Européisches
`Patentamt
`European
`Patent Office
`
`5’3ii=7=°v"e't‘3"ée"
`
`(11)
`
`EP 2 926 766 B1
`
`(12)
`
`EUROPEAN PATENT SPECIFICATION
`
`(51) Int CI.:
`A61F 2/01 (2005-9”
`
`A61F 2/24 (2006-0“
`
`(45) Date of publication and mention
`of the grant of the patent:
`24.02.2016 Bulletin 2016/08
`
`(21) Application number: 15167832.3
`
`(22) Date of filing: 22.12.2004
`
`(54) REPOSITIONABLE HEART VALVE
`
`NEUPOSITIONIERBARE HERZKLAPPE
`
`VALVE CARDIAQUE REPOSITIONNABLE
`
`(84) Designated Contracting States:
`AT BE BG CH CY CZ DE DK EE ES FI FR GB GR
`HU IE IS IT LI LT LU MC NL PL PT RO SE SI SK TR
`
`)
`
`Inventors:
`Salahieh, Amr
`Saratoga, CA California 95070 (US)
`Brandt, Brian D.
`
`(30) Priority: 23.12.2003 US 746280
`23.12.2003 US 746942
`23.12.2003 US 746240
`23.12.2003 US 746872
`23.12.2003 US 746887
`23.12.2003 US 746120
`23.12.2003 US 746285
`15.07.2004 US 893151
`15.07.2004 US 893131
`15.07.2004 US 893143
`15.07.2004 US 893142
`21.10.2004 US 972287
`21.10.2004 US 971535
`05.11.2004 US 982692
`05.11.2004 US 982388
`
`(43) Date of publication of application:
`07.10.2015 Bulletin 2015/41
`
`(62) Document number(s) of the earlier app|ication(s) in
`accordance with Art. 76 EPC:
`04815634.3I 1 702 247
`
`(73) Proprietor: Boston Scientific Scimed, Inc.
`Maple Grove, MN 55311-1566 (US)
`
`Las Gatos, CA 95032 (US)
`Morejohn, Dwight P.
`Davis, CA 95616 (US)
`Haug, Ulrich R.
`Campbell, CA 95008 (US)
`Dueri, Jean-Pierre
`Stockton, CA 95219 (US)
`Valencia, Hans F.
`Santa Clara, CA 95050 (US)
`Geshlider, Robert A.
`San Francisco, CA 94131 (US)
`Krolik, Jeff
`Campbell, CA 95008 (US)
`Saul, Tom
`Moss Beach, CA 94038 (US)
`Argento, Claudio
`Los Gatos, CA 95033 (US)
`Hildebrand, Daniel
`Menlo Park, CA 94025 (US)
`
`Representative: Peterreins Schley
`Patent- und Rechtsanwalte
`Soeltlstralse 2a
`
`81545 Miinchen (DE)
`
`(56) References cited:
`W0-A1-95128899
`
`US-A1- 2001 039 450
`
`EP2926766B1
`
`Note: Within nine months of the publication of the mention of the grant of the European patent in the European Patent
`Bulletin, any person may give notice to the European Patent Office of opposition to that patent, in accordance with the
`Implementing Regulations. Notice ofopposition shall not be deemed to have been filed until the opposition fee has been
`paid. (Art. 99(1) European Patent Convention).
`
`Printed by Jouve, 75001 PARIS (FR)
`
`Edwards Lifesciences Corporation, et al. Exhibit 1030, p. 1 of 112
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`Edwards Lifesciences Corporation, et al. Exhibit 1030, p. 1 of 112
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`EP 2 926 766 B1
`
`Description
`
`BACKGROUND OF THE INVENTION
`
`[0001] The present invention relates to an apparatus
`for endovascularly replacing a heart valve as set forth in
`the claims
`
`[0002] Heart valve surgery is used to repair or replace
`diseased heart valves. Valve surgery is an open-heart
`procedure conducted under general anesthesia. An in-
`cision is made through the patients sternum (sternoto—
`my), and the patient‘s heart is stopped while blood flow
`is rerouted through a heart—lung bypass machine.
