Europiilsches
`Patentamt
`European
`Patent Office
`Office europeen
`des brevets
`
`(19)
`
`(12)
`
`111111111111111111111111111111111111111111111111111111111111111111111111111
`
`(11)
`
`EP 2 749 254 81
`
`EUROPEAN PATENT SPECIFICATION
`
`(45) Date of publication and mention
`of the grant of the patent:
`17.06.2015 Bulletin 2015/25
`
`(21) Application number: 14161991.6
`
`(22) Date of filing: 22.12.2004
`
`(54) Repositionable heart valve
`
`Umpositionierbare Herzklappe
`
`Valvule cardiaque repositionnable
`
`(84) Designated Contracting States:
`AT BE BG CH CY CZ DE DK EE ES Fl FR GB GR
`HU IE IS IT Ll LT LU MC NL PL PT ROSE 51 SKTR
`
`(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:
`02.07.2014 Bulletin 2014/27
`
`(62) Document number(s) of the earlier application(s) in
`accordance with Art. 76 EPC:
`04815634.3/1 702 247
`
`(73) Proprietor: Sadra Medical, Inc.
`Campbell, CA 95008 (US)
`
`(72) Inventors:
`• Salahieh, Amr
`Saratoga, CA California 95070 (US)
`
`(51) lnt Cl.:
`A61 F 2101 (2006·01J
`
`A61F 2124(2006·01)
`
`• Brandt, Brian, D.
`San Jose, CA California 95119 (US)
`• Morejohn, Dwight, P.
`Davis, CA California 95616 (US)
`• Haug, Ulrich, R.
`Campbell, CA California 95008 (US)
`• Dueri, Jean-Pierre
`Stockton, CA California 95219 (US)
`• Valencia, Hans, F.
`San Jose, CA California 95125 (US)
`• Geshlider, Robert, A.
`San Francisco, CA California 94131 (US)
`• Krolik, Jeff
`Campbell, CA California 95008 (US)
`• Saul, Tom
`Moss Beach, CA California 94038 (US)
`• Argento, Claudio
`Los Gatos, CA California 95033 (US)
`• Hildebrand, Daniel
`Menlo Park, CA California 94025 (US)
`
`(7 4) Representative: Peterreins, Frank et al
`Peterreins Schley
`Patent- und Rechtsanwiilte
`SoltlstraBe 2a
`81545 Mi.inchen (DE)
`
`(56) References cited:
`WO-A1-00/47139 WO-A1-95/28899
`US-A- 5 258 023
`US-B1- 6 454 799
`
`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 of opposition 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 1022, p. 1 of 66
`
`

`
`EP 2 749 254 B1
`
`2
`
`Description
`
`BACKGROUND OF THE INVENTION
`
`[0001] The present invention relates to an apparatus
`for endovascularly replacing a heart valve comprising a
`seal 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(cid:173)
`cision is made through the patient's sternum (sternoto(cid:173)
`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.
`When replacing the valve, the native valve is excised and
`replaced with either a biologic or a mechanical valve.
`Mechanical valves require lifelong anticoagulant medi-
`cation to prevent blood clot formation, and clicking of the
`valve often may be heard through the chest. Biologic tis-
`sue valves typically do not require such medication. Tis-
`sue valves may be obtained from cadavers or may be
`porcine or bovine, and are commonly attached to syn(cid:173)
`thetic rings that are secured to the patient's heart.
`[0004] 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(cid:173)
`gery.
`[0005] Post-surgery, patients temporarily may be con(cid:173)
`fused due to emboli and other factors associated with
`the heart-lung machine. The first 2-3 days following sur(cid:173)
`gery are spent in an intensive care unit where heart func(cid:173)
`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.
`[0006]
`In recent years, advancements in minimally in(cid:173)
`vasive surgery and interventional cardiology have en(cid:173)
`couraged some investigators to pursue percutaneous re(cid:173)
`placement of the aortic heart valve. Percutaneous Valve
`Technologies ("PVT") of Fort Lee, New Jersey, has de(cid:173)
`veloped a balloon-expandable stent integrated with a bi(cid:173)
`oprosthetic valve. The stentlvalve 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.
