Implant tether tension applying and locking system and method

Abstract

A locking system for transcatheter annuloplasty may include an implantable lock body, a movable member configured to be slidably received in a lock body slot, a tether abutment portion, a coupling element disposed at a proximal portion of the lock body, a pull wire having a coupling member configured to detachably engage the coupling element, a flexible catheter configured to slidably receive a portion of the pull wire, and a collar disposed at a distal portion of the catheter and configured to slidably receive the lock body. When the pull wire and the catheter are both pushed distally, the lock body can be advanced along the tether, and when the pull wire is pulled proximally relative to the catheter, the movable member can be moved to a locking position to lock the tether to the lock body. A method of use is also provided.

Description

Technical Field

[0001] (Cross - Reference to Related Applications) This disclosure claims the benefit of U.S. Provisional Application No. 63 / 364,418, filed May 9, 2022, under the title "Implantable Tether Tension - Applying Locking System and Method", the entire disclosure of which is incorporated herein by reference.

[0002] (Incorporation by Reference) All publications and patent applications mentioned in this specification are hereby incorporated by reference in their entirety for all purposes to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference.

[0003] Embodiments of the present disclosure generally relate to implantable medical devices. Specifically, some implementations of the present invention relate to devices and methods for repairing the mitral valve.

Background Art

[0004] The mitral valve is located at the junction between the left atrium and the left ventricle of the heart. During diastole, the valve opens to allow blood flow from the left atrium to the left ventricle. During systole, when the left ventricle supplies blood to the body via the aorta, the valve closes to prevent backflow of blood into the left atrium. The mitral valve consists of two leaflets (posterior and anterior leaflets), which are located on the mitral annulus, which is a ring that forms the junction between the left atrium and the left ventricle. The mitral valve leaflets are tethered to the papillary muscles of the left ventricle via chordae tendineae. The chordae tendineae prevent the mitral valve leaflets from prolapsing into the left atrium during systole.

[0005] Mitral valve regurgitation is a disease in which the mitral valve does not close completely, resulting in backflow of blood from the left ventricle to the left atrium. In some cases, regurgitation occurs due to dilation of the mitral annulus, particularly an increase in the anteroposterior diameter of the mitral annulus. Alternatively or additionally, mitral valve regurgitation occurs due to dilation of the left ventricle, which can result from, for example, infarction. As a result of the dilation of the left ventricle, the papillary muscles will always tether the mitral valve leaflets in an open configuration via the chordae tendineae.

[0006] Prior art methods and devices exist for treating mitral valve insufficiency. These require replacing or repairing the mitral valve. Valve replacement is generally performed either transapically or transseptally. Valve repair generally falls into one of four categories: valve clip, direct annuloplasty, indirect annuloplasty, or chordal repair. Both direct and indirect annuloplasty require reshaping the subject's mitral annulus and / or left ventricle such that the anterior and posterior leaflets are properly joined. For some annuloplasty applications, a ring is implanted near the mitral annulus (e.g., behind the mitral valve or mitral valve). The purpose of the ring is to reduce the outer circumference of the mitral annulus. SUMMARY OF THE INVENTION PROBLEMS TO BE SOLVED BY THE INVENTION

[0007] In view of the above prior art, it is desirable to provide an improved system and method for treating mitral valve insufficiency. BRIEF DESCRIPTION OF THE DRAWINGS

[0008] A deeper understanding of the features and advantages of the present disclosure will be obtained by reference to the following detailed description presenting exemplary embodiments in which the principles of the present disclosure are utilized.

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DETAILED DESCRIPTION OF THE INVENTION

[0009] Referring to FIG. 1, the elements of the mitral valve are shown. Specifically, the mitral valve includes an anterior leaflet, a posterior leaflet, an anterior - lateral commissure, a posterior - medial commissure, an outer (sometimes referred to as left) triangular portion, and an inner (sometimes referred to as right) triangular portion. The anterior leaflet includes three segments A1, A2, A3. Similarly, the posterior leaflet also includes three segments P1, P2, P3. According to an aspect of the present disclosure, in some implementation examples, the device anchor can be installed at or near each of the target positions T as shown in the figure.

[0010] Referring to FIG. 2, an exemplary posterior bar 210 constructed in accordance with aspects of the present disclosure is shown. As will be described in more detail later, the posterior bar 210 is configured to be implanted adjacent to the posterior cusp into the mitral valve or near it into the left atrium. Thus, in this exemplary embodiment, the posterior bar 210 is an elongated tubular structure curved to conform to the biological structure of the mitral valve at this location. The posterior bar 210 may have a thin profile that minimizes the amount of atrial irregularities that can be a site of thrombosis, as shown in the figure. In this exemplary embodiment, the posterior bar 210 has a non-traumatic edge that limits the potential for tissue damage and is coated with a polyethylene terephthalate (PET) fabric that aids in tissue ingrowth.

[0011] In this exemplary embodiment, the posterior bar 210 includes an intermediate tissue anchor guide 212 and two end tissue anchor guides 214. In some embodiments, the intermediate tissue anchor guide 212 is the same as the end tissue anchor guide 214, and in other embodiments, it has a different configuration, such as having features that facilitate steering / torquing of the posterior bar 210 during delivery. In some embodiments, as will be described herein later, there may be no intermediate tissue anchor guide, and the tissue anchor guides provided in this exemplary embodiment may be more or less than three. The anchor guides 212 and 214 may be configured to pivot with respect to the posterior bar 210 so as to be movable from a stowed state to a deployed state. In the stowed state, the anchor guides may extend generally parallel to the bar 210 such that the anchor guides 212 and 214 and the bar 210 can pass through the lumen of the catheter together. In the deployed state, the anchor guides 212 and 214 may extend generally perpendicular to the bar 210 as shown in FIG. 2 so as to be used to guide tissue anchors through the holes of the bar 210 into adjacent tissue to fix the bar 210 to the tissue.

[0012] One or more snare features 216 may be provided on the rear bar 210. In this exemplary embodiment, two snare features 216 are provided, one near each end of the rear bar 210. The snare features 216 may extend substantially from the rear bar 210 so as to be readily engageable with one or more tension members / snares and may be configured to prevent disengagement of the tension members during operation. In some embodiments, the snare features 216 are readily imaged by fluoroscopy and echocardiography to assist in positioning the rear bar 210 during delivery and attachment to tissue and may be configured to assist in connecting the tension members to the snare features 216.

