ANNULOPLASTY SYSTEMS AND METHODS WITH PRELOADED TETHERS

An exemplary method of performing an annuloplasty procedure includes introducing a catheter into a left atrium of a heart, deploying first and second members from the catheter and anchoring them to an anterior side of a mitral valve, and deploying a third member from the catheter and anchoring it to a posterior side of the mitral valve. The first member has a first flexible tensile member attached and the second member has a second flexible tensile member attached. The third member slidably tracks over the first and the second flexible tensile members when it is being deployed. Tension is applied to the first and the second tensile members to draw the first member and the second member toward the third member, thereby bringing the posterior side and the anterior side of the mitral valve annulus into closer approximation. Annuloplasty systems, devices and components are also disclosed.

INCORPORATION BY REFERENCE

All publications and patent applications mentioned in this specification are herein incorporated by reference for all intents and purposes to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference.

FIELD

Embodiments of the disclosure relate generally to implanted medical devices. Specifically, some implementations of the present invention relate to apparatus and methods for repairing a mitral valve.

BACKGROUND

The mitral valve is located at the junction between the left atrium and the left ventricle of the heart. During diastole, the valve opens, in order to allow the flow of blood from the left atrium to the left ventricle. During systole, when the left ventricle pumps blood into the body via the aorta, the valve closes to prevent the backflow of blood into the left atrium. The mitral valve is composed of two leaflets (the posterior leaflet and the anterior leaflet), which are located at the mitral annulus, the annulus being a ring that forms the junction between the left atrium and the left ventricle. The mitral valve leaflets are tethered to papillary muscles of the left ventricle via chordae tendineae. The chordae tendineae prevent the mitral valve leaflets from averting into the left atrium during systole.

Mitral valve regurgitation is a condition in which the mitral valve does not close completely, resulting in the backflow of blood from the left ventricle to the left atrium. In some cases, regurgitation is caused by dilation of the mitral annulus, and, in particular, by an increase in the anteroposterior diameter of the mitral annulus. Alternatively or additionally, mitral regurgitation is causes by dilation of the left ventricle that, for example, may result from an infarction. The dilation of the left ventricle results in the papillary muscles consistently tethering the mitral valve leaflets into an open configuration, via the chordae tendineae.

Prior art methods and devices exist for treating mitral regurgitation. They involve either replacing or repairing the mitral valve. Replacing the valve is typically done either transapically or transseptally. Repairing the valve typically falls into one of four categories: leaflet clip; direct annuloplasty; indirect annuloplasty or chordae repair. Direct and indirect annuloplasty both involve reshaping the mitral annulus and or the left ventricle of a subject so that the anterior and posterior leaflet coapt properly. For some annuloplasty applications, a ring is implanted in the vicinity of (e.g., on or posterior to) the mitral annulus. The purpose of the ring is to reduce the circumference of the mitral annulus.

In light of the above prior art, it is desirable to provide improved systems and methods for treating mitral valve regurgitation.

DETAILED DESCRIPTION

Referring toFIG.1, elements of a mitral valve are shown. In particular, the mitral valve comprises an anterior leaflet, a posterior leaflet, an anterior-lateral commissure, a posterior-medial commissure, a lateral trigone (sometimes referred to as left) and a medial trigone (sometimes referred to as right). The anterior leaflet includes three divisions A1, A2and A3. Similarly, the posterior leaflet also includes three divisions P1, P2and P3. According to aspects of the present disclosure, in some implementations device anchors may be placed at or near each of the target locations T as shown.

Referring toFIG.2, an exemplary posterior bar210constructed according to aspects of the present disclosure is shown. Posterior bar210is configured to be implanted in the left atrium on or near the mitral annulus adjacent to the posterior leaflet, as will be subsequently described in more detail. As such, in this exemplary embodiment, posterior bar210is an elongated tubular structure that is curved to match the anatomy of the mitral annulus in this location. Posterior bar210may be provided with a low profile as shown to minimize the amount of irregular structure in the atrium that might be a potential site for thrombosis. In this exemplary embodiment, posterior bar210is provided with atraumatic edges to limit the potential for tissue damage, and is covered in polyethylene terephthalate (PET) fabric to aid with tissue ingrowth.

In this exemplary embodiment, posterior bar210is provided with a middle tissue anchor guide212and two end tissue anchor guides214. In some embodiments, middle tissue anchor guide212is identical to end tissue anchor guides214, and in other embodiments it is configured differently, such as having features that facilitate the steering/torquing of posterior bar210during delivery. In some embodiments, as will be subsequently described herein, there may be no middle tissue anchor guide, and there may be greater or fewer than the three tissue anchor guides provided in this exemplary embodiment. Anchor guides212and214may be configured to pivot relative to posterior bar210such that they can move from a retracted state and a deployed state. In the retracted state, anchor guides212and214may extend generally parallel to bar210so that they and bar210may together pass through a lumen of a catheter. In the deployed state, anchor guides212and214may extend generally perpendicular to bar210as shown inFIG.2so that they may be used to thread a tissue anchor over the guide, through apertures in bar210and into adjoining tissue to secure bar210to the tissue.

One or more snare features216may be provided on posterior bar210. In this exemplary embodiment, two snare features216are provided, one near each end of posterior bar210. Snare feature216may be configured to prominently extend from posterior bar210such that they can easily engage with one or more tensile members/snares, and also to prevent the tensile members from disengaging during manipulation. In some embodiments, snare features216are configured to be easily imaged under fluoroscopy and echocardiography to aid in positioning posterior bar210during delivery and attachment to tissue, and to aid in connecting tensile members to the snare features216.

