Post-implant adjustable annuloplasty ring

Abstract

Annuloplasty rings that are size-adjustable after implant and which facilitate deployment and reduce long-term complications. The rings each have a hollow support body with a cinching element extending therethrough whose length is controlled remotely via a deployment system handle. The ring may be anchored to the annulus and then the size adjusted while the heart beats and under visualization to minimize regurgitation. The cinching element may be a loop of braided metal cable which cooperates with a junction housing to which the deployment system attaches. The rings are especially beneficial for repairing the mitral annulus, and may be saddle shaped with the junction housing located on an anterior side. The support body may be shape set nitinol tube having cutouts for flexibility, and the cinching element may be a braided nitinol core having a braided polymer exterior. The cinching element may be a complete loop, have one end anchored in the junction housing, or have two free ends extending out of the junction housing.

Description

Attorney Docket No: SSHRG-23341 WOoiPOST-IMPLANT ADJUSTABLE ANNULOPLASTY RINGCROSS-REFERENCE TO RELATED APPLICATION

[0001] This application claims the benefit of U.S. Patent Application No. 63 / 680,465, filed August 7, 2024, the entire disclosure which is incorporated by reference for all purposes.TECHNICAL FIELD

[0002] The present disclosure relates generally to annuloplasty rings, and in particular to an adjustable mitral annuloplasty ring and deployment system.BACKGROUND

[0003] In vertebrate animals, the heart is a hollow muscular organ having four pumping chambers: the left and right atria and the left and right ventricles, each provided with its own one-way valve. The natural heart valves are identified as the aortic, mitral (or bicuspid), tricuspid and pulmonary, and each has flexible leaflets that coapt against each other to prevent reverse flow.

[0004] Various surgical techniques may be used to repair a diseased or damaged valve. A commonly used repair technique effective in treating incompetence is annuloplasty, which often involves reshaping or remodeling the annulus by attaching a prosthetic annuloplasty repair segment or ring thereto. The procedure is done with the heart stopped and the patient on cardiopulmonary bypass (“on pump”). For instance, the goal of a posterior mitral annulus repair is to bring the posterior mitral leaflet forward toward to the anterior leaflet to improve leaflet coaptation. Annuloplasty rings may be stiff, flexible or semi-rigid, and a “remodeling” annuloplasty ring typically has an inner core that is “generally rigid” or “semi-rigid” in that it will flex to a small extent but resist distortion when subjected to the stress imparted thereon by the mitral valve annulus of an operating human heart.

[0005] Currently, during a mitral valve repair procedure, the size of the annuloplasty ring is determined by comparing different sizer templates to the patient’s anatomy until the surgeon determines w hich one looks correct based on, for example, anterior leaflet area or length, intercommissural distance, and so on. However, unlike for an aortic valve replacement, w here the goal is to implant the largest valve that will safely fit the patient’s anatomy, mitral repair procedures implant a repair device that is somewhat smaller than the annulus to reduce the perimeter, or, more importantly, the anterior-posterior (AP) diameter, of the valve and restore leaflet coaptation. The surgeon must make an “educated guess” as to how much reduction in size is appropriate for any given patient and their specific disease state. If the wrong size repair product is chosen, the result may be a poor outcome manifested by residual mitral regurgitation (MR), insufficient coaptation length, highAttorney Docket No: SSHRG-23341 WOoi pressure gradients, or systolic anterior motion (SAM). If any of these conditions are found once the patient is weaned off-pump, the surgeon must make the difficult decision of going back on pump, w ith its associated morbidity and mortality, or leaving the patient with a sub- optimal repair, and its associated sequalae.

[0006] Given the above challenges, it would be desirable to have an annuloplasty device that could be adjusted once the patient was weaned off-pump in order to fine-tune the AP diameter (short axis) or AL-PM diameter (long axis) of the mitral valve in order to correct for small errors in the inherently imprecise sizing process. Such a ring would have the potential to reduce poor mitral valve repair outcomes and the need to go back on-pump in many cases to address them. Once adjustments were made and desired outcome achieved, the deployment system attachments could be disengaged, leaving the patient with a customized annuloplasty device that was tailored to their specific anatomy.

[0007] In attempts to vary the shape of the repair device, adjustable annuloplasty devices such as the Cardinal mitral annuloplasty system originally from Valtech Ltd. of Israel, now a part of Edwards Lifesciences of Irvine, CA. The Cardinal system has a semi-rigid annuloplasty ring enabled for ring diameter fine tuning and optimization of leaflet coaptation on a beating heart under real-time echocardiographic guidance. The Cardinal system is disclosed in U.S. Patent Nos. 8,241,351 and 10,363,136 which are expressly incorporated herein by reference for all purposes.

[0008] Despite past attempts, there is a need for an annuloplasty ring that may be shaped adjusted to effect repair of a malfunctioning valve while avoiding negative outcomes.SUMMARY

[0009] Disclosed here are adjustable annuloplasty rings and deployment systems. The annuloplasty rings are size-adjustable after implant and facilitate delivery and reduce longterm complications. The rings each have a hollow circumference with a cinching element extending therethrough whose length is controlled remotely via a deployment system handle. The ring may be anchored to the annulus and then the size adjusted while the heart beats and under visualization to minimize regurgitation. The cinching element may be a loop of metal which is clamped to size w ithin a junction housing to which the deployment system attaches.

[0010] The rings are especially beneficial for repairing the mitral annulus, and may be saddle shaped with the junction housing located on an anterior side or posterior side. Each ring is advanced down to the mitral annulus along anchoring sutures. A distal end of a delivery or deployment system attaches to a junction housing at a midpoint of an anterior or posterior segment of the annuloplasty ring and in conjunction with a semi-rigid ring holderAttorney Docket No: SSHRG-23341 WOoi handle is used to parachute the ring down the array of sutures. The deployment system has a shaft long enough to extend from outside the body to the surgical site, and is connected to a proximal control handle. The length of the shaft allows for partial / full sternotomy and right lateral thoracotomy procedures.

[0011] The present application discloses a number of variations of an annuloplasty ring and shape adjustment system, comprising an annuloplasty ring defining a continuous peripheral shape around a central aperture and a central axis. The annuloplasty ring has a contractible support body defining a lumen extending therethrough and surrounded by a fabric outer cover. The support body extends around the peripheral shape and has two free ends connected to each other by a junction housing positioned along an anterior segment of the annuloplasty ring, the annuloplasty ring further including a flexible non-extensible cinching element passing through the support body lumen and into the junction housing, wherein the junction housing has an inner cavity w ith three openings - first and second aligned openings in communication with the support body lumen at the two ends of the support body, and a third opening at an upper port facing axially up from the junction housing, with the cinching element extending through the upper port. And w herein the support body has a relaxed implant shape when the cinching element is under no tension and a smaller, contracted shape when the cinching element is placed under tension

[0012] In one embodiment, the support body of the system is formed of a nitinol tube having a three-dimensional saddle shape with cutouts around its periphery, A segment of the support body diametrically across from the junction housing has a first pattern of alternating cutouts on inner and outer peripheries thereof, and in series with the first pattern has a helical second pattern that extends around lateral side segments toward the junction housing, such that the side segments are flexible and compressible w-hile the posterior segment is compressible but stiffer in the plane of the support body than in other directions. In one embodiment, the alternating cutouts on the inner and outer peripheries describe elliptical gaps of the same or different sizes. In another embodiment, the elliptical gaps on the outer periphery are larger than the elliptical gaps on the inner periphery. In a further embodiment, the two free ends of the support body that connect to the junction housing are each substantially solicl-walled and linear with a number of slots close to a terminal end for attaching to a side leg extending outw ard from the junction housing. The tw o free ends of the support body may also have a series of circumferential slits on one or both top and bottom faces to facilitates a small upward bend in the anterior segment.

[0013] In any embodiment, the support body defines a rounded D-shape, with the anterior segment in which the junction housing is centered being relatively straight and located opposite a convex posterior segment. The saddle-shaped support body is formed byAttorney Docket No: SSHRG-23341 WOoi the anterior and posterior segments rising up from the side segments therebetween, and wherein a minor axis extends across the support body intersecting mid-points of the anterior and posterior segments and the support body is symmetric across the minor axis.

[0014] Example 7. The cinching element of the system is a complete loop with a main portion extending around the lumen of the support body and a subloop that projects perpendicular to the main portion through the upper port of the junction housing. A delivery shaft terminates in a distal housing that engages the upper port of the junction housing and the subloop. And, a locking clip situated in the distal housing over the upper port of the junction housing has an aperture through which the subloop passes. The locking clip includes an accordion- or spring-like expandable segment that is held in a compressed configuration. When a portion of the deliver}’ shaft retracts from the locking clip the expandable segment converts to an expanded configuration which both locks the subloop, holding the support body in the smaller, contracted shape, and causes a portion of the subloop to collapse, thus reducing its profile above the junction housing.

[0015] In another example of the system, the delivery’ shaft has a lock actuator with a pair of fingers that extend within the distal housing, and the locking clip has a pair of side cutouts that receive the fingers to hold the expandable segment in the compressed configuration, wherein retraction of the fingers from within the distal housing releases the expandable segment to convert to the expanded configuration. The delivery shaft may have tensioning structure to pull the subloop in a proximal direction to tension the cinching element and reduce the support body to the contracted shape, and the lock actuator is movable independently from the tensioning structure. The system may further include a harness attached to the junction housing which loops inside one of the fingers, the harness holding the distal housing against the junction housing, wherein retraction of the fingers from within the distal housing also releases the distal housing for detachment from the junction housing. The locking clip may reside within an inner cavity of the distal housing and be oriented lateral to a proximal-distal direction so that a midsection of the subloop is displaced laterally w’hen the expandable segment converts to the expanded configuration w hich both pinches the subloop and cause a portion of the subloop exposed above the locking clip to collapse downw ard. The locking clip may pinch the subloop to have a 180° bend and increase a holding force of the locking clip for a given amount of strain experienced by the expandable segment.

[0016] In another example of the system, the cinching element of the system has a main portion extending around the lumen of the support body and terminates at a first free end anchored within the junction housing with a second free end extending through the upper port of the junction housing. A delivery shaft terminates in a distal housing that engages theAttorney Docket No: SSHRG-23341 WOoi upper port of the junction housing and the first free end and has a lock shaft extending through the upper port. And, a locking member in the junction housing has a threaded lower shaft, wherein the lock shaft engages a shaped cavity in the locking member such that rotation thereof causes displacement of the locking member upward to clamp the second free end w ithin the junction housing and hold the support body in the smaller, contracted shape, And, wherein the lock shaft further includes a distal cutting rib that when retracted proximally within the delivery shaft is configured to sever the second free end close to the junction housing. The lock shaft may pass through a narrowing defined within the delivery' shaft, and the distal cutting rib may be frustoconical and larger than the narrowing such that when retracted proximally the distal cutting rib pinches and severs the second free end against the narrowing.

[0017] In another example of the system, the cinching element is a complete loop with a main portion extending around the lumen of the support body and a subloop that projects perpendicular to the main portion through the upper port of the junction housing. A delivery shaft terminates in a distal housing that engages the upper port of the junction housing and the subloop. The delivery shaft has a severing member bifurcated into halves flanking the subloop, each half having inwardly-directed teeth, and a camming shaft arranged for movement relative to the severing member. And, a clamping member wdthin the junction housing is bifurcated into halves flanking the subloop, each half having i vardly-directed teeth. Advancement of the camming shaft cams the severing member halves inward against the subloop and also causes inward movement of the clamping member halves against the subloop, wherein the teeth on the severing member halves are sharp and sever the subloop close to the junction housing. The severing member may be tapered with a narrow upper end and the clamping member is tapered with a narrow lower end, and advancement of the camming shaft acts on the tapered severing member to both cam the severing member halves inward and push the clamping member toward a frustoconical cam sleeve positioned within the junction housing to cause inw ard movement of the clamping member halves. Each severing member half may include two inwardly-directed sharp teeth facing identical teeth on the other severing member half, and each clamping member half may include two in ardly-directed sharp teeth facing identical teeth on the other clamping member half. The the camming shaft may be rotatable about its axis so as to facilitate severing of the subloop by the severing member. The delivery shaft distal housing may have an outer shroud that extends down around the junction housing, and further include a pair of retention arms pivotable on the outer shroud that hold the distal housing to the junction housing, wherein proximal retraction of the camming shaft frees the retention arms to pivot and permits removal of the distal housing from the junction housing.Attorney Docket No: SSHRG-23341 WOoi

[0018] In a rotating cap version of the system, the cinching element has a main portion extending around the lumen of the support body and a secondary portion that extends into the junction housing and anchors to an upper spinner cap that is positioned and rotatable on an upper rim of a base member of the junction housing. A locking clip located within an inner cavity of the base member has a cantilevered locking lever that engages and prevents rotation of the spinner cap. And, a delivery shaft engageable with the junction housing has a rotation tool with a distal end shaped the same as an aperture in an upper surface of the spinner cap for rotation thereof. The distal end has a length sufficient to flex the locking lever downward and unlock the spinner cap for rotation, wherein rotation of the spinner cap wraps the secondary portion around a central post of the base member of the junction housing and converts the support body to the smaller, contracted shape.

[0019] In the rotating cap version, the locking clip may be held on an upper pedestal of the central post, and the upper pedestal may have upward projections which orient and fix the rotational position of the locking clip and a slot into which the locking lever may be flexed downward. The spinner cap may have a tubular vertical wall extending downward into the inner cavity of the base member, and the vertical wall has a plurality of inwardly-directed ribs that interact with the locking lever to prevent rotation of the spinner cap until the locking lever is flexed downward. The locking clip may be held on an upper pedestal of the central post, the upper pedestal has upward projections which orient and fix the rotational position of the locking clip and a slot into which the locking lever may be flexed downward. The spinner cap may have a tubular vertical wall extending downward into the inner cavity of the base member, the vertical wall having a plurality of inwardly-directed ribs that interact with the locking lever to prevent rotation of the spinner cap until the locking lever is flexed dow nward. The cinching element secondary portion may include two free ends that extend into the inner cavity of the base member and pass upward through apertures in the spinner cap, free ends having balls fastened thereto that are held within depressions formed in the upper surface of the spinner cap to enable the rotating spinner cap to pull and wrap the free ends around the central post. Or, the cinching element secondary portion may include two free ends that extend into the inner cavity of the base member and have terminal loops that anchor on cleats formed in the spinner cap to enable the rotating spinner cap to pull and wrap the free ends around the central post. Still further, the cinching element may be a complete loop and the secondary portion extends through the junction housing and has a single loop formed in its midsection anchored to the spinner cap to enable the rotating spinner cap to pull and wrap the free ends around the central post. The spinner cap may have a tubular vertical wall extending dow nward into the inner cavity of the base member, the vertical wall having a cut out on one side through which the cinching element passes with the single loop anchored to the cleat in an opposite side of the vertical wall.Attorney Docket No: SSHRG-23341 WOoi

[0020] Any system may further include a braided polymer sleeve surrounding the cinching element at least w ithin the junction housing. The braided polymer sleeve may extend to a point above the upper port, leaving a portion of the cinching element exposed for grasping and tensioning. The braided polymer sleeve may extend entirely around the support body. The braided polymer sleeve may be a T-shaped insert that fits within the junction housing and extends out of the three openings therein. The braided polymer sleeve may have a radial thickness of between about o.i and 0.2 mm.

[0021] In any system herein, the cinching element may comprise a braided nitinol, stainless steel, or cobalt chromium (CoCr) alloy core having a braided polymer exterior.

[0022] In any system herein, the support body may be formed of a metallic tube having V-shaped gaps formed therein to permit contraction.

[0023] Any system herein may further include a hollow compressible filler member extending within the support body lumen and through which the cinching element extends.

[0024] In any system herein, the tubular fabric cover surrounding the support body may have a sewing cuff of a ring of fabric attached to an outer periphery thereof.

