Artificial Heart Valve Delivery System and Method

Abstract

Apparatus and method for delivering one or more portions of a valve prosthesis into a patient's heart. The apparatus may include one or more catheters operably coupled to one or more control units for controlling the axial movement, rotational movement, and / or deflection of one or more catheters during delivery of an artificial valve into the heart. The one or more control units can perform overall and delicate movement control over multiple degrees of freedom of the one or more catheters, thereby providing the operator with excellent control during the valve prosthesis delivery procedure.

Description

Technical Field

[0001] Cross - Reference to Related Applications

[0001] This application claims the benefit of U.S. Provisional Application No. 63 / 366,115, filed on June 9, 2022, entitled "PROSTHETIC HEART VALVE DELIVERY SYSTEM AND METHOD", which is hereby incorporated by reference in its entirety for all purposes. Incorporation by Reference

[0002] All publications and patent applications mentioned in this specification are hereby incorporated by reference in their entirety, as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference.

Summary of the Invention

Problems to be Solved by the Invention

[0002]

[0003] Blood flow between heart chambers is regulated by native valves, namely 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 differential pressure. Patients with valvular heart disease have abnormalities in the anatomical structure and / or function of at least one valve. For example, if a valve does not close completely, the valve may suffer from insufficiency, also called regurgitation, whereby blood flows in the reverse direction. Stenosis of the valve can cause the valve not to open properly. Other diseases can also lead to valve dysfunction.

[0003]

[0004] For example, the mitral valve is located between the left atrium and the left ventricle, and when functioning properly, blood can flow from the left atrium to the left ventricle while preventing backflow and retrograde flow. However, the native leaflets of an affected mitral valve do not close completely, and the patient experiences regurgitation.

[0004]

[0005] Medication may be used to treat an affected native valve, but at some point in the patient's life, the defective valve may need to be repaired or replaced.

Means for Solving the Problem

[0005]

[0006] Described herein are devices (e.g., devices 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 control units for controlling the axial movement, rotational movement, and / or deflection of the one or more catheters. The control unit can perform overall and delicate movement control over multiple degrees of freedom of the catheter, thereby providing the operator with excellent control during the valve prosthesis delivery procedure.

[0006]

[0007] According to some examples, an artificial heart valve delivery system, wherein the artificial heart valve comprises an anchor adapted to be disposed in a ventricle adjacent to a native valve of a patient's heart, and a frame supporting valve leaflets adapted to be expanded within the anchor, and the delivery system includes an anchor control catheter adapted to be advanced into an atrium of the patient's heart, the anchor control catheter having a lumen extending from a proximal end to a distal end of the anchor control catheter, the lumen sized and configured to slidably receive the anchor, a distal guide arm at a distal portion of the anchor control catheter, the distal guide arm having at least a portion with a helical or spiral shape at rest, and a proximal control device at a proximal end of the anchor control catheter, the proximal control device configured to change the shape of the distal guide arm. The distal guide arm may have a proximal portion and a distal portion, and the proximal portion includes a portion of the distal guide arm having a helical or spiral shape at rest. The proximal control device may include an actuator operably connected to the anchor within the lumen of the anchor control catheter to move the anchor distally and proximally within the lumen to change the shape of the distal portion of the distal guide arm. The actuator may be connected to a tether removably connected to the anchor. The proximal control device 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 within the lumen of the anchor control catheter, and a distal end of the actuating catheter is connected to the distal portion of the distal guide arm. The proximal control device may include an actuator operably connected to a proximal portion of the anchor control catheter and adapted to rotate the anchor control catheter. The distal guide arm may be sized and configured to move into a spiral shape within the atrium of the patient's heart. The proximal control device may be further configured to extend the distal guide arm from the atrium through the valve leaflets into the ventricle with the anchor disposed within the lumen. The proximal control device may be further configured to move the distal end of the distal guide arm within the ventricle to surround chordae tendineae of the heart with the distal guide arm.The proximal control device may be further configured such that after the distal guide arm surrounds the tendon cord, the anchor control catheter is removed from the anchor.

[0007]

[0008] According to another example, an artificial heart valve delivery system, the artificial heart valve comprising an anchor adapted to be disposed in a ventricle adjacent to a native valve of a patient's heart, and a frame supporting valve leaflets adapted to be expanded within the anchor, the delivery system comprising a valve capsule in which the valve frame is disposed in a compressed configuration, a capsule shaft catheter connected to the valve capsule and extending proximally from the valve capsule, a valve retainer removably connected to the valve frame, and a proximal control device at the proximal end of the capsule shaft catheter, the proximal control device being configured to remove the capsule from the valve frame, whereby the valve frame can expand. The delivery system may further include an internally steerable catheter disposed within the lumen of the capsule shaft catheter and an internal catheter steering control wire extending from the distal portion of the internally steerable catheter to the proximal control device, the proximal control device being further configured to apply and release tension to the internal catheter steering control wire. The delivery system may further include an externally steerable catheter and an external catheter control wire extending from the distal portion of the externally steerable catheter to the proximal control device, the proximal control device being further configured to apply and release tension to the external catheter control wire, and the capsule shaft catheter being disposed within the lumen of the externally steerable catheter. The capsule shaft catheter may include a plurality of axially sections having different rigidities, whereby, when actuated, it deflects to different degrees. 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 in 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.

[0008]

[0009] According to a further example, the track system is adapted to control the movement of a catheter system for delivering at least a portion of an artificial heart valve into a patient's heart, the catheter system including a first catheter disposed coaxially with a second catheter, the track system including a primary track and a secondary track positioned in parallel, and a first carriage having a proximal portion of the first catheter fixed thereto and adapted to translate along the primary track, the secondary track being coupled to the first carriage such that when the first carriage translates along the primary track, the secondary track translates with the first carriage, and a second carriage having a proximal portion of the second catheter fixed thereto and adapted to translate along the primary track, the second carriage including a coupler adapted to selectively engage the second carriage with the secondary track such that when the coupler is engaged and the first carriage translates along the primary track, the second carriage translates with the first carriage. The first carriage may include a fastener configured to transition between a first closed state in which the proximal portion of the first catheter is frictionally fixed to the first carriage and the first catheter is maintained in an intended rotational position but is rotatable relative to the first carriage, and a second closed state in which the proximal portion of the first catheter is fully fixed to and not rotatable relative to the first carriage. The track system may further include a third carriage having a proximal portion of a third catheter fixed thereto and adapted to translate along the primary track, the third carriage including a second coupler adapted to selectively engage the third carriage with the secondary track such that when the second coupler is engaged and the first carriage translates along the primary track, the third carriage translates with the first carriage. The first carriage may include a first fastener configured such that the proximal portion of the first catheter is removably fixed thereto, and the second carriage may include a second fastener configured such that the proximal portion of the second catheter is removably fixed thereto, wherein each of the first and second fasteners is configured such that the proximal portion of a different catheter is removably fixed thereto.The coupler may be adapted to disengage the second carriage from the secondary track such that when the coupler is disengaged, the second carriage translates independently from the first carriage. The coupler may be in a disengaged state by default. The track system may further comprise rails that support the primary and secondary tracks in parallel. The first carriage may include a first gear assembly adapted to translate the first carriage along the primary track, and the second carriage may include a second gear assembly adapted to translate the second carriage along the primary track. The first catheter may be slidably positioned within the second catheter. The second catheter may be slidably positioned within the first catheter. The second carriage may include a button adapted to engage and disengage the coupler. Each of the first and second carriages may include a gear assembly configured to engage the teeth of the primary track when the respective first or second carriage translates along the primary track. Each of the first and second carriages may include a dial, and the dial may be configured to translate the respective first or second carriage along the primary track upon rotation of the dial. Each of the first and second carriages may be provided with a lock for locking the translational position of the first or second catheter with respect to the primary track.

[0009]

[0010] According to another example, a method of delivering an anchor of an artificial heart valve into a patient's heart, the method comprising advancing an anchor control catheter having a distal guide arm, with the anchor slidably positioned within the anchor control catheter, into the atrium of the patient's heart; advancing the guide arm through the native valve annulus into the ventricle of the patient's heart, the guide arm having a first shape and a distal end; rotating the guide arm to capture a chordae tendineae near the native valve annulus at 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, including changing the distance that the distal end of the guide arm extends radially. 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. The anchor control catheter may be positioned with a steerable catheter having a deflected configuration when the guide arm has captured the chordae tendineae, wherein capturing the chordae tendineae further includes adjusting the steerable catheter to change the position of the guide arm within the ventricle. The guide arm may include a proximal end extending generally along a first axis, the distal end of the guide arm being in a plane substantially perpendicular to the first axis, and further, the change in distance is with respect to the first axis. Each of the first and second shapes of the guide arm may be a helical shape or a spiral shape.

[0010]

[0011] According to a further example, a delivery system for delivering an anchor of an artificial heart valve into a patient's heart is 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, and the distal portion of the anchor control catheter includes a guide arm having a distal end. The catheter assembly is provided with a control device coupled to the proximal portion of the anchor control catheter. The control device includes a first control unit configured to apply a preloading force to the guide arm while the guide arm is within the steerable catheter such that the guide arm self-assembles into a spiral or helical shape when the guide arm is advanced from the steerable catheter, and a second control unit configured to move the anchor within the guide arm to apply a force to change the distance that the distal end of the guide arm extends radially. The control device may further include a third control unit configured to control the axial height of the guide arm relative to the steerable catheter. The third control unit may be part of a carriage removably coupled to the proximal portion of the anchor control catheter, wherein the third control unit is configured to translate the proximal portion of the anchor control catheter along a rail relative to the proximal portion of the steerable catheter.

[0011]

[0012] According to a further example, a system for controlling the movement of a catheter for delivering at least a portion of an artificial 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, a carriage 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 cradle, the fastener being configured to transition between an open state in which the band is in an open position such that the handle can be removed from the cradle, a first closed state in which the band loosely surrounds the handle and the handle is frictionally secured to the cradle in an intended rotational position but is rotatable relative to the carriage, and a second closed state in which the band fixedly surrounds the handle such that the handle is non-rotatably fixed relative to the carriage. The support may include an orbital system configured to allow translation of the carriage with the handle secured thereto to allow axial movement of a distal portion of the catheter. The handle may be a first handle coupled to a first catheter, and the carriage may be a first carriage, where the system may further include a second handle coupled to a proximal portion of a second catheter coaxially aligned with the first catheter, and a second carriage configured to secure the second handle to the orbital system, the first and second carriages being configured to translate independently along the orbital system to cause independent axial movement of distal portions of the first and second catheters. The orbital system may be configured to selectively allow the first and second carriages to move together in a coupled translation along the orbital system to cause a coupled axial movement of distal portions of the first and second catheters. The cradle may include one or more engagement elements configured to frictionally engage corresponding elements of the handle to maintain the handle in an intended rotational position.

[0012]

[0013] According to a further example, a delivery system adapted to deliver an anchor of an artificial heart valve into a patient's heart includes an anchor control catheter having a distal guiding arm configured to take a spiral or helical shape, with the anchor slidably positioned within the anchor control catheter, an anchor control catheter, and a handle coupled to a proximal portion of the anchor control catheter. The handle includes a first control portion configured to bias the distal guiding arm towards a spiral or helical shape, and a second control portion configured to axially move the anchor within the anchor control catheter to change the extent to which the distal end of the distal guiding arm extends radially. The second control portion may be configured to radially extend the distal end of the distal guiding arm to capture a chordae tendineae of the patient's heart, whereby the distal guiding arm can surround the chordae tendineae. The delivery system may further include a steerable catheter within which the anchor control catheter is slidably positioned, and the first control portion is configured to bias the distal guiding arm towards a spiral or helical shape while the distal guiding arm is within the steerable catheter. The delivery system may further include a second handle coupled to the steerable catheter, the second handle including a deflection control portion configured to selectively deflect a distal portion of the steerable catheter to steer the distal guiding arm within the patient's heart. The delivery system may further include a second handle coupled to the steerable catheter, the second handle being translatable relative to the first handle to axially retract a distal portion of the steerable catheter relative to the distal guiding arm so that the distal guiding arm can be removed from the steerable catheter and take a spiral or helical shape. The delivery system may further include a rail system including a first carriage configured to hold the first handle to the rail system and a second carriage configured to hold the second handle to the rail system, the first and second carriages being translatable along a track.

[0013]

[0014] According to another example, a method of delivering an artificial heart valve anchor into a patient's heart includes the catheter system including an anchor control catheter positioned within a steerable catheter, the anchor being positioned within the anchor control catheter, the anchor control catheter including a distal guide arm, advancing the catheter system into the atrium of the patient's heart, biasing the distal guide arm toward a spiral or helical shape while the distal guide arm is within the steerable catheter, and advancing the distal guide arm such that the distal guide arm exits the distal end of the steerable catheter and assumes a spiral or helical shape. Biasing the distal guide arm may include actuating a control portion of a handle coupled to a proximal portion of the anchor control catheter. The method may further include advancing the distal guide arm through the native valve annulus by translating the handle along a rail system. The method may further include surrounding chordae tendineae with the distal guide arm near the native valve annulus, where surrounding the chordae tendineae includes varying the extent to which the distal end of the guide arm extends radially by axially moving the anchor within the distal guide arm. The method may further include retracting the distal guide arm over the anchor to remove the anchor from the distal guide arm, retracting the distal guide arm including translating the handle along the rail system.

[0014]

[0015] According to a further example, a delivery system adapted to deliver an artificial heart valve into a patient's heart includes a steerable catheter having a distal valve capsule configured to hold a frame of the artificial valve therein, and a handle coupled to a proximal portion of the steerable catheter. The handle includes a valve deployment knob configured to control a retraction of the distal valve capsule relative to the frame to remove at least a portion of the frame from the steerable catheter, a depth control knob configured to control an axial movement of a distal portion of the steerable catheter, and a deflection knob configured to control a deflection of the distal portion of the steerable catheter. The handle may be translationally coupled to an orbital system, and the orbital system includes a translation control portion configured to translate the handle to control an overall axial movement of the distal portion of the steerable catheter. The steerable catheter may include a plurality of axial sections having different flexibilities, and due to the deflection of the steerable catheter, the distal portion of the steerable catheter has a first bend and a second bend separated by a reach section of the steerable catheter.

[0015]

[0016] According to a further example, a method of delivering an artificial heart valve into a patient's heart comprises advancing a steerable catheter over a guide wire into the atrium of the patient's heart, the steerable catheter having a proximal portion coupled to a handle and a distal portion having a valve capsule that holds the frame of the artificial heart valve therein, advancing the steerable catheter into the atrium including translating the handle relative to a support that is translatably coupled to the handle, steering the valve capsule towards the native valve annulus of the patient's heart by deflecting the steerable catheter, the deflecting including actuating a deflection knob of the handle, advancing the valve capsule partially towards the native valve annulus of the patient's heart by actuating a depth control knob of the handle, releasing the frame of the artificial heart valve into the native valve annulus by actuating a valve deployment knob of the handle to retract the valve capsule relative to the frame, the frame expanding into an anchor that surrounds the chordae tendineae within and near the native valve annulus. The method includes releasing the ventricular side of the frame into the ventricle of the patient's heart by actuating the valve deployment knob of the handle and pulling the ventricular side of the frame towards the native valve annulus by actuating the depth control knob to position the anchor closer to the native valve annulus. The steerable catheter may be in a deflected state when pulling the ventricular side of the frame towards the native valve annulus, and 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 rail system, where the handle is coupled to the rail system by a carriage that is translatably coupled to the track, and translating the handle includes actuating a dial of the carriage to translate the carriage relative to the track.

