Systems and methods for deploying cardiac therapeutic devices

Abstract

This disclosure relates to transcatheter delivery systems, 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 at the tricuspid valve and the mitral 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 Application Serial No. 63 / 711,577, filed on October 24, 2024. 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 delivery 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. SUMMARY

[0008] In general, this disclosure relates to transcatheter delivery systems, 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.

[0009] Some embodiments described herein include a transcatheter delivery system for implanting a therapeutic device at a heart. The transcatheter delivery system may include a deployment tool, which can have a guide catheter configured to enter the heart. Further, the deployment tool may optionally include 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. The transcatheter deliver}' system may include an implantation system movable axially within a lumen of the guide catheter. The implantation system may be controllable in three planes of motion when the implantation system is exposed from the distal end of the guide catheter. Optionally, the deployment tool and implantation system can be configured to (i) position a therapeutic device between leaflets of a valve of the heart, and (ii) retract the deployment catheter from the therapeutic device while maintaining a suture connection between the therapeutic device and the deployment catheter.

[0010] Such a system can include one or more of the following optional features. The deployment tool and implantation system can be configured to (iii) retract the positioning catheter from the therapeutic device before retracting the deployment catheter from the therapeutic device. The deployment tool and implantation system can be configured to (iv) loosen the suture connection between the therapeutic device and the deployment catheter to release a tensile force between the deployment catheter and the therapeutic device. The deployment tool and implantation system can be configured to (v) tighten the suture connection between the therapeutic device and the deployment catheter to apply the tensile force between the deployment catheter and the therapeutic device. The deployment tool and implantation system can be configured to (vi) advance the deployment catheter to re-engage with the therapeutic device. The deployment tool and implantation system can be configured to (vii) in reengaged position, manipulate the position of the therapeutic device. The therapeutic device may have a first grip element moveable in relation to the first clip element; a second clip element coupled to a second side of the central member; and a second grip element moveable in relation to the second clip element. The first and second clip elements and the first and second grip elements can be independently adjustable to respectively grasp and hold together a first leaflet and a second leaflet of the heart to securely close a gap between the first and second leaflets. The therapeutic device can have detangling elements that are moveable away from the first clip element and the second clip element to release the cardiac therapeutic device from the first portion and second portion of the heart. The therapeutic device may include a heart valve clip. The system can include an imaging catheter that is movable axially within the lumen of the guide catheter. The imaging catheter may include an intracardiac echocardiography (ICE) imaging catheter. The frame can include a hub configured to engage a septum of the heart. The hub can be connected to the first stabilization rail, the second stabilization rail, and the guiderail.

[0011] Some embodiments described herein include a method of deploying a therapeutic device to a heart. The method may include placing a distal end of a guide catheter within the heart; deploying a frame from the distal end of the guide catheter to stabilize a distal portion of a deployment tool within the heart; advancing a delivery7catheter over a guiderail of the frame within the heart; adjusting a position of a placement catheter in relation to the guiderail of the frame; moving a deployment catheter and the therapeutic device axially or rotationally from the placement catheter and to a selected position within the heart; connecting one or more portions of the therapeutic device to one or more leaflets of a valve of the heart; and retracting the deployment catheter from the therapeutic device while maintaining a suture connection between the therapeutic device and the deployment catheter.

[0012] Such a method can include one or more of the following optional features. The method can include positioning the distal end of the guide catheter within a right atrium of the heart. The therapeutic device can include a tricuspid valve implant. The method can include positioning the distal end of the guide catheter within a left atrium of the heart. The therapeutic device can include a mitral valve implant. The method can include retracting the positioning catheter from the therapeutic device before retracting the deployment catheter from the therapeutic device. The method can include loosening the suture connection between the therapeutic device and the deployment catheter to release a tensile force between the deployment catheter and the therapeutic device. The method can include tightening the suture connection between the therapeutic device and the deployment catheter to apply the tensile force between the deployment catheter and the therapeutic device. The method can include advancing the deployment catheter to re-engage with the therapeutic device. In reengaged position, the deployment catheter and the positioning catheter are configured to manipulate the position of the therapeutic device. The therapeutic device can have a first grip element moveable in relation to the first clip element; a second clip element coupled to a second side of the central member; and a second grip element moveable in relation to the second clip element. The first and second clip elements and the first and second grip elements can be independently adjustable to respectively grasp and hold together a first leaflet and a second leaflet of the heart to securely close a gap between the first and second leaflets. The therapeutic device can have detangler elements that are moveable away from the first clip element and the second clip element to release the cardiac therapeutic device from the first portion and second portion of the heart. The method can include causing a stabilization rail of the frame to contact a wall of the heart to stabilize a distal portion of the frame within the heart. The method can include engaging a hub of the frame with a septal wall of the heart to prevent the distal end of the guide catheter from moving out of a right atrium of the heart. The distal end of the positioning catheter can be connected to a distal end of the delivery catheter with one or more positioning wires. The method can include moving the distal end of the positioning catheter with one or more positioning wires. The method can include lowering the therapeutic device into a valve of the heart. The method can include implanting the therapeutic device on the valve. The method can include inserting the guide catheter percutaneously; and advancing the guide catheter to the heart through a patient’s vasculature. The method can include deploying an imaging catheter to the heart to image the distal portion of the deployment tool within the heart. The method can include moving the imaging catheter axially through a lumen of the guide catheter. The method can include visualizing an anatomic landmark at an engagement between the frame and the heart. The method can include 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. The imaging catheter can have an intracardiac echocardiography (ICE) imaging catheter.

[0013] Some embodiments described herein include a cardiac therapeutic device. The cardiac therapeutic device can include a central member; a first clip element coupled to a first side of the central member; a first grip element moveable in relation to the first clip element; a second clip element coupled to a second side of the central member; a second grip element moveable in relation to the second clip element; and detangler elements that are moveable away from the first clip element and the second clip element. The first and second clip elements and the first and second grip elements can optionally be independently 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. Further, the detangler elements can be configured to release the cardiac therapeutic device from the first portion and second portion of the heart.

[0014] Such a device can include one or more of the following optional features. The cardiac therapeutic device can be configured to be delivered to the heart through a catheter. The detangling elements can be sutures that are moveable away from the first clip element and the second clip element to release the cardiac therapeutic device from the first portion and second portion of the heart. The detangling elements can be wires that are moveable away from the first clip element and the second clip element to release the cardiac therapeutic device from the first portion and second portion of the heart. The cardiac therapeutic device can include a heart valve implant. The first portion of the heart can be a first leaflet of a tricuspid valve and the second portion of the heart is a second leaflet of the tricuspid valve.

[0015] Some embodiments described herein include a cardiac therapeutic device. The cardiac therapeutic device can include a central member; a first clip element coupled to a first side of the central member; a first grip element moveable in relation to the first clip element; a second clip element coupled to a second side of the central member; a second grip element moveable in relation to the second clip element. Optionally, the first and second clip elements and the first and second grip elements are independently 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. Such a device can include one or more of the following optional features. The cardiac therapeutic device can be configured to be delivered to the heart through a catheter. The cardiac therapeutic device can include a heart valve implant. The first portion of the heart is a first leaflet of a tricuspid valve and the second portion of the heart is a second leaflet of the tricuspid valve. The first grip element and the second grip element can be translatable along each of the first clip element and the second clip element respectively. The first grip element and the second grip element can be translatable towards and away from a central axis of cardiac therapeutic device. The first and second grip elements can have an extended open position where each of the first and second grippers are open and extended outwardly away from the central axis of the cardiac therapeutic device. The first and second grip elements can have an extended closed position where each of the first and second grippers are closed and extended outwardly away from the central axis of the cardiac therapeutic device. The first and second grip elements can have a retracted closed position where each of the first and second grippers are closed and retracted inwardly towards the central axis of the cardiac therapeutic device.

[0016] Some embodiments described herein include a transcatheter delivery system for implanting one or more cardiac therapeutic devices. The transcatheter deliver}7system may include a deployment tool, which can have a guide catheter and a frame coupled to the guide catheter and configured to stabilize a distal end of the guide catheter. Further, the transcatheter delivery system can include an implantation system movable axially within a lumen of the guide catheter. Optionally, the deployment tool and implantation system are configured to position and install at least a first therapeutic device along at least a first leaflet.

[0017] Some embodiments described herein include method of deploying a cardiac therapeutic device. The method may include deploying a frame from the distal end of a guide catheter while the distal end of the guide catheter is positioned in a heart; and adjusting the frame into a functional configuration to stabilize a distal portion of a deployment tool within the heart.

[0018] Some embodiments described herein include a cardiac therapeutic device. The cardiac therapeutic device may include a central hub; a first clip element coupled to a first side of the central hub; a first grip element moveable in relation to the first clip element; a second clip element coupled to a second side of the central hub; and a second grip element moveable in relation to the second clip element. Some of the embodiments described herein may provide one or more of the following advantages. First, the transcatheter delivery system 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.