Posterior bar210may be designed to preferentially load anchors in shear versus tension with respect to the anatomy. Torque control features may be provided to allow the initial positioning of posterior bar210, and to allow the ability to move the implant as subsequent anchors are delivered to match the anatomy.

Posterior bar210may also be provided with some level of flexibility to allow for in vivo adjustment of the bar to contour to the particular subject’s anatomy. The flexibility of posterior bar210may also serve to allow the bar to flex during the cardiac cycle. In some embodiments, the flexibility of posterior bar210is created by providing a series of slits (not shown inFIG.1) transverse to the longitudinal axis of the bar. In some embodiments, the slits and or other flexibility-providing features may be configured to limit the minimum radius of posterior bar210when implanted to ensure it applies a more uniform tension to the posterior side of the mitral annulus.

Referring toFIG.3, an exemplary anterior pad310constructed according to aspects of the present disclosure is shown. Anterior pad310is configured to be implanted in the left atrium on or near the mitral annulus adjacent to the anterior leaflet, particularly on a trigone, as will be subsequently described in more detail. In this exemplary embodiment, anterior pad310is a generally flat structure provided with four petals312radially extending from a central portion. In other embodiments, more, fewer or no petals may be provided. A primary tissue anchor314may be located in the center of anterior pad310. In some embodiments, additional tissue anchors316may be provided, such as an additional anchor316near the center of each petal312, as shown. In some embodiments, primary tissue anchor314is identical to additional tissue anchors316, and in other embodiments it is configured differently, such as having features that facilitate the positioning of anterior pad310during delivery. The petals312may be designed to fold into a compact configuration such that anterior pad310may be delivered through a catheter.

Anterior pad310may be provided with a low profile as shown to minimize the amount of irregular structure in the atrium that might be a potential site for thrombosis. In this exemplary embodiment, anterior pad310is provided with atraumatic edges to limit the potential for tissue damage, and is covered in polyethylene terephthalate (PET) fabric to aid with tissue ingrowth.

One or more snare features may be provided on anterior pad310. In this exemplary embodiment, the top ends of tissue anchors314and316are configured to engage with one or more tensile members/snares These snare features may be configured to prominently extend from anterior pad310such that they can easily engage with one or more tensile members/snares, and also to prevent the tensile members from disengaging during manipulation. In some embodiments, the snare features and or the entire anterior pad310are configured to be easily imaged under fluoroscopy and echocardiography to aid in positioning anterior pad310during delivery and attachment to tissue, and to aid in connecting tensile members to the snare features. Anterior pad310may be designed to preferentially load anchors in shear versus tension with respect to the anatomy.

Referring toFIG.4, an exemplary method of performing an annuloplasty procedure according to aspects of the present disclosure is shown. The steps of this exemplary method410will be described in reference to the flowchart shown inFIG.4and the series of images shown inFIGS.5-22. In each of the images shown inFIGS.5-22, the view is looking in a generally caudal direction through the left atrium510toward the mitral valve512with the medial direction generally to the right. In some implementations of the method, one posterior bar210and one, two or more anterior pads310are implanted. In other implementations, different types or numbers of devices may be used. InFIGS.5-22, posterior bar210is shown without a fabric cover for clarity. In this exemplary embodiment, at least one device anchor is placed at or near each of the five target locations T shown inFIG.1.

In some implementations of method410, the first step412of the method is introducing the distal end of a delivery catheter into the left atrium510of a subject. This may be performed using a transseptal approach, a left atrial approach or other methodology for gaining access to the left atrium. In the images shown inFIGS.5-22, a transseptal approach is depicted with the distal end of catheter514passing through the septum516of the heart and into the left atrium510of the subject. In some implementations, an inner dilator (not shown) is located in the distal end of catheter514for crossing the septum.

Referring toFIGS.4and5, once the distal end of catheter514is introduced into the left atrium510, a posterior bar210, sometimes referred to herein as a first member, may be deployed from the distal end of catheter514in step414. In some implementations, catheter514is first introduced into the left atrium510before the posterior bar assembly is loaded into the proximal end of the catheter514. In other implementations the posterior bar210along with its tissue anchor guides212,214and snare features216may be pre-loaded into catheter (not shown) and advanced through catheter514. As seen inFIG.5, an anchor lead518may be removably attached to each of the tissue anchor guides212and214to push posterior bar210through catheter514and deploy it from the distal end.

Referring toFIG.6, once posterior bar210emerges from the distal end of catheter514, a lead518attached to one of its ends may be pushed and the other pulled from the proximal end of catheter514to pivot posterior bar210into an orientation that is generally perpendicular to catheter514, as shown. A steerable inner catheter520may be slid distally over middle lead518until features (such as recesses and/or castellations, not shown) engage with mating features on posterior bar210to keep bar210from rotating relative to inner catheter520. Steerable inner catheter520may then be used to position and rotate posterior bar210until it is steered into its desired implantation location and orientation, as shown inFIG.7. In some implementations, a torque driver coaxially located between lead518and steerable inner catheter520may be used to impart torque to posterior bar210. Such an implementation is subsequently described in relation toFIGS.40-46.

