Percutaneous transcatheter repair of heart valves via trans-apical access

WO 2012/167095 PCT/US2012/040481

PERCUTANEOUS TRANSCATHETER REPAIR OF HEART VALVES VIATRANS-APICAL ACCESS

Technical Field [0001] The present disclosure relates to treating and repairing heart valves, andspecifically to apparatus, systems, and methods for percutaneous transcatheterdelivery and fixation of annuloplasty rings to repair heart valves. Disclosedembodiments are configured to be delivered through a catheter using a trans-apicalapproach.

Background Information [0002] Heart valve defects, such as regurgitation, may be caused by a relaxationof the tissue surrounding a heart valve (e.g., the mitral valve or tricuspid valve). Thiscauses the valve opening to enlarge, which prevents the valve from sealing properly.Such heart conditions are commonly treated by a procedure during which anannuloplasty ring is fixed or secured around the valve. Cinching or securing thetissue to the ring can restore the valve opening to its approximate original size andoperating efficiency.

[0003] Typically, annuloplasty rings have been implanted during open heartsurgery, so the annuloplasty ring can be sewn into the valve annulus. Open heartsurgery is a highly invasive procedure that requires connecting a heart and lungmachine (to pump the patient’s blood and breathe for the patient), stopping thepatient’s heart, and cutting open the thoracic cavity and heart organ. The procedurecan expose the patient to high risk of infection and may result in a long and difficultrecovery. The recovery can be particularly difficult for patients in less than optimalhealth due to the effects of suffering from a heart valve defect such as regurgitation.

Summary of the Disclosure [0004] Disclosed herein are apparatus, systems, and methods for repairing heartvalves through percutaneous transcatheter delivery and fixation of annuloplasty ringsto heart valves via trans-apical access of the heart.

[0005] In certain embodiment, methods are disclosed for repairing a target heartvalve through percutaneous transcatheter delivery and fixation of an annuloplastyring to the annulus of the target heart valve via trans-apical access to the heart. Aguiding sheath may be introduced into a ventricle of the heart through an access siteat an apex of the heart. A distal end of the guiding sheath may be positionedretrograde through the target valve. The distal end and a distal portion of the guiding WO 2012/167095 PCT/US2012/040481 sheath are positioned within the atrium of the heart. An annuloplasty ring arrangedin a compressed delivery geometry is inserted into the guiding sheath. Theannuloplasty ring is positioned in the distal portion of the guiding sheath within theatrium of the heart. The distal end of the guiding sheath is retracted back throughthe heart valve and into the ventricle of the heart, thereby exposing the annuloplastyring. The annuloplasty ring may be expanded from the delivery geometry to anoperable geometry. Anchors of the annuloplasty ring may be deployed. Theanchors may be configured to be pressed into and engage tissue of the annulus ofthe target valve. The guiding sheath can then be retracted from the access site ofthe heart.

[0006] In certain embodiments, a segmented annuloplasty ring may be arrangedin a compressed delivery geometry. The annuloplasty ring may be compressedaround a balloon assembly comprising an upper balloon, a lower balloon, a doublelumen shaft, and a recess configured to accommodate the annuloplasty ring in thecompressed delivery geometry. The upper balloon may define an upper surface ofthe recess and the lower balloon may define a lower surface of the recess. Thedouble lumen shaft may have a first lumen coupled to and configured to direct a fluidor gas into the upper balloon from outside the heart and may have a second lumencoupled to and configured to direct a fluid or gas into the lower balloon from outsidethe heart. The annuloplasty ring and at least the upper balloon of the balloonassembly may be positioned through the guiding sheath and within the distal portionof the guiding sheath positioned within the atrium of the heart. The distal end of theguiding sheath may be retracted back through the heart valve and into the ventricleof the heart, thereby exposing the upper balloon, the lower balloon, the recess of theballoon assembly, and the annuloplasty ring. The upper balloon of the annuloplastyring may be inflated, at least partially, to a diameter larger than the diameter of theannulus of the target valve. The lower balloon of the balloon assembly may beinflated, at least partially, to expand the annuloplasty ring from the delivery geometryto an operable geometry. The balloon assembly may be retracted to position theannuloplasty ring planar to a plane of the annulus of the target valve on an atrialsurface of the annulus, such that the inflated upper balloon presses the annuloplastyring against the annulus of the target valve.

[0007] In certain embodiments, annuloplasty rings are disclosed that include anouter hollow member including a plurality of segments. Adjacent segments 2 WO 2012/167095 PCT/US2012/040481 cooperate with one another to allow the annuloplasty ring to expand from acompressed delivery geometry to an expanded operable geometry. Theannuloplasty ring also includes an internal anchor member located at least partiallywithin the outer hollow member. The internal anchor member includes a plurality ofanchors configured to attach the annuloplasty ring to tissue of a heart valve annulus.The internal anchor member is configured to move the plurality of anchors withrespect to a plurality of windows in the outer hollow member to selectively deploy theplurality of anchors through the respective windows.

[0008] In certain other embodiments, an annuloplasty ring includes anchors andone or more sutures attached to eyelets in the anchors. The one or more suturesmay be configured to connect to the anchors through the guiding sheath. Deployingthe anchors of the annuloplasty ring includes pulling one or more sutures as theannuloplasty ring is pressed against the target valve annulus. Pulling the one ormore sutures may cause the anchors to deploy and/or engage the tissue of theannulus of the target valve.

Brief Description ofthe Drawings [0009] Understanding that drawings depict only certain embodiments and are nottherefore considered to be limiting in nature, non-limiting and non-exhaustiveembodiments of the disclosure are described and explained with additionalspecificity and detail through the use ofthe accompanying drawings.

[0010] FIG. 1A illustrates a cross-sectional view of a heart accessed by a sheathvia a trans-apical approach according to one embodiment.

[0011] FIG. 1B illustrates a side view of a balloon assembly being deliveredthrough a guiding sheath inserted into a ventricle of the heart via a trans-apicalaccess according to one embodiment.

[0012] Fl G. 1C illustrates a cross-sectional top view of the balloon assemblywithin the guiding sheath, portraying a delivery configuration of an annuloplasty ringaccording to one embodiment.

[0013] FIG. 1D illustrates a cross-sectional top view of the balloon assemblywithin the guiding sheath, portraying a delivery configuration of an annuloplasty ringaccording to another embodiment.

[0014] FIG. 2 illustrates the guiding sheath retracted through the target valveexposing the balloon assembly of FIG. 1B. 3 WO 2012/167095 FCT/US2012/040481 [0015] FIG. 3 illustrates the balloon assembly of FIG. 1B with the upper ballooninflated.

[0016] FIG. 4 illustrates an upper balloon of the balloon assembly of FIG. 1Binflated and retracted to guide and/or secure the position of the annuloplasty ringrelative to the annulus of the target valve.

[0017] FIG. 5 illustrates the upper balloon and a lower balloon of the balloonassembly of FIG. 1B inflated to expand a diameter of the annuloplasty ring, [0018] FIG. 6 illustrates deployment of the anchors of the annuloplasty ring of theballoon assembly of FIG. 1B.

[0019] FIG. 7 illustrates anchoring of the annuloplasty ring of FIG. 1B.

[0020] FIG. 8 illustrates the annuloplasty ring of FIG. 1B anchored into theannulus of the target valve, the balloon assembly, guiding sheath, and guidewireremoved, and the heart access site closed.

[0021] FIGS. 9A, 9B, and 9C are a flow diagram of a method for repairing a targetheart valve through percutaneous transcatheter delivery and fixation of anannuloplasty ring to the target heart valve via trans-apical access of the heartaccording to one embodiment.

[0022] FIG. 10 illustrates an annuloplasty ring anchor deployment systemaccording to one embodiment.

[0023] FIG. 11 is a simplified schematic diagram illustrating a perspective view ofa segmented annuloplasty ring according to one embodiment.

[0024] FIGS. 11A and 11B are schematic diagrams illustrating a shape memoryhypotube cut to form a plurality of segments for use as an outer tube of a segmentedannuloplasty ring according to one embodiment.

[0025] FIG. 11C is a schematic diagram illustrating a cutting pattern used forlaser processing the hypotube shown in FIGS. 11A and 11B.

[0026] FIG. 12A is a simplified schematic diagram illustrating a side view of aninternal anchor ribbon including the curved anchors shown in FIG. 11 according toone embodiment.

[0027] FIG. 12B is a schematic diagram illustrating a top view of the anchors cutinto the internal anchor ribbon shown in FIG. 12A in an elongate geometry accordingto one embodiment. 4 WO 2012/167095 PCT/US2012/040481 [0028] FIG. 12C is a schematic diagram illustrating a side view of the interna!anchor ribbon in an elongate geometry and the anchors in a curled or curveddeployed configuration according to one embodiment.

[0029] FIG. 12D is a schematic diagram illustrating a top view of an interna! glide ribbon shown in FIG. 12A in an elongate geometry according to one embodiment.