[0013] The rear bar 210 may be designed to be loaded with the anchor in a manner suitable for shear and tension with respect to the biological structure. Torque control features may be provided to enable an initial positioning of the rear bar 210 and to impart the ability to move the implant to conform to the biological structure when the anchor is later delivered.

[0014] To enable in vivo adjustment of the rear bar 210 to have a profile adapted to the biological structure of a particular subject, the bar may further comprise some level of flexibility. The flexibility of the rear bar 210 may also serve to flex the bar during the cardiac cycle. In some embodiments, the flexibility of the bar is obtained by providing a series of slits (not shown in FIG. 1) transverse to the longitudinal axis of the rear bar 210. In some embodiments, the slits and / or other flexibility-imparting features may be configured to limit the minimum radius of the rear bar 210 during implantation to ensure a more uniform tension is applied to the posterior side of the mitral annulus.

[0015] Referring to FIG. 3, an exemplary anterior pad 310 constructed in accordance with aspects of the present disclosure is shown. As will be described in more detail later, the anterior pad 310 is configured to be implanted in the mitral annulus adjacent to or near the anterior leaflet, particularly in the triangular area, into the left atrium. In this exemplary embodiment, the anterior pad 310 is generally a flat structure having four flap portions 312 that radially extend from a central portion. In other embodiments, more or fewer flap portions may be provided, or no flap portions may be provided. The primary tissue anchor 314 may be disposed at the center of the anterior pad 310. In some embodiments, additional tissue anchors 316, such as additional anchors 316 near the center of each flap portion 312 as shown in the figure, may be provided. In some embodiments, the primary tissue anchor 314 is the same as the additional tissue anchor 316, and in other embodiments, it has a different configuration, such as a feature that facilitates positioning of the anterior pad 310 during delivery. The flap portions 312 may be designed to be folded into a compact configuration for delivery of the anterior pad 310 within a catheter.

[0016] To minimize the amount of atrial irregularities that can be potential sites of thrombosis, the anterior pad may have a thin profile as shown in the figure. In this exemplary embodiment, the anterior pad 310 has a non-traumatic edge that limits the potential for tissue damage and is coated with a polyethylene terephthalate (PET) fabric that aids in tissue ingrowth.

[0017] One or more snare features may be provided on the front pad. In this exemplary embodiment, the upper ends of the tissue anchors 314 and 316 are configured to mate with one or more tension members / snares. These snare features may be configured to extend substantially from the front pad 310 so as to easily mate with one or more tension members / snares and to prevent the tension members from becoming disengaged during operation. In some embodiments, the snare features and / or the front pad 310 as a whole are configured to be easily imaged by fluoroscopy and echocardiography to assist in positioning the front pad 310 during delivery and attachment to the tissue and to assist in connecting the tension members to the snare features. The front pad 310 may be designed to load the anchors in a manner suitable for shear and tension with respect to the biological structure.

[0018] Referring to FIG. 4, an exemplary method of performing a mitral annuloplasty according to aspects of the present disclosure is shown. The steps of this exemplary method 410 are described with reference to the flowchart shown in FIG. 4 and the series of images shown in FIGS. 5-22. In each of the images shown in FIGS. 5-22, the view is from the left atrium 510 toward the mitral valve 512, generally in the caudal direction and with the medial direction generally to the right. In some implementations of the method, one rear bar 210 and one, two, or more front pads 310 are implanted. In other implementations, different types or numbers of devices may be used. In FIGS. 5-22, the rear bar 210 is shown without a fabric cover for clarity. In this exemplary embodiment, at least one device anchor is placed at or near each of the five target positions T shown in FIG. 1.

[0019] In some implementations of method 410, the first step 412 of the method is to introduce the distal end of the delivery catheter into the left atrium 510 of the subject. This can be accomplished using a transseptal approach, a left atrial approach, or other methods to gain access to the left atrium. In the images shown in FIGS. 5 - 22, a transseptal approach is depicted in which the distal end of catheter 514 passes through the septum 516 of the subject's heart into the left atrium 510. In some implementations, an internal dilator (not shown) for crossing the septum is disposed at the distal end of catheter 514.

[0020] Referring to FIGS. 4 and 5, at step 414, when the distal end of catheter 514 is introduced into the left atrium 510, a rear bar 210, sometimes referred to herein as the first member, can be deployed from the distal end of catheter 514. In some implementations, catheter 514 is first introduced into the left atrium 510 before the rear bar assembly is loaded onto the proximal end of catheter 514. In other implementations, the rear bar 210, along with its tissue anchor guides 212, 214 and snare feature 216, is pre - loaded onto a catheter (not shown) and advanced within catheter 514. As seen in FIG. 5, an anchor lead 518 can be removably attached to each of the tissue anchor guides 212 and 214 to push the rear bar 210 within catheter 514 and deploy it from the distal end.

[0021] Referring to FIG. 6, when the rear bar 210 emerges from the distal end of the catheter 514, the lead 518 attached to one of the ends is pushed and the other is pulled from the proximal end of the catheter 514 so as to pivot the rear bar 210 into an orientation generally perpendicular to the catheter 514 as shown in the figure. The internal catheter 520 can be slid distally with the intermediate lead 518 until features (such as recesses and / or wall portions not shown) mate with the engagement features of the rear bar 210 and the bar 210 stops rotating relative to the steerable internal catheter 520. And, as shown in FIG. 7, the steerable internal catheter 520 can be used to position and rotate the rear bar 210 until it is steered to the desired implantation position and orientation. In some implementations, a torque driver coaxially disposed between the lead 518 and the steerable internal catheter 520 can be used to apply torque to the rear bar 210. Such an implementation will be described later in connection with FIGS. 40 - 46.

