`Bailey et al.
`
`USOO6652578B2
`(10) Patent No.:
`US 6,652,578 B2
`(45) Date of Patent:
`Nov. 25, 2003
`
`(54) ENDOLUMINAL CARDIAC AND VENOUS
`VALVE PROSTHESES AND METHODS OF
`MANUFACTURE AND DELIVERY THEREOF
`
`(75) Inventors: Steven R. Bailey, San Antonio, TX
`(US); Christopher T. Boyle, San
`Antonio, TX (US)
`s
`(73) Assignee: ABPS Venture One, Ltd., San Antonio,
`TX (US)
`Subject to any disclaimer, the term of this
`patent is extended or adjusted under 35
`U.S.C. 154(b) by 0 days.
`
`(*) Notice:
`
`21) Appl. No.: 09/854,002
`(21) App
`1854,
`(22) Filed:
`May 11, 2001
`(65)
`Prior Publication Data
`
`US 2001/0021872 A1 Sep. 13, 2001
`O
`O
`Related U.S. Application Data
`(62) Division of application No. PCT/US00/34591, filed on Dec.
`18, 2000, and a division of application No. 09/477,120, filed
`on Dec. 31, 1999, now Pat. No. 6,458,153.
`
`(51) Int. Cl." ................................................... A61F 2/06
`(52) U.S. Cl. ...................................... 623/124; 623/126
`(58) Field of Search ............................... 623/124, 1.25,
`623/126, 1.11, 2.11; 606/108, 194, 192,
`198; 604/96.01, 97.01, 103.05, 101.03,
`102.01 102.02 102.03
`s
`s
`
`(56)
`
`References Cited
`U.S. PATENT DOCUMENTS
`
`4,222,126 A 9/1980 Boretos et al. ................. 3/15
`4,994,077 A 2/1991 Dobben ......................... 623/2
`5,078.720 A * 1/1992 Burton et al. .
`... 606/108
`5,108,420 A 4/1992 Marks ..........
`... 606/213
`5,163,953 A 11/1992 Vince ............................ 623/2
`5,332,402 A 7/1994 Teitelbaum .................... 623/2
`5,334,217 A 8/1994 Das ..............
`... 606/213
`5,370,685 A 12/1994 Stevens ......................... 623/2
`
`
`
`5,397,351 A 3/1995 Pavcnik et al. ............... 623/11
`List continued
`t
`(List continued on next page.)
`FOREIGN PATENT DOCUMENTS
`
`EP
`EP
`EP
`WO
`
`7/1998 ............. A61F/2/24
`O 850 607
`* 7/1998 ................ 623/126
`O850607
`11/1998 ............. A61F/2/24
`O 808 614
`8/2000 ................ 623/126
`WO-OO/47139
`OTHER PUBLICATIONS
`“MASA Heart Valves', http://www.heart-Surgeons.com/
`Valvedesign.htm, pp. 1-3.
`“Aortic Valve Replacement', STS Patient Information,
`http://www.sts.org/doc/3620, pp. 1-5.
`“Minimallv Invasive Aortic Valve Surgery CTSNET
`y
`gery
`Experts' Techniques, http://www.ctsnet.org/doc.3358, pp.
`1-4.
`“Heartport Annouces Launch of Heartport InSite AVR Sys
`tem for Less Invasive Aortic Valve Replacement” Heartport,
`Inc. Company Press Release, pp 1-2.
`“ATS Medical Inc. Annual Report', pp. 1-7.
`“St. Jude Medical Heart Valve Division Expanding the
`Focus s www.sum.com/Stide/world.htmlexpand.htm.
`St. Jude Medical Heart Valve Division The Mechical Heart
`Valve Evolution”, www.sim.com/stude/world/htm.evo
`lut.htm.
`“Heartport Announces Launch of Heartport InSite AVR
`System for Less Invasive Aortic Valve Replacement”,
`Heartport, Inc. What's New Release, www.pddnet.com/
`Pddnews/08oct9903.htm, pp. 1–2.
`Primary Examiner-David H. Willse
`ASSistant Examiner Alvin Stewart
`(74) Attorney, Agent, or Firm-David G. Rosenbaum;
`Rosenbaum & Associates, P.C.; Thomas S. Kim
`(57)
`ABSTRACT
`This invention relates to prosthetic cardiac and venous
`Valves and a single catheter device and minimally invasive
`techniques for percutaneous and transluminal valvuloplasty
`and prosthetic valve implantation.
