(19) United States
`(12) Patent Application Publication (10) Pub. No.: US 2005/0283231 A1
`(43) Pub. Date:
`Dec. 22, 2005
`Haug et al.
`
`US 20050283231A1
`
`(54) EVERTING HEART VALVE
`
`(57)
`
`ABSTRACT
`
`(76) Inventors: Ulrich R. Haug, Campbell, CA (US);
`Hans F. Valencia, Berkeley, CA (US);
`Robert A. Geshlider, San Francisco,
`CA (US); Torn Saul, El Granada, CA
`(US); Amr Salahieh, Saratoga, CA
`(US); Dwight P. Morejohn, Davis, CA
`(US); Kenneth J. Michlitsch,
`Livermore, CA (US)
`
`Correspondence Address:
`WILSON SONSINI GOODRICH & ROSATI
`650 PAGE MILL ROAD
`PALO ALTO, CA 94304-1050 (US)
`
`(21) Appl. No.:
`
`10/870,340
`
`(22) Filed:
`
`Jun. 16, 2004
`
`Publication Classi?cation
`
`(51) rm.c1.7 ...................................................... ..A61F 2/24
`(52) U.S. c1. ....................... .. 623/211; 623/238; 623/900
`
`The present invention provides methods and apparatus for
`endovascularly replacing a patient’s heart valve. The appa
`ratus includes a replacement valve and an expandable
`anchor con?gured for endovascular delivery to a vicinity of
`the patient’s heart valve. In some embodiments, the replace
`ment valve is adapted to Wrap about the anchor, for example,
`by everting during endovascular deployment. In some
`embodiments, the replacement valve is not connected to
`expandable portions of the anchor. In some embodiments,
`the anchor is con?gured for active foreshortening during
`endovascular deployment. In some embodiments, the anchor
`includes expandable lip and skirt regions for engaging the
`patient’s heart valve during deployment. In some embodi
`ments, the anchor comprises a braid fabricated from a single
`strand of Wire. In some embodiments, the apparatus includes
`a lock con?gured to maintain anchor expansion. The inven
`tion also includes methods for endovascularly replacing a
`patient’s heart valve. In some embodiments, the method
`includes the steps of endovascularly delivering a replace
`ment valve and an expandable anchor to a vicinity of the
`heart valve, Wrapping at least a portion of the replacement
`valve about the anchor, and expanding the anchor to a
`deployed con?guration.
`
`Edwards Lifesciences Corporation, et al. Exhibit 1135, Page 1 of 78
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`Edwards Lifesciences Corporation, et al. Exhibit 1135, Page 57 of 78
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`Patent Application Publication Dec. 22, 2005 Sheet 57 0f 63
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`Patent Application Publication Dec. 22, 2005 Sheet 58 0f 63
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`Patent Application Publication Dec. 22, 2005 Sheet 59 of 63
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`Edwards Lifesciences Corporation, et al. Exhibit 1135, Page 60 of 78
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`Patent Application Publication Dec. 22, 2005 Sheet 60 of 63
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`Edwards Lifesciences Corporation, et al. Exhibit 1135, Page 61 of 78
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`Patent Application Publication Dec. 22, 2005 Sheet 61 of 63
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`Edwards Lifesciences Corporation, et al. Exhibit 1135, Page 62 of 78
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`Edwards Lifesciences Corporation, et al. Exhibit 1135, Page 63 of 78
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`Edwards Lifesciences Corporation, et al. Exhibit 1135, Page 63 of 78
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`Edwards Lifesciences Corporation, et al. Exhibit 1135, Page 64 of 78
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`Edwards Lifesciences Corporation, et al. Exhibit 1135, Page 64 of 78
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`

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`US 2005/0283231 A1
`
`Dec. 22, 2005
`
`EVERTING HEART VALVE
`
`BACKGROUND OF THE INVENTION
`
`[0001] The present invention relates to methods and appa-
`ratus 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 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.
`
`[0002] Heart valve surgery is used to repair or replace
`diseased heart valves. Valve surgery is an open-heart pro-
`cedure conducted under general anesthesia. An incision is
`made through the patient’s sternum (sternotomy), 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.
`
`In recent years, advancements in minimally inva-
`[0006]
`sive surgery and interventional cardiology have encouraged
`some investigators to pursue percutaneous replacement of
`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 pro-
`[0007]
`cedure, accurate placement of aortic valves relative to coro-
`nary 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 standard self-expanding systems, how-
`ever, 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 plasti-
`cally 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. There-
`fore, 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 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.
`
`In view of drawbacks associated with previously
`[0010]
`known techniques for endovascularly replacing a heart
`valve, it would be desirable to provide methods and appa-
`ratus that overcome those drawbacks.
`
`SUMMARY OF THE INVENTION
`
`[0011] One aspect of the present invention provides appa-
`ratus for endovascularly 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.
`
`[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: endovascu-
`larly 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 appa-
`ratus 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.
`
`Edwards Lifesciences Corporation, et al. Exhibit 1135, Page 65 of 78
`
`Edwards Lifesciences Corporation, et al. Exhibit 1135, Page 65 of 78
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`US 2005/0283231 A1
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`Dec. 22, 2005
`
`[0014] Still another aspect of the present invention pro-
`vides 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 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 under-
`standing 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:
`
`[0018] FIGS. 1A-B are elevational views of a replacement
`heart valve and anchor according to one embodiment of the
`invention.
`
`[0019] FIGS. 2A-B are sectional views of the anchor and
`valve of FIG. 1.
`
`[0020] FIGS. 3A-B show delivery and deployment of a
`replacement heart valve and anchor, such as the anchor and
`valve of FIGS. 1 and 2.
