquires cncloluminal removal
`of the naturâ1 valve because the l¡arb anchors will malfuc-
`
`4
`lion if they are orthotopically secured 1o the native leafiets
`instead of the mo¡e rigid tissue at the native annulus or
`vcsscl wall. Dclivery invoivcs a catheter u'ithin which thc
`clevice and a pusber rod are clisposecl. The clisaclvantages of
`the device are lack of a well clefined and trìased ilow-
`regulation mechanism, anatomic valve removal is required
`lhereby lengthening the procedure time, increasing difficulty
`and reducing clinical practicality, trauma-inducing barbs as
`descril¡cd al¡ovc and thc dcvicc is unstablc and pronc to
`migration if barbs are omittecl.
`The l{rosravi valve discloses a percutaneous prosthetic
`vaive comprised of a coiled sheet stent similar to lhat
`descril¡ecl by Derbl,shire, U.S. Pat. No. 5,007,926, to wlúch
`a plurality of llaps are mounled on the interior surface to
`form a llow-regulation mechanism that rnay be comprised of
`a biocompatible material. The disaclvantages of this clesign
`include problematic interactions between the stent and flaps
`in the delivery stale, lack of clinical data on coiled stent
`performance, the lack of a cletailed mechanism to ensure thâf
`the l'laps will create a competenl one-directional valve, lack
`of appropriate anchoring means, and the design require-
`ments imposed by surrounding anatomical structures are
`ignored.
`The Zadno-Azizi'r'alvc discloses a device in which flow-
`reguìation is provided by a flap disposcd rvithin a frame
`structure capable of taking an insertion state and an
`expanded state. The preferred embodiment of the flow-
`regulation mechanism is defrned by a longitudinal valve
`bodv made of a suflÌciently resilient malerial with a slit(s)
`that extends longituclinally through the valve body.
`Increascd sutr-valvular pressure is said to cause the valve
`borly to expand thereby opening the slit and allowing fìuirl
`flow there through. The vaive bocly exlends into the into the
`Iumen of ttre body pâssâge such that increased supra-
`valvular prcssure will prevcnt the slit ûom opening thereby
`effectíng one-directional florv. The device includes embed-
`ding the frame within the seal or graft material through
`injection molding, blow molding and insertion molding. The
`disadvantages of the device include the florv-regulation
`lnechanism provides a sr¡all effective vaive orifrce, the
`turbidity caused by the multiple slit mechanisms, the large
`clelivery profile required by the discloscd emt¡odiments and
`the lack of acute anchorr'ng means.
`Finally, the Leonhardt valve is comprised of a tubular
`graft having radially conpressible annular spring portions
`ancl a flow regulator, whicb is preferably a biological valve
`disposeçl within. In addition to oversizing the spring stent lry
`307a, anchoring means is provi<Jed by a light-activated
`biocclmpalible tissue adhcsive is located on the outside ol'
`the tubular graft and seals to the living tissue. The stent
`section is comprised of a single piece of superelastic wire
`lormcd into a zigzag shapc and connccfcd togethcr by
`crimping tubes, adhesives or welds. Amalleable thin-walled,
`biocompatible, flexible, expandable, woven fabric graft
`material is connecled to the outside of the stent that is in turn
`connected to the biological flow regulator. Disadvantages of
`this device include those proñle concerns associated with
`biological valves and unsupported graft-leaflet regulators, a
`large <iiameter complex delivery system and method which
`requires multiple anchoring balloons and the use of a light
`activated tissue adhesive in addition to ¿ìny prior valvuio-
`plasty performed, inferference rvith surrounding anatomy
`and the questionable clinical utility and feasibility of the
`light actùatcd anchoring mcans.
`SUMMARY OF'nlE INVENTION
`Wilh thc shorlcomings of thc prior arl deviccs, therc
`remaìns a need lbr a clinically effective endoluminally
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`NORRED EXHIBIT 2340 - Page 9
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`deliverable prosthetic valve that is capable of orthotopic
`deliver¡ provides a mechanically defrned, biased and hemo-
`dynamically sound florv-regulation mcchanism, provides
`sufficient force to maintain a large acute eftèctive valvular
`orifice dimension which expands to a known larger effèctive .5
`orif,ce dimension, compliant u'ith adjacent dynamic ana-
`tomical struch¡res, does not require valve removal, does not
`require chronic anticoagulation treatment, meets regulatory
`fatigue requirements for carcliac valve prostheses, provides
`a low-metal high-strengfh stent-annulus, is surgically ,o
`explantable or endoluminally removable, in additìon to
`being able to cleploy muitiple valves orthotopically, provicles
`a delivery proflle which cloes not exceed the 12 French size
`suitablc fbr periphcral vascular cncloluminal delivery, com-
`bines anatomic valvc exclusion and prosthetic valvc delivcry ,,,
`via a single catheter delivery system and with short clu¡ation
`atraumatic procedure which is easy to complete and benefi-
`cial to very sick patients.