`[0003] Valve replacement may be indicated when
`there is a narrowing of the native heart valve, commonly
`referred to as stenosis, or when the native valve leaks or
`regurgitates.
`[0004] When replacing the valve, the native valve is
`excised and replaced with either a biologic or a mechan-
`ical valve. Mechanical valves require lifelong anticoagu-
`lant medication to prevent blood clotformation, and click-
`ing of the valve often may be heard through the chest.
`Biologic tissue valves typically do not require such med-
`ication. Tissue valves may be obtained from cadavers or
`may be porcine or bovine, and are commonly attached
`to synthetic rings that are secured to the patient’s heart.
`[0005] Valve replacement surgery is a highly invasive
`operation with significant concomitant risk. Risks include
`bleeding, infection, stroke, heart attack, arrhythmia, renal
`failure, adverse reactions to the anesthesia medications,
`as well as sudden death. 2—5% of patients die during sur-
`gery.
`Post—surgery, patients temporarily may be con-
`[0006]
`fused due to emboli and other factors associated with
`
`the heart—lung machine. The first 2-3 days following sur-
`gery are spent in an intensive care unitwhere heartfunc—
`tions can be closely monitored. The average hospital stay
`is between 1
`to 2 weeks, with several more weeks to
`months required for complete recovery.
`[0007]
`in recent years, advancements in minimally in-
`vasive surgery and interventional cardiology have en-
`couraged some investigators to pursue percutaneous re-
`placement of the aortic heart valve. Percutaneous Valve
`Technologies ("PVT") of Fort Lee, New Jersey, has de-
`veloped a bal|oon—expandable stent integrated with a bi-
`oprosthetic valve. The stent/valve device is deployed
`across the native diseased valve to permanently hold the
`valve open, thereby alleviating a need to excise the native
`valve and to position the bioprosthetic valve in place of
`the native valve. PVT’s device is designed for delivery in
`a cardiac catheterization laboratory under local anesthe-
`sia using fluoroscopic guidance, thereby avoiding gen-
`eral anesthesia and open-heart surgery. The device was
`first implanted in a patient in April of 2002.
`[0008]
`PVT’s device suffers from several drawbacks.
`Deployment of PVT’s stent is not reversible, and the stent
`is not retrievable. This is a critical drawback because
`
`improper positioning too far up towards the aorta risks
`
`blocking the coronary ostia of the patient. Furthermore,
`a misplaced stent/valve in the other direction (away from
`the aorta, closerto the ventricle) will impinge on the mitral
`apparatus and eventually wear through the leaflet as the
`leaflet continuously rubs against
`the edge of
`the
`stent/valve.
`
`[0009] Another drawback of the PVT device is its rel-
`atively large cross-sectional delivery profile. The PVT
`system’s stent/valve combination is mounted onto a de-
`livery balloon, making retrograde delivery through the
`aorta challenging. An antegrade transseptal approach
`may therefore be needed, requiring puncture ofthe sep-
`tum and routing through the mitral valve, which signifi-
`cantly increases complexity and risk of the procedure.
`Very few cardiologists are currently trained in performing
`a transseptal puncture, which is a challenging procedure
`by itself.
`[0010] Other prior art replacement heart valves use
`self—expanding stents as anchors. in the endovascular
`aortic valve replacement procedure, accurate placement
`of aortic valves relative to coronary ostia and the mitral
`valve is critical. Standard self—expanding systems have
`very poor accuracy in deployment, however. Often the
`proximal end ofthe stent is not released from the delivery
`system until accurate placement is verified by fluorosco-
`py, and the stenttypicallyjumps once released. ltisthere—
`fore often impossible to know where the ends ofthe stent
`will be with respect to the native valve, the coronary ostia
`and the mitral valve.
`
`[0011] Also, visualization of the way the new valve is
`functioning prior to final deployment is very desirable.
`Visualization prior to final and irreversible deployment
`cannot be done with standard self—expanding systems,
`however, and the replacement valve is often not fully
`functional before final deployment.
