Systems and methods for deploying cardiac therapeutic devices

Abstract

This disclosure relates to transcatheter delivery systems, including cardiac therapeutic devices (e.g., implants), and related methods for deploying the cardiac therapeutic devices to the heart. For example, some embodiments described herein can provide improved transcatheter delivery in an efficient, repeatable, and effective manner for structural heart intervention devices to treat regurgitation at the mitral valve and the tricuspid valve.

Description

[0001] Systems and Methods for Deploying Cardiac Therapeutic Devices

[0002] CLAIM OF PRIORITY

[0003] This application claims the benefit of U.S. Provisional Patent Applications Serial Nos. 63 / 525,420, filed on July 7, 2023, and 63 / 532.508, filed on August 14, 2023. The entire contents of the foregoing are hereby incorporated by reference.

[0004] TECHNICAL FIELD

[0005] This disclosure relates to tools, systems, cardiac therapeutic devices, and related methods for deploying cardiac therapeutic devices to the heart for treating pathologies of the heart.

[0006] BACKGROUND

[0007] A number of cardiac interventions have been performed via a catheter, including the delivery' of replacement valves and valve clip devices intended to treat valve regurgitation, which can be a significant contributor to cardiovascular morbidity and associated mortality. The transcatheter delivery of devices for such structural heart interventions can be extraordinarily complex, especially since the heart is beating during the procedure. Even if the implant or other interventional device is satisfactorily designed for its final use within the heart, not all such devices can be accurately and efficiently delivered in a transcatheter procedure. For example, many devices used in structural heart interventions require proper alignment with anatomical features in the heart or the ability to track a particular path / be steered at a particular angle through an atrium / ventricle toward the final implantation site. In such cases, a clinically effective delivers’ of the interventional device might depend on one or more of the ability to navigate to an intended location within the three- dimensional space of the heart, stability to perform remote action after reaching a particular chamber within the heart, and the ability to evaluate the progress or placement via imaging in various planes.

[0008] SUMMARY

[0009] In general, this disclosure relates to transcatheter delivery systems, including cardiac therapeutic devices (e.g., implants), and related methods for deploying the cardiac therapeutic devices to the heart. For example, some embodiments described herein can provide improved transcatheter delivery in an efficient, repeatable, and effective manner for structural heart intervention devices to treat regurgitation at the mitral valve and the tricuspid valve. In some embodiments, a transcatheter delivery system includes a deployment tool, an implantation system, and a manipulation tool. In some implementations, the transcatheter delivery system may be operated to deploy a mitral valve implant or a tricuspid valve implant to a selected position within the heart and to respectively implant the valve implant at the mitral valve or the tricuspid valve.

[0010] In one aspect, a deployment tool for deploying a therapeutic device to a heart includes a guide catheter and a frame coupled to the guide catheter. The guide catheter is configured to enter the heart and defines a lumen through which the therapeutic device is movable to a selected position within the heart. The frame is configured to stabilize a distal portion of the deployment tool within the heart when a distal portion of the frame is exposed from the distal end of the guide catheter.

[0011] Embodiments may include one or more of the following features.

[0012] In some embodiments, the frame is disposed within the guide catheter along a majority of a length of the frame.

[0013] In some embodiments, one or more components of the frame are slidable axially along the guide catheter.

[0014] In some embodiments, one or more components of the frame are rotatable with respect to the guide catheter.

[0015] In some embodiments, the lumen extends along a central axis of the guide catheter.

[0016] In some embodiments, the lumen has a maximum width of about 2.6 mm to about 4. 1 mm.

[0017] In some embodiments, the frame includes a stabilization rail that is configured to limit a first movement of the frame in a first direction when the distal portion of the frame is exposed from the distal end of the guide catheter.

[0018] In some embodiments, the lumen includes a first lumen that extends along a central axis of the guide catheter, wherein the guide catheter further defines a second lumen extending along a first side of the central axis, and wherein the stabilization rail is disposed within the second lumen. In some embodiments, the stabilization rail is a first stabilization rail, wherein the frame further includes a second stabilization rail that is configured to limit a second movement of the frame in a second direction when the distal portion of the frame is exposed from the distal end of the guide catheter.

[0019] In some embodiments, the guide catheter further defines a third lumen extending along a second side of the central axis, wherein the second stabilization rail is disposed within the third lumen.

[0020] In some embodiments, the guide catheter includes a first wall portion having a first maximum thickness and a second wall portion having a second maximum thickness that is less than the first maximum thickness, wherein the first lumen extends within the first wall portion.

[0021] In some embodiments, the frame is configured such that at least a portion of the stabilization rail is disposed within an atrium of the heart when the distal portion of the frame is exposed from the distal end of the guide catheter.

[0022] In some embodiments, the frame is configured such that at least a portion of the stabilization rail is disposed within a ventricle of the heart when the distal portion of the frame is exposed from the distal end of the guide catheter.

[0023] In some embodiments, the stabilization rail has a thickness of about 0.38 mm to about 0.64 mm.

[0024] In some embodiments, the stabilization rail is made of one or more of nitinol or stainless steel.

[0025] In some embodiments, the stabilization rail is constructed as a wire or a ribbon.

[0026] In some embodiments, the frame includes a hub to which the stabilization extends distally.

[0027] In some embodiments, the stabilization rail and the hub are secured to each other at a threaded arrangement.

[0028] In some embodiments, the frame further includes a guiderail disposed within the first lumen and providing a path along which the therapeutic device is movable to the selected position within the heart.

[0029] In some embodiments, the guide catheter defines a third lumen, wherein the frame further includes a guidewire disposed within the third lumen and configured to be extended from the distal end of the guide catheter into a ventricle of the heart. In some embodiments, the frame includes a guiderail disposed within the lumen and providing a path along which the therapeutic device is movable axially to the selected position within the heart.

[0030] In some embodiments, the guiderail has a thickness of about 0.38 mm to about 0.97 mm.

[0031] In some embodiments, the guiderail is constructed as a wire or a ribbon.

[0032] In some embodiments, the guiderail is made of one or more of stainless steel or nitin ol.

[0033] In some embodiments, the frame includes a hub to which the guiderail extends distally.

[0034] In some embodiments, the frame includes a guidewire configured to be extended from the distal end of the guide catheter into a ventricle of the heart.

[0035] In some embodiments, the frame further includes a sheath that surrounds at least a portion of the guidewire.

[0036] In some embodiments, the guidewire includes a stabilization foot.

[0037] In some embodiments, the guidewire includes a free distal end.

[0038] In some embodiments, the frame is configured to form a loop distal to the guide catheter.

[0039] In some embodiments, the loop is separable into two segments at a location along the loop that is distal to the guide catheter.

[0040] In some embodiments, the frame includes a first stabilization rail that is configured to limit a first movement of the frame in a first direction when the distal portion of the frame is exposed from the distal end of the guide catheter, a second stabilization rail that is configured to limit a second movement of the frame in a second direction when the distal portion of the frame is exposed from the distal end of the guide catheter, and a third stabilization rail that is configured to limit a third movement of the frame in a third direction when the distal portion of the frame is exposed from the distal end of the guide catheter.

[0041] In some embodiments, the first, second, and third stabilization rails are equally spaced around a central axis of the guide catheter.

[0042] In some embodiments, the guide catheter includes a retention feature configured to engage a septum of the heart.

[0043] In some embodiments, the retention feature includes a terminal cone, a beveled edge, or one or more heat-set tubes. In some embodiments, the deployment tool further includes a delivery catheter slidably disposed within the lumen of the guide catheter and configured to extend past the distal end of the guide catheter to deliver the therapeutic device to the selected position within the heart.

[0044] In some embodiments, the frame extends from a distal end of the deliverycatheter.

[0045] In some embodiments, the frame is coupled to a distal end of the delivery catheter with one or more positioning wires.

[0046] In some embodiments, the therapeutic device is a heart valve clip.

[0047] In some embodiments, the deployment tool is further configured for one or both of removal of the therapeutic device and reversal of a functional effect of the therapeutic device after the therapeutic device has been implanted at the heart.

[0048] In some embodiments, the frame includes a segment carry ing an electrode.

[0049] In some embodiments, the segment is movable axially to align the electrode with the therapeutic device that has been implanted at the heart.

[0050] In another aspect, a deployment tool for deploying a therapeutic device to a heart includes a guide catheter and a frame coupled to the guide catheter. The guide catheter is configured to enter the heart, defines a central axis, a first lumen extending along a first side of the central axis, a second lumen extending along a second side of the central axis, and a third lumen extending along the central axis. The frame includes a first stabilization rail disposed within the first lumen and configured to limit a first movement of the frame in a first direction when a distal portion of the frame is exposed from a distal end of the guide catheter, a second stabilization rail disposed within the second lumen and configured to limit a second movement of the frame in a second direction when the distal portion of the frame is exposed from the distal end of the guide catheter, and a guiderail disposed within the third lumen and providing a path along which the therapeutic device is movable to a selected position within the heart.

[0051] In another aspect, a transcatheter delivery system for implanting a therapeutic device at a heart includes a deployment tool and an implantation system. The deployment tool includes a guide catheter configured to enter the heart and a frame coupled to the guide catheter. The frame is configured to stabilize a distal portion of the deployment tool within the heart when a distal portion of the frame is exposed from the distal end of the guide catheter. The implantation system is movable axially within a lumen of the guide catheter. The implantation system includes the therapeutic device and a deployment catheter to which the therapeutic device is secured.

[0052] Embodiments, may include one or more of the following features.

[0053] In some embodiments, the implantation system further includes a positioning catheter that is slidably disposed within the lumen of the guide catheter, wherein the deployment catheter is slidably disposed within the positioning catheter.

[0054] In some embodiments, a distal end of the positioning catheter is movable linearly in a direction orthogonal to a distal axis of the positioning catheter.

[0055] In some embodiments, the distal end of the positioning catheter is rotatable about an axis that is orthogonal to the distal axis of the positioning catheter.

[0056] In some embodiments, the implantation system further includes a delivery catheter to which the positioning catheter is coupled.

[0057] In some embodiments, the frame of the deployment tool includes a guiderail disposed within the lumen of the guide catheter.

[0058] In some embodiments, the delivery catheter is movable axially along the guiderail to position the therapeutic device at a selected location within the heart.

[0059] In some embodiments, a distal end of the positioning catheter is connected to a distal end of the delivery catheter with one or more positioning wires.

[0060] In some embodiments, a distal end of the positioning catheter is coupled to one or more positioning wires by which the distal end of the positioning catheter can be moved.

[0061] In some embodiments, the positioning catheter includes a distal collar.

[0062] In some embodiments, at least a portion of the frame is disposed within the guide catheter.

[0063] In some embodiments, one or more components of the frame is slidable axially along the guide catheter.

[0064] In some embodiments, one or more components of the frame are rotatable with respect to the guide catheter.

[0065] In some embodiments, the frame includes a stabilization rail that is configured to limit a first movement of the frame in a first direction when the distal portion of the frame is exposed from the distal end of the guide catheter. In some embodiments, the frame is configured such that at least a portion of the stabilization rail is disposed within an atrium of the heart when the distal portion of the frame is exposed from the distal end of the guide catheter.

[0066] In some embodiments, the frame is configured such that at least a portion of the stabilization rail is disposed within a ventricle of the heart when the distal portion of the frame is exposed from the distal end of the guide catheter.

[0067] In some embodiments, the frame is configured to form a loop distal to the guide catheter.

[0068] In some embodiments, the therapeutic device is a heart valve clip.

[0069] In some embodiments, the transcatheter delivery further includes a manipulation tool that is operable to manipulate a distal portion of the deployment tool and a distal portion of the implantation system.

[0070] In some embodiments, a proximal portion of the frame and a proximal portion of the deployment catheter are assembled with the manipulation tool.

[0071] In some embodiments, the transcatheter delivery system further includes an imaging catheter that is movable axially within the lumen of the guide catheter.

[0072] In some embodiments, the therapeutic device includes an annular band.

[0073] In another aspect, a method of deploying a therapeutic device to a heart placing a distal end of a guide catheter within the heart, deploying a frame from the distal end of the guide catheter, adjusting the frame into a functional configuration to stabilize a distal portion of the deployment tool within the heart, and moving the therapeutic device through the guide catheter to a selected position within the heart.

[0074] Embodiments, may include one or more of the following features.

[0075] In some embodiments, the method further includes positioning the distal end of the guide catheter within a left atrium of the heart.

[0076] In some embodiments, the therapeutic device is a mitral valve implant.

[0077] In some embodiments, the method further includes positioning the distal end of the guide catheter within a right atrium of the heart.

[0078] In some embodiments, the therapeutic device is a tricuspid valve implant.

[0079] In some embodiments, the method further includes sliding one or more components of the frame axially within the guide catheter.

[0080] In some embodiments, the method further includes causing a stabilization rail of the frame to contact a wall of the heart to stabilize a distal portion the frame within the heart. In some embodiments, in the functional configuration of the frame, at least a portion of the stabilization rail is disposed within an atrium of the heart.

[0081] In some embodiments, in the functional configuration of the frame, at least a portion of the stabilization rail is disposed within a ventricle of the heart.

[0082] In some embodiments, the method further includes advancing a distal portion of a guidewire of the frame into a ventricle of the heart.

[0083] In some embodiments, the method further includes retracting the guidewire until a stabilization foot adjacent the distal portion of the guidewire contacts an anatomical stop within the heart.

[0084] In some embodiments, the anatomical stop includes one or more of a portion of a valve of the heart or a portion of a wall of the heart.

[0085] In some embodiments, the method further includes engaging a retention feature on the guide catheter with a septal wall of the heart to prevent the distal end of the guide catheter from moving out of a left atrium of the heart.

[0086] In some embodiments, the method further includes advancing a positioning catheter distally out of the guide catheter and advancing the therapeutic device distally out of the positioning catheter on a deployment catheter.

[0087] In some embodiments, the method further includes moving a distal end of the positioning catheter linearly in a direction orthogonal to a distal axis of the positioning catheter.

[0088] In some embodiments, the method further includes rotating a distal end of the positioning catheter about an axis that is orthogonal to the distal axis of the positioning catheter.

[0089] In some embodiments, a delivery catheter is coupled to the positioning catheter, and the frame includes a guiderail disposed within a lumen of the guide catheter.

[0090] In some embodiments, the method further includes advancing the delivery' catheter distally along the guiderail.

[0091] In some embodiments, the distal end of the positioning catheter is connected to a distal end of the deliver}' catheter with one or more positioning wires.

[0092] In some embodiments, the method further includes moving the distal end of the positioning catheter with one or more positioning wires.

[0093] In some embodiments, the method further includes lowering the therapeutic device into a valve of the heart. In some embodiments, the method further includes implanting the therapeutic device on the valve.

[0094] In some embodiments, the method further includes manipulating a proximal portion of the frame to adjust the frame into the functional configuration.

[0095] In some embodiments, the method further includes inserting the guide catheter percutaneously and advancing the guide catheter to the heart through a patient's vasculature.

[0096] In some embodiments, the method further includes deploying an imaging catheter to the heart to image the distal portion of the deployment tool within the heart.

[0097] In some embodiments, the method further includes moving the imaging catheter axially through a lumen of the guide catheter.

[0098] In some embodiments, the method further includes visualizing an anatomic landmark at an engagement between the frame and the heart.

[0099] In some embodiments, the method further includes determining a position of a distal portion of the frame or a position of the therapeutic device within the heart based at least in part on a visualization of the anatomic landmark.

[0100] In some embodiments, the imaging catheter includes a camera, and the method further includes aligning the camera with one or more components of the frame and determining a position of the camera based at least in part on the visualization of the anatomic landmark.

[0101] In some embodiments, the method further includes inserting the guide catheter into a body containing the heart through an incision on the body.

[0102] In some embodiments, the method further includes inserting the imaging catheter into the body through the incision.

[0103] In some embodiments, the incision is a first incision, and the method further includes inserting the imaging catheter into the body without passing the imaging catheter through a second incision on the body.

[0104] In some embodiments, the method further includes deploying the imaging catheter to the heart without using transesophogeal echo imaging.

[0105] In some embodiments, the imaging catheter is an intracardiac echocardiography (ICE) imaging catheter.

[0106] Embodiments may provide one or more of the following advantages. In some embodiments, the guide catheter of the deployment tool can be inserted into the vasculature in a minimally invasive manner (e.g., without open-chest or open-heart surgery ) and then advanced through the vasculature into the heart, even while encountering varying tortuosity and varying pathway sizes of the vasculature.

[0107] In some implementations, use of the manipulation tool enables predictable, repeatable control of the deployment tool and implantation system for implanting the mitral valve implant at the mitral valve or the tricuspid valve implant at the tricuspid valve. For example, near-immediate correspondence between remote manipulations of the manipulation tool and local manipulations of the deployment tool and implantation system render the transcatheter delivery system easy to operate in an efficient manner by a user. Furthermore, deployment of the intracardiac echocardiography (ICE) imaging catheter to the atrium allows the maneuvers to be visualized in real time. Accordingly, the main lumen of the guide catheter is sized to accommodate the guiderail, the implantation system, and the ICE catheter.

[0108] In some embodiments, the stabilization rails of the frame can help stabilize the frame and the distal end of the guide catheter in any of lateral, medial, anterior, and posterior directions within the left atrium. In this manner, the stabilization rails provide localized stability of the frame within the heart without the need for an otherwise relatively rigid deployment structure. Furthermore, the guidewire can be retracted gently until its stabilization foot is wedged against or just beneath the anterolateral commissure or the sub-annular gutter to further stabilize the position of the frame within the heart. In this way, the anterolateral commissure or the subannular gutter and the left ventricular wall can serve as anatomic stabilization structures for the deployment tool. In some embodiments, the distal end of the guide catheter may be further secured in place within the atrial septum using an atrial retention feature.

[0109] In another aspect, a cardiac therapeutic device includes a central member, a first clipping element coupled to a first side of the central member, and a second clipping element coupled to a second side of the central member. The first and second clipping elements are adjustable to respectively grasp and hold together a first portion of a heart and a second portion of the heart to securely close a gap betw een the first and second portions of the heart.

[0110] Embodiments may provide one or more of the following features. In some embodiments, the cardiac therapeutic device is configured to be delivered to the heart through a catheter.

[0111] In some embodiments, the cardiac therapeutic device further includes a fabric cover that surrounds one or more of the central member and the first and second clipping elements.

[0112] In some embodiments, the central member includes a laser-cut structure.

[0113] In some embodiments, one or more of the central member and the first and second clipping elements is formed from a braided structure.

[0114] In some embodiments, the cardiac therapeutic device has a folded configuration that is formed from a single sheet of material.

[0115] In some embodiments, each of the first and second clipping arms has a comblike structure.

[0116] In some embodiments, one or both of the first and second clipping arms includes a loop.

[0117] In some embodiments, the cardiac therapeutic device further includes a first gripping arm and a second gripping arm that respectively facilitate positioning of the first portion and the second portion along the first clipping arm and the second clipping arm.

[0118] In some embodiments, each of the first and second gripping arms include one or more surface projections that facilitate respective gripping of the first and second portions.

[0119] In some embodiments, the first clipping arm is separable from the second clipping arm.

[0120] In some embodiments, the cardiac therapeutic device is a heart valve implant.

[0121] In another aspect, a cardiac therapeutic device includes a first implant element configured to be placed at a first commissure of a heart valve and a first clip configured to clip the first implant to the first commissure. The cardiac therapeutic device further includes a second implant element configured to be placed at a second commissure of the heart valve and a second clip configured to clip the second implant to the second commissure. The cardiac therapeutic device further includes a pull line connected to the first and second implants and configured to be pulled to draw the first and second implants towards each other while the first and second implants are secured to the first and second commissures. Other aspects, features, and advantages will be apparent from the description, the drawings, and the claims.

[0122] DESCRIPTION OF DRAWINGS

[0123] FIG. 1 A is a perspective view of a deployment tool and an implantation system of a transcatheter delivery system within the left atrium and left ventricle in a cross-sectional view of a heart.

[0124] FIG. IB is a perspective view of the deployment tool and the implantation system of FIG. 1 in a top perspective view of a left atrium of the heart.

[0125] FIG. 2A is a bottom view of a mitral valve of the heart of FIG. 1.

[0126] FIG. 2B is a top view of a tricuspid valve of the heart of FIG. 1.

[0127] FIG. 3 A is a perspective view of a distal portion of the deployment tool of FIG. 1.

[0128] FIG. 3B is a perspective view of the distal portion of the deployment tool of FIG. 3 A with the implantation system of FIG. 1 deployed to the distal portion.

[0129] FIG. 4A is a top view of a portion of the frame of the deployment tool of FIG. 1 within the heart.

[0130] FIG. 4B is a perspective view of the portion of the frame of FIG. 4A in a cross-sectional view of the heart.

[0131] FIG. 4C is a top view of the portion of the frame of FIG. 4A in a functional configuration.

[0132] FIG. 4D is a perspective view of the portion of the frame of FIG. 4C in a cross-sectional view of the heart.

[0133] FIG. 5 A is a perspective view of a hub of the deployment tool of FIG. 1 in a threaded engagement with a stabilization rail.

[0134] FIG. 5B is a perspective view of the hub of FIG. 5 A with the threaded engagement in a disconnected configuration.

[0135] FIG. 6A is a side view of a distal portion of the guiderail of the deployment tool of FIG. 1, equipped with a coil in a relaxed, extended configuration.

[0136] FIG. 6B is a side view of the distal portion of the guiderail of FIG. 6A with the coil in a compressed, stiffened configuration.