[0022] Referring to FIGS. 4 and 8-11, step 416 of exemplary method 410 is described. In this step, the rear bar 210 (i.e., the first member) is fixed to the rear side of the mitral valve 512. As shown in FIG. 8, this can be achieved by first sliding the drive tube 522 with the helical tissue anchor 524 disposed at the distal end in the lead 518 attached to the tissue anchor guide 214 disposed near the inner end of the rear bar 210. As seen in FIG. 9, while the steerable inner catheter 520 holds the rear bar 210 in the mitral valve annulus tissue, the drive tube 522 is rotated to screw the inner anchor 522 through the rear bar 210 into the underlying tissue. And as shown in FIG. 9, the drive tube 522 is removed from the inner anchor 214 and in the lead 518 attached to the tissue anchor guide 214 disposed near the outer end of the rear bar 210, this drive tube (or another drive tube 522 with another helical tissue anchor 524) can be slid. As seen in FIG. 10, while the inner anchor 524 and the steerable inner catheter 520 (and in some implementations the torque driver inside the catheter 520) hold the rear bar 210 in the mitral valve annulus tissue, the drive tube 522 is rotated and the outer tissue anchor 524 can be screwed through the bar 210 into the underlying tissue. And as shown in FIG. 11, the drive tube 522 is removed from the outer anchor 524 and in the lead 518 attached to the intermediate tissue anchor guide 212, this drive tube (or another drive tube 522 with another helical tissue anchor 524) can be slid. In some implementations, the steerable inner catheter 520 may be left at a predetermined location on the rear bar 210 when the central anchor is installed (as shown in FIG. 10), or removed from the rear bar 210 prior to the drive tube 522 and the intermediate anchor 524 being slid into engagement with the intermediate tissue anchor guide 212 (as shown in FIG. 11). While the inner and outer anchors 524 hold the rear bar 210 in the mitral valve annulus tissue, the drive tube 522 can be rotated to screw the intermediate anchor 524 through the bar 210 into the underlying tissue.Figures 10 and 11 show the rear bar 210 with the lead removed from the end tissue anchor guide by extraction or the like.

[0023] In step 416, it should be noted that after the first anchor is installed, torque control of the implant 210 by the steerable inner catheter 520 (or in some implementations, a torque driver disposed within the catheter 520) can subsequently be used to guide the installation of the anchor into the implant 210. This avoids the need for unguided anchor installation after the first anchor is installed. Figure 12 shows the rear bar 210 with three anchors installed and all leads removed.

[0024] Referring to FIGS. 4 and 12, step 418 of the exemplary method 410 is described. In this step, the front pad 310 (sometimes referred to herein as the second member) is positioned from the distal end of the catheter 514. In some implementations, the front pad 310 is steered to the outer triangular portion by the steerable inner catheter 520 as shown in FIG. 12 (the outer triangular portion is also shown in FIG. 1).

[0025] Referring to FIGS. 4, 12, and 13, step 420 of the exemplary method 410 is described. In this step, the front pad 310 (sometimes referred to herein as the second member) is fixed to the front side of the mitral valve 512. In some implementations, the front pad 310 shown as having a single anchor 314 is fixed to the outer triangular portion. A drive tube (not shown) can be used within the steerable inner catheter 520 to screw the anchor 314 into place. As shown in FIG. 13, additional anchors 316 may be used to further secure the front pad 310 to the outer triangular portion.

[0026] In step 420, it should be noted that after the first anchor is installed, a lead can be left at a predetermined location within the steerable inner catheter 520 so that the lead and the catheter 520 can be used to subsequently guide the installation of the anchor into the implant 310. This avoids the need for non-guided anchor installation after the first anchor is installed.

[0027] Referring to FIGS. 4 and 14, steps 422 and 424 of the exemplary method 410 are described. In these steps, another front pad 310 (sometimes referred to herein as a third member) is deployed from the distal end of the catheter 514. In some implementations, as shown in FIG. 14, the steerable inner catheter 520 steers the front pad 310 into the inner triangle. (The inner triangle is also shown in FIG. 1.) And the front pad 310 can be fixed to the front side of the mitral valve 512. In some implementations, the front pad 310, shown as being accompanied by a single anchor 314, is fixed to the inner triangle. A drive tube (not shown) can be used within the steerable inner catheter 520 to screw the anchor 314 into place. Similar to the outer front pad 310, additional anchors may be used to further secure the inner front pad 310 to the inner triangle.

[0028] In step 424, it should be noted that after the first anchor is installed, a lead can be left at a predetermined location within the steerable inner catheter 520 so that the lead and the catheter 520 can be used to later guide the installation of the anchor into the implant 310. This avoids the need for non-guided anchor installation after the first anchor is installed.

[0029] Referring to FIGS. 4 and 15, step 426 of exemplary method 410 is described. In this step, a tether or snare 526, which is a first tension member, is deployed from the distal end of catheter 514 through a steerable inner catheter 520 as shown in the figure. A snare sheath 528 may be used to guide the first tension member 526 to an implant feature. The sheath 528 may also be used to fasten the first tension member 526 around the implant feature by pulling the tension member 526 proximally relative to the snare sheath 528.

[0030] Referring to FIGS. 4 and 16 - 18, step 428 of exemplary method 410 is described. In this step, a first tension member or snare 526 is attached to a rear bar 210 (i.e., a first member) and a front pad 310 (i.e., a second member). As shown in FIG. 16, a steerable inner catheter 520 and a snare sheath 528 may be utilized to guide the first tension member 526 to an outer snare feature 216 of the bar 210. And as shown in FIG. 17, the first tension member 526 may be guided to a primary tissue anchor 314 of the front pad 310. And as shown in FIG. 18, a small amount of tension may be applied to this member with the snare sheath 528 to keep the first tension member 526 engaged with the bar 210 and the pad 310.

[0031] Referring to FIGS. 4 and 19, step 430 of exemplary method 410 is described. In this step, a second tension member or snare 530 is deployed from the distal end of catheter 514 through a steerable inner catheter 520 as shown in the figure. A snare sheath 532 may be used to guide the second tension member 530 to an implant feature. This sheath 532 may also be used to fasten the second tension member 530 around the implant feature by pulling the tension member 530 proximally relative to the snare sheath 532.