`[0012] Anotherdrawbackofpriorartself—expandingre-
`placement heart valve systems is their lack of radial
`strength. In order for self—expanding systems to be easily
`delivered through a delivery sheath, the metal needs to
`flex and bend inside the delivery catheter without being
`plastically deformed. in arterial stents, this is not a chal-
`lenge, and there are many commercial arterial stent sys-
`tems that apply adequate radial force against the vessel
`wall and yet can collapse to a small enough ofa diameter
`to fit inside a delivery catheter without plastically deform-
`ing.
`[0013] However when the stent has a valve fastened
`inside it, as is the case in aortic valve replacement, the
`anchoring ofthe stent to vessel walls is significantly chal-
`lenged during diastole. The force to hold back arterial
`pressure and prevent blood from going back inside the
`ventricle during diastole will be directly transferred to the
`stent/vessel wall interface. Therefore the amount ofradial
`
`force required to keep the self expanding stent/valve in
`contact with the vessel wall and not sliding will be much
`higher than in stents that do not have valves inside of
`them. Moreover, a self—expanding stent without sufficient
`radial force will end up dilating and contracting with each
`
`2
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`EP 2 926 766 B1
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`4
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`heartbeat, thereby distorting the valve, affecting its func-
`tion and possibly migrating and dislodging completely.
`Simply increasing strut thickness of the self—expanding
`stent is not a practical solution as it runs the risk of larger
`profile and/or plastic deformation of the self—expanding
`stent.
`
`No.
`Serial
`application
`patent
`[0014] U.S.
`2002/0151970 to Garrison et al. describes a two-piece
`device for replacement of the aortic valve that is adapted
`for delivery through a patient’s aorta. A stent is percuta—
`neously placed across the native valve, then a replace-
`ment valve is positioned within the lumen ofthe stent. By
`separating the stent and the valve during delivery, a pro-
`file of the device's delivery system may be sufficiently
`reduced to allow aortic delivery without requiring a trans-
`septal approach. Both the stent and a frame of the re-
`placement valve may be balloon—expandable or self—ex-
`panding.
`[0015] While providing for an aortic approach, devices
`described in the Garrison patent application suffer from
`several drawbacks. First, the stent portion of the device
`is delivered across the native valve as a single piece in
`a single step, which precludes dynamic repositioning of
`the stent during delivery. Stent foreshortening or migra-
`tion during expansion may lead to improper alignment.
`[0016] Additionally, Garrison’s stent simply crushes
`the native valve leaflets against the heart wall and does
`not engage the leaflets in a manner that would provide
`positive registration of the device relative to the native
`position of the valve. This increases an immediate risk
`of blocking the coronary ostia, as well as a longer—term
`risk of migration of the device post-implantation. Further-
`still, the stent comprises openings or gaps in which the
`replacement valve is seated post—delivery. Tissue may
`protrude through these gaps, thereby increasing a risk
`of improper seating of the valve within the stent.
`[0017]
`In view ofdrawbacks associated with previously
`known techniques for percutaneously replacing a heart
`valve, it would be desirable to provide methods and ap-
`paratus that overcome those drawbacks.
`[0018] WO 95/28899 describes a surgically implanta-
`ble stented bioprosthetic heart valve comprising a ring-
`shaped suturing cuff at the inflow portion of the valve.
`[0019] US 2001/0039450 describes a venous valve
`device having a generally serpentine shape and a corner
`flap.
`
`SUMMARY OF THE INVENTION
`
`[0020] The present invention is directed to an appara-
`tus for endovascularly replacing a patient’s heart valve
`as set forth in the appended claims. The apparatus com-
`prises an expandable cylindrical anchor supporting a re-
`placement valve. The anchor has a delivery configuration
`and a deployed configuration. The apparatus has at least
`one sac disposed about the exterior of the anchor to pro-
`vide a seal.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`[0021]
`
`Figures 1A—B are elevational views ofa replacement
`heart valve and anchor according to one embodi-
`ment of the invention.
`
`Figures 2A-B are sectional views of the anchor and
`valve of Figures 1.
`Figures 3A—B show delivery and deployment of a re-
`placement heart valve and anchor, such as the an-
`chor and valve of Figures 1 and 2.
`Figures 4A—F also show delivery and deployment of
`a replacement heart valve and anchor, such as the
`anchor and valve of Figures 1 and 2.