`[0007] 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
`
`5
`
`to
`
`20
`
`blocking the coronary ostia of the patient. Furthermore,
`a misplaced stentlvalve in the other direction (away from
`the aorta, closer to the ventricle) will impinge on the mitral
`apparatus and eventually wear through the leaflet as the
`leaflet continuously rubs against the edge of the
`stentlvalve.
`[0008] Another drawback of the PVT device is its rel(cid:173)
`atively large cross-sectional delivery profile. The PVT
`system's stentlvalve 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 of the sep(cid:173)
`tum and routing through the mitral valve, which signifi(cid:173)
`cantly increases complexity and risk of the procedure.
`15 Very few cardiologists are currently trained in performing
`a transseptal puncture, which is a challenging procedure
`by itself.
`[0009] 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 of the stent is not released from the delivery
`25 system until accurate placement is verified by fluorosco(cid:173)
`py, and the stenttypically jumps once released. It is there(cid:173)
`fore often impossible to know where the ends of the stent
`will be with respect to the native valve, the coronary ostia
`and the mitral valve.
`[0010] 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.
`[0011] Another drawback of prior art self-expanding re(cid:173)
`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(cid:173)
`lenge, and there are many commercial arterial stent sys(cid:173)
`tems that apply adequate radial force against the vessel
`wall and yet can collapse to a small enough of a diameter
`to fit inside a delivery catheter without plastically deform-
`in g.
`[0012] However when the stent has a valve fastened
`inside it, as is the case in aortic valve replacement, the
`anchoring of the stent to vessel walls is significantly chal(cid:173)
`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 of radial
`force required to keep the self expanding stentlvalve in
`55 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
`
`30
`
`35
`
`40
`
`45
`
`50
`
`2
`
`Edwards Lifesciences Corporation, et al. Exhibit 1022, p. 2 of 66
`
`

`
`3
`
`EP 2 749 254 B1
`
`4
`
`heartbeat, thereby distorting the valve, affecting its func(cid:173)
`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
`[0013] 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(cid:173)
`neously placed across the native valve, then a replace(cid:173)
`ment valve is positioned within the lumen of the stent. By
`separating the stent and the valve during delivery, a pro(cid:173)
`file of the device's delivery system may be sufficiently
`reduced to allow aortic delivery without requiring a trans(cid:173)
`septal approach. Both the stent and a frame of the re(cid:173)
`placement valve may be balloon-expandable or self-ex(cid:173)
`panding.
`[0014] 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.
`[0015] 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.
`In view of drawbacks associated with previously
`[0016]
`known techniques for percutaneously replacing a heart
`valve, it would be desirable to provide methods and ap-
`paratus that overcome those drawbacks.
`WO 00/47139 discloses a valve implantation sysetm hav-
`ing a valve displacer and a replacement valve attached
`to the valve displacer before or after introduction
`
`SUMMARY OF THE INVENTION
`
`[0017] The present invention relates to an apparatus
`for endovascularly replacing a heart valve comprising a
`seal as set forth in the claims.
`The apparatus comprises an expandable anchor (30)
`supporting a replacement valve, the anchor (20) having
`a delivery configuration and a deployed configuration and
`has a fabric seal that extends from the distal end of the
`valve (20) proximally over the anchor in the delivery con(cid:173)
`figuration. The seal is bunched up in the deployed con-
`figuration
`The fabric seal can bunch up to create fabric flaps and
`pockets. The seal can bunch up and creates pleats. The
`
`5
`
`seal can comprise a pleated seal. The pleating can create
`a seal around the replacement valve. The seal can bunch
`up in response to backflow blood pressure. The bunched
`up fabric or pleats can occur in particular when the pock-
`ets are filled with blood in response to backflow blood
`pressure. The expandable anchor can haves a delivery
`length in a delivery configuration that is substantially
`greater than a deployed length in a deployed configura(cid:173)
`tion. The anchor can foreshorten during deployment. The
`1o delivery configuration can be a collapsed configuration
`and the deployed configuration can be an expanded con(cid:173)
`figuration. The anchor can self-expand from the delivery
`configuration. The anchor can be balloon expandable.
`At least a portion of the seal can be adapted to be cap-
`tured between native valve leaflets and a wall of the pa(cid:173)
`tient's heart when the anchor and replacement valve are
`fully deployed. The seal can be adapted to prevent blood
`flow around the replacement valve and the anchor when
`the anchor and the replacement valve are fully deployed.
