Prosthetic heart valve delivery systems and methods

Abstract

Devices and methods for delivering one or more portions of a valve prosthesis into the heart of a patient. The device may include one or more catheters operably coupled to one or more controls for controlling axial movement, rotational movement, and / or deflection of the one or more catheters during delivery of the valve prosthesis to the heart. The one or more controls may provide coarse and fine motion control of multiple degrees of freedom of the one or more catheters, thereby providing better control to physicians during valve prosthesis delivery procedures.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to U.S. Provisional Application No. 63 / 366,115, filed on June 9, 2022, entitled “PROSTHETIC HEART VALVE DELIVERY SYSTEM AND METHOD,” the entire contents of which are incorporated herein by reference.

[0003] Reference Merge

[0004] All publications and patent applications mentioned in this specification are incorporated herein 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 Art

[0005] Blood flow between the heart chambers is regulated by native valves (i.e., the mitral valve, aortic valve, pulmonary valve, and tricuspid valve). Each of these valves is a passive, one-way valve that opens and closes in response to a pressure differential. Patients with valvular disease have abnormal anatomy and / or function of at least one valve. For example, a valve may suffer from insufficiency, also known as regurgitation, when the valve does not close completely, allowing blood to flow in the reverse direction. Valvular stenosis may result in the inability of the valve to open properly. Other diseases may also cause valve dysfunction.

[0006] For example, the mitral valve is located between the left atrium and the left ventricle and, when functioning normally, allows blood to flow from the left atrium to the left ventricle while preventing backflow or regurgitation in the opposite direction. However, the native valve leaflets of a diseased mitral valve cannot close completely, causing regurgitation in the patient.

[0007] While medications are available to treat diseased native valves, defective valves may need to be repaired or replaced at some point in a patient's life. Summary of the invention

[0008] The present invention describes devices (e.g., apparatus and systems) and methods for delivering one or more portions of a valve prosthesis into a patient's heart. The device may include one or more catheters operably coupled to one or more controls for controlling axial motion, rotational motion, and / or deflection of the one or more catheters. The one or more controls may provide coarse and fine motion control of multiple degrees of freedom of the one or more catheters, thereby providing a physician with greater control during a valve prosthesis delivery procedure.

[0009] According to some examples, a delivery system for a prosthetic heart valve, the prosthetic heart valve comprising an anchor adapted to be arranged in a ventricle of a native valve adjacent to a patient's heart and a frame supporting valve leaflets adapted to expand within the anchor, the delivery system comprising: an anchor control catheter adapted to be advanced into an atrium of the patient's heart, the anchor control catheter comprising: an inner cavity extending from a proximal end to a distal end of the anchor control catheter, the inner cavity being sized and configured to slidably accommodate 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 a stationary spiral or vortex shape; and a proximal controller at the proximal end of the anchor control catheter, the proximal controller being configured to change the shape of the distal guide arm. The distal guide arm may have a proximal portion and a distal portion, the proximal portion comprising a portion of the distal guide arm having a stationary spiral or vortex shape. The proximal controller may include an actuator operably connected to an anchor in the lumen of the anchor control catheter so that the anchor moves distally and proximally in the lumen to change the shape of the distal portion of the distal guide arm. The actuator may be connected to a tether that is detachably connected to the anchor. The proximal controller may include an actuator operably connected to the distal portion of the distal guide arm and adapted to change the shape of the distal portion of the distal guide arm. The actuator may be connected to an actuating catheter movably disposed in the lumen of the anchor control catheter, the distal end of the actuating catheter being connected to the distal portion of the distal guide arm. The proximal controller may include an actuator operably connected to the proximal portion of the anchor control catheter and adapted to rotate the anchor control catheter. The size and configuration of the distal guide arm may be configured to move into a vortex shape in the atrium of the patient's heart. The proximal controller may also be configured to extend the distal guide arm from the atrium through the valve leaflet to the ventricle through the anchor disposed in the lumen. The proximal controller may also be configured to move the distal end of the distal guiding arm in the ventricle to surround the chordae tendineae of the heart with the distal guiding arm. The proximal controller may also be configured to withdraw the anchor control catheter from the anchor after the distal guiding arm has surrounded the chordae tendineae.

[0010] According to another example, a delivery system for a prosthetic heart valve, the prosthetic heart valve comprising an anchor adapted to be arranged in a ventricle of a native valve adjacent to a patient's heart and a frame supporting valve leaflets adapted to expand within the anchor, the delivery system comprising: a valve capsule, the valve frame arranged in a compressed configuration within the valve capsule; a capsule shaft catheter, the capsule shaft catheter being 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 located at the proximal end of the capsule shaft catheter, the proximal controller being configured to remove the capsule from the valve frame, thereby allowing the valve frame to expand. The delivery system may further include an internal steerable catheter arranged within the lumen of the capsule shaft catheter and an internal catheter steering control line extending from a distal portion of the internal steerable catheter to the proximal controller, the proximal controller further configured to apply and release tension on the internal catheter steering control line. The delivery system may further include an external steerable catheter and an external catheter control line extending from a distal portion of the external steerable catheter to the proximal controller, the proximal controller further being configured to apply and release tension on the external catheter control line, the capsule shaft catheter being arranged in the inner cavity of the external steerable catheter. The capsule shaft catheter may include a plurality of axial sections with 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 bend. The first bend may be configured to be within the right atrium of the patient's heart, and the second bend may be configured to be within the left atrium of the patient's heart.

[0011] According to another example, a guide rail system is suitable for controlling the movement of a catheter system that delivers 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 guide rail system comprising: a main rail and a secondary guide rail positioned in parallel; a first bracket, wherein the first bracket is suitable for fixing a proximal portion of the first catheter to the first bracket and translating along the main rail, wherein the first bracket is connected to the secondary guide rail so that when the first bracket translates along the main rail, the secondary guide rail translates with the first bracket; and a second bracket, wherein the second bracket is suitable for fixing a proximal portion of the second catheter to the second bracket and translating along the main rail, wherein the second bracket includes a connector, wherein the connector is suitable for selectively engaging the second bracket with the secondary guide rail so that when the connector is engaged, the second bracket translates with the first bracket as the first bracket translates along the main rail. The first bracket may include a fastener configured to transition between a first closed state in which the proximal portion of the first catheter is frictionally secured to the first bracket, wherein the first catheter is maintained in an intended rotational position but is rotatable relative to the first bracket, and a second closed state in which the proximal portion of the first catheter is fully secured to the first bracket and is not rotatable relative to the first bracket. The rail system may also include a third bracket adapted to secure the proximal portion of the third catheter to the third bracket and translate along the primary rail, wherein the third bracket includes a second coupler adapted to selectively engage the third bracket with the secondary rail such that when the second coupler is engaged, the third bracket translates with the first bracket as the first bracket translates along the primary rail. The first bracket may include a first fastener configured to releasably fix the proximal portion of the first catheter to the first bracket, and the second bracket includes a second fastener configured to releasably fix the proximal portion of the second catheter to the second bracket, wherein each of the first fastener and the second fastener is configured to releasably fix the proximal portion of different catheters thereto. The coupling may be suitable for disengaging the second bracket from the secondary guide rail so that when the coupling is disengaged, the second bracket translates independently of the first bracket. The coupling may be disengaged in a default state. The rail system may also include a track that supports the primary and secondary guide rails in parallel. The first bracket may include a first gear assembly suitable for translating the first bracket along the primary rail, and wherein the second bracket includes a second gear assembly suitable for translating the second bracket along the primary rail. The first catheter may be slidably positioned in the second catheter. The second catheter may be slidably positioned in the first catheter. The second bracket may include a button suitable for engaging and disengaging the coupling. Each of the first bracket and the second bracket may include a gear assembly configured to mesh with the teeth of the primary rail when the corresponding first bracket or the second bracket translates along the primary rail. Each of the first bracket and the second bracket may include a turntable configured to translate the corresponding first bracket or the second bracket along the main rail when the turntable rotates.Each of the first bracket and the second bracket may include a lock to lock the translational position of the first or second guide tube relative to the primary rail.

[0012] According to another example, a method of delivering an anchor of a prosthetic heart valve into a patient's heart, the method comprising: 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 so that the anchor applies a force to the guide arm to change the first shape of the guide arm to a second shape and change the distance that the distal end of the guide arm radially extends. Changing the first shape of the guide arm to the second shape may include changing the radius of curvature of the distal end of the guide arm. When the guide arm captures the chordae, the anchor control catheter may be positioned together with a steerable catheter having a deflected configuration, wherein capturing the chordae also comprises adjusting the steerable catheter to change the position of the guide arm in the ventricle. The guiding arm may include a proximal end extending generally along a first axis, and wherein a distal end of the guiding arm is in a plane generally perpendicular to the first axis, and wherein the change in distance is relative to the first axis. Each of the first shape and the second shape of the guiding arm may have a spiral shape or a vortex shape.

[0013] According to another example, a delivery system for delivering an anchor of a prosthetic heart valve into a patient's heart includes: a catheter assembly having an 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 having a distal end; and a controller coupled to a proximal portion of the anchor control catheter, wherein the controller includes: a first control configured to apply a preload force to the guide arm when the guide arm is within the steerable catheter so that the guide arm self-assembles into a vortex or spiral 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 a force to the guide arm that changes the distance that the distal end of the guide arm radially extends. The controller may also include a third control configured to control the axial height of the guide arm relative to the steerable catheter. The third control can be part of a bracket releasably coupled to the proximal portion of the anchor control catheter, wherein the third control is configured to translate the proximal portion of the anchor control catheter on the track relative to the proximal portion of the steerable catheter.

[0014] According to another example, a system for controlling the movement of a catheter to deliver at least a portion of a prosthetic heart valve into a patient's heart includes: a handle coupled to a proximal portion of the catheter, the handle including a control configured to control the deflection of a distal portion of the catheter; and a bracket including a fastener configured to secure the handle to a support, the fastener including a band configured to surround the handle to secure the handle to a stent, wherein the fastener is configured to transition between the following states: an open state, in which the band is in an open position so that the handle can be removed from the stent; a first closed state, in which the band loosely surrounds the handle and the handle is frictionally secured to the stent at an intended rotational position, but can rotate relative to the bracket; and a second closed state, in which the band securely surrounds the handle so that the handle is rotatably secured relative to the bracket. The support may include a rail system configured to allow the bracket to translate with the handle secured thereto to allow axial movement of the distal portion of the catheter. The handle can be a first handle coupled to the first catheter, and the bracket can be a first bracket, wherein the system can further include: a second handle coupled to a proximal portion of a second catheter coaxially aligned with the first catheter; and a second bracket configured to fix the second handle to a rail system, wherein the first bracket and the second bracket are configured to translate independently along the rail system to cause independent axial movement of the distal portions of the first and second catheters. The rail system can be configured to selectively allow the first bracket and the second bracket to translate together along the coupling of the rail system to cause the coupling axial movement of the distal portions of the first and second catheters. The bracket may include one or more engagement features configured to frictionally engage with corresponding features of the handle to keep the handle in an intended rotational position.

[0015] According to another example, a delivery system suitable for delivering an anchor of a prosthetic heart valve into a patient's heart includes: an anchor control catheter having a distal guide arm configured to present a vortex or spiral shape, wherein the anchor is slidably positioned within the anchor control catheter; and a handle connected to the proximal portion of the anchor control catheter, wherein the handle includes: a first control configured to bias the distal guide arm toward the vortex or spiral shape; and a second control configured to cause the anchor to move axially within the anchor control catheter to change the extent to which the 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 the tendons of the patient's heart, thereby allowing the distal guide arm to surround the tendons. The delivery system may also include a steerable catheter, wherein the anchor control catheter is slidably positioned within the steerable catheter, wherein the first control is configured to bias the distal guide arm toward the vortex or spiral shape when the distal guide arm is within the steerable catheter. The delivery system may also include a second handle coupled to the steerable catheter, wherein the second handle includes a deflection control configured to selectively deflect the distal portion of the steerable catheter to steer the distal guide arm within the patient's heart. The delivery system may also include a second handle coupled to the steerable catheter, wherein the second handle is translatable relative to the first handle to axially retract the distal portion of the steerable catheter relative to the distal guide arm, thereby allowing the distal guide arm to be released from the steerable catheter and to assume a vortex or spiral shape. The delivery system may further include a track system, the track system including a first bracket configured to secure the first handle to the track system and a second bracket configured to secure the second handle to the track system, wherein the first bracket and the second bracket are translatable along the guide rail.

[0016] According to another example, a method for delivering an anchor of a prosthetic heart valve into a patient's heart includes: advancing a catheter system into an 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 vortex or spiral shape when the distal guide arm is within the steerable catheter; and advancing the distal guide arm so that the distal guide arm leaves the distal end of the steerable catheter and assumes a vortex or spiral shape. Biasing the distal guide arm may include activating a control of a handle coupled to a proximal portion of the anchor control catheter. The method may also include advancing the distal guide arm through a native valve annulus by translating the handle along a track system. The method may also include encircling chordae proximal to the native valve annulus by the distal guide arm, wherein encircling the chordae includes changing the extent to which the distal end of the guide arm radially extends by moving the anchor axially within the distal guide arm. The method may further include retracting a distal guide arm over the anchor to release the anchor from the distal guide arm, wherein retracting the distal guide arm includes translating the handle along the track system.

[0017] According to another example, a delivery system suitable for delivering a prosthetic heart valve into a patient's heart includes: a steerable catheter having a distal valve sac configured to hold a frame of the prosthetic valve inside; and a handle connected to a proximal portion of the steerable catheter, wherein the handle includes: a valve deployment knob configured to control retraction of the distal valve sac relative to the frame so as to release at least a portion of the frame from the steerable catheter; a depth control knob configured to control axial movement of the distal portion of the steerable catheter; and a deflection knob configured to control deflection of the distal portion of the steerable catheter. The handle can be translatably connected to a rail system, wherein the rail system includes a translation control configured to translate the handle so as to control the overall axial movement of the distal portion of the steerable catheter. The steerable catheter may include a plurality of axial sections having different degrees of flexibility, wherein deflection of the steerable catheter causes a distal portion of the steerable catheter to have a first bend and a second bend separated by an accessible section of the steerable catheter.

[0018] According to another example, a method for delivering a prosthetic heart valve into a patient's heart includes: advancing a steerable catheter via a guidewire into an atrium of the patient's heart, the steerable catheter having a proximal portion connected to a handle and a distal portion having a valve sac that holds a frame of the prosthetic heart valve inside, wherein advancing the steerable catheter into the atrium includes translating the handle relative to a support that is translatably connected to the handle; steering the valve sac toward a native valve annulus of the patient's heart by deflecting the steerable catheter, wherein the deflection includes activating a deflection knob of the handle; partially advancing the valve sac 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, wherein the activating valve deployment knob of the handle will retract the valve sac relative to the frame, wherein the frame expands into the native valve annulus and expands into anchors of chordae tendineae surrounding the native valve annulus. The method may also include: releasing the ventricular side of the frame in the ventricle of the patient's heart by activating a valve deployment knob of the handle; and pulling the ventricular side of the frame toward the native valve annulus to position the anchor closer to the native valve annulus by activating a depth control knob. When the ventricular side of the frame is pulled toward the native valve annulus, the steerable catheter can be in a deflected state, wherein the steerable catheter includes a first bend within the right atrium of the patient's heart and a second bend within the left atrium of the patient's heart. The support may include a track system, wherein the handle is coupled to the track system by a bracket that is translatably coupled to the guide rail, wherein the translation handle includes a turntable that activates the bracket to translate the bracket relative to the guide rail.

[0019] According to another example, a method for delivering a prosthetic heart valve into a patient's heart includes: advancing a steerable catheter via a guidewire into an atrium of the patient's heart, the steerable catheter having a proximal portion connected to a handle and a distal portion having a valve sac that holds a frame of the prosthetic heart valve inside, wherein advancing the steerable catheter into the atrium includes translating the handle relative to a support that is translatably connected to the handle; partially advancing the valve sac 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 surrounds chordae tendineae near the native valve annulus; releasing a ventricular side of the frame in a ventricle of the patient's heart by activating a valve deployment knob of the handle; pulling the ventricular side of the frame toward the native valve annulus by activating the depth control knob of the handle to position the anchor closer to the native valve annulus; and releasing the atrial side of the frame in the atrium of the patient's heart by activating the valve deployment knob of the handle to fully retract the valve sac relative to the frame, wherein the frame expands into the native valve annulus and within the anchor. When the ventricular side of the frame is pulled toward the native valve annulus, the anchor can be freely implanted in the patient's heart. The anchor may not be connected to the tether. The method may also include manipulating the valve sac toward the native valve annulus by deflecting the steerable catheter, wherein the deflection includes activating a deflection knob of the handle. When the ventricular side of the frame is pulled toward the native valve annulus, the steerable catheter can be in a deflected state, wherein the steerable catheter includes a first bend in the right atrium of the patient's heart and a second bend in the left atrium of the patient's heart. The support may include a track system, wherein the handle is connected to the track system by a bracket that is translatably connected to the guide rail, wherein the translation handle includes a turntable that activates the bracket to translate the bracket relative to the guide rail.