[0019] Second, use of the manipulation tool enables precise, predictable, and repeatable control of the deployment tool and implantation system for implanting the tricuspid valve implant at the tricuspid valve or the mitral valve implant at the mitral valve. The position of the deployment tool and implantation system can be controlled in three planes of motion to facilitate the precise control and positioning of the implant during the implantation process. 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.

[0020] 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.

[0021] Third, 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 right 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 guiderail can be advanced until its hub is wedged against or just beneath the anteroseptal commissure to further stabilize the position of the frame within the heart. In this way, the anteroseptal commissure and the atrial septum can serve as anatomic stabilization structures for the deployment tool.

[0022] Fourth, the implants are designed to be implanted at chordal regions (e.g., as opposed to chord-free regions) of the tricuspid and mitral valves. The implants provide easier delivery and facilitate detangling during instances of high chordal density. The implants described herein can effectively negotiate (e.g., manipulate around and through) these areas to provide improved positioning and secure implantation. Fifth, the implants can be secured in position with improved accuracy and with the ability to adjust the position of the implant after an initial implantation when a functional assessment has been performed. The functional assessment can be performed with minimal forces on the implant while retaining the ability to re-engage the implant for additional manipulation.

[0023] The details of one or more embodiments of the invention are set forth in the accompanying drawings and the description below. Other features, objects, and advantages of the invention will be apparent from the description and drawings, and from the claims.

[0024] DESCRIPTION OF DRAWINGS 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.

[0025] FIG. IB is a perspective view' of the deployment tool and the implantation system of FIG. 1A within the right atrium in a cross-sectional view of a heart.

[0026] FIG. 2A is a bottom view' of a mitral valve of the heart of FIG. 1 A.

[0027] FIG. 2B is a top view' of a tricuspid valve of the heart of FIG. 1 A.

[0028] FIG. 3 A is a top view' of a distal portion of the deployment tool and implantation system of FIG. 1A in a right atrium of a heart.

[0029] FIG. 3B is an imaging view of the system of FIG. 3 A.

[0030] FIG. 3C is a top view' of a distal portion of the deployment tool and implantation system of FIG. 1A in a right atrium of a heart with the frame extended.

[0031] FIG. 3D is an imaging view' of the system of FIG. 3C.

[0032] FIG. 3E is a top view of a distal portion of the deployment tool and implantation system of FIG. 1 A in a right atrium of a heart with the hub extended over the guiderail.

[0033] FIG. 3F is an imaging view' of the sy stem of FIG. 3E.

[0034] FIG. 3G is a top view of a distal portion of the deployment tool and implantation system of FIG. 1 A in a right atrium of a heart with the implantation system extended through a distal end of the guide catheter.

[0035] FIG. 3H is an imaging view' of the system of FIG. 3G. FIG. 31 is a top view of a distal portion of the deployment tool and implantation system of FIG. 1 A in a right atrium of a heart with the imaging catheter extended through a distal end of the guide catheter.

[0036] FIG. 3 J is an imaging view of the system of FIG. 31.

[0037] FIG. 3K is a top view of a distal portion of the deployment tool and implantation system of FIG. 1 A in a right atrium of a heart with an adjusted position of the positioning catheter.

[0038] FIG. 3L is an imaging view of the system of FIG. 3K.

[0039] FIG. 3M is a top view of a distal portion of the deployment tool and implantation system of FIG. 1A in a right atrium of a heart with the deployment catheter extended from the positioning catheter towards the tricuspid valve.

[0040] FIG. 3N is an imaging view of the system of FIG. 3M.

[0041] FIG. 4A is a top view of a distal portion of the deployment tool and implantation system of FIG. 1A in a right atrium of a heart with the hub extended over the guiderail into contact with the atrial septum.

[0042] FIG. 4B is a top view' of a distal portion of the deployment tool and implantation system of FIG. 1A in a right atrium of a heart with the implantation system extended through a distal end of the guide catheter and aligned with a portion of the tricuspid valve.

[0043] FIG. 4C is a top view of a distal portion of the deployment tool and implantation system of FIG. 1 A in a right atrium of a heart with the implantation system extended through a distal end of the guide catheter and aligned with another portion of the tricuspid valve.

[0044] FIG. 4D is a top view of a distal portion of the deployment tool and implantation system of FIG. 1A in a right atrium of a heart with the implantation system extended through a distal end of the guide catheter and aligned with another portion of the tricuspid valve.

[0045] FIG. 4E is a top view of a distal portion of the deployment tool and implantation system in the position of FIG. 4D with the deployment catheter extended from the positioning catheter into the tricuspid valve.

[0046] FIG. 4F is a top view of a distal portion of the deployment tool and implantation system of FIG. 1 A in a right atrium of a heart with the implantation system extended through a distal end of the guide catheter and aligned with another portion of the tricuspid valve. FIG. 4G is a top view of a distal portion of the deployment tool and implantation system in the position of FIG. 4F with the deployment catheter extended from the positioning catheter into the tricuspid valve.

[0047] FIG. 5A shows top and side views of the implantation system of FIG. 1A controlling the anterior-posterior trajectory of the implant.

[0048] FIG. 5B shows other top and side views of the implantation system of FIG. 1A controlling the anterior-posterior trajectory of the implant.

[0049] FIG. 5C shows top and side view's of the implantation system of FIG. 1A controlling the septal-lateral trajectory' of the implant.

[0050] FIG. 5D show s other top and side view s of the implantation system of FIG. 1A controlling the septal-lateral trajectory of the implant.

[0051] FIG. 5E shows top and side view s of the implantation system of FIG. 1A controlling the anterior-posterior position of the implant.

[0052] FIG. 5F show s other top and side views of the implantation system of FIG. 1A controlling the anterior-posterior position of the implant.

[0053] FIG. 5G shows top and side views of the implantation system of FIG. 1 A controlling the septal-lateral position of the implant.

[0054] FIG. 5H shows other top and side views of the implantation system of FIG. 1A controlling the septal-lateral position of the implant.

[0055] FIG. 51 shows other top and side views of the implantation system of FIG. 1A controlling the septal-lateral position of the implant.

[0056] FIG. 6 shows atop view' of an example handle assembly of the transcatheter delivery' system of FIG. 1A.

[0057] FIG. 7A is a top view of a distal portion of the deployment tool and implantation system of FIG. 1A in a right atrium of a heart with the positioning catheter extended.

[0058] FIG. 7B is a top view' of a distal portion of the deployment tool and implantation system of FIG. 7A, with the positioning catheter at a first retraction position.

[0059] FIG. 7C is a top view of a distal portion of the deployment tool and implantation system of FIG. 7A, with the positioning catheter at a second retraction position.

[0060] FIG. 7D shows a side view of an example implant configured for partial disengagement with the deployment catheter, consistent with some embodiments.

[0061] io FIG. 7E shows a side view of another example implant configured for partial disengagement with the deployment catheter, consistent with some embodiments.

[0062] FIG. 7F shows a perspective view of an implant from FIG. 7 A with a positioning catheter extended, consistent with some embodiments.

[0063] FIG. 7G shows a perspective view of the implant from FIG. 7A with a positioning catheter retracted and a deployment catheter extended, consistent with some embodiments.

[0064] FIG. 7H shows a perspective view of the implant from FIG. 7A with a positioning catheter and deployment catheter retracted, consistent with some embodiments.

[0065] FIG. 8 A is a side view of a tricuspid valve implant of the implantation system of FIG. 1A with the clipping arms in an open position and with each independent gripper in a collapsed configuration.

[0066] FIG. 8B is a side view of a tricuspid valve implant of the implantation system of FIG. 1 A with the clipping arms in an open position and with one independent gripper in an actuated configuration and the other independent gripper in a collapsed configuration.

[0067] FIG. 8C is a side view of a tricuspid valve implant of the implantation system of FIG. I A with the clipping arms in an open position and with each independent gripper in an actuated configuration.

[0068] FIG. 8D is a side view of a tricuspid valve implant of the implantation system of FIG. 1A with the clipping arms in a partially collapsed and with each independent gripper in an actuated configuration.

[0069] FIG. 8E is a side view of a tricuspid valve implant of the implantation system of FIG. 1A with the clipping arms in a collapsed and with each independent gripper in an actuated configuration.

[0070] FIG. 9A is a top perspective view of the tricuspid valve implant in the position of FIG. 8A and positioned above the tricuspid valve of a heart.

[0071] FIG. 9B is a top perspective view of the tricuspid valve implant in the position of FIG. 8B and wi th the clipping arms positioned below the tricuspid valve of a heart.

[0072] FIG. 9C is a top perspective view of the tricuspid valve implant in the position of FIG. 8C and with the clipping arms positioned below the tricuspid valve of a heart. FIG. 9D is a top perspective view of the tricuspid valve implant in the position of FIG. 8D and with the clipping arms positioned below the tricuspid valve of a heart.

