(19) United States
`(12) Patent Application Publication (10) Pub. No.: US 2001/0021872 A1
`Bailey et al.
`(43) Pub. Date:
`Sep. 13, 2001
`
`US 20010021872A1
`
`(54) ENDOLUMINAL CARDIAC AND VENOUS
`VALVE PROSTHESES AND METHODS OF
`MANUFACTURE AND DELIVERY THEREOF
`
`Related US. Application Data
`
`(62) Division of application No. 09/477,120, ?led on Dec.
`31, 1999.
`
`(76) Inventors: Steven R. Bailey, San Antonio, TX
`
`(30)
`
`Forelgn Apphcatlon Prmnty Data
`
`(Us); Chnstopher T- B°Yle> San
`Antonio, TX (US)
`
`Dec. 18, 2000 (US) ........................... .. PCT/US00/34591
`
`Correspondence Address:
`Rosenbaum & Associates, PC
`Suite #3653
`875 North Michigan Avenue
`Chicago, IL 60611 (US)
`
`(21) Appl, No;
`
`09/854,002
`
`22 Filed:
`
`Ma 11, 2001
`y
`
`Publication Classi?cation
`
`(51) Int. Cl.7 .............................. .. A61F 2/06; A61F 2/24
`(52) US. Cl. ........................................ .. 623/124; 623/218
`
`ABSTRACT
`(57)
`This invention relates to prosthetic cardiac and venous
`valves and a single catheter device and minimally invasive
`techniques for percutaneous and translurninal valvuloplasty
`and rosthetic valve irn lantation.
`P
`P
`
`Edwards Lifesciences Corporation, et al. Exhibit 1020, p. 1 of 15
`
`

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`Patent Application Publication Sep. 13, 2001 Sheet 1 0f 6
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`US 2001/0021872 A1
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`Edwards Lifesciences Corporation, et al. Exhibit 1020, p. 2 of 15
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`

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`Patent Application Publication Sep. 13, 2001 Sheet 2 0f 6
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`US 2001/0021872 A1
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`Fig. 125
`
`Edwards Lifesciences Corporation, et al. Exhibit 1020, p. 3 of 15
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`

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`Patent Application Publication Sep. 13, 2001 Sheet 3 0f 6
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`US 2001/0021872 A1
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`Edwards Lifesciences Corporation, et al. Exhibit 1020, p. 4 of 15
`
`

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`Patent Application Publication Sep. 13, 2001 Sheet 4 0f 6
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`US 2001/0021872 A1
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`Edwards Lifesciences Corporation, et al. Exhibit 1020, p. 5 of 15
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`

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`Patent Application Publication Sep. 13, 2001 Sheet 5 0f 6
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`US 2001/0021872 A1
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`Fig. 78A
`
`%
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`2/5
`
`Fig. 20A
`
`Fig. 208
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`Edwards Lifesciences Corporation, et al. Exhibit 1020, p. 6 of 15
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`

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`Patent Application Publication Sep. 13, 2001 Sheet 6 0f 6
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`US 2001/0021872 A1
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`Fig. 20H
`
`Fig. 201
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`Edwards Lifesciences Corporation, et al. Exhibit 1020, p. 7 of 15
`
`

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`US 2001/0021872 A1
`
`Sep. 13, 2001
`
`ENDOLUMINAL CARDIAC AND VENOUS VALVE
`PROSTHESES AND METHODS OF
`MANUFACTURE AND DELIVERY THEREOF
`
`CROSS-REFERENCE TO RELATED
`APPLICATION
`
`[0001] This application corresponds to and claims priority
`of pending U.S. utility patent application, Ser. No. 09/477,
`120, ?led Dec. 31, 1999 and PCT International Application,
`Ser. No. PCT/US00/34591, ?led Dec. 18, 2000.