[0020] According to another example, a method for delivering a prosthetic heart valve into a patient's heart includes: 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 handle and the second handle are translatably coupled to a track system; attaching a native valve around the patient's heart; The present invention relates to a method of implanting an anchor near a chord, wherein implanting the anchor includes translating a first handle along a track system independently of a second handle; removing the anchor delivery catheter system from the track system and coupling a valve delivery catheter system to the track system, wherein a steerable catheter handle of the valve delivery catheter system is translatably coupled to the track system, wherein the valve delivery catheter system includes a frame of a prosthetic heart valve inside it; and advancing the valve delivery catheter into the patient's heart and deploying the frame into the patient's heart's native valve and into the implanted anchor, wherein advancing the valve delivery catheter includes translating the steerable catheter handle along the track system. The first handle may be releasably coupled to a first bracket, the first bracket being translatably coupled to the track system, and wherein the second handle may be releasably coupled to a second bracket, the second bracket being translatably coupled to the track system. Translating the first handle along the track system may include translating the first bracket independently of the second bracket. The steerable catheter handle may be coupled to the first bracket or the second bracket. Implanting the anchor may further include unlocking a fastener securing 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 includes capturing the chordae tendineae within the guide arm.

[0021] These and other examples are described in the Summary section.

[0022] Any combination of all methods and apparatus described herein are contemplated by the present invention and may be used to achieve the benefits described herein. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] The features and advantages of the methods and apparatus of the present invention will be better understood by referring to the following detailed description and accompanying drawings which set forth illustrative embodiments, in which:

[0024] Figure 1 An exemplary prosthetic mitral valve is shown in place in a patient's heart.

[0025] Figure 2 An exemplary anchor delivery subsystem is shown.

[0026] Figure 3 Shown for Figure 2 An exemplary cross-sectional view of a nested catheter of an anchor delivery subsystem.

[0027] Figure 4A An exemplary cross-sectional view of an inner steerable catheter is shown.

[0028] Figure 4B An exemplary cross-sectional view of an externally steerable catheter is shown.

[0029] Figure 5 An example perspective view showing coil layers.

[0030] Figure 6 An example perspective view showing a braid.

[0031] Figure 7 An example perspective view of another braid is shown.

[0032] Fig. 8A and Figure 8B An example perspective view and a front view of a pull ring are shown, respectively.

[0033] Fig. 9 An example perspective view of a sheath assembly is shown.

[0034] Fig.10 and Fig.11 An example perspective view of a winch assembly is shown.

[0035] Figure 12A-12B An exemplary schematic cross-sectional view of an anchor-controlled catheter is shown.

[0036] Fig.13A An example side view of a rotation control shaft is shown.

[0037] Fig. 13B , Fig. 13C and Fig.13D Show Fig.13A Example front view of laser cut patterns for different areas of a rotation control shaft.

[0038] Fig.14A and Fig. 14B An example of a vortex guiding arm is shown.

[0039] Fig.15A and Fig. 15B An example of a helical guide arm is shown.

[0040] Fig.16A Show Fig.14A and Fig. 14B Sample cross-sectional image of the vortex guide arm.

[0041] Fig. 16B Show Fig.15A and Fig. 15B A sample cross-section image of the spiral guide arm.

[0042] Figures 17A-17D An exemplary support structure for the mid-portion of the guide arm is shown.

[0043] Fig.18A An exemplary guiding arm is shown in a self-assembled position with the anchor within the guiding arm fully axially extended.

[0044] Fig.18B and Fig.18C Show Fig.18A The guide arm is in a wrapped position with the anchor retracted within the guide arm.

[0045] Figures 19A-19D Details of exemplary anchors are shown.

[0046] Fig. 20 An example of a portion of a proximal controller for an anchor control catheter and tether is shown.

[0047] Fig.21 An example of a portion of another proximal controller incorporated into a handle actuator for an anchor control catheter and tethers is shown.

[0048] Fig. 22 An exemplary proximal controller for an anchor delivery subsystem is shown.

[0049] Fig.23 An example top view of an anchor is shown.

[0050] Fig.24 An exemplary valve delivery subsystem is shown.

[0051] Fig.25A Shown for Fig.24 An exemplary cross-sectional view of a nested catheter of a valve delivery subsystem.

[0052] Fig.25B An exemplary distal portion of a valve delivery subsystem is shown.

[0053] Fig.26A An example tab holder is shown as part of a valve delivery subsystem.

[0054] Fig.26B An example tab holder shaft is shown as part of a valve delivery subsystem.

[0055] Figure 27A-27C An exemplary steerable catheter that may be used as a single steerable catheter as part of a valve delivery subsystem is shown.

[0056] Fig.28 Another exemplary view of a proximal controller for a valve delivery subsystem is shown.

[0057] Fig.29A and Fig.29B An example of a valve prosthesis having a valve frame structure is shown.

[0058] Fig. 30A and Fig. 30B Another example proximal controller for an anchor delivery subsystem is shown.

[0059] Fig.31 Shown for use such as Fig. 30A and Fig. 30B An exploded view of an example proximal controller of an anchor delivery subsystem of an anchor delivery subsystem of an embodiment of the present invention.

[0060] Fig.32 Another example proximal controller for a valve delivery subsystem is shown.

[0061] Figure 33A to Figure 33V and Figure 33-1 to Figure 33-13 Systems and methods for implanting an anchor and a prosthetic mitral valve in a subject's heart are shown. DETAILED DESCRIPTION

[0062] The present invention relates to a delivery system for a prosthetic heart valve having two main components: an anchor adapted to be disposed in a ventricle adjacent to a native valve of a patient's heart, and a frame supporting the 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 the present invention delivers both components of the valve transseptally. In use, the delivery system is advanced distally from an entry point in the femoral vein of the patient, into the right atrium of the heart, and through the septum into the left atrium to implant the anchor and then expand the valve frame within the anchor.

[0063] Because the anatomy of the heart may vary from patient to patient, it is desirable to be able to control the motion, position and / or orientation of the delivery system while delivering and implanting the anchor and valve frame. It may also be necessary to retract the anchor and / or valve during implantation if the anchor and / or valve are not positioned exactly as intended. Thus, the prosthetic valve delivery system of the present invention provides a mechanism for guiding the anchor and valve and for controllably releasing the anchor and valve when the anchor and valve are properly positioned.

[0064] Figure 1 An exemplary prosthetic mitral valve 10 is shown in place in a patient's heart. The valve 10 includes an anchor 12 and a valve frame 14. A movable leaflet (not shown) attached to the valve frame replaces and performs the function of the native leaflets. As shown, the anchor 12 is placed around chordae tendineae 20 in the left ventricle 18. The valve frame 14 extends between the left atrium 16 and the left ventricle 18 through the native valve ring 22.

[0065] The anchor 12 and valve frame 14 of the valve 10 are implanted separately. The anchor 12 is first delivered and placed around the chordae tendineae 20. Thereafter, the valve frame 14 is delivered and expanded within the anchor 12. In order to advance the valve component from the opening in the patient's groin to the heart, the delivery system may need to be pushed, bent, and / or rotated to navigate the anatomy of the intervening vessel.

[0066] Since the anchor and the frame are delivered separately, the delivery system of the present invention has two main subsystems: an anchor delivery subsystem and a valve frame delivery subsystem. Figure 2 and Figure 3 A proximal controller 32 and three nested catheters (eg Figure 3 3 (shown in cross-section in FIG. 1 ): an external steering catheter 34, an internal steering catheter 36 movably disposed within the lumen of the external steering catheter 34, and an anchor control catheter 38 having an external rotation axis 40 and an internal actuation catheter 39 movably disposed within the lumen of the internal steering catheter. As described below, the guide arm ( Figure 3 ) extends from the distal end of the external rotating shaft 40 of the anchor control catheter 34. Figure 3 Also shown is a tether 42 which is releasably connected at its distal end to an anchor (not shown) movably disposed within the inner steering catheter 36. The outer steering catheter 34, the inner steering catheter 36, the anchor control catheter 38, and the tether 42 are all operably connected to the proximal controller 32. An introducer sheath (not shown) may be used to introduce the three nested catheters into a patient's vasculature.

[0067] Figure 4A and Figure 6 Various aspects of a catheter that may be used as an internal steerable catheter 36 are shown, and Figure 4B Aspects of a catheter that may be used as the externally steerable catheter 34 are shown. Figure 5 and Figure 7-Figure 11 Features common to the inner and outer steerable catheters are shown and reference is made to their use with the inner steerable catheter 36 .

[0068] Each of the steerable catheters 34 and 36 has a liner 44 formed of, for example, PTFE or other suitable material surrounding an inner lumen 45. A first coil layer 46 surrounds the liner. In the inner steerable catheter 36, as shown in FIG. Figure 4B As shown, the coil layer 46 can be formed, for example, using wires of a first pitch, while the coil layer 46 of the outer steerable catheter 34 can be formed of wires having a first pitch in a proximal region 61 and a second pitch (e.g., a larger pitch) in a distal region 63. Two axial reinforcement members 48 can be placed 180° apart on the coil layer 46; Figure 5An axial reinforcement member 48 is shown.

[0069] In the inner steerable catheter 36, as Figure 4A and Figure 6 As shown, the inner braided layer 50 surrounds the coil layer 46 and one or more reinforcing members 48. The braided layer 50 can be, for example, a diameter double-ended wire braid. Two longitudinal pull wire lumens 52 spaced 180° apart are placed on the braided layer 50, each at a position offset 90° from the axial reinforcing member 48. Figure 6 Only one puller lumen is shown. The puller lumen 52 may be formed of, for example, PTFE. The puller wire 54 (e.g., Fiber formation) extends through the inner cavity 52, as further explained below.

[0070] In the inner steerable catheter 36 and the outer steerable catheter 34, a braid 56 extends around the pull wire lumen 52. The braid 56 can be, for example, a braid in the inner steerable catheter 36 and a double-ended braid in the outer steerable catheter 34. In the inner steerable catheter 36 and the outer steerable catheter 34, the braid 56 can have a first braid density (ppi) at a proximal region 65 and a second braid density (ppi) (e.g., greater than the first braid density) at a distal region 67. A pull ring 58 is disposed on the braid 56 at the distal end of the catheter.

[0071] like Figure 8A-8B As shown, the pull ring 58 may be formed with an outer ring 60 welded to an inner ring 62. The pull wire 54 is looped around a cable post 64 disposed between the inner and outer rings 180° apart. The free end of the pull wire 54 extends proximally through the pull wire lumen 52 to a proximal controller.

[0072] Fig. 9 A distal tip 66 is shown extending around the pull ring 58. The distal tip 66 may be made, for example, of a polymer (e.g. ) is formed. The distal end of the liner 44 ( Figure 7 ) is everted around the distal tip 66. Three outer sheaths cover the various sections of the catheter. A flexible distal outer sheath 68 (e.g. or Extending proximally from the distal tip 66 is an intermediate sheath 70 that is less flexible than the distal outer sheath 68 (formed from, for example, a polymer (e.g., ) is formed) to provide an intermediate level of bending stiffness while providing sufficient stiffness to transmit torque to the distal portion of the catheter. A proximal outer sheath 72 (formed from a polymer) extends proximally from the intermediate sheath 70. The stiffness of the proximal outer sheath 72 provides good torque response and has low compression and elongation characteristics.

[0073] Fig.10 and Fig.11 The free end of the pull wire 54 is shown extending from the pull wire lumen 52 (e.g., Figure 6 ) extends through the braid 56 and the opening in the proximal outer sheath 72 to a handle 74 in a proximal controller at the proximal end of the catheter 34. The free end of the pull wire 54 is wound around a pair of capstans 76 disposed in the proximal controller 74. The capstans 76 are mounted on a lead screw that is actuated by a ring gear on a knob 73 attached to the proximal end of the handle. One capstan is connected to a right-hand lead screw and the other capstan is connected to a left-hand lead screw so that the two capstans 76 rotate equal amounts in opposite directions when actuated by the knob 73 to deflect the distal end of the catheter 34.

[0074] When used together, the external steering catheter and the internal steering catheter can be used to guide the patient's blood vessels to reach the patient's heart from an insertion point in the patient's groin through the blood vessels. Each of the internal steerable catheter and the external steerable catheter can be steered in a single plane. The external steerable catheter can be used to reach the right atrium and through the septum to the left atrium from a vascular access point in the femoral vein through the vena cava. The internal steerable catheter can be used to cross from the septum toward and through the native mitral valve to enter the left ventricle.

[0075] 12-19 illustrate various aspects of an anchor control catheter 38. The anchor control catheter 38 is used to deliver and deploy the anchor of a prosthetic valve after the outer and inner steering catheters have been used to advance the distal end of the inner steering catheter from the right atrium through the septal wall into the left atrium of the patient. Fig. 12A 3 is a schematic cross-sectional view of the main components of the anchor control catheter 38. The rotation control shaft 40 of the anchor control catheter 38 extends distally from the actuator 80 in the proximal controller. The guide arm 82 extends distally from the rotation control shaft 40.

[0076] As described below, the guide arm 82 has active and passive features that enable it to assemble into a spiral shape in the left atrium. In particular, the guide arm 82 has a shape setting feature and a cutting pattern feature that allows the guide arm to be flexible when it is within the steerable catheter. However, when the guide arm 82 emerges from the internal steerable catheter, the guide arm 82 achieves the desired shape through a combination of shape setting features and cutting pattern actuation to maintain the desired shape.

[0077] The actuation catheter 39 extends from the actuator 84 in the proximal controller through the lumen of the rotation control shaft 40 and the guide arm 82 to the distal end of the guide arm 82. The cap 86 extends over and is attached to the distal end of the guide arm 82. The cap 86 is a 72DPEBAX tip that couples the distal end of the actuation catheter 39, the distal end of the guide arm 82, and the outer sheath into a smooth and atraumatic distal tip. As described below, the proximal movement of the actuator 84 places the guide arm 82 and the rotation control shaft 40 in a compressed state to change the functional characteristics of these elements.

[0078] The rotational movement of the actuator 80 rotates the rotation control shaft 40, the guide arm 82, and the actuation catheter 39. The rotation control shaft 40 is a laser cut hypotube that is designed to be flexible and transmit rotational forces along the length of the anchor control catheter 38. The rotation control shaft 40 is configured to effectively transmit torque from the actuator 80 to the guide arm 82 to ensure that rotation of the proximal end of the rotation control shaft 40 results in a substantially equal amount of rotation of the guide arm 82 at the distal end of the rotation control shaft 40. Each region of the rotation control shaft 40 is cut according to a pattern (or not cut at all) to provide features useful for that region.

[0079] The tether 42 extends from an actuator 90 in the proximal controller to an anchor 88 of the prosthetic heart valve. The tether 42 is releasably attached to or abuts the anchor 88 at a junction region 89 so that the anchor 88 can be separated from the tether 42 once the anchor 88 is deployed in the heart. Fig. 12B An example is shown where the guide arm 82 is pulled proximally past the engagement region 89 and the anchor 88 is separated from the tether 42. For example, when the engagement region 89 is within the guide arm 82, the guide arm 82 may maintain a position where the anchor 88 is adjacent (e.g., abutting) or connected to the tether 42, but once the guide arm 82 is pulled proximally past the engagement region 89, the anchor 88 may be disconnected from the tether 42. In some examples, the proximal end of the anchor 88 and the distal end of the tether 42 include matching shaped interface features 43a and 43b, respectively, to increase the engagement of the anchor 88 and the tether 42 within the guide arm 82. In some examples, the tether 42 is releasably attached to the anchor 88 using one of the releasable connectors described in WO 2022 / 046678. The axial movement of the tether 42 and the anchor 88 may be controlled by an actuator 90 in the proximal controller. As described herein, axial movement of the anchor 88 relative to the guide arm 82 may be used, for example, to change the shape of the guide arm 82 .

