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`UTILITY
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`PATENT APPLICATION
`First Inventor
`TRANSMITTAL
`Title
`(Onlyfor new nonprovisional applications under 3 7 CFR l.53(b))
`Express Mail Label Na.
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`Everttng Heart Valve
`'
`EV 334638890 US
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`CzwrponbNIAUBlmH[\24806gg_l_DOC Edwards Lifesciences Corporation, et al. Exhibit 1143, Page 1 of 661
`
`Edwards Lifesciences Corporation, et al. Exhibit 1143, Page 1 of 661
`
`

`

`WSGR Docket No. 30207-710-201
`
`PATENT APPLICATION
`
`EVERTING HEART VALVE
`
`Inventors:
`
`'
`
`' Ulrich R. Haug
`Citizen of Germany, Residing at
`2479 Twyla Court, Campbell, CA' 95008 r
`
`Hans F. Valencia
`
`Citizen of Peru, Residing at
`1609 La Vereda Road, Berkeley, CA 94709
`
`Robert A. Geshlider
`
`Citizen of United States of America,.Residing at
`233 27‘h Street, San Francisco, CA 94131
`
`Tom Saul
`
`Citizen of United States of America, Residing at
`15] Madrid Avenue, El Granada, CA 94018
`
`Amr Salahieh
`Citizen of United States of America, Residingat
`18729 Metler Court, Saratoga, CA 95070
`
`Dwight P. Morejohn
`Citizen of United States of America, Residing at
`731 N. Campus Way, Davis, CA 95616
`
`Kenneth J. Michlitsch
`
`Citizen of United States of America, Residing at
`822 South M Street, Livermore, CA 94550
`
`W
`
`Wilson Sonsini Goodrich 8L Rosati
`PROFESSIONAL CORPORATION
`
`650 Page Mill Road
`Palo Alto, CA 94304
`(650) 493-9300
`(650) 493-6811
`
`Express Mail Label N0. EV 334638890 US
`
`C:\NrPoan\PALlB1\DH1\2430798-9.DOC
`
`WSGR Docket No. 30207-710201
`
`Edwards Lifesciences Corporation, et 31. Exhibit 1143, Page 2 of 661
`
`Edwards Lifesciences Corporation, et al. Exhibit 1143, Page 2 of 661
`
`

`

`EVERTING HEART VALVE
`
`BACKGROUND OF THE INVENTION
`
`[0001]
`
`The present invention relates to-methods and apparatus for endovascularly
`
`v replacing a heart valve. More particularly, the present invention relates to methods and
`
`apparatus for endovascularly replacing a heart valve with a replacement valve and an
`
`expandable and retrievable anchor. The replacement valve preferably is not connected to
`
`the expandable anchor and may be wrapped about an end of the anchor, for example, by
`
`everting during endovascular. deployment.
`Heart valve surgery is used to repair or replace diseased heart valves. Valve
`
`[0002]
`
`surgery is an open-heart procedure conducted under general anesthesia. An incision is
`made through the patient’s sternum (stemotomy), 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 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.
`
`[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 surgery.
`
`[0005]
`
`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
`
`spent in an intensive care unit where heart functions 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 invasive surgery and interventional
`
`cardiology have encouraged some investigators to pursue percutaneous replacement of
`
`C:\NrPorth\PAL1Bl\MSK\2430798_9.DOC
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`-2-
`
`WSGR Docket No. 30207-710201
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`Edwards Lifesciences Corporation, et al. Exhibit 1143, Page 3 of 661
`
`Edwards Lifesciences Corporation, et al. Exhibit 1143, Page 3 of 661
`
`