[0025] A further understanding of the nature and advantages will become apparent by reference to the remaining portions of the specification and drawings.BRIEF DESCRIPTION OF THE DRAWINGS

[0026] Features and advantages of the present disclosure will become appreciated as the same become better understood with reference to the specification, claims, and appended drawings wherein:

[0027] Figure 1A-1E are perspective view s of an atrial side of a mitral annulus illustrating several steps of implanting and adjusting an annuloplasty ring of the present application;

[0028] Figure 2 is a perspective view7of an exemplary deployment system for the adjustable annuloplasty ring, and Figure 2A is an enlarged view of the distal end of a deployment shaft coupled to the annuloplasty ring;

[0029] Figure 3 is a perspective view7of the distal end of the deployment shaft show n in phantom engaged with a junction housing of the annuloplasty ring;

[0030] Figure 4A is a perspective view7of an inner coupling member of the deployment shaft engaged with the ring junction housing, and Figure 4B shows disengagement of the coupling member from the junction housing;Attorney Docket No: SSHRG-23341 WOoi

[0031] Figure 5A is a vertical sectional view of the interaction between the distal end of the deployment shaft and the junction housing of the annuloplasty ring, Figure 5B is an exploded perspective view of the components thereof, and Figure 5C (sheet 12) is a vertical sectional view showing tension being applied by a tension adjustment cable through the deployment shaft to a cinching element within the annuloplasty ring;

[0032] Figure 6 is a perspective view of the exemplary adjustable annuloplasty ring, Figure 6A is an enlarged cutaway view of one portion thereof, and Figure 6B is a radial sectional view thereof;

[0033] Figure 7 is a perspective view of the distal end of the deployment shaft coupled to the adjustable annuloplasty ring having an outer cover removed, and Figure 7A is an exploded perspective view of the inner components of the annuloplasty ring;

[0034] Figure 8A is a perspective view of the adjustable annuloplasty ring with the outer cover and an inner filler tube removed, and Figure 8B is the same perspective view with a coiled body removed illustrating the cinching element;

[0035] Figure 9A is an enlarged perspective view of a junction housing of the adjustable annuloplasty ring, and Figure 9B is a cutaw ay viewrof the junction housing showing internal components thereof;

[0036] Figure 10A is a view similar to Figure 9B showing tension being applied by the adjustment cable to the cinching element, Figure 10 B is a view of the junction housing being acted on by a locking driver of the deployment system, and Figure 10C shows the junction housing after the cinching element has been locked in place;

[0037] Figure 11 is a front elevational view of a saddle-shaped support body for an annuloplasty ring formed by laser cutting a nitinol tube and a junction housing;

[0038] Figure 12 is a perspective view’ of another saddle-shaped support body for an annuloplasty ring formed by laser cutting a nitinol tube;

[0039] Figure 13 is a perspective view of a linear nitinol tube after having been laser cut, and Figure 14 is a different perspective view’ of the support body of Figure 12 after the linear nitinol tube has been shape set;

[0040] Figure 15A is a perspective view of a lower portion of a shape setting mandrel having the laser cut support body positioned thereon, and Figure 15B is a mandrel assembly that sandwiches the laser cut support body for shape setting;

[0041] Figures 16A-16C perspective views of one junction housing mechanism used to lock tension within a cinching element for an adjustable annuloplasty ring;Attorney Docket No: SSHRG-23341 WOoi

[0042] Figure 17A is a partial sectional view of a junction housing having a clamping mechanism for locking tension w ithin the cinching element, and Figure 17B is a sectional view thereof;

[0043] Figure 17C is a partial sectional view of the junction housing of Figure 17A after the clamping mechanism is actuated, and Figure 17D is a sectional view thereof;

[0044] Figures 18 and 19 are perspective assembled and exploded views, respectively, of an alternative adjustable annuloplasty ring having a clip-based locking mechanism;

[0045] Figures 20A and 20B show the operation of the clip-based locking mechanism to lock tension within a cinching element;

[0046] Figures 21A and 21B are perspective views of an alternative cinching element locking mechanism before and after actuation of a locking member;

[0047] Figures 22A and 22B are sectional views of an alternative cinching element locking mechanism before and after actuation of a locking member;

[0048] Figure 23 is a perspective view of the distal end of a deployment shaft engaged with a junction housing of an adjustable annuloplasty ring with a portion of the deployment shaft cutaway to show a locking clip therein, and Figure 23A is a perspective view of the locking clip in a relaxed configuration;

[0049] Figures 24A and 24B are sectional views through the deployment shaft and junction housing of Figure 23 before and after deployment of the locking clip;

[0050] Figures 25A and 25B illustrate a harness attached to a junction housing for ensuring that a delivery shaft remains attached during adjustment and release of the annuloplasty ring;

[0051] Figure 26 is a perspective view of an adjustable annuloplasty ring of the present application showing a subloop of the cinching element extending upward from a junction housing after having been tensioned by locking clips;

[0052] Figures 27A and 28A are cutaway and sectional views of a deployment shaft mechanism for applying tension to a cinching element, and Figures 27B and 28B illustrate release of the cinching element;

[0053] Figure 29 is a sectional view through a deployment shaft mechanism for applying tension to a cinching element;

[0054] Figures 30A-30C schematically illustrate steps in release of the cinching element of Figure 29;Attorney Docket No: SSHRG-23341 WOoi

[0055] Figure 31 is a perspective view of a junction housing having a loop control sleeve assembled thereon;

[0056] Figure 32 is a perspective view of a distal end of a deployment shaft engaging the junction housing of Figure 31 and showing fingers of the loop control sleeve flexed outward around the deployment shaft;

[0057] Figures 33A and 33B schematically illustrate operation of the fingers of the loop control sleeve to secure a subloop of a cinching element;

[0058] Figures 34A and 34B are before and after sectional views showing operation of a loop control insert of the present application;

[0059] Figure 35 is a plan view of the loop control insert in a flattened configuration, and Figures 36A and 36B show the loop control insert in elongated or flexed and relaxed shapes, respectively;

[0060] Figures 37A and 37B are before and after sectional views showing operation of an alternative loop control insert of the present application;

[0061] Figure 38 is a plan view of the alternative loop control insert in a flattened configuration, and Figures 39A and 39B show the loop control insert in elongated or flexed and relaxed shapes, respectively;

[0062] Figure 40 is a perspective view of an adjustable annuloplasty ring of the present application showing a subloop of the cinching element extending upward from a junction housing after having been tensioned by locking clips and showing the distal end of a deployment shaft in phantom thereover and the path of a loop control tether;

[0063] Figure 41 is a perspective view showing the subloop buried within the fabric cover of the annuloplasty ring by the loop control tether;

[0064] Figures 42A-42C are perspective views of a junction housing having a cinching element lock and cut mechanism in several stages of actuation;

[0065] Figure 43A shows a junction housing and a deployment shaft in sectional view having a cinching element tensioning and severing mechanism, and Figure 43B is an enlarged view of the severing mechanism comprising electrodes;

[0066] Figures 44A and 44B are sectional views of a still further cinching element locking mechanism before and after actuation, wherein the cinching element terminates at one end within the junction housing;

[0067] Figure 44C shows a further step where an actuating member of the deliverysystem severs the cinching element, and Figure 45 is an enlargement thereof;Attorney Docket No: SSHRG-23341 WOoi

[0068] Figure 46 is a perspective view of an adjustable annuloplasty ring without an outer fabric cover and show ing the engagement of a junction housing by a deployment system partly in phantom, and Figure 46A is an enlargement of the deployment system thereof;

[0069] Figures 47 A and 48A are sectional and perspective view s of the deployment system and junction housing of Figure 46 during a tensioning step, Figures 47B and 48B show a step of severing the cinching element; and Figures 47C and 48C show disengagement of the deployment system from the junction housing;

[0070] Figure 49 is a sectional view through an exemplary control handle for operating the deployment system of Figure 46;

[0071] Figure 50 is a perspective view of an adjustable annuloplasty ring without an outer fabric cover illustrating an alternative junction housing utilizing a spinner cap;

[0072] Figure 51 is an exploded perspective view of the adjustable annuloplasty ring ofFigure 50, and Figure 51A is an enlargement of components of the junction housing thereof;

[0073] Figure 52 is a perspective exploded view of the junction housing showing the path of the free ends of a cinching mechanism therein;

[0074] Figures 53A and 53B are bottom plan and radial sectional views through the spinner cap of the junction housing;

[0075] Figures 54A and 54B are schematic view s of the spinner cap cutaway and interaction of a locking lever of a locking clip therewith;

[0076] Figures 55A and 55B are sectional views through the junction housing during tensioning and locking steps, respectively;

[0077] Figure 56 is a perspective view of an alternative spinner cap for use with the junction housing of Figure 50;

[0078] Figures 57 and 58 are bottom plan views of two different versions of the alternative spinner cap of Figure 56 interacting with different cinching elements;

[0079] Figure 59 is an enlargement of one end of the cinching element seen in Figure 57;

[0080] Figure 60 is an enlargement of a midportion of the cinching element seen in Figure 58, and Figure 60A is an enlargement of a middle loop thereof;

[0081] Figure 61 is a schematic view' of a mandrel for creating the middle loop of the braided cinching element of Figure 60;Attorney Docket No: SSHRG-23341 WOoi

[0082] Figure 62 is a perspective view of another adjustable annuloplasty ring having a cinching element with two free ends extending upward through a junction housing and an intermediate friction reduction sleeve within a support body thereof;

[0083] Figure 63 is an exploded perspective view of the components of the adjustable annuloplasty ring of Figure 62;

[0084] Figures 64A-64C are several views of a junction housing of an adjustable annuloplasty ring illustrating a friction reduction tube surrounding a cinching element thereof;

[0085] Figure 65 is a schematic view’ of a manufacturing assembly for forming a friction reduction tube around a cinching element, and Figures 65A and 65B are enlargements of the cinching element and a braided cloth covering therein, respectively;

[0086] Figure 66A is a perspective view of an adjustable annuloplasty ring junction housing of an adjustable annuloplasty ring illustrating a friction reduction insert around a cinching element, Figure 66B shows the annuloplasty ring without an outer cover, and Figure 66C shows just the friction reduction insert;

[0087] Figure 67 is a schematic plan view of another adjustable annuloplasty ring having an alternative constriction mechanism;

[0088] Figure 68 is an enlargement of the alternative constriction mechanism including a rack and pinion assembly, and Figure 68A is an enlargement of a pinion thereof;

[0089] Figure 69 is a schematic plan view’ of a further adjustable annuloplasty ring having a constriction mechanism that utilizes a rack and pinion assembly;

[0090] Figure 70 is a perspective view of a cinching element and junction housing for the annuloplasty ring of Figure 69, and Figure 70A is an enlargement of the rack and pinion assembly thereof;

[0091] Figure 71 is a perspective view of another adjustable annuloplasty ring, and Figure 72 is a perspective view of the cinching element and junction housing thereof;

[0092] Figure 73 is an enlargement of the junction housing of the annuloplasty ring of Figure 71, and Figure 73A is an enlargement of the rack and pinion assembly thereof;

[0093] Figures 74A and 74 B are locked and unlocked views of the junction housing of Figure 73;

[0094] Figure 75 is a top plan view of an alternative cinching element and adjustment mechanism thereof;Attorney Docket No: SSHRG-23341 WOoi

[0095] Figures 76A and 76B are enlargements of the adjustment mechanism of Figure 75 illustrating two-way operation thereof;

[0096] Figure 77 is a top plan view of another adjustable annuloplasty ring having a worm screw type of adjustment mechanism, and Figure 77A is an enlargement of the adjustment mechanism;

[0097] Figures 78A and 78B are enlargements of portions of the adjustment mechanism of Figure 77A;

[0098] Figure 79 is a top plan view of another adjustable annuloplasty ring having a worm screw type of adjustment mechanism, and Figure 79A is an enlargement of the adjustment mechanism;

[0099] Figures 80A and 80B are enlargements of portions of the adjustment mechanism of Figure 79A;

[0100] Figure 81 is a top plan view of another adjustable annuloplasty ring having a worm screw type of adjustment mechanism, and Figure 81A is an enlargement of the adjustment mechanism;

[0101] Figure 82 illustrates operation of the adjustment mechanism of Figure 81A;

[0102] Figure 83 is a top plan view of another adjustable annuloplasty ring having a worm screw type of adjustment mechanism, and Figure 83A illustrates operation of the adjustment mechanism;

[0103] Figure 84 is a perspective view of a still further adjustable annuloplasty ring having an alternative outer fabric cover with an attachment flange, and Figure 84A is a sectional view thereof;

[0104] Figure 85 is a sectional view of the annuloplasty ring of Figure 84 showing sutures passing through the attachment flange and into the target annulus;

[0105] Figure 86 is an enlarged view of an outer fabric cover of the annuloplasty ring of Figure 84;

[0106] Figure 86A is an enlargement of a portion of Figure 86, and Figure 86B is a still further enlargement of one of the fabric strands from Figure 86A;

[0107] Figure 87 is a top plan view of an adjustable annuloplasty ring in accordance with any of the embodiments of the present application with a junction housing in the middle of an anterior side thereof; and

[0108] Figure 88 is a top plan view of an adjustable annuloplasty ring of the present application w ith the junction housing in the middle of a posterior side thereof.Attorney Docket No: SSHRG-23341 WOoiDETAILED DESCRIPTION

[0109] The right ventricle and left ventricle are separated from the right atrium and left atrium, respectively, by the tricuspid valve and mitral valve; e.g., the atrioventricular valves. Though correction of the mitral annulus is the primary focus of the present application, it should be understood that certain characteristics of the annuloplasty rings described herein may equally be used to treat the tricuspid valve, and thus the claims should not be constrained to the mitral ring unless expressly limited.

[0110] The term “axis” in reference to the illustrated annuloplasty rings, and other noncircular or non-planar rings, refers to a line generally through the centroid of the ring periphery when viewed in plan view. “Axial” or the direction of the “axis” can also be viewed as being parallel to the average direction of blood flow within the valve orifice and thus wit in the ring when implanted therein. Stated another way, an implanted mitral ring orients about a central flow axis aligned along an average direction of blood flow through the mitral annulus from the left atrium to the left ventricle. The plan views of the annuloplasty rings illustrated herein are as looking from the atrial side in the direction of blood flow. For the purpose of orientation, therefore, the atrial side of the ring is up and the ventricular side is down.

[0111] Figure 1A is a schematic perspective view from the atrial side of a mitral valve MV w ith posterior being down and anterior being up. The mitral valve MV primarily comprises a pair of floppy coapting leaflets - an anterior leaflet AL and a posterior leaflet PL - secured around their outer edges to a fibrous mitral annulus MA. The anterior leaflet AL attaches to a somewhat straighter anterior fibrous portion of the mitral annulus MA, which makes up about one-third of the total mitral annulus circumference. The anterior fibrous annulus forms part of the central fibrous skeleton of the heart, and the two ends are called the fibrous left and right trigones. The arcuate muscular portion of the mitral annulus MA constitutes the remaining two-thirds of the mitral annulus, and the posterior leaflet PL attaches thereto. An anterior commissure AC and a posterior commissure PC at the junction of the two leaflets on each side are located just posterior to each fibrous trigone.

[0112] The peripheral mitral annulus MA is often described as kidney bean or D-shaped with a somewhat straighter side adjacent the anterior leaflet AL and a more rounded or convex side adjacent the posterior leaflet PL. The mitral annulus MA is typically viewed as having a major axis across its widest part, approximately between the commissures AC and PC, and a perpendicular minor axis that generally bisects both the anterior leaflet AL and posterior leaflet PL. A central axis Z flow direction is arbitrarily defined at the intersection of the major and minor axes.Attorney Docket No: SSHRG-23341 WOoi

[0113] Figure 1A-1E illustrate several steps of implanting and adjusting an annuloplasty ring 20 of the present application. The procedure for gaining access to the mitral annulus involves making an incision through the patient’s sternum (sternotomy) and then stopping the heart and rerouting blood flow through a heart-lung “cardiopulmonary ” bypass machine. The mitral annulus is exposed through the left atrium. At this point a measurement is taken of the mitral annulus MA, typically by measuring the width across the major axis between the anterior and posterior commissures AC, PC as well as the leaflet area. Annuloplasty rings are conventionally provided in sizes between 24 and 40 mm, in 2-mm increments. The final size of the adjustable annuloplasty ring 20 as described herein is not constrained to these 2- mm increments, but is provided in a number of sizes per usual to best match the particular mitral annulus being repaired.

[0114] Once the mitral annulus MA is accessible, as seen in Figure 1A, a series of anchoring sutures 22 are pre-installed around the annulus. The anchoring sutures 22 are each looped through the atrial side to the ventricular side of the annulus, and then passed back up so that there are multiple pairs of sutures coming up out of the implantation site. In the illustrated embodiment, there are twelve pairs of sutures shown, though more or less may be utilized. Pledgets or small strips of fabric or other such backing (not shown) may be installed on the ventricular side of the suture loops to help prevent suture pull-through.

[0115] Figure 1B shows an annuloplasty ring 20 of the present application being advanced down to the mitral annulus MA along the pairs of sutures 22. A distal end of a delivery or deployment system 24 attaches to a junction housing 26 at a midpoint of an anterior segment of the annuloplasty ring 22 and is used to parachute the ring down the array of sutures 22. The deployment system 24 has a shaft 28 long enough to extend from outside the body to the surgical site, the shaft being connected to a proximal control handle as will be described below.

[0116] Figure 1C shows the implanted annuloplasty ring 20 after the pairs of sutures 20 have been tied off into knots 30 and severed close to the ring. The distal end of the deployment system 24 remains attached to the junction housing 26. Following the process of anchoring the annuloplasty ring 20 to the mitral annulus MA, the left atrium is closed around the deployment system 24 with one or more purse string sutures. All other incisions are closed to prevent blood loss, with the deployment system 24 remaining such that it may be controlled by its proximal control handle outside the body. Subsequently, the patient is weaned off of cardiopulmonary bypass and heart restarted.

