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] Attorney Docket No.: 56363-0012WO1

[0002] Systems and Methods for Deploying Cardiac Therapeutic Devices

[0003] CLAIM OF PRIORITY

[0004] This application claims the benefit of U.S. Provisional Patent Application Serial No. 63 / 742,243, filed on January 6, 2025. The entire contents of the foregoing are hereby incorporated by reference.

[0005] TECHNICAL FIELD

[0006] 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.

[0007] BACKGROUND

[0008] 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 mortality7. 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, many7devices used in structural heart interventions require proper alignment with anatomical features in the heart or the ability7to 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 ability7to 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.

[0009] In one example, a conventional treatment for mitral valve regurgitation can include implantation of a transcatheter “edge-to-edge"’ clip device, which may be intended for deployment in a manner that holds the opposing regions of the two mitralAttorney Docket No.: 56363-0012WO1

[0010] valve leaflets or tricuspid valve leaflets. Such implantable clip devices can include clip arms to engage a hold the opposing mitral valve leaflets. As described above, the delivery of such a clip device into a beating heart can be a complex procedure, especially where proper alignment with the valve leaflets and other anatomical features within the heart can impact the long-term effectiveness of the treatment.

[0011] SUMMARY

[0012] 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. For example, some versions of the implant described herein include an improved transcatheter edge-to-edge repair device.

[0013] Some embodiments described herein include a cardiac therapeutic device. The cardiac therapeutic device may include a central hub and a first clip element coupled to a first side of the central hub. Further, the cardiac therapeutic device may include a first clip actuator connected to the first clip element and moveable in relation to the first clip element and the central hub. The cardiac therapeutic device may include a second clip element coupled to a second side of the central hub. and a second actuator connected to the second clip element and moveable in relation to the second clip element and the central hub. In some embodiments, the first clip actuator and the second clip actuator may independently control respective positions of the first and second clip elements.

[0014] Such a device can include one or more of the following optional features. For example, the central hub can have a first hub hinge connected to the first clip element. The first hub hinge can connect to the first clip element at a position spaced apart from a base of the first clip element. The first clip element can have a first clip hinge at a base of the first clip element that is connected to a distal end of the first clipAttorney Docket No.: 56363-0012WO1

[0015] actuator. The first clip actuator can have a first clip actuator hinge spaced apart from the distal end of the first clip actuator. Independent proximal actuation of the first clip actuator can cause the distal end of the first clip element to deflect laterally outward. Independent proximal actuation of the first clip actuator can cause the first clip actuator hinge to translate proximally and the distal end of the first clip actuator to deflect laterally. The central hub can have a second hub hinge connected to the second clip element. The second hub hinge can connect to the second clip element at a position spaced apart from a base of the second clip element. The second clip element may have a second clip hinge at a base of the second clip element that is connected to a distal end of the second clip actuator. The second clip actuator can have a second clip actuator hinge spaced apart from the distal end of the first clip actuator.

[0016] Independent proximal actuation of the second clip actuator can cause the distal end of the second clip element to deflect laterally outward. Independent proximal actuation of the second clip actuator causes the second clip actuator hinge to translate proximally and the distal end of the second clip actuator to deflect laterally.

[0017] 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 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; actuating a first clip actuator to deflect a first clip element laterally outward from a central hub of the therapeutic device; actuating a second clip actuator to deflect a second clip element laterally outward from a central hub of the therapeutic device; connecting the first and second clip elements 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.

[0018] Such a method can include one or more of the following optional features. The method can include actuating first clip actuator in a proximal direction, which may cause the distal end of the first clip element to deflect laterally outward.

[0019] The method can include actuating first clip actuator in a proximal direction, which may cause a first clip actuator hinge to translate proximally and a distal end ofAttorney Docket No.: 56363-0012WO1

[0020] the first clip actuator to deflect laterally. The method can include actuating second clip actuator in a proximal direction, which may cause the distal end of the second clip element to deflect laterally outward. The method can include actuating second clip actuator in a proximal direction, which may cause a second clip actuator hinge to translate proximally and a distal end of the second clip actuator to deflect laterally. The first clip actuator and the second clip actuator can independently control respective positions of the first and second clip elements.

[0021] Some embodiments described herein include a transcatheter delivery system for implanting a therapeutic device in a heart. The transcatheter delivery system may include a therapeutic device that has a central hub, grip elements extending from the central hub, grip element control wires that extend through the hub and to each of the grip elements, and a deployment tool having a shaft and a tool interface at a distal end of the deployment tool. The tool interface can be configured to engage with a proximal end of the therapeutic device. Further, the deployment tool can be configured to rotate the central hub and control a tensile force on the grip element control wires to control a position of the grip elements between an expanded position and a collapsed position.

[0022] Such a system can include one or more of the following optional features. The deployment tool can be configured to disengage from the therapeutic device when the therapeutic device is in an implanted position. A connection between the central hub and the grip elements can be a threaded connection. The proximal end of the therapeutic device can include a keyed connection that interfaces with the distal end of the deployment tool. Rotation of the central hub in a first direction can extend the grip control wires to actuate the grip elements into the expanded position. Rotation of the central hub in a second direction can retract the grip control wires to actuate the grip elements into the collapsed position. The grip elements can be stabilized at each position between the expanded position and the collapsed position. In the collapsed position, the grip elements can be collapsed inwardly towards the central hub. In the expanded position, the grip elements can be deflected outwardly away from the central hub. The transcatheter delivery' system can be configured to (i) position the therapeutic device between leaflets of a valve of the heart, and (ii) retract the deployment tool from the therapeutic device when the therapeutic device is in an implanted position between leaflets of the valve of the heart. The therapeutic device can include a heart valve clip.Attorney Docket No.: 56363-0012WO1

[0023] 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 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 tool and the therapeutic device axially or rotationally from the placement catheter and to a selected position within the heart; rotating the deployment tool to actuate the therapeutic device from a collapsed position to an expanded position; connecting one or more portions of the therapeutic device to one or more leaflets of a valve of the heart; and retracting the deployment tool from the therapeutic device.

[0024] 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 may 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 rotating a central hub of the implant in a first direction to actuate clip elements into the expanded position. Rotation of the central hub in a second direction can actuate the clip elements into the collapsed position. 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 the 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.

[0025] Some embodiments described herein include a cardiac therapeutic device. The cardiac therapeutic device can include a hub at a distal end of the therapeutic device, a frame having proximal arms and distal arms, the proximal arms and distal arms are connected to each other by ball joints positioned between the proximal arms and distalAttorney Docket No.: 56363-0012WO1

[0026] arms, the distal arms being connected to the rotating hub at ball joints between a rotating hub and the distal arms. The cardiac therapeutic device further includes a first grip element moveable in relation to the frame and a second grip element moveable in relation to the frame. The therapeutic device can be configured to actuate between an extended position and an engagement position, and, in the engagement position, the first and second grip elements 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.