[0016]

[0017] According to another example, a method of delivering an artificial heart valve into a patient's heart comprises advancing a steerable catheter over a guide wire into the atrium of the patient's heart, the steerable catheter having a proximal portion coupled to a handle and a distal portion having a valve capsule that holds a frame of the artificial heart valve therein, advancing the steerable catheter into the atrium including translating the handle relative to a support translatably coupled to the handle, actuating a depth control knob of the handle to advance the valve capsule through a native valve annulus of the patient's heart such that an anchor of the artificial heart valve surrounds chordae tendineae near the native valve annulus, actuating a valve deployment knob of the handle to release a ventricular side of the frame within the ventricle of the patient's heart, pulling the ventricular side of the frame toward the native valve annulus to position the anchor closer to the native valve annulus by actuating the depth control knob of the handle, actuating the valve deployment knob of the handle to fully retract the valve capsule relative to the frame to release an atrial side of the frame into the atrium of the patient's heart, wherein the frame expands into the native valve annulus and into the anchor. The anchor may be freely embedded into the patient's heart while the ventricular side of the frame is being pulled toward the native valve annulus. The anchor may not be coupled to a mooring portion. The method may further include steering the valve capsule toward the native valve annulus by deflecting the steerable catheter, wherein deflecting includes actuating a deflection knob of the handle. The steerable catheter may be in a deflected state when pulling the ventricular side of the frame toward the native valve annulus, and 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 rail system, wherein the handle is coupled to the rail system by a carriage translatably coupled to a track, and translating the handle includes actuating a dial of the carriage to translate the carriage relative to the track.

[0017]

[0018] According to a further example, a method of delivering an artificial heart valve into a patient's heart comprises advancing an anchor delivery catheter system into the patient's heart, the anchor delivery catheter system including an anchor slidably positioned within an anchor control catheter, the anchor control catheter being slidably positioned within a steerable catheter, a distal portion of the anchor control catheter including a guide arm, a proximal portion of the steerable catheter being coupled to a first handle, a proximal portion of the anchor delivery catheter being coupled to a second handle, the first and second handles being slidably coupled to a rail system; advancing the anchor delivery catheter system into the patient's heart; embedding the anchor around a chordae tendineae near the patient's native valve, the embedding including translating the first handle independently of the second handle along the rail system; removing the anchor delivery catheter system from the rail system and coupling a valve delivery catheter system to the rail system, wherein a steerable catheter handle of the valve delivery catheter system is slidably coupled to the rail system, the valve delivery catheter system including an artificial heart valve frame therein; advancing the valve delivery catheter into the patient's heart and deploying the frame into the patient's native valve and into the embedded anchor, the advancing of the valve delivery catheter including translating the steerable catheter handle along the rail system. The first handle is removably coupled to a first carriage slidably coupled to the rail system, and the second handle is removably coupled to a second carriage slidably coupled to the rail system. Translating the first handle along the rail system may include translating the first carriage independently of the second carriage. The steerable catheter handle may be coupled to the first carriage or the second carriage. Embedding the anchor may further include unlocking a fastener that secures the second handle to the rail system and rotating the second handle to rotate the guide arm at the distal end of the anchor control catheter, the rotating of the guide arm including capturing the chordae tendineae within the guide arm.

[0018]

[0019] These and other examples are described herein.

[0020] All of the methods and apparatuses described herein may be contemplated and used in any combination to achieve the advantages as described herein.

[0019]

[0021] A better understanding of the features and advantages of the methods and apparatuses described herein can be obtained by reference to the following detailed description that defines exemplary embodiments, and to the accompanying drawings.

Brief Description of the Drawings

[0020]

Figure 1

[0022] An exemplary and simplified mitral valve is shown in a fixed position of a patient's heart.

Figure 2

[0023] An exemplary anchor delivery subsystem is shown.

Figure 3

[0024] An exemplary cross-sectional view of the nested catheter of the anchor delivery subsystem of FIG. 2 is shown.

Figure 4A

[0025] An exemplary cross-sectional view of an internally steerable catheter is shown.

Figure 4B

[0026] An exemplary cross-sectional view of an externally steerable catheter is shown.

Figure 5

[0027] An exemplary perspective view of a coil layer is shown.

Figure 6

[0028] An exemplary perspective view of a braided layer is shown.

Figure 7

[0029] An exemplary perspective view of another braided layer is shown.

Figure 8A

[0030] An exemplary perspective view of a pull ring is shown.

Figure 8B

Figure 9

[0031] An exemplary perspective view of a jacket assembly is shown.

Figure 10

[0032] Shows an exemplary perspective view of a capstan assembly.

Figure 11

Figure 12A

[0033] Shows an exemplary schematic cross-sectional view of an anchor control catheter.

Figure 12B

Figure 13A

[0034] Shows an exemplary side view of a rotation control shaft.

Figure 13B

[0035] Shows an exemplary front view of a laser cutting pattern of a region of the rotation control shaft of FIG. 13A.

Figure 13C

Figure 13D

Figure 14A

[0036] Shows an example of a spiral guide arm.

Figure 14B

Figure 15A

[0037] Shows an example of a helical guide arm.

Figure 15B

Figure 16A

[0038] Shows sample cross-sectional images of the spiral guide arm of FIGS. 14A and 14B.

Figure 16B

[0039] Shows sample cross-sectional images of the helical guide arm of FIGS. 15A and 15B.

Figure 17A

[0040] Shows an exemplary support structure of the middle part of the guide arm.

Figure 17B

Figure 17C

Figure 17D

Figure 18A

[0041] Shows an exemplary guiding wrist in the self - assembling position where the anchor within the guiding wrist is fully axially extended.

Figure 18B

[0042] Shows the guiding wrist of FIG. 18A in the enclosed position where the anchor is retracted within the guiding wrist.

Figure 18C

Figure 19A

[0043] Shows details of an exemplary anchor.

Figure 19B

Figure 19C

Figure 19D

Figure 20

[0044] Shows an example of a part of the proximal control device of the anchor control catheter and the tethering part.

Figure 21

[0045] Shows an example of a part of another proximal control device combined into one handle actuator of the anchor control catheter and the tethering part.

Figure 22

[0046] Shows an exemplary proximal control device of the anchor delivery subsystem.

Figure 23

[0047] Shows an exemplary top view of the anchor.

Figure 24

[0048] Shows an exemplary valve delivery subsystem.

Figure 25A

[0049] Shows an exemplary cross - sectional view of the nested catheter of the valve delivery subsystem of FIG. 24.

Figure 25B

[0050] Shows an exemplary distal part of the valve delivery subsystem.

Figure 26A

[0051] Shows an exemplary tab holder as part of the valve delivery subsystem.

Figure 26B

[0052] An exemplary tab holder shaft as part of a valve delivery subsystem is shown.

Figure 27A

[0053] An exemplary steerable catheter that may be used as a single steerable catheter as part of a valve delivery subsystem is shown.

Figure 27B

Figure 27C

Figure 28

[0054] Another exemplary view of the proximal control device of the valve delivery subsystem is shown.

Figure 29A

[0055] An example of a valve prosthesis having a valve frame structure is shown.

Figure 29B

Figure 30A

[0056] Another exemplary proximal control device of the anchor delivery subsystem is shown.

Figure 30B

Figure 31

[0057] An exploded view of an exemplary proximal control device of an anchor delivery subsystem, such as the anchor delivery subsystem of FIGS. 30A and 30B, is shown.

Figure 32

[0058] Another exemplary proximal control device of the valve delivery subsystem is shown.

Figure 33A

[0059] A system and method for implanting an anchor and an artificial mitral valve in a target heart are shown.

Figure 33B

Figure 33C

Figure 33D

Figure 33E

Figure 33F

Figure 33G

Figure 33H

Figure 33I

Figure 33J

Figure 33K

Figure 33L

Figure 33M

Figure 33N

Figure 33O

Figure 33P

Figure 33Q

Figure 33R

Figure 33S

Figure 33T

Figure 33U

Figure 33V

Figure 33-1

Figure 33-2

Figure 33-3

Figure 33-4

Figure 33-5

Figure 33-6

Figure 33-7

Figure 33-8

Figure 33-9

Figure 33-10

Figure 33-11

Figure 33-12

Figure 33-13

Mode for Carrying Out the Invention

[0021]

[0060] The present disclosure is directed to a delivery system for an artificial heart valve that includes two main components: an anchor adapted to be disposed in a ventricle adjacent to a native valve of a patient's heart (in other words, a natural valve), and a frame that is delivered after the delivery of the anchor and that supports the leaflets of an artificial valve adapted to be expanded within the anchor. In particular, the valve is an artificial mitral valve, and the delivery system of the present invention delivers the two components of the valve transseptally. In use, the delivery system advances distally from an entry point in a patient's femoral vein, enters the right atrium of the heart, passes through the septum and enters the left atrium, implants the anchor, and expands the valve frame within the anchor.

[0022]

[0061] Because the anatomical structure of the heart can vary from patient to patient, it may be desirable to be able to control the movement, position, and / or orientation of the delivery system while delivering and implanting the anchor and valve frame. Also, if the position of the anchor or valve is incorrect, it may be necessary to retrieve the anchor and / or valve during implantation. Accordingly, the artificial valve delivery system of the present invention provides a mechanism for manipulating the anchor and valve and for controllably releasing the anchor and valve when they are correctly positioned.

[0023]

[0062] FIG. 1 shows an exemplary mitral valve 10 in a fixed position of a patient's heart. The valve 10 includes an anchor 12 and a valve frame 14. A movable valve leaflet (not shown) attached to the valve frame replaces and functions in place of the leaflets of the native valve. As shown, the anchor 12 is disposed around the chordae tendineae 20 of the left ventricle 18. The valve frame 14 extends between the left atrium 16 and the left ventricle 18 through the native annulus 22.

[0024]

[0063] The anchor 12 and the valve frame 14 of the valve 10 are implanted separately. The anchor 12 is first delivered and disposed around the chordae tendineae 20. Thereafter, the valve frame 14 is delivered and expanded within the anchor 12. To advance the valve components from an opening in the patient's groin to the heart, the delivery system may need to be pushed, bent, and / or rotated to navigate the intervening vascular anatomy.

[0025]

[0064] Since the anchor and the frame are delivered separately, the delivery system described herein includes two main subsystems: an anchor delivery subsystem and a valve frame delivery subsystem. FIGS. 2 and 3 show aspects of an anchor delivery subsystem 30 having a proximal control device 32 and three nested catheters (as shown in the cross-sectional view of FIG. 3), namely, an outer steering catheter 34, an inner steering catheter 36 movably disposed within the lumen of the outer steering catheter 34, and an anchor control catheter 38 having an outer rotation shaft 40 and an inner actuation catheter 39 movably disposed within the lumen of the inner steering catheter. A guide arm (not shown in FIG. 3) extends from the distal end of the outer rotation shaft 40 of the anchor control catheter 34, as will be described later. Also shown in FIG. 3 is a tether 42 removably connected to an anchor (not shown) movably disposed within the inner steering catheter 36 at its distal end. 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 control device 32. An introducer sheath (not shown) may be used to introduce the three nested catheters into the patient's vasculature.

[0026]

[0065] Figures 4A and 6 show aspects of a catheter that can be employed as the internally steerable catheter 36, and Figure 4B shows an aspect of a catheter that can be employed as the externally steerable catheter 34. Figures 5 and 7-11 show features common to both the internally steerable catheter and the externally steerable catheter, with respect to their use with the internally steerable catheter 36.

[0027]

[0066] Each of the steerable catheters 34 and 36 has, for example, a liner 44 formed from PTFE or other suitable material surrounding a lumen 45. A first coil layer 46 surrounds the liner. In the internally steerable catheter 36, as shown in Figure 4B, the coil layer 46 may be formed using wire, for example, at a first pitch, while the coil layer 46 of the externally steerable catheter 34 may be formed of wire at a first pitch in the proximal region 61 and a second pitch (e.g., a larger pitch) in the distal region 63. Two axial reinforcement members 48 may be disposed 180° apart over the coil layer 46, and one axial reinforcement member 48 is shown in Figure 5.

[0028]

[0067] In the internally steerable catheter 36, as shown in Figures 4A and 6, an internal braid layer 50 surrounds the coil layer 46 and the reinforcement member 48. The braid layer 50 may be, for example, a wire braid at both ends of the diameter. Two longitudinal lead lumens 52 disposed 180° apart are disposed over the braid layer 50, each at a position 90° offset from the axial reinforcement member 48. (Only one lead lumen is shown in Figure 6) The lead lumen 52 may be formed from, for example, PTFE. A lead 54 (e.g., formed from Vectran® fiber) extends through the lumen 52, as will be further described below.

[0029]

[0068] For both the inner steerable catheter 36 and the outer steerable catheter 34, the braided layer 56 extends around the lead lumen 52. The braided layer 56 may be, for example, the braiding in the inner steerable catheter 36 and the braiding at both ends in the outer steerable catheter 34. In the inner steerable catheter 36 and the outer steerable catheter 34, the braiding 56 may have a first braiding density (ppi) in the proximal region 65 and a second braiding density (ppi) (e.g., greater than the first braiding density) in the distal region 67. The pull ring 58 is disposed on top of the braided layer 56 at the distal end of the catheter.

[0030]

[0069] As shown in FIGS. 8A - 8B, the pull ring 58 may be formed of an outer ring 60 welded to an inner ring 62. The lead 54 is looped around a bollard (in other words, a columnar part) 64 disposed 180° apart between the inner and outer rings. The free end of the lead 54 extends proximally through the lead lumen 52 to the proximal control device.

[0031]

[0070] FIG. 9 shows the distal tip 66 extending around the pull ring 58. The distal tip 66 may be formed, for example, from a polymer (e.g., Pebax®). The distal end of the liner 44 (FIG. 7) is turned inside out around the distal tip 66. Three outer jackets cover the sections of the catheter. The flexible distal outer jacket 68 (formed, for example, from a Tecoflex® or Tecothane® polymer) extends proximally from the distal tip 66. Extending proximally from the distal outer jacket 68 is a central jacket 70 having less flexibility than the distal outer jacket 68 (formed, for example, from a polymer (e.g., Pebax®)) and exhibiting an intermediate level of bending stiffness while presenting sufficient rigidity to transmit torque to the distal portion of the catheter. The proximal outer jacket 72 (formed, for example, from a Vestamid® polymer) having a greater rigidity than the central jacket 70 extends proximally from the central jacket 70. The proximal outer jacket 72 exhibits good torque responsiveness and has low compression and elongation characteristics.

[0032]

[0071] Figures 10 and 11 show that the free end of the pull wire 54 extends from the proximal end of the pull wire lumen 52 (e.g., FIG. 6), through the openings of the braided layer 56 and the proximal outer jacket 72, to the handle 74 within the proximal control device 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 within the proximal control device 74. The capstans 76 ride on a feed screw actuated by an annular gear attached to a rotary knob 73 at the proximal end of the handle. Since one capstan is connected to a right-hand feed screw and the other capstan is connected to a left-hand feed screw, the two capstans 76 rotate equally in both directions when actuated by the knob 73 to deflect the distal end of the catheter 34.

[0033]

[0072] When used together, the external and internal steering catheters can be used to advance through the patient's vasculature from the patient's groin insertion point through the vasculature to the patient's heart. Each of the internally steerable catheter and the externally steerable catheter may be steered in a single plane. The externally steerable catheter may be used to advance from the vascular entry point of the femoral vein through the vena cava into the right atrium and through the septum into the left atrium. The internally steerable catheter may be used to advance from the septal crossing toward the native mitral valve and through the native mitral valve into the left ventricle.

[0034]

[0073] Figures 12-19 show aspects of the anchor control catheter 38. After using the external and internal steering catheters to advance the distal end of the internal steering catheter from the patient's right atrium through the septum into the left atrium, the anchor control catheter 38 is used to deliver and deploy the anchor of the prosthetic valve. FIG. 12A 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 of the proximal control device. The guide arm 82 extends distally from the rotation control shaft 40.