[0080] like Fig.13AAs shown, the rotation control shaft 40 extends from the proximal end 200 (at the proximal end 200, the rotation control shaft 40 is connected to the actuator 80) through the proximal region 202, the IVC region 204, the OS region 206, the IS region 208 and the distal region 210 to reach the distal end 212 (at the distal end 212, the rotation control shaft 40 is connected to the guide arm 82). Fig. 13B A pattern of laser cut lines 214 (shown in white against a black background) is shown for removing material from region 216 to form a connector at the distal end of distal region 210 to engage a mating connector at the proximal end of guide arm 82 to form a joint. The laser cut pattern in the remainder of distal region 210 (not shown) is in the form of cut segments arranged in a swirling pattern.

[0081] The IS region 208 corresponds to the portion of the rotation control shaft 40 that will be disposed within the distal region of the inner steerable catheter 36 . Fig. 13C and Fig.13D 2 shows a pattern of laser cut lines 218 (shown in white against a black background) used to remove material to create an opening 220 extending circumferentially around the IS region 208 of the rotation control shaft 40. Fig.13D As shown in detail, each opening 220 has a wide portion 222 and two narrow portions 224. Adjacent rings of openings 220 are offset so that the center of each opening in one ring is aligned with the uncut portion 226 in the adjacent ring. Figure 3 C shows only two partial rings of openings, but the openings 220 occupy the entire IS region 208 .

[0082] The OS region 206 has a cutting pattern that is the same as the cutting pattern of the distal region 210: 336 cutting segments arranged in a spiral shape with a first pitch, each cutting segment having a first cut, a first length, and a first spacing from adjacent cuts. The IVC region 204 has a spiral cutting pattern that is different from the OS region 206 and the distal region 210. The IVC region 204 extends 43 inches and has a cutting segment pattern arranged in a spiral with a second pitch (e.g., greater than the first pitch), each cutting segment having a first cut, a second length (e.g., less than the first length), and a second spacing from adjacent cuts (e.g., greater than the first spacing).

[0083] Figure 14A-Figure 15B 82 and the distal end of the rotation control shaft 40. As shown in the figure, the guide arm 82 is in the vortex configuration ( Fig.14A and Fig. 14B ) and / or helical configuration ( Fig.15A and Fig. 15B), for example, a configuration controllably assumed after emerging from the distal end of an internally steerable catheter within the left atrium of the heart. The geometry of the guide arm 82 provides self-assembly consistent with a proven wrapping geometry. As will be described in more detail, the anchor control catheter serves as a wrapping tool that separates the anchor itself from (e.g., direct) wrapping.

[0084] See also Fig.14A and Fig. 14B , the guide arm 82 has three parts: a curved portion 90 extending radially outward from the joint at the distal end of the rotation control shaft 40, an intermediate portion 92 extending from the curved portion 90 to a transition point 94, and a distal portion 96 extending from the transition point 94 to the distal end of the guide arm including the cap 86. The rotation control shaft 40 generally extends axially along the longitudinal axis of the anchor delivery subsystem and the three nested catheters. The curved portion 90 of the guide arm 82 bends at a bend 91 and extends radially outward, and then bends sharply inward again at a bend 93 when it transitions to the intermediate portion. The distal portion 96 and the intermediate portion 92 are generally located in a plane 97 that is orthogonal to the axis 79 of the rotation control shaft 40 (or the longitudinal axis of the anchor delivery subsystem). The curved portion and the bends 91, 93 help the guide arm 82 transition from being aligned with the longitudinal axis of the rotation control shaft to the proximal and distal portions located in a plane orthogonal to the longitudinal axis. This embodiment of the guide arm 82 is described as having a vortex configuration.

[0085] Fig.15A and Fig. 15B A view of another embodiment of a guide arm 82a is shown having a helical configuration that is the opposite of the vortex configuration of guide arm 82. As with the above-described embodiment, guide arm 82a includes a curved portion 90 extending radially outward, and the intermediate portion 92 and distal portion 96 do not lie together in a single plane orthogonal to the longitudinal axis of the anchor delivery subsystem or nested catheter. Instead, in this embodiment, the intermediate portion includes a helical segment that includes turns (e.g., rings) that are axially spaced apart (e.g., lying in more than one plane). It can be seen that, depending on the number of turns, this causes the proximal portion to rotate in a helical manner so as to lie in at least planes 97 and 99 before transitioning to the distal portion 96 lying in plane 99. In the example shown, the intermediate portion may include, for example, less than two turns. Fig.15A and Fig. 15B The opposite of the in-plane arrangement of the guide arm 82 is shown (see Fig. 14B), including how the distal and intermediate portions of the guide arm 82a are located in planes 97 and 99. The geometry of the guide arm, e.g., the distal portion 96 being located in plane 99 that is substantially orthogonal to the axis 79 of the rotational control shaft, facilitates delivery of the anchor into a planar arrangement with the mitral annulus. The anchor delivery system is designed to maintain the orthogonal arrangement of the guide arm to the rotational control axis throughout the delivery process, which, along with independent user control of system rotation, grasper extension, and system (axial) position, enables the clinician to have repeatable and fine-tunable control of depth / radial extent during the circumference process.

[0086] Because the guide arm is not implanted or remains in the patient's body, visualization features or markings that facilitate real-time imaging (e.g., using ultrasound and / or fluoroscopy) can be included on the guide arm without considering the impact of these features on the delivery or performance of the implant (e.g., anchor). For example, the guide arm can include radiopaque markings to allow such visualization. Additionally or alternatively, the construction of the anchor control catheter with a laser cut shape memory or nitinol tube provides highly reflective features that are easily visualized by ultrasound.

[0087] Fig.16A Is from Fig.14A and Fig. 14B The sample cross-sectional echo image of the guide arm 82 is shown in FIG. Fig.16A As shown, the curved portion 90 can be seen in a single plane under ultrasound along with a circular cross-section representing the intermediate portion 92, distal portion 96 and distal tip 98 of the guide arm 82. Fig. 16B Is from Fig.15A and Fig. 15B 82a of the guide arm 82a. In this image, because the middle portion 92 forms more than one helical turn, the middle portion stays in more than one plane, so the circular cross section of the middle portion 92 is easily visualized and distinguished in the ultrasound image. In addition, this allows for easier visualization of the distal tip 98 because it is distinguishable as a single circular cross section spaced apart from the paired cross sections of the helical middle portion. This makes visualization of the distal tip of the guide arm 82a easier because the distal tip is more prominent on the echo imaging, thereby helping the user to surround the selected anatomical structure with the distal tip.

[0088] refer to Figures 17A-17D, the guide arm can be a shape memory material laser cut of a combination of an active segment (e.g., 92) and a passive segment (e.g., 96) having a transition region 94 and a tether connection portion 95. The active segment 92 may include a tapered spiral pattern having a longitudinal ridge 102 that extends generally spirally in the proximal portion of the active segment 92 and extends longitudinally in the distal portion of the active segment 92. A series of windows 104 may be arranged opposite the ridge 102, and a pair of toothed segments 106 are arranged 90° apart from the windows 104 and the ridge 102. In some embodiments, the passive segment 96 includes a generally vortex cut pattern with a periodic bridging structure. In some embodiments, the passive segment 96 includes a longitudinal ridge (or multiple ridges) having spaces (or cutouts) disposed on the radially inward and / or outward portions of the guide arm (providing radial flexibility and axial stability). This combination of these active and passive segments and the preset (shape memory) shape causes the guide arm to present a vortex (e.g., Fig.17A 82) or spiral (e.g. Fig. 17B 82a) shape (depending on Fig.14A and Fig. 14B Whether the configuration is used or Fig.15A and Fig. 15B The proximal movement of the actuating catheter 39 relative to the guiding arm 82 (FIG. 12) engages the opposing edges of the tapered spiral cut pattern to lock the active section 92 into the desired shape, i.e., the flat vortex or spiral shape extending from the longitudinal axis of the inner steerable catheter through an approximately 90 degree bend. Since the shape of the anchor control catheter is formed from shape memory or Nitinol laser cut tubing, the complex surface features are acoustically very well reflective and enable different echo visualizations.

[0089] Fig. 17C A spiral (e.g., Fig. 17B ) exemplary aspects of the guide arm. As shown, a series of windows 104 can be disposed opposite the ridge 102, and a pair of toothed sections 106 are disposed 90 degrees apart from the windows 104 and the ridge 102. This structure and the preset shape of the proximal portion 92 cause it to assume a spiral shape when it emerges from the steerable catheter. Proximal movement of the actuating catheter 39 relative to the guide arm 82 engages the opposing edges of the tapered spiral cut pattern to lock the proximal portion 92 into the desired shape, i.e., a flat vortex extending from the longitudinal axis of the inner steerable catheter through a 90 degree bend to the distal portion 96.

[0090] The distal portion 96 of the guide arm 82 can be configured to provide proximal and distal movement of the anchor 88 within the distal portion 96 of the guide arm 82 by moving the tether 42 to manipulate its set shape into a more open and / or more closed shape ( FIG. 12 ). The support structure of the distal portion 96 can be laser cut in a pattern of alternating spiral components 98 and bridges 100 that provide flexibility so that proximal and distal movement of the stiffer anchor within the intermediate portion 92 and the distal portion 96 can bend or straighten the distal portion 96. The shape of the distal portion 96 can also be controlled by movement of the actuating catheter 39.

[0091] Fig.18A The guide arm 82 is shown in a self-assembled position, wherein the distal portion of the anchor within the guide arm 82 is deployed to a depth indicated by arrow 120, and the proximal portion of the anchor within the guide arm 82 is deployed to a depth indicated by arrow 127. In the self-assembled position, the shape and depth of the anchor within the guide arm 82 causes the distal end (e.g., tip) and distal portion (which may be referred to as a grabber, grabber arm, or grabber portion) of the guide arm 82 to rest against itself as shown. This configuration provides a minimal "envelope" of the guide arm, facilitating: 1) deployment of the guide arm 82 within the atrium, and 2) anchor control of catheter advancement from the atrium to the ventricle without harmful contact / entanglement with native tissue. Fig.18B and Fig.18C The guide arm 82 is shown in a wrapping position, wherein the distal portion of the anchor is retracted within the guide arm 82 to a depth indicated by arrows 121 and 122, and the proximal portion of the anchor is retracted within the guide arm 82 to a depth indicated by arrows 128 and 129, respectively. As shown, retracting the anchor causes the distal end (e.g., tip) and distal portion of the guide arm 82 to extend radially outward while maintaining the proximal portion of the anchor away from the bend 93 of the guide arm 82. That is, the movement of the anchor within the guide arm 82 can change the shape of the guide arm 82 (e.g., change the radius of curvature). This allows the user to finely control the angle and distance of the distal end (e.g., tip) of the guide arm 82 relative to the rest of the guide arm 82 to assist the user in wrapping the chordae tendineae. Maintaining the proximal portion of the anchor distal to the bend 93 of the guide arm 82 maintains a prescribed geometry of the guide arm 82 while enabling the distal end (e.g., tip) of the guide arm 82 to be adjusted during the wrapping process.

[0092] Figures 19A-19DDetails of the anchor 88 are shown. When the anchor 88 is loaded into the anchor control catheter, the anchor 88 presents a generally straight shape. In its unconstrained state, the anchor 88 extends in a vortex form from the distal end 124 to the proximal connector 126, where the anchor is releasably attached to the tether. The laser cut section 125 at the distal end is more flexible than the central portion of the anchor, and therefore less traumatic to the delivery system and the patient's anatomy. The flexible laser cut section can also be set on the proximal end of the anchor. The vortex portion of the anchor control catheter 38 is then advanced through the leaflet of the native valve using the internal steerable catheter 36 under ultrasound and / or fluoroscopy.

[0093] Fig.19B Shows Fig.19A An anchor comprising one or more layers of expanded polytetrafluoroethylene (ePTFE) disposed on the anchor to provide a lubricious and bioinert coating that protects the anatomical structure from damage or abrasions that may be caused by uncoated metal. Although ePTFE is used in the present embodiment, it should be understood that other similar materials may also be used with the anchor. Fig.19C and Fig.19D Additional cross-sectional views of an anchor are provided, including a core 1 (e.g., a shaped material such as Nitinol), a distal tip 2, and a proximal terminal assembly 3. The anchor may include one or more ePTFE coatings, in this embodiment, the anchor includes an inner coating 4, an intermediate coating 5, and an outer coating 6. In addition, the anchor may include suture points 7 on one or both of the proximal and distal tips, which can be used to secure one or more coatings to the anchor.

[0094] In order to deliver the anchor to the patient's heart, the external steerable catheter 34 and the internal steerable catheter 36 are used to guide the delivery system in the sheath (not shown) to the patient's right atrium RA and through the septum to the left atrium LA. The anchor control catheter includes flexibility and smooth rotation control of the catheter across the septum. Then, the guide arm 82 of the anchor control catheter 38 is advanced to leave the distal end of the internal steerable catheter 36, wherein the guide arm presents a vortex shape or spiral shape under the control of the shape setting of the middle part of the control arm 82 by the actuating catheter 39 and the control of the distal part of the control arm 82. The anchor is also completely self-assembled and presents its static shape in the guide arm of the anchor control catheter in the left atrium. When the distal end of the anchor is positioned approximately adjacent to the distal end of the anchor control catheter, the smaller radius or contour of the anchor relative to the radius of the distal arm drives the smaller self-assembly envelope of the anchor control catheter in the left atrium.

[0095] The vortex or spiral portion of the anchor control catheter 38 is then advanced through the leaflets of the native valve 130 into the left ventricle LV using the internal steerable catheter 36 for manipulation under fluoroscopic imaging. The distal end of the guide arm 82 is extended radially outward from the guide arm using the actuating catheter 39, and the anchor control catheter 38 is rotated within the left ventricle to advance the guide arm 82 between the chordae tendineae and the heart wall, with the anchor still within the anchor control catheter. As described above, because the anchor is harder than the guide arm, the position of the anchor relative to the distal portion of the guide arm can also be used to align that portion of the guide arm with the vortex shape of the anchor (e.g., the radius of the anchor). The guide arm can then be used to wrap the chordae tendineae around at least the full length of the anchor (e.g., approximately 1.5 full turns). Once the anchor and guide arm are in place, a surgical strategy to reduce left ventricular outflow tract obstruction (LVOTO) from a prosthetic valve is to implant the anchor as high as possible into the anatomical structure. Satisfactory encirclement of the chordae and / or leaflets may also be assessed by ultrasound and / or fluoroscopy, taking into account the echogenic and radiopaque features of the anchor control catheter and / or anchor. This may be accomplished by lifting the anchor prior to pulling the anchor toward the left atrium. In some embodiments, such adjustment is performed by pulling on the anchor control catheter as the anchor remains residing within the guide arm. In other embodiments, if the anchor has been deployed from the guide arm, the anchor may be repositioned or pulled upward or toward the atrium by the tether.

[0096] To fully deploy the anchor in the left ventricle, the anchor control catheter 38 is withdrawn from the anchor while holding the tether 42 stationary. The anchor control catheter 38 is withdrawn into the inner steerable catheter 36 until the distal end clears the proximal end of the anchor. The tether is then separated from the anchor, the inner steerable catheter 36 is withdrawn into the outer steerable catheter 34, and the anchor delivery subsystem is withdrawn from the patient. The anchor does not lose the chordae tendineae and remains stable during the retraction of the anchor control catheter. Retraction of the anchor control catheter is a simple process.

[0097] An anchor delivery subsystem including the above-mentioned anchor control catheter and guide arm provides a special chord wrapping tool configured to deliver the anchor. As described above, the anchor delivery subsystem is configured to safely assemble the anchor in the anchor control catheter in the left atrium and away from the chord device. The anchor delivery subsystem includes a small envelope with low end penetration to avoid contact with the left atrium. This structure provides a simplified system in which only a single tube (e.g., an anchor control catheter guide arm) surrounds the anchor. When wrapping in the left ventricle, only the fully self-assembled anchor control catheter contacts the chords, and there is almost no friction accumulation during the wrapping process as may occur in alternative devices.

[0098] When the anchor control catheter and anchor are advanced from the left atrium to the left ventricle, the anchor control catheter provides good visualization in a single echo plane through a standard echocardiographic view in the left ventricle during the wraparound process. As described above, the user can easily see the loop of the anchor control catheter, with the middle and tip of the guide arm clearly visible. Wraparound control is achieved in depth (e.g., down / up) control (by advancing / retracting the anchor control catheter) and independent range (e.g., radial) control (by moving the anchor axially within the anchor control catheter to modify the radial reach of the anchor at its distal tip). This combination provides the user with fine-tuning adjustability of the wraparound position within the heart. This visualization combined with tip control greatly simplifies the wraparound process for navigating various patient anatomical structures.