[0030] F!G. 12E is a schematic diagram illustrating a side view of the internalglide ribbon shown in FIG. 12D.

[0031] FIGS. 13A and 13B are simplified schematics illustrating cross-sectionside views of an annuioplasty ring before (FIG. 13A) and after (FIG. 13B)deployment of the anchors shown in FIG. 12C according to one embodiment.

[0032] FIG. 14A is a schematic diagram illustrating a perspective view of a portionof the annuioplasty ring shown in FIGS. 13A and 13B with a deployed curved anchoraccording to one embodiment.

[0033] FIG. 14B is a schematic diagram illustrating a side view of a portion of theannuioplasty ring shown in FIG. 14A.

[0034] FIG. 15 is a simplified schematic diagram illustrating a side view of theinternal glide ribbon shown in FIG. 12A used as a selectively adjustable memberaccording to one embodiment.

[0035] FIGS. 15A, 15B, and 15C are schematic diagrams of circuitry for using RFinduction to activate the shape memory material of the internal glide ribbonaccording to one embodiment.

[0036] FIG. 16A is a schematic diagram illustrating a perspective view of asegmented annuioplasty ring including a plurality of linear anchors according to oneembodiment.

[0037] FIG. 16B is a schematic diagram illustrating a side view of a portion of theannuioplasty ring shown in FIG. 16A.

[0038] FIG. 17 is a simplified schematic diagram illustrating a side view of aninternal anchor member including linear anchors according to one embodiment.

[0039] FIG. 18A is a schematic diagram illustrating an enlarged perspective viewof a single-barbed anchor of a percutaneous transcatheter annuioplasty ring in anaffixation configuration according to one embodiment.

[0040] FIG. 18B is a schematic diagram of an enlarged perspective view of adual-barbed anchor of a percutaneous transcatheter annuioplasty ring in anaffixation configuration according to one embodiment. 5 WO 2012/167095 PCT/US2012/040481 [0041] FIG. 19 is a simplified schematic diagram illustrating a side view of theinternal anchor member shown in FIG. 17 and a selectively adjustable memberaccording to one embodiment.

[0042] FIG. 20 is a schematic diagram illustrating a partial cross-sectional view ofthe selectively adjustable member shown in FIG. 19 according to one embodiment.

[0043] FIG. 21A is a schematic diagram illustrating a percutaneous transcatheterannuloplasty ring according to another embodiment.

[0044] FIG. 21B is a schematic diagram illustrating an enlarged side view of theannuloplasty ring of FIG. 21A according to one embodiment.

[0045] FIG. 21C is a schematic diagram of the annuloplasty ring of FIG. 21A withthe anchors in an affixation configuration protruding away from the annuloplasty ringaccording to one embodiment.

Detailed Description of Preferred Embodiments [0046] The present disclosure provides apparatus, systems, and methods forrepairing heart valves through percutaneous transcatheter delivery and fixation ofannuloplasty rings to heart valves via trans-apical access of the heart. Anannuloplasty ring that may be flexible and/or segmented can be configured in both acompressed delivery geometry that can be inserted into, and delivered through, acatheter tube and an expanded operable geometry providing a curved and rigid orsemi-rigid annular shape. In certain embodiments, an annuloplasty ring may bedelivered percutaneously to the mitral and/or tricuspid valve annulus of the heart viaa trans-apical approach through a thoracotomy.

[0047] Certain annuloplasty rings disclosed herein are small and flexible enoughto be percutaneously delivered into the heart through a catheter, and can be put intoa rigid or semi-rigid ring shape and then securely anchored into the heart valveannulus. Disclosed embodiments enable trans-apical delivery methods and providefor anchoring and cinching the annuloplasty ring around the valve annulus.

[0048] FIG. 1A is a schematic diagram illustrating an example trans-apicalapproach for inserting an annuloplasty ring (not shown) through the mitral valve 15 ofa heart 10 according to one embodiment. In this example, a guiding sheath 104 isshown passing through an access site 11 at the apex 30 of the heart 10, through theleft ventricle LV, through the mitral valve 15, and into the left atrium LA. Theannuloplasty ring may be delivered through the catheter 104 into the left atrium LAand anchored to an annulus of the mitral valve 15. In one embodiment, a needle or 6 WO 2012/167095 PCT/US2012/040481 trocar may be used to puncture through the apex 30 to create a small openingthrough which a guidewire (not shown) can be inserted through the left ventricle LVinto the left atrium LA. Then, the guidewire may be used to guide successivelylarger and stiffer catheters so as to gradually increase the size of the opening in theapex 30 of the heart 10.

[0049] As can be appreciated, a trans-apical approach to accessing the heart canbe used to access other chambers of the heart, including, for example, the rightventricle RV and right atrium RA. Accordingly, subsequent figures do not depict theentire heart, but rather they merely depict a ventricle and an atrium. A person havingordinary skill in the art appreciates that the ventricle and atrium shown can be anytwo chambers of any heart that are separated by a valve, and that the valve can beaccessed from a tip or apex of the heart proximate to the more “down-flow” of thetwo chambers of the heart.

[0050] FIG. 1B illustrates a partial sectional side view of a balloon assembly 106,including an annuioplasty ring 114, being delivered via a trans-apical access site 11,according to one embodiment. A patient’s heart 10 may be exposed minimallyand/or visibly via a small thoracotomy, and the apex of the heart may be pierced witha needle to allow introduction of a guidewire 102. The guidewire 102 may beinserted through a ventricle chamber 12 of the heart 10, through a target valve 16 ofthe heart 10, and into an atrium 14 chamber of the heart 10. A guiding sheath 104can be inserted over the guidewire 102 and also into the atrium chamber 14 of theheart 10. The size of the guiding sheath 104 may be, for example, betweenapproximately 18 Fr and 24 Fr (approximately 6 mm to 8 mm) in diameter toaccommodate the balloon assembly 106. As shown, the guiding sheath 104 may bepositioned retrograde through leaflets 18 of the target valve 16.

[0051] The balloon assembly 106 can be inserted over the guidewire 102 andthrough the guiding sheath 104. The balloon assembly 106 may include a shaft 108,an upper balloon 110, and a lower balloon 112. A recess 111 (or narrow waist)between the upper balloon 110 and the lower balloon 112 accommodates andsecures the annuioplasty ring 114 on the balloon assembly 106. In FIG. 1B, theannuioplasty ring 114 is in a compressed delivery geometry around the recess 111of the balloon assembly 106. In the delivery geometry, the plane of the annuioplastyring 114 may be transverse to a major axis of the guiding sheath 104 andsubstantially parallel to a plane of an annulus 20 of the target valve 16. 7 WO 2012/167095 PC T/IJS2012/040481 [0052] FIG. 1C illustrates a cross-sectional view of the balloon assembly 106 ofFIG. 1B within the guiding sheath 104, according to one embodiment. FIG. 1Cportrays a delivery configuration of the annuloplasty ring 114 positioned in the recess111 of the balloon assembly 106 as it is delivered through the guiding sheath 104.The annuloplasty ring 114 may be segmented to enable it to fold over itself aroundthe balloon assembly 106 in a delivery geometry. The annuloplasty ring 114 may becompressed and folded within a plane transverse to a longitudinal axis of the guidingsheath 104.

[0053] FIG. 1C also depicts a cross-section of the shaft 108 of the balloonassembly 106. The shaft 108 includes a guidewire lumen 116 and a double inflationlumen 118. The guidewire lumen 116 of the balloon assembly 106 is over theguidewire 102. The double inflation lumen 118 includes an upper balloon inflationportion 118a and a lower balloon inflation portion 118b. The double inflation lumen118 may allow the upper balloon (see FIG. 1B) and the lower balloon 112 to beseparately inflated. The annuloplasty ring is positioned around the shaft 108 andportions of the lower balloon 112, in the recess 111 of the balloon assembly 106.For sake of clarity, only a portion of the lower balloon 112 is shown.

[0054] In another embodiment, a portion of an upper balloon may be positionedwithin the recess 111 and configured to expand when inflated to expand theannuloplasty ring. In another embodiment, the lower balloon inflation portion 118bmay end below the recess 111, such that it would not be visible in the cross-sectionof FIG. 1C. As can be appreciated, other configurations of a double inflation lumenare possible.