[0027] 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 can be a first leaflet of a tricuspid valve and the second portion of the heart is a second leaflet of the tricuspid valve. In the engagement position, the first and second grip elements can respectively grasp and hold together the first portion of the heart and a second portion of the heart between the first and second grip elements and the proximal arms of the frame. In the engagement position, the first and second grip elements can respectively grasp and hold together the first portion of the heart and a second portion of the heart betw een the first and second grip elements and the proximal arms of the frame. In the extended position, the proximal arms and the distal arms can be retracted inwardly towards a central axis of the therapeutic device. The therapeutic device may optionally be configured to actuate into an intermediate position between the extended position and the engagement position, and, in the intermediate position, distal ends of the proximal arms are deflected laterally outward from the central axis.

[0028] Some embodiments described herein include a transcatheter delivery system for implanting a therapeutic device at a heart. The transcatheter delivery system can including a deployment tool that has a guide catheter configured to enter the heart and a frame coupled to the guide catheter and configured to stabilize a distal end of the guide catheter within the heart when a distal portion of the frame is exposed from the distal end of the guide catheter. Further, the system can include an implantation system movable axially within a lumen of the guide catheter. The implantation system can have an inner delivery catheter and an outer delivery catheter. The system can include a therapeutic implant configured to connect to the implantation system, the therapeutic implant having a rotating hub at a distal end of the therapeutic implant; aAttorney Docket No.: 56363-0012WO1

[0029] frame having proximal arms and distal arms, the proximal arms and distal arms are connected to each other at ball joints positioned between the proximal arms and distal arms; a first grip element moveable in relation to the frame; and a second grip element moveable in relation to the frame. 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) control an orientation of the therapeutic implant between an extended position and an engagement position.

[0030] Such a system can include one or more of the following optional features. The therapeutic implant can be configured to be delivered to the heart through a catheter. The therapeutic implant 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 can be a second leaflet of the tricuspid valve. In the engagement position, the first and second grip elements can respectively grasp and hold together the first portion of the heart and a second portion of the heart between the first and second grip elements and the proximal arms of the frame. In the engagement position, the first and second grip elements can respectively grasp and hold together the first portion of the heart and a second portion of the heart between the first and second grip elements and the proximal arms of the frame. In the extended position, the proximal arms and the distal arms can be retracted inwardly towards a central axis of the therapeutic device. The therapeutic device can be configured to actuate into an intermediate position between the extended position and the engagement position, and, in the intermediate position, distal ends of the proximal arms are deflected laterally outward from the central axis.

[0031] Some embodiments described herein include a transcatheter delivery system for implanting one or more cardiac therapeutic devices. The system can include a deployment tool having a guide catheter and a frame coupled to the guide catheter and configured to stabilize a distal end of the guide catheter. The system can include an implantation system movable axially within a lumen of the guide catheter. The deployment tool and implantation system can be configured to position and install at least a first therapeutic device along at least a first leaflet.

[0032] Some embodiments described herein include a method of deploying a cardiac therapeutic device. The method can 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.Attorney Docket No.: 56363-0012WO1

[0033] 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 surgery7) and then advanced through the vasculature into the heart, even while encountering vary ing tortuosity7and vary ing pathway sizes of the vasculature.

[0034] 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 delivery7system easy to operate in an efficient manner by a user.

[0035] 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.

[0036] 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 stability7of 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.

[0037] 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 delivery7and facilitate detangling during instances of high chordal density7. The implants described herein can effectively negotiate (e.g., manipulate around and through) these areas to provide improved positioning and secure implantation.Attorney Docket No.: 56363-0012WO1

[0038] Fifth, the implants can be secured in position with improved accuracy and precise control of one or more clip arms during the implantation process to facilitate accurate positioning of the implant within the target anatomy.

[0039] 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.

[0040] DESCRIPTION OF DRAWINGS FIG. 1 A is a perspective view of a deployment tool and an implantation system of a transcatheter delivery system. FIG. IB is a perspective view of the deployment tool and the implantation system of FIG. 1 A within the right atrium in a cross-sectional view of a heart.

[0041] FIG. 2A is a bottom view of a mitral valve of the heart of FIG. IB.

[0042] FIG. 2B is a top view of a tricuspid valve of the heart of FIG. IB.

[0043] FIG. 3 A 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.

[0044] FIG. 3B is an imaging view of the system of FIG. 3 A.

[0045] FIG. 3C 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 frame extended.

[0046] FIG. 3D is an imaging view of the system of FIG. 3C.

[0047] FIG. 3E 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.

[0048] FIG. 3F is an imaging view of the system of FIG. 3E.

[0049] 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.

[0050] FIG. 3H is an imaging view of the system of FIG. 3G.

[0051] 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.

[0052] FIG. 3 J is an imaging view of the system of FIG. 31.Attorney Docket No.: 56363-0012WO1

[0053] 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.

[0054] FIG. 3L is an imaging view of the system of FIG. 3K.

[0055] FIG. 3M 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 deployment catheter extended from the positioning catheter towards the tricuspid valve.

[0056] FIG. 3N is an imaging view of the system of FIG. 3M.

[0057] 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.

[0058] FIG. 4B 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 a portion of the tricuspid valve.

[0059] FIG. 4C is a top view of a distal portion of the deployment tool and implantation system of FIG. 4B with the deployment catheter extended from the positioning catheter into the tricuspid valve..

[0060] FIG. 4D 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.

[0061] 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.

[0062] 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.

[0063] 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.

[0064] FIG. 5 A shows top and side views of the implantation system of FIG. 1A controlling the anterior-posterior trajectory of the implant.Attorney Docket No.: 56363-0012WO1

[0065] FIG. 5B shows other top and side views of the implantation system of FIG. 1 A controlling the anterior-posterior trajectory’ of the implant.

[0066] FIG. 5C shows top and side views of the implantation system of FIG. 1A controlling the septal-lateral trajectory’ of the implant.

[0067] FIG. 5D shows other top and side views of the implantation system of FIG. 1A controlling the septal-lateral trajectory of the implant.

[0068] FIG. 5E shows top and side views of the implantation system of FIG. 1 A controlling the anterior-posterior position of the implant.

[0069] FIG. 5F shows other top and side views of the implantation system of FIG. 1A controlling the anterior-posterior position of the implant.

[0070] FIG. 5G shows top and side views of the implantation system of FIG. 1A controlling the septal-lateral position of the implant.

[0071] FIG. 5H shows other top and side views of the implantation system of FIG. 1A controlling the septal-lateral position of the implant.

[0072] FIG. 51 shows other top and side views of the implantation system of FIG. 1A controlling the septal-lateral position of the implant.

[0073] FIG. 6 shows atop view of an example handle assembly of the transcatheter delivery' system of FIG. 1A.