[0137] FIG. 7A is a side view of a distal portion of the guiderail of the deployment tool of FIG. 1, with a relatively small diameter. FIG. 7B is a side view of the distal portion of the guiderail of FIG. 7A, with a relatively large diameter.

[0138] FIG. 8 is a perspective view of the deployment tool of FIG. 3B in a side cross- sectional view of the heart.

[0139] FIG. 9A is an enlarged perspective view of a distal portion of the implantation system of FIG. 1.

[0140] FIG. 9B is a side view of a mitral valve implant of the implantation system of FIG. 9A with clipping arms in a partially collapsed configuration.

[0141] FIG. 9C is a side view of the implant of FIG. 9B with the clipping arms in an extended configuration.

[0142] FIG. 9D is a side view of the implant of FIG. 9B with the clipping arms in a closed configuration.

[0143] FIG. 9E is a front view of the implant of FIG. 9D.

[0144] FIG. 9F is a top view of the implant of FIG. 9D with the clipping arms closed onto leaflets of the mitral valve.

[0145] FIG. 9G is a side view of the implant of FIG. 9D with a flexible cover.

[0146] FIG. 9H is an enlarged side view of a threaded distal connection of the implant of FIG. 9B.

[0147] FIG. 91 is a side view of an intact connection between the implant of FIG. 9B and a deployment catheter.

[0148] FIG. 9J is a side view of a released connection between the implant of FIG. 9B and a deployment catheter.

[0149] FIG. 9K is a side view of a disconnection betw een the implant of FIG. 9B and a deployment catheter.

[0150] FIG. 9L is a side view of a laser-cut collar of a valve implant.

[0151] FIG. 9M is a front view of the collar of FIG. 9L.

[0152] FIG. 1 OA is a side perspective cutaway view of a distal portion of the guide catheter of the deployment tool of FIG. 1, with the mitral valve implant disposed within the guide catheter.

[0153] FIG. 1 OB is a cross-sectional view of the distal portion of the guide catheter of FIG. 10 A.

[0154] FIG. 11 A is a side perspective cutaway view of the distal portion of the guide catheter of FIG. 10A, with the mitral valve implant and the ICE imaging catheter deployed distal to the guide catheter. FIG. 1 IB is a cross-sectional view of the distal portion of the guide catheter of FIG. HA.

[0155] FIG. 12A is a perspective view of the guide catheter of the deployment tool of FIG. 1, equipped with a distal nose cone in a closed configuration in a side cross- sectional view of the heart.

[0156] FIG. 12B is a perspective view of the distal nose cone of FIG. 12Ain an open configuration with the frame extending therethrough in a side cross-sectional view of the heart.

[0157] FIG. 13A is a perspective view of a the guide catheter of the deployment tool of FIG. 1 with a distal beveled edge.

[0158] FIGS. 13B-D are perspective views that sequentially illustrate delivery and positioning of the guide catheter of FIG. 13A at the atrial septum.

[0159] FIG. 14A is a perspective view of the guide catheter of the deployment tool of FIG. 1, equipped with a heat-set tube that extends distally from a lumen within a wall of the guide catheter.

[0160] FIG. 14B is a perspective view of the guide catheter of the deployment tool of FIG. 1, equipped with a tubular frame that extends radially from a distal end of the guide catheter.

[0161] FIG. 14C is a perspective view of the guide catheter of the deployment tool of FIG. 1. equipped with heat-set wires that extends axially from a distal end of the guide catheter through respective lumens within the wall of the guide catheter.

[0162] FIG. 15 is a perspective view of a patient on an operating table undergoing a percutaneous deployment of a mitral valve implant using the deployment tool of FIG. 1 and an associated manipulation tool.

[0163] FIG. 16 is a schematic illustration of the controls of the manipulation tool of FIG. 15.

[0164] FIG. 17A is a perspective view of a bar-linkage frame.

[0165] FIG. 17B is a side view of a flexible frame that is adjustable to differing extents at opposite ends of the frame.

[0166] FIG. 17C is a side view of a flexible frame that is adjustable in one direction.

[0167] FIG. 17D is a side view of a flexible frame that is adjustable axially in a manner that effects a corresponding radial adjustment.

[0168] FIGS. 18A-18M are respective, perspective views of distal portions of other embodiments of deployment tools. FIG. 19Ais a side view of an interlocking feature of a closed stabilization loop of a deployment tool.

[0169] FIG. 19B is a side view of an interlocking feature of a closed stabilization loop of a deployment tool in another embodiment.

[0170] FIG. 20A is a side view of a guidewire equipped with a tube having a stabilization foot positioned below the mitral plane.

[0171] FIG. 20B is a side view of a guidewire equipped with a tube having a stabilization foot positioned below the mitral plane.

[0172] FIG. 20C is a side view of a guidewire equipped with two tubes respectively having a stabilization foot above and below the mitral plane.

[0173] FIG. 20D is a side view of a guidewire equipped with a tube having a stabilization foot above the mitral plane, where the guidewire has a stabilization foot below the mitral plane.

[0174] FIGS. 21-26A are respective, perspective views of distal portions of other embodiments of deployment tools in side cross-sectional views of the heart.

[0175] FIG. 26B is a side perspective view of a positioning frame of a deployment tool.

[0176] FIG. 26C is a top view of the positioning frame of FIG. 26B.

[0177] FIG. 26D is a side perspective view of an alternative embodiment of a positioning frame of a deployment tool.

[0178] FIG. 26E is a side perspective view of another alternative embodiment of a positioning frame of a deployment tool.

[0179] FIG. 27Ais a perspective view of a deployment tool in a side cross-sectional view of the heart.

[0180] FIG. 27B is a top view of the deployment tool of FIG. 27A above the mitral valve in the heart.

[0181] FIG. 28A is a perspective view of a deployment tool in a side cross-sectional view of the heart.

[0182] FIG. 28B is a top view of the deployment tool of FIG. 28A above the mitral valve in the heart.

[0183] FIG. 28C is a top view of a deployment tool above the mitral valve in the heart.

[0184] FIG. 29A is a perspective view of a distal portion of a deployment tool. FIG. 29B is a top view of the distal portion of the deployment tool of FIG.

[0185] 29A.

[0186] FIG. 29C is a side view of a distal portion of the deployment tool of FIG. 29 A.

[0187] FIG. 29D is a top view of a portion of a deployment tool.

[0188] FIG. 30A is a perspective view of a deployment tool in a side cross-sectional view of the heart.

[0189] FIG. 30B is a perspective view of the deployment tool of FIG. 30A above the mitral valve in the heart.

[0190] FIG. 30C is a perspective view of a portion of the deployment tool of FIG. 30A.

[0191] FIG. 30D is a top view of a portion of the deployment tool of FIG. 30A.

[0192] FIG. 31 A is a perspective view of a deployment tool in a side cross-sectional view of the heart.

[0193] FIG. 3 IB is a perspective view of the deploy ment tool of FIG. 31 A above the mitral valve in the heart.

[0194] FIG. 32A is a perspective view of a deployment tool in a side cross-sectional view of the heart.

[0195] FIG. 32B is a perspective view of the deployment tool of FIG. 32A above the mitral valve in the heart.

[0196] FIG. 32C is a perspective view of a deployment tool in a side cross-sectional view of the heart.

[0197] FIG. 32D is a perspective view of the deployment tool of FIG. 32C above the mitral valve in the heart.

[0198] FIG. 33A is a perspective view of a deployment tool in a side cross-sectional view of the heart.

[0199] FIG. 33B is a perspective view of the deployment tool of FIG. 33 A above the mitral valve in the heart.

[0200] FIG. 34A is a perspective view of a deployment tool in a side cross-sectional view of the heart.

[0201] FIG. 34B is a perspective view of the deployment tool of FIG. 34A above the mitral valve in the heart.

[0202] FIG. 35Ais a perspective view of a deployment tool in a side cross-sectional view of the heart. FIG. 35B is a perspective view of the deployment tool of FIG. 35A equipped with an implantation system in a side cross-sectional view of the heart.

[0203] FIG. 36A is a top view of a deployment tool above the mitral valve of the heart.

[0204] FIG. 36B is a perspective view of the deploy ment tool of FIG. 36A in a side cross-sectional view of the heart.

[0205] FIGS. 37A and 37B are side views of a deployment tool in a side cross- sectional view of the heart.

[0206] FIG. 38A is a perspective view of the deployment tool in a side cross-sectional view of the heart.

[0207] FIG. 38B is a perspective view of the deployment tool of FIG. 38A with a mitral clip deployed to the mitral valve in a side cross-sectional view of the heart.

[0208] FIG. 39 is a perspective view of a deployment tool in a side cross-sectional view of the heart.

[0209] FIG. 40 is a perspective view of the deployment tool of FIG. 1 within the right atrium and right ventricle in a side cross-sectional view of the heart.

[0210] FIG. 41 A is a perspective view of a deployment tool within the right atrium and right ventricle in a side cross-sectional view of the heart.

[0211] FIG. 41B is a perspective view of the deployment tool of FIG. 41 A above the tricuspid valve of the heart.

[0212] FIG. 42 is a perspective view of a deployment tool within the right atrium and right ventricle in a side cross-sectional view of the heart.

[0213] FIG. 43 is a perspective view of a deployment tool within the right atrium and right ventricle in a side cross-sectional view of the heart.

[0214] FIG. 44 is a perspective view of the deployment tool of FIG. 18E within the right atrium and right ventricle in a side cross-sectional view of the heart.

[0215] FIG. 45 is a perspective view of a distal portion of a deployment tool.

[0216] FIG. 46A is a front view of a mitral valve implant with a braided structure.

[0217] FIG. 46B is a side view of a braided component from which a portion of the implant of FIG. 46A is formed.

[0218] FIG. 46C is a front view of the braided component of FIG. 46B.

[0219] FIG. 46D is a front view of another mitral valve implant with a braided structure. FIGS. 47A-47F are various views of a mitral valve implant with a “butterfly’' configuration.

[0220] FIGS. 48A-47D are various views of another mitral valve implant with a “butterfly” configuration.

[0221] FIGS. 49A-49F are various views of a mitral valve implant that has a folded functional configuration.

[0222] FIGS. 49G and 49H are side and front views, respectively, of a distal end of a delivery catheter used to deploy the mitral valve implant of FIGS. 49A-49F.

[0223] FIGS. 50A-50G are various views that sequentially illustrate a method of implanting the mitral valve implant of FIGS. 49A-49F.

[0224] FIGS. 51A-51C are various views of a mitral valve implant with a comb-like structure.

[0225] FIGS. 52A-52E are various views of another mitral valve implant with a comb-like structure.

[0226] FIGS. 53A-53C are various views of a mitral valve implant with a dual-loop structure.

[0227] FIGS. 53D-53I are various views that sequentially illustrate a method of implanting the mitral valve implant of FIGS. 53A-53C.

[0228] FIGS. 54A-54D are front views of a mitral valve implant with separable clipping elements in various configurations.

[0229] FIGS. 55A-55D are various views of a mitral valve implant with clipping loops.

[0230] FIG. 56 is a front view of a mitral valve implant with textured gripping control lines.

[0231] FIG. 57 is a front view of a mitral valve implant with threaded gripping arms.

[0232] FIG. 58 is a perspective view of a deployment tool in a side cross-sectional view of the heart and which is used to reverse the effect of an implanted mitral valve implant.

[0233] FIGS. 59A-59D are various views of another deployment tool in the heart and which is used to reverse the effect of an implanted mitral valve implant.

[0234] FIGS. 60A-60D are various views of a deployment tool that is used to remove an implanted mitral valve implant.

[0235] FIG. 61 is a front view of a mitral valve implant with separable clipping elements that are held together by sutures around central base members. FIGS. 62A-62C are various views of an annular band that can be deployed with the deployment tool of FIG. 18D.

[0236] FIG. 63 is a perspective view of the deployment tool of FIG. 18D within the right atrium and right ventricle in a side cross-sectional view of the heart while deploying the annular band of FIGS. 62A-62C.

[0237] FIGS. 64A-64K are various views of a deployment tool that can be used to deploy both a cinching implant and a tricuspid valve implant to the tricuspid valve.

[0238] FIGS. 65 and 66 are various views of regions of the mitral valve.

[0239] DETAILED DESCRIPTION

[0240] Referring to FIGS. 1 A and IB, some embodiments of a transcatheter delivery system 150 can be configured to provide improved positioning, stability , and orientation during delivery of a therapeutic device within a patient’s heart 1. In the depicted embodiment of the transcatheter deliver}' system 150, the therapeutic device is a mitral valve implant 51 that can be implanted at a mitral valve 2 of the patient’s heart 1 to treat a pathology of the mitral valve 2. In some embodiments, the mitral valve implant 51 may be provided as an edge-to-edge closure device, such as an edge- to-edge clip or another type of edge-to-edge closure device. The transcatheter delivery system 150 includes an implantation system 50 that facilitates implantation of the mitral valve implant 51 and a deployment tool 100 by which the implantation system 50 can be deployed to a left atrium 5 of the patient’s heart.

[0241] In particular, the deployment tool 100 can be navigated through the patient’s vasculature to the left atrium 5 and then operated to deliver, locate, and implant the mitral valve implant 51 at a desired position, orientation, and configuration with respect to the mitral valve 2. The deployment tool 100 can be inserted into the vasculature in a minimally invasive manner (e.g., without open-chest or open-heart surgery) and then advanced through the vasculature into the heart 1 . Referring to FIG. 15, in some implementations, the deployment tool 100 may be inserted into a femoral vein or an iliac vein through an incision 36 in the patient's groin area using a manipulation tool 152 by which the deployment tool 100 can be actuated, manipulated, and otherwise controlled, as will be discussed in more detail further below.

[0242] In FIGS. 1A and IB, the heart 1 is illustrated in cross-section from an anterior perspective in stylized form. In addition to the mitral valve 2 and the left atrium 5. which is defined by a left atrial wall 26, the heart 1 includes a right atrium 3 defined by a right atrial wall 29, a right ventricle 4 defined by a right ventricular wall 30, and a left ventricle 6 defined by a left ventricular wall 28. The heart 1 also includes a tricuspid valve 7, an atrial septum 8, an inferior vena cava 9, a superior vena cava 10, chordae tendineae 40 within the right ventricle 4, papillary' muscles 41 within the right ventricle 4, chordae tendineae 31 within the left ventricle 6, and papillary muscles 32 within the left ventricle 6.

[0243] The mitral valve 2 separates the left atrium 5 from the left ventricle 6, and the tricuspid valve 7 separates the right atrium 3 from the right ventricle 4. The atrial septum 8 separates the right atrium 3 from the left atrium 5. The inferior vena cava 9 and the superior vena cava 10 lead into (e.g., are confluent with) the right atrium 3.

[0244] Referring to FIG. 2A, the mitral valve 2 includes an anterior leaflet 11 and posterior leaflet 12. The posterior leaflet 12 is a three-part structure that includes a lateral scallop 13, a middle scallop 14, and a medial scallop 15. Free edges of the posterior leaflet 12 and the anterior leaflet 13 meet along a coaptation line 16. The mitral valve 2 further includes an annulus 17, an anterolateral commissure 18, and a posteromedial commissure 19. The annulus 18 is substantially D-shaped and provides a structure from which the anterior and posterior leaflets 11, 12 extend and articulate. A sub-annular gutter 22 extends along the annulus 17 and the posterior leaflet 22. The chordae tendineae 31 connect the mitral valve 2 to the papillary- muscles 32.

[0245] Referring to FIG. 2B, the tricuspid valve 7 generally includes an anterior leaflet 37, a posterior leaflet 38, and a septal leaflet 39. Free edges of the leaflets 37, 38, 39 meet along coaptation lines 42, 43, 44. The tricuspid valve 7 further includes an annulus 45, an anteroseptal commissure 46, a posteroseptal commissure 47, and an anteroposterior commissure 48. The annulus 45 is substantially saddle-shaped and provides a structure from yvhich the leaflets 37, 38, 39 extend and articulate. The chordae tendineae 40 connect the tricuspid valve 7 to the papillary' muscles 41.

[0246] Referring to FIGS. 1A, IB. 3A, and 3B, the deployment tool 100 includes a guide catheter 102 that can be passed through the atrial septum 8 into the left atrium 5 and a frame 124 that is coupled to (e.g., slidably disposed within) the guide catheter 102. The deployment tool 100 (e.g., and all of the below-discussed deployment tools, whether provided for either the mitral valve 2 or the tricuspid valve 7) advantageously utilizes distal engagement of the heart’s anatomy for stabilization of the frame 124 within the heart 1. Such stabilization facilitates tracking (e.g., delivering the mitral valve implant 51 into the left atrium 5 along a guiderail path) and angular positioning of the mitral valve implant 51 with respect to the mitral valve 2. For example, interaction between the frame 124 and the heart’s anatomy facilitates preferred positioning and orienting of the distal end of the guide catheter 102 and the distal portion of the frame 124 for improved precision in carry ing out a therapeutic procedure. Example interactions include interactions or engagements of the frame 124 with the commissures of the mitral valve 2 (e.g., or with the commissures of the tricuspid valve 7, as will be discussed in more detail below) or with other features of the heart 1.

[0247] The guide catheter 102 defines a central axis 156 and is movable axially in a distal direction 101 (e.g.. away from a user) and in a proximal direction 103 (e.g., towards the user). The guide catheter 102 is also movable rotationally (e.g., angularly) in first and second directions 105, 107 with respect to the central axis 156. In some embodiments, the guide catheter 102 may have a curved distal end portion to effect an off-axial directionality during delivery of the guide catheter 102. In some embodiments, the guide catheter 102 may include an active steerable element.

[0248] The frame 124 includes an anterior stabilization rail 106, a posterior stabilization rail 108, a guiderail 110, and a hub 104 to which the rails 106, 108, 110 extend. The rails 106, 108, 110 are separately slidable distally (e.g., can be pushed or advanced) and slidably proximally (e.g.. can be pulled or retracted) within the guide catheter 102. The guiderail 1 10 provides a path along which the mitral valve implant 51 can be tracked (e.g., moved to a selected axial position) within the heart 1. The frame 124 also includes a sheath 112 that extends to the hub 104 and a guidewire 114 that extends through the sheath 112 into the left ventricle 6. The sheath 112 is slidable distally and proximally within the guide catheter 102. The guidewire 114 is slidable distally and proximally within the sheath 112 and is rotatable within the sheath 112. The hub 104 is sized and shaped to be placed at a selected anatomical structure (e.g., the anterolateral commissure 18 or the left atrial wall 26) the within the heart 1. thereby defining a global position of the frame 124 within the heart 1.

[0249] Once a distal end 116 of the guide catheter 102 is located at desired axial and rotational positions within left atrium 5, a distal portion 158 of the frame 124 (e.g., the portion of the frame 124 visible in FIGS. 1 A, IB, 3A, and 3B) can be advanced out of the guide catheter 102 until the hub 104 is located at the selected anatomical structure to produce a functional configuration of the frame 124, which is shown in FIGS. 1A, IB, 3A, and 3B. In the functional configuration, the hub 104 is typically located at an axial distance of about 3.5 cm to about 6.5 cm from the distal end 116 of the guide catheter 102. Accordingly, this distance corresponds to an exposed length of the guiderail 110.

[0250] Referring to FIGS. 4A-4D, with the hub 104 placed at the selected anatomical structure, the stabilization rails 106, 108 can be further advanced out of the guide catheter 102 until the stabilization rails 106. 108 bow outwardly with respect to the central axis 156 of the guide catheter 102 to form generally curved shapes. The rails 106, 108 may be advanced until the rails 106, 108 push gently against the left atrial wall 26. Accordingly, the rails 106, 108 can respectively help stabilize the frame 124 and the distal end 116 of the guide catheter 102 (e.g., limit an extent of movement of the frame 124 and the distal end 116 of the guide catheter 102) in any of lateral, medial, anterior, and posterior directions within the left atrium 5. In this manner, the rails 106, 108 provide localized stability of the frame 124 within the heart 1 without the need for an otherwise relatively rigid deployment structure. The rails 106, 108 are flexible enough to move with a small amount of play as the heart 1 beats. Similarly, the guiderail 110 is flexible enough to move minimally as the mitral valve implant 51 is advanced along the guiderail 110 towards the hub 104.

[0251] Referring again to FIGS. 1A, IB, 3 A, and 3B, the sheath 112 can also be further advanced out of the guide catheter 102 until the sheath 112 bows upwardly with respect to the central axis 156 of the guide catheter 102 to form a generally curved shape in the functional configuration of the frame 124. The sheath 112 may be advanced until the sheath 112 pushes gently against left atrial wall 26. Accordingly, the sheath 112 can help stabilize the frame 124 within the left atrium 5 in a direction orthogonal to the guiderail 1 10. The sheath 112 is flexible enough to move with a small amount of play as the heart 1 beats.

[0252] In the functional configuration of the frame 124, the guidewire 114 is extended out of the sheath 112 and has passed through the frame hub 104. The guidewire 114 therefore extends downward through the mitral valve 2 and into the left ventricle 6 once the frame 124 has been globally positioned and stabilized within the heart 1. The guidewire 114 defines a free (e.g., unattached), terminal section 118 and a foot 120 that is formed to be placed at and engage the selected anatomical structure, such as the sub-annular gutter 19 to further stabilize the frame 124 at the mitral valve 2. In some embodiments, the foot 120 may be formed or shaped as a hook, a protrusion, a projection, an extension, or another type of feature that can help to stabilize or otherwise secure the guidewire 114 in place.