[0055] In another embodiment, the balloon assembly 106 comprises a singleballoon including an upper balloon portion (e.g., upper balloon 110 shown in FIG.1B) and a lower balloon portion (e.g., lower balloon 112 shown in FIG. 1B) that aremore pliant than a recess portion (e.g., recess 111 shown in FIG. 1B) of the balloon.The recess portion may be more rigid (e.g., formed of a thicker portion of materialforming the balloon assembly 106) than the upper balloon and lower balloonportions. A single inflation lumen 118 may be used to inflate both the upper balloonportion of the balloon assembly 106 and the lower balloon portion of the balloonassembly 106. The more pliant upper and lower balloon portions may be configuredto inflate more readily than the recess portion and, thus, may inflate more rapidlyand/or readily than (e.g., before or prior to) the recess portion. Inflation (and 8 WO 2012/167095 PCT/US2012/040481 expansion) of the upper balloon portion more rapidly than inflation (and expansion)of the recess portion may restrict distal shifting of the annuloplasty ring relative to therecess portion, for example, as the delivery assembly is advanced and positioned ina target valve. Similarly, inflation (and expansion) of the lower balloon portion morerapidly than inflation (and expansion) of the recess portion may restrict proximalshifting of the annuloplasty ring relative to the recess as the delivery assembly isadvanced and positioned in the target valve. Inflation of the balloon assembly maycause expansion of the upper balloon portion and the lower balloon portion initially,and eventually expansion of the recess portion. Expansion of the recess portionmay expand the annuloplasty ring from the compressed delivery geometry to anexpanded operable geometry.

[0056] FIG. 1D illustrates a cross-sectional top view of the balloon assemblywithin the guiding sheath 104, portraying a delivery geometry of an annuloplasty ring114’, according to another embodiment. In the embodiment of FIG. 1D, theannuloplasty ring 114’ is configured to have two ends that are separated andconfigured to snap together to form the ring-shape of the annuloplasty ring 114’.Because the ends are separated, the annuloplasty ring, in the compressed deliverygeometry, can be wound around the shaft 108 of the balloon assembly and withinthe recess 111 in a spiral fashion, as shown. The annuloplasty ring 114’ iscompressed (e.g., wound in a spiral) within a plane transverse to a longitudinal axisof the guiding sheath 104. The annuloplasty ring 114' may be formed of a shapememory material configured to restrict expansion of the annuloplasty ring 114’beyond a shape that would allow undesired disconnection or separation from therecess 111 of the balloon assembly.

[0057] FIGS. 1C and 1D provide example embodiments of an annuloplasty ringand a delivery geometry. A person having ordinary skill in the art appreciates thatother delivery geometries are possible.

[0058] FIG. 2 illustrates the guiding sheath 104 retracted back through the targetvalve 16 to expose the balloon assembly 106. The upper balloon 110, the lowerballoon 112 and the recess 111, in which the annuloplasty ring 114 is disposed, areexposed outside of and distal to the distal end of the guiding sheath 104. Theguiding sheath 104 may be retracted, but not removed from the heart 10 during theprocedure to provide a channel by which the balloon assembly 106 can be removed 9 WO 2012/167095 PCT/US2012/040481 from the heart 10 and to maintain access to the target vaive 16 should theannuloplasty ring 114 need to be retrieved during the procedure.

[0059] FIG. 3 illustrates the balloon assembly 106 of FIG. 1B with the upperballoon 110 inflated. The upper balloon 110 may be inflated first to secure theposition of the annuloplasty ring 114 relative to the target valve 16. Inflation of theupper balloon 110 may limit undesired shifting of the annuloplasty ring 114 in a distaldirection (toward the end of the balloon assembly and further into the atrium 14),particularly during anchoring of the annuloplasty ring 114, Furthermore, inflation ofthe upper balloon 110 may prevent the annuloplasty ring 114 from popping off (orsimilarly separating from) the balloon assembly 106 during expansion of theannuloplasty ring 114, so that the annuloplasty ring 114 cannot be inadvertentlyseparated from the balloon assembly 106 prior to anchoring and left to floatundesirably in the atrium 14 of the heart 10. Inflation of the upper balloon 110 maybe sufficient such that a size (e.g. diameter) of the upper balloon 110 provides asurface to allow a practitioner to pull back on the balloon assembly 106 withoutdrawing the balloon assembly 106 through the target valve 16.

[0060] Inflation of the upper balloon 110 to a size larger than the diameter of theannulus of the target valve allows the practitioner to exert a force against the atrialsurface of the annulus 20 of the target valve 16. The practitioner can pull back theupper balloon 110 of the balloon assembly 106 against the annulus 20, enabling apositioning force to be applied to the annuloplasty ring 114. The positioning forcecan be applied by a practitioner to determine proper positioning of the annuloplastyring 114 for anchoring. The positioning force against the annuloplasty ring 114 mayalso press the annuloplasty ring 114 against the annulus 20 and prevent undesiredshifting of the annuloplasty ring 114 during anchoring.

[0061] FIG. 4 illustrates the upper balloon 110 of the balloon assembly 106 ofFIG. 1B inflated to secure the position of the annuloplasty ring 114 relative to theannulus 20 of the target valve 16 and the balloon assembly 106 retracted such thatthe annuloplasty ring 114 is positioned at the level of the annulus 20 of the targetvalve 16. The annuloplasty ring 114 is oriented so as to be planar to the plane Pv ofthe target valve 16, on the atrial surface of the target valve 16. The upper balloon110 and the annuloplasty ring 114 are positioned within the atrium 14 of the heart,above the target valve 16. As illustrated, the inflated upper balloon 110 may restrictproximal movement of the balloon assembly with respect to the target valve 16. 10 WO 2012/167095 PCT/US2012/040481

Movement of the inflated upper balloon 110 through the target valve 16 may beimpeded by the size of the inflated upper balloon 110 relative to a diameter of theannulus 20 of the target valve 16.

[0062] The lower balloon 112 can be inflated to expand the annuloplasty ring 114from the compressed delivery geometry to an expanded operable geometry. FIG. 5illustrates the upper balloon 110 and the lower balloon 112 of the balloon assembly106 of FIG. 1B partially inflated to expand the annuloplasty ring 114. The upperballoon 110 and lower balloon 112 may be further expanded together to furthertransition the annuloplasty ring 114 from the delivery geometry to the operablegeometry. Inflation of the balloons 110, 112 may increase the circumference of therecess 111, causing the annuloplasty ring 114 to, for example, unfold or otherwiseexpand. In certain other embodiments, the annuloplasty ring 114 may compriseshape memory material configured to automatically transition (or spring) back to anoperable geometry upon retraction of the guide catheter past the annuloplasty ring114.

[0063] FIG. 6 illustrates deployment of anchors 602 of the annuloplasty ring 114.The anchors 602 may be barbed prongs configured to protrude from theannuloplasty ring 114. In certain embodiments, the anchors 602 may be deployedautomatically as the annuloplasty ring 114 expands, similar to one or moreembodiments of annuloplasty rings discussed below. In certain other embodiment,the anchors 602 may be deployed by a practitioner, similar to one or moreembodiments of annuloplasty rings discussed below.

[0064] FIG. 7 illustrates anchoring of the annuloplasty ring of FIG. 1B. The upperballoon 110 and the lower balloon 112 may be further inflated to further expand theannuloplasty ring 114 and drive the anchors 602 into the tissue of the annulus 20.As can be appreciated, in other embodiments, inflation of either the upper balloon110 or the lower balloon 112 alone may be sufficient to expand the annuloplasty ring114.

[0065] FIG. 8 illustrates the annuloplasty ring 114 anchored into the annulus 20 ofthe target valve 16. If the annuloplasty ring 114 is appropriately positioned, forexample, secured to the annulus 20 on the plane Pv of the target valve 16, or asotherwise desired by the practitioner, then the balloon assembly 106 may bewithdrawn and/or otherwise removed, leaving the annuloplasty ring 114 anchored inplace at the target valve 16. The annuloplasty ring 114 may then be cinched, 11 WO 2012/167095 PCT/US2012/040481 snapped together, or otherwise reduced in diameter to reduce a diameter of theannulus 20 of the target valve 16 to treat regurgitation. Reducing the diameter of theannulus may improve the coaptation of the leaflets such that a gap between theleaflets sufficiently closes during left ventricular contraction, thereby treatingregurgitation. Cinching the annuloplasty ring, snapping together free ends of theannuloplasty ring, and other methods of reducing the diameter of the ring once it isimplanted are discussed below in greater detail. The guiding sheath 104 and theguidewire 102 can also be removed and the heart access site 11 can be closed, forexample, with one or more sutures 24.

[0066] FIGS. 9A, 9B, and 9C are a flow diagram of a method 900 for repairing atarget heart valve through percutaneous transcatheter delivery and fixation of anannuloplasty ring to the target heart valve via trans-apical access of the heart. Asprovided in FIG. 9A, the heart may be exposed 902, for example, via a thoracotomydone at the fifth or sixth rib of a patient, where the pulse of the heart can be felt onthe chest of the patient. A mini-retractor may be positioned at the thoracotomy tomaintain patency of the thoracotomy opening. A needle may be used to pierce 904the apex of the heart to create an access site into the heart. The access site mayaccess a ventricle chamber of the heart, for example, in a human patient. One ormore sets of purse-string sutures may be inserted 906 around the access site so asto provide a way to nearly immediately close the access site should there be anemergency or other need to quickly close the opening of the access site into theheart. A guidewire may be inserted 908 into the heart, for example into a ventricle,and through the target valve into an atrium of the heart. The guidewire may guide, orotherwise facilitate, insertion of other components to complete the desired valverepair procedure. For example, the guidewire may guide insertion 910 of a guidingsheath into the heart. The guiding sheath may be inserted 910 over the guidewireand retrograde through the target valve into the atrium chamber of the heart. Asdescribed above, the guiding sheath may have a diameter in a range of 18 Fr to 24Fr. Accordingly, insertion of the guiding sheath over the guidewire may includemultiple steps of inserting a dilator over the guidewire to dilate the access site,inserting a larger sheath, and then repeating.