[0074] FIG. 7A 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 positioning catheter extended.

[0075] 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.

[0076] 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.

[0077] FIG. 7D shows a side view of an example implant configured for partial disengagement with the deployment catheter, consistent with some embodiments.

[0078] FIG. 7E shows a side view of another example implant configured for partial disengagement with the deployment catheter, consistent with some embodiments.

[0079] FIG. 7F shows a perspective view of an implant from FIG. 7A with a positioning catheter extended, consistent with some embodiments.Attorney Docket No.: 56363-0012WO1

[0080] 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.

[0081] FIG. 7H shows a perspective view of the implant from FIG. 7A with a positioning catheter and deployment catheter retracted, consistent with some embodiments.

[0082] FIG. 8A 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 each independent gripper in a retracted configuration.

[0083] FIG. 8B 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 one independent gripper in an actuated configuration and the other independent gripper in a retracted configuration.

[0084] FIG. 8C 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 an actuated configuration.

[0085] 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 configuration and with each independent gripper in an actuated configuration.

[0086] FIG. 8E is a side view of a tricuspid valve implant of the implantation system of FIG. 1 A with the clipping arms in a collapsed and with each independent gripper in an actuated configuration.

[0087] 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.

[0088] FIG. 9B is a top perspective view of the tricuspid valve implant in the position of FIG. 8B and with the clipping arms positioned below the tricuspid valve of a heart.

[0089] 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.

[0090] 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.

[0091] 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.Attorney Docket No.: 56363-0012WO1

[0092] 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.

[0093] FIG. 10C 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.

[0094] 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.

[0095] 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.

[0096] FIG. 11C is a top perspective view of the tricuspid valve implant in the position of FIG. 10C and with one clipping arm released from the tricuspid valve of a heart.

[0097] FIG. 11D is atop perspective view of the tricuspid valve implant in the position of FIG. 10C and with each clipping arm released from the tricuspid valve of a heart.

[0098] FIG. 1 IE is a top perspective view of the tricuspid valve implant in the position of FIG. 10C and with the implant released from and positioned above the tricuspid valve of a heart.

[0099] FIG. 12Ais 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 aligned with the clipping arms.

[0100] 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 detangling wire at an intermediate release configuration.

[0101] FIG. 12C 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 wire at a release configuration.

[0102] FIG. 13Ais a side view of a tricuspid valve implant in an open configuration during an active leaflet capture process.Attorney Docket No.: 56363-0012WO1

[0103] FIG. 13B 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. 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.

[0105] FIG. 13D is a side view of a tricuspid valve implant in an open configuration with the grippers open and extended outwardly and fully contacting leaflets during an active leaflet capture process.

[0106] 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.

[0107] 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.

[0108] 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.

[0109] FIG. 14Ais a side view of an example implant in a collapsed position.

[0110] FIG. 14B is a side view of the implant of FIG. 14A with one clip arm partially extended outwardly during an independent arm actuation process.

[0111] FIG. 14C is a side view of the implant of FIG. 14Ain an open configuration with the grippers open and contacting leaflets during an independent arm actuation process.

[0112] FIG. 14D is a side view of the implant of FIG. 14Ain an open configuration with the grippers open and contacting leaflets during an independent arm actuation process.

[0113] FIG. 14E is a side view of the implant of FIG. 14A in a partially open configuration with one of the grippers closed and securing a leaflet and one clip arm being rotated towards a closed position during an independent arm actuation process.

[0114] FIG. 14F is a side view of the implant of FIG. 14A with one clip arm closed during an independent arm actuation process.Attorney Docket No.: 56363-0012WO1

[0115] FIG. 15A is a side view of example tricuspid valve implants in an expanded and implanted position and in a collapsed position for navigation through chordal regions.

[0116] FIG. 15B is a side view of the example implant of FIG. 15Ain an expanded position.

[0117] FIG. 15C is a side view of example implant arms of the example implants of FIG. 15 A in an expanded position and in a collapsed position.

[0118] FIG. 15D is a side view of the example implant of FIG. 15A in a collapsed position during navigation through chordal regions.

[0119] FIG. 15E is a side view of the example implant of FIG. 15A in an expanded position and engaged with a leaflet.

[0120] FIG. 16A is a front view of an example implant in a collapsed position during an active leaflet capture process.

[0121] FIG. 16B is a side view of the implant of FIG. 16A.

[0122] FIG. 16C is a front view of the implant of FIG. 16Ain an intermediate position during an active leaflet capture process.

[0123] FIG. 16D is a side view of the implant of FIG. 16C.

[0124] FIG. 16E is a side view of the implant of FIG. 16D rotated to a navigation position during an active leaflet capture process.

[0125] FIG. 16F is aside view of the implant of FIG. 16Ain in an engagement position with the grippers actuated towards the frame during an active leaflet capture process.

[0126] FIG. 16G is a side view of the implant of FIG. 16A in a closed position.

[0127] DETAILED DESCRIPTION

[0128] 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 delivery’ system 150 includes an implantation system 50 that facilitatesAttorney Docket No.: 56363-0012WO1

[0129] 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.

[0130] 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. 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.

[0131] In FIG. IB, the heart 1 is illustrated in cross-section from an anterior perspective in sty lized 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 right ventricle 4, chordae tendineae 31 within the left ventricle 6. and papillary muscles 32 within the left ventricle 6.

[0132] 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.

[0133] 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 17 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 postenor leaflet 12. The chordae tendineae 31 connect the mitral valve 2 to the papillary muscles 32.Attorney Docket No.: 56363-0012WO1

[0134] 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.

[0135] 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.

[0136] 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.

[0137] 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 trajectory / orientation of the frame 124 as it exits the guide 102 into the right atrium 3. In some embodiments, the guide catheter 102 controls the precise position of the tricuspid valve implant 51 in three planes of motion throughout the implantation process.Attorney Docket No.: 56363-0012WO1

[0138] The frame 124 includes an anterior stabilization rail 106, a sheath 112, a guiderail 110, and a hub 104 to which the rail 106, sheath 112 and guiderail 110 extend. The rail 106, sheath 112, and guiderail 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 sheath 112 extends to the hub 104, and a guidewire 114 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.

[0139] 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, 3 A, 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.

[0140] 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 rail 106 and sheath 112can be further advanced out of the guide catheter 102 until the stabilization rail 106 and sheath 112 bow outwardly with respect to the central axis 156 of the guide catheter 102 to form generally curved shapes. The rail 106 and sheath 112 may be advanced until the rail 106 and sheath 112 push gently against the atrial septum 8 and the right atrial wall 29. Accordingly, the rail 106 and sheath 112 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 rail 106 and sheath 112 provide localized stability of the frame 124Attorney Docket No.: 56363-0012WO1

[0141] within the heart 1 without the need for an otherw ise relatively rigid deployment structure. The rail 106 and sheath 112 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.