`Figures 5A-l show the use of a replacement heart
`valve and anchor to replace an aortic valve.
`Figures 6A—F show the use of a replacement heart
`valve and anchor with a positive registration feature
`to replace an aortic valve.
`Figure 7 shows the the use of a replacement heart
`valve and anchor with an alternative positive regis-
`tration feature to replace an aortic valve.
`Figures 8A-C show another embodiment of a re-
`placement heart valve and anchor according to the
`invention.
`
`Figures 9A—H show delivery and deployment of the
`replacement heart valve and anchor of Figures 8.
`Figure 10 is a cross—sectional drawing ofthe delivery
`system used with the method and apparatus of Fig-
`ures 8 and 9.
`
`Figures 11 A-C show alternative locks for use with
`replacement heart valves and anchors of this inven-
`tion.
`
`Figures 12 A-C show a vessel wall engaging lockfor
`use with replacement heart valves and anchors of
`this invention.
`
`Figure 13 demonstrates paravalvular leaking around
`a replacement heart valve and anchor.
`Figure 14 shows a seal for use with a replacement
`heart valve and anchor of this invention.
`
`Figures 15A—E show alternative arrangements of
`seals on a replacement heart valve and anchor.
`Figures 16A—C show alternative seal designs for use
`with replacement heart valves and anchors.
`Figure 17 shows an alternative embodiment ofa re-
`placement heartvalve and anchor and a deployment
`tool according to the invention in an undeployed con-
`figuration.
`Figure 18 shows the replacement heart valve and
`anchor of Figure 17 in a partially deployed configu-
`ration.
`
`Figure 19 shows the replacement heart valve and
`anchor of Figures 17 and 18 in a more fully deployed
`configuration but with the deployment tool still at-
`tached.
`
`Figure 20 shows yet another embodiment of the de-
`livery and deployment apparatus of the invention in
`
`3
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`Edwards Lifesciences Corporation, et al. Exhibit 1030, p. 3 of 112
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`EP 2 926 766 B1
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`use with a replacement heart valve and anchor.
`F'gure 21 shows the delivery and deployment appa-
`ratus of Figure 20 in the process of deploying a re-
`placement heart valve and anchor.
`F'gure 22 shows an embodimentofthe invention em-
`ploying seals at the interface of the replacement
`heart valve and anchor and the patient’s tissue.
`F'gure 23 is a longitudinal cross-sectional view of
`the seal shown in Figure 22 in compressed form.
`F'gure 24 is a transverse cross—sectional view of the
`seal shown in Figure 23.
`F'gure 25 is a longitudinal cross—sectional view of
`the seal shown in Figure 22 in expanded form.
`F'gure 26 is a transverse cross—sectional view of the
`seal shown in Figure 25.
`F'gure 27 shows yet another embodiment of the re-
`placement heart valve and anchor of this invention
`in an undeployed configuration.
`F'gure 28 shows the replacement heart valve and
`anchor of Figure 27 in a deployed configuration.
`Fgure 29 shows the replacement heart valve and
`anchor of Figures 27 and 28 deployed in a patient’s
`heart valve.
`
`F'gures 30A-H show yet another embodiment of a
`replacement heart valve, anchor and deployment
`system according to this invention.
`F'gures 31A—E show more detail of the anchor of the
`embodiment shown in Figures 30A—H.
`F'gures 32A—B show further details of the embodi-
`ment of Figures 3OA-H.
`F'gures 33 A—C illustrate a method for percutaneous—
`ly replacing a patient’s diseased heart valve.
`F'gures 34A and 34B show replacement valve ap-
`paratus in accordance with the present invention.
`F'gure 34 illustrates the apparatus in a collapsed de-
`livery configuration within a delivery system. Figure
`34B illustrates the apparatus in an expanded config-
`uration partially deployed from the delivery system.
`Figures 35A—35F show an anchor of the apparatus
`of Figures 34 in the collapsed delivery configuration
`and the expanded deployed configuration, as well
`as the full apparatus in the deployed configuration,
`and optional locking mechanisms for use with the
`apparatus.
`F'gure 36 is a schematic top view of an apparatus
`for fabricating braided anchors in accordance with
`the present invention.
