Patent Description:
The present invention relates to minimally invasive delivery of a suture into the heart. More particularly, the disclosed embodiments relate to inserting and anchoring one or more sutures as artificial chordae tendineae for a flailing or prolapsing leaflet in a beating heart.

The mitral and tricuspid valves inside the human heart include an orifice (annulus), two (for the mitral) or three (for the tricuspid) leaflets and a subvalvular apparatus. The subvalvular apparatus includes multiple chordae tendineae, which connect the mobile valve leaflets to muscular structures (papillary muscles) inside the ventricles. Rupture or elongation of the chordae tendineae results in partial or generalized leaflet prolapse, which causes mitral (or tricuspid) valve regurgitation. A commonly used technique to surgically correct mitral valve regurgitation is the implantation of artificial chordae (usually <NUM>-<NUM> or <NUM>-<NUM> Gore-Tex sutures) between the prolapsing segment of the valve and the papillary muscle.

This technique for implantation of artificial chordae was traditionally done by an open heart operation generally carried out through a median sternotomy and requiring cardiopulmonary bypass with aortic cross-clamp and cardioplegic arrest of the heart. Using such open heart techniques, the large opening provided by a median sternotomy or right thoracotomy enables the surgeon to see the mitral valve directly through the left atriotomy, and to position his or her hands within the thoracic cavity in close proximity to the exterior of the heart for manipulation of surgical instruments, removal of excised tissue, and/or introduction of an artificial chordae through the atriotomy for attachment within the heart. However, these invasive open heart procedures in which the heart is stopped beating produce a high degree of trauma, a significant risk of complications, an extended hospital stay, and a painful recovery period for the patient. Moreover, while heart valve surgery produces beneficial results for many patients, numerous others who might benefit from such surgery are unable or unwilling to undergo the trauma and risks of such open heart techniques.

Techniques for minimally invasive thoracoscopic repair of heart valves while the heart is still beating have also been developed. <CIT> to Speziali discloses a thoracoscopic heart valve repair method and apparatus. Instead of requiring open heart surgery on a stopped heart, the thoracoscopic heart valve repair methods and apparatus taught by Speziali utilize fiber optic technology in conjunction with transesophageal echocardiography (TEE) as a visualization technique during a minimally invasive surgical procedure that can be utilized on a beating heart. More recent versions of these techniques are disclosed in <CIT> and <CIT> to Zentgraf disclose an integrated device that can enter the heart chamber, navigate to the leaflet, capture the leaflet, confirm proper capture, and deliver a suture as part of a mitral valve regurgitation (MR) repair. In some procedures, these minimally invasive repairs are generally performed through a small, between the ribs access point followed by a puncture into the ventricle through the apex of the heart. Although far less invasive and risky for the patient than an open heart procedure, these procedures still require significant recovery time and pain.

Some systems have therefore been proposed that utilize a catheter routed through the patient's vasculature to enter the heart and attach a suture to a heart valve leaflet as an artificial chordae. While generally less invasive than the approaches discussed above, transcatheter heart valve repair can provide additional challenges. For example, with all artificial chordae replacement procedures, in addition to inserting a suture through a leaflet, the suture must also be anchored at a second location, such as at a papillary muscle in the heart, with a suture length, and tension and positioning of the suture should be adjustable to enable the valve to function naturally. If the suture is too short and/or has too much tension, the valve leaflets may not properly close. Conversely, if the suture is too long and/or does not have enough tension, the valve leaflets may still be subject to prolapse. Proper and secure anchoring of the suture at the second position away from the leaflet is therefore a critical aspect of any heart valve repair procedure for inserting an artificial chordae. In the case of transcatheter procedures, such anchoring can be difficult because it can be difficult for the flexible catheter required for routing through the patient's vasculature to apply sufficient force to stably insert traditional suture anchors into the heart wall, e.g., the myocardium. <CIT> relates to techniques for tightening tethers of percutaneous implants transluminally, in order to enable percutaneous treatment of functional tricuspid and/or mitral regurgitation. <CIT> relates to a method, including implanting, at an intraventricular site of a ventricle of a patient, a spool coupled to a first end portion of a longitudinal member, and coupling a second end portion of the longitudinal member to a portion of tissue facing a lumen of the ventricle.

Disclosed herein are various embodiments of cardiac anchors configured to be inserted into a heart wall of a patient to anchor a suture as an artificial chordae under an appropriate tension for proper valve function. Such cardiac anchors are particularly suitable for use in intravascular, transcatheter procedures.

In an embodiment, an anchor assembly is configured to implant a cardiac anchor into a heart wall of a patient to anchor a suture configured to extend from a valve leaflet of the heart as an artificial chordae. The anchor assembly can include an anchor hub defining an open interior and a helical coil extending distally from the anchor hub and having a sharpened tip configured to embed the helical coil into the heart wall upon rotation of the helical coil. A spring can be disposed within the open interior of the anchor hub. Compressing the spring distally can create an open space within the open interior of the anchor hub for a suture extending through the anchor hub to slide freely and releasing compression on the spring can cause the spring to expand in a proximal direction to clamp the suture within the open interior of the anchor hub.

In an embodiment, an anchor assembly is configured to implant a cardiac anchor into a heart wall of a patient to anchor a suture configured to extend from a valve leaflet of the heart as an artificial chordae. Anchor assembly can include an anchor base and a helical coil extending distally from the anchor base and having a sharpened tip configured to embed the helical coil into the heart wall upon rotation of the helical coil. In some embodiments, a stabilizing needle can extend longitudinally through and distally beyond the helical coil and have a sharpened tip configured to pierce the heart wall to stabilize the helical coil for insertion of the helical coil into the heart wall. A suture clamp can be configured to be rotated to clamp a suture under tension between the suture clamp and the anchor base. In embodiments, the suture clamp can include an anchor washer movable along a body of the anchor base and configured to have a suture inserted through a space between the anchor washer and the body of the anchor base and an anchor clamp nut threadedly attached to the anchor base. Rotation of the anchor clamp nut in a first direction can move the anchor clamp nut distally to clamp a suture inserted through the space between the anchor washer and the body of the anchor base between the anchor base and the anchor washer and between the anchor clamp nut and the anchor washer.

In an embodiment, an anchor assembly is configured to implant a cardiac anchor into a heart wall of a patient to anchor a suture configured to extend from a valve leaflet of the heart as an artificial chordae. The anchor assembly can include a suture anchor including an anchor hub, a helical coil extending distally from the anchor hub and having a sharpened tip configured to embed the helical coil into the heart wall upon rotation of the helical coil, and a suture lock threadedly attached to a proximal end of the anchor hub. The assembly can include an anchor hub driver having a drive end configured to mate with the anchor hub and an anchor hub driver tube configured to be rotated to rotate the suture anchor for insertion into the heart wall. The assembly can further include a suture lock driver having a drive end configured to mate with the suture lock and a suture lock driver tube, such that rotation of the suture lock driver in a first direction moves the suture lock distally to clamp a suture between the suture lock and the anchor hub. In embodiments, the suture lock can include a suture locking wedge including a threaded distal portion configured to interface with a threaded distal portion of the anchor hub and a tapered clamping surface configured to clamp the suture between a chamfered interior surface of the anchor hub and the tapered clamping surface of the suture locking wedge.

