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`[I Continuation
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`C:WMbIWUB1\QN2\2549862-'DOC Edwards Lifesciences Corporation, et al. Exhibit 1142, Page 1 of 630
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`PATENT APPLICATION
`TRANSMITTAL
`
`Title
`
`
`
`i
`
`7 l\
`LEAFLET ENGAGEMENT
`ELEMENTS AND METHODS FOR‘
`USE THEREOF
`
`EV 517773864 US
`
`‘r
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`APPLICATION ELEMENTS
`See MPEP chapter 600 concerning utility patent application contents.
`El Fee Transmittal Form (fig, pTO/SB/l 7)
`(Submit an original, and a duplicateforfee processing)
`|Zl Applicant claims small entity status. See 37 CFR 1.27.
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`2.
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`[Total Pages 26 l
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`8‘
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`3. E Specification
`(preferred arrangement setforth below)
`- Descriptive title ofthe invention
`- Cross References to Related Applications
`- Statement Regarding Fed sponsored R&D
`- Reference to sequence listing, a table, or a computer program
`listing appendix
`- Background of the invention
`- Brief Summary of the invention
`- Brief Detailed Description of the Drawings (iffiled)
`- Detailed Description
`- Claim(s)
`- Abstract of the Disclosure
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`'
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`4. E Drawing“) (35 use 113)
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`5.
`[:I Oath or Declaration
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`[Tom] Sheets 27 I
`[Total Pages
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`c.
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`10.
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`El Assignment Papers (cover sheet & document(s))
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`[:1 37 CFR 3.73(b) Statement
`(when there is an assignee)
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`El Power of Attorney
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`11. El English Translation Document (ifapplicable)
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`~
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`f l
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`1:] Information Disclosure
`El Coples 0 DS
`Statement (lDS)/PTO-1449
`Citations
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`Edwards Lifesciences Corporation, et al. Exhibit 1142, Page 1 of 630
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`

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`WSGR Docket No. 30207.702.501
`
`PATENT APPLICATION
`
`LEAFLET ENGAGEMENT ELEMENTS AND METHODS FOR USE THEREOF
`
`Inventors:
`
`Amr Salahieh
`
`Citizen of United States of America, Residing at
`18729 _Metler Court, Saratoga, CA 95070
`
`Brian D. Brandt
`
`.
`
`Citizen of United States of America, Residing at
`3015 Cameron Way, Santa Clara, CA 95051‘\'
`
`Robert A.Geshlider
`
`Citizen of United States of America, Residing at
`233 27th Street, San Francisco, CA 94131
`
`Dwight P. Morejohn
`Citizen of United States of America, Residing at
`731 N; Campus Way, Davis, CA 95616
`
`Tom Saul
`
`Citizen of United States of America, Residing at
`151 Madrid Avenue, El Granada, CA 94018
`
`W
`
`Wilson Sonsini Goodrich 8c Rosati
`PROFESSIONAL CORPORATION
`
`650 Page Mill Road
`Palo Alto, CA 94304
`(650) 493-9300
`(650) 493-6811
`
`Express Mail Label No. EV 517773864 US
`
`C:\NrPortbl\PALlBI\DH1\2533053_4.DOC
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`WSGR Docket No. 30207.702.501
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`Edwards Lifesciences Corporation, et 31. Exhibit 1142, Page 2 of 630
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`Edwards Lifesciences Corporation, et al. Exhibit 1142, Page 2 of 630
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`

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`LEAFLET ENGAGEMENT ELEMENTS AND METHODS FOR USE THEREOF
`
`‘
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`CROSS-REFERENCE
`
`'
`
`[0001]
`
`This application is a continuation-in-part application of Application Serial
`
`No. '10/746,240, filed December 23, 2003, which is incorporated herein by reference in
`
`its entirety and to which application we claim priority under 35 USC § 120.
