Methods and apparatus for mitral chordal repair

Abstract

The present invention relates to a method and device for transvascular artificial chordae implantation. A catheter is advanced toward the left atrium. From the atrial side, the catheter can be anchored to the upper surface of the mitral valve leaflet, and leaflet anchors can be advanced into the mitral valve leaflet to secure the mitral valve leaflet to the leaflet sutures. A ventricular anchor is secured to the ventricular wall to secure the ventricular wall to the ventricular sutures. The leaflet sutures and ventricular sutures are tensioned and connected by suture locks to form the artificial chordae.

Description

Technical Field

[0001] This application claims the benefit of priority of U.S. Provisional Application No. 63 / 040,389, filed on Jun. 17, 2020. The entire contents of which are hereby incorporated by reference into this application.

[0002] All applications identified in the PCT Request as having foreign or domestic priority claims filed with this application are hereby incorporated by reference.

Background Art

[0003] The present disclosure relates to the repair or replacement of the mitral valve, and more particularly, to methods and devices for reshaping, repairing and / or replacing the mitral valve chordae tendineae to appropriately repair the function of the mitral valve from mitral regurgitation.

[0004] The heart has four heart valves that allow blood to pass through the four ventricles of the heart in one direction. The four valves are the tricuspid valve, the mitral valve, the pulmonary valve, and the aortic valve. The four chambers are the left atrium and the right atrium (upper chambers) and the right ventricle and the left ventricle (lower chambers).

[0005] The mitral valve is formed from two valve leaflets called the anterior leaflet and the posterior leaflet. These leaflets open and close in response to the pressure applied to the leaflets by the contraction of the heart. Several problems can occur with the mitral valve. One of the problems is mitral regurgitation (MR). Mitral regurgitation has the symptom that the mitral valve leaflets do not close properly, and for this reason, leakage from the mitral valve may occur. Severe mitral regurgitation can have an adverse effect on cardiac function and may reduce the quality of life and life expectancy of the patient.

[0006] Techniques for treating mitral regurgitation have been developed. These techniques include heart transplantation, valve replacement or repair, shortening or replacement of the chordae tendineae, and repair of the mitral valve annulus, also known as valvuloplasty. The above techniques are selected according to the stage and etiology.

Summary of the Invention

Problems to be Solved by the Invention

[0007] Because it relates to the replacement or repair of chordae tendineae, certain surgical approaches and a transapical approach have been proposed. However, despite such proposals, and without being particularly limited, a transvascular approach for the replacement or repair of chordae tendineae is still needed to reduce or eliminate MR.

Means for Solving the Problems

[0008] A method and apparatus for transvascular artificial chordae transplantation are disclosed. The catheter advances toward the left atrium. From the atrial side, the catheter is fixed to the upper surface of the mitral valve, and the mitral valve anchor can advance into the mitral valve and fix the mitral valve to the valve suture thread. The ventricular anchor is fixed to the ventricular wall and fixes the ventricular wall to the ventricular suture thread. The leaflet suture thread and the ventricular suture thread may be tensioned and connected by a suture lock to form an artificial chordae.

[0009] According to one aspect (Example 1) of the present disclosure, the tissue anchor includes a hub, a suture portion extending proximally from the hub, a helical anchor extending distally from the hub, and a second anchor that is axially movable distally from a first configuration to a deployed second configuration so as to engage with the tissue and prevent the helical anchor from coming off.

[0010] According to another aspect (Example 2) of the present disclosure related to Example 1, the second anchor has a branch portion extending between a proximal end portion and a pointed distal end portion. end portion.

[0011] According to another aspect (Example 3) of the present disclosure related to Example 2, the branch portion is supported by a support portion.

[0012] According to another aspect (Example 4) of the present disclosure related to Example 3, the support portion has an annular structure.

[0013] According to another aspect of the present disclosure according to Example 1 or 4 (Example 5), the support portion receives a tubular structure of a deployment system for advancing the support portion distally relative to the helical anchor.

[0014] According to another aspect of the present disclosure according to Example 2 (Example 6), the hub has an axially movable branch guide for receiving the branches.

[0015] According to another aspect of the present disclosure according to Example 6 (Example 7), the branch guide has a deflection surface for deflecting the branches at a launch angle inclined radially outward in the distal direction.

[0016] According to another aspect of the present disclosure according to Example 7 (Example 8), the launch angle ranges from about 30° to 45°.

[0017] According to another aspect of the present disclosure according to Example 1 (Example 9), the hub has an axially movable opening for receiving the second anchor.

[0018] According to another aspect of the present disclosure according to any of Examples 1 to 9 (Example 10), it further comprises a core wire attached to the hub and extending concentrically through the helical anchor.

[0019] According to another aspect of the present disclosure according to any of Examples 1 to 10 (Example 11), it further comprises a suture anchor guide extending proximally from the hub.

[0020] According to another aspect of the present disclosure according to Example 11 (Example 12), in the deployed second configuration, the second anchor extends through the suture anchor guide.

[0021] According to another aspect of the present disclosure according to Example 12 (Example 13), the second anchor extends through an opening in the suture anchor guide.

[0022] According to another aspect of the present disclosure according to Example 13 (Example 14), when the second anchor moves to the deployed second configuration, the second anchor is operable to penetrate the suture anchor guide.

[0023] According to another aspect of the present disclosure according to Example 1 (Example 15), it further includes a radiopaque marker supported by a second anchor.

[0024] According to another aspect of the present disclosure according to any of Examples 1 to 15 (Example 16), it further includes a core wire attached to the hub and extending concentrically through the helical anchor.

[0025] According to another aspect of the present disclosure according to Example 16 (Example 17), it further includes a radiopaque marker movably supported axially by the core wire.

[0026] According to another aspect of the present disclosure according to Example 16 (Example 18), it further includes a spring supported by the core wire.

[0027] According to another aspect of the present disclosure according to Example 16 (Example 19), the core wire extends distally beyond the helical anchor. beyond and extends distally.

[0028] According to another aspect of the present disclosure according to Example 16 (Example 20), it further includes a distal stopper provided on the core wire and operable to limit the distal movement of the radiopaque marker.

[0029] According to another aspect of the present disclosure according to Example 1 (Example 21), it further includes a tissue penetration point at the distal end of the helical anchor and a folded-back portion provided on the helical anchor, located proximal to the point and configured to resist the rotation of the helical anchor disengaging from engagement with the tissue.

[0030] According to another aspect of the present disclosure according to any of Examples 1 to 21 (Example 22), the second anchor is operable to increase the anchor torque resistance of the tissue anchor by 2 to 5 times compared to the anchor torque resistance of the tissue without the second anchor.

[0031] According to another aspect of the present disclosure according to any of Examples 1 to 21 (Example 23), the anchor torque resistance of the helical anchor having the second anchor is 2 N / cm to 5N / cm It is as follows.

[0032] According to another aspect of the present disclosure (Example 24) according to any one of Examples 1 to 21, the second anchor is operable to increase the anchor torque resistance of the tissue anchor by at least twice as compared to the anchor torque resistance of the anchor of the tissue without the second anchor.

[0033] According to another aspect of the present disclosure (Example 25) according to any one of Examples 1 to 21, the anchor torque resistance of the helical anchor is greater than 2 N / cm.

[0034] According to one aspect of the present disclosure (Example 26), a method of implanting a transvascular artificial chordae tendineae includes advancing a catheter into the left atrium and through the mitral valve into the left ventricle; deploying a ventricular anchor from the catheter to the wall of the left ventricle by rotating a helical tissue anchor to the wall of the left ventricle; deploying a second tissue anchor to the wall of the left ventricle to prevent the helical tissue anchor from detaching; maintaining a ventricular suture while attached to the ventricular anchor and extending proximally through the catheter; fixing a leaflet anchor catheter from the atrial side to the mitral valve leaflet; advancing a leaflet anchor from the catheter through the mitral valve leaflet to fix the mitral valve leaflet to a leaflet suture while the leaflet anchor catheter is fixed to the leaflet, wherein the leaflet suture extends proximally through the catheter; and fixing the leaflet suture to the ventricular suture to limit the range of movement of the leaflet in the direction of the left atrium.

[0035] According to another aspect of the present disclosure (Example 27) according to Example 26, the step of deploying the second tissue anchor includes axially advancing the second tissue anchor distally with respect to the helical tissue anchor.

[0036] According to another aspect of the present disclosure (Example 28) according to Example 26, the step of deploying the second tissue anchor increases the anchor torque resistance of the ventricular anchor by 2 to 5 times as compared to the anchor torque resistance of the ventricular anchor without the second anchor.

[0037] According to another aspect of the present disclosure (Example 29) according to Example 26, the anchor torque resistance of the tissue anchor and the second tissue anchor is between 2 N / cm and 5 N / cm.

[0038] According to another aspect of the present disclosure (Example 30) according to Example 26, the second tissue anchor increases the anchor torque resistance of the ventricular anchor by at least two times compared to the anchor torque resistance of the ventricular anchor without the second anchor.

[0039] According to another aspect of the present disclosure (Example 31) according to Example 26, the anchor torque resistance between the second tissue anchor and the ventricular anchor is greater than at least 2 N / cm.

[0040] According to one aspect of the present disclosure (Example 32), an access system for directing a ventricular anchor sheath to a target site in the left ventricle includes a delivery catheter having an elongated flexible tubular body with a proximal end, a distal end, a central axis, and a steering zone near the distal end, the steering zone being actively deflectable to provide a delivery catheter curve within the delivery catheter curve plane, a delivery catheter, and an anchor sheath axially advanceable through the delivery catheter, the anchor sheath having a proximal preset curve and a distal preset curve existing within a proximal preset curve plane, the anchor sheath being configured to rotate within the delivery catheter and bias to align the proximal preset curve plane with the delivery catheter curve plane in response to axial alignment of the proximal preset curve within the delivery catheter curve.

[0041] According to another aspect of the present disclosure (Example 33) according to Example 32, the distal preset curve exists in a distal preset curve plane that is angled from the proximal preset curve plane.

[0042] According to another aspect of the present disclosure (Example 34) according to Example 32 or 33, the delivery catheter curve is actively adjustable over an entire range of at least 10 to 150°.

[0043] According to one aspect of the present disclosure (Example 35), an access system for directing a ventricular anchoring sheath to a target site in the left ventricle includes a delivery catheter having an elongated flexible tubular body with a proximal end, a distal end, and a steering zone near the distal end, the steering zone being actively deflectable to provide a delivery catheter curve that lies within the delivery catheter curve plane, a delivery catheter, and an anchoring sheath that is axially advanceable through the delivery catheter, the anchoring sheath having a proximal preset curve and a distal preset curve that lie within a proximal preset curve plane, and the proximal preset curve and the delivery catheter curve are configured to cooperate to provide a tactile indication of the rotational alignment of the anchoring sheath within the delivery catheter.

[0044] According to one aspect of the present disclosure (Example 36), a ventricular anchor delivery sheath includes an elongated flexible tubular body having a proximal end, a distal end, and a longitudinal axis, a proximal preset curve of the tubular body, and a distal preset curve of the tubular body.

[0045] According to another aspect of the present disclosure (Example 37) related to Example 36, the proximal preset curve lies in a first plane, the distal preset curve lies in a second plane, and the second plane is rotationally angled from the first plane.

[0046] According to another aspect of the present disclosure (Example 38) related to Example 37, the second plane is rotationally angled from the first plane by an angle within the range of 40° to 75°.

[0047] According to another aspect of the present disclosure (Example 39) related to Example 37 or 38, the distal preset curve has an angle within the range of 5° to 60° in the first plane.

[0048] According to another aspect of the present disclosure (Example 40) related to any of Examples 36 - 39, the length of the distal preset curve is 50% or less of the length of the proximal preset curve.

[0049] According to another aspect (Example 41) of the present disclosure according to Examples 36 to 39, the length of the distal preset curve is 20% or less of the length of the proximal preset curve.

[0050] According to another aspect (Example 42) of the present disclosure according to Examples 36 to 41, the distance between the longitudinal center of the proximal preset curve and the longitudinal center of the distal preset curve has a range between 45 and 85 millimeters.

[0051] According to another aspect (Example 43) of the present disclosure according to Examples 36 to 41, the longitudinal center of the distal preset curve is within a range of 50 to 70 millimeters from the distal end of the ventricular anchor delivery sheath.

[0052] According to another aspect (Example 44) of the present disclosure according to Examples 36 to 41, the longitudinal center of the proximal preset curve is within a range of 100 to 145 millimeters from the distal end of the ventricular anchor delivery sheath.

[0053] According to another aspect (Example 45) of the present disclosure according to Examples 36 to 44, it further includes a distal anchor section having a foldable sidewall.

[0054] According to one aspect (Example 46) of the present disclosure, the ventricular anchor delivery sheath includes an elongated flexible tubular body having a proximal end, a distal end, and a longitudinal axis, and a distal preset curve of the tubular body.

[0055] According to another aspect (Example 47) of the present disclosure according to Example 46, the longitudinal center of the distal preset curve is within a range of 50 to 70 millimeters from the distal end of the ventricular anchor delivery sheath.

[0056] The foregoing and other features of the present disclosure will become more fully apparent from the following description and the appended claims in conjunction with the accompanying drawings. It should be understood that these drawings illustrate only some embodiments according to the present disclosure and should not be regarded as limiting the scope.

Brief Description of the Drawings

[0057]

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DETAILED DESCRIPTION OF THE INVENTION

[0058] U.S. Patent Application No. 15 / 858,671, filed on December 29, 2017 (incorporated herein by reference in its entirety), discloses a method and system for implanting a transvascular artificial chordae tendineae. One aspect includes advancing a catheter through the mitral valve into the left atrium and left ventricle, deploying a ventricular anchor from the catheter onto the wall of the left ventricle, attaching the ventricular anchor and maintaining the ventricular suture while extending proximally through the catheter, advancing a leaflet anchor to the mitral valve leaflet to fix the mitral valve leaflet to the leaflet suture, wherein the leaflet suture extends proximally through the catheter, extending the leaflet suture above the junction edge and fixing the leaflet suture to the ventricular suture to limit the movement range of the leaflet in the direction of the left atrium. Specific aspects are further described herein.

[0059] The approach to the mitral valve is achieved by a standard transseptal approach to provide access to the left atrium. In this access, the first step includes fixing a leaflet capture catheter to the leaflet of the mitral valve at a position determined to optimally correct the regurgitation. It is advantageous because by examining the surface of the leaflet from the surface of the superior vena cava, immediate feedback regarding the optimal position for adding additional mitral valve chordae tendineae can be provided. In other embodiments of the present disclosure, first the ventricular anchor is deployed and then the leaflet anchor is deployed.

[0060] Referring to FIG. 1, ventricular anchors such as helical anchor 32 are deployed in the vicinity of the tip 20 of the left ventricle 24. The helical anchor 32 is shown positioned in the vicinity of the tip 20, but the anchor 32 may be attached at a point offset from the thin tissue of the tip and may be embedded in a thicker adjacent wall portion of the ventricle, such as between two papillary muscles. This allows the implanted neo chordae construct (suture, optional neo papillary muscle and / or helical anchor) to be aligned along a longitudinal axis that is substantially parallel or concentric with the original path of the native chordae. In certain embodiments, the implanted neo chordae construct is aligned along a longitudinal axis that is within 5°, 10° or 15° of a position parallel to the original path of the native chordae and / or the original path of an adjacent native chordae. Further, while a helical anchor is shown, the anchor may have a different structure for engagement with the tissue of the heart and, instead of a helical structure, may use other tissue anchor structures including various spike structures, hook structures or radially expandable structures that are well known with respect to tissue engagement.

[0061] Referring to FIGS. 2A and 2B, a tissue anchor suitable for use as a ventricular anchor according to one aspect of the present disclosure is shown. The anchor assembly 50 will be described primarily with respect to current chordae repair applications. However, the anchor can be used in many other applications where a soft tissue or bone anchor is desired.

[0062] The anchor assembly 50 generally has a coil 54. The coil is made of various materials such as stainless steel or nitinol. The coil 54 extends helically between a proximal end 56 and a distal end 58. The distal end 58 has a sharp tip or tissue penetration point 59 and also has a fold-back (barb) 61 configured to resist reverse rotation of the coil and separation from the tissue. The proximal end 56 of the coil 54 is carried (attached to or formed by) a hub 57, which will be described in more detail below.

[0063] The elongated core wire 62 extends distally from the hub 57 in the coil 54. The core wire 62 has a sharp distal end 64 that penetrates tissue. The distal end 64 is located distal to the distal end 58 of the coil 54. Thereby, the sharp distal end 64 can penetrate the tissue upon contact and embed the coil within the target tissue before the rotation of the coil 54 is initiated. By engaging the end 64 prior to rotation of the anchor, the anchor is stabilized against lateral movement, enabling a single placement of the anchor 50 against the tissue and rotation of the coil 54, and engaging the tissue without moving the anchor away from the desired target site, as will be understood by those skilled in the art. The proximal end of the core wire 62 may be attached to the hub by various methods such as soldering, brazing, adhesives, and / or insertion into an opening in the outer surface or side wall of the hub 57, such as mechanical interference.

[0064] The radiopaque depth marker 66 has an opening 68 and is carried axially movably on the core wire 62. A distal stopper 70, such as a radially outwardly extending projection or an annular ridge, is provided on the core wire 62 and is spaced proximally of the sharp distal end 64 so as to provide a core wire tip segment 72 on the distal side of the stopper 70. Thereby, the marker 66 does not interfere with the tissue anchoring function of the distal tip 64. The stopper 70 functions to limit the distal movement of the marker 66. The marker 66 may have a disc-shaped annular structure with a central opening to receive the core wire 62.

[0065] The coil spring 71 is provided concentrically with the core wire 62 and biases the radiopaque marker 66 distally. Accordingly, the radiopaque marker 66 is held in a position opposing the proximal face of the stopper 70. During use, the marker 66 is at the target attachment site, the tissue It contacts the surface of the fabric. As the helical coil anchor 54 rotates and advances distally into the tissue, the marker 66 moves proximally on the core wire 62 with the tissue surface and compresses the coil spring 71 until it retreats proximally towards the marker 66 hub when the tissue anchor is fully embedded. By observing the changing distance between the marker 66 and a reference object such as the hub 57 or other radiopaque markers, it becomes possible to visually observe in perspective the advancement of the coil into the tissue and the fully engaged end point of the embedded portion of the coil 54 with respect to the target tissue.

[0066] The hub 57 has a proximal connector for engagement with a rotary driver as described elsewhere in this specification. In one embodiment, the connector has an opening such as a hexagonal opening for removably engaging a complementary surface structure at the distal end of the driver. The suture (suture thread) 74 is fixed to the anchor assembly 50, for example, to the hub 57, the coil 54 or the core wire 62. In the illustrated embodiment, the suture 74 is attached to a cross pin 76. The cross pin 76 is inserted into one or more openings in the side wall of the hub so as to cross the central hub passage. The suture may further have one or more radiopaque markers 82 spaced apart from the hub 57 or may extend proximally through the central passages of the proximal connector and the rotary driver.

[0067] Suture locking guides, such as the tubular sleeve 78, extend proximally from the hub 57 for at least about 2 mm or 4 mm or 8 mm, but are generally about 5 cm or less, or 2 cm or less, depending on the desired performance. In certain exemplary embodiments, suture locking guides, such as the tubular sleeve 78, extend proximally from the hub 57 for at least 2 mm or 4 mm or 8 mm, but are generally about 5 cm or less, or 2 cm or less, depending on the desired performance. The guide sleeve 78 may comprise (or be formed of) a flexible material such as ePTFE. The radiopaque marker band 80 is provided at the proximal end of the sleeve 78 and may be axially spaced from the marker 82 at the suture 74, facilitating the fluoroscopic visualization of suture locking as it advances distally across the suture 74. The marker band may be placed on the sleeve and the sleeve inverted to enclose the ring, such that the marker band 80 is disposed between the inner and outer layers of the ePTFE sleeve.

[0068] The suture locking guide extends proximally from the illustrated sleeve or hub and may have various structures, such as alignment pins, received in the internal passageway at the suture lock to maintain the orientation of the suture lock after removal from the deployment catheter. Since the tension on the suture is optimized while the suture lock is held in place by the deployment catheter, a change in the orientation of the suture lock after release from the catheter may affect the tension of the valve leaflet and adversely affect the therapeutic value of the implant. The suture locking guide functions to keep the maximum distance between the ventricular anchor and the valve leaflet anchor constant both before and after deployment from the catheter. In this way, the maximum tension on the valve leaflet suture (during systole) remains unchanged after the suture lock is locked, both before and after removal of the catheter.

[0069] The helical anchor assembly 50 is delivered by the ventricular anchor delivery subsystem 300. FIGS. 2C-2E are diagrams showing the ventricular anchor delivery subsystem 300 and its components. FIG. 2C is a perspective view of the distal end of the subsystem 300. FIG. 2D is a perspective view of the proximal end of the subsystem 300. FIG. 2E is a partial deployment view of the distal end of the subsystem 300.

[0070] The subsystem 300 may be delivered through the delivery catheter 100. The delivery catheter 100 can access the left atrium by conventional techniques such as atrial trans-septal puncture. When various subsystems are disposed on and removed from the delivery catheter 100, the delivery catheter 100 can be maintained in a substantially fixed position throughout the procedure. For example, the distal end of the delivery catheter 100 may be disposed in the left atrium. In other examples, the distal end of the delivery catheter 100 may be disposed in the left atrium throughout the procedure. As shown in FIGS. 2C-2E, the ventricular anchor delivery subsystem 300 includes an outer sheath 304, a driver (including a shaft 307 and a head 306), an anchor hub 308, and an anchor 302. The anchor is a helical anchor 302, and the driver head 306 is configured to rotate the helical anchor 302. The helical anchor 302 may have an inner diameter configured to be disposed across the outer diameter of the anchor hub 308. The helical anchor 302 may be firmly fixed to the anchor hub 308 by interference fit, other frictional engagement, soldering, or other well-known attachment techniques. The anchor hub 308 may remain embedded with the helical anchor 302.

[0071]

[0072] ​​The anchor hub 308 may have an internal passage (lumen) provided substantially along the central axis of the anchor hub 308 for receiving the suture 74 (FIG. 2A) and attaching the suture 74 to the helical anchor 302. In some embodiments, the suture 74 may have an attachment element (e.g., a knot, a tie, or a washer) having a diameter sized to prevent the suture 74 from being pulled proximally through the internal passage of the anchor hub 308. For example, the suture 74 may be tied distally of the internal passage. In some embodiments, the suture 74 may be coupled to the anchor hub 308 (e.g., wound around a structure such as an outer surface or around a cross pin 76 as shown in FIG. 2B through the internal passage and may be self-coupled).

[0073] The helical anchor 302 may include a distal section of the winding and a proximal section of the winding. The proximal section of the winding may have a smaller separation distance from each other than the distal section of the winding and may be configured to secure the helical anchor 302 to the anchor hub 308. The distal section of the winding may be further separated from the proximal section of the winding or may be configured to be inserted into ventricular tissue. The anchor hub 308 may have an enlarged cross-section at the proximal end configured to abut the helical anchor 302 and / or prevent the helical anchor 302 from advancing proximally beyond the proximal end of the anchor hub 308. Other helical anchors as described elsewhere in this specification may be configured to be used with the ventricular anchor delivery subsystem 300 described in this specification.

[0074] The proximal surface of the helical anchor 308 may have a recess for receiving the extending portion 306' of the driver head 306. The recess may be non-circular (e.g., polygonal such as rectangular or hexagonal) so as to be configured to transmit torque from the driver to the anchor hub 308 during rotation of the driver. The recess may be disposed around the central internal passage of the anchor hub 308.

[0075] In other embodiments, the anchor hub 308 may have an extension portion, and the driver 306 may have complementary recesses. The driver head 306 may be cylindrical with an opening or a strut facing distally having a complementary structure for rotatably engaging a corresponding component on the anchor. The driver head 306 may be fixedly coupled to the drive shaft 307. The driver may have a central internal passage through the drive shaft 307 and the driver head 306 configured to receive the suture 74. The central internal passage of the driver may be configured to align with the central internal passage of the anchor hub 308. The drive shaft 307 may be received within the guide shaft 305. The diameter of the driver head 306 is larger than the inner diameter of the guide shaft 305. The outer sheath 304 may be sized to receive the guide shaft 305, the driver head 306, the anchor hub 308, and the helical anchor 302.

[0076] The outer sheath 304 is sent to the left ventricle via the delivery catheter 100 and delivered proximal to the ventricular attachment site. In some embodiments, the outer sheath 304 may be sent without a delivery catheter. In some implementations, the helical anchor 302 may be hidden within the outer sheath 304 until the outer sheath 304 is positioned at the ventricular attachment site and pushed distally through the outer sheath 304, or until the outer sheath 304 retracts proximally and the helical anchor 302 is exposed. The helical anchor 302 may be positioned to contact the ventricular tissue. Rotation of the drive shaft 307 causes the driver head 306, the anchor hub 308, and the helical anchor 302 to rotate, thereby screwing the ventricular anchor 302 into the ventricular tissue. Rotation of the driver 309 causes the driver 309, the anchor hub 308, and the helical screw 302 to advance distally and axially relative to the outer sheath 304.