[0073] FIG. 10A is a side view of a tricuspid valve implant of the implantation system of FIG. 1 A with the clipping arms in an open position and with a detangling suture at a start of a release configuration.

[0074] FIG. 1 OB is a side view of a tricuspid valve implant of the implantation system of FIG. 1 A with the clipping arms in a partially collapsed position and with the detangling suture at an intermediate release configuration.

[0075] FIG. IOC is a side view of a tricuspid valve implant of the implantation system of FIG. 1 A with the clipping arms in a collapsed position and with the detangling suture at a release configuration.

[0076] FIG. 11 A is a top perspective view of the tricuspid valve implant in the position of FIG. 10A and with the clipping arms and detangling suture positioned below the tricuspid valve of a heart.

[0077] FIG. 1 IB is a top perspective view of the tricuspid valve implant in the position of FIG. 10B and with the clipping arms positioned below the tricuspid valve of a heart and the detangling suture positioned at least partially above the tricuspid valve.

[0078] FIG. 11C is a top perspective view of the tricuspid valve implant in the position of FIG. IOC and with one clipping arm released from the tricuspid valve of a heart.

[0079] FIG. 11D is atop perspective view of the tricuspid valve implant in the position of FIG. IOC and with each clipping arm released from the tricuspid valve of a heart.

[0080] FIG. HE is atop perspective view of the tricuspid valve implant in the position of FIG. 1 OC and with the implant released from and positioned above the tricuspid valve of a heart.

[0081] FIG. 12A is a side view of a tricuspid valve implant of the implantation system of FIG. 1 A with the clipping arms in an open position and with a detangling wire at aligned with the clipping arms.

[0082] FIG. 12B is a side view of a tricuspid valve implant of the implantation system of FIG. 1 A with the clipping arms in a partially collapsed position and with the detanghng wire at an intermediate release configuration. FIG. 12C is a side view of a tn cuspid valve implant of the implantation system of FIG. 1 A with the clipping aims in a collapsed position and with the detangling wire at a release configuration.

[0083] FIG. 13A is a side view of a tricuspid valve implant in an open configuration during an active leaflet capture process.

[0084] FIG. 13B is a side view of a tricuspid valve implant in an open configuration ith the grippers open and extended outwardly during an active leaflet capture process.

[0085] FIG. 13C is a side view' of a tricuspid valve implant in an open configuration with the grippers open and extended outwardly and partially contacting leaflets during an active leaflet capture process.

[0086] FIG. 13D is a side view of a tricuspid valve implant in an open configuration with the grippers open and extended outw ardly and fully contacting leaflets during an active leaflet capture process.

[0087] FIG. 13E is a side view of a tricuspid valve implant in an open configuration with the grippers closed and extended outwardly and fully contacting leaflets during an active leaflet capture process.

[0088] FIG. 13F is a side view of a tricuspid valve implant in an open configuration with the grippers closed and retracted inwardly and fully contacting leaflets during an active leaflet capture process.

[0089] FIG. 13G is a side view of a tricuspid valve implant in a closed configuration with the grippers closed and retracted inwardly and fully contacting leaflets during an active leaflet capture process.

[0090] FIG. 14A is a perspective view of a tricuspid valve implant in an open configuration during an active leaflet capture process.

[0091] FIG. 14B is a perspective view of a tricuspid valve implant in an open configuration w ith the grippers open with one of the grippers extended outwardly during an active leaflet capture process.

[0092] FIG. 14C is a perspective view of a tricuspid valve implant in an open configuration with one of the grippers closed and extended outwardly and the other gripper open and retracted inwardly during an active leaflet capture process.

[0093] FIG. 14D is a perspective view of a tricuspid valve implant in an open configuration with one of the grippers closed and retracted inwardly and the other gripper open and retracted inwardly during an active leaflet capture process. FIG. 14E is a perspective view of a tricuspid valve implant in an open configuration with one of the grippers closed and retracted inwardly and the other gripper open and extended outwardly during an active leaflet capture process.

[0094] FIG. 14F is a perspective view of a tricuspid valve implant in an open configuration with one of the grippers closed and retracted inwardly and the other gripper closed and extended outwardly during an active leaflet capture process.

[0095] FIG. 14G is a perspective view of a tricuspid valve implant in an open configuration with both grippers closed and retracted inwardly during an active leaflet capture process.

[0096] FIG. 15Ais a side view of a tricuspid valve implant in an open configuration during an active leaflet capture process.

[0097] FIG. 15B is a side view of a tricuspid valve implant in an open configuration with the grippers open and extended outwardly during an active leaflet capture process.

[0098] FIG. 15C is a side view of a tricuspid valve implant in an open configuration with the grippers closed and extended outwardly during an active leaflet capture process.

[0099] FIG. 15D is a side view of a tricuspid valve implant in an open configuration with the grippers closed and retracted inwardly during an active leaflet capture process.

[0100] FIG. 15E is a side view of a tricuspid valve implant in a closed configuration with the grippers closed and retracted inwardly and fully contacting leaflets during an active leaflet capture process.

[0101] FIG. 16A is a side view of a tricuspid valve implant in a closed configuration with the grippers closed and retracted inwardly during an active leaflet capture process.

[0102] FIG. 16B is a side view of a tricuspid valve implant in an open configuration with the grippers open and retracted inwardly during an active leaflet capture process.

[0103] FIG. 16C is a side view of a tricuspid valve implant in an open configuration with the grippers open and extended outwardly during an active leaflet capture process.

[0104] FIG. 16D is a side view of a tricuspid valve implant in an open configuration with the grippers partially closed and extended outwardly during an active leaflet capture process. FIG. 16E is a side view of a tricuspid valve implant in an open configuration with the grippers closed and extended outwardly during an active leaflet capture process.

[0105] FIG. 16F is a side view of a tricuspid valve implant in an open configuration with the grippers open and in a detangle position during an active leaflet capture process.

[0106] FIG. 16G is a side view of a tricuspid valve implant in an open configuration with the grippers closed and retracted inwardly during an active leaflet capture process.

[0107] FIG. 16H is a side view- of a tricuspid valve implant in a closed configuration with the grippers closed and the clipping elements closed during an active leaflet capture process.

[0108] FIG. 17A is a side view of a tricuspid valve implant in an open configuration with the grippers open and extended outwardly during an active leaflet capture process.

[0109] FIG. 17B is a top view of the tricuspid valve implant of FIG. 17A.

[0110] FIG. 17C is a side view of a tricuspid valve implant in an open configuration with the grippers open and leaflets pulled inwards during an active leaflet capture process.

[0111] FIG. 17D is atop view of the tricuspid valve implant of FIG. 17C.

[0112] FIG. 18A is a side view of an example tricuspid valve implant in an open configuration with the grippers partially open and extended outwardly during an active leaflet capture process.

[0113] FIG. 18B is a side view of the tricuspid valve implant of FIG. 18A in an open configuration with the grippers closed and retracted inwardly during an active leaflet capture process.

[0114] FIG. 18C is a side view' of the tricuspid valve implant of FIG. 18A in a closed configuration with the grippers closed and retracted inwardly during an active leaflet capture process.

[0115] FIG. 18D is a distal end view? of the tricuspid valve implant of FIG. 18A. FIG. 18E is a side view' of the tricuspid valve implant of FIG. 18 A w ith one gripper partially open and retracted inwardly and the other gripper partially open and extended outwardly during an active leaflet capture process. FIG. 18F is a side view of one side of the tricuspid valve implant of FIG. 18A in a detangle position.

[0116] FIG. 18G is a section view along the line 18G-18G of FIG. 18F with the griper in a closed position. Like reference symbols in the various drawings indicate like elements.

[0117] DETAILED DESCRIPTION

[0118] Referring to FIGS. 1A and IB. some embodiments of a trans catheter 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 delivery system 150, the therapeutic device is a tricuspid valve implant 51 that can be implanted at a tricuspid valve 7 of the patient’s heart 1 to treat a pathology of the tricuspid valve 7. In some embodiments, the tricuspid 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 deliver}’ system 150 includes an implantation system 50 that facilitates implantation of the tricuspid valve implant 51 and a deployment tool 100 by which the implantation system 50 can be deployed to a right atrium 3 of the patient’s heart 1.

[0119] In particular, the deployment tool 100 can be navigated through the patient's vasculature to the right atrium 3 and then operated to deliver, locate, and implant the tricuspid valve implant 51 at a desired position, orientation, and configuration with respect to the tricuspid valve 7. 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. In some implementations, the deployment tool 100 may be inserted into a femoral vein or an iliac vein through an incision 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.