[0253] The guidewire 114 is slidable proximally to advance the foot 120 out of the sheath 112 so that the foot 120 can be utilized for stabilization. The guidewire 114 is also slidable distally and proximally to adjust the position of the foot 120 within the left ventricle 6. In some implementations, a user may desire to use the deployment tool 100 without the foot 120 and therefore refrain from advancing the guidewire 1 14 far enough to expose the foot 120 from the sheath 112. In such implementations, the terminal section 118 of the guidewire 114 may still be exposed within the left ventricle 6. The guidewire 114 is flexible enough to move with a small amount of play as the heart 1 beats. In some embodiments, an overall stiffness of the combination of the sheath 112 and the guidewire 114 may be adjusted by changing one or more of a diameter of the guidewire 114, a diameter the sheath 112, and a wall thickness of the sheath 112. In some embodiments, the stiffness of the guidewire 114 can be altered by tapering the diameter of the guidewire 114 along the length of the guidewire 114. In some embodiments, a higher stiffness along the curved portion of the sheath 112 and guidewire 114 may result in a correspondingly higher force applied downwardly to the hub 104. Alternatively, the stabilization rails 106, 108 may be configured to extend laterally at non-orthogonal angles relative to the sheath 112.

[0254] Referring to FIGS. 3 A and 3B, the hub 104 may be shaped substantially as a solid rectangle or, in other embodiments, have a different shape, such as that of a sphere, a solid cylinder, a “T,’‘ or another shape. In some embodiments, the hub 104 has of a width and a length each of about 1.0 mm to about 2.1 mm. In some embodiments, the hub 104 may be made of one or more metals (e.g., stainless steel (304, 316) titanium, titanium alloy (6-4,) or nitinol) or one or more rigid plastics (e.g., polyether ether ketone (PEEK), polycarbonate, acrylonitrile butadiene styrene (ABS), polyoxymethylene, polymethyl methacrylate, or the like). In some embodiments, the hub 104 has a rigidity that maintains a position and orientation of connected components under load. The profile of the hub 104 is atraumatic so as not to damage any contacted anatomy.

[0255] In some embodiments, the hub 104 may include one or more of a variety of attachment features (e.g., a crimp, weld, adhesive bond, or press fit) by which distal ends of the rails 106, 108, 110 are secured to the hub 104. The hub 104 also includes a channel through which the guidewire 114 passes.

[0256] Referring again to FIGS. 1 A, IB, 3A, and 3B, in some embodiments, the rails 106, 108, 110 and guidewire 114 have a substantially solid cylindrical shape (e.g., with a circular cross-sectional shape). In some embodiments, the rails 106, 108 have a diameter of about 0.38 mm to about 0.64 mm (e.g., about 0.51 mm). In some embodiments, the rails 106, 108 are constructed as wires or ribbons. In some embodiments, the rails 106, 108 may be made of one or more materials, such as nitinol, stainless steel, and high tensile-strength stainless steel. In some embodiments, the elastic modulus of the rails 106, 108 (e.g., in the case of nitinol) may be in a range of about 50 GPa to about 90 GPa. In other embodiments, the elastic modulus may be in a different range. In some embodiments, the rails 106, 108 are characterized by a super-elastic range that facilitates delivery through the guide catheter 102. In some embodiments, a shape of the rails 106, 108 may be heat-set. In the functional configuration of the frame 124, a maximum width between any two opposing portions of the stabilization rails 106, 108 is typically about 4 cm to about 8 cm.

[0257] In some embodiments, the guiderail 110 has a diameter of about 0.38 mm to about 0.97 mm (e.g., about 0.51 mm). In some embodiments, the guiderail 110 is constructed as a wire, a ribbon, or configurations (e.g., a compressible coil) that can be stiffened post-delivery. In the functional configuration of the frame 124, a maximum height of the guidewire 1 14 (e.g., surrounded by the sheath 112) from the guiderail 110 is typically about 0 cm to about 1.5 cm. In some embodiments, the guiderail 110 may be made of one or more materials, such as nitinol, stainless steel, high-tensile-strength stainless steel.

[0258] In some embodiments, the guidewire 1 14 has a diameter of about 0.35 mm to about 0.97 mm (e.g., about 0.46 mm). In some embodiments, the guiderail 110 is constructed as a wire or a taper ground distal with over-coil or polymer encapsulation. In some embodiments, the guidewire 114 may be made of nitinol or stainless steel along a majority of its length. In some embodiments, the terminal section 118 has a large, coiled loop-like configuration as the terminal section 118 exits the hub 104. Such configuration can advantageously avoid chordal entanglement as the terminal section 118 is extended downward into the left ventricle 6. In these embodiments, the terminal section 118 may be made of platinum or gold. In some embodiments, the tip of the guidewire 114 may be constructed as a loaded polymer and made of one or more of tungsten, barium (BaSO4), and bismuth (BiO3)(BiCO3). In some embodiments, the guidewire 114 has a relatively high elastic modulus such that the guidewire 114 has a small diameter, but is relatively stiff. In some embodiments, the guidewire 114 may have a super elastic character. Furthermore, in some embodiments, the guidewire 114 has an atraumatic tip 122 that avoids damaging the leaflets 11, 12, the chordae tendineae 31, and the papillary’ muscles 32 as the guidewire 114 is deployed to the mitral valve 2. In some embodiments, the tip 122 of the guidewire 114 has a degree of radiopacity to allow flurovisualization.

[0259] In some embodiments, any of the rails 106, 108, 110 and guidewire 114 may be coated with one or more substances to minimize friction (e.g., resistance to axial movement) between the rails 106, 108, 110 and guidewire 114 and any surrounding structure while sliding within the guide catheter 102. Such substances may also avoid or minimize injury’ to the heart 1 (e.g., the leaflets 11, 12, the chordae tendineae 31, and the papillary muscles 32) along the distal, exposed portion 158 of the frame 124. Example substances include fluorocarbons (e.g., polytetrafluoroethylene (PTFE) and fluorinated ethylene propylene (FEP))hydrophilic poly(vinylpyrrolidone) (PVP), poly(methyl methacrylate) macromolecule, polyethylene oxide (PEO), poly(vinyl alcohol) (PVA), and other substances.

[0260] In some embodiments, friction along the guiderail 110 may also be minimized by varying the stiffness of the rail 110 (e.g., by varying the material, size, or taper profde) or varying the stiffness profile along the length of the guide catheter 102, while maintaining column strength (e.g., allowing minimal compression) and high resistance to buckling (e.g., by using coils, a braided structure, etc.).

[0261] As discussed above, in some embodiments, the rails 106, 108. 110 and guidewire 114 may have an elastic modulus in a range of super-elasticity such that the rails 106, 108, 110 and guidewire 114 can bend without permanently deforming. A diameter of any of the rails 106, 108, 110 can be increased to correspondingly increase a stiffness of the rail 106, 108, 110 exponentially. Owing to the solid cylindrical shape, the rails 106, 108. 110, may not have a preferential bending orientation (e.g., a preferential bending direction with respect to a central axis of the rail 106, 108, 110). In some embodiments, one or more properties (e.g., lateral stiffness, column strength, lubricity', or other material or mechanical properties) of the rails 106. 108, 110 or guidewire 114 may change along their lengths. Referring to FIGS. 6A-7B, in some embodiments, stiffening the portion of the guiderail 110 between the distal end 116 of the guide catheter 102 and the hub 104 can improve the mechanical integrity of this portion of the guiderail 110, improve the ability to move a therapeutic device along this portion of the guiderail 110, and provide stability7during deployment and manipulation of the mitral valve implant 51. For example, in some embodiments, the guiderail 110 may be equipped with a coil 162 (e.g.. a spring) that can be compressed (refer to FIG. 6B) to increase the ability of the guiderail 110 to resist bending or extended to decrease such ability (refer to FIG. 6A). In some embodiments, a thin flexible wire (refer to FIG. 7A) may be replaced with a thicker, stiffer wire 164 (e.g., one that is thicker or has a higher elastic modulus) to increase the ability of the guiderail 110 to resist bending, as shown in FIG. 7B.

[0262] Referring again to FIGS. 3 A and 3B, in some embodiments, the sheath 112 is formed as a tube that surrounds the guidewire 114. The sheath 112 ty pically has an inner diameter of about 0.4 mm to about 1.1 mm and an outer diameter of about 0.6 mm to about 1.4 mm. In some embodiments, the sheath 112 has a tubular or coiled construction. Example materials from which the sheath 112 may be made include thermoplastic elastomer (TPE, e.g., polyether block amide (PEBA)) PE, nylon, PET, materials for a braided reinforced construction, PTFE / FEP for a lined construction, stainless steel coil (e.g., using a round or square wire), and any combinations thereof. In some embodiments, the sheath 112 is highly flexible. In some embodiments, a compression stiffness of the sheath 112 minimizes displacement between the foot 120 of the guidewire 114 and the hub 104 during loading.

[0263] Referring to FIGS. 8-1 IB, the mitral valve implant 51 of the implantation system 50 can be implanted to close together portions of the leaflets 11, 12 of the mitral valve 2 that no longer close together properly. The implantation system 50 further includes a delivery catheter 52 that surrounds and slides along the guiderail 110 to position the mitral valve implant 51 over the mitral valve 2. Referring particularly to FIGS. 10A-11B, the implantation system 50 also includes a sheath 57 that is joined with the delivery catheter 52 along an exterior wall surface 54 of the sheath 57 and an exterior wall surface 55 of the delivery catheter 52. Accordingly, axial movement of the delivery7catheter 52 causes a corresponding axial movement of the sheath 57, and rotation of the delivery catheter 52 in the rotational directions 61a. 61b causes a corresponding rotational movement of the sheath 57. In some embodiments, the delivery catheter 52 has a substantially cylindrical shape with a central lumen having a diameter of about 0.5 mm to about 1.1 mm. In some embodiments, the central lumen may have a non-circular cross-sectional shape. In some embodiments, the sheath 57 has a substantially cylindrical shape with a lumen having a diameter of about 1.39 mm to about 2.42 mm. In some embodiments, the delivery’ catheter 52 and the sheath 57 have a liner, braided, or laminate construction (e.g., with or without an external coating). In some embodiments, a liner construction may be made of one or more of PTFE, FEP, PE, or high density PE. In some embodiments, a braided construction may be made of one or more of stainless wire or ribbon. In some embodiments, the jacket may be made of one or more of TPE (e.g., PEBA), PET. and segmented PU.

[0264] In some embodiments, the delivery catheter 52 allows for high compressive modulus tracking (e.g., axial movement along the guiderail 110). In some embodiments, the delivery catheter 52 has torsional rigidity to help with planar ordination of the implant 51. In some embodiments, a flexibility of the delivery catheter 52 is balanced with an effective stiffness provided by the guiderail 110 to resist buckling. In some embodiments, the delivery catheter 52 and the sheath 57 have an internal lumen lubricity’ that facilitates guiderail tracking and maneuvering of a positioning catheter of the implantation system 50.

[0265] The positioning catheter 53 is slidable axially within the sheath 57 and is rotatable within the sheath 57 to control an angular position (e.g., an orientation) of the mitral valve implant 51. In some embodiments, the positioning catheter 53 has an inner diameter of about 1.0 mm to about 1.8 mm and an outer diameter of about 1.2 mm to about 2.3 mm. In some embodiments, the positioning catheter 53 has a liner, braided, or laminate construction (e.g., with or without an external coating). In some embodiments, a liner construction may be made of one or more of PTFE, FEP, PE, or high density7PE. In some embodiments, a braided construction may be made of one or more of stainless wire or ribbon. In some embodiments, the jacket may be made of one or more of TPE (e.g., PEBA), PET, and segmented PU. In some embodiments, the positioning catheter 53 is highly flexible for tight bends. In some embodiments, the positioning catheter 53 has a torsional rigidity’ and compressive stiffness that is sufficient to obtain and hold a delivery orientation of the mitral valve implant 51.

[0266] In some embodiments, the positioning catheter 53 has a resistance to kinking or ovaling to minimize friction with a deployment catheter disposed within the positioning catheter 53. Accordingly, the implantation system 50 further includes a deployment catheter 56 to which the mitral valve implant 51 is secured. The deployment catheter 56 is slidable and rotatable within the positioning catheter 53.

[0267] In some embodiments, as shown in FIGS. 9 A, 10 A, and 11A the positioning catheter 53 is equipped with a collar 58 that protects (e.g., surrounds or otherwise covers) the mitral valve implant 51 as the implant 51 is advanced within the guide catheter 102. An adjustment wire 59 and an adjustment wire 60 connect a distal end of the delivery catheter 52 to a distal end of the positioning catheter 53 (e.g., or to the collar 58 positioned thereon). The delivery catheter 52 is constrained in anterior and posterior directions by the guiderail 110. The adjustment wire 59 allow s passive linear displacement of the distal end of the positioning catheter 53 from the distal end of the delivery catheter 52 along an anterior-posterior direction 62. For example, in some embodiments, the adjustment wire 59 may be provided as a spring or a spring actuation line. In some embodiments, the adjustment wire 59 may alternatively be formed as a partial loop or as an adjustment ribbon.

[0268] The adjustment wire 60 is disposed in a lumen within a wall of the delivery catheter 52 and extends from a user to the distal end of the positioning catheter 53 (e.g., or to the collar 58 positioned thereon). The adjustment wire 60 can be tensioned (e.g., pulled) or loosened (e.g., released) to actively displace the distal end of the positioning catheter 53 (e.g.. or the collar 58 positioned thereon) with respect to the distal end of the delivery catheter 52 along the direction 62. Accordingly, the adjustment wire 60 manipulates the collar 58 and distal section of the positioning catheter 53 to create an orthogonal vector for the deployment catheter 56 to travel axially. In some embodiments, the adjustment wire 60 is constructed as a wire, cable, or braided line or string.

[0269] The deployment catheter 56 (e.g., carrying the mitral valve implant 51) can be moved axially and rotationally within the positioning catheter 53 to a desired position and orientation above the mitral valve 2 for subsequent lowering of the implant 51 into and implantation of the implant 51 at the mitral valve 2. In some embodiments, the deployment catheter 56 has an inner diameter of about 0.5 mm to about 1 .1 mm and an outer diameter of about 0.8 mm to about 1.6 mm. In some embodiments, the deployment catheter 56 has a lined, braided, or laminate construction. In some embodiments, a liner construction may be made of one or more of PTFE. FEP, PE. or high density PE. In some embodiments, a braided construction may be made of one or more of stainless wire or ribbon. In some embodiments, the jacket may be made of one or more of TPE (e.g., PEBA), PET, and segmented PU. In some embodiments, the deployment catheter 56 provides a torque response that allows rotational control of the implant 51.

[0270] Referring to FIGS. 9A-9K, in some embodiments, the mitral valve implant 51 includes a head 64 that is surrounded by a flexible cover 78 (e.g., a fabric cover, as shown in FIG. 9E, or a cover or sleeve made of a different expandable or flexible material). In some embodiments, the head 64 includes multiple, adjustable gripping arms 65 and respective, adjustable clipping arms 69 that extend from the gripping arms 65. In some embodiments, the gripping arms 65 may be equipped with surface projections (e.g., barbs) that facilitate gripping of the leaflets 11, 12 of the mitral valve 2. The head 64 also includes respective gripping control wires 66 that are connected to the gripping arms 65. The gripping control wires 66 are disposed within respective lumens within a wall of the deployment catheter 56. The gripping control wires 66 can be moved axially within the respective lumens independently of each other to effect bulk axial movement of the arms 65, 69 along a central axis 67 of the head 64.

[0271] In some embodiments, the gripping control wires 66 have a diameter of about 0.12 mm to about 0.26 mm (e.g.. about 0.15 mm). In some embodiments, the gripping control wires 66 are constructed as a solid wire, a braided fiber, or a multilayer cable. Example materials from which the gripping control wires 66 may be made include nitinol (e.g., for a wire construction), stainless steel (e.g., for a cable construction), and ultra-high molecular weight polyethylene (e.g.. for a braided construction). The gripping control arms 66 are typically flexible and slippery.

[0272] The head 64 also includes a shoulder 73 that connects the head 64 to the deployment catheter 56, a proximal support 79, an intermediate support 74 to which the both the gripping and clipping arms 65, 69 are connected, and a distal support 75 to which distal ends of the clipping arms 69 are connected. The head 64 further includes a central body 76 (e.g., a nitinol tube with a laser cut pattern) that extends between the proximal support 79 and the intermediate support 74. An extension wire 77 extends through the deployment catheter 56 from a user to the distal support 75.

[0273] Referring particularly to FIG. 9C, the extension wire 77 can be advanced to place the gripping and clipping arms 65. 69 in an extended length configuration that facilitates passage of the head 64 downward through the mitral valve 2. Referring to FIGS. 9A and 9B, once the head 64 is located below the plane of the mitral valve 2, the extension wire 77 can be retracted to collapse the clipping arms 69 upon themselves such that they extend radially from the extension wire 77 to engage the leaflets 11, 12 of the mitral valve 2. The gripping arms 65 are then lowered towards the radially extended clipping arms 69 (e.g., swung outward with respect to the central axis 67 of the head 64) to grip the leaflets 11, 12 of the mitral valve 2 between the gripping arms 65 and the clipping arms 69. The mitral valve implant 51 is then closed to its final configuration (e.g., an implanted configuration).

[0274] In some embodiments, the extension wire 77 has a diameter of about 0.25 mm to about 50. 1 mm (e.g., about 0.38 mm). In some embodiments, the extension wire 77 is constructed as a solid wire or a multi-layer cable. In some embodiments, the extension wire 77 may be made of nitinol, stainless steel, or another material. In some embodiments, the extension wire 77 has a torsional rigidity that is sufficient to mechanically withstand a threaded distal connection to the distal support 75, as shown in FIG. 9H and 91.

[0275] Referring to FIGS. 9D-9F, in an implanted configuration of the mitral valve implant 51, the clipping arms 69 are snuggly folded up against the gripping arms 65 with the leaflets 11, 12 between the arms 65, 69 in a closed configuration. The closed configuration creates a w affling of the leaflets 11, 12 betw een the arms 65, 69, which enhances the grip or hold of the arms 65, 69 on the leaflets 11, 12. FIG. 9G illustrates the head 64 in a closed configuration with its flexible cover 78. When the mitral valve implant 51 is implanted at the mitral valve 2, the flexible cover 78 can promote tissue ingrowth for long-term stabilization of the implant 51 and can function to prevent thrombus formation, which may lead to embolization. In some embodiments, the cover 78 is made of one or both of a fabric (e.g., PET) and a polymer (e.g., expanded PTFE (ePTFE)). The cover 78 can expand and recoil to snuggly accommodate the arms 65, 69 in various configurations during an implantation procedure.

[0276] Referring to FIGS. 9I-9K, the shoulder 73 of the head 64 includes a support base 81 and two flexible arms 82 with respective retention heads 83 (e.g., arrowshaped heads) for securing the shoulder 73 to the proximal support 79 along an interior surface of the proximal support 79. When the extension wire 77 is attached to the distal support 75 (refer to FIGS. 9A-9C), the extension wire 77 is located between the flexible arms 82 such that the flexible arms 82 are forced into an orientation that is parallel to the extension wire 77. Referring to FIGS. 9H and 91, in some embodiments, the distal end of the extension wire 77 and the distal support 75 have corresponding threaded portions, and the extension wire 77 may be rotated to remove the extension wire 77 from the distal support 75.

[0277] Referring to FIGS. 9J and 9K, continued retraction of the extension wire 77 removes the extension wire 77 from the shoulder 73, allowing the flexible arms 82 to relax radially inward into a natural configuration in which the retention heads 83 no longer engage the interior surface of proximal support 79. Separation of the flexible arms 82 from the proximal support 79 allows the assembly of the shoulder 73 and deployment catheter 56 to be removed from the head 64 of the implant 51 altogether after implantation. In this manner, the mitral valve implant 51 may be disconnected from the deployment catheter 56 at the proximal support 79. Accordingly, upon successful implantation of the mitral valve implant 51, the shoulder 73, deployment catheter 56, control wires 66, and extension wire 77 are detached from the remaining components of the head 64, which remain implanted at the mitral valve 2.

[0278] Referring to FIGS. 9L and 9M, in some embodiments, the collar 58 and the adjustment wire 59 of the implant 51 may be provided as an integral laser-cut structure that facilitates manufacturing. In some embodiments, the laser cut structure allows additional play for flexibly accommodating the head 64 of the implant 51 (e.g., before the implant 51 is deployed) and additional flexibility for facilitating movement of the adjustment wire 59 and the distal end of the delivery catheter 52 (e.g., attached to adjustment wire 59). In some embodiments, the laser cut collar 58 and adjustment wire 59 are made of nitinol. The collar 58 defines a connection site 95 for the adjustment wire 60.

[0279] Referring to FIGS. 10A-1 IB, the guide catheter 102 is formed as a substantially tubular wall 130 with a thick-walled portion 132 and a thin-walled portion 134 that together define a main lumen 136. In some embodiments, the main lumen 136 has a maximum width of about 4.0 mm to about 10.0 mm. The main lumen 136 is sized to accommodate the guiderail 110. the implantation system 50, and an intracardiac echocardiography (ICE) imaging catheter 190 for visualization. In some embodiments, the main lumen 136 has an inner diameter of about 2.6 mm to about 4. 1 mm.

