Automated prosthetic heart valve delivery system and method

Abstract

Apparatuses and methods for delivering one or more parts of a valve prosthesis into a patient's heart. The apparatuses may include one or more catheters that are operationally coupled to one or more controls for controlling axial movement, rotational movement and / or deflection of the one or more catheters during the valve prosthesis delivery into the heart. The one or more controls may provide gross and fine movement control over multiple degrees of freedom of one or more catheter, thereby providing superior control for a practitioner during the valve prosthesis delivery procedure. The apparatuses and controls may be automated via robotics to carry out segments or the entirety of delivering the valve prosthesis into the patient's heart.

Description

AUTOMATED PROSTHETIC HEART VALVE DELIVERY SYSTEM AND METHODPRIORITY CLAIM

[0001] This patent application claims priority to U.S. provisional patent application no. 63 / 692,606, titled “AUTOMATED PROSTHETIC HEART VALVE DELIVERY SYSTEM AND METHOD,” and filed on September 9, 2025, which is herein incorporated by reference in its entirety.CROSS REFERENCE TO RELATED APPLICATIONS

[0002] This application is related to International Application No. PCT / US2023 / 068213, filed on June 9, 2023, entitled “PROSTHETIC HEART VALVE DELIVERY SYSTEM AND METHOD”, the entirety of which is incorporated herein by reference for all purposes.INCORPORATION BY REFERENCE

[0003] All publications and patent applications mentioned in this specification are herein incorporated by reference in their entirety to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference.BACKGROUND

[0004] Blood flow between heart chambers is regulated by native valves, i.e., the mitral valve, the aortic valve, the pulmonary valve, and the tricuspid valve. Each of these valves is a passive one-way valve that opens and closes in response to differential pressures. Patients with valvular disease have abnormal anatomy and / or function of at least one valve. For example, a valve may suffer from insufficiency, also referred to as regurgitation, when the valve does not fully close, thereby allowing blood to flow retrograde. Valve stenosis can cause a valve to fail to open properly. Other diseases may also lead to dysfunction of the valves.

[0005] The mitral valve, for example, sits between the left atrium and the left ventricle and, when functioning properly, allows blood to flow from the left atrium to the left ventricle while preventing backflow or regurgitation in the reverse direction. Native valve leaflets of a diseased mitral valve, however, do not fully close, causing the patient to experience regurgitation.- 1 -SG Docket No.: 10844-724.667

[0006] While medications may be used to treat diseased native valves, the defective valve may need to be repaired or replaced at some point during the patient’s lifetime.SUMMARY OF THE DISCLOSURE

[0007] Described herein are apparatuses (e.g., devices and systems) and methods for delivering one or more parts of a valve prosthesis into a patient’s heart. The apparatuses may include one or more catheters that are operationally coupled to one or more controls for controlling axial movement, rotational movement and / or deflection of the one or more catheters. The control(s) may provide gross and fine movement control over multiple degrees of freedom of the catheter(s), thereby providing superior control for a practitioner during the valve prosthesis delivery procedure. Furthermore, the controls may be automated to carry out a segment or entirety of the prosthetic valve delivery including positioning and positional feedback, failure mode risk mitigation, guide arm / anchor and valve control including steering, release and installation, valve plunge and deplunge, as well as removal of a defective valve. Automation may be implemented, for example, via motors, gearmotors, actuators, drives, and sensors integrated across the apparatuses, methods, and systems, including being coupled to catheters, carriages, locks, control handles, knobs, dials, buttons, etc.

[0008] According to some examples, a delivery system for a prosthetic heart valve, the prosthetic heart valve comprising an anchor adapted to be disposed in a ventricle adjacent a native valve of a patient’s heart and a frame supporting valve leaflets adapted to be expanded within the anchor, the delivery system comprises: an anchor control catheter adapted to be advanced into an atrium of the patient’s heart, the anchor control catheter comprising: a lumen extending from a proximal end to a distal end of the anchor control catheter, the lumen being sized and configured to slidingly contain the anchor; a distal guide arm in a distal portion of the anchor control catheter, at least a portion of the distal guide arm having an at- rest helical or spiral shape; and a proximal controller at the proximal end of the anchor control catheter, the proximal controller being configured to change a shape of the distal guide arm. The distal guide arm may have a proximal portion and a distal portion, the proximal portion comprising the portion of the distal guide arm having an at-rest helical or spiral shape. The proximal controller may comprise an actuator operatively connected to the anchor in the lumen of the anchor control catheter to move the anchor distally and proximally within the lumen to change the shape of the distal portion of the distal guide arm. The actuator may be connected to a tether which is removably connected to the anchor. The proximal controller may comprise an actuator operatively connected to the distal portion of- 2 -SG Docket No.: 10844-724.667the distal guide arm and adapted to change a shape of the distal portion of the distal guide arm. The actuator may be connected to an actuation catheter movably disposed within the lumen of the anchor control catheter, a distal end of the actuation catheter being connected to the distal portion of the distal guide arm. The proximal controller may comprise an actuator operatively connected to a proximal portion of the anchor control catheter and adapted to rotate the anchor control catheter. The distal guide arm may be sized and configured to move to a spiral shape within the atrium of the patient’s heart. The proximal controller may be further configured to extend the distal guide arm from the atrium through valve leaflets into the ventricle with the anchor disposed within the lumen. The proximal controller may be further configured to move a distal end of the distal guide arm within the ventricle to encircle chordae of the heart with the distal guide arm. The proximal controller may further be configured to withdraw the anchor control catheter from the anchor after the distal guide arm has encircled the chordae.

[0009] According to another example, a delivery system for a prosthetic heart valve, the prosthetic heart valve comprising an anchor adapted to be disposed in a ventricle adjacent a native valve of a patient’s heart and a frame supporting valve leaflets adapted to be expanded within the anchor, the delivery system comprises: a valve capsule, the valve frame being disposed within the valve capsule in a compressed configuration; a capsule shaft catheter connected to the valve capsule and extending proximally from the valve capsule; a valve retainer removably connected to the valve frame; and a proximal controller at a proximal end of the capsule shaft catheter, the proximal controller being configured to remove the capsule from the valve frame, thereby permitting the valve frame to expand. The delivery system may further comprise an inner steerable catheter disposed within a lumen of the capsule shaft catheter and an inner catheter steering control line extending from a distal portion of the inner steerable catheter to the proximal controller, the proximal controller being further configured to apply and release tension on the inner catheter steering control line. The delivery system may further comprise an outer steerable catheter and an outer catheter control line extending from a distal portion of the outer steerable catheter to the proximal controller, the proximal controller being further configured to apply and release tension on the outer catheter control line, the capsule shaft catheter being disposed in a lumen of the outer steerable catheter. The capsule shaft catheter may include multiple axial sections having different stiffnesses, thereby providing different degrees of deflection when activated. When the capsule shaft catheter is in a deflected state, the capsule shaft catheter may include a first bend and a second. The first bend may be configured to be in a right atrium of the patient’s heart and the second bend is configured to be within a left atrium of the patient's heart.- 3 -SG Docket No.: 10844-724.667

[0010] According to a further example, a track system is adapted to control movement of a catheter system for delivering at least a portion of a prosthetic heart valve into a patient’s heart, wherein the catheter system includes a first catheter coaxially arranged with a second catheter, the track system comprising: a primary track and a secondary track positioned in parallel; a first carriage adapted to secure a proximal portion of the first catheter thereto and to translate along the primary track, wherein the first carriage is coupled to the secondary track such that the secondary track translates with the first carriage when the first carriage translates along the primary track; and a second carriage adapted to secure a proximal portion of the second catheter thereto and to translate along the primary track, wherein the second carriage includes a coupler that is adapted to selectively engage the second carriage with the secondary track such that, when the coupler is engaged, the second carriage translates with the first carriage when the first carriage translates along the primary track. The first carriage may include a fastener that is configured to transition between: a first closed state in which the proximal portion of the first catheter is frictionally secured to the first carriage, wherein the first catheter is maintained at an intended rotational position but is rotatable with respect to the first carriage; and a second closed state in which the proximal portion of the first catheter is fully secured to and not rotatable with respect to the first carriage. The track system may further comprise a third carriage adapted to secure a proximal portion of a third catheter thereto and to translate along the primary track, wherein the third carriage includes a second coupler that is adapted to selectively engage the third carriage with the secondary track such that, when the second coupler is engaged, the third carriage translates with the first carriage when the first carriage translates along the primary track. The first carriage may include a first fastener configured to releasably secure the proximal portion of the first catheter thereto, and the second carriage includes a second fastener configured to releasably secure the proximal portion of the second catheter thereto, wherein each of the first and second fasteners are configured to releasably secure a proximal portion of a different catheter thereto. The coupler may be adapted to disengage the second carriage from the secondary track such that, when the coupler is disengaged, the second carriage translates independently from the first carriage. The coupler may be disengaged in a default state. The track system may further comprise a rail that supports the primary and secondary tracks in parallel. The first carriage may include a first gear assembly adapted to translate the first carriage along the primary track, and wherein the second carriage includes a second gear assembly adapted to translate the second carriage along the primary track. The first catheter may be slidably positioned within the second catheter. The second catheter may be slidably positioned within the first catheter. The second carriage may include a button adapted to engage and disengage- 4 -SG Docket No.: 10844-724.667the coupler. Each of the first and second carriages may include a gear assembly that is configured to engage with teeth of the primary track when the respective first or second carriage translates along the primary track. Each of the first and second carriages may include a dial that is configured to translate the respective first or second carriage along the primary track upon rotation of the dial. Each of the first and second carriages may comprise a lock to lock a translational position of the first or second catheter relative to the primary track.

[0011] According to another example, a method of delivering an anchor of a prosthetic heart valve into a patient’s heart, the method comprises: advancing an anchor control catheter into an atrium of the patient’s heart, the anchor control catheter having a distal guide arm, wherein the anchor is slidably positioned within the anchor control catheter; advancing the guide arm through a native valve annulus and into a ventricle of the patient’s heart, wherein the guide arm has a first shape and a distal end; and rotating the guide arm to capture chordae near the native valve annulus with the distal end of the guide arm, wherein capturing the chordae comprises moving the anchor within the guide arm such that the anchor applies a force against the guide arm to change the first shape of the guide arm to a second shape and to change a distance to which the distal end of the guide arm radially extends. Changing the first shape of the guide arm to the second shape may comprise changing a radius of curvature of the distal end of the guide arm. The anchor control catheter may be positioned with a steerable catheter having a deflected configuration when the guide arm is capturing the chordae, wherein capturing the chordae further comprises adjusting the steerable catheter to alter a position of the guide arm within the ventricle. The guide arm may comprise a proximal end extending generally along a first axis, and wherein the distal end of the guide arm is in a plane that is substantially perpendicular to the first axis, and further wherein the change in distance is with respect to the first axis. Each of the first and second shapes of the guide arm may have a helical shape or a spiral shape.

[0012] According to an additional example, a delivery system for delivering an anchor of a prosthetic heart valve into a patient’s heart comprises: a catheter assembly having the anchor slidably positioned within an anchor control catheter, wherein the anchor control catheter is slidably positioned within a steerable catheter, wherein a distal portion of the anchor control catheter includes a guide arm with a distal end; and a controller coupled to a proximal portion of the anchor control catheter, wherein the controller comprises: a first control configured to apply a pre-load force the guide arm while the guide arm is within the steerable catheter such that the guide arm self-assembles into a spiral or helical shape when the guide arm is advanced out of the steerable catheter; and a second control configured to move the anchor within the guide arm to apply force against the guide arm that changes a - 5 -SG Docket No.: 10844-724.667distance to which the distal end of the guide arm radially extends. The controller may further comprise a third control configured to control an axial height of the guide arm relative to the steerable catheter. The third control may be part of a carriage that is releasably coupled to the proximal portion of the anchor control catheter, wherein the third controller is configured to translate the proximal portion of the anchor control catheter on a rail relative to a proximal portion of the steerable catheter.