In an embodiment, an anchor assembly is configured to implant a cardiac anchor into a heart wall of a patient to anchor a suture configured to extend from a valve leaflet of the heart as an artificial chordae. The anchor assembly can include a suture anchor including an anchor hub, a helical coil extending distally from the anchor hub and having a sharpened tip configured to embed the helical coil into the heart wall upon rotation of the helical coil. In some embodiments, a stabilizing needle extending longitudinally through and distally beyond the helical coil has a sharpened tip configured to pierce the heart wall to stabilize the helical coil for insertion of the helical coil into the heart wall. An anchor delivery assembly can include an anchor driver configured to mate with the anchor hub to rotate the suture anchor for insertion into the heart wall. A suture lock delivery system can include a lock carrier configured to mate with the anchor hub and to carry a suture lock and a pusher movable with respect to the lock carrier. The pusher can be configured to push the suture lock off of the lock carrier and onto the anchor hub to clamp a suture between the suture lock and the anchor hub. In embodiments, the suture lock is configured as a spring.

In an embodiment, an anchor assembly is configured to implant a cardiac anchor into a heart wall of a patient to anchor a suture configured to extend from a valve leaflet of the heart as an artificial chordae. The anchor assembly can include an anchor hub defining an open interior and a proximal end cap covering the open interior. A helical coil can extend distally from the anchor base and have a sharpened tip configured to embed the helical coil into the heart wall upon rotation of the helical coil. In some embodiments, a stabilizing needle can extend longitudinally through and distally beyond the anchor hub and the helical coil. The stabilizing needle can have a sharpened tip configured to pierce the heart wall to stabilize the helical coil for insertion of the helical coil into the heart wall and a threaded proximal portion rotatingly attached to the end cap of the anchor hub. A piston chamber can be disposed within the open interior of the anchor hub, with the piston chamber and the end cap each having one or more openings enabling one or more sutures to pass through the piston chamber and the end cap. A spring can be disposed within the piston chamber between a proximal end of the piston chamber and a distal end of the anchor hub such that the spring biases the piston chamber proximally towards the end cap. Rotation of the stabilizing needle in a first direction can move the piston chamber distally to compress the spring to provide space between the piston chamber and the end cap for a suture to move freely and rotation of the stabilizing needle in a second direction can move the piston chamber proximally to clamp the suture between the piston chamber and the end cap.

Subject matter hereof may be more completely understood in consideration of the following detailed description of various embodiments in connection with the accompanying figures, in which:.

While various embodiments are amenable to various modifications and alternative forms, specifics thereof have been shown by way of example in the drawings and will be described in detail. It should be understood, however, that the intention is not to limit the claimed inventions to the particular embodiments described.

The present disclosure is generally directed to inserting and anchoring one or more sutures as artificial chordae into one or more heart valve leaflets through an intravascular, transcatheter approach. A heart valve leaflet may be captured and a suture inserted through the leaflet in any manner known in the art. Examples of such leaflet capture catheters are disclosed in copending <CIT> and <CIT>. Other transcatheter procedures for inserting an artificial chordae are disclosed in <CIT> and <CIT>.

In each of the below described embodiments, access into the heart to the valve being repaired can be gained through an intravascular, transcatheter approach. If the valve being repaired is the mitral valve, the valve may further be accessed transseptally. <FIG> depicts a schematic representation of an embodiment of an access approach for a heart valve repair system accessing the mitral valve <NUM>. <FIG> depicts a guide catheter <NUM> accessing the interior of the heart via the femoral vein. In some embodiments, such a system can further include an outer guide catheter and an inner guide catheter. In such embodiments, the outer guide catheter can be inserted into the femoral vein at the patient's groin and advanced through the femoral vein into the inferior vena cava <NUM> and then into the right atrium <NUM>. In various embodiments, the outer guide catheter can be steerable in a single plane and can have an outer diameter of about or less than about <NUM> French, such as, for example <NUM> French. The septum <NUM> can then be punctured using an appropriate puncture tool and the outer guide catheter advanced into the septum <NUM> or through the septum <NUM> into the left atrium <NUM>. The inner guide catheter can then be axially advanced through the outer guide catheter into the left atrium <NUM>. In some embodiments, the inner guide catheter can have two plans of steerability and can be maneuvered along with and/or beyond the outer guide catheter to establish a stable position superior to the mitral valve <NUM> and to provide a desired trajectory for operation of a leaflet capture catheter to repair the valve. In other embodiments, anchors as described herein may be implanted through other intravascular approaches as well as non-intravascular approaches.

<FIG> depict various views of an anchor assembly <NUM> for anchoring a suture as an artificial chordae in a heart wall of a patient and <FIG> depict the various components thereof. Anchor assembly <NUM> includes an anchor coil <NUM> that embeds the anchor assembly <NUM> into heart tissue and, in some embodiments, a central stabilizing needle <NUM> extending longitudinally through the coil <NUM> to stabilize the anchor assembly <NUM> while the coil <NUM> is driven into the tissue. An anchor base <NUM> can connected to the anchor coil <NUM> and the stabilizing needle <NUM>. Anchor assembly <NUM> can further include a plurality of suture clamping components, including an anchor washer <NUM>, an anchor clamp ring <NUM>, an anchor clamp nut <NUM>, an anchor clamp nut cap <NUM>, an anchor clamp nut driver <NUM> and an anchor cap <NUM>, which will be described in more detail below. An anchor sheath <NUM> is used to deliver and cover the anchor assembly <NUM> before it is deployed and the components of the anchor assembly <NUM> are actuated with an anchor tether <NUM> and an anchor driver tube <NUM> as will also be described in more detail below.

Referring to <FIG>, stabilizing needle <NUM> can include a sharp tip <NUM> capable of piercing the tissue of the heart wall. By piercing the heart wall with stabilizing needle <NUM>, the anchor assembly is stably held in position to enable the anchor coil <NUM> to be embedded into the heart wall to anchor the assembly by rotating anchor assembly <NUM>. A proximal threaded end <NUM> of the stabilizing needle <NUM> can be configured to be to be connected to anchor base <NUM>. The proximal threaded end <NUM> can also be drilled out to provide a hollow interior configured to enable the tether <NUM> to be attached thereto such as, for example, by laser welding. In other embodiments, anchor assembly <NUM> can be provided without stabilizing needle <NUM>. In some such embodiments, a stabilizing needle can alternatively be provided with an anchor delivery catheter, as described below with respect to <FIG>.