[0280] Accommodation of the ICE catheter 190 within the guide catheter 102 advantageously allows for optimal delivery of the ICE catheter 190 to the heart 1 without the need for a separate incision dedicated specifically to the ICE catheter 190. In some embodiments, seals are present between the ICE catheter 190 and an interior surface of the main lumen 136. A proximal side port 191 is provided for inserting the ICE catheter 190 into the main lumen 136, as shown in FIG. 16. In some embodiments, the ICE catheter 190 has a diameter of about 3.0 mm to about 12.8 mm and a length of about 90 cm. In some embodiments, the port has a diameter in a range of about 4.5 mm to about 6.0 mm (e.g., about 4.6 mm). In some embodiments, the port may be made of polycarbonate. In some embodiments, the port may have a different material constituency.

[0281] In some embodiments, the thick-walled portion 132 has a maximum thickness of about 2.0 mm to about 3.0 mm, and the thin-walled portion 134 has a thickness of about 0.25 mm to about 0.6 mm. The thick-walled portion 132 defines anterior and posterior lumens 138, 140 through which the anterior and posterior stabilization rails 106, 108 respectively pass. The thick-walled portion 132 also defines a central guide lumen 142 through which the guidewire 114 and surrounding sheath 112 pass. In some embodiments, the guide catheter 102, sized for delivery through the inferior vena cava 9, has a length of about 70 cm to about 80 cm.

[0282] In some embodiments, the guide catheter 102 has one or more of a liner, braided, or laminate construction. In some embodiments, a liner construction may be made of one or more of polytetrafluoroethylene (PTFE), fluorinated ethylene propylene (FEP), and polyethylene (PE) or high density PE. In some embodiments, a braided construction may be made of one or more of stainless wire or ribbon. In some embodiments, the jacket may be made of one or more of TPE (e.g., PEBA), poly(ethylene terephthalate) (PET), and segmented polyurethane (PU). In some embodiments, the laminate construction may be coated with one or more hydrophilic substances, such as poly(vinylpyrrolidone) (PVP), poly(methyl methacrylate) macromolecule, polyethylene oxide (PEO), poly(vinyl alcohol) (PVA), and other substances of.

[0283] The guide catheter 102 has several mechanical properties that facilitate its functioning within the heart 1. In some embodiments, torsional rigidity may be important for directing a distal guide tip and for stabilizing an orientation of the guide catheter 102 during a therapeutic procedure. In some embodiments, the guide catheter 102 may have a pre-shaped distal end portion that is advantageously simple, but in other embodiments, deflection and steering may be beneficial. In some embodiments, a kink resistance of the guide catheter 102 is important because large main lumen 136 is not supported by co-axial catheters. Furthermore, in some embodiments, flexibility provides reduced vascular damage at the access sight and through the tortuous path of the pelvis. Additionally, external lubricity (e.g., likely hydrophilic) facilitates tracking and reduces vascular trauma. In some embodiments, the guide catheter 102 has an internal lubricity (e.g., likely hydrophobic) that facilitates co-axial catheter movement.

[0284] In some embodiments, the distal end 1 16 of the guide catheter 102 may be secured in place within the atrial septum 8 using an atrial retention feature. For example, FIGS. 12A and 12B illustrate a nose cone 144 at the distal end 116 of the guide catheter 102. The nose cone 144 may be deployed to the left atrium 5 in a closed configuration, as shown in FIG. 12A. Referring to FIG. 12B, two portions 146 of the nose cone 144 may then be opened to allow the frame 124 (only a portion of the frame 124 is illustrated in in FIG. 12B) to be advanced into the left atrium 5, and the open nose cone 144 is gently retracted (e.g., pulled) against the atrial septum 8. which prevents further retraction of the guide catheter 102. In some embodiments, a nose cone that is otherwise substantially similar in construction and function to the nose cone 144 may include more than two portions that are openable and closeable.

[0285] FIG. 13A illustrates the distal end 116 of the guide catheter 102 with a beveled edge 148 that forms a retention lip 180. Referring to FIGS. 13B and 13C, the distal end 1 16, equipped with a dilator 182, is initially passed through the atrial septum 8 with the beveled edge 148 facing the atrial septum 8, and the dilator 182 is then removed from the guide catheter 102. Referring to FIG. 13D. the guide catheter 102 is rotated approximately 180 degrees such that the bevel edge 148 faces away from the atrial septum 8 and then gently retracted to cause the retention lip 180 to engage the atrial septum 8 to secure the distal end 116 of the guide catheter 102 within the left atrium 5.

[0286] In another embodiment, FIG. 14A illustrates a heat-set nitinol tube 184 that is deployed from the distal end 116 of the guide catheter 102 after guide catheter 102 has passed through the atrial septum 8. The nitinol tube 184 can engage the atrial septum 8 to limit the extent to which the guide catheter 102 can be retracted tow ards the right atrium 4. As shown in FIGS. 14B and 14C, respectively, the distal end 116 of the guide catheter 102 may additionally or alternatively be equipped with nitinol wires 186 that extend from the sidewall of the guide catheter 102 or heat-set nitinol wires 188 that extend from the distal tip 116 of the guide catheter 102. In some embodiments, the nitinol wires 186 may be heat-set wires.

[0287] Referring to FIG. 15, the transcatheter delivery system 150 also includes a manipulation tool 152 to which the guide catheter 102 and other components of the deployment tool 100 and the implantation system 50 (e.g., the rails 106, 108, 110, sheath 112. guidewire 114. delivery catheter 52, positioning catheter 57, deployment catheter 56, and wires 59, 60, 77, as previously illustrated in various other figures) extend proximally. The manipulation tool 152 is designed to allow a user to remotely (e.g., with respect to the heart 1) actuate and control movements of the various components of the deployment tool 100 and the implantation system 50.

[0288] The manipulation tool 152 is permanently or releasably attached to an operating table 109 on which the patient is laying via a support stand 113. In some embodiments, the manipulation tool 152 is separated or substantially separated from the operating table 109. The guide catheter 102 of the deployment tool 100 may be inserted into a femoral vein or an iliac vein through an incision 36 in the patient's groin area using the manipulation tool 152. From the site of the incision 36, the guide catheter 102 can be safely navigated to the heart 1 through the patient’s vasculature, even while encountering varying tortuosity and vary ing vascular pathway sizes. In other implementations, such as when the guide catheter 102 of the deployment tool 100 is used to access the superior vena cava 10 for deploying an implant to treat the tricuspid valve 7, the incision will be placed at a different location on the patient’s body, such as at an appropriate location on the patient’s neck.

[0289] Various controls 154 of the manipulation tool 152 can be adjusted by the user to advance, retract, and rotate the guide catheter 102, rails 106, 108, 110, sheath 112. guidewire 114, delivery catheter 52, deployment catheter 56, and wires 59, 60, 77 to position the guide catheter 102 within the left atrium 5, position and stabilize the frame 124, deploy the implantation system 50, manipulate and implant the mitral valve implant 51, retract the other components of the implantation system 50, and retract the deployment tool 100.

[0290] FIG. 16 illustrates a schematic of the various controls 154 of the manipulation tool 152. The controls 154 include control assemblies 115, 119, 123, 127, each with one or more of various control mechanisms, such as slider mechanisms, rotational mechanisms, rotational lock mechanisms, or other mechanisms. The controls 154 include a control assembly 1 15 at which the guide catheter 102, a side port 191 for the ICE catheter 190, stabilization rail 106, stabilization rail 108, sheath 112, and guidewire 114 terminate. Accordingly, the control assembly 115 includes mechanisms 117a-l 17i for respectively moving the guide catheter 102 axially, rotating the guide catheter 102, moving the ICE catheter 190 axially, rotating the ICE catheter 190, moving the stabilization rail 106 axially, moving the stabilization rail 108 axially, moving the sheath 112 axially moving the guidewire 114 axially, and rotating the guidewire 114.

[0291] The controls 1 4 also include a control assembly 119 at which the guiderail 110, delivery7catheter 52, sheath 57, and adjustment wire 60 terminate. Accordingly, the control assembly 119 includes mechanisms 121a-e for respectively moving the guiderail 110 axially, holding the guiderail 110 proximally in tension, moving the delivery catheter 52 and sheath 57 axially, rotating the delivery catheter 52 and sheath 57, and moving the adjustment wire 60 axially.

[0292] The controls 154 also include a control assembly 123 at which the positioning catheter 53 terminates. Accordingly, the control assembly 123 includes mechanisms 125a, 125b for respectively moving the positioning catheter 53 axially and rotating the positioning catheter 53. The controls 154 also include a control assembly 127 at which the deployment catheter 56 and the extension wire 77 terminate. Accordingly, the control assembly 127 includes mechanisms 129a-c for respectively moving the deployment catheter 56 axially, rotating the deployment catheter 56, and moving the extension wire 77 axially for opening and closing the clipping arms 69.

[0293] Referring to FIGS. 1A, IB, and 8, the transcatheter delivery' system 150 may be used to carry' out a therapeutic procedure, such as a mitral transcatheter edge-to- edge repair (TEER) procedure to repair the mitral valve 2. During a mitral TEER procedure, the guide catheter 102 is advanced through the atrial septum 8 such that the distal end 116 of the guide catheter 102 extends into the left atrium 5 by a distance of about 3 cm to about 8 cm. The frame 124 is then advanced through and out of the guide catheter 102 to a position short of the anterolateral commissure 18 and a lateral region of the left atrial wall 26. The guidewire 114 is then advanced out of the hub 104 and into the left ventricle 6. The frame 124 is further advanced out of the guide catheter 102 until the hub 104 abuts the lateral region of the left atrial w all 26 just above the anterolateral commissure 18. Abutment of the hub 104 w ith the left atrial wall 26 helps to stabilize a position of the frame 124 along the distal direction 101 within the heart 1. In this way, the left atrial wall 26 serves as an anatomic stabilization structure for the deployment tool 100.

[0294] With the hub 104 abutted against the left atrial wall 26, the foot 120 and the terminal portion 118 of the guidewire 114, guided by the anatomy of the mitral valve 2 (e.g., including the leaflets 11, 12), naturally fall into the anterolateral commissure 18. The guidewire 114 may then be gently retracted to engage the foot 120 with the sub-annular gutter 22 and pull the hub 104 toward the anterolateral commissure 18 in a final functional position. Engagement of the frame components with the heart anatomy (e.g., abutment of the hub 104 with left atrial wall 26 and positioning of the guidewire 114 within the anterolateral commissure 18) plays a key role in properly positioning the hub 104 and guiderail 110 into proper positions above the mitral valve 2, with the guiderail 110 extending across the mitral valve 2 in an in-line arrangement (e.g., in-line with the coaptation line 16).

[0295] Referring to FIGS. 4 A and 4B, with the hub 104 positioned against the left atrial wall 26, the stabilization rails 106, 108 are further extended from the guide catheter 102 until the rails bow 106, 108 outwardly to contact the left atrial wall 26. Such contact helps to stabilize a position of the frame 124 along distal, anterior, posterior, atrial, and ventricular directions within the heart 1. In this way, the extended frame 124 effects much of the stability of the deployment tool 100. The heart anatomy (e.g., the left atrial wall 26) further helps to position the frame 124 and supports its anatomic positional stability. In addition to providing enhanced stability, the anatomy allows for vector control and precision for reaching the anatomic target with the mitral valve implant 51.

[0296] Referring to FIGS. 1A. IB. and 8, with the hub 104. rail 106, and rail 108 positioned against the left atrial wall 26, the sheath 112 may be optionally further extended from the guide catheter 102 until the sheath 112 bows orthogonally from the guiderail 110 to contact an upper region of the left atrial wall 26. Such contact may help to further stabilize a position of the frame 124 within the heart 1 along the orthogonal direction 109. In this way. the left atrial wall 26 still further serves as an anatomic stabilization structure for the deployment tool 100.

[0297] In an alternative method of operating the deployment tool 100, the hub 104 of the frame 124 is abutted against the lateral region of the left atrial wall 26 just above the anterolateral commissure 18 and stably positioned within the left atrium 5 before the guidewire 114 is advanced through and out of the sheath 112 into the left ventricle 6. In embodiments where such a maneuver is carried out, the frame 124 additionally includes a mechanism to displace the hub 104 apically to engage the left atrial wall 26 above the annulus 17. As discussed above, the guidewire 114 can then be retracted gently until the foot 120 is wedged against or just beneath the anterolateral commissure 18 or the sub-annular gutter 19 to further stabilize the position of the frame 124 within the heart 1. In this way, the anterolateral commissure 18 or the subannular gutter 19 and the left ventricular wall 28 serve as additional anatomic stabilization structures for the deployment tool 100.

[0298] Once the frame 124 is stabilized in a functional configuration within the left atrium 5 with the guidewire 114 located in the left ventricle 6, the delivery catheter 52 of the implantation system 50 is advanced (e.g., slid) along the guiderail 110 and out of the guide catheter 102 to position the delivery catheter 52 at a desired axial position (e.g., medial-lateral position) within the left atrium 5. The delivery catheter 52 is also rotated to a desired orientation. The sheath 57, owing to its attachment to the deliver ’ catheter 52, is moved axially and rotationally in a corresponding manner. The positioning catheter 53 is then advanced through the sheath 57 to a desired position and rotated within the sheath 57 to a desired orientation. The adjustment wire 59 allows the distal end of the positioning catheter 53 (e.g., or the collar 58) to be displaced flexibly (e.g., linearly) from the distal end of the delivery catheter 52 while the positioning catheter 53 is advanced and rotated.

[0299] The deployment catheter 56, carrying the mitral valve implant 51 , is then advanced just out of the positioning catheter 53 and rotated to a desired orientation. Referring to FIG. 8, with the mitral valve implant 51 positioned and oriented as desired, the mitral valve implant 51 is lowered into the left ventricle 6 and implanted onto the leaflets 11, 12 of the mitral valve 2 by manipulating controls of the manipulation tool 152. The mitral valve implant 51 is implanted by advancing or retracting the extension w ire 77 to adjust the length of the head 64 and by retracting (e.g., pulling) or releasing (e g., pushing) the gripping control wires 66 to adjust the gripping arms 65 to close the gripping and clipping arms 65, 69 onto the leaflets 11, 12 as desired, and as discussed above with respect to FIGS. 9A-9F.

[0300] After implantation, the deployment catheter 56 is disconnected from the mitral valve implant 51 in the manner illustrated in FIGS. 9G-9J. The guidewire 114 is retracted until its distal tip 122 is located within the sheath 112. and the guide catheter 102, carry ing the frame 124 (e.g., itself earn ing the other components of the implantation system 50). is retracted from the patient.

[0301] Use of the manipulation tool 152 enables predictable, repeatable control of the deployment tool 100 and implantation system 50 for implanting the mitral valve implant 51 at the target location of the mitral valve 2. For example, near-immediate correspondence between remote manipulations of the tool 152 and local manipulations of the deployment tool 100 and implantation system 50 render the transcatheter elivery system 150 easy to operate in an efficient manner by a user. Furthermore, deployment of the ICE catheter 190 to the left atrium 5 allows the maneuvers to be visualized in real time.

[0302] While the implantation system 50 has been described and illustrated as including the adjustment wire 59 (e.g., the spring 59) and the adjustment wire 60 that together allow displacement of the distal end of the positioning catheter 53 (e.g., or the collar 58) from a distal end of the delivery catheter 52, in some embodiments, an implantation system that is similar in function to the implantation system 50 can alternatively include a different type of adjustment mechanism. For example, FIG. 17A illustrates a portion of an implantation system 50a that has a telescopically adjustable delivery' catheter 52a that can be adjusted along a guiderail 68a. The implantation system 50a also includes a bar-linkage mechanism 59a that is connected to a distal end of the positioning catheter 53 to allow the distal end of the positioning catheter 53 to be displaced in the anterior-posterior direction 68b.

[0303] FIG. 17B illustrates a portion of an implantation system 50b that has a flexible frame 80b (e.g., a nitinol frame) connected to a delivery catheter 52b, as well as to a distal end 57b of the positioning catheter 53. The flexible frame 80b includes upper and lower platforms 81b, 82b and two springs 59b, 60b by which the distal end 57b of the positioning catheter 53can be pulled towards or extended away from the delivery catheter 52b (e.g., along an anterior-posterior direction) at two opposite ends by two respective pull wires 81a, 81b. That is, the springs 59b, 60b can extend to differing intermediate extents simultaneously.

[0304] FIG. 17C illustrates a portion of an implantation system 50c that has a flexible frame 80c (e.g., a nitinol frame) connected to a delivery' catheter 52c, as well as to a distal end 57c of the positioning catheter 53 51. The flexible frame 80c is formed as a spring by which the distal end 57c of the positioning catheter 53 can be pulled towards or extended away from the delivery catheter 52c along the anterior-posterior direction by a pull wire 81c.

[0305] FIG. 17D illustrates a portion of an implantation system 50d that has a flexible frame 80d (e.g., a nitinol ribbon) connected to a delivery catheter 52d, as well as to a distal end 57d of the positioning catheter 53. The flexible frame 80d can be moved axially at its proximal end to cause the distal end 57d of the positioning catheter 53 to be displaced from the delivery catheter 52d along an anterior-posterior direction.

[0306] Other embodiments of a deployment tool may form part of a transcatheter delivery system, where such deployment tool and transcatheter delivery system overall are respectively similar in construction, function, and operation to the deployment tool 100 and the transcatheter delivery system 150. For example, referring to FIG. 18 A, a deployment tool 100a that is similar in construction and function to the deployment tool 100 does not include a guiderail such that a sheath 112a is used as a guiderail for the implantation system 50. The deployment tool 100a includes a guide catheter 102a and a frame 124a. In addition to the sheath 112a, the frame 124a further includes stabilization rails 106a, 108a, a guidewire 114a, and a hub 104a. FIG. 18B illustrates a deployment tool 100b that is identical to the deployment tool 100a, except that the deployment tool 100b does not include a sheath or a stabilization foot. The deployment tool 100b includes a guide catheter 102b and a frame 124b. The frame 124b includes stabilization rails 106b, 108b and a hub 104b.

[0307] FIG. 18C illustrates a deployment tool 100c that is similar in construction and function to the deployment tool 100, except that the deployment tool 100c includes a guidewire 114c with a terminal loop 118c instead of a foot or elongate terminal portion. Advantageously, the terminal loop 118c avoids chordal entanglement while being advanced through the mitral valve 2 and into the left ventricle 6. The deployment tool 100c includes a guide catheter 102c and a frame 124c. In addition to the guidewire 114c, the frame 124c includes stabilization rails 106c, 108c, a guiderail 110c, a sheath 112c, and a hub 104c.

[0308] FIG. 18D illustrates a deployment tool lOOd that is similar in construction and function to the deployment tool 100, except that the deployment tool lOOd does not include a sheath and an associated portion of a guidewire. The deployment tool lOOd includes a guide catheter 102d and a frame 124d. The frame 124d includes stabilization rails 106d, 108d, a guiderail HOd, a hub 104d. and a ventricular stabilization loop 114d that forms a closed loop between the hub 104d and the guide catheter 102d. FIG. 18E illustrates a deployment tool lOOe that is similar in construction and function to the deployment tool lOOd, except that the deployment tool lOOe does not include a guiderail. The deployment tool lOOe includes a guide catheter 102e and a frame 124e. The frame 124e includes stabilization rails 106e, 108e, a hub 104e, and a ventricular stabilization loop 114e that forms a closed loop between the hub 104e and the guide catheter 102e.

[0309] FIG. 18F illustrates a deployment tool lOOf that is similar in construction and function to the deployment tool lOOd, except that a guiderail 1 lOf extends downward to a second hub 192f along a ventricular stabilization loop 114f instead of to a hub 104f. The deployment tool lOOf includes a guide catheter 102f and a frame 124f. In addition to the second hub 192f, the ventricular stabilization loop 114f. and the hub 104f, the frame 124f further includes stabilization rails 106f, 108f. FIG. 18G illustrates a deployment tool 100g that is similar in construction and function to the deployment tool lOOf, except that the deployment tool 100g includes a movable hub 192g. an adjustment sheath 112g that can move axially to adjust a position of the hub 192g, and a guiderail 110g attached to the hub 192g. The deployment tool 100g includes a guide catheter 102g and a frame 124g. In addition to the movable hub 192g, the adjustment sheath 112g, the hub 192g, and the guiderail 110g, the frame 124g further includes stabilization rails 106g, 108g, ahub 104g, and a ventricular stabilization loop 114g.

[0310] FIG. 18H illustrates a deployment tool 1 OOh that is similar in construction and function to the deployment tool 100g, except that the deployment tool lOOh does not include a sheath and does include a stabilization loop 114h that extends from a guide catheter 102h at both ends of the stabilization loop 114h. In addition to the stabilization loop 1 14h, a frame 124h of the deployment tool lOOh further includes stabilization rails 106h, 108h, a guiderail 11 Oh, a hub 104h, and a hub 192h. The stabilization loop 114h passes freely through the hub 124, and the hub 192h is fixed to the loop 114. Accordingly, pulling or pushing of the loop 114h causes a corresponding movement of the hub 192h.

[0311] FIG. 181 illustrates a deployment tool lOOi that is similar in construction and function to the deployment tool lOOh, except that the deployment tool lOOi does not include a guiderail or a second hub. The deployment tool lOOi includes a guide catheter 102i and a frame 124i. The frame 124i includes stabilization rails 106i, 108i, a hub 104i, and a stabilization loop 114i. FIG. 18J illustrates a deployment tool lOOj that includes a guide catheter 102j and a frame 124j provided as a single stabilization loop 114j.