[0032] Referring to FIGS. 4 and 20 - 22, step 432 of exemplary method 410 is described. In this step, a second tension member or snare 530 is attached to the rear bar 210 (i.e., the first member) and the next forward pad 310 (i.e., the third member). As shown in FIG. 20, a steerable internal catheter 520 and a snare sheath 532 can be utilized to guide the second tension member 530 to the inner snare feature 216 of the bar 210. And as shown in FIG. 21, the second tension member 530 can be guided to the major tissue anchor 314 of the forward pad 310. As shown in FIG. 22, a small amount of tension can be applied to the second tension member 530 with the snare sheath 532 to maintain the mating state with the bar 210 and the pad 310. In some implementations, the snare shape can be configured to more easily mate with the snare features of the implant. For example, each snare can form a D - shape that contacts the outside or inside of the atrium. And the atrial wall is used to guide the snare to the lower valve ring and then tighten it without necessarily having to guide the snare to each snare feature. In some embodiments, the snare has a dumbbell (or dog - bone) shape, such as the exemplary snare 550 shown in FIG. 54. The snare 550 includes a distal loop 552 and a proximal loop 554 having a predetermined diameter, and the remainder of the snare has substantially parallel tension members that form a gap smaller than the loop diameter therebetween. The distal loop 552 can first be exposed and mated with the first snare feature of the implant, and subsequently the proximal loop 554 can be exposed to constrain the second snare feature of the implant. In some embodiments, as depicted in FIG. 55, two snares 560 and 562, each having a predetermined shape, are loaded in parallel. The individual snares 560 and 562 can be connected to a coupler 564 and can slide independently to mate separately with the snare features of the implant.

[0033] When both the first tension member 526 and the second tension member 530 are placed at a predetermined location, additional tension can be applied to both to bring the front and rear sides of the mitral valve 512 closer together. In some implementation examples, the tensions of members 526 and 530 can increase simultaneously. In some implementation examples, the tension can gradually increase alternately between members 526 and 530 until the desired tension and / or valve proximity is reached. In some implementation examples, the final tension and / or tissue proximity of each tension member 526 and 530 is approximately the same. In some implementation examples, the final tension and / or tissue proximity of each tension member 526 and 530 is different. Since the inner and outer tightening can be performed independently, the allowable range for the installation of each bar is wider. This generally applies to all of the systems disclosed herein. In some implementation examples, real-time transesophageal echocardiography of the mitral valve is used to monitor the relief of mitral valve regurgitation when the tension members 526 and 530 are tightened.

[0034] After the desired tension and / or tissue proximity is obtained, the tension members 526 and 530 can be ligated. In some implementation examples, a reversible lock configured to permanently hold the position of the tension member can be used during the tightening process. A cutting member can be used to separate the snare from the delivery system, or a portion of the tension member can be cut to release it. Then, together with the steerable inner catheter 520 and the snare sheaths 528 and 532, the catheter 514 can be withdrawn from the left atrium (step 436 shown in FIG. 4). In addition to applying tension to the device during the new procedure, additional tension devices may be added later, or at a later date, and / or the existing devices may be re-tensioned to further reduce the A-P dimension.

[0035] Additional embodiments of the prior systems and methods can be found in U.S. Patent Application Publication No. 2021 / 0052387, entitled "Annuloplasty System and Method," filed by the applicant and having the same filing date.

[0036] Referring to FIGS. 23 - 47B, a second exemplary embodiment of an implanted valve annulus forming system 600 constructed in accordance with aspects of the present disclosure is shown. Referring to FIG. 23, the valve annulus forming system 600 is constructed and functions in a manner similar to the systems already described. Again, it includes a long posterior implant 610 configured to be implanted in the left atrium adjacent to or near the mitral valve annulus at the posterior leaflet, and two anterior implants 612 each configured to be implanted in the left atrium adjacent to or near the mitral valve annulus at the anterior leaflet, particularly in the triangle. However, in this second exemplary embodiment, instead of attaching a tension member or tether to the implant after placement, the tether 614 is pre - attached to the anterior implant 612 before being deployed from the catheter. In this embodiment, first the anterior implant 612 is implanted and its tether 614 is passed through the posterior implant 610 before being deployed from the catheter. Then, as the posterior implant 610 is deployed from the catheter and placed on the posterior side of the mitral valve annulus, it advances along the tether 614. As will be described in more detail later, after the posterior implant 610 is anchored at a predetermined location by the anchor 616, tension can be applied to the tether 614 and fixed with the lock 618. This mechanism saves a significant amount of time during surgery and eliminates the need to capture each implant with a tether. This also ensures increased consistency and reliability of the tether attachment points.

[0037] In this second exemplary embodiment, the posterior implant 610 includes five anchors 616 and each of the anterior implants 612 includes two anchors 616. Each end of the posterior implant 610 includes a swivel eyelet assembly 620 that advances along the tether 614 to provide an anti - reverse device to the tether lock 618.

[0038] Referring to FIG. 24, another perspective view of the system 600 showing the anchors 616 at various stages of insertion is provided. Each anchor 616 is guided to a predetermined location by its own lead 622 that is removably connected to the spinner assembly 624. Each spinner assembly 624 is rotatably mounted to the posterior implant plate 626. A separate driver head 628 is removably connected to the upper portion of each anchor 616. When the driver head 628 is rotated by a driver tube (not shown) extending in the proximal direction, the implanted anchor 616 is driven through the spinner assembly 624 to the underlying heart tissue until it fits into its spinner assembly 624, thereby fixing the implant plate 626 to the tissue. Each implant is provided with a torque head 630 (only two are shown in FIG. 24). Each torque head 630 is rotationally driven longitudinally by a torque tube (not shown) extending in the proximal direction and engages with the respective implant to drive the implant to a fixed position.

[0039] Referring to FIG. 25, a posterior implant plate 626 in an exposed state with no components mounted for clarity is shown. This has five through-holes 632 for rotatably holding the spinner assembly 624 (shown in FIGS. 23 and 24). Two holes 634 for rotatably holding the eyelet assembly 620 (shown in FIGS. 23 and 24) are also provided. As will be described in more detail later, a series of slots 636 spaced around the central spinner assembly hole 632 are provided for engaging with the torque head 630 (shown in FIGS. 23 and 24). Additional through-holes 638 and scallops 640 are provided as shown in the figure to reduce the amount of metal in the plate 626 for good echo imaging and tissue ingrowth.

[0040] Referring to FIGS. 26 - 29, the rear implant plate 626 is shown with the anchor spinner assembly 624 and the tether eyelet assembly 620 mounted thereon to the base plate 626. FIG. 26 is a perspective view, FIG. 27 is a top view, FIG. 28 is a side view, and FIG. 29 is a bottom view.