`
`BACKGROUND OF THE INVENTION
`
`[0002]
`
`The present invention relates to methods and apparatus for endovascularly
`
`replacing a heart valve. More particularly, the present invention relates to methods and
`
`apparatus for endovascularly replacing a heart valve with a replacement valve using an
`
`expandable and retrievable anchor.
`
`[0003]
`
`Heart valve surgery is used to repair or replace diseased heart valves. Valve
`
`surgery is an open-heart procedure conducted under general anesthesia. An incision is
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`made through the patient’s sternum (sternotomy), and the patient’s heart is stopped while
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`blood flow is rerouted through a heart-lung bypass machine.
`Valve replacement may be indicated when there is a narrowing of the native heart
`
`[0004]
`
`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 medication to
`prevent blood clot formation, and clicking of the valve often may be heard through the
`chest. Biologic tissue valves typically do not require such medication. 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,
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`renal failure, adverse reactions to the anesthesia medications, as well as sudden death. 2-
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`5% of patients die during surgery.
`
`[0006]
`
`Post-surgery, patients temporarily may be confused due to emboli and other
`
`factors associated with the heart-lung machine. The first 2-3 days following surgery are
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`spent in an intensive care unit where heart functions can be closely monitored. The
`
`C:\NrPortbl\PALlBl\DHl\2533053_4.DOC
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`-2-
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`WSGR Docket No. 30207.702.50|
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`Edwards Lifesciences Corporation, et al. Exhibit 1142, Page 3 of 630
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`Edwards Lifesciences Corporation, et al. Exhibit 1142, Page 3 of 630
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`

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`average hospital stay is between 1 to 2 weeks, with several more weeks to months
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`required for complete recovery.
`
`[0007]
`
`In recent years, advancements in minimally invasive surgery and interventional
`
`cardiology have encouraged some investigators to pursue percutaneous replacement of
`
`the aortic heart valve. However, the current devices suffer from several drawbacks.
`
`[0008]
`
`First, many of the devices available today can become mispositioned with respect
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`to the native valve. This is a critical drawback because improper positioning too far up
`towards the aorta risksblocking the coronary ostia of the patient. Furthermore, a
`
`misplaced stent/valve 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 stent/valve.
`
`[0009]
`
`Moreover, some stent/valve devices simply crush the natiVe valve leaflets against
`
`the heart wall and do 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
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`immediate risk of blocking the coronary ostia, as well as a longer-term risk of migration
`
`of the device post-implantation.
`
`I
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`_
`
`[0010]
`
`Another drawback of the devices known today is that during implantation they
`
`may still require the patient to be on life support as the valve does not function for a
`
`portion of the procedure. This further complicates the implantation procedure.
`
`[0011]
`
`Furtherstill, the stent comprises openings or gaps, thereby increasing a risk of
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`improper seating of the valve within the stent and increasing the risk of paravalvular
`
`leaks. The interface between the stent and the native valve may additionally comprise
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`gaps which again would increase the risks of paravalvular leaks.
`
`[0012]
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`In view of drawbacks associated with previously known techniques for
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`endovascularly replacing a heart valve, it would be desirable to provide methods and
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`apparatus that overcome those drawbacks. '
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`_
`
`SUMMARY OF THE INVENTION
`
`[0013]
`
`One aspect of the invention provides an apparatus for endovascularly replacing a
`
`patient’s heart valve. The apparatus includes: an expandable anchor and a replacement
`
`valve, wherein both are adapted for percutaneous delivery and deployment. The
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`expandable anchor further includes a leaflet engagement element on its proximal end to
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`C:\NrPortbl\PALlB I\DH l\2533053_4.DOC
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`-3-
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`WSGR Docket No. 30207.702.501
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`Edwards Lifesciences Corporation, et al. Exhibit 1142, Page 4 of 630
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`Edwards Lifesciences Corporation, et al. Exhibit 1142, Page 4 of 630
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`

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`/
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`engage the leaflets of the patient’s heart valve. When the leaflets engagement element is
`
`engaged, the anchor is substantially distal to the coronary ostia of the patient. Moreover,
`
`once engaged, the leaflet engagement element prevents the distal movement of the
`anchor. In some embodiments, the-leaflet engagement element is integral with the anchor
`
`or part of the anchor (especially when the anchor is an anchor braid). In other
`
`embodiments, the leaflet engagement element is attached to the proximal end of the
`
`anchor. In any of the embodiments herein, the anchor may be adapted for active
`
`foreshortening during deployment. Active foreshortening can occur by actuating the
`
`proximal and/or distal actuation elements of the anchor. The anchor herein may also be
`
`configured for locking and may include a locking element. The replacement valve of the
`apparatus herein is situated within the anchor and is adapted to permit blood flow and
`
`prevent blood backflow both during and after deployment.