`
`7 Claims, 6 Drawing Sheets
`
`Edwards Lifesciences Corporation, et al. Exhibit 1011, p. 1 of 16
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`US 6,652,578 B2
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`U.S. PATENT DOCUMENTS
`
`552. A 89 Steven- 623/2
`E. A : 8. l cal
`s
`Y/ / 12
`f
`urek et al. ..
`... 623/
`5,713.953 A 2/1998 Vallana et al.
`... 623/2
`5,725,552 A 3/1998 Kotula et al. .
`... 606/213
`5,741,297 A 4/1998 Simon .......
`... 606/213
`5,824,063 A 10/1998 Cox .............................. 623/2
`5,824,064 A 10/1998 Taheri ........................... 623/2
`5,840,081 A 11/1998 Andersen ....................... 623/2
`5,843,090 A 12/1998 Schetz ........................ 606/108
`5,846.261. A 12/1998 Kotula ......
`... 606/213
`5,855,597 A
`1/1999 Jayaraman ..................... 623/1
`
`1/1999 Bessler et al. ................. 623/2
`5,855,601 A
`5,895.419 A 4/1999 Tweden et al. ......
`... 623/2
`5,919,224. A
`7/1999 Thompson et al.
`... 623/1
`5,925,063 A
`7/1999 Khosravi .................... 606/200
`5,954,766. A
`9/1999 Zadno-Azizi .................. 623/2
`5,957,949 A * 9/1999 Leonhardt et al. .......... 606/194
`5,964,782 A 10/1999 Lafontaine et al. ......... 606/213
`5.997,573 A 12/1999 Quijano et al. ......
`... 623/1
`6,168,614 B1 * 1/2001 Andersen et al. .
`... 623/1
`6,231,588 B1 * 5/2001 Zadno-Azizi .....
`. 606/200
`6.425,916 B1 * 7/2002 Garri
`tal
`62.3/2.11
`2 : 1 - 2
`f
`aSOl C al. ...........
`f2.
`
`
`
`* cited by examiner
`
`Edwards Lifesciences Corporation, et al. Exhibit 1011, p. 2 of 16
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`U.S. Patent
`
`Nov. 25, 2003
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`Sheet 1 of 6
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`Edwards Lifesciences Corporation, et al. Exhibit 1011, p. 3 of 16
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`U.S. Patent
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`Edwards Lifesciences Corporation, et al. Exhibit 1011, p. 4 of 16
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`U.S. Patent
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`Nov. 25, 2003
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`Edwards Lifesciences Corporation, et al. Exhibit 1011, p. 5 of 16
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`F.G. 18A
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`FIG. 18B
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`FIG. 20A
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`FIG.20B
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`Edwards Lifesciences Corporation, et al. Exhibit 1011, p. 7 of 16
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`Edwards Lifesciences Corporation, et al. Exhibit 1011, p. 8 of 16
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`
`1
`ENDOLUMINAL CARDIAC AND VENOUS
`VALVE PROSTHESES AND METHODS OF
`MANUFACTURE AND DELIVERY THEREOF
`
`CROSS-REFERENCE TO RELATED
`APPLICATION
`This application is a division of U.S. utility patent appli
`cation Ser. No. 09/477,120, filed Dec. 31, 1999 now U.S.
`Pat. No. 6,458,153 and PCT International Application, Ser.
`No. PCT/US00/34591, filed Dec. 18, 2000.
`
`BACKGROUND OF THE INVENTION
`The present invention relates generally to implantable
`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 intrac
`ardiac or intravenous site without the need for anatomic
`valve removal. The prosthetic valves of the present inven
`tion are well-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 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)
`configuration which is particularly well-Suited as an aortic
`valve prosthesis to facilitate blood flow from the left ven
`tricle to the aorta. In a Second embodiment, there is provided
`a prosthetic valve in a chamber-to-chamber (CC) configu
`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)
`configuration, which is well Suited for venous valve eXclu
`Sion and replacement.
`Common to each of the CV, CC and VV embodiments 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 flaps
`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 flaps being
`coupled to the Stent in a manner which biases the valve flaps
`So they close upon a Zero pressure differential across the
`Valve region.
`It is important for the present invention to provide orien
`tational definitions. For purposes of the present invention,
`references to positional aspects of the present invention will
`be defined relative to the directional flow vector of blood
`flow through the implantable device. Thus, the term “proxi
`mal' is intended to mean on the inflow or upstream flow side
`of the device, while “distal' is intended to mean on the
`outflow or downstream flow 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
`The prior art discloses certain common device Segments
`inherently required by a percutaneous prosthetic valve: an
`expandable Stent Segment, an anchoring Segment and a
`flow-regulation Segment.