`F'gures 37A—37D are schematictopviews illustrating
`a method of using the apparatus of Figure 36 to fab-
`ricate a braided anchor of the present invention.
`F'gures 38A—38O are schematic detail views illus-
`trating features of braid cells at an anchor edge.
`F'gures 39A-39E illustrate further features of braid
`cells at an anchor edge.
`F'gures 40A-40J are schematic detail views termi-
`nations forone or more wire strandsforming anchors
`of the present invention.
`F'gures 41 A and 41B are schematic side views of
`
`alternative embodiments ofthe anchor portion of the
`apparatus of the present invention.
`Figures 42A—42E are schematic side views of further
`alternative embodiments ofthe ofthe anchor portion
`of the apparatus of the present invention.
`Figures 43A—43D are schematic views of different
`weave configurations.
`Figures 44A-44E are schematic side views ofvarious
`braided anchor configurations.
`Figures 45A—45E are schematic side views of a de-
`ployment process.
`Figures 46A and 46B illustrate a braided anchor in
`the heart.
`
`Figures 47A and 47B illustrate a bilaterally symmet-
`rical anchorand an asymmetricanchor, respectively.
`Figure 48 illustrates a braided anchor ofthe present
`invention with closed end turns Tu.
`
`Figures 49A—49E illustrate additional features for end
`turns of a braided anchor.
`
`Figures 50A—50F illustrate deployment of an anchor
`with leaflet engagement elements on the deploy-
`ment system.
`Figure 51 illustrates a deployed anchor with leaflet
`engagement elements on the proximal end of the
`anchor.
`
`Figures 52A—52C illustrate deployment of an anchor
`with anchor registration elements and a seal.
`Figures 53A—53B illustrate an embodiment ofthe ap-
`paratus with a seal that does not reach the proximal
`end of the anchor during both systole and diastole.
`Figures 54A—54B illustrate an embodiment ofthe ap-
`paratus with a seal that reaches the proximal end of
`the anchor during both systole and diastole.
`
`DETAILED DESCRIPTION
`
`[0022] The present invention relates to apparatus and
`methods forendovascularly or percutaneously delivering
`and deploying a prosthesis, e.g., an aortic prosthesis,
`within and/or across a patient’s native heart valve, re-
`ferred to hereinafter as replacing the patient’s heart
`valve. A delivery system and/or deployment tool is pro-
`vided including a sheath assembly and a guidewire for
`placing the prosthetic apparatus endovascularly within
`the patient and a user control allowing manipulation of
`the prosthetic apparatus from external to the patient
`through the application of a non-hydraulically expanding
`or non—pneumatica|ly expanding force on the anchor. A
`hydraulically or pneumatically expanding force would be,
`for example, a force applied to the anchor by a balloon
`expanded within the anchor. In certain embodiments, the
`application of a non—hydraulically expanding or non-
`pneumatically expanding force could include the use of
`a hydraulic component transmitting a proximally or dis-
`tally directed force on an anchor.
`[0023] The apparatus includes an anchor and a re-
`placement valve. The anchor includes an expandable
`anchor such as a braid. In preferred embodiments, the
`
`4
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`EP 2 926 766 B1
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`expandable braid includes closed edges, but the edges
`may alternatively be open. The replacement valve is
`adapted to be secured within the anchor, and as such,
`be delivered endovascularly to the patient’s heart to re-
`place one of the patient’s native heart valves. More pref-
`erably, the apparatus and methods ofthe present inven-
`tion contemplate replacement of the patient’s aortic
`valve.
`
`[0024] With reference now to Figures 1-4, a first em-
`bodiment of replacement heart valve apparatus in ac-
`cordance with the present invention is described, includ-
`ing a method of actively foreshortening and expanding
`the apparatus from a delivery configuration and to a de-
`ployed configuration. Apparatus 10 comprises replace-
`ment valve 20 disposed within and coupled to anchor 30.
`Figures 1 schematically illustrate individual cells of an-
`chor 30 of apparatus 10, and should be viewed as if the
`cylindrical anchor has been cutopen and laid flat. Figures
`2 schematically illustrate a detail portion of apparatus 10
`in side—section.