`
`BACKGROUND OF THE INVENTION
`
`[0002] The present invention relates generally to implant
`able prosthetic cardiac and venous valves. More particularly,
`the present invention pertains to prosthetic cardiac and
`venous valve implants Which are capable of being delivered
`using endovascular techniques and being implanted at an
`intracardiac or intravenous site Without the need for ana
`tomic valve removal. The prosthetic valves of the present
`invention are Well-suited for cardiac delivery via a femoral
`or subclavian artery approach using a delivery catheter, and,
`depending upon the speci?c con?guration selected, may be
`deployed Within the heart to repair valve defects or disease
`or septal defects or disease. According to one embodiment
`of the invention, there is provided a chamber-to-vessel (CV)
`con?guration Which is particularly Well-suited as an aortic
`valve prosthesis to facilitate blood ?oW from the left ven
`tricle to the aorta. In a second embodiment, there is provided
`a prosthetic valve in a chamber-to-chamber (CC) con?gu
`ration Which is particularly Well-adapted for mitral valve
`replacement or repair of septal defects. Finally, a third
`embodiment is provided in a vessel-to-vessel (VV) con?gu
`ration, Which is Well suited for venous valve exclusion and
`replacement.
`[0003] Common to each of the CV, CC and VV embodi
`ments of the present invention are a stent support member,
`a graft member Which covers at least a portion of either or
`both the lumenal and ablumenal surfaces of the stent, valve
`?aps Which are formed either by biological xenograft valves,
`synthetic valves formed from either the same material or a
`different material as the graft member, the valve ?aps being
`coupled to the stent in a manner Which biases the valve ?aps
`so they close upon a Zero pressure differential across the
`valve region.
`
`[0004] It is important for the present invention to provide
`orientational de?nitions. For purposes of the present inven
`tion, references to positional aspects of the present invention
`Will be de?ned relative to the directional ?oW vector of
`blood ?oW through the implantable device. Thus, the term
`“proximal” is intended to mean on the in?oW or upstream
`?oW side of the device, While “distal” is intended to mean on
`the out?oW or doWnstream ?oW side of the device. With
`respect to the catheter delivery system described herein, the
`term “proximal” is intended to mean toWard the operator end
`of the catheter, While the term “distal” is intended to mean
`toWard the terminal end or device-carrying end of the
`catheter.
`
`SUMMARY OF PRIOR ART
`
`[0005] The prior art discloses certain common device
`segments inherently required by a percutaneous prosthetic
`
`valve: an expandable stent segment, an anchoring segment
`and a ?oW-regulation segment.
`
`[0006] Prior art percutaneous prosthetic valve devices
`include the Dobben valve, US. Pat. No. 4,994,077, the
`Vince valve, US. Pat. No. 5,163,953, the Teitelbaum valve,
`US. Pat. No. 5,332,402, the Stevens valve, US. Pat. No.
`5,370,685, the Pavcnik valve, US. Pat. No. 5,397,351, the
`Taheri valve, US. Pat. No. 5,824,064, the Anderson valves,
`US. Pat. Nos. 5,411,552 & 5,840,081, the Jayaraman valve,
`US. Pat. No. 5,855,597, the Besseler valve, US. Pat. No.
`5,855,601, the Khosravi valve, US. Pat. No. 5,925,063, the
`Zadano-AZiZi valve, US. Pat. No. 5,954,766, and the Leon
`hardt valve, US. Pat. No. 5,957,949. Each of these pre
`existing stent valve designs has certain disadvantages Which
`are resolved by the present invention.
`
`[0007] The Dobben valve has a disk shaped ?ap threaded
`on a Wire bent like a safety pin to engage the vessel Wall and
`anchor the valve. A second embodiment uses a stent of a
`cylindrical or croWn shape that is made by bending Wire into
`a ZigZag shape to anchor the device and attach the How
`regulator ?ap. The device presents signi?cant hemody
`namic, delivery, fatigue and stability disadvantages.
`[0008] The Vince valve has a stent comprised of a toroidal
`body formed of a ?exible coil of Wire and a ?oW-regulation
`mechanism consisting of a ?ap of biologic material. Numer
`ous longitudinal extensions Within the stent are provided as
`attachment posts to mount the ?oW-regulation mechanism.