`

`the aortic heart valve. See, e. g., US. Pat. No. 6,168,614. In many of these procedures,
`
`the replacement valve 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
`
`replacement valve in place of the native valve.
`In the endovascular aortic valve replacement procedure, accurate placement of
`
`[0007]
`
`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 system until accurate placement is
`verified by fluoroscopy, and the stent typically jumps once released.
`It is therefore 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.
`
`[0008]
`
`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 stande self-expanding systems, however, and the replacement
`
`valve is often not fully functional before final deployment.
`
`[0009]
`
`'Another drawback of prior art self-expanding replacement 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 challenge, and there are
`
`many commercial arterial stent systems 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 plastic deformation. 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 challenged 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 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 heartbeat, thereby distorting the valve, affecting its function and
`
`possibly migrating and dislodging completely. Simply increasing strut thickness of the
`
`C:\NrPortbl\PALlBl\MSK\2430798_9.DOC
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`-3-
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`Edwards Lifesciences Corporation, et al. Exhibit 1143, Page 4 of 661
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`

`

`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.
`
`[0010]
`
`-
`
`In view of drawbacks associated with previously known techniques for
`
`endovascularly replacing a heart valve, it would be desirable to provide methods and
`
`apparatus that overcome those drawbacks.
`
`[0011]
`
`One aspect of the present invention provides apparatus for endovascularly
`
`SUMMARY OF THE INVENTION
`
`replacing a patient’s heart valve, the apparatus including: a replacement valve; and an
`
`expandable anchor, wherein the replacement valve and expandable anchor are configured
`for endovascular delivery to the vicinity of the heart valve, and wherein at least a portion
`
`of the replacement valve is configured to evert about the anchor during endovascular
`
`deployment.
`
`I
`
`_
`
`[0012]
`
`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 a replacement valve and an expandable anchor to a vicinity of
`
`the heart _valve; everting at least a portion of the replacement valve about the anchor; and
`
`expanding the anchor to a deployed configuration.
`
`[0013]
`
`Yet another aspect of the invention provides apparatus for endovascularly
`
`replacing a patient’s heart valve including: an anchor comprising a lip region and a skirt
`
`region; and a replacement valve, wherein at least a portion of the replacement valve is
`
`configured to evert about the anchor during endovascular deployment, and wherein the
`
`lip region and skirt region are configured for percutaneous expansion to engage the
`
`patient’s heart valve.
`
`[0014]
`
`Still another aspect of the present invention provides a method for endovascularly
`
`replacing a patient’s heart valve, the method including: endovascularly delivering a
`
`replacement valve and an expandable anchor to a vicinity of the heart valve,
`
`endovascularly wrapping at least a portion of the replacement valve about the anchor, and
`
`expanding the anchor to a deployed configuration.
`
`[0015]
`
`Another aspect of the present invention provides apparatus for endovascularly
`replacing a patient’s heart valve, the apparatus including: a replacement valve, and an
`
`expandable anchor, wherein the replacement valve and the anchor are configured for
`
`C:\NrPortbl\PALIB]\MSK\2430798_9.DOC
`
`-4-
`
`WSGR Docket No. 30207-710201
`
`Edwards Lifesciences Corporation, et al. Exhibit 1143, Page 5 of 661
`
`Edwards Lifesciences Corporation, et al. Exhibit 1143, Page 5 of 661
`
`

`

`endovascular delivery to a vicinity of the patient’s heart valve, and wherein at least a
`
`portion of the replacement valve is wrapped about an end of the anchor in a deployed
`
`configuration.
`
`INCORPORATION BY REFERENCE
`
`[0016]
`
`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.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`[0017]
`
`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:
`I
`
`[0018]
`
`Figures lA-B are elevational views of a replacement heart valve and anchor
`
`according to one embodiment of the invention.
`
`'
`
`[0019]
`[0020]
`
`Figures 2A-B are sectional views of the anchor and valve of Figures 1.
`Figures 3A-B show delivery and deployment of a replacement heart valve and
`
`anchor, such as the anchor and valve of Figures 1 and 2.
`
`I
`
`[0021]
`
`[0022]
`
`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.
`I
`Figures 5A-F show the-use of a replacement heart valve and anchor to replace an
`
`aortic valve.
`
`[0023]
`
`[0024]
`
`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 use of a replacement heart valve and anchor with an
`
`alternative positive registration feature to replace an aortic valve.
`
`[0025]
`
`Figures 8A-C show another embodiment of a replacement heart valve and anchor
`
`according to the invention.
`
`[0026]
`
`1 Figures 9A-H show delivery and deployment of the replacement heart valve and
`
`anchor of Figures 8.
`
`C:\NrPonbl\PALlBl\MSK\2430798_9.DOC
`
`-5-
`
`WSGR Docket No. 30207-710201
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`Edwards Lifesciences Corporation, et al. Exhibit 1143, Page 6 of 661
`
`Edwards Lifesciences Corporation, et al. Exhibit 1143, Page 6 of 661
`
`