[0099] Additionally, the wrapping process can be easily reversed as many times as necessary to capture the desired chordae and get the anchor in place. If the chordae are lost or the user is not satisfied with the position of the anchor control catheter or the anchor, both can be repositioned simply by unwrapping the wrap and starting the wrapping process again. The simplified design and limited cross-sectional diameter of the anchor control catheter further provides stable hemodynamics throughout the anchor delivery process.

[0100] Fig. 20 1 shows a portion of a proximal controller including actuators for anchor control catheters and tethers according to an embodiment of the present invention. A handle 110 is attached to a rotation control shaft 40 ( Fig. 20 114 ), so that rotation of the handle 110 rotates the shaft 40 and the guide arm 82. The slider controller 112 extends from the actuation catheter 39 through the slot 114. Proximal and distal movement of the slider controller 112 respectively moves the actuation catheter 39 proximally and distally. A second handle 116 is attached to the tether 42. Proximal and distal movement of the handle 116 relative to the handle 110 causes the tether 42 and the anchor attached thereto to move proximally and distally within the anchor control catheter. Similarly, proximal movement of the handle 110 relative to the fixed handle 116 will keep the anchor fixed when the guide arm 82 is retracted, as described below. Pressing the button 117 on the handle 116 causes the handle 116 to grasp the tether 42, and releasing the button 117 allows the tether 42 to move relative to the handle 116.

[0101] Fig.21 111 is another embodiment of a proximal controller that combines the actuators for the anchor control catheter and the tether into one handle. The handle 111 is attached to the rotation control shaft 40 ( Fig.21114 (not shown), so that the rotation of the ring 113 rotates the shaft 40 and the guide arm 82. The proximal and distal movement of the ring 115 causes the actuation catheter 39 to move proximally and distally, respectively. Pressing the button 119 causes the handle 111 to grasp the tether 42, so that the tether moves with the handle 119.

[0102] Fig. 22 Components of the proximal controller 32 for the anchor delivery subsystem are shown. The tether control handle 116 is located at the proximal end of the controller 32 and is movable relative to the anchor control catheter handle 110 to control the relative movement between the anchor control catheter 38 and the tether 42, as described above with reference to Fig. 20 A. Anchor control catheter handle 110 is mounted on track 120 and is movable relative to control handle 75 of inner steerable catheter 36. Lock 122 holds handle 110 in place on track 120 when the handle is not moving. Likewise, control handle 75 is adjacent control handle 74 of outer steerable catheter 34. Lock 122 holds handles 74 and 75 in place on track 120 when handles 74 and 75 are not moving.

[0103] Fig.23 Detail of the anchor 12 is shown. When loaded into the anchor control catheter, the anchor 12 assumes a straight shape. In its unconstrained state, as shown in FIG. Fig. 22 As shown, the anchor 12 extends in a spiral shape from the distal end 124 to the proximal connector 126, where the anchor is releasably attached to the tether. The laser cut section 125 at the distal end is more flexible than the central portion of the anchor and is therefore less traumatic to the delivery system and the patient's anatomy. The flexible laser cut section can also be set on the proximal end of the anchor. Under fluoroscopic imaging, the internal steerable catheter 36 is used for manipulation, and then the spiral portion of the anchor control catheter 38 is advanced through the leaflet of the native valve 130.

[0104] To deliver the anchor to the patient's heart, the outer steerable catheter 34 and the inner steerable catheter 36 are used to guide the delivery system within the sheath 35 to the patient's right atrium RA and through the septum to the left atrium LA. The guide arm 82 of the anchor control catheter 38 is then advanced out of the distal end of the inner steerable catheter 36, wherein the guide arm 82 assumes a vortex shape under the control of the shape setting of the proximal portion of the control arm 82 and the control of the distal portion of the control arm 82 by the actuation catheter 39. The vortex portion of the anchor control catheter 38 is then advanced through the leaflets of the native valve 130 into the left ventricle LV using the inner steerable catheter 36 for manipulation under fluoroscopic imaging. The distal portion 96 of the guide arm 82 is extended out of the vortex shape using the actuation catheter 39, and the anchor control catheter 38 is rotated within the left ventricle to advance the guide arm 82 between the chordae tendineae 132 and the heart wall, wherein the anchor 12 is still within the anchor control catheter. Because the anchor 12 is stiffer than the guide arm 82, as described above, the position of the anchor 12 relative to the distal portion of the guide arm can also be used to conform that portion of the guide arm to the vortex shape of the anchor (e.g., the radius of the anchor). After the chord 132 has been wrapped around the entire length of the anchor, the anchor control catheter 38 is withdrawn from the anchor 12 while holding the tether 42 stationary. The anchor control catheter 38 is withdrawn into the inner steerable catheter 36, the inner steerable catheter 36 is withdrawn into the outer steerable catheter 34, and the anchor delivery subsystem is withdrawn from the patient while leaving the tether 42 connected to the anchor 12.

[0105] Before the expandable valve is delivered to the implanted anchor, a guide wire is inserted through the anchor. One technique for placing the guide wire is to advance an inflatable balloon catheter through the implanted anchor toward the apex of the heart. The position of the balloon can be monitored with ultrasound. Using a balloon with a sufficiently large diameter (e.g., >12 mm) helps ensure that the balloon does not pass between the chordae tendineae. Once the balloon passes through the anchor and enters the ventricle, the guide wire can be advanced through the inner lumen of the balloon catheter. The balloon catheter is then withdrawn, leaving the guide wire in place for advancing the valve delivery catheter.

[0106] Fig.24 and Fig.25A A proximal controller 142 and three nested catheters (eg, Fig.25A1 and 1 ) are views of various aspects of a valve delivery subsystem 140 (shown in cross-section in FIG): an external steerable catheter 144, a balloon shaft 146 movably disposed in the lumen of the external steerable catheter 144, and an internal steerable catheter 148 movably disposed in the lumen of the balloon shaft. As shown, a tether 42 still extending proximally from a previously implanted anchor is disposed outside the external steerable catheter 144. In some embodiments, the tether 42 is disconnected from the anchor and removed from the patient prior to introduction of the valve delivery subsystem 140. Disposed within the lumen of the internal steerable catheter 148 is a tab holder shaft 149, and disposed within the lumen of the tab holder shaft 149 is a nose cone shaft 150. A guidewire (not shown) may be disposed in the lumen of the nose cone shaft 150. The external steerable catheter 144 and the internal steerable catheter 148 may be configured similarly to the external steerable catheter and the internal steerable catheter described above with respect to the anchor delivery subsystem. In some examples, only one of the outer steerable catheter 144 and the inner steerable catheter 148 is included in the valve delivery subsystem 140, and steering is provided by the single steerable catheter (eg, the inner steerable catheter 148).

[0107] Fig.25B The distal end of the valve delivery subsystem is shown, and Figure 26A-26B Details of the tab holder are shown. Fig.25B 1, a balloon shaft 146 is shown extending distally from the distal end of the external steerable catheter 144. A valve balloon 152 containing a compressed prosthetic valve 154 is attached to the distal end of the balloon shaft 146. When the valve 154 is loaded into the balloon 152, the tabs (not shown) on the proximal (atrial) end of the valve 154 are disposed in the slots 145 of the tab holder 147 at the distal end of the tab holder shaft 149, as shown. Fig.26A As shown. Nose cone 156 extends from the distal end of capsule 152. Nose cone 156 is connected to the nose cone shaft 150 (at Fig.25A shown in Fig.25B not shown).

[0108] In some examples, the valve delivery subsystem includes a single steerable catheter, rather than multiple steerable catheters (e.g., Fig.25A The outer steerable catheter 144 and the inner steerable catheter 148 in the embodiment of the present invention are provided. Figure 27A-27C An example of a steerable catheter 2700 is shown that can be used as a single steerable catheter as part of a valve delivery subsystem. Fig.27AAs shown, the steerable catheter 2700 includes a proximal section 2702, a pivot transition section 2704, a pivot section 2706, an extension section 2708, a steering section 2710, and a terminal section 2712. Each of the sections 2702-2712 may include one or more materials (e.g., polymers) that provide different degrees of stiffness. For example, the proximal section 2702 may have the maximum stiffness of the sections 2702-2712, the pivot section 2706 may have the minimum stiffness of the sections 2702-2712, and the steering section 2710 may have a stiffness that is intermediate between the stiffness of the proximal section 2702 and the pivot section 2706. Pivot transition section 2704.

[0109] In some examples, the pivoting section 2706 can have a hardness ranging from 35D to 60D (e.g., 35D, 40D, 45D, 50D, 55D, or 60D). The pivoting transition portion 2704 serves as a bridge between the proximal section 2702 and the pivotable section 2706 and has a stiffness between the stiffness of the proximal section 2702 and the pivotable section 2706 to reduce stress on the transition portion between the two sections. In some examples, the pivoting transition section 2704 can have a hardness ranging from 60D to 80D (e.g., 60D, 65D, 70D, 75D, or 80D). The extension section 2708 serves as a bridge between the proximal section 2702 and the pivotable section 2706 and has a stiffness greater than that of the pivoting section 2706 and less than that of the pivoting transition section 2704 to reduce stress on the transition portion between the two sections. In some examples, the extension section 2708 can have a stiffness ranging from 50D to 70D (e.g., 50D, 55D, 60D, 65D, or 70D). The end section 2712 can have a stiffness greater than that of the pivoting section 2706 and less than that of the pivoting transition section 2704 and the extension section 2708. The end section 2712 can be configured to abut or couple to a valve bag carrying a prosthetic valve therein. In some examples, the end segment 2712 can have a durometer ranging from 40D to 65D (eg, 40D, 45D, 50D, 60D, or 65D).

[0110] Similar to Figure 4A and Figure 4B In the example of the present invention, the steerable catheter 2700 includes two longitudinally placed traction lumens 2714 and braided layers 2730 and 2732. For example, pulling one traction lumen 2714 causes the catheter 2700 to bend in one direction, while pulling the other traction lumen 2714 causes the catheter 2700 to bend in the opposite direction. In this way, the steerable catheter is configured to bend transversely along a plane.

[0111] The variation in axial stiffness of the steerable catheter 2700 allows the steerable catheter 2700 to assume a desired shape during various portions of valve delivery. Fig.27B An example of a steerable catheter 2700 in a deflected (e.g., bent or curved) configuration is shown when the valve sac 152 is being steered through the mitral annulus 2720 of the heart. Since the pivot section 2708 and the steering section 2710 are relatively flexible, the catheter 2700 is preferably bent at the pivot section 2708 and the steering section 2710. As shown, the steerable catheter 2700 can be arranged so that the pivot section 2706 is at or near the oval fossa 2722 and the steering section 2710 aligns the valve sac 152 with the steering section 2710.

[0112] Fig.27C A schematic diagram of a steerable catheter 2700 in a deflected configuration within a heart 2750 is shown, illustrating how the steerable catheter 2700 can provide a mechanical advantage and is adapted to reduce forces applied to tissue of the heart 2750. In the illustrated example, the steerable catheter 2700 is used to pull the lower portion of the prosthetic valve 154 "upward" toward the mitral annulus 2754 of the heart 2750 to ensure good positioning of the anchor 88 and / or the prosthetic valve 154. The prosthetic valve 154 is partially expanded from the valve sac 152 so that the lower portion of the prosthetic valve 154 expands within the left ventricle LV. As shown, the curved portion of the steering section 2710 is within the left atrium LA, while the curved portion of the pivot section 2706 is within the right atrium RA. The valve upward pulling force 2752 is applied to the lower portion of the prosthetic valve 154 and the anchor 88. This causes a first reaction force 2756 to act on the diaphragm 2758 and a second reaction force 2760 to act on the catheter 2700. The reaction forces 2756 and 2758 acting on the diaphragm 2758 and the catheter 2700 reduce the magnitude of these two forces. The extended section 2708 can be used as a lever, and the pivot section 2706 can be used as a fulcrum, so that the diaphragm 2758 gains a mechanical advantage. The higher bending stiffness of the pivot section 2706 also helps to reduce the forces on the diaphragm 2758. For example, the stiffness of the pivot section 2706 can have a certain compliance, so that the bending angle of the pivot section 2706 can change slightly as the force is applied. This can reduce the amount of pressure applied to the diaphragm 2758, thereby reducing (e.g., preventing) damage to the diaphragm 2758.

[0113] Fig.28 A method for use with an externally steerable catheter (e.g., Fig.25A) is an example of a proximal controller 142 of a valve delivery subsystem of a valvular endotracheal ventilator. The tab holder shaft 149 and the nose cone shaft 150 therein are disposed on a bracket 151, which is mounted on the track 120 at the proximal end of the proximal controller 142. The guidewire described above can be inserted into the nose cone shaft 150. Control handles 158, 160, and 162 for the externally steerable catheter 144, the balloon shaft 146, and the internally steerable catheter 148 are also movably mounted on the track 120. When the control handles are not moved, locks 164, 166, and 168 hold the control handles in place on the track 120.

[0114] The valve delivery subsystem is placed into the patient's vascular system through the same femoral vein introducer sheath used for anchor delivery and implantation. To advance the valve sac to the heart, control handles 158, 160 and 162 and bracket 151 are advanced together along track 120 under fluoroscopic guidance. During navigation of the prosthetic valve through the vessel, the distal end of the valve delivery subsystem is manipulated by bending the distal ends of the inner steering catheter 148 and the outer steering catheter 144 using control handles 162 and 158, respectively, as described above with respect to the inner steering catheter and the outer steering catheter of the anchor delivery subsystem. During advancement into the patient's heart, the valve sac 152 and nose cone 156 are just distal to the distal end of the outer steerable catheter 144.

[0115] When the distal end of the nose cone 156, valve sac 152 and external steerable catheter 144 have passed through the septum into the left atrium of the heart, the internal steerable catheter 148 and valve sac 152 are advanced out of the external steerable catheter by moving the control handles 160 and 162 and the carriage 151 distally while keeping the control handle 158 stationary to move the valve sac 152 to a position within the previously implanted anchor. Once in place, the capsule shaft 146 can be retracted while keeping the tab holder shaft 149 and valve 154 stationary to retract the capsule 152 and expose the distal end of the valve 154, thereby allowing it to begin self-expansion within the anchor. The partially self-expanding valve can be pulled proximally against the anchor to move the valve and anchor close to the ventricular side of the native valve ring. Thereafter, the capsule shaft is further retracted to expose the proximal end of the valve 154, thereby allowing it to fully self-expand. When the balloon 152 has been retracted sufficiently to expose the slots 145 of the tab holder 147, the tabs on the valve move out of the slots 145 to release the valve 154 from the tab holder 147. The valve delivery subsystem can then be removed from the patient.

[0116] Fig.29A and Fig.29BA valve prosthesis 154 is shown having a valve frame structure 14 and configured to support a plurality of leaflets therein (not shown). As described above, the valve prosthesis can be delivered to the deployed anchor using the valve delivery subsystem described above. The valve frame 14 can include an internal commissure attachment mechanism 1111 for attaching the leaflets to the frame structure 14. During surgery to replace or repair an autologous valve (e.g., a mitral valve), the valve frame structure 14 can be deployed from a contracted (delivery) configuration to an expanded configuration via the valve delivery subsystem. The valve frame 14 can include multiple rows (e.g., 3-7 rows) of substantially diamond-shaped cells 1299. The valve frame structure 14 can be configured to foreshorten through the cell structure during delivery (i.e., when the valve frame structure 14 transitions from a contracted configuration to an expanded configuration). In some embodiments, the valve frame structure 14 can be configured to self-expand from a contracted configuration to an expanded configuration (e.g., can be made of a shape memory material (e.g., nitinol)). Valve frame 14 may provide circumferential strength and / or longitudinal strength to valve prosthesis 154 .

[0117] Valve prosthesis 154 can be deployed into an expanded configuration according to the methods of the present invention. In the expanded configuration, valve prosthesis 154 can be positioned and / or anchored in a target area of ​​a subject (e.g., an organ or tissue of an animal such as a dog, cat, horse, or human). For example, valve prosthesis 154 can be positioned in an expanded configuration within the orifice of a heart valve such as a mitral valve or a tricuspid valve (e.g., for use as a temporary or permanent replacement for an existing mitral valve or tricuspid valve of the heart).