[0312] FIG. 18K illustrates a deployment tool 100k that is similar in construction and function to the deployment tool lOOd, except that a ventricular stabilization loop 114k includes a stabilization foot 120k. The deployment tool 100k further includes a guide catheter 102k and a frame 124k. In addition to the ventricular stabilization loop 114k, the frame 124k includes stabilization rails 106k. 108k, a guiderail 110k, and a hub 104k. FIG. 18L illustrates a deployment tool 1001 that is similar in construction and function to the deployment tool 100k, except that a stabilization foot 1201 of a ventricular stabilization loop 1141 is directed inward (e.g., medially) instead of outward (e.g., laterally). Such a configuration of the foot 1201 allows the stabilization loop 1141 to stabilize the frame 1241 both above and below the annulus. The deployment tool 1001 includes a guide catheter 1021 and a frame 1241. In addition to the ventricular stabilization loop 1141, the frame 1241 includes stabilization rails 1061, 1081, a guiderail 1101, and a hub 1041.

[0313] FIG. 18M illustrates a deployment tool 100m that is similar in construction and function to the deployment tool 100k, except that an overall profile of a ventricular stabilization loop 114m extends outward (e.g., laterally) of a hub 104m. Accordingly, a stabilization foot 120m with a slightly curved profile extends outward of the hub 104m. The deployment tool 100m includes a guide catheter 102m and a frame 124m. In addition to the ventricular stabilization loop 114m and the hub 104m, the frame 124m includes stabilization rails 106m, 108m and a guiderail 110m.

[0314] In some embodiments, frames of any of the configurations of FIGS. 1 and 18A-18M may be shape set to facilitate insertion through the mitral valve 2. In some embodiments, such shape setting reduces the need for use of an orthogonal stabilization loop, such as that formed by the stabilization rails 106, 108 or any of the other horizontal stabilization rails discussed above. The shape setting allows for an easier and more stable deployment. Furthermore, generally speaking, any of the above-discussed or below-discussed frame rails, loops, or guidewires (e.g.. pertaining to applications for both the mitral valve 2 and the tricuspid valve 7) may be utilized as a guiderail along which an implantation system can be advanced. Additionally, in some embodiments, such rails, loops, or guidewires may not extend from the guide catheter, but may come through the guide catheter and terminate proximally. In some embodiments, any of the above-discussed or below-discussed closed loop or closed guidewire configurations of 114c, 114d, 114e, 114f, 114g, 114h, 114i. 114k, 1 141, 114m, 114pq, 114x, 114y, 114z, 114za may be secured to a hub (e.g., a hub 104xx) in a threaded arrangement, as shown in FIGS. 5A and 5B, so that a distal end 114x of the loop or guidewire can be separated from the hub 104xx when the loop or guidewire must be removed from the heart 1. The hub 104xx also includes a channel 160xx through which another segment of the frame can pass. In some embodiments, the hub 104xx may include one or more of a variety of other, different attachment features (e.g., a crimp, weld, adhesive bond, press fit) by which the distal end 114xx is secured to the hub 104xx.

[0315] Referring to FIG. 19A. in some embodiments, a closed stabilization loop of a frame that extends into a guide catheter at both ends (e.g., any of the stabilization loops 18d-18m) should be opened in order to be retracted into the guide catheter for removal from the heart 1 once the valve repair procedure has been completed. Accordingly, a stabilization loop 194a may include an interlocking arrangement 194b at which adjoining loop portions 194c, 194d of the loop 194a can be disconnected. The loop portions 194c, 194d may disconnect from each other either when the interlocking arrangement 194b is advanced past a distal end 194e of a guide catheter 194f, or when the guide catheter 194f is retracted to expose the interlocking arrangement 194b. Referring to FIG. 19B, in some embodiments, a protective sheath 194g may surround a section of the loop 194a within a wall of the guide catheter 194f such that advancing the interlocking arrangement 194b past a distal end of the sheath 194g or retracting the sheath 194g to expose the interlocking arrangement 194b will allow the loop portions 194c, 194d to disconnect from each other.

[0316] Referring to FIGS. 18D-18M, the global axial and angular positions of each of the frame configurations of deployment tools 18d-18m are substantially fixed at a proximal end by the guide catheter 102d-102m and substantially fixed at a distal end by the hub 104d-104m. The tendency of the loop 114d- 114m to twist upon itself (e.g., the twist deformation) can be mitigated in several ways, such as by reducing a global stiffness of the loop 114d- 114m, reducing a regional stiffness of the loop 114d- 114m, creating a flexibility profile with a directional variation, adjusting an orientation of the lower frame loop 114d- 114m at the hub 104d-104m, rotationally constraining the loop 114d- 114m, and shaping (e.g., heat-setting a shape) the loop 114d-114m. As to reducing the global stiffness of the loop 114d- 114m, the loop 114d- 114m is prevented from twisting upon itself by maintaining the stiffness of the loop 114d- 114m sufficiently low compared to the diameter of the loop 1 14d- 114m. This can be effected by reducing a flexural modulus of the material of the loop 114d- 114m or by changing the cross-sectional width of the loop 114d-114m, where the flexural stiffness is proportional to the bending modulus (E) multiplied by the moment of inertia (I), and where I=nR4 / 12 for a round wire. Regional changes in stiffness can also reduce the propensity of twist deformation in the loop 114d- 114m. For example, by tapering a thickness of the loop 114d- 114m, the stiffness of the loop 114d-l 14m can be reduced along a section near the distal tip of the guide catheter 102d-102m or within the left ventricle 6.

[0317] Directionally varying the flexibility profile of the loop 1 14d-l 14m can be accomplished by changing its cross-sectional profile. For example, forming the loop 114d- 114m as a ribbon or with an oval-shaped cross-section would allow the loop 114d-l 14m to bend preferentially in one bending plane, while resisting bending in any other bending plane. Such configuration has the effect of resisting rotation.

[0318] The orientation of the loop 114d- 114m at the distal end of the guide catheter 102d-102m can also be adjusted. For example, adjusting the loop 114d- 114m by an angle of 90 degrees (e.g., orthogonal to the central axis of the guide catheter) using an elbow causes the loop 114d- 114m at this region to be oriented substantially parallel to the section of the loop 1 14d- 1 14m that is secured to the hub 104. The parallel ordination of these two opposite portions of the loop 114d- 114m significantly reduces the propensity of the loop 114d- 114m to twist. In some embodiments, such an elbow could be retracted into the guide catheter 102d-102m during insertion and removal. In some embodiments, rotationally constraining the loop 114d- 1 14m can also resist the twist deformation.

[0319] Referring to FIG. 20 A, in some embodiments, any of the above-discussed or below-discussed stabilization rails or guidewires (e.g., pertaining to applications for both the mitral valve 2 and the tricuspid valve 7) may be equipped with a tube 196a that has a foot 196b for stabilizing the stabilization rails or guidewires at plane 168 of the mitral valve 2. For example, an upper portion of a guidewire 196c (e.g., relative to the mitral valve plane) is equipped with the tube 196a, which is formed to be inserted distally into the mitral valve 2 and then gently retracted proximally to stabilize the guidewire 196c with the foot 196b at the sub-annular gutter 19. Referring to FIG. 20B, in some embodiments, a tube 196d may be arranged on a lower portion of the guidewire 196c such that the tube 196d is inserted distally until the guidewire 196c is stabilized at the sub-annular gutter 19 by the foot 196e. Referring to FIG. 20C, in some embodiments, the guidewire 196c may be equipped with both the upper tube 196a and the lower tube 196j to stabilize the guidewire 196c at the sub-annular gutter 19 with the feet 196b, 196e. Referring to FIG. 20D. in some embodiments, a guidewire 196f that includes a stabilization foot 196g may be equipped with the upper tube 196a. Accordingly, the guidewire 196f may be stabilized at the mitral valve 2 with both the foot 196b and the foot 196g.

[0320] Referring to FIG. 21, in some embodiments, a deployment tool lOOn that is similar in construction and function to the deployment tool 100 includes a guide catheter 102n, a frame 124n with a single stabilization loop 114n, a sheath 112n that guides a lateral portion of the stabilization loop 114n distally into the left atrium 5, and a delivery' catheter 52n for delivering the mitral valve implant 51 to a desired location above the mitral valve 2. The stabilization loop 114n includes two opposing feet 120n that can stabilize the loop 114n at the mitral valve 2.

[0321] FIG. 22A illustrates a deployment tool lOOo that is similar in construction and function to the deployment tool 100. The tool lOOo includes a guide catheter 102o and a frame 124o that is provided as a guidewire 114o. A distal end of the guidewire 114o terminates in a loop 118o that can be located against the left atrial wall 26 to help stabilize the guidewire 1 14o at the mitral valve 2. The guidewire 114o includes a lateral stabilization foot 120o that can further stabilize the guidewire 114o at the mitral valve 2. FIG. 22B illustrates a deployment tool lOOo' that is similar in construction and function to the deployment tool lOOo, except that a frame 124o', provided as a guidewire 114o', includes both lateral and medial stabilization feet 120o'.

[0322] FIG. 23 A illustrates a deployment tool lOOp that is similar in construction and function to the deployment tool lOOo. The tool lOOp includes a guide catheter 102p and a frame 124p. The frame 124p includes a stabilization loop 114p, a hub 104p that connects two portions 106p, 108p of the stabilization loop 114p, two sheaths 112p, 113p that respectively guide the portions 106p, 108p laterally and medially within the left atrium 5, and a guiderail 1 lOp that extends between the portions 106p, 108p to the hub 104p. The portions 106p, 108p can be disconnected from the hub 104p to allow for separate retraction of the portions 106p, 108p and guiderail 1 lOp from the heart 1. The portions 106p, 108p includes two distal connectors 117p, 119p (e.g., ballshaped connectors) that are formed to be securely received in two receptacles 12 Ip, 123p of the hub 104p. Upper and lower portions of the receptacles 121 p, 123p are attached to opposite ends of an extendable rail 125p of the hub 104p. The guiderail 1 lOp is also rotationally coupled to the rail 125p such that rotation of the guiderail 1 lOp in opposing directions causes a corresponding lengthening or shortening of the rail 125p. Lengthening of the rail 125 accordingly opens the receptacles 12 Ip. 123p to release the connectors 117p, 119p of the guiderail portions 106p, 108p from the hub 104p. Once released, the portions 106p, 108p and the guiderail I lOp can be retracted from the heart 1.

[0323] FIG. 23B illustrates a deployment tool lOOpq that is similar in construction and function to the deployment tool lOOp. The tool 1 OOpq includes a guide catheter 102pq and a frame 124pq. The frame 124pq includes a stabilization loop 114pq with opposite segments 106pq, 108pq, and two sheaths 112pq, 113pq that respectively guide the segments 106pq, 108pq laterally and medially within the left atrium 5. The tool lOOpq also includes a guiderail 1 lOpq that extends between the segments 106pq, 108pq. The guiderail HOpq and the segments 106pq, 108pq terminate at respective hubs 104pq, 105pq, 107pq along a steering wire 125pq. Opposite ends of the steering wire 125pq extend proximally through the sheaths 112pq, 113pq. The steering wire 125pq can be pulled or pushed at its proximal ends to adjust a medial-lateral position of the hub 104pq, which is fixed to the steering wire 125pq. The portions 106pq, 108pq can be adjusted axially by equal amounts to cause anterior-posterior movements of the hub 104pq. The stabilization loop 114pq includes lateral stabilization feet 120pq, 121pq that can further stabilize the stabilization loop 114pq at the mitral valve 2.

[0324] FIG. 24 illustrates a deployment tool lOOq that is similar in construction and function to the deployment tool lOOp. The tool lOOq includes a guide catheter 102q and a frame 124q. The frame 124q includes two guidewires 114q, 115q that extend between lateral and medial sides of the left ventricle 6, and a guiderail 1 lOq. Each guidewire 114q, 115q includes a stabilization foot I20q, 13 Iq and ball-shaped distal ends 118q, 129q that secure the guidewires 114q, 115q in place at the mitral valve 2 by engaging the supra-annular “bowl” of the mitral valve 2 for stabilization and anchoring. The tool lOOq also includes a gripper 117q that is operable within the guiderail 1 lOq to hold the guidewires I I4q, 115q against the guiderail 1 lOq. In this manner, the guidewires 114q, 115q together form a loop within the left ventricle 6. The guidewires 114q, 115q are respectively held at coupling sections 119q. 121 q. The gripper 117q can be operated to release the guidewires 114q, 1 15q to allow for separate retraction of the guidewires 114q, 115q and guiderail 110 from the heart 1.

[0325] FIGS. 25A-25C illustrate a deployment tool lOOr that is similar in construction and function to the deployment tool lOOq. Referring to FIG. 25A, the tool lOOr includes a guide catheter 102r and a frame 124r. The frame 124r includes a guiderail 1 lOr and two guidewires 114r, 1 15r that are movable axially within the guiderail HOr. The guidewires 114r, 115r include stabilization feet 120r, 13 Ir and ball-shaped distal ends 118r, 129r. The implantation system 50 can be deploy ed to the mitral valve along the guiderail 1 lOr. as shown in FIG. 25B. The guidewires 114r, 115r can retracted from the heart 1 through the guiderail 1 lOr, as shown in FIG. 25C.

[0326] FIG. 26A illustrates a deployment tool 100s that is similar in construction and function to the deployment tool 100. The tool 100s includes a guide catheter 102s and a frame 124s. The frame 124s includes two guidewires 114s, 115s that are movable within the guide catheter 102s and a connection rail 141s that connects the guidewires 114s, 1 15s to each other distally. The guidewires 114s, 115s include ball-shaped atrial stabilization features 106s, 108s and terminal loops 117s, 119s. A curved end 143s (e g., a j-tip) of the connection rail 141s can be inserted through and past the loops 117s. 119s when they are aligned to connect the terminal loops 117s. 119s to each other. In this configuration, the guidewires 1 14s, 115s together form a loop within the left ventricle 6. An implantation system 50s can be deployed along the guidewires 114s, 115s via a delivery catheter 52s. A collar 58s of the implantation system 50s is connected to the distal end of the delivery catheter 52s via three connectors 145s, 147s, 149s that allow for angular adjustment of the mitral valve implant 51 in two rotational directions and linear adjustment of the mitral valve implant 51 along one direction. The connection rail 141s can be withdrawn to allow the guidewires 114s, 115s to separate for retrieval from the heart 1.

[0327] FIGS. 26B-26E illustrate positioning frames 124ya, 124yb, 124yc that are attached to a center guiderail 1 lOya, 1 lOyb, 1 lOyc and anchor to the sub-annular gutter 22 in the anterior commissural regions (Al, A3) and in the center of the posterior annulus (P2). These frames differ from the above-discussed frames in that they are not attached to the end of a catheter lumen. These frames provide distal anchoring of the guiderail HOya, 11 Oyb, 11 Oyc to facilitate tracking over the guiderail and provide orientation and alignment with respect to the anatomy. The frames, along with the attached guiderail, are delivered to the mitral valve 2 through a trans-septal guide catheter (not shown). In some embodiments, these frames 124ya, 124yb, 124yc provide important functions, such as tracking and orientation.

[0328] FIGS. 26B and 26C illustrate the frame 124ya. The frame 124ya includes a central hub 104ya to which the guiderail 1 lOya and three stabilization rails 106ya, 107ya, 108ya are attached. The rail 107ya is a posterior stabilization rail with a subannular anchoring foot 120ya located in the P2 region of the posterior annulus. The rails 106ya, 108ya are anterior stabilization rails that include sub-annular feet 121ya and supra-annular feet 122ya. To perform a TEER procedure, the frame 124ya is deployed utilizing a transseptal catheter by passing the feet below the valve 2 and then retracting the frame 124ya to engage the feet with the sub-annular gutter 22. Once in place, an implant delivery catheter can be tracked (e.g., moved downward) along the guiderail 1 lOya to the mitral valve 2. Once the mitral valve implant is placed, the open frame 124ya can be extracted by inverting the frame into a catheter and removing the frame 124ya from the body.

[0329] FIG. 26D illustrates a frame 124yb that is particularly suitable for procedures that require a higher guiderail tension. The frame 124yb includes a guiderail 1 lOyb, and two anterior stabilization rails 106yb, 108yb that are attached to a supra-annular hub 104yb. When tension is applied to the guiderail 1 lOyb during tracking, the tension is transferred to anterior feet 120yb through tension in the atrial stabilization rails 106yb, 108yb. Because these stabilization rails are in tension, they remain stable under higher tension, as compared to a sub-annular stabilization rail that may invert with sufficient guiderail tension. After implantation of the TEER implant, the rails 106yb, 108yb are then collapsed into an over-the-guiderail removal catheter. A posterior stabilization rail is inverted into the tip of the removal catheter and the frame 124yb is withdrawn from the body.

[0330] FIG. 26E illustrates another frame 124yc that is particularly suitable for procedures that require a higher guiderail tension. The frame 124yc includes a guiderail 1 lOyc and closed anterior stabilization rails 106yc, 108yc that are connected to both a proximal supra-annular hub 104yc and the distal sub-annular hub 105yc. The closed rails 106yc, 108yc provide additional stability of the sub-annular feet 120yc and supra-annular feet 121yc during tensile loading of the guiderail 1 lOyc. After implantation of the TEER implant, the rails 106yb, 108yb are then detached from the distal hub 105yc, allowing collapse and removal of the frame 124yc.

[0331] FIGS. 27A and 27B illustrate a deployment tool lOOt that is similar in construction and function to the deployment tool 100. The deployment tool lOOt includes a guide catheter 102t and a frame 124t. The frame 1241 includes a relatively stiff guidewire 114t that is slidable within the guide catheter 102t. The guidewire 114t stabilizes the frame 124t at the anterolateral commissure 18. The implantation system 50 can be advanced into the heart 1 and to the mitral valve 2 along the guidewire 114t.

[0332] FIGS. 28A and 28B illustrate a deployment tool lOOu that includes a guide catheter 102u, a delivery catheter 52u. and a frame 124u. The frame 124u includes a hub 104u disposed at a distal end of the delivery catheter 52u, as well as atrial stabilization loops 106u, 108u. The loops 106u, 108u extend radially from the hub 104u to contact the left atrial wall 26, thereby defining a desired position the hub 104u. The mitral valve implant 51 can be deployed through the delivery catheter 52u on a deployment catheter 56u to the mitral valve 2. FIG. 28C illustrates a deployment tool lOOv that is substantially similar in construction and function to the deployment tool lOOu, except that the deployment tool lOOv includes a frame 124v with a third loop 114v. The deployment tool lOOv also includes a guide catheter 102v and loops 106v. 108v as part of the frame 124v.

[0333] FIGS. 29A-29C illustrate a deployment tool 1 OOw that is similar in construction and function to the deployment tool lOOu. The deployment tool lOOw includes a guide catheter 102w, a delivery catheter 52w, and a frame 124w. The frame 124w includes a hub 104w and an atrial stabilization loop 106w that surrounds the hub 104w. Three sets of two positioning wires 60w, 61w, 62w each connect the hub 104w to the loop 106w and can be pulled or relaxed to adjust a position and orientation of a deployment wire (e.g., not shown, but passing through the deliverycatheter lOOw and the hub 104w), equipped with a mitral valve implant 51. The three sets of two positioning wires provide 6-wire control, which allows for controlling the positioning and orientation of the hub 104w. In some embodiments, a similar stabilization loop 108w may have a non-circular shape (e.g., a triangular shape or another shape), such as that shown in FIG. 29D.

[0334] FIGS. 30A-30D illustrate portions of a deployment tool lOOx that includes a guide catheter 102x and a frame 124x. The frame 124x is slidable within the guide catheter 102x and includes a lead screw assembly 125x, an expandable cylindrical support structure 127x (e.g., a cage) surrounding the lead screw assembly 125x, and an atrial stabilization loop 106x, and a ventricular stabilization loop 114x. Torque shafts within tubes 129x are rotatable to control a position and an orientation of a delivery' catheter 52x through which a mitral valve implant 51 (not shown) can be deployed. In some embodiments, the support structure 127x may be laser cut or made of braided nitinol.

[0335] FIGS. 31 A and 3 IB illustrate a deployment tool lOOy that is similar in construction and function to the deployment tool 100. The deployment tool lOOy has a “cross-bow” configuration and includes a guide catheter 102y and a frame 124y. The frame 124y includes a curved (e.g., bowed) guiderail I lOy. a tension string 106y, and a guidewire 114y. The guidewire 114y includes a stabilization foot !20y. In some embodiments, the tension string 106y holds a selected dimension, and the guiderail 1 lOy is advanced or retracted to control an anterior-posterior position. A delivery’ catheter 52y, with an attached positioning catheter 53y, can be advanced along the guiderail 1 lOy to position the mitral valve implant 51 as desired. In some embodiments, the guiderail 11 Oy may be provided as a nitinol ribbon.

[0336] FIGS. 32A and 32B illustrate a deployment tool lOOz that is similar in construction and function to the deployment tool 100. The deployment tool lOOz includes a guide catheter 102z and a frame 124z including stabilization rails 106z, 108z, a delivery catheter 52z, and a hub 104z. The frame 124z also includes a left ventricle stabilization loop 114z. A deployment catheter 56z, carry ing the mitral valve implant 51, can be delivered to the left atrium 5 through the delivery catheter 52z. The frame 124z further includes three positioning lines 109z, 11 Iz, 113z (e.g., pull wires) that can be tensioned or relaxed to adjust a position of the deployment catheter 56z over the mitral valve 2. The positioning lines 109z, 11 Iz, 113z extend proximally through a hub 105z at a distal end of the delivery' catheter 52z. Additionally, the direction of the mitral valve implant 51 may be controlled by advancing, retracting, and rotating the delivery catheter 52z.