[0013] According to a further example, a system for controlling movement of a catheter for delivering at least a portion of a prosthetic heart valve into a patient’s heart comprises: a handle coupled to a proximal portion of the catheter, the handle comprising a control configured to control deflection of a distal portion of the catheter; and a carriage including a fastener that is configured to secure the handle to a support, the fastener including a band that is configured to surround the handle to secure the handle to a cradle, wherein the fastener is configured to transition among: an open state in which the band is in an open position such that the handle can be removed from the cradle; a first closed state in which the band loosely surrounds the handle, and the handle is frictionally secured to the cradle at an intended rotational position but is rotatable with respect to the carriage; and a second closed state in which the band securely surrounds the handle such that the handle is rotatably fixed with respect to the carriage. The support may include a track system that is configured to allow translation of the carriage with the handle fastened thereto to allow axial movement of the distal portion of the catheter. The handle may be a first handle coupled to a first catheter, and the carriage may be a first carriage, wherein the system may further comprise: a second handle coupled to a proximal portion of a second catheter that is coaxially aligned with the first catheter; and a second carriage that is configured to secure the second handle to the track system, wherein the first and second carriages are configured to independently translate along the track system to cause independent axial movement of the distal portions of the first and second catheters. The track system may be configured to selectively allow coupled translation of the first and second carriages together along the track system to cause coupled axial movement of the distal portions of the first and second catheters. The cradle may include one or more engagement features that is configured to frictionally engage with corresponding features of the handle to maintain the in handle in the intended rotational position.

[0014] According to an additional example, a delivery system adapted to deliver an anchor of a prosthetic heart valve into a patient’s heart comprises: an anchor control catheter having a distal guide arm that is configured to take on a spiral or helical shape, wherein the anchor is slidably positioned within the anchor control catheter; and a handle coupled to a proximal portion of the anchor control catheter, wherein the handle includes: a first control - 6 -SG Docket No.: 10844-724.667that is configured to bias the distal guide arm toward the spiral or helical shape; and a second control that is configured to axially move the anchor within the anchor control catheter to change an extent to which a distal end of the distal guide arm radially extends. The second control may be configured to radially extend the distal end of the distal guide arm to capture chordae of the patient’s heart, thereby allowing encircling of the distal guide arm around the chordae. The delivery system may further comprise a steerable catheter in which the anchor control catheter is slidably positioned within, where the first control is configured to bias the distal guide arm toward the spiral or helical shape while the distal guide arm is within the steerable catheter. The delivery system may further comprise a second handle coupled to the steerable catheter, wherein the second handle includes a deflection control that is configured to selectively deflect a distal portion of the steerable catheter to steer the distal guide arm within the patient’s heart. The delivery system may further comprise a second handle coupled to the steerable catheter, wherein the second handle is translatable with respect to the first handle to axially retract a distal portion of the steerable catheter with respect to the distal guide arm to allow the distal guide arm to be released from the steerable catheter and take on the spiral or helical shape. The delivery system may further comprise a rail system comprising a first carriage configured to fasten the first handle to the rail system and a second carriage configured to fasten the second handle to the rail system, wherein the first and second carriages are translatable along a track.

[0015] According to another example, a method of delivering an anchor of a prosthetic heart valve into a patient’s heart comprises: advancing a catheter system into the atrium of the patient’s heart, wherein the catheter system includes an anchor control catheter positioned within a steerable catheter, wherein the anchor is positioned within the anchor control catheter, and wherein the anchor control catheter includes a distal guide arm; biasing the distal guide arm toward a spiral or helical shape while the distal guide arm is within the steerable catheter; and advancing the distal guide arm such that the distal guide arm exits a distal end of the steerable catheter and takes on the spiral or helical shape. Biasing the distal guide arm may comprise activating a control of a handle coupled to a proximal portion of the anchor control catheter. The method may further comprise advancing the distal guide arm through a native valve annulus by translating the handle along a rail system. The method may further comprise encircling chordae near the native valve annulus with the distal guide arm, wherein encircling the chordae comprises changing an extent to which a distal end of the guide arm radially extends by axially moving the anchor within the distal guide arm. The method may further comprise retracting the distal guide arm over the anchor to release the- 7 -SG Docket No.: 10844-724.667anchor from the distal guide arm, wherein retracting the distal guide arm comprises translating the handle along the rail system.

[0016] According to an additional example, a delivery system adapted to deliver a prosthetic heart valve into a patient’s heart comprises: a steerable catheter having a distal valve capsule configured to hold a frame of the prosthetic valve therein; and a handle coupled to a proximal portion of the steerable catheter, wherein the handle includes: a valve deployment knob that is configured to control retraction the distal valve capsule with respect to the frame to release at least a portion of the frame from the steerable catheter; a depth control knob that is configured to control axial movement of the distal portion of the steerable catheter; and a deflection knob that is configured to control deflection of the distal portion of the steerable catheter. The handle may be translatably coupled to a track system, wherein the track system includes a translation control that is configured to translate the handle to control gross axial movement of the distal portion of the steerable catheter. The steerable catheter may include multiple axial sections having different degrees of flexibility, wherein deflection of the steerable catheter causes the distal portion of the steerable catheter have a first bend and a second bend separated by a reach section of the steerable catheter.

[0017] According to a further example, a method of delivering ca prosthetic heart valve into a patient’s heart comprises: advancing a steerable catheter over a guide wire into an atrium of the patient’s heart, the steerable catheter having a proximal portion coupled to a handle and a distal portion having a valve capsule holding a frame of the prosthetic heart valve therein, wherein advancing the steerable catheter into the atrium comprises translating the handle with respect to a support translatably coupled to the handle; steering the valve capsule toward a native valve annulus of the patient’s heart by deflecting the steerable catheter, wherein the deflecting comprises activating a deflection knob of the handle; advancing the valve capsule partially through the native valve annulus of the patient’s heart by activating a depth control knob of the handle; and releasing the frame of the prosthetic heart valve into the native valve annulus by activating a valve deployment knob of the handle that retracts the valve capsule with respect to the frame, wherein the frame expands into the native valve annulus and within an anchor that encircles chordae near the native valve annulus. The method may further comprise: releasing a ventricle side of the frame within the ventricle of the patient’s heart by activating the valve deployment knob of the handle; and pulling the ventricle side of the frame toward the native valve annulus to position the anchor closer to the native valve annulus by activating the depth control knob. The steerable catheter may be in a deflected state when pulling the ventricle side of the frame toward the native valve annulus, wherein the steerable catheter includes a first bend within a right atrium of the- 8 -SG Docket No.: 10844-724.667patient’s heart and a second bend within a left atrium of the patient's heart. The support may include a rail system, wherein the handle is coupled to the rail system by a carriage that is translatably coupled to a track, wherein translating the handle comprises activating a dial of the carriage to translate the carriage with respect to the track.

[0018] According to another example, a method of delivering a prosthetic heart valve into a patient’s heart comprises: advancing a steerable catheter over a guide wire into an atrium of the patient’s heart, the steerable catheter having a proximal portion coupled to a handle and a distal portion having a valve capsule holding a frame of the prosthetic heart valve therein, wherein advancing the steerable catheter into the atrium comprises translating the handle with respect to a support translatably coupled to the handle; advancing the valve capsule partially through a native valve annulus of the patient’s heart by activating a depth control knob of the handle, wherein an anchor of the prosthetic heart valve encircles chordae near the native valve annulus; releasing a ventricle side of the frame within a ventricle of the patient’s heart by activating a valve deployment knob of the handle; pulling the ventricle side of the frame toward the native valve annulus to position the anchor closer to the native valve annulus by activating the depth control knob of the handle; and releasing an atrium side of the frame within the atrium of the patient’s heart by activating the valve deployment knob of the handle to fully retract the valve capsule with respect to the frame, wherein the frame expands into the native valve annulus and within the anchor. The anchor may be freely implanted within the patient’s heart while the ventricle side of the frame is pulled toward the native valve annulus. The anchor may not be coupled to a tether. The method may further comprise steering the valve capsule toward the native valve annulus by deflecting the steerable catheter, wherein the deflecting comprises activating a deflection knob of the handle. The steerable catheter may be in a deflected state when pulling the ventricle side of the frame toward the native valve annulus, wherein the steerable catheter includes a first bend within a right atrium of the patient’s heart and a second bend within a left atrium of the patient's heart. The support may include a rail system, wherein the handle is coupled to the rail system by a carriage that is translatably coupled to a track, wherein translating the handle comprises activating a dial of the carriage to translate the carriage with respect to the track.

[0019] According to an additional example, a method of delivering a prosthetic heart valve into a patient’s heart comprises: advancing an anchor delivery catheter system into the patient’s heart, wherein the anchor delivery catheter system includes an anchor slidably positioned within an anchor control catheter, and the anchor control catheter is slidably positioned within a steerable catheter, wherein a distal portion of the anchor control catheter includes a guide arm, wherein a proximal portion of the steerable catheter is coupled to a first - 9 -SG Docket No.: 10844-724.667handle and a proximal portion of the anchor delivery catheter is coupled to a second handle, wherein the first and second handles are translatably coupled to a rail system; implanting the anchor around chordae near a native valve of the patient’s heart, wherein implanting the anchor comprises translating the first handle along the rail system independent of the second handle; removing the anchor delivery catheter system from the rail system and coupling a valve delivery catheter system to the rail system, wherein a steerable catheter handle of the valve delivery catheter system is translatably coupled to the rail system, wherein the valve delivery catheter system includes a frame of the prosthetic heart valve therein; and advancing the valve delivery catheter into the patient’s heart and deploying the frame into the native valve of the patient’s heart and within the implanted anchor, wherein advancing the valve delivery catheter comprise translating the steerable catheter handle along the rail system. The first handle may be releasably coupled to a first carriage that is translatably coupled to the rail system, and wherein the second handle is releasably coupled to a second carriage that is translatably coupled to the rail system. Translating the first handle along the rail system may comprise translating the first carriage independent of the second carriage. The steerable catheter handle may be coupled to the first carriage or the second carriage. Implanting the anchor may further comprise unlocking a fastener that secures the second handle to the rail system, and rotating the second handle to rotate a guide arm at a distal end of the anchor control catheter, wherein rotating the guide arm comprise capturing chordae within the guide arm.

[0020] According to an additional example, a method for robotically controlling delivery of a prosthetic heart valve into a patient’s heart includes: advancing a steerable catheter over a guide wire into an atrium of the patient’s heart, the steerable catheter having a proximal portion coupled to a handle and a distal portion having a valve capsule holding a frame of the prosthetic heart valve therein, in which advancing the steerable catheter into the atrium includes robotically translating the handle with respect to a support translatably coupled to the handle; advancing the valve capsule partially through a native valve annulus of the patient’s heart by robotically activating a depth control knob of the handle, wherein an anchor of the prosthetic heart valve encircles chordae near the native valve annulus; releasing a ventricle side of the frame within a ventricle of the patient’s heart by robotically activating a valve deployment knob of the handle; pulling the ventricle side of the frame toward the native valve annulus to position the anchor closer to the native valve annulus by robotically activating the depth control knob of the handle; and releasing an atrium side of the frame within the atrium of the patient’s heart by robotically activating the valve deployment knob of- 10 -SG Docket No.: 10844-724.667the handle to fully retract the valve capsule with respect to the frame, in which the frame expands into the native valve annulus and within the anchor.