[0142] 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,”oranother shape. In some embodiments, the hub 104 has a width of about 3.0 to 10.0 mm and a height of about 5.0 mm to about 21.0 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., poly ether ether ketone (PEEK), polycarbonate, acrylonitrile butadiene styrene (ABS), polyoxymethylene, polymethyl methacrylate, or the like). In some embodiments, the hub 104 has a rigidity' that maintains a position and orientation of connected components under load. The profile of the hub 104 is atraumatic so as not to damage any contacted anatomy. 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 rail 106, sheath 112, and guiderail 110 are secured to the hub 104. The sheath 112 is connected to the hub 104, with the guidewire 114 passing through the sheath 112.

[0143] Referring again to FIGS. 1 A, IB, and 3A-N, in some embodiments, the rail 106, sheath 112, guiderail 110, and guidewire 114 have a substantially solid cylindrical shape (e.g., with a circular cross-sectional shape). In some embodiments, the rail 106 and sheath 112 have a diameter of about 0.38 mm to about 0.64 mm (e.g., about 0.51 mm). In some embodiments, the rail 106 and sheath 112 are constructed as wires or ribbons. In some embodiments, the rail 106 and sheath 112 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 rail 106 and sheath 112 (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 rail 106 and sheath 112 are characterized by a super-elastic range that facilitates delivery through the guide catheter 102. In some embodiments, a shape of the rail 106 and sheath 112 may be heat-set. In the functional configurationAttorney Docket No.: 56363-0012WO1

[0144] of the frame 124, a maximum width between any two opposing portions of the stabilization rail 106 and the guiderail 110 is typically about 4 cm to about 8 cm.

[0145] 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 6 cm or about 0 cm to about 10 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.

[0146] 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 majority of 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 fluorovisualization.

[0147] In some embodiments, any of the rails 106, 110, sheath 112, and guidewire 114 may be coated with one or more substances to minimize friction (e.g., resistance to axial movement) between the rails 106, 110, sheath 112, 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.

[0148] 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,Attorney Docket No.: 56363-0012WO1

[0149] while maintaining column strength (e.g., allowing minimal compression) and high resistance to buckling (e.g., by using coils, a braided structure, etc.).

[0150] As discussed above, in some embodiments, the rails 106, 110, sheath 112, and guidewire 114 may have an elastic modulus in a range of super-elasticity such that the rails 106, 110, sheath 112, and guidewire 114 can bend without permanently deforming. A diameter of any of the rail 106, 110 and sheath 112 can be increased to correspondingly increase a stiffness ofthe rail 106, HO and sheath 112 exponentially. Owing to the solid cylindrical shape, the rails 106, 110, and sheath 112 may not have a preferential bending orientation (e.g., a preferential bending direction with respect to a central axis of the rail 106, 110 and sheath 112). In some embodiments, one or more properties (e.g., lateral stiffness, column strength, lubricity, or other material or mechanical properties) of the rails 106, 110, sheath 112, or guidewire 114 may change along their lengths.

[0151] Referring again to FIGS. 1A, IB, and 3A-N, the tricuspid valve implant 51 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.

[0152] 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.

[0153] 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 is a laser cut stainless steel tube. In some embodiments, the positioning catheter 53 has a liner, braided, orAttorney Docket No.: 56363-0012WO1

[0154] 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.

[0155] In some embodiments, the positioning catheter 53 has a resistance to kinking or ovaling to minimize friction with a deployment catheter 56 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.

[0156] 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.

[0157] 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 w ith respect to the distal end of the delivery’ 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 59 is constructed as a wire, cable, or braided line or string.

[0158] The deployment catheter 56 (e.g., carrying the tricuspid valve implant 51) can be moved axially7and rotationally within the positioning catheter 53 to a desiredAttorney Docket No.: 56363-0012WO1

[0159] 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 alined, braided, torque cable construction, 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.

[0160] 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 atnal 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.

[0161] With the hub 104 positioned against the atrial septum 8, the stabilization rail 106 and sheath 112 are further extended from the guide catheter 102 until the rail 106 and sheath 112 bow 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 affects much of the stability7of 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 stability7. In addition to providing enhancedAttorney Docket No.: 56363-0012WO1

[0162] stability', the anatomy allows for vector control and precision for reaching the anatomic target with the tricuspid valve implant 51.

[0163] 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.

[0164] 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.

[0165] 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.

[0166] 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 right ventricle 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. 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.

[0167] 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 frameAttorney Docket No.: 56363-0012WO1

[0168] 124 (e.g., itself carrying the other components of the implantation system 50), is retracted from the patient.

[0169] 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.

[0170] 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 8.0 mm or about 24 French inner diameter.

[0171] Accommodation of the ICE catheter 190 within the guide catheter 102 advantageously allows for optimal delivery7of the ICE catheter 190 to the heart 1 without the need for a separate incision dedicated specifically to the ICE catheter 190. In some embodiments, seals are present between the ICE catheter 190 and an interior surface of the guide catheter 102. In some embodiments, the ICE catheter 190 has a diameter of about 2.3 mm to about 4.3 mm and a length of about 90 cm.

[0172] 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-density7PE. In some embodiments, a braided construction may be made of one or more of stainless wire or ribbon. In some embodiments, the jacket may be made of one or more of TPE (e.g., PEBA), 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 methacry late) macromolecule, polyethylene oxide (PEO), poly(vinyl alcohol) (PVA), and other substances of.Attorney Docket No.: 56363-0012WO1

[0173] 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.

[0174] 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 rail 106 and sheath 112 can be further advanced out of the guide catheter 102 until the stabilization rail 106 and sheath 112 bow outwardly with respect to the central axis 156 of the guide catheter 102 to form generally curved shapes. The rail 106 and sheath 112 may be advanced until the rail 106 and sheath 112 push gently against the atrial septum 8 and the right atrial wall 29. Accordingly, the rail 106 and sheath 112 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 rail 106 and sheath 112 provide localized stability of the frame 124 within the heart 1. The rail 106 and sheath 112 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.

[0175] 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 theAttorney Docket No.: 56363-0012WO1

[0176] 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.

[0177] 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 trajectory7that 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).

[0178] 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 (e.g., perpendicular to the guiderail 110 as the guiderail 110 extends in the anterior-posterior direction). 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).

[0179] Referring to FIGS. 4A-G and 5G-I, with the frame 124 stabilized, the septal-lateral positioning of the positioning catheter 53 can be adjusted in relation to theAttorney Docket No.: 56363-0012WO1

[0180] 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 w ith the anterior-posterior adjustments of the delivery' catheter 52 and the positioning catheter 53 facilitate navigation to various positions in relation to the tncuspid valve 7. For example, the implant 51 can be adjusted into various positions for implantation betyveen leaflets 36, 37, and 38 of the tricuspid valve 7. The implant 51 can be positioned betyveen 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).