Referring toFIGS.4and8-11, step416of exemplary method410will be described. In this step, posterior bar210(i.e. the first member) is anchored to the posterior side of mitral valve512. This may be accomplished by first sliding a drive tube522with a helical tissue anchor524located on its distal end over lead518attached to the tissue anchor guide214located near the medial end of posterior bar210, as shown inFIG.8. While steerable inner catheter520holds posterior bar210against the mitral valve annulus tissue, drive tube522may be rotated to screw medial anchor522through posterior bar210and into the underlying tissue, as seen inFIG.9. Drive tube522may then be removed from the medial anchor214and it (or another drive tube522with another helical tissue anchor524) may be slid over lead518attached to the tissue anchor guide214located near the lateral end of posterior bar210, as shown inFIG.9. While medial anchor524and steerable inner catheter520(and in some implementations a torque driver inside catheter520) hold posterior bar210against the mitral valve annulus tissue, drive tube522may be rotated to screw lateral tissue anchor524through bar210and into the underlying tissue, as seen inFIG.10. Drive tube522may then be removed from the lateral anchor524and it (or another drive tube522with another helical tissue anchor524) may be slid over lead518attached to the middle tissue anchor guide212, as shown inFIG.11. In some implementations, steerable inner catheter520may remain in place against posterior bar210when the center anchor is being placed (as shown inFIG.10), or it may be removed from posterior bar210prior to drive tube522and middle anchor524being slid into engagement over middle tissue anchor guide212(as shown inFIG.11.) While medial and lateral anchors524hold posterior bar210against the mitral valve annulus tissue, drive tube522may be rotated to screw middle anchor524through bar210and into the underlying tissue.FIGS.10and11show posterior bar210with the leads removed from the end tissue anchor guides, such as by unthreading.

In step416, it should be noted that after the initial anchor has been placed, torque control of the implant210provided by steerable inner catheter520(or in some implementations a torque driver located within catheter520) can be used to guide the placement of subsequent anchors to implant210. This eliminates the need for unguided anchor placement after the initial anchor has been placed.FIG.12shows posterior bar210with the three anchors placed and all leads removed.

Referring toFIGS.4and12, step418of exemplary method410will be described. In this step, anterior pad310(sometimes referred to herein as a second member) is deployed from the distal end of catheter514. In some implementations, anterior pad310is steered toward the lateral trigone with steerable inner catheter520as shown inFIG.12. (The lateral trigone is also shown inFIG.1.)

Referring toFIGS.4,12and13, step420of exemplary method410will be described. In this step, anterior pad310(sometimes referred to herein as a second member) is anchored to the anterior side of mitral valve512. In some implementations, anterior pad310is anchored to the lateral trigone as shown with a single anchor314. A drive tube (not shown) may be used within steerable inner catheter520to screw anchor314into place. As shown inFIG.13, additional anchor(s)316may be used to further secure anterior pad310to the lateral trigone.

In step420, it should be noted that after the initial anchor has been placed, its lead can remain in place through steerable inner catheter520such that the lead and catheter520can be used to guide the placement of subsequent anchors to implant310. This eliminates the need for unguided anchor placement after the initial anchor has been placed.

Referring toFIGS.4and14, steps422and424of exemplary method410will be described. In these steps, another anterior pad310(sometimes referred to herein as a third member) is deployed from the distal end of catheter514. In some implementations, anterior pad310is steered toward the medial trigone with steerable inner catheter520as shown inFIG.14. (The medial trigone is also shown inFIG.1.) Anterior pad310may then anchored to the anterior side of mitral valve512. In some implementations, anterior pad310is anchored to the medial trigone as shown with a single anchor314. A drive tube (not shown) may be used within steerable inner catheter520to screw anchor314into place. As with the lateral anterior pad310, additional anchor(s) may be used to further secure the medial anterior pad310to the medial trigone.

In step424, it should be noted that after the initial anchor has been placed, its lead can remain in place through steerable inner catheter520such that the lead and catheter520can be used to guide the placement of subsequent anchors to implant310. This eliminates the need for unguided anchor placement after the initial anchor has been placed.

Referring toFIGS.4and15, step426of exemplary method410will be described. In this step, a first tensile member, tether or snare526is deployed from the distal end of catheter514through steerable inner catheter520as shown. A snare sheath528may be used to direct the first tensile member526toward implant features. Snare sheath528may also be used to tighten first tensile member526around the implant features by pulling proximally on the tensile member526relative to the sheath528.

Referring toFIGS.4and16-18, step428of exemplary method410will be described. In this step, first tensile member or snare526is attached to the posterior bar210(i.e. the first member) and anterior pad310(i.e. the second member.) Steerable inner catheter520and snare sheath528may be utilized to guide first tensile member526over the lateral snare feature216of bar210, as shown inFIG.16. First tensile member526may then be guided over primary tissue anchor314of anterior pad310, as shown inFIG.17. A small amount of tension may then be applied to first tensile member526with snare sheath528to keep it engaged with bar210and pad310, as shown inFIG.18.

Referring toFIGS.4and19, step430of exemplary method410will be described. In this step, a second tensile member or snare530is deployed from the distal end of catheter514through steerable inner catheter520as shown. A snare sheath532may be used to direct the second tensile member530toward implant features. Snare sheath532may also be used to tighten second tensile member530around the implant features by pulling proximally on the tensile member530relative to the sheath532.

Referring toFIGS.4and20-22, step432of exemplary method410will be described. In this step, second tensile member or snare530is attached to the posterior bar210(i.e. the first member) and the next anterior pad310(i.e. the third member.) Steerable inner catheter520and snare sheath532may be utilized to guide second tensile member530over the medial snare feature216of bar210, as shown inFIG.20. Second tensile member530may then be guided over primary tissue anchor314of anterior pad310, as shown inFIG.21. A small amount of tension may then be applied to second tensile member530with snare sheath532to keep it engaged with bar210and pad310, as shown inFIG.22. In some implementations, the snare shape may be configured to more easily engage the snare features on the implants. For example, each snare may form a D-shape that makes contact with the lateral side or medial side of the atrium. The wall of the atrium is then used to guide the snare down to the annulus and then cinch without necessarily needing to guide the snare to each snare feature. In some embodiments, the snare has a dumbbell (or dog bone) shape, such as the exemplary snare550shown inFIG.54. Snare550includes a distal loop552and a proximal loop554having predefined diameter(s), with the rest of the snare having generally parallel tensile members forming a smaller gap between them than the loop diameter(s). Distal loop552may first be exposed to engage a first snare feature on an implant, and subsequently the proximal loop554may be exposed to capture a second snare feature on an implant. In some embodiments, as depicted inFIG.55, two snares560and562are loaded in parallel, each with a predefined shape. Individual snares560and562may be connected with a coupler564and can slide independently to engage snare features on implants separately.