`
`15
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`[0018]
`
`Figures 1A-B are elevational views of a replacement
`heart valve and anchor according to one embodi(cid:173)
`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 are(cid:173)
`placement heart valve and anchor, such as the an(cid:173)
`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-I 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(cid:173)
`tration feature to replace an aortic valve.
`Figures 8A-C show another embodiment of a re(cid:173)
`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 of the delivery
`system used with the method and apparatus of Fig(cid:173)
`ures 8 and 9.
`Figure 11 demonstrates paravalvular leaking around
`a replacement heart valve and anchor.
`Figure 12 shows a seal for use with a replacement
`heart valve and anchor of this invention.
`Figures 13A-E show alternative arrangements of
`seals on a replacement heart valve and anchor.
`Figures 14A-C show alternative seal designs for use
`
`20
`
`25
`
`30
`
`35
`
`40
`
`45
`
`50
`
`55
`
`3
`
`Edwards Lifesciences Corporation, et al. Exhibit 1022, p. 3 of 66
`
`

`
`5
`
`EP 2 749 254 B1
`
`6
`
`with replacement heart valves and anchors.
`Figure 15 shows yet another embodiment of the de(cid:173)
`livery and deployment apparatus of the invention in
`use with a replacement heart valve and anchor.
`Figure 16 shows the delivery and deployment appa(cid:173)
`ratus of Figure 15 in the process of deploying a re(cid:173)
`placement heart valve and anchor.
`Figure 17 shows an embodimentofthe invention em(cid:173)
`ploying seals at the interface of the replacement
`heart valve and anchor and the patient's tissue.
`Figure 18 is a longitudinal cross-sectional view of
`the seal shown in Figure 17 in compressed form.
`Figure 19 is a transverse cross-sectional view of the
`seal shown in Figure 18.
`Figure 20 is a longitudinal cross-sectional view of
`the seal shown in Figure 17 in expanded form.
`Figure 21 is a transverse cross-sectional view of the
`seal shown in Figure 20.
`Figure 22 shows yet another embodiment of the re(cid:173)
`placement heart valve and anchor of this invention
`in an undeployed configuration.
`Figure 23 shows the replacement heart valve and
`anchor of Figure 22 in a deployed configuration.
`Figure 24 shows the replacement heart valve and
`anchor of Figures 22 and 23 deployed in a patient's
`heart valve.
`Figures 25A and 258 show replacement valve ap(cid:173)
`paratus in accordance with the present invention.
`Figure 25 illustrates the apparatus in a collapsed de(cid:173)
`livery configuration within a delivery system. Figure
`258 illustrates the apparatus in an expanded config(cid:173)
`uration partially deployed from the delivery system.
`Figures 26A-26F show an anchor of the apparatus
`of Figures 25 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.
`Figures 27 A-27F illustrate deployment of an anchor
`with leaflet engagement elements on the deploy-
`ment system.
`Figure 28 illustrates a deployed anchor with leaflet
`engagement elements on the proximal end of the
`anchor.
`Figures 29A-29C illustrate deployment of an anchor
`with anchor registration elements and a seal.
`Figures 30A-308 illustrate an embodiment of the ap(cid:173)
`paratus with a seal that does not reach the proximal
`end of the anchor during both systole and diastole.
`Figures 31A-31 8 illustrate an embodiment of the ap-
`paratus with a seal that reaches the proximal end of
`the anchor during both systole and diastole.
`
`DETAILED DESCRIPTION
`
`[0019] The present invention relates to apparatus and
`methods for endovascularly or percutaneously delivering
`and deploying a prosthesis, e.g., an aortic prosthesis,
`
`5
`
`30
`
`35
`
`within and/or across a patient's native heart valve, re(cid:173)
`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-pneumatically expanding force on the anchor. A
`1o 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(cid:173)
`pneumatically expanding force could include the use of
`15 a hydraulic component transmitting a proximally or dis(cid:173)
`tally directed force on an anchor.
`[0020] The apparatus includes an anchor and a re(cid:173)
`placement valve. The anchor includes an expandable
`anchor such as a braid. In preferred embodiments, the
`20 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(cid:173)
`place one of the patient's native heart valves. More pref-
`25 erably, the apparatus and methods of the present inven(cid:173)
`tion contemplate replacement of the patient's aortic
`valve.