`The device requires balloon expansion to deliver to the body
`ori?ce. The main shortcoming of this design is delivery
`pro?le. Speci?cally, the device and method put forth Will
`require a 20+ French siZe catheter (approximately 9 French
`siZes to accommodate the balloon and 14+ French siZes to
`accommodate the compressed device) making the device
`clinically ineffective as a minimally invasive technique.
`Additionally, the device does not adequately address hemo
`dynamic, stability and anchoring concerns.
`
`[0009] The Teitelbaum valve is made of shape memory
`nitinol and consists of tWo components. The ?rst component
`is stent-like and comprised of a meshWork or braiding of
`nitinol Wire similar to that described by Wallsten, US. Pat.
`No. 4,655,771, With trumpet like distal a proximal ?ares.
`The purpose of the stent is to maintain a semi-ridged patent
`channel through the diseased cardiac valve after initial
`balloon dilation. The ?ared ends are intended to maintain the
`position of the stent component across the valve thereby
`anchoring the device. Embodiments for the ?oW-regulation
`mechanism include a sliding obturator and a caged ball both
`Which are delivered secondary to the stent portion. The
`disadvantages of the device are the How regulators reduce
`the effective valve ori?ce and generate sub-optimal hemo
`dynamic characteristics; fatigue concerns arise from the
`separate nature of the stent and ?oW-regulation components;
`the high metal and exposed metal content raises thrombo
`genesis, valvular stenosis and chronic anticoagulation con
`cerns; and the separate delivery requirements (although
`addressing the need for small delivery pro?le) in addition to
`any initial valvuloplasty performed increases the time, costs,
`risks, dif?culty and trauma associated With the percutaneous
`procedure.
`[0010] The Pavcnik valve is a self-expanding percutane
`ous device comprised of a poppet, a stent and a restraining
`element. The valve stent has barbed means to anchor to the
`
`Edwards Lifesciences Corporation, et al. Exhibit 1020, p. 8 of 15
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`

`
`US 2001/0021872 A1
`
`Sep. 13, 2001
`
`internal passageway. The device includes a self-expanding
`stent of a ZigZag con?guration in conjunction With a cage
`mechanism comprised of a multiplicity of crisscrossed Wires
`and a valve seat. The disadvantages of the device include
`large delivery pro?le, reduced effective valvular ori?ce,
`possible perivalvular leakage, trauma-inducing turbulent
`?oW generated by the cage occlusive apparatus and valve
`seat, thrombogenesis, valvular stenosis, chronic anticoagu
`lation, problematic physiological and procedural concerns
`due to the barb anchors and complex delivery procedure that
`includes in?ation of occlusive member after initial implan
`tation.
`[0011] Stevens discloses a percutaneous valve replace
`ment system for the endovascular removal of a malfunc
`tioning valve folloWed by replacement With a prosthetic
`valve. The valve replacement system may include a pros
`thetic valve device comprised of a stent and cusps for
`?oW-regulation such as a ?xed porcine aortic valve, a valve
`introducer, an intraluminal procedure device, a procedure
`device capsule and a tissue cutter. The devices disclosed
`indicate a long and complex procedure requiring large
`diameter catheters. The valve device disclosed Will require
`a large delivery catheter and does not address the key
`mechanisms required of a functioning valve. Additionally,
`the device requires intraluminal-securing means such as
`suturing to anchor the device at the desired location.
`[0012] The Taheri valve describes an aortic valve replace
`ment combined With an aortic arch graft. The devices and
`percutaneous methods described require puncture of the
`chest cavity.
`[0013] Anderson has disclosed various balloon expand
`able percutaneous prosthetic valves. The latest discloses a
`valve prosthesis comprised of a stent made from an expand
`able cylindrical structure made of several spaced apices and
`an elastically collapsible valve mounted to the stent With the
`commissural points of the valve mounted to the apices. The
`device is placed at the desired location by balloon expanding
`the stent and valve. The main disadvantage to this design is
`the 20+ French siZe delivery requirement. Other problems
`include anchoring stability, perivalvular leakage, dif?cult
`manufacture and suspect valve performance.