Anchor coil <NUM> includes a distal tip <NUM> for piercing the tissue of the heart wall. In embodiments, the anchor coil <NUM> is configured to be rotated clockwise to screw into the tissue. Anchor coil <NUM> can further be provided with anti-backout features, such as one or more barbs, that prevent rotation of anchor coil <NUM> due to natural heart rhythms from backing the coil out of the tissue. The anchor coil <NUM> can be connected to the anchor base <NUM> such as, for example, by laser welding.

The inside diameter of the anchor base <NUM> can be drilled out to create a hollow passage <NUM> to receive the proximal portion of the stabilizing needle, including an internally and externally threaded portion <NUM> that internally interfaces with the proximal threaded end <NUM> of the stabilizing needle <NUM>. A chamfer surface <NUM> of anchor base <NUM> that is longitudinally angled with respect to the assembly functions as one of the clamping surfaces for clamping the suture.

The anchor washer <NUM> is not threaded or welded to any component. The washer <NUM> can float rotationally and axially unconstrained on the shaft <NUM> of the anchor base. Anchor washer <NUM> functions to clamp the suture between the anchor base <NUM> and the anchor clamp ring <NUM>. The anchor clamp ring <NUM> is similarly not threaded or welded onto any component and can axially float on the anchor base shaft <NUM> but is rotationally constrained on the anchor base <NUM>. Anchor clamp ring <NUM> is prevented from rotating because it interfaces directly with the suture (which does not rotate) but is pushed down by the anchor clamp nut <NUM> (which rotates while threading down on the anchor base). In embodiments, anchor clamp ring <NUM> can be prevented from rotating by cutting off the outer threads on two sides of the anchor base <NUM>. The anchor clamp nut <NUM> includes internal threading <NUM> to rotationally attach the anchor clamp nut <NUM> to the external threading of threaded portion <NUM> of anchor base <NUM>. As the anchor clamp nut <NUM> is rotated counterclockwise, it moves down along the threading of threaded portion <NUM> to clamp the suture. The anchor clamp nut cap <NUM> interfaces with an open proximal end <NUM> of the anchor clamp nut <NUM> and can be attached, e.g., by laser welding, after the anchor clamp nut <NUM> is threaded on to the anchor base <NUM> to lock the anchor clamp nut <NUM> on and prevent removal of the anchor clamp nut <NUM> from the anchor base <NUM>. After the anchor clamp nut cap <NUM> is attached to the anchor clamp nut <NUM>, the anchor clamp driver <NUM> can be attached such as by laser welding onto the anchor clamp nut cap <NUM> with a drive end <NUM> (e.g., a hex drive) of the anchor clamp driver <NUM> interfacing with a correspondingly shaped aperture <NUM> in the anchor clamp nut cap <NUM>. Rotation of the anchor clamp driver <NUM> therefore rotates the anchor clamp nut <NUM>. The anchor cap <NUM> can be attached to the anchor base <NUM>, such as by laser welding, after the anchor washer <NUM>, anchor clamp ring <NUM> and anchor clamp nut <NUM> have been assembled with anchor base <NUM>, which locks anchor clamp nut <NUM> onto anchor base <NUM> to eliminate the risk of accidentally threading the anchor clamp nut <NUM> back off of the anchor base <NUM>.

The anchor tether <NUM> can be a flexible, generally cylindrical component that can travel through the anchor driver tube <NUM> and the anchor base <NUM> and be attached to the stabilizing needle <NUM> by, for example, laser welding. In one embodiment, tether <NUM> is a Nitinol wire. The anchor <NUM> is driven into tissue by twisting the anchor tether <NUM> clockwise, with the torque being transferred from the anchor tether <NUM> to the stabilizing needle <NUM> and the anchor base <NUM> to which the anchor coil <NUM> is attached, thus causing rotation of the anchor coil <NUM> to embed the coil into tissue. In embodiments that do not utilize a stabilizing needle <NUM> as part of the anchor assembly, the anchor tether <NUM> can attach to and directly rotate the anchor base <NUM>.

The anchor driver tube <NUM> is attached to the anchor clamp nut cap <NUM> such that rotation of the anchor driver tube <NUM> causes rotation of the anchor clamp nut <NUM> to move the anchor clamp nut <NUM> along the threaded portion <NUM> of the anchor base <NUM> to clamp the suture between the anchor base <NUM>, anchor washer <NUM> and anchor clamp ring <NUM>. As can be seen in <FIG>, the suture <NUM> is threaded through the anchor washer <NUM> and is clamped therein between chamfer surface <NUM> of anchor base <NUM> and anchor clamp ring <NUM>. The anchor sheath <NUM> covers the anchor coil <NUM> before the anchor <NUM> is deployed. The anchor sheath <NUM> can include a slit <NUM> on one side of anchor sheath <NUM> that enables the suture to access the anchor locking components and then enter the anchor sheath proximal to the anchor. Following seating of the anchor in the heart wall, the anchor driver tube <NUM> and anchor cap <NUM> and then the tether <NUM> and stabilizing needle <NUM> can be withdrawn by twisting the tether counter-clockwise.

Referring to <FIG>, the routing of suture <NUM> through anchor assembly <NUM> is depicted. After suture <NUM> is inserted into a valve leaflet, suture <NUM> is threaded through anchor washer <NUM> outside of the body. The anchor <NUM> is inserted into anchor sheath <NUM> and delivered into the heart such that the suture <NUM> extends through anchor sheath <NUM> back out of the body to enable suture <NUM> tension to be adjusted from outside the body. As the anchor clamp nut <NUM> is tightened, the suture is clamped between the chamfer surface <NUM> of anchor base and the distal side of anchor washer <NUM> and between the anchor clamp ring <NUM> and the proximal side of anchor washer <NUM> to securely hold the suture <NUM> at a desired tension. Although depicted as a single suture <NUM>, it should be understood that a plurality of sutures could be locked in this manner.

<FIG> depict schematic representations of various steps of a method of repairing a heart valve according to another embodiment that utilizes anchor system <NUM>. After the sutures <NUM> are inserted into the leaflet <NUM>, they can be threaded through anchor washer <NUM> of anchor <NUM> outside of the body. The anchor <NUM> can then be inserted into anchor delivery catheter or sheath <NUM> and positioned adjacent the heart wall. The stabilizing needle <NUM> first pierces the tissue to stabilize the anchor while the coil <NUM> is driven into the tissue by rotating the anchor <NUM> as described above. After the anchor <NUM> has been inserted, the sutures can be tensioned and then locked by rotating an anchor clamp nut <NUM> to clamp down on the sutures <NUM>. The stabilizing needle <NUM> can then be removed and the sutures ends severed as depicted in <FIG>.