[0117] Adjustment of the annuloplasty ring 20 to optimize the repair is guided by a visualization technique such as transesophageal echocardiography (TEE) or in rare cases fluoroscopy, mainly focusing on residual mitral regurgitation, degree of leaflet coaptationAttorney Docket No: SSHRG-23341 WOoi and the presence of transmitral gradients. For example, Figure 1D illustrates the mitral valve MV during systole when the anterior leaflet AL and posterior leaflet PL come together or coapt. In this illustration, mitral regurgitation is indicated by the escaping blood flow which can be seen on TEE. This means that the leaflets AL, PL are not coapting, which may be corrected by reducing the size of the annuloplasty ring 20. Even if there is no regurgitation seen, the surgeon may still decide to adjust the ring size in order to obtain a larger surface of coaptation.

[0118] Figure 1E shows the annuloplasty ring 20 being reduced in size using the proximal control handle 32, which again is outside the body. Cinching the annuloplasty ring 20 in this regard brings the leaflets AL, PL closer together, and also the AL-PM diameter when desired, thus improving coaptation. In the illustration, the mitral valve MV is closed during systole w ith the leaflets coapting and no regurgitation detected. The annuloplasty ring 20 may be reduced in size by at least about 2 mm across the major axis, equivalent to one standard ring size. Further reduction in major axis dimension may be provided up to about 4 mm. Expansion of at least about 2 mm is also contemplated. Following ring size adjustments, the deployment system 24 is disengaged from the annuloplasty ring 20 and removed from the body. The purse string suture through the left atrial wall and any other openings are then closed to complete the procedure.

[0119] Figure 2 is a perspective view of an exemplary deployment system 24 for the adjustable annuloplasty ring 20, and Figure 2A is an enlarged Anew of the distal end of a deployment shaft 28 coupled to the junction housing 26 of the annuloplasty ring. The proximal control handle 32 is shown in approximately the actual proportional size relative to the annuloplasty ring 20, and generally comprises a cylindrical body having a plurality of controls thereon. The elongated shaft 28 is shown with a break, but may have a length of between 40-80 cm. The shaft is configured to have some lateral flexibility, but is stiff under compression and torque.

[0120] The distal end of the shaft 28 terminates in a tapered shroud or housing 34 with a pair of diametrically-opposed extensions 36 that straddle the junction housing 26 on radially inner and outer sides. Another way to see the housing 34 is that the extensions 36 define cutouts therebetween aligned around the periphery of the annuloplasty ring 20. As will be explained below, the distal housing 34 encloses a number of operative elements which engage the junction housing 26 to adjust the size of the annuloplasty ring 20 and perform several other tasks.

[0121] Figure 3 is a perspective view of the distal end of the deployment shaft 28 shown in phantom engaged with the junction housing 26, while Figure 4A illustrates an inner coupling member 40 of the deployment system 24 engaged with the junction housing. OneAttorney Docket No: SSHRG-23341 WOoi way to couple the deployment system 24 w ith the annuloplasty ring is by using an internally threaded coupling member 40 which engages external threads 42 on the junction housing 26. The junction housing 26 has a main body 44 defining a three-way connection. Oppositely-directed side legs 46 extend along the periphery of the annuloplasty ring 20 and connect with an internal passage therein. A single upper port 48 having the external threads 42 thereon projects upward perpendicularly relative to the side legs 46. The deployment shaft 28 connects to the annuloplasty ring 20 in line with the upper port 48, and the coupling member 40 screws onto the external threads 42. Figure 4B shows disengagement (unscrewing and retraction) of the coupling member 40 from the junction housing 26, which is how the deployment system 24 is decoupled from the annuloplasty ring 20.

[0122] Figure 5A is a vertical sectional view of the interaction between the distal end of the deployment shaft 28 and the junction housing 26, while Figure 5B is an exploded perspective view of the components thereof. The outer shroud or housing 34 has an upper recess 50 into which the distal end of the deployment shaft 28 is fixed, and a w ider internal distal end which matches the cup-shape of the coupling member 40. The coupling member 40, in turn, is located at the distal end of an elongated tubular first shaft 52 which extends through a lumen of the deployment shaft 28 to the control handle 32. A tubular second shaft 54 slides and rotates concentrically within the first shaft 52 and has a distal non-circular torque driver 56 thereon. As will be explained below, the torque driver 56 engages an element within the junction housing 26 to lock the shape of the adjustable annuloplasty ring 20.

[0123] A final element of the deployment system 24 is an adjustment cable 58 that extends from the control handle 32 through the lumen of the tubular second shaft 54 to the junction housing 26. Figure 5A shows the adjustment cable 58 in the form of a loop which extends through a subloop of the cinching element 60 that projects up through a central opening in the junction housing 26. Figure 5C (sheet 12) is a vertical sectional view showing tension being applied by the adjustment cable 58 through the deployment shaft 28 to the cinching element 60. In one embodiment, the adjustment cable 58 comprises a filament, such as a polymeric suture or metal cable, while the cinching element 60 is formed by a flexible metallic wire. The cinching element 60 may be formed of nitinol, stainless steel, or a cobalt chromium (CoCr) alloy, and will be described in greater detail below.

[0124] Figure 6 is a perspective view of the exemplary adjustable annuloplasty ring 20, and to better explain the construction thereof, Figure 6A is an enlarged cutaway view of one portion and Figure 6B is a radial sectional view thereof. As mentioned above, the annuloplasty ring defines a rounded D-shape with a straighter anterior segment 62 in which is centered the junction housing 26 opposite a rounded posterior segment 64. Aside from theAttorney Docket No: SSHRG-23341 WOoi junction housing 26, the exterior of the annuloplasty ring 20 is covered with a tubular fabric cover 66 with a sewing cuff 68 added to a peripheral outer edge. The fabric cover 66 closely surrounds a coiled body 70 through which a hollow filler member 72 extends. Finally, the cinching element 60 passes around the entire peripheiy of the annuloplasty ring 20 within a central lumen in the filler member 72. The filler member 72 acts as a cushion between the cinching element 60 and coiled body 70.

[0125] The radial sectional view of Figure 6B shows the extent that one embodiment of a sewing cuff 68 extends outward from the fabric cover 66, w hich will be more fully discussed below. The sewing cuff 68 comprises a ring of fabric 74 formed by a single layer that is attached by a series of stitches 76 along the upper and lower edges to the fabric cover 66. In one embodiment, the stitches 76 are colored differently than both the fabric cover 66 and ring of fabric 74 so that the upper and lower edges of the ring of fabric is accentuated. This serves to inform a surgeon where to pass the anchoring sutures - e.g., between the stitches 76 along the upper and lower edges of the ring of fabric 74. The outer cover 66 further has a plurality of discrete marker bands 78 sew n thereto, at positions indicating the points on the ring corresponding to the fibrous trigones and midpoint of the posterior segment of the mitral annulus. The marker bands 78 help position the ring 20 around the annulus during implantation.

[0126] To further explain the structure of the annuloplasty ring 20, Figure 7 is a perspective view of the distal end of the deployment shaft 28 coupled to the ring having the outer cover removed, and Figure 7A is an exploded perspective view of the inner components of the annuloplasty ring, w hile Figure 8A is a perspective view of the ring with the outer cover 66 and inner filler member 72 removed, and Figure 8B is the same perspective view with the coiled body 70 removed illustrating the cinching element 60. As can be seen from these images, each of the components of the cinching element 60, coiled body 70 and filler member 72 approximately define the rounded D-shape of the annuloplasty ring 20, and are preferably pre-formed into such a shape. For example, the coiled body 70 is desirably a highly elastic metal such as nitinol and may be heat set into the illustrated shape.

[0127] As seen best in Figure 7A, both the coiled body 70 and filler member 72 define two free ends on their straighter anterior sides that are spaced apart to accommodate the junction housing 26 therebetween. In contrast, the cinching element 60 forms a continuous loop that passes into the interior of the junction housing 26 and projects upward in a vertical subloop 80 through the upper port 48 thereof (Figure 8A). As seen by the arrows in Figure 8B, pulling on the subloop 80 constricts the remainder of the cinching element 60 to reduce the circumference of the annuloplasty ring 20. That is, both the coiled body 70 and filler member 72, not to mention the outer fabric cover 66, are flexible in terms of constriction,Attorney Docket No: SSHRG-23341 WOoi and thus the cinching element 60 determines their final size. As will be seen, the cinching element 60 is locked in its reduced diameter constricted state within the junction housing 26. Due to the metallic nature of the cinching element 60 the ring size remains the same after constriction and is not subject to stretching from material creep.

[0128] The cinching element 60 provides an advantage over prior adjustable annuloplasty rings in that it remains in a continuous loop before and after ring adjustment. Prior annuloplasty rings having sutures that extend around the periphery of the annuloplasty ring required a tool to cut them, adding complexity to the deployment system. Furthermore, once cut, the free ends of the sutures sometimes presented sharp trimmed ends extending away from the annuloplasty ring potentially leading to tissue irritation or worse. Finally, sutures have been exclusively used in the past which are made of a polymer and subject to material creep, thus allowing the ring to expand over time. The cinching element 60, on the other hand, is made of a metal such as a cobalt chromium alloy which resists creep.

[0129] Figures 8A-8B also indicate how the junction housing 26 connects to the body of the annuloplasty ring 20. The coiled body 70 in the illustrated embodiment has a series of regularly spaced apart coils around most of its periphery except at its free ends 82 which are more tightly coiled, forming something of a tube. The tubular free ends 82 abut outer flanges formed on the side legs 46 of the junction housing 26. Although not shown, the outer cover 66 extends inward over the free ends 82 and is secured within a pair of grooves 84 defined between flanges on the side legs 46. The outer cover 66 may have smaller diameter ends formed by a cinched portion or constriction ring or the like to hold the ends within the grooves 84. The filler body 72 may terminate co-extensively with the coiled body 70, or may extend a short distance into the hollow side legs 46.

[0130] Figure 9A is an enlarged perspective view of the junction housing 26 of the adjustable annuloplasty ring 20, and Figure 9B is a cutaway view showing internal components thereof. As mentioned above, the junction housing 26 has a three-way connection with a main body 44 and oppositely-directed side legs 46. The upper port 48 defines an upper opening of a vertical channel which leads down to a horizontal channel through the side legs 46. As mentioned, the cinching element 60 extends around the ring and into the channels of the side legs 46, and then upward in the subloop 80 so as to be accessible through the upper port 48. The subloop 80 passes through the hollow center of a locking screw 86 positioned in the vertical channel. The locking screw 86 has external threads 88 which engage internal threads defined within the vertical channel of the junction housing 26. For example, Figure 9B illustrates an inward projection 90 formed by the side legs 46 that may be shaped to mate with the external threads 88. The locking screw 86 has a non-circular internal throughbore 92 to enable rotation by the torque driver 56 (See Figure 5B). In the embodiment illustrated inAttorney Docket No: SSHRG-23341 WOoiFigures 9-10, the through bore 92 has a square configuration, though the torque driver 56 is shown with an alternative star-shaped configuration. Either can be utilized, and both are shown for just that purpose.

[0131] Now with reference to Figures 10A-10C and 5C, the process for locking the cinching element 60 is explained. To recap, however, cinching the annuloplasty ring 20 and locking the cinching element 60 is done after anchoring the annuloplasty ring to the mitral annulus, as was described w ith reference to Figures 1A-1E. That is, the annuloplasty ring 20 has been anchored to the annulus with sutures, and then in Figure 1E the ring is constricted via a mechanism within the control handle 32 to reduce the size of the annulus.Furthermore, this procedure is done under visualization after closing up the access incisions and restarting the patient’s heart so as to observe any regurgitation through the mitral valve. The deployment shaft 28 extends from outside the patient’s body into engagement with the annuloplasty ring 20 during this process. Prior to cinching the annuloplasty ring 20, the surgeon observes the mitral valve function and if regurgitation is present, incrementally reduces the size of the ring 20 and then locks it w hen there is no more regurgitation.

[0132] Figure 5C illustrates the loop of the adjustment cable 58 being pulled in a proximal direction from the control handle 32. The adjustment cable 58 passes through the subloop 80 of the cinching element 60, and thus pulls the subloop up through the hollow locking screw 86 and reduces the circumference of the cinching element around the annuloplasty ring 20, as was depicted in Figure 8C.

[0133] Once the proper size of the annuloplasty ring 20 is determined, the locking screw 86 is advanced by rotating and advancing the torque driver 56, as seen in Figure 10B. Eventually, the lower end of the locking screw 86 pinches the diverging strands of the cinching element 60 against the interior lower wall of the junction housing 26. The optimal extent to which the locking screw 86 advances and clamps against the cinching element 60 within the junction housing 26 may be determined empirically, and then implemented in a number of ways. For example, the locking screw 86 may be calibrated in terms of its thread pitch to advance a particular axial distance upon a predetermined angular rotation, monitored at the control handle 32. Alternatively, the torque driver 56 may be actuated within the control handle 32 using a clutch mechanism which slips upon a predetermined reaction torque being sensed. Still further, the female threads within the junction housing 26 may be configured like a standard locking nut with a nylon insert or the like which provides a frictional resistance to further advancement of the locking screw 86 at a particular point. A nylon insert provides a further advantage in preventing reverse rotation of the locking screw 86.Attorney Docket No: SSHRG-23341 WOoi

[0134] Finally, after advancing the locking screw 86 to firmly clamp against the cinching element 60, as seen in Figure 10C, the deployment system 24 is disengaged from the junction housing 26, such as was shown and described with respect to Figures 4A-4B, and withdrawn from within the body, while closing up any remaining incisions. This is done simply by severing or releasing one strand of the looped adjustment cable 58 from the control handle 32, and then pulling the released strand from within the subloop 80. No special cutter or other such instrument at the distal end of the deployment system 24 is required to sever the adjustment cable 58 or the cinching element 60. What is left is the subloop 80 projecting somewhat from the upper port 48 of the junction housing 26.

[0135] The cinching elements disclosed herein are continuous loops, and thus the portion that sticks out the junction housing is relatively smooth and thus unobtrusive. Because of the rounded nature of the subloop 80, it presents minimal danger of lacerating or otherw ise irritating tissue or leaflets with i n the mitral valve. However, sometimes the subloop 80 extending out of the junction housing is relatively long due to a large size reduction in the ring, which can act as an irritant to the cardiac tissue, especially if the cinching element 60 and its subloop 80 are w holly or partly formed of metallic cable. These problems can be managed as described below.Shaped ring support bodies

[0136] Many commercial annuloplasty rings for treating patients with mitral regurgitation have semi rigid cores or support bodies, such as the Physio II and Physio Flex annuloplasty rings from Edwards Lifesciences and the Memo 4D annuloplasty ring from Corcym. Semi-rigid support bodies have the ability to remodel the annulus while preserving flexibility of movement. They typically include a saddle-shaped core to restore the shape and dynamic motion of the annulus. Occasionally, a sizing mismatch between the annulus and the semi rigid ring occurs once the heart is taken off cardiopulmonary bypass resulting in residual mitral regurgitation. The present application contemplates an improvement ring support body design w hich both maintains sufficient stiffness for annular remodeling while enabling adjustment of the ring size post-implant. Moreover, the support bodies disclosed herein present a reduced risk for suture dehiscence and maintain acceptable strain levels within the materials.

[0137] The adjustable continuous loop annuloplasty rings of the present application are designed to reduce mitral regurgitation in patients through a geometrical reduction of the mitral annulus anterior / posterior (A / P) dimension, as well as the Anterolateral posteromedial (AL-PM) dimension, thereby improving coaptation. The adjustable rings are primarily indicated for patients with degenerative mitral regurgitation. Providing a support body which is saddle shaped better matches the three-dimensional mitral annulus. In oneAttorney Docket No: SSHRG-23341 WOoi embodiment, the support body is formed from a nitinol tube which is laser cut to have a specific pattern fine-tuned to meet the tensile strain requirements for nitinol, while still providing optimal stiffness to satisfy the annulus reconstruction or remodeling function. The rings thus promote the natural behavior of the mitral valve while also reducing the geometrical dimensions of the annulus. Further, the saddle shape of the ring combined with its semi-rigidity e.g., semi-flexibility) helps alleviate the stress on the annulus, thereby reducing the risk of suture dehiscence and minimizing the rate of bleeding and stroke. Finally, the overall hoop flexibility of the semi-rigid nitinol rings is enough to accommodate a future valve-in-ring procedure, where an expandable valve is implanted within the ring.

[0138] Several proposed laser cut patterns in nitinol tubes are shown below. The designs were developed using finite element modeling to optimize the pattern for a given wall thickness to match the tensile strain levels established for nitinol, which designs could then be used to build prototypes for empirical testing. The laser cut patterns on the nitinol tubes are intended to achieve the following goals:

[0139] 1. Maintain strains within the material property boundaries for nitinol if the annuloplasty ring is completely downsized.

[0140] 2. Provide a stiffness which is comparable to annuloplasty rings formed of a cobalt-chromium alloy, for example, Elgiloy® alloy (Elgiloy Specialty Metals).