[0041] Referring to FIGS. 30 - 32, various views of the eyelet assembly 620 are shown. FIG. 30 is a perspective view, FIG. 31 is a side view, and FIG. 32 is a top view. (The bottom view of the eyelet assembly 620 is shown in FIG. 29.) As most clearly seen in FIG. 31, the eyelet assembly 620 can be formed from six separate components, namely a cylindrical core 642, an upper ring 644, a bottom ring 646, an eyelet 648, a wedge or filler material 650, and an eyelet coating 652. As most clearly seen in FIGS. 31 and 32, the core 642 includes two pairs of arcuate fins 654, one pair projecting from the upper portion of the core 642 and one pair projecting from the bottom. Each of the upper ring 644 and the bottom ring 646 may include an engagement slot for receiving the arcuate fins 654. In some embodiments, the fins 654 are fastened to the rings 644 and 646 by swaging, welding, epoxy bonding, press - fitting, and / or other suitable means. In other embodiments, as described later, only a slip fit is provided between the fins 654 and the rings 644 and 646, and the rings are held in place by being sandwiched between the core 642 and both ends of the straight body portion of the eyelet 648 and / or by the eyelet body expanding onto the rings. In some embodiments, the fins 654 can serve as a centering feature for the core 642 and / or as an anti - rotation feature so that the rings 644 and 646 do not rotate relative to the core 642 and / or the eyelet 648. In other embodiments (not shown), feature shapes other than arcuate fins may be used.

[0042] The eyelet 648 has a linear body portion with an elliptical or rectangular cross-section (most clearly seen in FIG. 29). The core 642 may comprise a central bore with an engaging elliptical or rectangular cross-section or circular cross-section for receiving the eyelet body portion. The linear body portion is divided centrally and a gap is provided between the two halves. Thus, as shown in the figure, the anti-friction tube 652 can slide over one half of the body portion to the circular portion of the eyelet 648. In some embodiments, the tube 652 is made of or coated with polytetrafluoroethylene (PTFE) to reduce the friction between the eyelet 648 and the tether passing through it. In other embodiments, the eyelet 648 may be directly immersed in PTFE or another anti-friction coating.

[0043] During assembly, the linear body portion of the eyelet 648 may pass through the upper ring 644, the center of the core 642 (which is located in one of the holes 634 of the rear implant plate 626 as shown in FIG. 25), and the bottom ring 646. And a wedge or filler material 650 may be provided between the two halves of the eyelet body portion so as to be biased outwardly against the inner walls of the elliptical or rectangular bores of the rings 644 and 646. In some embodiments, the material 650 is an elastic compression material provided in the body gap before assembly, so that it can be compressed during assembly and then apply an outward elastic force after assembly. In other embodiments, the material 650 is metallic (i.e., non-compressible). In some embodiments, the eyelet body portion has a constricted portion (not shown) with an axial length slightly longer than the distance between the upper part of the upper ring 644 and the bottom part of the bottom ring 646. By this mechanism, after the split body portion is radially compressed to pass through other components and then radially expanded, the core 642 and the rings 644 and 646 can be constrained by the constricted portion. When the eyelet assembly 620 is assembled, the rear implant plate 626 (shown in FIG. 25) is clamped between the upper ring 644 and the bottom ring 646 of the eyelet assembly 620. The core 642 may have a height slightly greater than the thickness of the implant plate 626 so that the eyelet assembly 620 can rotate freely relative to the plate 626.

[0044] In each of the exemplary embodiments described above, an eyelet assembly 620 having the ability to rotate relative to the posterior implant 610 is provided, such that a tether passing through the eyelet assembly 620 is aligned with the central lumen of the catheter during delivery and can rotate to align with the anterior triangular implant 612 when implanted.

[0045] Referring to FIGS. 33 - 36, various views of the spinner assembly 624 are shown. FIG. 33 is a side view, FIG. 34 is another side view in a direction orthogonal to the direction of FIG. 33, FIG. 35 is a bottom view, and FIG. 36 is a top view. The spinner assembly 624 can be formed from six separate components, namely a central hoop 656, an upper disk 658, a bottom lock ring 660, a crossbar 662, a U - shaped connecting rod 664, and a lead nut 666. The central hoop 656 is configured to be rotatably received within one of the holes 632 of the posterior implant plate 626 (shown in FIG. 25). Each of the disk 658 and the ring 660 can be welded or otherwise connected to the hoop 656 to rotatably constrain the implant plate 626 therebetween. The crossbar 662 bridges the central bore of the hoop 656 (parallel to the plate 626). As most clearly seen in FIG. 35 (and also shown in FIG. 41), the U - shaped connecting rod 664 is pivotally attached to the crossbar 662. The lead nut 666 can be welded or otherwise fastened to the upper portion of the connecting rod 664. The lead nut 666 includes a central threaded bore for receiving the threaded end of the anchor lead 622 (shown in FIGS. 24 and 37). A fixing flange 668 can be provided on the crossbar 662 such that the connecting rod 664 and the lead nut 666 are centered within the hoop 656. The connecting rod 664 can be laser - cut into an open (V - shaped) configuration and then closed (made U - shaped) around the crossbar 662 between the flanges 668 before the nut 666 is attached to the upper portions of the two protrusions.

[0046] With the mechanism described above, the lead nut 666 pivots relative to the spinner assembly 624, and the spinner assembly spins relative to the posterior implant 610 (shown in FIGS. 23, 24, 37). Thus, the anchor lead 622 is disposed generally flat against the implant 610 when pre-loaded into the delivery catheter (as shown in FIG. 44) and can extend orthogonally or at another angle when the implant is deployed. As most clearly seen in FIGS. 33 and 40, one or more recesses 670 may be provided in the upper portion of the hoop 656 so that the connection rod 664, the lead nut 666, and the anchor lead 622 (shown in FIGS. 24 and 37) can be placed more flatly against the implant.

[0047] Another advantage of the spinner assembly 624 is that it ensures that the anchor 616 passing therethrough (shown in FIGS. 23 and 24) can draw the implant across the tissue without leaving any gap between the heart tissue and the implant. The same spinner assembly 624 can be used with the two anterior implants 612 and function in exactly the same manner as for the posterior implant 610. As shown in FIGS. 23 and 24, a spinner assembly is provided for each anchor 616, so five spinner assemblies are attached to the posterior implant 610 and two to each of the two anterior implants 612.