`Prior art percutaneous prosthetic valve devices include the
`Dobben valve, U.S. Pat. No. 4,994,077, the Vince valve,
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`U.S. Pat. No. 5,163,953, the Teitelbaum valve, U.S. Pat. No.
`5,332,402, the Stevens valve, 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 Anderson valves, U.S. Pat. Nos.
`5,411,552 & 5,840,081, the Jayaraman valve, U.S. Pat. No.
`5,855,597, the Besseller valve, U.S. Pat. No. 5,855,601, the
`Khosravi valve, U.S. Pat. No. 5,925,063, the Zadano-Azizi
`valve, U.S. Pat. No. 5,954,766, and the Leonhardt valve,
`U.S. Pat. No. 5,957,949. Each of these pre-existing stent
`Valve designs has certain disadvantages which are resolved
`by the present invention.
`The Dobben valve has a disk shaped flap 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 flow
`regulator flap. The de Vice present S Significant
`hemodynamic, delivery, fatigue and Stability disadvantages.
`The Vince valve has a stent comprised of a toroidal body
`formed of a flexible coil of wire and a flow-regulation
`mechanism consisting of a flap of biologic material. Numer
`ous longitudinal extensions within the Stent are provided as
`attachment posts to mount the flow-regulation mechanism.
`The device requires balloon expansion to deliver to the body
`orifice. The main Shortcoming of this design is delivery
`profile. Specifically, 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
`hemodynamic, Stability and anchoring concerns.
`The Teitelbaum valve is made of shape memory nitinol
`and consists of two components. The first component is
`Stent-like and comprised of a meshwork or braiding of
`nitinol wire similar to that described by Wallsten, U.S. Pat.
`No. 4,655,771, with trumpet like distal a proximal flares.
`The purpose of the Stent is to maintain a Semi-ridged patent
`channel through the diseased cardiac valve after initial
`balloon dilation. The flared ends are intended to maintain the
`position of the Stent component across the valve thereby
`anchoring the device. Embodiments for the flow-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 flow regulators reduce
`the effective valve orifice and generate Sub-optimal hemo
`dynamic characteristics, fatigue concerns arise from the
`Separate nature of the Stent and flow-regulation components,
`the high metal and exposed metal content raises
`thrombogenesis, Valvular Stenosis and chronic anticoagula
`tion concerns, and the Separate delivery requirements
`(although addressing the need for Small delivery profile) in
`addition to any initial valvuloplasty performed increases the
`time, costs, risks, difficulty and trauma associated with the
`percutaneous procedure.
`The Pavcnik valve is a Self-expanding percutaneous
`device comprised of a poppet, a Stent and a restraining
`element. The valve stent has barbed means to anchor to the
`internal passageway. The device includes a Self-expanding
`Stent of a ZigZag configuration 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 profile, reduced effective valvular orifice,
`possible perivalvular leakage, trauma-inducing turbulent
`flow generated by the cage occlusive apparatus and valve
`Seat, thrombogenesis, Valvular Stenosis, chronic
`anticoagulation, problematic physiological and procedural
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`Edwards Lifesciences Corporation, et al. Exhibit 1011, p. 9 of 16
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`3
`concerns due to the barb anchors and complex delivery
`procedure that includes inflation of occlusive member after
`initial implantation.
`Stevens discloses a percutaneous valve replacement SyS
`tem for the endovascular removal of a malfunctioning valve
`followed by replacement with a prosthetic valve. The valve
`replacement System may include a prosthetic valve device
`comprised of a Stent and cusps for flow-regulation Such as a
`fixed porcine aortic valve, a valve introducer, an intralumi
`nal 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.
`The Taheri valve describes an aortic valve replacement
`combined with an aortic arch graft. The devices and percu
`taneous methods described require puncture of the chest
`cavity.
`Anderson has disclosed various balloon expandable per
`cutaneous prosthetic valves. The latest discloses a valve
`prosthesis comprised of a Stent made from an expandable
`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, difficult
`manufacture and Suspect valve performance.
`The Jayaraman Valve includes a Star-shaped 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 interconnected Star-shaped Stent Segments in the
`center of which sits a replacement valve. The flow
`regulation mechanism consists of three flaps cut into a flat
`piece of graft material that is rolled to form a conduit in
`which the three flaps may be folded inwardly in an over
`lapping manner. An additional flow-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 Sufficient 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 flow-regulation mechanism; uncertain
`effective valve orifice, difficult manufacture; balloon dila
`tion requirement; complex, difficult and inaccurate delivery
`and large delivery profile.