`

`[0027]
`
`Figure 10 is a cross-sectional drawing of the delivery system used with the
`
`method and apparatus of Figures 8 and 9.
`
`_
`
`[0028]
`
`Figures 1 lA-C show alternative locks for use with replacement heart valves and
`
`anchors of this invention.
`
`[0029]
`
`Figures l2A-C show a vessel wall engaging lock for use with replacement heart
`
`valves and anchors of this invention.
`
`[0030]
`
`Figure 13 demonstrates paravalvular leaking around a replacement heart valve
`
`and anchor.
`
`[0031]
`
`Figure 14 shows a seal for use with a replacement heart valve and anchor of this
`
`invention.
`
`[0032]
`
`Figures lSA-E show alternative arrangements of seals on a replacement heart
`
`valve and anchor.
`
`[0033]
`
`Figures l6A-C 'show alternative seal designs for use with replacement heart
`
`valves and anchors.
`
`[0034]
`
`Figures 17 show an alternative anchor lock embodiment in an unlocked
`
`configuration.
`
`[0035]
`
`[0036]
`
`Figures 18A-B show the anchor lock of Figure 17 in a locked configuration.
`
`Figure 19 shows an alternative anchor deployment tool attachment and release
`
`mechanism for use with the invention.
`
`[0037]
`
`Figure 20 shows the attachment and release mechanism of Figure 19 in the
`
`process of being released.
`
`[0038]
`
`Figure 21 shows the attachment and release mechanism of Figures 19 and 20 in a
`
`released condition.
`
`[0039]
`
`Figure 22 shows an alternative embodiment of a replacement heart valve and
`I
`anchor and a deployment tool according to the invention in an undeployed configuration.
`
`[0040]
`
`Figure 23 shows the replacement heart valve and anchor of Figure 22 in a
`partially deployed configuration.
`7
`
`[0041]
`
`Figure 24 shows the replacement heart valve and anchor of Figures 22 and 23 in a
`
`more fully deployed configuration but with the deployment tool still attached.
`Figure'25 shows yet another embodiment of the delivery and deployment
`
`[0042]
`
`apparatus of the invention in use with a replacement heart valve and anchor.
`
`C:\NrPortbl\PALlBl\DH1\2430798_9.DOC
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`'6‘
`
`WSGR DOCket N0. 30207-710201
`
`Edwards Lifesciences Corporation, et al. Exhibit 1143, Page 7 of 661
`
`Edwards Lifesciences Corporation, et al. Exhibit 1143, Page 7 of 661
`
`