`It is, therefore, a primary of the present invention to
`provide a prosthetic endoluminally-deliverable unidirec- rs
`tional valvc. Thc invcntion has multiple conflgurations to
`treat malfunctioning anatomical valves including heart and
`venous valves. P¡osthetic cardiac valve confìgurations
`include the chamber-to-vessel for orthotopic placement at
`the valurlarjunction between a heart chamber and a vessel,
`and the chamber-to-chaml¡er for orthotopic placement at the
`valvular junction lret,Á'een two heart char¡be¡s or for septal
`defect repair where a septal clccluding membcr is substituted
`for the flow regulator valve flaps. Prosthetic venous valve
`configurations inclucle the vessel-to-vessel for orthotopic or 36
`non-orthotopic placcment aT a valr'rla¡ junction within a
`vcsscl.
`'Ihe invention consists generally of a stent body membcr,
`a grafi, and valve flaps. The stent bocly member may be
`fashionecl by laser cutting a hypotube or by weaving wires -i5
`into a tubular slructure, and is preferably made lrom shape
`memory or super-elastic materials, such as nickel-tilanium
`alloys known as MTINOL, but may bc made of balloon
`cxpandable stainlcss steel or othcr plastically deformablc
`stent m¿rterials as are knorvn in the art, such as titanium or +o
`lantalum, or may be self-expanding such as by w,eaving
`stainless steel wi¡e into a stressed-tubuiar configuration in
`ordeÍ to imirart elastic strain to the u'ire. The graft is
`preferably a biocompatible, fatigue-resistant membrane
`*hich is cltnlhìe rrlcncln!hclirlízrlirrn- ¡nrl is rtlacherl lrr lhe ,.:
`stent bocly member on at least portions of either or both the
`iumenal and ablumenal surfaces of the stent bocly member
`by suturing to or encapsulating stcnt struts. Thc vah,c
`lcaflcts arc prctcrably formecl by sections of the graft matc-
`rial attached to the stent body member.
`'Ihe stent bocly member is shapecl to include the following
`stent sections: proximal and distal anchors, a iritermecliate
`ânnular slent section, and at least one valve arm or bloocl
`flow regulator struts. The proximal and clistal anchor sec-
`tions arc present at opposing ends of thc prosthcsis and ss
`subtcnd cithcr an acutc, right or obtuse angle with a central
`longitudinal axis that dehnes the cylinclrical prosthesis. In
`eithe¡ thc CV or CC configurations, the proximal anchor is
`confrgured 10 assume approximately a right angle radiating
`outward from the central longitudinal axis of the prosthesis oo
`in a manner v,hich provides an anchoring flange. When
`being delivered from a delivery catheter, the proximal
`anchor is depkryed fìrst and engages the native tissue and
`anatomical structures just proximal to the anatomic valve,
`such as thc lcft vcntriclc wall in the caso of rctrogradc es
`orthotopic dclivcry at the aortic valve. Dcployment of thc
`proximal anchor permits the intermediate annular stent
`
`50
`
`6
`section to be deployed an reside u'ithin the native valve
`annular space and the al¡lumenal surface of the intermediate
`annular steot section to abut and outwardly radially com-
`press the anatomic valve lealìets against the vascular wail.
`The distal anchor is then deployed and radially expands to
`contact the vascular wall ancl retain the prosthesis in
`position, thereby excluding the anatomic valve leaflets from
`thc bloodflow and replacing them with thc prosthetic valve
`1caflets.