`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
`flexible valve disposed within. The stent member is of a
`Self-expanding cylindrical shape made from a closed wire in
`formed in a ZigZag configuration that can be a Single piece,
`Stamped or extruded or formed by welding the free ends
`together. The flow-regulation mechanism is comprised of an
`arcuate portion which contains a slit (or slits) to form leaflets
`and a cuff portion which is Sutured to and encloses the Stent.
`The preferred flow regulator is a porcine pericardium with
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`4
`three cusps. An additional flow regulator is described in
`which the graft material that comprises the leaflets (no
`additional mechanisms for flow-regulation) extends to form
`the outer cuffportion 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 leaflets
`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 defined and biased flow
`regulation mechanism, anatomic valve removal is required
`thereby lengthening the procedure time, increasing difficulty
`and reducing clinical practicality, trauma-inducing barbs as
`described above and the device is unstable and prone to
`migration if barbs are omitted.
`The Khosravi Valve discloses a percutaneous prosthetic
`Valve comprised of a coiled Sheet Stent Similar to that
`described by Derbyshire, U.S. Pat. No. 5,007,926, to which
`a plurality of flaps are mounted on the interior Surface to
`form a flow-regulation mechanism that may be comprised of
`a biocompatible material. The disadvantages of this design
`include problematic interactions between the Stent and flaps
`in the delivery State, lack of clinical data on coiled Stent
`performance, the lack of a detailed mechanism to ensure that
`the flaps will create a competent one-directional valve, lack
`of appropriate anchoring means, and the design require
`ments imposed by Surrounding anatomical Structures are
`ignored.
`The Zadno-Azizi valve discloses a device in which flow
`regulation is provided by a flap disposed within a frame
`Structure capable of taking an insertion State and an
`expanded state. The preferred embodiment of the flow
`regulation mechanism is defined by a longitudinal valve
`body made of a sufficiently 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 fluid
`flow 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 flow. 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 flow-regulation
`mechanism provides a Small effective valve orifice, the
`turbidity caused by the multiple slit mechanisms, the large
`delivery profile required by the disclosed embodiments and
`the lack of acute anchoring means.
`Finally, the Leonhardt valve is comprised of a tubular
`graft having radially compressible annular Spring portions
`and a flow regulator, which is preferably a biological 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 Superelastic wire
`formed into a ZigZag shape and connected together by
`crimping tubes, adhesives or welds. Amalleable thin-walled,
`biocompatible, flexible, expandable, woven fabric graft
`material is connected to the outside of the Stent that is in turn
`connected to the biological flow regulator. Disadvantages of
`this device include those profile concerns associated with
`biological valves and unsupported graft-leaflet regulators, a
`large diameter complex delivery System and method which
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`Edwards Lifesciences Corporation, et al. Exhibit 1011, p. 10 of 16
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`requires multiple anchoring balloons and the use of a light
`activated tissue adhesive in addition to any prior valvulo
`plasty performed, interference with Surrounding anatomy
`and the questionable clinical utility and feasibility of the
`light actuated anchoring means.
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`6
`either the CV or CC configurations, the proximal anchor is
`configured to assume approximately a right angle radiating
`outward from the central longitudinal axis of the prosthesis
`in a manner which provides an anchoring flange. When
`being delivered from a delivery catheter, the proximal
`anchor is deployed first 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 leaflets against the vascular wall.
`The distal anchor is then deployed and radially expands to
`contact the vascular wall and retain the prosthesis in
`position, thereby excluding the anatomic valve leaflets from
`the bloodflow and replacing them with the prosthetic valve
`leaflets.
`Flow regulation in the inventive Stent valve prosthesis is
`provided by the combination of the prosthetic valve leaflets
`and the valve 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 preferably configured to be posi
`tioned to radiate inward from the stent body member toward
`the central longitudinal axis of the prosthesis. The graft
`leaflet has the appearance of a partially-everted tube where
`the innermost layer, on the lumenal Surface of the Stent body
`member, forms the leaflets and the outer-most layer, on the
`ablumenal Surface of the Stent body member, forms a Sealing
`graft which contacts and excludes the immobilized anatomi
`cal valve leaflets. The Struts of the Stent are encapsulated by
`the Outer graft-membrane. The valve regulator-Struts are
`encapsulated by the inner leaflet-membrane and Serve to bias
`the valve to the closed position. The regulator-Struts also
`prevent inversion or prolapse of the otherwise unsupported
`leaflet-membrane during increased Supra-Valvular pressure.
`The inner leaflet-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, U.S.