`

`[0043]
`I
`[0044]
`
`Figure 26 shows the delivery and deployment apparatus ofFigure 25 in the
`process of deploying a replacement heart valve and anchor.
`Figure 27 shows an embodiment of the invention employing seals at the interface
`
`of the replacement heart valve and anchor and the patient’s tissue.
`Figure 28 is a longitudinal cross-sectional view of the seal shown in Figure 27 in
`
`[0045]
`
`I
`
`compressed form.
`
`[0046]
`
`[0047]
`
`[0048]
`
`[0049]
`
`Figure 29 is a transverse cross-sectional view of the seal shown in Figure 28.
`
`Figure 30 is a longitudinal cross-sectional view of the seal shown in Figure 27 in
`
`expanded form.
`
`Figure 31 is a transverse cross-sectional view of the seal shown in Figure 30.
`
`Figure 32 shows yet another embodiment of the replacement heart valve and
`
`anchor of this invention in an undeployed configuration.
`
`[0050]
`
`Figure 33 shows the replacement heart valve and anchor of Figure 32 in a
`
`deployed configuration.
`
`I
`
`[0051]
`
`Figure 34 shows the replacement heart valve and anchor of Figures 32 and 33
`
`deployed in a patient’s heart valve.
`
`[0052]
`
`Figures 35A-H show yet another embodiment of a replacement heart valve,
`
`anchor and deployment system according to this invention.
`
`[0053]
`
`Figures 36A-E show more detail of the anchor of the embodiment shown in
`
`Figures 35A-H.
`
`[0054]
`
`Figures 37A-B show other embodiments of the replacement heart valve and
`
`anchor of the invention.
`
`[0055]
`
`Figures 38A-C illustrate a method for endovascularly replacing a patient’s
`
`diseased heart valve.
`
`[0056]
`
`Figures 39A-G are side views, partially in section, as well as an isometric view,
`
`_
`
`illustrating a method for endovascularly replacing a patient’s diseased heart valve with an
`
`embodiment of the present invention comprising a replacement valve that is not
`
`connected to the expandable anchor, the replacement valve wrapped about the anchor,
`
`illustratively by everting during deployment.
`
`C:\NrP0rtbl\PALlB1\MSK\2430798_9.DOC
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`-7-
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`WSGR Docket No. 30207-710201
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`
`Edwards Lifesciences Corporation, et al. Exhibit 1143, Page 8 of 661
`
`

`

`[0057]
`
`Figures 40A-D are side views, partially in section, illustrating a method for
`
`endovascularly replacing a patient’s diseased heart valve with another everting
`
`embodiment of the present invention.
`
`.
`
`[0058]
`
`Figures 41A-E are side views, partially in section, illustrating a method for
`
`endovascularly replacing a patient’s diseased heart valve with yet another everting
`
`embodiment of the present invention, wherein the replacement valve and the anchor are
`
`telescoped relative to one another during endovascular delivery.
`
`[0059]
`
`Figures 42A-B are side-sectional views of alternative everting apparatus
`
`comprising everting valve leaflets.
`
`[0060]
`
`Figures 43A-B, are side-sectional views of further alternative everting apparatus
`
`comprising a locking mechanism coupled to the everting segment.
`
`[0061]
`
`Figures 44A-B are side-sectional views of telescoping embodiments of the present
`
`invention comprising U-shaped valve frames.
`
`DETAILED DESCRIPTION OF THE INVENTION
`
`[0062]
`
`While preferred embodiments of the present invention have been shown and
`
`described herein, it will be obvious to those skilled in the art that such embodiments are
`
`provided by way of example only. Numerous variations, changes, and substitutions will
`now occur to those skilled in the art without departing from'the invention.
`It should be
`
`understood that various alternatives to the embodiments of the invention described herein
`
`may be employed in practicing the invention. For example, for the two-part locking
`
`mechanisms described hereinafter, it will be apparent that the locations of the male and
`
`female elements may be reversed.
`
`It is intended that the following claims define the
`
`scope of the invention and that methods and structures within the scope of these claims
`
`and their equivalents be covered thereby.
`
`[0063]
`
`With reference now to Figures 1-4, a first embodiment of replacement heart valve
`
`apparatus in accordance with the present invention is described, including a method of
`
`actively foreshortening and expanding the apparatus from a delivery configuration and to
`
`a deployed configuration. Apparatus 10 comprises replacement valve 20 disposed within
`
`and coupled to anchor 30. Figures 1 schematically illustrate individual cells of anchor 30
`
`of apparatus 10, and should be viewed as if the cylindrical anchor has been cut open and
`
`C:\NrPonbl\PALlBl\DHl\2430798_9.DOC
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`-8-
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`WSGR Docket No. 30207-710201
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`Edwards Lifesciences Corporation, et al. Exhibit 1143, Page 9 of 661
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`