[0048] With reference to FIGS. 37-39, the structure and operation of the implant anchor 616 are described. In this exemplary embodiment, each anchor 616 is constructed of two components, namely a coil 672 and an anchor head 674. The distal end of the anchor head 674 may include a helical slot for receiving the proximal end of the coil 672. In some embodiments, the proximal end of the coil 672 is welded to the head 674. In this exemplary embodiment, the center of the anchor head 674 is hollow so that when the anchor 616 is implanted, it fits onto the lead nut 666 and the connecting rod 664. The proximal end of the anchor head 674 may include a releasable mating feature or clasp 676 in the shape of a cylindrical hook. Identical and / or complementary engagement features or clasps 676 may be provided at the distal end of the driver head 628. When the implant is assembled and pre-loaded onto the delivery catheter, the two clasps 676 may engage with each other and be held together by the anchor lead 622. As shown in FIG. 38, when engaged, the clasps 676 transmit axial and rotational movement from the driver head 628 to the anchor 616 through the spinner assembly 624 to drive the anchor into the underlying heart tissue. As shown in FIG. 39, after all the anchors 616 of the implant have been installed, the distal end of each anchor lead 622 is loosened from the associated lead nut 666 and pulled proximally through the clasp 676, and each anchor driver can be disengaged from the anchor 616. As shown in FIGS. 38 and 39, a series of slots or laser cuts 677 may be formed in the wall thickness of the driver head 628 to form flexures or living hinges. These flexures relieve pressure and allow the clasps 676 to engage and disengage from each other more easily when axial misalignment is seen or a lateral moment is applied to the driver head 628. In other embodiments (not shown), a hollow braided cable may be used instead of a rigid tube with or without flexures.

[0049] As also depicted in FIG. 37, the torque head 630 may comprise a flared distal end configured to fit into the central spinner assembly 624 when a tab 678 extending in the distal direction to steer the implant 610 fits into a slot 636. The torque head 630 may also comprise a central bore large enough to store the anchor 616 when implanted.

[0050] Referring to FIGS. 40 and 41, additional views of the torque head 630 are shown. FIG. 40 shows the distal end of the torque head 630 as it approaches the central spinner assembly 624. The torque head 630 can be mated with the implant 610 by pushing the proximal end of the torque tube (not shown) in the distal direction while pulling the proximal end of the central anchor lead 622 (shown in FIG. 23) in the proximal direction. The torque tube needs to be rotated until the tab 678 engages the slot 636. FIG. 41 shows the distal end of the torque head 630 and the central spinner assembly 624, with some portions cut away to show further details of these components.

[0051] Referring to FIGS. 42 and 43, views of the components of the anterior implant 612 are shown. FIG. 42 shows the exposed anterior implant base plate 680 with only the tether assembly 682 attached. Since the two anterior implants 612 shown in FIGS. 23 and 24 are mirror images of each other, the same plate 680 and assembly 682 can be used to construct either one, depending on the orientation of the spinner assembly 624. The outer anterior implant 612 (shown on the left side of FIGS. 23 and 24) is formed when the spinner assembly 624 is attached to the nearer side of the plate 680 shown in FIG. 42 (such that the lead nut 666 is upward as shown in FIG. 43). The inner anterior implant 612 (shown on the right side of FIGS. 23 and 24) is formed when the spinner assembly 624 is attached to the farther side of the plate 680 shown in FIG. 42 (opposite to that shown in FIG. 43 such that the lead nut 666 is downward).

[0052] In this exemplary embodiment, the same components already described for the posterior implant 610, such as the spinner assembly 624, the anchor 616, the torque head 630, etc., are used for the anterior implant 612. As shown in FIG. 42, the spacing of the slots 636 can be the same as the spacing used for the posterior implant plate 626 (shown in FIG. 25) to accommodate the two side tabs 678 (only one tab 678 is visible in FIG. 43) of the torque head 630. Since the slots 636 are spaced 60 degrees apart, the torque head can be moved back and forth up to plus or minus 30 degrees or rotated up to 60 degrees in one direction before the tab 678 engages a pair of engagement slots 636.

[0053] As shown in FIG. 43, the thimble 682 and the sleeve 684 can be used to terminate the distal end of the tether 614 to the beam of the anterior implant 612 so that the tether can pivot freely with respect to the implant. Thus, the implant 612, together with its pre-attached tether 614, can be more reliably loaded into and then deployed from the delivery catheter. This pivoting allows the tether 614 to be aligned directly with the posterior implant 610 (as shown in FIGS. 23 and 24) without imparting a moment of rotation to the implanted anterior implant 612 and the underlying heart tissue.

[0054] In some embodiments, the tether or tension member 614 has a composite structure. The continuous braided filament core may include ultra-high molecular weight polyethylene (UHMPE) fibers such as Dyneema® supplied by Koninklijke DSM N.V. of the Netherlands, combined with polyethylene terephthalate (PET) fibers. Dyneema® can be used for strength and durability, and PET improves bonding with epoxy. In some embodiments, a 50% / 50% combination of Dyneema® and PET is used. This continuous braided filament core may be inserted into or coated with a polyvinylidene fluoride (PVDF) outer sheath to impart desirable handling characteristics such as high column strength for advancing the catheter through the tether without tether crushing. In some embodiments, at least one platinum wire is placed at the distal portion of each tether 614 for radiopacity so that the tether is more visible during imaging. Prior to insertion into the outer sheath, the filament core may be saturated with epoxy. This can be done to bind the composite materials together. In some embodiments, the outer sheath is passed through a necking die to reduce the diameter and compress it into a filament. The tether 614 may be color-coded so that the surgeon can distinguish the inner tether from the outer tether. In some embodiments, markings are provided on the tether 614 every 5 mm so that tightening can be observed. By using the above features, the applicants have discovered that the ability to cut the tether in vivo is obtained, and the tether is imparted with excellent longitudinal stiffness for high-response tightening while ensuring the full in vivo load of the heart valve adjustment, and excellent durability over the life of the implant.