[0035]

[0074] The guiding wrist portion 82 has active and passive features that enable it to be assembled in a spiral in the left atrium, as described below. Specifically, the guiding wrist portion 82 has shape-setting features and cutting pattern features that enable the guiding wrist portion to be flexible when it is within the steerable catheter. However, when it exits the inner steerable catheter, the guiding wrist portion 82 achieves the desired shape through a combination of shape-setting features and the activation of a cutting pattern that retains the desired shape.

[0036]

[0075] The actuating catheter 39 extends from the actuator 84 of the proximal control device to the distal end of the guiding wrist portion 82 through the lumen of the rotation control shaft 40 and the guiding wrist portion 82. The cap 86 extends over the distal end of the guiding wrist portion 82 and is attached to the distal end. The cap 86 is a 72D PEBAX (registered trademark) tip that joins the distal end of the actuating catheter 39, the distal end of the guiding wrist portion 82, and the outer jacket into a smooth and non-traumatic distal tip. The proximal movement of the actuator 84 arranges the guiding wrist portion 82 and the rotation control shaft 40 in a compressed state, changing the functional features of these elements, as described below.

[0037]

[0076] The rotational movement of the actuator 80 rotates the rotation control shaft 40, the guiding wrist portion 82, and the actuating catheter 39. The rotation control shaft 40 is a laser-cut hypo tube that is flexible and designed to transmit rotational force 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 guiding wrist portion 82, such that the amount of rotation of the guiding wrist portion 82 at the distal end of the rotation control shaft 40 is reliably and substantially equal to the amount of rotation at the proximal end of the rotation control shaft 40. Each region of the rotation control shaft 40 is cut (or not cut at all) in a pattern to provide useful features for that region.

[0038]

[0077] The tethering portion 42 extends from the actuator 90 of the proximal control device to the anchor 88 of the artificial heart valve. The tethering portion 42 is removably attached to or abuts against the anchor 88 at the joining region 89 such that the anchor 88 can be separated from the tethering portion 42 when the anchor 88 is deployed in the heart. FIG. 12B shows an example where the guide arm portion 82 is pulled proximally over the joining region 89 and the anchor 88 is separated from the tethering portion 42. For example, the guide arm portion 82 may maintain a position adjacent (e.g., abutting) or connected to the tethering portion 42 of the anchor 88 while the joining region 89 is within the guide arm portion 82, but when the guide arm portion 82 is pulled proximally over the joining region 89, the anchor 88 may be detached from the tethering portion 42. In some examples, the proximal end of the anchor 88 and the distal end of the tethering portion 42 each include mating-shaped interface features 43a and 43b that enhance the engagement of the anchor 88 and the tethering portion 42 within the guide arm portion 82. In some examples, the tethering portion 42 is removably attached to the anchor 88 using one of the removable connectors described in WO2022 / 046678. Axial movement of the tethering portion 42 and the anchor 88 may be controlled by the actuator 90 within the proximal control device. Axial movement of the anchor 88 relative to the guide arm portion 82 may be useful, for example, when changing the shape of the guide arm portion 82 as described herein.

[0039]

[0078] As shown in FIG. 13A, the rotational control shaft 40 extends from a proximal end 200 connected to the actuator 80, through a proximal region 202, an IVC region 204, an OS region 206, an IS region 208, and a distal region 210, to a distal end 212 connected to the guide arm portion 82. FIG. 13B shows a pattern of laser cut lines 214 (shown white against a black background) for removing material from area 216, thereby creating a connector at the distal end of the distal region 210 to engage a mating connector at the proximal end of the guide arm portion 82 to form a joint. The laser cut pattern for the remaining portion (not shown) of the distal region 210 is in the form of spirally arranged cut segments.

[0040]

[0079] The IS region 208 corresponds to a portion of the rotation control shaft 40 disposed within the distal region of the internally steerable catheter 36. FIGS. 13C and 13D show the pattern of laser cut lines 218 (shown in white against a black background) for removing material and thereby creating an opening 220 that extends circumferentially around the IS region 208 of the rotation control shaft 40. As shown in the detailed view of FIG. 13D, each opening 220 has a wide portion 222 and two narrow portions 224. The adjacent rings of the openings 220 are offset such that the center of each opening of one ring is aligned with the uncut portion 226 of the adjacent ring. FIG. 3C shows only two partial rings of the opening, but the opening 220 occupies the entire IS region 208.

[0041]

[0080] The OS region 206 has cuts in the same pattern as that of the distal region 210, with 336 cut segments arranged in a spiral at a first pitch, and each cut segment having a first cut, a first length, and a first separation from an adjacent cut. The IVC region 204 has a spiral cut pattern different from that of the OS region 206 and the distal region 210. The IVC region 204 extends 109.22 cm (43 inches) and has a pattern of cut segments arranged in a spiral at a second pitch (e.g., larger than the first pitch), and each cut segment having a first cut, a second length (e.g., smaller than the first length), and a second separation from an adjacent cut (e.g., larger than the first separation).

[0042]

[0081] FIGS. 14A - 15B are embodiments of the guide arm 82 and the distal end of the rotation control shaft 40. As shown, the guide arm 82 is in a spiral configuration (FIGS. 14A and 14B) and / or a helical configuration (FIGS. 15A and 15B), and is configured to be controllable, for example, after exiting the distal end of an internally steerable catheter in the left atrium of the heart. The geometric shape of the guide arm 82 presents a consistent self - assembly in a demonstrated surrounding shape. As will be described in more detail, the anchor control catheter is used as an enclosure that (e.g., directly) separates the anchor itself from the enclosure.

[0043]

[0082] Referring to FIGS. 14A and 14B, the guide arm 82 has three portions: a curved portion 90 extending radially outward from the junction at the distal end of the rotation control shaft 40, an intermediate portion 92 extending from the curved portion 90 to a transition (in other words, a shift) 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 the bending portion 91, extends radially outward, and then bends sharply inward again at the bending portion 93 when transitioning to the intermediate portion. The distal portion 96 and the intermediate portion 92 are generally in a plane 97 perpendicular to the axis 79 of the rotation control shaft 40 (or the longitudinal axis of the anchor delivery subsystem). The curved portion and the bending portions 91 and 93 facilitate the transition to the proximal and distal portions laid in a plane perpendicular to the longitudinal axis from the alignment with the longitudinal axis of the rotation control shaft of the guide arm 82. This embodiment of the guide arm 82 is described as having a spiral configuration.

[0044]

[0083] Figures 15A and 15B show another embodiment of a guide arm 82a having a helical configuration as opposed to the spiral configuration of the guide arm 82. Similar to the above embodiment, the guide arm 82a includes a curved portion 90 extending radially outward, and an intermediate portion 92 and a distal portion 96 that are not located together in a single plane orthogonal to the longitudinal axis of the anchor delivery subsystem or the nested catheter. Instead, in this embodiment, the intermediate portion includes a helical section including wound portions (e.g., loops) spaced axially apart (e.g., present in multiple planes). As can be seen, depending on the number of wound portions, this causes the proximal portion to wind helically such that it is at least in planes 97 and 99 and then transitions to the distal portion 96 in plane 99. In the illustrated example, the intermediate portion can include, for example, less than 2 wound portions. Figures 15A and 15B show the helical guide arm 82a, including how the distal and intermediate portions of the guide arm 82a are positioned in planes 97 and 99 as opposed to the in-plane arrangement of the guide arm 82 (see Figure 14B). The geometric shape of the guide arm, e.g., the distal portion 96 located in a plane 99 generally orthogonal to the axis 79 of the rotation control axis, facilitates delivery of the anchor into the plane arrangement with the mitral annulus. The anchor delivery system is designed to maintain an orthogonal arrangement to the rotation control axis of the guide arm throughout the delivery procedure, enabling reproducible and finely adjustable control of the depth / radial extent for the clinician within the enclosure, along with independent user control of the rotation of the system, the reach of the gripper, and the (axial) position of the system.

[0045]

[0084] Since the guide arm is not implanted in or left behind in the patient, visualization features or markers can be included thereon to facilitate real-time imaging such as ultrasound and / or fluoroscopy without considering the impact such features have on implant (e.g., anchor) delivery or performance. For example, the guide arm can include radiopaque markers to enable this visualization. Additionally, or alternatively, the structure of the anchor control catheter with laser cut shape memory or nitinol tubing exhibits highly reflective features that are easily visualized via ultrasound.

[0046]

[0085] FIG. 16A is a representation of a sample cross-sectional echo image of the guide arm 82 from FIGS. 14A and 14B. As shown in FIG. 16A, the curved portion 90 is visible under ultrasound with a circular cross-section in a single plane representing the intermediate portion 92, the distal portion 96, and the distal tip 98 of the guide arm 82. FIG. 16B is a representation of a sample cross-sectional echo image of the guide arm 82a from FIGS. 15A and 15B. In this image, since the intermediate portion 92 forms a plurality of spiral winding portions, the intermediate portion is stationary in a plurality of planes, and thus, the circular cross-section of the intermediate portion 92 is easily visualized and identified in the ultrasound image. Further, thereby, since it can be identified as a single circular cross-section spaced apart from the cross-sections forming a pair of spiral intermediate portions, visualization of the distal tip 98 can be facilitated. Thereby, visualization of the distal tip of the guide arm 82a is facilitated and becomes clearer on echo imaging, so that the user can use it to surround the selected anatomical structure at the distal tip.

[0047]

[0086] Referring to FIGS. 17A - 17D, the guide arm is a shape memory material laser cut in a combination of an active section (e.g., 92) and a passive section (e.g., 96), and can include a transition region 94 and a tether coupling portion 95. The active section 92 can include a tapered (in other words, conical) spiral pattern, with a longitudinal backbone 102 extending generally spirally in its proximal portion and longitudinally in the distal portion of the active section 92. A series of windows 104 can be disposed opposite the backbone 102, and a pair of tooth sections 106 are disposed 90° away from the windows 104 and the backbone 102. In some embodiments, the passive section 96 includes a generally spiral cut pattern with a periodic bridge structure. In some embodiments, the passive section 96 includes a longitudinal backbone (or backbones) having spaces (or cuts) disposed in an inward and / or outward manner in the radial direction of the guide arm (exhibiting radial flexibility and axial stability). Due to the combination of these active and passive sections and a preset (shape memory) shape, when the guide arm exits the steerable catheter, it takes a spiral (e.g., 82 in FIG. 17A) or helical (e.g., 82a in FIG. 17B) shape (depending on whether the configuration of FIGS. 14A and 14B or the configuration of FIGS. 15A and 15B is used). By the proximal movement of the actuating catheter 39 relative to the guide arm 82 (FIG. 12), the opposing edges of the tapered spiral cut pattern engage to lock (in other words, lock or fix) the active section 92 in a desired shape, that is, extending through a bend of about 90 degrees from the longitudinal axis of the inner steerable catheter to the above-mentioned flat spiral shape or helical shape. Since the shape of the anchor control catheter is formed by shape memory or nitinol laser cut tubing, complex surface features reflect very well acoustically, enabling characteristic echo visualization.

[0048]

[0087] FIG. 17C shows an exemplary embodiment of a helical (e.g., FIG. 17B) guide arm. As shown, a series of windows 104 may be disposed on the opposite side of the backbone portion 102, and a pair of tooth sections 106 are disposed 90 degrees away from the windows 104 and the backbone portion 102. The proximal portion 92, due to this configuration and the preset shape, takes on a helical shape when exiting the steerable catheter. The proximal movement of the actuation catheter 39 relative to the guide arm 82 engages both edges of the tapered helical cut pattern and locks the proximal portion 92 into the desired shape, i.e., a shape extending from a 90-degree bend from the longitudinal axis of the inner steerable catheter to the flat spiral portion of the distal portion 96.

[0049]

[0088] The distal portion 96 of the guide arm 82 can be configured to be manipulated from its set shape to a more open shape and / or a more closed shape by moving the tether portion 42 to effect proximal and distal movement of the anchor 88 within the distal portion 96 of the guide arm 82 (FIG. 12). The support structure of the distal portion 96 can be laser cut in a pattern of alternating helical components 98 and bridges 100 that exhibit flexibility. Thus, the proximal and distal movement of the stiff 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 the movement of the actuation catheter 39.

[0050]

[0089] FIG. 18A shows a guide arm 82 in a self-assembling position where the distal portion of the anchor within the guide arm 82 is deployed to the depth indicated by arrow 120 and the proximal portion of the anchor within the guide arm 82 is deployed to the depth indicated by arrow 127. In the self-assembling position, due to the shape and depth of the anchor within the guide arm 82, the distal end (e.g., tip) of the guide arm 82 and the distal portion (which may also be referred to as a grasping portion, grasping arm, or grasping part) contact and rest against itself as shown. Such a configuration constitutes a minimized "envelope" of the guide arm and is useful in 1) deployment of the guide arm 82 within the atrium and 2) advancement of the anchor control catheter from the atrium to the ventricle without harmful contact / intertwining with native tissue. FIGS. 18B and 18C show the guide arm 82 in an encompassing position where the distal portion of the anchor is retracted within the guide arm 82 to the depths indicated by arrows 121 and 122, and the proximal portion of the anchor is retracted within the guide arm 82 to the depths indicated by arrows 128 and 129, respectively. As shown, when the anchor is retracted, the distal end (e.g., tip) and the distal portion of the guide arm 82 extend radially outward, while the proximal portion of the anchor is maintained distal to the bend 93 of the guide arm 82. That is, 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 enables fine user control of the angle and distance of the distal end (e.g., tip) from the remainder of the guide arm 82, which can be useful for the user to encompass the chordae tendineae. Keeping the proximal portion of the anchor distal to the bend 93 of the guide arm 82 maintains the defined geometric shape of the guide arm 82 while allowing adjustment of the distal end (e.g., tip) of the encompassing guide arm 82.

[0051]

[0090] Figures 19A - 19D show details of the anchor 88. When loaded into the anchor control catheter, the anchor 88 assumes a generally straight shape. In its unconstrained state, the anchor 88 extends in a spiral from the distal tip 124 to the proximal connector 126, where it is removably attached to the mooring portion. The laser cut segment 125 at the distal end is more flexible than the central portion of the anchor and thus causes less trauma to the delivery system and the patient's anatomy. A flexible laser cut segment may also be provided at the proximal end of the anchor. Using the internal steerable catheter 36 for steering during visualization by ultrasound and / or fluoroscopy, the spiral portion of the anchor control catheter 38 is then advanced through the valve leaflet of the native valve.

[0052]

[0091] Figure 19B shows the anchor of Figure 19A including one or more layers of expanded polytetrafluoroethylene (ePTFE) disposed on the anchor to provide a lubricious and biologically inert coating that protects the anatomy from damage or abrasion caused by the uncoated metal. Although ePTFE is used in this embodiment, it should be understood that other similar materials can be used with the anchor. Figures 19C and 19D show additional cutaway views of the anchor including a core 1 (e.g., a shape memory material such as nitinol), a distal tip 2, and a proximal end 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. Further, the anchor may include suture points 7 that can be used to secure one or more coatings to the anchor at one or both of the proximal and distal tips.