`
`[0025] Anchor 30 has a lip region 32, a skirt region 34
`and a body region 36. First, second and third posts 38a,
`38b and 38c, respectively, are coupled to skirt region 34
`and extend within lumen 31 ofanchor 30. Posts 38 pref-
`erably are spaced 120° apart from one another about the
`circumference of anchor 30.
`
`[0026] Anchor 30 preferably is fabricated by using self-
`expanding patterns (laser cut or chemically milled),
`braids, and materials, such as a stainless steel, nickel-
`titanium ("Nitino|") or cobalt chromium but alternatively
`may be fabricated using ba||oon—expandab|e patterns
`where the anchor is designed to plastically deform to it’s
`final shape by means of balloon expansion. Replacement
`valve 20 is preferably from biologic tissues, e.g. porcine
`valve leaflets or bovine or equine pericardium tissues,
`alternatively it can be made from tissue engineered ma-
`terials (such as extracellular matrix material from Small
`intestinal Submucosa (SlS)) but alternatively may be
`prostheticfrom an elastomeric polymeror silicone, Nitinol
`or stainless steel mesh or pattern (sputtered, chemically
`milled or laser cut). The leaflet may also be made of a
`composite of the elastomeric or silicone materials and
`metal alloys or other fibers such Kevlar or carbon. Annu-
`lar base 22 of replacement valve 20 preferably is coupled
`to skirt region 34 of anchor 30, while commissures 24 of
`replacement valve leaflets 26 are coupled to posts 38.
`[0027] Anchor 30 may be actuated using external non-
`hydraulic or non—pneumatic force to actively foreshorten
`in order to increase its radial strength. As shown below,
`the proximal and distal end regions ofanchor 30 may be
`actuated independently. The anchor and valve may be
`placed and expanded in order to visualize their location
`with respect to the native valve and otheranatomical fea-
`tures and to visualize operation of the valve. The anchor
`and valve may thereafter be repositioned and even re-
`trieved into the delivery sheath or catheter. The appara-
`tus may be delivered to the vicinity of the patient’s aortic
`valve in a retrograde approach in a catheter having a
`
`diameter no more than 23 french, preferably no more
`than 21 french, more preferably no more than 19 french,
`or more preferably no more than 17french. Upon deploy-
`ment the anchor and replacement valve capture the na-
`tive valve leaflets and positively lock to maintain config-
`uration and position.
`[0028] Adeployment tool is used to actuate, reposition,
`lock and/or retrieve anchor 30. in order to avoid delivery
`of anchor 30 on a balloon for balloon expansion, a non-
`hydraulic or non—pneumatic anchor actuator is used. in
`this embodiment, the actuator is a deployment tool that
`includes distal region control actuators 50, control actu-
`ators 60 (embodied here as rods or tubes) and proximal
`region control actuators 62. Locks 40 include posts or
`arms 38 preferably with male interlocking elements 44
`extending from skirt region 34 and mating female inter-
`locking elements 42 in lip region 32. Male interlocking
`elements 44 have eyelets 45. Control actuators 50 pass
`from a delivery system for apparatus 10 through female
`interlocking elements 42, through eyelets 45 of male in-
`terlocking elements 44, and back through female inter-
`locking elements 42, such that a double strand of wire
`50 passes through each female interlocking e|ement42
`for manipulation by a medical practitioner external to the
`patientto actuate and control the anchor by changing the
`anchor’s shape. Control actuators 50 may comprise, for
`example, strands of suture or wire.
`[0029] Actuators 60 are reversibly coupled to appara-
`tus 10 and may be used in conjunction with actuators 50
`to actuate anchor 30, e.g., to foreshorten and lock appa-
`ratus 1O in the fully deployed configuration. Actuators 60
`also facilitate repositioning and retrieval of apparatus 10,
`as described hereinafter. For example, anchor 30 may
`be foreshortened and radially expanded by applying a
`distally directed force on actuators 60 while proximally
`retracting actuators 50. As seen in Figures 3, control ac-
`tuators 62 pass through interior lumens 61 of actuators
`60. This ensures that actuators 60 are aligned properly
`with apparatus 10 during deployment and foreshorten-
`ing. Control actuators 62 can also actuate anchor 60;
`proximally directed forces on control actuators 62 con-
`tacts the proximal lip region 32 of anchor 30. Actuators
`62 also act to couple and decouple actuators 60 from
`apparatus 10. Actuators 62 may comprise, for example,
`strands of suture or wire.