[0141] 3. Enable the support body to achieve a three-ring size reduction.

[0142] 4. Enable the support body to achieve a one-ring size increase.

[0143] 5. Provide variable tube stiffness along different regions of the support body for different patient etiologies.

[0144] Figure 11 is a front elevational view of an annuloplasty ring too having a saddle- shaped support body 102 formed by laser cutting a nitinol tube. A series of elliptical-shaped and other gaps 104 are cut into portions of a tubular nitinol body, before heat setting the body into the appropriate saddle-shape. The elliptical shape of the gaps 104 permits the design to be optimized to minimize high tensile strain concentration areas. This construction enhances the ability to control the stiffness of the annuloplasty ring too, while still being flexible and enabling post-implant circumferential constriction as described herein. The width of the elliptical shaped gaps 104 around a circumference of the support body 102 may be varied to vary the post-implant flexibility around the ring. Again, it may be desirable to increase the flexibility at the lateral commissure regions while maintaining relatively stiffer upward anterior and posterior curves to better support a diseased mitral valve prone to regurgitation. Furthermore, the wall thickness of the tubular blank used to form the support body may be modified to increase the overall stiffness if needed.Attorney Docket No: SSHRG-23341 WOoi

[0145] Figure 12 is a perspective view of another saddle-shaped support body 120 for an annuloplasty ring formed by laser cutting a nitinol tube. Figure 13 is a perspective view of the support body 120 in the form of a linear nitinol tube after having been laser cut, and Figure 14 is a perspective view of the support body after the linear tube has been shape set. The support body 120 has a plan or atrial-side view which generally defines a rounded D-shape, with a relatively straight anterior segment A opposite a curved or convex posterior segment P. A posterior plane PP that denotes the ends of the posterior segment P is shown perpendicular to a minor axis MA across which the support body 120 is symmetric. The anterior segment A has a pair of substantially solid-walled and linear free ends 122, while the posterior segment P is formed by a series of tubular segments 124 broken up by alternating inner and outer gaps 126. The anterior segment A is separated from the posterior segment P by lateral or side segments 128 formed by generally helical portions of the nitinol tube. The posterior segment P rises up to a midpoint, and the free ends 122 also rise up but not quite as much as on the posterior side.

[0146] In one embodiment, the alternating inner and outer gaps 126 between the tubular segments 124 in the posterior segment P describe elliptical shapes of the same or different sizes. The depth of each of the gaps 126 alternates on opposite sides of the support body 120, with larger elliptical gaps 126 on the outer peripheiy and smaller ones on the inner periphery. A wall thickness of about 0.25 mm is considered suitable.

[0147] The free ends 122 are each substantially a solid-walled tube 130 having a number of slots close to terminal ends for attaching to a junction housing, as seen below. A series of circumferential slits 134 on one or both top and bottom faces facilitates a small upward (atrial) bend in the anterior segment A to conform to the native rise in the anterior aspect.

[0148] The support body 120 is thus provided with areas of varying flexibility. The free ends 122 are relatively stiff, to both enable attachment to a junction housing and provide stiffness along the stiffer native anterior aspect. The side segments 128 on the other hand are highly flexible and notably compressible to facilitate the circumferential ring size reduction. Lastly, the posterior segment P is also somewhat flexible and compressible to facilitate ring size reduction, but not as flexible as the side segments 128 in order to maintain the upward bow or saddle and maintain conformance with the native posterior aspect. Looked at another w?ay, the side segments 128 are relatively compressible / expandable in all directions, while the posterior segment P is somewhat compressible / expandable but stiffer in the plane of the support body 120 than in other directions, such as up and down.

[0149] The support body 120 is laser cut when in the linear tubular shape of Figure 13, and then converted to the three-dimensional ring shape of Figure 14 by heat treating the tube to shape set it. Figure 15A is a perspective view of a lower portion 140 of a shape settingAttorney Docket No: SSHRG-23341 WOoi mandrel having the laser cut support body 120 positioned thereon, and Figure 15B is a mandrel assembly including an upper portion 144 that sandw iches the laser cut support body for shape setting. The lower portion defines a shaped groove 142 size to closely receive the tubular support body 120, which may be manually flexed and placed into the groove due to the flexibility of the laser cut nitinol. The upper portion 144 may have a groove similar but mirror image of the groove 142. The upper portion 144 of the mandrel assembly is then placed over the lower portion 140, w ith a mandrel alignment pin 146 helping to hold the support body 120 in place within the grooves 142. The lower portion 140 also includes an upwardly-projecting block 148 on the anterior side which both separates the free ends 122 of the support body 120 and fits within a similar-sized recess (not shown) in the upper portion 144.

[0150] Once the support body 120 is held w ithin the grooves 142 w ith the upper and lower portions 140, 144 held together, heat is applied for a predetermined amount of time to change the crystalline structure of the nitinol in the support body and set its shape. In one example, the shape setting parameters are about 260 °C (about 500 °F) for about five minutes, although these may change depending on the particular alloy of nitinol used as well as the wall thickness. Once shape set, the support body 120 is electropolished to remove any sharp burrs or other roughness / particles. The tensile strain within the nitinol material of the support body 120 formed in accordance with the patterns and shape setting herein is not expected to exceed about 0.07%.Alternative locking systems

[0151] Figures i6A-t6C perspective views of a mechanism in a junction housing 150 used to lock tension within a cinching element 151 for an adjustable annuloplasty ring 152. As with the earlier-described embodiments, the cinching element 151 extends around the circumference of the annuloplasty ring 152 and the emerges from the junction housing 150 in a subloop 154 projecting up on the atrial side of the ring. Although not shown, a delivery shaft includes actuators for pulling the subloop 154 to tension the cinching element 151 and reduce the circumference of the annuloplasty ring 152.

[0152] The junction housing 150 includes a pair of inner clamping members 156 that are acted on by an outer shroud 158. As seen in Figure 16C, the shroud 158 has a series of flats 160 distributed around its periphery to form a nut of sorts which is engaged by a wrench (not shown) within the delivery7shaft. Internal threads can be seen on the cutaway of the shroud 158 which enable the shroud to move up and down on a portion of the junction housing 150 and relative to the clamping members 156. The clamping members 156 comprise a pair of identical elements having frusto-conical upper surfaces which can be cammed inward when the shroud 158 is rotated to advance it downward on the housing 150. Facing inner surfacesAttorney Docket No: SSHRG-23341 WOoi of the clamping members 156 may have channels that receive the two links of the subloop 154 and clamp them tightly when the shroud 158 is advanced, as seen in Figure 16B. The junction housing 150 and inner components may be formed of various biocompatible polymers or metals.

[0153] Figure 17A is a partial sectional view of a junction housing 170 having a clamping mechanism for locking tension within an adjustable annuloplasty ring cinching element 172, and Figure 17B is a sectional view thereof. The cinching element 172 extends upward through passages 176 in the junction housing 170 to a subloop 174 which can be grasped by a delivery shaft actuator and pulled upward to reduce the size of the annuloplasty ring. When the desired annuloplasty ring circumference is reached, the clamping mechanism w ithin the junction housing 170 is actuated.

[0154] In this embodiment, the junction housing 170 has an upstanding, generally tubular portion 178 that is split into three segments by axial slits 180. A clamping nut 182 is arranged to travel along external threads on the tubular portion 178. Once the proper tension in the cinching element 172 is established, with the annuloplasty ring properly sized, the operator advances the clamping nut 182 using an actuator within a delivery shaft (not shown). The outer diameter of the tubular portion 178 is slightly tapered to be wider at its base than at its top so that the clamping nut 182 forces the outer portions inward to close the slits 180, as seen in Figures 17C and 17D. The material of the junction housing 170 and clamping nut 182 may be a relatively soft polymer so that the clamping nut self-locks by virtue of deformation of the mating threads.

[0155] Figures 18 and 19 are perspective assembled and exploded views, respectively, of an alternative adjustable annuloplasty ring 190 having a clip-based locking mechanism. As described previously, the annuloplasty ring 190 has a peripheral ring body 192 with free ends terminating at a junction housing 194. A cinching element 196 extends around the ring body 192 and extends upward through passages within the junction housing 194 to form a subloop 196 which can be grasped to tension the cinching element and reduce the size of the ring. The junction housing 194 may comprise molded halves 200, 202 when assembled, the subloop 198 extends upward or to the atrial side of the ring through an upper mouth 204 and has a pair of locking clips 206 engage therewith.

[0156] Figures 20A and 20B show the operation of the clip-based locking mechanism to lock tension within the cinching element 196. Each of the locking clips 206 includes a rigid outer portion 208 defining a passage or slit therethrough in which a cantilevered gripping flap 210 extends. The gripping flaps 210 are flexed in an upward or atrial direction and permit passage in one direction of the subloop 198 through the middle of the locking clips 206. Figure 20B shows tension being pulled on the subloop 198 while the outer portions 208Attorney Docket No: SSHRG-23341 WOoi of the locking clips 206 are pushed downward into the cavity within the mouth 204 of the junction housing 194. Once the clips 206 are fully seated, the gripping flaps 210 are angled upward and grip onto the subloop 198 preventing release of the tension.

[0157] Figure 20A also illustrates terminal ends 212 of a support body of the annuloplasty ring mating with the junction housing 194. The terminal ends 212 includes slits or openings 214 sized and positioned to receive projections on both the housing halves 200, 202. The housing halves 200, 202 may be glued or otherwise snap together to finalize the assembly.

[0158] The locking clips 206 described above permit one-way movement of the subloop 198 therethrough, and then provided irreversible lock on the cinching element. However, sometimes re-sizing is required when further adjustment of the annuloplasty ring is needed. Moreover, the cinching element 196 is desirably a braided {e.g., cobalt-chromium alloy (e.g., 35N-LT™ alloy) or nitinol 7X7) cable which can be up to about 18 mm long when the annuloplasty ring is adjusted to its smallest size. This long exposed cable subloop may pose a thrombogenicity risk and be traumatic to surrounding tissue. Accordingly, several reversible locking solutions are presented below, as well as techniques to minimize the extent of the subloop that remains above the junction housing.

[0159] Figures 21A and 21B are perspective views of an alternative cinching element locking mechanism before and after actuation of a locking member. More particularly, an adjustable annuloplasty ring includes a junction housing 220 typically positioned at the midpoint of the anterior side of the ring which has an upstanding portion 222 defining an open mouth 224. A cinching element 226 extends around the annuloplasty ring and exits through the open mouth 224 in a subloop 228 (instead of a subloop, the free ends of the cinching element may exit the housing). Although not shown, a delivery shaft which engages the junction housing 220 incorporates a tensioning mechanism to pull on the subloop / free ends 228 to adjust the size of the annuloplasty ring, as described above.

[0160] The junction housing 220 further incorporates a rotatable locking member 230 having an upwardly opening cavity 232 just below the open mouth 224. The cavity 232 is shown as having hexagonal walls which receive an Allen-head actuator. Of course, other shaped cavities that enable rotation of the locking member 230 are possible. The delivery shaft (not shown) supplies the actuator for rotating the locking member 230. The locking member 230 has a generally rectangular configuration with opposite rounded corners 233 that engage and cam a pair of locking balls 234 positioned within the junction housing passageway. Figure 21B illustrates the outward forces exerted on the locking balls 234 by the locking member 230 when rotated by 90°. The locking balls 234, in turn, contact and clamp against portions of the cinching element 226 within the housing passageway, thusAttorney Docket No: SSHRG-23341 WOoi maintaining the tension around the annuloplasty ring. The cinching element 226 may be coated to provide a compliant layer and increase compression resulting in a more effective lock.

[0161] Because the locking of the cinching element 226 occurs inside the junction housing 220, the subloop / free ends 228 that are exposed above the housing may be cut off. For example, a cutting mechanism (not shown) within the delivery shaft or incorporated into the junction housing may be utilized to trim the exposed length of cinching element 226 to completely eliminate any exposed portions.

[0162] Figures 22A and 22B are sectional views of an alternative cinching element locking mechanism before and after actuation of a locking member. Once again, the junction housing 240 has an upstanding portion 242 through which the cinching element 244 may pass in a subloop or free ends. The cavity within the junction housing 240 provide space for a locking member 246 having an upwardly frustoconical shape and a lower threaded shaft 248. Although not shown, an upper face of the locking member 246 below the opening in the junction housing has a shaped cavity for receiving a rotation or actuation tool 250 provided by the delivery system (not shown).

[0163] Figure 22B illustrates rotation of the actuator 250 to rotate the locking member 246 and cause it to screw upward within the junction housing 240. The outer conical walls of the locking member 246 clamp segments of the cinching element 244 against the internal passage walls of the junction housing 240. A predetermined displacement of the locking member 246 based on the number of turns is rotated can be calibrated to ensure the same level of clamping force against the cinching element 244 every time.

[0164] Figure 23 is a perspective view of the distal end of a deployment system 266 engaged with a junction housing 260 of an adjustable annuloplasty ring. A cinching element 262 passes through and around the annuloplasty ring (not shown), and through the junction housing 260 to emerge upward or in an atrial direction in a subloop or free ends 264. A distal housing 267 of the delivery’ system is shown engaged with the junction housing 260, while a lock actuator 268 having a pair of dow nward fingers 270 engages the distal housing 267.

[0165] A locking clip 272 resides at the top of an upstanding portion of the junction housing 260 and has an aperture 276 therethrough for passage of the subloop / free ends 264. Figure 23A is a perspective view’ of the locking clip 272 in a relaxed configuration, also showing a pair of side cutouts 274 and an accordion- or spring-like expandable segment 278. When the locking clip 272 is loaded within the delivery system 266, the expandable segmentAttorney Docket No: SSHRG-23341 WOoi278 is compressed as seen in Figure 23 with the fingers 270 of the lock actuator 268 holding it in this compressed configuration.

[0166] Figures 24A and 24B are sectional views through the deployment system 266 and junction housing 260 of Figure 23 before and after deployment of the locking clip 272. While the delivery system 266 pulls upward on the cinching element 262, the locking clip 272 is held down along with the distal housing 267. The delivery shaft has tensioning structure (such as the adjustment cable 58 that extends from the control handle in Figures 5A and 5B) to pull the subloop 264 in a proximal direction to tension the cinching element 262, and the lock actuator 268 is movable independently from the tensioning structure. After the proper tension in the cinching element 262 is attained, the lock actuator 268 is displaced in a proximal direction as seen in Figure 24B. Upon removal of the fingers 270 from the cutouts 274 on either side of the locking clip 272, the expandable segment 278 is permitted to expand.

[0167] By virtue of the cinching element passing through the clip aperture 276, a midsection of the subloop (or free ends) 264 of the cinching element is displaced laterally. Because the locking clip 272 resides within an inner cavity of the distal housing 267, the aperture 276 of the locking clip 272 pinches the subloop 264 of the cinching element 262 therein, also tending to cause the exposed portion of the subloop 264 to collapse downw ard, thus reducing its profile within the left atrium (loop management). The 180° of bends that are created in the subloop 264 by the locking clip 272 pinches the cinching element 262 within the distal housing 267. Due to the Capstan effect, the additional bends increases the holding force of the locking clip 272 without increasing the strain on it. This allows the spring-like expandable segment 278 to be designed to experience a strain of under 0.7%, w hich is within the fatigue strength of nitinol used. The rest of the deliver}’ system 266 is then detached from the distal housing 267 and removed from the body.Delivery system improvements

[0168] As described in a number of places herein, downsizing of the annuloplasty ring is typically accomplished by pulling or tensioning the cinching element that extends upward through the junction housing. However, in certain instances tension in the cinching element must be released to either upsize the annuloplasty ring, or to reverse a previous downsize. In these instances, disconnection of the delivery system from the junction housing is possible because of the lack of tension between the two. Accordingly, it is useful to positively engage the delivery system with the junction housing during the annuloplasty ring sizing procedure, and only when that process is complete disengage the two.

[0169] Figures 25A and 25B illustrate a harness or self-releasing suture attached to a junction housing for ensuring that a delivery shaft remains attached during adjustment andAttorney Docket No: SSHRG-23341 WOoi release of the annuloplasty ring. In particular, a junction housing 280 is shown by itself without the rest of the annuloplasty ring. A distal housing 282 of the del ivery system engages the junction housing 280. As before, a lock actuator 284 surrounds a subloop 286 of the cinching element.

[0170] Figure 25B shows release of a harness 288 from removal of the lock actuator 284. More quickly, lock actuator to before has a pair of downw ardly-directed fingers 290 w hich engage a locking clip (not shown) within the distal housing 282. Removal of the fingers 290 from the locking clip sets the locking clip against the subloop 286. Because the harness 288 loops inside one of the fingers 290, retraction of the lock actuator 24 and its fingers 290 releases the harness. As the harness 288 is attached to the junction housing 280, thus also releases the distal housing 282 for removal if it is not being left in position against the junction housing 280. There may be two of the harnesses 288 on each side for greater stability. This arrangement ensures that the distal housing 282 of the delivery system remains held against the junction housing 280 until deployment of the locking clip. It should be understood that the delivery system is typically assembled and then packaged and shipped with the annuloplasty ring, enabling this pre-connection prior to introduction into the body.