[0118] One or more portions of the valve frame structure 14 can be shaped or configured to help secure the valve frame structure 14 in a certain position (e.g., within the orifice of a native heart valve). For example, the valve frame structure 14 may include an atrial flared portion 127 and a ventricular portion 103 that are configured to help secure the frame in the anatomical structure. The atrial flared portion 127 and the ventricular portion 103 can extend radially outward from the narrow central waist 101. For example, the atrial flared portion 127 can be configured to extend from the central waist 101 into the atrium of the heart when the valve prosthesis is deployed in the native mitral valve. When the valve prosthesis is deployed in the native mitral valve, the ventricular portion 103 can extend from the central waist 101 into the ventricle of the heart. The narrow central waist 101 is configured to engage with the aforementioned anchor. The atrial flared portion 127 and the ventricular portion 103 can, for example, be configured to be positioned on either side of the anchor 88 (e.g., wrapped around the chordae tendineae and the central waist) to anchor the valve frame structure 14 in the anatomical structure. Alternatively or additionally, the atrial flared portion 127 and the ventricular portion 103 can be configured to engage with tissue to prevent the valve prosthesis from sliding past the native valve orifice.

[0119] Reference Fig.29A, the frame structure 14 of the valve prosthesis 154 can be in a partial hourglass shape, so that the ventricular portion 103 initially flares radially outward from the central waist 101 in the ventricular direction (e.g., above 107), but then bends back inward toward the center of the frame structure (e.g., below 107). As shown, the internal commissure attachment mechanism 1111 can be positioned inside the ventricular end of the ventricular portion 103. In some embodiments, the inner surface of the internal commissure attachment mechanism 1111 can be configured to be radially aligned with the narrow central waist 101. This semi-hourglass or cup-shaped shape of the ventricular portion 103 can advantageously help provide space for the chordae tendineae surrounding it. The ventricular portion 103 is designed to be as short as possible (e.g., having a length of approximately 8mm to 15mm in the axial direction) while still achieving the purpose of supporting the attachments to the leaflets and avoiding the commissures / chordae tendineae. In addition, the axial length (or shortness) of the ventricular portion is specifically designed to avoid or prevent left ventricular outflow tract obstruction (LVOTO).

[0120] like Figure 29A-29B As shown, the atrial flared portion 127 also flares radially outward from the central waist in the atrial direction, terminating in a wide atrial rim 105. As shown, the atrial rim 105 of the atrial flared portion 127 may be slightly curved inward from the rest of the atrial flared portion, but still point radially outward from the frame structure 12. The atrial flared portion 127, including the atrial rim, is the widest portion of the frame structure and extends radially farther than the ventricular portion. Typically, as shown in FIG. Figure 29A-29B As shown, the atrial flared portion 127 can extend radially outward farther than the ventricular portion 103. Having a larger atrial flared portion can help prevent paravalvular leakage (PVL). The atrial edge 105 can be very conformable and compliant against the anatomical structure without damaging the tissue, while also providing a seal without the need for a PVL guard or other additional structure for sealing. In addition, the size and adaptability of the atrial flared portion and the atrial edge allow the valve frame structure to be used in a wide range of anatomical structures and conditions.

[0121] The specific design and shape of the frame structure 12, including the atrial flared portion 127 and the central waist 101, and the interaction between the frame structure 14 and the anchor 88, serve to properly secure the frame structure in the atrium. In particular, when the anchor is placed in the target anatomy (e.g., in the left ventricle, around the chordae tendineae, and positioned "high" near the valve annulus), the engagement between the central waist 101 and the anchor 88 serves to pull the frame structure 12 "downward" toward the native valve, and in particular the atrial flared portion 127 and the wide atrial rim 105, to secure the prosthetic valve and form a seal.

[0122] The stiffness and compliance of the atrial rim are optimized to help expand the entire frame structure into the anchors. The atrial flared portion and in particular the atrial rim need to be stiff enough to withstand (e.g., initially) non-ideal anchor placement and still achieve full valve expansion. Non-ideal anchor placement can include anchors positioned: i) at an axial position along the frame other than at the waist, and / or ii) at an angle relative to the valve frame. The struts or cell patterns of the atrial flared portion are designed and constructed to increase the stiffness of the atrial rim to overcome these positioning conditions while still allowing the atrial rim to be sufficiently compliant to conform to the anatomical structure in a manner that prevents injury.

[0123] In some embodiments, the atrial flared portion 127 is the softest, most compliant, most conformable or least rigid portion of the valve prosthesis, while still having the stiffness required to present a fully self-expanding configuration when placed in the anchor. This flexibility allows the atrial portion to adapt to the patient's atrium. The central waist and ventricular portion may optionally be harder than the atrial portion. The stiffness of the central annular portion may help it to self-expand to the target diameter and engage with the anchor. In some embodiments, the central waist needs to be able to expand to overcome the reaction force of the anchor. In certain embodiments, the stiffness of the anchor is selected so that when the valve expands, the anchor is partially expanded by the valve. For example, anchor expansion can increase the circumference of the anchor, so that the number of turns in the delivery state of the anchor is reduced by about 5% to about 25%. For example, an anchor that initially has 1.5 turns and whose turns are reduced by about 25% when the valve expands will maintain about 1.13 turns after implantation. It should be understood that any percentage of turns can be reduced within the above-mentioned reduction range. In another aspect, the number of turns of the anchor can be reduced from about 1.75 turns to about 1.5 turns or about 1.2 turns, or from about 1.5 turns to about 1.3 turns or 1.1 turns.

[0124] The replacement mitral valve of the present invention is for the purpose of mitral valve position construction. As described above, the atrial margin is wide and flexible so as to seal the PVL in various patient anatomies without damaging the atrial tissue. The replacement valve prosthesis also has a short (e.g., less than 10 mm) ventricular margin to avoid LVOT obstruction in various patient anatomies. Valve implantation as described above does not obstruct the native valve, so the system provides good hemodynamics without the need for pacing. The valve frame structure of the present invention does not obstruct the native valve until the atrial margin is expanded, at which time the valve is competent.

[0125] Fig. 30A and Fig. 30BAn example of a proximal controller 3000 for an anchor delivery subsystem is shown. Control handles 3002, 3004, and 3006 are movably mounted on a track system 3020 (also referred to as a guide rail system) via brackets 3003, 3005, and 3007, respectively. The track system 3020 is fixedly coupled to a stabilizer 3008, which can be configured to support the track system 3020 at an angle to a horizontal axis (e.g., a horizontal axis of a floor). In some cases, the stabilizer 3008 can include a knob 3011 (or other angle adjustment device) configured to adjust the angle of the track system 3020 relative to the horizontal axis (e.g., a floor). For example, such an adjustment can be based on the position of the patient, the position of the user, or both. The stabilizer 3008 can include a flat bottom surface for placement on a flat surface of a support 3010, which can be a stool or a table. The vertical height of the proximal controller 3000 may be adjusted by placing the controller 3000 on a support 3010 having a different height, or by placing the controller 3000 on a support having an adjustable height.

[0126] The first bracket 3003 includes a first dial 3013, which is configured to be rotated (e.g., by the hand of a user) to control the distal and proximal movement of the first handle 3002, thereby controlling the distal advancement and proximal retraction of the outer steerable catheter 34. The second bracket 3005 includes a second dial 3015, which is configured to be rotated (e.g., by the hand of a user) to control the distal and proximal movement of the second handle 3004, thereby controlling the distal advancement and proximal retraction of the inner steerable catheter 36. The third bracket 3007 includes a third dial 3017, which is configured to be rotated (e.g., by the hand of a user) to control the distal and proximal movement of the third handle 3006, thereby controlling the distal advancement and proximal retraction of the anchor control catheter 38 (the distal end of which includes the guide arm 82). Therefore, the third dial 3017 can be configured to control the axial height of the guide arm 82 within the patient's heart.

[0127] In some examples, one or more of the dials 3013, 3015, and 3017 and / or the brackets 3003, 3005, and 3007 include one or more locks to lock the translational movement of the handles 3002, 3004, and / or 3006. This can be used as a safety feature to prevent accidental advancement and / or retraction (e.g., when in a patient's body) of the external steerable catheter 34, the internal steerable catheter 36, and / or the anchor control catheter 38. In some cases, the default state of one or more of the dials 3013, 3015, and 3017 will be locked, so that one or more of the dials 3013, 3015, and 3017 must be activated to unlock. For example, the turntables 3013, 3015 and / or 3017 can be configured to be unlocked by pressing the turntables 3013, 3015 and / or 3017 (or a portion of the turntables 3013, 3015 and / or 3017) inward toward the track system 3020, whereupon the user is able to rotate the turntables 3013, 3015 and / or 3017.

[0128] One or more of the turntables 3013, 3015, and 3017 can be configured to provide independent or coordinated movement with one or more of the other turntables 3013, 3015, and / or 3017. For example, when in an independent mode, the second turntable 3013 can be configured to allow the second bracket 3005 to translate independently relative to the first bracket 3003 and / or the third bracket 3007; and when in a coupled mode, the second turntable 3013 can be configured to couple the translational movement of the second bracket 3005 with the translation of the first bracket 3003 and / or the third bracket 3007. In this way, the catheters 34, 36, and / or 38 can be selected to advance and / or retract independently or together. This can be used for surgeries that require independent translation of the catheters 34, 36, and 38 during one or more portions of the anchor deployment process, but require coordinated movement between two or more of the catheters 34, 36, and 38 during one or more other portions of the anchor deployment process.

[0129] For example, the first turntable 3013 of the first bracket 3003 includes a button (e.g., a first button) 3063 configured to couple the translational movement of the first bracket 3003 with the translational movement of the second bracket 3005. When the button 3063 is activated (e.g., by pushing), the rotation of the second turntable 3015 of the second bracket 3005 causes both the first bracket 3003 and the second bracket 3005 to translate along the track system 3020. Similarly, the third turntable 3017 of the third bracket 3007 includes a button (e.g., a second button) 3067 configured to couple the translational movement of the third bracket 3007 with the translational movement of the second bracket 3005. When the button 3067 is activated (e.g., by pushing), the rotation of the second turntable 3015 of the second bracket 3005 causes both the second bracket 3005 and the third bracket 3007 to translate along the track system 3020. When both button 3063 and button 3067 are activated, rotation of the second turntable 3015 of the second bracket 3005 causes all three of the first bracket 3003 , the second bracket 3005 , and the third bracket 3007 to translate along the track system 3020 .

[0130] An example where the coupled axial movement of the catheters 34, 36, and 38 / 82 is useful is when the catheters 34, 36, and 38 / 82 are advanced together through the septum and into the atria of the patient's heart. When such coupled movement is desired, buttons 3063 and 3067 can be activated, and the turntable 3015 can be rotated to advance the catheters 34, 36, and 38 / 82 together in the heart. The turntable 3015 can also be rotated (in the opposite direction to the advancement) to retract the catheters 34, 36, and 38 / 82 together outside the atria of the heart. Fasteners 3032, 3034, and 3037 are configured to secure the handles 3002, 3004, and 3006 to the rail system 3020, respectively. One or more of the fasteners 3032, 3034, and 3037 can also be configured to allow rotational adjustment of the corresponding handles 3002, 3004, and 3006. For example, as Fig. 30BAs shown in the enlarged view of the fastener 3034 in FIG. 3 , the fastener 3034 includes a band 3044 (or loop) configured to surround the outer surface of the handle 3004. When the rod 3045 is moved to the locked position (e.g., by pressing the rod 3045 and pivoting the rod 3045 inwardly toward the band 3044), tension is applied to the band 3044, thereby restricting the movement of the handle 3004 located within the band 3044. When the rod 3045 is moved to the unlocked position (e.g., by pulling the rod 2035 and pivoting the rod 3045 outwardly away from the band 3044), tension is released from the band 3044, thereby allowing rotational movement of the handle 3004. Therefore, when the fastener 3034 is in the unlocked position, the user can manually rotate the handle 3004 to rotate the corresponding catheter 36. In the example of the proximal controller 3000, each of the fasteners 3032, 3034 and 3037 is configured to allow a user to rotate the corresponding handle 3002, 3004 and 3006, thereby allowing rotation of the corresponding catheter 34, 36 and 38 (e.g., when within a patient's body).

[0131] Each of the fasteners 3032, 3034, and 3037 can be configured to be in an open state, in which the corresponding band is open, so that the corresponding handle can be easily removed from the corresponding bracket. In addition, each of the fasteners 3032, 3034, and 3037 can be configured to switch between a first closed state and a second closed state. For example, when the second fastener 3034 is in the first closed state, the proximal portion of the catheter 36 (e.g., the handle 3004) is frictionally fixed to the second bracket 3005, so that the catheter 36 remains in an expected rotational position, but can be rotated relative to the second bracket 3005. For example, the bracket 3074 of the fastener 3034 may include one or more engagement features (e.g., one or more notches, one or more protrusions and / or one or more textured surfaces) that are configured to frictionally engage with the corresponding one or more features of the handle 3004 so as to maintain the rotational position of the handle 3004 when the handle 3004 is positioned in the fastener 3034. In the first closed state, the strap 3004 can be around the handle 3004 but loose enough so that the handle 3004 can be rotated relative to the bracket 3005 (e.g., by the user's hand). When the second fastener 3034 is in the second closed state, the strap 3004 is completely tightened down (sinched) so that the handle 3004 is completely fixed to the bracket 3005 and cannot rotate relative to the bracket 3005.

[0132] The handles 3002, 3004, and 3006 include knobs 3022, 3024, and 3026, respectively, which are configured to deflect the distal portions of the respective catheters 34, 36, and 38. The knobs 3022, 3024, and 3026 can be rotated (e.g., by a user's hand) to deflect the distal portions of the catheters 34, 36, and / or 38, respectively (e.g., each along a single plane) to steer the catheters 34, 36, and / or 38 through a patient's vasculature. For example, the knob 3024 can be rotated to deflect (e.g., bend) the internal steering catheter 36, thereby controlling the position of the anchor control catheter 38 / guide arm 82 relative to the patient's anatomy. For example, the knob 3024 can be rotated to bend the guide arm 82 toward the patient ("positive bend") and / or away from the patient ("negative bend").

[0133] The knob 3026 of the third handle 3006 can be rotated to "activate" the guide arm 82, thereby biasing the guide arm (e.g., from a straight shape) to present a spiral or vortex shape. Once the guide arm 82 is activated, the knob 3026 can be locked to continuously apply force and maintain the bias to the guide arm 82. In some examples, the guide arm 82 is activated when it is located in the internal steerable catheter, and the internal steerable catheter preloads the guide arm 82 so that when the internal steerable catheter 36 is pulled away from the guide arm 82 to expose the guide arm 82, the guide arm 82 self-assembles. This can be called "active" self-assembly because the guide arm is activated to allow the guide arm to self-assemble. This preload allows the guide arm 82 to present a spiral or vortex shape within the limits of the atrium, while minimal (or no) contact with the inner wall of the atrium.

[0134] The proximal rotation knob 3018 of the third handle 3006 can be coupled to a tether (e.g., tether 42) that is coupled to an anchor (e.g., anchor 12) and used to position the anchor relative to the guide arm 82 (the distal end of the anchor control catheter 38). For example, the knob 3018 can be rotated in a first direction to retract the tether / anchor proximally and rotated in a second direction to advance the tether / anchor distally. Figures 18A-18C As described above, the shape of the guide arm 82 (at the distal end of the anchor control catheter 38) can be determined in part by the extent of the anchor within the guide arm 82. As previously described, controlling the distal and proximal movement of the anchor within the guide arm 82 can be used to control the shape of the guide arm 82 during positioning and wrapping of the guide arm 82 around the chordae and / or leaflets.

[0135] The proximal knob 3018 of the third handle 3006 can also be used to maintain the position of the anchor during the retraction of the guide arm 82 on the anchor (via the anchor control catheter 38) in the patient's heart. For example, the proximal knob 3018 can be kept fixed (e.g., by the user's hand) and / or locked (using the lock of the knob 3018) to prevent axial movement of the anchor. This is useful, for example, to keep the anchor stable when rotating the turntable 3017 to retract the guide arm 82 on the anchor. The procedure can be used to ensure that when the guide arm 82 is retracted, the anchor remains in the desired position and / or orientation around the chordae tendineae and / or leaflets. For example, this can compensate for any friction between the guide arm 82 and the anchor. This can also compensate for any flexibility / compressibility differences between the guide arm 82 and the anchor.

[0136] Each of the handles 3002, 3004, and 3006 can include a flush port 3064, 3066, and 3068, respectively. The flush ports 3064, 3066, and 3068 can provide access to the lumen of the respective catheters 34, 36, and 38, such as for saline flushing.