`Pat. No. 5,824,063. The combination of the thin walled
`properties of the leaflet-membrane, the one-sided open
`lumen Support of the intermediate annular Stent Section, the
`free ends of the valve leaflets, 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 hemo
`dynamic properties of a healthy anatomical cardiac or
`venous valve.
`BRIEF DESCRIPTION OF FIGURES
`FIG. 1 is a perspective view of the inventive valve stent
`chamber-to-vessel embodiment in its fully deployed State.
`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.
`FIG. 3 is a top view of the inventive valve stent chamber
`to-vessel embodiment in its fully deployed State.
`FIG. 4 shows the cross-sectional taken along line 4-4 of
`FIG. 1.
`FIG. 5 is a bottom view of the inventive valve stent
`chamber-to-vessel embodiment in its fully deployed State.
`FIG. 6A illustrates a cross-sectional view of a human
`heart during systole with the inventive valve stent chamber
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`SUMMARY OF THE INVENTION
`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 defined, biased and hemo
`dynamically Sound flow-regulation mechanism, provides
`Sufficient force to maintain a large acute effective valvular
`orifice dimension which expands to a known larger effective
`orifice 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 profile which does not exceed the 12 French size
`Suitable for peripheral vascular endoluminal delivery, com
`bines anatomic valve eXclusion and prosthetic valve delivery
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`via a single catheter delivery System and with short duration
`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
`tional valve. The invention has multiple configurations to
`treat malfunctioning anatomical valves including heart and
`venous valves. Prosthetic cardiac valve configurations
`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 flow regulator valve flaps. Prosthetic venous valve
`configurations include the vessel-to-vessel for Orthotopic or
`non-Orthotopic placement at a valvular junction within a
`vessel.
`The invention consists generally of a Stent body member,
`a graft, and valve flaps. 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 configuration 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
`leaflets are preferably formed by Sections of the graft mate
`rial attached to the stent body member.
`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
`flow regulator Struts. The proximal and distal anchor Sec
`tions are present at opposing ends of the prosthesis and
`Subtend either an acute, right or obtuse angle with a central
`longitudinal axis that defines the cylindrical prosthesis. In
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`to-vessel embodiment implanted in the aortic valve and
`illustrating a blood flow vector of an ejection fraction
`leaving the left ventricle and passing through the inventive
`valve stent.
`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 flow vector of blood passing from the left
`atrium, through the mitral valve and into the left ventricle
`during and a retrograde blood flow vector blocked by the
`inventive valve Stent in the aorta.
`FIG. 7 is a perspective view of the inventive valve stent
`chamber-to-chamber embodiment in its fully deployed state.
`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.
`FIG. 9 is a top view of the inventive valve stent chamber
`to-chamber embodiment in its fully deployed state.
`FIG. 10 shows the cross sectional view taken along line
`10-10 of FIG. 7.
`FIG. 11 is a bottom view of inventive valve stent
`chamber-to-chamber embodiment in its fully deployed state.
`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 flow vector of a
`filling fraction leaving the left atrium and entering the left
`Ventricle.
`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 flow vector of an
`ejection fraction from the left ventricle to the aorta and the
`back pressure against the implanted mitral valve prosthesis.
`FIG. 13 is a perspective view of the chamber-to-vessel
`configuration in the fully deployed State.
`FIG. 14 is a perspective view of the same configuration in
`the fully deployed State with the outermost graft layer and
`Stent layer partially removed to Show an embodiment of the
`Valve apparatus.
`FIG. 15 is a top view of the same configuration.
`FIG. 16 shows the cross sectional view of the same
`configuration for the deployed State.
`FIG. 17 is a bottom view of the same configuration.
`FIGS. 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.
`FIG. 19 is a cross-sectional diagrammatic view of a
`Valvuloplasty and Stent valve delivery catheter in accordance
`with the present invention.
`FIGS. 20A-20I are diagrammatic cross-sectional views
`illustrating Single catheter Valvuloplasty, inventive Stent
`Valve delivery and Stent valve operation in Situ in accor
`dance with the method of the present invention.
`DETAILED DESCRIPTION OF THE
`PREFERRED EMBODIMENTS
`The present invention consists generally of three preferred
`embodiments, each embodiment corresponding to a proS
`thetic Stent valve configuration adapted for either heart
`chamber to blood vessel communication, chamber to cham
`ber communication or vessel to vessel, or intravascular
`configuration. Certain elements are common to each of the
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`preferred embodiments of the invention, Specifically, each
`embodiment includes a stent body member which defines 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 flap member which is
`coupled to each biasing arm Such that the biasing arm biases
`the valve flap 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.
`Addi