[0171] Figure 26 is a perspective view of an adjustable annuloplasty ring 300 of the present application having a ring body 302 through and around which a cinching element extends culminating in an upwardly directed subloop 304. The subloop 304 extends upward from a junction housing 305 and is tensioned and then held in that position by a pair of nitinol locking clips 306. This illustration emphasizes the potential unwieldy length of the subloop 304 can result from a fully dow nsized annuloplasty ring 300. Once again, the cinching element may be formed of a braided nitinol, stainless steel, or a cobalt chromium (CoCr) alloy cable which is relatively stiff and can detrimentally affect functioning of the heart valve if left in an elongated state.

[0172] Figures 27A and 28A are cutaway and sectional views of a deployment shaft mechanism for applying tension to the subloop 304 of the cinching element, and Figures 27B and 28C illustrate release of the cinching element. The mechanism includes an outer shaft 310 and the clip locking actuator 312. Additionally, an inner shaft 314 extends downward and has a lateral cutout 316 for receiving and pulling on the subloop 304. The subloop 304 is held wfthin the cut out 316 by a movable rod 318. By displacing the inner shaft 314 in a proximal direction as shown in Figure 28A, the subloop 304 is pulled to create tension w ithin the cinching element and reduce the size of the annuloplasty ring body 302.

[0173] Figures 27B and 28C show first removal of the clip locking actuator 312 from within the locking clips 306 once the proper size of the annuloplasty ring is attained.Attorney Docket No: SSHRG-23341 WOoiAlthough not shown, the locking actuator 312 is typically connected to an intermediate shaft or cable which is used to pull the actuator in a proximal direction. At this stage, the delivery system releases the subloop 304 by retraction of the movable rod 318. This removes any impediment to the subloop 304 remaining in the lateral cutout 360. A lower edge of the cutout 316 is typically angled in a distal direction to facilitate this disengagement.

[0174] Figure 29 is a sectional view through another deployment shaft mechanism for applying tension to a cinching element. In particular, the annuloplasty ring 340 has a junction housing 342 and is adjusted by applying tension to a cinching element 344. The cinching element 344 has a subloop 346 which project upward from the junction housing 342 through a pair of locking clips 348 which are held in an unlocked position by a lock actuator 350. The subloop 346 is captured within a downwardly angled slot 352 formed in an inner shaft 354 passing through an outer shaft 356 of the delivery system. Tension on the cinching element 344 may be adjusted by pulling upward on the inner shaft 354.

[0175] Figures 30A-30C schematically illustrate steps in release of the cinching element of Figure 29. Once the proper annuloplasty ring size is attained, the locking clip 348 are deployed to hold the subloop 346 in a fixed position, and the inner shaft 354 is displaced in a distal direction as seen in Figure 30B. Subsequently, rotation of the inner shaft 354 as in Figure 30C releases the subloop 354 from the angled slot 352. At this point, the delivery system can be removed from the body.Subloop management

[0176] Figure 31 is a perspective view of an anterior segment 360 of an annuloplasty ring having a junction housing 362 with a loop control sleeve 364 assembled thereon. The loop control sleeve 364 is formed as a partial tube with a lower axial slit to enable a snap-fit assembly over the upper side of the junction housing 362. The upper side of the control sleeve 364 features tubular segments on each end 365a, 365b with two pairs of elongated fingers extending toward each other. Namely, a first pair of fingers 366 extends from the left end 365b toward the right, while a second pair of fingers 368 extends from the right end 365a toward the left hand. The control sleeve 364 may be nitinol with the fingers 366, 368 formed by laser cutting the nitinol tube. As such, the fingers 366, 368 have a relaxed configuration within the shape of the tube, as shown.

[0177] Figure 32 shows a distal end of a deployment shaft 370 engaging the junction housing 362 with the fingers 366, 368 of the loop control sleeve 364 flexed outward around the deployment shaft. As will be apparent below-, the fingers 366, 368 will be covered in a biocompatible fabric in the final product, as will the annuloplasty ring 360.Attorney Docket No: SSHRG-23341 WOoi

[0178] Figure 33A shows the annuloplasty ring 360 covered in a biocompatible fabric, with the second pair fingers also covered in a sleeve of fabric 374. The first pair fingers 366 is left uncovered to illustrate a suture 372 knotted at both ends through holes in the tips of the first fingers 366. The suture 372 extends through an elongated slot at the distal end of the deployment shaft 370 and wraps around or connects to the middle of a subloop 376, seen through the slot. After tensioning the subloop 376 to reduce the size of the annuloplasty ring 360, the deployment shaft 370 and any internal components will be removed from the body.

[0179] Figure 33B schematically illustrates operation of the fingers of the loop control sleeve 364 to secure the subloop 366 of the cinching element. In particular, as the deployment shaft 370 raises up, the first pair of fingers 366 is released to spring back to its original position because the first pair is shorter than the second pair of fingers 368. This is seen in step No. 1 where the suture 372 is seen pulling the middle portion of the subloop 376 to the right against the annuloplasty ring 360. After the deployment shaft 370 rises up farther, the second pair of fingers 368 springs back down to its original linear alignment w ith the annuloplasty ring 360. This causes the sleeve of fabric 374 to w rap around the remainder of the subloop 376 and folded dow n along the annuloplasty ring 360.

[0180] Figures 34A and 34B are before and after sectional view's showing operation of a loop control insert of the present application. As before, an adjustable annuloplasty ring 380 has a junction housing 382 through which a cinching element 384 passes and defines a subloop 386. The subloop 386 passes through a pair of locking clips 388 adjacent the junction housing 382 held open by a lock actuator 390. The subloop 386 is held within a lateral slot 392 of tension shaft 394 by the movable rod 396. In addition, a loop control insert 398 is integrated along the subloop 386 and also held in a stretched configuration by the movable shaft 396. Proximal retraction of the tension shaft 394 thus sets the proper size of the annuloplasty ring 380.

[0181] Figure 34B shows both proximal retraction of the lock actuator 390 to close the locking clips 388, and proximal retraction of the movable shaft 396 to release the delivery system, in that order. Once the movable shaft 396 retracts, the loop control insert 398 curls up upon itself which also wraps the subloop 386 in a spiral, just above the locking clips 388. Alternatively, the junction housing 382 may be provided with a cavity with in which the locking clips 388 and folded up insert and subloop 386 are concealed. This greatly reduces the chance of damage to the surrounding anatomy from an elongated subloop.

[0182] Figure 35 is a plan view- of the loop control insert 398 in a flattened configuration, and Figures 36A and 36B show the loop control insert in elongated or flexed and relaxed shapes, respectively. The loop control insert 398 is formed as a flat sheet in an elongated oval with three holes 400 along its length. The holes 400 permit passage of the subloop 386Attorney Docket No: SSHRG-23341 WOoi therethrough, with a larger upper hole also receiving the movable shaft 396. The insert 398 is formed of nitinol and is shape set into the coiled configuration of Figure 36B. By stretching the insert 398 into its elongated shape, it is pre-assembled along with the annuloplasty ring 380 and delivery system as in Figure 34A.

[0183] Figures 37A and 37B are before and after sectional views showing operation of an alternative loop control insert of the present application.

[0184] An adjustable annuloplasty ring 420 has a junction housing 422 through which a cinching element passes to define a subloop 424. The subloop 424 passes through a pair of locking clips 426 adjacent the junction housing 422 held open by a lock actuator 428. A delivery system 430 includes an inner lock actuator shaft 432 having a lateral slot 434 therein. The subloop 424 is held within the lateral slot 434 by a movable rod 436. In addition, a loop control insert 438 is integrated along the subloop 424 and also held in a stretched configuration by the movable shaft 436. Proximal retraction of the tension shaft 432 thus sets the proper size of the annuloplasty ring 420.

[0185] Figure 37B shows the annuloplasty ring 420 after proper tensioning and clipping of the subloop 424, and removal of the delivery system 430. Once the movable shaft 436 retracts, the subloop 424 is released and folded up by the loop control insert 438.

[0186] Figure 38 is a plan view of the alternative loop control insert 438 in a flattened configuration, and Figures 39A and 39B show the loop control insert in elongated or flexed and relaxed shapes, respectively. A plurality of holes spaced along the length of the insert 438 permit passage of the subloop 424 as well as the movable rod 436. The insert 438 is formed of nitinol and shape set to collapse upon itself into the shape of Figure 39B, with multiple layers and bends. Once released, the insert 438 traps the subloop 424 in between the different layers to reduce its profile above the junction housing 422. Alternatively, the junction housing 422 may be provided w ith a cavity with in which the locking clips 426 and folded up insert and subloop 424 reside.

[0187] Figures 40 and 41 are perspective views of an adjustable annuloplasty ring 450 with another subloop management solution. The ring 450 again has a junction housing 452 out of which the subloop 454 projects, as well as a pair of nitinol locking clips 454. The distal end of the delivery system 458 is shown in phantom in Figure 40 and includes components for tensioning the subloop 454 until the annuloplasty ring 450 is at its proper shape.

[0188] The loop control suture 460 passes through the subloop 454 and extends down along the junction housing 452 and into a first opening 462 in a biocompatible fabric cover 464 around the annuloplasty ring. The loop control suture 462 continues for a short ways under the fabric cover 464 until it emerges from a second opening 466, at which point theAttorney Docket No: SSHRG-23341 WOoi suture doubles back toward the junction housing 452 and extends in a proximal direction along the length 468 within the delivery system 458. Ultimately, the loop control suture 462 emerges outside the body, typically at a control handle (not shown), and can be pulled in a proximal direction as indicated by the arrows in Figure 40. Once the annuloplasty ring 450 has been resized, and the delivery system 458 at least partially removed, the proximal length 468 of the loop control suture 462 is pulled approximately to drag the subloop 454 underneath the fabric cover 464, as seen in Figure 41. Subsequently, the loop control suture 462 can be removed completely by pulling one of the free ends until the entire suture is removed from the body. To facilitate this operation, the fabric cover 464 may be slightly oversized in the area around the junction housing 452 to permit the loop control suture 462 and subloop 454 to slide more easily thereunder.

[0189] Figures 42A-42C are perspective views of a junction housing 470 having a cinching element lock and cut mechanism in several stages of actuation. A subloop 472 of the cinching element is show n projecting upward from the junction housing 470 between a pair of clamp halves 474 defining a slot 476 therebetw een. After proper tensioning of the cinching element, a delivery shaft (not shown) actuates a clamping mechanism to force the clamp halves 474 together, as seen in Figure 42B. Subsequently, an inner shaft 478 of the delivery system is advanced to encompass the subloop 472, as seen in Figure 42C within the inner shaft 478 are sharp edges or other such tool for severing the subloop 472 at the top of the clamp halves 474. Rotation is indicated may facilitate this cutting operation.

[0190] Should also be knows that the junction housing 470 has a pair of outward tubular extensions 480 which are designed to mate with the support body of the annuloplasty ring. In particular, support bodies shown in Figures 12, 20A, and 31 include free ends that have apertures or other such features for meeting with junction housings. The junction housing 470 includes an elongated slot 484 into which the cable-like cinching element can be inserted, as well as a number of outer projections 482 for mating with the support bodies. The components are desirably made to snap together.

[0191] Figure 43A shows a junction housing 500 with a subloop 502 projecting therefrom through a pair of locking clips 504. A deployment shaft 506 in sectional view shown engaging the junction housing 500 with an inner tension actuator 508 pulling upward on the subloop 502. An inner shaft or portion 510 maintains downward force on the locking clips 504. Once the proper tensioning the subloop 502 is attained, with the annuloplasty ring and its proper size, the locking clips 504 are actuated to hold the position of the subloop 502. At this stage, the subloop 502 may be unduly long, requiring management.

[0192] Figure 43B is an enlarged view of a subloop severing mechanism comprising electrodes 512. The electrodes 512 may extend along the deployment shaft 506 intoAttorney Docket No: SSHRG-23341 WOoi proximity with an aperture through which the subloop 502 passes. By energizing the electrodes 512, the subloop 502 can be severed on both sides and removed w ith the deployment shaft 506.

[0193] Figures 44A and 44B are sectional views of a still further cinching element locking mechanism before and after actuation in the configuration where the cinching element terminates at one end within the junction housing instead of forming a subloop. As mentioned above, forming a subloop with the cinching element projecting proximally from the junction housing is a convenient way to enable tensioning, as a second loop or hook or other such device can be used to pull on the subloop. However, two free ends or one free end w ith the other free end held within the junction housing can be similarly tensioned, and the invention embodied in the claims should not be considered limited to a subloop unless specifically recited.

[0194] In Figure 44A, an annuloplasty ring junction housing 520 has a pair of outward extensions that define passages 522 therein. A braided cinching element 524 extends into the junction housing 520 and through the passages to emerge upward into a delivery system 526. The opposite end of the cinching element 524 has an enlarged bead or ball 528 secured thereon which is held by a narrowing within the junction housing 520. Consequently, pulling on the proximal end of the cinching element 524 that extends up the delivery system 526 creates tension and reduces the size of the annuloplasty ring.

[0195] The delivery system 526 includes a lock shaft 530 having a shaped distal end 532 which fits within a similarly-shaped cavity in a locking member 534. As was described above with respect to Figures 22A and 22B, the locking member 534 has a threaded lower shaft 536 which mate with internal threading on the junction housing 520. Rotation of the lock shaft 530 with us causes displacement of the locking member 534 upward, as indicated in Figure 44B. The locking member 534 again has a frustoconical outer surface which impinges on the cinching element 524, clamping it against the internal passages 522 of the junction housing 520. It is thus apparent to see, that the operation of the junction housing 520 and cinching element 524 is similar to those described above with subloops.

[0196] Figure 44C shows a further step where the lock shaft 530 of the delivery' system 526 severs the cinching element 524, and Figure 45 is an enlargement thereof. In particular, the lock shaft 530 defines a frustoconical distal cutting rib 538 which has an outer diameter slightly larger than an inner narrowing 540 of a shaft within the delivery system. The cinching element 524 passes upward between the lock shaft 530 and a narrowing 540 such that when the cutting rib 538 reaches the narrowing 540, it shears the cinching element against the sharp narrowing, causing it to sever. In this way, the extent of the cinching element 524 left projecting upward from the junction housing 520 is minimized. TheAttorney Docket No: SSHRG-23341 WOoi solution is highly advantageous because the same tool used to lock the cinching element is also used to sever the cinching element when it is retracted.

[0197] Figure 46 is a perspective view of an adjustable annuloplasty ring 550 without an outer fabric cover having a junction housing 552 and cinching element 554 passing therethrough. A deployment system 556 is partly in phantom engaging the junction housing 552, and Figure 46A is an enlargement thereof. The deployment system 556 incorporates a severing member 560 bifurcated into symmetrical halves for cutting the cinching element 554 as well as a pair of pivoting retention arms 562 that hold the deployment shaft to the junction housing 552.

[0198] Figures 47 A and 48A are sectional and perspective views of the deployment system and junction housing 552 during a tensioning step. The deployment system includes an outer shroud 564 which extends down around the junction housing 552 and cooperates with the retention arms 562. The deployment system also includes a camming shaft 566 that engages tapered outer surfaces of the severing member halves 560. The cinching element 554 is shown at 568 extending outward from the junction housing 552 in Figure 48A, and is seen passing upward between the two halves of the severing member 560 in Figure 47 A. The two halves of the severing member 560 both include at least one, and preferably two, inwardly-directed and facing sharp teeth 570. The cinching element 554 also passes through a clamping member 572 bifurcated into symmetrical halves disposed immediately below the severing member 560. The clamping member 572 may be an identical but inverted copy of the severing member 560, and also includes a pair of inwardly-directed teeth 576 on each half. As will be seen, the inner teeth 576 of the clamping member halves 572 are desirably not quite as sharp as the teeth 570 of the severing member halves 560.