[0137] Fig.31 An exploded view of an exemplary track system 3120 (also referred to as a guide rail system) for a proximal controller is shown to illustrate exemplary features for providing independent and coupled translation of catheters (e.g., catheters 34, 36, and 38). The track system 3120 includes a primary track 3155 and a secondary track 3156 arranged in parallel on the track 3140. The bracket 3144 is configured to fix the handle 3104 to the track 3140 through the bracket 3105. The bracket 3144 includes a fastener 3134, which includes a rod 3145, which is configured to apply and release pressure on the band or ring portion of the fastener 3134. The activation of the rod 3145 limits the movement of the handle 3104, and the release of the rod 3145 allows the handle 3104 to rotate (e.g., by the user's hand). As shown, the bracket 3144 can be fixed to the bracket 3105 by one or more screws.

[0138] The carriage 3105 includes a knob assembly configured to engage with the main guide rail 3155. The knob assembly includes a gear 3162, an outer shaft 3157, an insert 3158, a knob 3161, an inner shaft 3159, and a button 3160. When the knob 3161 is rotated, the teeth of the gear 3162 engage with the teeth of the main guide rail 3155 to translate the carriage 3105 along the main guide rail 3155.

[0139] In this example, the bracket 3105 includes a button 3160 configured to couple the translational movement of the bracket 3105 with another bracket. Fig. 30A, the bracket 3105 may correspond to the first bracket 3003 or the third bracket 3007 configured to couple the translational motion with the second bracket 3005. Activating the button 3160 (e.g., by pushing the button once) causes the coupler 3152 to engage with the secondary rail 3156, thereby coupling the translational motion of the bracket 3105 with another bracket (e.g., the second bracket 3005). Deactivating the button 3160 (e.g., by pushing the button twice) causes the coupler 3152 to disengage from the secondary rail 3156, thereby allowing independent translational motion of the bracket 3105 relative to another bracket (e.g., the second bracket 3005).

[0140] Fig.32 Another example of a proximal controller 3200 for a valve delivery subsystem is shown. In this example, the same stabilizer 3008, support 3010, rail system 3020, and bracket 3003 are used as in the embodiment of the present invention. Figure 30A-Figure 30B The valve delivery subsystem of the present invention is used together with the proximal controller 3000 of the anchor delivery subsystem in the embodiment of the present invention. That is, after the anchor is implanted in the patient's heart and the catheters 34, 36 and 38 of the anchor delivery subsystem are retracted from the patient, the handles 3002, 3004 and 3006 of the anchor delivery subsystem can be removed from the corresponding brackets 3003, 3005 and 3007. The valve delivery handle 3202 can then be positioned in the fastener 3032 of the bracket 3003 (or bracket 3004 or 3006) for delivering the valve delivery catheter system, which includes a steerable catheter 2700 (e.g., such as a steerable catheter 2700 having a balloon shaft at the distal portion) . Figure 27A-27C shown).

[0141] The proximal controller 3200 includes a handle 3202 including a valve deployment knob 3272, a depth control knob 3274, and a steering / bending shape control knob 3276. The valve deployment knob 3272 can be rotated to cause distal advancement of the prosthetic valve (e.g., FIG. 26, Fig.29A and Fig.29B 154 in). The valve deployment knob 3272 can include a lock that prevents deployment of the valve when in a locked configuration (e.g., as a safety feature). The depth control knob 3274 can be rotatable to cause fine axial movement of the catheter 2700 (e.g., distal advancement or proximal retraction). For example, as described herein, the depth control knob 3274 can be used during pulling the ventricular side of the partially deployed valve toward the native valve annulus. The deflection knob 3276 (also known as a steering / bending shape control knob) can be rotatable to deflect (e.g., bend and change shape) the distal portion of the catheter 2700.

[0142] The turntable 3013 of the bracket 3003 can be used to control the overall axial movement of the catheter 2700. For example, the turntable 3013 can be rotated to introduce the catheter 2700 into the heart and / or advance the catheter 2700 through the septum and into the atrium. The turntable 3013 can also be rotated in the opposite direction to retract the catheter 2700 from the heart after the prosthetic valve has been fully deployed. In some cases, the turntable 3013 can be used to pull the ventricular side of the partially deployed valve toward the native valve annulus (e.g., instead of or in combination with rotation of the depth control knob 3274).

[0143] The handle 3202 may include flushing ports 3264, 3266, and 3268. As with the anchor delivery catheter system, flushing ports may be used at various points in the delivery process. For example, each catheter may be initially flushed to fill with saline. At various points in the procedure, heparinized saline may be added to prevent any clotting in the space within and / or between the catheters, frames, anchors, etc.

[0144] Figure 33A to Figure 33V and Figure 33-1 to Figure 33-13 Exemplary systems and methods for delivering and implanting a prosthetic mitral valve and anchor in a subject's heart are shown. It should be understood that any valve, anchor, anchor delivery subsystem, and valve delivery subsystem described herein may be used in any of a variety of combinations and are not limited to Figure 33A to Figure 33V and Figure 33-1 to Figure 33-13 As will be described below, the system and method provide a consistent, safe delivery process that can accommodate a range of patient anatomies while fully resolving the patient's valve regurgitation without obstructing the LVOT. As will be apparent from the present disclosure, the prosthetic mitral valve and delivery system and method provide numerous clinical benefits and features over other systems on the market.

[0145] The valve delivery system of the present invention provides a safe delivery of an anchor through the septum through the native valve and into the left ventricle. During the encircling process, the clinician can precisely control the position of the anchor, thereby precisely controlling the shape of the guide arm, allowing the radial position of the guide arm to be adjusted to ensure that the desired chordae are captured. While the delivery system provides the ability to capture all chordae in a single pass (e.g., from 1 turn of the guide arm to up to 2.5 turns), the delivery system also provides the ability to capture only some chordae in the first rotation (e.g., 1 turn) of the guide arm / anchor, and the ability to capture the remaining chordae in the subsequent rotation (e.g., the remaining 1-1.5 turns) of the guide arm / anchor. If the clinician is not satisfied with the placement of the device or does not capture the desired anatomical structure (e.g., chordae) within the anchor, the anchor delivery system provides a rotation-based encircling that has the ability to reverse and re-encircle the anchor. Since the anchor is (e.g., completely) contained within the guide arm of the delivery device during the encircling period, the clinician can easily reverse and re-encircle to safely solve the problem and continue the operation without having to recapture the deployed anchor. The system is designed and constructed to protect the anatomy from chordae tendineae injury / rupture.

[0146] In addition to being able to control the extension of the guide arm, the clinician can also control the axial height of the anchor and the rotational position of the anchor and the guide arm completely independently during and after the circumference. The delivery system and method disclosed in the present invention further facilitate the determination of chord capture. During circumference and delivery, the position and orientation of the guide arm and therefore the position and direction of the anchor (carried in the guide arm) can be visualized using echo (ultrasound) alone. This provides visualization of the movement of the leaflets outside the guide arm and / or visualization of the direction of the chordae tendineae. The biplane view can be fixed during surgery, so the clinician can check the leaflet mobility throughout the delivery process. Visualization of the guide arm also allows for proper alignment of the anchor. The clinician can use echo visualization to align the guide arm (e.g., the distal portion of the guide arm) to be coplanar with the valve annulus. If the clinician achieves balanced capture of the chordae tendineae, the guide arm will remain coplanar with the valve annulus after circumference. An unbalanced or tilted guide arm after circumference can indicate to the clinician that additional circumference or recircumference is required.

[0147] In some embodiments, when the anchor is deployed (e.g., completely) from the delivery system into the heart, the anchor is completely released, with no tethers or other connections to other devices, and the valve is then deployed. The anchor is stably positioned by constraining and gently gathering the chordae / leaflets in the left ventricle, while having no (e.g., anchor) delivery system interaction once deployed. The inner diameter of the anchor without tethers provides a target for placement of a guidewire, over which the valve delivery system is advanced. All of the above-described features provide fine-tuned control over the encircling device, as well as easy reversibility, safety, and re-encircling without undue risk to patient tissue.

[0148] The prosthetic valve of the present invention also provides patients with many advantages and clinical benefits that are superior to competitors. Importantly, the prosthetic valve is designed and constructed to be self-centered in the target anatomical structure after being deployed from the valve delivery system. The prosthetic valve is constructed to be self-centered even if the valve is delivered or placed non-coaxially in the valve ring and anchor. In the present invention, coaxial delivery refers to the central (longitudinal) axis of the prosthetic valve and the central axis of the anchor (e.g., perpendicular to the axis of one or more planes containing the anchor). For example, the frame allows up to 45 degrees of off-axis delivery. The rigidity of the wide atrial edge achieves this self-centering, balances the softness or compliance of the atrial flared portion to become non-traumatic, and prevents damage to the atrial and valve ring tissues. The short axial height (e.g., less than 10mm) of the ventricular flare or ventricular side of the prosthetic valve allows the valve to be deployed and self-centered.

[0149] The prosthetic mitral valve of the present invention prevents paravalvular leakage (PVL) after implantation. The frame design, including a soft and wide atrial rim, a narrow central waist that interacts with the anchor to clamp the lower / upper side of the valve annulus, and a combination of the fabric selection of the valve, completely seals the valve to the anatomical structure, thereby reducing or eliminating the risk of blood flow between the implanted valve and the heart tissue. After the valve is implanted, it is fixed to the atrium bottom with the wide atrial rim.

[0150] The prosthetic valve of the present invention is also designed and constructed to reduce or limit left ventricular outflow tract obstruction (LVOTO). The short ventricular height of the valve (e.g., less than 10 mm), the self-centering properties of the valve (e.g., optimizing the angle of the valve relative to the LVOT), and the tissue interaction between the valve and the anatomical structure (e.g., anterior leaflet capture / upregulation) all provide a solution to LVOTO that other competing devices have not yet achieved. In particular, during valve expansion and axial adjustment of the anchor position, the valve and anchor capture and pull the anterior leaflet away from the LVOT, further reducing LVOTO.

[0151] refer to Fig.33A, the nested catheter system of the anchor delivery subsystem including the outer steerable catheter 34, the inner steerable catheter 36, and the guide arm 82 is navigated to the right atrium of the patient and through the septum to the left atrium of the subject's heart. In some cases, the user (e.g., a surgeon) manually advances the nested catheter system through the patient's blood vessels. In some examples, a separate puncture procedure is used to puncture the septum before advancing the nested catheter system through the septum.

[0152] Figure 33-1 Shown as Fig.33A Exemplary manipulation of the anchor delivery controller 3000 is shown to advance the outer steerable catheter 34, the inner steerable catheter 36, and the guide arm 82 (which is located at the distal portion of the anchor control catheter 38) together through the septum. The button 3063 of the first dial 3013 and the button 3067 of the third dial 3017 can be activated to couple the translational movement of the first bracket 3003 and the third bracket 3007 with the translational movement of the second bracket 3005. The second knob 3015 can then be rotated to advance the outer steerable catheter 34, the inner steerable catheter 36, and the guide arm 82 together through the septum. The buttons 3063 and 3067 can then be deactivated.

[0153] Fig.33B and Fig.33C The inner steerable catheter 36 is shown being pushed out of the distal end of the outer steerable catheter 34 and into the left atrium. In addition, the guide arm 82 is pushed out of the distal end of the inner steerable catheter 36 and into the left atrium. The active and passive portions of the guide arm 82, in combination with the anchor carried therein, enable the guide arm 82 to self-assemble to form a vortex shape ( Figure 14A-14B As previously described, in other examples, the guide arms 82 are configured to self-assemble into a spiral shape ( Figure 15A-15B As previously described, when the guide arm 82 is deployed within the left atrium, the anchor also fully self-assembles and assumes its resting shape within the guide arm 82.

[0154] Figure 33-2 Shown as Fig.33A and Fig.33B Exemplary operation of the anchor delivery controller 3000 is shown for advancing the inner steerable catheter 36 and the guide arm 82. The user can rotate the second dial 3015 to advance the inner steerable catheter 36 distally relative to the outer steerable catheter 34. The user can rotate the third dial 3017 to advance the guide arm 82 distally relative to the inner steerable catheter 36 and the outer steerable catheter 34.

[0155] exist Fig.33DIn the embodiment, the inner steerable catheter 36 is deflected to steer the guide arm 82 toward the mitral valve annulus. In the illustrated example, the spiral shape of the guide arm 82 (e.g., the guide arm 82 at the bend ( Fig. 14B The distal portion of the guide arm 82 is approximately parallel to the mitral valve annulus. In the case where the guide arm 82 has a spiral shape, the guide arm 82 is at the curved portion ( Fig. 15B The distal portion of 93) can have a spiral shape.

[0156] Figure 33-3 How to use the anchor delivery controller 3000 to manipulate Fig.33D The user can rotate the knob 3024 of the second handle 3004 to deflect the inner steerable catheter 36, thereby steering the guide arm 82 toward the mitral valve annulus, such as Fig.33D shown.

[0157] exist Fig.33E In the example, the guide arm 82 is reversed and advanced across the mitral valve, through the leaflets and into the left ventricle. In this example, when the guide arm 82 is advanced across the mitral valve, the guide arm 82 is fully deployed and the anchor is fully assembled within the guide arm 82. The shape of the guide arm 82 (and the planarity of the guide arm 82 relative to the mitral valve) can be maintained when the guide arm 82 crosses the mitral valve, as shown.

[0158] Figure 33-4 Shown as Fig.33E How to use the anchor delivery controller 3000 to rotate the guide arm 82 is shown. The user can unlock (e.g., pull) the rod 3065 of the fastener 3037 of the third bracket 3007 to release the tension on the band portion of the fastener 3037. The user can then rotate the handle 3006, thereby rotating the anchor control catheter 38 therein. Since the guide arm 82 is the distal portion of the anchor control catheter 38, the guide arm 82 also rotates. To advance the guide arm 82, the user can rotate the dial 3017 (e.g., the third dial) to advance the handle 3006 and the guide arm 82 distally.

[0159] refer to Fig.33F , the encircling process can begin. As previously described, the distal end of the guide arm 82 can be extended radially outward, for example by selecting a proximal retraction of the anchor. In the example shown, the distal end of the guide arm 82 extends toward the left ventricular outflow tract (LVOT).

[0160] Figure 33-5 Shown as Fig.33F How to use the anchor delivery controller 3000 to extend the distal end of the guide arm 82 is shown. The user can rotate the proximal knob 3018 to advance and / or retract the anchor within the guide arm 82. As previously described with reference to Figures 18A-18C As described above, the movement of the anchor within the guide arm 82 can cause the distal portion of the guide arm 82 to extend radially outward. In some examples, after the anchor moves within the guide arm 82 to cause sufficient radial extension of the distal end of the guide arm 82, the proximal knob 3018 can be locked to maintain the guide arm 82 in the desired radial extension state.

[0161] exist Figure 33G In the embodiment of the present invention, when in a radially extended state, the guide arm 82 is rotated to surround the chordae / leaflets within the left ventricle. Since the surrounding 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 can include extending the distal tip of the guide arm 82 radially outward or pulling the distal tip radially inward, depending on the patient's specific anatomy.

[0162] Figure 33-6 Shown as Figure 33G 3006 to rotate and manipulate the guide arm 82. The user can unlock the fastener 3037 to release the tension around the handle 3006. The user can then rotate the handle 3006, causing the anchor control catheter 38 with the guide arm 82 to rotate in the same direction. In some examples, the second handle 3004 can also be rotated (after unlocking the fastener 3034) to rotate the inner steerable catheter 36, thereby increasing the reach of the distal tip of the guide arm 83. To actively manipulate the distal tip of the guide arm 82, the user can rotate the proximal knob 3018 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 radially inward, giving the user control to capture the chordae / leaflets in different areas near the mitral annulus.

[0163] exist Fig.33H , the position of the guide arm 82 has been evaluated and it has been determined that at least some chordae or leaflet tissue is not properly encircled. To reposition the anchor delivery subsystem, the clinician can easily 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 needed. This delivery flexibility of the anchor delivery catheter, along with the unique visualization features, provides the clinician with precise and repeatable control over encircling the chordae and / or leaflets. Fig.33I In the embodiment of the present invention, the guide arm 82 is retracted or reversely rotated to partially encircle certain portions of the previously encircled chordae tendineae.

[0164] Figure 33-7 Shown as Fig.33H and 33I3000 is shown to manipulate the guide arm 82. After unlocking the fastener 3037, the user can rotate the handle 3006 to rotate the guide arm 82, causing the guide arm 82 to unwind. To adjust the axial height of the guide arm 82, the user can rotate the dial 3017 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 user can rotate the proximal knob 3018 in a clockwise and / or counterclockwise direction.