[0120] In FIG. IB, the heart 1 is illustrated in cross-section from an anterior perspective in stylized form. The heart 1 includes a mitral valve 2 and the left atrium 5, which is defined by a left atrial wall 26, the right atrium 3 defined by a right atrial wall 29, the 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 the 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 nght ventncle 4, chordae tendineae 31 within the left ventricle 6, and papillary muscles 32 within the left ventricle 6.

[0121] 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.

[0122] 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.

[0123] 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 36, 37, and 38 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 which the leaflets 36, 37, 38 extend and articulate. The chordae tendineae 40 connect the tricuspid valve 7 to the papillary- muscles 41.

[0124] Referring to FIGS. 1 A and IB, the deployment tool 100 includes a guide catheter 102 that can be passed into the right atrium 3 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 tricuspid valve implant 51 into the right atrium 3 along a guiderail path) and angular positioning of the tricuspid valve implant 51 with respect to the tricuspid valve 7. 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 carrying out a therapeutic procedure. Example interactions include interactions or engagements of the frame 124 with the commissures of the tricuspid valve 7 (e.g., or with the commissures of the mitral valve 2, as will be discussed in more detail below) or with other features of the heart 1.

[0125] 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 includes an active steerable element (e.g., implantation system 50 described in further detail below) that controls the precise position of the tricuspid valve implant 51 in three planes of motion throughout the implantation process.

[0126] 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 110 provides a path along which the tricuspid 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 and into the right ventricle 3. 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 anteroseptal commissure 46 or the atrial septum 8) the within the heart 1, thereby defining a global position of the frame 124 within the heart 1.

[0127] Once a distal end 116 of the guide catheter 102 is located at desired axial and rotational positions within right atrium 3, 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 FIG. IB (and again below at least in FIGS. 3C-L). 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.

[0128] Referring to FIGS. 3A-D, the hub 104 can be advanced over the guidewire 114 until the hub 104 is placed at the selected anatomical structure. With the hub 104 placed at the selected anatomical position, 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 atrial septum 8 and the right atrial wall 29. 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 right atrium 3. 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 tricuspid valve implant 51 is advanced along the guiderail 110 towards the hub 104.

[0129] Referring to FIGS. 1 A, IB, and 3A-N, the hub 104 may be shaped substantially as a cone, 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 aposition and orientation of connected components under load. The profile of the hub 104 is atraumatic so as not to damage any contacted anatomy. 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. Referring again to FIGS. 1A. IB, and 3A-N, 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.

[0130] 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-deli very. In the functional configuration of the frame 124, a maximum height of the guidewire 114 (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.

[0131] In some embodiments, the guidewire 114 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 majority7of its length. 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. In some embodiments, the tip 122 of the guidewire 114 has a degree of radiopacity to allow flurovisualization. In some embodiments, any of the rails 106, 108, 110 and guide wire 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 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.

[0132] 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 profile) 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.).

[0133] 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.

[0134] Referring again to FIGS. 1A, IB, and 3A-N, the tricuspid valve implant 1 of the implantation system 50 can be implanted to close together portions of the leaflets 36, 37, 38 of the tricuspid valve 7 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 facilitate the positioning of the tricuspid valve implant 51 over the tricuspid valve 7. 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 noncircular cross-sectional shape. 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.

[0135] The positioning catheter 53 is slidable axially and is rotatable within the guide catheter 102 to control an angular position (e g., an orientation) of the tricuspid 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 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 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 tricuspid valve implant 51.

[0136] 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 tricuspid valve implant 51 is secured. The deployment catheter 56 is slidable and rotatable within the positioning catheter 53.

[0137] In some embodiments, an adjustment wire 59 connects a distal end of the delivery catheter 52 to a distal end of the positioning catheter 53. Movement of the delivery' catheter 52 is controlled in anterior and posterior directions by the guiderail 110. The adjustment wire 59 facilitates control of the linear displacement of the distal end of the positioning catheter 53 from the distal end of the delivery catheter 52 along a septal-lateral direction 62 (see e.g., FIGS.5G-I). 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. In some embodiments, an adjustment catheter 60 is disposed in a lumen within a wall of the delivery catheter 52 and extends between a proximal exit 55 along the delivery catheter 52 to the distal end of the positioning catheter 53. The adjustment catheter 60 can be tensioned (e.g., pulled) or loosened (e.g., released) to actively displace the distal end of the positioning catheter 53 with respect to the distal end of the deliver}’ catheter 52 along the direction 62 (see e.g., FIGS.5G-I). Accordingly, the adjustment catheter 60 manipulates the 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.

[0138] The deployment catheter 56 (e.g., carrying the tricuspid valve implant 51) can be moved axially and rotationally within the positioning catheter 53 to a desired position and orientation above the tricuspid valve 7 for subsequent lowering of the implant 51 into and implantation of the implant 51 at the tricuspid valve 7. 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.

[0139] Referring to FIGS. 1 A. IB, and 3A-N. the transcatheter delivery’ system 150 may be used to carry out a therapeutic procedure, such as a tricuspid transcatheter edge-to-edge repair (TEER) procedure to repair the tricuspid valve 7. Other embodiments can include a mitral transcatheter edge-to-edge repair (TEER) procedure to repair the mitral valve 2. During a tricuspid TEER procedure, the guide catheter 102 is advanced to the right atrium 3 such that the distal end 116 of the guide catheter 102 extends into the right atrium 3 (see e.g., FIGS. 3A-B). The frame 124 is then advanced through and out of the guide catheter 102 to contact at least one of the atrial septum 8 and the right atrial wall 29. As illustrated in FIGS. 3C-J, the frame 124 is further advanced out of the guide catheter 102 until the hub 104 abuts the atrial septum 8 just above the tricuspid valve 7. Abutment of the hub 104 with the atrial septum 8 helps to stabilize a position of the frame 124 within the heart 1. In this way, the atrial septum 8 sen es as an anatomic stabilization structure for the deployment tool 100.

[0140] With the hub 104 positioned against the atrial septum 8, the stabilization rails 106, 108 are further extended from the guide catheter 102 until the rails bow 106, 108 outwardly to contact at least one of the atrial septum 8 and the right atrial wall 29. 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 atrial septum 8) 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 tricuspid valve implant 51.

[0141] Referring to FIGS. 3C-H, once the frame 124 is stabilized within the right atrium 3, the delivery’ catheter 52 and the positioning catheter 53 of the implantation system 50 are 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., anterior-posterior position) within the right atrium 3. The delivery’ catheter 52 and the positioning catheter 53 can each be independently rotated to a desired orientation. The positioning catheter 53 can also adjust an orthogonal position of the implant after the positioning catheter 53 is extended into the right atrium 3. FIGS. 3G-H illustrate an example orthogonal adjustment of the positioning catheter 53 to tip-up the implant 51 and point the implant 51 towards a desired location of the tricuspid valve 7.

[0142] Referring to FIGS. 3I-L, an intracardiac echocardiography (ICE) imaging catheter 190 for visualization is inserted into the right atrium 3. The ICE catheter 190 is positionable in relation to the implant 51 to visualize the implant and to facilitate orientation and positioning of the implant 51 and the implantation system 50.

[0143] Referring to FIGS. 3K-L, the adjustment wire 59 and adjustment catheter 60 control a displacement of the distal end of the positioning catheter 53 (e.g., linearly) from the distal end of the delivery catheter 52 while the positioning catheter 53 is advanced and rotated.

[0144] Referring to FIGS. 3M-N, the deployment catheter 56, carry ing the tricuspid valve implant 51, is then advanced just out of the positioning catheter 53 and rotated to a desired orientation. With the tricuspid valve implant 51 positioned and oriented as desired, the tricuspid valve implant 51 is lowered into the nght ventncle 4 and implanted onto at least one pair of the leaflets 36, 37, 38 of the tricuspid valve 7 by manipulating controls of the manipulation tool 152 (see e.g., FIGS. 1 A and 6). The tricuspid valve implant 51 is implanted by advancing or retracting one or more extension wires 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 one or more leaflets 36, 37, 38 as desired.

[0145] After implantation, the deployment catheter 56 is disconnected from the tricuspid valve implant 51. The guidewire 114 is retracted until its distal tip 122 is located within the guide catheter 102, and the guide catheter 102. carrying the frame 124 (e g., itself carrying the other components of the implantation system 50), is retracted from the patient.

[0146] Use of the manipulation tool 152 enables predictable, repeatable control of the deployment tool 100 and implantation system 50 for implanting the tricuspid valve implant 51 at the target location of the tricuspid valve 7. 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 delivery’ system 150 easy to operate in an efficient manner by a user. Furthermore, deployment of the ICE catheter 190 to the right atrium 3 allows the maneuvers to be visualized in real time.

[0147] Referring to FIGS. 1 A-B and 3A-N, the guide catheter 102 has a maximum width of about 4.0 mm to about 10.0 mm. The guide catheter 102 is sized to accommodate the guiderail 110, the implantation system 50, and the intracardiac echocardiography (ICE) imaging catheter 190 for visualization. In some embodiments, the guide catheter 102 has an inner diameter of about 2.6 mm to about 4.1 mm.