[0067] Referring now to FIG. 9B, a delivery assembly, such as a balloonassembly, including an annuloplasty ring in a delivery geometry, may be inserted912 over the guidewire and through the guiding sheath into a distal portion of the 12 WO 2012/167095 PCT/US2012/040481 guiding sheath positioned within the atrium. An exampie of an insertion 912 of aballoon assembly, including an annuloplasty ring, is shown in FIG. 1B. With theballoon assembly positioned within the atrium of the heart, the guiding sheath maybe retracted 914 back through the target valve to expose the balloon assembly. Thering may be positioned 916 at the level of the annulus of the target valve, planar tothe plane of the target valve, above the atrial surface of the target valve. An upperballoon of the balloon assembly may be inflated 918 to guide and/or secureappropriate positioning of the annuloplasty ring proximate the annulus of the targetvaive. The upper balioon and lower balloon may be concurrently and/orsimultaneously inflated 920 to expand the diameter of the annuloplasty ring and/or totransition the annuloplasty ring from the delivery geometry to an operable geometry.Inflation of the upper balloon alone may not cause substantial expansion of a recessformed between the upper balloon and the lower balloon. The balloon assemblymay be configured such that inflation of the lower balloon, or concurrent inflation ofthe upper balloon and lower balloon results in expansion of the recess (or waist) ofthe balloon assembly.

[0068] Referring now to FIG. 9C, the anchors of the annuloplasty ring aredeployed 922. In certain embodiments, the anchors may deploy automatically withexpansion of the annuloplasty ring (and/or with transition of the annuloplasty ringfrom the delivery geometry to the operable geometry). In certain otherembodiments, a practitioner may be enabled to control deployment of the anchors.Once the anchors are fully deployed, the anchors (and the annuloplasty ring) can beimplanted into the tissue of the annulus. The upper and lower balloons may befurther inflated 924 to cause the annuloplasty ring to further expand and drive theanchors into the tissue of the annulus of the target valve and allow the anchors toengage the tissue of the annulus. The anchors engage the tissue of the annulusimplants and secure the annuloplasty ring to the target valve. The upper and lowerballoons can be deflated 926, for example to test securement of the annuloplastyring and/or to prepare for removal of the balloon assembly from the heart. Properimplantation and/or securement of the annuloplasty ring in the target valve canenable repair of the target valve. The annuloplasty ring can be ratcheted and/orcinched 928 to decrease the diameter of the annuloplasty ring, and in turn theannulus of the target valve, which can allow the valve leaflets to function properly,eliminate regurgitation, and repair the valve. The balloon assembly, the guiding 13 WO 2012/167095 PCT/US2012/040481 sheath, and the guidewire can be removed 930 from the heart through the accesssite. Then the heart access site can be closed 932, using for example the purse-string sutures and/or other closure mechanism or method.

Example Anchor Deployment Mechanism [0069] FIG. 10 illustrates an annuloplasty ring anchor deployment system 1000,according to one embodiment. In the illustrated embodiment, the annuloplasty ring1002 includes a plurality of fish hook shaped, curved anchors 1004. Each of theplurality of anchors 1004 includes a laser hole (not shown), or other eyelet-typeopening, on the anchor 1004. A suture 1006 may be coupled to the laser hole ofeach of the anchors 1004. The sutures 1006 may be formed of, for example, nylon,prolene, or the like. The plurality of sutures 1006 coupled to the laser hole may passthrough the guiding sheath and out of the patient’s body where they can bemanipulated by a practitioner. For example, the practitioner may be able to pull thesutures 1006 to deploy the anchors and/or to drive the tips of the anchors into tissue.[0070] A knot pusher 1008 may be disposed on the sutures 1006 to knot and cutthe sutures 1006 once the anchors are deployed. With the annuloplasty ring forceddown by an upper balloon of a balloon assembly or pulled down via the catheter ontothe annulus, exposed anchors 1004 may start penetrating surrounding tissue of theannulus of the target valve. A practitioner can grip each suture 1006, for example, insequence and attach the knot pusher 1008 with a clip attached to a small ancillarycatheter. The ancillary catheter can be advanced along a presently gripped suture1006 to advance a knot (e.g., a loop in the suture), sliding it to an appropriatesecurement position, and tighten the knot. For example, the knot may be advancedtoward the base of the annuloplasty ring 1002. Once the knot is snug against theannuloplasty ring 1002, the knot may be tightened and a miniature clip may secure inplace and cut the suture at the level of the annuloplasty ring 1002. The annuloplastyring 1002 is thereby secured via both tissue penetration by the anchors 1004 andadded sutures 1006 with knots. As another example, the knot may be advanced toan access site of the suture 1006 and/or anchor 1004 into the surrounding tissue ofthe annulus of the target valve. The knot may then be tightened against the base ofthe anchor 1006 and/or the tissue to secure the anchor in the tissue.

[0071] In another embodiment, the knot pusher 1008 may advance a fastener(rather than a loop in the suture 1006) disposed on the suture. The fastener mayhave an internal lumen extending axially therethrough and one or more engagement 14 WO 2012/167095 PCT/US2012/040481 members) formed, for example, on an end of the lumen and/or the fastener.Between the engagement members may be defined an engagement aperture thatmay align with or otherwise be in communication with, for example, a lumen of anancillary catheter, which may be configured to deploy the fastener. The engagementaperture may be sized to receive the suture 1006. Prior to deployment, theengagement member(s) may be deflected radially away (e.g., outward) from the axisof the fastener such that the engagement aperture has a relatively large firstdiameter sufficient to permit the suture 1006 to slide therethrough. Accordingly thefastener can move relative to the suture 1006 to be advanced and/or withdrawnalong the suture 1006.

[0072] After the suture 1006 has been retracted or otherwise drawn taught todeploy the anchors 1004, the fastener may be deployed. Upon deployment thefastener may be, for example, detached from the ancillary catheter and theengagement members may be urged or permitted to spring back (e.g., inward)toward the axis of the fastener such that the engagement aperture assumes asecond smaller diameter compressing and securing the suture 1006 in place.Preferably the engagement member(s) tend to spring toward a natural position at ortoward the axis of fastener. Each engagement member may further include apointed tip that, when the engagement member(s) are in the deployed position,engages and restricts movement of the fastener relative to the suture 1006. Thefastener in the deployed position may resist proximal movement relative to the suture1006, while allowing advancement distally to a desired position along the suture1006, thereby providing a securement mechanism. The fastener may operatesimilar to Chinese handcuffs, allowing movement in one direction while restrictingmovement in the opposite direction. In another embodiment, a deployed fastenermay resist both proximal and distal movement relative to the suture 1006. Thefastener may be manufactured from a variety of materials including, for example,Nickel-Titanium (e.g., nitinol) alloys, shape-memory alloys, stainless steel, titanium,various plastics, and other biologically-compatible materials. The ancillary cathetermay provide a cutting mechanism to cut the suture 1006 (e.g., cut off the excess ofthe suture 1006) once the fastener is appropriately positioned.

Example Ring Embodiments with Curved Anchors [0073] FIG. 11 is a simplified schematic diagram illustrating a perspective view ofa segmented annuloplasty ring 1100 according to one embodiment. Additional ring 15 WO 2012/167095 PCT/US2012/040481 embodiments and discussion of the same may be found in U.S. Patent ApplicationNo. 13/198,582, which is hereby incorporated herein by reference in its entirety. Thesegmented annuloplasty ring 1100 may include a plurality of segments 1102, aplurality of anchors 1104, and a ring closure lock 1106. In FIG. 11, as well as inother embodiments disclosed herein, the plurality of segments 1102 are arranged Ina "D-shape" in the operable geometry (e.g., when implanted around the annulus).The D-shaped ring 1100 has a certain geometrical ratio that is in conformance withthe anatomical geometry of the human mitral valve annulus. For example, the ratioin certain embodiments of the anterior-posterior (A-P) distance to the commissure-commissure (C-C) distance of the ring 1100 when implanted is in a range betweenabout 0.60 and about 0.70. In one embodiment, the implanted ratio of the A-Pdistance to the C-C distance is about 0.62. Artisans will recognize from thedisclosure herein, however, that other operable geometries may also be used. Forexample, circular or oval operable geometries may be used. By way of exampleonly, and not by limitation, the table below provides some example dimensions.