[0077] As shown in FIG. 2D, the drive shaft 307 is manually rotated by the user using the drive handle 312. As shown in FIG. 2D, the proximal end of the ventricular anchor delivery subsystem 300 is hemostatic valves 314, 316. The first hemostatic valve 314 may be disposed distal to the drive handle 312 or may provide access to the guide shaft 305. The second hemostatic valve 316 may be disposed proximal to the drive handle 312 or may provide access to the central internal passage of the driver. The ventricular anchor suture (not shown) may extend through the second hemostatic valve 316.

[0078] In some implementations, the insertion portion 306' of the driver head 306 and the recess of the anchor hub 308 may have a frictional engagement that temporarily holds the two components together. When the helical anchor 302 is inserted and the driver is retracted proximally by the reaction force from the ventricular tissue, the frictional engagement is released. In some implementations, the proximal tension on the suture 74 provides an engagement force between the proximal hub 308 and the driver head 306. This is released when the driver 309 is retracted. Before the outer sheath 304 is retracted into the delivery catheter 100, the driver head 306 may be retracted proximally into the outer sheath 304.

[0079] The non-implanted components of the ventricular anchor delivery subsystem 300 may be removed from the delivery catheter 100, and then the subsystem may be placed in the delivery catheter 100 to complete the implantation of the neo-chordae. In a variant, subsequent subsystems such as the ventricular anchor delivery subsystem 300 and the valve tip anchor delivery subsystem 330 may be placed simultaneously within the delivery catheter 100, and in one configuration example, both the tissue anchor and the valve tip anchor may be pre-loaded into the delivery catheter. In other embodiments, the implantation of the ventricular anchor may be performed in a different order (e.g., after the implantation of the valve tip anchor). The ventricular anchor delivery components may be retracted proximally beyond the proximal end of the suture 74, and the suture 74 may remain extended through the delivery catheter 100 to the ventricular anchor 302.

[0080] In certain embodiments of the present disclosure, it is desirable to provide a second anchor to prevent the helical coil 54 of the ventricular anchor 32, which may become detached from the attachment site, from rotating in the reverse direction after implantation. Generally, the second anchor is deployed from a first configuration for attachment of the first helical anchor and for transcatheter guidance, etc., to a deployed second configuration that engages tissue and prevents the helical anchor 54 from becoming detached from the attachment site.

[0081] In certain embodiments, the second anchor may be automatically deployed to the second configuration in response to full engagement of the first helical anchor. Alternatively, the second anchor may be deployed by control of a pusher by the attending physician or clinician or by manual operation of a forward movement in the distal direction. The pusher may be in the form of a tubular body provided to be axially movable on the anchor driver. Alternatively, the pusher may have an anchor driver. In such an example , the anchor driver may have an engagement surface structure such as a ratchet that cooperates with a complementary surface structure on a surface facing radially inward of the second anchor assembly. The anchor driver can be retracted proximally without affecting the second anchor, but the subsequent forward movement of the anchor driver distally deploys the second anchor. In an alternative, the pusher may have a suture lock catheter as described below.

[0082] The second anchor described above with reference to FIGS. 2F and 2G may be used independently and / or in combination with the features and aspects of the ventricular anchor 32 described herein with respect to the embodiments described with reference to FIGS. 2A-2E.

[0083] Figures 2F and 2G show a ventricular anchor 32 according to an embodiment, including a second anchor 110. In the illustrated embodiment, the second anchor 110 has at least a first tine 112 extending between a proximal end 114 and a sharp distal end 116. The tine 112 can be supported by a support 118, such as by connection to the proximal end 114. The support 118 facilitates the axial advancement of the tine 112. In the illustrated embodiment, the support 118 comprises an annular structure, such as a ring 122, having an opening 120. The opening 120 is configured to axially movably receive an anchor driver (not shown) or another tubular structure or component that may be part of an anchor deployment system.

[0084] The hub 57 has at least one first tine guide 124, such as an opening or passage, for axially movably receiving the first tine 112. The first tine guide 124 may have a deflection surface for deflecting the tine 112 at an emission angle that is inclined radially outward in the distal direction. The emission angle measured at the exit from the tine guide 124 ranges from about 30° to about 45°, and in other embodiments, ranges from about 35° to about 40° from the central longitudinal axis of the anchor. In a particular exemplary embodiment, the emission angle measured at the exit from the tine guide 124 may be within the range of 30° to 45° from the central longitudinal axis of the anchor, and in some embodiments, within the range of 35° to 40°.

[0085] As an alternative to or in addition to the deflecting surface, the branch portion may be pre-biased radially outward so as to incline outward when advancing from the branch guide 124. The distal advancement of the first branch portion 112 advances the branch portion through the first branch guide, and distally thereof, the branch portion 112 extends radially outward in the distal direction, and at least about 1 mm or 2 mm or 3 mm or 4 mm or more of the length of the branch portion is exposed according to the desired performance (function). In a particular exemplary embodiment, the distal advancement of the first branch portion 112 advances the branch portion through the first branch guide, and distally thereof, the branch portion 112 extends radially outward, and at least 1 mm or 2 mm or 3 mm or 4 mm or more of the length of the branch portion is exposed according to the desired performance. When measured perpendicular to the longitudinal axis, the distal tip 116 of the fully deployed branch portion is at least about 1 mm or 2 mm or 3 mm or 4 mm or more spaced from the outer surface of the helical coil 54. In a particular exemplary embodiment, when measured perpendicular to the longitudinal axis, the distal tip 116 of the fully deployed branch portion is at least 1 mm or 2 mm or 3 mm or 4 mm or more spaced from the outer surface of the helical coil 54. The distal tip 116 when fully deployed may be laterally spaced from the helical coil by at least about 50% or 75% or 100% or more of the outer diameter of the helical coil. In a particular exemplary embodiment, the distal tip 116 when fully deployed may be laterally spaced from the helical coil by at least 50% or 75% or 100% or more of the outer diameter of the helical coil.

[0086] The branch portion 112 may be formed of or may include any of a variety of materials such as stainless steel or nitinol that have sufficient structural integrity to resist rotation and / or hold the bias. The branch portion 112 may be a flat ribbon or a round wire, and in one embodiment, it consists of a 0.016-inch round wire made of stainless steel.

[0087] Advancement of the first branch portion 112 distally may be achieved by applying distal pressure to the support 118 by, for example, a catheter advancing over the suture 74 and / or an anchor driver described elsewhere in this specification or a second anchor deployment pusher. As an alternative, the second anchor 110 may be deployed by advancing the support 118 distally and advancing the suture lock distally on the suture to engage the support 118 so as to restrain the support 118 between the hub 57. In this way, the suture lock may function as a second anchor lock to prevent or inhibit the second anchor from retracting from the deployment site.

[0088] The second branch portion 126 may extend through the second branch guide 128 and be provided to be connected to the support ring 122. Depending on the desired performance of the second anchor system, three, four or more branch portions may be provided. In the illustrated embodiment, two branch portions are shown spaced approximately 180° apart along the circumference of the helical anchor. In an embodiment including three branch portions, the branch portions are equally spaced at intervals of approximately 120°.

[0089] As shown, the branch guides 124, 128 can guide the branch portions 112, 126 through a suture-like suture anchor guide material (fiber). The suture may have an opening aligned with the path of the branch portion, or alternatively, the branch portion may penetrate the material during deployment. The exit path of the branch portion is movable distally as needed, such that the branch portion extends axially through the hub into the helical coil and exits laterally between the windings of two adjacent coils spaced apart from each other. The branch portion and / or the support 118 may include a radiopaque marker or material to enable a fluoroscopic confirmation of complete deployment.

[0090] One or more second anchors 110 to be used can increase the anchor torque resistance of the helical coil 54, suppressing or preventing the helical coil 54 of the ventricular anchor 32 from rotating reversely after implantation. Such reverse rotation after implantation can cause the helical coil 54 to become detached or loose from the attachment site. In some embodiments, the second anchor 110 can increase the torque resistance of the ventricular anchor 32 by at least 2, 4, 6, 8, or 10 times compared to the use of the ventricular anchor 32 without the second anchor 110. In certain embodiments, the addition of one or more of the second anchors 110 can increase the torque resistance by 2 to 10 times compared to the use of the ventricular anchor 32 by itself, and in certain embodiments, one or more of the second anchors can increase the torque resistance by 2 to 5 times. In such embodiments, a plurality of branches of the second anchor can be used, and in certain embodiments, 2, 3, 4, or 5 can be used, which can be in the form of the branches 112, 126 as described above. In some embodiments, the torque resistance using one or more second anchors 110 can be greater than 2 N / cm. In some examples, the torque resistance with the addition of one or more branches of the second anchor 110 can be between at least 2 N / cm and 5 N / cm.

[0091] Furthermore, the use of one or more of the second anchors 110 can increase the torque stiffness of the helical coil 54, preventing or suppressing wobbling or displacement, which can also prevent the helical coil 54 of the ventricular anchor from becoming detached from the attachment site. For example, the second anchor 110 can increase the torque stiffness by at least 2, 4, 6, 8, or 10 times compared to the use of the ventricular anchor without the second anchor 110, and in certain embodiments, the torque stiffness can be increased by 2 to 10 times, and in certain embodiments, 3 to 8 times compared to the ventricular anchor without the second anchor 110. In such embodiments, one or more second anchors can be used, and in certain embodiments, 2, 3, 4, or 5 second anchors 110 are used, and in certain embodiments, the second anchor can be in the form of the branches 112, 126 as described above. In certain embodiments, by one or more second anchors 110 The torque resistance can be made greater than 0.02 N-cm / deg, and in some examples the torque resistance by one or more second anchors 110 can be between 0.01 N-cm / deg and 0.03 N-cm / deg.

[0092] In some examples, each of one or more branch portions of the second anchor 110 can have a length of at least 5 mm as measured from the hub 57. In some examples, each of one or more branch portions of the second anchor 110 can have a length of 1 mm to 8 mm, in certain embodiments, a length of 4 mm to 7 mm, and in certain embodiments, a length of 5 mm. The width between any two branch portions of the second anchor 110 can be about 12 mm. In some examples, the width between any two branch portions can be 5 mm to 15 mm. The length and width of the branch portions advantageously enable the branch portions of the second anchor 110 to extend into the pericardial cavity without penetrating the ventricular wall while still providing sufficient torque resistance and rigidity. In some examples, each of one or more branch portions of the second anchor 110 can have a length of at least 5 mm as measured from the hub 57. In some examples, each of one or more branch portions of the second anchor 110 can have a length of 1 mm to 8 mm, in certain embodiments, a length of 4 mm to 7 mm, and in certain embodiments, a length of 5 mm. The width between any two branch portions of the second anchor 110 can be about 12 mm. In some examples, the width between any two tines can be 5 mm to 15 mm. The length and width of the tines advantageously enable the branch portions of the second anchor 110 to extend into the pericardial cavity without penetrating the ventricular wall while still providing sufficient torque resistance and rigidity.

[0093] The thickness of each branch portion can be about 0.3 mm. In some examples, the thickness of each branch portion can be 0.1 mm to 0.5 mm. This thickness of the branch portion can provide appropriate bending or yielding when the branch portion advances.

[0094] Furthermore, the angle of each branch portion from the center line of the helical coil 54 can be about 40°. In some examples, the angle of each branch portion from the center line of the helical coil 54 can be between 25° and 60°. This angle can advantageously expand to provide the desired torque resistance and rigidity without piercing the ventricular wall. This can also provide the desired orientation of each branch portion facing the mitral valve when the anchor is obliquely disposed on the ventricular wall.

[0095] The ends of each branch portion can be optionally coined along its length. This can prevent the second anchor from being pulled back too far into the hub 57 by catching the coining portion distal to the holes in each branch guide 124 or hub 57 through which the branch portion passes.

[0096] Figures 3 - 6 show the deployment of the leaflet anchor. Referring to Figure 3, the ventricular anchor 32 is deployed, connected to the catheter 100 by the ventricular anchor suture 74, and the ventricular anchor subsystem is removed. The leaflet anchor is carried within a needle 338 shown directed towards the target site on the atrial side of the leaflet. The needle 338 is sent axially reciprocating within the catheter 100, such as within a tubular sleeve or leaflet anchor catheter 332 that can be advanced through the catheter 100. The needle and needle driver are further described below.

[0097] As shown in Figure 3, in the illustrated configuration, the needle can pass through the leaflet from the atrium to the ventricle and then advance a pre - loaded suture into the ventricle. Next, as shown in Figure 4, the suture can be used to fold the pledget against the ventricular side of the leaflet and secure the suture to the leaflet. Thus, the pledget forms a radially expandable leaflet anchor. In certain embodiments, a radially expandable leaflet anchor having other forms may be used.

[0098] The leaflet anchor and suture effectively form a new mitral valve chordae as shown in Figure 5 It can be used in combination with the ventricular anchor suture and suture lock. As described above, the leaflet anchor and suture can be used in combination with the transvascular artificial chordae implantation method and system disclosed in U.S. Patent Application No. 15 / 858,671 (incorporated herein by reference in its entirety), which discloses various embodiments of the ventricular anchor suture and suture lock.

[0099] The leaflet anchor deployment subassembly includes a temporary anchor for capturing and stabilizing the leaflet while the needle tip 338 passes and advances on the target side. As shown in FIGS. 3 and, the distal end 400 of the delivery tube 332 or other system components include a temporary tissue anchor such as a helical tissue anchor 402. Since the temporary anchor 402 is only intended to engage the leaflet instantaneously, it may be similar to the ventricular anchor except that it does not have a distal fold (barb). Thus, the anchor 402 includes a helical element 406 that terminates at the distal tip 408.

[0100] In use, the distal tip 408 is positioned at the target site on the surface of the leaflet, and the helical element 406 rotates about or around the axis to engage and penetrate the leaflet. Similar to the method described for the ventricular anchor with reference to FIGS. 2A and 2B, the needle tip 338 can be optionally engaged with the leaflet prior to rotation of the helical element 406 and used to stabilize the anchor against movement away from the target site in response to the rotation.

[0101] Following engagement of the helical element 406 to capture the leaflet from the atrial side and secure the leaflet to the catheter, the needle advances distally through the central internal passage defined by the helical element 406 and completely through the leaflet. Thereby, as shown in FIG. 4, the needle tip 338 protrudes from the ventricular side of the leaflet. An anchor deployment actuator, such as a pusher extending through the needle, can be utilized to deploy the anchor from the needle into the ventricle using the anchor deployment actuator.

[0102] Referring to FIG. 5, the valve tip anchor may be the cotton suture 340 described elsewhere in this specification. The cotton suture 340 may be attached or coupled to the distal end of the valve tip anchor suture 344. The cotton suture may comprise a soft and / or flexible material such as a fiber (fabric, cloth). The suture 344 may extend through the needle 336. The cotton suture 340 may be folded or compressed in a form that includes a reduced radial cross-section so that it can be disposed within the needle 336 for delivery (described below with reference to FIGS. 8 and 10). As shown in FIG. 5, the cotton suture 340 can expand from a reduced cross-section to a larger radial cross-section when deployed from the distal end of the needle tip 338. In some embodiments, the cotton suture 340 is pushed through the needle 336 via a push wire or release wire (not shown). When delivered through the needle tip 338, the proximalward retraction of the valve tip suture 344 shown in FIG. 6 causes the valve tip anchor to be axially folded and radially expanded, thereby preventing the valve tip anchor from retracting through the puncture of the valve tip and fixing the valve tip suture 344 to the valve tip as shown in FIG. 7.

[0103] FIGS. 6A-6D schematically show a cotton suture 340 connected to the distal end of the valve tip suture 344. The cotton suture 340 comprises two wings 341, 342 that are rounded / folded (e.g., clockwise or counterclockwise) about the longitudinal axis of the cotton suture 340 so as to form a reduced cross-sectional shape. In some embodiments, the valve tip suture 344 may be integrally formed with the cotton suture 340. To form a foldable or foldable structure, as shown in FIG. 6A, the suture 344 extends distally through the cotton suture, loops at the distal end of the cotton suture, returns proximally, and proceeds to sew one or more openings (e.g., two openings, three openings, four openings, etc.) formed in the cotton suture 340. In some embodiments, the openings are aligned along the center of the cotton suture 340.

[0104] The opening may extend through the cotton wadding 340 and the portion of the embedded portion of the stitching portion 344 that is integral with the cotton wadding 340. The embedded portion of the stitching portion 344 is at least partially flat within the cotton wadding 340. In some embodiments, the opening may be disposed substantially near the center of the cotton wadding (e.g., immediately to the left or right of the embedded stitching portion 344 or alternating between the left and right sides of the stitching portion 344). When deployed, the stitching portion 344 is effectively coupled to the distal end of the cotton wadding 340 (e.g., the stitching portion 344 loops back to the location where it was inserted between the cotton wadding sheets).

[0105] Figures 6B - 6D schematically illustrate examples of cotton wadding described elsewhere in this specification. Figure 6B schematically shows a cotton wadding 340 formed by attaching the distal end (shown by a dashed line) of the stitching portion 344 between two flat sheets that are sheets for the left and right wings 341, 342. Figure 6C is a cross-sectional view of the cotton wadding 340 along the axis B - B of Figure 6B. In some embodiments, the stitching portion 344 is inserted between two sheets (e.g., substantially at the center of the sheet) and is pressed and / or laminated (stacked) (e.g., under heat and / or pressure) to join the three components together. At least one layer may be partially sintered. The stitching portion 344 may be flattened and / or densified to improve resistance to breakage and tearing of the stitching. The sheet may be a flat polytetrafluoroethylene (PTFE) sheet (e.g., a thin uncured expanded PTFE (ePTFE) sheet) or any suitable material. In one embodiment, the valve tip stitching portion 344 may be disposed between the sheets in an alternative configuration such as a zigzag or S-shape. Figure 6D shows the cotton wadding 340 of Figure 6B. The cotton wadding 340 has a plurality of openings 343 passing through the proximal tail of the stitching portion 344.

[0106] In some embodiments, as described elsewhere herein, to form a foldable structure configured to secure the suture 344 to the leaflet tip of the mitral valve, one or more openings 343 are formed through the cotton suture in various configurations. FIG. 6D shows openings 343 that are alternately arranged on the back side of the suture 344. In some embodiments, the openings 343 may be formed on the same side of the suture 344 (e.g., in the wing 341 or the wing 342). In some embodiments, the openings 343 may be formed through the suture 344. The openings 343 may be aligned along the center of the cotton suture 340. The openings 343 may be aligned along the length of the suture 344 (e.g., forming a straight line). The suture 344 is at least partially flattened between the two opposing sheets, thereby facilitating the placement of the opening 343 through the suture 344. Various combinations of the openings 343, including the above positioning, may be used.

[0107] The cotton suture 340 may be formed such that the wings 341, 342 are approximately the same size or different sizes. When the leaflet tip suture 344 retracts in the proximal direction, as shown in FIG. 6A, the cotton suture 340 is folded like an accordion. The cotton suture 340 may take a form that includes a proximal plane that is substantially perpendicular to the longitudinal axis. With this form, the suture 344 can be easily fixed to the leaflet tip. When the leaflet tip suture 344 is fixed to the leaflet tip, the leaflet tip anchor delivery subsystem 340 is withdrawn from the delivery catheter 100. The leaflet tip anchor delivery element may be retracted proximally across the proximal end of the suture 344. The suture 344 continues to extend through the delivery catheter 100 to the leaflet tip anchor 340 alongside the ventricular anchor suture 74.

[0108] FIGS. 8-10 are diagrams showing the leaflet tip anchor delivery subsystem 330 and its components. FIG. 8 is a perspective view of the distal end of the subsystem 330. FIG. 9 is a perspective view of the proximal end of the subsystem 330. FIG. 10 is an exploded view of the distal end of the subsystem 330.

[0109] As shown in FIGS. 8 and 10, the valve tip anchor delivery subsystem 330 may include an outer delivery tube 332. The tube 332 may optionally have a flexure zone and may be configured to be operable by an operator by proximal retraction of one or more pull wires (not shown) along various sides of the flexible tube 332. The operator may control the bending of the flexible tube via a knob 352 or lever or other actuation mechanism disposed on a handle 350 at the proximal end of the valve tip anchor delivery subsystem 330, as shown in FIG. 9.

[0110] An inner tubular shaft or needle 336 terminating at a distal end including a tip point 338 may extend through the delivery tube 332. The inner needle 336 includes a hypodermic tube, an extruded or braided tube, or a catheter having sufficient flexibility to conform to the optional shape of the flexible tube 332. The tip 338 of the needle may be coupled to the distal end of the flexible shaft 336. A flexible jacket 333 may surround the flexible tube 332 and the delivery shaft 334.

[0111] As shown in FIG. 9, the proximal end of the inner tubular shaft 336 may be connected to a needle handle 354. The needle handle 354 may include a hemostatic valve 356. The valve tip suture 344 may be inserted through the valve 356. The valve 356 may be a tuohy-borst valve. The needle handle 354 may have an additional port 358 for accessing the internal passage of the inner flexible shaft 336. The needle handle 354 may be disposed proximal to the handle 350 such that the inner flexible shaft 336 extends through the handle 350 into the internal passage of the delivery shaft 334. The handle 350 may have a hemostatic valve for receiving the inner flexible shaft 336 and sealing the internal components of the handle including the opening from the ambient environment to the delivery shaft 334.

[0112] The needle tip 338 may be extendable or retractable by extending the needle handle 354 toward the handle 350 or by retracting the needle handle 354 from the handle 350. Forward movement of the needle 336 in the distal direction can be achieved by manually advancing the handle 354. As an alternative, forward movement of the needle in the distal direction may be assisted by a mechanical or electromechanical mechanism to achieve a relatively high-speed, short-stroke forward movement in the distal direction.

[0113] When pressure is applied to the valve tip when the needle tip 338 is extended distally beyond the tube 332, the needle tip 338 punctures the valve tip and, as shown in FIG. 4, the needle tip 338 extends to the opposite side of the valve tip (e.g., the atrial side). This pressure can be applied by extending the needle tip 338 and / or by retracting the entire delivery device 330 with the needle tip 338 in the extended position.

[0114] The ventricular anchor suture 74 and the valve tip anchor suture 344 are coupled to each other in a tensioned state to form a neo-chord implant or to couple two sections of the neo-chord implant to each other such that the neo-chord extends between the ventricular anchor 302 and the valve tip anchor 340 across the atrial side of the junction end of the valve tip. The total length of the neo-chord can be adjusted by pulling one or both sutures 74, 344 proximally before engaging the suture lock 376 such that appropriate tension is applied to the valve tip and the tension is maintained by the ventricular anchor 302. The sutures 74, 344 can continue to extend proximally through the delivery catheter 100 to an external location. In some embodiments, the proximal ends of the sutures 74, 344 can be supplied to the handle or the proximal portion of the suture lock delivery system 370 to facilitate placement of the suture lock and cutting of the sutures 74, 344. In some embodiments, the proximal ends may be free ends or may be coupled or fixed to other means.

[0115] Figure 11 shows the advancement of suture lock 376 over ventricular anchor suture 74 and leaflet suture 344. Suture lock delivery subsystem 370 advances through delivery catheter 100, and tubular pusher catheter 372 pushes suture lock 376 along the distal direction of sutures 74, 344. Once suture lock 376 reaches the ventricle, it continues to be pushed along ventricular suture 74 by retracting suture 74 in the proximal direction, while allowing leaflet suture 344 to be fed distally through the catheter when suture lock 376 needs to advance distally towards the ventricular anchor. As further described below, Figure 12 shows the final structure in which the leaflet anchor and ventricular anchor are joined to form an artificial chordae tendineae. The proximal tails of the two sutures are cut, and the catheter is retracted proximally from the ventricle through the mitral valve.

[0116] Figures 13 - 14 are diagrams showing suture lock delivery subsystem 370 and its components. Figure 13 is a perspective view of the distal end of subsystem 370. Figure 14 is a perspective view of the proximal end of subsystem 370. Figure 15 is a partial exploded view of the distal end of subsystem 370. Figure 16 is a perspective view of the distal end of the cutting assembly. Figures 17, 18 are side views of the cutting assembly portion of subsystem 370. Figure 19 is a side view of the distal end of suture lock 376 and torque driver 388 configured to engage suture lock 376. Figures 20, 21 show the proximal end and distal end of suture lock 376 respectively.