[0165] Fig.33J and Figure 33K The process of re-circling the guide arm 82 after re-rotating the guide arm 82 is shown. The re-circling 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 be optionally completed at any point during the circling (rotation) or decircling (reverse rotation).

[0166] Figure 33-8 Shown as Fig.33J and Figure 33K How to use anchor delivery controller 3000 to manipulate guide arm 82 is shown. The user can rotate the handle to rotate and re-encircle the guide arm 82 around the chordae and / or leaflets. In order to adjust the radial position of the distal end of the guide arm 82, the user can rotate the proximal knob 3018.

[0167] Once it is determined that the chordae tendineae are satisfactorily (e.g., completely) surrounded by the guide arms 82, as Figure 33L As shown, the guide arm 82 and the anchor delivery catheter system can be retracted proximally from the anchor without disturbing the position of the anchor until the anchor delivery catheter system is removed from the patient. This process is achieved by maintaining the position of the anchor and tether while retracting 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 separated from the anchor. The inner steerable catheter 36 is then pulled into the outer steerable catheter 34 and the entire subsystem is removed from the subject. After the guide arm 82 is fully retracted and removed from the patient, the anchor 88 remains in the proper position within the left ventricle around the desired chordae / leaflets, as shown. Figure 33M As shown. The anchor 88 can then be disconnected from the tether. As a result, the anchor 88 is deployed and anchored around the chordae and / or leaflets of the left ventricle without connection to any other system components (e.g., no tethers or other connectors are left when the anchor 88 is deployed). In addition, when the anchor 88 is deployed around the chordae and / or leaflets, the axial position of the anchor 88 is not fixed to the anatomical structure. Therefore, the anchor 88 can slide or move axially (e.g., toward or away from the valve annulus). This will be described more fully below when describing the self-expansion and positioning of the valve.

[0168] Figure 33-9 Shown as Figure 33L and Figure 33M 10. The guide arm 82 is shown as being retracted from the anchor 88 using the anchor delivery controller 3000. The user may lock (or hold) the proximal knob 3018 to maintain the anchor position in the proper position around the desired chordae / leaflets. When the proximal knob 3018 is locked (or held), the user may rotate the dial 3017 (e.g., the third dial) to withdraw the guide arm 82 proximally into the inner steerable catheter 36. Retracting the guide arm 82 on the anchor 88 causes the anchor to separate from the tether, as described herein. After fully retracting the guide arm 82, the user may rotate the dial 3015 (e.g., the second dial) to withdraw the inner steerable catheter 36 proximally into the outer steerable catheter 34. After the inner steerable catheter 36 is retracted into the outer steerable catheter 34, the user may activate the button 3063 of the first dial 3013 and the button 3067 of the third dial 3007. This couples the translational movement of the second carriage 3005 with the first carriage 3003 and the third carriage 3007. The second turntable 315 can then be rotated to retract the catheters 34, 36, and 38 together out of the atrium.

[0169] exist Fig.33N 33O , valve delivery can be initiated. First, a guidewire 99 can be inserted through the septum, into the left atrium, through the mitral annulus, and into the left ventricle through the anchor 88. In FIG. 33O , the valve delivery subsystem is advanced over the guidewire 99, through the septum, and into the left atrium. FIG. 33O shows the valve sac 152 (containing the valve prosthesis) and the nose cone 150 in the left atrium.

[0170] Figure 33-10 shows how the valve delivery controller 3200 is used Fig.33N 33O . First, when the valve delivery subsystem is not connected to the track system, the valve delivery subsystem can be delivered through the patient's vasculature over the guidewire 99. After the distal end of the valve delivery catheter is advanced into approximately the inferior vena cava (IVC) (e.g., before entering the heart chamber / crossing the septum), the valve delivery controller 3200 (which is coupled to the proximal end of the valve delivery subsystem) can be attached to the track system 3020. The turntable 3013 can be rotated to advance the valve sac 152 and nose cone 150 in the left atrium, as shown in FIG. 33O .

[0171] Figure 33P The valve sac 152 and nose cone 150 are shown advanced through the valve annulus, with the nose cone 150 positioned past the anchor 88 and the valve sac 152 extending across / through the anchor 88. Figure 33QIn some embodiments, the valve sac 152 is partially retracted from the nose cone 150 to allow (partial) self-expansion or assembly of the ventricular portion of the valve prosthesis 154. In some embodiments, the ventricular portion of the valve 154 is expanded into the anchor 88.

[0172] Figure 33-11 Shown as Figure 33P and Figure 33Q The valve delivery controller 3200 is shown as being used to advance the valve sac 152 and partially release the valve prosthesis 154. The steering / bending shape control knob 3276 of the handle 3202 can be rotated to change the shape of the distal portion of the inner steerable catheter 2700, such as Figure 33P In addition, Figure 33P As shown, the depth control knob 3274 of the handle 3202 can be rotated to advance the valve sac 152 and the nose cone 150 into the mitral valve annulus. Figure 33Q As shown, valve deployment knob 3272 may be rotated to retract valve sac 152 and partially release valve prosthesis 154 into the left ventricle.

[0173] In other embodiments, reference Figure 33R , the valve delivery subsystem can be retracted or pulled toward the mitral annulus to capture the ventricular portion of the frame of the valve 154 within the anchor 88. In some embodiments, as indicated by the arrow, the anchor 88 can be lifted or pulled toward the valve annulus along with the partially expanded valve 154 by manipulation (e.g., proximal retraction) via the valve delivery subsystem. As described above, implanting the valve and anchor higher in the anatomy can help reduce or prevent LVOTO. When the anchor 88 is lifted or pulled toward the valve annulus, the anterior leaflet can be captured by the anchor 88 and gathered into or against the valve annulus. This action of capturing the anterior leaflet and pulling or gathering the leaflet against the valve annulus moves tissue away from the LVOT, thereby reducing LVOTO.

[0174] exist Figure 33S In the embodiment of the present invention, the valve sac 152 is fully retracted from the valve prosthesis 154 to expose the atrial portion of the valve frame structure and the atrial rim 105, thereby allowing the atrial portion of the valve prosthesis 154 to self-expand within the left atrium. Once the atrial portion is fully expanded, the mitral annulus seals with the wide and conformable atrial rim 105 of the valve frame, the position of which is maintained and / or pressed downward by anchors firmly positioned at the waist of the valve 154 and capturing the autologous tissue therebetween.

[0175] Figure 33-12 Shown as Figure 33R and Figure 33S How the valve delivery controller 3200 is used is shown to retract the catheter 2700 and allow the atrial edge 105 of the valve 154 to release. Figure 33RPulling the valve 154 proximally as shown can be accomplished by rotating the depth control knob 3274 and / or the dial 3013. The valve deployment knob 3272 can be rotated to retract the valve sac 152 over the valve 154 and release the remainder of the valve 154 from the valve sac 152.

[0176] exist Figure 33T , the valve delivery subsystem is being removed, leaving the valve prosthesis 154 and anchor 88 implanted within the native mitral valve, thereby sealing the native mitral valve annulus.

[0177] Figure 33-13 Shown as Figure 33T How to use the valve delivery controller 3200 to retract the catheter 2700 to retract the valve delivery subsystem from the native mitral valve is shown. The depth control knob 3274 of the handle 3202 can be rotated to retract the catheter 2700 including the valve sac 152 from the patient's heart and body. During the retraction process, the steering / bending shape control knob 3276 of the handle 3202 can be rotated to straighten the distal portion of the catheter 2700 from the deflected state.

[0178] Figure 33U and Figure 33V A left atrium view of a valve frame prosthesis 154 implanted within the mitral annulus with the leaflets closed ( Figure 33U ) and open ( Figure 33U ).

[0179] The valve delivery subsystem is a low profile valve delivery system that controls the valve position until the end of the delivery process. The valve delivery subsystem is a true 28Fr delivery profile with maneuverability that allows familiarity and ease in positioning the valve frame at the target location. The valve delivery subsystem allows a contracted or compressed valve frame to be deployed within an already deployed anchor. The expansion of the valve frame structure captures the anchor and controls the final anchor position. It has been emphasized above that it is desirable to deploy the anchor in a "high" position toward the left atrium in order to avoid LVOTO. Although the anchor position can be controlled by the anchor delivery subsystem, it should also be understood that the anchor position can be adjusted or pulled upward by the valve delivery subsystem after the valve has been allowed to expand within the anchor.

[0180] The present invention provides details of a safe mitral valve replacement procedure and system specifically designed for the mitral valve anatomy. The disclosed systems and methods address unmet needs by providing a delivery system and delivery procedure for physicians familiar with small tilt curvatures, an implant that is adaptable and applicable to all anatomies, and an implant that reliably eliminates mitral regurgitation (MR) without the risk of complications associated with other mitral valve replacement devices on the market.

[0181] When a feature or element is referred to as being "on" another feature or element in the present invention, it may be directly on another feature or element, or there may also be intermediate features and / or elements. On the contrary, when a feature or element is referred to as being "directly on" another feature or element, there is no intermediate feature or element. It should also be understood that when a feature or element is referred to as being "connected", "attached" or "coupled" to another feature or element, it may be directly connected, attached or coupled to another feature or element, or there may be intermediate features or elements. On the contrary, when a feature or element is referred to as being "directly connected", "directly attached" or "directly coupled" to another feature or element, there is no intermediate feature or element. Although described or shown with reference to one embodiment, the features and elements described or shown in this way may be applied to other embodiments. Those skilled in the art will also understand that the reference to the structure or feature set "adjacent" another feature may have a portion overlapping or located below the adjacent feature.

[0182] The terms used in the present invention are only used for the purpose of describing specific embodiments and are not intended to limit the present invention. For example, as used in the present invention, the singular forms "one", "an" and "the" are also intended to include plural forms, unless the context clearly indicates otherwise. It will also be understood that the terms "include" and / or "comprise" specify the presence of the features, steps, operations, elements and / or parts when used in this specification, but do not exclude the presence or addition of one or more other features, steps, operations, elements, parts and / or groups thereof. As used in the present invention, the term "and / or" includes any and all combinations of one or more of the associated listed items and can be abbreviated as " / ".

[0183] The spatial relative terms used in the present invention, such as "under ...", "below ...", "lower ...", "above ...", "upper ...", etc., can facilitate the description of the relationship between an element or feature shown in the figure and one or more other elements or features. It should be understood that, in addition to the orientation shown in the figure, the spatial relative terms are intended to cover different orientations of the device in use or operation. For example, if the device in the figure is inverted, the elements described as "under" or "below" other elements or features will be oriented to be "above" other elements or features. Therefore, the exemplary term "under ..." can include orientations above and below. The device can be oriented in other ways (rotated 90 degrees or in other orientations), and the spatial relative descriptors used herein are interpreted accordingly. Similarly, the terms "upward", "downward", "vertical", "horizontal", etc. are used only for the purpose of explanation in the present invention unless otherwise specifically noted.

[0184] Although the present invention uses the terms "first" and "second" to describe various features / elements (including steps), these features / elements should not be limited by these terms unless the context indicates otherwise. These terms can be used to distinguish one feature / element from another feature / element. Therefore, the first feature / element discussed below can be referred to as the second feature / element, and similarly, the second feature / element discussed below can be referred to as the first feature / element without departing from the teachings of the present invention.

[0185] In this specification and the appended claims, unless the context requires otherwise, the word "comprise" and variations such as "include" and "comprising" mean that various components can be used together in methods and articles of manufacture (e.g., combinations and devices including apparatus 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.

[0186] As used in the specification and claims of the present invention, including as used in the examples, and unless otherwise expressly provided, all numbers may be interpreted as if beginning with the word "about" or "approximately", even if the term does not appear explicitly. When describing a value and / or position, the phrase "about" or "approximately" may be used to indicate that the value and / or position described is within the reasonable expected range of the value and / or position. For example, a numerical value may include a value of + / -0.1% of the value (or range of values), a value of + / -1% of the value (or range of values), a value of + / -2% of the value (or range of values), a value of + / -5% of the value (or range of values), a value of + / -10% of the value (or range of values), etc. Unless the context indicates otherwise, any numerical value given in the present invention should also be understood to include approximately or approximately the value. For example, if the value "10" is disclosed, "approximately 10" is also disclosed. Any numerical range listed in the present invention is intended to include all sub-ranges contained therein. It should also be understood that when a numerical value is disclosed, "less than or equal to" the numerical value, "greater than or equal to the numerical value," and possible ranges between the numerical values ​​are also disclosed, as appropriately understood by those skilled in the art. For example, if a value "X" is disclosed, "less than or equal to X" and "greater than or equal to X" (e.g., where X is a numerical value) are also disclosed. It should also be understood that throughout the application, data is provided in a variety of different formats, and that the data represents endpoints and starting points, as well as ranges for any combination of data points. For example, if a specific data point "10" and a specific data point "15" are disclosed, it should be understood that greater than, greater than or equal to, less than, less than or equal to, and equal to 10 and 15, as well as between 10 and 15 are considered disclosed. It should also be understood that every unit between two specific units is also disclosed. For example, if 10 and 15 are disclosed, 11, 12, 13, and 14 are also disclosed.

[0187] Although various exemplary embodiments are described above, any of a number of changes may be made to the various embodiments without departing from the scope of the invention as described by the claims. For example, in alternative embodiments, the order of the various described method steps performed may generally be changed, and in other alternative embodiments, one or more method steps may be skipped entirely. Optional features of various device and system embodiments may be included in some embodiments and not in other embodiments. Therefore, the foregoing description is provided primarily for exemplary purposes and should not be construed as limiting the scope of the invention as set forth in the claims.

[0188] The examples and descriptions included in the present invention show specific embodiments in which the present invention can be implemented in an illustrative and non-limiting manner. As described above, other embodiments can be utilized and derived therefrom so that structural and logical replacements and changes can be made without departing from the scope of the present invention. If more than one invention or inventive concept is actually disclosed, these embodiments of the subject matter of the present invention can be referred to herein individually or collectively by the term "invention", which is only for convenience and is not intended to voluntarily limit the scope of the present application to any single invention or inventive concept. Therefore, although the present invention shows and describes specific embodiments, any arrangement calculated to achieve the same purpose can replace the specific embodiments shown. The present invention is intended to cover any and all modifications or changes of various embodiments. After reading the above description, the combination of the above embodiments and other embodiments not specifically described in the present invention will be apparent to those skilled in the art.

Claims

1. A delivery system for a prosthetic heart valve, the prosthetic heart valve comprising an anchor and a frame, the anchor being adapted to be disposed in a ventricle adjacent to a native valve of a patient's heart, the frame supporting valve leaflets adapted to expand within the anchor, the delivery system comprising: 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 slidably receive the anchor; a distal guiding arm in a distal portion of the anchor control catheter, at least a portion of the distal guiding arm having a stationary swirl shape; and A proximal controller at the proximal end of the anchor control catheter is configured to change the shape of the distal guide arm.

2. The delivery system according to claim 1, wherein The distal guiding arm has a proximal portion and a distal portion, the proximal portion comprising a portion of the distal guiding arm having a stationary spiral or vortex shape.

3. The delivery system according to claim 2, wherein: The proximal controller includes 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 guiding arm.

4. The delivery system according to claim 3, wherein The actuator is connected to a tether, which is removably connected to the anchor.

5. The delivery system according to claim 2, wherein: The proximal controller includes an actuator operatively connected to the distal portion of the distal guiding arm and adapted to change a shape of the distal portion of the distal guiding arm.

6. The delivery system according to claim 5, wherein The actuator is connected to an actuation catheter that is movably disposed within the lumen of the anchor control catheter, and a distal end of the actuation catheter is connected to a distal portion of the distal guiding arm.

7. The delivery system according to claim 2, wherein: The proximal control includes an actuator operatively connected to a proximal portion of the anchor control catheter and adapted to rotate the anchor control catheter.

8. The delivery system according to claim 1, wherein The distal guiding arm is sized and configured to move in a spiral or vortex shape within an atrium of the patient's heart.

9. The delivery system according to claim 8, wherein The proximal controller is further configured to enable the distal guide arm to extend from the atrium through the valve leaflets into the ventricle via the anchor disposed in the lumen.

10. The delivery system according to claim 9, wherein The proximal controller is also configured to enable movement of the distal end of the distal guiding arm within the ventricle to wrap the chordae tendineae of the heart with the distal guiding arm.

11. The delivery system according to claim 10, wherein The proximal control is also configured to withdraw the anchor control catheter from the anchor after the distal guide arm has encircled the chordae tendineae.