[0053]

[0092] To deliver the anchor to the patient's heart, an externally steerable catheter 34 and an internally steerable catheter 36 are used to advance a delivery system within a sheath (not shown) to the patient's right atrium RA and through the septum to the left atrium LA. The anchor control catheter includes flexible and smooth rotational control of the catheter across the septum. The guiding arm 82 of the anchor control catheter 38 is then advanced from the distal end of the internally steerable catheter 36, which takes a spiral or helical shape under control of shaping of the middle portion of the control arm 82 and control of the distal portion of the control arm 82 by the actuating catheter 39. Also, the anchor fully self-assembles and assumes a stationary shape within the guiding arm of the anchor control catheter within the left atrium. When positioned generally adjacent to the distal end of the anchor control catheter at its distal end, the smaller the radius or profile of the anchor (in other words, the contour) relative to the radius of the distal arm, the smaller the self-assembly envelope of the anchor control catheter within the left atrium is driven.

[0054]

[0093] Using an internally steerable catheter 36 for steering under fluoroscopic visualization, the helical or spiral portion of the anchor control catheter 38 is then advanced through the valve tip of the native valve 130 into the left ventricle LV. Using the actuation catheter 39 to extend the distal tip of the guide arm 82 radially outward from the guide arm, 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 remaining within the anchor control catheter. Since the anchor is more rigid than the guide arm, as described above, the position of the anchor relative to the distal portion of the guide arm can also be used to match that portion of the guide arm to the helical shape of the anchor (e.g., the radius of the anchor). Thereafter, the chordae tendineae can surround at least the entire length of the anchor (e.g., about 1.5 full rotations) with the guide arm. With the anchor and guide arm in place, one procedural strategy for reducing left ventricular outflow tract obstruction (LVOTO) from the prosthetic valve is to embed the anchor as high as possible within the anatomical structure. Good enclosure of the chordae tendineae and / or valve tip can also be evaluated by ultrasound and / or fluoroscopy with respect to the echogenic and radiopaque features of the anchor control catheter and / or the anchor. This can be accomplished by lifting the anchor and then pulling the anchor towards the left ventricle. In some embodiments, this adjustment is done by pulling the anchor control catheter since the anchor is still present within the guide arm. In other embodiments, if the anchor has already been deployed from the guide arm, the anchor can be tethered, repositioned, lifted, or pulled towards the atrium.

[0055]

[0094] To fully deploy the anchor in the left ventricle, the anchor control catheter 38 is withdrawn from the anchor while securing and holding the tether 42. The anchor control catheter 38 is retracted into the inner steerable catheter 36 until the distal end passes through the proximal end of the anchor. The tether is then detached from the anchor, the inner steerable catheter 36 is retracted into the outer steerable catheter 34, and the anchor delivery subsystem is removed from the patient. The anchor remains stable during retraction of the anchor control catheter without losing the chordae tendineae. Retraction of the anchor control catheter is a simple process.

[0056]

[0095] The anchor delivery subsystem, including the anchor control catheter and the guide arm described above, provides a dedicated chordae tendineae enclosure configured to deliver the anchor. As described above, the anchor delivery subsystem is configured to safely assemble the anchor within the anchor control catheter in the left atrium and away from the chordae tendineae apparatus. The anchor delivery subsystem includes a small envelope with a low tip penetration force to avoid contact with the left atrium. This configuration provides a simplified system with only a single tube (e.g., the anchor control catheter guide arm) surrounding the anchor. When surrounding the left ventricle, only the fully self-assembled anchor control catheter contacts the chordae tendineae, and there is little accumulation of friction during enclosure that can occur with alternative devices.

[0057]

[0096] When the anchor control catheter and the anchor are advanced from the left atrium into the left ventricle, the anchor control catheter provides excellent visualization in a single echo plane in a standard cardiac echogram of the surrounding left ventricle. As described above, the user can easily visualize the rotation of the anchor control catheter by clearly visualizing the middle portion and the tip of the guiding arm. The surrounding control is enabled in both depth (e.g., downward / upward) control by advancing / retracting the anchor control catheter and independent reach (e.g., radial) control by axially moving the anchor within the anchor control catheter to modify the radial reach at its distal tip. This combination allows the user to finely adjust the surrounding position within the heart. By combining this visualization with the tip control, the surrounding process for advancing through various patient anatomical structures is significantly simplified.

[0058]

[0097] In addition, the surrounding process can be easily reversed as many times as necessary to capture the intended chordae tendineae and obtain the anchor in a fixed position. If the chordae tendineae are missing or the user is not satisfied with the position of the anchor control catheter or the anchor, both can be repositioned by simply releasing the surrounding and restarting the process. The simplified design and limited cross-sectional diameter of the anchor control catheter further provide stable hemodynamics throughout the anchor delivery process.

[0059]

[0098] FIG. 20 shows a portion of a proximal control device including an anchor control catheter and an actuator of a tethering portion according to an embodiment of the present invention. The handle 110 is attached to a rotation control shaft 40 (not shown in FIG. 20) such that the shaft 40 and the guide arm portion 82 rotate by rotation of the handle 110. The sliding control portion 112 extends from the operating catheter 39 through the slot 114. By moving the sliding control portion 112 proximally and distally, the operating catheter 39 is moved proximally and distally, respectively. The second handle 116 is attached to the tethering portion 42. By moving the handle 116 proximally and distally with respect to the handle 110, the tethering portion 42 and the anchor attached thereto are moved proximally and distally within the anchor control catheter. Similarly, by moving the handle 110 proximally with respect to the stationary handle 116, the anchor remains stationary as the guide arm portion 82 retracts, as will be described below. When the button 117 of the handle 116 is pressed, the handle 116 grips the tethering portion 42, and when the button 117 is released, the tethering portion 42 can move with respect to the handle 116.

[0060]

[0099] FIG. 21 shows another embodiment of a proximal control device that combines an actuator for an anchor control catheter and a tethering portion in one handle. The handle 111 is attached to a rotation control shaft 40 (not shown in FIG. 21) such that the shaft 40 and the guide arm portion 82 are rotated by rotation of the ring 113. By moving the ring 115 proximally and distally, the operating catheter 39 is moved proximally and distally, respectively. When the button 119 is pressed, the handle 111 grips the tethering portion 42 such that the tethering portion moves with the handle 119.

[0061]

[0100] FIG. 22 shows the components of the proximal control device 32 for the anchor delivery subsystem. The tether control handle 116 is at the proximal end of the control device 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 respect to FIG. 20A. The anchor control catheter handle 110 is mounted on the rail 120 and is movable relative to the control handle 75 of the inner steerable catheter 36. The lock 122 holds the handle 110 in a fixed position on the rail 120 when the handle is not being moved. Similarly, the control handle 75 is proximal to the control handle 74 of the outer steerable catheter 34. The lock 122 holds the handles in a fixed position on the rail 120 when the handles 74 and 75 are not being moved.

[0062]

[0101] FIG. 23 shows details of the anchor 12. When loaded into the anchor control catheter, the anchor 12 assumes a straight shape. In its unconstrained state, as shown in FIG. 22, the anchor 12 extends in a spiral from the distal tip 124 to the proximal connector 126 where it is removably attached to the tether. The laser cut segment 125 at the distal end is more flexible than the central portion of the anchor, resulting in less trauma to the delivery system and the patient's anatomy. A flexible laser cut segment may also be provided at the proximal end of the anchor. Using the inner steerable catheter 36 for steering during fluoroscopic visualization, the spiral portion of the anchor control catheter 38 is then advanced through the valve tip of the native valve 130.

[0063]

[0102] To deliver the anchor to the patient's heart, an externally steerable catheter 34 and an internally steerable catheter 36 are used to advance a delivery system within a sheath 35 to the patient's right atrium RA and through the septum to the left atrium LA. Next, the guide arm 82 of the anchor control catheter 38 is advanced from the distal end of the internally steerable catheter 36, which takes a spiral shape under the control of the shaping 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. Using the internally steerable catheter 36 for steering under fluoroscopic visualization, the spiral portion of the anchor control catheter 38 is then advanced through the valve tip of the native valve 130 into the left ventricle LV. The actuation catheter 39 is used to extend the distal portion 96 of the guide arm 82 from the spiral shape, 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 while the anchor 12 remains within the anchor control catheter. Since the anchor 12 is more rigid than the guide arm 82, as described above, the position of the anchor 12 relative to the tip of the guide arm can also be used to match that portion of the guide arm to the spiral shape of the anchor (e.g., the radius of the anchor). After the chordae tendineae 132 surround the entire length of the anchor, the anchor control catheter 38 is removed from the anchor 12 while fixing and holding the tethering portion 42. The anchor control catheter 38 is retracted into the internally steerable catheter 36, the internally steerable catheter 36 is retracted into the externally steerable catheter 34, and the anchor delivery subsystem is removed from the patient with the tethering portion 42 still connected to the anchor 12.

[0064]

[0103] Before delivering an expandable valve to an implanted anchor, a guide wire is inserted through the anchor. One technique for positioning the guide wire is to advance an inflated balloon catheter through the implanted anchor toward the apex of the heart. The position of the balloon may be monitored by ultrasound. Using a balloon of a sufficiently large diameter (e.g., >12 mm) helps ensure that the balloon does not pass between the cords. Once the balloon has been passed through the anchor and into the ventricle, the guide wire can be advanced through the balloon catheter lumen. The balloon catheter is then removed, leaving the guide wire in place for use in advancing the valve delivery catheter.

[0065]

[0104] Figures 24 and 25A show aspects of a valve delivery subsystem 140 having a proximal control device 142 and three nested catheters (as shown in cross-section in Figure 25A), including an externally steerable catheter 144, a capsule shaft 146 movably disposed within the lumen of the externally steerable catheter 144, and an internally steerable catheter 148 movably disposed within the lumen of the capsule shaft. As shown, the tether 42 still extends proximally from a previously implanted anchor and is disposed outside the externally steerable catheter 144. In some embodiments, the tether 42 is detached from the anchor and removed from the patient prior to introduction of the valve delivery subsystem 140. A tab holder shaft 149 is disposed within the lumen of the internally steerable catheter 148, and a nose cone shaft 150 is disposed within the lumen of the tab holder shaft 149. A guide wire (not shown) may be disposed within the lumen of the nose cone shaft 150. The externally steerable catheter 144 and the internally steerable catheter 148 may be configured like the externally steerable catheter and the internally steerable catheter described above with respect to the anchor delivery subsystem. In some examples, only one of the externally steerable catheter 144 and the internally steerable catheter 148 is included in the valve delivery subsystem 140, and steering is performed by a single steerable catheter (e.g., the internally steerable catheter 148).

[0066]

[0105] Figure 25B shows the distal end of the valve delivery subsystem, and FIGS. 26A-26B show details of the tab holder. In FIG. 25B, the capsule shaft 146 is shown to extend distally beyond the distal end of the externally steerable catheter 144. A valve capsule 152 containing a compressed artificial valve 154 is attached to the distal end of the capsule shaft 146. When loaded into the capsule 152, a tab (not shown) at the proximal (atrial) end of the valve 154 is disposed in a slot 145 of a tab holder 147 at the distal end of a tab holder shaft 149, as shown in FIG. 26A. A nose cone (in other words, a conical nose) 156 extends from the distal end of the capsule 152. The nose cone 156 is connected to a nose cone shaft 150 (shown in FIG. 25A but not in FIG. 25B).

[0067]

[0106] In some examples, the valve delivery subsystem includes a single steerable catheter, as opposed to a plurality of steerable catheters (e.g., the externally steerable catheter 144 and the internally steerable catheter 148 in FIG. 25A). FIGS. 27A-27C show an example of a steerable catheter 2700 that may be used as a single steerable catheter as part of the valve delivery subsystem. As shown in FIG. 27A, the steerable catheter 2700 includes a proximal section 2702, a pivot transition section 2704, a pivot section 2706, a reach section 2708, a steering section 2710, and a tip section 2712. Each of the sections 2702-2712 may include one or more materials (e.g., polymers) exhibiting different degrees of stiffness. For example, the proximal section 2702 may have the greatest stiffness among the sections 2702-2712, the pivot section 2706 may be the least stiff among the sections 2702-2712, and the steering section 2710 may have a stiffness intermediate to that of the proximal section 2702 and the pivot section 2706. The pivot transition section 2704

[0107] In some examples, the pivot section 2706 may have a durometer in the range of 35D to 60D (e.g., 35D, 40D, 45D, 50D, 55D, or 60D). The pivot transition section 2704 acts as a bridge between the proximal section 2702 and the pivotable section 2706, has rigidity between the proximal section 2702 and the pivotable section 2706, and reduces stress on the transition between the two sections. In some examples, the pivot transition section 2704 may have a durometer in the range of 60D to 80D (e.g., 60D, 65D, 70D, 75D, or 80D). The reach section 2708 acts as a bridge between the proximal section 2702 and the pivotable section 2706, has a rigidity greater than that of the pivot section 2706 and less than that of the pivot transition section 2704, and reduces stress on the transition between the two sections. In some examples, the reach section 2708 may have a durometer in the range of 50D to 70D (e.g., 50D, 55D, 60D, 65D, or 70D). The tip section 2712 may have a rigidity greater than that of the pivot section 2706 and less than that of the pivot transition section 2704 and the reach section 2708. The tip section 2712 may be configured to abut or be coupled to a valve capsule that carries an artificial valve therein. In some examples, the tip section 2712 may have a durometer in the range of 40D to 65D (e.g., 40D, 45D, 50D, 60D, or 65D).

[0068]

[0108] The steerable catheter 2700 includes two longitudinally disposed draw lumen 2714 and braid layers 2730 and 2732, similar to the example of FIGS. 4A and 4B. For example, when one of the draw lumen 2714 is pulled, the catheter 2700 bends in one direction, and when the other draw lumen 2714 is pulled, the catheter 2700 bends in the opposite direction. In this way, the steerable catheter is configured to bend laterally along a plane.

[0069]

[0109] Due to the variable axial stiffness of the steerable catheter 2700, the steerable catheter 2700 can assume a desired shape between various parts of the valve delivery. FIG. 27B shows an example of the steerable catheter 2700 in a deflected (e.g., bent or curved) configuration when steering the valve capsule 152 through the mitral valve annulus 2720 of the heart. The catheter 2700 preferably bends at the pivot section 2708 and the steering section 2710 due to the relative flexibility of these sections. As shown, the steerable catheter 2700 may be arranged such that the pivot section 2706 is at or near the fossa ovalis 2722 and the steering section 2710 is aligned with the steering section 2710 and points to the valve capsule 152.

[0070]

[0110] FIG. 27C shows a schematic view of a steerable catheter 2700 in a deflected configuration within the heart 2750, showing how the steerable catheter 2700 provides a mechanical advantage and is adapted to reduce the force imparted to the tissue of the heart 2750. In the example shown, 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, ensuring a good positioning of the anchor 88 and / or the prosthetic valve 154. The prosthetic valve 154 is partially expanded from the valve capsule 152 such that the lower portion of the prosthetic valve 154 is expanded within the left ventricle LV. As shown, the bend of the steering section 2710 is within the left atrium LA, and the bend of the pivot section 2706 is within the right atrium RA. The valve pulling force 2752 is applied to the lower portion of the prosthetic valve 154 and the anchor 88. Thereby, a first reaction force 2756 acts on the septum 2758, and a second reaction force 2760 acts on the catheter 2700. The reaction forces 2756 and 2758 acting on the septum 2758 and the catheter 2700 reduce the magnitude of both forces. The reach section 2708 acts as a lever, and the pivot section 2706 can act as a fulcrum such that the septum 2758 obtains a mechanical advantage. The higher the bending stiffness of the pivot section 2706, the more it contributes to reducing the force on the septum 2758. For example, the stiffness of the pivot section 2706 can have a certain amount of give such that the bending angle of the pivot section 2706 changes slightly when a force is applied. Thereby, the amount of pressure applied to the septum 2758 can be reduced, thereby reducing (e.g., preventing) damage to the septum 2758.