[0148] 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 betw een the ICE catheter 190 and an interior surface of the guide catheter 102. 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 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.

[0149] 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.

[0150] Referring to FIGS. 4A-5I, the transcatheter delivery system 150 facilitates precise positioning of the implant 51 for implantation at various positions of the tricuspid valve 7. The hub 104 can be advanced over the guidewire 114 until the hub 104 is placed at the selected anatomical structure. With the hub 104 stabilized at the selected anatomical position, 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 atrial septum 8 and the right atrial wall 29. 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 right atrium 3. In this manner, the rails 106, 108 provide localized stability of the frame 124 within the heart 1. 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 tricuspid valve implant 51 is advanced along the guiderail 110 towards the hub 104.

[0151] Referring to FIGS. 4A-G and 5E-F, once the frame 124 is stabilized within the right atrium 3, the delivery catheter 52 and the positioning catheter 53 of the implantation system 50 are advanced (e.g., slid) along the guiderail 110 and out of the guide catheter 102. The delivery catheter 52 and the positioning catheter 53 can be axially slid along the guiderail 110 to control the anterior-posterior position of the delivery catheter 52 and the positioning catheter 53 (see e.g., FIGS. 5E-F) within the right atrium 3.

[0152] Referring to FIGS. 4A-G and 5A-B, the orthogonal positioning of the positioning catheter 53 is adjustable in an anterior-posterior direction to orient the implant 51 towards a desired location in the tricuspid valve 7. In some embodiments, the orthogonal position of the implant 51 is controlled by the orthogonal positioning of the positioning catheter 53. For example, the anterior-posterior trajectory’ can be adjusted to various angles between 0 and 180 degrees with respect to the guiderail 110. The orthogonal adjustment of the positioning catheter 53 facilitates control of the trajectory' that the deployment catheter 56 exits the positioning catheter 53 to engage with the tricuspid valve. Some embodiments include orienting the orthogonal position of the implant 51 vertically before insertion. Some embodiments include orienting the orthogonal position of the implant 51 in a posterior direction before insertion (see e.g., FIG. 5A). Some embodiments include orienting the orthogonal position of the implant 51 in an anterior direction before insertion (see e.g., FIG. 5B).

[0153] Referring to FIGS. 4A-G and 5C-D, the orthogonal positioning of the positioning catheter 53 is adjustable in a septal-lateral direction to orient the implant 51 towards a desired location in the tricuspid valve 7. In some embodiments, the orthogonal position of the implant 51 is controlled by the orthogonal positioning of the positioning catheter 53. For example, the septal -lateral trajectory can be adjusted to various angles between 0 and 180 degrees with respect to the guiderail 110. The orthogonal adjustment of the positioning catheter 53 facilitates control of the trajectory that the deployment catheter 56 exits the positioning catheter 53 to engage with the tricuspid valve. Some embodiments include orienting the orthogonal position of the implant 51 vertically before insertion. Some embodiments include orienting the orthogonal position of the implant 51 in a posterior direction before insertion (see e.g., FIG. 5A). Some embodiments include orienting the orthogonal position of the implant 51 in an anterior direction before insertion (see e.g., FIG. 5B).

[0154] Referring to FIGS. 4A-G and 5G-1, with the frame 124 stabilized, the septal-lateral positioning of the positioning catheter 53 can be adjusted in relation to the delivery' catheter 52 and guiderail 110. For example, the adjustment wire 59 and adjustment catheter 60 control a displacement of the distal end of the positioning catheter 53 (e.g., linearly) from the distal end of the delivery catheter 52 while the positioning catheter 53 is advanced and rotated. The septal-lateral adjustments of the positioning catheter 53 along with the anterior-posterior adjustments of the delivery catheter 52 and the positioning catheter 53 facilitate navigation to various positions in relation to the tricuspid valve 7. For example, the implant 51 can be adjusted into various positions for implantation between leaflets 36, 37, and 38 of the tricuspid valve 7. The implant 51 can be positioned between the anterior leaflet 37 and the septal leaflet 36 (see e.g., FIGS. 4B-C), between the anterior leaflet 37 and the posterior leaflet 38 (see e.g., FIGS. 4D-E), and between the septal leaflet 36 and the posterior leaflet 38 (see e.g.. FIGS. 4F-G).

[0155] Referring to FIGS. 4C, 4E, and 4G, with the positioning catheter 53 aligned across from a desired leaflet installation location, the deployment catheter 56, carrying the tricuspid valve implant 51, is then advanced just out of the positioning catheter 53 and rotated to a desired orientation. With the tricuspid valve implant 51 positioned and oriented as desired, the tricuspid valve implant 51 is lowered into the right ventricle 4 and implanted onto at least one pair of the leaflets 37, 38, 38 of the tricuspid valve 7 by manipulating controls of the manipulation tool 152 (see e.g., FIGS. 1A and 6). The tricuspid valve implant 51 is implanted by advancing or retracting one or more extension wires 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 one or more leaflets 36, 37, 38 as desired.

[0156] Referring to FIGS. 1A and 6, 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, 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.

[0157] The manipulation tool 152 can be permanently or releasably attached to an operating table 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. The guide catheter 102 of the deployment tool 100 may be inserted into a femoral vein or an iliac vein through an incision in the patient’s groin area (e.g., made with or without the manipulation tool 152). From the site of the incision, 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 some embodiments, 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 can be placed at a different location on the patient’s body, such as at an appropriate location on the patient’s neck.

[0158] Various controls 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, to position the guide catheter 102 within the right atrium 3, position and stabilize the frame 124, deploy the implantation system 50, manipulate and implant the tricuspid valve implant 51, retract the other components of the implantation system 50, and retract the deployment tool 100.

[0159] The controls 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 include a control assembly 115 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-e 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.

[0160] The controls 154 also include a control assembly 119 at which the guiderail 110, delivery catheter 52, wire 59, and adjustment wire 60 terminate. Accordingly, the control assembly 119 includes mechanisms 121a-b 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.

[0161] The controls 154 also include a control assembly 123 at which the positioning catheter 53 terminates. Accordingly, the control assembly 123 includes mechanisms 125a-b 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 controlling the implant 51 (e.g., including opening and closing the clipping arms 69).

[0162] Referring to FIGS. 7A-H, the implant 51 can be positioned at the valve 7 (E.g., between leaflets 36 and 38 during an implantation process. In some embodiments, the implantation process can also include a functional assessment where the implant 51 is connected a pair of leaflets (e g., leaflets 36 and 37, leaflets 36 and 38, and / or leaflets 36 and 38) while remaining at least partially connected to the implantation system 50. The functional assessment can include observation of the performance of the implant 51 while the heart 1 is beating and the implant 51 is installed. For example, the imaging catheter 190 or other imaging modalities can be implemented to observe the performance of the implant 51. For example, performance parameters including gaps between leaflets, positioning of the implant 51, security of the implant 51 (e.g., strength of connection, slippage, drift), tricuspid regurgitation, right ventricular dilation, among other performance parameters.

[0163] In some embodiments, the functional assessment can occur with minimal or reduced forces from the implantation system 50 on the implant 51, which facilitates improved accuracy of the functional assessment for when the implantation system 50 is removed from the heart 1. In some embodiments, the functional assessment can occur with the positioning catheter 53 and the deployment catheter 56 connected to the implant 51 and extended (see e.g., FIG. 7 A). In such a configuration, the deployment catheter 56 and the positioning catheter 53 can be flexible to facilitate movement of the valve 7 while the deployment catheter 56 and the positioning catheter 53 are connected to the implant 51 after the implant is connected to the leaflets.

[0164] In some embodiments, the functional assessment can occur with the deployment catheter 56 connected to the implant 51 and extended and with the positioning catheter 53 retracted (see e.g., FIGS. 7B-C, 7G). In such a configuration, the deployment catheter 56 facilitates control of the implant 51 while facilitating flexibility' at the implant 51 to assess the performance of the implant 51. For example, the implant 51 can be connected to the leaflets (e.g., with the deployment catheter 56 and the positioning catheter 53 extended). The positioning catheter 53 can subsequently be retracted proximally away from the implant 51 while the deployment catheter 56 remains extended (see e.g., retraction of positioning catheter 53 in FIGS.

[0165] 7B-C, 7G).

[0166] The functional assessment can occur with additional flexibility while maintaining a connection with the implantation system 50 by retracting the deployment catheter 56 away from the implant 51 as shown in FIGS. 7D-E and 7H. In such a configuration, sutures 61 maintain a connection between the implant 51 and the implantation system 50. The sutures 61 are configured to be tightened into tension betw een the implant 51 and the deployment catheter 56. The sutures 61 are configured to be loosened to release the tension on the sutures 61 while maintaining a connection between the implant 51 and the deployment catheter 56. With the sutures 61 in a loosened configuration, forces from the implantation system 50 are reduced and the functional assessment of the implant 51 adheres to an implanted state of the implant 51.