`[0014] The Jayaraman valve includes a star-shaped stent
`and a replacement valve and/or replacement graft for use in
`repairing a damaged cardiac valve. The device is comprised
`of a chain of interconnected star-shaped stent segments in
`the center of Which sits a replacement valve. The ?oW
`regulation mechanism consists of three ?aps cut into a ?at
`piece of graft material that is rolled to form a conduit in
`Which the three ?aps may be folded inWardly in an over
`lapping manner. An additional ?oW-regulation mechanism is
`disclosed in Which a patch (or multiple patches) is sutured to
`the outside of a conduit Which is then pulled inside out or
`inverted such that the patch(s) reside on the fully inverted
`conduit. A balloon catheter is required to assist expansion
`during delivery. The disadvantages of this design include
`lack of suf?cient anchoring mechanism; problematic inter
`ference concerns With adjacent tissues and anatomical struc
`tures; fatigue concerns associated With the multiplicity of
`segments, connections and sutures; lack of an adequately
`controlled and biased ?oW-regulation mechanism; uncertain
`effective valve ori?ce, dif?cult manufacture; balloon dila
`tion requirement; complex, dif?cult and inaccurate delivery
`and large delivery pro?le.
`
`[0015] The Besseler valve discloses methods and devices
`for the endovascular removal of a defective heart valve and
`the replacement With a percutaneous cardiac valve. The
`device is comprised of a self-expanding stent member With
`a ?exible valve disposed Within. The stent member is of a
`self-expanding cylindrical shape made from a closed Wire in
`formed in a ZigZag con?guration that can be a single piece,
`stamped or extruded or formed by Welding the free ends
`together. The ?oW-regulation mechanism is comprised of an
`arcuate portion Which contains a slit (or slits) to form lea?ets
`and a cuff portion Which is sutured to and encloses the stent.
`The preferred ?oW regulator is a porcine pericardium With
`three cusps. An additional ?oW regulator is described in
`Which the graft material that comprises the lea?ets (no
`additional mechanisms for ?oW-regulation) extends to form
`the outer cuff portion and is attached to the stent portion With
`sutures. The anchoring segment is provided by a plurality of
`barbs carried by the stent (and therefor penetrating the
`cuff-graft segment). Delivery requires endoluminal removal
`of the natural valve because the barb anchors Will malfunc
`tion if they are orthotopically secured to the native lea?ets
`instead of the more rigid tissue at the native annulus or
`vessel Wall. Delivery involves a catheter Within Which the
`device and a pusher rod are disposed. The disadvantages of
`the device are lack of a Well de?ned and biased ?oW
`regulation mechanism, anatomic valve removal is required
`thereby lengthening the procedure time, increasing dif?culty
`and reducing clinical practicality, trauma-inducing barbs as
`described above and the device is unstable and prone to
`migration if barbs are omitted.
`
`[0016] The Khosravi valve discloses a percutaneous pros
`thetic valve comprised of a coiled sheet stent similar to that
`described by Derbyshire, US. Pat. No. 5,007,926, to Which
`a plurality of ?aps are mounted on the interior surface to
`form a ?oW-regulation mechanism that may be comprised of
`a biocompatible material. The disadvantages of this design
`include problematic interactions betWeen the stent and ?aps
`in the delivery state, lack of clinical data on coiled stent
`performance, the lack of a detailed mechanism to ensure that
`the ?aps Will create a competent one-directional valve, lack
`of appropriate anchoring means, and the design require
`ments imposed by surrounding anatomical structures are
`ignored.
`
`[0017] The Zadno-AZiZi valve discloses a device in Which
`?oW-regulation is provided by a ?ap disposed Within a frame
`structure capable of taking an insertion state and an
`expanded state. The preferred embodiment of the ?oW
`regulation mechanism is de?ned by a longitudinal valve
`body made of a suf?ciently resilient material With a slit(s)
`that extends longitudinally through the valve body.