`
`[0014]
`
`Another aspect of the invention provides a method for endovascularly replacing a
`patient’s heart valve.
`In some embodiments the method includes the steps of:
`
`endovascularly delivering an anchor comprising a leaflet engagement element on its
`
`proximal end and a replacement valve supported within the anchor to a vicinity of the
`
`heart valve in a collapsed delivery configuration; unsheathing the anchor allowing it to
`
`take a relaxed configuration intermediate between its sheathed and expanded
`
`configurations; expanding the anchor; and, engaging the leaflet engagement element with
`
`the native leaflets. The expanding step may further comprise actively foreshortening the
`
`anchor. Active foreshortening can include actuating proximal and/or distal actuation
`
`elements of the anchor. The method may also include the step of locking the anchor after
`
`it is in its deployed configuration. In some embodiments, when the anchor engages the
`
`patient’s heart, the anchor is substantially distal to the coronary ostia. In any of the
`
`embodiments herein, leaflet engagement element prevents the anchor from distally
`
`migrating at its proximal end.
`
`INCORPORATION BY REFERENCE
`
`[0015]
`
`All publications and patent applications mentioned in this specification are herein
`
`'
`
`incorporated by reference to the same extent as if each individual publication or patent
`
`application was specifically and individually indicated to be incorporated by reference.
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`C:\NrPortbl\PALIBl\DHl\2533053_4.DOC
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`-4-
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`WSGR Docket'No. 30207.I702.501
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`Edwards Lifesciences Corporation, et al. Exhibit 1142, Page 5 of 630
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`Edwards Lifesciences Corporation, et al. Exhibit 1142, Page 5 of 630
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`

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`BRIEF DESCRIPTION OF THE DRAWINGS
`
`[0016]
`
`The novel features of the invention are set forth with particularity in the appended
`
`claims. A better understanding of the features and advantages of the present invention
`
`will be obtained by reference to the following detailed description that sets forth
`
`illustrative embodiments, in which the principles of the invention are utilized, and the
`
`accompanying drawings of which:
`
`[0017]
`
`Figures 1A and 1B are schematic views of an anchor and valve apparatus in
`
`accordance with the present invention. Figure 1A illustrates the apparatus in a collapsed
`
`delivery configuration within a delivery system. Figure 1B illustrates the apparatus in an
`
`expanded configuration partially deployed from the delivery system.
`Figure 2 illustrates an anchor of Figures 1 in the collapsed delivery configuration
`
`[0018]
`
`'with looking elements separated.
`
`[0019]
`
`Tu.
`
`[0020]
`
`anchor.
`
`[0021]
`
`[0022]
`
`Figure 3 illustrates a braided anchor of the present invention with closed end turns
`
`Figures 4A—4O are schematic detail views illustrating end turns for a braided
`
`Figures 5A-5E illustrate additional features for end turns of a braided anchor.
`
`Figures 6A-6F illustrate deployment of an anchor with leaflet engagement
`
`elements on the deployment system.
`[0023]
`2 Figure 7 illustrates a deployed anchor with leaflet engagement elements on the
`
`proximal end of the anchor.
`
`Figures 8A-8C illustrate deployment of an anchor with anchor registration
`[0024]
`elements and a seal.
`
`[0025]
`
`Figures 9A-9B illustrate an embodiment of the apparatus with a seal that does not
`
`reach the proximal end of the anchor during both systole and diastole.