[0167] At any point throughout the functional assessment steps described in relation to FIGS. 7A-H, the steps can be reversed and the implantation system 50 can reengage with the implant 51. The re-engagement with the implant 51 facilitates manipulation of the implant 51 in any manner described above or below . For example, during the functional assessment a user may decide to adjust a position of the implant 51 between the leaflets. From the position in FIGS. 7D-E and 7H with the sutures 61 loosened, the sutures 61 can be tightened, the deployment catheter 56 can be advanced to re-engage with the implant 51, and the positioning catheter 53 can be re-advanced over the deployment catheter 53. Additionally, from the position in FIGS. 7D-E and 7H, the sutures 61 can be released to facilitate a completion of the implantation process 51 where the implantation system 50 can be removed from the heart 1, leaving the implant 51 in position.

[0168] Referring to FIGS. 8A-E, in some embodiments, the tricuspid valve implant 51 includes ahead 64 that includes multiple, adjustable gripping arms 65 and respective, adjustable clipping arms 69. In some embodiments, the gripping arms 65 may facilitate gripping of the leaflets 36, 37, 38 of the tricuspid valve 7. 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.

[0169] 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 wi re, a braided fiber, or a multilayer cable. Example materials from w hich the gripping control wires 66 may be made include ni tinol (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.

[0170] Referring particularly to FIG. 8E, the gripping and clipping arms 65, 69 can be in a collapsed configuration that facilitates passage of the head 64 downw ard through the tricuspid valve. Referring to FIGS. 9A and 9B, once the head 64 is located below the plane of the tricuspid valve 7, the clipping arms 69 can be extended radially to engage the leaflets 36, 37, 38 of the tricuspid valve 7. The gripping arms 65 are then individually or concurrently lowered tow ards 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 36, 37, 38 of the tricuspid valve 7 between the gripping arms 65 and the clipping arms 69. The tricuspid valve implant 51 is then closed to its final configuration (e.g., an implanted configuration).

[0171] Referring to FIGS. 8D-8E, in an implanted configuration of the tricuspid valve implant 51, the clipping arms 69 are snuggly folded up against the gripping arms 65 with the leaflets (E.g., at least one pair of leaflets 36, 37, 38) between the arms 65, 69 in a closed configuration. FIG. 8E illustrates the head 64 in a closed configuration.

[0172] FIGS. 9A-D illustrate a sequential method of implanting the implant 51 at the tricuspid valve 7. Referring to FIG. 9A, the implant 51 is delivered to the right ventricle just above the tricuspid valve 7. Referring to FIG. 9B, the implant 51 is then advanced through the valve 7. As shown in FIG. 9C, one of the gripping control wires 66 is independently actuated to engage one of the gripping arms 65 with a leaflet (e.g., posterior leaflet 38) of the tricuspid valve 7. The other gripping arm 65 can remain unengaged from a leaflet at this stage. As shown in FIG. 9D, the other gripping control wire 66 is independently actuated to engage the other gripping arm 65 with another leaflet (e.g., septal leaflet 36) of the tricuspid valve 7.

[0173] Referring to FIGS. 10A-1 IE, in some embodiments, the tricuspid valve implant 51 includes detangling elements 71a that extend between a wire along the central axis 67 and opposing ends of each clipping arm 69. The detangling elements 71a can be sutures, wires, or other detangling elements that can facilitate a release of the implant 51 from the leaflets and facilitate the detangling of the implant 51 from chordae tendineae (e.g., chordae tendineae 40 within the right ventricle 4). For example, the gripping arms 65 can be released and in a collapsed position along or near the central axis 67 of the implant. The detangling elements 71a can be actuated and pull upwards as illustrated in the sequence from FIG. 10A to FIG. IOC. The upward movement of the detangling elements 71a can dislodge the implant from engaged tissues (e.g., leaflets, chordae tendineae, or other tissues) and create a slope along the detangling sutures 71 that minimizes or reduces engagement with surrounding tissues. FIGS. IOC and 1 IE illustrate a collapsed configuration with the detangling elements 71a pulled upwards to a steep slope, facilitating removal and detangling of the implant 51 from various tissues.

[0174] In some embodiments, the detangling elements 71a can facilitate the release of the implant 51 from one or more leaflets after installation and facilitate the adjustment of the position of the implant 51. For example, the implant 51 can be connected to one or more leaflets at a first position. A user (e.g., a surgeon) may determine the first position should be adjusted and, advantageously, during the same procedure and with the same transcatheter system 150 and deployment tool 100 that user can release the implant 51 from the leaflets (e.g., by releasing the gapping arms 65 and actuating the detangling elements 71a). Once released, the detangling elements 71a can be lowered such that the gripping arms 65 can engage with the leaflets at the adjusted second position.

[0175] Referring to FIGS. 12A-12C, in some embodiments, the tricuspid valve implant 51 includes detangling elements 71b that extend between a wire along the central axis 67 and opposing ends of each clipping arm 69. The detangling elements 7 lb can be wires, sutures, a wire frame, or other detangling elements facilitate a release of the implant 51 from the leaflets and facilitate the detangling of the implant 51 from chordae tendineae (e.g., chordae tendineae 40 within the right ventricle 4). For example, the gripping arms 65 can be extended and actuated away from the central axis 67 of the implant. The detangling elements 71b can be actuated and pull upwards as illustrated in the sequence from FIG. 12B-C. For example, the detangling elements 71b can be connected to a distal end of the positioning catheter 53 such that, as the positioning catheter 53 is retracted and the detangling elements 71b are engaged with the positioning catheter 53, the detangling elements 71b can pull upwards with the positioning catheter 53. The upward movement of the detangling elements 71b can dislodge the implant from engaged tissues (e.g., leaflets, chordae tendineae, or other tissues) and create a slope along the detangling elements 71b that minimizes or reduces engagement with surrounding tissues. FIG. 12C illustrate a collapsed configuration of the clipping elements 69 with the detangling elements 71b pulled upwards to a steep slope, facilitating removal and detangling of the implant 51 from various tissues.

[0176] In some embodiments, the detangling elements 71b can facilitate the release of the implant 51 from one or more leaflets after installation and facilitate the adjustment of the position of the implant 51. For example, the implant 51 can be connected to one or more leaflets at a first position. A user (e.g., a surgeon) may determine the first position should be adjusted and, advantageously, during the same procedure and with the same transcatheter system 150 and deployment tool 100 that user can release the implant 51 from the leaflets (e.g., by releasing the gripping arms 65 and actuating the detangling elements 71b). Once released, the detangling elements 71b can be lowered such that the gripping arms 65 can engage with the leaflets at the adjusted second position.

[0177] Referring to FIGS. 13A-G an implant 1351 is illustrated that shares features with implant 51. The implant 1351 also includes translating gnppers 1369 that are slidable along the clipping arms 1369. The clipping arms 1369 can be extended radially to engage the leaflets 36, 37, 38 of the tncuspid valve 7. The translating grippers 1369 can each include pairs of gripping arms that are controllable to hinge with respect to each other to clamp down and sandwich a leaflet between the gripping arms of the grippers 1469.

[0178] In FIG. 13A, the translating grippers 1369 are in an open configuration where the translating grippers 1369 are positioned inward (e.g., towards a central axis 1367 of the implant 1351). FIG. 13B shows a next step of an active leaflet capture process where the implant 1351 is in an open configuration with the translating grippers 1369 open and extended outwardly (e.g., away from the central axis 1367) and towards the leaflets 36, 37. FIG. 13C shows a next step of an active leaflet capture process with the implant 1351 in an open configuration with the translating grippers 1369 open and extended outwardly and partially contacting the leaflets 36, 37. FIG. 13D shows a next step of an active leaflet capture process with the implant 1351 in an open configuration with the grippers 1369 open and extended outwardly and fully contacting leaflets 36, 37. FIG. 13E shows a next step of an active leaflet capture process with the implant 1351 in an open configuration with the grippers 1369 closed and extended outwardly and fully contacting leaflets 36, 37. FIG. 13E shows a next step of an active leaflet capture process with the implant 1351 in an open configuration with the grippers 1369 closed and retracted inwardly and fully contacting leaflets 36, 37. FIG. 13G shows a next step of an active leaflet capture process with the implant 1351 in a closed configuration with the grippers 1369 closed and retracted inwardly and fully contacting leaflets 36, 37.

[0179] Referring to FIGS. 14A-G, an implant 1451 is illustrated that shares features with implants 51 and 1351. The implant 1451 includes translating grippers 1469 that are slidable along the clipping arms 1465. The clipping arms 1469 can be extended radially to engage the leaflets 36, 37, 38 of the tricuspid valve 7. The translating grippers 1469 can each include pairs of gripping arms that are controllable to hinge with respect to each other to clamp down and sandwich a leaflet between the gripping arms of the grippers 1469. Each gripper 1469 is individually controllable to extend, retract, open, and close, facilitating customized and individual control during the active leaflet capture process.