`Increased sub-valvular pressure is said to cause the valve
`body to expand thereby opening the slit and alloWing ?uid
`?oW there through. The valve body extends into the into the
`lumen of the body passage such that increased supra
`valvular pressure Will prevent the slit from opening thereby
`effecting one-directional ?oW. 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 ?oW-regulation
`mechanism provides a small effective valve ori?ce, the
`turbidity caused by the multiple slit mechanisms, the large
`delivery pro?le required by the disclosed embodiments and
`the lack of acute anchoring means.
`
`Edwards Lifesciences Corporation, et al. Exhibit 1020, p. 9 of 15
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`

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`US 2001/0021872 A1
`
`Sep. 13, 2001
`
`[0018] Finally, the Leonhardt valve is comprised of a
`tubular graft having radially compressible annular spring
`portions and a ?oW regulator, Which is preferably a biologi
`cal valve disposed Within. In addition to oversiZing the
`spring stent by 30%, anchoring means is provided by a
`light-activated biocompatible tissue adhesive is located on
`the outside of the tubular graft and seals to the living tissue.
`The stent section is comprised of a single piece of super
`elastic Wire formed into a ZigZag shape and connected
`together by crimping tubes, adhesives or Welds. A malleable
`thin-Walled, biocompatible, ?exible, expandable, Woven
`fabric graft material is connected to the outside of the stent
`that is in turn connected to the biological ?oW regulator.
`Disadvantages of this device include those pro?le concerns
`associated With biological valves and unsupported graft
`lea?et regulators, a large diameter complex delivery system
`and method Which requires multiple anchoring balloons and
`the use of a light activated tissue adhesive in addition to any
`prior valvuloplasty performed, interference With surround
`ing anatomy and the questionable clinical utility and feasi
`bility of the light actuated anchoring means.
`
`SUMMARY OF THE INVENTION
`
`[0019] With the shortcomings of the prior art devices,
`there remains a need for a clinically effective endoluminally
`deliverable prosthetic valve that is capable of orthotopic
`delivery, provides a mechanically de?ned, biased and hemo
`dynamically sound ?oW-regulation mechanism, provides
`sufficient force to maintain a large acute effective valvular
`ori?ce dimension Which expands to a knoWn larger effective
`ori?ce dimension, compliant With adjacent dynamic ana
`tomical structures, does not require valve removal, does not
`require chronic anticoagulation treatment, meets regulatory
`fatigue requirements for cardiac valve prostheses, provides
`a loW-metal high-strength stent-annulus, is surgically
`explantable or endoluminally removable, in addition to
`being able to deploy multiple valves orthotopically, provides
`a delivery pro?le Which does not exceed the 12 French siZe
`suitable for peripheral vascular endoluminal delivery, com
`bines anatomic valve exclusion and prosthetic valve delivery
`via a single catheter delivery system and With short duration
`atraumatic procedure Which is easy to complete and bene?
`cial to very sick patients.
`
`[0020] It is, therefore, a primary of the present invention
`to provide a prosthetic endoluminally-deliverable unidirec
`tional valve. The invention has multiple con?gurations to
`treat malfunctioning anatomical valves including heart and
`venous valves. Prosthetic cardiac valve con?gurations
`include the chamber-to-vessel for orthotopic placement at
`the valvular junction betWeen a heart chamber and a vessel,
`and the chamber-to-chamber for orthotopic placement at the
`valvular junction betWeen tWo heart chambers or for septal
`defect repair Where a septal occluding member is substituted
`for the ?oW regulator valve ?aps. Prosthetic venous valve
`con?gurations include the vessel-to-vessel for orthotopic or
`non-orthotopic placement at a valvular junction Within a
`vessel.
`
`[0021] The invention consists generally of a stent body
`member, a graft, and valve ?aps. The stent body member
`may be fashioned by laser cutting a hypotube or by Weaving
`Wires into a tubular structure, and is preferably made from
`shape memory or super-elastic materials, such as nickel
`titanium alloys knoWn as NITINOL, but may be made of
`
`balloon expandable stainless steel or other plastically
`deformable stent materials as are knoWn in the art, such as
`titanium or tantalum, or may be self-expanding such as by
`Weaving stainless steel Wire into a stressed-tubular con?gu
`ration in order to impart elastic strain to the Wire. The graft
`is preferably a biocompatible, fatigue-resistant membrane
`Which is capable of endothelialiZation, and is attached to the
`stent body member on at least portions of either or both the
`lumenal and ablumenal surfaces of the stent body member
`by suturing to or encapsulating stent struts. The valve
`lea?ets are preferably formed by sections of the graft mate
`rial attached to the stent body member.
