(12)
`
`United States Patent
`Bailey et al.
`
`(10) Patent N0.:
`(45) Date of Patent:
`
`US 6,458,153 B1
`Oct. 1, 2002
`
`US006458153B1
`
`(54) ENDOLUMINAL CARDIAC AND VENOUS
`VALVE PROSTHESES AND METHODS ()1?
`MANUFACTURE AND DELIVERY THEREOF
`
`7/1999 Khosravi .................. .. 606/200
`5,925,063 A
`9/1999 Zadno-AZiZi ................ .. 623/2
`5,954,766 A
`9/1999 Leonhardt et a1. ........ .. 606/194
`5,957,949 A
`5,964,782 A 10/1999 Lafontaine et a1. ....... .. 606/213
`
`
`
`
`
`Christopher TI Inventors: Steven I‘I Boyle, both of San Antonio, TX (US)
`
`
`
`A FOREIGN PATENT DOCUMENTS Quqano 618.1. . . . . . . . . . . . . . . ..
`
`
`
`(73) Assignee: ABPS Venture One, Ltd., San Antonio,
`TX (Us)
`
`EP
`EP
`
`0850607
`0808614
`
`12/1996
`5/1997
`
`~~~~~~~~~~~ ~~ A61F/2/24
`........... .. A61F/2/06
`
`( * ) Notice:
`
`Subject to any disclaimer, the term of this
`patent is extended or adjusted under 35
`U_S,C, 154(b) by 0 days,
`
`(21) APPL No: 09/477,120
`
`(22) Filed:
`
`Dec. 31, 1999
`
`7
`(51) Int. Cl. ................................................. .. A61F 2/06
`
`(52) U_‘S‘ Cl‘ ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' '
`' ' ' " 623/1‘24’ 623/1'26
`(58) Field of Search ............................. .. 623/1.24, 1.25,
`623/126
`
`(56)
`
`_
`References Clted
`U_S_ PATENT DOCUMENTS
`
`4,222,126 A
`
`9/1980 Boretos 618.1. ............... .. 3/15
`
`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.
`“Minimally Invasive Aortic Valve Surgery” CTSNET
`Experts’ Techniques, http://WWW.ctsnet.org.org/doc.3358,
`pp. 1—4.
`“Heartport Announces Launch of Heartport lnsite AVR
`
`System for Less Invasive Aortic Valve Replacement” Heart
`port) Inc Company Press Release, pp 1_2_
`“ATS Medical Inc. Annual Report”, pp. 1—7.
`“St. Jude Medical Heart Valve Division Expanding the
`Focus”, WWW.sum.com/stjde/World.htm/eXpand.htm.
`“St. Jude Medical Heart Valve Division The Mechical Heart
`Valve Evolution”, WWW.sjm.com/stjude/World/htm.evo
`luthtm
`
`2
`i/
`globltlsen ' ' ' ' ' ' ' ' ' ' '
`5’163’953 A llilggz viirce """ "
`5’332’4O2 A
`7/1994 Teitelbi'i'l'lg ' ' ' ' '
`5,334,217 A
`8/1994 Das ............ ..
`
`' ' '
`
`6/23/2
`' ' ' ' ' " 623/2
`606/213
`
`“Heartport Announces Launch of Heartport InSite AVR
`System for Less Invasive Aortic Valve Replacement”,
`Heartport, Inc. What’s New Release, WWW.pddnet.com/
`PddneWS/08OCt-9903htm, PP- 1—2~
`
`5,370,685 A 12/1994 Stevens . . . . . . . . . . . .
`
`. . . . . .. 623/2
`
`-
`
`~
`
`-
`
`3/1995 Pavenik et a1. ......... .. 623/11
`5,397,351 A
`8/1996 Stevens ................. .. 623/2
`5 545 214 A
`2/1998 Vallana et a1.
`.... .. 623/2
`5,713,953 A
`3/1998 Kotula et a1.
`606/213
`5,725,552 A
`4/1998 Simon ........ ..
`.. 606/213
`5,741,297 A
`5,824,063 A 10/1998 COX . . . . . .
`. . . . . .. 623/2
`
`E316“ """"
`1C1”
`6/21/3
`'
`5’846’261 A 121998 Kotuelgsen et a '
`623/1
`5’855’597 A
`1/1999 layarami'i'r'l """" "
`623/2
`5,855,601 A
`1/1999 Bessler et a1.
`623/2
`5,895,419 A
`4/1999 TWeden et a1. ........ ..
`5,919,224 A
`7/1999 Thompson et a1. .......... .. 623/1
`
`5r 17”” y %am”.1er—C°rr.meSMCDerm°tt
`Sslsmm xammer “Mn tewart
`_
`(7951mm?) Agent) 0’ Firm—DaV1d G- Rosenbaum;
`Rosenbaum & ASS°C1ateS>P-C
`
`(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
`
`25 Claims, 6 Drawing Sheets
`
`NORRED EXHIBIT 2123 - Page 1
`Medtronic, Inc., Medtronic Vascular, Inc.,
`& Medtronic Corevalve, LLC
`v. Troy R. Norred, M.D.
`Case IPR2014-00110
`
`