`[0021] With reference now to Figures 1-4, a first em(cid:173)
`bodiment of replacement heart valve apparatus in ac(cid:173)
`cordance with the present invention is described, includ(cid:173)
`ing a method of actively foreshortening and expanding
`the apparatus from a delivery configuration and to a de(cid:173)
`ployed configuration. Apparatus 10 comprises replace(cid:173)
`ment valve 20 disposed within and coupled to anchor 30.
`Figures 1 schematically illustrate individual cells of an(cid:173)
`chor 30 of apparatus 1 0, and should be viewed as if the
`cylindrical anchor has been cut open and laid flat. Figures
`2 schematically illustrate a detail portion of apparatus 10
`in side-section.
`[0022] 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 of anchor 30. Posts 38 pref(cid:173)
`erably are spaced 120° apart from one another about the
`circumference of anchor 30.
`[0023] Anchor 30 preferably is fabricated by using self(cid:173)
`expanding patterns (laser cut or chemically milled),
`braids, and materials, such as a stainless steel, nickel(cid:173)
`titanium ("Nitinol") or cobalt chromium but alternatively
`may be fabricated using balloon-expandable 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,
`55 alternatively it can be made from tissue engineered ma(cid:173)
`terials (such as extracellular matrix material from Small
`Intestinal Submucosa (SIS)) but alternatively may be
`prosthetic from an elastomeric polymer or silicone, Nitinol
`
`40
`
`45
`
`50
`
`4
`
`Edwards Lifesciences Corporation, et al. Exhibit 1022, p. 4 of 66
`
`

`
`7
`
`EP 2 749 254 B1
`
`8
`
`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(cid:173)
`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.
`[0024] Anchor 30 may be actuated using external non(cid:173)
`hydraulic or non-pneumatic force to actively foreshorten
`in order to increase its radial strength. As shown below,
`the proximal and distal end regions of anchor 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 other anatomical fea(cid:173)
`tures and to visualize operation of the valve. The anchor
`and valve may thereafter be repositioned and even re(cid:173)
`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 17 french. Upon deploy(cid:173)
`ment the anchor and replacement valve capture the na-
`tive valve leaflets and positively lock to maintain config(cid:173)
`uration and position.
`[0025] A deployment 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(cid:173)
`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(cid:173)
`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(cid:173)
`terlocking elements 44, and back through female inter-
`locking elements 42, such that a double strand of wire
`50 passes through each female interlocking element 42
`for manipulation by a medical practitioner external to the
`patient to actuate and control the anchor by changing the
`anchor's shape. Control actuators 50 may comprise, for
`example, strands of suture or wire.
`[0026] Actuators 60 are reversibly coupled to appara(cid:173)
`tus 10 and may be used in conjunction with actuators 50
`to actuate anchor 30, e.g., to foreshorten and lock appa(cid:173)
`ratus 10 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(cid:173)
`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-
`
`5
`
`15
`
`20
`
`25
`
`ing. Control actuators 62 can also actuate anchor 60;
`proximally directed forces on control actuators 62 con(cid:173)
`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.
`[0027] Figures 1A and 2A illustrate anchor 30 in a de(cid:173)
`livery configuration or in a partially deployed configura(cid:173)
`tion (e.g., after dynamic self-expansion expansion from
`1o 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 18 and 28.
`In Figures 1A and 2A, replacement valve 20 is
`[0028]
`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(cid:173)
`placement valve 20 within lumen 31 of anchor 30. Im(cid:173)
`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(cid:173)
`erably greater than 0,907 kg [2 pounds], or more prefer(cid:173)
`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(cid:173)
`ditional means to prevent anchor migration and enhance
`long term stability of the device.
`[0029] Deployment of apparatus 10 is fully reversible
`until lock 40 has been locked via mating of male inter(cid:173)
`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 other end of the actuator until each actuator
`has been removed from eyelet 45 of its corresponding
`55 male interlocking element 44.
`[0030] As best seen in Figure 28, body region 36 of
`anchor 30 optionally may comprise barb elements 37 that
`protrude from anchor 30 in the fully deployed configura-
`
`30
`
`35
`
`40
`
`45
`
`50
`
`5
`
`Edwards Lifesciences Corporation, et al. Exhibit 1022, p. 5 of 66
`
`

`
`9
`
`EP 2 749 254 B1
`
`10
`
`5
`
`1o
`
`leaflets.