[0199] Figures 47B and 48B show a step of severing the cinching element 554. Distal displacement of the camming shaft 566 from a proximal control handle (see Figure 49) causes the mating tapered surfaces of the severing members 562 pushed inward, such that the sharp teeth 570 bite into the cinching element 554. At the same time, the lower ends of the severing members 562 pushed the clamping member halves 572 downward (see comparison of Figures 47 A and 47B). The clamping member halves 572 have tapered outer surfaces which interact with a frustoconical cam sleeve 574, thus forcing the clamping member halves inward. This causes the teeth 576 to grip on to the cinching element 554, thus fixing the position of the cinching member within the annuloplasty ring. At a predetermined distal advancement, the operator stops the camming shaft 566 and instead rotates it about its axis, as seen in Figure 48B. If the cinching element 554 has not already been severed, this creates torsional shear which cuts the cinching element 524 between the severing member 560 and the clamping member 572.Attorney Docket No: SSHRG-23341 WOoi

[0200] Subsequently, Figures 47C and 48C show disengagement of the deployment system from the junction housing 552. First of all, the camming shaft 566 carrying the severing member 560 and proximal portion of the cinching element 554 are retracted proximally, as seen in Figure 47C, while the outer shroud 564 remains stationary’. Once the lower end of the camming shaft 566 has risen above the top ends of the retention arms 562, the retention arms can release the delivery’ system from the junction housing 552. More particularly, the retention arms 562 are shown in Figure 48C pivoting within axial slots defined within the outer shroud 564. Lower ends of each of the retention arms 562 have inwardly directed pawls 578 which fit within cavities 579 at the bottom of the junction housing 552. It is not until the camming shaft 566 has cleared the top ends of the retention arms 562 that top ends of the arms can pivot inward as shown. This displaces the pawls 578 outward from in the cavities 579 and permits removal of the outer shroud 564 and remainder of the delivery system.

[0201] Figure 49 is a sectional view through an exemplary control handle 580 for operating the deployment system of Figure 46. An outer shaft of the deployment system 556 is seen entering an outer housing 582 at the left or distal end of the handle 580. A proximal end 584 of the cinching element 554 passes through the deployment system 556 and is secured to a tension shaft 586. The tension shaft 586 terminates at a proximal end in a threaded hub 588 which engages internal threads on a proximal cinch knob 590. Rotating the cinch knob 590 causes linear displacement of the threaded hub 588 w hich, in turn, displaces the tension shaft 586 and the cinching element 554. Thus, rotation of the cinch knob 590 adjust the size of the annuloplasty ring.

[0202] Within the deployment system 556 passes the camming shaft 566, which is held by a set screw 595 to a ring 593 arranged to slide within a lock tube 592 having a proximal threaded extension 594. The proximal threaded extension 594 is displaced axially by rotation of an internally threaded locking and severing knob 596. Rotating the knob 596 thus translates into axial displacement of the lock tube 592 and ring 593, by virtue of an intervening spring 597, and ultimately axial displacement of the camming shaft 566. A release slider 598 is also affixed to the camming shaft 566 and enables retraction thereof due to the intervening spring 597 when the annuloplasty ring is deployed and to release the delivery system.Cinch winding mechanisms

[0203] Figure 50 is a perspective view of an adjustable annuloplasty ring 600 having a shaped, laser-cut nitinol support body 602 with generally rigid tubular ends 604 on an anterior side and without an outer fabric cover. A cable-like cinching element 606 extends around and through the support body 602 and engages an alternative junction housing 608Attorney Docket No: SSHRG-23341 WOoi utilizing a spinner cap for winding the cinching element w ithin the annuloplasty ring. The cinching element 606 has a main portion extending around the lumen of the support body 602 and a secondary portion that extends into the junction housing 608 and anchors to the spinner cap that is rotatable on the junction housing, as will be shown and described.

[0204] Figure 51 is an exploded perspective view of the adjustable annuloplasty ring 600 of Figure 50, and Figure 51A is an enlargement of components of the junction housing thereof. The junction housing 608 has a stationary central base member 610 with a pair of outward tubular extensions 612 that mate with the tubular ends 604 of the support body 602. As described above, the tubular ends 604 are desirably split so as to flex open, enable insertion of projections on the tubular extension 612 to snap into various apertures. The junction housing base member 610 has an internal generally cylindrical cavity and a central post 611 (see Figure 55A) which supports a disk-shaped locking clip 614 having a cantilevered locking lever 616 formed thereon. The central post 611 defines an upper pedestal 618 w ith a central diametric slot and two small up ard projections 620 w hich orient and fix the position of the locking clip 614. As wall be seen, the cantilevered locking lever 616 may be depressed into the central diameter slot of the pedestal 618.

[0205] As seen also in Figure 52, an upper spinner cap 622 sits on an upper rim of the base member 610 and is rotatable thereon. The spinner cap 622 has a horizontal top wall 623 and a tubular vertical wall 625 extending dow nw ard therefrom. The vertical wall 625 extends down into the cylindrical cavity of the base member 610 and its space therefrom. Figure 52 show s free ends 624 of the cinching element 606 passing through from below to above the spinner cap 622. More particularly, the cinching element 606 extends into the inner cavity of the base member and passes upward through apertures in the top wall 623 of the spinner cap 622. The spinner cap 622 has a pair of radial slots in the top wall 623 that enable passage of the free ends 624 outside of the vertical w all 625. The free ends 624 thus extend between the vertical walls of the base member 610 and the spinner cap 622 and through the apertures in the top wall 623 which have shaped upper depressions 626. Beads or balls 628 fastened to the free ends 624 of the cinching element nest within the chamfered depressions 626. As will be seen, rotation of the spinner cap 622 winds the free ends 624 of the cinching element 606 within the tubular vertical w all 625 of the spinner cap 622, and around the central post 611 (see Figure 55A) of the base member 610.

[0206] Figures 53A and 53B are bottom plan and radial sectional views through the spinner cap 622 of the junction housing 608 which show the path of the free ends 624 of the cinching element 606, and the terminal balls 628 nested within the chamfered depressions 626. A shaped central through hole 630 through the top wall 623 enables engagement of the spinner cap 622 by a rotation tool through a delivery system. The through hole 630 is shownAttorney Docket No: SSHRG-23341 WOoi as a square hole, but may also be hexagonal, star-shaped, or other configurations. Within the vertical wall 625, a plurality of inwardly-directed ribs 632 interact with the locking lever 616 of the locking clip 614, as will be shown.

[0207] Figures 54A and 54B are schematic view-s of the spinner cap 622 with the vertical w all 625 cut away and interaction of the locking lever 616 of the locking clip 614 therewith. A rotation tool 634 having a distal end 636 shaped the same as the central through hole 630 is advanced through the deliver}’ system to engage the through hole and rotate the spinner cap 622. Prior to introduction of the rotation tool 634, the locking lever 616 of the locking clip 614 extends outward in between two of the ribs 632. Because of the projections 620 extending upw ard from the pedestal 618 within the base member 610, the locking clip 614 is held rotationally stationary. Therefore, the locking lever 616 prevents rotation of the spinner cap 622. However, as seen in Figure 54B, the shaped distal end 636 has a length sufficient to contact the center of the locking dish 614, w hich pushes on and flexes the locking lever 616 downward. This means the outer end of the locking lever 616 out of engagement with the ribs 632, thus permitting rotation of the spinner cap 622 relative to the base member 610.

[0208] Now with reference to the sectional view’s of Figures 55A and 55B, depression of the locking lever 616 by the shaped distal end 636 of the rotation tool 634 is seen. Once the spinner cap 622 is rotated by the tool 634, the free ends 624 of the cinching element 606 are rotated along with the spinner cap 622. This winds the free ends 624 around the stationary central post 611 within the cavity of the base member 610, as seen in Figure 55B, and tensions the cinching element 606 to reduce the size of the annuloplasty ring. Once the proper annuloplasty ring size is reached, Figure 55B shows removal of the rotation tool 634 w-hich permits the cantilevered locking lever 616 to spring back upward into engagement with the ribs 632 of the spinner cap 622. Thus, the rotational position of the spinner cap 622 is fixed relative to the base member 610, and the size of the annuloplasty ring is also fixed. Plus, there are no extensions of the cinching element 606 above the junction housing 608.

[0209] Figure 56 is a perspective view of an alternative spinner cap 640 for use with the junction housing 608 of Figure 50. Once again, there is a shaped central through hole 642 in the top wall of the spinner cap 640 to enable rotation. A vertical side wall that depends down from the spinner cap 640 has a T-shaped cleat 644 defined by cutouts 646 in the wall. As will be seen, several different configurations of cinching element may be engaged w ith the T- shaped cleat 644.

[0210] Figures 57 and 58 are bottom plan views of two different versions of the alternative spinner cap 640 of Figure 56 interacting w ith different cinching elements. Figure 57 shows two free ends of a cinching element 648 (see Figure 59) each having terminal loops 650 that anchor on the T-shaped cleats 644. By rotating the spinner cap 640 about its axis,Attorney Docket No: SSHRG-23341 WOoi the cinching element 648 can be wound up around the stationary central post 611 of the base member 610 to reduce the size of the annuloplasty ring. Figure 58 shows another cinching element 652 (see Figures 60 and 60A) which has a single loop 654 formed in its midsection. That is, the cinching element 652 has a main portion that circumscribes the support body and a secondary portion that spans across the junction housing, with the single loop 654 formed in its midsection. In this case, the cinching element 652 passes through one cut out 646 in the wall of the spinner cap 640 with the loop 654 anchored to the T-shaped cleat 644 in the opposite wall. Once again, rotating the spinner cap 640 about its axis winds up the cinching element 652 stationary central post 611 of the base member 610 until the appropriate size of the annuloplasty ring is attained. Although not shown, the same locking clip 614 as described above may be provided below the spinner cap 642 fix the tension in the cinching elements 648, 652.

[0211] Figure 61 is a schematic view of a system for creating the middle loop of the braided cinching element of Figure 60. A length of the braided cinching element 652 bifurcated into two braided segments 658 which will eventually form the loop 654 in the midsection of the cinching element. Separate strands of the braided segments 658 are shown extending in opposite directions about an annular mandrel 656. Once the proper length of the loop 654 is created, the separate strands are then braided back together to continue the single braided cinching element 652.

[0212] In one embodiment, the braided cinching element 652 is formed of 48 wires of 0.03 mm cobalt-chromium alloy (for example, 35N-LT™ alloy, Fort Wayne Metals) wire braided together to provide a main braided body. To form the loop / eyelet 654, an end of the main braided body is split into two 24-wire sections. The two sections are then braided in a l-wire l-over 1-under pattern to form the bifurcated section of the loop 654. After forming the desired length of bifurcation, all 48 wires are braided back again to close the loop.Cinch friction reduction

[0213] As mentioned herein, one example of an effective cinching element comprises braided cobalt-chromium alloy wire, which is both sufficiently flexible and strong to withstand the significant tension in this application. One drawback with some examples of braided cable is undesired friction against the surrounding nitinol support body and / or against the polymer junction housing. Reducing such friction and wear is desirable, and also facilitates sliding movement of the cinching element for symmetric and predictable contraction of the annuloplasty ring, thereby promoting structural integrity and long-term durability. The use of polymer filler cloth between the cinching element and the surrounding support body and / or junction housing is one way to reduce the friction.Attorney Docket No: SSHRG-23341 WOoi

[0214] Figures 62 and 63 are perspective assembled and exploded views of an adjustable annuloplasty ring 660 having a nitinol support body 662 attached at a generally tubular free ends two a junction housing 664. A braided polymer filler cloth 666 extends within and around the tubular support body 662 and has a central lumen which receives a cinching element 665 extending out of the junction housing 664 at free ends 668. In this configuration, the free ends 668 have terminal loops 670 thereon.

[0215] The braided polymer filler cloth 666 prevents abrasion of the cinching element 665 with the surrounding support body 662. The cloth 666 further enables smooth sliding movement of the cinching element 665 during a tensioning procedure. Furthermore, the cloth 666 fills the interior spaces of the annuloplasty ring 660 to prevent blood clotting. Finally, the cloth 666 provides a buffer around the cinching element 665 to keep it aw ay from the needle used to anchor the annuloplasty ring to the surrounding annulus when implanted. The polymer cloth 666 should be made of a material which avoids fretting for over 600 million cycles of cardiac motion. Furthermore, the cloth 666 should be capable of compression and elongation to avoid interfering with the changing size of the annuloplasty ring during downsizing or upsizing. Several suitable examples include 100% ultrahigh molecular weight polyethylene (UhMWPE), too % polyethylene terephthalate (PET), 100% polytetrafluoroethylene (PTFE), 50 / 50 PET / PTFE, and 50 / 50 UHMwPE / PET, and combinations thereof.

[0216] Shaped polymer cloth inserts may be useful for the complex passages within the junction housing as disclosed herein. Figures 64A-64C are several views of a junction housing 672 of an adjustable annuloplasty ring having a cinching element extending up to a subloop 674. A friction reduction tube 676 is shown surrounding the cinching element within and beyond the junction housing 672. More particularly, the friction reduction tube 676 comprises a braided polymer tube that closely surrounds each strand of the subloop 674 and extends downward through the junction housing 672 and then all the way around the annuloplasty ring, as seen in the bottom view of Figure 64C.

[0217] One way to create a friction reduction tube such as described above is to braid the tube directly onto a braided cinching element. Figure 65 is a schematic view of a manufacturing assembly for forming a friction reduction tube around a cinching element. Figures 65A and 65B are enlargements of the cinching element in the form of a braided cable 680 and a braided cloth covering 682 thereon, respectively. The braided cable 680 is shown being wrapped with a number of the braided lengths 682 of polymer cloth separated around a generally tubular mandrel 684. The resulting polymer covered cinching element 686 results. The braided lengths 682 may be formed using various materials, including thoseAttorney Docket No: SSHRG-23341 WOoi described above w ith respect to the tubular filler cloth 666. The radial thickness of the surrounding braided polymer tube is between about o.i and 0.2 mm.

[0218] Finally, Figure 66A is a perspective view of an adjustable annuloplasty ring junction housing 690 of an adjustable annuloplasty ring illustrating a vertical portion 696 of a friction reduction insert around a cinching element 694. Figure 66B shows the annuloplasty ring without an outer cover, and Figure 66C shows just the friction reduction insert, which includes the vertical portion 696 and a horizontal portion 698. This T-shaped insert thus fits well within the junction housing 690 and reduces friction w ith the cinching element 694 therein.Alternative cinch mechanisms

[0219] A large part of the application has been focused on adjustable annuloplasty rings having flexible cinching elements that are either polymer, nitinol, stainless steel, or cobalt chromium (CoCr) alloy cables which are tensioned, and the management of any subloops or free ends projecting from the junction housing that result. However, certain aspects disclosed such as the laser cut nitinol cores and exterior fabric sewing rings may be incorporated into adjustable annuloplasty rings having alternative cinching mechanisms. Therefore, a number of such alternative mechanisms are described below.

[0220] Figure 67 is a schematic plan view of another adjustable annuloplasty ring having an alternative constriction mechanism. The ring has a junction housing 700 containing a mechanism for applying or releasing tension to a cinching element 702. As seen in Figure 68, the cinching element 702 comprises a thin flexible band having a series of slits therein that are sized to mate with a worm gear 704. The worm gear 704 is held and rotatable within the junction housing 700, and has a pinion gear 706 on one end, also seen in the enlargement of Figure 68A. An adjustment tool 708 haying a pinion is shoyvn in Figure 68 engaging the pinion 706. By rotating the pinion 706, the worm gear 704 rotates and adjusts the size of the cinching element 702. As seen in Figure 67, one end of the cinching element 702 is fixed by a terminal bead or ball within the junction housing 700.

[0221] Figure 69 is a schematic plan view of a further adjustable annuloplasty ring having a constriction mechanism in a junction housing 710 that utilizes a rack and pinion assembly to tension and a cinching element 712. Figure 70 is a perspectiye view of the cinching element 712 and junction housing 710, and Figure 70A is an enlargement of the rack and pinion assembly thereof. The cinching element 712 comprises a thin flexible band having a series of slits in both free ends. A shaft 714 that is rotatable within the junction housing 710 has a pinion gear 716 on its end yvhich engages the slits in both free ends of the cinching element 712. By engaging the shaft 714 yvith a tool extending along the delivery' system, theAttorney Docket No: SSHRG-23341 WOoi size of the annuloplasty ring can be adjusted by changing the circumference of the cinching element 712 within the ring body.

[0222] Figure 71 is a perspective view of another adjustable annuloplasty ring having an alternative cinching mechanism within a junction housing 720, and Figure 72 is a perspective view of the cinching element 722 and internal components of the junction housing. Once again, the cinching element 722 comprises a thin flexible band having slits or apertures 724 on free ends thereof. Junction housing 720 incorporates a rotatable nut 726 on the end of the shaft which extends into a fixed tube 728 of the junction housing 720.

[0223] Figure 73 is an enlargement of the junction housing 720, and Figure 73A is an enlargement of the rack and pinion assembly thereof. The pinion gear 730 rotates on the shaft of the nut 726 and has teeth engage the slits 724 in the cinching element 722. By rotating the pinion gear 730, the size of the annuloplasty ring can be adjusted. The mechanism further includes a self-actuating lock as seen in locked and unlocked positions in Figures 74A and 74B. The nut 726 sits on a plate 732 having features that ordinarily engage outer ribs of the nut and prevent its rotation. The plate 732 has a pair of outer wings w hich may be depressed downward against the force of a wave washer 734. By pushing down on the wings of the plate 732, the nut 726 can be rotated. Although not shown, a tool to simultaneously push the plate 732 downward and rotate the nut 726 is incorporated into the delivery system.