`[0022] The stent body member is shaped to include the
`folloWing stent sections: proximal and distal anchors, a
`intermediate annular stent section, and at least one valve arm
`or blood ?oW regulator struts. The proximal and distal
`anchor sections are present at opposing ends of the prosthe
`sis and subtend either an acute, right or obtuse angle With a
`central longitudinal axis that de?nes the cylindrical prosthe
`sis. In either the CV or CC con?gurations, the proximal
`anchor is con?gured to assume approximately a right angle
`radiating outWard from the central longitudinal axis of the
`prosthesis in a manner Which provides an anchoring ?ange.
`When being delivered from a delivery catheter, the proximal
`anchor is deployed ?rst and engages the native tissue and
`anatomical structures just proximal to the anatomic valve,
`such as the left ventricle Wall in the case of retrograde
`orthotopic delivery at the aortic valve. Deployment of the
`proximal anchor permits the intermediate annular stent
`section to be deployed an reside Within the native valve
`annular space and the ablumenal surface of the intermediate
`annular stent section to abut and outWardly radially com
`press the anatomic valve lea?ets against the vascular Wall.
`The distal anchor is then deployed and radially expands to
`contact the vascular Wall and retain the prosthesis in posi
`tion, thereby excluding the anatomic valve lea?ets from the
`blood?oW and replacing them With the prosthetic valve
`lea?ets.
`[0023] How regulation in the inventive stent valve pros
`thesis is provided by the combination of the prosthetic valve
`lea?ets and the valve arms and is biased closed in a manner
`similar manner to that described for a surgically implanted
`replacement heart valve by Boretos, U.S. Pat. No. 4,222,
`126. The valve regulator-struts are preferably con?gured to
`be positioned to radiate inWard from the stent body member
`toWard the central longitudinal axis of the prosthesis. The
`graft-lea?et has the appearance of a partially-everted tube
`Where the innermost layer, on the lumenal surface of the
`stent body member, forms the lea?ets and the outer-most
`layer, on the ablumenal surface of the stent body member,
`forms a sealing graft Which contacts and excludes the
`immobiliZed anatomical valve lea?ets. The struts of the stent
`are encapsulated by the outer graft-membrane. The valve
`regulator-struts are encapsulated by the inner lea?et-mem
`brane and serve to bias the valve to the closed position. The
`regulator-struts also prevent inversion or prolapse of the
`otherWise unsupported lea?et-membrane during increased
`supra-valvular pressure. The inner lea?et-membrane may
`also be attached to the outer graft-membrane at points
`equidistant from the valve strut-arms in a manner analogous
`to that described for a surgically implanted replacement
`heart valve by Cox, US. Pat. No. 5,824,063. The combina
`tion of the thin Walled properties of the lea?et-membrane,
`the one-sided open lumen support of the intermediate annu
`
`Edwards Lifesciences Corporation, et al. Exhibit 1020, p. 10 of 15
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`US 2001/0021872 A1
`
`Sep. 13, 2001
`
`lar stent section, the free ends of the valve lea?ets, the
`biasing and support provided by the valve regulator-struts
`and the attachment points all Work to provide a prosthetic
`valvular device capable of endoluminal delivery Which
`simulates the hemodynamic properties of a healthy anatomi
`cal cardiac or venous valve.
`
`BRIEF DESCRIPTION OF FIGURES
`
`[0024] FIG. 1 is a perspective vieW of the inventive valve
`stent chamber-to-vessel embodiment in its fully deployed
`state.
`
`[0025] FIG. 2 is a perspective vieW of the inventive valve
`stent chamber-to-vessel embodiment in its fully deployed
`state With the outermost graft layer and stent layer partially
`removed to shoW an embodiment of the valve apparatus.