<FIG> depict various views of an anchor assembly <NUM> for anchoring a suture as an artificial chordae in a heart wall of a patient and <FIG> depict the various components thereof. Anchor assembly <NUM> includes an anchor coil <NUM> configured to embed the anchor into the tissue of the heart wall and a suture locking system that locks one or more sutures at a set tension for proper valve function.

Anchor coil <NUM> includes a sharpened distal tip <NUM> configured to pierce the tissue and is configured to be embedded into the heart wall by clockwise rotation and can be used with anti-backout features, such as one or more barbs. The anchor coil <NUM> is connected to the anchor hub <NUM>, such as, for example, by laser welding. The anchor hub <NUM> includes a proximal drive end <NUM> such, as for, example a hex drive configured to interface with an anchor hub driver <NUM> to enable rotation of the hub <NUM> and coil <NUM>. As can be seen in <FIG>, the anchor hub <NUM> can further include an interior threaded portion <NUM> at a distal portion of the anchor hub <NUM> and an interior chamfered chamber <NUM> at a proximal portion thereof.

Suture locking wedge <NUM> includes a distal threaded portion <NUM> configured to interface with the interior threaded portion <NUM> of anchor hub <NUM>. A tapered outer surface <NUM> of suture locking wedge <NUM> interfaces with the interior chamfered chamber <NUM> of the anchor hub to lock the suture between the two surfaces. A hollow longitudinal chamber <NUM> extends from distal threaded portion <NUM> of suture locking wedge <NUM> and is in communication with a cross aperture <NUM> through tapered outer surface <NUM>. As can be seen in <FIG>, this enables one or more sutures <NUM> to extend proximally up through anchor coil <NUM>, through the hollow chamber <NUM> and out of the cross apertures <NUM> of anchor base and back proximally through the device. At the distal end, suture locking wedge <NUM> can further include a drive end <NUM>, such as a hex drive, to interface with a suture lock driver <NUM>. The center of the drive end <NUM> can include internal threading <NUM> to interface with a threaded distal end <NUM> of tether crimp <NUM>. Proximal portion <NUM> of tether crimp includes a drilled out hollow chamber that is crimped onto the tether <NUM>. In an embodiment, tether <NUM> is a Nitinol wire that is, for example, <NUM> inches in diameter. The tether crimp <NUM> and tether <NUM> are fastened to the suture locking wedge <NUM> to ensure that the anchor is not prematurely released.

Suture lock driver <NUM> has a drive end <NUM> with an internal geometry, e.g., hex, matching that of the drive end <NUM> of the suture locking wedge <NUM>. In embodiments, the two components interface with a slip fit. Suture lock driver <NUM> further includes two open sides <NUM> that enable sutures to enter suture lock driver <NUM> and exit out of a proximal aperture <NUM>. Suture lock driver <NUM> is connected to suture lock driver tube <NUM> such as, for example, by laser welding. Suture lock driver <NUM> can be rotated clockwise via suture lock driver tube <NUM> to move the suture locking wedge <NUM> distally to clamp the suture <NUM> between the suture locking wedge <NUM> and the anchor hub <NUM>. In some embodiments, suture lock driver tube <NUM> can be laser cut at lines <NUM> to provided added flexibility for maneuvering the device through the vasculature and to reduce torque buildup on the distal portion of the system.

Anchor hub driver <NUM> includes a drive end <NUM> with an internal geometry, e.g., hex, matching that of the drive end <NUM> of the anchor hub <NUM>. Rotating of the anchor hub driver <NUM> via the anchor hub driver tube <NUM> in a clockwise direction rotates the anchor hub <NUM> and the anchor coil <NUM> to embed the anchor coil <NUM> into the heart tissue. Applying a counter-force on the anchor hub <NUM> with the anchor hub driver <NUM> can also provide a counter-torque when applying a final torque to the suture locking wedge <NUM> with the suture lock driver <NUM> to lock the sutures within the anchor hub <NUM> with the suture locking wedge <NUM>. In embodiments, the anchor hub driver tube <NUM> can also be connected to the anchor hub driver <NUM> by laser welding and can be laser cut along lines <NUM> to provide added flexibility. A covering dome <NUM> can be provided to mate with the anchor hub <NUM> and cover the sutures once the sutures have been tensioned, locked, and cut. In embodiments, the covering dome <NUM> can be covered with ePTFE to encourage tissue ingrowth and discourage thrombosis.

Referring to <FIG>, the routing of sutures <NUM> through anchor system is depicted (in which a pair of sutures is depicted, by fewer or greater sutures could be employed). After each suture <NUM> is deployed into a leaflet, the ends of the suture <NUM> are threaded through anchor system <NUM> such that they extend back through anchor coil <NUM> and anchor hub <NUM>, into the distal chamber <NUM> and out of the cross aperture <NUM> of the suture locking wedge <NUM>, and back through suture lock driver <NUM>, suture lock drive tube <NUM> and anchor hug drive tube <NUM> to be able to be tensioned from outside of the body. When the suture locking wedge <NUM> is advanced distally, the sutures <NUM> are clamped between the tapered surface <NUM> of the suture locking wedge <NUM> and the chamfered chamber <NUM> of the anchor hub <NUM> to lock the suture at a desired tension.

<FIG> depict schematic representations of various steps of a method of repairing a heart valve according to another embodiment that also utilizes anchor system <NUM>. After sutures <NUM> are inserted into the leaflet <NUM>, the sutures <NUM> can be threaded through the anchor coil <NUM> and anchor body <NUM> of anchor exterior to the body. Anchor catheter <NUM> can then be used to deliver the anchor system <NUM> to the heart wall. The anchor hub driver <NUM> can then be used with the anchor hub driver tube <NUM> to rotate the anchor to <NUM> embed the coil <NUM> into the heart wall. As the coil <NUM> advances, the suture <NUM> slides through the coil and to the anchor hub <NUM> once the coil is full inserted into the tissue. The anchor hub driver <NUM> and anchor hub driver tube <NUM> can then be withdrawn above as depicted in <FIG>. The sutures can then be preliminarily tensioned and locked by rotating suture lock driver <NUM> clockwise with suture lock driver tube <NUM> to advance suture locking wedge <NUM> (see <FIG>) to clamp the suture in anchor hub <NUM> as described above. In embodiments, if the tension is not appropriate the suture locking wedge <NUM> can be unlocked and the sutures retensioned. Once desired tension is achieved and the suture locking wedge <NUM> is preliminarily locked, the anchor hub driver <NUM> can be brought back down to apply a counter torque while applying a strong torque to the suture locking wedge <NUM> with the suture lock driver <NUM> for final locking. The suture lock driver <NUM> and anchor hub driver <NUM> can then be withdrawn, leaving tether <NUM> extending from the anchor <NUM> back out of the heart. The free ends of the suture <NUM> can then be severed and a suture cover <NUM> can be advanced along the tether <NUM> to be seated on the anchor hub <NUM> to cover sutures <NUM>. The tether <NUM> can then be severed and withdrawn from the body, leaving the anchor <NUM> in place.