[0181] 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 loyvered 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.

[0182] Referring to FIGS. 1 A 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, 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 alloyv 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.

[0183] 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 someAttorney Docket No.: 56363-0012WO1

[0184] 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 varying 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.

[0185] Various controls of the manipulation tool 152 can be adjusted by the user to advance, retract, and rotate the guide catheter 102, rails 106, 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.

[0186] 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, sheath 112, and guidewire 114 terminate.

[0187] 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 sheath 112 axially moving the guidewire 114 axially, and rotating the guidewire 114. In some embodiments, mechanism 117a can move the sheath 112 axially and mechanism 117b can move the guiderail 110 axially.

[0188] The controls 152 also include a control assembly 119 at which the delivery catheter 52, adjustment wire 59, and adjustment catheter 60 terminate. The controls 152 also include a control assembly 121a at which the positioning catheter 53 terminates. The control assembly 121a facilitates axially positioning the positioning catheter 53 and rotating the positioning catheter 53. The controls 152 also include a control assembly 123 at which the positioning catheter 53 terminates. Accordingly,Attorney Docket No.: 56363-0012WO1

[0189] the control assembly 123 includes mechanisms 125a that facilitate actuating the adjustment wire 59 to allow the positioning catheter 53 to deflect away from the guiderail 110. In some embodiments, the control assembly 127 can be translated (e.g., proximally or distally) to control the position of the deployment catheter 56.

[0190] The controls 152 also include a control assembly 127 at which the deployment catheter 56 terminated. Accordingly, the control assembly 127 includes mechanisms 129a-d for respectively opening and closing the gripping arms 65, actuating the detangling sutures 71, opening and closing the clipping arms 69, 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). Additionally, the entire control assembly 127 can actuate to control the deployment catheter 56. In some embodiments, the mechanisms 129a-b can open and close the gripping arms 65, the mechanism 129c can actuate the detangling sutures 71, and the mechanism 129d can open and close the clipping arms 69. Referring to FIGS. 7A-D, the imaging catheter 190 can be utilized to track and visualize the components of the transcatheter delivery system 150 such as the implant 51, the implantation system 50, and deployment tool 100. The ICE catheter 190 can be inserted through the guide catheter 102 and separated from the implant 51 to create a field of view 193 that is oriented towards the implant 51 to visualize the implant 51 throughout the implantation process. The ICE catheter 190 can also generate a cartesian coordinate system 195 including three planes that facilitate precise imaging of the implant 51, the plantation system 50, and the deployment tool 100 during the procedure.

[0191] 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 ofAttorney Docket No.: 56363-0012WO1

[0192] the implant 51 (e.g., strength of connection, slippage, drift), tricuspid regurgitation, right ventricular dilation, among other performance parameters.

[0193] 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.

[0194] 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.

[0195] 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.

[0196] 7B-C, 7G).

[0197] 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 between 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.Attorney Docket No.: 56363-0012WO1

[0198] 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.

[0199] 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 along a central axis 67 of the head 64.

[0200] In some embodiments, the gripping control w ires 66 have a diameter of about 0.12 mm to about 0.26 mm (e.g.. about 0.15 mm). In some embodiments, the gripping control wires 66 are constructed as a solid wire, a braided fiber, or a multilayer cable. Example materials from which the gripping control wires 66 may be made include nitinol (e.g., for a wire construction), stainless steel (e.g., for a cable construction), and ultra-high molecular weight polyethylene (e.g., for a braided construction). The gripping control arms 66 are typically flexible and slippery.

[0201] 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 downward 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 towards the radially extended clipping arms 69Attorney Docket No.: 56363-0012WO1

[0202] (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).

[0203] 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.

[0204] 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 atrium 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.

[0205] 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 pulled upwards as illustrated in the sequence from FIG. 10A to FIG. 10C. 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. 10C 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.

[0206] 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 adjustmentAttorney Docket No.: 56363-0012WO1

[0207] 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 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.

[0208] 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 71b 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 pulled 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.

[0209] 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 theAttorney Docket No.: 56363-0012WO1

[0210] 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.

[0211] Referring to FIGS. 13A-G an implant 1351 is illustrated that shares features with implant 51. The implant 1351 also includes translating grippers 1369 that are slidable along the clipping arms 1365. The clipping arms 1369 can be extended radially to engage the leaflets 36, 37, 38 of the tricuspid 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 dow n and sandwich a leaflet between the gripping arms of the grippers 1369.

[0212] In FIG. 13 A, 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 anext 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 anext 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.

[0213] Referring now to FIGS. 14A-B, some embodiments of an implant 1451 can provide improved control options for opposing clipping arms. As shown in FIGS. 14A-B, the implant 1451 can share some features with above-described implant 51 and / or implant 1351, and the implant 1451 in this embodiment includes additional structural features. The implant 1451 includes respective clipping arms 1465a, 1465b that are independently controllable between a retracted position (e g., both armsAttorney Docket No.: 56363-0012WO1

[0214] retracted in FIG. 14A) and an extended position (see one clipping arm 1465 partially extended in FIG. 14B). The implant 1451 includes a central hub 1468 positioned at the distal end of the implant 1451. The central hub 1468 connects to each respective clipping arm 1465a, 1465b on opposing sides of the central hub 1468. The implant 1451 includes a first clip actuator 1469a and a second clip actuator 1469b that are connected to the respective clipping arms 1465 a, 1465b that independently control the positions of each clipping arm 1465a, 1465b. In some embodiments, the implant 1451 can be controlled and implemented in the transcatheter delivery system 150. For example, the first clip actuator 1469a and the second clip actuator 1469b can be configured to extend through the transcatheter delivery system 150 for control at manipulation tool 152.

[0215] In some embodiments, the implant 1451 includes a plurality of hinges that facilitate independent actuation and control of each clipping arm 1465. For example, the central hub 1468 has a first hub hinge 1471a connected to the first clip element 1465a. The first hub hinge 1471a connects to the first clip element 1465a at a position spaced apart from a base 1472a of the first clip element 1465a. The first clip element 1465a has a first clip hinge 1473a at the base 1472a of the first clip element 1465a. The first clip hinge 1473a is connected to a distal end 1474a of the first clip actuator 1469a. The first clip actuator 1469a has a first clip actuator hinge 1475a spaced apart from the distal end 1474a of the first clip actuator 1469a.

[0216] In some embodiments, the central hub 1468 has a second hub hinge 1471b connected to the second clip element 1465b. The second hub hinge 1471b connects to the second clip element 1465b at a position spaced apart from abase 1472b of the second clip element 1465b. The second clip element 1465b has a second clip hinge 1473b at the base 1472b of the second clip element 1465b. The second clip hinge 1473b is connected to a distal end 1474b of the second clip actuator 1469b. The second clip actuator 1469b has a second clip actuator hinge 1475b spaced apart from the distal end 1474b of the second clip actuator 1469b.