`
`[0026]
`
`Figures lOA-l 0B illustrate an embodiment of the apparatus with a seal that
`
`reaches the proximal end of the anchor'during both systole and diastole.
`
`[0027]
`
`Figures llA-l ID are schematic side views of various braided anchor
`
`configurations.
`
`[0028]
`
`braid.
`
`Figures 12A-12E are schematic side views of a deployment process for an anchor
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`C:\NrPortbl\PALlBl\DHl\2533053_4.DOC
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`I
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`WSGR Docket No. 3020770250]
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`Edwards Lifesciences Corporation, et al. Exhibit 1142, Page 6 of 630
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`Edwards Lifesciences Corporation, et al. Exhibit 1142, Page 6 of 630
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`

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`[0029]
`
`Figures 13A-13E are schematic views of different weave configurations for an
`
`anchor braid.
`
`[0030]
`
`' Figures l4A-14C illustrate an embodiment of a replacement heart valve and
`
`anchor in the undeployed and deployed configurations.
`
`DETAILED DESCRIPTION OF THE INVENTION
`
`[0031]
`
`The present invention relates to an apparatus and methods for endovascularly
`
`delivering and deploying an aortic prosthesis within a patient’s native heart valve, referred to
`
`here out as “replacing” a patient’s heart valve. The delivery system includes a sheath assembly,
`
`a multi-lumen shaft, and a guide wire for placing the apparatus endovascularly within a patient
`
`and a user control allowing manipulation of the aortic prosthesis. The apparatus includes an
`
`anchor and a replacement valve. The anchor and the replacement valve are adapted for
`
`percutaneous delivery and deployment within a patient’s heart valve. In preferred embodiments,
`
`the anchor includes a leaflet engagement element and/or a seal inverting element situated on its
`
`proximal end. The leaflet engagement element is adapted for engaging the native leaflets of the
`
`patient’s heart, or more preferably the proximal edge and/or the commissural attachments of the
`
`native leaflets. The leaflet engagement element need not extendall the way into the pocket or
`the distal end of the native leaflet. Preferred embodiments of the apparatus herein are depicted in
`
`Figures 1-14, which are discussed in more detail below.
`
`[0032]
`
`Figures 1A and 1B illustrate one embodiment of a delivery system and the
`
`apparatus of the present invention.
`
`[0033]
`
`As illustrated by Figure 1A, apparatus 10 may be collapsed for delivery within a
`
`delivery system 100. Delivery system 100 includes a guidewire 102, a nosecone 104, anchor
`
`actuation elements 106 (in this case fingers) coupled to a multi-lumen shaft 108, an external
`
`sheath 110 having a proximal handle 111, and a control handle 120. Delivery system 100 further
`
`comprises distal region control elements (not shown), comprised of or actuated by control wires
`
`112, which pass through one or more lumens of shaft 108 and are reversibly coupled to posts 32
`
`of anchor 30 for manipulating a distal region of apparatus 10. Thus, the distal region control
`
`elements may function as a distal actuation element.
`
`[0034]
`
`The delivery system also comprises proximal region control elements comprised
`
`of or actuated by control wires 112 that pass through one or more lumens of shaft 108 and anchor
`
`actuation elements 106 to reversibly couple the control tubes to a proximal region of anchor 30.
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`C:\NrPortbl\PAL1Bl\DH1\2533053_4.DOC
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`WSGR Docket No. 30207702501
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`Edwards Lifesciences Corporation, et al. Exhibit 1142, Page 7 of 630
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`

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`The control wires may comprise, for example, strands of suture, or metal or polymer wires.
`
`Control handle 120 is coupled to multi-lumen shaft 108. In some embodiments, these fingers
`
`and wires may be referred to as proximal actuation elements. A knob 122 disposed in slot 123 is
`
`coupled to the distal region control wires for controlling movement of the distal region of
`
`apparatus 10. Likewise, a knob 124 disposed in slot 125 is coupled to proximal region control
`
`wires 112 for control of the proximal region of apparatus 10. Handle 120 may also have a knob
`
`126 for, e. g., decoupling the proximal and/or distal region control wires from apparatus 10, or for
`
`‘ performing other control functions.