[0021] These and other examples are described herein.

[0022] All of the methods and apparatuses described herein, in any combination, are herein contemplated and can be used to achieve the benefits as described herein.BRIEF DESCRIPTION OF THE DRAWINGS

[0023] A better understanding of the features and advantages of the methods and apparatuses described herein will be obtained by reference to the following detailed description that sets forth illustrative embodiments, and the accompanying drawings of which:

[0024] FIGS. 1 A and IB show an example of a proximal robotic controller for an automated anchor delivery subsystem.

[0025] FIG. 2A illustrates automated movement of a proximal robotic controller for an automated anchor delivery subsystem.

[0026] FIG. 2B shows an example of a proximal controller for a valve delivery subsystem having an outer steerable catheter.

[0027] FIG. 3 shows another example of a proximal controller for a valve delivery subsystem.

[0028] FIGS. 4A-4B depict fastener of the proximal controller in a fully locked configuration, free-spinning configuration, and various integration mechanisms, respectively.

[0029] FIGS. 5A-5C shows a guide arm in a self-assembly position in which the distal portion of the anchor within the guide arm is deployed to a depth indicated by arrow 520 and the proximal portion of the anchor within the guide arm is deployed to a depth indicated by arrow 527.

[0030] FIGS. 6 A to 6V and 6-1 to 6-13 illustrate systems and methods for automated implanting of an anchor and a prosthetic mitral valve in a heart of a subject.DETAILED DESCRIPTION

[0031] This disclosure is directed to a delivery system for a prosthetic heart valve that has two main components: an anchor adapted to be disposed in a ventricle adjacent a native valve of a patient’s heart and a frame supporting prosthetic valve leaflets adapted to be delivered after delivery of the anchor and then expanded within the anchor. In particular, the valve is a prosthetic mitral valve, and the delivery system of this invention delivers the valve’s two components transeptally. In use, the delivery system advances distally from an entry point in- 11 -SG Docket No.: 10844-724.667the patient’s femoral vein, enters the right atrium of the heart, and passes through the septum into the left atrium to implant the anchor and then expand the valve frame inside the anchor.

[0032] Because the anatomy of the heart may differ from patient to patient, it may be desirable to be able to control the movement, position, and / or orientation of the delivery system while delivering and implanting the anchor and the valve frame. It may also be necessary to retrieve the anchor and / or the valve during implantation if their position is not quite right. The prosthetic valve delivery system of this invention therefore provides mechanisms for navigating the anchor and the valve and for controllably releasing the anchor and the valve when they have been correctly placed.

[0033] FIGS. 1 A and IB show an example of a proximal robotic carriage assembly or robotic controller 1000 for an automated valve prosthesis and anchor delivery subsystem. Aspects of the valve prosthesis and / or anchor delivery subsystem(s) are further illustrated and described in FIGS. 6A-6V. The robotic controller 1000 is configured to control and maneuver the prosthesis and anchor delivery subsystem to deliver an anchor and a prosthetic valve into a subject. In some aspects, the anchor can be delivered separately from the prosthetic valve. The valve anchor may be delivered with an anchor delivery catheter / subsystem, followed by delivery of the valve within the anchor with a separate valve delivery catheter / subsystem. The robotic controller may be compatible with both the anchor delivery catheter / subsystem and the valve delivery catheter / subsystem, as will be described in more detail below.

[0034] Control handles 1002, 1004 and 1006 are moveably mounted on a rail system 1020 (also referred to as a track system) via carriages 1003, 1005 and 1007, respectively. The rail system 1020 is fixedly coupled to a stabilizer 1008, which may be configured to support the rail system 1020 at an angle with respect to a horizonal axis (e.g., of the floor). In some cases, the stabilizer 1008 may include a knob 1011 (or other angle adjustment device) that is configured to adjust the angle of the rail system 1020 relative to the horizontal axis (e.g., floor). Such adjustment may be based, for example, on the position of the patient, the position of the user, or both. The stabilizer 1008 may include a flat bottom surface for placement on a flat surface of a support 1010, which may be as a stool or table. The vertical height of the proximal controller 1000 may be adjusted by placing the controller 1000 on a support 1010 having a different height, or placing the controller 1000 on an adjustable height support.

[0035] The first carriage 1003 includes a first dial 1013 that is configured to be rotated (e.g., with a motor or robotics system) to control distal and proximal movement of a first handle 1002, thereby controlling distal advancement and proximal retraction of an outer steerable catheter 14. The second carriage 1005 includes a second dial 1015 that is configured- 12 -SG Docket No.: 10844-724.667to be rotated (e.g., with a motor or robotics system) to control distal and proximal movement of a second handle 1004, thereby controlling distal advancement and proximal retraction of an inner steerable catheter 16. The third carriage 1007 includes a third dial 1017 that is configured to be rotated (e.g., with a motor or robotics system) to control distal and proximal movement of a third handle 1006, thereby controlling distal advancement and proximal retraction of an anchor control catheter 18 (the end of which includes a guide arm 82). Thus, the third dial 1017 may be configured to control an axial height of the guide arm 82 within the patient’s heart.

[0036] In some examples, one or more of the dials 1013, 1015 and 1017 and / or carriages 1003, 1005 and 1007 includes one or more robotically controlled locks to lock translational movement of the handles 1002, 1004 and / or 1006. The locks can be automatically actuated and / or controlled with the proximal robotic controller to lock or release translational movement of the handles as needed or required. This may act as a safety feature to prevent unintentional advancement and / or retraction of the outer steerable catheter 34, the inner steerable catheter 36 and / or the anchor control catheter 38, for example when in the patient’s body. In some cases, the default state of one or more of the dials 1013, 1015 and 1017 is to be locked such that it / they must be activated to be unlocked. For example, the dial 1013, 1015 and / or 1017 may be configured to be unlocked by pressing the of the dial 1013, 1015 and / or 1017 (or a portion of the dial 1013, 1015 and / or 1017) inward toward the rail system 1020 before the user is able to rotate the dial 1013, 1015 and / or 1017.

[0037] One or more of the dials 1013, 1015 and 1017 may be configured to provide independent and / or coordinated motion with one or more of the other dials 1013, 1015 and / or 1017 via the robotic controller. For example, when in an independent mode, the second dial 1013 may be configured to allow independent translation of the second carriage 1005 with respect to the first carriage 1003 and / or the third carriage 1007; and when in a coupled mode, the second dial 1013 may be configured to couple translational movement of the second carriage 1005 with translation of the first carriage 1003 and / or the third carriage 1007. The robotic controller can automatically select between the independent mode and the coupled mode depending on the stage of delivery. In this way, the catheters 14, 16 and / or 18 may be selected to be advanced and / or retracted independently or together. This may be useful in procedures that require independent translation of catheters 14, 16 and 18 during one or more parts of the anchor deployment process, but require coordinated movement between two or more of the catheters 14, 16 and 18 during one or more other parts of the anchor deployment process.- 13 -SG Docket No.: 10844-724.667

[0038] For example, the first dial 1013 of the first carriage 1003 includes a button (e.g., first button) 1063 that is configured to couple translational movement of the first carriage 1003 with translational movement of the second carriage 1005. When the button 1063 is activated (e.g., either automatically with the robotic controller, or upon being pressed by a user), rotation of the second dial 1015 of the second carriage 1005 causes both the first carriage 1003 and the second carriage 1005 to translate along the rail system 1020. Likewise, the third dial 1017 of the third carriage 1007 includes a button (e.g., second button) 1067 that is configured to couple translational movement of the third carriage 1007 with translational movement of the second carriage 1005. When the button 1067 is activated (e.g., either automatically with the robotic controller, or upon being pressed by a user), rotation of the second dial 1015 of the second carriage 1005 causes both the second carriage 1005 and the third carriage 1007 to translate along the rail system 1020. When both the buttons 1063 and 1067 are activated, rotation of the second dial 1015 of the second carriage 1005 causes all three of the first carriage 1003, the second carriage 1005 and the third carriage 1007 to translate along the rail system 1020. In some aspects, the physical buttons can be relocated from the robotic controller and instead incorporated into a console of the system, or removed entirely and controlled electronically by the controller.

[0039] One example in which coupled axial movement of the catheters 14, 16 and 18 / 82 may be useful is when the catheters 14, 16 and 18 / 82 are advanced together through the septum and into the atrium of the patient’s heart. When such coupled movement is desired, the buttons 1063 and 1067 may be activated and the dial 1015 may be rotated with the robotic controller to advance the catheters 14, 16 and 18 / 82 together in the heart. The dial 1015 may also be rotated (in the opposite direction as advancing) to retract the catheters 14, 16 and 18 / 82 together out of the atrium of the heart.

[0040] Fasteners 1032, 1034 and 1037 are configured to secure the handles 1002, 1004 and 1006, respectively, to the rail system 1020. The fasteners may be electronically or robotically controlled to lock or unlock the handles to the rail system. The fasteners may also be electronically controlled to apply a desired pressure or tightening to the handles. For example, the fasteners may be clamped enough to prevent the handles from sliding out of, or being removed from the fasteners, but still allow some degree of rotation within the fasteners. One or more of the fasteners 1032, 1034 and 1037 may also be configured to allow for rotational adjustment of the corresponding handles 1002, 1004 and 1006. For example, as shown in the closeup view of fastener 1034 in FIG. IB, the fastener 1034 includes a band 1044 (or ring) that is configured to surround an outer surface of the handle 1004. When the lever 1045 is moved to a locked position (e.g., with a motor, piston, or some other robotically- 14 -SG Docket No.: 10844-724.667controlled actuator coupled to the lever 1045 and causing the lever 1045 to pivot inward toward the band 1044), tension is applied on the band 1044, thereby constraining movement of the handle 1004 positioned within the band 1044. When the lever 1045 is moved to an unlocked position (e.g., by actuating the lever 1035 and causing the lever 1045 to pivot outward away from the band 1044), the tension is released from the band 1044, thereby allowing rotational movement of the handle 1004. Thus, when the fastener 1034 is in the unlocked position, the handle 1004 may be robotically controlled to rotate the corresponding catheter 16. In the example of proximal controller 1000, each of the fastener 1032, 1034 and 1037 is configured to automatically or robotically rotate corresponding handles 1002, 1004 and 1006, thereby allowing rotation of corresponding catheters 14, 16 and 18 (e.g., when in the patient’s body).

[0041] While the fasteners 1032, 1034, and 1037 are described above with an actuatable lever, it should be understood that other automated techniques can be used to constrain / release the handles within the fasteners. For example, in one embodiment, inflatables can be positioned within the bands 1044. Inflation of the inflatables can compress against the handles, preventing rotation of the handles with respect to the fasteners. In another embodiment, pins or locking mechanisms can be advanced and retracted from the fasteners to engage / di sengage with the handles. Any automated process for locking or unlocking the handles with respect to the fasteners is contemplated.