[0224] Figure 75 is a top plan view of an alternative cinching element adjustment mechanism 730. In this schematic illustration, the cinching element 732 comprises a flexible band having helical threads 734 on semi-cylindrical ends thereof. Flat faces on each free end of the cinching element 732 slot against one another. A rotatable sleeve 736 will be held within a junction housing (not shown) and has internal threads which engage the threads 734. By rotating the sleeve 736 within the junction housing, the two sets of helical threads 734 are caused to slide toward and away one another. Figures 76A and 76B are enlargements of the adjustment mechanism of Figure 75 illustrating two-way operation thereof. Although not shown, there are a number of ways for causing rotation of the internally threaded sleeve 736 within a fixed outer junction housing.

[0225] Figure 77 is a top plan view of another adjustable annuloplasty ring having a worm screw type of adjustment mechanism 740 , and Figure 77A is an enlargement of the adjustment mechanism. A flexible cinching element 742 is shown with two ends having beads or balls 744 thereon extending from both sides into the junction housing with the adjustment mechanism 740. The ball 744 on the right side is fixed, while the ball 744 on the left side travels with a carriage 746 having helical threads on its exterior, as seen in Figure 78A. Internal helical threads 748 are formed on a rotatable sleeve 750 which is turned by aAttorney Docket No: SSHRG-23341 WOoi central ring 754. By rotating the sleeve 750, the internal threads 748 engage the threads on the carriage 746 and cause the carriage to move linearly, thus adjusting the size of the annuloplasty ring. The carriage 746 slides along and axial rod 752 which extends through the sleeve 750 to help prevent binding. Once again, although not shown there are a number of ways to cause rotation of the central ring 754, which is shown w ith axial grooves or ribs on its exterior for better gripping.

[0226] Figure 79 is a top plan view of another adjustable annuloplasty ring having a worm screw type of adjustment mechanism 760, and Figure 79A is an enlargement thereof. Once again, one end of a cable-like cinching element 761 terminates in a bead or ball 762, while the other end is fixed within the adjustment mechanism 760. The ball 762 moves linearly within helical grooves of a worm screw 764 and is constrained by an outer sleeve 766. A ring 768 having outer gear teeth rotates the worm screw 764. As seen in Figures 80A and 80B, rotation in either direction of the worm gear 764 causes linear translation of the ball 762 and cinching element 761, which in turn adjusts the size of the annuloplasty ring. The teeth on the ring 768 can be engaged by a pinion or other such actuator provided by a delivery system (not shown).

[0227] Figure 81 is a top plan view of another adjustable annuloplasty ring having a worm screw type of adjustment mechanism 770, and Figure 81A is an enlargement thereof. Once again, one end of a cinching element 772 has a bead or ball 774 thereon. The ball 774 is caused to translate axially along a linear channel of an inner shaft 776 when cammed by helical grooves formed on an inner lumen of a rotatable sleeve 778. An outer fixed gear 779 causes rotation of the sleeve 778. Figure 82 illustrates operation of the adjustment mechanism with the ball 774 cause to move axially by rotation of the sleeve 778. The gear teeth on the gear 779 can be engaged by a pinion or other such actuator provided by a delivery system (not shown).

[0228] Finally, Figure 83 is a top plan view of another adjustable annuloplasty ring having a worm screw type of adjustment mechanism. Figure 83A illustrates operation of the adjustment mechanism. In this embodiment, the cinching element comprises a threaded shaft 780 connected via a ball joint to one free end of the annuloplasty ring. The other free end carries an internally threaded sleeve 782 rotated by an outer ring 784. The sleeve 782 is mounted to a ball joint 786. By rotating the ring 784 and sleeve 782, the distance that the threaded shaft 780 extends into the sleeve can be adjusted, thus adjusting the size of the annuloplasty ring. Once again, the ring 784 may have gear teeth on its exterior which are engaged by a pinion or the like in a delivery system (not shown)Attorney Docket No: SSHRG-23341 WOoiSewing flange

[0229] A geometrical reduction in annuloplasty ring size is only meaningful when the corresponding reduction in the annulus size is achieved. One factor contributing to a minimal change in annulus movement is attributed to the sew ing cuff as it is an independent stretchable entity primarily resulting in the ring cinching down with the annulus only partially moving inwards upon pulling on the cinching element.

[0230] Non-uniform movement of the ring core w ith certain sewing cuffs sometimes results during upsizing from a downsized configuration, as the sewing cuff hinders outward movement of the ring core due to its profile and attachment location on the ring. Additionally, the location of the anchoring sutures matters as the suturing locations could further act as an obstruction to the outward ring movement.

[0231] In order to get closer to 1:1 annular movement from ring adjustment and also promote a more uniform movement of the continuous loop ring core mainly during upsizing, a new “low roll-over sewing cuff’ is disclosed. This sewing cuff is made with the same biocompatible fabric as before, but positioned at the base of the continuous loop ring core. The “low” positioning allows the core to roll-over during upsizing from a downsized configuration irrespective of the position of the anchoring sutures.

[0232] Figure 84 is a perspective view of a still further adjustable annuloplasty ring 790 having the alternative outer fabric cover 792 with an attachment flange 794, and Figure 84A is a sectional view thereof. The attachment flange 794 extends outward at the base of the annuloplasty ring 790. As seen in the sectional view of Figure 85, implantation sutures are passed through the attachment flange 794 and into the target annulus.

[0233] Figure 86 is an enlarged view of an outer fabric cover 792 of the annuloplasty ring of Figure 84, while Figure 86A is an enlargement thereof, and Figure 86B is a still further enlargement of one of the fabric strands 800 of the fabric cover. Figure 86 shows a crosspattern of fabric strands 800, 802 which are braided together to form the tubular fabric cover 792. One problem experienced when constructing an adjustable annuloplasty ring having an outer fabric cover is the potential for the cover to bunch or bundle up when the annuloplasty ring is reduced in size. As will be described, the braided fabric cover 792 is configured so that the fabric strands 800, 802 more easily slide over each other and adjust themselves during adjustment of the particular annuloplasty ring. More particularly, the braided fabric cover 792 desirably is a combination of 24 lengths of strands 800 braided with 24 lengths of strands 802, each strand being made up of four textured yarns 806, all made of a biocompatible polymer. In a preferred embodiment, the biocompatible polymer is a textured polyethylene terephthalate (PET) yarn.Attorney Docket No: SSHRG-23341 WOoi

[0234] The strands 800, 802 are shown disposed along diagonal angles with respect to a linear axis of the tubular cover 792 and adjacent strands are woven under and over one another, as shown. An included braid angle 0 between the strands 800, 802 may vary, but is preferably between about 90-100°. In a preferred embodiment, the braid angle 0 is between about 93-950, and with an average of about 940. The four textured yarns 806 are each made of a plurality of individual polymer strands. Once the strands 800, 802 have been braided into the tubular cover 792, the tube is sterilized in an ultrasonic bath and then heat set at 180° C for proximally 10 minutes to dry and fix the shape of the tube. The heat set temperature does not melt the polymer strands but instead stiffens them so that the tube maintains its shape.

[0235] The included braid angle 0 along w ith the number and size of strands together influence the amount of elongation that the tubular fabric cover 792 will undergo when subject to an expansion force. In tests of a braided tubular cover 792 having an inner luminal diameter of 2.7 mm and an outer diameter of 3.25 mm, the elongation from application of a 27 N (about 6 pound) force should be no greater than about 60%, and preferably no greater than about 45%. The particular tubular cover 792 described above has pores between the diagonally crossing strands 800, 802 at an average of 38 per inch looking along each line of pores which results in a poor structure that enhances tissue ingrowth.

[0236] Figure 87 is a top plan view of an adjustable mitral annuloplasty ring 900 in accordance with any of the embodiments of the present application with a junction housing 902 in the middle of an anterior side A thereof. As explained above, the mitral annulus MA as a rounded D-shape with a somewhat straighter side adjacent the anterior leaflet AL and a more rounded or convex side adjacent the posterior leaflet PL. The anterior side A of the annuloplasty ring 900 is thus implanted against the annulus surrounding the anterior leaflet AL and secured thereto, w ith the remaining circumference of the ring secured to the annulus around the posterior leaflet PL. The annulus on the anterior side is on the inner w all of the mitral valve structure w hich is mainly composed of a fibrous skeleton within the heart, while the annulus on the posterior side is cardiac muscle termed myocardium.

[0237] Placing the junction housing 902 in the middle of the anterior side A creates a point of stability at that location such that cinching or expanding the periphery of the annuloplasty ring 900 primarily alters the shape of the posterior side of the ring. Changing the size of the posterior side is somewhat easier because of the more flexible myocardium in that area. Several different adjustment sizes are indicated in dashed line. Namely, a first reduced size 904 is show n w hich may reduce the diameter of the ring by approximately 2 mm. A second reduced size 906 may be a reduction in diameter of approximately 4 mm. Similarly, a first increased size 908 may correspond to an increase diameter of about 2 mm.Attorney Docket No: SSHRG-23341 WOoiOf course, the actual adjusted size of the ring need not correspond to 2-mm increments, and may be a continuum therebetween. Desirably, any of the adjustable annuloplasty rings described herein may be reduced in size by up to about 4 mm, an increase in size by up to about 2 mm. It should be noted that the anterior side A remains substantially unchanged in size, with just the lateral ends being bent inward or outward, with most of the size change occurring around the posterior side. As mentioned, the particular final size of the ring is determined after implant and during observation of the amount of regurgitation reduction using visualization such as fluoroscopy or echocardiography.

[0238] Although the junction housing used to adjust the annuloplasty rings described herein has been primarily located in the middle of the anterior side of the ring, it may be located in other locations around the ring, depending on what changes shape is desired. For example, Figure 88 is a top plan view of an adjustable annuloplasty ring 920 of the present application wdth a junction housing 922 in the middle of a posterior side thereof. In this illustration, the anterior leaflet AL and posterior leaflet PL are indicated as seen from the atrial or upstream side of the mitral valve. The posterior leaflet PL is typically defined by three lobes, and the corresponding segments around the posterior side of the annuloplasty ring 920 are indicated as Pl, P2 and P3. The junction housing 922 is situated in the middle of the central span P2, but may also be located w ithin the side segments Pi or P3. When implanted, adjusting the size of the ring grades a slightly different shape than that shown in Figure 87, in that the adjustment is done from the housing 922 on the posterior side.Because of the relative stiffness inherent in the annulus around the anterior side, the size reduction will be more uniform around the ring 900 as opposed to mostly cinching the posterior side as indicated in Figure 87.

[0239] It should be apparent that the individual features of the various size-adjustable annuloplasty rings described herein may be combined, if not explicitly stated. For instance, the cinching element and tension suture loops described with respect to certain figures may easily be incorporated into the annuloplasty rings of other embodiments, and the laser-cut nitinol support bodies may house a variety of different cinching elements with varied junction housings and delivery systems. It is therefore an axiom that any combination of features is contemplated short of them being redundant, mutually exclusive and / or physically impossible, and the claims presented below should not be viewed otherwise.Additional Examples of the Disclosed Technology

[0240] In view of the above described implementations of the disclosed subject matter, this application discloses the additional examples enumerated below. It should be noted that one feature of an example in isolation or more than one feature of the example taken inAttorney Docket No: SSHRG-23341 WOoi combination and, optionally, in combination w ith one or more features of one or more further examples are further examples also falling within the disclosure of this application.

[0241] Each of the examples below is in the context of an annuloplasty ring and shape adjustment system, comprising an annuloplasty ring defining a continuous peripheral shape around a central aperture and a central axis. The annuloplasty ring has a contractible support body defining a lumen extending therethrough and surrounded by a fabric outer cover. The support body extends around the peripheral shape and has two free ends connected to each other by a junction housing positioned along an anterior segment of the annuloplasty ring, the annuloplasty ring further including a flexible non-extensible cinching element passing through the support body lumen and into the junction housing, wherein the junction housing has an inner cavity with three openings - first and second aligned openings in communication with the support body lumen at the two ends of the support body, and a third opening at an upper port facing axially up from the junction housing, w ith the cinching element extending through the upper port. And wherein the support body has a relaxed implant shape when the cinching element is under no tension and a smaller, contracted shape w hen the cinching element is placed under tension

[0242] Example 1. The support body of the system is formed of a nitinol tube having a three-dimensional saddle shape with cutouts around its periphery, A segment of the support body diametrically across from the junction housing has a first pattern of alternating cutouts on inner and outer peripheries thereof, and in series with the first pattern has a helical second pattern that extends around lateral side segments toward the junction housing, such that the side segments are flexible and compressible while the posterior segment is compressible but stiffer in the plane of the support body than in other directions.

[0243] Example 2. The system of any example herein, particularly example 1, wherein the support body defines a rounded D-shape, with the anterior segment in which the junction housing is centered being relatively straight and located opposite a convex posterior segment. The saddle-shaped support body is formed by the anterior and posterior segments rising up from the side segments therebetween, and wherein a minor axis extends across the support body intersecting mid-points of the anterior and posterior segments and the support body is symmetric across the minor axis.

[0244] Example 3. The system of any example herein, particularly example 1, wherein the alternating cutouts on the inner and outer peripheries describe elliptical gaps of the same or different sizes.Attorney Docket No: SSHRG-23341 WOoi

[0245] Example 4. The system of any example herein, particularly example 3, wherein the elliptical gaps on the outer periphery' are larger than the elliptical gaps on the inner periphery'.

[0246] Example 5. The system of any example herein, particularly example 1, wherein the two free ends of the support body that connect to the junction housing are each substantially solid-walled and linear w ith a number of slots close to a terminal end for attaching to a side leg extending outw ard from the junction housing.

[0247] Example 6. The system of any example herein, particularly example 5, wherein the two free ends of the support body also have a series of circumferential slits on one or both top and bottom faces to facilitates a small upward bend in the anterior segment.

[0248] Example 7. The cinching element of the system is a complete loop w ith a main portion extending around the lumen of the support body and a subloop that projects perpendicular to the main portion through the upper port of the junction housing. A delivery shaft terminates in a distal housing that engages the upper port of the junction housing and the subloop. And, a locking clip situated in the distal housing over the upper port of the junction housing has an aperture through which the subloop passes. The locking clip includes an accordion- or spring-like expandable segment that is held in a compressed configuration. When a portion of the delivery shaft retracts from the locking clip the expandable segment converts to an expanded configuration which both locks the subloop, holding the support body in the smaller, contracted shape, and causes a portion of the subloop to collapse, thus reducing its profile above the junction housing.

[0249] Example 8. The system of any example herein, particularly example 7, wherein the delivery' shaft has a lock actuator w ith a pair of fingers that extend w ith in the distal housing, and the locking clip has a pair of side cutouts that receive the fingers to hold the expandable segment in the compressed configuration, wherein retraction of the fingers from within the distal housing releases the expandable segment to convert to the expanded configuration.

[0250] Example 9. The system of any example herein, particularly example 8, wherein the delivery shaft has tensioning structure to pull the subloop in a proximal direction to tension the cinching element and reduce the support body to the contracted shape, and the lock actuator is movable independently from the tensioning structure.

[0251] Example to. The system of any example herein, particularly example 8, further including a harness attached to the junction housing which loops inside one of the fingers, the harness holding the distal housing against the junction housing, wherein retraction of theAttorney Docket No: SSHRG-23341 WOoi fingers from within the distal housing also releases the distal housing for detachment from the junction housing.

[0252] Example 11. The system of any example herein, particularly example 7, wherein the locking clip resides within an inner cavity of the distal housing and is oriented lateral to a proximal-distal direction so that a midsection of the subloop is displaced laterally when the expandable segment converts to the expanded configuration which both pinches the subloop and cause a portion of the subloop exposed above the locking clip to collapse downward.

[0253] Example 12. The system of any example herein, particularly example 7, wherein the locking clip pinches the subloop to have a 180° bend and increases a holding force of the locking clip for a given amount of strain experienced by the expandable segment.

[0254] Example 13. The cinching element of the system has a main portion extending around the lumen of the support body and terminates at a first free end anchored within the junction housing w ith a second free end extending through the upper port of the junction housing. A delivery shaft terminates in a distal housing that engages the upper port of the junction housing and the first free end and has a lock shaft extending through the upper port. And, a locking member in the junction housing has a threaded lower shaft, wherein the lock shaft engages a shaped cavity in the locking member such that rotation thereof causes displacement of the locking member upward to clamp the second free end within the junction housing and hold the support body in the smaller, contracted shape, And, wherein the lock shaft further includes a distal cutting rib that when retracted proximally within the delivery shaft is configured to sever the second free end close to the junction housing.

[0255] Example 14. The system of any example herein, particularly example 13, wherein the lock shaft passes through a narrowing defined within the delivery shaft, and the distal cutting rib is frustoconical and larger than the narrowing such that w hen retracted proximally the distal cutting rib pinches and severs the second free end against the narrowing.