Once both first tensile member526and second tensile member530are in place, additional tension may be applied to both to draw the anterior and posterior sides of mitral valve512into closer approximation. In some implementations, tension in members526and530may be increased simultaneously. In some implementations, tension may be increased incrementally in members526and530, alternating between the two until the desired tensions and or valve approximation is reached. In some implementations, the final tension and or tissue approximation of each tensile member526and530is approximately the same. In some implementations, the final tension and or tissue approximation of each tensile member526and530is different. Because medial and lateral cinching can be performed independently, the placement of each bar is more forgiving. This generally holds true for all of the systems disclosed herein. In some implementations, real time echocardiography of the mitral valve is used to monitor the reduction in mitral regurgitation as tensile members526and530are tightened.

After the desired tensions and or tissue approximations are obtained, tensile members526and530may be tied off. In some implementations, a reversible lock may be used during the cinching process which is configured to permanently hold the position of the tensile member. A disconnect member may be used to decouple the snare from the delivery system, or a portion of the tensile member may be cut to release it. Catheter514may then be withdrawn from the left atrium, along with steerable inner catheter520and snare sheaths528and532(step436shown inFIG.4.) In addition to tensioning the device during the de novo procedure, additional tensioning devices can be added at a later time or date, and or the existing devices can be re-tensioned to further reduce the A-P dimension.

Additional embodiments of the preceding system and method can be found in Applicant’s co-pending U.S. Pat. Application Publication 2021/0052387, entitled Annuloplasty Systems and Methods.

Referring toFIG.23-47B, a second exemplary embodiment of an annuloplasty system600constructed and implanted according to aspects of the present disclosure is shown. Referring first toFIG.23, annuloplasty system600is constructed and functions in a manner similar to the previously described system. It too includes an elongated posterior implant610configured to be implanted in the left atrium on or near the mitral annulus adjacent to the posterior leaflet, and two anterior implants612each configured to be implanted in the left atrium on or near the mitral annulus adjacent to the anterior leaflet, particularly on a trigone. However, in this second exemplary embodiment, instead of attaching tensile members or tethers to the implants after they have been deployed, tethers614are pre-attached to anterior implants612before they are deployed from a catheter. The anterior implants612are implanted first in this embodiment, and their tethers614are threaded through the posterior implant610before it is deployed from its catheter. The posterior implant610is then deployed from its catheter and tracks over tethers614as it is placed on the posterior side of the mitral annulus. After the posterior implant610is secured in place with anchors616, tethers614can be tensioned and secured with locks618, as will be subsequently described in detail. This arrangement saves considerable time during the procedure, not needing to snare each of the implants with the tethers. It also ensures the tether attachment points are more consistent and reliable.

In this second exemplary embodiment, posterior implant610is provided with five anchors616and anterior implants612are each provided with two anchors616. Each end of posterior implant610is provided with a swiveling eyelet assembly620for tracking over a tether614and providing a backstop for a tether lock618.

Referring toFIG.24, another perspective view of system600is provided, showing anchors616in various stages of insertion. Each anchor616is guided into place by its own lead622detachably connected to a spinner assembly624. Each spinner assembly624is rotatably attached to posterior implant plate626. A separate driver head628is detachably connected to the top of each anchor616. When a driver head628is rotated by a proximally extending driver tube (not shown), the attached anchor616is driven through its spinner assembly624and into the underlying heart tissue until it seats against its spinner assembly624, thereby securing implant plate626against the tissue. A torque head630is provided for each implant (only two are shown inFIG.24.) Each torque head630is longitudinally and rotationally driven by a proximally extending torque tube (not shown) to engage with its respective implant and drive the implant into position for anchoring.

Referring toFIG.25, a bare posterior implant plate626is shown without any components attached for clarity. It is provided with five through holes632for rotatably retaining spinner assemblies624(shown inFIGS.23and24.) Two holes634are also provided for rotatably retaining eyelet assemblies620(shown inFIGS.23and24.) A series of slots636spaced around the center spinner assembly hole632are provided for engaging with torque head630(shown inFIGS.23and24), as will be subsequently described in detail. Additional through holes638and scallops640may be provided as shown to reduce the amount of metal in plate626for better echo imaging and tissue ingrowth.

Referring toFIGS.30-32, various views of eyelet assembly620are shown.FIG.30is a perspective view,FIG.31is a side view andFIG.32is a top plan view. (A bottom view of eyelet assembly620is provided inFIG.29.) As best seen inFIG.31, eyelet assembly620may be formed from six separate components: a cylindrical core642, a top ring644, a bottom ring646, an eyelet648, a wedge or filler material650and an eyelet covering652. As best seen inFIGS.31and32, core642may be provided with two pairs of arcuate fins654, one pair protruding from the top of core642and one pair protruding from the bottom. Top ring644and bottom ring646may each be provided with mating slots for receiving the arcuate fins654. In some embodiments, fins654are swaged, welded, epoxied, press-fit and or fastened to rings644and646by other suitable means. In other embodiments, there is only a sliding fit between fins654and rings644and646, and the rings are held in place by being sandwiched between core642and the ends of a straight shank portion of eyelet648, and or by the eyelet shank expanding against the rings, as will be described next. In some embodiments, fins654may serve as centering features for core642, and or as anti-rotation features such that rings644and646do not rotate relative to core642and or eyelet648. In other embodiments (not shown), feature shapes other than arcuate fins may be used.