[0071]

[0111] FIG. 28 shows an example of the proximal control device 142 of the valve delivery subsystem having an externally steerable catheter (e.g., FIG. 25A). The tab holder shaft 149 and the internal nose cone shaft 150 are disposed on a carriage 151 mounted on the rail 120 at the proximal end of the proximal control device 142. The above-described guide wire may be inserted into the nose cone shaft 150. Control handles 158, 160, 162 for the externally steerable catheter 144, the capsule shaft 146, and the internally steerable catheter 148 are also movably mounted on the rail 120. Locks 164, 166, and 168 hold the control handles in a fixed position on the rail 120 when the control handles are not being moved.

[0072]

[0112] The valve delivery subsystem is placed into the patient's vasculature through the same femoral vein introducer sheath used for anchor delivery and implantation. To advance the valve capsule to the heart, the control handles 158, 160, 162, and the carriage 151 are advanced together along the rail 120 under fluoroscopic guidance. During the operation of the prosthetic valve through the vasculature, the distal end of the valve delivery subsystem is steered by bending the distal ends of the internal and external steerable catheters 148 and 144 using the control handles 162 and 158, respectively, as described above with respect to the internal and external steerable catheters of the anchor delivery subsystem. The valve capsule 152 and the nose cone 156 are just distal to the distal end of the externally steerable catheter 144 during advancement into the patient's heart.

[0073]

[0113] When the distal ends of the nose cone 156, valve capsule 152, and externally steerable catheter 144 pass through the septum and enter the left atrium of the heart, the internally steerable catheter 148 and valve capsule 152 are advanced from the externally steerable catheter by moving the control handles 160 and 162 and carriage 151 distally while keeping the control handle 158 fixed, and the valve capsule 152 is moved into the position within the pre-embedded anchor. Once positioned, the capsule shaft 146 may be retracted while holding the tab holder shaft 149 and valve 154 fixed, retracting the capsule 152, exposing the distal end of the valve 154, thereby enabling the valve to begin self-expansion within the anchor. The partially self-expanded valve is pulled proximally relative to the anchor, moving the valve and anchor closer to the ventricular side of the native valve annulus. Thereafter, the capsule shaft is further retracted to expose the proximal end of the valve 154 and the valve can fully self-expand. When the capsule 152 is retracted far enough to expose the slot 145 of the tab holder 147, the valve tab moves out of the slot 145, removing the valve 154 from the tab holder 147. Thereafter, the valve delivery subsystem may be removed from the patient.

[0074]

[0114] Figures 29A and 29B show a valve prosthesis 154 having a valve frame structure 14 configured to support a plurality of valve leaflets (not shown) therein. As described above, the valve prosthesis can be delivered into the deployed anchor using the valve delivery subsystem described above. The valve frame 14 can include an internal interconnecting attachment mechanism 1111 for attaching valve leaflets to the frame structure 14. The valve frame structure 14 can be deployed from a folded (delivered) configuration via the valve delivery subsystem to an expanded configuration during a procedure for replacement or repair of a native valve such as a mitral valve. The valve frame 14 can include multiple rows (e.g., 3 to 7 rows) of substantially diamond-shaped cells 1299. The valve frame structure 14 can be configured to contract during delivery (i.e., when the valve frame structure 14 transitions from a folded configuration to an expanded configuration) due to the cell structure. In some embodiments, the valve frame structure 14 can be configured to self-expand from a folded configuration to an expanded configuration (e.g., can be made of a shape memory material such as nitinol). The valve frame 14 can provide circumferential strength and / or longitudinal strength to the valve prosthesis 154.

[0075]

[0115] The valve prosthesis 154 can be deployed in an expanded configuration according to the methods described herein. In the expanded configuration, the valve prosthesis 154 can be positioned and / or fixed in a target target region (e.g., an organ or tissue of an animal such as a dog, cat, horse, or human). For example, the valve prosthesis 154 can be positioned in an expanded configuration within an orifice of a heart valve such as a mitral valve or tricuspid valve (e.g., to function as a temporary or permanent replacement for an existing mitral or tricuspid valve of the heart).

[0076]

[0116] One or more portions of the valve frame structure 14 can be shaped or configured to help secure the valve frame structure 14 in place (e.g., within the orifice of a native heart valve). For example, the valve frame structure 14 can include an atrial extension portion 127 and a ventricular portion 103 configured to help secure the frame to the anatomical structure. The atrial extension portion 127 and the ventricular portion 103 can extend radially outwardly from a narrow central waist portion 101. The atrial extension portion 127 can be configured, for example, to extend from the central waist portion 101 into the atrium of the heart when the valve prosthesis is deployed in the native mitral valve. The ventricular portion 103 can then extend from the central waist portion 101 into the ventricle of the heart when the valve prosthesis is deployed in the native mitral valve. The narrow central waist portion 101 is configured to engage the anchor described above. The atrial extension portion 127 and the ventricular portion 103 can be configured, for example, to be disposed on either side of the anchor 88 (e.g., wrapped around the chordae tendineae and the central waist portion) to secure the valve frame structure 14 to the anatomical structure. Alternatively or additionally, the atrial extension portion 127 and the ventricular portion 103 can be configured to engage tissue to prevent the valve prosthesis from passing through the native valve orifice.

[0077]

[0117] Referring to FIG. 29A, the frame structure 14 of the valve prosthesis 154 can be made into a partial hourglass shape where the ventricular portion 103 initially projects radially outward from the central waist portion 101 in the ventricular direction (e.g., above 107), and then curves back inward toward the center of the frame structure (e.g., below 107). As shown, the internal interconnect attachment mechanism 1111 can be positioned inside the ventricular end of the ventricular portion 103. In some embodiments, the inner surface of the internal interconnect attachment mechanism 1111 can be configured to be radially aligned with the narrow central waist portion 101. This semi-hourglass or cup shape of the ventricular portion 103 can advantageously serve to provide space for the chordae tendineae around it. The ventricular portion 103 is designed to be as short as possible (e.g., having an axial length of about 8 mm to 15 mm), but still achieves the purpose of supporting the attachment to the valve leaflet and avoiding the commissure / 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).

[0078]

[0118] As shown in FIGS. 29A - 29B, the protruding atrial portion 127 also projects radially outward from the central waist portion in the atrial direction and ends with a wide atrial flange 105. As shown, the atrial flange 105 of the protruding atrial portion 127 may curve slightly inward from the rest of the atrial projection portion, but still points radially outward from the frame structure 12. The protruding atrial portion 127 including the atrial flange is the widest part of the frame structure and extends further radially outward than the ventricular portion. Generally, as shown in FIGS. 29A - 29B, the atrial projection portion 127 can extend further radially outward than the ventricular portion 103. A large atrial projection portion can help prevent para-valvular leakage (PVL). The atrial flange 105 is very conformable and flexible to rest against the anatomical structure without damaging the tissue, and seals without the need for a PVL protection material or other additional structures for sealing. Further, due to the size and conformability of the protruding atrial portion and the atrial flange, the valve frame structure can be used over a wide range of anatomical structures and conditions.

[0079]

[0119] The specific design and shape of the frame structure 12, including the protruding atrial portion 127 and the central waist portion 101, and the interaction between the frame structure 14 and the anchor 88 act to properly seat the frame structure in the atrium. Specifically, when the anchor is placed in the target anatomical structure (e.g., the left ventricle, the surrounding chordae tendineae, and the "high" position near the annulus), the engagement between the central waist portion 101 and the anchor 88 acts to pull the frame structure 12, particularly the protruding atrial portion 127 and the wide atrial flange 105, "downward" toward the native valve, seating the prosthetic valve and forming a seal.

[0080]

[0120] The rigidity and flexibility of the atrial flange are optimized to help expand the entire frame structure into the anchor. The protruding atrial portion, particularly the atrial flange, must withstand (e.g., initially) non-ideal anchor placement and still require sufficient rigidity to achieve complete valve expansion. Non-ideal anchor placement includes the anchor being positioned at an axial location along the frame other than the waist and / or being angled with respect to the valve frame. The struts or cell pattern of the protruding atrial portion are designed and configured to increase the rigidity of the atrial flange to overcome these positioning cases, while the atrial flange can be flexible enough to conform to the anatomical structure in a non-invasive manner.

[0081]

[0121] In some embodiments, the atrial extension portion 127 is the softest, most flexible, most conformable, or least rigid portion of the valve prosthesis, while still having the rigidity necessary to assume a fully self-expanded configuration when disposed within the anchor. This flexibility allows the atrial portion to conform to the patient's atrium. The central waist portion and the ventricular portion can optionally have a higher rigidity than the atrial portion. The rigidity of the central annular portion can assist in self-expansion to the target diameter and engagement with the anchor. In some embodiments, the central waist portion needs to be able to expand against the reaction force of the anchor. In one embodiment, the rigidity of the anchor is selected such that the anchor is partially expanded by the valve during valve expansion. For example, expansion of the anchor can increase the circumference of the anchor, and the number of revolutions of the anchor in the delivered state is reduced by about 5% to about 25%. For example, an anchor having an initial 1.5 revolutions and a reduction of about 25% in the number of revolutions due to internal valve expansion retains about 1.13 revolutions after implantation. It is understood that within the aforementioned reduction ranges, the number of revolutions can be reduced by any percentage. In another aspect, the number of revolutions of the anchor can be reduced from about 1.75 revolutions to about 1.5 revolutions or about 1.2 revolutions, or from about 1.5 revolutions to about 1.3 revolutions or 1.1 revolutions.

[0082]

[0122] The mitral valve replacement of the present disclosure is specifically designed for the position of the mitral valve. As described above, the atrial flange is wide and flexible to seal against PVL in various patient anatomies without damaging the atrial tissue. The replacement valve prosthesis further has a short (e.g., less than 10 mm) ventricular flange to avoid obstruction of the left ventricular outflow tract (LVOT) in various patient anatomies. When the valve is implanted as described above, the native valve is not occluded, so the system provides good hemodynamics without the need for pacing. The valve frame structure of the present disclosure does not occlude the native valve until the atrial flange is deployed, at which point the valve is functioning normally.

[0083]

[0123] Figures 30A and 30B show an example of a proximal control device 3000 for an anchor delivery subsystem. Control handles 3002, 3004, and 3006 are movably attached to a rail system 3020 (also referred to as a track system) via carriages 3003, 3005, and 3007, respectively. The rail system 3020 is fixedly coupled to a stabilizer 3008, which may be configured to support the rail system 3020 at an angle relative to a horizontal axis (e.g., the floor). In some cases, the stabilizer 3008 may include a knob 3011 (or other angle adjustment device) configured to adjust the angle of the rail system 3020 relative to the horizontal axis (e.g., the floor). Such adjustment may be based on, for example, the position of the patient, the position of the user, or both. The stabilizer 3008 may include a flat bottom surface for placement on a flat surface of a support 3010, which may be a stool or a table. The vertical height of the proximal control device 3000 may be adjusted by placing the control device 3000 on supports 3010 having different heights or by placing the control device 3000 on an adjustable height support.

[0084]

[0124] The first carriage 3003 includes a first dial 3013 configured to be rotated (e.g., by a user's hand) to control distal and proximal movement of the first handle 3002, thereby controlling distal advancement and proximal retraction of the externally steerable catheter 34. The second carriage 3005 includes a second dial 3015 configured to be rotated (e.g., by a user's hand) to control distal and proximal movement of the second handle 3004, thereby controlling distal advancement and proximal retraction of the internally steerable catheter 36. The third carriage 3007 includes a third dial 3017 configured to be rotated (e.g., by a user's hand) to control distal and proximal movement of the third handle 3006, thereby controlling distal advancement and proximal retraction of the anchor control catheter 38 (the end of which includes the guide arm 82). Accordingly, the third dial 3017 may be configured to control the axial height of the guide arm 82 within the patient's heart.

[0085]

[0125] In some examples, one or more of the dials 3013, 3015, 3017, and / or carriages 3003, 3005, 3007 include one or more locks that lock the translational movement of the handles 3002, 3004, and / or 3006. This may act as a safety feature to prevent unintentional advancement and / or retraction of the externally steerable catheter 34, internally steerable catheter 36, and / or anchor control catheter 38, for example, when within the patient's body. In some cases, the default state of one or more of the dials 3013, 3015, and 3017 is locked such that the lock must be actuated to be released. For example, the dials 3013, 3015, and / or 3017 may be configured to be unlocked by pushing the dials 3013, 3015, and / or 3017 (or a portion of the dials 3013, 3015, and / or 3017) inwardly toward the rail system 3020 before the user can rotate the dials 3013, 3015, and / or 3017.

[0086]

[0126] One or more of dials 3013, 3015, 3017 may be configured to move independently or in cooperation with one or more of the other dials 3013, 3015, and / or 3017. For example, in the independent mode, the second dial 3013 may be configured to allow independent translation of the second carriage 3005 relative to the first carriage 3003 and / or the third carriage 3007, and in the coupled mode, the second dial 3013 may be configured to couple the translational movement of the second carriage 3005 with the translation of the first carriage 3003 and / or the third carriage 3007. Thus, catheters 34, 36, and / or 38 may be selected to move forward and / or backward independently or together. This can be useful in procedures that require independent translation of catheters 34, 36, and 38 during one or more parts of the anchor deployment process, but require coordinated movement between two or more of catheters 34, 36, and 38 during one or more other parts of the anchor deployment process.

[0087]

[0127] For example, the first dial 3013 of the first carriage 3003 includes a button (e.g., the first button) 3063 configured to couple the translational movement of the first carriage 3003 with the translational movement of the second carriage 3005. When the button 3063 is actuated (e.g., by pressing), both the first carriage 3003 and the second carriage 3005 translate along the rail system 3020 due to the rotation of the second dial 3015 of the second carriage 3005. Similarly, the third dial 3017 of the third carriage 3007 includes a button (e.g., the second button) 3067 configured to couple the translational movement of the third carriage 3007 with the translational movement of the second carriage 3005. When the button 3067 is actuated (e.g., by pressing), both the second carriage 3005 and the third carriage 3007 translate along the rail system 3020 due to the rotation of the second dial 3015 of the second carriage 3005. When both buttons 3063 and 3067 are actuated, all three of the first carriage 3003, the second carriage 3005, and the third carriage 3007 translate along the rail system 3020 due to the rotation of the second dial 3015 of the second carriage 3005.

[0088]

[0128] An example where the combined axial movement of catheters 34, 36, and 38 / 82 can be useful is when catheters 34, 36, and 38 / 82 are advanced together through the septum into the atrium of the patient's heart. If such combined movement is desired, buttons 3063 and 3067 can be actuated and dial 3015 can be rotated to advance catheters 34, 36, and 38 / 82 together within the heart. Dial 3015 can also be rotated (in the opposite direction of advancement) to retract catheters 34, 36, and 38 / 82 together from the atrium of the heart. Fasteners 3032, 3034, 3037 are configured to secure handles 3002, 3004, 3006 to rail system 3020, respectively. One or more of fasteners 3032, 3034, 3037 can be configured to allow rotational adjustment of the corresponding handle 3002, 3004, 3006. For example, as shown in the close-up view of fastener 3034 in FIG. 30B, fastener 3034 includes a band 3044 (or ring) configured to surround the outer surface of handle 3004. When lever 3045 is moved to the locked position (e.g., by pushing lever 3045 so that it pivots inwardly towards band 3044), tension is applied to band 3044, thereby restraining the movement of handle 3004 positioned within band 3044. When lever 3045 is moved to the unlocked position (e.g., by pulling lever 2035 so that lever 3045 pivots outwardly away from band 3044), the tension is released from band 3044, thereby allowing rotational movement of handle 3004. Thus, when fastener 3034 is in the unlocked position, the user can rotate handle 3004 by hand to rotate the corresponding catheter 36. In the example of the proximal control device 3000, each of fasteners 3032, 3034, 3037 is configured to allow the user to rotate the corresponding handle 3002, 3004, 3006, thereby allowing rotation of the corresponding catheters 34, 36, 38 (e.g., when they are within the patient's body).