[0117] The suture lock delivery subsystem 370 can be configured to advance (e.g., slide) a suture lock 376 that secures both sutures 74, 344 (or three or four or additional sutures) thereacross. The sutures 74, 344 can each retract distally relative to the suture lock 376 to apply tension to the sutures 74, 344 and adjust the length of each suture 74, 344 between the suture lock 376 and each tissue anchor 302, 340. When the tension and length of the neo-chordal implant are optimized, the suture lock 376 is locked to fix the length of the sutures 74, 344 so that the sutures 74, 344 cannot move relative to the suture lock 376. The sutures 74, 344 can then be cut at a point proximal to the suture lock 376. The sutures 74, 344 can be cut by the same suture lock delivery subsystem 370 that fed the suture lock 376. In other embodiments, after the suture lock is locked in place, a separate cutting device is inserted into the delivery catheter 100.

[0118] The suture lock allows adjustment of the suture by advancing one or more sutures therethrough, and the suture can be locked with a sufficient clamping effect to prevent the ePTFE suture from slipping from the suture lock under normal use conditions (e.g., withstand a tension of at least about 60% or 80% or more of the breaking strength of the suture without slipping). In certain exemplary embodiments, the suture lock allows adjustment of the suture by advancing one or more sutures therethrough, and the suture can be locked with a sufficient clamping effect to prevent the ePTFE suture from slipping from the suture lock under normal use conditions (e.g., withstand a tension of at least 60% or 80% or more of the breaking strength of the suture without slipping). The lock can be released to readjust the tension of the mitral valve leaflet and retightened until the desired result is obtained. The tightening tool is then removed, leaving the suture lock in place.

[0119] The suture lock 376 may advance along the suture by means of the retriever catheter 373. The distal end of the retriever catheter 373 may be coupled to a retriever element 377 (FIG. 15). The retriever element may include a flange 371 or other mechanical feature configured to engage the suture lock 376. For example, the flange 371 may be inserted into a recess at the proximal end of the suture lock 376. In some embodiments, the retriever catheter 373 may be rotated and / or moved in a direction substantially perpendicular to the axial direction of the retriever catheter 373 to remove the retriever catheter 373 from the suture lock 376.

[0120] The sutures 74, 344 extend from their respective tissue anchors through the suture lock 376, enter through the distal opening 395 at the distal surface of the suture lock 376 shown in FIG. 21, and exit through the proximal opening 394 to the suture path at the proximal surface of the suture lock 376 shown in FIG. 20. The sutures 74, 344 may pass through the channel of the proximal cutter head 375 of the suture lock 376, along the outside of the retriever catheter 373, and through the delivery catheter 100. The cutter head 375 may be coupled to the distal end of a cutter catheter 372. The retriever catheter 373 may extend within the internal passage of the cutter catheter 372 such that the two catheters 372, 373 extend (expand) or contract relative to each other.

[0121] When the suture portions 74, 344 are locked (fixed) within the suture lock 376, the proximal ends of the suture portions 74, 344 can be cut adjacent to the proximal surface of the suture lock. The suture portions 74, 344 can be cut by advancing a cutter catheter 372 coupled to a cutter head 375 toward the proximal surface of the suture lock 376. As schematically shown in FIGS. 17 - 18, when the cutter head 375 advances along the retainer catheter 373 toward the retainer element 377, the cutter head brings the suture portions 74, 344 into proximity with a cutting blade 379 disposed in the retainer element 377. The cutter head 375 is configured to advance across the retainer element 377 such that the channel of the cutter head 375 that holds the suture portions 74, 344 is gradually and spatially occupied by the blade 379. When the blade 379 is pushed into the channel of the cutter head 375, the blade 379 shears the suture portions 74, 344. Applying proximal tension to the suture portions 74, 344 facilitates cutting of the suture portions 74, 344. In other embodiments, different actuation (e.g., rotation of the cutting catheter) may be configured to cut the suture portions 74, 344.

[0122] In some implementations, two or more suture portions may be used, may be locked within the suture lock 376, and may be cut by the suture lock delivery subsystem 370 in the same manner. In some embodiments, the advancement of the cutter head 375 across the retainer element 377 facilitates release of the retainer catheter 373 from the suture lock 376. For example, the cutter head 375 advances to a distal position that stabilizes the suture lock 376 and releases the retainer catheter 373 from the suture lock 376 in an axial and / or rotational direction.

[0123] FIG. 19 shows a side view of an exemplary suture lock 376 (shown with the outer casing / shell removed). As described elsewhere in this specification, the suture passes through the suture lock 376 from its distal end to its proximal end. The suture lock 376 includes a screw 382 configured to advance the push wedge 384 distally or retract it proximally in response to the direction of rotation of the screw. The screw 382 can be rotated by a torque shaft 388. The torque shaft 388 has a driver head configured to engage a recess 381 (e.g., a polygonal recess or other non-circular recess as shown in FIG. 20) disposed at the proximal end of the suture lock 376, whereby the screw 382 is rotated by the rotation of the torque shaft 388. The torque shaft 388 extends through the internal passage of the retainer catheter 373. The torque shaft 388 is rotated at its proximal end by a knob 398 or other actuation mechanism disposed at the proximal end of the subsystem handle 396. The handle 396 has a hemostatic valve 397. In some implementations, the sutures 311, 344 pass through the hemostatic valve 397.

[0124] Advancement of the push wedge 384 by the torque shaft 388 gradually compresses one or more springs, such as spring pins 388, against a ramp (inclined path) or inclined surface 386. The springs bias the clamp upward to open the suture path until forced closed by rotation of the torque shaft 388. Compression of the one or more springs 388 presses the clamp 390 downward onto the sutures 311, 344, compressing the sutures 311, 344 between two opposing surfaces. In some embodiments, the clamp 390 and opposing surface 392 may have notch surfaces configured to fit together in discrete increments. The mating notch surfaces enhance friction and, in some embodiments, provide mechanical interference for holding the sutures 311, 344 between the opposing surfaces so that the sutures 311, 344 are not pulled out of the suture lock 376 in the proximal or distal direction. In some embodiments, the tightening can be reversed by rotating the torque shaft in the opposite direction.

[0125] When the suture lock is properly positioned and locked at a predetermined position on sutures 74, 344, the sutures 74, 344 can be cut as described elsewhere in this specification. FIG. 12 shows the retraction of the suture lock delivery subsystem 370 after the sutures 74, 344 have been cut. When the suture lock delivery subsystem 370 is removed from the delivery catheter 100, the delivery catheter 100 can be withdrawn from the body.

[0126] (Foldable Anchor Delivery Sheath) Depending on the configuration of the anchor assembly 50, coil 54, and / or tubular sleeve 78, in certain embodiments, the outer profile of the deployed anchor assembly 50 may be larger than the inner diameter of the delivery catheter 100 and / or the introducer sheath. Thus, in certain embodiments, as shown in FIGS. 22A - E, the ventricular anchor delivery subsystem 300 may be modified to have a foldable anchor delivery sheath 404 that provides protection and support for the anchor assembly 50, coil 54, and / or tubular sleeve 78 during feeding of the ventricular anchor delivery subsystem 400 and that conforms to the inner diameter of the delivery catheter 100. In this way, the foldable anchor delivery sheath 404 can be folded to a smaller diameter while the sheath 404 is being retracted into the delivery catheter 100. Also, for example, the foldable delivery sheath 404 can be configured to secure the anchor assembly 50 during feeding so that the anchor assembly 50 does not become disengaged from the delivery sheath 404 due to, for example, the beating ventricle or other movements or shapes encountered during introduction and placement. Also, in certain embodiments, when the coil 54 of the anchor assembly 50 engages the heart wall, the delivery sheath 404 has sufficient torsional resistance to resist the movement of the beating ventricle. As described below, the sheath 404 may include a radiopaque tip for detection. The delivery sheath 404 in certain embodiments has an inner diameter sufficient to hold the coil 54 and tubular sleeve 78, but can have an outer diameter small enough to fit within the delivery catheter 100 or introducer sheath. In certain embodiments, the anchor delivery sheath 404 is foldable such that it can be withdrawn through the narrower constriction of the delivery catheter 100 without applying excessive force and without breaking when the anchor assembly 50 is being fed. In certain embodiments, the anchor delivery sheath 404 is adapted to transition in diameter from the size of the inner diameter of the delivery catheter 100 (e.g., about 9Fr in some embodiments) to a larger second size (e.g., about 19Fr in some embodiments) necessary to accommodate the anchor assembly 50.In certain embodiments, the anchor delivery sheath 404 is sized to transition in diameter from the inner diameter of the delivery catheter 100 (e.g., 9Fr in some embodiments) to a second larger size (e.g., 19Fr in some embodiments) necessary to accommodate the anchor assembly 50.

[0127] In one non-limiting and exemplary embodiment of the foldable anchor sheath 404, the sheath is composed of a thermoplastic elastomer material (e.g., such as Pebax) having a wall thickness of about 0.005 inches and is configured from three tubes of different diameters. For example, two relatively short component pieces (pieces) can be used to transition from a smaller diameter catheter (9Fr (French) in one embodiment) to a larger diameter for accommodating the anchor assembly 50 (19Fr diameter in one embodiment). The third tube forms the foldable portion of the sheath itself. All three component pieces can be formed on a tapered mandrel using heat adhesion or other suitable molding processes. In a further embodiment, a radiopaque marker, such as a polymeric radiopaque marker band formed from a thermoplastic elastomer containing 60 wt% tungsten, incorporated into and suitably bonded to the sheath thermally or otherwise, may be used.

[0128] Figures 22A - F show a ventricular anchor delivery sub - system 400 having a foldable sheath 404. The ventricular anchor delivery sub - system 400 is used in the methods and steps described above and can be used with a drive shaft 37, a driver head 306, and other components described above to rotate and feed the anchor assembly 50. The ventricular anchor delivery sub - system 400 includes a sheath 405 having a proximal portion 410, an intermediate portion 412, and a distal portion 414 that includes a foldable sheath 404. The proximal portion 410 may include a hemostatic valve 416 with a side port 418. In the illustrated embodiment, the intermediate portion 412 and the proximal portion 410 of the sheath 405 may be formed from a tube, such as a stainless - steel hypodermic tube, having an outer diameter of 9Fr (French). The foldable sheath 404 may be formed from a separate material that is coupled or attached to a smaller - diameter tube.

[0129] As shown in FIGS. 22D and 22E, the distal end of the foldable sheath 404 has a larger diameter than the intermediate portion 412. FIG. 22E is a longitudinal cross - sectional view of FIG. 22D. Threads 422 may be formed on the inner surface of the distal end of the foldable sheath 404 to hold the anchor assembly 50 within the foldable sheath 404. Thus, in one configuration example, the coil 54 of the anchor assembly 50 engages the threads 422 in the foldable sheath 404 such that the anchor assembly 50 is held within the sheath 404. Rotation of the anchor assembly 50 drives the anchor assembly 502 forward through the sheath 404. In this way, the sheath 404 supports the anchor assembly 50 during feeding so that the anchor assembly 50 does not come out of the delivery sheath 404 during feeding. Also, the larger - diameter distal end of the sheath 404 is foldable to conform to the inner diameter of the delivery catheter 100 such that the foldable anchor delivery sheath 404 is drawn into the delivery catheter 100. In a variant, the sheath 404 may include a groove, a protrusion, or other elements for engaging the anchor assembly 50.

[0130] Typically, the sheath 404 may removably engage an implantable device such as a helical tissue anchor and include any of a variety of interference elements that resist axial withdrawal of the helical anchor disposed within the sheath. Rotating the anchor in a first direction relative to the sheath causes the anchor to move distally axially as the helix disengages from the sheath. The interference element may be at least about one, two, four, or more helical (extending radially outward) channels that extend completely around the inner circumference of the sheath, or alternatively (extending radially inward) ridges. In certain exemplary embodiments, the interference element may be at least one, two, four, or more helical (extending radially outward) channels that extend completely around or about the inner circumference of the sheath, or alternatively (extending radially inward) ridges.

[0131] As an alternative, at least about one, two, six, or more tabs extending radially inward are provided, and each tab does not rotate completely around the circumference of the sheath. In certain exemplary embodiments, at least one, two, six, or more tabs extending radially inward are provided, and each tab does not rotate completely around the circumference of the sheath. The engagement tab may have a circumferential length of about 90° or less, and in some embodiments, has a length of about 45°, 20°, 10°, or less across the inner surface of the sheath. In certain exemplary embodiments, the engagement tab may have a circumferential length of 90° or less, and in some embodiments, has a length of 45°, 20°, 10°, or less across the inner surface of the sheath. Depending on the desired performance, the implant can be removed from the catheter by a plurality of complete rotations, or by a rotation less than a complete rotation, such as, for example, less than about one-half or one-quarter rotation relative to the catheter. In certain exemplary embodiments, depending on the desired performance, the implant can be removed from the catheter by a plurality of complete rotations, or by a rotation less than a complete rotation, such as, for example, less than one-half or one-quarter rotation relative to the catheter.

[0132] The catheter sidewall and / or the rotational anchor driver may have torque transmission elements, such as helical incisions or braided sidewalls, to facilitate rotation of the driver and prevent rotation of the deployed catheter.

[0133] The sheath extends between a proximal end attached to the catheter shaft and a distal open end. The proximal end has an angled engagement surface for slidably engaging the distal opening of the delivery catheter, whereby the sheath is deformable from a radially expanded configuration to a radially contracted configuration in response to proximal retraction of the sheath relative to the delivery catheter.

[0134] The sheath generally has an axial length corresponding to an intended implant that is less than about 15 cm and, in many embodiments, about 10 cm or 5 cm or 3 cm or less. In certain exemplary embodiments, the sheath generally has an axial length corresponding to an intended implant that is less than 15 cm and, in many embodiments, 10 cm or 5 cm or 3 cm or less.

[0135] In embodiments where the OD of the device is smaller than the ID of the internal passage of the deployment catheter, the rotational interlock function described above may be implemented on the inner surface of the flexible (foldable) sidewall or on a fixed (non-foldable) sidewall catheter as described above. In an example implementation of a foldable sheath, when in a radially expanded configuration to accommodate an implantable device, proximal retraction of the sheath relative to a delivery catheter having an ID smaller than the OD of the sheath causes the sheath to fold after deployment of the device.

[0136] Figure 22F shows a method of forming a foldable sheath 404. A mandrel 426 having a first diameter 430 and a smaller second diameter 432 is disposed. Figure 22F is a longitudinal cross-sectional view of the mandrel similar to the end view of Figure 2E. The small-diameter portion 432 of the mandrel 426 can be disposed within the distal end of the intermediate portion 412. The mandrel 426 can have a transition region 427 between the first portion 430 and the second portion 432 of the mandrel 426. A coil 450 can be disposed on the outer surface of the large-diameter portion 430 of the mandrel 426. A sheath 452 for forming the foldable sheath 404 can be disposed over the mandrel 426 and the distal end of the intermediate portion 412. In one embodiment, the sheath 452 can include a wall portion made of a wall thermoplastic elastomer (such as Pebax) of about 0.005 inches. When on the mandrel 426, the sheath 452 can be heat-treated such that the diameter of the proximal end of the sheath 452 decreases and is coupled to the intermediate portion 412, and the distal end of the sheath 452 takes the form of the coil 450 to form the inner threads in the sheath 404. As described above, the sheath 404 has a radiation-impermeable marker such as a polymer radiation-impermeable marker band formed from a thermoplastic elastomer containing 60 wt% tungsten, for example, incorporated into the sheath and properly coupled to the sheath 404 thermally or otherwise. In one embodiment, the marker is disposed at the distal end of the sheath.

[0137] FIG. 22G is a side view of a steering zone near the distal end of delivery catheter 100 that is articulable or bendable in a first direction relative to the central axis of delivery catheter 100. Delivery catheter 100 as described herein can be used to deliver various subsystems. Thus, delivery catheter 100 can be configured to be positioned in the left atrium (as shown in FIGS. 3-6A) or the left ventricle (as shown in FIG. 1). To achieve this position, delivery catheter 100 can include a steering zone or first bend 102 such that the distal portion 108 of catheter 100 is angled away from the proximal portion 106 of catheter 100. In this way, the steering zone of delivery catheter 100 can be actively deflected to form a delivery catheter curve that lies in the delivery catheter curve plane (also referred to herein as the first plane or X-Y plane). As shown in FIG. 22G the delivery catheter 100 can bend at a range of angles. For example, delivery catheter 100 can be articulated to include a first bend 102 such that the longitudinal central axis of the portion of delivery catheter 100 distal to the bend forms an angle A with the longitudinal central axis of the portion of the delivery catheter proximal to bend 102. Angle A can be between 10 and 150°, and in certain embodiments, angle A can be between 30 and 80°, and in certain embodiments, between 35 and 70°. In some examples, the first bend 102 can be gentle such that the radius of curvature is at least 0.9 inches. In some examples, the first bend 102 can have a radius of curvature between 0.5 and 1.0 inches. Delivery catheter 100 can include various devices and mechanisms for articulating the steering zone, such as various combinations of pull wires that can be used to manipulate catheter 100, for example.

[0138] FIG. 22H is a perspective view of an embodiment of a ventricular anchor delivery sheath 700 that can include an elongated flexible tubular body having a proximal end, a distal end, and a longitudinal axis. The ventricular anchor delivery sheath 700 can include a proximal preset curve 702 and a distal preset curve 704 and can be advanced axially through a delivery catheter 100. The access system can include a delivery catheter 100 and a ventricular anchor sheath 700 for directing the ventricular anchor sheath to a target site within the left ventricle. The ventricular anchor sheath 700 can have a proximal portion 706, an intermediate portion 708, and a distal portion 710. As shown, the ventricular anchor sheath 700 can include a foldable sheath 404 at the distal end of the distal portion 710, which can be configured such that the distal end of the foldable sheath 404 forms the distal end of the ventricular anchor sheath 700. The foldable sheath 404 can be a distal anchor section having a foldable sidewall. The proximal preset curve 702 can be positioned between the proximal portion 706 and the intermediate portion 708. The distal preset curve 704 can be positioned between the intermediate portion 708 and the distal portion 710. The ventricular anchor sheath 700 can have the proximal preset curve 702 and the distal preset curve 704 pre-formed or preset such that the ventricular anchor sheath 700 assumes the configuration illustrated in FIG. 22H when not constrained by an outer sheath such as the delivery sheath 100 described above. The proximal preset curve 702 can be proximal to the distal preset curve 704. The distal preset curve 704 can be distal to the proximal preset curve 702. In certain embodiments, the ventricular anchor sheath 700 is heat set to the shape shown in FIG. 22H to form the proximal and distal preset curves 702, 704 by placing the vertical anchor sheath 700 on a mandrel having a desired shape and then heat treating the sheath 700 to apply a preformed shape to the sheath 700. In some examples, the ventricular anchor 700 can be formed by applying heat and manually bending the ventricular anchor 700 around the fixture to achieve the desired shape. In other examples, the ventricular anchor 700 can also be formed by loading the ventricular anchor 700 into a cassette having a pre-set shape and applying heat to set the ventricular anchor 700 into the desired shape. This can also be done by.

[0139] The proximal preset curve 702 of the ventricular anchor 700 can be bent within the proximal preset curve plane (also referred to as the X-Y plane or the first plane) to create a range of angle B between the central longitudinal axis 705 of the proximal portion 706 and the central longitudinal axis 715 of the intermediate portion 708. For example, the angle B can be between 70° and 100°, in certain embodiments can be between 85° and 95°, and in certain embodiments can be 90°. In some examples, near The proximal preset curve 702 may be a gentle one with a radius of curvature of 2.0 inches. In some examples, the proximal preset curve 702 can have a radius of curvature between 0.5 and 3.0 inches. As described below, the proximal preset curve 702 can assist or direct the ventricular sheath 700 within the delivery catheter 100. For example, the proximal preset curve 702 can have a radius corresponding to or similar to the radius of the first curved portion 102 of the delivery catheter 100. Thus, when the ventricular sheath 700 is advanced through the delivery catheter 100, the proximal preset curve 702 causes the distal portion 7100 of the ventricular sheath 700 to assume a particular rotational orientation within the delivery catheter 100 such that when it is present in the delivery catheter 100, it is present in a particular rotational direction. Accordingly, the distal portion 710 of the ventricular sheath 700 can be oriented in a particular direction when it is present in the delivery catheter 100. If the ventricular sheath 700 is not in the correct rotational orientation, the user can receive tactile feedback in the form of resistance to the axial advancement of the sheath 700 through the delivery catheter 100. Rotating the sheath 700 to the appropriate rotational orientation reduces this resistance, which provides feedback to the user that the sheath 700 is correctly oriented. As shown in FIG. 22H, the proximal preset curve 702 can be present in a first plane 725, which may be referred to herein as the X-Y plane or the proximal preset curve plane 725.

[0140] As shown in FIG. 22H, the ventricular anchoring sheath 700 can be bent such that portions of the sheath 700 can extend in two different planes. The proximal portion 706, the proximal preset curve 702, and the intermediate portion 708 can be present within a first plane 725, which can be referred to as the X-Y plane or the proximal preset curve plane as described above. The Y-axis can be perpendicular to the first plane 725 as shown in FIG. 22H. The central longitudinal axis 720 of the distal portion 710 can be present within a second plane 730. The proximal preset curve 702 can be angled within the first plane 725 to move the intermediate portion 708 away from the proximal portion 706 as described. The distal preset curve 704 can then be angled within a second plane 730, which can also be referred to as the distal preset curve plane or the second plane, to move the distal portion 710 away from the intermediate portion 708. The distal preset curve 704 of the ventricular anchoring sheath 700 can form an angle defined between the central longitudinal axis 715 of the intermediate portion 708 and the central longitudinal axis 720 of the distal portion 710. The angle between the central longitudinal axis 715 of the intermediate portion 708 and the central longitudinal axis 720 of the distal portion 710 can have two components: an angle α in the X-Z plane as shown in FIG. 22I, and an angle β in the Z-Y plane as shown in FIG. 22J such that the distal portion 710 is in a plane different from the intermediate 708 and proximal portion 710 of the sheath 800 and has an angle with respect to the X-Y plane. The intermediate portion 708 can have a length between about 20 mm and 50 mm, such as about 32 mm, and the distal portion 710 can have a length between about 20 mm and 50 mm, such as about 31 mm. The length of the intermediate portion 708 can be used to control the position of the ventricular implant within the ventricle such that in a particular embodiment, the ventricular implant can be positioned at the base of the papilla. The length of the distal portion 710 can be used to control the distance from the centerline of the heart to the wall of the heart. As described below, the intermediate portion 708 can center the distal portion 710 of the ventricular sheath over the mitral valve. The distal preset curve 704 can direct the distal portion 710 of the sheath 700 from above the mitral valve through the mitral valve and toward the ventricle to a position where a ventricular anchor as described above can be placed. The length of the intermediate portion 708 can be used to control the position of the ventricular implant within the ventricle such that in a particular embodiment, the ventricular implant can be positioned at the base of the papilla. The length of the distal portion 710 can be used to control the distance from the centerline of the heart to the wall of the heart. As described below, the intermediate portion 708 can center the distal portion 710 of the ventricular sheath over the mitral valve. The distal preset curve 704 can direct the distal portion 710 of the sheath 700 from above the mitral valve through the mitral valve and toward the ventricle to a position where a ventricular anchor as described above can be placed.

[0141] In an exemplary embodiment, the distance between the distal end of the ventricular anchor 700 and the longitudinal center or midpoint of the distal preset curve 704 can be in the range of 30 to 90 millimeters in one embodiment, 50 to 70 millimeters in another embodiment, and about 60 millimeters in another embodiment. In a particular exemplary embodiment, the distance between the distal end of the ventricular anchor 700 and the longitudinal center or midpoint of the distal preset curve 704 can be within the range of 30 to 903 mi limeters in one embodiment, 50 to 70 millimeters in another embodiment, and within the range of 60 millimeters in another embodiment. In an exemplary embodiment, the distance between the distal end of the ventricular anchor 700 and the longitudinal center or midpoint of the proximal preset curve 702 can be within the range of 80 to 165 millimeters in one embodiment, 100 to 145 millimeters in another embodiment, and about 125 millimeters in another embodiment. In a particular exemplary embodiment, the distance between the distal end of the ventricular anchor 700 and the longitudinal center or midpoint of the proximal preset curve 702 can be within the range of 80 to 165 millimeters in one embodiment, 100 to 145 millimeters in another embodiment, and within the range of 125 millimeters in another embodiment. In an exemplary embodiment, the distance between the longitudinal center or midpoint of the distal preset curve 704 and the longitudinal center or midpoint of the proximal preset curve 702 can be within the range of 45 to 85 millimeters in one embodiment, 25 to 105 millimeters in another embodiment, and about 65 millimeters in another embodiment. In a particular exemplary embodiment, the distance between the longitudinal center or midpoint of the distal preset curve 704 and the longitudinal center or midpoint of the proximal preset curve 702 can be within the range of 45 to 85 millimeters in one embodiment, 25 to 105 millimeters in another embodiment, and within the range of 65 millimeters in another embodiment.