Eyelet648may be formed with a straight shank section that has an oval or oblong transverse cross-section (best seen inFIG.29.) Core642may be provided with a central bore having a mating oval or oblong transverse cross-section or a circular cross-section for receiving the eyelet shank. The straight shank section may be split down the center, with a gap between the two halves. This allows an anti-friction tube652to be slid over one half of the shank and onto the circular portion of eyelet648, as shown. In some embodiments, tube652is made of or coated with polytetrafluoroethylene (PTFE) to reduce friction between eyelet648and the tether that passes through it. In other embodiments, eyelet648may be dipped directly into PTFE or another friction-reducing coating.

During assembly, the straight shank section of eyelet648may be passed through top ring644, the center of core642(which resides in one of the holes634of posterior implant plate626, shown inFIG.25) and through bottom ring646. A wedge or filler material650may then be placed between the two halves of the eyelet shank such that they are urged outwardly against the inside walls of oval or oblong bores within rings644and646. In some embodiments, material650is a resiliently compressible material placed in the shank gap before assembly, such that it can be compressed during assembly and then exert a resilient outward force after assembly. In other embodiments, material650is a metal (i.e. non-compressible.) In some embodiments, the eyelet shank is provided with a necked-down portion (not shown) having an axial length slightly longer than the distance between the top of top ring644and the bottom of bottom ring646. This arrangement allows core642and rings644and646to be captivated within the necked-down portion after the split shank is radially compressed, passed through the other components and then radially expanded. Once eyelet assembly620is assembled, posterior implant plate626(shown inFIG.25) is sandwiched between top ring644and bottom ring646of eyelet assembly620. Core642may be provided with a height that is slightly larger than the thickness of implant plate626such that eyelet assembly620may freely rotate relative to plate626.

Each of the exemplary embodiments described above provide eyelet assembly620with the ability to rotate relative to posterior implant610, thereby allowing the tether passing through the eyelet assembly620to align with a central lumen of a catheter during delivery and then rotate to align with an anterior trigone implant612once implanted.

Referring toFIGS.33-36, various views of spinner assembly624are shown.FIG.33is a side view,FIG.34is another side view, taken in a direction orthogonal to that ofFIG.33,FIG.35is a bottom view andFIG.36is a top view. Spinner assembly624may be formed from six separate components: a central hoop656, a top disc658, a bottom lock ring660, a crossbar662, a U-shaped connecting rod664and a lead nut666. Central hoop656is configured to be rotatably received within one of holes632in posterior implant plate626(shown inFIG.25.) Disc658and ring660may each be welded or otherwise connected to hoop656to rotatably captivate implant plate626therebetween. Crossbar662spans across a central bore in hoop656(parallel to plate626.) U-shaped connecting rod664is pivotably mounted to crossbar662, as best seen inFIG.35(and also shown inFIG.41.) Lead nut666can be welded or otherwise fastened to the top of connecting rod664. Lead nut666is provided with a central threaded bore for receiving a threaded end of an anchor lead622(shown inFIGS.24and37.) Fixed flanges668may be provided on crossbar662to keep connecting rod664and lead nut666centered within hoop656. Connecting rod664may be laser cut in an open (V-shaped) configuration and then closed (made into a U-shape) around crossbar662between flanges668before nut666is attached to the tops of its two prongs.

With the above-described arrangement, lead nut666may pivot with respect to spinner assembly624, which in turn spins with respect to posterior implant610(shown inFIGS.23,24and37.) This allows an anchor lead622to generally lay flat against implant610when it is preloaded into a delivery catheter (as shown inFIG.44), and to extend orthogonally or at another angle when the implant is being deployed. As best seen inFIGS.33and40, one or more recesses670may be provided in the top of hoop656to allow connecting rod664, lead nut666and anchor lead622(shown inFIGS.24and37) to lay flatter against the implant.

Another advantage of spinner assemblies624is that they ensure that anchors616(shown inFIGS.23and24) which thread through them are able to pull the implant all the way against the heart tissue without leaving any gaps between the tissue and the implant. The same spinner assemblies624may also be used with the two anterior implants612and work in much the same way as they do with posterior implant610. As shown inFIGS.23and24, a spinner assembly is provided for each anchor616, so there are five spinner assemblies mounted on posterior implant610and two on each of the two anterior implants612.

Referring toFIGS.37-39, construction and operation of implantable anchors616will be described. In this exemplary embodiment, each anchor616is constructed from two components: a coil672and an anchor head674. The distal end of anchor head674may be provided with a helical slot for receiving the proximal end of coil672. In some embodiments, the proximal end of coil672is welded to head674. In this exemplary embodiment, the center of anchor head674is hollow so that it fits over lead nut666and connecting rod664when anchor616is being implanted. The proximal end of anchor head674may be provided with a cylindrical, hook-shaped releasable engagement feature or clasp676. An identical and or complementary mating feature or clasp676may be located on the distal end of driver head628. When the implants are assembled and pre-loaded into delivery catheters, the two clasps676may be interlocked with each other and held together by an anchor lead622. When interlocked, as shown inFIG.38, clasps676transmit axial and rotation motion from driver head628to anchor616for driving the anchor through spinner assembly624and into the underlying heart tissue. After all the anchors616of an implant are installed, the distal end of each anchor lead622may be unscrewed from its associated lead nut666and withdrawn proximally through clasps676to allow each anchor driver to be disengaged from its anchor616, as shown inFIG.39. As shown inFIGS.38and39, a series of slots or laser cuts677may be formed through the wall thickness of driver heads628to form flexures or living hinges. These flexures can relieve pressure and allow clasps676to more easily engage and disengage from one another when there is axial misalignment, or a lateral moment being applied to driver head628. In other embodiments (not shown), a hollow stranded cable may be used instead of a rigid tube with or without flexures.