[0055] Referring to FIGS. 44 - 46, diagrams of exemplary implants pre - loaded into the delivery system are shown. In some embodiments, each of the implants is loaded into a unique implant loader 686. The implant loader 686 has a proximal hub 688 configured to slide at the distal end of an internal steering catheter (not shown) (shown in FIG. 45). The distal end 690 of the implant loader 686 can be configured to slide within the proximal end of an external steering catheter (not shown). During implant placement, while the implant loader 686 remains at a predetermined location at the proximal end of the external catheter, the implant and the distal end of the internal catheter slide distally with the implant loader 686 and the external catheter.

[0056] FIG. 44 shows a posterior implant 610 pre - loaded into the implant loader 686. As shown in the figure, the implant 610 is generally parallel to the central axis of the implant loader 686. Each of the five anchor leads 622 is attached to the spinner assembly 624 of the implant and is generally flat against the implant 610 during pre - loading. Each anchor lead 622 extends proximally within the anchor 616 and is attached to an anchor driver 628. Since the fifth anchor is located inside the torque head 630, only four anchors 616 are visible.

[0057] Each of a pair of tether pull - out portions 694 can extend distally from the implant loader 686 through the spin - eyelet assembly 620 of the posterior implant 610 as shown in the figure. After the anterior implant is implanted, its tether 614 can be attached to the protruding end of the tether pull - out portion 694 by a sleeve or the like that is attached to each pull - out portion and crimped to the tether. And the tether can be pulled proximally by the tether pull - out portion 694 until the proximal end of the tether emerges from an internal steering catheter (not shown).

[0058] Figure 45 shows the medial anterior implant 612 preloaded in the implant loader 686. As shown in the figure, the implant 612 forms an acute angle with the central axis of the implant loader 686. The two anchor leads 622 are attached to the spinner assembly 624 of the implant and extend proximally through the anchor 616 and the attached anchor driver 628. Since the second anchor is located inside the torque head 630 and the torque tube 692, only one anchor 616 is visible.

[0059] Figure 46 shows the lateral anterior implant 612 preloaded in the implant loader 686 and extruded from the distal end 690. In this exemplary embodiment, the preloading and placement of the lateral anterior implant 612 are essentially the same as those of the medial anterior implant 612 shown in Figure 45, but a tether pull portion 694 is provided for attachment to the proximal end of the tether from the initially implanted medial anterior implant 612. In this exemplary embodiment, an axially extending spring lumen 696 is provided to guide the tether pull portion 694. In this embodiment, the spring lumen 696 is similar to an automotive "curve sensor" in that it is biased to return from a linear orientation under lateral force during operation to its original linear orientation. The spring lumen 696 serves to prevent the tether pull portion 694, and later the tether itself, from wrapping around the implant, another tether, a lead, or a tube.

[0060] Referring to Figures 47A, 47B, and 24, an exemplary method of performing a valve annuloplasty according to aspects of the present disclosure is schematically shown. The steps of this exemplary method 710 are similar to those already described with reference to the flowchart shown in Figure 4 and the series of images shown in Figures 5 - 22. For ease of understanding, the description of the details that are the same between the two methods will not be repeated below. In some implementations of the method, two anterior implants 612 and one posterior implant 610 are implanted. In other implementations, different types or numbers of devices may be used.

[0061] In some implementations of method 710, the first step 712 of the method is to introduce the distal end of a steerable external delivery catheter (not shown) into the left atrium of a subject. This can be accomplished using a transseptal approach, a left atrial approach, or other methods for gaining access to the left atrium. In some implementations, an internal dilator (not shown) for crossing the septum is disposed at the distal end of the steerable external delivery catheter. A steerable internal delivery catheter (not shown) can be disposed within the external steerable delivery catheter for more accurate delivery of the implant.

[0062] In step 714 of this exemplary embodiment, when the internal delivery catheter is introduced into the external catheter, a first forward implant 612 (see FIG. 24), sometimes referred to herein as a first member, and the distal end of the internal delivery catheter can be positioned from the distal end of the external delivery catheter into the left atrium. In this exemplary embodiment, the inner forward device 612 is first implanted, followed by the outer forward device 612. In other embodiments, the order of implantation may be changed. An anchor lead 622 and the internal catheter can be used to push the forward implant 612 within the external delivery catheter and position it from the distal end. After the first forward implant 612 emerges from the distal end of the external delivery catheter, the anchor lead 622 can be manipulated from the proximal end of the internal delivery catheter to pivot the forward implant 612 into an orientation generally perpendicular to the internal delivery catheter. The distal end of a tether or first tension member 614 is pre-attached and the first forward implant 612 emerges from the external delivery catheter. The proximal end of the attached tether 614 extends from the proximal end through the delivery catheter. The torque head 630 can slide distally along the anchor lead 622 until a distally extending tab 678 fits into a slot 636 (see FIG. 43) so that the implant 612 can be steered to the desired implantation position and orientation. Alternatively, the torque head 630 can remain stationary relative to the catheter and the anchor lead 622 can be used to pull the implant 612 proximally until it engages the torque head 630.

[0063] In step 716, the front implant 612 (i.e., the first member) is fixed to the front side of the mitral valve. This can be achieved by individually rotating each of the two spiral tissue anchors 616 together with the mounted driver head 628. While the torque head 630 holds the front implant 612 in the mitral valve annulus tissue, one drive tube can be rotated to screw the anchor 616 from the spinner assembly 624 into the underlying tissue. And the torque head 630 can be used to finely adjust / rotate the implant 612 before the second anchor 616 is screwed into place together with the drive tube and the driver head 628. Proper placement of the first member can be confirmed through imaging. When the surgical staff is ready to remove the delivery instrument, the lead 622 can be loosened from the spinner assembly 624, passed through the driver head 628, and at least partially withdrawn into the connected drive tube. Thus, the driver head 628 can be disengaged from the anchor 616. When the driver head 628 is disengaged, the mounted drive tube, the anchor lead 622, the torque head 630, and the inner catheter can be withdrawn proximally from the outer delivery catheter.