`Florv regulation in the inventive stent valve prosthesis is
`provided by the combination of the prosthctic valve lcaflcts
`and the valvc arms and is biased closed in a manner similar
`manner to that described for a surgically implanted replace-
`ment heart valve by Boretos, U-S. Pat. No. 4,222,126. The
`valve regulator-struts are preferabl¡, configured to be posi-
`tioned to radiate inç'ard from the stent body member toward
`the central longitudinal axis of the prosthesis. The graft-
`leaIlel has the appearance of a partially-everted tube lvhere
`the innermost 'layer, on the lumenal surlace of the slent body
`member, forms the leaflets ancl the outer-most layer, on the
`ablumenal surface of the stent body member, forms a sealing
`graft rvhich contacls and excludes the immobilized analomi-
`cal valve lcaflets. Thc stmts of the stcnt are cncapsulated by
`the outcr graft-mcmbranc. Thc valvc regulator-struLs aro
`encapsulated by the inner leaflet-membrane and serve to bias
`the valve to the closed position, The reguiator-struts also
`prevent inversion or prolapse of the othe¡rvise unsupported
`leaflet-membrane during increased supra-vah'ular pressure.
`The inner leaflet-membrane may also be attached to the
`outer graft-membrane at points equidistant lrom the valve
`strul-arms in a manner analogous to thaf clescribed lbr a
`surgically implanted replacement heart valve by Cox, U.S.
`Pat. No. 5,824,063. The combination of the thin wallecl
`properties of the leaflet-membrane, thc onc-sided opcn
`lumen support of the intermediate annular stent section, the
`free ends of the valve leaflets, the biasing and support
`provided by the valve reguìator-struts and the attachment
`points all work to provide a proslhetic valvular device
`capable of endoluminal delivery rvhich simulates the hemo-
`dynamic properties of a healthy anatomical cardiac or
`vcnous valve.
`
`1
`
`BRIEF DESCRIPTION OF FIGURES
`FIG. f. is a perspective view of the inventive valve sfent
`chainbcr-ir)-v¿ssei e¡nborlirüe¡t .iu its fuil;v cieplo_vcd siaie.
`FIG. 2 is a pcrspectivc vier¡' of the inventive vah'c stcnt
`chamber-to-vessel embocliment in its ful1y deployed state
`\ñ'ith the outermost graft layer and stent layer partially
`removed to show an embodiment of the valve apparatus.
`FIG.3 is a top view of the inventive vah'e stent chambc¡-
`to-vessel embodiment in its f,1ly deployed state.
`FIG. 4 shows the cross-scctional taken along linc 4-4 of
`EII:
`FIG. 5 is a bottom view of the inventive valve stent
`chamber-to-vessel embodiment in its fuI11, deployed state.
`FIG. 6A illuslralr:s a cross-scctional vicw o[ a hu¡nun
`heart during systole r.r,ith the inventive valve stent chamber-
`to-vessel embodiment implanted in the aortic valve and
`illustrating a blood flow vector of an cjection fraction
`leaving thc lcft vcntriclc and passing through the inventivc
`valve stent.
`FIG, 6R illustrates a cross-sectional view oI a human
`heart cluring diastole lÁ'ith the inventive v¿ìh'e stent chamtrer-
`to-vcsscl embodiment implanteci in the aortic valvc and
`ilhstrating a l¡1oocl flow vcctor of bloocl passing fiom the Icft
`atrium, through the mitral valve and inlo the left ventricle
`
`NORRED EXHIBIT 2340 - Page 10
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`
`us 6,458,153 81
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`I
`
`during and a retrograde blood flow vector blocked by rhe
`inventive valve stent in the aorta.
`FIG. 7 is a perspective view of the ìnventive valve stent
`chamber-!o-chamber embodimenI jn its lully deployed state.
`FIG. I is a is a perspective vierv of the invenTive valve 5
`stent chamber-lo-chamber embodiment in ils fuily deployed
`state with the outermosT graft layer and slen1 la)'er nutt'uttt
`removed to show an embocliment of the valve apparaÏus.
`FIG. 9 is a top vierv of the inventive vaivc stcnl chamber- ,o
`1o-chamber embodiment in its fully deployed stare,
`FIG. 10 shows the cross sectional view talien along line
`10-10 of FIG. 7.
`FIG. 11 is a bottom view of inventive valve stent
`chambcr-to-chamber embodiment in its fu1ly deployed sf ate. r5
`FIG. 124 illustrates a cross-sectional view of a human
`heart during atrial sl,stoie with the ìnventive vå'lve slent
`chamber-lo-chamber embocliment implanted at the site of
`the mitral valve and iliustrating a blood florv vector of a
`filling fraction lcaving the left atrium and cntering thc lcft 20
`ventricle.
`FIG. 128 illustrates a cross-sectional view of a human
`heart cluring atrial diastole rvith the inventive valve stent
`cbaml¡er-to-chamber embodiment impianted a1 the site of
`the mitral valve and illustrating a blóod flow vector of an 25
`ejection liaction lrom the lelt ventricle to the aorta and the
`back pressurc agâinst the implanted mitral valve prosthcsis.