As also depicted inFIG.37, torque head630may be provided with a flared distal end configured to fit over the center spinner assembly624when distally extending tabs678fit into slots636for steering implant610. Torque head630may also be provided with a central bore large enough for an anchor616to be housed in when it is being installed.

Referring toFIGS.40and41, additional views of torquer head630are shown.FIG.40shows the distal end of torquer head630as it approaches the central spinner assembly624. Torquer head630may be engaged with implant610by pushing the proximal end of the torquer tube (not shown) in a distal direction while pulling the proximal end of central anchor lead622(shown inFIG.23) in a proximal direction. The torquer tube may need to be rotated until tabs678engage with slots636.FIG.41shows the distal end of torquer head630and central spinner assembly624with portions cut away to show further details of these components.

Referring toFIGS.42and43, views of anterior implant612components are shown.FIG.42shows a bare anterior implant base plate680with only a tether thimble682attached. Since the two anterior implants612shown inFIGS.23and24are mirror images of one another, the same plate680and thimble682may be used to construct either one, depending on which direction spinner assemblies624are facing. When spinner assemblies624are mounted on the near side of plate680shown inFIG.42(such that the lead nuts666are pointed up, as shown inFIG.43), a lateral anterior implant612is formed (shown on the left side ofFIGS.23and24.) When spinner assemblies624are mounted on the far side of plate680shown inFIG.42(such that the lead nuts666are pointed down, opposite of what is shown inFIG.43), a medial anterior implant612is formed (shown on the right side ofFIGS.23and24.)

In this exemplary embodiment, identical components such the spinner assemblies624, anchors616, torque head630, etc. are used for anterior implants612previously described for posterior implant610. As shown inFIG.42, the spacing of slots636may be the same as that used on the posterior implant plate626(shown inFIG.25) for receiving the two opposing tabs678of torque head630(only one tab678seen inFIG.43.) With slots636spaced every 60 degrees, torque head can be dithered no more than plus or minus 30 degrees or rotated no more than 60 degrees in one direction, before tabs678engage with a pair of mating slots636.

As shown inFIG.43, thimble682and sleeve684can be used to terminate the distal end of a tether614on a beam of an anterior implant612such that the tether can freely pivot relative to the implant. This can allow the implants612with their pre-attached tethers614to be more reliably loaded into and deployed from a delivery catheter. This pivoting also allows the tethers614to align directly towards the posterior implant610(as shown inFIGS.23and24) rather than imparting rotational moments to the implanted anterior implants612and the underlying heart tissue.

In some embodiments, tethers or tensile members614have a composite structure. A continuous braided filament core may comprise an Ultra High Mechanical Polyethylene (UHMPE) fiber such as Dyneema® provided by Koninklijke DSM N.V. of the Netherlands, combined with a polyethylene terephthalate (PET) fiber. Dyneema® may be used for strength and durability and PET provides improved bonding with epoxy. In some embodiments, a 50%/50% combination of Dyneema® and PET is used. This continuous braided filament core may be inserted into or coated with a polyvinylidene fluoride (PVDF) jacketing to provide desirable handling characteristics, such as high column strength for threading the tether through a catheter and advancing the catheter without the tether collapsing. In some embodiments, at least one platinum wire is placed in the distal section of each tether614for radiopacity so that the tethers can be better seen under imaging. The filament core may be saturated with epoxy prior to being inserted into an outer jacket. This may be done to bind the composite together. In some embodiments, the outer jacket is run through a necking die to reduce its diameter and compress it into the filament. Tethers614may be color-coded so that the surgeons can distinguish a medial tether from a lateral tether. In some embodiments, markings are provided on the tethers614every 5 mm so that cinching may be observed. Applicants have discovered that the use of the above features provides the ability to cut the tethers in vivo, provides tethers with superior longitudinal stiffness for responsive cinching and superior durability for the life of the implants while supporting the full in vivo load of heart valve adjustment.

Referring toFIGS.44-46, views of the exemplary implants are shown preloaded into delivery systems. In some embodiments, the implants are each loaded into their own implant loader686. Implant loader686has a proximal hub688(shown inFIG.45) configured to slide over the distal end of an inner steerable catheter (not shown.) The distal end690of implant loader686may be configured to slide within the proximal end of an outer steerable catheter (not shown.) During deployment of the implant, the implant loader686remains in place in the proximal end of the outer catheter while the implant and distal end of inner catheter slide distally through implant loader686and the outer catheter.

FIG.44shows a posterior implant610preloaded into an implant loader686. As shown, implant610is close to parallel with the central axis of implant loader686. Five anchor leads622are each attached to a spinner assembly624on the implant and lie generally flat against implant610when preloaded. Each anchor lead622extends proximally through an anchor616and attached anchor driver628. Only four anchors616are visible, as the fifth anchor is located inside torque head630.

A pair of tether pullers694may each be threaded through a spinning eyelet assembly620of posterior implant610and extend distally out of the implant loader686as shown. After the anterior implants are implanted, their tethers614may be attached to the protruding ends of the tether pullers694, such as with a sleeve attached to each puller that can be crimped onto the tether. The tethers may then be pulled proximally with the tether pullers694until the proximal ends of the tethers emerge from the inner steerable catheter (not shown.)