Ring Size Implant Shape (mm) C-C A-P Ratio 28 28.00 17.36 0.62 30 30.00 18.60 0.62 32 32.22 19.84 0.62 34 34.00 21.08 0.62 36 36.00 22.32 0.62 [0074] In addition to the operable geometry, the plurality of segments 1102 allowthe ring 1100 to be placed in a compressed delivery geometry such that the ring1102 can be disposed in a recess of a balloon assembly or other delivery assemblyand positioned through a catheter into the heart. As discussed in detail below, incertain embodiments, the segmented annuloplasty ring 1100 includes a shapememory (e.g., Nitinol) hypotube into which the plurality of segments 1102 is lasercut. The shape memory hypotube is heat set to a “memorized" annular shape (e.g.,the D-shaped operable geometry). The shape memory hypotube is superelasticsuch that applying sufficient stress places the plurality of segments 1102 into the 16 WO 2012/167095 PCT/US2012/040481 compressed delivery geometry and releasing the stress allows the plurality ofsegments 1102 to resume the D-shaped operable geometry.

[0075] The plurality of anchors 1104 are configured to secure the segmentedannuloplasty ring 1100 to the annulus of the heart valve. In certain embodiments,the anchors 1104 are sufficient such that additional suturing of the segmentedannuloplasty ring 1100 to the valve annulus is not needed. In FIG. 11, the anchors1104 are curved in the illustrated deployed configuration. Anchors in otherembodiments may include other shapes, such as linear or helical deployedconfigurations. In certain embodiments, the anchors 1104 include a shape memorymaterial (e.g., Nitinol) that is heat set to a deployed configuration (e.g., linear, helical,or curved configuration shown in FIG. 11). Artisans will recognize from thedisclosure herein, that combinations of different deployed configurations may also beused.

[0076] The anchors 1104 are superelastic such that applying sufficient stressplaces the anchors 1104 into an introduction configuration and releasing the stressallows the anchors 1104 to resume their respective deployed configurations. Incertain embodiments, the anchors 1104 lay flat against the plurality of segments1102 in the introduction configuration during insertion of the ring 1100 through thecatheter. As discussed below, in other embodiments, the anchors 1104 areretracted inside the segmented ring 1100 in the introduction configuration duringinsertion of the ring 1100 through the catheter. In such embodiments, the anchors1104 may be selectively deployed at a desired time (e.g., after the segmented ring1100 is properly positioned against the annulus of the heart valve). In certainembodiments, the superelastic property of the anchors 1104 is used to self-propelthe anchors 1104 into the annulus of the heart valve.

[0077] The ring closure lock 1106 is used to secure the two open ends of thesegmented annuloplasty ring 1100 to form a closed ring. As shown in FIG. 11, incertain embodiments, the ring closure lock 1106 includes a female snap 1110 and amale snap 1112. As discussed below, the segmented annuloplasty ring 1100 maybe “snap locked” using wires or sutures to pull the male snap 1112 into the femalesnap 1110. In certain embodiments, a gap (e.g., between about 3 mm and 5 mm) isleft between the female snap 1110 and the male snap 1112 after the anchors 1104are deployed within the tissue of the valve annulus. Then, the two ends are snappedtogether to provide cinching of the valve annulus. This cinching is similar to a 17 WO 2012/167095 PCT/US2012/040481 technique used by surgeons during open heart surgery (e.g., using sutures) to drawthe valve annulus into a smaller or improved shape that reduces regurgitation ofblood back through the vaive.

[0078] Although not shown in FIG. 11, certain ring embodiments include aselectively adjustable member (discussed below) for changing the size and/or shapeof the segmented annuloplasty ring 1100 postoperatively to compensate for changesin the size of the heart and/or the treated heart valve. Also not shown in FIG. 11,certain ring embodiments include a cover disposed about the entire circumference ofthe segmented ring 1100, or selected portions thereof. For example, in certainembodiments, the cover is disposed so as to enclose the plurality of segments 1102,while leaving uncovered at least portions of the ring closure lock 1106 (to permitsnapping the lock together). The cover may include openings aligned with windows(discussed below) in the plurality of segments 1102 through which the plurality ofanchors 1104 is deployed. In other embodiments, the plurality of anchors 1104 isconfigured to puncture through the cover during deployment. The cover may includea biocompatible material such as Dacron®, woven velour, polyurethane,polytetrafluoroethylene (PTFE), heparin-coated fabric, or the like. In otherembodiments, the cover includes a biological material such as bovine or equinepericardium, homograft, patient graft, or cell-seeded tissue.

[0079] FIGS. 11A and 11B are schematic diagrams illustrating a shape memoryhypotube 1113 cut to form a plurality of segments 1102 for use as an outer tube(also referred to herein as an “outer hollow member") of a segmented annuloplastyring according to one embodiment. FIG. 11A is a plan view of a first side of thehypotube 1113 in which a plurality of anchor deployment windows 1114 are cut.FIG. 11B is a plan view of a second side of the hypotube 1113 that is opposite thewindows 1114 shown in FIG. 11 A. For illustrative purposes, FIG. 11C is a schematicdiagram illustrating a cutting pattern 1116 used for laser processing the hypotube1113 shown in FIGS. 11A and 113. While FIGS. 11A and 113 show respective(opposite) sides of the hypotube 1113, the cutting pattern 1116 corresponds to theentire hypotube 1113 as if the hypotube were cut along an axis 1118 of the surfaceshown in FIG. 11A and unrolled. Thus, for example, each window 1114 shown inFIG. 11A is shown in FIG. 11C as being split between a first half of the window1114(a) and a second half of the window 1114(b). 18 WO 2012/167095 PCT/US2012/040481 [0080] The hypotube 1113 includes a through hole 1120, 1121 at each end (ortwo perpendicular through holes at each end according to FIG. 11C) to allow one ormore pins (not shown) to couple the male and female components of the ring closurelock 1106 to respective ends of the hypotube 1113, The hypotube 1113 alsoincludes a through hole 1122 (the opening 1122 shown in FIG. 11A beingrepresented in FIG. 11C as 1122(a) and 1122(b)). As shown in FIG. 11C, thehypotube 1113 may also include a window 1124 (passing vertically through thehypotube 1113 with respect to the views shown in FIGS. 11A and 11B) that allowsone or more lines or sutures (not shown) to exit the hypotube 1113. As discussedbelow, the sutures are used to snap iock the ring and/or to deploy the anchors 1104.

[0081] The cutting pattern 1116 shown in FIG. 11C defines the configuration ofthe plurality of segments 1102 and how the segments 1102 interact with adjacentsegments as the hypotube transitions from a compressed delivery geometry shownin FIGS. 1C and 1D to the annular operable geometry shown in FIG. 11. As shownin FIG. 11B, the hypotube in this example embodiment includes a “tongue andgroove” pattern wherein a tongue 1126 of one segment interfaces with a groove1128 of an adjacent segment as the inner circumference of the ring is formed. Thecutting pattern 1116 provides rigidity to the hypotube 1113 in the annular operablegeometry, allows the hypotube 1113 to easily transition from the compresseddelivery geometry to the annular operable geometry.

[0082] In certain embodiments, deployment of the anchors 1104 is accomplishedusing an internal anchor member that is selectively movable within the hollow tubeformed by the plurality of segments 1102. For example, FIG. 12A is a simplifiedschematic diagram illustrating a side view of an internal anchor ribbon 1200 includingthe curved anchors 1104 shown in FIG. 11 according to one embodiment. Thecurved anchors 1104 may be affixed (e.g., laser welded) to the internal anchorribbon 1200 or directly cut into the internal anchor ribbon 1200 (as discussed withrespect to FIGS. 12B and 12C). Like the anchors 1104, the internal anchor ribbon1104 includes a superelastic shape memory material (e.g., Nitinol) that is heat set tothe same memorized annular shape as the plurality of segments 1102 (shown inFIGS. 11 and 12Aas D-shaped).

[0083] The internal anchor ribbon 1200 may be slid (e.g., using wires or sutures)within the hollow tube formed by the plurality of segments 1102 of the ring 1100. Toreduce friction between the internal anchor ribbon 1200 and the plurality of segments 19 WO 2012/167095 PCT/US2012/040481 1102, certain ring embodiments include an internal glide ribbon 1210. The internalglide ribbon 1210 may include a low-friction material (e.g., as a coating or covering)such as PTFE or other polymer. In addition, or in other embodiments, the internalglide ribbon 1210 includes a superelastic shape memory material (e.g., Nitinol) thatis heat set to the same memorized annular shape as the plurality of segments 1102(shown in FIGS. 11 and 12A as D-shaped). Thus, certain embodiments includethree D-shaped superelastic members (the outer tube of segments 1102, the internalanchor ribbon 1200, and the internal glide ribbon 1210), which cooperate to increasethe rigidity of the ring 1100.