[0042] Each of the fasteners 1032, 1034 and 1037 may be configured to be in an open state in which the respective band is open such that the respective handle may easily be removed from the respective carriage. In addition, each of the fasteners 1032, 1034 and 1037 may be configured transition between a first closed state and a second closed state. For example, when the second fastener 1034 is in the first closed state, the proximal portion (e.g., handle 1004) of the catheter 36 is frictionally secured to the second carriage 1005 so the catheter 16 is maintained at an intended rotational position but is rotatable with respect to the second carriage 1005. For example, the cradle 1074 of the fastener 1034 can include one or more engagement features (e.g., indent(s), protrusion(s) and / or textured surface(s)) that is configured to frictionally engage with corresponding one or more features of the handle 1004 to maintain the rotational position of the handle 3004 when positioned in the fastener 1034. In the first closed state, the band 1004 may surround the handle 1004 but be loose enough so that the handle 1004 is rotatable with respect to the carriage 1005 (e.g., by a user’s hand). When the second fastener 1034 is in the second closed state, the band 1004 is fully sinched down such that the handle 1004 is fully secured to the carriage 1005 and is not rotatable with respect to the carriage 1005.- 15 -SG Docket No.: 10844-724.667

[0043] The handles 1002, 1004 and 1006 include rotational knobs 1022, 1024 and 1026, respectively, that are configured to deflect the distal portions of corresponding catheters 14, 16 and 18. The knobs 1022, 1024 and 1026 can be rotated (e.g., automatically controlled by the robotic controller) to deflect the distal portions of the catheters 14, 16 and / or 18 (e.g., each along a single plane), respectively, to steer the catheters 14, 16 and / or 18 through the patient’s vasculature. For example, the knob 1024 may be rotated to deflect (e.g., flex) the inner steering catheter 16 to control the position of the anchor control catheter 18 / guide arm 82 with respect to the patient’s anatomy. For instance, the knob 1024 can be rotated to flex the guide arm 82 toward the patient (“positive flex”) and / or away from the patient (“negative flex”).

[0044] The knob 1026 of the third handle 1006 may be controlled to “activate” the guide arm 82 to bias the guide arm to take on the helical or spiral shape (e.g., from a straight shape). Once the guide arm 82 is activated, the knob 1026 may be locked to continuously apply force and maintain the bias on the guide arm 82. In some examples, the guide arm 82 is activated while positioned within the inner steerable, which pre-loads the guide arm 82 such that the guide arm 82 self-assembles when the inner steerable catheter 16 is pulled proximally off the guide arm 82 to expose the guide arm 82. This may be referred to as “active” selfassembly since the guide arm is activated in order to allow the guide arm to self-assemble. Such pre-loading may allow the guide arm 82 to take on the helical or spiral shape within the confines of the atrium with minimal (or no) contact with the inner walls of the atrium.

[0045] A proximal knob 1018 of the third handle 1006 may be coupled to the tether (not shown), which is coupled to the anchor (also not shown) and used to position the anchor relative to the guide arm 82 (distal end of the anchor control catheter 18). For example, the knob 1018 may be rotatable in a first direction to retract the tether / anchor proximally and in a second direction to advance the tether / anchor distally. As described above with respect to FIGS. 5A-5C, the shape of the guide arm 82 (at the distal end of the anchor control catheter 18) may be determined, in part, by the extent to which the anchor is within the guide arm 82. As described previously, controlling distal and proximal movement of the anchor within the guide arm 82 may be used to control the shape of the guide arm 82 during positioning and encircling of the guide arm 82 around the chordae and / or leaflets.

[0046] The proximal knob 1018 of the third handle 1006 may also be used to maintain the position of the anchor during retraction of the guide arm 82 (via the anchor control catheter 38) over the anchor within the patient’s heart. For example, the proximal knob 1018 may be held fixed (e.g., by the user’s hand) and / or locked (using a lock of the knob 1018) to prevent axial movement of the anchor. This may be useful, for example, to hold the anchor- 16 -SG Docket No.: 10844-724.667steady while the dial 1017 is rotated to retract the guide arm 82 over the anchor. This procedure may be used to ensure that the anchor remains in a desired location and / or orientation around the chordae and / or leaflets as the guide arm 82 is being retracted. For example, this may compensate for any friction between guide arm 82 and the anchor. This may also compensate for any flexibility / compressibility differences between the guide arm 82 versus the anchor.

[0047] Each of the handles 1002, 1004 and 1006 may include flush ports 1064, 1066 and 1068, respectively. The flush ports 1064, 1066 and 1068 may provide access to the lumens of respective catheters 14, 16 and 18, for example, for saline flushing.

[0048] The various functions of proximal robotic controller 1000 may be automated, for example via control handle motors 1022 A, 1024 A, and 1026 A for automating control handle steering. The movement of carriages 1003, 1005, and 1007 on rail 1020 may also be automated via carriage dial motors 1003 A, 1005 A, and 1007A which may also automate locking, distal advancement, and proximal retraction of inner catheter 16, outer catheter 14, and anchor control catheter (ACC) 18 / guide arm 82, respectively. The angle of rail 1020 and control handles 1002, 1004, and 1006 and carriages 1003, 1005, and 1007 may be automatically adjusted via stabilizer knob motor 1011 A coupled to stabilizer knob 1011. Similarly, the vertical height of support 1010 and by extension, rail 1020, control handles 1002, 1004, and 1006, carriages 1003, 1005, and 1007 may be automatically adjusted via controller support motor 1010A coupled to support 1010. Nosecone sensor 1018 at the proximal end of proximal robotic controller 1000 may automate the sensory relationship including feedback data between anchor control catheter 1034 and a valve contained in valve capsule 150 (see FIG. 60), for example during valve release. In addition, fastener / anchor motor 1034A may be coupled to a coordinated interlock mechanism which is further coupled to inner and outer shafts of carriages 1005, 1003, and 1007 and / or carriage motors 1005A, 1003 A, and 1007A for steering control and anchor control catheter (ACC) 1034 activation.

[0049] In any of the embodiments described herein, the proximal robotic controller may further include and implement the use of various sensors to assist with automation of control and delivery of the various delivery subsystems. For example, any of the motors, knobs, dials, etc. of the robotic controller may include force sensors, strain sensors, pressure sensors, etc., to determine the amount of force or load applied to each motor / knob. The force / pressure feedback can be used during a delivery procedure to apply an appropriate level of force to a given delivery control, and optionally identify when forces applied by the delivery system to tissue exceed a threshold. This can be useful in identifying, for example, when a component of the delivery systems are engaged or caught up with tissue.- 17 -SG Docket No.: 10844-724.667

[0050] FIG. 2A illustrates automated movement of a proximal robotic controller 200 for an automated anchor delivery subsystem. As shown here, there is a net forward / proximal direction of drive automation / valve delivery 201. Automated main drive 250 moves central carriage 205 and affects similar movement in carriages 203 and 207 resulting in coupled motion 255 of carriages 203 and 207. As previously described in FIG. 1, carriages 203, 205, and 207 are coupled to carriage dial motors 203 A, 205A, and 207A, respectively, which according to certain embodiments may automate locking, distal advancement, and proximal retraction of inner catheter 216, outer catheter 214, and anchor control catheter 218 / guide arm 282, respectively. Control of stabilizer knob 211 and control handles 202, 204, and 206 may also be automated as previously mentioned.

[0051] FIG. 2B shows an example of a proximal controller 260 for the valve delivery subsystem having an outer steerable catheter 314. The tab retainer shaft 249 and nose cone shaft 150 within it (see FIG. 60) are disposed on a carriage 251 mounted on a rail 220 at the proximal end of proximal controller 260. A guidewire 99 (see FIG. 6N) may be inserted into the nose cone shaft. Control handles 202, 204, and 206 for the outer steerable catheter 214, capsule shaft 216, and inner steerable catheter 218 are also movably mounted on rail 220. Locks 203, 205, and 207 hold control handles 202, 204, and 206 on rail 220 in place, respectively, when they are not being moved and may be automated to lock and unlock via motor locks 203 A, 205A, and 207A. Control handle motors 202A, 204A, and 206A are coupled to control handles 202, 204, 206 (which automate the steering of outer control steerable catheter 214, capsule shaft 216, and inner steerable catheter 218, respectively). Motor 251 A is coupled to carriage 251 for automation of carriage 251 functions such as movement and locking. Proximal knob 288 is also shown, and may be coupled to proximal knob motor 288A to automate its control.

[0052] The valve delivery subsystem is placed into the patient’s vasculature through the same femoral vein introducer sheath used for the anchor delivery and implantation. To advance the valve capsule to the heart, the control handles 202, 204, and 206, and carriage 251, are controlled by the robotic controller to be advanced together along rail 220 under fluoroscopic guidance. During navigation of the prosthetic valve through the vasculature, the distal end of the valve delivery subsystem is steered by bending the distal ends of inner and outer steering catheters 218 and 214 using control handles 206 and 202, respectively, as described above with respect to the inner and outer steering catheters of the anchor delivery subsystem. A valve capsule 152 and nose cone 150 (see FIG. 60) are just distal to the distal end of the outer steerable catheter 214 during advancement into the patient’s heart.- 18 -SG Docket No.: 10844-724.667

[0053] When the nose cone 150, valve capsule 152, and the distal end of the outer steerable catheter 214 have passed through the septum into the left atrium of the heart, the inner steerable catheter 218 and valve capsule 152 are advanced out of the outer steerable catheter 214 by moving control handles 204 and 206 and carriage 251 distally while keeping control handle 202 stationary to move the valve capsule 152 into position within the previously implanted anchor. Once in position, the capsule shaft 216 may be retracted while keeping the tab retainer shaft 249 and valve stationary to retract capsule and expose the distal end of the valve 154 (see FIG. 6Q), thereby allowing it to begin to self-expand within the anchor. The partially self-expanded valve may be pulled proximally against the anchor to move the valve and anchor closer to the ventricular side of the native valve annulus. Thereafter, the capsule shaft is retracted further to expose the proximal end of the valve 154 to allow it to fully self-expand. When the capsule 152 has been retracted sufficiently to expose the slots of a tab retainer, the tabs on the valve move out of the slots to release the valve from the tab retainer. The valve delivery subsystem may then be removed from the patient.

[0054] FIG. 3 shows another example of a proximal controller 300 setup for use with the valve delivery subsystem. In this example, the same stabilizer 308, support 310, rail system 320 and carriage 303 is used, as with the proximal controller 1000 and the anchor delivery subsystem in FIGS. 1 A-1B. That is, after the anchor is implanted in the patient’s heart and the catheters 14, 16 and 18 of the anchor delivery subsystem are retracted out of the patient, the handles 1002, 1004 and 1006 of the anchor delivery subsystem may be removed from respective carriages 1003, 1005 and 1007. In some embodiments, the proximal controller can detect, either automatically or via a user input, which delivery subsystem is installed in the handles of the controller. For example, the controller may detect if the anchor delivery subsystem or the valve delivery subsystem are installed in the controller. Upon detection of the appropriate delivery system, the controller can automatically load or implement a delivery protocol based on which delivery system is installed.

[0055] A valve delivery handle 302 of the valve delivery subsystem is shown positioned in the fasteners 1032 of the carriage 303 (or carriage 305 or 307) for delivery of the prosthetic valve. The valve delivery subsystem includes the steerable catheter (valve delivery catheter) 314 with a distal portion having a capsule shaft. Valve delivery catheter may be inserted on a guidewire such as guidewire 99 (see FIG. 6N). Components or the entirety of proximal controller 300 may be automated via the aforementioned control handle motors 1022 A, 1024A, and / or 1026A, carriage dial motors 1003 A, 1005A, and / or 1007A, stabilizer knob motor 1011 A, controller support motor 1010A, or other actuators, motors, or controls to- 19 -SG Docket No.: 10844-724.667manage functions such as valve release, plunge, and steering via valve release controller 372, plunge controller 374, and steering controller 376, respectively. Steering controller 376 manages steering, for example to progress steerable catheter 214 through an anchor). Plunge controller 375 pushes the steerable catheter 214 towards its apex, which may be followed by other automated mechanisms to slide a valve catheter sheath back and expose an outflow, followed by a deplunge mechanism to disengage steerable catheter 214 or a valve.