12. A delivery system for a prosthetic heart valve, the prosthetic heart valve comprising an anchor adapted to be positioned in a ventricle adjacent to a native valve of a patient's heart, the frame supporting valve leaflets adapted to expand within the anchor, the delivery system comprising: a valve pocket in which the valve frame is disposed in a compressed configuration; a balloon shaft catheter connected to the valve pocket and extending proximally from the valve pocket; a valve holder removably connected to the valve frame; as well as A proximal controller is located at a proximal end of the balloon shaft catheter, the proximal controller being configured to remove the balloon from the valve frame, thereby allowing the valve frame to expand.

13. The delivery system according to claim 12 further includes an internal steerable catheter disposed within the inner cavity of the balloon shaft catheter and an internal catheter steering control line extending from the distal portion of the internal steerable catheter to the proximal controller, and the proximal controller is also configured to be able to apply tension to and release tension on the internal catheter steering control line.

14. The delivery system according to claim 13 further includes an externally steerable catheter and an external catheter control line extending from a distal portion of the externally steerable catheter to the proximal controller, the proximal controller being further configured to apply tension to and release tension on the external catheter control line, the balloon shaft catheter being disposed in an inner cavity of the externally steerable catheter.

15. The delivery system of claim 13, wherein: The balloon shaft catheter includes multiple axial sections having different stiffnesses, thereby providing different degrees of deflection when activated.

16. The delivery system of claim 15, wherein: When the balloon shaft catheter is in a deflected state, the balloon shaft catheter includes a first bend and a second bend.

17. The delivery system of claim 16, wherein: The first bend is configured to be located within a right atrium of the patient's heart, and the second bend is configured to be located within a left atrium of the patient's heart.

18. A rail system adapted to control movement of a catheter system to deliver at least a portion of a prosthetic heart valve into a patient's heart, wherein the catheter system comprises a first catheter coaxially arranged with a second catheter, the rail system comprising: Parallel positioning of the main and auxiliary rails; a first bracket adapted to secure a proximal portion of the first catheter to the first bracket and translate along the primary rail, wherein the first bracket is coupled to the secondary rail such that the secondary rail translates with the first bracket when the first bracket translates along the primary rail; as well as A second bracket, wherein the second bracket is adapted to secure a proximal portion of the second catheter to the second bracket and translate along the primary rail, wherein the second bracket includes a connector adapted to selectively engage the second bracket with the secondary rail such that when the connector is engaged, the second bracket translates with the first bracket as the first bracket translates along the primary rail.

19. The guide rail system according to claim 18, wherein: The first bracket includes a fastener configured to be transitionable between the following two states: a first closed state in which a proximal portion of the first catheter is frictionally secured to the first bracket, wherein the first catheter is maintained at a desired rotational position but is rotatable relative to the first bracket; as well as A second closed state in which the proximal portion of the first catheter is completely secured to the first bracket and cannot rotate relative to the first bracket.

20. The guide rail system according to claim 18 further includes a third bracket, which is suitable for fixing the proximal portion of the third catheter to the third bracket and translating along the main rail, wherein the third bracket includes a second connector, and the second connector is suitable for selectively engaging the third bracket with the secondary guide rail so that when the second connector is engaged, the third bracket translates together with the first bracket when the first bracket translates along the main rail.

21. The guide rail system according to claim 18, wherein: The first bracket includes a first fastener configured to releasably secure the proximal portion of the first catheter to the first bracket, and the second bracket includes a second fastener configured to releasably secure the proximal portion of the second catheter to the second bracket, wherein each of the first fastener and the second fastener is configured to releasably secure the proximal portion of a different catheter thereto.

22. The guide rail system of claim 18, wherein: The coupler is adapted to disengage the second bracket from the secondary rail such that the second bracket translates independently of the first bracket when the coupler is disengaged.

23. The guide rail system according to claim 22, wherein: The coupler is disengaged in a default state.

24. The guide rail system of claim 18, further comprising a rail supporting the primary guide rail and the secondary guide rail in parallel.

25. The guide rail system of claim 18, wherein: The first carriage includes a first gear assembly adapted to translate the first carriage along the primary rail, and wherein the second carriage includes a second gear assembly adapted to translate the second carriage along the primary rail.

26. The guide rail system of claim 18, wherein: The first conduit is slidably positionable within the second conduit.

27. The guide rail system of claim 18, wherein: The second conduit is slidably positionable within the first conduit.

28. The guide rail system of claim 18, wherein: The second bracket includes a button adapted to engage and disengage the coupler.

29. The guide rail system of claim 18, wherein: Each of the first and second brackets includes a gear assembly configured to engage with teeth of the primary rail when the corresponding first or second bracket translates along the primary rail.

30. The guide rail system of claim 18, wherein: Each of the first bracket and the second bracket includes a turntable configured to translate the corresponding first bracket or second bracket along the main rail when the turntable rotates.

31. The guide rail system of claim 18, wherein: Each of the first bracket and the second bracket includes a lock to lock a translational position of the first guide tube or the second guide tube relative to the main rail.

32. A method of delivering an anchor for a prosthetic heart valve into a patient's heart, the method comprising: 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 the 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 Rotate the guide arm to capture chordae tendineae near the native valve ring using the distal end of the guide arm, wherein capturing the chordae tendineae includes moving the anchor within the guide arm so that the anchor applies a force to the guide arm to change the first shape of the guide arm to a second shape and change the distance that the distal end of the guide arm radially extends.

33. The method of claim 32, wherein: Changing the first shape of the guiding arm to the second shape includes changing a radius of curvature of the distal end of the guiding arm.

34. The method of claim 32, wherein: The anchor control catheter is positioned with the steerable catheter having a deflected configuration when the guide arm captures the chordae, wherein capturing the chordae further comprises adjusting the steerable catheter to change the position of the guide arm within the ventricle.

35. The method of claim 32, wherein: The guide arm includes a proximal end extending generally along a first axis, and wherein a distal end of the guide arm lies in a plane generally perpendicular to the first axis, and further wherein the change in distance is relative to the first axis.

36. The method of claim 32, wherein: Each of the first shape and the second shape of the guide arm is a spiral or swirl shape.

37. A delivery system for delivering an anchor of a prosthetic heart valve into a patient's heart, the delivery system comprising: 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 having a distal end; as well as a controller coupled to a proximal portion of the anchor control catheter, wherein the controller comprises: a first control configured to apply a preload force to the guide arm while the guide arm is within the steerable catheter so that the guide arm self-assembles into a spiral or vortex shape as the guide arm advances out of the steerable catheter; as well as A second control is configured to enable movement of the anchor within the guide arm to apply a force to the guide arm that changes the distance a distal end of the guide arm radially extends.

38. The delivery system of claim 37, wherein: The controller also includes a third control configured to control an axial height of the guide arm relative to the steerable catheter.

39. The delivery system of claim 38, wherein: The third control is part of a bracket releasably coupled to the proximal portion of the anchor control catheter, wherein the third control is configured to translate the proximal portion of the anchor control catheter on a track relative to the proximal portion of the steerable catheter.

40. A system for controlling movement of a catheter to deliver at least a portion of a prosthetic heart valve into a patient's heart, the system comprising: a handle coupled to the proximal portion of the catheter, the handle including a control configured to control deflection of the distal portion of the catheter; as well as A bracket comprising a fastener configured to secure the handle to a support, the fastener comprising a strap configured to wrap around the handle to secure the handle to the bracket, wherein the fastener is configured to transition between: an open state in which the strap is in an open position enabling the handle to be removed from the stand; a first closed condition in which the strap is loosely around the handle and the handle is frictionally secured to the bracket at an intended rotational position but is rotatable relative to the bracket; as well as A second closed condition in which the strap securely surrounds the handle such that the handle is rotatably fixed relative to the bracket.

41. The system of claim 40, wherein: The support includes a rail system configured to allow the bracket to translate with the handle secured thereto to allow axial movement of the distal portion of the catheter.

42. The system according to claim 41, wherein: The handle is a first handle coupled to a first catheter, and the bracket is a first bracket, wherein the system further comprises: a second handle coupled to a proximal portion of a second catheter coaxially aligned with the first catheter; and a second bracket configured to secure the second handle to the rail system, Wherein, the first bracket and the second bracket are configured to be independently translatable along the guide rail system to cause independent axial movement of the distal portion of the first catheter and the distal portion of the second catheter.

43. The system of claim 42, wherein: The rail system is configured to selectively permit coupled translation of the first and second brackets together along the rail system to cause coupled axial movement of the distal portions of the first and second catheters.

44. The system of claim 40, wherein: The bracket includes one or more engagement features configured to frictionally engage corresponding features of the handle to retain the handle in the intended rotational position.

45. A delivery system adapted to deliver an anchor of a prosthetic heart valve into a patient's heart, the delivery system comprising: an anchor control catheter having a distal guide arm configured to assume a swirl or spiral shape, wherein the anchor is slidably positioned within the anchor control catheter; as well as a handle coupled to a proximal portion of the anchor control catheter, wherein the handle comprises: a first control configured to bias the distal guiding arm toward the swirl or spiral shape; as well as A second control is configured to enable the anchor to move axially within the anchor control catheter to change the extent to which the distal end of the distal guiding arm radially extends.

46. ​​The delivery system of claim 45, wherein The second control is configured to radially extend the distal end of the distal guiding arm to capture chordae tendineae of the patient's heart, thereby allowing the distal guiding arm to surround the chordae tendineae.

47. The delivery system of claim 45, further comprising a steerable catheter, wherein the anchor control catheter is slidably positioned within the steerable catheter, wherein the first control is configured to bias the distal guide arm toward the vortex or spiral shape when the distal guide arm is within the steerable catheter.

48. The delivery system of claim 47, further comprising a second handle coupled to the steerable catheter, wherein the second handle comprises a deflection control configured to selectively deflect a distal portion of the steerable catheter to steer the distal guide arm within the patient's heart.

49. The delivery system of claim 47, further comprising a second handle coupled to the steerable catheter, wherein the second handle is capable of translating relative to the first handle to axially retract the distal portion of the steerable catheter relative to the distal guide arm, thereby allowing the distal guide arm to be released from the steerable catheter and assume the vortex or spiral shape.

50. The delivery system of claim 49, further comprising a track system comprising a first bracket configured to secure the first handle to the track system and a second bracket configured to secure the second handle to the track system, wherein The first bracket and the second bracket are capable of translating along the guide rail.

51. A method of delivering an anchor for a prosthetic heart valve into a patient's heart, the method comprising: advancing a catheter system into an 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 guiding arm toward a swirl or spiral shape when the distal guiding arm is within the steerable catheter; as well as The distal guiding arm is advanced such that the distal guiding arm exits the distal end of the steerable catheter and assumes the swirl or spiral shape.

52. The method of claim 51, wherein: Biasing the distal guiding arm includes activating a control of a handle coupled to a proximal portion of the anchor control catheter.

53. The method of claim 52, further comprising advancing the distal guide arm through the native valve annulus by translating the handle along a rail system.

54. The method according to claim 53 also includes using the distal guide arm to surround the chordae tendineae near the native valve ring, wherein surrounding the chordae tendineae includes changing the degree of radial extension of the distal end of the guide arm by causing the anchor to move axially within the distal guide arm.

55. The method of claim 54, further comprising retracting the distal guide arm on the anchor to release the anchor from the distal guide arm, wherein: Retracting the distal guide arm includes translating the handle along the track system.

56. A delivery system adapted to deliver a prosthetic heart valve into a patient's heart, the delivery system comprising: a steerable catheter having a distal valve pocket configured to retain a frame of the prosthetic valve within the distal valve pocket; as well as a handle coupled to a proximal portion of the steerable catheter, wherein the handle comprises: a valve deployment knob configured to control retraction of the distal valve sac relative to the frame to release at least a portion of the frame from the steerable catheter; a depth control knob configured to control axial movement of a distal portion of the steerable catheter; and A deflection knob is configured to control the deflection of the distal portion of the steerable catheter.

57. The delivery system of claim 56, wherein The handle is translatably coupled to a rail system, wherein the rail system includes a translation control configured to translate the handle to control overall axial movement of the distal portion of the steerable catheter.

58. The delivery system of claim 56, wherein The steerable catheter includes a plurality of axial sections having different degrees of flexibility, wherein deflection of the steerable catheter causes a distal portion of the steerable catheter to have a first bend and a second bend separated by an accessible section of the steerable catheter.

59. A method of delivering a prosthetic heart valve into a patient's heart, the method comprising: advancing a steerable catheter over a guidewire 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 pocket that retains a frame of the prosthetic heart valve within the valve pocket, wherein advancing the steerable catheter into the atrium includes translating the handle relative to a support translatably coupled to the handle; steer the valve pocket 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 sac partially through a native valve annulus of the patient's heart by activating a depth control knob of the handle; as well as The frame of the prosthetic heart valve is released into the native valve annulus by activating a valve deployment knob of the handle that retracts the valve sac relative to the frame, wherein the frame expands into the native valve annulus and within anchors of chordae tendineae surrounding the vicinity of the native valve annulus.

60. The method of claim 59, further comprising: releasing the ventricular side of the frame in a ventricle of the patient's heart by activating the valve deployment knob of the handle; as well as By activating the depth control knob, the ventricular side of the frame is pulled toward the native valve annulus to position the anchor closer to the native valve annulus.

61. The method of claim 60, wherein: The steerable catheter is in a deflected state when the ventricular side of the frame is pulled toward the native valve annulus, wherein the steerable catheter includes a first bend within the right atrium of the patient's heart and a second bend within the left atrium of the patient's heart.

62. The method of claim 59, wherein: The support includes a track system, wherein the handle is coupled to the track system via a bracket translatably coupled to the track, wherein translating the handle includes activating a dial of the bracket to translate the bracket relative to the track.

63. A method of delivering a prosthetic heart valve into a patient's heart, the method comprising: advancing a steerable catheter over a guidewire into an atrium of a heart of the patient, the steerable catheter having a proximal portion coupled to a handle and a distal portion having a valve pocket that retains a frame of a prosthetic heart valve within the valve pocket, wherein advancing the steerable catheter into the atrium includes translating the handle relative 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 tendineae proximal to the native valve annulus; releasing the ventricular side of the frame in a ventricle of the patient's heart by activating a valve deployment knob of the handle; pulling the ventricular side of the frame toward the native valve annulus by activating the depth control knob of the handle to position the anchor closer to the native valve annulus; as well as The atrial side of the frame is released within the atrium of the patient's heart by activating the valve deployment knob of the handle to fully retract the valve sac relative to the frame, wherein the frame expands into the native valve annulus and within the anchor.

64. The method of claim 63, wherein: When the ventricular side of the frame is pulled toward the native valve annulus, the anchor is free to implant within the patient's heart.

65. The method of claim 64, wherein: The anchor is not coupled to the tether.

66. The method of claim 63, further comprising manipulating the valve sac toward the native valve annulus by deflecting the steerable catheter, wherein The deflecting includes activating a deflection knob of the handle.

67. The method of claim 63, wherein: The steerable catheter is in a deflected state when the ventricular side of the frame is pulled toward the native valve annulus, wherein the steerable catheter includes a first bend within the right atrium of the patient's heart and a second bend within the left atrium of the patient's heart.

68. The method of claim 63, wherein: The support includes a track system, wherein the handle is coupled to the track system via a bracket translatably coupled to the track, wherein translating the handle includes activating a dial of the bracket to translate the bracket relative to the track.

69. A method of delivering 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 wherein the proximal portion of the anchor delivery catheter is coupled to a second handle, wherein the first handle and the second handle are translatably coupled to a rail system; implanting the anchor around chordae tendineae proximal to a native valve of the patient's heart, wherein implanting the anchor comprises translating the first handle along the track system independently of the second handle; removing the anchor delivery catheter system from the track system and coupling a valve delivery catheter system to the track system, wherein a steerable catheter handle of the valve delivery catheter system is translatably coupled to the track system, wherein the valve delivery catheter system includes a frame of the prosthetic heart valve therein; as well as The valve delivery catheter is advanced into the patient's heart and the frame is deployed into a native valve of the patient's heart and within an implanted anchor, wherein advancing the valve delivery catheter includes translating a steerable catheter handle along the track system.

70. The method of claim 69, wherein: The first handle is releasably coupled to a first bracket that is translatably coupled to the track system, and the second handle is releasably coupled to a second bracket that is translatably coupled to the track system.

71. The method of claim 70, wherein: Translating the first handle along the track system includes translating the first bracket independently of the second bracket.

72. The method of claim 70, wherein: The steerable catheter handle is coupled to the first bracket or the second bracket.

73. The method of claim 69, wherein: Implanting the anchor further includes unlocking a fastener securing 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 includes capturing chordae tendineae within the guide arm.

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