`FIG. 13 is a perspective view of the chamber-to-vessel
`configurâtion in the fu1ly deployed state.
`FIG. 14 is a perspectivc vierv of thc samc conflguralion in
`the fully dcploycd state with thc outcrmost graft layer and
`stent layer partially removed to show an embodiment of the
`vah,e apparatus.
`FIG. 15 is a top view of the same configuration.
`FIG. 16 shows the cross sectional vieq' of the sane
`configuration for the cleployed state.
`FIG. 17 is a lrottc¡m view of lhe same conlìguration.
`FIGS. 18,4. and 188 show cross-sectional vieu's of a vein *o
`and venous valve illustraling rhe inventive prosthetic venous
`valve in the open and closed state.
`FIG. 19 are cliagrammatic cross-sectional views illustral-
`ing single catheter vah'uloplasty, inventive stenl valve cleliv-
`ery and slent val\¡e operation in situ in accordance with the 45
`method of the present invention.
`FIGS. 204-20I is a cross-sectional diagrammatic vierv of
`a valvuloplasty and slent valvc delivcry cathctcr in accor-
`dancc with thc prcscnt invcntion.
`DEIAII.-ED DESCIIIP]ìON OIì ]I]E
`PREFERRED EMBODIMENTS
`The present invenlion consists generally of three preferred
`embodiments, each enrbodiment corresponding to a pros-
`tllctic stenl valve conflguration aclaptcd for cithcr heart ss
`chamber to blood vessci communication, chambcr to cham-
`ber communication or vessel 1o vessel, or intravascular
`conûguration. Certain elements are common to each of thr:
`preferred enbodimenls of the invention, specifically, each
`embodiment includes a stent body memlrer*hich defines a oo
`central annular opening along the longitudinal axìs of the
`stent body memtrer, a grâft member rvhich c<lvcrs aL lsast a
`portion o1 the stenL body mcmber along cither thc lumenal
`or ablumenal surfaces of the stent body member, at leasl one
`biasing arm is providcd and projects from thc stcnt body 6-5
`membcr and into thc ccnlral annular opening of thc stcnt
`bodv member, and at least one valve flap member whiqh is
`
`30
`
`-35
`
`coupled to each biasing arm such that the biasing arm biases
`the valve flap member 1o occlude the central annulâr open-
`ing of the stent body member under condifions of a zero
`pressure dil1èrential acrcrss the prosthesis. 'Ihe stent body
`memher is pref erably macle of a shape memory matcrial or
`superelastic material, such as NITINOL, but also be fal¡ri-
`cated from either plasticallv cleformable materials or spring-
`elastic malerials such as is well knou.n in thc art.
`Additionally, the stent bod)¡ memtrcr has thrcc mâin opcrabic
`seclions, a proximai anchor section, a distai anchor section
`and an intermediate annular section \Ã,hich is intermediate
`the proximal and ciistai anchor sections. Depending upon the
`specifrc inventive embodiment, the distal and proximal
`anchor sections may be eitber a diametrically enlarged
`section or may be a flanged section. 'l'he intermediate
`annular section delìnes a valve exclusion region iLnd primary
`blood flow channel of the inventive valve stent. The inter-
`mediâle annular section defines a lumenal opening through
`which blood flow is estal¡lished. The transverse cross-
`scction of the lumenal opening may bc circular, clliptical,
`ovular, triangular or quadralinear, depending upon thc spc-
`ciûc applicalion for rvhich the valve stent is being employed.
`Thus, for example, where a tricuspid valve is particularly
`stenosed, it ma.v be preferable to employ a valve stent with
`a lumenal opening in the intermedìate annular section $'hich
`has a triangular transverse cross-sectional dimension.
`Ch amber-lo-Vcssul ( lonfi gu ration
`Àn implantable prosLhesis or prosthetic valve in accor-
`dance rvith certain embocliments of the chamber-to-vessel
`CV conûguration of the present invention is illustrated
`generall¡' in FIGS. 1-5. The chamber-lo-vessel valve sfent
`10 consists of an expandable stent body member L2 and graft
`meml¡er 11. The stent body member 12 is preferably made
`from a shape memory anðlor superelastic NITINOL
`material, or thermomechanicail¡, similar materials, but may
`be macle of plastically deformal¡le or