[0056] FIGS. 4A-4B depict fasteners of the proximal controller (e.g., fasteners 1034 / 1036 / 1037) in a fully locked configuration and in a free-spinning configuration, respectively. FIG. 4A shows fastener 434 in a fully locked position with lever (paddle) 445 in an upwards (locked) position. When the fastener is fully locked, a handle disposed therein is prevented from spinning. Also shown is cradle 474 and band (ring / yoke) 444. FIG. 4B shows fastener 434 in a closed / free-spinning configuration. Lever 445 is in a downwards (free spinning or closed but unlocked position) and a handle disposed therein can spin freely inside of yoke 435. According to certain embodiments, paddle 445 may be wide or narrow in a certain area depending on surgical preferences and needs. In both examples, the lever or paddle 445 can be automatically or robotically controlled or actuated to actively switch between the locked position and the free spinning configuration. In some aspects, an interior surface of the yoke may include gears, motors, or other rotatable elements that can engage with a handle disposed therein to cause the handle to rotate or spin when in the free spin configuration.

[0057] FIG. 5A shows a guide arm 82 of an anchor delivery sub system / catheter in a selfassembly position in which the distal portion of the anchor within the guide arm 82 is deployed to a depth indicated by arrow 520 and the proximal portion of the anchor within the guide arm 82 is deployed to a depth indicated by arrow 527. In the self-assembly position, the shape and depth of the anchor within the guide arm 82 results in the distal end (e.g., tip) and distal part (which may be referred to as a grabber, grabber arm or grabber portion) of the guide arm 82 resting against itself as shown. Such a configuration provides a minimized “envelope” of the guide arm, assisting in: 1) deployment of the guide arm 82 within the atrium, and 2) advancement of the anchor control catheter from the atrium to the ventricle — without deleterious contact / entanglement with native tissue. FIGS. 5B and 5C show the guide arm 82 in an encircling position in which the distal portion of the anchor is retracted within the guide arm 82 to a depth indicated by arrows 521 and 522, and the proximal portion of the anchor is retracted within the guide arm 82 to a depth indicated by arrows 528 and 529, respectively. As shown, retracting the anchor results in the distal end (e.g., tip) and distal part of the guide arm 82 extending radially outwards, while maintaining the proximal portion- 20 -SG Docket No.: 10844-724.667of the anchor distal to a bend (not shown) of the guide arm 82. That is, movement of the anchor within the guide arm 82 can change a shape (e.g., change a radius of curvature) of the guide arm 82. This allows for fine user control of the angle and distance of the distal end (e.g., tip) from the rest of the guide arm 82 to assist the user with encircling of the chordae. Keeping the proximal portion of the anchor distal to the bend of the guide arm 82 maintains the prescribed geometry of the guide arm 82 while enabling adjustability of the distal end (e.g., tip) of the guide arm 82 during encircling. As previously discussed, control of guide arm 82 may be automated, for example via automation of anchor control catheter 18. Therefore, the robotic controller of the systems as described herein can be used to automatically adjust or control the position of the anchor within the guide arm, to therefore change the chape and / or curvature of the guide arm.

[0058] FIGS. 6 A to 6V and 6-1 to 6-13 illustrate example systems and methods for delivering and implanting a prosthetic mitral valve and an anchor within a heart of a subject with the robotically controlled proximal controller as described above. It should be understood that any of the valves, anchors, anchor delivery subsystems, and valve delivery subsystems described herein may be used in any of a number of combinations, and are not limited by the examples shown in FIGS. 6 A to 6V and 6-1 to 6-13. As will be described below, the systems and methods provide a consistent, forgiving delivery procedure that can accommodate a range of patient anatomies, while fully addressing patient valve regurgitation without obstruction of LVOT. As will be apparent from the present disclosure the prosthetic mitral valve and systems and methods of delivery provide a number of clinical benefits and features over other systems on the market.

[0059] Any aspect of the systems and methods described in FIGS. 6A-6V and 6-1 to 6-13 can be performed and controlled with the robotic controller or robotic carriage assembly. In some aspects, the robotic controller can synchronously or simultaneously control several (e.g., more than two) aspects of the valve delivery catheter or the anchor delivery catheter. For example, the controller can simultaneously control multiple aspects of the delivery catheters both rotationally and axially. Such level of control is not possible manually, when a user is limited to interacting with only two aspects of the system by hand. The robotic controller, on the other hand, can control rotational and axial movement of all three control handles, plus the additional robotic features of the carriage assembly described herein.

[0060] The valve delivery system of the present disclosure provides forgiving delivery of the anchor transeptally through the native valve and into the left ventricle. The clinician, via the proximal robotic controller, is given fine control of the position of the anchor, and therefore the shape of the guide arm, during encircling, allowing for adjustment of the guide - 21 -SG Docket No.: 10844-724.667arm radial position to ensure desired chords are captured. While the delivery system provides the ability to capture all of the chords in a single pass (e.g., from between 1 and up to 2.5 rotations of the guide arm), the delivery system also provides the ability to capture only some of the chords in a first revolution (e.g., 1 rotation) of the guide arm / anchor, and to capture the remaining chords on the subsequent revolutions of the guide arm / anchor (e.g., the remaining 1-1.5 rotations). The anchor delivery system provides rotation-based encircling with the ability to reverse and re-encircle the anchor if the clinician is unhappy with device placement or does not capture the desired anatomy within the anchor (e.g., the chords). Since the anchor is (e.g., wholly) contained within the guide arm of the delivery device during encircling, the clinician can easily reverse and re-encircle to safely fix the issue and continue the procedure without having to recapture a deployed anchor. The system is designed and configured to protect the anatomy from chordal injury / rupture. Additionally, the proximal robotic controller can automatically control encircling of the guide arm, and adjust the guide arm radial position automatically.

[0061] In some aspects, the proximal robotic controller can automatically initiate an encircling procedure and stop encircling when a desired number of turns or rotations are performed. The robotic controller can use force or other real-time feedback to detect when chordae are engaged, and use that feedback to adjust the radial guide arm position. Additionally, if the robotic controller detects excessive (or minimal force), the robotic controller can either terminate or pause a procedure, or make appropriate adjustments to correct the excessive or minimal force being applied.

[0062] In addition to being able to control the reach of the guide arm with the robotic controller, the clinician is also given full independent control via the proximal robotic controller over the axial height of the anchor during and after encircling, as well as the rotational position of the anchor and guide arm. The delivery system and methods disclosed herein further facilitate determination of chordal capture. The position and orientation of the guide arm, and therefore the anchor (carried within), can be visualized with echo (ultrasound) alone during encircling and delivery. This provides for visualization of leaflets traveling outside the guide arm and / or direction visualization of chords. Biplane views can be fixed during the procedure, so the clinician can check leaflet mobility throughout delivery. Visualization of the guide arm also allows for proper alignment of the anchor. The clinician can use the echo visualization to align the (e.g., distal portion of the) guide arm to be coplanar with the annulus. If the clinician achieves balanced capture of the chordae, the guide arm will remain coplanar with the annulus after encircling. An unbalanced or canted guide- 22 -SG Docket No.: 10844-724.667arm after encircling can indicate to the clinician that additional encircling or re-encircling is required.

[0063] In some embodiments, when the anchor is (e.g., fully) deployed from the delivery system into the heart, the anchor is completely released with no tether or other connection to other devices prior to valve deployment. The anchor is stably positioned by circumscribing and gently gathering chordae / leaflets in the left ventricle, while being completely free from (e.g., anchor) delivery system interaction once deployed. The inner diameter of the untethered anchor provides a target through which a guidewire is placed, with the valve delivery system advanced along the guidewire. All of the above features provide fine-tuned control of encircling device, and easy reversibility and safety and re-encircling without undue risk to patient tissue.

[0064] The prosthetic valve of the present disclosure also provides a number of advantages over competitors and clinical benefits to the patient. Importantly, the prosthetic valve is designed and configured to self-center within the target anatomy after deployment from the valve delivery system. The prosthetic valve is configured to self-center even with non-coaxial delivery or placement of the valve within the annulus and anchor. Coaxial delivery in this context refers to a central (longitudinal) axis of the prosthetic valve and a central axis of the anchor (e.g., axis perpendicular to the plane(s) containing the anchor). For example, the frame is tolerant to up to 45 degrees of off-axis delivery. The stiffness of the wide atrial brim enables this self-centering, balanced against the softness or compliance of the atrial flared portion to be atraumatic and prevent damage to tissue of the atrium and annulus. The short axial height of the ventricular flare or ventricular side of the prosthetic valve (e.g., less than 10mm) allows the valve to deploy and self-center.

[0065] The prosthetic mitral valve of the present disclosure prevents paravalvular leaks (PVL) after implantation. The frame design, including the combination of a soft and wide atrial brim, a narrow central waist that interacts with the anchor to pinch inferior / superior to the annulus, and the fabric selection of the valve completely seals the valve against the anatomy reducing or eliminating the risk of blood flowing between the implanted valve and the cardiac tissue. Once the valve is implanted, is seated to the atrial floor with the wide atrial brim.

[0066] The prosthetic valve of the present disclosure is further designed and configured to reduce or limit left ventricular outflow tract obstruction (LVOTO). The short ventricular height of the valve (e.g., less than 10mm), the self-centering nature of the valve (e.g., optimizing the angle of the valve with respect to the LVOT), and the tissue interaction between the valve and the anatomy (e.g., anterior leaflet capture / superior adjustment) all - 23 -SG Docket No.: 10844-724.667provide for a solution to LVOTO that has not been achieved with other competing devices. Specifically, the valve and anchor capture and pull the anterior leaflet away from the LVOT during expansion of the valve and axial adjustment of the anchor position, further reducing LVOTO.

[0067] Referring to FIG. 6A, a nested catheter system of an anchor delivery subsystem, which includes an outer steerable catheter 14, an inner steerable catheter 16, and a guide arm 82, is navigated to the patient’s right atrium and through the septum to the left atrium of the subject’s heart via the robotic controller described herein. In some cases, the nested catheter system is advanced through the patient’s vasculature. In some examples, a separate puncture procedure is used to puncture the septum prior to advancing the nested catheter system through the septum. According to other embodiments, navigation is automated via the motors and other robotics previously described, which may be connected to an outer console or master control panel that a user may activate via, for example, a button or command, or which may function independently of user input.

[0068] FIG. 6-1 shows an example manipulation of the robotic controller 1000 for advancing the outer steerable catheter 14, the inner steerable catheter 16, and the guide arm 82 (which is at the distal portion of the anchor control catheter 18) together though the septum, as shown in FIG. 6 A. The button 1063 of the first dial 1013 and the button 1067 of the third dial 1017 may be robotically activated (for example via carriage dial motors 1003 A and 1007A, respectively) to couple translational movement of the first carriage 1003 and the third carriage 1007 with translational movement of the second carriage 1005. The second knob 1015 may then be robotically rotated (for example via carriage dial motor 1005 A) to advance the outer steerable catheter 14, the inner steerable catheter 16, and the guide arm 82 together though the septum. The buttons 1063 and 1067 may then be robotically deactivated via carriage dial motors 1003 A and 1007A, respectively. All the motors may be activated / deactivated, and controlled simultaneously or in unison via the robotic controller, providing a level of control, automation, and delivery capabilities that would otherwise not be possible with manual control by a single user.