[0180] In FIG. 14 A, the translating grippers 1469 are in an open configuration where the translating grippers 1469 are positioned inward (e.g., towards a central axis 1467 of the implant 1451). FIG. 14B shows a next step of an active leaflet capture process where the implant 1451 is in an open configuration with one of the translating grippers 1469 open and extended outwardly (e.g., away from the central axis 1367) and towards leaflets (e.g., leaflets 36, 37, 38) and the other gripper 1465 open and positioned inward. FIG. 14C shows a next step of an active leaflet capture process with the implant 1451 in an open configuration with one translating gripper 1465 closed and extended outwardly (e.g., to capture one leaflet). FIG. 14D shows a next step of an active leaflet capture process with the implant 1451 in an open configuration with the gripper 1465 that was extended in FIGS. 14A-C, closed and retracted inwards. FIG. 14E shows a next step of an active leaflet capture process with the implant 1451 in an open configuration with the other grippers 1469 open and extended outwardly. FIG. 14F shows a next step of an active leaflet capture process with the implant 1451 in an open configuration with one gripper 1465 closed and retracted inwardly and the other gripper 1465 closed and extended outwardly. FIG.

[0181] 14G shows a next step of an active leaflet capture process with the implant 1451 in an open configuration with the grippers 1469 closed and retracted inwardly.

[0182] Referring to FIGS. 15A-E, an implant 1551 is illustrated that shares features with implants 51, 1351, and 1451. The implant 1551 includes translating grippers 1569 that are slidable along the clipping arms 1565 and positions of the translating grippers 1569 are controllable using control wires 1571a and 1571b. The control wires 1571a and 157 lb can facilitate the control of both translating grippers 1569 by controlling an open or closed position (e.g., by control wire 1571a) and by controlling the translational position of the grippers 1569 along the clip arms 1565 (e.g., by control wire 1571b). The clipping arms 1565 and translating grippers 1569 share features with the clipping arms 65. 1365, and 1369 and the grippers 69. 1369, 1469. Additionally, the translating grippers 1569 can include textured surfaces 1573 that facilitate engagement with tissues (e.g., leaflets).

[0183] Referring to FIGS. 16A-H, an implant 1651 is illustrated that shares features with implants 51, 1351, 1451, and 1551. The implant 1651 includes translating grippers 1669 that are slidable along the clipping arms 1665 and positions of the translating grippers 1669 are controllable using control wires 1671. The control wires 1671 can coordinate with the positioning catheter 1656 to facilitate the control of both translating grippers 1669. For example, the control wires 1671 can control an open or closed position of the grippers 1669 by controlling the translational position of the grippers 1669 along the clip arms 1665. The clipping arms 1665 and translating gnppers 1569 share features with the clipping arms 65, 1365, and 1369 and the grippers 69, 1369, 1469. Additionally, the translating grippers 1669 can include textured surfaces 1673 that facilitate engagement with tissues (e.g., leaflets). In some embodiments, the control wires 1671 can be spring-loaded such that as the positioning catheter 1653 is retracted, the control wires 1671 deflects the grippers 1669 outward (see e.g., FIG. 16C). The positioning catheter 1656 can be subsequently extended to actuate the grippers 1669 towards a closed position (see e.g., FIGS. 16D-E). The control wires 1671 and the positioning catheter 1653 can control the grippers 1669 into a detangle position when the control wires 1671 and the positioning catheter 1653 are actuated proximally or upwards (see e.g., FIG. 16F). The wires 1671 can retract the grippers 1669 as the wires 1671 are translated proximally (see e.g., FIG. 16G). The implant 1651 can be in a fully retracted and closed position as shown in FIG. 16H.

[0184] Referring to FIGS. 17A-E, an implant 1751 is illustrated that shares features with implants 51, 1351, 1451, 1551, and 1651. The implant 1751 includes translating grippers 1769 that are slidable along the clipping arms 1765 and positions of the translating grippers 1769 are controllable to extend outwardly from the clipping arms 1765.

[0185] Referring to FIGS. 18A-G, an implant 1851 is illustrated that shares features with implants 51, 1351, 1451, 1551. 1651. and 1751. The implant 1751 includes translating grippers 1869 that are slidable along the clipping arms 1865 and positions of the translating grippers 1869 are controllable to extend outwardly from the clipping arms 1865. The retraction and extension of translating grippers 1869 (e g., towards and away from central axis 1867 are controllable by an actuation wire 1871a that extends along and is connected along the central axis 1867. The opening and closing of the translating grippers 1869 is controllable by a control wire 1871b that connects to each translating gripper 1869 to facilitate actuation of each gripper 1869 between an open position (see e.g., FIG. 18A) and a closed position (see e.g., FIG. 18B). FIG.

[0186] 18A illustrates the actuation wire 1871a retracted inwards to extend the grippers 1869 outwards and the control wire 1871b pulled partially proximally to pull the grippers 1869 into an open configuration. FIG. 18B show s the actuation wire 1871a extended from a distal end of the implant 1851 to retract the grippers 1869 the control wire 1871b extended distally position the grippers 1869 into a closed configuration (e.g., against the clipping arms 1865 and / or tissues captured betw een the clipping arms 1865 and the gnppers 1869). FIG. 18C shows the implant 1851 in a closed configuration with the grippers 1869 closed and the clipping arms 1865 closed.

[0187] Each of the grippers 1869 and clipping arms 1865 can be independently controlled. For example, FIG. 18E illustrates the implant 1851 with one gripper 1869 partially open and retracted inwardly (e.g., with the actuation wire 1871a extended outwardly) and the other gripper 1869 partially open and extended outwardly (e.g., with the actuation wire 1871 a retracted inwardly). In some embodiments, the actuation wire 1871a can have at least two separately controllable elements, each element is connected to a respective side of each gripper 1869 to facilitate independent control.

[0188] The implant 1851 can also actuate into a detangle position. For example, FIG.

[0189] 18F show's a detangle position of the implant 1851 that facilitates a release of the implant 1851 from one or more leaflets and facilitates the detangling of the implant 1851 from chordae tendineae (e.g., chordae tendineae 40 within the right ventricle 4). In some embodiments, the gripper 1869 can be hinged to pull proximally and extend into the detangle position. For example, the gripper 1869 can include a hinge 1881 that facilitates movement of the grippers 1869 betw een an open position, a closed position, and a detangle position. The control wire 1871b can connect to an end 1882 of a top portion 1883 of the gripper 1869 and to a second end 1884 near the hinge 1881 and / or a connection between the top and bottom portions of the gripper 1869. The detangle position can include the grippers 1869 extending proximally, and the upw ard movement of the grippers 1869 can dislodge the implant from engaged tissues (e.g., leaflets, chordae tendineae, or other tissues) and create a slope along the grippers 1869 that minimizes or reduces engagement with surrounding tissues.

[0190] 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 along with the improved steering and precise control of the implantation process 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 and facilitate detangling during instances of high chordal density'. The implants described herein can effectively negotiate (e.g., manipulate around and through) these areas to provide improved positioning and secure implantation.

[0191] 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 deliver ’ 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.

[0192] A number of embodiments of the invention have been described.

[0193] Nevertheless, it will be understood that various modifications may be made without departing from the spirit and scope of the invention. For example, design features of the embodiments described herein can be combined with other design features of other embodiments described herein. Accordingly, other embodiments are within the scope of the following claims.

Claims

WHAT IS CLAIMED IS:

1. 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,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; andan implantation system movable axially within a lumen of the guide catheter, the implantation system is controllable in three planes of motion when the implantation system is exposed from the distal end of the guide catheter;wherein the deployment tool and implantation system are configured to (i) position a therapeutic device between leaflets of a valve of the heart, and (ii) retract the deployment catheter from the therapeutic device while maintaining a suture connection between the therapeutic device and the deployment catheter.

2. The transcatheter delivery' system of claim 1, wherein the deployment tool and implantation system are configured to (iii) retract the positioning catheter from the therapeutic device before retracting the deployment catheter from the therapeutic device.

3. The transcatheter delivery system of claim 2, wherein the deployment tool and implantation system are configured to (iv) loosen the suture connection between the therapeutic device and the deployment catheter to release a tensile force between the deployment catheter and the therapeutic device.

4. The transcatheter delivery system of claim 3, wherein the deployment tool and implantation system are configured to (v) tighten the suture connection between the therapeutic device and the deployment catheter to apply the tensile force between the deployment catheter and the therapeutic device.

5. The transcatheter delivery' system of claim 4, wherein the deployment tool and implantation system are configured to (vi) advance the deployment catheter to reengage with the therapeutic device.