[0337] FIGS. 32C and 32D illustrate a deployment tool lOOza that is similar in construction and function to the deployment tool 1 OOz. The deployment tool 1 OOza includes a guide catheter 102za and a frame 124za including stabilization rails 106za, 108za, a hub 104za, and a left ventricle stabilization loop 114za. An implantation system 50za includes a delivery catheter 52za, a deployment catheter 56za extending through the delivery catheter 52za and carrying the mitral valve implant 51, and two sleeves 172za, 174za extending over the rails 106za, 108za. respectively. The delivery catheter 52za is attached to the sleeves 172za, 174za within the guide catheter 102za such that the sleeves 172za, 174za can be moved axially to move the delivery' catheter 52za. A positioning wire 182za is attached to the deployment catheter 56za and extends proximally through lumens within respective sleeves 172za, 174za such that pulling and relaxing either proximal end of the positioning wire 182za will effect corresponding anterior or posterior movement of the mitral valve implant 51. In some embodiments, the sleeves 172za, 174za may be independent of the delivery' catheter 52za. Whether the sleeves 172za, 174za are attached to or independent of the delivery catheter 52za, the locations of the sleeves 172za, 174za, and the positioning wire 182za will control the position of the delivery catheter 52za.

[0338] FIGS. 33A and 33B illustrate a deployment tool lOOab with a frame 124ab that is located externally adjacent to a delivery catheter 52ab. A deployment catheter 56ab. carrying the mitral valve implant 51, can be moved distally through the delivery catheter 52ab into the heart 1. The frame 124ab includes a deployment catheter 1 14ab that runs along the delivery' catheter 52ab and terminates at a foot 118ab. The deployment catheter 56ab is coupled to a stabilization loop 106ab, and the stabilization loop 106ab is coupled to a distal end of the delivery catheter 52ab by three positioning wires 109ab, 11 lab, 1 Bab (e.g.. pull lines) that can be tensioned or released to adjust a position of the deployment catheter 56ab over the mitral valve 2. The positioning wires 109ab, 11 lab, 1 Bab extend proximally through respective lumens within the wall of the delivery catheter 52ab. In some embodiments, a configuration with separate positioning wires 109ab, 11 lab, 1 Bab at their proximal ends reduces the stiffness of the larger coaxial deployment tool.

[0339] FIGS. 34A and 34B illustrate a deployment tool lOOac that is similar to the deployment tool lOOab. The tool lOOac includes a guide catheter 102ac and a frame 124ac that is movable axially within the guide catheter 102ac. A delivery’ catheter 52ac. carrying a deployment catheter (not shown) to which the mitral valve implant 51 is attached, is connected to the guide catheter 102ac along an exterior surface. The distal end of the guide catheter 102ac is coupled to a distal end of the delivery' catheter 52ac by two pull wires 109ac, 11 lac that can be tensioned or released to adjust a position of the distal end of the delivery catheter 52ac with respect to the distal end of the guide catheter 102ac. The pull wires 109ac, l i lac extend proximally through respective lumens within the wall of the deliver}' catheter 52ac. The guide catheter 102ac is rotatable, thereby allowing the delivery catheter 52ac to move in both medial-lateral and anterior-posterior directions through a combination of rotation and extension of the pull w ires 109ac, 111 ac. In some embodiments, anterior-posterior positioning of the delivery catheter 52ac by the pull wires 109ac, 111 ac may also incorporate a flexible frame or spring.

[0340] FIGS. 35A and 35B illustrate a deployment tool lOOad that is similar to the deployment tool lOOac. Referring to FIG. 35A, the tool lOOad includes a guide catheter 102ad and a frame 124ad that is movable axially within the guide catheter 102ad. Referring to FIG. 35B. once the frame 124ad has been deploy ed and positioned as desired within the heart 1, the guide catheter 102ad can be retracted, and a deliver}' catheter 52ad, carrying a deployment catheter (not shown) to which the mitral valve implant 51 is attached, can be guided along the frame 124ad into the heart 1 by an insertion catheter 112ad that is advanced along the frame 124ad. The deliver ’ catheter 52ad can be rotated for medial-lateral and anterior-posterior positioning. The insertion catheter 112ad is coupled to a distal end of the delivery catheter 52ad by two pull wires 109ad, 11 lad that can be tensioned or released to adjust a position of the distal end of the delivery' catheter 52ad w ith respect to the insertion catheter 112ad. The pull wires 109ad, I l iad extend proximally through respective lumens within the wall of the delivery catheter 52ad. In some embodiments, a flexible frame or spring may be provided with the pull wires 109ad, I l iad.

[0341] FIGS. 36A and 36B illustrate a deployment tool 200 including a guide catheter 202 and a frame 224 extending from the guide catheter 202. The frame 224 includes a left ventricle loop 214, a posterior atrial stabilization loop 206, and an anterior atrial stabilization loop 208 that provide stabilization within the heart 1.

[0342] FIGS. 37A and 37B illustrate a deployment tool 200a including a guide catheter 202a and a frame 224a extending from the guide catheter 202a. The frame 224a includes an atrial structure 214a including a medial-lateral atrial stabilization loop 206a and an anterior-posterior atrial stabilization loop 208a.

[0343] FIGS. 38A and 38B illustrate a deployment tool 200b including a guide catheter 202b and a frame 224b formed as an atrial stabilization loop 206b extending from the guide catheter 202b. The atrial stabilization loop 206b provides vertical stabilization within the heart 1. The guide catheter 202b defines a sidewall opening 204b through which a delivery catheter 252b can be advanced to deliver the mitral valve implant 51 to the mitral valve 2.

[0344] FIG. 39 illustrates a deployment tool 200c including a guide catheter 202c and a frame 224c extending from the guide catheter 202c. The frame 224c is formed as an atrial portion 206c and a ventricular portion 208c that are connected by a hub 204c. A sheath 212c extends from the guide catheter 202c to the hub 204c, and a frame extender 218c can be advanced through the sheath 212c to an additional hub 205c positioned along the ventricular portion 208c. The frame extender 218c can be advanced or retracted to elongate or widen the ventricular portion 208c in an inverse manner (e.g., as the ventricular portion 208c lengthens, the ventricular portion 208c narrows, and as the ventricular portion 208c is shortened, the ventricular portion 208c can widen). A deployment catheter 256c extending through a delivery catheter 252c can be advanced distally through the guide catheter 202c into a guide hole 203c along an upper end of the atrial portion 206c to position the mitral valve implant (not shown) as desired.

[0345] In some implementations, a transcatheter delivery system that is substantially similar in construction and function to the transcatheter delivery system 150 can be used to treat a pathology7of the tricuspid valve 7 that separates the right atrium 3 from the right ventricle 4. For example, referring to FIG. 40, the deployment tool 100 is equipped with a tricuspid valve implant 71 instead of the mitral valve implant 51.

[0346] During a TEER procedure to implant the tricuspid valve implant 71 at the tricuspid valve 7, the deployment tool 100 is operated in a manner similar to that discussed above for treating the mitral valve 2, except that the guide catheter 102 remains within the right atrium 3 (e.g., without passing through the atrial septum 8). Accordingly, once the distal end 116 of the guide catheter 102 has been positioned as desired within the right atrium 3, the frame 124 is extended proximally until the hub 104 is located at a desired anatomical feature (e.g., the septum 8 just above the tricuspid valve 7). Once the frame 124 is adjusted into a functional configuration within the right atrium 3 (e.g., with or without exposure of the foot 120, which is shown in FIG. 1A, but not in FIG. 40), the tricuspid valve implant 71 is adjusted to a desired position and orientation along the guiderail 110, lowered into the right ventricle 4, and implanted to close the leaflets 37, 38, 39 of the tricuspid valve 7.

[0347] Other embodiments for repairing the tricuspid valve 7 are also possible. For example, FIGS. 41 A and 41B illustrate a transcatheter system 351 that includes a deployment tool 300, an implantation system 350, and a manipulation tool (not shown). The transcatheter system 351 is similar in construction and function to the transcatheter system 150, except that the transcatheter system 351 is designed to enter the heart 1 from the superior vena cava 10 instead of the inferior vena cava 9. For example, the deployment tool 300 includes a guide catheter 302 and a frame 324 that is slidable within the guide catheter 302. The implantation system 350 includes all of the components of the implantation system 50, except that the implantation system 350 includes the tricuspid valve implant 71 instead of the mitral valve implant 51.

[0348] The frame 324 spans portions of both the right atrium 3 and the right ventricle 4 and is similar in construction and function to the frame 124. The frame 324 includes a guiderail 310 and first, second, and third stabilization rails 306, 308. 370 that stabilize the frame 324 within the right ventricle 4 in respective directions that are orthogonal to the rails 306, 308, 370. The rails 306, 308, 370 are approximately equally spaced around a central axis 356 of the guide catheter 302. The frame 324 does not include a guidewire and respective sheath, such as the guidewire 114 and the sheath 112. Accordingly, in other embodiments, the guide catheter 302 may be substantially similar in construction and function to the guide catheter 102, except that a thick-walled portion of the guide catheter 302 includes an arrangement of lumens that accommodates the three rails 306, 308, 370 instead of the two rails 106, 108 and the sheath 112 of the frame 124. In some embodiments, the lumens are equally- spaced around a circumference of the guide catheter 302. The frame 324 is substantially similar in material makeup and mechanical properties as those of the frame 124.

[0349] The rails 310, 306, 308, 370 extend distally to a hub 304, and the rails 306, 308, 370 can be slid proximally to bow outwards into a functional configuration. Each rail 306, 308, 370 is positioned within a comer of a commissure 46, 47, 48 (illustrated in FIG. 2B) of the tricuspid valve 7. In this manner, the commissures 46, 47, 48 anatomically position the frame 324 in the right atrium 3 and right ventricle 4. The hub 304 is substantially similar in construction and function to the hub 104, except that the hub 304 is formed to receive the three stabilization rails 306, 308, 370. The hub 304 is positioned within the right ventricle 4, approximately aligned with the coaptive leaflet center where the three leaflets 37, 38, 39 of the tricuspid valve 7 come together. Once the frame 324 is adjusted into a functional configuration, the tricuspid valve implant 71 can be adjusted to a desired position and orientation along the guiderail 310, lowered into the right ventricle 4, and implanted to close the leaflets 37, 38, 39 of the tricuspid valve 7. The manipulation tool of the transcatheter system 351 is substantially similar in construction and function to the manipulation tool 152, except that its controls are tailored to manipulate the rail configuration of the frame 324. In some embodiments, the hub 304 may contain a detachment feature that allows the rails 306, 308, 370 to detach from the hub 304 for removal after implantation of the tricuspid valve implant 71.

[0350] In some embodiments, as illustrated in FIG. 42, a transcatheter delivery system 450 that is similar in construction and function to the transcatheter delivery7system 351 does not include the guiderail 310. Instead, a frame 424 of a delivery tool 400 of the transcatheter delivery system 450 includes sleeves 472, 474, 476 that can be used to position and orient the tricuspid valve 71 . The sleeves 472, 474, 476 respectively surround the rails 406, 408, 470, and a respective positioning wire (e.g., pull line) 482, 484, 486 passes through a respective lumen of each sleeve 472, 474, 476. The positioning wires 482, 484, 486 are also connected to a distal end of a delivery catheter 452, such that moving the sleeves 472, 474, 476 and / or the positioning wires 482, 484, 486 axially (e.g., proximally or distally) causes resulting orthogonal movements of the tricuspid valve implant 71 above the tricuspid valve 7. Once the frame 424 is adjusted into a functional configuration and the tricuspid valve implant 71 is adjusted to a desired position and orientation, the tricuspid valve implant 71 is lowered into the right ventricle 4 and implanted to close the leaflets 37, 38, 39 of the tricuspid valve 7. A manipulation tool of the transcatheter system 450 has additional controls that are tailored to additionally manipulate the sleeves 472, 474, 476 and the positioning wires 482. 484, 486.

[0351] FIG. 43 illustrates a transcatheter delivery system 550 that is similar in construction and function to the transcatheter system 450, except that a frame 524 of a deployment tool 500 does not include the sleeves 372, 374, 376. Instead, respective positioning wires (e.g.. pull lines) 582. 584, 586 pass through a respective lumen of a delivery catheter 552. The positioning wires 582. 584, 586 are also connected to a hub 504 at a distal end of the delivery catheter 552, such that moving the positioning wires 582, 584, 586 axially (e.g., proximally or distally) causes resulting movements of the tricuspid valve implant 71. Once the frame 524 is adjusted into a functional configuration and the tricuspid valve implant 71 is adjusted to a desired position and orientation, the tricuspid valve implant 71 is lowered into the right ventricle 4 and implanted to close the leaflets 37, 38, 39 of the tricuspid valve 7. A manipulation tool of the transcatheter system 550 has controls that are tailored to additionally manipulate the positioning wires 582, 584, 586.

[0352] Referring to FIG. 44, in some embodiments, the deployment tool 1 OOe (discussed above with respect to FIG. 18E) can be used for deploying the tricuspid valve implant 71 (not shown) to the tricuspid valve 7.

[0353] FIG. 45 illustrates another deployment tool 500a that can be used to access the tricuspid valve 7. The tool 500a includes a guide catheter 502a that can be passed into the right atrium 3 through the superior vena cava 10. The tool 500a also includes a single stabilization loop 514a as a frame. The loop 514a can be positioned within the right ventricle 4.

[0354] Other embodiments of implants may be used with deployment tools and manipulation tools that are similar in construction and function to any of the deployment tools and manipulation tools discussed above to treat the mitral valve 2 and the tricuspid valve 7. For example, FIG. 46 A illustrates a mitral valve implant 51a that is similar in construction and function to the implant 51, except that certain components of the implant 5 la are provided as a braided structure. The implant 51a includes a head 64a that may be surrounded by a fabric or otherwise flexible cover that promotes tissue ingrowth.

[0355] In some embodiments, the head 64a includes a braided structure from which a central body 76a and two limbs 85a are integrally formed. For example, referring to FIGS. 46A-46C, a tubular braid portion 86a forms the central body 76a, and the tubular braid portion 86a bifurcates (e.g., splits) into two opposing flat braid portions 87a that respectively form the two limbs 85a. A gripping arm 65a and an adjustable clipping arm 69a are integrally formed from each limb 85a. In some embodiments, the limbs 85a and the central body 76a may be made of braided nitinol ware. In other embodiments, the limbs 85a and central body 76a may be made of ultra-high molecular weight polyethylene (UHMWPE) or another material.

[0356] The head 64a also includes respective gripping control wires 66a that are connected to the gripping arms 65 a. In some embodiments, the gripping control wires 66a are made of UHMWPE. The gripping control wires 66a are disposed within respective lumens within a w all of a deployment catheter 56a. The gripping control wires 66a can be moved axially within the respective lumens independently of each other to effect bulk axial movement of the arms 65 a, 69a along a central axis of the head 64a.

[0357] The head 64a also includes a shoulder 73a that connects the head 64a to the deployment catheter 56a, a proximal support 79a, and a distal support 75a to which distal ends of the clipping arms 69a are connected. The central body 76a extends from the proximal support 79a. An extension wire extends through the deployment catheter 56a from a user to the distal support 75a. The central body 76a is adjustable axially. In a fully elongated configuration, as shown in FIG. 46A, the clipping arms 69a are fully open (e.g., fully extended radially). In a contracted (e.g., axially compressed) configuration of the central body 76a, the clipping arms 69a are oriented more radially inward (e.g.. in a partially or fully closed configuration). The implant 51a may be implanted at the mitral valve 2 in a manner similar to that described above with respect to the implant 51.

[0358] FIG. 46D illustrates a mitral valve implant 51b that is similar in construction and function to the implant 51a, except that gripping arms 65b of the implant 51b are not integral with clipping arms 69b. The implant 51b includes a head 64b that may be surrounded by a fabric or otherwise flexible cover that promotes tissue ingrowth.

[0359] In some embodiments, the head 64b includes a braided structure from which a central body 76b and two clipping arms 69b are integrally formed. For example, a tubular braid portion 86b forms the central body 76b, and the tubular braid portion 86b bifurcates (e.g., splits) into two opposing flat braid portions 87b that respectively form the two clipping arms 69b. In some embodiments, the clipping arms 69b and the central body 76b may be made of nitinol. The two gripping arms 65b are integrally formed from a single, separate component. The gripping arms 65b may be equipped with surface projections 88b (e.g., barbs) that facilitate gripping of the leaflets 11, 12 of the mitral valve 2.

[0360] The head 64b also includes respective gripping control wires 66b that are connected to the gripping arms 65b. The gripping control wires 66b are disposed w ithin respective lumens within a wall of a deployment catheter 56b. The gripping control wires 66b can be moved axially within the respective lumens independently of each other to effect bulk axial movement of the arms 65b, 69b along a central axis of the head 64b.

[0361] The head 64b also includes a shoulder 73b that connects the head 64b to the deployment catheter 56b, a proximal support 79b, and a distal support 75b to which distal ends of the clipping arms 69b are connected. The central body 76b extends from the proximal support 79b. An extension wire 77b extends through the deployment catheter 56b from a user to the distal support 75b. The central body 76b is adjustable axially. In a fully elongated configuration, the clipping arms 69b are fully open (e.g., fully extended radially). In a contracted (e.g., axially compressed) configuration of the central body 76b, as shown in FIG. 46D, the clipping arms 69b are oriented more radially inward (e.g., in a partially or fully closed configuration). The implant 51b may be implanted at the mitral valve 2 in a manner similar to that described above with respect to the implant 51.

[0362] FIGS. 47A-47F illustrate a mitral valve implant 51c with a “butterfly'’ configuration. For example, referring to FIG. 47 A, the implant 51c includes two clipping assemblies 69c that are attached to a central elongate body 76c at respective hinged connections 81c. Each clipping assembly 69c includes two panels 65c that can be manipulated with one or more control wires to securely hold the leaflets 11, 12 of the mitral valve 2 together. In some implementations, the implant 51c may be delivered to the mitral valve 2 in a relatively narrow delivery configuration such as that illustrated in FIGS. 47B and 47C to facilitate movement through the chordae tendineae 31. Once below the plane of the mitral valve 2, the panels 65c can be opened (e.g., moved radially outward, as shown in FIG. 47D) to form a substantially orthogonal configuration in which the leaflets 11, 12 are held securely together between the panels 65c to effect implantation of the implant 51 c. This configuration is illustrated in FIGS. 47E and 47F. Example materials from which the panels 65c may be made include nitinol, titanium alloys, stainless steel (e.g., 304 stainless steel or 316 stainless steel), cobalt chrome alloys (e.g., containing one or more of cobalt, chromium, nickel, and molybdenum), or rigid implantable plastics (e.g., PEEK, etc.).

[0363] FIGS. 48A-48D illustrate another mitral valve implant 5 Id with a “butterfly” configuration. For example, referring to FIG. 48A, the implant 5 Id includes two clipping assemblies 69d that are attached at respective hinged connections 8 Id. Each clipping assembly 69d includes two panels 65 d that can be manipulated with one or more control w ires to securely hold the leaflets 11, 12 of the mitral valve 2 together. In some implementations, the implant 5 Id may be delivered to the mitral valve 2 in a relatively narrow delivery configuration such as that illustrated in FIGS. 48A and 48B to facilitate movement through the chordae tendineae 31. Once below the plane of the mitral valve 2, the panels 65d can be opened (e.g., moved radially outward, as shown in FIGS. 47C and 47D) to form a substantially orthogonal configuration in which the leaflets 11, 12 are held securely together between the panels 65d to effect implantation of the implant 51 d. Example materials from which the panels 65d may be made include nitinol, titanium alloys, stainless steel (e.g., 304 stainless steel or 316 stainless steel), cobalt chrome alloys (e.g., containing one or more of cobalt, chromium, nickel, and molybdenum), or rigid implantable plastics (e.g., PEEK, etc.).

[0364] In some embodiments, a mitral valve implant may be provided as a device formed from folding one or more sheets of material. For example, FIGS. 49A-49F illustrate a mitral valve implant 51e formed from a single sheet 81e of material. In some embodiments, the sheet 81e may be a laser-cut structure formed from nitinol. The sheet 81e includes a substantially rectangular central portion 82e defining a central fold line 83e and a central opening 84e positioned along the fold line 83e. Two opposing clipping portions 85e, 86e extend from respective sides of the central portion 82e, and each clipping portion 85e, 86e includes two panels 87e, 88e that are separated by an elongate gap 89e, 90e.

[0365] Referring to FIG. 49B, the sheet 81e can be folded along the fold line 83e with heat setting into a u-shaped clip. Referring to FIGS. 49C and 49D, top and front views of the u-shaped clip illustrate that the two panels 87e can be folded radially inward along fold lines 91e through the gaps 89e, 90e, and the two panels 88e can be folded outwardly along fold lines 92e around the central portion 82e to achieve a final configuration of the implant 51 e. The final configuration of the folded implant 51 e is shown in FIGS. 49E and 49F.

[0366] FIG. 49F illustrates a portion of an implantation system 50e that includes the implant 51e. The implantation system 50e is similar in construction and function to the implantation system 50. Accordingly, the implantation system 50e further includes an extension wire 77e, a deployment catheter 56e, a positioning catheter 53e, and a collar 8e. As shown in FIGS. 49G and 49H, the deployment catheter 56e has a bifurcated, tapered distal end portion 93e through which a threaded distal portion 94e of the extension wire 77e passes. Prior to the start of a TEER procedure, the distal portion 94e can be threaded through the central opening 84e in the implant 5 le to securely hold the implant 51 e at the central portion 82e.