[0084] FIG. 12B is a schematic diagram illustrating a top view of the anchors1104 cut into the internal anchor ribbon 1200 shown in FIG. In this example, a laseris used to cut the anchors 1104 along a first side 1212, a second side 1214 (e.g., ina pointed or tip shape), and a third side 1216, while leaving a fourth side 1218 of theanchor 1104 uncut and attached to the internal anchor ribbon 1200. After cutting,the anchors 1104 are heat set to the desired memorized shape for the deployedconfiguration. For example, FIG. 12C is a schematic diagram illustrating a side viewof the internal anchor ribbon 1200 and the anchors 1104 in a curled or curveddeployed configuration according to one embodiment. The amount of curvature inthe deployed configuration of the anchors 1104 may depend on the particularapplication. In the example shown in FIG. 12C, the anchors 1104 fold back onthemselves such that the prong or tip 1220 points parallel to or away from theinternal anchor ribbon 1200. FIG. 12D is a schematic diagram illustrating a top viewof the internal glide ribbon 1210, and FIG. 12E is a schematic diagram illustrating aside view of the internal glide ribbon 1210, according to one embodiment.

[0085] FIGS. 13A and 13B are simplified schematics illustrating cross-sectionside views of an annuloplasty ring 1300 before (FIG. 13A) and after (FIG. 13B)deployment of the anchors 1104 shown in FIG. 12C according to one embodiment.For illustrative purposes, the ring 1300 in FIGS. 13A and 13B is shown in anelongate geometry. Artisans will recognize from the disclosure herein, however, thatthe anchors 1104 are generally deployed when the ring 1300 is in the annularoperable geometry.

[0086] The illustrated ring 1300 includes an outer tube 1310 (e.g., formed by theplurality of segments 1102 shown in FIG. 11) including a plurality of anchordeployment windows 1312. During the manufacturing of the ring 1300, and before 20 WO 2012/167095 PCT/US2012/040481 the ring 1300 is loaded into the catheter, the interna! anchor ribbon 1200 and theinternal glide ribbon 1210 are inserted into the outer tube 1310 in a position wherethe anchors 1104 are prevented from exiting through the windows 1312. As shownin FIG. 13A, inserting the internal anchor ribbon 1200 into the outer tube 1300prevents the anchors from assuming their fully curved deployed configuration.

[0087] For deploying the anchors 1104, the internal anchor ribbon 1200 mayinclude (or may be attached to) a hook or loop 1314 for engaging a wire or suture1316 that may be pulled by a user through the catheter (e.g., in the direction of arrow1318 in FIG. 13A) to move the tip of each anchor 1104 to a corresponding window1312. In certain embodiments, the anchors 1104 and windows 1312 are arrangedsuch that the tip of each anchor 1104 reaches its respective window 1312 atsubstantially the same time as the other anchor/window pairs. As shown in FIG.13B, once the tips of the anchors 1104 reach the respective windows 1312, thesuperelasticity of the anchors 1104 propel the internal anchor ribbon 1200 in theopposite direction (as indicated by arrow 1320) as the anchors 1104 spring out thewindows 1312 (as indicated by arrow 1322) to resume their curved configurations,which drives the anchors 1104 into surrounding tissue (e.g., the heart valveannulus). Thus, the superelasticity of the anchors 1104 allows the anchors 1104 tobe self-propelled into the tissue adjacent or proximate to the ring 1300.

[0088] FIG. 14A is a schematic diagram illustrating a perspective view of a portionof the annuloplasty ring 1300 shown in FIGS. 13A and 13B with a deployed curvedanchor 1104 according to one embodiment. FIG. 14B is a schematic diagramillustrating a side view of a portion of the annuloplasty ring shown in FIG. 14A. Asshown in FIGS. 14A and 14B, the outer tube 1310 may be cut to define segments(such as the plurality of segments 1102 shown in FIG. 11). The outer tube 1310 alsoincludes the windows 1312 (one window shown in FIG. 14A) described above andschematically represented in FIGS. 13A and 13B. As shown in FIG. 14B, in certainembodiments, the deployed anchors 1104 form an angle a (e.g., approximately 45degrees) with a plane 1410 of the ring 1300 to provide the anchors 1104 withimproved access to the valve annulus when the ring is positioned against the valveannulus. During anchor deployment, the plane 1410 of the ring 1300 is substantiallyparallel to the plane of the annulus of the target valve.

[0089] FIG. 15 is a simplified schematic diagram illustrating a side view of theinternal glide ribbon 1210 shown in FIG. 12A used as a selectively adjustable 21 WO 2012/167095 PCT/US2012/040481 member according to one embodiment. As discussed above, certain ringembodiments include a selectively adjustable member for changing the size and/orshape of the annuloplasty ring 1100 (shown in FIG. 11) postoperatively tocompensate for changes in the size of the heart and/or the treated heart valve.Thus, FIG. 15 illustrates the internal glide ribbon 1210 in the D-shaped geometryused immediately after implanting the ring, as well as an "activated” geometry orshape 1210' (shown as dashed lines) that further reduces the size of the mitral valveannulus in the (A-P) direction (as indicated by arrows 1510). Such A-P contractionimproves the coaptation of the leaflets such that a gap between the leafletssufficiently closes during left ventricular contraction. In certain embodiments, theactivated shape 1210' also expands in the direction of arrows 1512 (the C-Cdirection) to pull leaflet commissures away from each other, which draws the leafletscloser together and further improves their coaptation. However, in certain otherembodiments, the ring 1100 does not expand in the direction of the arrows 1512.[0090] As used herein, "postoperatively" refers to a time after implanting anannuloplasty ring, such as the segmented annuloplasty ring 1100 shown in FIG. 11or other rings described in other embodiments, and closing the body openingthrough which the ring 1100 was introduced into the patient's body. For example,the ring 1100 may be implanted in a child whose heart grows as the child gets older.Thus, the size of the ring 1100 may need to be increased. As another example, thesize of an enlarged heart may start to return to its normal size after the ring 1100 isimplanted. Thus, the size of the ring 1100 may need to be decreasedpostoperatively to continue to reinforce the heart valve annulus.

[0091] Thus, in certain embodiments, the ring 1100 includes a selectivelyadjustable member (e.g., the internal glide ribbon 1210 shown in FIGS. 12A and 15)with a shape memory material (e.g., NiTi, Alloy-B) that is responsive to changes intemperature and/or exposure to a magnetic field. The ring 1100 is adjusted in vivoby applying an energy source to activate the selectively adjustable member andcause it to change to a memorized shape. The energy source may include, forexample, radio frequency (RF) energy, x-ray energy, microwave energy, ultrasonicenergy such as focused ultrasound, high intensity focused ultrasound (HIFU) energy,light energy, electric field energy, magnetic field energy, combinations of theforegoing, or the like. For example, one embodiment of electromagnetic radiationthat is useful is infrared energy, having a wavelength in a range between 22 WO 2012/167095 PCT/U82012/040481 approximately 1750 nanometers and approximately 11600 nanometers. This type ofinfrared radiation may be produced efficiently by a solid state diode laser. In certainembodiments, the implanted ring 1100 is selectively heated using short pulses ofenergy having an on and off period between each cycle. The energy pulses providesegmental heating that allows segmental adjustment of portions of the annuloplastyring without adjusting the entire implant.

[0092] In certain embodiments, the ring 1100 includes an energy absorbingmaterial to increase heating efficiency and localize heating in the area of theselectively adjustable member. Thus, damage to the surrounding tissue is reducedor minimized. Energy absorbing materials for light or laser activation energy mayinclude nanoshells, nanospheres and the like, particularly where infrared laserenergy is used to energize the material. Such nanoparticles may be made from adielectric, such as silica, coated with an ultra thin layer of a conductor, such as gold,and be selectively tuned to absorb a particular frequency of electromagneticradiation. In certain such embodiments, the nanoparticles range in size betweenabout 15 nanometers and about 120 nanometers and can be suspended in asuitable material or solution, such as saline solution. Coatings comprisingnanotubes or nanoparticles can also be used to absorb energy from, for example,HIFU, MRI, inductive heating, or the like.

[0093] In other embodiments, thin film deposition or other coating techniquessuch as sputtering, reactive sputtering, metal ion implantation, physical vapordeposition, and chemical deposition can be used to cover portions or all of theselectively adjustable member. Such coatings can be either solid or microporous.When HIFU energy is used, for example, a microporous structure traps and directsthe HIFU energy toward the shape memory material. The coating improves thermalconduction and heat removal. In certain embodiments, the coating also enhancesradio-opacity of the annuloplasty ring implant. Coating materials can be selectedfrom various groups of biocompatible organic or non-organic, metallic or non-metallicmaterials such as Titanium Nitride (TiN), Iridium Oxide (Irox), Carbon, Platinumblack, Titanium Carbide (TiC) and other materials used for pacemaker electrodes orimplantable pacemaker leads. Other materials discussed herein or known in the artcan also be used to absorb energy.