`
`[0035]
`
`As illustrated by Figure 1B, apparatus 10 comprises an anchor 30 and a
`
`replacement valve 20. Anchor 30 preferably comprises a braid. Such braid can have closed ends
`
`at either or both of its ends but preferably at least in its proximal end. Replacement valve 20 is
`
`preferably coupled to the anchor at posts 32 attached at distal region of the anchor. Post 32
`
`therefore, may function as valve support and may be adapted to support the replacement valve
`
`within the anchor. In the embodiment shown, there are three posts, corresponding to the valve’s
`
`three commissure attachments. The posts can be attached to braid portion of anchor 30. The
`
`posts can be attached to the braid’s distal end, as shown in Figure 2, central region, or proximal
`
`end. Replacement 'Valve 20 can be composed of a metal, a synthetic material and/or may be ‘
`
`derived from animal tissue. Replacement valve 20 is preferably configured to be secured within
`
`anchor 30.
`
`[0036]
`
`In preferred embodiments, anchor 30 is collapsible and/or expandable and is
`
`formed from material such as NitinolTM, cobalt-chromium steel or stainless steel wire. More
`
`preferably, an anchor 30 is self-collapsing and/or self-expanding and is made out of shape
`
`memory material, such as NitinolTM. An anchor composed of shape memory material may self—
`expand to or toward its “at-rest” configuration. This “at rest” configuration of an anchor can be,
`for example its expanded configuration, its collapsed configuration, or a partially expanded
`
`configuration (between the collapsed configuration and the expanded configuration).
`
`In
`
`preferred embodiments, an anchor’s at—rest configuration is between its collapsed configuration
`
`and its expanded configuration. Depending on the “at rest” diameter of the anchor and the
`
`diameter of the patient’s anatomy at the chosen deployment location, the anchor may or may not
`
`self—expand to come into contact with the diameter of the patient’s anatomy at that location.
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`C:\NrPortbl\PALlB1\DH1\2533053_4.DOC
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`-7—
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`WSGR Docket No. 30207.702.501
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`Edwards Lifesciences Corporation, et al. Exhibit 1142, Page 8 of 630
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`

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`[0037]
`
`Anchor 30 may be expanded to a fully'deployed configuration from a partial
`
`deployed configuration (e.g., self-expanded configuration) by actively foreshortening anchor 30
`
`during endovascular deployment. Active foreshortening is described in more detail in US.
`
`Patent Appl. Ser. No. 10/746,280, which is incorporated herein by reference in its entirety.
`
`During active foreshortening, the distal region of anchor 30 may be pulled proximally via a
`
`. proximally directed force applied to posts 32 via a distal deployment system interface comprised
`
`of the distal system control elements. The distal deployment system interface is adapted to
`
`expand radially during application of a proximally directed force on the distal end of the anchor
`
`when opposed by a distally directed force applied to the proximal end of the anchor.
`
`[0038]
`
`In some embodiments, actuating foreshortening of the apparatus involves
`
`applying a proximally directed force on a deployment system interface at the distal end of the
`
`anchor, while maintaining the proximal end of the anchor in the same location. In other
`embodiments, foreshortening of the apparatus involves applying a distally directed force on
`proximal end of the anchor (e.g., by applying a distally directed force on the anchor actuation
`
`elements).
`
`[0039]
`
`Anchor actuation elements 106 (e.g., fingers, tubes, posts, and control wires
`
`connecting to posts) are preferably adapted to expand radially as the anchor expands radially and
`
`to contract radially as the anchor contracts radially. Furthermore, proximally or distally directed
`forces by the anchor actuation elements on one end of the anchor do not diametrically constrain .