`

`laid flat. Figures 2 schematically illustrate a detail portion of apparatus 10 in side-
`
`section.
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`[0064]
`
`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
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`extend within lumen 31 of anchor 30. Posts 38 preferably are spaced 120° apart from one
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`another about the circumference of anchor 30.
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`'
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`[0065]
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`Anchor 30 preferably is fabricated by using self-expanding patterns (laser cut or
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`chemically milled), braids and materials, such as a stainless steel, nickel-titanium
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`(“Nitinol”) or cobalt chromium, but alternatively may be fabricated using balloon-
`expandable patterns where the anchor is designed to plastically deform to its final shape
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`by means of balloon expansion. Replacement valve 20 is preferably made from biologic
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`tissues, e.g. porcine valve leaflets or bovine or equine pericardium tissues or human ,
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`cadaver tissue. Alternatively, it can be made from tissue engineered materials (such as
`extracellular matrix material from Small Intestinal Submucosa ($18)) or may be
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`prosthetic and made from an elastomeric polymer or silicone, Nitinol or stainless steel
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`mesh or pattern (sputtered, chemically milled or laser cut). The leaflet may also be made
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`of a composite of the elastomeric or silicone materials and metal alloys or other fibers
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`such Kevlar or carbon. Annular base 22 of replacement valve 20 preferably is coupled to
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`skirt region 34 of anchor 30, while commissures 24 of replacement valve leaflets 26 are
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`coupled to and supported by posts 38.
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`I
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`[0066]
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`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
`'
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`proximal and distal end regions of anchor 30 may be actuated independently. The anchor
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`and valve may be placed and expanded in order to visualize their location with respect to
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`the native valve and other anatomical features and to visualize operation of the valve.
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`The anchor and _valve may thereafter be repositioned and even retrieved into the delivery
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`sheath or catheter. The apparatus may be delivered to the vicinity of the patient’s aortic
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`- valve in a retrograde approach in a catheter having a diameter no more than 23 french, ~
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`preferably no more than 21 french, more preferably no more than 19 french, or more
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`preferably no more than 17 french. Upon deployment the anchor and replacement valve
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`-9-
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`WSGR Docket No. 30207-710201
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`capture the native valve leaflets and positively lock to maintain configuration and
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`position.
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`.
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`[0067]
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`A deployment tool is used to actuate, reposition, lock and/or retrieveanchor 30.
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`In order to avoid delivery of anchor 30 on a balloon for balloon expansion, a non-
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`hydraulic or non-pneumatic anchor actuator is used.
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`In this embodiment, the actuator is a
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`deployment tool that includes distal region control wires 50, control rods or tubes 60 and
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`proximal region control wires 62. Locks 40 include posts or arms 38 preferably with
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`male interlocking elements 44 extending from skirt region 34 and mating female
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`interlocking elements 42 in lip region 32. Male interlocking elements 44 have eyelets 45.
`Control wires 50 pass from a delivery system for apparatus 10 through female
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`interlocking elements 42, through eyelets 45 of male interlocking elements 44, and back
`through female interlocking elements 42, such that a-double strand of wire 50 passes
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`through each female interlocking element 42 for manipulation by a medical practitioner
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`external to the patient to actuate and control the anchor by changing the anchor’s shape.
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`Control wires 50 may comprise, for example, strands of suture.
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`[0068]
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`Tubes 60 are reversibly coupled to apparatus 10 and may be used in conjunction
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`with wires 50 to actuate anchor 30, e.g., to foreshorten and lock apparatus 10 in the fully
`deployed configuration. Tubes 60 also facilitate repositioning and retrieval of apparatus
`10, as described hereinafter. For example, anchor 30 may be foreshortened and radially
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`expanded by applying a distally directed force on tubes 60 while proximally retracting
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`wires 50. As seen in Figures 3, control wires 62 pass through interior lumens 6] of tubes
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`60. This ensures thattubes 60 are aligned properly with apparatUS 10 during deployment
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`and foreshortening. Control wires 62 can also actuate anchor 60; proximally directed
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`forces on control wires 62 contacts the proximal lip region 32 of anchor 30. Wires 62