<FIG> depict various views of an anchor assembly for anchoring a suture as an artificial chordae in a heart wall of a patient and <FIG> depict the various components thereof. Anchor assembly includes an anchor delivery assembly <NUM> and suture lock assembly <NUM>. Once the anchor delivery assembly <NUM> is used to embed the anchor in the heart wall, the anchor delivery assembly <NUM> is withdrawn and the suture lock assembly <NUM> is used to deliver and lock the sutures to the anchor.

Anchor delivery assembly <NUM> includes an anchor coil <NUM> with a central stabilization needle <NUM> in some embodiments extending longitudinally through the anchor coil <NUM>. Stabilization needle <NUM> provides stability against the ventricular wall during anchor deployment and also provides the attachment to the tether <NUM> that extends out of the body and is used to rotate the anchor assembly. Needle <NUM> includes a sharpened distal tip <NUM> configured to penetrate the heart tissue and a threaded portion <NUM> that releasably secures the needle <NUM> within internal threads in the anchor hub <NUM>. Anchor coil <NUM> connects to anchor hub <NUM>, such as, for example, by welding, and can include an anti-backout feature. Anti-backout feature can be configured as a barb <NUM> positioned around coil <NUM> that keeps the coil <NUM> from rotating back out of the tissue due to the natural rhythm of the heart. In embodiments, barb <NUM> can be welded onto the coil <NUM>. Coil <NUM> includes a sharpened distal tip <NUM> configured to penetrate the tissue in the heart. In other embodiments, anchor assembly <NUM> can be provided without stabilizing needle <NUM>. In some such embodiments, a stabilizing needle can alternatively be provided with an anchor delivery catheter, as described below with respect to <FIG>.

As noted above, anchor hub <NUM> includes internal threading in a distal portion of anchor hub to releasably secure needle <NUM> therein. Anchor hub <NUM> also provides a proximally facing suture clamping surface <NUM> extending around anchor hub <NUM>. Anchor driver <NUM> includes a drive end <NUM> that mates with corresponding internal geometry in the proximal portion of anchor hub <NUM> to enable rotation of anchor hub <NUM> with anchor driver <NUM>. Anchor driver <NUM> can further includes a helical hollow strand (HHS) <NUM> that extends out of the body and is twisted to provide the torque necessary to drive the anchor coil <NUM> into the tissue. As can be seen in <FIG>, tether <NUM> extends through anchor driver HHS <NUM> and anchor driver <NUM> to a connection within anchor hub <NUM> to an aperture in the proximal end of stabilizing needle <NUM>. A stiffening tube <NUM> can be threaded over tether <NUM> within anchor hub <NUM> to stiffen a small portion of the tether <NUM> to provide better alignment to component that need to mate within the anchor hub <NUM>. In embodiments that do not utilize a stabilizing needle <NUM> as part of the anchor assembly, the tether <NUM> can attach to the anchor hub <NUM>.

Suture lock assembly <NUM> includes a suture lock configured as a spring <NUM> that locks the suture by compressing the suture against the suture capture surface <NUM> of the anchor hub <NUM>. Suture lock spring <NUM> can be delivered to the anchor on a spring carrier <NUM>. Spring carrier <NUM> can include a pair of upwardly raised ledges <NUM> defining a suture channel <NUM> therebetween. Each ledge <NUM> can include a lock depression <NUM> in which suture lock spring <NUM> is seated for delivery and a retention lip <NUM> projecting upwardly from lock depression <NUM> to prevent inadvertent dislodgement of suture lock spring <NUM>. Spring carrier <NUM> includes a distal portion <NUM> that mates with the anchor hub <NUM> to provide a tensioning point that is near the final point of suture lock to ensure proper tension is maintained. Tubing <NUM> extends from spring carrier <NUM> back out of the body to provide a hollow pathway for the tether <NUM> to enable advancement of the spring carrier <NUM> guided to the anchor hub <NUM>. In embodiments, tubing <NUM> can be comprised of PEEK and can be bonded to the spring carrier. A pusher <NUM> can be advanced over tubing <NUM> and spring carrier <NUM> and includes a distal surface <NUM> configured to engage the suture spring lock <NUM> to push the suture lock <NUM> over the retention lips <NUM> and off of the spring carrier <NUM>, onto the anchor hub <NUM> and against the suture clamping surface <NUM> of the anchor hub <NUM>. A pusher connector <NUM> can be employed to connect the pusher to a catheter <NUM> used to move the suture lock assembly <NUM>.

The routing of a suture <NUM> through suture lock assembly <NUM> can be seen with respect to <FIG>. Outside of the body the suture <NUM> extending from the leaflet is threaded through the suture channel <NUM> of the spring carrier <NUM> beneath the suture lock spring <NUM>, into the pusher <NUM> and out a suture aperture <NUM> in the pusher. The suture <NUM> can then extend back through the anchor catheter out of the body for suture tensioning. When the suture lock spring <NUM> is deployed with the pusher <NUM>, the suture <NUM> is crimped under tension between the suture lock spring <NUM> and the suture capture surface <NUM> of the anchor base <NUM>.

<FIG> depict schematic representations of various steps of a method of repairing a heart valve with an anchor system including anchor delivery assembly <NUM> and suture locking assembly <NUM>. An anchor delivery catheter <NUM> delivers the anchor delivery assembly <NUM> into the heart and the anchor is partially rotated out of the catheter <NUM> by twisting anchor driver HHS <NUM> to rotate anchor driver <NUM> to expose the stabilizing needle <NUM> to enable insertion of the needle <NUM> into the heart wall without exposing the anchor coil <NUM>. The anchor hub <NUM> is then further rotated to insert the anchor coil <NUM> into the heart tissue and the anchor catheter <NUM> and anchor driver <NUM> withdrawn as depicted in <FIG>, leaving a tether <NUM> in place extending from an anchor hub <NUM> back out of the heart. Suture lock delivery system <NUM> is then loaded into anchor catheter <NUM> and threaded over tether <NUM> to bring one or more sutures to the anchor as depicted in <FIG>. The suture locking assembly <NUM> is then primarily withdrawn, leaving the spring carrier <NUM> that holds a locking spring <NUM> attached to anchor hub <NUM> as depicted in <FIG>. The sutures <NUM> can then be appropriately tensioned and then the suture lock delivery system <NUM> brought back to the anchor as depicted in <FIG> with pusher <NUM> deploying the locking spring <NUM> off of the spring carrier <NUM> and onto the anchor hub <NUM> to clamp the sutures <NUM> between the locking spring <NUM> and the anchor hub <NUM> at the adjusted tension. The suture lock delivery system <NUM> can then be removed, followed by removal of the tether <NUM> and attached stabilizing needle <NUM> and the sutures <NUM> cut to complete the procedure.