[0069] FIGS. 6B and 6C show the inner steerable catheter 16 being advanced out of the distal end of the outer steerable catheter 14 into the left atrium with the robotic controller. In addition, the guide arm 82 is advanced out of the distal end of the inner steerable catheter 16 into the left atrium. In some aspects, all three catheter elements (e.g., the inner catheter, the outer catheter, and the guide arm) are advanced axially simultaneously by the robotic system. In addition to axial control of the three catheter elements, the robotic system can also synchronously control rotation of one or more of the inner catheter, outer catheter, and / or - 24 -SG Docket No.: 10844-724.667guide arm to assembly the guide arm within the atrium. The active and passive portions of the guide arm 82, in combination with the anchor carried within, enable the guide arm 82 to selfassemble to form, in this case, a spiral shape in a left atrium. As previously described, in other examples, the guide arm 82 is configured to self-assemble into a helical shape. The anchor also fully self-assembles and assumes it is at-rest shape within the guide arm 82 when the guide arm 82 is deployed in the left atrium.

[0070] FIG. 6-2 shows an example manipulation of the robotic controller 1000 for advancing the inner steerable catheter 16 and the guide arm 82 as shown in FIGS. 6 A and 6B. The robotic controller (for example via carriage dial motor 1005 A) may rotate the second dial 1015 to advance the inner steerable catheter 16 distally relative to the outer steerable catheter 14. The robotic controller may rotate the third dial 1017 (for example via carriage dial motor 1007A) to advance the guide arm 82 distally relative to the inner steerable catheter 16 and the outer steerable catheter 14. Rotation of motors 1005 A and 1007A can be controlled simultaneously and / or in coordination to achieve assembly of the guide arm within the atrium of the patient.

[0071] In FIG. 6D, the inner steerable catheter 16 is deflected via the robotic controller to steer the guide arm 82 towards the mitral annulus. In the illustrated example, the spiral shape of the guide arm 82 (e.g., the portion of the guide arm 82 distal to the bend is generally parallel with the mitral annulus. In cases where the guide arm 82 has a helical shape, the portion of the guide arm 82 distal to the bend can have a helical shape.

[0072] FIG. 6-3 shows how the robotic controller 1000 can be used to steer the guide arm 82 as shown in FIG. 6D. The robotic controller (for example via control handle motor 1024 A) may rotate the rotation knob 1024 of the second handle 1004 to cause the inner steerable catheter 16 to deflect, thereby steering the guide arm 82 toward the mitral annulus, as shown in FIG. 6D.

[0073] In FIG. 6E, the guide arm 82 is counter-rotated and advanced via the robotic controller to cross the mitral valve, through the leaflets, and into the left ventricle. In this example, the guide arm 82 is fully deployed and the anchor is fully assembled within the guide arm 82 when the guide arm 82 is advanced across the mitral valve. The shape of the guide arm 82 (and the planarity of the guide arm 82 with respect to the mitral valve) can be maintained as the guide arm 82 crosses the mitral valve, as shown.

[0074] FIG. 6-4 shows how the robotic controller 1000 can be used to rotate the guide arm 82 as shown in FIG. 6E. The robotic controller (for example via fasten er / anchor motor 1065 A) may unlock (e.g., pull) a lever 1065 of the fastener 1037 of the third carriage 1007 to release tension on the band portion of the fastener 1037. The robotic controller(i.e. control - 25 -SG Docket No.: 10844-724.667handle motor 1026A) may then rotate the handle 1006, thereby causing the anchor control catheter 18 to rotate in. Since the guide arm 82 is a distal part of the anchor control catheter 18, the guide arm 82 also rotates. To advance the guide arm 82, the robotic controller(for example via carriage dial motor 1007A) may rotate the dial 1017 (e.g., third dial) to advance the handle 1006 and the guide arm 82 distally.

[0075] Referring to FIG. 6F, the encircling process can begin. As described previously, the distal tip of the guide arm 82 can be extended radially outwards, for example by selected proximal retraction of the anchor therein. In the example illustrated, the distal tip of the guide arm 82 is extended toward the left ventricular outflow tract (LVOT).

[0076] FIG. 6-5 shows how the robotic controller 1000 can be used to extend the distal tip of the guide arm 82 as illustrated in FIG. 6F. The robotic controller(i.e. via proximal knob motor 1018A) may rotate the proximal knob 1018 to advance and / or retract the anchor within the guide arm 82. As described previously with reference to FIGS. 5A-5C, axial movement of the anchor within the guide arm 82 via the robotic controller can cause the distal part of the guide arm 82 to extend radially outward. In some examples, after the anchor is moved within the guide arm 82 to cause sufficient radial extension of the distal tip of the guide arm 82, the proximal knob 1018 may be locked to keep the guide arm 82 in the desired radially extended state, for example via an automated proximal knob lock 1019A.

[0077] In FIG. 6G, the guide arm 82, while in a radially extended state, is rotated to encircle chordae / leaflets within the left ventricle. Since the encircling process can be performed under echo imaging to provide visualization of the guide arm 82, the user can actively manipulate the distal tip of the guide arm 82 to capture the desired chordae / leaflets. This may include extending the distal tip of the guide arm 82 radially outwards or pulling the distal tip radially inwards, depending on the patient specific anatomy.

[0078] FIG. 6-6 shows how the robotic controller 1000 can be used to rotate and manipulate the guide arm 82 as shown in FIG. 6G. The robotic controller (for example via fastener / anchor motor 1037 A) may unlock the fastener 1037 to release tension around the handle 1006. Then the robotic controller (for example via control handle motor 1006A) may rotate the handle 1006, thereby causing the anchor control catheter 18 with the guide arm 82 to rotate in the same direction. In some examples, the second handle 1004 may also be rotated (after unlocking the fastener 1034) to rotate the inner steerable catheter 36 to increase the reach of the distal tip of the guide arm 83. Rotating second handle 1004 may be automated via control handle motor 1004A or via rotation mechanisms / motors disposed in the fastener of the proximal controller as previously described. To actively manipulate the distal tip of the guide arm 82, the robotic controller (for example via an proximal knob rotator 1018B) can- 26 -SG Docket No.: 10844-724.667rotate the proximal knob 1018 to move the anchor proximally within the guide arm 82. This causes the distal tip of the guide arm 82 to extend radially and pull inward radially, thereby giving the user control to capture chordae / leaflets in different regions near the mitral annulus.

[0079] In FIG. 6H, the position of the guide arm 82 has been assessed and a determination made that at least some chordae or leaflet tissue has not been correctly encircled. In some examples, this determination can be made by the proximal robotic controller, for example, by evaluating forces applied against the guide arm during encircling. If no forces are experienced, or optionally excessive forces are experienced, it can be an indication that the guide arm has not properly encircled the chordae. For repositioning the anchor delivery subsystem, the clinician can readily and independently adjust the axial height, circumferential (rotational) position, and / or radial reach of the distal end of the guide arm 82 to de-encircle / re-encircle, as often as desired. This delivery flexibility, along with the distinctive visualization characteristics of the anchor delivery catheter, provides the clinician with precise and repeatable control of encircling chordae and / or leaflets. At FIG. 61, the guide arm 82 is retracted or counter-rotated to partially de-encircle some portion of previously encircled chordae.

[0080] FIG. 6-7 shows how the robotic controller 1000 can be used to manipulate the guide arm 82 as shown in FIGS. 6H and 61. After unlocking the fastener 1037, the robotic controller(for example via control handle motor 1006 A) may rotate the handle 1006 to rotate the guide arm 82, causing the guide arm 82 to de-encircle. To adjust the axial height of the guide arm 82, the robotic controller(for example via carriage dial motor 1017A) may rotate the dial 1017 to move the guide arm 82 distally and / or proximally. To adjust the radial reach of the distal end of the guide arm 82, the robotic controller(for example via proximal knob rotator 1018A) may rotate the proximal knob 1018 in clockwise and / or counterclockwise directions.

[0081] FIGS. 6 J and 6K show the process of re-encircling the guide arm 82 after counterrotating the guide arm 82. The re-encircling process is used to fully capture the desired anatomy (chordae / leaflets). Adjusting or changing the radial position of the distal tip of the guide arm 82 can optionally be done at any point during encircling (rotating) or de-encircling (counter-rotating). This process may be automated via robotics.

[0082] FIG. 6-8 shows how the robotic controller 1000 can be used to manipulate the guide arm 82 as shown in FIGS. 6 J and 6K. The robotic controller may rotate the handle to cause the guide arm 82 to rotate and re-encircle the chordae and / or leaflets. To adjust the radial position of the distal end of the guide arm 82, the robotic controller (for example via proximal knob rotator 1018A) may rotate the proximal knob 1018.- 27 -SG Docket No.: 10844-724.667

[0083] Once the chordae are determined to be satisfactorily (e.g., fully) encircled with the guide arm 82, optionally by the robotic controller, as shown in FIG. 6L, the guide arm 82 and the anchor delivery catheter system can be proximally retracted from the anchor without disturbing the anchor’s position until the anchor delivery catheter system is removed from the patient. This is accomplished by maintaining the anchor and tether positions while withdrawing the guide arm 82 into the inner steerable catheter 36, until the distal end of the guide arm 82 clears the proximal end of the anchor and the anchor delivery catheter system is decoupled from the anchor. The inner steerable catheter 36 is then pulled into the outer steerable catheter 14 and the entire subsystem is removed from the subject. After the guide arm 82 is fully retracted and removed from the patient, the anchor 3 remains in place within the left ventricle surrounding the desired chordae / leaflets as shown in FIG. 6M. The anchor 88 may then be disconnected from the tether. The result is the anchor 88 is deployed and anchored around chordae and / or leaflets of the left ventricle with no connection to any other system component (e.g., no tether or other linkage is left behind when the anchor 88 is deployed). Additionally, while the anchor 88 is deployed around the chordae and / or leaflets, the axial position of the anchor 88 is not fixed to the anatomy. Therefore, the anchor 88 can slide or be moved axially (e.g., towards or away from the annulus). This is described more fully below when self-expansion and positioning of the valve is described.

[0084] FIG. 6-9 shows how the robotic controller 1000 can be used to retract the guide arm 82 from the anchor 88 as shown in FIGS. 6L and 6M. The robotic controller (for example via proximal knob lock 1018B) may lock (or hold) the proximal knob 1018 to maintain the anchor position in place around the desired chordae / leaflets. While the proximal knob 1018 is locked (or held), the robotic controller (for example via carriage dial motor 1017A) may rotate the dial 1017 (e.g., third dial) to withdraw the guide arm 82 proximally into the inner steerable catheter 16. Retraction of the guide arm 82 over the anchor 88 causes the anchor to detach from the tether, as described herein. After the guide arm 82 is fully retracted, the robotic controller (for example via carriage dial motor 1015 A) may rotate the dial 1015 (e.g., second dial) to withdraw the inner steerable catheter 16 proximally into the outer steerable catheter 34. After the inner steerable catheter 16 is retracted into the outer steerable catheter 14, the robotic controller (for example via carriage button motor 1003B and carriage button motor 1007B, respectively) may activate the button 1063 of the first dial 1013 and the button 1067 of the third dial 1007. This couples translational movement of the second carriage 1005 with the first carriage 1003 and the third carriage 1007. The second dial 1015 may then be rotated via a user or automation (via carriage dial motor 1015 A) to retract the catheters 14, 16 and 18 together out of the atrium.- 28 -SG Docket No.: 10844-724.667

[0085] At FIG. 6N, the valve delivery can be initiated. The anchor delivery catheter / sub system can be removed from the proximal robotic controller, and the valve delivery catheter / sub system can be mounted / disposed in the robotic controller. First, a guidewire 99 can be inserted through the septum, into the left atrium, through the mitral valve annulus, and through the anchor 88 into the left ventricle. In FIG. 60, the valve delivery subsystem is advanced over the guidewire 99, through the septum, and into the left atrium via the robotic controller. FIG. 60 shows the valve capsule 152 (containing the valve prosthesis) and the nose cone 150 in the left atrium.