`In Figure 48, control actuators 50 are retracted
`[0035]
`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(cid:173)
`shortens apparatus 10, as seen in Figure 4C. Deploy(cid:173)
`ment of apparatus 10 is fully reversible even after fore(cid:173)
`shortening has been initiated and has advanced to the
`point illustrated in Figure 4C.
`In Figure 40, continued foreshortening causes
`[0036]
`male interlocking elements 44 of locks 40 to engage fe(cid:173)
`male interlocking elements 42. The male elements mate
`with the female elements, thereby locking apparatus 1 0
`in the foreshortened configuration, as seen in Figure 4E.
`15 Actuators 50 are then pulled through eyelets 45 of male
`elements 44 to remove the actuators from apparatus 1 0,
`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
`20 10. Fully deployed apparatus 10 is shown in Figure 4F.
`[0037] Referring to Figures 5, a method of percutane(cid:173)
`ously replacing a patient's diseased aortic valve with ap(cid:173)
`paratus 10 and delivery system 100 is described. As seen
`in Figure 5A, sheath 11 0 of delivery system 1 00, having
`apparatus 10 disposed therein, is percutaneously ad(cid:173)
`vanced over guide wire G, preferably in a retrograde fash-
`ion (although an antegrade or hybrid approach alterna(cid:173)
`tively may be used), through a patient's aorta A to the
`patient's diseased aortic valve AV. A nosecone 102 pre(cid:173)
`cedes sheath 110 in a known manner. In Figure 58,
`sheath 110 is positioned such that its distal region is dis-
`posed within left ventricle LV of the patient's heart H.
`[0038] Apparatus 10 is deployed from lumen 112 of
`sheath 110, for example, under fluoroscopic guidance,
`35 such that anchor 30 of apparatus 10 dynamically self(cid:173)
`expands to a partially deployed configuration, as in Fig(cid:173)
`ure 5C. Advantageously, apparatus 10 may be retracted
`within lumen 112 of sheath 110 via actuators 50 - even
`after anchor 30 has dynamically expanded to the partially
`40 deployed configuration, for example, to abort the proce(cid:173)
`dure or to reposition apparatus 10 or delivery system
`100. As yet another advantage, apparatus 1 0 may be
`dynamically repositioned, e.g. via sheath 110 and/or ac(cid:173)
`tuators 60, in order to properly align the apparatus relative
`to anatomical landmarks, such as the patient's coronary
`ostia or the patient's native valve leaflets L. When prop(cid:173)
`erly aligned, skirt region 34 of anchor 30 preferably is
`disposed distal of the leaflets, while body region 36 is
`disposed across the leaflets and lip region 32 is disposed
`proximal of the leaflets.
`[0039] Once properly aligned, actuators 50 are retract(cid:173)
`ed relative to actuators 60 to impose foreshortening upon
`anchor 30 and expand apparatus 10 to the fully deployed
`configuration, as in Figure 50. Foreshortening increases
`the radial strength of anchor 30 to ensure prolonged pa(cid:173)
`tency of valve annulus An, as well as to provide a better
`seal for apparatus 10 that reduces paravalvular regurgi(cid:173)
`tation. As seen in Figure 5E, locks 40 maintain imposed
`
`tion, for example, for engagement of a patient's native
`valve leaflets and to preclude migration of the apparatus.
`[0031] 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(cid:173)
`figuration within lumen 112 of sheath 110, such that ap(cid:173)
`paratus 1 0 may be delivered via delivery system 1 00. 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(cid:173)
`ployed configuration. Control actuators 50 then are re(cid:173)
`tracted relative to apparatus 10 and actuators 60 to im(cid:173)
`pose foreshortening upon anchor 30, as seen in Figure
`38.
`foreshortening, actuators 60 push
`[0032] During
`against lip region 32 of anchor 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 lock locks 40 and fully deploy apparatus 10 with
`replacement valve 20 properly seated within anchor 30,
`as in Figures 1 B and 28. Apparatus 10 comprises en-
`hanced radial strength in the fully deployed configuration
`as compared to the partially deployed configuration of
`Figure 3A. Onc