<FIG> depict various views of an anchor assembly <NUM> for anchoring a suture as an artificial chordae in a heart wall of a patient and <FIG> depict the various components thereof. As with the previous embodiment, anchor assembly <NUM> includes an anchor coil <NUM> and, in some embodiments, a stabilizing needle <NUM> as well as a suture lock configured as a locking spring <NUM> for locking the sutures at an adjusted tension.

Anchor coil <NUM> includes a sharpened distal tip <NUM> for penetrating tissue and, in some embodiments, can be include anti-backout features as described herein. Anchor coil <NUM> can be attached to anchor hub <NUM>, such as, for example, by laser welding. The proximal portion of anchor hub <NUM> can comprise a drive end <NUM> having, e.g., a hex geometry for mating with an anchor driver such as those disclosed above. A suture aperture <NUM> can be disposed in a distal end of anchor hub <NUM> to enable a suture to pass from coil <NUM> through anchor hub <NUM>. Anchor hub <NUM> can further define an internal piston opening <NUM> matching an outer diameter of a piston chamber <NUM> and that enables the piston chamber to slide distally and proximally within the piston opening <NUM>. Suture locking spring <NUM> can be disposed between the distal end of anchor hub <NUM> and a proximal end of piston chamber <NUM> to bias the piston chamber <NUM> proximally. The piston chamber <NUM> includes a distally facing spring opening <NUM> (see <FIG>) that constrains the spring <NUM> and enables the spring <NUM> expand and contract as piston chamber <NUM> moves proximally and distally. Piston chamber <NUM> can further include a central needle opening <NUM> and a pair of suture openings <NUM> that enable passage of the needle <NUM> and one or more sutures therethrough, respectively.

An end cap <NUM> can be connected to anchor hub <NUM> such as, for example, by welding after the piston chamber <NUM> and spring <NUM> are loaded into the anchor hub <NUM>. The outer geometry <NUM> of the end cap can include a matching, e.g., hex geometry to the anchor hub <NUM>. End cap <NUM> can also include a pair of suture openings <NUM> to enable ends of a suture to pass through the end cap <NUM>. A needle opening <NUM> through end cap <NUM> can be threaded to receive a threaded portion <NUM> of the needle <NUM>. Needle shaft <NUM> and needle shoulder <NUM> can be inserted through the needle opening <NUM> of end cap <NUM> to enable threaded portion <NUM> of needle <NUM> to be screwed into needle opening <NUM>. A tether (not pictured) such as those described herein can be secured within tether aperture <NUM> in needle cap <NUM> and twisted to provide the torque necessary to turn the needle <NUM>, with needle cap <NUM> further preventing the needle <NUM> from being screwed distally through needle opening <NUM> of end cap <NUM>. Needle shaft <NUM> can fit through needle opening <NUM> in piston chamber <NUM>, but needle shoulder <NUM> cannot, such that needle shoulder <NUM> abuts piston chamber <NUM>, such that distal movement of needle <NUM> presses down on piston chamber <NUM> to move the chamber distally and compresses the spring <NUM>. Conversely, proximal movement of needle <NUM> releases the pressure on the piston chamber <NUM> enabling the spring <NUM> to move the chamber <NUM> proximally within the anchor hub <NUM>. In other embodiments, anchor assembly <NUM> can be provided without stabilizing needle <NUM>. In some such embodiments, a stabilizing needle can alternatively be provided with an anchor delivery catheter, as described below with respect to <FIG>. In such embodiments, the tether can be connected to components similar to the needle cap <NUM>, threaded portion <NUM>, and needle shoulder <NUM> (without the needle shaft <NUM>) to control movement of the end cap <NUM>.

<FIG> depict the manner in which a suture <NUM> is routed through anchor assembly <NUM>. Following insertion of the suture into the leaflet, the suture is threaded through the anchor assembly outside of the body by passing the suture ends through the coil <NUM> and suture aperture <NUM> of the anchor hub <NUM> and then separately through the suture openings <NUM> of the piston chamber <NUM> and the suture openings <NUM> of the end cap <NUM> such that the suture ends extend back through the anchor catheter out of the body to enabling suture tensioning. As the needle <NUM> is moved distally, the needle shoulder <NUM> pushing on the piston chamber <NUM> to compress the spring <NUM> causes the suture <NUM> to be able to slide freely for tensioning. When proper tension is achieved, the needle can be moved back proximally to release the pressure on the spring <NUM> and move the piston chamber <NUM> upward to lock the suture by crimping the suture between the piston chamber <NUM> and the end cap <NUM>. Note that the suture openings <NUM> is the piston chamber <NUM> are not longitudinally aligned with the suture openings <NUM> in the end cap <NUM>, which enables the suture to be crimped between the piston chamber <NUM> and the end cap <NUM> when the two components are abutting one another under the force of the spring.

<FIG> depict various views of an anchor assembly <NUM> for anchoring a suture as an artificial chordae in a heart wall of a patient and <FIG> depict the various components thereof. Anchor assembly <NUM> includes an anchor coil <NUM> that embeds the anchor assembly <NUM> into heart tissue. Anchor coil <NUM> includes a sharpened distal tip <NUM> to enable the coil to penetrate the tissue. Anchor coil <NUM> can also include an anti-backout feature such as a barb <NUM> that prevents the motion of the heart from twisting the anchor coil <NUM> out of the tissue. In embodiments, barb <NUM> can be welded onto the coil <NUM>.

Anchor assembly <NUM> can also include an anchor hub <NUM> that can be connected to anchor coil <NUM>, such as, for example, by welding. Anchor hub <NUM> includes a drive end <NUM> having a shape, e.g., hexagonal, to mate with an anchor driver <NUM>. Anchor hub <NUM> can also include a hollow hub chamber <NUM> within which a suture locking spring <NUM> and suture clamp plate <NUM> are contained. An end cap <NUM> can attach to the proximal end of the anchor hub <NUM> and can include internal threading <NUM> that can rotatably receive a threaded tether crimp <NUM> having a hollow interior portion configured to receive a tether <NUM> that can be torqued to rotate the tether crimp <NUM>. End cap <NUM> can further include a proximal drive end <NUM> configured to mate with the anchor driver <NUM>.

The suture clamp plate <NUM> can include a pair of suture windows <NUM> that enable the pair of free ends of the suture <NUM> to pass through the suture clamp plate <NUM> (one suture end through each window). The distal surface of the suture clamp plate <NUM> interfaces with the proximal end of the suture locking spring <NUM> and the proximal surface of the suture clamp plate (between the suture windows <NUM>) interfaces with a drive end <NUM> of the tether crimp <NUM>. The end cap <NUM> can also include a pair of suture windows <NUM>. In embodiments, the suture windows <NUM> of the suture clamp plate can be offset about <NUM> degrees from the suture windows <NUM> of end cap <NUM>. The anchor driver <NUM> can have an internal geometry matching that of the anchor hub <NUM> drive end <NUM> and/or the end cap <NUM> drive end <NUM> such that rotation of the anchor driver <NUM> with driver hypotube <NUM> extending back to the control handle outside of the body rotates anchor assembly. In embodiments, driver hypotube <NUM> can be cut, e.g., by laser cutting, with a special pattern <NUM> at a plurality of locations along its length to make the driver hypotube <NUM> torqueable yet flexible.