[0086] FIG. 6-10 shows how the robotic controller 200 can be used in the operations shown in FIGS. 6N and 60. At first, the valve delivery subsystem may be delivered over the guidewire 99 through the patient’s vasculature while the valve delivery subsystem is not connected to the rail system. After the distal end of the valve delivery catheter is advanced to approximately in the inferior vena cava (IVC) (e.g., before entering the heart chambers / crossing the septum), the robotic controller 200 (which is coupled to the proximal end of the valve delivery subsystem) may be attached to the rail system 220. The dial 213 may be automated to rotate (via carriage dial motor 213 A) to advance the valve capsule 152 and nose cone 150 in the left atrium as shown in FIG. 60.

[0087] FIG. 6P shows the valve capsule 152 and nose cone 150 advanced through the annulus with the nose cone 150 positioned past the anchor 88 and the valve capsule 152 extending across / through the anchor 88. In FIG. 6Q, the valve capsule 152 is partially retracted from the nose cone 150, to allow for (partial) self-expansion or assembly of the ventricular portion of the valve prosthesis 154. In some embodiments, the ventricular portion of the valve 154 expands into the anchor 88. The robotic controller can precisely control retraction of the valve capsule from the nose cone to release only the desired portion of the valve. Additionally, pressure or force sensors in the system can detect when the valve capsule contacts and expands into the anchor.

[0088] FIG. 6-11 shows how the robotic controller 200 can be used to advance the valve capsule 152 and partially release the valve prosthesis 154 as shown in FIGS. 6P and 6Q. The steering / flex shape control knob 276 of the handle 202 can be rotated to change a shape of the distal portion of the inner steerable catheter 214, as shown in FIG. 6P. In addition, the depth control knob 274 of the handle 202 can be controlled by the robotic controller to advance the valve capsule 152 and the nose cone 150, into the mitral annulus, as shown in FIG. 6P. The valve deployment knob 272 can be rotated to retract the valve capsule 152 and to cause partial release of the valve prosthesis 154 into the left ventricle, as shown in FIG. 6Q. Each of these processes may be automated via robotics, including various motors and rotators 272A,- 29 -SG Docket No.: 10844-724.667274A, and 276A attached to valve deployment knob 272, depth control knob 274, and steering / flex control knob 276, respectively.

[0089] In other embodiments, referring to FIG. 6R, the valve delivery subsystem can be retracted or pulled towards the mitral annulus to capture the ventricular portion of the frame of the valve 154 within the anchor 88. In some embodiments, the anchor 88 can be lifted or pulled towards the annulus with the partially expanded valve 154 by manipulation (e.g., proximal retraction) via the valve delivery subsystem, as indicated by the arrows. Pressure or force sensors in the system can detect when the valve capsule contacts and pulls against the anchor, and can use the force or pressure measurements to determine when the valve and / or anchor have been pulled proximately into the desired position. As described above, implanting the valve and anchor higher in the anatomy can help to reduce or prevent LVOTO. When the anchor 88 is lifted or pulled towards annulus, the anterior leaflet can be captured and bunched up by the anchor 88 into or against the annulus. This act of capturing the anterior leaflet, and pulling or bunching up the leaflet against the annulus moves tissues away from the LVOT, thereby reducing LVOTO. Each of these processes may be automated via robotics, including various motors and rotators 213 A, 272A, 274A, and 276A attached to dial 213, valve deployment knob 272, depth control knob 274, and steering / flex control knob 276, respectively.

[0090] In FIG. 6S, the valve capsule 152 is fully retracted from the valve prosthesis 154 to expose the atrial portion and atrial brim 105 of the valve frame structure, allowing for selfexpansion or the atrial portion of the valve prosthesis 154 within the left atrium. Once the atrial portion is fully expanded, the mitral annulus is sealed with the wide and conformable atrial brim 105 of the valve frame, the position of the atrial brim 105 maintained and / or pressed downward by the anchor firmly positioned at the valve 154 waist and capturing native tissues therebetween.

[0091] FIG. 6-12 shows how the robotic controller 200 can be used to retract the catheter 214 and to cause release of the atrial brim 105 of the valve 154, as shown in FIGS. 6R and 6S. Pulling the valve 154 proximally as shown in FIG. 6R may be accomplished by rotating the depth control knob 274 and / or the dial 213 via a user, or via automation using depth control knob motor 274A and carriage dial motor 213 A, respectively. The valve deployment knob 272 can be rotated to retract the valve capsule 152 over the valve 154 and release the remainder of the valve 154 from the valve capsule 152. This can be done via a user or via automation using valve deployment knob motor 272A.- 30 -SG Docket No.: 10844-724.667

[0092] In FIG. 6T, the valve delivery subsystem is being removed, leaving the valve prosthesis 154 implanted within the native mitral valve and the anchor 88, and thereby sealing the native mitral annulus.

[0093] FIG. 6-13 shows how the robotic controller 200 can be used to retract the catheter to cause retraction of the valve delivery subsystem from the native mitral valve, as shown in FIG. 6T. The depth control knob 274 of the handle 202 can be rotated to retract the catheter, including the valve capsule 152, from the patient’s heart and body. This can be done via a user or via automation using depth control knob motor 274A. During retraction process, the steering / flex shape control knob 276 of the handle 202 may be rotated to straighten the distal portion of the catheter from the deflected state. This can be done via a user or via automation using steering / flex shape control knob 276A.

[0094] FIGS. 6U and 6V illustrate a left-atrial view of the valve frame prosthesis 154 implanted within the mitral annulus with the leaflets closed (FIG. 6U) and opened (FIG. 6U).

[0095] The valve delivery subsystem is a robotically controlled, low profile valve delivery system that allows for precise and automated control of valve position until the very end of the delivery procedure. The valve delivery subsystem is a true 28Fr delivery profile with steerability that allows for familiar and easy positioning of the valve frame in the target location. The valve delivery subsystem allows for deployment of the collapsed or compressed valve frame within an already deployed anchor. Expansion of the valve frame structure captures the anchor and controls the final anchor position. Emphasis has been provided above that it is desirable to have the anchor deployed in a “high” position towards the left atrium so as to avoid LVOTO. While the anchor position can be controlled with the anchor delivery subsystem, it should also be understood that the anchor position can be adjusted or pulled upwards with the valve delivery subsystem after the valve has been allowed to expand within the anchor.

[0096] This disclosure provides details around automation of a forgiving mitral valve replacement procedure and system specifically designed for the mitral anatomy. The systems and methods disclosed herein solve for an unmet need by providing an automated delivery system and delivery procedure that is familiar to physicians with a small learning curve and may be used with ease, an implant that is adaptable and applicable to all anatomies, and an implant that reliable eliminates mitral regurgitation (MR) without the risk of complications associated with other mitral valve replacement devices on the market.

[0097] Automation as described in this disclosure may be carried out via one or more of motors, gearmotors, actuators, drives, sensors, and other hardware. Sensors may include one- 31 -SG Docket No.: 10844-724.667or more of cameras, image analysis devices, radiopaque fluorescent markers, and linear variable transformers (LVDTs).

[0098] Image analysis may include one or more of computer tomography (CT), ultrasound, fluoroscopy, and magnetic resonance imaging (MRI). Placement of a prosthetic heart valve and an anchor may be confirmed via image analysis prior to release of the heart valve.

[0099] LVDTs provide positional feedback via converting linear displacement of the steerable catheter into one or more electrical signals. According to certain embodiments, LVDTs may be placed at distal ends of the steerable catheters described in this disclosure, and the LVDTs may be copper coils.

[0100] As described in this disclosure, a user may activate the automation of one or sequences involved in valve delivery. Alternatively, a user may activate the automation of the entire process of valve delivery.

[0101] When a feature or element is herein referred to as being “on” another feature or element, it can be directly on the other feature or element or intervening features and / or elements may also be present. In contrast, when a feature or element is referred to as being “directly on” another feature or element, there are no intervening features or elements present. It will also be understood that, when a feature or element is referred to as being “connected”, “attached” or “coupled” to another feature or element, it can be directly connected, attached or coupled to the other feature or element or intervening features or elements may be present. In contrast, when a feature or element is referred to as being “directly connected”, “directly attached” or “directly coupled” to another feature or element, there are no intervening features or elements present. Although described or shown with respect to one embodiment, the features and elements so described or shown can apply to other embodiments. It will also be appreciated by those of skill in the art that references to a structure or feature that is disposed “adjacent” another feature may have portions that overlap or underlie the adjacent feature.

[0102] Terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. For example, as used herein, the singular forms “a”, “an” and “the” are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms “comprises” and / or “comprising,” when used in this specification, specify the presence of stated features, steps, operations, elements, and / or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and / or groups thereof.- 32 -SG Docket No.: 10844-724.667As used herein, the term “and / or” includes any and all combinations of one or more of the associated listed items and may be abbreviated as “ / ”.

[0103] Spatially relative terms, such as “under”, “below”, “lower”, “over”, “upper” and the like, may be used herein for ease of description to describe one element or feature’s relationship to another element(s) or feature(s) as illustrated in the figures. It will be understood that the spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if a device in the figures is inverted, elements described as “under” or “beneath” other elements or features would then be oriented “over” the other elements or features. Thus, the exemplary term “under” can encompass both an orientation of over and under. The device may be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly. Similarly, the terms “upwardly”, “downwardly”, “vertical”, “horizontal” and the like are used herein for the purpose of explanation only unless specifically indicated otherwise.

[0104] Although the terms “first” and “second” may be used herein to describe various features / elements (including steps), these features / elements should not be limited by these terms, unless the context indicates otherwise. These terms may be used to distinguish one feature / element from another feature / element. Thus, a first feature / element discussed below could be termed a second feature / element, and similarly, a second feature / element discussed below could be termed a first feature / element without departing from the teachings of the present invention.

[0105] Throughout this specification and the claims which follow, unless the context requires otherwise, the word “comprise”, and variations such as “comprises” and “comprising” means various components can be co-jointly employed in the methods and articles (e.g., compositions and apparatuses including device and methods). For example, the term “comprising” will be understood to imply the inclusion of any stated elements or steps but not the exclusion of any other elements or steps.