`
`Figures 1Aand 2A illustrate anchor 30 in a de-
`[0030]
`livery configuration or in a partially deployed configura-
`tion (e.g., after dynamic self—expansion expansion from
`a constrained delivery configuration within a delivery
`sheath). Anchor 30 has a relatively long length and a
`relatively small width in the delivery or partially deployed
`configuration, as compared to the foreshortened and fully
`deployed configuration of Figures 1B and 2B.
`[0031]
`In Figures 1A and 2A, replacement valve 20 is
`collapsed within lumen 31 of anchor 30. Retraction of
`actuators 50 relative to actuators 60 foreshortens anchor
`
`30, which increases the anchor’s width while decreasing
`its length. Such foreshortening also properly seats re-
`
`5
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`EP 2 926 766 B1
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`10
`
`placement valve 20 within lumen 31 of anchor 30. Im-
`posed foreshortening will enhance radial force applied
`by apparatus 10 to surrounding tissue over at least a
`portion of anchor 30. in some embodiments, the anchor
`exerts an outward force on surrounding tissue to engage
`the tissue in such way to prevent migration of anchor
`caused by force of blood against closed leaflet during
`diastole. This anchoring force is preferably 0,454 kg to
`0,907 kg [1 to 2 lbs], more preferably 0,907 kg to 1,814
`kg [2 to 4 lbs], or more preferably 1,814 kg to 4,536 kg
`[4 to 10 lbs]. In some embodiments, the anchoring force
`is preferably greater than 0,454 kg [1 pound], more pref-
`erably greater than 0,907 kg [2 pounds], or more prefer-
`ably greater than 1,814 kg [4 pounds]. Enhanced radial
`force of the anchor is also important for enhanced crush
`resistance of the anchor against the surrounding tissue
`due to the healing response (fibrosis and contraction of
`annulus over a longer period of time) or to dynamic
`changes of pressure and flow at each heart beat. In an
`alternative embodiment, the anchor pattern or braid is
`designed to have gaps or areas where the native tissue
`is allowed to protrude through the anchor slightly (not
`shown) and as the foreshortening is applied, the tissue
`is trapped in the anchor. This feature would provide ad-
`ditional means to prevent anchor migration and enhance
`long term stability of the device.
`[0032] Deployment of apparatus 10 is fully reversible
`until lock 40 has been locked via mating of male inter-
`locking elements 44 with female interlocking elements
`42. Deployment is then completed by decoupling actua-
`tors 60 from lip section 32 of anchor 30 by retracting one
`end of each actuator 62 relative to the other end of the
`
`actuator, and by retracting one end of each actuator 50
`relative to the otherend ofthe actuatoruntileach actuator
`
`has been removed from eyelet 45 of its corresponding
`male interlocking element 44.
`[0033] As best seen in Figure 2B, body region 36 of
`anchor 30 optionally may com prise barb elements 37 that
`protrude from anchor 30 in the fully deployed configura-
`tion, for example, for engagement of a patient’s native
`valve leaflets and to preclude migration ofthe apparatus.
`[0034] With reference now to Figures 3, a delivery and
`deployment system for a self—expanding embodiment of
`apparatus 10 including a sheath 110 having a lumen 112.
`Self—expanding anchor 30 is collapsible to a delivery con-
`figuration within lumen 112 of sheath 110, such that ap-
`paratus 10 may be delivered via delivery system 100. As
`seen in Figure 3A, apparatus 10 may be deployed from
`lumen 112 by retracting sheath 110 relative to apparatus
`10, control actuators 50 and actuators 60, which causes
`anchor 30 to dynamically self—expand to a partially de-
`ployed configuration. Control actuators 50 then are re-
`tracted relative to apparatus 10 and actuators 60 to im-
`pose foreshortening upon anchor 30, as seen in Figure
`3B.