It should be noted that although <FIG> appear to show only a single strand of suture <NUM>, typically a pair of free ends of a suture <NUM> extending from a leaflet will extend through anchor assembly <NUM>. Referring primarily to <FIG>, in operation the free ends of the suture <NUM> are threaded through the anchor coil <NUM>, into the anchor hub <NUM> and through the suture locking spring <NUM>, through the suture windows <NUM>, <NUM> of the suture clamp plate <NUM> and the end cap <NUM> and the through the hollow interior of the driver hypotube <NUM> out of the body. In the initial configuration, the tether crimp <NUM> can be in a distally advanced position that drives the suture clamp plate <NUM> down to compress the suture locking spring <NUM> to create open space <NUM> between the suture clamp plate <NUM> and the end cap <NUM> to create a low friction path for the suture <NUM> to move generally freely before and during suture tensioning, as depicted in <FIG>. To crimp the suture <NUM> under tension after anchor deployment and suture tensioning, the tether <NUM> is rotated with the control handle to unscrew the tether crimp <NUM> and pull the tether crimp <NUM> proximally through the threading <NUM> of the end cap <NUM>. As the tether crimp 512moves proximally, the force of the tether crimp <NUM> on the suture clamp plate <NUM> compressing the suture locking spring <NUM> is released, which causes the spring <NUM> to expand to push the suture clamp plate <NUM> against end cap <NUM> to compress the suture <NUM> across a tortuous path defined by the offset suture locking windows <NUM>, <NUM> of the suture clamp plate <NUM> and the end cap <NUM>. The suture <NUM> is then locked in place at a set tension with respect to the leaflet. Thus, in this embodiment the natural force of the spring provides the clamping force rather than providing by a component that requires a rotational torque force to clamp the suture.

After the suture <NUM> is locked, an anchor cap <NUM> to can be advanced over the tether <NUM> along a cap aperture <NUM> to anchor hub <NUM>. The end cap <NUM> can include a conical or otherwise tapered proximal end <NUM> to aid in guiding the anchor cap <NUM> onto the anchor. Anchor cap <NUM> can further include an internal retention ring <NUM> having a plurality of retention projections <NUM> configured to snap onto anchor hub <NUM> to hold the anchor cap <NUM> in place on the anchor hub <NUM>. In embodiments, the retention projections <NUM> can be flexible to be flexed across a circumferential retention lip <NUM> on anchor hub <NUM> at the distal and of a tapered region and snap into a circumferential retention recess <NUM> to hold the anchor cap <NUM> on the anchor hub <NUM> via interference between the retention projections <NUM> and the retention lip <NUM>.

<FIG> depict schematic representations of various steps of a method of repairing a heart valve according to an embodiment that utilizes anchor system <NUM>. After sutures <NUM> are inserted into a leaflet, the free ends of the suture <NUM> can be threaded through the anchor assembly <NUM> as described above exterior to the body such that the suture <NUM> extend distally out of anchor coil <NUM> to the leaflet. Anchor catheter <NUM> can then be used to deliver the anchor system <NUM> to the heart wall. In this embodiment, the anchor catheter <NUM> can include a stabilizing needle <NUM> extendable from a hollow channel <NUM> or a lumen within anchor catheter. As the anchor catheter <NUM> is delivered into the heart and near the heart wall, in some embodiments a stabilizing needle <NUM> can remain within the channel <NUM> as depicted in <FIG>. When the anchor catheter <NUM> nears the heart wall, the stabilizing needle <NUM> can be actuated to extend distally of the catheter <NUM> to penetrate the heart tissue to stabilize the anchor assembly <NUM> within the anchor catheter <NUM> when the anchor assembly is subsequently rotated. Although specifically described with respect to the depicted embodiment, such a stabilizing needle provided as part of the anchor catheter could be used with any of the embodiments described herein or a stabilizing needle may not be used with any of those embodiments.

Referring to <FIG>, the anchor catheter <NUM> can be advanced to contact the heart wall with the stabilizing needle <NUM> embedded in the wall and the anchor coil <NUM> rotated via the anchor driver <NUM> and driver hypotube <NUM> as described above. The anchor catheter <NUM> and stabilizing needle <NUM> can then be withdrawn. As depicted in <FIG>, the anchor driver <NUM> can be disengaged from the anchor assembly <NUM> and the anchor driver <NUM> and driver hypotube <NUM> withdrawn. After the suture <NUM> has been tensioned, the tether <NUM> is actuated to unscrew the tether crimp <NUM> which, as described above, releases the distal pressure on the suture locking spring <NUM> to enable the spring <NUM> to expand to compress the suture ends <NUM> between the suture clamp plate <NUM> and the end cap <NUM>. The anchor cap <NUM> can then be advanced along the tether530 to the anchor assembly and interfaced with the anchor hub <NUM>. The tether <NUM> and tether crimp <NUM> can then be removed and the excess suture extending up from the anchor assembly and out of the anchor cap <NUM> can be cut.

Referring to <FIG>, the suture <NUM> now extends from the anchor assembly <NUM> to the leaflet as an artificial chordae. Although the suture <NUM> is clamped within the anchor assembly by the force of the suture locking spring <NUM> the suture <NUM> is also captured between the anchor coil <NUM> and/or anchor hub <NUM> and the tissue and/or partially embedded within the tissue. As opposed to anchor configurations in which the suture extends out of a more upward portion of the anchor (e.g., out of the top of the end cap <NUM>), this reduces the torque on the anchor from the naturally forces of the leaflet pulling on the suture <NUM> because the forces act at the very bottom of the anchor at the level of the tissue. This significantly reduces the potential for an anchor failure causing the artificial chordae to fail.

<FIG> depict an anchor assembly 500A that is similar to anchor assembly <NUM>. Anchor assembly 500A also includes an anchor coil 502A with a sharpened distal tip 522A that embeds the anchor assembly <NUM> into heart tissue and can also include an anti-backout feature such as a barb 504B that prevents the motion of the heart from twisting the anchor coil <NUM> out of the tissue. Anchor assembly 500A can also include an anchor hub 506A that can contain a suture locking spring 528A and suture clamp plate 510A. In this embodiment, the proximal end of the anchor hub 506A is unitarily formed with the anchor body and an end cap 514A is positioned at a distal end of the anchor hub 506A to retain the suture locking spring 528A and suture clamp plate 510A within the anchor hub 506A. Proximal end of anchor hub 506A can include a proximal drive end 535A configured to mate with an anchor driver. Although not depicted in these figures, anchor assembly 500A would also include a tether crimp such as tether crimp <NUM> of anchor assembly <NUM> (as shown, for example, in <FIG> and <FIG>) extending through threaded opening 534A in anchor hub 506A.