`
`[0026] FIG. 3 is a top vieW of the inventive valve stent
`chamber-to-vessel embodiment in its fully deployed state.
`
`[0027] FIG. 4 shoWs the cross-sectional taken along line
`4—4 of FIG. 1.
`
`[0028] FIG. 5 is a bottom vieW of the inventive valve stent
`chamber-to-vessel embodiment in its fully deployed state.
`
`[0029] FIG. 6A illustrates a cross-sectional vieW of a
`human heart during systole With the inventive valve stent
`chamber-to-vessel embodiment implanted in the aortic valve
`and illustrating a blood ?oW vector of an ejection fraction
`leaving the left ventricle and passing through the inventive
`valve stent.
`
`[0030] FIG. 6B illustrates a cross-sectional vieW of a
`human heart during diastole With the inventive valve stent
`chamber-to-vessel embodiment implanted in the aortic valve
`and illustrating a blood ?oW vector of blood passing from
`the left atrium, through the mitral valve and into the left
`ventricle during and a retrograde blood ?oW vector blocked
`by the inventive valve stent in the aorta.
`
`[0031] FIG. 7 is a perspective vieW of the inventive valve
`stent chamber-to-chamber embodiment in its fully deployed
`state.
`
`[0032] FIG. 8 is a is a perspective vieW of the inventive
`valve stent chamber-to-chamber embodiment in its fully
`deployed state With the outermost graft layer and stent layer
`partially removed to shoW an embodiment of the valve
`apparatus.
`
`[0033] FIG. 9 is a top vieW of the inventive valve stent
`chamber-to-chamber embodiment in its fully deployed state.
`
`[0034] FIG. 10 shoWs the cross sectional vieW taken along
`line 10—10 of FIG. 7.
`
`[0035] FIG. 11 is a bottom vieW of inventive valve stent
`chamber-to-chamber embodiment in its fully deployed state.
`
`[0036] FIG. 12A illustrates a cross-sectional vieW of a
`human heart during atrial systole With the inventive valve
`stent chamber-to-chamber embodiment implanted at the site
`of the mitral valve and illustrating a blood ?oW vector of a
`?lling fraction leaving the left atrium and entering the left
`ventricle.
`
`[0037] FIG. 12B illustrates a cross-sectional vieW of a
`human heart during atrial diastole With the inventive valve
`stent chamber-to-chamber embodiment implanted at the site
`
`of the mitral valve and illustrating a blood ?oW vector of an
`ejection fraction from the left ventricle to the aorta and the
`back pressure against the implanted mitral valve prosthesis.
`[0038] FIG. 13 is a perspective vieW of the chamber-to
`vessel con?guration in the fully deployed state.
`
`[0039] FIG. 14 is a perspective vieW of the same con?gu
`ration in the fully deployed state With the outermost graft
`layer and stent layer partially removed to shoW an embodi
`ment of the valve apparatus.
`[0040]
`[0041] FIG. 16 shoWs the cross sectional vieW of the same
`con?guration for the deployed state.
`
`FIG. 15 is a top vieW of the same con?guration.
`
`[0042] FIG. 17 is a bottom vieW of the same con?gura
`tion.
`
`[0043] FIG. 18A and 18B shoW cross-sectional vieWs of
`a vein and venous valve illustrating the inventive prosthetic
`venous valve in the open and closed state.
`
`[0044] FIGS. 19 is a cross-sectional diagrammatic vieW of
`a valvuloplasty and stent valve delivery catheter in accor
`dance With the present invention.
`
`[0045] FIG. 20A-20I are diagrammatic cross-sectional
`vieWs illustrating single catheter valvuloplasty, inventive
`stent valve delivery and stent valve operation in situ in
`accordance With the method of the present invention.