[0106] As used herein in the specification and claims, including as used in the examples and unless otherwise expressly specified, all numbers may be read as if prefaced by the word “about” or “approximately,” even if the term does not expressly appear. The phrase “about” or “approximately” may be used when describing magnitude and / or position to indicate that the value and / or position described is within a reasonable expected range of values and / or positions. For example, a numeric value may have a value that is + / - 0.1% of the stated value (or range of values), + / - 1% of the stated value (or range of values), + / - 2% of the stated value (or range of values), + / - 5% of the stated value (or range of values), + / - 10% of the stated - 33 -SG Docket No.: 10844-724.667value (or range of values), etc. Any numerical values given herein should also be understood to include about or approximately that value, unless the context indicates otherwise. For example, if the value “10” is disclosed, then “about 10” is also disclosed. Any numerical range recited herein is intended to include all sub-ranges subsumed therein. It is also understood that when a value is disclosed that “less than or equal to” the value, “greater than or equal to the value” and possible ranges between values are also disclosed, as appropriately understood by the skilled artisan. For example, if the value “X” is disclosed the “less than or equal to X” as well as “greater than or equal to X” (e.g., where X is a numerical value) is also disclosed. It is also understood that the throughout the application, data is provided in a number of different formats, and that this data, represents endpoints and starting points, and ranges for any combination of the data points. For example, if a particular data point “10” and a particular data point “15” are disclosed, it is understood that greater than, greater than or equal to, less than, less than or equal to, and equal to 10 and 15 are considered disclosed as well as between 10 and 15. It is also understood that each unit between two particular units are also disclosed. For example, if 10 and 15 are disclosed, then 11, 12, 13, and 14 are also disclosed.

[0107] Although various illustrative embodiments are described above, any of a number of changes may be made to various embodiments without departing from the scope of the invention as described by the claims. For example, the order in which various described method steps are performed may often be changed in alternative embodiments, and in other alternative embodiments one or more method steps may be skipped altogether. Optional features of various device and system embodiments may be included in some embodiments and not in others. Therefore, the foregoing description is provided primarily for exemplary purposes and should not be interpreted to limit the scope of the invention as it is set forth in the claims.

[0108] The examples and illustrations included herein show, by way of illustration and not of limitation, specific embodiments in which the subject matter may be practiced. As mentioned, other embodiments may be utilized and derived there from, such that structural and logical substitutions and changes may be made without departing from the scope of this disclosure. Such embodiments of the inventive subject matter may be referred to herein individually or collectively by the term “invention” merely for convenience and without intending to voluntarily limit the scope of this application to any single invention or inventive concept, if more than one is, in fact, disclosed. Thus, although specific embodiments have been illustrated and described herein, any arrangement calculated to achieve the same purpose may be substituted for the specific embodiments shown. This disclosure is intended - 34 -SG Docket No.: 10844-724.667to cover any and all adaptations or variations of various embodiments. Combinations of the above embodiments, and other embodiments not specifically described herein, will be apparent to those of skill in the art upon reviewing the above description.- 35 -SG Docket No.: 10844-724.667

Claims

1. CLAIMSWhat is claimed is:

1. A method for robotically controlling delivery of a prosthetic heart valve system into a patient’s heart, the method comprising: receiving, in a robotic carriage assembly, an anchor delivery catheter; robotically advancing the anchor delivery catheter with the robotic carriage assembly into an atrium of the patient’s heart; deploying, with the robotic carriage assembly, a guide arm of the anchor delivery catheter into a helical configuration in the atrium; advancing the guide arm of the anchor delivery catheter from the atrium, across a mitral valve, and into a ventricle of the patient’s heart with the robotic carriage assembly; robotically encircling one or more chordae of the patient’s heart with the guide arm via the robotic carriage assembly; retracting, with the robotic carriage assembly, the guide arm and the anchor delivery catheter from the anchor to release the anchor from the anchor delivery catheter; releasing the anchor delivery catheter from the robotic carriage assembly; receiving, in the robotic controller, a valve delivery catheter; robotically advancing the anchor delivery catheter with the robotic controller into the atrium, at least partially through the mitral valve, and at least partially through an interior of the anchor in the ventricle of the patient’s heart; and releasing a prosthetic valve from the valve delivery catheter into the anchor with the robotic carriage assembly.

2. The method of claim 1, wherein placement of the prosthetic valve and the anchor of the prosthetic heart valve is confirmed via image analysis prior to release of the prosthetic valve.

3. The method of claim 2, wherein the image analysis includes one or more of: (i) computer tomography (CT), (ii) ultrasound, (iii) fluoroscopy, and (iv) magnetic resonance imaging (MRI).- 36 -SG Docket No.: 10844-724.6674. The method of claim 1, wherein receiving the anchor delivery catheter comprises receiving first and second control handles of the anchor delivery catheter into first and second carriages, respectively, of the robotic carriage assembly.

5. The method of claim 4, further comprising independently translating the first and second carriages along a track system of the robotic carriage assembly to cause independent axial movement of first and second coaxial catheters of the anchor delivery catheter.

6. The method of claim 4, further comprising simultaneously independently translating the first and second carriages along a track system of the robotic carriage assembly to cause independent axial movement of first and second coaxial catheters of the anchor delivery catheter synchronously.

7. The method of claim 4, further comprising selectively allowing coupled translation of the first and second carriages together along the track system to cause coupled axial movement of the first and second catheters.

8. The method of claim 4, further comprising robotically controlling rotational movement of the first or second control handles with the robotic carriage assembly.

9. The method of claim 4, further comprising robotically controlling rotational movement of the first and second control handles simultaneously with the robotic carriage assembly.

10. The method of claim 1, wherein receiving the anchor delivery catheter comprises receiving first, second, and third control handles of the anchor delivery catheter into first, second, and third carriages, respectively, of the robotic carriage assembly.

11. The method of claim 10, wherein the robotic carriage assembly is configured to synchronously control more than two aspects of the anchor delivery catheter synchronously.

12. The method of claim 10, wherein the robotic carriage assembly is configured to synchronously control axial movement and rotational movement of the first, second, and third control handles synchronously.- 37 -SG Docket No.: 10844-724.66713. A method for robotically controlling delivery of a prosthetic heart valve into a patient’s heart, the method comprising: advancing an anchor delivery catheter system into the patient’s heart, wherein the anchor delivery catheter system includes an anchor slidably positioned within an anchor control catheter, and the anchor control catheter is slidably positioned within a steerable catheter, wherein a distal portion of the anchor control catheter includes a guide arm, wherein a proximal portion of the steerable catheter is coupled to a first handle and a proximal portion of the anchor delivery catheter is coupled to a second handle, wherein the first and second handles are translatably coupled to a rail system; implanting the anchor around chordae near a native valve of the patient’s heart, wherein implanting the anchor comprises robotically translating the first handle along the rail system independent of the second handle; removing the anchor delivery catheter system from the rail system and coupling a valve delivery catheter system to the rail system, wherein a steerable catheter handle of the valve delivery catheter system is translatably coupled to the rail system, wherein the valve delivery catheter system includes a frame of the prosthetic heart valve therein; and advancing the valve delivery catheter into the patient’s heart and deploying the frame into the native valve of the patient’s heart and within the implanted anchor, wherein advancing the valve delivery catheter comprises robotically translating the steerable catheter handle along the rail system.

14. The method of claim 13, wherein a towel wring control system couples the anchor control catheter to automated rotational controls for outer steering and inner steering of the steerable catheter via a worm gear mechanism.

15. The method of claim 13, wherein a rachet in a yoke mechanism of the anchor control catheter toggles the anchor control catheter between (i) a fully locked state and (ii) a free- spinning state.

16. The method of claim 13, wherein the valve delivery catheter is loaded on a guidewire.

17. A robotic delivery system for a prosthetic heart valve, the prosthetic heart valve comprising an anchor adapted to be disposed in a ventricle adjacent a native valve of a- 38 -SG Docket No.: 10844-724.667patient’s heart and a frame supporting valve leaflets adapted to be expanded within the anchor, the delivery system comprising: an anchor control catheter adapted to be robotically advanced into an atrium of the patient’s heart, the anchor control catheter comprising: a lumen extending from a proximal end to a distal end of the anchor control catheter, the lumen being sized and configured to slidingly contain the anchor, a distal guide arm in a distal portion of the anchor control catheter, at least a portion of the distal guide arm having an at-rest spiral shape, and a proximal controller at the proximal end of the anchor control catheter, the proximal controller being configured to change a shape of the distal guide arm by robotically changing an axial position of the anchor within the distal guide arm; a valve delivery catheter configured to deliver the prosthetic heart valve in the ventricle, the valve delivery catheter comprising: a valve capsule, the valve frame being disposed within the valve capsule in a compressed configuration, a capsule shaft catheter connected to the valve capsule and extending proximally from the valve capsule, a valve retainer removably connected to the valve frame, a proximal controller at a proximal end of the capsule shaft catheter, the proximal controller being configured to robotically remove the capsule from the valve frame, thereby permitting the valve frame to expand; and a track system adapted to robotically control movement of the robotic delivery system for delivering at least a portion of the prosthetic heart valve into a patient’s heart, wherein the robotic delivery system includes a first catheter coaxially arranged with a second catheter, the track system comprising: a primary track and a secondary track positioned in parallel, a first carriage adapted to secure a proximal portion of the first catheter thereto and to robotically translate along the primary track, wherein the first carriage is coupled to the secondary track such that the secondary track robotically translates with the first carriage when the first carriage robotically translates along the primary track, and a second carriage adapted to secure a proximal portion of the second catheter thereto and to robotically translate along the primary track, wherein the second carriage includes a coupler that is adapted to selectively engage the second- 39 -SG Docket No.: 10844-724.667carriage with the secondary track such that, when the coupler is engaged, the second carriage robotically translates with the first carriage when the first carriage robotically translates along the primary track.

18. The robotic delivery system of claim 17, wherein one or more sequences of the robotic delivery system is automated, including: (i) robotically advancing the anchor control catheter, (ii) robotically changing the shape of the distal guide arm, (iii) robotically controlling the valve delivery catheter to dispose the prosthetic heart valve, and (iv) robotically controlling the track system to robotically control movement of the robotic delivery system via robotically translating the first and second carriage along the primary and secondary tracks.

19. The robotic delivery system of claim 18, wherein the automation is carried out via one or more of (i) motors, (ii) gearmotors, (iii) actuators, (iv) drives, and (v) sensors.

20. The robotic delivery system of claim 19, wherein the sensors include one or more of (i) cameras, (ii) image analysis, (iii) radiopaque fluorescent markers, (iv) nose cone sensors, and (v) linear variable differential transformers (LVDTs).

21. The robotic delivery system of claim 20, wherein the LVDTs provide positional feedback via converting linear displacement of the steerable catheter into one or more electrical signals, wherein the LVDTs are placed at distal ends of the steerable catheter, wherein the LVDTs are copper coils.

22. The robotic delivery system of claim 17, wherein a user activates the automation of one or more sequences of the delivery.

23. The robotic delivery system of claim 17, wherein placement of the prosthetic heart valve and the anchor of the prosthetic heart valve is confirmed via image analysis prior to release of the heart valve.

24. The robotic delivery system of claim 23, wherein the image analysis includes one or more of (i) computer tomography (CT), (ii) ultrasound, (iii) fluoroscopy, and (iv) magnetic resonance imaging (MRI).- 40 -SG Docket No.: 10844-724.66725. The robotic delivery system of claim 17, wherein a towel wring control system couples the anchor control catheter to automated rotational controls for outer steering and inner steering of a steerable catheter via a worm gear mechanism.

26. The robotic delivery system of claim 17, wherein a rachet in a yoke mechanism of the anchor control catheter toggles the anchor control catheter between (i) a fully locked state and (ii) a free-spinning state.

27. The robotic delivery system of claim 17, wherein the valve delivery catheter is loaded on a guidewire.- 41 -SG Docket No.: 10844-724.667

Images