[0217] In some embodiments, independent proximal actuation of the first clip actuator 1469a can cause the distal end 1463a of the first clip element 1465a to deflect laterally outward and away from the central hub 1468. The outward deflection of the first clip element 1465a can facilitate contract with one or more leaflets (e.g., the leaflets 36, 37). Independent proximal actuation of the first clip actuator causes the first clip actuator hinge 1475a to translate proximally and the distal end 1474a of theAttorney Docket No.: 56363-0012WO1

[0218] first clip actuator 1469a to deflect laterally. In some embodiments, the first clip element 1465a rotates about first hub hinge 1471a during the lateral deflection of the distal end 1463a. While partial translation of the first clip element 1465a and first clip actuator 1469a are shown in FIG. 14B, the second clip element 1465b and second clip actuator 1469b can independently operate in a similar manner.

[0219] Referring to FIGS. 14C-F, the implant 1451 can be configured for independent clip actuation. For example, in FIG. 14C, the grippers 1469 and clip elements 1465a-b are in an open configuration where the grippers 1469 are positioned inward (e.g., towards a central axis 1467 of the implant 1451). FIG. 14D shows a next step of an independent clip actuation process where the implant 1451 is in an open configuration with one of the grippers 1469 open and the other gripper 1469 beginning to actuate towards a leaflet (e.g., leaflet 37) and the clip element 1469a. FIG. 14E shows a next step of an independent clip actuation process where the implant 1451 has one side engaged with leaflet and the first clip element 1465 a beginning to actuate towards the axis 1467 with the gripping element 1469 engaged with the leaflet 37. FIG. 14F shows a next step of an independent clip actuation process where the implant 1451 has one side engaged with leaflet and the first clip element 1465a actuated towards the axis 1467 with the gripping element 1469 engaged with the leaflet 37.

[0220] Referring now to FIGS. 15A-C, some embodiments of an implant 1551 can include an improved options the permit deployment of the clipping arms at chordal regions of the valve leaflets. As shown in FIGS. 15A-C, the implant 1551 can share some structural features with the above-described implants 51, 1351, and / or 1451. For example, the implant 1551 can be compatible with the transcatheter delivery system 150, which can be used to position and control the implant 1551 during an implantation process. The implant 1551 includes a central hub 1568 and clipping arms 1565 that are configured to extend from the central hub 1568 to engage with one or more leaflets (e.g., the leaflets 36, 37). The central hub 1568 can connect to the clipping arms 1565 via a threaded connection that facilitates rotation of the central hub 1568.

[0221] In some embodiments, the positions of the clipping arms 1565 are controllable using control wires 1571a and 1571b. The control wires 1571a and 1571b can facilitate the control of both clipping arms 1565 by actuating the clipping arms 1565. For example, the control wires 1571a, 1571b can actuate the clipping arms 1565 between an expanded position where the clipping arms extend outwardly from theAttorney Docket No.: 56363-0012WO1

[0222] central hub 1568 and a collapsed position where the clipping arms 1565 are retracted inwardly towards the central hub 1568.

[0223] The implant 1551 is configured to engage with a deployment tool 1561. The deployment tool 1561 can interface with the implant 1551 to actuate the control wires 1571a, 1571b. The deployment tool 1561 has a shaft 1562 and a tool interface 1563 at a distal end of the deployment tool 1561. The implant 1551 can have an actuator interface 1569 at a proximal end of the implant 1551 that is configured to engage with the tool interface 1563 of the deployment tool 1561. For example, the actuator interface 1569 can be a keyed connection that interfaces with the tool interface 1563 at the distal end of the deployment tool 1561. The deployment tool 1561 is configured to disengage from the implant 1551 when the implant 1551 is in an implanted position.

[0224] In some embodiments, the deployment tool 1561 is configured to actuate the clipping arms 1565 between an expanded position and a collapsed position. The tool interface 1563 can engage with the actuator interface 1569 so that the deployment tool 1561 can transfer rotational motion of the deployment tool 1561 to the central hub 1568. The deployment tool 1561 is configured to rotate the central hub 1568 and control a tensile force on the control wires 1571a, 1571b to control a position of the clipping arms 1565 between the expanded position and the collapsed position. For example, rotation of the central hub 1568 in a first direction extends the control wires 1571a, 1571b to actuate the clipping arms 1565 into the expanded position. Rotation of the central hub 1568 in a second direction retracts the control wires 1571a, 1571b to actuate the clipping arms 1565 into the collapsed position.

[0225] In some embodiments, the implant 1551 is designed to be implanted at chordal regions (e g., as opposed to chord-free regions) of the valve leaflets. Control of the clipping arms 1565 between the expanded and collapsed positions facilitate easier delivery' and facilitate detangling during instances of high chordal density. The implant 1551 can effectively negotiate (e.g.. manipulate around and through) these areas to provide improved positioning and secure implantation.

[0226] The clipping arms 1565 are stabilized at each position between the expanded position and the collapsed position. In some embodiments, the control wires 1571a, 1571b maintain a tensile force on the clipping arms 1565 at the expanded position, the collapsed position, and positions therebetween to provide rigid engagement with the implant 1551 in all orientations of the implant 1551.Attorney Docket No.: 56363-0012WO1

[0227] Referring to FIGS. 16A-H, some embodiments of an implant 1651 can provide rotation of clipping arm orientation (e.g., using ball joint connections) so as to reduce the likelihood of chordal entanglement during deployment to an underside of the opposing leaflets. As shown in FIGS. 15A-C, the implant 1651 shares some structural features with the above-described implants 51, 1351, 1451, and / or 1551. For example, the implant 1651 can be compatible with the transcatheter delivery system 150, which can be used to position and control the implant 1651 during an implantation process. The implant 1651 can include a hub 1652 at a distal end of the implant 1651. In some embodiments, the hub 1652 is configured to rotate (e.g., with respect to an outer delivery' catheter 52). The implant 1651 can include a frame 1653 having proximal arms 1653a and distal arms 1653b. The implant 1651 also includes a first grip element 1669 moveable in relation to the frame 1653 and a second grip element 1669b moveable in relation to the frame 1653.

[0228] In some embodiments, the proximal arms 1653a and distal arms 1653b are connected to each other by ball joints 1654 positioned between the proximal arms 1653a and distal arms 1653b. The distal arms 1653b can be connected to the hub 1652 at ball joints 1655 between the rotating hub 1652 and the distal arms 1653b. The ball joints 1654, 1655 facilitate rotation of the implant 1651 and manipulation of the implant 1551 between an extended position and a collapsed position. The implant 1651 is configured to actuate between an extended position and an engagement position, and, in the engagement position, the first and second grip elements 1669a, 1669b respectively grasp and hold together a first portion of a heart and a second portion of the heart (e.g., leaflets) to securely close a gap between the first and second portions of the heart.