[0089]

[0129] Each of the fasteners 3032, 3034, and 3037 may be configured such that each handle can be easily removed from its respective carriage, and such that each band is in an open state where it is open. Further, each of the fasteners 3032, 3034, 3037 may be configured to transition 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 carriage 3005, so that the catheter 36 is maintained in the intended rotational position but is rotatable relative to the second carriage 3005. For example, the cradle 3074 of the fastener 3034 may include one or more engagement features (e.g., depressions, protrusions, and / or textured surfaces) configured to frictionally engage one or more corresponding features of the handle 3004 to maintain the rotational position of the handle 3004 when positioned within the fastener 3034. In the first closed state, the band 3044 may surround the handle 3004 but may be loose enough for the handle 3004 to be rotatable relative to the carriage 3005 (e.g., by the user's hand). When the second fastener 3034 is in the second closed state, the band 3004 is in a fully gripped state where the handle 3004 is completely fixed to the carriage 3005 and is non-rotatable relative to the carriage 3005.

[0090]

[0130] The handles 3002, 3004, and 3006 each include rotary knobs 3022, 3024, and 3026 configured to deflect the distal portions of the corresponding catheters 34, 36, and 38. The knobs 3022, 3024, and 3026 are 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), so that the catheters 34, 36, and / or 38 can be steered through a patient's vasculature. For example, the knob 3024 may be rotated to deflect (e.g., bend) the inner steering catheter 36 to control the position of the anchor control catheter 38 / guide arm 82 relative to the patient's anatomical structure. For example, the knob 3024 can be rotated to bend the guide arm 82 toward the patient ("bending in the positive direction") and / or away from the patient ("bending in the negative direction").

[0091]

[0131] The knob 3026 of the third handle 3006 may be rotated to "actuate" the guide arm 82 to bias the guide arm into a helical or spiral shape (e.g., from a linear shape). When the guide arm 82 is actuated, the knob 3026 may be locked to continuously apply a force and maintain the bias on the guide arm 82. In some examples, the guide arm 82 is actuated while positioned within the inner steerable catheter, thereby preloading the guide arm 82 such that the guide arm self-assembles when the inner steerable catheter 36 is withdrawn proximally from the guide arm 82 to expose the guide arm 82. This may be referred to as "active" self-assembly because the guide arm is actuated to enable the guide arm to self-assemble. With such preloading, the guide arm 82 can assume a helical or spiral shape within the boundaries of the atrium with minimal (or no) contact with the inner wall of the atrium.

[0092]

[0132] The proximal knob 3018 of the third handle 3006 may be coupled to a tethering portion (e.g., tethering portion 42), which is coupled to an anchor (e.g., anchor 12) and is 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 may be rotatable in a first direction to retract the tethering portion / anchor proximally and may also be rotatable in a second direction to advance the tethering portion / anchor distally. As described above with respect to FIGS. 18A-18C, the shape of the guide arm 82 (at the distal end of the anchor control catheter 38) may be determined in part by the extent to which the anchor is positioned within the guide arm 82. As described above, controlling the distal and proximal movement of the anchor within the guide arm 82 may be used to control the shape of the guide arm 82 while positioning and surrounding the guide arm 82 around the chordae tendineae and / or valve leaflets.

[0093]

[0133] The proximal knob 3018 of the third handle 3006 may be used to maintain the position of the anchor when the guide arm 82 is retracted over the anchor (via the anchor control catheter 38) within the patient's heart. For example, the proximal knob 3018 may be held stationary (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 may be useful, for example, in stably holding the anchor while the dial 3017 is rotated to retract the guide arm 82 over the anchor. This procedure may be used to ensure that the anchor remains in the desired location and / or orientation around the chordae tendineae and / or valve leaflets while the guide arm 82 is being retracted. For example, this may compensate for any friction between the guide arm 82 and the anchor. This may also compensate for any differences in flexibility / compressibility between the guide arm 82 and the anchor.

[0094]

[0134] Each of the handles 3002, 3004, and 3006 may include a cleaning port 3064, 3066, and 3068, respectively. The cleaning ports 3064, 3066, and 3068 may provide access to the lumens of the respective catheters 34, 36, and 38, for example, for saline flushing.

[0095]

[0135] FIG. 31 shows an exploded view of an exemplary rail system 3120 (also referred to as an orbital system) for a proximal control device to illustrate exemplary features for performing independent combined translation of catheters (e.g., catheters 34, 36, and 38). The rail system 3120 includes a primary rail 3155 and a secondary rail 3156 disposed in parallel on a rail 3140. The cradle 3144 is configured to fix the handle 3104 to the rail 3140 via a carriage 3105. The cradle 3144 includes a fixture 3134 that includes a lever 3145, and the lever is configured to apply and release pressure to a band or ring portion of the fixture 3134. By actuating the lever 3145, the movement of the handle 3104 is restricted, and by releasing the lever 3145, the handle 3104 can be rotated (e.g., by a user's hand). The cradle 3144 may be fixed to the carriage 3105 by one or more screws as shown.

[0096]

[0136] The carriage 3105 includes a knob assembly configured to engage with the primary rail 3155. The knob assembly includes a gear 3162, an outer shaft 3157, an insert 3158, a rotary 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 primary rail 3155 to translate the carriage 3105 along the primary rail 3155.

[0097]

[0137] In this example, carriage 3105 includes a button 3160 configured to couple the translational movement of carriage 3105 to another carriage. For example, referring back to FIG. 30A, carriage 3105 may correspond to the first carriage 3003, or a third carriage 3007 configured to couple translational movement to a second carriage 3005. Actuating button 3160 (e.g., by pressing the button once) causes coupler 3152 to engage secondary track 3156, thereby coupling the translational movement of carriage 3105 to another carriage (e.g., second carriage 3005). De-actuating button 3160 (e.g., by pressing the button twice) causes coupler 3152 to disengage from secondary track 3156, thereby enabling independent translational movement of carriage 3105 with respect to another carriage (e.g., second carriage 3005).

[0098]

[0138] FIG. 32 shows another example of a proximal control device 3200 for a valve delivery subsystem. In this example, the same stabilizer 3008, support 3010, rail system 3020, and carriage 3003 are used as in the proximal control device 3000 of the anchor delivery subsystem of FIGS. 30A-30B. That is, after the anchor is implanted in the patient's heart and catheters 34, 36, 38 of the anchor delivery subsystem are withdrawn from the patient, handles 3002, 3004, 3006 of the anchor delivery subsystem may be removed from their respective carriages 3003, 3005, 3007. The valve delivery handle 3202 may then be positioned in the fixture 3032 of carriage 3003 (or carriage 3004 or 3006) for delivery of a valve delivery catheter system that includes a steerable catheter 2700 having a distal portion with a capsule shaft (e.g., as shown in FIGS. 27A-27C).

[0099]

[0139] The proximal control device 3200 includes a handle 3202, which includes a valve deployment knob 3272, a depth control knob 3274, and a steering / flexure shape control knob 3276. The valve deployment knob 3272 is rotatable to cause distal advancement of an artificial valve (e.g., 154 of FIGS. 26, 29A, and 29B). The valve deployment knob 3272 may include a lock to prevent valve deployment when in a locked configuration (e.g., as a safety feature). The depth control knob 3274 may be rotatable to cause fine axial movement of the catheter 2700 (e.g., distal advancement or proximal retraction). For example, the depth control knob 3274 may be used to pull the ventricular side of a partially deployed valve toward the native valve annulus as described herein. The deflection knob 3276 (also referred to as the steering / flexure shape control knob) may be rotatable to cause deflection (e.g., bending and shape change) of the distal portion of the catheter 2700.

[0100]

[0140] The dial 3013 of the carriage 3003 may be used to control the overall axial movement of the catheter 2700. For example, the dial 3013 may be rotated to introduce the catheter 2700 into the heart and / or advance the catheter 2700 through the septum and into the atrium. The dial 3013 may be rotated in the opposite direction to retract the catheter 2700 from the heart after the artificial valve is fully deployed. In some cases, the dial 3013 may be used to pull the ventricular side of a partially deployed valve toward the native valve annulus (e.g., instead of or in combination with rotation of the depth control knob 3274).

[0101]

[0141] The handle 3202 may include irrigation ports 3264, 3266, and 3268. Similar to the anchor delivery catheter system, the irrigation ports may be used at various points in the delivery procedure. For example, each of the catheters may first be irrigated to be filled with saline. Heparinized saline may be added at various points in the procedure to address any clotting in the internal and / or between spaces of the catheter, frame, anchor, etc.

[0102]

[0142] Figures 33A through 33V and Figures 33-1 through 33-13 illustrate exemplary systems and methods for delivering and implanting an artificial mitral valve and an anchor into a target heart. It should be understood that any of the valves, anchors, anchor delivery subsystems, and valve delivery subsystems described herein may be used in any of a number of combinations and are not limited by the examples shown in Figures 33A through 33V and Figures 33-1 through 33-13. As will be described below, these systems and methods provide a consistent and broad tolerance delivery procedure that can accommodate a variety of patient anatomies while fully addressing a patient's valvular regurgitation without occluding the LVOT. As is apparent from the present disclosure, the artificial mitral valve and the delivery system and method provide more clinical advantages and features than other systems on the market.

[0103]

[0143] The valve delivery system of the present disclosure delivers an anchor into the left ventricle through a native valve via a transseptal approach with a broad tolerance. The clinician can finely control the position of the anchor, and thus the shape of the guiding arm, during the enclosure, and can adjust the radial position of the guiding arm to ensure that the desired cord is captured. The delivery system has the ability to capture all cords in a single operation (e.g., between 1 and up to 2.5 rotations of the guiding arm), but the delivery system can also capture only a portion of the cord on the first rotation of the guiding arm / anchor (e.g., 1 rotation) and the remaining cord on subsequent rotations of the guiding arm / anchor (e.g., the remaining 1 to 1.5 rotations). The anchor delivery system has the ability to invert and re-enclose the anchor in the case where the clinician is dissatisfied with the placement of the device or where the desired anatomy (e.g., a cord) within the anchor is not captured, with a rotation-based enclosure. Since the anchor is (e.g., fully) contained within the guiding arm of the delivery device during the enclosure, the clinician can easily invert and re-enclose to safely correct the problem and continue the procedure without recapturing the deployed anchor. This system is designed and configured to protect the anatomy from damage / rupture of the cords.

[0104]

[0144] Not only can the clinician control the reach of the guiding wrist as much as possible, but also the clinician can completely independently control the axial height of the anchor during and after envelopment, as well as the rotational position of the anchor and the guiding wrist. The delivery systems and methods disclosed herein further facilitate the determination of cord capture. The position and orientation of the guiding wrist, and thus the anchor (carried internally), can be visualized by echo (ultrasound) alone during envelopment and delivery. This enables visualization of the valve tip moving outside the guiding wrist and / or visualization of the direction of the cord. The two-dimensional image can be fixed during the procedure, so the clinician can confirm the mobility of the valve tip during delivery. Visualizing the guiding wrist also enables proper alignment of the anchor. The clinician can use echo visualization to align the guiding wrist (e.g., the distal portion) in the same plane as the annulus. When the clinician achieves a balanced capture of the chordae tendineae, the guiding wrist remains in the same plane as the annulus after envelopment. If the balance of the guiding wrist is disrupted or tilted after envelopment, it can indicate to the clinician that additional envelopment or re-envelopment is required.

[0105]

[0145] In some embodiments, when the anchor is deployed (e.g., fully) from the delivery system into the heart, the anchor is completely removed without any tethering or other connection to another device prior to valve deployment. The anchor circumscribes the chordae tendineae / valve tip in the left ventricle and is stably positioned by gently gathering, but when deployed, it is completely released from interaction with the (e.g., anchor) delivery system. The inner diameter of the anchor without a tether indicates the object on which the guide wire is placed, and the valve delivery system is advanced along the guide wire. All of the above features enable fine-tuned control of the envelopment device and easy reversibility, safety, and re-envelopment without undue risk to the patient's tissue.

[0106]

[0146] The prosthetic valve of the present disclosure also provides a number of advantages over competing products and clinical advantages to patients. Importantly, the prosthetic valve is designed and configured to be self - standing within the target anatomical structure after deployment from the valve delivery system. The prosthetic valve is configured to be self - standing even if the valve is non - coaxially delivered or positioned within the ring and anchor. Coaxial delivery in this context refers to the central (longitudinal) axis of the prosthetic valve and the central axis of the anchor (e.g., the axis perpendicular to the plane containing the anchor). For example, the frame can withstand an off - axis delivery of up to 45 degrees. Such self - standing, balanced with the softness or flexibility of the atrial overhang due to the rigidity of the wide atrial flange, is non - traumatic and can prevent damage to the atrial and ring tissues. Due to the short axial height of the ventricular overhang or the ventricular side of the prosthetic valve (e.g., less than 10 mm), the valve can be deployed and self - stand.

[0107]

[0147] The mitral valve prosthesis of the present disclosure prevents paravalvular leakage (PVL) after implantation. The frame design includes a combination of a soft and wide atrial flange, a narrow central waist that interacts with the anchor to pinch below / above the ring, and the selection of the valve fabric, which completely seals the valve against the anatomical structure and reduces or eliminates the risk of blood flowing between the implanted valve and the heart tissue. When the valve is implanted, it seats on the atrial floor with the wide atrial flange.

[0108]

[0148] The prosthetic valve of the present disclosure is further designed and configured to reduce or limit left ventricular outflow tract obstruction (LVOTO). The short ventricular height of the valve (e.g., less than 10 mm), the self - standing nature of the valve (e.g., optimization of the valve angle with respect to the LVOT), and the tissue interaction between the valve and the anatomical structure (e.g., capture / optimal alignment of the anterior leaflet) all provide solutions for LVOTO that have not been achieved with other competing devices. Specifically, the valve and the anchor capture the anterior leaflet and pull it away from the LVOT during valve expansion and axial adjustment of the anchor position, further reducing LVOTO.

[0109]

[0149] Referring to FIG. 33A, the nested catheter system of the anchor delivery subsystem includes an externally steerable catheter 34, an internally steerable catheter 36, and a guide arm 82, and is advanced through the septum to the left atrium of the target heart up to the patient's right atrium. In some cases, the nested catheter system is advanced through the patient's vasculature by hand of a user (e.g., a surgeon). In some examples, another puncture procedure is used to puncture the septum prior to advancing the nested catheter system through the septum.

[0110]

[0150] FIG. 33-1 shows an exemplary operation of an anchor delivery control device 3000 for advancing an externally steerable catheter 34, an internally steerable catheter 36, and a guide arm 82 (at the distal portion of the anchor control catheter 38) together through the septum, as shown in FIG. 33A. Buttons 3063 of the first dial 3013 and buttons 3067 of the third dial 3017 may be actuated to couple the translational movement of the first carriage 3003 and the third carriage 3007 with the translational movement of the second carriage 3005. Then, the second knob 3015 may be rotated to advance the externally steerable catheter 34, the internally steerable catheter 36, and the guide arm 82 together through the septum. Thereafter, buttons 3063 and 3067 may be deactivated.

[0111]

[0151] FIGS. 33B and 33C show that the internally steerable catheter 36 is advanced from the distal end of the externally steerable catheter 34 into the left atrium. Further, the guide arm 82 is advanced from the distal end of the internally steerable catheter 36 into the left atrium. The active and passive portions of the guide arm 82 are combined with an anchor carried internally to enable the guide arm 82 to self-assemble, in this case to form a spiral shape (FIGS. 14A - 14B) in the left atrium. As described above, in other examples, the guide arm 82 is configured to self-assemble in a helical shape (FIGS. 15A - 15B). As described above, the anchor fully self-assembles within the guide arm 82 and assumes its stationary shape when the guide arm 82 is deployed in the left atrium.