[0142] FIG. 22I is a top view of the ventricular anchoring sheath 700 of FIGS. 22H - I for explaining an angle, α, in the X - Y plane. As shown in FIG. 22I, the distal portion 710 can be inclined at an angle α within a range of 5° to 60° with respect to the central longitudinal axis of the intermediate portion 708 in the X - Z plane. For example, the angle α of the distal preset curve 704 can be about 45° with respect to the central longitudinal axis of the intermediate portion 708 in the X - Z plane.

[0143] FIG. 22J is a side view of the ventricular anchoring sheath 700 of FIGS. 22H - I. As shown in FIG. 22J, the central longitudinal axis 720 of the distal portion 710 can be inclined at an angle, β, with respect to the central longitudinal axis 705 of the proximal portion 706 or the Z - axis in the above - mentioned X - Z plane, and the angle β can be within a range of 40 to 75°. For example, the angle β formed by the distal preset curve 704 can be about 40 to 75° in the Y - direction measured from the Z - axis that can be substantially parallel to the central longitudinal axis 705 of the proximal portion 706. In a particular embodiment, the angle β can be 60°. Thus, in the illustrated embodiment, the distal preset curve 704 can also be present in a second plane, also referred to herein as a distal preset curve plane, that is rotationally offset from the first plane (i.e., the X - Z plane or the proximal preset curve plane) at an angle within a range of 40 to 75°, 60° in a particular embodiment.

[0144] FIG. 22K is a front view of the ventricular anchoring sheath 700 of FIGS. 22H - J. As shown in FIG. 22K, the distal portion 710 can be inclined at an angle θ in the x - direction measured from the y - axis. For example, the angle θ of the distal preset curve 704 can be about 30 to 60°, 45° in some embodiments, in the x - direction measured from the y - axis, which can be substantially perpendicular to the longitudinal axis 705 of the proximal portion 706.

[0145] In some examples, the distal preset curve 704 may be sharper than the proximal preset curve 702. For example, the distal preset curve 704 can have a radius of curvature of 0.45 inches. In some examples, the distal preset curve 704 can have a radius of curvature between 0.1 and 0.5 inches. In certain embodiments, the distal preset curve The arc length of is at most about 50% of the arc length of the proximal preset curve, and in certain embodiments, the arc length of the distal preset curve is at most about 20% of the arc length of the proximal preset curve. In certain exemplary embodiments, the arc length of the distal preset curve is at most 50% of the arc length of the proximal preset curve, and in certain embodiments, the arc length of the distal preset curve is at most 20% of the arc length of the proximal preset curve.

[0146] FIG. 22L is a diagram showing the placement of the ventricular anchor 302 with the ventricular anchor sheath 700 of FIGS. 22H-K and the delivery sheath of FIG. 22G. The ventricular anchor sheath 700 can be used in the methods and steps described above (e.g., with the drive shaft 307, driver head 306, and other components described above for rotating and delivering the anchor assembly 50). For example, the ventricular anchor delivery sheath 700 can be inserted and passed through the catheter 100. The ventricular anchor delivery sheath 700 can deliver a ventricular anchor such as the helical anchor 32.

[0147] The ventricular anchor 700 can be advanced within the delivery catheter 100. When the ventricular anchor 700 is fully inserted within the delivery catheter 100 such that the intermediate portion 708 and the distal portion 710 are advanced outside the delivery catheter 100, the proximal preset curve 702 of the ventricular anchor 700 can be aligned with the first curvature 102 of the delivery catheter 100 and the delivery catheter curve. The proximal portion 106 of the delivery catheter 100 can be aligned with the proximal portion 706 of the ventricular anchor 700. The intermediate portion 708 and the distal portion 710 of the ventricular anchor 700 can extend beyond the distal portion 106 of the delivery catheter 100 as shown in FIG. 22L. Alignment of the first curvature 102 of the delivery catheter 100 with the proximal preset curve 702 of the ventricular anchor 700 can ensure that the distal portion 710 of the ventricular anchor 700 is correctly oriented when it exits the delivery catheter 100. For example, the delivery catheter 100 can have the first curvature 102 in the delivery catheter curve to position and orient the distal portion 108 within the ventriculoatrial chamber. The ventricular anchor 700 can be positioned within the delivery catheter 100 such that the distal portion 710 of the ventricular anchor 700 extends from the distal end of the delivery catheter 100 and is positioned within the left ventricle. The anchor 700 is configured to rotate within the delivery catheter 100 to bias the proximal preset curve surface into alignment with the delivery catheter curve surface in response to the axial alignment of the anchor proximal preset curve within the delivery catheter curve. In a particular embodiment, the proximal preset curve 702 and the delivery catheter curve 102 are configured to cooperate to provide a tactile indication of the rotational alignment of the anchor 700 within the delivery catheter 100.

[0148] The ventricular anchor 700 can be positioned such that the proximal preset curve 702 aligns the intermediate portion 708 partially within the left atrium and across the valve, and the distal preset curve 704 aligns the distal portion 710 within the left ventricle. The delivery catheter 100 can be positioned within the left atrium as shown in FIGS. 11 and 12 and FIG. 22L. The ventricular anchor 700 can be positioned within the delivery catheter 100 such that the first curvature 102 of the delivery catheter 100 aligns with the proximal preset curve 702 of the ventricular anchor 700. A ventricular anchor, such as ventricular anchor 32, can then be inserted through the ventricular anchor 700 for delivery. For example, the ventricular anchor 302 can be delivered within cardiac tissue, such as near the apex of the left ventricle or near a papillary muscle.

[0149] The proximal preset curve 702 and the distal preset curve 704 of the ventricular anchor 700 can be preset. As described above, in some examples, the ventricular anchor The ventricular anchor 700 can be manufactured with a curved mandrel to thermally set the angle of curvature of the ventricular anchor 700. The ventricular anchor 700 can be made substantially flexible and bendable such that when the ventricular anchor 700 is inserted into the delivery catheter 100, the ventricular anchor 700 can be substantially aligned with the delivery catheter 100. For example, if the delivery catheter 100 is substantially straight, the ventricular anchor 700 can be substantially straight when disposed within the delivery catheter 100. When the distal preset curve 704 and the distal portion 710 are exposed without being constrained within the delivery catheter 100, the preset curve of the proximal preset curve 702 aligns with the curved portion 102 of the delivery catheter 100, and the preset curve of the proximal preset curve 704 can direct the distal portion 710 in a desired orientation within the heart. The ventricular anchor 700 can include a distal marker near the second curved portion 704 to indicate how far the inner ventricular anchor 700 should extend beyond the delivery catheter 100. The advantage of the two preset curves (proximal and distal) in the anchor catheter sheath 700 described herein is that when the delivery catheter 100 is positioned centrally above the mitral valve within the atrium, by simply advancing the anchor catheter sheath 700 distally from the end of the delivery catheter 100, the tip of the anchor catheter sheath 700 can be guided to a target position that can be between the bases of the papillary muscles of the left ventricular posterior wall without additional catheter manipulation.

[0150] As described above, the above-described embodiments having the preset proximal and distal curves 702 and 704 can advantageously direct the distal end of the anchor sheath to the desired location for the anchor when the anchor sheath exits the delivery catheter. In a variant, the anchor sheath 700 can be maneuvered through the use of a pull wire or other mechanism for maneuvering the catheter. In such an embodiment, the maneuverable anchor sheath 700 can be configured in the position described above and can be configured to have proximal and distal steering zones that can be articulated via the angles described above with respect to the preset proximal and distal curves 702, 704. In another embodiment, a preset mandrel can be provided with the preset proximal and distal curves 702, 704 arranged as described above. The preset mandrel can then be inserted through the anchor sheath such that the anchor sheath takes the shape of the preset mandrel.

[0151] (Rotational suture cutter) FIGS. 23A-C, FIGS. 24A-D, FIGS. 25A-B and FIG. 26 show other embodiments of a cutter catheter 500 used to cut sutures 74, 344 in one or more of the above procedures and systems. For example, when the sutures 74, 344 are locked (fixed) within the suture lock 376, the proximal end of the sutures 74, 344 can be cut adjacent to the proximal face of the suture lock 376 using a suture cutter catheter 500 according to one embodiment described herein.

[0152] Referring to FIGS. 23A and 23B, a cutter catheter (also referred to as an intravascular suture cutter) 500 has an outer sheath 504 extending through a delivery catheter 502 and an inner shaft 506 extending through the outer sheath 504. The proximal end of the outer sheath 504 can be coupled to a luer lock 503. Referring to FIG. 24, the outer sheath 504 is coupled to a cutter housing 510 at the distal end of the outer sheath 504. The cutter housing 510 can be in the shape of a barrel forming a cylindrical chamber. The distal end of the cutter housing 510 has a hole 512. The suture extends through the hole 512 and then extends through a window 514 formed in the side surface of the cutter housing 510 so as to define a suture path extending through the cutter housing 510. Thus, the sutures 74, 344 can advance through the cutter housing 510 as shown in FIG. 23C.

[0153] Referring to FIGS. 25A, 25B, and 26, a cutter head 520 is disposed to rotate within the cutter housing 510. The cutter head 520 can have a hollow half-barrel shape or a partial barrel shape including a cutting edge 522. The cutting edge 522 extends from the distal end to the proximal end of the cutter head 520 and thus has a helical path or a curved shape. As shown in FIG. 26, the cutting edge 522 can extend along the side surface of the cutter head 520. The suture extending through the distal hole 512 and the side window 514 can be cut by rotating the cutter head 520 within the cutter housing 510. By rotation, the suture is compressed between the cutting edge 522 and the inner surface of the cutter housing 510. Due to the shape of the cutting edge 522, the suture is sliced. This is a more efficient and reliable cutting operation compared to a compression or chopping operation.

[0154] ​Advantageously, when the intravascular suture cutter 500 advances within the heart, the cutting edge 522 of the cutter head 520 is not exposed and is covered by the surface of the cutter housing 510. For example, as shown in FIG. 26, the cutting edge 522 is covered by the inner surface of the cutter housing 510. In the illustrated embodiment, the cutter catheter 500 has a lock 540 at the distal end of the intravascular suture cutter 500 to prevent rotation between the cutter head 520 and the cutter housing 510. In the illustrated embodiment, the lock 540 has a protrusion 550 on the cutter head 520 that engages a corresponding recess 552 in the cutter housing 510. When engaged, the protrusion 550 and the recess 552 prevent rotation between the cutter head 520 and the cutter housing 510. Thus, the cutting edge 522 remains in a position covered by the inner surface of the cutter housing 510 without being exposed. The protrusion 520 and the recess 522 can be disengaged by axially advancing the rotating housing 520 relative to the cutter housing 510. In the non-engaged position, the cutter head 520 can be rotated relative to the cutter housing 510 to cut the suture as described above. The protrusion 520 and the recess 522 may be reversed in other configurations and may be disposed on other portions of the cutter housing 510 and the cutter head 520.

[0155] Figure 27 shows a proximal handle 570 that can be formed around the lure lock 503. The handle 570 can be used to control the movement of the cutter head 520 and the cutter housing 510. In this configuration, the cutter head 510 can be fixed relative to the handle 570. The cutter head 520 can be rotationally coupled and engaged to the suture cutter handle 572 such that rotation of the suture cutter handle 572 causes the cutter head 520 to rotate relative to the cutter housing 510. As shown, the suture cutter handle 572 is disposed in a retracted position relative to the handle 570, in which position the protrusion 550 and the recess 552 engage to prevent rotation between the cutter head 520 and the cutter housing 510. A lock 578 is provided on the handle 570. By releasing the lock 578, the cutter head handle 572 can move axially (e.g., distally in the illustrated embodiment) relative to the handle 570. In this way, the engagement of the protrusion 550 and the recess 552 is released, and the suture cutter handle 572 cuts the rotational suture relative to the handle 570.

[0156] (Cotton fluff having a radiopaque marker) Figures 28-31 show examples of valve tip anchors 641 having a cotton fluff 640 and that can be used with the systems and methods described herein. Figures 28 and 29 schematically show an example of a cotton fluff 640 formed by securing it to the distal end of a suture 644 between two flat sheets 645a, 645b. Figure 29 shows a cross-section of the cotton fluff 640 along line B-B shown in Figure 28. In some embodiments, the suture 644 is inserted (e.g., substantially in the center of the sheet) between the two sheets 645a, 645b, compressed and / or laminated such that the three components are joined (e.g., under heat and / or pressure). At least one layer may be partially sintered. The suture 644 is flattened to improve resistance to suture breakage. And / or may be densified. The sheet may be a flat polytetrafluoroethylene (PTFE) sheet (e.g., a thin uncured expanded PTFE (ePTFE) sheet) or any other suitable material. In some implementations, the valve tip suture 644 may be arranged between the sheets in a zigzag or S-shape. FIG. 30 shows the cotton suture 640 of FIG. 28 including a plurality of openings 643 passing through the proximal tail 660 of the suture 644. In some embodiments, one or more of the openings 643 may be formed through the cotton suture in various configurations so as to form a foldable structure as described elsewhere herein configured to secure the suture 644 to the valve tip of the mitral valve. FIG. 30 shows an opening 643 extending through the suture 644 and through the center of the cotton suture. In some embodiments, the openings 643 are formed alternately on opposite sides of the suture 644. In some embodiments, the openings 643 may be formed on the same side of the suture 644 (e.g., on the wing 641 or the wing 642). In the illustrated configuration, a plurality of openings 643 may be formed through the suture 644. The plurality of openings 643 may be aligned along the center of the cotton suture 640. The plurality of openings 643 may be aligned along the length of the suture 644 (e.g., form a straight line). The opening 643 may extend from a first end that is proximal to the cotton suture 640 to a second end that is distal. The suture 644 may be at least partially flattened between two opposing sheets, thereby facilitating the placement of the opening 643 through the suture 644. Various combinations of the openings 643, including the arrangements described above, may be used.

[0157] A radiopaque marker may be added to the cotton suture 640. For example, in the embodiments shown in FIGS. 28 - 31, the marker band 660a may be arranged around or about the suture adjacent to the second end, i.e., the distal end, of the cotton suture 640. The marker band 660a may be crimped to the suture 64 at this location. Then, as shown in FIG. 31, the proximal end 660 of the suture 644 is the m Starting from the opening 643 closest to the marker band 660a, it is passed through the opening 643 formed in the cotton spreading thread 640. Thereby, the marker band 660a is arranged at the distal end of the cotton spreading thread 640 during deployment. The cotton spreading thread 640 may be deformable from an elongated strip (piece) - like configuration to a radially expanded and axially shortened configuration by the proximal - direction retreat (contraction) of the suture 644.

[0158] (Flexible cotton spreading thread feeding needle) As described above, in certain embodiments, a radially expandable valve tip anchor moves within a hollow needle having a sharp end for penetrating the valve tip. The radially expandable valve tip anchor may have a cotton spreading thread. The cotton spreading thread may be deformable from an elongated strip (piece) - like configuration to a radially expanded (enlarged) and axially shortened configuration by the proximal - direction retreat of the suture.

[0159] In some embodiments, the hollow needle includes an outer surface having one or more helical grooves. In other embodiments, the hollow needle may have one or more raised helical coils, for example, a thin coil attached to the outside of the hollow needle. FIG. 32 shows an embodiment in which the hollow needle 1204 has a helical coil 1205 attached to the outer surface of the needle 1204. Since the valve tip may move before, during, and after the puncture process, the valve tip may have a range of motion where a hollow needle without grooves or a raised helical coil may slip off the valve tip. There are several advantages to the grooved surface or raised helical coil. First, if the hollow needle does not completely puncture the valve tip, i.e., the distal portion of the hollow needle does not allow the feeding of the cotton spreading thread, or if the physician determines that there is a possibility that the hollow needle may disengage from the valve tip earlier than intended, the physician can apply force to the catheter or a mechanism within the catheter that transmits rotational force to the needle to further screw the hollow needle into the valve tip tissue to secure it so that the valve tip does not disengage from the needle. Second, when the cotton spreading thread is fed, the physician can apply force to the catheter or a mechanism within the catheter that transmits rotational force to the needle, and the physician can remove the needle by loosening the hollow needle from the valve tip.

[0160] According to the catheter system used, the hollow needle can be oriented to puncture the needle from the left atrial side to the left ventricular side of the heart. In other embodiments, the hollow needle can be oriented to puncture the valve tip from the left ventricular side to the left atrial side of the heart. Since the entry point from outside the patient to the heart may be different, it is desirable that at least a part of the hollow needle is flexible. By using a flexible hollow needle, the hollow needle can move across all the curved portions to access the valve tip, and the physician can finely adjust the placement of the needle before puncturing the valve tip. FIG. 32 shows a cut portion 1203 of the hollow needle that provides flexibility to the hollow needle as needed. In some embodiments, the cut portion 1203 of the hollow needle is formed by laser cutting, machining, or other well-known methods.

[0161] Also, the system may include a hollow needle that punctures the valve tip through the release of an accumulated energy source. For example, the accumulated energy is a spring, a pressurized liquid, a pressurized gas, an electrically actuated piston, or by other well-known methods. In some embodiments, the energy storage device is a spring. In a further embodiment, as shown in FIG. 33, the spring is disposed in the cotton floss delivery handle 1202.

[0162] The amount of stored energy needs to provide sufficient force to the hollow needle to puncture the valve tip at a sufficient distance or depth. As used herein, "sufficient distance or depth" means that the distal end of the hollow needle completely punctures the valve tip without contacting or puncturing other structures within the heart, allows the needle to remain engaged with the valve tip while the valve tip is moving, and / or allows the physician to feed the pledget. If the needle does not puncture the valve tip at a sufficient distance or depth, the physician rotates the hollow needle to further advance it through the valve tip tissue. If the needle does not puncture the valve tip at the correct position, the physician rotates the hollow needle in the opposite direction to remove it from the valve tip tissue. Next, the system is rearmed, i.e., stored energy is applied to the system to properly position the hollow needle for pledget delivery, and the system is repositioned and activated. In some embodiments, the system includes a control device. The physician places the catheter (including the retracted hollow needle) on or near the valve tip, confirms that the catheter is in the correct position relative to the valve tip, and releases the stored energy to puncture the valve tip. At least a portion of the distal end of the catheter, the distal end of the hollow needle, or both is radiopaque or includes other visualization aids that allow the physician to confirm the correct position of the puncture prior to feeding the pledget via the release of the stored energy.

[0163] (Component Stabilization and Suture Management System) Aspects of the present disclosure that can be used alone or in combination with the above-described aspects are stabilization systems for transvascular cardiac repair used to stabilize and / or adjust the position of the proximal portion (e.g., the handle) of the components of one or more of the aforementioned subassemblies (e.g., the delivery catheter 100 and / or one or more various subsystems that can advance into the delivery catheter). The stabilization system can also include a suture management system for adjusting the length and / or tension of one or both of the ventricular anchor suture and at least one valve tip suture.

[0164] In certain embodiments, a suture management system for transvascular cardiac repair assists in maintaining a substantially fixed force or tension on the suture while a physician adjusts the length of the suture and sets the tension of the suture lock. Those skilled in the art will understand that the term "substantially fixed force" includes allowing for small variations in tension. For example, in one embodiment, a 10% variation in tension occurs.

[0165] An advantage of using such a suture management system is that it allows the valve leaflets to continue to move in a "natural" state in response to the heartbeat during the repair procedure, while applying a substantially constant tension to the suture such that each pledget remains in substantial contact with the valve leaflet. Additionally, by using the device, suture entanglement can be prevented or minimized. A further advantage is that the physician can individually adjust each suture to increase or decrease the tension and thereby adjust the final movement of the valve leaflet as needed. The suture management system can be positioned in the operating room near the physician during the procedure. After the anchors and valve leaflet sutures are deployed to the patient, the ends of the sutures passing through the delivery catheter can be attached to the suture management system and held at the aforementioned substantially constant tension.

[0166] In certain aspects of the present disclosure, aspects of the stabilization system are beneficial and can be used independently of aspects of the suture management system or device. Similarly, certain aspects of the suture management system are beneficial and can be used independently of aspects of the stabilization system. Nevertheless, as described herein, certain advantages can be achieved by systems that utilize various combinations and sub - combinations of the aspects of the stabilization and suture management systems described herein.

[0167] Figures 34A and 34B illustrate an embodiment of a stabilization system (referred to as the "system") 1500. The system 1500 has a base or tray 1502 that can be placed on a stand or table (not shown) to avoid movement of the device during treatment. As shown in Figure 35, the base has an upper or top plate 1504 and a bottom or lower plate 1506. The upper plate and the lower plate (also referred to herein as the upper plate and the bottom plate) 1504, 1506 can be movably connected to each other via an adjustable positioning mechanism 1510 (also referred to herein as the "adjustment mechanism") having a lower threaded boss 1512 coupled to the lower plate 1506 and an upper threaded boss 1514 coupled to the upper plate 1504 in the illustrated embodiment. A screw 1516 extends through the lower threaded boss 1512 and the upper threaded boss 1514. Axial movement of the screw 1516 (see Figure 35) relative to the lower plate 1506 is restricted such that rotation of the screw handle 1518 causes the upper plate 1504 to move relative to the lower plate 1506. Thus, the adjustment mechanism 1510 can relocate the upper plate 1504 (and components coupled thereto) in the direction of arrow 1520 relative to the lower plate 1506 that is attached to the stand or table as needed. The adjustment mechanism 1510 may include a lock to prevent movement between the upper plate 1504 and the lower plate 1506. In some embodiments, other mechanisms such as slide plates, complementary rails, and a second channel or rollers that axially move the upper plate and the lower plate relative to each other may be used.

[0168] The stabilization portion 1550 of the system 1500 includes a plurality of components that are used to hold or stabilize the components of the mitral valve chordal repair device described above. In particular, as described in detail below, the device includes the proximal portion of the introducer sheath (e.g., the handle), the delivery catheter 100, the ventricular anchor delivery subsystem 300, the suture lock delivery subsystem 370, the cotton suture delivery subsystem or handle 1202, and / or the suture It can be used to hold or stabilize the handle or proximal end of the cutter catheter 500. Such components can be configured according to the examples and aspects described herein.

[0169] For example, the system may include a first docking platform 1600 that can be disposed at the distal portion of the system 1500. As used herein, the first docking platform 1600 is referred to as the "distal docking platform 1600". The distal docking platform 1600 can be configured to hold or stabilize the handle or proximal portion of the introducer catheter. The various components of the delivery subsystem described herein advance through the introducer catheter. Referring to FIG. 35, the distal docking platform 1600 has a first stabilizing device 1602 in the form of a clamp 1602. The first stabilizing device 1602 can be configured to clamp (fix with a clamp) around the annular portion of a catheter such as an introducer or access sheath. In the illustrated embodiment, the clamp 1602 has a pair of clamp plates 1604, 1606 that move closer to or away from each other by a threaded post 1608 coupled to a handle 1610. Thus, in the illustrated arrangement, operation of a control device such as rotation of the handle 1610 causes the plates 1604, 1606 to clamp (fix) the introducer sheath (not shown) to the system 1500. In some embodiments, other mechanisms such as a friction fit device, a collet, or a device that securely attaches to an engagement feature on the handle of the introducer sheath may be used for the first stabilizing device 1600 to stabilize the catheter or introducer sheath.

[0170] As shown in FIGS. 34A, 34B, and 35, the clamp can be coupled to the upper plate 1504 and the base 1502 by the arm 1620. The arm 1620 has an "L" shape that positions the clamp 1602 upward and forward along the axial direction of the upper plate 1504. The arm 1620 can be coupled to the upper plate such that movement of the upper plate 1504 relative to the lower plate 1506 causes the clamp 1602 to move axially.

[0171] As shown in FIG. 36, the distal docking platform 1600 has a second stabilization device 1650. In the illustrated embodiment, the second stabilization device 1650 is in the form of a clamp and is provided on the arm 1620. In the illustrated embodiment, the second stabilization device 1650 can be disposed at the elbow portion of the arm 1620. The second stabilization device 1650 can be used to stabilize other components of the mitral valve repair system described herein. For example, the second stabilization device 1650 can be used to stabilize the proximal end (or handle) of the suture lock delivery subsystem (see, e.g., FIG. 14).

[0172] The illustrated second stabilization device 1650 has a clamp 1652 for holding components. See FIG. 34A. In the illustrated embodiment, the clamp 1652 includes a pair of plates that move towards and away from each other by a control mechanism such as a screw, similar to the first stabilization device. Thus, in the illustrated configuration, rotation of the screw clamps (fixes) a part of the suture lock delivery subsystem (not shown) to the system 1500. In some embodiments, other mechanisms such as a friction engagement device or a device that securely connects to an engagement feature of the suture lock delivery subsystem may be used in the front mount to stabilize the suture lock delivery subsystem. As shown in FIG. 36, the arm may include a platform 1660 used to support a part of the handle or other part of the suture lock delivery subsystem. In one configuration example, the second stabilization device 1650 can be used to fix the front part of the suture lock delivery subsystem while the rear part or the back of the handle suture lock delivery subsystem is located on the platform 1660.