`the opposite end of the anchor. In addition, when a proximally or distally directed force is
`applied on the anchor by the anchor actuation elements, it is preferably applied without passing
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`any portion of a deployment system through a center opening of the replacement valve. This
`
`arrangement enables the replacement valve to operate during deployment and before removal of
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`the deployment system.
`
`[0040]
`
`The distal deployment system interface may include control wires that are
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`controlled, e. g., by control knob 122 of control handle 120. Similarly, the proximal regions of
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`anchor 30 may be pushed distally via a proximal deployment system interface at the proximal
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`end of the anchor. The proximal deployment system interface is adapted to permit deployment
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`system to apply a distally directed force to the proximal end of anchor 30 through, e.g., fingers,
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`which are controlled by, e.g., control knob 124 of control handle 120. The proximal deployment
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`system interface may be further adapted to expand radially during application of a distally
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`directed force on the proximal end of the anchor. Preferably, the proximal deployment system
`interface is adapted to permit deployment system to apply a distally directed force on the
`
`proximal end of the anchor system through a plurality of deployment system fingers or tubes
`
`160. Such expansion optionally may be assisted via inflation of a balloon catheter (not shown)
`
`reversibly disposed within apparatus 10, as described in U.S. Patent Appl. SeriNo. 10/746,280.
`[0041]
`Once anchor 30 is fully deployed, posts 32 and buckles 34 of anchor 30 may be
`used to lock and maintain the anchor in the deployed configuration. In one embodiment, the
`
`control wires attached to posts 32 are threaded through buckles 34 so that the proximally directed
`
`force exerted on posts 32 by the control wires during deployment pulls the proximal locking end
`
`of posts 32 toward and through buckles 34. Such lock optionally may be selectively reversible to
`
`allow for repositioning and/or retrieval of apparatus 10 during or post-deployment. Apparatus 10
`
`may be repositioned or retrieved from the patient until the two-part locking mechanism of posts
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`32 and buckles 34 of anchor 30 have been actuated. When the lock is selectively reversible, the
`apparatus may be repositioned and/or retrieved as desired, e.g., even after actuation of the two-
`
`part locking mechanism. Once again, further details of this and other anchor locking structures
`
`may be found in U.S. Patent Appl. Ser. No. 10/746,280. Locking mechanisms used herein may
`
`also include a plurality of levels of locking wherein each level of locking results in a different
`
`amount of expansion. For example, the proximal end of the post can have multiple
`
`configurations for locking within the buckle wherein each configuration results in a different
`
`amount of anchor expansion. Figure 2 illustrates a braided anchor of Figures 1 in the collapsed
`
`delivery configuration with locking elements separated.
`
`[0042]
`
`Figure 3 provides a detail view of a front side region of anchor braid 30 with
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`closed end turns Tu. Anchor braid 30 includes various cells, some having an end turn (Tu). End
`
`turns can serve various functions. For example, end turns can be configured to reduce the
`
`sheathing force, to reduce stress within the braid during delivery and deployment, to prevent
`
`distal migration during expansion of the anchor, and/or to positively register the anchor against
`
`the native valve during deployment.
`In preferred embodiments, an end turn feature functions to
`prevent distal migration and to register the anchor by engaging the native leaflets. In preferred
`
`embodiments, the proximal end of an anchor comprises embodiments (Tu).
`
`[0043]
`
`Figures 4A-4N provide multiple examples of edge cells having end turn feature.
`
`The end turn features disclosed and others known in the art may be used as leaflet engagement
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`elements to engage the native heart leaflets with the anchor. The leaflet engagement elements
`
`are preferably integral with the anchor, or more preferably part of a braided anchor. The end
`
`turn features can occur at the proximal end, the distal end, or both proximal and distal ends of the
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`anchor.
`
`[0044]
`
`For example, Figure 4A illustrates a detail view of a standard end turn Tu in an
`
`anchor braid resulting in a braid with substantially uniform cell size and shape.