[0256] Example 15. The cinching element of the system is a complete loop with a main portion extending around the lumen of the support body and a subloop that projects perpendicular to the main portion through the upper port of the junction housing. A delivery shaft terminates in a distal housing that engages the upper port of the junction housing and the subloop. The delivery shaft has a severing member bifurcated into halves flanking the subloop, each half having inwardly-directed teeth, and a camming shaft arranged for movement relative to the severing member. And, a clamping member within the junction housing is bifurcated into halves flanking the subloop, each half having i n w ardly-directed teeth. Advancement of the camming shaft cams the severing member halves inward againstAttorney Docket No: SSHRG-23341 WOoi the subloop and also causes inward movement of the clamping member halves against the subloop, wherein the teeth on the severing member halves are sharp and sever the subloop close to the junction housing.

[0257] Example 16. The system of any example herein, particularly example 15, wherein the severing member is tapered with a narrow upper end and the clamping member is tapered with a narrow lower end, and advancement of the camming shaft acts on the tapered severing member to both cam the severing member halves inward and push the clamping member toward a frustoconical cam sleeve positioned within the junction housing to cause inward movement of the clamping member halves.

[0258] Example 17. The system of any example herein, particularly example 15, wherein each severing member half includes two inwardly-directed sharp teeth facing identical teeth on the other severing member half, and each clamping member half includes two inwardly- directed sharp teeth facing identical teeth on the other clamping member half.

[0259] Example 18. The system of any example herein, particularly example 15, wherein the camming shaft is rotatable about its axis so as to facilitate severing of the subloop by the severing member.

[0260] Example 19. The system of any example herein, particularly example 15, wherein the delivery shaft distal housing has an outer shroud that extends down around the junction housing, and further including a pair of retention arms pivotable on the outer shroud that hold the distal housing to the junction housing, wherein proximal retraction of the camming shaft frees the retention arms to pivot and permits removal of the distal housing from the junction housing.

[0261] Example 20. The cinching element of the system has a main portion extending around the lumen of the support body and terminates at first and second free ends anchored to an upper spinner cap that is positioned and rotatable on an upper rim of a base member of the junction housing. A locking clip located within an inner cavity of the base member has a cantilevered locking lever that engages and prevents rotation of the spinner cap. And, a delivery shaft engageable with the junction housing has a rotation tool w ith a distal end shaped the same as an aperture in an upper surface of the spinner cap for rotation thereof. The distal end has a length sufficient to flex the locking lever downward and unlock the spinner cap for rotation, wherein rotation of the spinner cap wraps the free ends around a central post of the base member of the junction housing and converts the support body to the smaller, contracted shape.

[0262] Example 21. The system of any example herein, particularly example 20, wherein the locking clip is held on an upper pedestal of the central post, and the upper pedestal hasAttorney Docket No: SSHRG-23341 WOoi upward projections which orient and fix the rotational position of the locking clip and a slot into which the locking lever may be flexed downward.

[0263] Example 22. The system of any example herein, particularly example 20, wherein the spinner cap has a tubular vertical wall extending downward into the inner cavity of the base member, and the vertical wall has a plurality of inwardly-directed ribs that interact w ith the locking lever to prevent rotation of the spinner cap until the locking lever is flexed downward.

[0264] Example 23. The system of any example herein, particularly example 20, wherein the cinching element free ends extend into the inner cavity of the base member and pass upward through apertures in the spinner cap. The free ends have balls fastened thereto that are held within depressions formed in the upper surface of the spinner cap to enable the rotating spinner cap to pull and wrap the free ends around the central post.

[0265] Example 24. The system of any example herein, particularly example 20, wherein the cinching element free ends have terminal loops that anchor on cleats formed in the spinner cap to enable the rotating spinner cap to pull and wrap the free ends around the central post.

[0266] Example 25. The cinching element of the system is a complete loop w ith a main portion extending around the lumen of the support body and a secondary portion that extends through the junction housing and has a single loop formed in its midsection anchored to an upper spinner cap that sits on an upper rim of a base member of the junction housing. A locking clip located within an inner cavity of the base member has a cantilevered locking lever that engages and prevents rotation of the spinner cap. And, a delivery shaft engageable with the junction housing and has a rotation tool with a distal end shaped the same as an aperture in an upper surface of the spinner cap for rotation thereof. The distal end has a length sufficient to flex the locking lever downw ard and unlock the spinner cap for rotation, wherein rotation of the spinner cap wraps the cinching element around a central post of the base member of the junction housing and converts the support body to the smaller, contracted shape.

[0267] Example 26. The system of any example herein, particularly example 25, w herein the locking clip is held on an upper pedestal of the central post, and the upper pedestal has upward projections which orient and fix the rotational position of the locking clip and a slot into which the locking lever may be flexed downward.

[0268] Example 27. The system of any example herein, particularly example 25, wherein the spinner cap has a tubular vertical wall extending downward into the inner cavity of the base member, and the vertical wall has a plurality of inwardly-directed ribs that interact withAttorney Docket No: SSHRG-23341 WOoi the locking lever to prevent rotation of the spinner cap until the locking lever is flexed downward.

[0269] Example 28. The system of any example herein, particularly example 25, wherein the spinner cap has a tubular vertical wall extending downward into the inner cavity of the base member, and the vertical wall having a cut out on one side through which the cinching element passes with the single loop anchored to the cleat in an opposite side of the vertical wall.

[0270] Example 29. The system of any example herein, further including a braided polymer sleeve surrounding the cinching element at least within the junction housing.

[0271] Example 30. The system of any example herein, particularly example 29, wherein the braided polymer sleeve extends to a point above the upper port, leaving a portion of the cinching element exposed for grasping and tensioning.

[0272] Example 31. The system of any example herein, particularly example 29, wherein the braided polymer sleeve extends entirely around the support body.

[0273] Example 32. The system of any example herein, particularly example 29, wherein the braided polymer sleeve is a T-shaped insert that fits within the junction housing and extends out of the three openings therein.

[0274] Example 33. The system of any example herein, particularly example 29, wherein the braided polymer sleeve has a radial thickness of between about 0.1 and 0.2 mm.

[0275] Example 34. The system of any example herein, wherein the cinching element comprises a braided nitinol, stainless steel, or cobalt chromium (CoCr) alloy core having a braided polymer exterior.

[0276] Example 35. The system of any example herein, wherein the support body is formed of a metallic tube having V-shaped gaps formed therein to permit contraction.

[0277] Example 36. The system of any example herein, further including a hollow compressible filler member extending within the support body lumen and through which the cinching element extends.

[0278] Example 37 The system of any example herein, wherein the tubular fabric cover surrounding the support body has a sewing cuff of a ring of fabric attached to an outer peri phery thereof.

[0279] While the foregoing is a complete description of the preferred examples, various alternatives, modifications, and equivalents may be used. Moreover, it will be obvious that certain other modifications may be practiced within the scope of the appended claims.

Claims

Attorney Docket No: SSHRG-23341 WOoiWHAT IS CLAIMED IS:

1. An annuloplasty ring and shape adjustment system, comprising: an annuloplasty ring defining a continuous peripheral shape around a central aperture and a central axis, the annuloplasty ring having a contractible support body defining a lumen extending therethrough and surrounded by a fabric outer cover, wherein the support body extends around the peripheral shape and has two free ends connected to each other by a junction housing positioned along an anterior segment of the annuloplasty ring, the annuloplasty ring further including a flexible non-extensible cinching element passing through the support body lumen and into the junction housing, wherein the junction housing has an inner cavity with three openings - first and second aligned openings in communication with the support body lumen at the two ends of the support body, and a third opening at an upper port facing axially up from the junction housing - and wherein the support body has a relaxed implant shape when the cinching element is under no tension and a smaller, contracted shape when the cinching element is placed under tension, wherein the cinching element is a complete loop with a main portion extending around the lumen of the support body and a subloop that projects perpendicular to the main portion through the upper port of the junction housing; a delivery7shaft terminating in a distal housing that engages the upper port of the junction housing and the subloop; and a locking clip situated in the distal housing over the upper port of the junction housing having an aperture through which the subloop passes, the locking clip including an accordion- or spring-like expandable segment that is held in a compressed configuration until a portion of the delivery shaft retracts from the locking clip wherein the expandable segment converts to an expanded configuration which both locks the subloop, holding the support body in the smaller, contracted shape, and causes a portion of the subloop to collapse, thus reducing its profile above the junction housing.

2. The system of claim 1, wherein the delivery shaft has a lock actuator with a pair of fingers that extend within the distal housing, and the locking clip has a pair of side cutouts that receive the fingers to hold the expandable segment in the compressed configuration, wherein retraction of the fingers from within the distal housing releases the expandable segment to convert to the expanded configuration.Attorney Docket No: SSHRG-23341 WOoi3. The system of claim 2, wherein the delivery7shaft has tensioning structure to pull the subloop in a proximal direction to tension the cinching element and reduce the support body to the contracted shape, and the lock actuator is movable independently from the tensioning structure.

4. The system of claims 2 or 3, further including a harness attached to the junction housing which loops inside one of the fingers, the harness holding the distal housing against the junction housing, wherein retraction of the fingers from w ith i n the distal housing also releases the distal housing for detachment from the junction housing.

5. The system of any of the preceding claims, wherein the locking clip resides within an inner cavity of the distal housing and is oriented lateral to a proximal-distal direction so that a midsection of the subloop is displaced laterally when the expandable segment converts to the expanded configuration which both pinches the subloop and cause a portion of the subloop exposed above the locking clip to collapse downward.

6. The system of any of the preceding claims, wherein the locking clip pinches the subloop to have a 180° bend and increases a holding force of the locking clip for a given amount of strain experienced by the expandable segment.

7. An annuloplasty ring and shape adjustment system, comprising: an annuloplasty ring defining a continuous peripheral shape around a central aperture and a central axis, the annuloplasty ring having a contractible support body defining a lumen extending therethrough and surrounded by a fabric outer cover, wherein the support body extends around the peripheral shape and has two free ends connected to each other by a junction housing positioned along an anterior segment of the annuloplasty' ring, the annuloplasty ring further including a flexible non-extensible cinching element passing through the support body lumen and into the junction housing, wherein the junction housing has an inner cavity' w ith three openings - first and second aligned openings in communication with the support body lumen at the two ends of the support body7, and a third opening at an upper port facing axially up from the junction housing - and wherein the support body7has a relaxed implant shape when the cinching element is under no tension and a smaller, contracted shape when the cinching element is placed under tension, wherein the cinching element is a complete loop with a main portion extending around the lumen of the support body7and a subloop that projects perpendicular to the main portion through the upper port of the junction housing;Attorney Docket No: SSHRG-23341 WOoi a delivery7shaft terminating in a distal housing that engages the upper port of the junction housing and the subloop, the delivery' shaft having a severing member bifurcated into halves flanking the subloop, each half having inwardly-directed teeth, and a camming shaft arranged for movement relative to the severing member; and a clamping member within the junction housing bifurcated into halves flanking the subloop, each half having inwardly-directed teeth, wherein advancement of the camming shaft cams the severing member halves inward against the subloop and also causes inward movement of the clamping member halves against the subloop, wherein the teeth on the severing member halves are sharp and sever the subloop close to the junction housing.

8. The system of claim 7, wherein the severing member is tapered with a narrow upper end and the clamping member is tapered with a narrow lower end, and advancement of the camming shaft acts on the tapered severing member to both cam the severing member halves inw ard and push the clamping member toward a frustoconical cam sleeve positioned within the junction housing to cause i n ward movement of the clamping member halves.

9. The system of any of claims 7-8, wherein each severing member half includes two inwardly-directed sharp teeth facing identical teeth on the other severing member half, and each clamping member half includes two inw ardly-directed sharp teeth facing identical teeth on the other clamping member half.

10. The system of any of claims 7-9, wherein the camming shaft is rotatable about its axis so as to facilitate severing of the subloop by the severing member.

11. The sy stem of any' of claims 7-10, w herein the delivery' shaft distal housing has an outer shroud that extends down around the junction housing, and further including a pair of retention arms pivotable on the outer shroud that hold the distal housing to the junction housing, wherein proximal retraction of the camming shaft frees the retention arms to pivot and permits removal of the distal housing from the junction housing.

12. An annuloplasty ring and shape adjustment system, comprising: an annuloplasty ring defining a continuous peripheral shape around a central aperture and a central axis, the annuloplasty ring having a contractible support body' defining a lumen extending therethrough and surrounded by' a fabric outer cover, wherein the support body extends around the peripheral shape and has tw o free ends connected to each other by a junction housing positioned along an anterior segment of the annuloplasty' ring, the annuloplasty ring further including a flexible non-extensible cinching elementAttorney Docket No: SSHRG-23341 WOoi passing through the support body lumen and into the junction housing, wherein the junction housing has an inner cavity w ith three openings - first and second aligned openings in communication w ith the support body lumen at the two ends of the support body, and a third opening at an upper port facing axially up from the junction housing - and wherein the support body has a relaxed implant shape when the cinching element is under no tension and a smaller, contracted shape when the cinching element is placed under tension, w herein the cinching element has a main portion extending around the lumen of the support body and a secondary portion that extends into the junction housing and anchors to an upper spinner cap that is positioned and rotatable on an upper rim of a base member of the junction housing; a locking clip located w ithin an inner cavity of the base member having a cantilevered locking lever that engages and prevents rotation of the spinner cap; and a delivery7shaft engageable with the junction housing and having a rotation tool with a distal end shaped the same as an aperture in an upper surface of the spinner cap for rotation thereof, and the distal end has a length sufficient to flex the locking lever downward and unlock the spinner cap for rotation, wherein rotation of the spinner cap wraps the secondary portion around a central post of the base member of the junction housing and converts the support body to the smaller, contracted shape.

13. The system of claim 12, w herein the locking clip is held on an upper pedestal of the central post, the upper pedestal has upw ard projections which orient and fix the rotational position of the locking clip and a slot into w hich the locking lever may be flexed downward.

14. The system of any of claims 12-13, wherein the spinner cap has a tubular vertical wall extending downw ard into the inner cavity of the base member, the vertical wall having a plurality of i n w ardly- i reeled ribs that interact with the locking lever to prevent rotation of the spinner cap until the locking lever is flexed downward.

15. The system of any of claims 12-14, wherein the cinching element secondary portion includes two free ends that extend into the inner cavity of the base member and pass upward through apertures in the spinner cap, the free ends having balls fastened thereto that are held within depressions formed in the upper surface of the spinner cap to enable the rotating spinner cap to pull and wrap the free ends around the central post.

16. The system of any of claims 12-14, wherein the cinching element secondary portion includes two free ends that extend into the inner cavity of the base member and haveAttorney Docket No: SSHRG-23341 WOoi terminal loops that anchor on cleats formed in the spinner cap to enable the rotating spinner cap to pull and wrap the free ends around the central post.

17. The system any of claims 12-14, wherein the cinching element is a complete loop and the secondary portion extends through the junction housing and has a single loop formed in its midsection anchored to the spinner cap to enable the rotating spinner cap to pull and wrap the free ends around the central post.

18. The system of any preceding claim, wherein the support body is formed of a nitinol tube having a three-dimensional saddle shape with cutouts around its periphery, wherein a segment of the support body diametrically across from the junction housing has a first pattern of alternating cutouts on inner and outer peripheries thereof, and in series with the first pattern has a helical second pattern that extends around lateral side segments toward the junction housing, such that the side segments are flexible and compressible while the posterior segment is compressible but stiffer in the plane of the support body than in other directions.

19. The system of claim 18, wherein the alternating cutouts on the inner and outer peripheries describe elliptical gaps of the same or different sizes.

20. The system of claim 19, wherein the elliptical gaps on the outer periphery’ are larger than the elliptical gaps on the inner periphery.

21. The system of any preceding claim, wherein the support body defines a rounded D-shape, with the anterior segment in which the junction housing is centered being relatively straight and located opposite a convex posterior segment, the saddle-shaped support body is formed by the anterior and posterior segments rising up from the side segments therebetween, and wherein a minor axis extends across the support body intersecting mid-points of the anterior and posterior segments and the support body is symmetric across the minor axis.

22. The system of any preceding claim, wherein the two free ends of the support body that connect to the junction housing are each substantially solid-walled and linear with a number of slots close to a terminal end for attaching to a side leg extending outward from the junction housing.

23. The system of claim 22, wherein the two free ends of the support body also have a series of circumferential slits on one or both top and bottom faces to facilitates a small upward bend in the anterior segment.

24. The system of any preceding claim, further including a braided polymer sleeve surrounding the cinching element at least within the junction housing.Attorney Docket No: SSHRG-23341 WOoi25. The system of claim 24, wherein the braided polymer sleeve is a T-shaped insert that fits w ithin the junction housing and extends out of the three openings therein.

26. The system of any preceding claim, wherein the cinching element comprises a braided nitinol, stainless steel, or cobalt chromium (CoCr) alloy core having a braided polymer exterior.

27. The system any preceding claim, further including a hollow compressible filler member extending within the support body lumen and through which the cinching element extends.

28. The system any preceding claim, wherein the tubular fabric cover surrounding the support body has a sewing cuff of a ring of fabric attached to an outer periphery thereof.

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