[0173] Referring to FIGS. 35 and 36, the system 1500 has a second docking platform 1700. The second docking platform 1700 is disposed proximal to the first docking platform 1600 and is referred to herein as the proximal docking platform 1700. Proximal, i.e., the second docking platform 1700, is supported above the base 1502 by an arm 1702 extending from the upper plate 1504. The proximal docking platform 1700 may be located at the same height as the aforementioned stabilization device. The proximal docking platform 1700 can include components of the suture management system, which will be described in more detail below. The proximal docking platform 1700 includes a third stabilization device 1710. The device 1710 can include an elongated concave support surface such as an axially extending U-shaped channel that can be used to support components such as the handle of the ventricular anchor delivery subsystem according to the embodiments described herein. The second docking platform 1700 can be coupled to the upper plate 1504 via an arm 1702 such that movement of the upper plate 1504 causes the platform 1700 to move. Thus, in the illustrated arrangement, the proximal docking platform 1700 and the distal platform 1600 are supported by the upper plate and, in some embodiments, are fixedly supported by the upper plate.

[0174] Referring to FIGS. 35 and 36, system 1500 has a third docking platform 1800. The third docking platform 1800 can be disposed between the first and second docking platforms 1600, 1700 in the axial direction of the attached instrument. As described above, the first and second docking platforms 1600, 1700 are respectively disposed in the distal and proximal directions with respect to each other. In this specification, the third docking platform 1800 is also referred to as the intermediate docking platform 1800. The intermediate docking platform 1800 includes a fourth stabilizing device 1802 that can be in the form of a vise or a clamp. The intermediate docking platform 1800 is disposed between the first and second docking platforms 1600, 1700. The intermediate docking platform 1800 includes an adjustment mechanism 1810. In the illustrated embodiment, the adjustment mechanism 1810 can include a threaded engagement between the stabilizing device 1802 and the lower rail 1812. The lower rail 1812 can be fixed to the upper plate 1505. The screw 1816 is rotated to move the stabilizing device 1802 relative to the rail 1812 and the upper plate 1504. The adjustment mechanism 1810 is repositioned in the fourth stabilizing device (and components coupled thereto) to the lower plate 1506 that is attached to the stand or table as needed. The adjustment mechanism 1810 can have a lock to prevent movement. The intermediate docking platform is supported by the upper plate 1504. Also, the adjustment mechanism 1810 is repositioned in the fourth stabilizing device (and components coupled thereto) to components supported by or fixedly supported by the upper plate 1504 and the distal and proximal docking platforms (and components coupled thereto) such as the upper plate.

[0175] In use in one embodiment, a fourth stabilization device is used to stabilize a delivery catheter, such as the aforementioned delivery catheter 100. In a particular embodiment, a first stabilization device 1650 is used to stabilize an introducer catheter, and a fourth stabilization device 1802 is used to stabilize a delivery catheter 100 inserted into the introducer catheter. Thus, rotation of the screw 1816 allows for slight movement of the delivery catheter relative to the introducer catheter. That is, movement of the intermediate docking platform allows the delivery catheter to move relative to the distal docking platform and the introducer catheter attached thereto.

[0176] Referring to FIGS. 37, 38, a suture management system 1700 has at least one, two, three or more tension elements. The tension elements are used to hold each suture and assist in keeping the suture under constant tension, thus avoiding sagging where the cotton suture may be drawn into the left atrium or left ventricle by the forces generated with each heartbeat, and further avoiding a sagging suture from becoming entangled in the left atrium or left ventricle, or a sagging suture from becoming entangled with other chordae tendineae in the left ventricle.

[0177] For example, in one embodiment, an anchor suture is attached to an anchor tension element 1720. The anchor tension element 1720 has a rotating spool 1712. The rotating spool 1712 includes a torque limiting fixture, such as a clutch, for limiting the amount of tension applied to a suture (e.g., a suture coupled to a ventricular anchor) wound around the spool. If excessive tension is applied to the anchor suture, the anchor tension element 1720 can advantageously avoid or reduce the risk of the anchor being pulled out of the heart wall. In other embodiments, the anchor tension element 1720 may include a spring strut structure that applies tension to the suture. In one embodiment, the proximal end of the suture coupled to the ventricular anchor 302 of the ventricular anchor delivery subsystem 300 is wrapped around the anchor tension element 1720 after the ventricular anchor is deployed. In this way, a certain amount of tension is applied to the suture, and a torque limiting fixture such as a clutch prevents or limits excessive tension from being applied to the ventricular anchor. In one embodiment, the torque limit of the clutch is from about 2 N to about 5 N. In certain embodiments, the torque limit of the clutch is 2 N to 5 N.

[0178] Referring to FIGS. 37 and 38, at least one, two, three, or more suture adjustment finger portions 1770 are provided that enable adjustment of the tension of the suture to the valve tip. In use, the suture coupled to the pledget is attached to a tensioning portion such as a weight 1750 to provide a desired tension. In certain embodiments, the weight is from about 2 to about 8 grams. In certain embodiments, the weight is 2 to 8 grams. In the illustrated embodiment, the weight 1750 is received in the proximal platform 1700 by providing a weight attachment portion such as a plurality of holes (openings), recesses, or sockets for receiving the weight 1750. The suture (e.g., valve tip suture) is disposed in a suture guide 1760 that is a notch or groove formed in the platform 1700. The guide 1760 can be configured to allow the suture to slide axially while imposing some restraint on lateral movement. The proximal docking platform 1700 has at least one, two, three, or more suture guides 1760. By hooking the end of the suture (e.g., valve tip suture) attached to the weight 1750 over the edge of the platform 1700, a certain amount of tension can be applied to the suture of the pledget that acts to limit or prevent entanglement of the suture. As described above, the platform 1700 includes a plurality of guides 1760, whereby it is hooked over the edge of the platform 1700.

[0179] As shown in FIGS. 37 and 38, the platform 1700 includes a suture adjustment mechanism or finger portion 1770 disposed near or adjacent to the notch or groove 1760. The suture adjustment mechanism 1770 includes or consists of a rotating spool. Each spool has a slot 1774 through which the suture extends. The rotating spool 1770 can rotate to adjust the tension on the suture.

[0180] The suture management system provides a dynamic valve leaflet management system. The advantages of using such a system are that during a repair procedure, while allowing the valve leaflets to continue to move in a "natural" state in response to the heartbeat of the heart, each suture is maintained in substantial contact with the valve leaflets by applying a substantially constant tension to the suture. Further, by using the system, suture entanglement is prevented or minimized. A further advantage is that the physician is provided with the ability to individually adjust each suture to decrease or increase the tension to adjust the final movement of the valve leaflets as needed. For example, in one embodiment of use, after advancing the suture lock (described in the previous embodiment) against the patient and before locking and cutting the suture, the tension on the suture can be adjusted while observing the operation of the valve. This can be accomplished by rotating the spool to increase or decrease the slack of the wire and the corresponding tension. Once the desired tension is achieved, the suture lock can be actuated as described above.

[0181] For example, up to four, a plurality of sutures can be fixed to the suture management device, and a plurality of suture management devices can be used as needed. The components of the device can include any suitable sterilizable material that meets the performance requirements of the device, including, by way of non-limiting example, stainless steel, acetal resins such as polyoxymethylene, PTFE, aluminum, 3D printed resin materials, and the like.

[0182] (Valve Leaflet Tissue Anchor Deployment System) According to a further aspect of the present disclosure, an alternative valve leaflet tissue a An anchor deployment system is provided. Referring to FIG. 39, the needle deployment catheter 332 reciprocates the needle 336 axially. A radiopaque marker band 1900 is provided at the distal end of the needle deployment catheter 332, whereby the position of the marker band 1900 is visualized in relation to the leaflet tips of the mitral valve while the needle 336 is retracted proximally into the catheter 332.

[0183] In FIG. 39, the needle 336 is shown in a configuration advanced in the distal direction. The needle 336 comprises a tubular body 1902 having at least one flexibility enhancing feature such as a side wall 1904 and a slot pattern. In the illustrated embodiment, at least one serpentine slot 1906 extends through the side wall. The serpentine slot 1906 can be formed by various methods well known in the art such as laser etching a hypotube. The serpentine slot 1906 improves the lateral flexibility of the needle 336 along the flexure zone and facilitates targeting the appropriate position on the mitral valve leaflet. The flexure zone is typically less than about 4 cm or less than about 2 cm in length, but is of sufficient length to accommodate the entire length of the cotton suture. In a particular embodiment, the flexure zone is typically less than 4 cm or less than 2 cm in length, but is of sufficient length to accommodate the entire length of the cotton suture.

[0184] The needle 336 terminates distally at a sharp tip 1908 spaced from the tubular side wall 1904 by an inclined surface 1910. The inclination angle of the inclined surface 1910 is typically in the range of about 30° to 85, alternatively in the range of about 70° to 80, and in one embodiment is about 75°. In one embodiment, the inclination angle of the inclined surface 1910 is typically in the range of 30° to 85, alternatively in the range of 70° to 80, and in one embodiment is 75°.

[0185] At least one tissue retention element 1912 is provided to allow the needle 336 to advance distally through the tissue by a rapid and forced motion, but to resist the proximal retraction of the needle 336 from the target tissue. The retention element 1912 may have various structures extending radially outward from the tubular sidewall 1904, such as at least one or two or five or ten or more folded portions (barbs), annular rings, or tabs. In the illustrated embodiment, the retention element 1912 has an annular ring in the form of a continuous helix 1914 that can be formed from a polymeric strand or metal wire wound helically around the tubular body 1902. In one embodiment, the helical wire is, for example, 0.008-inch wire and is fixed to the tubular body 1902 by welding or other means.

[0186] By advancing the needle 336 distally from the diplo catheter 332 at a sufficient speed, the needle 336 can penetrate the valve tip without the need for the valve tip stabilization anchor shown at 406 in FIG. 3. The retention element 1912 holds the valve tip sufficiently on the needle until the cotton suture is deployed. Thereafter, the needle is retracted proximally without being rotated, or is rotated to loosen the needle and remove it from the valve tip.

[0187] If additional valve tip stabilization is desired, stabilization can be achieved by the aforementioned temporary valve tip anchor, or by alternative mechanical techniques for gripping or grasping the valve tip, or by suction or cryogrip using a cryo (freezing) catheter. These techniques include the types of cryo catheters used in ablation procedures for freezing target tissue. Cryoablation catheters used for atrial fibrillation often accidentally adhere to the valve tips of the mitral valve and it is necessary to stop the operation to release the adhered valve tips. The same cryo attachment can be used to find and separate the valve tips that have been problematic for stabilization during the deployment of the valve tip anchor deployment needle. The cryo catheter uses gas exchange (NO or argon) to lower the temperature at the tip of the catheter and can reach a low temperature of minus 75 degrees Celsius.

[0188] (Actuator control system) The deployment of the mitral valve leaflet anchor described herein is achieved by piercing (stabbing) the valve leaflet from the atrial side of the valve. To avoid the need for a grasping structure to capture and support the valve leaflet during piercing of the valve leaflet, and to use a needle as shown in FIG. 39, the withdrawal of the valve leaflet anchor deployment needle distally can be timed to correspond to the peak (systolic) pressure of the ventricle that occurs near or around the QRS complex. This synchronizes the piercing of the valve leaflet with mitral valve closure, and the systolic pressure within the ventricle provides the necessary backup support during penetration of the valve leaflet from the atrium.

[0189] The timing of the valve leaflet needle firing with the cardiac cycle may be done manually by the clinician or may be partially or fully automated depending on the implementation of the objective. For example, a visual signal or an audio signal or a fluorescence image may alert the clinician to the timing of the QRS complex, and the clinician presses a firing trigger or other control to deploy the needle. Since the reaction time of the clinician can vary, it may be desirable to partially or fully automate the needle firing procedure.

[0190] For example, the needle 338 may comprise an automatic needle driver such as a solenoid carried by the proximal end of the catheter. The solenoid is activated to project the needle distally in response to an activation signal that temporally corresponds to a target time in the cardiac cycle, such as during mitral valve closure.

[0191] As an alternative, the activation signal is a visual, tactile or auditory signal to the clinician, in response to which the clinician operates a control such as a button or a slider to manually advance the needle or operates a control device that activates an electromechanical or mechanical needle driver.

[0192] In other embodiments of the present disclosure, the deployment of the needle can be performed manually by a clinician, but can only be performed after unlocking the lockout. In this embodiment, the removable mechanical interference portion can be formed at or coupled to the proximal portion of the needle shaft. The interference surface facing distally is provided on a radially outwardly extending tab or annular flange coupled to the needle, or on the distal surface of an opening extending through the needle. For this purpose, "needle" refers to the needle itself, as well as any structure (e.g., extension tube or rod) that is mechanically coupled to the needle and extends proximally and moves with the needle, as understood by those skilled in the art.

[0193] The interference surface facing proximally is configured to be movable between an engaged state in which it engages with the interference surface facing distally of the needle by an interference fit (frictional engagement), and a non-engaged state in which the interference surface facing distally and the corresponding structure are free to advance distally to withdraw the needle. The interference surface facing proximally is provided on a stopper such as a pivotable or sliding lever that is movably carried by an axially movable pin or proximal handpiece. A stopper driver, such as a solenoid, is configured to move the stopper between the engaged state and the non-engaged state.

[0194] To prevent deployment of the needle, the stopper may first be engaged. In response to an activation signal indicating a target time (e.g., during or before or around the QRS complex), the stopper retracts to the non-engaged state. This prevents the clinician from deploying the needle prematurely, but allows the clinician to manually deploy the needle at the desired target time. To prevent a late deployment of the needle and to form a narrow window that allows the clinician to fire the needle, after a preset time window following the activation signal, the stopper automatically returns to the engaged state. If the clinician is unable to deploy the needle on time within the window, an opportunity to fire the needle is obtained again, after which the QRS complex occurs.

[0195] Various techniques have been developed to directly detect the QRS complex or to detect a proxy for a point in the cardiac cycle. Direct detection techniques include power spectrum analysis, band It includes real-time technologies that rely on pass filtering, differentiation, template matching, and waveform functions. The proxy includes blood pressure measured invasively, such as blood pressure measured on the arterial side or venous side or in the atrium or ventricle, or non-invasively measured blood pressure such as peripheral blood pressure. Since the aortic valve is open when the mitral valve is closed, the measured value on the venous side functions as a proxy (substitute) for the timing of the QRS complex, and distinct features appear in the periodic venous pressure curve. Data from any of the aforementioned sources is preferably adjusted to take into account the time delay from the true QRS complex according to the desired time sensitivity. The ECG signal is usually already present and can also be obtained from a conventional ECG monitor operating in the operating room.

[0196] A typical ECG waveform is composed of a P wave indicating atrial depolarization, a QRS complex indicating ventricular depolarization, a T wave indicating ventricular repolarization, and a U wave that may indicate an extension of repolarization in some cases. The main activity of the ECG is usually related to the real-time identification of the QRS complex for various monitoring and diagnostic purposes. The QRS complex or QRS wave usually has a duration of about 80 to 120 milliseconds and corresponds to the start of ventricular contraction and the ejection of blood through the aortic valve. In certain embodiments, the QRS complex or QRS wave usually has a duration of 80 to 120 milliseconds and corresponds to the start of ventricular contraction and the ejection of blood through the aortic valve. This corresponds to the pressure-responsive closure of the mitral valve and is important for the purposes of the present disclosure.

[0197] Figures 40-45 show a system that provides control of an actuator in synchronization with the heart 10. As used herein, an actuator refers to one that is activated in response to a control signal triggered by an event in the cardiac cycle, such as visual, audio, or tactile feedback to a clinician, an automated needle firing mechanism, or a lockout mechanism in an embodiment related to manual operation needle deployment that prevents a clinician from deploying a needle until the actuator releases the lock of the firing mechanism.

[0198] The overall such system is shown in FIG. 40. The illustrated system includes components for sensing the cardiac cycle 212, components for generating a trigger pulse for the actuator in response to the sensed cardiac cycle 218, components for positioning the leading edge of the trigger pulse at a specified time within the cardiac cycle 232, components for defining the width of the trigger pulse that occurs during the cardiac cycle 234, and components for controlling the arcing of the actuator for a certain period in response to the trigger pulse and in response to the defined width 222.

[0199] In particular, the electrocardiogram (ECG) unit 212 is electrically connected to the patient's heart 10 so as to sense the cardiac cycle and provide an ECG signal 216. The ECG unit 212 can be connected to the heart in any known manner for sensing cardiac signals, typically including surface-mounted electrodes and internal or intracavitary electrodes attached to the patient's chest. As an alternative, the sensing connection can be incorporated integrally with the catheter 332, such as by providing one or more electrical leads extending through the catheter 332 to conduct an electrical signal or by operating a sensor (e.g., a pressure sensor) or electrode at the distal end of the catheter 332. The electrodes can be of a unipolar structure where surface contact is used or a bipolar structure. The electrical leads extend proximally through the catheter 332 and can then be removably connected to the ECG unit 212 and terminated with a standard electrical connector for transmitting the sensed signal 216.

[0200] The signal 216 is sent to a trigger generator 218. The trigger generator 218 provides a trigger pulse 220 to the actuator arcing circuit 222. The actuator arcing circuit 222 applies a voltage to the actuator 224, such as firing a needle or removing a barrier that inhibits the clinician from firing the needle prematurely.

[0201] The position of the trigger pulse 220 in the heartbeat cycle of the ECG signal 216 is determined by a pulse positioning circuit 232. The width and duration of the pulse 220 during the heartbeat cycle are It is determined by the pulse width circuit 234. The trigger generator 218, the pulse positioning circuit 232, and the pulse width circuit 234 are included as additional boards in the PC or microprocessor 236. In this case, the system can be controlled via a computer keyboard and appropriate software. The PC 236 and the ECG 212 either have separate monitors or have a single monitor 238 that displays both information regarding the ECG and the trigger pulse 220 and surrounding information.

[0202] The trigger generator 218 may include a marker pulse circuit 250 that provides a marker pulse 252 and a trigger pulse circuit 254 that generates a trigger pulse 220 in response to the marker pulse 252. As an alternative, the marker pulse circuit 250 is included in the ECG itself.

[0203] This can be understood in more detail by referring to FIG. 44. Here, the ECG signal 216 can be considered to consist of a series of heartbeat cycles 256a, 256b, 256c including waveforms Q, R, S, and T. When the waveform R crosses a preselected threshold 258, marker pulses 252a, 252b, 252c are generated. Next, trigger pulses 220a, 220b, 220c are generated by the trigger pulse circuit 254. The position of the leading edge 260 and the full width 262 of each trigger pulse 220 are determined by the pulse positioning circuit 232 and the pulse width circuit 234. In response to the trigger pulse 220, firing pulses 264 shown as 264a, 264b, 264c in FIG. 44 are generated to apply a voltage to the actuator 224.

[0204] Figure 42 shows the actuator ignition circuit 222. The actuator ignition circuit 222 includes a gate 270 that inhibits the feeding of the trigger circuit 220 to the actuator laser power supply 272 (when relevant) in the actuator unit 224. The inhibiting effect of the gate 270 is realized when the operator activates the switch 274. However, the trigger pulse 220 is inhibited by an arming circuit 276 that has an inhibiting effect realized by the operation of the arming switch 278. This double lock on the feeding of the trigger pulse 220 to the actuator power supply 272 ensures that the ignition of the actuator is truly desired and not accidental. Thus, the operator must first make the system operable by operating the arming switch 278 to enable the arming circuit 276. Only then can the operator, by activating the switch 274, pass the next occurring trigger pulse 220 through the gate 270 to the actuator power supply 272. Details of a suitable design for synchronizing the trigger signal with the QRS wave are disclosed in U.S. Patent No. 5,674,217 to Wahlstrom et al., filed November 16, 1993. The disclosure thereof is incorporated herein by reference in its entirety.

[0205] (Fusion Suture) In certain embodiments, the disclosed system may use polytetrafluoroethylene (PTFE) or expanded polytetrafluoroethylene (ePTFE) sutures for their desirable tensile strength and relatively low creep. However, sutures made of PTFE and ePTFE cannot be easily cut by cutting or melting.

[0206] To overcome this problem, some embodiments of the present disclosure relate to a suture in which at least a portion of the suture is meltable. In some embodiments, the suture can be a two-component suture that includes a suture material at the distal end of the suture that is meltable and a non-meltable suture material at the proximal end of the suture. In some embodiments, the distal portion of the suture comprises less than 50% of the total length of the suture. In other embodiments, the proximal end of the suture comprises more than the total length of the suture. In other embodiments, the two-component suture includes a portion of the meltable suture, and the meltable portion is a relatively small meltable region that includes non-meltable suture material on either side of the meltable region. The meltable The region needs to be positioned at the location of the suture so as not to affect the tensile strength or creep resistance of the implanted prosthetic chordae. When using a two-component suture, the junction between the meltable portion and the non-meltable portion should be positioned in the vicinity of the point where the suture is tied or the position of the suture lock so as not to affect the strength of the suture. After implantation of the prosthetic chordae, while the heart is functioning normally, there should be no tension applied to the meltable suture at all, or tension should be applied to a relatively small portion of the suture. The two-component suture should have sufficient tensile strength over the entire length of the suture, particularly at any interface (junction) between the meltable and non-meltable portions, so that the physician can apply sufficient tension to the suture during the step of applying tension so that the suture does not break (rupture) when tension is applied to correct mitral regurgitation.

[0207] FIG. 46 is a schematic side view of the heart according to an embodiment, showing a left atrium 3301 and a left ventricle 3302 separated by a posterior mitral valve and an anterior mitral valve (not labeled). In this embodiment, the cotton suture 3303 is fixed to the valve tip on the ventricular side, and a part of the non-melting suture 3304 extends from the cotton suture to the left atrium 3301, passes between the two valve tips, and extends to the left ventricle 3302. In the left ventricle 3302, the tissue anchor 3305 is fixed to the heart tissue by the helical anchor 3306. The non-dissolving suture 3308 is joined to the non-dissolving suture 3304 via the knot 3307. The melting suture 3309 shows only a part of the suture after being cut, and the remaining distal end of the melting suture has retreated through the catheter (not shown). In this embodiment, the tension due to the beating heart is applied to all of the sutures 3304 and 3308, and substantially no tension is applied to the melting suture 3309. The length of the distal end of the suture needs to be as short as possible. Note that only one distal part of the sutures 3304 and 3308 is shown.

[0208] The system further comprises a suture cutter. When tension is set on one or more sutures and mitral regurgitation is corrected or minimized, the suture cutter can be advanced through a catheter disposed across the distal ends of the one or more sutures to melt the melting suture and cut the suture. The distal end of the melting suture is retracted through the catheter so as to be removed from the patient. Each of the one or more sutures is cut one at a time, or two or more sutures are melted at a time. The suture cutter includes a heat source, for example, a coil, and a voltage is applied to heat the coil so that the temperature proximate to the coil rises above the melting temperature of the melting suture.

[0209] FIG. 47 shows an example in which the suture cutter 3310 advances through a catheter (not shown) across the distal end 3311 of the suture to the suture lock 3312. The suture connected to the cusp cotton suture 3303 and the suture connected to the anchor 3306 with tension applied to minimize or correct mitral valve regurgitation are fixed (clamped) to the suture lock 3312 so that the suture cannot move through the suture lock 3312 when tension is applied to the suture while the heart is functioning normally. The suture cutter 3310 includes a heat source, for example, a heater coil 3315, a short tube coaxial with the heater coil 3315, including a heater housing 3316, having an inner diameter larger than the outer diameter of the heater coil, for insulating the heart structure from heat, a hypo tube 3317 for preventing blood from entering the catheter, and an insulated conductor 3318 for supplying electrical energy to the heater coil to provide a temperature exceeding the melting point of the fusible suture. The supply of electrical energy to the heater coil is performed by the physician when the suture cutter is moved to a predetermined position and stopped by the physician after cutting the suture. In FIG. 47, the non-fusible suture (not numbered) extends beyond the suture lock (towards the direction of the suture cutter), and the fusible portion of the suture is arranged coaxially with the coil of the suture cutter and inside the inner diameter of the coil. Thus, when the distal portion of one or more sutures is removed, only a relatively short portion of the end or tail of the suture extends beyond the suture lock, and the remaining portion of the suture extending to the cusp and ventricular anchor is a non-fusible suture and remains firmly fixed to the suture lock.

[0210] The fusible suture component includes, but is not limited to, a suitable fusible composition including polyolefin, polyethylene, ultra-high molecular weight polyethylene, polypropylene, polyester, polyamide, polyglycolide / L-lactide, polyethylene terephthalate, silicone, amino acid proteins such as collagen, and combinations thereof. In some embodiments, a portion of the suture is made fusible using any one of the aforementioned polymers as the fusible portion of the suture or the fusible region. The non-fusible portion of the suture can be PTFE or ePTFE.