[0094] In addition, or in other embodiments, fine conductive wires such asplatinum coated copper, titanium, tantalum, stainless steel, gold, or the like, are 23 WO 2012/167095 PCT/US2012/040481 wrapped around the selectively adjustable member to allow focused and rapidheating of the selectively adjustable member while reducing undesired heating ofsurrounding ring 1100 and/or tissues. In certain such embodiments, the electricallyconductive wires are electrically insulated from other components of the ring 1100,such as the shape memory material used in the plurality of segments 1102 and/orthe plurality of anchors 1104.

[0095] The energy source for activating the shape memory material of theselectively adjustable member may be surgically applied after the ring 1100 hasbeen implanted by percutaneously inserting a catheter into the patient’s body andapplying the energy through the catheter. For example, RF energy, light energy, orthermal energy (e.g., from a heating element using resistance heating) can betransferred to the selectively adjustable member through a catheter positioned on ornear the selectively adjustable member. Alternatively, thermal energy can beprovided to the shape memory material by injecting a heated fluid through a catheteror circulating the heated fluid in a balloon through the catheter placed in closeproximity to the selectively adjustable member. As another example, the shapememory material in the selectively adjustable member can be coated with aphotodynamic absorbing material that is activated to heat the selectively adjustablemember when illuminated by light from a laser diode or directed to the coatingthrough fiber optic elements in a catheter. In certain such embodiments, thephotodynamic absorbing material includes one or more drugs that are released whenilluminated by the laser light. In certain embodiments, a subcutaneous electrode orcoil couples energy from a dedicated activation unit. In certain such embodiments,the subcutaneous electrode provides telemetry and power transmission between thesystem and the annuioplasty ring. The subcutaneous electrode allows more efficientcoupling of energy to the implant with minimum or reduced power loss. In certainembodiments, the subcutaneous energy is delivered to the selectively adjustablemember via inductive coupling.

[0096] In other embodiments, the energy source is applied in a non-invasivemanner from outside the patient's body. In certain such embodiments, the externalenergy source Is focused to provide directional heating to the shape memorymaterial of the selectively adjustable member so as to reduce or minimize damage tothe surrounding tissue. For example, in certain embodiments, a handheld orportable device including an electrically conductive coil generates an 24 WO 2012/167095 PCT/US2012/040481 electromagnetic field that non-invasively penetrates the patient's body and induces acurrent in the selectively adjustable member. The current heats the selectivelyadjustable member and causes the shape memory material therein to transform to amemorized shape. In certain such embodiments, the selectively adjustable memberalso includes an electrically conductive coil wrapped around or embedded in thememory shape material. The externally generated electromagnetic field induces acurrent in the selectively adjustable member’s coil, causing it to heat and transferthermal energy to the shape memory material therein.

[0097] By way of example, FIGS. 15A, 15B, and 15C are schematic diagrams ofcircuitry for using RF induction to activate the shape memory material of the internalglide ribbon 1210 according to one embodiment. FIG. 15A illustrates circuitrylocated in a selectively adjustable annuloplasty ring and FIG. 15B illustrates circuitryof an external (i.e., external to the patient) RF induction activation system accordingto one embodiment. FIG. 15C is a block diagram of a system 1520 for inductivelyactivating a selectively adjustable member 1522 (e.g., the internal glide ribbon 1210)of a ring according to certain embodiments.

[0098] Referring to FIGS. 15A, 15B, and 15C, the RF induction activation system1520 includes a power source 1524 (also referred to herein as an RF generator orRFG) capable of creating an alternating electrical signal of suitable power. Thepower source 1524 is connected to a delivery coil 1526 tuned to resonate at thesame frequency as the output of the power source 1524. A capacitor 1528 is usedto tune the delivery coil 1526 to resonate at the desired frequency. The implantabledynamically adjustable annuloplasty ring assembly includes a second (receiving) coil1530 positioned within the patient that is designed to resonate at substantially thesame frequency as that of the delivery coil 1526 connected to the power source1524. A capacitor 1532 is used to tune the receiving coil 1530 to resonate at thedesired frequency. The receiving coil 1530 is connected to a heating element 1534(represented by a resistance R1 in FIG. 15A) wrapped around the selectivelyadjustable member 1522 (as shown in FIG. 15C). To activate the annuloplasty ring,the delivery coil 1526 is placed near the receiving coil 1530 of the selectivelyadjustable member 1522 (e.g., near the patient’s chest) and switched on. Powerfrom the resonating magnetic field 1536 (shown in FIG. 15C) is then inductivelytransferred across the skin barrier to the receiving coil 1530 and converted toelectrical current that is subsequently used to heat the selectively adjustable member 25 WO 2012/167095 PCT/US2012/040481 1522. In an example embodiment, the inductance frequency is above about 1100kHz so that any leakage current that may come in contact with the patient would notcause uncomfortable sensations during activation.

[0099] In certain embodiments, embedded computing and/or remote temperaturesensing is used. For example, FIG. 15C shows that additional circuitry 1538 may beimplanted in the patient. The additional circuitry 1538 may include transmittercircuitry (including an antenna 1540), a microprocessor, power circuitry, andtemperature measuring circuitry (e.g., one or more thermocouple (TC) devices 1542,coupled to the additional circuitry 1538). Similarly, the RFG 1524 may includereceiver circuitry 1544 (including an antenna 1546) for receiving temperature andother data from the additional circuitry 1538 implanted in the patient. Although notshown, the RFG 1524 may also include a processor for processing and displayingthe information received from the additional circuitry 1538 implanted within thepatient [00100] The information received from the additional circuitry 1538 may include, forexample, the power induced in the selectively adjustable member 1522. In oneembodiment, the power transferred to the selectively adjustable member 1522 ismeasured by reading the voltage across the selectively adjustable member 1522and/or heating element 1534 and, because the resistance of the selectivelyadjustable member 1522 and/or heating element 1534 is known, the power can becalculated and communicated to the RFG 1524 by the telemetry link. In anotherexample, the temperature and size of the selectively adjustable member 1522 maybe sensed and sent by transmitter circuitry in the additional circuitry 1538 to thereceiving circuitry 1544 via radiotelemetry. Temperature may be sensed using thethermocouple device 1542, and the size of the ring may be deduced via built in straingauges 1548 (e.g., different resistance values equal a proportional change in size).

[00101] In one embodiment, the RFG 1524 automatically finds a resonant point.The RFG 1524 may be programmed to analyze wattage delivered during operation(e.g., as discussed above) and may adjust the output frequency to increase ormaximize the greatest power transfer. This may be accomplished in certainembodiments by directly monitoring the current output on the delivery coil 1526, orthe peak voltage induced in the receiving coil 1530 via telemetry.

[00102] In one embodiment, the system 1520 is capable of multiple resonantfrequencies. For example, the heating element 1534 (coupled to the selectively 26 WO 2012/167095 PCT/US2012/040481 adjustable member 1522) may be electrically connected to more than one coil -each coil having a different natural resonance. In another embodiment, differentcoils may be attached to different heating elements or devices in the ring that can beoperated separately. The transmitting power source 1524 may have a set of coils(e.g., including the delivery coil 1526) that can be selectively used to couple to itsrespective sister coil (e.g., including the receiving coil 1530) coupled to theselectively adjustable member 1522.

[00103] By using this wireless technique of power transmission, the patient may beelectrically isolated from the system 1520 during activation of an implanted device.Thus, the possibility of electrocution due to a ground fault is eliminated and/orreduced.

[00104] In some embodiments, centering of coils is used. Such embodiments usetechniques of aligning the coils, such as through the use of physical landmarksmolded into a housing of the implanted receiving coil, magnets, and/or infraredlighting. For example, an infrared light emitting diode (LED) may be installed on theimplanted receiving coil 1530 and may light during activation. An infrared detectorlocated on the delivery coil 1526 may be configured to give a user feedback on howmuch light it receives. A set of magnets may also be strategically placed in thedelivery coil 1526 and receiving coil 1530. As the magnets are brought closetogether, the magnetic attraction may be utilized to align the coils 1526,1530.

Example Ring Embodiments with Linear Anchors [00105] FIG. 16A is a schematic diagram illustrating a perspective view of asegmented annuloplasty ring 1600 including a plurality of linear anchors 1610according to one embodiment. Seven linear anchors 1610 are shown. However,artisans will understand from the disclosure herein that more linear anchors 1610 orfewer linear anchors may be used. For example, certain embodiments may use tenor more linear anchors 1610.