`
`DETAILED DESCRIPTION OF THE
`PREFERRED EMBODIMENTS
`
`[0046] The present invention consists generally of three
`preferred embodiments, each embodiment corresponding to
`a prosthetic stent valve con?guration adapted for either heart
`chamber to blood vessel communication, chamber to cham
`ber communication or vessel to vessel, or intravascular
`con?guration. Certain elements are common to each of the
`preferred embodiments of the invention, speci?cally, each
`embodiment includes a stent body member Which de?nes a
`central annular opening along the longitudinal axis of the
`stent body member, a graft member Which covers at least a
`portion of the stent body member along either the lumenal
`or ablumenal surfaces of the stent body member, at least one
`biasing arm is provided and projects from the stent body
`member and into the central annular opening of the stent
`body member, and at least one valve ?ap member Which is
`coupled to each biasing arm such that the biasing arm biases
`the valve ?ap member to occlude the central annular open
`ing of the stent body member under conditions of a Zero
`pressure differential across the prosthesis. The stent body
`member is preferably made of a shape memory material or
`superelastic material, such as NITINOL, but also be fabri
`cated from either plastically deformable materials or spring
`elastic materials such as is Well knoWn in the art. Addition
`ally, the stent body member has three main operable
`sections, a proximal anchor section, a distal anchor section
`and an intermediate annular section Which is intermediate
`the proximal and distal anchor sections. Depending upon the
`speci?c inventive embodiment, the distal and proximal
`anchor sections may be either a diametrically enlarged
`section or may be a ?anged section. The intermediate
`annular section de?nes a valve exclusion region and primary
`blood ?oW channel of the inventive valve stent. The inter
`mediate annular section de?nes a lumenal opening through
`
`Edwards Lifesciences Corporation, et al. Exhibit 1020, p. 11 of 15
`
`

`
`US 2001/0021872 A1
`
`Sep. 13, 2001
`
`Which blood How is established. The transverse cross
`section of the lumenal opening may be circular, elliptical,
`ovular, triangular or quadralinear, depending upon the spe
`ci?c application for Which the valve stent is being employed.
`Thus, for example, Where a tricuspid valve is particularly
`stenosed, it may be preferable to employ a valve stent With
`a lumenal opening in the intermediate annular section Which
`has a triangular transverse cross-sectional dimension.
`[0047] Chamber-to-Vessel Con?guration
`[0048] An implantable prosthesis or prosthetic valve in
`accordance With certain embodiments of the chamber-to
`vessel CV con?guration of the present invention is illus
`trated generally in FIGS. 1-5. The chamber-to-vessel valve
`stent 10 consists of an expandable stent body member 12 and
`graft member 11. The stent body member 12 is preferably
`made from a shape memory and/or superelastic NITTNOL
`material, or thermomechanically similar materials, but may
`be made of plastically deformable or elastically compliant
`materials such as stainless steel, titanium or tantalum. The
`graft member 11 is preferably made of biologically-derived
`membranes or biocompatible synthetic materials such as
`DACRON or expanded polytetra?uoroethylene. The stent
`body member 12 is con?gured to have three functional
`sections: a proximal anchor ?ange 22, an intermediate
`annular section 20 and a distal anchor section 16. The stent
`body member 12, as With conventional stents is formed of a
`plurality of stent struts 13 Which de?ne interstices 14
`betWeen adjacent stent struts 13. The stent body member
`preferably also includes a transitional section 18 Which
`interconnects the intermediate annular section 20 and the
`distal anchor section 16, Which together de?ne a valve
`exclusion region of the inventive stent valve 10 to exclude
`the anatomic valve after implantation. The proximal anchor
`?ange 22, the intermediate annular section 20 and the distal
`anchor section 16 are each formed during the formation of
`the stent body member and are formed from the same
`material as the stent body member and comprise stent struts
`13 and intervening interstices 14 betWeen adjacent pairs of
`stent struts 13. The anchor ?ange 22, for example, consists
`of a plurality of stent struts and a plurality of stent inter
`stices, Which project radially outWardly aWay from the
`central longitudinal axis of the stent body member. Thus, the
`different sections of the stent body member 12 are de?ned by
`the positional orientation of the stent struts and interstices
`relative to the central longitudinal axis of the stent body
`member 12.
`
`[0049] With reference to FIG. 2, there is shoWn in greater
`detail the valve body 26 and valv