[0112]

[0152] As shown in FIGS. 33A and 33B, FIG. 33-2 shows an exemplary operation of an anchor delivery control device 3000 for advancing an internally steerable catheter 36 and a guide arm 82. The user may rotate a second dial 3015 to advance the internally steerable catheter 36 distally relative to the externally steerable catheter 34. The user may rotate a third dial 3017 to advance the guide arm 82 distally relative to the internally steerable catheter 36 and the externally steerable catheter 34.

[0113]

[0153] In FIG. 33D, the internally steerable catheter 36 is deflected to steer the guide arm 82 toward the mitral annulus. In the illustrated example, the spiral shape of the guide arm 82 (e.g., the portion distal to the bend 93 of the guide arm 82 in FIG. 14B) is generally parallel to the mitral annulus. If the guide arm 82 has a helical shape, the portion distal to the bend 93 of the guide arm 82 (in FIG. 15B) can have a helical shape.

[0114]

[0154] As shown in FIG. 33D, FIG. 33-3 shows how the anchor delivery control device 3000 can be used to steer the guide arm 82. The user rotates a rotation knob 3024 of a second handle 3004, and the internally steerable catheter 36 deflects, thereby steering the guide arm 82 toward the mitral annulus as shown in FIG. 33D.

[0115]

[0155] In FIG. 33E, the guide arm 82 is rotated counterclockwise, crosses the mitral valve, and advances through the valve tip into the left ventricle. In this example, the guide arm 82 is fully deployed when the guide arm 82 is advanced across the mitral valve, 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 as the guide arm 82 crosses the mitral valve as shown.

[0116]

[0156] Figure 33-4 shows how the anchor delivery control device 3000 can be used to rotate the guide arm 82, as shown in Figure 33E. The user may unlock (e.g., pull) the lever 3065 of the fastener 3037 of the third carriage 3007 to release the tension on the band portion of the fastener 3037. The user may then rotate the handle 3006, whereby the anchor control catheter 38 rotates. 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 may rotate the dial 3017 (e.g., the third dial) to advance the handle 3006 and the guide arm 82 distally.

[0117]

[0157] Referring to Figure 33F, the enclosing process can be initiated. As described above, the distal tip of the guide arm 82 can be radially expanded, for example, by a selected proximal retraction of the anchor therein. In the illustrated example, the distal tip of the guide arm 82 expands toward the left ventricular outflow tract (LVOT).

[0118]

[0158] Figure 33-5 shows how the anchor delivery control device 3000 can be used to expand the distal tip of the guide arm 82, as shown in Figure 33F. The user may rotate the proximal knob 3018 to advance and / or retract the anchor within the guide arm 82. As described above with reference to Figures 18A-18C, movement of the anchor within the guide arm 82 may cause the distal portion of the guide arm 82 to extend radially outward. In some examples, after the anchor has been moved within the guide arm 82 to cause sufficient radial expansion of the distal tip of the guide arm 82, the proximal knob 3018 may be locked to hold the guide arm 82 in the radially expanded state as desired.

[0119]

[0159] In FIG. 33G, while the guiding arm portion 82 is in a radially expanded state, it is rotated to surround the chordae tendineae / cusp in the left ventricle. Since the surrounding process can be performed under echo imaging to visualize the guiding arm portion 82, the user can actively operate the distal tip of the guiding arm portion 82 to capture the desired chordae tendineae / cusp. This may include expanding the distal tip of the guiding arm portion 82 radially outward or pulling the distal tip radially inward, depending on the patient-specific anatomical structure.

[0120]

[0160] FIG. 33-6 shows how the anchor delivery control device 3000 can be used to rotate and operate the guiding arm portion 82, as shown in FIG. 33G. The user may unlock the fastener 3037 to release the tension around the handle 3006. The user then rotates the handle 3006, whereby the anchor control catheter 38 may rotate in the same direction as the guiding arm portion 82. In some examples, the second handle 3004 may be rotated (after unlocking the fastener 3034) to rotate the internally steerable catheter 36 to increase the reach of the distal tip of the guiding arm portion 83. To actively operate the distal tip of the guiding arm portion 82, the user can rotate the proximal knob 3018 to move the anchor proximally within the guiding arm portion 82. Thereby, the distal tip of the guiding arm portion 82 extends radially and is pulled radially inward, enabling the user to control to capture the chordae tendineae / cusp in different regions near the mitral annulus.

[0121]

[0161] In FIG. 33H, the position of the guiding arm portion 82 was evaluated and it was determined that at least some of the chordae tendineae or leaflet tissue were not correctly enclosed. To reposition the anchor delivery subsystem, the clinician can enclose / reenclose at a desired frequency by easily and independently adjusting the axial height, circumferential (rotational) position, and / or radial reach of the distal end of the guiding arm portion 82. This delivery flexibility, along with the clear visualization characteristics of the anchor delivery catheter, provides the clinician with accurate and reproducible control of the enclosure of the chordae tendineae and / or leaflets. In FIG. 33I, the guiding arm portion 82 is retracted or rotated in reverse to partially unenclose a portion of the previously enclosed chordae tendineae.

[0122]

[0162] FIG. 33-7 shows how the anchor delivery control device 3000 can be used to operate the guiding arm portion 82, as shown in FIGS. 33H and 33I. After unlocking the fastener 3037, the user may rotate the handle 3006 to rotate the guiding arm portion 82, and the guiding arm portion 82 unencloses. To adjust the axial height of the guiding arm portion 82, the user may rotate the dial 3017 to move the guiding arm portion 82 distally and / or proximally. To adjust the radial reach of the distal end of the guiding arm portion 82, the user may rotate the proximal knob 3018 clockwise and / or counterclockwise.

[0123]

[0163] FIGS. 33J and 33K show the process of reenclosing the guiding arm portion 82 after rotating it in reverse. The reenclosing process is used to fully capture the desired anatomical structure (chordae tendineae / leaflet). Adjustment or change of the radial position of the distal tip of the guiding arm portion 82 can optionally be performed at any point during enclosure (rotation) or unenclosure (reverse rotation).

[0124]

[0164] FIG. 33-8 shows how the anchor delivery control device 3000 can be used to manipulate the guide arm 82, as shown in FIGS. 33J and 33K. The user may rotate the guide arm 82 and rotate the handle to re-encircle the chordae and / or leaflets. To adjust the radial position of the distal end of the guide arm 82, the user may rotate the proximal knob 3018.

[0125]

[0165] When it is determined that the chordae are sufficiently (e.g., completely) surrounded by the guide arm 82, as shown in FIG. 33L, 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 is accomplished by maintaining the position of the anchor and the tether while retracting the guide arm 82 into the inner steerable catheter 36 until the distal end of the guide arm 82 passes the proximal end of the anchor and the anchor delivery catheter system is detached from the anchor. The inner steerable catheter 36 is then drawn 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 a fixed position within the left ventricle surrounding the desired chordae / leaflets, as shown in FIG. 33M. The anchor 88 may then be detached from the tether. As a result, the anchor 88 is deployed and fixed around the chordae and / or leaflets of the left ventricle without being connected to other system components (e.g., no tether or other linkage remains when the anchor 88 is deployed). In addition, while 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. Thus, the anchor 88 can slide or move axially (e.g., towards or away from the annulus). This will be explained in more detail below when the self-expansion and positioning of the valve are described.

[0126]

[0166] FIG. 33-9 shows how the anchor delivery control device 3000 can be used to retract the guide arm 82 from the anchor 88, as shown in FIGS. 33L and 33M. The user may lock (or hold) the proximal knob 3018 to maintain the anchor position at a desired fixed position around the chordae tendineae / cusp tip. While the proximal knob 3018 is locked (or held), the user may rotate the dial 3017 (e.g., the third dial) to retract the guide arm 82 proximally into the internally steerable catheter 36. When the guide arm 82 is retracted over the anchor 88, the anchor disengages from the mooring portion, as described herein. After the guide arm 82 is fully retracted, the user may rotate the dial 3015 (e.g., the second dial) to retract the internally steerable catheter 36 proximally into the externally steerable catheter 34. After the internally steerable catheter 36 is retracted into the externally 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 to the first carriage 3003 and the third carriage 3007. The second dial 3015 may then be rotated to retract the catheters 34, 36, and 38 together retrograde from the atrium.

[0127]

[0167] In FIG. 33N, valve delivery can be initiated. First, the guide wire 99 can be inserted through the septum into the left atrium, through the mitral annulus, and through the anchor 88 into the left ventricle. In FIG. 33O, the valve delivery subsystem is advanced over the guide wire 99 through the septum into the left atrium. FIG. 33O shows the valve capsule 152 (including the valve prosthesis) and the nose cone 150 within the left atrium.

[0128]

[0168] Figure 33-10 shows how the valve delivery control device 3200 can be used in the operations shown in FIGS. 33N and 33O. First, the valve delivery subsystem may be delivered through the patient's vasculature over guide wire 99, although the valve delivery subsystem is not connected to the rail system. After the distal end of the valve delivery catheter has been advanced substantially into the inferior vena cava (IVC) (e.g., before entering the heart cavity / before crossing the septum), the valve delivery control device 3200 (which is coupled to the proximal end of the valve delivery subsystem) may be attached to the rail system 3020. Dial 3013 may be rotated to advance the valve capsule 152 and nose cone 150 into the left atrium, as shown in FIG. 33O.

[0129]

[0169] Figure 33P shows the valve capsule 152 and nose cone 150 being advanced through the loop, the nose cone 150 being positioned past the anchor 88, and the valve capsule 152 extending across / passing through the anchor 88. In FIG. 33Q, the valve capsule 152 is partially retracted from the nose cone 150 to allow for (partial) self-expansion or assembly of the ventricular portion of the valve prosthesis 154. In some embodiments, the ventricular portion of the valve 154 expands into the anchor 88.

[0130]

[0170] Figure 33-11 shows how the valve delivery control device 3200 can be used to advance the valve capsule 152 and partially release the valve prosthesis 154, as shown in FIGS. 33P and 33Q. The steer / flex shape control knob 3276 of the handle 3202 can be rotated to change the shape of the distal portion of the internally steerable catheter 2700, as shown in FIG. 33P. Also, the depth control knob 3274 of the handle 3202 can be rotated to advance the valve capsule 152 and nose cone 150 into the mitral valve annulus, as shown in FIG. 33P. The valve deployment knob 3272 can be rotated to retract the valve capsule 152 and partially release the valve prosthesis 154 into the left ventricle, as shown in FIG. 33Q.

[0131]

[0171] In other embodiments, referring to FIG. 33R, the valve delivery subsystem can be retracted or pulled toward the mitral annulus to capture the ventricular portion of the frame of valve 154 within anchor 88. In some embodiments, anchor 88 can be lifted or pulled toward the annulus with a partially deployed valve 154 by an operation (e.g., proximal retraction) via the valve delivery subsystem, as indicated by the arrow. As described above, embedding the valve and anchor at a high position in the anatomical structure helps to reduce or prevent LVOTO. When anchor 88 is lifted or pulled toward the annulus, the anterior leaflet can be captured and bundled within or against the annulus by anchor 88. The act of capturing the anterior leaflet and pulling or bundling the leaflet against the annulus moves tissue away from the LVOT, thereby reducing LVOTO.

[0132]

[0172] In FIG. 33S, valve capsule 152 is fully retracted from valve prosthesis 154, exposing the atrial portion of the valve frame structure and atrial collar 105, allowing for self-expansion of the atrial portion of valve prosthesis 154 within the left atrium. When the atrial portion is fully expanded, the mitral annulus is sealed with the wide and conformable atrial collar 105 of the valve frame, and the position of atrial collar 105 is firmly positioned at the waist of valve 154 and maintained and / or pressed downward by an anchor that captures the native tissue therebetween.

[0133]

[0173] FIG. 33-12 shows how valve delivery control device 3200 can be used to retract catheter 2700 and cause release of atrial collar 105 of valve 154, as shown in FIGS. 33R and 33S. Pulling valve 154 proximally, as shown in FIG. 33R, may be accomplished by rotating depth control knob 3274 and / or dial 3013. Valve deployment knob 3272 can be rotated to retract valve capsule 152 over valve 154 and release the remaining portion of valve 154 from valve capsule 152.

[0134]

[0174] In FIG. 33T, the valve delivery subsystem is removed, and the valve patch 154 remains embedded within the native mitral valve and anchor 88, thereby sealing the native mitral valve annulus.

[0135]

[0175] FIG. 33-13 shows how the valve delivery control device 3200 can be used to retract the catheter 2700 and the valve delivery subsystem from the native mitral valve, as shown in FIG. 33T. The depth control knob 3274 of the handle 3202 can be rotated to retract the catheter 2700, which includes the valve capsule 152, from the patient's heart and body. During the retraction process, the steering / flexure shape control knob 3276 of the handle 3202 may be rotated to straighten the distal portion of the catheter 2700 from a deflected state.

[0136]

[0176] FIGS. 33U and 33V show left atrial views of the valve frame patch 154 embedded within the mitral valve annulus with the valve leaflets closed (FIG. 33U) and open (FIG. 33V).

[0177] The valve delivery subsystem is a thin valve delivery system that can control the valve position until the end of the delivery procedure. The valve delivery subsystem has a true approximately 9.33 mm (28Fr: 28 French) delivery profile with steerability, is easy to use, and can easily position the valve frame at the target location. Using the valve delivery subsystem, a folded or compressed valve frame can be deployed within an already deployed anchor. 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 towards the left atrium 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 up by the valve delivery subsystem after the valve has been expanded within the anchor.

[0137]

[0178] The present disclosure provides details regarding a mitral valve replacement procedure and system with a wide tolerance range specifically designed for the anatomical structure of the mitral valve. The systems and methods disclosed herein provide an easy-to-use delivery system and delivery procedure for physicians with a small learning curve, an implant adaptable and applicable to all anatomical structures, and an implant that reliably eliminates mitral regurgitation (MR) without the risk of complications associated with other mitral valve replacement devices on the market, thereby solving unmet needs.

[0138]

[0179] When a feature or element is referred to herein as being “above” another feature or element, it can be directly on the other feature or element or intervening features and / or elements may be present. In contrast, when a feature or element is referred to as being “directly above” another feature or element, no intervening features or elements are present. Also, when a feature or element is referred to as being “connected,” “attached,” or “coupled” to another feature or element, it can be directly connected, attached, or coupled to the other feature or element or intervening features or elements may be present. In contrast, when a feature or element is referred to as being “directly connected,” “directly attached,” or “directly coupled” to another feature or element, no intervening features or elements are present. Features and elements described or shown with respect to one embodiment can be applied to other embodiments. Also, reference to a structure or feature disposed “adjacent” to another feature is understood by those skilled in the art to have a portion that overlaps or is under the adjacent feature.

[0139]

[0180] The terms used in this specification are for the purpose of describing particular embodiments and are not intended to limit the invention. For example, as used herein, the singular forms "a", "an", and "the" are intended to include the plural forms as well, unless the context clearly dictates otherwise. Further, as used in this specification, the terms "comprises" and / or "comprising" specify the presence of the described features, steps, operations, elements, and / or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and / or groups thereof. As used herein, the term "and / or" includes any and all combinations of one or more of the associated listed items and may be abbreviated as " / ".