FIG.45shows a medial anterior implant612preloaded into an implant loader686. As shown, implant612forms an acute angle with the central axis of implant loader686. Two anchor leads622are each attached to a spinner assembly624on the implant and extend proximally through an anchor616and attached anchor driver628. Only one anchor616is visible, as the second anchor is located inside the torque head630torque tube692.

FIG.46shows a lateral anterior implant612that has been preloaded into an implant loader686and is being pushed out of its distal end690. In this exemplary embodiment, the preloading and deployment of the lateral anterior implant612is essentially the same as that of the medial anterior implant612shown inFIG.45, but a tether puller694is provided for attaching to the proximal end of the tether from medial anterior implant612which is implanted first. In this exemplary embodiment, an axially extending spring lumen696is provided to guide tether puller694. In this embodiment, spring lumen696resembles an automobile “curb feeler” in that it may be deflected from a straight orientation by a lateral force in operation but is biased to return to its original straight orientation. Spring lumen696serves to prevent tether puller694and later a tether itself from wrapping about the implant, another tether, lead or tube.

Referring toFIGS.47A,47B and24, an exemplary method of performing an annuloplasty procedure according to aspects of the present disclosure is schematically shown. The steps of this exemplary method710are similar to those previously described in reference to the flowchart shown inFIG.4and the series of images shown inFIGS.5-22. For ease of understanding, descriptions of details that are the same between the two methods will not be repeated below. In some implementations of the method, two anterior implants612and one posterior implant610are implanted. In other implementations, different types or numbers of devices may be used.

In some implementations of method710, the first step712of the method is introducing the distal end of a steerable outer delivery catheter (not shown) into the left atrium of a subject. This may be performed using a transseptal approach, a left atrial approach or other methodology for gaining access to the left atrium. In some implementations, an inner dilator (not shown) is located in the distal end of the steerable outer delivery catheter for crossing the septum. A steerable inner delivery catheter (not shown) may be placed through the outer steerable delivery catheter for more precise delivery of the implants.

In step714of this exemplary embodiment, once the inner delivery catheter is introduced into the outer catheter, a first anterior implant612(seeFIG.24), sometimes referred to herein as a first member, and the distal end of the inner delivery catheter may be deployed into the left atrium from the distal end of the outer delivery catheter in. In this exemplary embodiment, a medial anterior device612is implanted first, followed by a lateral anterior device612. In other embodiments, the order of implantation may be changed. Anchor leads622and the inner catheter may be used to push anterior implant612through the outer delivery catheter and deploy it from the distal end. After the first anterior implant612emerges from the distal end of the outer delivery catheter, anchor leads622may be manipulated from the proximal end of the inner delivery catheter to pivot anterior implant612into an orientation that is generally perpendicular to the inner delivery catheter. The first anterior implant612emerges from the outer delivery catheter with the distal end of its tether or first tensile member614pre-attached. The proximal end of the attached tether614extends through the delivery catheters and out the proximal ends. Torque head630may be slid distally over anchor lead622until distally extending tabs678fit into slots636(seeFIG.43) so that implant612may be steered into its desired implantation location and orientation. Alternatively, torque head630may remain stationary relative to the catheter and anchor lead622may be used to pull implant612proximally until it engages with torque head630.

In step716, anterior implant612(i.e., the first member) is anchored to the anterior side of the mitral valve. This may be accomplished by individually turning each of the two helical tissue anchors616with their attached driver heads628. While torque head630holds anterior implant612against the mitral valve annulus tissue, one drive tube may be rotated to screw its anchor616through its spinner assembly624and into the underlying tissue. The torque head630may be used to then finely adjust/rotate implant612before the second anchor616is screwed into place with its drive tube and driver head628. Proper placement of the first member may be confirmed through imaging. When the surgical staff is ready to remove the delivery instrumentation, leads622may be unscrewed from spinner assemblies624, withdrawn past driver heads628and at least partially into the connected drive tubes. This allows the driver heads628to disengage from the anchors616. Once driver heads628are disengaged, the attached drive tubes, anchor leads622, torque head630and inner catheter can be proximally withdrawn through the outer delivery catheter.

In this exemplary embodiment, steps718and720are similar to steps714and716, respectively. In step718, a lateral anterior implant612(sometimes referred to herein as a second member) and the distal end of an inner delivery catheter may be deployed into the left atrium from the distal end of the outer delivery catheter in much the same way as previously described for the medial anterior implant612in step714. In some embodiments, a separate, pre-loaded and pre-sterilized steerable inner catheter is provided for each of the anterior implants612. In some embodiments, the tether614from the previously implanted first member612remains in the outer catheter after the inner catheter for the first member has been removed. To avoid entanglement, this tether614may be threaded through the second inner catheter before the second inner catheter is introduced into the outer steerable catheter. In this exemplary embodiment, the second member612is deployed with its own tether or tensile member614attached, such that the proximal ends of both the first and second tethers614extend through the second inner catheter and out of its proximal end. In step720, the lateral anterior implant612(i.e., the second member) is anchored to the anterior side of the valve in much the same way as previously described for the medial anterior implant612(i.e., the first member.)