In this embodiment, the anchor hub 506A further includes a helical slot 507A extending around anchor body and the suture clamp plate 510A can include a pair of corresponding outwardly projecting tabs 511A configured to interface with slot 507A. As will be described in more detail below, as the suture clamp plate 510A moves along the helical slot 507A, the suture clamp plate <NUM> rotates within the anchor hub 506A. Suture clamp plate 510A can further include a suture window 536A and the proximal end of the anchor hub 506A can also include a suture window 540A. Referring to <FIG>, when the suture clamp plate 510A is initially inserted into the anchor hub 506A by inserting the tabs 511A into the helical slot 507A, the suture windows 536A, <NUM> of the two components can be aligned with each other. Suture clamp plate 510A can also include an opening 537A that enables the plate to be held with a forceps for proper positioning within anchor hub 506A as described herein during assembly. Similar to anchor assembly <NUM>, in operation the free ends of the suture(s) are threaded through the anchor coil 502A of anchor assembly 500A, through the end cap 514A into the anchor hub 506A and through the suture locking spring 528A, through the aligned suture windows 536A, 540A of the suture clamp plate 510A the anchor hub 506A and out of the body. In this initial configuration, the suture clamp plate 510A can be distally positioned with the tether crimp (not pictured) to compress the suture locking spring 528A to create open space between the suture clamp plate 510A and the proximal end of the anchor hub 506A. This creates a generally straight, low friction path through the anchor to enable free movement of the suture for suture length adjustment for tensioning of the suture for proper valve function. The suture can be crimped under tension as described above by unscrewing the tether crimp proximally to release the compression on the suture locking spring 528A to cause the spring 528A to expand to push the suture clamp plate 510A against the proximal end of the suture hub 506A. As the suture clamp plate 510A moves upward, the projecting tabs 511A in helical slot 507A cause the suture clamp plate 510A to rotate within the anchor hub 506A. This causes the suture window 536A in the suture clamp plate 510A to rotate out of alignment with the suture window 540A in the proximal end of the suture hub 506A to enable the suture to be crimped between a solid proximally facing surface of the suture clamp plate 510A and a solid distally facing surface of the proximal end of the anchor hub 506A. In various embodiments, the suture window 536A can be rotated approximately, for example, between <NUM> degrees and <NUM> degrees offset from the suture window 540A of the suture hub 506A when in the locked position. After the suture is locked, the anchor assembly 500A can be capped in a similar manner to anchor assembly <NUM> described above.

<FIG> depict a coil <NUM> and a barb <NUM> for an anchor assembly that can be used with embodiments described herein. In the depicted embodiment, barb <NUM> is positioned approximately ¾ to <NUM> revolution of the coil <NUM> from the tip <NUM> of the coil. Barb <NUM> is further sized such that it does not protrude beyond the outer diameter of coil <NUM> so that it does not interfere with insertion of the coil <NUM> into the heart tissue. To prevent the coil <NUM> from backing out of the heart tissue, the barb <NUM> is positioned at an angle relative to the angle of coil <NUM>. In the depicted embodiment, the barb <NUM> is positioned at an angle of <NUM> degrees, plus or minus <NUM> degrees, relative to the coil <NUM>. While a body portion of the barb <NUM> is welded to the coil to be smooth and free of any burrs or sharp edges, the prong of the barb <NUM> that extends at an angle from the coil <NUM> is not welded to the coil.

The anchor assemblies described herein generally each include one or more of an anchor body, anchor hub, anchor cap, dome etc. In embodiments, such components may be comprised of a rigid material such as, for example, stainless steel. In order to limit wear and abrasion on portions of a suture that may repeatedly contact such components due to natural forces of the heart, any such components or combination of components may be provided with a thin cover or jacket over the component or a portion thereof. In embodiments, the cover or jacket can be comprised of a polymer material, such as, for example, ePTFE. In some embodiments, the cover or jacket can have a length greater than the components it is covering such that the polymer or other material extends beyond the components to create a compressible "skirt" to provide additional anchor coverage and/or softening of the tissue interface at the point of contact with the anchor.

It should be noted that in some embodiments, anchor coils are larger in diameter and length and require a greater number of turns that known anchor coils used to anchor other devices such as pacing leads in the heart. This is because unlike pacing leads, anchor coils that serve to anchor sutures as artificial chordae are under immediate and constant forces from the moving valve leaflets that could potentially pull the anchors back out of the heart wall. As such, a more robust fixation provided by a larger and/or longer coil may be desirable to more reliably embed the anchor in the heart wall. In some embodiments, the coil can be inserted generally perpendicularly to the interior surface of the heart wall. In other embodiments, due to the interior geometry of the hard the coil may be inserted at a non-perpendicular angle to the heart wall. In addition, in some embodiments the sharpened distal end of the coil and the sharpened distal end of the stabilizing needle can be oriented generally orthogonal to each other.

Various other anchors can be interchangeably employed in each of the above-described systems. Such anchors can include those disclosed in <CIT>; <CIT>; <CIT>; and <CIT>.

Various embodiments of systems, devices, and methods have been described herein. These embodiments are given only by way of example and are not intended to limit the scope of the claimed inventions. It should be appreciated, moreover, that the various features of the embodiments that have been described may be combined in various ways to produce numerous additional embodiments. Moreover, while various materials, dimensions, shapes, configurations and locations, etc. have been described for use with disclosed embodiments, others besides those disclosed may be utilized without exceeding the scope of the claimed inventions.

Claim 1:
An anchor assembly (<NUM>; <NUM>; 500A) configured to be implanted into a heart wall of a heart of a patient to anchor a suture that is configured to extend from a valve leaflet of the heart as an artificial chordae, the anchor assembly comprising:
an anchor hub (<NUM>; <NUM>; 506A) defining an open interior;
a helical coil (<NUM>; <NUM>; 502A) extending distally from the anchor hub and having a sharpened tip configured to embed the helical coil into the heart wall upon rotation of the helical coil;
a spring (<NUM>; <NUM>; 528A) disposed within the open interior of the anchor hub selectively configured to be in one of a compressed state or a released state;
wherein when the spring is in the compressed state the spring distally creates an open space within the open interior of the anchor hub for the suture to be extended through the anchor hub so as to slide freely within the open interior of the anchor hub, and wherein when the spring is in the released state the spring expands in a proximal direction to clamp the suture across a tortuous path within the open interior of the anchor hub,
characterized in that the anchor hub further comprises a proximal end covering the open interior.