[0140]

[0181] Spatially relative terms such as "under", "below", "lower", "above", "upper", etc. may be used herein for ease of explanation to describe the relationship of one element or feature to another as shown in the figures. It is understood that spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation shown in the figures. For example, if the device in the figures is inverted, an element described as "under" or "beneath" another element or feature will be oriented "above" the other element or feature. Thus, the exemplary term "under" can encompass both an orientation of "above" and "under". The device may be oriented in other ways (rotated 90 degrees or otherwise), and the spatially relative descriptors used herein are to be interpreted accordingly. Similarly, terms such as "upward", "downward", "vertical", "horizontal", etc. are used for explanatory purposes only, unless otherwise specifically indicated.

[0141]

[0182] The terms "first" and "second" may be used herein to describe various features / elements (including steps), but these features / elements should not be limited by these terms unless the context otherwise indicates. These terms may be used to distinguish one feature / element from another. Thus, the first feature / element discussed below could be called the second feature / element, and similarly, the second feature / element discussed below could be called the first feature / element without departing from the teachings of the present invention.

[0142]

[0183] Throughout this specification and the following claims, unless the context otherwise requires, the word "comprise", and variations such as "comprises" and "comprising", are to be interpreted as an open-ended inclusion, i.e. that a variety of components may be jointly employed in a method and article (e.g., a composition and apparatus including devices and methods). For example, the term "comprising" is understood to imply the inclusion of the stated elements or steps but not the exclusion of other elements or steps.

[0143]

[0184] As used in this specification and the claims, all numerical values, including when used in examples and unless otherwise expressly specified, may be read as if the term "about" or "approximately" preceded the numerical value, even if the term does not explicitly appear. The phrases "about" or "approximately" may be used when describing a magnitude and / or position to indicate that the described value and / or position is within a reasonable expectation range of the value and / or position. For example, a numerical value may have a value of + / -0.1% of the recited value (or range of values), + / -1% of the recited value (or range of values), + / -2% of the recited value (or range of values), + / -5% of the recited value (or range of values), + / -10% of the recited value (or range of values), etc. Any numerical value recited herein is to be understood as including a value about or approximately that value, unless the context dictates otherwise. For example, if the value "10" is disclosed, "about 10" is also disclosed. Any numerical range recited herein is intended to include all sub-ranges subsumed therein. Also, when a value is disclosed, it is to be understood that "less than" that value, "greater than or equal to" that value, and the possible ranges between values are also disclosed, as would be appropriately understood by one of ordinary skill in the art. For example, if the value "X" is disclosed, "less than X" as well as "greater than or equal to X" (e.g., X is a numerical value) are also disclosed. Also, throughout the application, data is provided in a plurality of different formats, and it is understood that this data represents endpoints and starting points for any combination of data points, as well as ranges. For example, if a particular data point "10" and a particular data point "15" are disclosed, it is understood that those greater than, greater than or equal to, less than, less than or equal to, and equal to 10 and 15 are considered to be disclosed in the same way as those between 10 and 15. It is also understood that each unit between two particular units is also disclosed. For example, if 10 and 15 are disclosed, 11, 12, 13, 14 are also disclosed.

[0144]

[0185] Although various exemplary embodiments have been described above, various changes may be made to the various embodiments without departing from the scope of the invention as set forth in the claims. For example, the order in which the various method steps are performed may often be changed in alternative embodiments, and in other alternative embodiments, one or more method steps may be completely omitted. Optional features of the various device and system embodiments may or may not be included in some embodiments. Accordingly, the foregoing description has been provided primarily for illustrative purposes and should not be construed as limiting the scope of the invention as set forth in the claims.

[0145]

[0186] The examples and figures included herein are for illustration and not limitation, showing specific embodiments in which the subject matter may be practiced. As noted above, other embodiments may be utilized and derived from those, without departing from the scope of the disclosure, so that structural and logical substitutions and changes may be made. Such embodiments of the subject matter of the present invention, when more than one is actually disclosed herein, may be referred to herein, individually or collectively, by the term "invention" merely for convenience and without any intention of voluntarily limiting the scope of this application to any single invention or inventive concept. Accordingly, while specific embodiments have been illustrated and described herein, any arrangement calculated to achieve the same purpose may be substituted for the specific embodiments shown. This disclosure is intended to cover any adaptations or variations of the various embodiments. Combinations of the above embodiments and other embodiments not specifically described herein will be apparent to those skilled in the art upon review of the above description.

Claims

1. An artificial heart valve delivery system, wherein the artificial heart valve comprises an anchor adapted to be positioned in a ventricle adjacent to the patient's natural valve, and a frame supporting valve leaflets adapted to expand within the anchor, and the delivery system is The anchor control catheter is fitted to advance into the atrium of the patient's heart, and the anchor control catheter is A lumen extending from the proximal end to the distal end of the anchor control catheter, the lumen being sized and configured to slidably accommodate the anchor, The distal guide arm portion of the anchor control catheter, wherein at least a portion of the distal guide arm portion has a vortex shape when at rest, A delivery system comprising: a proximal control device at the proximal end of the anchor control catheter, the proximal control device configured to change the shape of the distal guide arm;

2. The delivery system according to claim 1, wherein the distal guide arm has a proximal portion and a distal portion, and the proximal portion includes a portion of the distal guide arm having a helical or spiral shape when at rest.

3. The delivery system according to claim 2, wherein the proximal control device comprises an actuator operably connected to the anchor in the lumen of the anchor control catheter to move the anchor distally and proximal within the lumen in order to change the shape of the distal portion of the distal guide arm.

4. The delivery system according to claim 3, wherein the actuator is connected to a mooring portion that is detachably connected to the anchor.

5. The delivery system according to claim 2, wherein the proximal control device includes 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.

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

7. The delivery system according to claim 2, wherein the proximal control device includes an actuator operably connected to the 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 guide arm is sized and configured to move in a spiral or vortex shape within the atrium of the patient's heart.

9. The delivery system according to claim 8, wherein the proximal control device is further configured to extend the distal guide arm from the atrium through the valve leaflet into the ventricle, with the anchor disposed within the lumen.

10. The delivery system according to claim 9, wherein the proximal control device is further configured to move the distal end of the distal guide arm within the ventricle in order to surround the chordae tendineae of the heart with the distal guide arm.

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

12. An artificial heart valve delivery system, wherein the artificial heart valve comprises an anchor adapted to be positioned in a ventricle adjacent to the patient's natural valve, and a frame supporting the valve leaflets adapted to expand within the anchor, and the delivery system is A valve capsule, wherein the valve frame is arranged inside in a compressed configuration, A capsule axial catheter connected to the valve capsule and extending proximal to the valve capsule, A valve retainer that is detachably connected to the valve frame, A delivery system comprising: a proximal control device located at the proximal end of the capsule axial catheter, configured to detach the capsule from the valve frame, thereby allowing the valve frame to expand.

13. The delivery system according to claim 12, further comprising: an internally steerable catheter disposed within the lumen of the capsule axial catheter; and an internal catheter steering control line extending from the distal portion of the internally steerable catheter to the proximal control device, wherein the proximal control device is further configured to apply and release tension to the internal catheter steering control line.

14. The delivery system according to claim 13, further comprising an externally steerable catheter and an external catheter control line extending from the distal portion of the externally steerable catheter to the proximal control device, wherein the proximal control device is further configured to apply and release tension to the external catheter control line, and the capsule axis catheter is disposed in the lumen of the externally steerable catheter.

15. The delivery system according to claim 13, wherein the capsule axial catheter comprises a plurality of axial sections having different rigidities, thereby deflecting to different degrees when actuated.

16. The delivery system according to claim 15, wherein when the capsule axial catheter is in a deflected state, the capsule axial catheter includes a first bend and a second bend.

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

18. A trajectory system adapted to control the movement of a catheter system for delivering at least a portion of an artificial heart valve into a patient's heart, wherein the catheter system includes a first catheter arranged coaxially with a second catheter, and the trajectory system is The primary and secondary orbits are positioned parallel to each other, A first carriage to which the proximal portion of the first catheter is fixed and adapted to translate along the primary trajectory, wherein the first carriage is coupled to the secondary trajectory such that the secondary trajectory translates together with the first carriage when the first carriage translates along the primary trajectory. A trajectory system comprising: a second carriage to which the proximal portion of the second catheter is fixed and fitted to translate along the primary trajectory, the second carriage including a coupling, the coupling being fitted to selectively engage the second carriage with the secondary trajectory such that when the coupling is engaged, the second carriage translates together with the first carriage as the first carriage translates along the primary trajectory.

19. The first carriage is, A first closed state in which the proximal portion of the first catheter is frictionally fixed to the first carriage, and the first catheter is maintained in the intended rotational position but is rotatable relative to the first carriage, The proximal portion of the first catheter is completely fixed to the first carriage and not rotatable in a second closed state, The track system according to claim 18, comprising a fastener configured to transition between two positions.

20. The orbital system according to claim 18, further comprising a third carriage to which the proximal portion of a third catheter is fixed and adapted to translate along the primary orbital, wherein the third carriage includes a second coupling, the second coupling being adapted to selectively engage the third carriage with the secondary orbital such that, when the second coupling is engaged, the third carriage translates together with the first carriage as the first carriage translates along the primary orbital.

21. The orbital system according to claim 18, wherein the first carriage includes a first fastener configured to removably secure the proximal portion of the first catheter, and the second carriage includes a second fastener configured to removably secure the proximal portion of the second catheter, and each of the first and second fasteners is configured to removably secure the proximal portions of different catheters.

22. The orbital system according to claim 18, wherein the coupling is adapted to disengage the second carriage from the secondary orbital such that when the coupling is disengaged, the second carriage translates independently from the first carriage.

23. The orbital system according to claim 22, wherein the coupling is disengaged in the default state.

24. The track system according to claim 18, further comprising rails that support the primary and secondary tracks in parallel.

25. The track system according to claim 18, wherein the first carriage includes a first gear assembly adapted to translate the first carriage along the primary track, and the second carriage includes a second gear assembly adapted to translate the second carriage along the primary track.

26. The orbital system according to claim 18, wherein the first catheter is slidably positioned within the second catheter.

27. The orbital system according to claim 18, wherein the second catheter is slidably positioned within the first catheter.

28. The orbital system according to claim 18, wherein the second carriage includes a button adapted for engaging and disengaging the coupling.

29. The track system according to claim 18, wherein each of the first and second carriages includes a gear assembly configured to engage with the teeth of the primary track when each of the first or second carriages translates along the primary track.

30. The trajectory system according to claim 18, wherein each of the first and second carriages includes a dial, the dial being configured to translate each of the first or second carriages along the primary trajectory when the dial is rotated.

31. The orbital system according to claim 18, wherein each of the first and second carriages is provided with a lock for locking the translational position of the first or second catheter with respect to the primary orbit.

32. A delivery system for delivering an artificial heart valve anchor into a patient's heart, 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, and the distal portion of the anchor control catheter includes a guide arm having a distal end; The system comprises a control device coupled to the proximal portion of the anchor control catheter, and the control device is A first control unit is configured to apply a preload force to the guide arm while it is inside the steerable catheter, such that the guide arm self-assembles into a spiral or helical shape when it is advanced from the steerable catheter. A delivery system comprising: a second control unit configured to move the anchor within the guide arm in order to apply a force to the guide arm that changes the distance the distal end of the guide arm extends radially.

33. The delivery system according to claim 32, wherein the control device further comprises a third control unit configured to control the axial height of the guide arm with respect to the steerable catheter.

34. The delivery system according to claim 33, wherein the third control unit is part of a carriage detachably coupled to the proximal portion of the anchor control catheter, and the third control unit is configured to translate the proximal portion of the anchor control catheter on a rail relative to the proximal portion of the steerable catheter.

35. A system for controlling the movement of a catheter for delivering at least a portion of an artificial heart valve into a patient's heart, wherein the system is A handle connected to the proximal portion of the catheter, comprising a control unit configured to control the deflection of the distal portion of the catheter, A carriage comprising a fastener configured to secure the handle to a support, wherein the fastener includes a band configured to surround the handle for securing the handle to a cradle, and the fastener is The band is in an open position so that the handle can be removed from the cradle, The band loosely surrounds the handle, and the handle is frictionally fixed to the cradle in its intended rotational position, but is rotatable relative to the carriage in a first closed state. A system in which the band is configured to transition between a second closed state in which the band fixedly surrounds the handle so that the handle is rotatably fixed to the carriage.

36. The system according to claim 35, wherein the support includes a trajectory system configured to allow translation of the carriage with the handle locked, in order to allow axial movement of the distal portion of the catheter.

37. The handle is a first handle coupled to a first catheter, the carriage is a first carriage, and the system further comprises: A second handle is coupled to the proximal portion of a second catheter which is coaxially aligned with the first catheter, The system further comprises a second carriage configured to fix the second handle to the track system, The system according to claim 36, wherein the first and second carriages are configured to translate independently along the trajectory system to produce independent axial movement of the distal portions of the first and second catheters.

38. The system according to claim 37, wherein the orbital system is configured to selectively allow the first and second carriages to perform coupled translation along the orbital system in order to produce coupled axial movement of the distal portions of the first and second catheters.

39. The system according to claim 35, wherein the cradle includes one or more engaging elements configured to frictionally engage with corresponding elements of the handle in order to maintain the handle in the intended rotational position.

40. A delivery system adapted to deliver an artificial heart valve anchor into the patient's heart, An anchor control catheter having a distal guide arm configured to take a spiral or helical shape, wherein the anchor is slidably positioned within the anchor control catheter, The anchor control catheter comprises a handle connected to the proximal portion, and the handle is A first control unit configured to bias the distal guide arm toward the spiral shape or the helical shape, A delivery system comprising: a second control unit configured to move the anchor axially within the anchor control catheter in order to change the extent to which the distal end of the distal guide arm extends radially.

41. The delivery system according to claim 40, wherein the second control unit is configured to extend the distal end of the distal guide arm radially to capture the chordae tendineae of the patient's heart, so that the distal guide arm can surround the chordae tendineae.

42. The delivery system according to claim 40, further comprising a steerable catheter in which the anchor control catheter is slidably positioned, wherein the first control unit is configured to bias the distal guide arm toward the spiral or helical shape while the distal guide arm is inside the steerable catheter.

43. The delivery system according to claim 42, further comprising a second handle coupled to the steerable catheter, the second handle including a deflection control unit configured to selectively deflect the distal portion of the steerable catheter in order to steer the distal guide arm within the patient's heart.

44. The delivery system according to claim 42, further comprising a second handle coupled to the steerable catheter, wherein the second handle is translationally translatable relative to the first handle so as to retract the distal portion of the steerable catheter axially relative to the distal guide arm so that the distal guide arm can be detached from the steerable catheter and take the spiral or helical shape.

45. The delivery system according to claim 44, further comprising a rail system, the rail system including a first carriage configured to secure the first handle to the rail system, and a second carriage configured to secure the second handle to the rail system, wherein the first and second carriages are translatable along a track.

46. A delivery system adapted to deliver an artificial heart valve into a patient's heart, A steerable catheter having a distal valve capsule configured to hold the frame of the artificial valve internally, The steerable catheter comprises a handle connected to the proximal portion of the steerable catheter, and the handle is A valve deployment knob configured to control the retraction of the distal valve capsule relative to the frame in order to remove at least a portion of the frame from the steerable catheter, A depth control knob configured to control the axial movement of the distal portion of the steerable catheter, A delivery system comprising: a deflection knob configured to control the deflection of the distal portion of the steerable catheter.

47. The delivery system according to claim 46, wherein the handle is translatably coupled to an orbital system, and the orbital system includes a translational control unit configured to translate the handle in order to control the overall axial movement of the distal portion of the steerable catheter.

48. The delivery system according to claim 46, wherein the steerable catheter comprises a plurality of axial sections having different degrees of flexibility, and the deflection of the steerable catheter causes the distal portion of the steerable catheter to have a first bend and a second bend separated by the reaching section of the steerable catheter.

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