In step722, posterior implant610(sometimes referred to herein as a third member) is deployed into the heart. As with the first and second members, the third member may be provided to the surgeons preloaded into its own steerable inner catheter. In some embodiments, before the third inner catheter is introduced into the outer catheter, the tethers or tensile members614extending from the first and second members are threaded through eyelet assemblies620on posterior implant610and through the third inner catheter. Anchor leads622and the inner catheter may be used to push anterior implant612through the outer delivery catheter and deploy it from the distal end. After the posterior implant610emerges from the distal end of the outer delivery catheter, anchor leads622may be manipulated from the proximal end of the inner delivery catheter to pivot posterior implant610into an orientation that is generally perpendicular to the inner delivery catheter. By keeping some tension on the proximal ends of the tethers614connected to the implanted first and second members, the posterior implant610or third member emerges from the outer delivery catheter and tracks over the first and second tensile members614. One advantage to this arrangement is that the first and second tensile members614help guide the third member610into a proper orientation. Having the tensile members614pre-connected to the three implants also saves time during the surgical procedure and ensures that the tensile members are properly and consistently connected to the implants. Torque head630may be slid distally over the center anchor lead622until distally extending tabs678fit into slots636(seeFIG.40) so that implant610may be further steered into its desired implantation location and orientation. Alternatively, torque head630may remain stationary relative to the catheter and anchor lead622may be used to pull implant610proximally until it engages with torque head630.

In step724, posterior implant610(i.e., the third member) is anchored to the posterior side of the mitral valve. This may be accomplished by individually turning each of the five helical tissue anchors616with their attached driver heads628. While torque head630holds posterior implant610against the mitral valve annulus tissue, one drive tube may be rotated to screw its anchor616through its spinner assembly624and into the underlying tissue. The torque head630may be used to then finely adjust/rotate implant610before the next anchors616are screwed into place with their drive tubes and driver heads628. Proper placement of the third member may be confirmed through imaging. When the surgical staff is ready to remove the delivery instrumentation, leads622may be unscrewed from spinner assemblies624, withdrawn past driver heads628and at least partially into the connected drive tubes. This allows the driver heads628to disengage from the anchors616. Once driver heads628are disengaged, the attached drive tubes, anchor leads622, torque head630and inner catheter can be proximally withdrawn through the outer delivery catheter.

In other embodiments, the order of deployment and attachment of the multiple implants can be changed. In these other embodiments, the first implant or implants are deployed with tether(s) attached, and at least one subsequently deployed implant tracks over the tether(s) when it is being deployed and attached to heart tissue. For example, a posterior implant may be implanted first with two tethers pre-attached at opposite ends of the implant. A medial anterior implant may then be deployed, tracking over one of the tethers of the posterior implant. After the medial anterior implant is secured to underlying heart tissue, a lateral anterior implant may be deployed, tracking over the other tether of the posterior implant. In another embodiment, a single anterior implant with two tethers is implanted first, and a single posterior implant may then be deployed, tracking over the two tethers of the anterior implant. Other embodiments having different orders of implant deployment may also utilize the principles of the present disclosure.

In exemplary method710, once all three implants have been deployed and anchored, additional tension may be applied to the interconnecting tethers614to draw the anterior and posterior sides of the mitral valve into closer approximation. This may be accomplished in steps726,728and730of method710. In step726, a first lock618is deployed over the first tensile member614which is connected to the medial anterior implant612. In step728, a second lock618is deployed over the second tensile member614which is connected to the lateral anterior implant612. The locks618may be pushed over the tensile members614from their proximal ends by sleeve-like tools (not shown) that urge the locks618distally until they abut against eyelet assemblies620, as shown inFIGS.23and24. In step730, tension is then applied to the first and second tensile members614by pulling proximally on the tensile members while pushing distally against locks618with the sleeve-like tools.

In some implementations, tension in tensile members614may be increased simultaneously. In some implementations, tension may be increased incrementally in members614, alternating between the two until the desired tensions and or valve approximation is reached. In some implementations, the final tension and or tissue approximation of each tensile member614is approximately the same. In some implementations, the final tension and or tissue approximation of each tensile member614is different. Because medial and lateral cinching can be performed independently, the placement of each implant is more forgiving. In some implementations, real time echocardiography of the mitral valve is used to monitor the reduction in mitral regurgitation as tensile members614are tightened. In some embodiments, one or both locks618may be temporarily released if it is desired to reduce the tension in the tensile members614.

After the desired tensions and or tissue approximations are obtained, the excess length of tensile members614extending proximally from locks618may be cut off. In step732, a cutter assembly may be slid distally along each tensile member614until it reaches the lock618. It may then be activated to cut the tensile member and then withdrawn with the cut off portion of the tensile member. In step734, the outer delivery catheter may then be withdrawn from the left atrium,

In some embodiments, the systems and methods disclosed herein or portions thereof may be utilized in a similar manner on either atrioventricular valve.

Advantages provided by the systems and methods disclosed herein can include the following. A more direct reduction in the anterior-posterior (A-P) direction can be achieved. Because the A-P direction is the most clinically relevant dimension to be reduced, it is advantageous to directly affect this dimension as opposed to simultaneously changing other dimensions of the annulus. This can be accomplished with a reduced cinching force because the action is directly in the A-P direction, rather than larger forces that are generally needed with circumferential remodeling. Lower cinching force typically translates to fewer anchors required. The systems and methods also allow for a high level of customization to suit a particular anatomy. This relates to there being distinct components that are placed separately, and the ability to adjust the medial and lateral sides separately. The separate components are each easier to implant compared with one superstructure. Each of the components can be retrieved prior to anchor detachment. The systems and methods allow for in vivo adjustability, allow for reduced accuracy needed to place the components and simplify the implantation procedure. A smaller number of implant sizes and configurations can also be accommodated. In addition to tensioning the device during the de novo procedure, additional tensioning devices can be added at a later time or date, and or the existing devices can be re-tensioned to further reduce the A-P dimension.