`
`[0035] During foreshortening, actuators 60 push
`against lip region 32 ofanchor 30, while actuators 50 pull
`on posts 38 of the anchor. Actuators 62 may be retracted
`
`along with actuators 50 to enhance the distally-directed
`pushing force applied by actuators 60 to lip region 32.
`Continued retraction of actuators 50 relative to actuators
`
`60 would look locks 40 and fully deploy apparatus 10 with
`replacement valve 20 properly seated within anchor 30,
`as in Figures 1B and 2B. Apparatus 10 comprises en-
`hanced radial strength in the fully deployed configuration
`as compared to the partially deployed configuration of
`Figure 3A. Once apparatus 10 has been fully deployed,
`actuators 50 and 62 may be removed from apparatus 10,
`thereby separating delivery system 100 including actua-
`tors 60 from the apparatus.
`[0036] Deployment of apparatus 10 is fully reversible
`until locks 40 have been actuated. For example, just prior
`to locking the position of the anchor and valve and the
`operation of the valve may be observed under fluoros-
`copy. if the position needs to be changed, by alternately
`relaxing and reapplying the proximally directed forces
`exerted by control actuators 50 and/or control actuators
`62 and the distally directed forces exerted by actuators
`60, expansion and contraction of the lip and skirt regions
`of anchor 30 may be independently controlled so that the
`anchor and valve can be moved to, e.g., avoid blocking
`the coronary ostia or impinging on the mitral valve. Ap-
`paratus 10 may also be completely retrieved within lumen
`112 of sheath 110 by simultaneously proximally retract-
`ing actuators 50 and actuators 60/actuators 62 relative
`to sheath 110. Apparatus 10 then may be removed from
`the patientor repositioned for subsequent redeployment.
`[0037] Referring now to Figures 4, step-by-step de-
`ployment of apparatus 10 via delivery system 100 is de-
`scribed. In Figure 4A, sheath 110 is retracted relative to
`apparatus 10, actuators 50 and actuators 60, thereby
`causing self—expandab|e anchor 30 to dynamically self-
`expand apparatus 10 from the collapsed delivery config-
`uration within lumen 112 of sheath 110 to the partially
`deployed configuration. Apparatus 10 may then be dy-
`namically repositioned via actuators 60 to properly orient
`the apparatus, e.g. relative to a patient’s native valve
`leaflets.
`
`In Figure 4B, control actuators 50 are retracted
`[0038]
`while actuators 60 are advanced, thereby urging lip re-
`gion 32 of anchor 30 in a distal direction while urging
`posts 38 of the anchor in a proximal direction. This fore-
`shortens apparatus 10, as seen in Figure 4C. Deploy-
`ment of apparatus 10 is fully reversible even after fore-
`shortening has been initiated and has advanced to the
`point illustrated in Figure 4C.
`[0039]
`In Figure 4D, continued foreshortening causes
`male interlocking elements 44 of locks 40 to engage fe-
`male interlocking elements 42. The male elements mate
`with the female elements, thereby locking apparatus 10
`in the foreshortened configuration, as seen in Figure 4E.
`Actuators 50 are then pulled through eyelets 45 of male
`elements 44 to remove the actuators from apparatus 10,
`and actuators 62 are pulled through the proximal end of
`anchor 30 to uncouple actuators 60 from the apparatus,
`thereby separating delivery system 100 from apparatus
`
`6
`
`Edwards Lifesciences Corporation, et al. Exhibit 1030, p. 6 of 112
`
`Edwards Lifesciences Corporation, et al. Exhibit 1030, p. 6 of 112
`
`

`

`11
`
`EP2926 766 B1
`
`12
`
`10. Fully deployed apparatus 10 is shown in Figure 4F.
`[0040] Referring to Figures 5, a method of percutane-
`ously replacing a patient’s diseased aortic valve with ap-
`paratus 10 and deliverysystem 100 is described. As seen
`in Figure 5 A, sheath 110 of delivery system 100, having
`apparatus 10 disposed therein,
`is percutaneously ad-
`vanced overguide wire G, preferably in a retrograde fash-
`ion (although an antegrade or hybrid approach alterna-
`tively may be used), through a patient’s aorta A to the
`patients d