[0211] (Suture Lock Guide) The foregoing embodiments provide an effective mechanism for transcatheter mitral valve chordal repair, such as the implantation and effect of an artificial chord. The following embodiments are based on many of the above concepts to provide additional advantages. For example, the normal function of the heart can cause periodic movement and load on the mitral valve chord repair system. In particular, as a result of the normal compression cycle of the heart, the suture lock or other components (e.g., the suture) may vibrate or move within the ventricle. This movement is shown in FIG. 48. Arrows 4180 and 4182 indicate the movement of the suture and the movement of the suture lock, respectively.

[0212] The oscillatory motion of the suture and suture lock can contribute to excessive wear at the suture, particularly at the junction of the suture lock and the suture. The resulting wear can ultimately lead to premature degradation and breakage (rupture) of the artificial chordae tendineae. In particular, in one system, the suture passes through the suture lock, for example, along its longitudinal direction. The suture connecting the leaflet tip of the mitral valve to the anchor extends from one end of the suture. Due to the weight of the suture lock, the other end of the suture lock is slightly pulled down relative to the orthogonal direction, and this angular movement presses the suture against the suture lock. When the suture lock forms an acute angle, this angle can result in shear forces that may cause the suture to break prematurely (rupture). For example, FIG. 49 shows a suture lock 4206, and due to the orientation of the suture lock 4206, the suture 4211 is disposed relative to the acute angle of the suture lock 4206. During the movement of the suture 4211 and the suture lock 4206, the acute angle creates shear forces on the suture 4211. The suture 4244 can be subject to similar shear forces. These shear forces can be amplified by the rotational movement of the suture lock 4206, as indicated by the arrow 4202.

[0213] Furthermore, as the tension on the suture increases, for example, as shown in FIG. 50, the suture lock tends to rotate in a direction substantially orthogonal to the suture. This movement, in addition to the mass of the suture lock and the resulting inertia during other movements, applies a high impact force to the suture, for example, as part of a "whiplash" motion. Depending on the situation, the suture may break into pieces due to its viscoelastic properties. Thus, the movement of the suture lock (e.g., relative to the anchor) can be an additional cause of potential failures in the mitral valve chordae repair system.

[0214] Furthermore, changes in tension on the suture can potentially change the length of the artificial chordae tendineae, which can, for example, negatively impact the effectiveness of the artificial chordae tendineae in, for example, MR resolution. For example, as shown in FIGS. 49 and 50, when the tension on the suture is decreased or removed, the suture lock 4206 assumes a specific orientation with respect to the sutures 4211, 4244. In this situation, the artificial chordae tendineae has a specific length when measured, for example, between the valve leaflet (where suture 4244 is attached to the valve leaflet) and the ventricular tissue (where suture 4211 is fixed to the anchor 4202). In fact, a portion of the suture (e.g., suture 4211) is wound around the suture lock 4206 and does not contribute to the overall length of the artificial chordae tendineae. However, when tension is applied to the suture, that tension causes the suture lock 4206 to rotate as shown in FIG. 50. As a result, the portion of the suture 4211 that was previously wound around the suture lock 4206 is pulled away from the suture lock 4206, and correspondingly, the length of the artificial chordae tendineae increases. In certain situations depending on the situation, this increase can be from about 0.10 mm to 0.30 mm and, in some cases, 0.50 mm. In some embodiments, the amount of change depends on the width of the suture lock 4206 and the angle of rotation of the suture lock 4206. Depending on the situation, these length changes can reduce the effectiveness of the artificial chordae tendineae, requiring readjustment or reattachment of the artificial chordae tendineae by the physician.

[0215] Embodiments of the present disclosure are designed to mitigate some or all of the effects of these problems and provide additional advantages of improving the effectiveness of the artificial chordae tendineae and / or increasing ease of implementation. For example, some embodiments include a transcatheter mitral valve chordae tendineae repair system designed to reduce or eliminate movement of the suture with respect to the suture lock and other system components. Further, certain embodiments act to reduce the amount of unconstrained suture within the ventricle. Some embodiments provide an artificial chordae tendineae incorporating an artificial papillary muscle capable of reducing the flail effect.

[0216] Certain embodiments are designed to limit or eliminate the movement of the suture lock relative to the anchor. Also, these embodiments limit or eliminate the movement of the suture relative to the anchor, at least in the location near the anchor. As a result, these embodiments reduce suture wear and extend the lifespan of the mitral valve chordal repair system.

[0217] In some embodiments, a transcatheter mitral valve chordal repair system forms an artificial papillary structure using a retaining member, also referred to as a suture lock guide (e.g., a socket or sleeve), that limits the movement of the suture lock. An example of such a suture lock guide was in the form of a tubular sleeve 78, as described above with reference to FIGS. 2A, 2B. The movement of the suture relative to the suture lock is also constrained in the vicinity of the suture lock, thereby reducing suture wear. In some embodiments, the transcatheter mitral valve chordal repair system includes a suture lock guide, referred to as an anchor socket, that limits the movement of the suture lock relative to the anchor and the movement of the suture relative to the suture lock.

[0218] The embodiments herein can provide an artificial (prosthetic) system designed to maintain integrity over about 800 million cycles or about 20 years. In certain embodiments, the embodiments herein can provide an artificial (prosthetic) system designed to maintain integrity over 800 million cycles or 20 years. An artificial chord is disclosed that can last at least 400 million cycles or about 10 years. In certain embodiments, an artificial chord is disclosed that can last at least 400 million cycles or 10 years. These artificial chords function in various situations and environments without excessive structural damage and / or dysfunction after 400 million cycles, i.e., without holes, tears, overall delamination, cuts, fraying, incomplete leaflet junctions, excessive regurgitation, etc.

[0219] Figures 51 and 52 show a trans-catheter mitral valve chordal repair system 4300 according to some embodiments of the present disclosure. This system 300 uses a trans-catheter delivery system to provide one or more artificial chords using one or more sutures or tethers deployed on a beating heart without extracorporeal circulation. These embodiments reduce wear of the anchor sutures or tethers over time by using a retention member or a restraint member. In some embodiments, the retention member or the restraint member includes a stent-like or stent-graft-like socket fixed to a fixation device or an anchor disposed on the epicardium. To deliver the components of the system 4300 described above, the delivery systems and techniques disclosed in the above-mentioned and / or International Applications PCT / US2017 / 069046 and PCT / US2019 / 021480 can be used. These are incorporated by reference.

[0220] Figures 51 and 52 show the anchor 4302, the retaining member 4304, and the suture lock 3406. In some embodiments of this specification, the retaining member 4304 is a socket or sleeve similar to the sleeve 78 or socket described with reference to FIGS. 2A and 2B in a particular aspect of the present disclosure. In other embodiments, the retaining member can be a pin, hook, clasp (fastener), claw, catch, buckle, suture, and the like. The anchor 4302 can be partially or wholly any of the anchors disclosed in the foregoing and / or International Application No. PCT / US2017 / 069046 or International Application No. PCT / US2020 / 021480. FIGS. 51 and 52 show the suture 4308 and the anchor suture 4310. FIGS. 51 and 52 show two sutures 4308, but only one suture or more than two sutures may be used. For example, using the systems or techniques described in the foregoing and / or International Application No. PCT / US2017 / 069046 or International Application No. PCT / US2020 / 021480, the suture 4308 can be coupled to one or more cusp tips of the mitral valve, for example using cotton pledgets. Accordingly, the suture 4308 is referred to as a cotton pledget suture. The anchor 4302 can engage the ventricular tissue, and the retaining member 4304 can receive and secure the suture lock 4306 and the sutures 4308, 4310.

[0221] The suture lock guide or retaining member 4304, in some embodiments, restricts the movement of the suture 4308 and / or suture lock 4306 while facilitating the placement, adjustment, and ultimately manipulation of the suture 4308 as part of an artificial chordae tendineae. For example, in some embodiments, the retaining member (also referred to as the suture lock guide) 4304 is configured to selectively couple and decouple from the suture lock 4306. When coupled to the suture lock 4306, the retaining member 4304 provides a fixation force strong enough to prevent slippage during the cardiac cycle (e.g., a force of up to about 1N, 1.5N, 2.0N, 2.5N, or 3N, non-limiting), yet still allows the physician to tighten or loosen the suture 4308 by pulling on the suture 4308 without displacing the suture lock 4306. In other embodiments, the retaining member 4304 is designed to secure the suture 4308 and suture lock 4306, and when adjusting the suture, the physician removes the suture lock 4306 from the retaining member 4304, adjusts the suture 4308, and then reinserts the suture lock 4306 into the retaining member 4304. Removing the suture lock from the retaining member 4304 requires, in certain embodiments, a greater force, e.g., a force exceeding about 6N to about 9N, or in some embodiments, a force exceeding 10N. That is, in non-limiting embodiments, the retaining member 4304 is configured to exert a retaining force on the suture lock that resists a force of from about 4N to at least 10N, including a force of about 4.5N, 5N, 5.5N, 6N, 6.5N, 7N, 7.5N, 8N, 8.5N, 9N, 9.5N, 10N, 10.5N, or 11N.

[0222] As a result of the retaining member 4304, the suture lock 4306 can maintain its positional relationship with the anchor 4302. For example, when the heart tissue moves during the cardiac cycle, the retaining member 4304 resists the displacement force applied to the suture lock 4306 (e.g., via the suture 4308). In some embodiments, the retaining member 4304 transmits the force applied to the suture lock 4306 to the anchor 4302. The displacement force may range up to about 1N, and optionally, the displacement force may be about 1.5N or up to about 3N.

[0223] In some embodiments, the retaining member 4304 is a socket formed by inverting a vascular graft tube. The retaining member 4304 is designed to be radially conformable such that the suture lock 4306 can be inserted into the retaining member 4304 while providing a restraining force. Further, the retaining member 4304 has axial rigidity and is wear-resistant. Due to the axial rigidity, the suture lock 4306 can be inserted into the retaining member 4304 without buckling. The wear resistance is minimized by PTFE-PTFE interaction.

[0224] For example, in the embodiments shown in FIGS. 51 and 52, the retaining member 4304 includes an inner surface 4330 that defines a chamber for receiving and fixing the suture lock 4306 and / or the suture 4308. In some embodiments, the retaining member 4304 is flexible enough to accommodate the suture lock 4306 and is formed of a material that allows adjustment of the suture 4308 relative to the suture lock 4306 even after the suture lock 4306 is inserted into the retaining member 4304. In some embodiments, the retaining member 4304 is radially conformable to allow the suture lock 4306 to be inserted and coupled to the retaining member 4304. The retaining member 4304 may be coupled to the suture lock 4306 using an interference fit or frictional engagement or the like.

[0225] In some embodiments, the retaining member 4304 is coupled to an outer surface of the suture lock 4306, for example, a portion of the outer surface located between the proximal and distal ends of the suture lock 4306. For example, the retaining member 4304 contacts the opposite side of the suture lock 4306 so as to be coupled to the suture lock 4306. In other embodiments, the retaining member 4304 contacts the suture lock 4306 at three or more points so as to inhibit movement of the suture lock 4306 relative to the anchor 4302. In FIGS. 51 and 52, the retaining member 4304 and the suture lock 4306 are cylindrical, and the retaining member 4304 engages the suture lock 4306 along or around the periphery. In FIGS. 51 and 52, the engagement contact between the retaining member 4304 and the suture lock 4304 extends longitudinally along the circumferential surface of the suture lock. In some embodiments, the engagement contact extends over at least half of the longitudinal extent of the suture lock. In other embodiments, the engagement contact extends over from about 20% to about 98% of the longitudinal extent of the suture lock. In other embodiments, the above range may be more restricted, for example, from about 40% to about 80%, from 50% to about 70% or a combination of the ranges (partial ranges of the explicitly recited ranges by way of example).

[0226] Also, FIGS. 51 and 52 illustrate a support member 4354 or support coil that reinforces the material of the retaining member 4304 when the retaining member 4304 secures the suture lock 4306 and the suture 4308. In some embodiments, the anchor 4302 and the support member 4354 are two separate structures that can be integrated. In other embodiments, the anchor 4302 and the support member 4354 are integrally formed of a single material. The support member 4354 may extend along the length of the retaining member 4304 such that it terminates at a position substantially aligned with the distal face of the suture lock 4306 when fully inserted into the socket 4304. In other embodiments, the support member 4354 extends along the length of the retaining member 4304 at a position substantially aligned with the upper portion of the suture lock 4306 and terminates at a position below the distal (or proximal) face of the suture lock 4306. The support member 4354 contacts the outer surface of the retaining member 4304. The adhesive material 4362 is disposed along the exposed outer surfaces of the support member 4354 and the retaining member 4304. This adhesive material 4362 may contact the exposed outer surface of the anchor hub 4338.

[0227] In some embodiments, the support member 4354 provides axial rigidity to prevent folding when the suture lock 4306 enters the retaining member 4304. For example, in FIGS. 51 and 52, the support member 4354 is a support coil that resists the longitudinal force applied to the retaining member 4304 by the suture lock 4306 when the suture lock 4306 is pushed into the retaining member 4304. This additional rigidity holds the retaining member 4304 stably, thereby allowing for easy installation. In other embodiments, the retaining member 4304 may be formed of other materials and have other configurations. For example, the support member 4304 is formed from a plurality of metal strips extending longitudinally along the outer surface of the retaining member 4304, or is one or more cylindrical cuffs spaced longitudinally along another surface of the retaining member 4304. In some embodiments, the retaining member 4354 is a branch formed of nitinol or a similar material.

[0228] In some embodiments, the support member 4354 provides additional fixing force to maintain the suture lock 4306 and the suture 430 8 within the retaining member 4304. For example, in FIGS. 51 and 52, the support member 4354 is a support coil. In some embodiments, when the suture lock 4306 is pushed into the retaining member 4304, the support coil is linearly compressed and its inner diameter is expanded to accommodate the suture lock 4306. The compression force of the support coil (e.g., upon reaction to the original configuration and a smaller inner diameter) increases the frictional force between the retaining member 4304 and the suture lock 4306. Further, in some embodiments, the support coil is configured to linearly extend in response to a force pulling the suture lock 4306 from the retaining member 4304. This further reduces the inner diameter of the support coil and increases the frictional force between the retaining member 4304 and the suture lock 4306.

[0229] In some embodiments, the support member 4354 terminates at an intermediate portion of the retaining member 4304 below the distal portion of the retaining member 4304. Thus, the distal portion of the retaining member 4304 above the support member 4354 exerts a relatively small force on the suture lock 4306 and the suture 4308 compared to the combination of the retaining member 4304 and the support member 4354. With a relatively small force, the physician can adjust the tension or length of the suture 4308 without moving the suture lock 306 from the retaining member 4304.

[0230] In other words, in some embodiments, the retaining member 4304 (alone or in combination with the support member 4354) provides a force sufficient to hold the suture lock 4306 during the cardiac cycle (e.g., a force of about 0 N to about 4 N). By the force applied by the physician to the valve leaflet (e.g., pulling on the distal end of the suture 4308) and / or the suture 4308 (e.g., pulling on the proximal end of the suture 4308), the physician can adjust the suture 4308 relative to the suture lock 4306, and the suture lock 4306 remains fixed within the retaining member 4304 to adjust the length of the suture 4308 between the suture lock 4306 and the valve leaflet. In some embodiments, the force required to move the suture 4308 is 1 N to 2 N. Thus, the retaining member 4304 (alone or in combination with the support member 4354) secures the suture lock 4306 relative to the anchor 4302 during adjustment of the suture 4308. When the suture lock 4306 engages the suture 4308 (as described below), the retaining member 4304 secures the suture lock 4306, thereby fixing the suture 4308 as part of the artificial mitral valve chordae tendineae.

[0231] Continuing to refer to the embodiment described with reference to FIGS. 51 and 52, the retaining member 4304 has a generally cylindrical structure. The retaining member 4304 may be a stent or stent graft structure formed (in whole or in part) from ePTFE. The material forming the retaining member 4304 promotes ingrowth of tissue to further secure the anchor 4302 and / or the artificial chordae tendineae. The material forming the retaining member 4304 includes a film microstructure in which the fiber orientation is in a direction substantially parallel to the longitudinal axis of the retaining member 4304. Thus, the longitudinal movement of the suture 4308 (e.g., a suture made of ePTFE) is aligned with the fiber orientation to further reduce suture friction and wear.

[0232] In other words, in some embodiments, the retention member 4304 is made of ePTFE graft, elastomer, other polymers, or combinations of these materials. For example, in some embodiments, the retention member 4304 is composed of a stretch graft made of ePTFE and can be densified to enhance column strength. In some embodiments, the retention member 4304 is partially or completely bioresorbable or biodegradable and, for example, provides temporary fixation up to a biological fibrous adhesion between tissue and other components. In some embodiments, the retention member 4304 includes a mesh designed to enhance biocompatibility and fibrosis after implantation. All or part of the surface of the retention member 4304 can be configured to promote tissue growth on and / or through its surface. In one example, this growth is achieved by providing a relatively rough and / or porous surface. In another example, one or more holes are drilled in the material of the retention member 4304 to allow scar tissue fibroblasts to grow through these holes and thereby strengthen the fixation. Additionally, a biological coating of a type known in the art is included on the surface of the retention member 4304 to promote healing and tissue growth.

[0233] The suture lock 4306 is fixed within the retention member 4304 and is coaxially aligned with the anchor 4302. This configuration minimizes or eliminates the relative movement of the suture lock 4306 with respect to the suture 4308, at least within the retention member 4304. Also, this configuration minimizes or eliminates the movement of the suture 4308 within the retention member 4304 with respect to the suture lock 4306 and the anchor 4302.

[0234] In some embodiments, the length of the support member 4354 is from about 0.5 mm to 3.0 mm. In other embodiments, the length of the support member 4354 is from one quarter of the length of the retention member 4304 to the full length of the retention member 4304.

[0235] Other embodiments (e.g., the embodiments shown in FIGS. 2A, 2B, 55) do not include the support member 4354. Some embodiments apply various restraint forces via other mechanisms, such as changing the materials and / or surface treatments used to construct different portions of the socket or changing the size of the socket at different locations. Still other embodiments utilize an external tool that expands the upper portion of the socket or reduces the restraint force on the suture and suture lock in the upper portion.

[0236] As shown in FIG. 52, the suture 4308 can be disposed between the outer surface of the suture lock 4306 and the inner surface of the retaining member 4304. In some embodiments, these surfaces (in whole or in part) are designed to facilitate fixation of the suture 4308, for example, having a higher coefficient of friction. In other embodiments, these surfaces (in whole or in part) are designed to facilitate easy adjustment of the suture 4308 and have a lower coefficient of friction. One or both of these surfaces may have elasticity to assist in fixing the suture 4308 while allowing adjustment.

[0237] Fixing the suture 4308 between the suture lock 4306 and the retaining member 4304 provides additional advantages. For example, even if the tension on the proximal portion of the suture (e.g., the portion extending from the socket 4306 to the proximal end of the physician's or catheter's device) fluctuates or is removed, the suture lock 4304 and the retaining member 4304 maintain the logarithmic tension on the distal portion of the suture (e.g., the portion extending from the suture lock 4306 to the valve tip). As a result, when the suture lock 4306 is disposed within the retaining member 4304, thereby fixing the suture 4308, a change in tension in the proximal portion of the suture (e.g., if the physician accidentally bumps the catheter) does not substantially affect the tension in the distal portion of the suture 4308. Thus, the physician does not need to maintain the tension state of each suture 4308 during the operation. Further, in some embodiments, the suture lock 4306 and the retaining member 4304 can be used to maintain the tension in the distal portion of one suture during the adjustment of other sutures.

[0238] As shown in FIG. 52, in some embodiments, the retention member 4304 has an upper enlarged portion 4376 and a lower enlarged portion 4378. These enlarged portions 4376, 4378 provide additional axial rigidity to prevent folding or buckling when the suture lock 4306 is pushed into the retention member 4304. Further, the upper enlarged portion 4376 can incorporate a band that increases rigidity and provides a radiopaque marker. In some embodiments, the upper enlarged portion 4376 includes an outer surface that is located further outward (e.g., along a radial direction) than the lower portion of the socket. The upper enlarged portion 4376 has an inner surface that is located further outward (e.g., along a radial direction) than the lower portion of the retention member 4304. For example, the upper enlarged portion 43 76 is tapered (e.g., funnel-shaped) to assist in receiving the suture lock 4306.

[0239] The sutures 4308, 4310 may be formed from a surgical grade material such as a biocompatible polymer suture material. Examples of such materials include 2-0 ePTFE (polytetrafluoroethylene) or 2-0 polypropylene. In some embodiments, the sutures 4308, 4310 do not have an elastic force. In other embodiments, the sutures 4308, 4310 have a partial or complete elastic force. In some embodiments, the sutures 4308, 4310 are partially or completely bioresorbable or biodegradable and provide temporary fixation, for example, up to a biological fibrous adhesion between tissue and other components. Thus, the sutures 4308, 4310 may be formed from a biocompatible material (e.g., nitinol, ePTFE, PTFE, PET, or polyester, nylon, silicone, collagen or other amino acid proteins, stainless steel, cobalt chrome, combinations thereof, etc.).

[0240] Figures 51 and 52 show an anchor hub 4338 that contacts the heart tissue 4352 and functions as a stop point for the anchor 4302 when screwed into the heart tissue. In some embodiments, the anchor hub 4338 includes an upper surface that is coupled to a bushing 4353 (as described below). The anchor 4302 and the anchor hub 4338 are joined together via mechanical means such as frictional engagement, chemical means, or other means. The anchor hub 4338 transmits the force applied to the retaining member 4304 to the heart tissue 4252 via the anchor 4302 (e.g., via the suture 4308). Thus, the anchor hub 4338 is interlocked with the retaining member 4304 to dampen the vibratory motion caused by the movement of the heart.

[0241] In some embodiments, the proximal surface of the anchor hub 4338 contacts a suture lock 4306 (e.g., the nose portion of the suture lock 4306) and a suture 4308. The anchor hub 4338 (or at least its proximal surface) is designed from a material that increases frictional force to secure the suture 4308 disposed between the anchor hub 4338 and the suture lock 4306. It may be formed from, or alternatively, may be formed from a material that reduces frictional force to facilitate adjustment of the suture 4308 disposed between the anchor hub 4338 and the suture lock 4306. The anchor hub 4338 is formed from PFA, silicone material, PTFE material, ePTFE material, thermoplastic plastic, etc. (or combinations thereof). In some embodiments, the anchor hub 4338 is formed, in part or in whole, from a rigid plastic such as metal, stainless steel, titanium, or PEEK, or other sufficiently rigid material. The proximal surface or bushing of the anchor hub 4338 that interacts with the suture lock is formed from PFA, silicone material, PTFE material, ePTFE material, thermoplastic plastic, etc. (or combinations thereof).

[0242] In some embodiments, the bushing 4353 is disposed adjacent to the anchor hub 4338 to relieve the buffering of the suture lock 4306. The bushing may be formed from PFA or another polymer. The bushing provides a surface that contacts the suture 4308 and, in combination with the nose portion of the suture lock 4306, aids in securing the suture 4308. In some embodiments, the bushing facilitates adjustment of the suture by virtue of the interaction between the PFA material of the bushing and the ePTFE material of the suture 4308. Also, the bushing may provide a surface that reduces wear of the suture, particularly when the anchor hub 4338 presents a rougher surface to the suture 4308 (e.g., due to the material and / or surface of the anchor hub 4338). The proximal surface of the bushing 4353, or the anchor hub 4338 that interacts with the suture lock, is formed from PFA, silicone material, PTFE material, ePTFE material, thermoplastic, etc.

[0243] In some embodiments, the diameter of the hub (e.g., hub 4338) corresponds to the small diameter or inner diameter of the support member 4354. Depending on how it is attached, the length of the hub 4338 is sufficient to attach the support member 4354 to the hub 4338 and engage a driver with the hub 4338. The shape by which the retaining member 4304 is attached to the hub 4338 is smaller than the small diameter of the support member 4354. In some embodiments, the outer diameter of the retaining member 4304 is smaller than the diameter of the support member 4354.

[0244] As shown in FIG. 52, the anchor suture 4310 can pass through the channel 4336 of the anchor hub 4338 and be fixed in the vicinity of the bottom surface 4340 of the anchor hub 4338. In some embodiments, the channel 4336 includes a bottleneck portion 4342 that secures the anchor suture 4310 (e.g., by capturing a knot formed at the end of the anchor suture 4310 below the anchor suture 4342). In other embodiments, the anchor suture 4310 and the anchor hub 4338 are joined to each other by mechanical means such as friction fitting, chemical means, or other similar means.