[0229] FIGS. 16A and 16B show the implant 1651 in the extended position, where the proximal arms 1653a and the distal arms 1653b are retracted inwardly towards a central axis 1656 of the implant 1651. In the extended position, the inner delivery' catheter 53 (e.g., connected to the hub 1652) can be extended so that the proximal arms 1653a and the distal arms 1653b are retracted inwardly.

[0230] FIGS. 16C and 16D show the therapeutic device is configured to actuate into an intermediate position between the extended position and the engagement position. In the intermediate position, distal ends of the proximal arms 1653a are deflected laterally outward from the central axis 1656 and proximal ends of the distal arms 1653b are deflected laterally outward from the central axis 1656. To transition fromAttorney Docket No.: 56363-0012WO1

[0231] the extended position to the intermediate position, the inner delivery' catheter 53 can be actuated proximally to translate the hub 1652 proximally and deflect the distal ends of the proximal arms 1653a and the proximal ends of the distal arms 1653b laterally outwards. The outer delivery' catheter 52 can also be rotated less than 90 degrees from the expanded position to the intermediate position.

[0232] FIG. 16E shows the implant 1651 in an intermediate position before the grippers 1669 are actuated into contact with the frame 1653. From FIG. 16D, the inner delivery catheter 53 and the outer delivery' catheter 52 are rotated to 90 degrees to achieve the position illustrated. FIG. 16F shows the implant 1651 in a closed position with the grippers 1669 actuated towards the frame 1653 and with the frame 1653 extended. FIG. 16G shows the implant 1651 in a closed configuration with the grippers 1669 closed and the frame 1653 closed.

[0233] 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 density7. The implants described herein can effectively negotiate (e.g., manipulate around and through) these areas to provide improved positioning and secure implantation.

[0234] While the transcatheter delivery systems, deployment tools, implantation systems, and manipulation tools discussed herein have been described and illustrated with respect to certain dimensions, sizes, shapes, arrangements, materials, components, and methods, in some embodiments, a transcatheter delivery’ system, deployment tool, implantation system, or manipulation tool that is otherwise substantially similar in construction and function to any' of the transcatheter delivery systems, deployment tools, implantation systems, and manipulation tools discussed herein may include one or more different dimensions, sizes, shapes, arrangements, configurations, materials, and components, or may be utilized according to different methods.Attorney Docket No.: 56363-0012WO1

[0235] A number of embodiments of the invention have been described.

[0236] 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

1. Attorney Docket No.: 56363-0012WO1WHAT IS CLAIMED IS:

1. A cardiac therapeutic device comprising:a central hub;a first clip element coupled to a first side of the central hub;a first clip actuator connected to the first clip element and moveable in relation to the first clip element and the central hub;a second clip element coupled to a second side of the central hub; and a second actuator connected to the second clip element and moveable in relation to the second clip element and the central hub;wherein the first clip actuator and the second clip actuator independently control respective positions of the first and second clip elements.

2. The cardiac therapeutic device of claim 1, wherein the central hub has a first hub hinge connected to the first clip element.

3. The cardiac therapeutic device of claim 2, wherein the first hub hinge connects to the first clip element at a position spaced apart from a base of the first clip element.

4. The cardiac therapeutic device of claim 3, wherein the first clip element has a first clip hinge at a base of the first clip element that is connected to a distal end of the first clip actuator.

5. The cardiac therapeutic device of claim 4, wherein the first clip actuator has a first clip actuator hinge spaced apart from the distal end of the first clip actuator.

6. The cardiac therapeutic device of claim 5. wherein independent proximal actuation of the first clip actuator causes the distal end of the first clip element to deflect laterally outward.

7. The cardiac therapeutic device of claim 6, wherein independent proximal actuation of the first clip actuator causes the first clip actuator hinge to translate proximally and the distal end of the first clip actuator to deflect laterally.Attorney Docket No.: 56363-0012WO18. The cardiac therapeutic device of claim 1. wherein the central hub has a second hub hinge connected to the second clip element.

9. The cardiac therapeutic device of claim 8, wherein the second hub hinge connects to the second clip element at a position spaced apart from a base of the second clip element.

10. The cardiac therapeutic device of claim 9, wherein the second clip element has a second clip hinge at a base of the second clip element that is connected to a distal end of the second clip actuator.

11. The cardiac therapeutic device of claim 10, wherein the second clip actuator has a second clip actuator hinge spaced apart from the distal end of the first clip actuator.

12. The cardiac therapeutic device of claim 11, wherein independent proximal actuation of the second clip actuator causes the distal end of the second clip element to deflect laterally outward.

13. The cardiac therapeutic device of claim 12, wherein independent proximal actuation of the second clip actuator causes the second clip actuator hinge to translate proximally and the distal end of the second clip actuator to deflect laterally.

14. 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; actuating a first clip actuator to deflect a first clip element laterally outward from a central hub of the therapeutic device;Attorney Docket No.: 56363-0012WO1actuating a second clip actuator to deflect a second clip element laterally outward from a central hub of the therapeutic device;connecting the first and second clip elements of the therapeutic device to one or more leaflets of a valve of the heart; andretracting the deployment catheter from the therapeutic device while maintaining a suture connection between the therapeutic device and the deployment catheter.

15. The method of claim 14, wherein actuating first clip actuator in a proximal direction causes the distal end of the first clip element to deflect laterally outward.

16. The method of claim 14 or 15, w herein actuating first clip actuator in a proximal direction causes a first clip actuator hinge to translate proximally and a distal end of the first clip actuator to deflect laterally.

17. The method of any one of claims 14 to 16, wherein actuating second clip actuator in a proximal direction causes the distal end of the second clip element to deflect laterally outw ard.

18. The method of any one of claims 14 to 17. wherein actuating second clip actuator in a proximal direction causes a second clip actuator hinge to translate proximally and a distal end of the second clip actuator to deflect laterally.

19. The method of any one of claims 14 to 18. wherein the first clip actuator and the second clip actuator independently control respective positions of the first and second clip elements.

20. A transcatheter delivery system for implanting a therapeutic device at a heart, the transcatheter deliver}' system comprising:a therapeutic device comprising:a central hub;grip elements extending from the central hub;grip element control wires that extend through the hub and to each of the grip elements: andAttorney Docket No.: 56363-0012WO1a deployment tool having a shaft and a tool interface at a distal end of the deployment tool, the tool interface being configured to engage with a proximal end of the therapeutic device;wherein the deployment tool is configured to rotate the central hub and control a tensile force on the grip element control wires to control a position of the grip elements between an expanded position and a collapsed position.

21. The transcatheter delivery system of claim 20, wherein the deployment tool is configured to disengage from the therapeutic device when the therapeutic device is in an implanted position.