[0367] FIGS. 50A-50G illustrate a sequential method of implanting the implant 5 le at the mitral valve 2. Referring to FIGS. 50A, the implant 51 e, substantially contained within the collar 58e, is delivered to the left ventricle just above the mitral valve 2. Referring to FIG. 50B, the implant 51e is then advanced through the valve 2. As shown in FIG. 50C, the extension wire 77e (shown in FIG. 49F) is advanced, thereby- causing the panels 87e, 88e to open (e.g., unfold) and slip between the chordae tendineae 31. Referring to FIGS. 50D and 50E, the deployment catheter 56e is then withdrawn to effect clipping of the leaflets 11, 12 and opening of the panels 87e, 88e such that the implant 5 le achieves the “U” shape in side view. Referring to FIGS. 50F and 50G, the extension wire 77 may then be detached (e.g.. unthreaded) from the central portion 82e of the implant 51 through the opening 84e to leave the implant 51 implanted at the mitral valve 2.

[0368] FIGS. 51A-51C illustrate a mitral valve implant 5 If with a comb-like structure. Referring to FIG. 51 A, the implant 5 If includes a clip 64 f, an actuation rod 81 f that is movable with respect to the clip 64f, and a string 82f that secures the clip 64f to a deployment catheter 56f. The clip 64f defines a pocket 83f sized to receive the actuation rod 8 If and two sets of multiple clipping arms 69f that extend integrally from opposite sides of the pocket 83f. Referring to 5 IB, the actuation rod 8 If can be withdrawn from the pocket 83f into an opening 84f of the pocket 83f to urge (e.g., force) the clipping arms 69f open (e.g., extending radially aw ay from the deployment catheter 56f). Alternatively, the actuation rod 81 f can be urged into the pocket 83f to allow the clipping arms 69f to spring closed (e.g., so that the clipping arms 69f can securely hold the leaflets 11. 12 together between the sets of clipping arms 69f). Accordingly, the clip 64f is made of one or more flexible materials, such as nitinol, titanium alloys, stainless steel (e.g., 304 stainless steel or 316 stainless steel), cobalt chrome alloys (e.g., containing one or more of cobalt, chromium, nickel, and molybdenum), or rigid implantable plastics (e.g., PEEK, etc.). In some embodiments, forming the clip 64f from nitinol may be particularly advantageous due to the superelastic properties of nitinol. Example materials from which the actuation rod 8 If may be made also include nitinol, titanium alloys, stainless steel (e.g., 304 stainless steel or 316 stainless steel), cobalt chrome alloys (e.g., containing one or more of cobalt, chromium, nickel, and molybdenum), or rigid implantable plastics (e.g., PEEK, etc.).

[0369] FIGS. 52A-52E illustrate another mitral valve implant 51g with a comb-like structure. Referring to FIG. 52A, the implant 51g includes a clip 64g, a deformable actuation spring 81g that is attached to the clip 64g, a distal support 75g that is attached to a bottom end of the actuation spring 81g, and a proximal support 79g that is attached to both a distal end of a deployment catheter 56g and an upper end of the actuation spring 81g. Referring to FIG. 52B, the clip 64g includes two separate sets of clipping arms 69g that are attached to opposite sides of the actuation spring 81g.

[0370] Referring to FIG. 52C, an extension wire 77g with a threaded distal end extends through the deployment catheter 56g and is coupled to a mating threaded internal surface of the distal support 75g. The actuation spring 81g is provided as a round structure (e.g., a ring) that can be compressed and thereby widened into the shape of a horizontally oriented oval when the deployment catheter 56g (e.g.. attached to the proximal support 79g) is advanced. Widening of the actuation spring 81g urges the sets of clipping arms 69g radially outward to form an open configuration of the implant 51g. Referring to FIGS. 52D and 52E, withdrawal of the deployment catheter 56g pulls (e.g.. elongates) and narrows a width of the actuation spring 81g such that the actuation spring 81g has the shape of a vertically oriented oval. Narrowing of the actuation spring 81g pulls the sets of clipping arms 69g radially inward to close the clipping arms 69g to securely hold the leaflets 11, 12 together between the sets of clipping arms 69g.

[0371] Once the implant 51g has been secured in place at the mitral valve 2, the deployment catheter 56g can be detached from the proximal support 79 and removed from the implant 51g, as shown in FIG. 52E. Similarly, the extension wire 77g can be detached (e.g., unthreaded) from the distal support 75g and withdrawn from the implant 51g. The clip 64g is made of one or more flexible materials, such as nitinol. titanium alloys, stainless steel (e.g., 304 stainless steel or 316 stainless steel), cobalt chrome alloys (e.g., containing one or more of cobalt, chromium, nickel, and molybdenum), or rigid implantable plastics (e.g., PEEK, etc.). In some embodiments, the actuation spring 81g may be made of nitinol.

[0372] FIGS. 53A-53C illustrate a mitral valve implant 51h with a dual-loop structure. The implant 5 Ih includes a clip 64h and a support 75h that is attached to the clip 64h. The support 75h is secured to a distal end of an extension wire 77h that is positioned within a deployment catheter 56h. The clip 64h includes two opposing looped clipping arms 69h that each have two lobes 65h. Prior to delivering the implant 51h to the mitral valve 2, the clip 64 can be loaded into the deployment catheter 56h by withdrawing the extension wire 77h into the deployment catheter 56h, as indicated by the arrow in FIG. 53C.

[0373] FIGS. 53D-53I illustrate a sequence of steps by which the implant 5 Ih can be implanted at the mitral valve 2. Referring to FIG. 53D, the implant 5 Ih, loaded within the deployment catheter 56h is delivered to the left ventricle, just above the mitral valve 2. Referring to FIG. 53E. the implant 51h is then advanced to expose the clipping arms 69h above the mitral valve 2. The implant 5 Ih is then advanced downward into the mitral valve 2 such that the clipping arms 69h pass through the chordae tendineae 31. Next, the implant 51h is retracted to cause the clipping arms 69h to engage the leaflets 11, 12. Referring to FIG. 53G, the delivery catheter 56h is then withdrawn with respect to the implant 51h to fully express the implant 51h. Accordingly, the clipping arms 69h are allowed to spring closed against the leaflets 11, 12. As shown in FIGS. 53H, the extension wire 77h is then detached from the support 75h and withdrawn through the deployment catheter 56h. Referring to FIGS. 53H and 531. the deployment catheter 56h is removed to leave the implant 5 Ih in place at the mitral valve 2. In some embodiments, the clipping arms 69h are made of nitinol. In some embodiments, the support 75h is made of a titanium alloy.

[0374] FIGS. 54A-54D illustrate a mitral valve implant 51 i with a separable (e.g., splittable) design. The implant 5 li includes a head 64i that may be surrounded by a fabric or otherwise flexible cover that promotes tissue ingrowth. The head 641 includes tw o portions 81 i, 85i that are coupled to each other via two tethers 82i. Each portion 8 li, 85i includes a base member 83i, a clipping arm 69i that is pivotable with respect to the base member 83i at a pin 75i, and a gripping arm 65i. The gripping arm 65i is fixed to the base member 83i and controlled by a gripping control wire 66i, as will be discussed in more detail below. A pin 74i positioned along the clipping arm 69i provides a pivot point for a bar that is linked to and used to control movement of the clipping arm 69i. The gripping arms 65i may be equipped with surface projections 88i (e.g., barbs) that facilitate gripping of the leaflets 11, 12 of the mitral valve 2.

[0375] The head 64i also includes respective gripping control wires 66i that are connected to the gripping arms 65i. The gripping control wires 66i are disposed within respective lumens within a wall of a deployment catheter 56i. The gripping control wires 66i can be moved axially within the respective lumens independently of each other to effect bulk axial movement of the arms 65i, 69i along a central axis of the head 64i. From the head 64i, the tethers 82i extend proximally through the deployment catheter 56i The head 64i also includes a shoulder 73i that connects the head 64i to the deployment catheter 56i. Referring to FIG. 54 A, during a TEER procedure, the implant 51 i is advanced downward into the mitral valve 2. Referring to FIG. 54B. the tethers 82i are then advanced distally to cause the portion 81i of the head 64i to separate (e.g., to move laterally away) from the portion 85i to capture a leaflet between the closed gripping arm 65i and clipping arm 69i of the portion 8 li. Referring to FIG. 54C, the portion 85i is then manipulated to capture the other leaflet between the closed gripping arm 65i and clipping arm 69i of the portion 85i. Next, the tethers 82i are retracted to draw the portion 8 li back to the portion 85i. Referring to FIG. 54D, the portions 8 li, 85i are then locked in position to each other, and the shoulder 73i is detached from the base members 83i so that the deployment catheter 56i can be removed to leave the implant 5 li in place at the mitral valve 2.

[0376] FIGS. 55A-55D illustrate a mitral valve implant 5 Ij with both clipping arms 69j and clipping loops 81j. In addition to the clipping arms 69j and clipping loops 81j. a head 64j of the implant 5 Ij includes a central body 76j, two gripping arms 65j, a shoulder 73j that connects the head 64j to a deployment catheter 56j, and a proximal support 79j. The gapping arms 65j may be equipped with surface projections 88j (e.g., barbs) that facilitate gripping of the leaflets 11, 12 of the mitral valve 2 and respective gripping control wires for opening and closing the gripping arms 65j. One or more components of the implant 51 j (e.g., the central body 76j and the clipping arms 69j) may be surrounded by a fabric or otherwise flexible cover that promotes tissue ingrowth.

[0377] Referring to FIGS. 55A and 55B, during a TEER procedure, the implant 5 Ij is advanced downward into the mitral valve 2 with the clipping loops 8 Ij in a vertical orientation to pass through the chordae tendineae 31. Referring to FIGS. 55C and 55D, the clipping loops 8 Ij may then be rotated into a horizontal orientation, and the entire implant 5 Ij retracted to capture the leaflets 11, 12 betw een the clipping loops 8 Ij and the gripping arms 65j. The clipping arms 69j and clipping loops 8 Ij can then be closed upward against the gripping arms 65j to securely hold the leaflets 11. 12 together. In this manner, the leaflets 1 1. 12 are inserted into the implant 5 Ij . The shoulder 73j can then be detached from the proximal support 79j so that the deployment catheter 56j can be removed to leave the implant 5 Ij in place at the mitral valve 2.

[0378] FIG. 56 illustrates a mitral valve implant 51k that is similar in construction and function to the implant 5 Ij, except that the implant 51k includes textured gripping control lines 66k instead of clipping loops. Accordingly, in addition to the gripping control lines 66k, a head 64k of the implant 5 Ik includes a central body 76k, two clipping arms 69k, a shoulder 73k that connects the head 64k to a deployment catheter 56k, and a proximal support 79k.

[0379] The textured gripping control wires 66k are be equipped with a series of surface projections 88k (e.g.. barbs or other types of projections) that facilitate gripping of the leaflets 11. 12 of the mitral valve 2. For example, when the gripping control wires 66k are retracted, the gripping control wires circulate through openings in the gripping arms 65k, thereby pulling the gripping arms 65k radially inward. Such movement of the wires 66k and the arms 65k causes the projections 88k on the gripping arms 65k to grasp the leaflets 11. 12 to draw (e.g., insert) the leaflets into the implant 5 Ik between the gripping arms 65k and the clipping arms 69k. One or more components of the implant 51k (e.g., the central body 76k and the clipping arms 69k) may be surrounded by a fabric or otherwise flexible cover that promotes tissue ingrowth.

[0380] FIG. 57 illustrates a mitral valve implant 511 that is similar in construction and function to the implant 51k, except that the implant 511 includes threaded gripping arms 651 and gripping control lines 661 without any engaging surface projections. Accordingly, in addition to the gripping control lines 661 and the gripping arms 651, a head 641 of the implant 511 includes a central body 761, two clipping arms 691, a shoulder 731 that connects the head 641 to a deployment catheter 561, and a proximal support 791.

[0381] The gripping control wires 661 are coupled to the gripping arms 651 in a manner such that when the gripping control wires 661 are rotated, the gripping arms 651 rotate correspondingly. When the gripping control wires 661 are retracted such that they rotate in the direction 821, threads on the gripping arms 651 grasp the leaflets 11, 12 to draw (e.g., insert) the leaflets into the implant 511 between the gripping arms 651 and the clipping arms 691. One or more components of the implant 511 (e.g., the central body 761 and the clipping arms 691) may be surrounded by a fabric or otherwise flexible cover that promotes tissue ingrowth.

[0382] In some implementations, any of the above-discussed valve implants may be removed or separated from one or more leaflets of a valve to facilitate or otherwise allow a subsequent procedure or treatment to be performed on the valve. In some implementations, a deployment tool that is similar in construction and function to one or more of the deployment tools discussed above may be used to carry' out the removal or separation of the implant. FIG. 58 illustrates a deployment tool 600 that can be used to reverse the effect of a mitral valve implant 651 that was previously implanted at the mitral valve 2 (e.g., to render the mitral valve implant 651 nonfunctional). The implant 651 may represent any of the above-discussed mitral valve implants.

[0383] The deployment tool 600 is similar in construction to the deployment tool 100. For example, the deployment tool 600 includes a guide catheter 602 and a frame 624 that is coupled to the guide catheter 602. The frame 624 includes a stabilization rail 606, a stabilization rail 608, a sheath 612, and a hub 604. The frame 624 also includes an implant removal rail 609, which includes a medial segment 614, a lateral segment 615, and an electrode 620 at which the segments 614, 615 meet. In some embodiments, the segments 614, 615 may be heat set into the curved shapes illustrated in FIG. 58. In some embodiments, the segments 614, 615 may be made of nitinol. The electrode 620 has an arced or otherwise curved shape and provides a electrocautery segment along which the implant removal rail 609 can capture (e.g., saddle upon) the implant 651.

[0384] The medial and lateral segments 614, 615 can each be moved axially with respect to the guide catheter 602 to position the electrode 620 directly over the implant 651. Once the electrode 620 has been properly placed at the implant 651 , the electrode 620 can be activated to cut one of the leaflets 11 , 12 from the implant 651 to allow a subsequent treatment or procedure to be carried out at the mitral valve 2. The implant 651b remains attached to the other leaflet in a non-functional state at the open mitral valve 2.

[0385] FIGS. 59A-59D illustrate another deployment tool 600a that can be used to reverse the effect of a mitral valve implant 651a that was previously implanted at the mitral valve 2 (e.g., to render the mitral valve implant 651a non-functional). The implant 65 la may represent any of the above-discussed mitral valve implants. The deployment tool 600a is similar in construction and function to the deployment tool 600. For example, the deployment tool 600a includes a guide catheter 602a and a frame 624a that is coupled to the guide catheter 602a. The frame 624a includes a stabilization rail 606a, a stabilization rail 608a, a sheath 612a. a hub 604a, and an implant removal rail 609a. The frame 624a also includes a guide rail 610a and a hub 605a by which the guide rail 1 10a is connected to the implant removal rail 609a. The implant removal rail 609a includes a medial segment 614a and a lateral segment 615a that meet at the hub 605a. In some embodiments, the segments 614a, 615a may be heat set into the curved shapes illustrated in FIGS. 59A and 59B. In some embodiments, the segments 614a, 615a may be made of nitinol. The segments 614a, 615a and the hub 605a together form an arced or otherwise curved section 620a that can be aligned with (e.g., saddle upon) the implant 651a. The medial and lateral segments 614a. 615a can each be moved axially with respect to the guide catheter 602a to position the section 620a directly over the implant 651a.

[0386] Referring to FIGS. 59B and 59C, once the section 620a has been properly placed at the implant 651a. a cutting tool 621a can be deployed to the implant 651a over the guide rail 610a. For example, the cutting tool 621a includes a positioning catheter 653a that can be advanced along the guide rail 610a and a cutting device 654a (e.g., scissors or another type of cutting device) that is coupled to the positioning catheter 653a. Once within adequate proximity to the implant 651, the cutting device 654a can be manipulated to cut one of the leaflets 11, 12 from the implant 651a to allow a subsequent treatment or procedure to be carried out at the mitral valve 2. The implant 651a remains attached to the other leaflet in a non-functional state at the open mitral valve 2, as shown in FIG. 59D.

[0387] FIGS. 60A-60D illustrate another deployment tool 600b that is similar in construction and function to the deployment tools 600, 600a. The deployment tool 600b can be used to remove a mitral valve implant 651b that was previously implanted at the mitral valve 2. The implant 651b may represent any of the abovediscussed mitral valve implants. The deployment tool 600b includes a guide catheter 602b and a frame 624b that is coupled to the guide catheter 602b. The frame 624b includes a stabilization rail 606b, a stabilization rail 608b, a sheath 612b, a hub 604b, an implant removal rail 609b, a guide rail 610b, and a hub 605b by which the guide rail 610b is connected to the implant removal rail 609b.

[0388] The implant removal rail 609b includes a medial segment 614b and a lateral segment 615b that meet at the hub 605b. In some embodiments, the segments 614b, 615b may be heat set into the curved shapes illustrated in FIGS. 60A and 60B. In some embodiments, the segments 614b, 615b may be made of nitinol. The segments 614b. 615b and the hub 605b together form an arced or otherwise curved section 620b that can be aligned with (e.g., saddle upon) the implant 651b. Additionally, the section 620b is equipped with an electrode 623b that provides an electrocautery segment. The medial and lateral segments 614b, 615b can each be moved axially with respect to the guide catheter 602b to position the electrode 623 b directly over the implant 651b.

[0389] Once the electrode 623b has been properly placed at the implant 65 lb, a gripping tool 121b can be deployed to the implant 651b over the guide rail 610b. For example, the gripping tool 121b includes a positioning catheter 653b that can be advanced along the guide rail 610b and a gripping device 654b (e.g., a tissue grabber, clamp, jaws, or another type of gripping device) that is coupled to the positioning catheter 653b. The gripping device 654b can be manipulated to grip the implant 651b to stabilize a position and orientation of the implant 651b. The electrode 623b can then be activated sequentially at each side of the implant 651b to cut each leaflet 11, 12 from the implant 65 lb. Cutting both leaflets 11, 12 from the implant 65 lb allows the implant 651b to be removed from the mitral valve 2 altogether. A subsequent treatment or procedure may then be carried out at the open mitral valve 2, shown in FIG. 60D.

[0390] In some implementations, in addition to cutting both leaflets 11, 12 at respective sides of the implant 651b, the electrode 623b must also be manipulated to cut dow n a middle plane of the implant 651b to fully separate or free the implant 651b from the mitral valve 2. For example, FIG. 61 illustrates a mitral valve implant 65 li that must be freed from the mitral valve 2 in this manner. The implant 65 li is substantially similar in construction and function to the implant 51 i, except that the implant 65 li includes sutures 690i, 691i that hold two portions 68 li, 685i of the implant 65 li together. For example, the sutures 690i, 69 li are securely wound around coupling ends 692i, 693i of base members 683i. To free the implant 65 li from the mitral valve 2, the electrode 623b must be operated and manipulated to cut down a middle plane of the implant 651i to cut open the sutures 690i, 691i.

[0391] In some implementations, one or more of the above-discussed deployment tools may be used to deliver and implant an annular band 651c (e g., an annuloplasty band) to the mitral valve 2 to repair a leak in the mitral valve 2. For example, FIGS. 62A-62C illustrate that the deployment tool 106d (illustrated in FIG. 18D) can be used to deploy an annular band 651c to the mitral valve 2. An implantation system 650c be advanced along the frame 124d to the mitral valve 2. The implantation system 650c is substantially similar in construction and function to the implantation system 50, except that the system 650c is configured to deploy the annular band 651c instead of a mitral valve implant provided as a mitral valve clip. The annular band 651c includes a tube 664c (e.g., a synthetic polyester tube) and multiple screws 669c that are attached to the tube 664c a length of the tube 664c.

[0392] Accordingly, the implantation system 650c includes a delivery catheter 652c that can be advanced along the guide rail 1 lOd, a positioning catheter 653c through which the annular band 651c is advanced, and adjustment wires 659c, 660c that connect distal ends of the catheters 652c, 653c. The implantation system 650c also includes a tensioning line 677c that passes through the tube 664c to form a loop such that both ends of the tensioning line 677c extend proximally within the guide catheter 102d.

[0393] With the stabilization rails 106d. 108d of the frame 124d appropriately placed within the left atrium 5, a distal end of the positioning catheter 653c can be swept around the annulus 17 of the mitral valve 2 while the annular band 651 c is advanced distally out of the positioning catheter 653. As the annular band 651c is advanced, the annular band 651c progressively covers more of the tensioning line 677c. and the screws 669c are screwed into the annular tissue to secure the annular band 651c in place. In a fully deployed configuration, the annular band 651c is bounded at opposite ends by stops 665c at ends of the tensioning line 677c. FIG. 63 shows that the deployment tool 106d can also be used to deploy the annular band 651c to the tricuspid valve 7.

[0394] In some implementations, a deployment tool that is similar in construction and function to one or more of the above-discussed deployment tools may be used to deliver and implant a cinching implant to the tricuspid valve 7 to repair a leak in the tricuspid valve 7. For example, FIGS. 64A-64H illustrate a deployment tool 700 that can be used to deploy such a cinching implant 751 to the tricuspid valve 7. The deployment tool 700 is substantially similar in construction and function to the deployment tool 300, except that stabilization rails 706, 708, 770 and a guide rail 710 of a frame 724 extend through a main central lumen of a guide catheter 702 instead of through dedicated lumens within a wall of the guide catheter 702.