[0245] The suture lock 4306 may have the features of the suture lock described herein and / or disclosed in International Applications PCT / US2017 / 069046 and PCT / US2019 / 021480. The suture lock 4306 has a cylindrical outer surface corresponding to the cylindrical chamber of the holding member 4304 to provide frictional engagement or interference fit. The suture lock 4306 may have a locking mechanism (e.g., an internal locking mechanism) that selectively secures the anchor suture 4310 and the suture 4308. The illustrated suture lock 4306 includes a nose portion 4370 that provides a rounded surface against which the suture is pressed when tension is applied. In this way, the suture lock 4306 avoids sharp edges that could abrade the suture 4308. In some embodiments, the nose portion 4370 is formed from, for example, PFA or other materials designed to reduce wear of the suture.

[0246] The suture lock 4306 moves down along the anchor suture 4310 until it enters the cylindrical chamber of the retaining member 4304. The retaining member 4304 provides some radial resistance to the suture lock 4306 but is radially conforming to receive the suture lock 4306. In some embodiments, the suture 4308 can be adjusted even when the suture lock 4306 is in its lowest position (i.e., down to the end of the socket 4304, including pushing the bushing 4353). For example, the suture 4308 is most easily adjusted while the suture lock 4306 is outside the retaining member 4304. However, the suture 4308 can still be adjusted even after the suture lock 4306 has entered the retaining member 4304. In some embodiments, when the suture lock 4306 is in its lowest position, the suture 4308 is sandwiched between the PFA bushing 4353 and the PFA nose 4370 of the suture lock 4306. In some embodiments, at this stage, there is greater resistance, but the suture 4308 can still be adjusted. For example, the suture lock nose 4370 and the bushing 4353 reduce friction for easier adjustment. In other embodiments, alternatively, the bushing 4353 and the nose 4370 are designed to fix the suture and prevent further movement.

[0247] In some of the embodiments described above, the anchor 4302 is pre - assembled with the retaining member 4304. In other words, the anchor 4302 and the retaining member 4304 are coupled outside the patient's body. Then, the suture lock 4306 is coupled to the retaining member 4304 inside the patient's body (e.g., via frictional engagement or interference fit). In other embodiments, the retaining member 4304 and the suture lock 4306 are coupled outside the patient's body. Then, the retaining member 4304 and the anchor 4302 are coupled to each other inside the patient's body (e.g., via frictional engagement or interference fit).

[0248] In some embodiments, the retaining member 4304 is configured to expand. For example, In some embodiments, the retaining member 4304 is formed of an elastic material that expands when the suture lock 4306 is pushed down onto the retaining member 4304 and assists in resealing around the suture lock 4306 and fixing it in place. In other embodiments, the retaining member 4304 has an expanded structure and a retracted (contracted) position. The retaining member 4304 is fed in the expanded structure, and when the suture lock 4306 is positioned in place, the retaining member 4304 is folded to the retracted position to fix the suture lock 4306 in place.

[0249] In some embodiments, as shown in FIG. 53, the anchor 4402 defines a longitudinal line 4403, and the retaining member 4404 or a restraint member (e.g., a socket) restricts the movement of the suture lock 4406 relative to the anchor 4402 in a direction orthogonal to the longitudinal line 4403 defined by the anchor 4402. In some embodiments, the retaining member 4404 restricts the movement of the suture lock 4406 relative to the anchor 4402 in a plane orthogonal to the longitudinal line 4403. In some embodiments, the retaining member or restraint member (e.g., socket 4404) restricts the movement of the suture lock relative to the anchor along the longitudinal line 4403.

[0250] As shown in FIG. 53, the restraint member 4404 substantially aligns the longitudinal line 4403 defined by the anchor 4402 and / or the longitudinal line 4405 defined by the restraint member 4404 with the longitudinal line 4407 defined by the suture lock 4406. In some embodiments, the retaining member 4404 fixes the suture lock 4406 in a coaxial relationship with the anchor 4402 and / or the retaining member 4404. In some embodiments, the longitudinal lines defined by the anchor 4402, the retaining member 4404, and / or the suture lock 4406 extend to the cusp of the mitral valve.

[0251] In some embodiments, as shown in FIG. 54, the retaining member 4504 restricts the angular movement of the suture (suture 4511) with respect to the suture lock 4506. As previously described with reference to FIGS. 49 and 50, in some embodiments, the suture lock rotates in response to forces during the cardiac cycle, and as a result, the angles formed by the portion of the suture extending from the suture lock toward the valve tip with respect to the longitudinal line defined by the suture lock vary widely. The position of the suture lock above the anchor and close to the valve tip also contributes to the angular movement. However, as shown in FIG. 54, the retaining member 4504 suppresses the angular movement of the suture 4511 by fixing the suture lock 4560 in a specific direction. For example, in some embodiments, the angle 4520 formed between the portion of the suture 4511 extending from the suture lock 4506 toward the valve tip and the longitudinal line 4522 of the suture lock 4506 is less than 45°. In some embodiments, the angle 4520 ranges from about -45° to +45°, which is in the range of about 0° to 45° in two opposite directions. This angle 4520 can be formed in any plane including the said portion of the suture 4511 and the longitudinal line 4522 of the suture lock.

[0252] The suture 4511 moves during the cardiac cycle, but the retaining member 4504 can limit the angular movement (change in angle 4520) to less than 90°. In some embodiments, the change in angle is less than 45°, and in other embodiments, the change in angle is less than about 40°, 35°, 30°, 25°, 20°, 15°, 10°, 8°, or about 5°.

[0253] A method for measuring the change in angle between the ventricular anchor and the suture lock will be described.

[0254] The change in angle between the anchor and the suture lock is determined, for example, by the following steps:

[0255] 1. Fix the ventricular anchor to one side of a tensile testing machine. This can simulate the anatomical structure of the ventricle, such as a silicon pad, or clamp it to the jaws of the clamp of a standard tensile testing machine (cl It can be carried out by fixing with a lamp.

[0256] 2. Fix the artificial chord to the opposite side of the tensile testing machine. This can be carried out by simulating the valve tip structure such as a silicon pad or clamping (fixing with a clamp) it to the jaw part of the clamp of a standard tensile testing machine.

[0257] 3. Use a suture lock to connect the ventricular anchor and the artificial chord.

[0258] 4. Apply a load to the system including the ventricular anchor, the artificial chord, and the suture lock at a minimum tension of 2N.

[0259] 5. Measure the angle (angle 1) between the axis of the suture lock or any linear feature of the suture lock and the axis of the ventricular anchor or any linear feature of the ventricular anchor.

[0260] 6. Unload the system including the ventricular anchor, the artificial chord, and the suture lock to a load less than 0N or a load corresponding to the static weight with which the system is hanging on the load cell.

[0261] 7. Measure the angle (angle 2) between the axis of the suture lock or any linear feature of the suture lock and the axis of the ventricular anchor or any linear feature of the ventricular anchor.

[0262] 8. Calculate the difference between angle 1 and angle 2.

[0263] During the installation of the artificial chordae, the anchor and the retention member are fed (e.g., via a catheter), and the anchor is implanted into the ventricular tissue. The anchor suture extends from the anchor. Next, the suture (e.g., a pledgetted suture) is coupled to one or more mitral valve leaflets. The suture lock advances the anchor suture and the pledgetted suture. In some embodiments, the physician can adjust the position of the suture lock relative to the pledgetted suture so that the length of the pledgetted suture between the suture lock and the leaflet ensures proper operation of the artificial chordae (e.g., to reduce and / or eliminate MR). For example, the physician can pull on the proximal portion of one suture to reduce the amount of suture located between the suture lock and the leaflet of the mitral valve.

[0264] However, in certain embodiments, the suture lock is not restricted. As a result, adjusting the suture (e.g., pulling on the suture) moves the suture lock upward, which affects the tension of the portion of the suture between the suture lock and the mitral valve. This problem can be exacerbated when multiple sutures are used with the suture lock. Adjusting one suture causes the suture lock to rise and undo previous adjustments of the other sutures.

[0265] For example, the suture can be attached to the leaflet and passes through a suture lock that functions as a movable pulley for the suture. Specifically, when the physician pulls on the end of the suture located outside the body, the suture moves. However, pulling on the proximal end of the suture can cause the suture lock to move upward, so the physician's movement on the suture located outside the body does not correspond one-to-one with the movement of the suture between the suture lock and the leaflet.

[0266] This problem can worsen when multiple sutures pass through a single suture lock. For example, a physician can adjust the first suture to the correct length. However, when the physician begins to adjust the second suture, the suture lock displaces due to this movement. This affects the first suture and requires the physician's force to readjust the first suture. This can affect the second suture and additional adjustments are required.

[0267] Additional problems occur when the physician cuts the suture after engaging the suture lock. Suture Before cutting the suture, the physician maintains the tension of the suture, thereby keeping the suture lock in a higher position. Cutting the suture (and / or disconnecting the suture lock from the catheter) can release the tension and cause the suture lock to move downward. This can affect the effectiveness of the suture as an artificial chord. The physician needs to maintain the tension of the suture (e.g., the first suture while adjusting the second suture), thus causing further problems. For example, inadvertent movement of the catheter (e.g., accidental collision) can cause the suture lock to move, potentially changing the length of the suture between the suture lock and the tissue (e.g., valve leaflet).

[0268] Some of the embodiments described herein address the above problems by fixing the suture lock within the retaining member, thereby forming a pivot point for the suture that is stationary relative to the anchor. This is particularly beneficial when adjusting the suture during the formation of an artificial chord by a physician. By fixing the suture lock to the anchor (e.g., using a retaining member), upward movement of the suture lock during adjustment can be substantially eliminated.

[0269] Furthermore, having a stationary pivot point results in a more direct correlation between the adjustment of the proximal portion of the suture (i.e., pulling a part of the suture closer to the physician) and the resulting adjustment of the distal portion of the suture (i.e., the portion of the suture between the suture lock and the mitral valve). In particular, many of the embodiments described herein are bidirectional and allow for precise adjustment of the suture, such that the movement of a guide device (e.g., a catheter) is translated into a change in the length of the suture, for example, between the valve leaflet and the suture lock. For example, moving the guide device 1 mm forward results in the suture also moving 1 mm forward. This is referred to as a "one-to-one motion." As will be readily understood by those skilled in the art from the present disclosure, some embodiments herein allow for a one-to-one motion or a near one-to-one motion under various conditions. In particular, International Application PCT / US2017 / 062014 and International Application PCT / US2019 / 021400, which are incorporated herein by reference, disclose mechanisms that allow the suture to be "pushed." This includes, for example, placing a rigid tubular structure (i.e., a coil) on the suture. The rigidity provided by the coil allows the suture to be pushed, such as a cardiac guide wire. In this regard, the modified movement of the suture follows the movement of the guide device (e.g., a catheter or a coil) "one-to-one."

[0270] In other words, by fixing the suture lock within the holding member, a fixed pivot point for the suture is formed, such that the movement by the physician on the suture located outside the body has a one-to-one correspondence with the movement of the suture between the suture lock and the valve leaflet. As will be readily understood by those skilled in the art, depending on the situation, for example, in non-limiting embodiments, other variations where the nature and extent of the problem are significantly different from the movement of the suture lock (e.g., a slight elongation of the suture or a small movement of the suture lock) may result in the one-to-one motion becoming a near one-to-one motion. For example, the ratio of the movements (movement ratio) can range from 1:1 to about 1:0.95, 1:0.90, 1:0.85, 1:0.80, etc., and can vary up to 1:0.50.

[0271] Additional advantages are obtained by forming a pivot point fixed by a suture lock. For example, when multiple sutures pass through the suture lock, each suture can be adjusted independently without substantially affecting the other sutures. In particular, with a suture lock fixed within the holding member, the first suture can be adjusted to the correct length. Since the suture lock does not move with the second suture, the physician can start adjusting the second suture without interfering with the adjustment of the first suture.

[0272] Furthermore, in some embodiments, a portion of the first suture is positioned between the outer surface of the suture lock and the inner surface of the socket. When the physician adjusts the second suture, the force provided by said surface holds the portion of the first suture in place. This configuration provides an additional advantage since the physician does not need to maintain an external tension on the first suture, reducing or eliminating suture tension can reduce suture elongation or other detrimental effects.

[0273] Furthermore, the first suture can be cut without changing the position of the suture lock and without changing the length of the suture between the suture lock and the tissue. One of ordinary skill in the art will understand that in this context there may be minor movements (e.g., less than 5 / 1000 inch or less than 5 / 100 inch) that are considered less than a substantial change in position.

[0274] Furthermore, in some embodiments, the suture lock functions as a fixed pivot point located in the vicinity of the tissue of the target area (e.g., in the vicinity of the apex of the heart), thereby facilitating attachment.

[0275] In some embodiments, a plurality of sutures are coupled to tissue (e.g., one or more leaflet tips) and pass through suture locks. Each suture has a length that extends between the suture lock and the tissue. When the suture lock is disposed on the retaining member, the suture is held in a predetermined position. If it is necessary to adjust the first suture (e.g., reduce the length of the first suture between the suture lock and the tissue), the suture lock is removed from the retaining member and the physician pulls the first suture to reduce the length. However, during this adjustment, the position of the suture lock remains relatively stationary (e.g., the movement of the suture lock is within 1 mm). Therefore, the physician does not need to further adjust or readjust other sutures. In some embodiments, the suture can be adjusted while the suture lock is within the retaining member. The retaining member secures the suture lock and further reduces or eliminates the movement of the suture lock during adjustment of the suture. For example, the movement of the suture lock is about 0.5 mm or less.

[0276] In some embodiments, the suture lock engaged with the retaining member is sufficiently loose so that the force of the leaflet on the suture (e.g., a chord made of ePTFE) passes through the boundary between the suture lock and the retaining member, extends around the nose portion of the suture lock, and through the open clamp mechanism of the suture lock to pull the suture back to the pushable portion of the suture assembly with sufficient force. The operable force in this situation varies in the range of 0 N to about 2 N. In some embodiments, the force is between 0.15 N and 1.50 N.

[0277] In some embodiments, the physician pulls on the outer portion of the suture to shorten the length of the suture between the suture lock and the valve tip. If the physician desires to lengthen the length of the suture between the suture lock and the valve tip, the physician releases the tension on the outer portion of the suture, and the suture is pulled by the movement of the valve tip during the natural cardiac cycle of the heart. In some embodiments, the suture lock is disposed on a first portion of the retaining member. At this position, the force acting on the suture is small enough (e.g., a force of 0 N to 2 N) such that the physician and the valve tip can cause a change in the length of the suture between the suture lock and the valve tip. At the same time, the fixing force provided by the retaining member prevents the suture lock from moving or limits the movement of the suture lock to approximately 0.5 mm during the adjustment.

[0278] In some embodiments, when the length of the suture between the suture lock and the corresponding tissue is corrected (e.g., MR is clinically reduced or eliminated), the suture lock is pushed into a second portion of the retaining member. At this position, the retaining member applies a greater fixing force to the suture lock and the suture. As a result, the suture does not move (or moves slightly, e.g., approximately 0.5 mm) within the suture lock due to the force provided by the valve tip, so that the length of the suture between the suture lock and the tissue remains constant (or the amount of elongation by the suture only moves, e.g., approximately 10%). At this point, the physician can perform a measurement and analysis of the tension and placement provided by the artificial chordae tendineae. If the analysis results in a satisfactory outcome, the physician engages the suture lock to fix the suture. In this configuration, the artificial chordae tendineae can be used for at least 400 million cycles, i.e., approximately 10 years or 8 million cycles or approximately 20 years. In certain embodiments, in this configuration, the artificial chordae tendineae can be used for at least 400 million cycles, i.e., 10 years or 8 million cycles or 20 years.

[0279] In some embodiments, the suture is permanently fixed singly or in combination with the outer surface of the suture lock using only the restraining force of the retaining member. For example, the suture lock may lack an internal clamping or restraining mechanism and, together with the inner surface of the retaining member, provides an outer surface that secures the suture against further movement from the forces resulting from the natural cardiac cycle of the heart.

[0280] In some embodiments, the retaining member enables the suture lock to cooperate with sutures of various sizes. For example, when the suture lock is inserted into the first portion of the retaining member, a larger and / or thicker suture is secured. Also, a smaller suture may be secured, for example, by pushing the suture lock deeper into the retaining member.

[0281] Embodiments of the present disclosure provide the further advantage of being able to easily adjust the suture. Friction can make it difficult to adjust the suture as well as affect the lifespan and effectiveness of the suture. Some embodiments address this problem by using a suture lock having a tapered nose portion. For example, as shown in FIG. 52, the distal end of the suture lock 4306 has a tapered nose portion 4370. The outer surface of the suture lock 4306 is cylindrical, and similarly, the outer surface of the nose portion 4370 has a cylindrical shape with a decreasing radius towards the distal end of the nose portion 4370.

[0282] The front surface of the nose portion 4370 has an inner opening surrounded by a ring of the tapered nose portion. In some embodiments, the diameter of the inner opening is from 1 mm to 3 mm. The thickness of the ring is from 0.5 mm to 2.0 mm.

[0283] The tapered nose portion 4370 facilitates the insertion of the suture lock 4306 into the retaining member 4304. In some embodiments, the nose portion 4370 has a sharp taper (more rapidly tapering) In other embodiments, the taper of the nose portion 4370 is gentle (not tapering too sharply). Further or alternatively, the retaining member 4304 includes a proximal portion that tapers outwardly to guide the suture lock 4306 to the inner portion of the retaining member 4304. For example, the proximal end of the retaining member 4304 may have a larger radius than the middle portion of the retaining member 4304. As described above, the anchor suture 4310 may be used to guide the suture lock 4306 to the retaining member 4304.

[0284] As shown in FIG. 52, the inner surface of the nose portion 4370 includes a proximal portion whose thickness increases from the front portion toward the middle portion along the longitudinal line. After the middle portion, the thickness of the nose portion decreases toward the distal portion. In some embodiments, the proximal end of the nose portion may be configured to snap fit into the suture lock body.

[0285] To facilitate two-way adjustment, in certain embodiments, the frictional force applied to the suture is reliably reduced via the suture lock and the retaining member. For example, the outer shape (profile) of the nose portion provides a rounded surface that facilitates the passage of the suture around the nose portion without forming sharp edges that would wear the suture. Further, the composition of the nose portion includes, for example, PFA or other materials that further reduce the friction between the suture and the nose portion.

[0286] The nose portion may be configured to accommodate a plurality of sutures simultaneously. At the same time, it is tapered. The outer shape facilitates access to the holding member. To utilize both of these functions, the size of the opening in the nose portion corresponds to the number of sutures used. For example, when using two sutures, the diameter of the opening in the nose portion is 1 mm, and when using four sutures, the diameter of the opening in the nose portion is 2 mm. Generally, the ratio of the diameter to the number of sutures is approximately 0.5 mm per suture. In some embodiments, multiple different nose portions (e.g., nose portions having different-sized openings) can be used interchangeably with a single suture lock body. In other embodiments, the size of the suture lock (e.g., the diameter of the suture lock) is larger or smaller to accommodate different numbers of sutures.

[0287] In some embodiments, the fibril orientation of the film microstructure is formed of an ePTFE material oriented in a direction substantially parallel to the longitudinal axis of the holding member. In this way, the longitudinal movement of the suture (e.g., a suture made of ePTFE) is along the fibril orientation to further reduce the friction and wear of the suture. For example, in some embodiments, the holding member (entirely or at least the inner surface) is formed from a substantially monolithic ePTFE cover having nodes and a fibril microstructure. The nodes are oriented substantially perpendicular to the longitudinal axis of the holding member, and the fibrils are substantially parallel to the longitudinal axis of the holding member.

[0288] As described above, the retaining member engages the suture portion and / or the suture lock. In some embodiments, it is necessary to remove the suture lock from the retaining member in order to slacken the suture portion. This simplifies the maintenance of tension in one suture portion relative to other suture portions. This is because there is no change in length occurring via the catheter. In the said embodiment, in order to slacken the suture portion, the suture lock is removed from the interference fit with the retaining member. In other words, in some embodiments, a plurality of suture portions pass through a suture lock inserted into the retaining member. As a result, the suture portion is held in a predetermined position between the outer surface of the suture lock and the inner surface of the retaining member. When a physician needs to adjust one suture portion, the suture lock is removed from the retaining member. At this stage, the suture portion in question can be adjusted by moving the suture lock substantially upward. Thus, even if the said suture portion is adjusted, the tension of other suture portions does not change significantly.

[0289] In some embodiments, the retaining member functions as an artificial papillary muscle as part of an artificial chordae tendineae. For example, the materials of the retaining member and the suture portion (as well as the anchor and / or the suture lock) are selected to promote tissue encapsulation, tissue ingrowth and / or specific biological reactions.

[0290] FIG. 55 shows a transcatheter mitral valve chordae repair system 4600 according to another embodiment. This system 4600 has features similar to those shown in FIGS. 51 and 52. However, in this embodiment, the retaining member 4604 does not include a support member. Instead, it extends around the anchor 4602 and the anchor hub 4638 and terminates at the lower surface of the retaining member 4604. The mechanical coupling or joint 4601 secures the retaining member 4604 to the anchor hub 4638. The anchor 4602 and the anchor hub 4638 can be coupled to each other as described above. In FIG. 55 The mechanical coupling or joint 4601 secures the retaining member 4604 to the anchor hub 4638. The anchor 4602 and the anchor hub 4638 can be coupled to each other as described above. In FIG. 55 Further, the wall portion of the retaining member 4604 is 25% to 100% thicker than the socket wall portions in FIGS. 51 and 52. The thicker wall portion provides axial support to prevent buckling when the suture lock 4606 enters the retaining member 4604 while maintaining sufficient compliance to allow passage. By mechanical coupling or joining, the anchor hub 4638 is secured to the retaining member 4604 extending across the anchor hub 4638.

[0291] Some embodiments include a method of transcatheter mitral chordal repair using a transcatheter mitral chordal repair system. During this process, the anchor and anchor socket are fed together, for example, via a delivery catheter. FIGS. 56 - 58 illustrate a method of feeding the anchor 4702, socket 4704, and suture lock 4706. In FIG. 56, the anchor 4702 is positioned within the socket 4704. In this configuration, both the anchor 4702 and the socket 4704 pass through the catheter and reach the left ventricle (e.g., via the left atrium). In some embodiments, the anchor 4702 is fully retracted (accommodated) within the socket 4704 to prevent the anchor 4702 from contacting or puncturing the catheter or other tissue. When the socket 4704 is positioned against the ventricular wall, the anchor 4702 advances from the socket 4704 into the tissue. As the anchor 4702 exits the socket 4704, the socket attachment device 4755 captures the coil thread until it finally contacts the anchor hub 4738 to lock the anchor 4702 in place. In some embodiments, the socket attachment device 4755 is a suture having one loop or a series of loops through which the coil passes. In other embodiments, the socket attachment device 4755 is an extension of the socket material at the distal end of the socket 4704, and this extension has one hole or a series of holes through which the coil passes. In both of the above examples, the extrusion of the coil through the hole or loop advances the coil until the socket attachment device 4755 is secured to the anchor hub 4738.

[0292] FIG. 57 shows the anchor 4702 and the socket 4704 when the anchor 4702 is deployed within ventricular tissue. The socket attachment device 4755 secures the anchor hub 4738 (and thus the anchor 4702) in a predetermined position relative to the socket 4704. Then, as shown in FIG. 58, the suture lock 4706 advances within the socket 4704 along the anchor suture 4710 until it contacts the bushing 4753. When the correct tension is applied to the suture 4708, the suture lock 4706 actuates to lock the suture 4708 and the anchor suture 4710 in a predetermined position. The suture lock 4706 is coaxially aligned with the anchor 4702 and is parallel to the suture 4708 that is pinned between the outer surface of the suture lock 4706 and the inner surface of the socket 4704. Also, the suture 4708 is pinned between the curved nose portion of the suture lock 4706 and the bushing 4753.

[0293] FIGS. 59 and 60 show another embodiment of the transcatheter mitral valve chordal repair system 4800. This system has features similar to those shown in FIGS. 51 and 52. In this embodiment, the anchor fluff yarn 4860 is incorporated into the anchor suture 4810. As the suture lock 4806 advances within the socket 4804, the anchor fluff yarn 4860 is folded to form a bushing between the anchor hub 4838 and the suture lock 4806. The suture lock 4806 selectively engages the suture 4808 that is coupled to the valve leaflet and the remaining portion of the anchor suture 4810.

[0294] FIG. 61 shows a socket formed from a densified ePTFE 4850. In some embodiments, the socket is formed from ePTFE. The socket is formed into two layers by folding back the tube. This reinforces the socket so that it resists axial compression and folding when the suture lock enters the socket. In some embodiments, the retaining member is formed from a thick graft material. To increase axial rigidity, the thick graft material is densified (compressed). As an example, a wound (rolled) graft material is shown in FIG. 61 to obtain an appropriate thickness and density. Further, the resulting two-layer structure improves the densified flexibility.