22. The transcatheter delivery system of claim 21, wherein a connection between the central hub and the grip elements is a threaded connection.

23. The transcatheter delivery system of claim 22. wherein the proximal end of the therapeutic device includes a keyed connection that interfaces with the distal end of the deployment tool.

24. The transcatheter delivery system of claim 21, wherein rotation of the central hub in a first direction extends the grip control wires to actuate the grip elements into the expanded position.

25. The transcatheter delivery system of claim 24, wherein rotation of the central hub in a second direction retracts the grip control wires to actuate the grip elements into the collapsed position.

26. The transcatheter delivery7system of claim 25, wherein the grip elements are stabilized at each position between the expanded position and the collapsed position.

27. The transcatheter delivery system of claim 21, wherein, in the collapsed position, the grip elements are collapsed inwardly towards the central hub.

28. The transcatheter delivery system of claim 27, wherein, in the expanded position, the grip elements are deflected outwardly away from the central hub.Attorney Docket No.: 56363-0012WO129. The transcatheter delivery system of claim 21. wherein the transcatheter delivery system is configured to (i) position the therapeutic device between leaflets of a valve of the heart, and (ii) retract the deployment tool from the therapeutic device when the therapeutic device is in an implanted position between leaflets of the valve of the heart.

30. The transcatheter delivery system of any one of claims 21 to 29, wherein the therapeutic device comprises a heart valve clip.

31. 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 tool and the therapeutic device axially or rotationally from the placement catheter and to a selected position within the heart;rotating the deployment tool to actuate the therapeutic device from a collapsed position to an expanded position;connecting one or more portions of the therapeutic device to one or more leaflets of a valve of the heart; andretracting the deployment tool from the therapeutic device.

32. The method of claim 31, further comprising positioning the distal end of the guide catheter within a right atrium of the heart.

33. The method of claim 31, wherein the therapeutic device comprises a tricuspid valve implant.

34. The method of any one of claims 31 to 33, further comprising positioning the distal end of the guide catheter within a left atrium of the heart.Attorney Docket No.: 56363-0012WO135. The method of claim 31, wherein the therapeutic device comprises a mitral valve implant.

36. The method of any one of claims 31 to 35, further comprising rotating a central hub of the implant in a first direction to actuate clip elements into the expanded position.

37. The method of any one of claims 36, wherein rotation of the central hub in a second direction actuates the clip elements into the collapsed position.

38. The method of any one of claims 31 to 37. 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.

39. The method of any one of claims 31 to 38. 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.

40. The method of any one of claims 31 to 39, wherein the distal end of the positioning catheter is connected to a distal end of the delivery catheter with one or more positioning wires.

41. The method of any one of claims 31 to 40, further comprising moving the distal end of the positioning catheter with one or more positioning wires.

42. The method of any one of claims 31 to 41, further comprising lowering the therapeutic device into a valve of the heart.

43. The method of claim 42, further comprising implanting the therapeutic device on the valve.

44. The method of any one of claims 31 to 43, further comprising:inserting the guide catheter percutaneously; andadvancing the guide catheter to the heart through a patient’s vasculature.Attorney Docket No.: 56363-0012WO145. A cardiac therapeutic device comprising:a hub at a distal end of the therapeutic device;a frame having proximal arms and distal arms, the proximal arms and distal arms are connected to each other by ball j oints positioned between the proximal arms and distal arms, the distal arms being connected to the rotating hub at ball joints between a rotating hub and the distal arms;a first grip element moveable in relation to the frame; anda second grip element moveable in relation to the frame;wherein the therapeutic device is configured to actuate between an extended position and an engagement position, and, in the engagement position, the first and second grip elements 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.

46. The cardiac therapeutic device of claim 45, wherein the cardiac therapeutic device is configured to be delivered to the heart through a catheter.

47. The cardiac therapeutic device of claim 45 or 46, wherein the cardiac therapeutic device comprises a heart valve implant.

48. The cardiac therapeutic device of any one of claims 45 to 47, 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.

49. The cardiac therapeutic device of any one of claims 45 to 48, wherein, in the engagement position, the first and second grip elements respectively grasp and hold together the first portion of the heart and a second portion of the heart between the first and second grip elements and the proximal arms of the frame.

50. The cardiac therapeutic device of any one of claims 45 to 49, wherein, in the engagement position, the first and second grip elements respectively grasp and holdAttorney Docket No.: 56363-0012WO1together the first portion of the heart and a second portion of the heart between the first and second grip elements and the proximal arms of the frame.

51. The cardiac therapeutic device of any one of claims 45 to 50, wherein, in the extended position, the proximal arms and the distal arms are retracted inwardly towards a central axis of the therapeutic device.

52. The cardiac therapeutic device of claim 51, wherein the therapeutic device is configured to actuate into an intermediate position between the extended position and the engagement position, and, in the intermediate position, distal ends of the proximal arms are deflected laterally outward from the central axis.

53. 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; anda 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;an implantation system movable axially within a lumen of the guide catheter, the implantation system comprising:an inner del i x ery catheter; andan outer delivery catheter;a therapeutic implant configured to connect to the implantation system, the therapeutic implant comprising:a rotating hub at a distal end of the therapeutic implant; a frame having proximal arms and distal arms, the proximal arms and distal arms are connected to each other at ball joints positioned between the proximal arms and distal arms;a first grip element moveable in relation to the frame; and a second grip element moveable in relation to the frame; 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)Attorney Docket No.: 56363-0012WO1control an orientation of the therapeutic implant between an extended position and an engagement position.

54. The transcatheter delivery system of claim 53, wherein the therapeutic implant is configured to be delivered to the heart through a catheter.

55. The transcatheter delivery system of claim 53 or 54, wherein the therapeutic implant comprises a heart valve implant.

56. The transcatheter delivery system of any one of claims 53 to 47, 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.

57. The transcatheter delivery' system of any one of claims 53 to 56, wherein, in the engagement position, the first and second grip elements respectively grasp and hold together the first portion of the heart and a second portion of the heart between the first and second grip elements and the proximal arms of the frame.

58. The transcatheter delivery system of any one of claims 53 to 57, wherein, in the engagement position, the first and second grip elements respectively grasp and hold together the first portion of the heart and a second portion of the heart between the first and second grip elements and the proximal arms of the frame.

59. The transcatheter delivery system any one of claims 45 to 50, wherein, in the extended position, the proximal arms and the distal arms are retracted inwardly towards a central axis of the therapeutic device.

60. The transcatheter delivery system of claim 59. wherein the therapeutic device is configured to actuate into an intermediate position between the extended position and the engagement position, and, in the intermediate position, distal ends of the proximal arms are deflected laterally outward from the central axis.

61. A transcatheter delivery system for implanting one or more cardiac therapeutic devices, comprising:Attorney Docket No.: 56363-0012WO1a 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.

62. 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.

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