`
`[0045]
`
`Figure 4B illustrates a turn that has been elongated to lengthen the distance over
`
`which forces concentrated in the turn may be distributed, resulting in an anchor braid having
`
`edge cells that are longer along the anchor axis than the other cells defined by the braid. This
`
`elongated turn feature may be formed by routing the wire of braid about outer posts and then
`
`heat setting the wire.
`[0046]
`Figure 4C illustrates
`
`alternative anchor edge cell configuration, wherein the tip
`
`of the elongated wire turn may be bent out of a cylindrical shape defined by the braid of anchor
`braid 30. This may be achieved, for example, via a combination of routing of wire W within a
`
`fixture and then heat setting. Such a turn Tu in the anchor edge cells in Figure 4C may reduce
`
`stress in some configurations without increasing height, and may also provide a lip for engaging
`
`the patient’s native valve leaflets to facilitate proper positioning of apparatus 10 during
`
`' deployment.
`
`V
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`[0047]
`
`In Figure 4D, a W-shaped turn feature has been formed at the wire turn, e. g., by
`
`routing the wire of anchor braid 30 about a central inner post and two flanking outer posts. As
`
`with the elongated braid cells of Figures 4B and 4C, the W-shape may better distribute stress-
`
`about turn Tu.
`
`-
`
`[0048]
`
`The anchor edge cell configuration in Figure 4E includes a loop formed in braid
`
`30 at the turn, which may be formed by looping wire W around an inner or outer post.
`
`[0049]
`
`Figure 4F provides another alternative anchor edge cell configuration having a
`
`figure-eight shape. Such a shape may be formed, for example, by wrapping wire W about an
`
`inner post and an aligned outer post in a figure-eight fashion, and then heat setting the wire in the
`resultant shape.
`I
`
`[0050]
`
`In Figure 4G, the edge cells of braid 30 include a heart-shaped configuration,
`
`which may be formed by wrapping the wire about an aligned inner and outer post in the desired
`manner.
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`[0051]
`
`In Figure 4H, the edge cells of braid 30 have an asymmetric loop at turn Tu. The
`
`asymmetric loop will affect twisting of braid 30 during expansion and collapse of the braid, in
`
`addition to affecting stress concentration.
`
`[0052]
`
`In Figure 41, the anchor edge cells have a double-looped turn configuration, e.g.
`
`via wrapping about two adjacent inner or outer posts. Additional loops may also be employed.
`
`[0053]
`
`The double loop turn feature may be formed with a smooth transition between the
`
`loops, as in Figure 41, or may be heat set with a more discontinuous shape, as in Figure 4].
`
`[0054]
`
`Figure 4K illustrates that the edgecells of braid 30 may have multiple different
`
`configurations about the anchor’s circumference. For example, the anchor edge cells shown in
`
`Figure 4K have extended length cells as in Figure 4B disposed adjacent to standard size edge
`
`cells, as in Figure 4A.
`
`[0055]
`
`-
`
`The anchor edge cells of Figure 4L haVe an extended turn configuration having an
`
`extended loop.
`[0056]
`
`i
`_
`The anchor edge cells shown in Figure 4M have an alternative extended
`
`configuration with a specified heat set profile.
`
`[0057]
`
`In Figure 4N, some or all anchor edge cells are interwoven. When interwoven,
`
`one or more edge cells may be shorter or longer than an adjacent edge cell. This permits one or
`
`more edge 'cells to extend into one or more leaflet pocket(s). ‘ For example, in Figure 4N the
`
`middle Tu may be taller than the two adjacent edge cells thus permitting the edge cell to be
`situated within a leaflet pocket.
`
`[0058]
`In any of the embodiments herein, edge cells may be wrapped using wire, string,
`or sutures, at a location where the wire overlaps after an end turn as is illustrated in Figure 40.
`This tied-end turn feature prevents cells from interlocking with each other during deployment.
`
`[0059]
`
`The anchor and any of its features may be heat set at different configurations. For
`
`example, the anchor may be heat set ay its “at rest” configuration such that upon unsheathing it
`
`expands radially. The end turn features/leaflet engagement elements may be heat set at a
`different “at