[00106] The segmented annuloplasty ring 1600 includes a plurality of segments1612 at least partially cut into a shape memory hypotube that forms a “D-shape” inthe annular operable geometry (e.g., when implanted around the annulus) and maybe compressed into a compressed delivery geometry for implanting the ring 1600within a patient’s heart through a catheter. As discussed above with respect to FIG.11, the ring 1600 may also include a ring closure lock 1614 (shown in a connected orlocked position) for snap locking the two ends of the ring together. 27 WO 2012/167095 PCT/US2012/040481 [00107] As discussed above with respect to other embodiments, the ring 1600includes a plurality of anchor deployment windows 1618 cut into the shape memoryhypotube. The plurality of linear anchors 1610 may be selectively deployed throughthe windows 1618 in a manner similar to that described above for curved anchors1104.

[00108] FIG. 16B is a schematic diagram illustrating a side view of a portion of theannuloplasty ring shown in FIG. 16A. As shown in FIG. 16B, in certainembodiments, the deployed linear anchors 1610 form an angle β (e.g., about 145degrees) with a plane 1620 of the ring 1600 to provide the linear anchors 1610 withimproved access to the valve annulus when the ring is positioned against the valveannulus. During anchor deployment, the plane 1620 of the ring 1600 is substantiallyparallel to the plane of the valve annulus. As shown in FIG. 16B, the linear anchors1610 may include a pointed prong 1621 for penetrating tissue and a barb 1622 thatsecures the anchor to the tissue.

[00109] FIG. 17 is a simplified schematic diagram illustrating a side view of aninternal anchor member 1700 including linear anchors 1710 according to oneembodiment. The linear anchors 1710 may be affixed (e.g., laser welded) to theinternal anchor member 1700. In the embodiment shown in FIG. 17, however, theinternal anchor member 1700 and linear anchors 1710 are cut from a singlesuperelastic shape memory (e.g., Nitinol) hypotube. FIG. 17, for example, showsremaining tubular portions 1712 after the hypotube is cut to form prongs 1714 of thelinear anchors 1710. The remaining tubular portions 1712 facilitate sliding (e.g.,using wires or sutures accessible through the catheter) the internal anchor member1700 coaxially within the hollow tube of the ring (e.g., within the segmentedannuloplasty ring 1600 shown in FIG. 16).

[00110] The internal anchor member 1700 is heat set to the same memorizedannular shape as the ring. The anchors prongs 1714 can be heat set to protrudeoutward through windows cut in the segmented annuloplasty ring 1600. Barbs 1716may be laser welded to the prongs 1714 to form the linear anchors 1710. The linearanchors 1710 are retracted/deployed by sliding the internal anchor member 1700within the segmented annuloplasty ring 1600.

[00111] FIG. 18A is a schematic diagram illustrating an enlarged perspective viewof a single-barbed anchor 1808 of a percutaneous transcatheter annuloplasty ring1800 in an affixation configuration according to one embodiment. The anchor 1808 28 WO 2012/167095 PCT/US2012/040481 includes a prong 1810 and a single barb 1812 welded to the prong 1810. The prong1810 is integrated with or connected to an inner tube member (not shown, but seeFIG. 17) and protrudes through a window 1820 cut in an outer tube member formedby a plurality of segments 1802.

[00112] FIG. 18B is a schematic diagram of an enlarged perspective view of adual-barbed anchor 1858 of a percutaneous transcatheter annuloplasty ring in anaffixation configuration according to one embodiment. The anchor 1858 includes aprong 1860 and two barbs 1862 welded to the prong 1860. The prong 1860 isintegrated with or connected to an inner tube member (not shown) and protrudesthrough a window 1820 cut in an outer tube member formed by a plurality ofsegments 1852.

[00113] FIG. 19 is a simplified schematic diagram illustrating a side view of theinternal anchor member 1700 shown in FIG. 17 and a selectively adjustable member1900 according to one embodiment. As discussed above, the selectively adjustablemember 1900 is configured to change the size and/or shape of the annuloplasty ring1600 postoperatively to compensate for changes in the size of the heart and/or thetreated heart valve. In FIG. 19, the selectively adjustable member 1900 is shownpassing through the remaining tubular portions 1712 of the cut hypotube of theinternal anchor member 1700. In such embodiments, the selectively adjustablemember 1900 may be rod shaped and may have an outer diameter of about 140microns. In other embodiments, the selectively adjustable member 1900 may belocated adjacent to the internal anchor member 1700 (e.g., around the externalcircumference, the internal circumference, or lateral to the internal anchor member1700).

[00114] The selectively adjustable member 1900 includes a shape memorymaterial (e.g., NiTi Alloy-B) that is responsive to changes in temperature and/orexposure to a magnetic field. The selectively adjustable member 1900 may beactivated, for example, using any of the energy sources or methods described abovewith respect to FIGS. 15, 15A, 15B, and 15C. The activated geometry of theselectively adjustable member 1900, according to certain embodiments, reduces thesize of the mitral valve annulus in the AP direction.

[00115] FIG. 20 is a schematic diagram illustrating a partial cross-sectional view ofthe selectively adjustable member 1900 shown in FIG. 19 according to oneembodiment. The selectively adjustable member 1900 in this example includes a 29 WO 2012/167095 PCT/US2012/040481 shape memory rod 2010, a heating element 2012 (e.g., electrically conductive wire)coiled around the shape memory rod 2010, and an electrically insulating cover 2013surrounding the shape memory rod 2010 and heating element 2012. The electricallyinsulating cover 2013 prevents current passing through the heating element 2012from flowing to nearby metals or other shape memory alloys in the ring (e.g., theouter segmented annuloplasty ring 1600 and/or the internal anchor member 1700),or to surrounding tissue. The electrically insulating cover 2013 may also providethermal insulation to protect the surrounding tissue from excessive heat.

[00116] As shown in FIG. 20, the selectively adjustable member 1900 may includeleads 2014, 2016 for providing induced current through the heating element 2012.The leads 2014, 2016 may exit through the septal wall, the right atrium subclavianvein, or both leads may follow the ring contour and exit at P1/P2 leaflet junction orP3/P2 leaflet junction.

[00117] In certain embodiments, the receiving coil 1530 (shown in FIGS. 15A and15C) and any associated internal circuitry may be placed anywhere within the patientand outside the heart of the patient. For example, the receiving coil 1530 and/oradditional circuitry 1538 may be implanted immediately below the surface of the skinand coupled to the heating element 2012 (coupled to the selectively adjustablemember 1900) via one or more wires extending into the heart. In anotherembodiment, the receiving coil 1530 and associated internal circuitry may beintegrated with the annuloplasty ring and/or the selectively adjustable member 1900.For example, the receiving coil 1530 and additional circuitry 1538 may beincorporated internal to the annuloplasty ring. In still another embodiment, thereceiving coil 1530 may be implanted adjacent the lead wire and/or the receiving coil,in close proximity to the selectively adjustable member 1900.

[00118] FIG. 21A is a schematic diagram illustrating a percutaneous transcatheterannuloplasty ring 2100 according to another embodiment. The annuloplasty ring2100 is shown in FIG. 21A in an annular operable geometry with anchors 2108 in anintroduction configuration. FIG. 21B is a schematic diagram illustrating an enlargedside view of the annuloplasty 2100 ring of FIG. 21A. The annuloplasty ring 2100may include an inner support structure 2140 and an outer shell 2142. In FIG. 21A,the inner support structure 2140 is shown in phantom lines as being hidden by theouter shell 2142, The inner support structure 2140 may be formed of a plurality ofsegments 2102, as shown in FIG. 1D and discussed more fully in other 30 WO 2012/167095 PCT/US2012/040481 embodiments disclosed herein. The outer shell 2142 may be formed of a thin super-elastic material, such as Nitinol. The anchors 2108 may extend from and/or beintegrated with the outer shell 2142. Superelastic shape memory material in theplurality of segments 2102 of the inner support structure 2140 and/or the outer shell2142 enable the annuloplasty ring 2100 to transition between an insertion geometryand an operable geometry.

[00119] The anchors 2108, when in an introduction configuration, may be folded orwrapped to lie in close proximity to the outer shell 2142, as shown in FIG. 21B, so asto not protrude away from the surface of the annuloplasty ring 2100. The anchors2108 may include a prong 2152 and a barb 2154 at an end of the prong. The barb2154 may facilitate securement of the anchor 2108 in tissue.

[00120] FIG. 21C is a schematic diagram of the annuloplasty ring 2100 of FIG. 21Awith the anchors 2108 in an affixation configuration protruding away from theannuloplasty ring 2100. An integrated diaphragm 2162 may be integrated with theouter shell 2142 and/or the inner support structure 2140. Inflation of the integrateddiaphragm 2162 unfurls the anchors 2108 to expose the barbs 2154 for affixation(implantation) of the annuloplasty ring 2100 into a heart valve annulus. In anotherembodiment, rather than including an integrated diaphragm 2162, a balloon catheter(not shown) may be used to deploy the anchors 2108.

[00121] Those having skill in the art will understand from the disclosure herein thatmany changes may be made to the details of the above-described embodimentswithout departing from the underlying principles of the invention. The scope of thepresent invention should, therefore, be determined only by the following claims. 31