6. The transcatheter delivery7system of claim 5, wherein the deployment tool and implantation system are configured to (vii) in re-engaged position, manipulate the position of the therapeutic device.

7. The transcatheter delivery system of any one of claims 1 to 6, wherein the therapeutic device comprises:a first grip element moveable in relation to the first clip element;a second clip element coupled to a second side of the central member; and a second grip element moveable in relation to the second clip element.

8. The transcatheter delivery system of claim 7, wherein the first and second clip elements and the first and second grip elements are independently adjustable to respectively grasp and hold together a first leaflet and a second leaflet of the heart to securely close a gap between the first and second leaflets.

9. The transcatheter delivery system of claim 7, wherein the therapeutic device comprises detangling elements that are moveable away from the first clip element and the second clip element to release the cardiac therapeutic device from the first portion and second portion of the heart.

10. The transcatheter delivery system of any one of claims 1 to 9, wherein the therapeutic device comprises a heart valve clip.

11. The transcatheter delivery system of any one of claims 1 to 10, further comprising an imaging catheter that is movable axially within the lumen of the guide catheter.

12. The transcatheter delivery7system of claim 11, wherein the imaging catheter comprises an intracardiac echocardiography (ICE) imaging catheter.

13. The transcatheter delivery' system of any one of claims 1 to 12, wherein the frame comprises a hub configured to engage a septum of the heart.

14. The transcatheter delivery system of claim 13, wherein the hub is connected to the first stabilization rail, the second stabilization rail, and the guiderail.

15. 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 to stabilize a distal portion of a deployment tool within the heart;advancing a delivery catheter over a guiderail of the frame within the heart; adjusting a position of a placement catheter in relation to the guiderail of the frame;moving a deployment catheter and the therapeutic device axially or rotationally from the placement catheter and to a selected position within the heart;connecting one or more portions of the therapeutic device to one or more leaflets of a valve of the heart;retracting the deployment catheter from the therapeutic device while maintaining a suture connection between the therapeutic device and the deployment catheter.

16. The method of claim 15, further comprising positioning the distal end of the guide catheter within a right atrium of the heart.

17. The method of claim 16, wherein the therapeutic device comprises a tricuspid valve implant.

18. The method of any one of claims 15 to 17. further comprising positioning the distal end of the guide catheter within a left atrium of the heart.

19. The method of claim 18, wherein the therapeutic device comprises a mitral valve implant.

20. The method of any one of claims 15 to 19, further comprising retracting the positioning catheter from the therapeutic device before retracting the deployment catheter from the therapeutic device.

21. The method of any one of claims 15 to 20, further comprising loosening the suture connection between the therapeutic device and the deployment catheter to release a tensile force between the deployment catheter and the therapeutic device.

22. The method of claim 21, further comprising tightening the suture connection between the therapeutic device and the deployment catheter to apply the tensile force between the deployment catheter and the therapeutic device.

23. The method of claim 22, further comprising advancing the deployment catheter to re-engage with the therapeutic device.

24. The method of claim 23, wherein, in re-engaged position, the deployment catheter and the positioning catheter are configured to manipulate the position of the therapeutic device.

25. The method of any one of claims 15 to 24. wherein the therapeutic device comprises:a first grip element moveable in relation to the first clip element;a second clip element coupled to a second side of the central member; and a second grip element moveable in relation to the second clip element.

26. The method of claim 25, wherein the first and second clip elements and the first and second grip elements are independently adjustable to respectively grasp and hold together a first leaflet and a second leaflet of the heart to securely close a gap between the first and second leaflets.

27. The method of claim 26, wherein the therapeutic device comprises detangler elements that are moveable away from the first clip element and the second clip element to release the cardiac therapeutic device from the first portion and second portion of the heart.

28. The method of any one of claims 15 to 27. further comprising causing a stabilization rail of the frame to contact a wall of the heart to stabilize a distal portion of the frame within the heart.

29. The method of any one of claims 15 to 28, further comprising engaging a hub of the frame with a septal wall of the heart to prevent the distal end of the guide catheter from moving out of a right atrium of the heart.

30. The method of any one of claims 15 to 29, wherein the distal end of the positioning catheter is connected to a distal end of the delivery catheter with one or more positioning wires.

31. The method of any one of claims 15 to 30, further comprising moving the distal end of the positioning catheter with one or more positioning wires.

32. The method of any one of claims 15 to 31, further comprising lowering the therapeutic device into a valve of the heart.

33. The method of claim 32, further comprising implanting the therapeutic device on the valve.

34. The method of any one of claims 15 to 33, further comprising:inserting the guide catheter percutaneously; andadvancing the guide catheter to the heart through a patient’s vasculature.

35. The method of any one of claims 15 to 34, further comprising deploying an imaging catheter to the heart to image the distal portion of the deployment tool within the heart.

36. The method of claim 35, further comprising moving the imaging catheter axially through a lumen of the guide catheter.

37. The method of claim 35 or 36, further comprising visualizing an anatomic landmark at an engagement between the frame and the heart.

38. The method of claim 37, 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.

39. The method of claim 35, wherein the imaging catheter comprises an intracardiac echocardiography (ICE) imaging catheter.

40. A cardiac therapeutic device comprising:a central member;a first clip element coupled to a first side of the central member;a first grip element moveable in relation to the first clip element;a second clip element coupled to a second side of the central member; a second grip element moveable in relation to the second clip element; and detangler elements that are moveable away from the first clip element and the second clip element;wherein the first and second clip elements and the first and second grip elements are independently 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; andwherein the detangler elements are configured to release the cardiac therapeutic device from the first portion and second portion of the heart.

41. The cardiac therapeutic device of claim 40, wherein the cardiac therapeutic device is configured to be delivered to the heart through a catheter.

42. The cardiac therapeutic device of any one of claims 40 to 41, wherein the detangling elements are sutures that are moveable away from the first clip element and the second clip element to release the cardiac therapeutic device from the first portion and second portion of the heart.

43. The cardiac therapeutic device of any one of claims 40 to 42, wherein the detangling elements are wires that are moveable away from the first clip element and the second clip element to release the cardiac therapeutic device from the first portion and second portion of the heart.

44. The cardiac therapeutic device of any one of claims 40 to 43, wherein the cardiac therapeutic device comprises a heart valve implant.

45. The cardiac therapeutic device of any one of claims 42 to 44, wherein the first portion of the heart is a first leaflet of a tricuspid valve and the second portion of the heart is a second leaflet of the tricuspid valve.

46. A cardiac therapeutic device comprising:a central member;a first clip element coupled to a first side of the central member;a first grip element moveable in relation to the first clip element;a second clip element coupled to a second side of the central member;a second grip element moveable in relation to the second clip element; and wherein the first and second clip elements and the first and second grip elements are independently 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.

47. The cardiac therapeutic device of claim 46, wherein the cardiac therapeutic device is configured to be delivered to the heart through a catheter.

48. The cardiac therapeutic device of claim 46 or 47, wherein the cardiac therapeutic device comprises a heart valve implant.

49. The cardiac therapeutic device of any one of claims 46 to 48, wherein the first portion of the heart is a first leaflet of a tricuspid valve and the second portion of the heart is a second leaflet of the tricuspid valve.

50. The cardiac therapeutic device of any one of claims 46 to 49, wherein the first grip element and the second grip element are translatable along each of the first clip element and the second clip element respectively.

51. The cardiac therapeutic device of claim 50, wherein the first grip element and the second grip element are translatable towards and away from a central axis of cardiac therapeutic device.

52. The cardiac therapeutic device of claim 50, wherein the first and second grip elements have an extended open position where each of the first and second grippers are open and extended outwardly away from the central axis of the cardiac therapeutic device.

53. The cardiac therapeutic device of claim 46, wherein the first and second grip elements have an extended closed position where each of the first and second grippers are closed and extended outwardly away from the central axis of the cardiac therapeutic device.

54. The cardiac therapeutic device of claim 46, wherein the first and second grip elements have a retracted closed position where each of the first and second grippers are closed and retracted inwardly towards the central axis of the cardiac therapeutic device.

55. A transcatheter delivery system for implanting one or more cardiac therapeutic devices, comprising:a deployment tool including a guide catheter and a frame coupled to the guide catheter and configured to stabilize a distal end of the guide catheter; andan implantation system movable axially within a lumen of the guide catheter; wherein the deployment tool and implantation system are configured to position and install at least a first therapeutic device along at least a first leaflet.

56. A method of deploying a cardiac therapeutic device, comprising:deploying a frame from the distal end of a guide catheter while the distal end of the guide catheter is positioned in a heart: andadjusting the frame into a functional configuration to stabilize a distal portion of a deployment tool within the heart.

57. A cardiac therapeutic device comprising:a central hub;a first clip element coupled to a first side of the central hub;a first gnp element moveable in relation to the first clip element;a second clip element coupled to a second side of the central hub; and a second grip element moveable in relation to the second clip element.

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