[0295] FIG. 62 shows the "wound" end 4852 of a PTFE socket. In some embodiments, the socket is formed from ePTFE. The marker band 4854 is disposed on the outer surface of the tube before the tube is wound, and a band is disposed between the two wound layers at the top of the socket. This band is a radiopaque band. In some embodiments, the retaining member includes an end portion that is radially rigidly different from other portions. For example, the proximal portion of the retaining member can be formed to have a high radial rigidity. In some embodiments, as shown in FIG. 62, when wound to form the retaining member, the marker band is between the layers of the graft material disposed. This marker band increases the radial rigidity and makes this portion of the retaining member radiopaque. In some embodiments, the marker band is held between two layers of PTFE or ePTFE and densified into a PTFE or ePTFE structure.

[0296] Figures 63 and 64 show a high-density PTFE socket 5004 designed to interact with an anchor hub 5016. In some embodiments, the socket 5004 is formed from ePTFE. The high-density PTFE or ePTFE socket 5004 includes a lower extension 5070 that fits into a corresponding groove 5072 in the anchor hub 5016. This fixes the socket 5004 to the hub 5072. A radiopaque band 5074 is located near the top of the socket 5004. The high-density PTFE or ePTFE can be used to continue to hold the anchor. As shown in FIG. 63, the anchor is held in place by pushing the PTFE or ePTFE into the anchor's retaining ring. FIG. 64 shows an exemplary retaining member that includes a high-density portion designed such that a marking band is incorporated into the proximal portion and the distal portion holds an anchor (not shown in FIG. 64).

[0297] Figures 65A and 65B show a socket that forms an outer wall and an inner wall by inverting a vascular graft tube. Thereby, the socket is formed from a biocompatible material. This material may be the same as the material of the suture, thereby minimizing or reducing wear of the suture at the location where the suture socket is located. The direction of the fibrils on the socket surface is oriented to match the direction of the fibrils of the suture so as to minimize wear.

[0298] The various artificial chordae tendineae deployment systems described above can be used for many different medical applications. According to the above embodiments, the movement of the suture with respect to the suture lock and the movement of the suture lock with respect to the anchor can be reduced or eliminated. For example, in some embodiments, the anchor is sent to cardiac tissue near the apex of the left ventricle or near the papillary muscle. As described above, the anchor is advanced through a transseptal catheter advanced into the left atrium and through the left atrium and mitral valve. The anchor is a helical anchor and is coupled to a holding member. In some embodiments, the anchor is first sent into the holding member and advanced from the holding member into the cardiac tissue. The anchor suture is attached to the anchor (e.g., via an anchor hub). Then, a valve leaflet anchor (e.g., a pledget) is fed and attached to the valve leaflet of the mitral valve. In some embodiments, the pledget is located on the ventricular side of the valve leaflet together with a pledget suture extending from the atrial side of the valve leaflet. In other embodiments, the pledget is located on the atrial side of the valve leaflet and the pledget suture extends from the ventricular side of the valve leaflet. A plurality of pledgets and sutures may be arranged on one or more valve leaflets.

[0299] In certain embodiments, to affect the artificial chordae tendineae, the suture lock travels over the anchor suture and the suture. Specifically, the proximal end of the suture penetrates through an opening in the suture lock and passes through the suture lock. The suture lock is guided by the suture anchor and advances towards the holding member. Since the suture lock is radiopaque and the holding member may include a radiopaque band near the proximal surface, a physician can use imaging techniques to confirm the position of the suture lock with respect to the holding member. Further, by using a radiopaque band in the holding member, a physician can confirm that the suture lock has been fully inserted into the holding member.

[0300] In certain embodiments, when the suture lock reaches the retaining member, the physician adjusts the length of the suture between the suture lock and the valve leaflet so as to affect the new artificial chordae tendineae. In some embodiments, some or all of said adjustment is performed at or within the suture lock in the retaining member. In certain embodiments, since the suture lock is maintained at a relatively fixed position in the retaining member, any movement of the suture results in a one-to-one or substantially one-to-one movement of the distal suture of the suture lock. For example, the ratio of the movement of the proximal suture to the movement of the distal suture can be between 0.5 and 1.0.

[0301] In some embodiments, this adjustment is performed using the suture lock just outside the retaining member while the physician holds the suture lock in place and holds the suture under tension. In other embodiments, this adjustment is performed using the suture lock in the retaining member (either the proximal portion of the retaining member or the distal portion of the retaining member adjacent to the anchor hub). In said embodiments, the retaining member holds the suture lock in place, but allows the suture to slide through the suture lock. The physician does not need to hold the suture lock in place.

[0302] Furthermore, in some embodiments, the restraining force of the retaining member is sufficient to hold the suture in place against the force applied by the valve leaflet, yet allows the suture to slide in response to a pulling force from the physician. In these embodiments, the physician does not need to hold the suture lock in place, nor does the physician need to hold each suture in a taut state. Instead, the retaining member maintains the tension of the distal portion of the continuous suture (i.e., the portion of the continuous suture that is distal to the retaining member and extends to the valve leaflet). Thereby, the physician can adjust each continuous suture individually, and inadvertent movement of the catheter (such as accidental collision) does not affect the suture. The adjustment by the physician in this situation is in one direction (i.e., shortening the length of the suture between the suture lock and the continuous suture). If the physician needs to lengthen the length of the suture between the suture lock and the continuous suture, the physician removes the suture lock from the suture so that the movement by the valve leaflet pulls the suture through the suture lock again.

[0303] When the suture is properly tightened, the physician can lock the suture in place, for example, using the techniques disclosed in this specification and / or International Applications PCT / US2017 / 069046 and PCT / US2019 / 021480. In other embodiments, the retention member locks the suture in place without requiring an additional locking mechanism within the suture lock. Next, the physician cuts the excess suture (e.g., the suture located proximal to the retention member). Since the suture is not under tension proximal to the retention member, cutting the suture will not cause significant movement of the suture lock and / or the suture located between the suture lock and the valve tip.

[0304] In other embodiments, the retention member and the suture lock are integrated and sent as a unit. In some embodiments, this unit includes an anchor or is coupled to the anchor during the delivery process. The physician can adjust the length of the suture extending between the suture lock and the valve tip and use the suture lock to permanently lock the suture in place.

[0305] The artificial chordae tendineae obtained in the above embodiments are more durable than conventional artificial chordae tendineae. First, the movement of the suture relative to the suture lock is reduced or eliminated, reducing suture wear. Second, the movement of the suture lock relative to the anchor is reduced or eliminated, further reducing suture wear. Also, suture wear is reduced by the orientation of the suture relative to the suture lock. The additional features described above (e.g., including the nose portion of the suture lock) extend the life of the artificial chordae tendineae.

[0306] FIG. 66 shows an anchor, a retention member, and a suture lock according to one aspect of the present disclosure. FIG. 67 shows the orientation of an artificial chordae tendineae according to an aspect of the present disclosure.

[0307] Suture Lock Boot: In certain aspects herein, once the tension and length of the neochordae implant is optimized, the suture lock is locked to fix the length of the sutures so that they no longer move relative to the suture lock.

[0308] In a further aspect of the present disclosure, a physician may attach a suture to the mitral valve to correct or minimize damage to the mitral valve. After tensioning, the sutures are clamped or pinned or engaged and locked with a suture lock such that the applied suture tension and length adjustment is maintained. This step and the resulting lock engagement can correct or minimize damage to the mitral valve and remain corrected for the functional life of the neochordae (i.e., prosthetic chordae). To advance the suture lock through the delivery catheter and clamp or pin the sutures in the suture lock, the suture lock can be coupled to a lock driver mechanism, such as a lock driver, such as a lock screw driver in one alternative, e.g., a stored energy mechanism, that allows for providing the necessary force to clamp or pin the sutures in the suture lock, depending on the tightening requirements of the suture lock.

[0309] In some embodiments, the suture lock may be further coupled to a boot located on or disposed with the locking driver. The boot includes a retaining mechanism configured to reversibly hold the suture lock to the boot to enhance engagement of the locking driver. According to some embodiments, for example, as shown in FIG. 68, the system includes a delivery catheter 6905, a suture lock 6935, and a boot 6915. As shown in FIG. 68, the suture lock 6935 has a screw 6925 that engages a locking driver 6910. The locking driver can be rotated to advance or retract a ram (or push wedge) 6930, thereby clamping (securing) the suture 6945 against the inner surface of the suture lock 6940. The suture lock 6935 is coupled to the boot 6915. The locking driver 6910 (shown in dashed lines) engages the head of the screw 6925. By coaxially inserting the locking driver 6910 through the boot 6915, a suture lock retaining member 6920 (two suture lock retaining members 6920 are shown on both sides of the boot 6915 in FIG. 68) can be pushed to protrude from the outer surface of the boot 6915. The suture lock retaining member 6920 provides a friction fit (not shown) to the suture lock 6935 or engages one or more indentations (shown in the dashed perspective view) in the suture lock 6935. In an alternative embodiment, only the friction fit between the locking driver and the boot may be used without the need for a suture lock retaining member or indentation. When the locking driver 6910 is disposed at the distal position of the suture lock retaining member 6920, the suture lock retaining member 6920 of the boot 6915 couples to the suture lock 6935 to limit or eliminate movement of the suture lock 6935 relative to the boot 6915. When the physician applies tension to the suture to correct the movement of the mitral valve, the physician then rotates the locking driver 6910 to clamp (secure) or pin the suture within the suture lock 6935. Those skilled in the art will understand that alternative suture lock clamp or lock configurations, such as pushing or pulling multiple components together to engage the lock of the suture lock, are within the scope of the present disclosure.

[0310] When the suture is clamped within the suture lock, the physician uses any known visualization technique to confirm that mitral valve damage or defects have been corrected or minimized. For example, if further adjustment is required, the lock driver 6910 is rotated to relieve the force applied to the suture 6945, adjust the tension as needed, and repeat the procedure to clamp the suture. Once it is confirmed that mitral valve damage has been corrected or minimized, the lock driver 6910 is retracted, thereby disengaging from the head of the screw 6925.

[0311] Figures 69 and 70 show the state of removing the lock driver 6910 and the boot 6915 from the suture lock 6935. When the lock driver 6910 retracts from the suture lock and passes the suture lock retaining member, the suture lock retaining member retracts from the boot, whereby the boot 6915 disengages from the suture lock. When the suture lock retaining member retracts, the boot 6915 disengages from the suture lock. When the boot 6915 disengages the suture lock retaining member 6920 (not shown) from the suture lock 6935, the physician can remove the lock driver 6910 and the boot 6915 from the catheter.

[0312] In some embodiments, the anchor may further include a retaining member configured to couple with the suture lock such that the suture lock maintains its position relative to the anchor. In these embodiments, the physician can apply pressure to the lock driver and the boot to insert the suture lock into the retaining member. Once the suture lock is inserted into the retaining member and appropriate tension is applied to the suture, the suture can be clamped (fixed) to the suture lock, and as described above, the lock driver and the boot can be retracted from the suture lock and the catheter.

[0313] The suture lock further includes an alternative mechanism configured to operate the suture holding mechanism. In some embodiments, the suture holding mechanism is a screw that can reversibly apply and remove pressure to the suture by rotation. FIGS. 68 - 70 show an embodiment where the suture holding mechanism has a face of screw 6925, one or more ramps 6930, and suture lock 6940. The ramp and / or opposite face of the suture lock includes a plurality of notches. Each notch has a height that advances to clamp (fix) the suture by rotation of the screw. The height of each notch may increase or decrease from the innermost notch to the outermost notch. For example, another suture thread holding mechanism such as a spring or other energy storage mechanism may be used to provide a force to clamp the suture within the suture lock. For example, the spring can be actuated in any known manner, whereby the stored energy of the spring is released when removing the boot from the suture lock.

[0314] In certain configurations, the suture may include a thread (string), cable, wire, filament, strand, line, fabric yarn, gut, or similar structure in the form of a monofilament, composite filament, or multifilament (braided, woven, twisted, or otherwise held together), whether natural and / or synthetic.

[0315] Although the present disclosure describes specific embodiments and examples, various aspects of the above systems and methods may be combined differently and / or modified to form further alternative or acceptable embodiments. All such modifications and variations are included within the scope of the present disclosure. In fact, a wide variety of designs and techniques are possible and are included within the scope of the present disclosure.

[0316] Furthermore, certain features described in the context of separate embodiments of the present disclosure may be implemented in combination in a single embodiment. Alternatively, the various features described in the context of a single embodiment may be implemented separately or in any suitable combination in a plurality of embodiments. Further, although a particular combination of features is described as acting, one or more features of the combinations recited in the claims may, if desired, be isolated from the combination and the combination may be claimed as a sub-combination or variation of a sub-combination.

[0317] The disclosure herein of any particular feature, aspect, method, characteristic, quality, attribute, element, etc. related to the various embodiments can be used in all other embodiments described herein. Also, any method described herein can be implemented using any apparatus suitable for performing the recited steps.

[0318] Furthermore, although components and operations are illustrated or described in a particular arrangement or order, such components and operations need not be arranged or performed in the particular arrangement and order illustrated or described in order to obtain a desired result, nor do they need to include all components and operations. Other components and operations not illustrated or described may be incorporated into the embodiments and examples. For example, one or more additional operations may be performed before, after, simultaneously with or during any of the operations described. Further, in other embodiments, rearrangement or reordering of the operations may be performed. Also, the separation of the various system components in the above embodiments should not be understood as requiring such separation in all embodiments, and the components and systems described are generally integrated into a single product or packaged into a plurality of products.

[0319] That is, various exemplary embodiments and examples are described herein. Although the systems and methods are disclosed in connection with the above embodiments and examples, the present disclosure extends to other alternative embodiments and / or other uses of the embodiments, as well as modifications and equivalents, other than the specifically disclosed embodiments. The present disclosure clearly intends that various features and aspects in the disclosed embodiments may be combined with each other or substituted for each other. Accordingly, the scope of the present disclosure is not limited to the specific embodiments disclosed, but should be determined only by fairly reading the following claims and the full scope of their equivalents. According to aspect (1), a hub, a suture extending proximally from the hub, a helical anchor extending distally from the hub, and a second anchor movable axially distally from a first configuration to a deployed second configuration to engage tissue and prevent the helical anchor from disengaging. It is a tissue anchor comprising: According to aspect (2), the second anchor has a branch portion extending between a proximal end and a pointed distal end, characterized in that. According to aspect (3), the branch portion is supported by a support portion, characterized in that. According to aspect (4), the support portion has an annular structure, characterized in that. According to aspect (5), the support portion receives a tubular structure of a deployment system for advancing the support portion distally relative to the helical anchor, characterized in that. According to aspect (6), the hub has an axially movable branch guide for receiving the branch portion, characterized in that. According to aspect (7), the branch guide has a deflection surface for deflecting the branch portion at a launch angle inclined radially outwardly distally, characterized in that. According to aspect (8), the emission angle is in the range of about 30° to 45°, which is characterized by this. According to aspect (9), the hub has an axially movable opening for receiving the second anchor, which is characterized by this. According to aspect (10), it further comprises a core wire attached to the hub and extending concentrically through the helical anchor, which is characterized by this. According to aspect (11), it further comprises a suture anchor guide extending proximally from the hub, which is characterized by this. According to aspect (12), in the deployed second configuration, the second anchor extends through the suture anchor guide, which is characterized by this. According to aspect (13), the second anchor extends through an opening in the suture anchor guide, which is characterized by this. According to aspect (14), when the second anchor moves to the deployed second configuration, the second anchor is operable to penetrate the suture anchor guide, which is characterized by this. According to aspect (15), it further comprises a radiopaque marker supported by the second anchor, which is characterized by this. According to aspect (16), it further comprises a core wire attached to the hub and extending concentrically through the helical anchor, which is characterized by this. According to aspect (17), it further comprises a radiopaque marker axially movably supported by the core wire, which is characterized by this. According to aspect (18), it further comprises a spring supported by the core wire, which is characterized by this. According to aspect (19), the core wire extends distally beyond the helical anchor, which is characterized by this. According to aspect (20), it further comprises a distal stopper provided on the core wire operable to limit distal movement of the radiopaque marker, which is characterized by this. According to aspect (21), it further includes a tissue penetration point at the distal end of the helical anchor and a folded-back portion provided on the helical anchor, located proximal to the point and configured to resist rotation of the helical anchor disengaging from engagement with the tissue. According to aspect (22), the second anchor is operable to increase the anchor torque resistance of the tissue anchor by 2 to 5 times compared to the anchor torque resistance of the tissue without the second anchor, which is characterized by this. According to aspect (23), the anchor torque resistance of the helical anchor having the second anchor is 2 N / cm to 5 N / cm, which is characterized in that. According to aspect (24), the second anchor is operable to increase the anchor torque resistance of the tissue anchor by at least twice as compared to the anchor torque resistance of the anchor of the tissue without the second anchor, which is characterized in that. According to aspect (25), the anchor torque resistance of the helical anchor is greater than 2 N / cm, which is characterized in that. According to aspect (26), there is provided a method for implanting a transvascular artificial chordae tendineae, Advancing a catheter into the left atrium and through the mitral valve into the left ventricle; Deploying a ventricular anchor from the catheter to the wall of the left ventricle by rotating a helical tissue anchor to the wall of the left ventricle; Deploying a second tissue anchor to the wall of the left ventricle to prevent the helical tissue anchor from coming off; Maintaining a ventricular suture portion while being attached to the ventricular anchor and extending proximally through the catheter; Fixing a leaflet anchor catheter to the mitral valve leaflet from the atrial side; Advancing a leaflet anchor through the mitral valve leaflet from the catheter to fix the mitral valve leaflet to a leaflet suture portion with the leaflet anchor catheter fixed to the leaflet, wherein the leaflet suture portion extends proximally through the catheter; Fixing the leaflet suture portion to the ventricular suture portion to limit the range of movement of the leaflet in the direction of the left atrium; Including, which is a method characterized in that. According to aspect (27), the step of deploying the second tissue anchor includes advancing the second tissue anchor axially in a distal direction with respect to the helical tissue anchor, which is characterized in that. According to aspect (28), the step of deploying the second tissue anchor increases the anchor torque resistance of the ventricular anchor by 2 to 5 times as compared to the anchor torque resistance of the ventricular anchor without the second anchor, which is characterized in that. According to aspect (29), the anchor torque resistance of the tissue anchor and the second tissue anchor is between 2 N / cm and 5 N / cm, which is characterized in that. According to aspect (30), the second tissue anchor increases the anchor torque resistance of the ventricular anchor by at least twice as much as the anchor torque resistance of the ventricular anchor without the second anchor. According to aspect (31), the anchor torque resistance of the second tissue anchor and the ventricular anchor is greater than at least 2 N / cm. According to aspect (32), an access system for directing a ventricular anchor sheath to a target site in the left ventricle, A delivery catheter having an elongated flexible tubular body with a proximal end, a distal end, a central axis, and a steering zone near the distal end, wherein the steering zone is actively deflectable to provide a delivery catheter curve existing in the delivery catheter curve plane, the delivery catheter; An anchor sheath axially advanceable through the delivery catheter, the anchor sheath having a proximal preset curve and a distal preset curve existing in a proximal preset curve plane; an anchor sheath. The access system, wherein the anchor sheath is configured to rotate within the delivery catheter and bias the proximal preset curve plane to align with the delivery catheter curve plane in response to axial alignment of the proximal preset curve within the delivery catheter curve. According to aspect (33), the distal preset curve exists in a distal preset curve plane angled from the proximal preset curve plane. According to aspect (34), the delivery catheter curve is actively adjustable over the entire range of at least 10° to 150°. According to aspect (35), an access system for directing a ventricular anchor sheath to a target site in the left ventricle, A delivery catheter having an elongated flexible tubular body with a proximal end, a distal end, and a steering zone near the distal end, wherein the steering zone is actively deflectable to provide a delivery catheter curve existing in the delivery catheter curve plane, the delivery catheter; An anchor sheath that can be advanced axially through the delivery catheter, the anchor sheath having a proximal preset curve and a distal preset curve that lie in a proximal preset curve plane, an anchor sheath, and, The proximal preset curve and the delivery catheter curve are configured to cooperate to provide a tactile indicator of the rotational alignment of the anchor sheath within the delivery catheter. An access system. According to aspect (36), a ventricular anchor delivery sheath, An elongated flexible tubular body having a proximal end, a distal end, and a longitudinal axis, A proximal preset curve of the tubular body, And a distal preset curve of the tubular body. According to aspect (37), the proximal preset curve lies in a first plane, the distal preset curve lies in a second plane, and the second plane is rotationally angled from the first plane. According to aspect (38), the second plane is rotationally angled from the first plane by an angle within the range of 40° to 75°. According to aspect (39), the distal preset curve has an angle within the range of 5° to 60° in the first plane. According to aspect (40), the length of the distal preset curve is 50% or less of the length of the proximal preset curve. According to aspect (41), the length of the distal preset curve is 20% or less of the length of the proximal preset curve. According to aspect (42), the distance between the longitudinal center of the proximal preset curve and the longitudinal center of the distal preset curve has a range between 45 and 85 millimeters. According to aspect (43), the longitudinal center of the distal preset curve is within the range of 50 to 70 millimeters from the distal end of the ventricular anchor delivery sheath. According to aspect (44), the longitudinal center of the proximal preset curve is within the range of 100 to 145 millimeters from the distal end of the ventricular anchor delivery sheath. According to aspect (45), it further comprises a distal anchor section having a foldable sidewall. According to aspect (46), a ventricular anchor delivery sheath, An elongated flexible tubular body having a proximal end, a distal end, and a longitudinal axis, And a distal preset curve of the tubular body, a ventricular anchor delivery sheath. According to aspect (47), the longitudinal center of the distal preset curve is within the range of 50 to 70 millimeters from the distal end of the ventricular anchor delivery sheath.

Claims

1. A hub, A suture extending proximally from the hub, A helical anchor extending distally from the hub, A second anchor engageable with tissue and axially movable distally from a first configuration to a deployed second configuration to prevent the helical anchor from disengaging, A tissue anchor comprising.

2. The second anchor has a branch portion extending between a proximal end and a pointed distal end, The tissue anchor according to claim 1, characterized in that.

3. The branch portion is supported by a support portion, The tissue anchor according to claim 2, characterized in that.

4. The support portion has an annular structure, The tissue anchor according to claim 3, characterized in that.

5. The support portion receives a tubular structure of a deployment system for advancing the support portion distally relative to the helical anchor, The tissue anchor according to claim 3 or 4, characterized in that.

6. The hub has an axially movable branch guide for receiving the branch portion, The tissue anchor according to claim 2, characterized in that.

7. The branch guide has a deflection surface for deflecting the branch portion at a launch angle inclined radially outward in the distal direction, The tissue anchor according to claim 6, characterized in that.

8. The launch angle ranges from about 30° to 45°, The tissue anchor according to claim 7, characterized in that.

9. The hub has an axially movable opening for receiving the second anchor, The tissue anchor according to claim 1, characterized in that.

10. Further comprising a core wire attached to the hub and extending concentrically through the helical anchor, The tissue anchor according to any one of claims 1 to 9, characterized in that.

11. Further comprising a suture anchor guide extending proximally from the hub, The tissue anchor according to any one of claims 1 to 10, characterized in that.

12. In the deployed second configuration, the second anchor extends through the suture anchor guide, The tissue anchor according to claim 11, characterized in that.

13. The second anchor extends through an opening in the suture anchor guide, The tissue anchor according to claim 12, characterized in that.

14. The tissue anchor according to claim 13, wherein when the second anchor moves to the deployed second configuration, the second anchor is operable to penetrate the suture anchor guide.

15. The tissue anchor according to claim 1, further comprising a radiopaque marker supported by the second anchor.

16. The tissue anchor according to any one of claims 1 to 15, further comprising a core wire attached to the hub and extending concentrically through the helical anchor.

17. The tissue anchor according to claim 16, further comprising a radiopaque marker movably supported axially by the core wire.

18. The tissue anchor according to claim 16, further comprising a spring supported by the core wire.

19. The tissue anchor according to claim 16, wherein the core wire extends distally beyond the helical anchor.

20. The tissue anchor according to claim 16, further comprising a distal stopper provided on the core wire and operable to limit distal movement of the radiopaque marker.

21. The tissue anchor according to claim 1, further comprising a tissue penetration point at the distal end of the helical anchor and a fold provided on the helical anchor, located proximal to the point and configured to resist rotation of the helical anchor out of engagement with the tissue.

22. The tissue anchor according to any one of claims 1 to 21, wherein the second anchor is operable to increase the anchor torque resistance of the tissue anchor by 2 to 5 times compared to the anchor torque resistance of the tissue without the second anchor.

23. The tissue anchor according to any one of claims 1 to 21, wherein the anchor torque resistance of the helical anchor having the second anchor is 2 N / cm to 5 N / cm.

24. The tissue anchor according to any one of claims 1 to 21, wherein the second anchor is operable to increase the anchor torque resistance of the tissue anchor by at least 2 times compared to the anchor torque resistance of the anchor of the tissue without the second anchor.

25. The anchor torque resistance of the helical anchor is greater than 2 N / cm, and the tissue anchor according to any one of claims 1 to 21, characterized in that.

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