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`also act to couple and decouple tubes 60 from apparatus 10. Wires 62 may comprise, for
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`example, strands of suture.
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`[0069]
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`Figures 1A and 2A- illustrate anchor 30 in a delivery configuration or in a partially
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`deployed configuration (e.g., after dynamic self-expansion from a constrained delivery
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`configuration within a delivery sheath). Anchor 30 has a relatively long length and a
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`relatively small width in the delivery or partially deployed configuration, as compared to
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`the foreshortened and fully deployed configuration of Figures 1B and ZB.
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`C:\NrPortbl\PALlBl\MSK\2430798_9.DOC
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`-] 0-
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`WSGR Docket No. 30207-71020]
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`[0070]
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`In Figures 1A and 2A, replacement valve 20 is collapsed within lumen 31 of
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`anchor 30. Retraction of wires 50 relative to tubes 60 foreshortens anchor 30, which
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`increases the anchor’s width while decreasing its length. Such foreshortening also
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`properly seats replacement valve 20 within lumen 31 of anchor 30. Imposed
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`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 is capable of
`
`exerting an outward radial force on surrounding tissue to engage the tissue in such way to
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`prevent migration of anchor. This outward radial force is preferably greater than 2 psi,
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`more preferably greater than 4 psi, more preferably greater than 6 psi, more preferably
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`greater than 8 psi, more preferably greater than 10 psi, more preferably greater than 20
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`psi, or more preferably greater than 30 psi. Enhanced radial force of the anchor is also
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`important for enhanced crush resistance of the anchor against the surrounding tissue due
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`to the healing response (fibrosis and contraction of annulus over a longer period of time)
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`or to dynamic changes of pressure and flow at each heart beat. In an alternative
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`embodiment, the anchor pattern or braid is designed to have gaps or areas where the
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`native tissue is allowed to protrude through the anchor slightly (not shown) and, as the
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`foreshortening is applied, the tissue and anchor become intertwined and immobilized.
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`This feature would provide additional means to prevent anchor migration and enhance
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`long-term stability of the device.
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`-
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`[0071]
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`Deployment of apparatus 10 is fully reversible until lock 40 has been locked via
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`mating of male interlocking elements 44 with female interlocking elements 42.
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`Deployment is then completed by decoupling tubes 60 from lip section 32 of anchor 30
`by retracting one end of each wire 62 relative to the other end of the wire, and by
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`retracting one end of each wire 50 relative to the other end of the ‘wire until each wire has
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`'
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`‘ [0072]
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`been removed from eyelet 45 of its corresponding male interlocking element 44.
`As best seen in Figure 28, body region 36 of anchor 30 optionally may comprise
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`barb elements 37 that protrude from anchor 30 in the fully deployed configuration, for
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`example, for engagement of a patient’s native valve leaflets and to preclude migration of
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`the apparatus.
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`[0073]
`
`With reference now to Figures 3, a delivery and deployment system for a self-
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`expanding embodiment of apparatus 10 including a sheath 110 having a lumen 112. Self-
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`C:\NrPortbl\PALlB l\MSK\2430798_9.DOC
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`-1 1-
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`WSGR Docket No. 30207-7l0.201
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`expanding anchor 30 is collapsible to a delivery configuration within lumen 112 ofsheath
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`' 110, such that apparatus 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
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`apparatus 10, control'wires 50 and tubes 60, which causes anchor 30 to dynamically self—
`expand to a partially deployed configuration. Control wires 50 then are retracted relative
`
`to apparatus 10 and tubes 60 to impose foreshortening upon anchor 30, as seen in Figure
`
`3B.
`
`[0074]
`
`I
`
`1 During foreshortening, tubes 60 push against lip region 32 of anchor 30, while
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`wires 50 pull on posts 38 of the anchor. Wires 62 may be retracted along with wires 50
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`to enhance the distally directed pushing force applied by tubes 60 to lip region 32.
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`Continued retraction of wires 50 relative to tubes 60 would lock locks 40 and fully
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`deploy apparatus 10 with replacement valve 20 properly seated within anchor 30, as in
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`FigureslB and 2B. Apparatus 10 comprises enhanced radial strength in the fully
`
`deployed configuration as compared to the partially deployed configuration of Figure 3A.
`Once apparatus 10 has been fully deployed, wires 50 and 62 may be removed from
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`apparatus 10, thereby s