`
`[0021] FIGS. 4A-F also show delivery and deployment of
`a replacement heart valve and anchor, such as the anchor and
`valve of FIGS. 1 and 2.
`
`[0022] FIGS. 5A-F show the use of a replacement heart
`valve and anchor to replace an aortic valve.
`
`[0023] FIGS. 6A-F show the use of a replacement heart
`valve and anchor with a positive registration feature to
`replace an aortic valve.
`
`[0024] FIG. 7 shows the use of a replacement heart valve
`and anchor with an alternative positive registration feature to
`replace an aortic valve.
`
`[0025] FIGS. 8A-C show another embodiment of a
`replacement heart valve and anchor according to the inven-
`tion.
`
`[0026] FIGS. 9A-H show delivery and deployment of the
`replacement heart valve and anchor of FIG. 8.
`
`[0028] FIGS. 11A-C show alternative locks for use with
`replacement heart valves and anchors of this invention.
`
`[0029] FIGS. 12A-C show a vessel wall engaging lock for
`use with replacement heart valves and anchors of this
`invention.
`
`[0030] FIG. 13 demonstrates paravalvular leaking around
`a replacement heart valve and anchor.
`
`[0031] FIG. 14 shows a seal for use with a replacement
`heart valve and anchor of this invention.
`
`[0032] FIGS. 15A-E show alternative arrangements of
`seals on a replacement heart valve and anchor.
`
`[0033] FIGS. 16A-C show alternative seal designs for use
`with replacement heart valves and anchors.
`
`[0034] FIG. 17 show an alternative anchor lock embodi-
`ment in an unlocked configuration.
`
`[0035] FIGS. 18A-B show the anchor lock of FIG. 17 in
`a locked configuration.
`
`[0036] FIG. 19 shows an alternative anchor deployment
`tool attachment and release mechanism for use with the
`invention.
`
`[0037] FIG. 20 shows the attachment and release mecha-
`nism of FIG. 19 in the process of being released.
`
`[0038] FIG. 21 shows the attachment and release mecha-
`nism of FIGS. 19 and 20 in a released condition.
`
`[0039] FIG. 22 shows an alternative embodiment of a
`replacement heart valve and anchor and a deployment tool
`according to the invention in an undeployed configuration.
`
`[0040] FIG. 23 shows the replacement heart valve and
`anchor of FIG. 22 in a partially deployed configuration.
`
`[0041] FIG. 24 shows the replacement heart valve and
`anchor of FIGS. 22 and 23 in a more fully deployed
`configuration but with the deployment tool still attached.
`
`[0042] FIG. 25 shows yet another embodiment of the
`delivery and deployment apparatus of the invention in use
`with a replacement heart valve and anchor.
`
`[0043] FIG. 26 shows the delivery and deployment appa-
`ratus of FIG. 25 in the process of deploying a replacement
`heart valve and anchor.
`
`[0044] FIG. 27 shows an embodiment of the invention
`employing seals at the interface of the replacement heart
`valve and anchor and the patient’s tissue.
`
`[0045] FIG. 28 is a longitudinal cross-sectional view of
`the seal shown in FIG. 27 in compressed form.
`
`[0046] FIG. 29 is a transverse cross-sectional view of the
`seal shown in FIG. 28.
`
`[0047] FIG. 30 is a longitudinal cross-sectional view of
`the seal shown in FIG. 27 in expanded form.
`
`[0048] FIG. 31 is a transverse cross-sectional view of the
`seal shown in FIG. 30.
`
`[0027] FIG. 10 is a cross-sectional drawing of the delivery
`system used with the method and apparatus of FIGS. 8 and
`9.
`
`[0049] FIG. 32 shows yet another embodiment of the
`replacement heart valve and anchor of this invention in an
`undeployed configuration.
`
`Edwards Lifesciences Corporation, et al. Exhibit 1135, Page 66 of 78
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`Edwards Lifesciences Corporation, et al. Exhibit 1135, Page 66 of 78
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`US 2005/0283231 A1
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`Dec. 22, 2005
`
`[0050] FIG. 33 shows the replacement heart valve and
`anchor of FIG. 32 in a deployed configuration.
`
`[0051] FIG. 34 shows the replacement heart valve and
`anchor of FIGS. 32 and 33 deployed in a patient’s heart
`valve.
`
`[0052] FIGS. 35A-H show yet another embodiment of a
`replacement heart valve, anchor and deployment system
`according to this invention.
`
`[0053] FIGS. 36A-E show more detail of the anchor of the
`embodiment shown in FIGS. 35A-H.
`
`[0054] FIGS. 37A-B show other embodiments of the
`replacement heart valve and anchor of the invention.
`
`[0055] FIGS. 38A-C illustrate a method for endovascu-
`larly replacing a patient’s diseased heart valve.
`
`[0056] FIGS. 39A-G are side views, partially in section, as
`well as an isometric view, illustrating a method for endo-
`vascularly replacing a patient’s diseased heart valve with an
`embodiment of the present invention comprising a replace-
`ment valve that is not connected to the expandable anchor,
`the replacement valve wrapped about the anchor, illustra-
`tively by everting during deployment.
`
`[0057] FIGS. 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] FIGS. 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] FIGS. 42A-B are side-sectional views of alterna-
`tive everting apparatus comprising everting valve leaflets.
`
`[0060] FIGS. 43A-B, are side-sectional views of further
`alternative everting apparatus comprising a locking mecha-
`nism coupled to the everting segment.
`
`[0061] FIGS. 44A-B are side-sectional views of telescop-
`ing embodiments of the present
`invention comprising
`U-shaped valve frames.
`
`DETAILED DESCRIPTION OF THE
`INVENTION
`
`[0062] While preferred embodiments of the present inven-
`tion 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
`
`th