`
`U.S. Patent
`
`0a. 1, 2002
`
`Sheet 1 0f 6
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`US 6,458,153 B1
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`NORRED EXHIBIT 2123 - Page 2
`
`

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`U.S. Patent
`
`0a. 1, 2002
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`Sheet 2 0f 6
`
`US 6,458,153 B1
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`Fig. 125
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`NORRED EXHIBIT 2123 - Page 3
`
`

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`U.S. Patent
`
`0a. 1, 2002
`
`Sheet 3 0f 6
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`US 6,458,153 B1
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`NORRED EXHIBIT 2123 - Page 4
`
`

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`U.S. Patent
`
`0a. 1, 2002
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`Sheet 4 0f 6
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`US 6,458,153 B1
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`NORRED EXHIBIT 2123 - Page 5
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`

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`U.S. Patent
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`0a. 1, 2002
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`Sheet 5 0f 6
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`US 6,458,153 B1
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`Fig. 78A
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`Fig. 785
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`2/6
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`2/4
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`200\
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`Q
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`' ——| '~
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`E
`220 2/ 7
`22/
`2/5
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`I '
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`. W
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`Fig. 20A
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`Fig. 205
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`NORRED EXHIBIT 2123 - Page 6
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`

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`U.S. Patent
`
`0a. 1, 2002
`
`Sheet 6 0f 6
`
`US 6,458,153 B1
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`NORRED EXHIBIT 2123 - Page 7
`
`

`
`US 6,458,153 B1
`
`1
`ENDOLUMINAL CARDIAC AND VENOUS
`VALVE PROSTHESES AND METHODS OF
`MANUFACTURE AND DELIVERY THEREOF
`
`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 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?guration, 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 ?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.
`It is important for the present invention to provide orien
`tational de?nitions. For purposes of the present invention,
`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 “proxi
`mal” 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
`
`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.
`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 Leonhardt valve,
`
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`2
`US. 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 ?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
`hemodynamic, delivery, fatigue and stability disadvantages.
`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
`hemodynamic, stability and anchoring concerns.
`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
`thrombogenesis, valvular stenosis and chronic anticoagula
`tion concerns; 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.
`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 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
`anticoagulation, problematic physiological and procedural
`concerns due to the barb anchors and complex delivery
`procedure that includes in?ation 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
`
`NORRED EXHIBIT 2123 - Page 8
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`

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`US 6,458,153 B1
`
`3
`comprised of a stent and cusps for ?oW-regulation such as a
`?xed 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, dif?cult
`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 ?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.
`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
`
`4
`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.
`The Khosravi valve discloses a percutaneous prosthetic
`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.
`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.
`Finally, the Leonhardt valve is comprised of a tubular
`graft having radially compressible annular spring portions
`and a How 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, ?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 valvulo
`plasty performed, interference With surrounding anatomy
`and the questionable clinical utility and feasibility of the
`light actuated anchoring means.
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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
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`NORRED EXHIBIT 2123 - Page 9
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`US 6,458,153 B1
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`5
`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.
`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.
`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?guration 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.
`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 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 de?nes the cylindrical prosthesis. 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
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`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
`position, thereby excluding the anatomic valve lea?ets from
`the blood?oW and replacing them With the prosthetic valve
`lea?ets.
`FloW regulation in the inventive stent valve prosthesis 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 replace
`ment heart valve by Boretos, U.S. Pat. No. 4,222,126. The
`valve regulator-struts are preferably con?gured to be posi
`tioned 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 anatomi
`cal 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-membrane 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 combination of the thin Walled
`properties of the lea?et-membrane, the one-sided open
`lumen support of the intermediate annular 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 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 ?lly 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
`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.
`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
`
`NORRED EXHIBIT 2123 - Page 10
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`US 6,458,153 B1
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`7
`during and a retrograde blood ?oW 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 ?oW vector of a
`?lling 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 ?oW 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
`con?guration in the fully deployed state.
`FIG. 14 is a perspective vieW of the same con?guration 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 con?guration.
`FIG. 16 shoWs the cross sectional vieW of the same
`con?guration for the deployed state.
`FIG. 17 is a bottom vieW of the same con?guration.
`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 are diagrammatic cross-sectional vieWs illustrat
`ing single catheter valvuloplasty, inventive stent valve deliv
`ery and stent valve operation in situ in accordance With the
`method of the present invention.
`FIGS. 20A—20I is a cross-sectional diagrammatic vieW of
`a valvuloplasty and stent valve delivery catheter in accor
`dance With 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 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
`
`10
`
`15
`
`25
`
`35
`
`45
`
`55
`
`65
`
`8
`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.
`Additionally, 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
`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.
`Chamber-to-Vessel Con?guration
`An implantable prosthesis or prosthetic valve in accor
`dance With certain embodiments of the chamber-to-vessel
`CV con?guration of the present invention is illustrated
`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 NITINOL
`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 functi