[0395] Referring to FIG. 64B-64H, the implant 751 includes three tubular implant elements 756, 757, 758 that are designed to be implanted at respective commissures 46, 47, 48. The implant elements 756. 757, 758 are covered with a fabric (e.g., made of synthetic polyester) that facilitates tissue ingrowth. The implant 751 further includes clips 746, 747, 748 for respectively clipping the implant elements 756, 757, 758 to the commissures 46, 47, 48.

[0396] Each positioning element 756, 757, 758 is delivered to the tricuspid valve 7 on a delivery catheter 752 that is advanced along a stabilization rail 706, 708, 770. The stabilization rails 706, 708, 770 naturally locate the commissures 46, 47, 48 such that the implant elements 756, 757. 758 are accurately placed. The delivery catheter 752 is attached along its sidewall to a positioning catheter 753 such that axial movement of the delivery catheter 752 results in a corresponding axial movement of the positioning catheter 753. The positioning catheter 753 provides a conduit through which the clip 746, 747, 748 can be advanced at a distal end of a deployment catheter 786. Once the clip 746, 747. 748 has been manipulated to securely clip the implant element 756, 757, 758 to the commissure 46, 47, 48, the deployment catheter 786 is detached from the clip 746, 747, 748, and the deployment catheter 786, delivery catheter 752, and positioning catheter 753 are withdrawn from the right atrium 3 along the frame 724.

[0397] Referring to FIGS. 64F-64H, once all of the implant elements 756, 757, 758 have been placed, a cinching mechanism 790 is deployed along the frame 724 to connect the implant elements 756, 757, 758 with a cinching line 792. In some embodiments, the cinching mechanism 790 includes three delivery catheters 794 that are advanced axially along the stabilization rails 706, 708, 770. The cinching line 792 is secured to each implant 756, 757, 758 at respective locks 786, 787, 788. A proximal portion of the cinching line 792 can be retracted (e.g., pulled) axially through the guide catheter 702 to pull the implant elements 756, 757, 758, associated clips 746, 747, 748, and attached commissures 46, 47. 48 radially inward (e.g., with respect to the guide catheter 702) to close gaps between the leaflets and accordingly improve coaptation. Such pulling draws the free wall 30 of the right ventricle 4 radially inward (e.g., medially towards the atrial septum 8), further improving coaptation.

[0398] Referring to FIGS. 641 and 64J, once the leaflets 37. 38. 39 have been cinched together, the tricuspid valve implant 71 may be implanted at the tricuspid valve 7 in an improved manner (e.g., with improved clipping and coaptation). The stabilization rails 706, 708, 770 can then be detached from the hub 704. The frame 724, carrying the delivery catheter 52 and positioning catheter 53. can subsequently be withdrawn from the heart, as shown in FIG. 64K. The various implants described in this disclosure provide for improved efficacy (e.g., with respect to coaptation) and durability when repairing leaks at the mitral and tricuspid valves. In some embodiments, any of the above-discussed implants may include clipping arms of increased width to address broad, complex blood jets. In some embodiments, above-discussed implants with bulbous central bodies may provide improved efficacy for cases of large gaps and tethering. In some embodiments, TEER implants that are designed to be implanted at chordal regions (e.g., as opposed to chord-free regions) of the valves 2, 7 may provide easier delivery. For example, referring to FIGS. 65 and 66, most of the mitral leaflets have chordal connections to the tip or edge (e.g., at segments Al, Pl, A3, P3). The implants described herein can effectively negotiate (e.g., manipulate around and through) these areas to provide improved positioning and secure implantation.

[0399] While the transcatheter delivery systems, deployment tools, implantation systems, and manipulation tools discussed herein have been described and illustrated with respect to certain dimensions, sizes, shapes, arrangements, materials, components, and methods, in some embodiments, a transcatheter delivery system, deployment tool, implantation system, or manipulation tool that is otherwise substantially similar in construction and function to any of the transcatheter delivery systems, deployment tools, implantation systems, and manipulation tools discussed herein may include one or more different dimensions, sizes, shapes, arrangements, configurations, materials, and components, or may be utilized according to different methods.

[0400] Other embodiments are also within the scope of the following claims.

Claims

WHAT IS CLAIMED IS:

1. A deployment tool for deploying a therapeutic device to a heart, the deployment tool comprising: a guide catheter configured to enter the heart and defining a lumen through which the therapeutic device is movable to a selected position within the heart; and a frame coupled to the guide catheter and configured to stabilize a distal portion of the deployment tool within the heart when a distal portion of the frame is exposed from the distal end of the guide catheter.

2. The deployment tool of claim 1, wherein the frame is disposed within the guide catheter along a majority of a length of the frame.

3. The deployment tool of any one of claims 1 to 2, wherein one or more components of the frame are slidable axially along the guide catheter.

4. The deployment tool of any one of claims 1 to 3, wherein one or more components of the frame are rotatable with respect to the guide catheter.

5. The deployment tool any one of claims 1 to 4. wherein the lumen extends along a central axis of the guide catheter.

6. The deployment tool of any one of claims 1 to 5, wherein the lumen has a maximum width of about 2.6 mm to about 4. 1 mm.

7. The deployment tool of any one of claims 1 to 6, wherein the frame comprises a stabilization rail that is configured to limit a first movement of the frame in a first direction when the distal portion of the frame is exposed from the distal end of the guide catheter.

8. The deployment tool of claim 7, wherein the lumen comprises a first lumen that extends along a central axis of the guide catheter, wherein the guide catheter further defines a second lumen extending along a first side of the central axis, and wherein the stabilization rail is disposed within the second lumen.

9. The deployment tool of claim 8, wherein the stabilization rail is a first stabilization rail, wherein the frame further comprises a second stabilization rail that is configured to limit a second movement of the frame in a second direction when the distal portion of the frame is exposed from the distal end of the guide catheter.

10. The deployment tool of claim 9, wherein the guide catheter further defines a third lumen extending along a second side of the central axis, and wherein the second stabilization rail is disposed within the third lumen.

11. The deployment tool of claim 8, wherein the guide catheter comprises a first wall portion having a first maximum thickness and a second wall portion having a second maximum thickness that is less than the first maximum thickness, and wherein the first lumen extends within the first wall portion.

12. The deployment tool of claim 7, wherein the frame is configured such that at least a portion of the stabilization rail is disposed within an atrium of the heart when the distal portion of the frame is exposed from the distal end of the guide catheter.

13. The deployment tool of claim 7, wherein the frame is configured such that at least a portion of the stabilization rail is disposed within a ventricle of the heart when the distal portion of the frame is exposed from the distal end of the guide catheter.

14. The deployment tool of claim 7, wherein the stabilization rail has a thickness of about 0.38 mm to about 0.64 mm.

15. The deployment tool of claim 7, wherein the stabilization rail comprises one or more of nitinol or stainless steel.

16. The deployment tool of claim 7, wherein the stabilization rail is constructed as a wire or a ribbon.

17. The deployment tool of claim 7, wherein the frame comprises a hub to which the stabilization extends distally.

18. The deployment tool of claim 17, wherein the stabilization rail and the hub are secured to each other at a threaded arrangement.

19. The deployment tool of claim 8, wherein the frame further comprises a guiderail disposed within the first lumen and providing a path along which the therapeutic device is movable to the selected position within the heart.

20. The deployment tool of claim 8, wherein the guide catheter defines a third lumen, and wherein the frame further comprises a guidewire disposed within the third lumen and configured to be extended from the distal end of the guide catheter into a ventricle of the heart.

21. The deployment tool of any one of claims 1 to 20, wherein the frame comprises a guiderail disposed within the lumen and providing a path along which the therapeutic device is movable axially to the selected position within the heart.

22. The deployment tool of claim 21, wherein the guiderail has a thickness of about 0.38 mm to about 0.97 mm.

23. The deployment tool of claim 22, wherein the guiderail is constructed as a wire or a ribbon.

24. The deployment tool of claim 21, wherein the guiderail comprises one or more of stainless steel or nitinol.

25. The deployment tool of claim 21, wherein the frame comprises a hub to which the guiderail extends distally.

26. The deployment tool of any one of claims 1 to 25, wherein the frame comprises a guidewire configured to be extended from the distal end of the guide catheter into a ventricle of the heart.

27. The deployment tool of claim 26, wherein the frame further comprises a sheath that surrounds at least a portion of the guidewire.

28. The deployment tool of claim 26, wherein the guidewire comprises a stabilization foot.

29. The deployment tool of claim 26, wherein the guidewire comprises a free distal end.

30. The deployment tool of any one of claims 1 to 29, wherein the frame is configured to form a loop distal to the guide catheter.

31. The deployment tool of claim 30, wherein the loop is separable into two segments at a location along the loop that is distal to the guide catheter.

32. The deployment tool of any one of claims 1 to 31, wherein the frame comprises: a first stabilization rail that is configured to limit a first movement of the frame in a first direction when the distal portion of the frame is exposed from the distal end of the guide catheter; a second stabilization rail that is configured to limit a second movement of the frame in a second direction when the distal portion of the frame is exposed from the distal end of the guide catheter; and a third stabilization rail that is configured to limit a third movement of the frame in a third direction when the distal portion of the frame is exposed from the distal end of the guide catheter.

33. The deployment tool of claim 32, wherein the first, second, and third stabilization rails are equally spaced around a central axis of the guide catheter.

34. The deployment tool any one of claims 1 to 33, wherein the guide catheter comprises a retention feature configured to engage a septum of the heart.

35. The deployment tool of claim 34, wherein the retention feature comprises a terminal cone, a beveled edge, or one or more heat-set tubes.

36. The deployment tool of any one of claims 1 to 35, further comprising a delivery' catheter slidably disposed within the lumen of the guide catheter and configured to extend past the distal end of the guide catheter to deliver the therapeutic device to the selected position within the heart.

37. The deployment tool of claim 36, wherein the frame extends from a distal end of the delivery catheter.

38. The deployment tool of claim 36, wherein the frame is coupled to a distal end of the delivery catheter with one or more positioning wires.

39. The deployment tool of any one of claims 1 to 38, wherein the therapeutic device comprises a heart valve clip.

40. The deployment tool of any one of claims 1 to 39, wherein the deployment tool is further configured for one or both of removal of the therapeutic device and reversal of a functional effect of the therapeutic device after the therapeutic device has been implanted at the heart.

41. The deployment tool of any one of claims 1 to 40, wherein the frame comprises a segment carrying an electrode.

42. A deployment tool for deploying a therapeutic device to a heart, the deployment tool comprising: a guide catheter configured to enter the heart, the guide catheter defining a central axis, a first lumen extending along a first side of the central axis, a second lumen extending along a second side of the central axis, and a third lumen extending along the central axis; a frame coupled to the guide catheter and comprising:a first stabilization rail disposed within the first lumen and configured to limit a first movement of the frame in a first direction when a distal portion of the frame is exposed from a distal end of the guide catheter, a second stabilization rail disposed within the second lumen and configured to limit a second movement of the frame in a second direction when the distal portion of the frame is exposed from the distal end of the guide catheter, and a guiderail disposed within the third lumen and providing a path along which the therapeutic device is movable to a selected position within the heart.

43. A transcatheter delivery' system for implanting a therapeutic device at a heart, the transcatheter delivery system comprising: a deployment tool comprising: a guide catheter configured to enter the heart, and a frame coupled to the guide catheter and configured to stabilize a distal end of the guide catheter within the heart when a distal portion of the frame is exposed from the distal end of the guide catheter; and an implantation system that is movable axially within a lumen of the guide catheter and that comprises: the therapeutic device, and a deployment catheter to which the therapeutic device is secured.

44. The transcatheter delivery system of claim 43, wherein the implantation system further comprises a positioning catheter that is slidably disposed within the lumen of the guide catheter, and wherein the deployment catheter is slidably disposed within the positioning catheter.

45. The transcatheter delivery' system of claims 43 or 44, wherein a distal end of the positioning catheter is movable linearly in a direction orthogonal to a distal axis of the positioning catheter.

46. The transcatheter delivery' system of claim 45, wherein the distal end of the positioning catheter is rotatable about an axis that is orthogonal to the distal axis of the positioning catheter.

47. The transcatheter delivery' system of claim 46, wherein the implantation system further comprises a delivery catheter to which the positioning catheter is coupled.

48. The transcatheter delivery' system of claim 47, wherein the frame of the deployment tool comprises a guiderail disposed within the lumen of the guide catheter.

49. The transcatheter delivery system of claim 48, wherein the delivery' catheter is movable axially along the guiderail to position the therapeutic device at a selected location within the heart.

50. The transcatheter delivery system of claim 49, wherein a distal end of the positioning catheter is connected to a distal end of the delivery' catheter with one or more positioning wires.

51. The transcatheter delivery system of any7one of claims 44 to 50, wherein a distal end of the positioning catheter is coupled to one or more positioning wires by which the distal end of the positioning catheter can be moved.

52. The transcatheter delivery system of any one of claims 44 to 51 , wherein the positioning catheter comprises a distal collar.

53. The transcatheter delivery system of any one of claims 43 to 52, wherein at least a portion of the frame is disposed within the guide catheter.

54. The transcatheter delivery' system of any one of claims 43 to 53, wherein one or more components of the frame are slidable axially along the guide catheter.

55. The transcatheter delivery system of any one of claims 44 to 54, wherein one or more components of the frame are rotatable with respect to the guide catheter.

56. The transcatheter delivery system of any one of claims 43 to 55, wherein the frame comprises a stabilization rail that is configured to limit a first movement of theframe in a first direction when the distal portion of the frame is exposed from the distal end of the guide catheter.

57. The transcatheter delivery system of claim 56, wherein the frame is configured such that at least a portion of the stabilization rail is disposed within an atrium of the heart when the distal portion of the frame is exposed from the distal end of the guide catheter.

58. The transcatheter delivery system of claim 56, wherein the frame is configured such that at least a portion of the stabilization rail is disposed within a ventricle of the heart when the distal portion of the frame is exposed from the distal end of the guide catheter.

59. The transcatheter deliver}' system of any one of claims 43 to 58, wherein the frame is configured to form a loop distal to the guide catheter.

60. The transcatheter delivery system of any one of claims 43 to 59, wherein the therapeutic device comprises a heart valve clip.

61. The transcatheter delivery system of any one of claims 43 to 60, further comprising a manipulation tool that is operable to manipulate a distal portion of the deployment tool and a distal portion of the implantation system.

62. The transcatheter delivery system of claim 61. wherein a proximal portion of the frame and a proximal portion of the deployment catheter are assembled with the manipulation tool.

63. The transcatheter delivery system of any one of claims 43 to 62, further comprising an imaging catheter that is movable axially within the lumen of the guide catheter.

64. The transcatheter delivery' system of any one of claims claim 43 to 63, wherein the therapeutic device comprises an annular band.

65. A method of deploying a therapeutic device to a heart, the method comprising: placing a distal end of a guide catheter within the heart; deploying a frame from the distal end of the guide catheter; adjusting the frame into a functional configuration to stabilize a distal portion of the deployment tool within the heart; and moving the therapeutic device through the guide catheter to a selected position within the heart.

66. The method of claim 65, further comprising positioning the distal end of the guide catheter within a left atrium of the heart.

67. The method of claim 66, wherein the therapeutic device comprises a mitral valve implant.

68. The method of any one of claims 65 to 67. further comprising positioning the distal end of the guide catheter within a right atrium of the heart.

69. The method of claim 68, wherein the therapeutic device comprises a tricuspid valve implant.

70. The method of any one of claims 65 to 69, further comprising sliding one or more components of the frame axially within the guide catheter.

71. The method of any one of claims 65 to 70. further comprising causing a stabilization rail of the frame to contact a wall of the heart to stabilize a distal portion the frame within the heart.

72. The method of claim 71 , wherein in the functional configuration of the frame, at least a portion of the stabilization rail is disposed within an atrium of the heart.

73. The method of claim 71, wherein in the functional configuration of the frame, at least a portion of the stabilization rail is disposed within a ventricle of the heart.

74. The method of any one of claims 65 to 73, further comprising advancing a distal portion of a guidewire of the frame into a ventricle of the heart.

75. The method of claim 74, further comprising retracting the guidewire until a stabilization foot adjacent the distal portion of the guidewire contacts an anatomical stop within the heart.

76. The method of claim 75, wherein the anatomical stop comprises one or more of a portion of a valve of the heart or a portion of a wall of the heart.

77. The method of any one of claims 65 to 76. further comprising engaging a retention feature on the guide catheter with a septal wall of the heart to prevent the distal end of the guide catheter from moving out of a left atrium of the heart.

78. The method of any one of claims 65 to 77. further comprising: advancing a positioning catheter distally out of the guide catheter; and advancing the therapeutic device distally out of the positioning catheter on a deployment catheter.

79. The method of claim 78, further comprising moving a distal end of the positioning catheter linearly in a direction orthogonal to a distal axis of the positioning catheter.

80. The method of claim 79, further comprising rotating a distal end of the positioning catheter about an axis that is orthogonal to the distal axis of the positioning catheter.

81. The transcatheter delivery system of claim 80, wherein a delivery catheter is coupled to the positioning catheter, and wherein the frame comprises a guiderail disposed within a lumen of the guide catheter.

82. The method of claim 81, further comprising advancing the delivery catheter distally along the guiderail.

83. The method of claim 81 or 82, wherein the distal end of the positioning catheter is connected to a distal end of the delivery catheter with one or more positioning wires.

84. The method of any one of claims 78 to 83, further comprising moving the distal end of the positioning catheter with one or more positioning wires.

85. The method of any one of claims 78 to 84, further comprising lowering the therapeutic device into a valve of the heart.

86. The method of claim 85, further comprising implanting the therapeutic device on the valve.

87. The method of any one of claims 65 to 86, further comprising manipulating a proximal portion of the frame to adjust the frame into the functional configuration.

88. The method of any one of claims 66 to 87, further comprising: inserting the guide catheter percutaneously; and advancing the guide catheter to the heart through a patient’s vasculature.

89. The method of any one of claims 65 to 88, further comprising deploying an imaging catheter to the heart to image the distal portion of the deployment tool within the heart.

90. The method of claim 89, further comprising moving the imaging catheter axially through a lumen of the guide catheter.

91. The method of claim 89 or 90, further comprising visualizing an anatomic landmark at an engagement between the frame and the heart.

92. The method of claim 91, further comprising determining a position of a distal portion of the frame or a position of the therapeutic device within the heart based at least in part on a visualization of the anatomic landmark.

93. The method of claim 91 or 92, wherein the imaging catheter comprises a camera, and wherein the method further comprises: aligning the camera with one or more components of the frame; and determining a position of the camera based at least in part on the visualization of the anatomic landmark.

94. The method of claim 90, further comprising inserting the guide catheter into a body containing the heart through an incision on the body.

95. The method of claim 94, further comprising inserting the imaging catheter into the body through the incision.

96. The method of any one of claims 94 to 95, wherein the incision is a first incision, and wherein the method further comprises inserting the imaging catheter into the body without passing the imaging catheter through a second incision on the body.

97. The method of claim 96, further comprising deploying the imaging catheter to the heart without using transesophogeal echo imaging.

98. The method of claim 89, wherein the imaging catheter comprises an intracardiac echocardiography (ICE) imaging catheter.

99. A cardiac therapeutic device comprising: a central member; a first clipping element coupled to a first side of the central member; and a second clipping element coupled to a second side of the central member, wherein the first and second clipping elements are adjustable to respectively grasp and hold together a first portion of a heart and a second portion of the heart to securely close a gap between the first and second portions of the heart.

100. The cardiac therapeutic device of claim 99, wherein the cardiac therapeutic device is configured to be delivered to the heart through a catheter.

101. The cardiac therapeutic device of any one of claims 99 to 100, further comprising a fabric cover that surrounds one or more of the central member and the first and second clipping elements.

102. The cardiac therapeutic device of any one of claims 99 to 101, wherein the central member comprises a laser-cut structure.

103. The cardiac therapeutic device of any one of claims 99 to 102, wherein one or more of the central member and the first and second clipping elements is formed from a braided structure.

104. The cardiac therapeutic device of any one of claims 99 to 103, wherein the cardiac therapeutic device comprises a folded configuration that is formed from a single sheet of material.

105. The cardiac therapeutic device of any one of claims 99 to 104, wherein each of the first and second clipping arms comprise a comb-like structure.

106. The cardiac therapeutic device of any one of claims 99 to 105, wherein one or both of the first and second clipping arms comprise a loop.

107. The cardiac therapeutic device of any one of claims 99 to 106, further comprising a first gripping arm and a second gripping arm that respectively facilitate positioning of the first portion and the second portion along the first clipping arm and the second clipping arm.

108. The cardiac therapeutic device of claim 107, wherein each of the first and second gripping arms comprise one or more surface projections that facilitate respective gripping of the first and second portions.

109. The cardiac therapeutic device of any one of claims 99 to 108, wherein the first clipping arm is separable from the second clipping arm.

110. The cardiac therapeutic device of any one of claims 99 to 109, wherein the cardiac therapeutic device comprises a heart valve implant.

111. The deployment tool of claim 110, wherein the segment is movable axially to align the electrode with the therapeutic device that has been implanted at the heart.

112. A cardiac therapeutic device comprising: a first implant element configured to be placed at a first commissure of a heart valve and a first clip configured to clip the first implant to the first commissure; a second implant element configured to be placed at a second commissure of the heart valve and a second clip configured to clip the second implant to the second commissure; a pull line connected to the first and second implants and configured to be pulled to draw the first and second implants towards each other while the first and second implants are secured to the first and second commissures.

Images