[0064] In this exemplary embodiment, steps 718 and 720 are each similar to steps 714 and 716. In step 718, the outer front implant 612 (sometimes referred to herein as the second member) and the distal end of the internal delivery catheter can be positioned in the left atrium from the distal end of the external delivery catheter in exactly the same manner as already described for the inner front implant 612 in step 714. In some embodiments, separate steerable internal catheters that are pre-loaded and pre-sterilized are provided for each of the front implants 612. In some embodiments, after the internal catheter for the first member is removed, the tether 614 from the already implanted first member 612 remains in the external catheter. To avoid entanglement, this tether 614 can be passed through the second internal catheter before the second internal catheter is introduced into the external steerable catheter. In this exemplary embodiment, since the second member 612 is positioned with its own attached tether or tension member 614, the proximal ends of both the first and second tethers 614 extend from the proximal end through the second internal catheter. In step 720, the outer front implant 612 (i.e., the second member) is fixed to the front side of the valve in exactly the same manner as already described for the inner front implant 612 (i.e., the first member).

[0065] In step 722, a rear implant 610 (sometimes referred to herein as the third member) is placed in the heart. Like the first and second members, a third member pre-loaded in a unique steerable internal catheter may be provided to the surgeon. In some embodiments, prior to the third internal catheter being introduced into the external catheter, a tether or tension member 614 extending from the first and second members is passed through the eyelet assembly 620 of the rear implant 610 and the third internal catheter. An anchor lead 622 and the internal catheter may be used to push the front implant 612 within the external delivery catheter and position it from its distal end. After the rear implant 610 emerges from the distal end of the external delivery catheter, the anchor lead 622 may be manipulated from the proximal end of the internal delivery catheter to pivot the rear implant 610 into an orientation generally perpendicular to the internal delivery catheter. By maintaining some tension at the proximal end of the tether 614 connected to the implanted first and second members, the rear implant 610 or third member emerges from the external delivery catheter and travels along the first and second tension members 614. One advantage of this mechanism is that the first and second tension members 614 assist in guiding the third member 610 into the proper orientation. Pre-connecting the tension members 614 to the three implants also saves time during the surgery and ensures that the tension members are properly and consistently connected to the implants. The torque head 630 may be slid distally along the central anchor lead 622 until the distally extending tab 678 fits into the slot 636 (see FIG. 40) so that the implant 610 can be further steered to its desired implanted position and orientation. Alternatively, the torque head 630 may remain stationary relative to the catheter, and the anchor lead 622 may be used to pull the implant 610 proximally until it mates with the torque head 630.

[0066] In step 724, the posterior implant 610 (i.e., the third member) is fixed to the posterior side of the mitral valve. This can be achieved by individually rotating each of the five spiral tissue anchors 616 together with its mounted driver head 628. With the torque head 630 holding the posterior implant 610 in the mitral valve annulus tissue, one drive tube can be rotated to screw the anchor 616 through the spinner assembly 624 into the underlying tissue. And the torque head 630 can be used to finely adjust / rotate the implant 610 before the next anchor 616 is screwed into place with its drive tube and driver head 628. Proper placement of the third member can be confirmed through imaging. When the surgical staff is ready to remove the delivery instrument, the lead 622 can be loosened from the spinner assembly 624 and at least partially withdrawn through the driver head 628 and into the connected drive tube. Thus, the driver head 628 can be disengaged from the anchor 616. Once the driver head 628 is disengaged, the mounted drive tube, anchor lead 622, torque head 630, and inner catheter can be withdrawn proximally from the outer delivery catheter.

[0067] In other embodiments, the placement and order of implantation of multiple implants can be varied. In these other embodiments, one or more first implants are placed with a mounted tether, and at least one subsequently placed implant advances along the tether when being placed and mounted in the heart tissue. For example, initially the posterior implant can be implanted with two tethers pre-mounted at both end portions of the implant. Then the inner anterior implant can be placed and can advance along one of the tethers of the posterior implant. After the inner anterior implant has been seated in the underlying heart tissue, the outer anterior implant can be placed and can advance along the other tether of the posterior implant. In another embodiment, a single anterior implant with two tethers is first implanted, and then a single posterior implant is placed and can advance along the two tethers of the anterior implant. Other embodiments with different implant placement orders can also utilize the principles of this disclosure.

[0068] In exemplary method 710, once all three implants are positioned and secured, additional tension can be applied to interconnected tether 614 to bring the anterior and posterior sides of the mitral valve closer together. This can be accomplished in steps 726, 728, 730 of method 710. In step 726, first lock 618 is positioned on first tension member 614 connected to inner anterior implant 612. In step 728, second lock 618 is positioned on second tension member 614 connected to outer anterior implant 612. As shown in FIGS. 23 and 24, lock 618 can be pushed from the proximal end on tension member 614 by a sleeve tool (not shown) that biases lock 618 distally until it abuts against eyelet assembly 620. And in step 730, tension is applied to first and second tension members 614 by pulling the tension members proximally while pushing lock 618 distally with the sleeve tool.

[0069] In some implementations, the tension of tension members 614 can be increased simultaneously. In some implementations, the tension in the members can be gradually increased alternately between the two members 614 until the desired tension and / or valve proximity is reached. In some embodiments, the final tension and / or tissue proximity of each tension member 614 is substantially the same. In some implementations, the final tension and / or tissue proximity of each tension member 614 is different. Since the inner and outer tightening can be performed independently, the tolerance for the placement of each implant is even wider. In some implementations, real-time transesophageal echocardiography of the mitral valve is used to monitor for mitral valve regurgitation when the tension members 614 are tightened. In some embodiments, one or both locks 618 can be temporarily released if it is desirable to decrease the tension in tension member 614.

[0070] After the desired tension and / or tissue proximity is obtained, the excess length of the tension member 614 extending proximally from the lock 618 can be cut. In step 732, the cutter assembly can be slid distally along each tension member 614 until it reaches the lock 618. When activated, it cuts the tension member and is then withdrawn along with the excised portion of the tension member. And in step 734, the external delivery catheter can be withdrawn from the left atrium.

[0071] In some embodiments, the systems and methods disclosed herein, or portions thereof, can be utilized in a similar manner at any atrioventricular valve.

[0072] The advantages provided by the systems and methods disclosed herein can include the following. A more direct reduction in the anteroposterior (A-P) direction can be achieved. Since the A-P direction is the relevant dimension that is most clinically reduced, it is advantageous to directly affect this dimension as opposed to simultaneously changing other dimensions of the valve annulus. This can be achieved by a reduction in the clamping force, since it is a direct A-P direction movement rather than the large forces generally required for circumferential remodeling. A reduction in the clamping force generally translates to a reduction in the number of anchors required. The systems and methods also allow for a high level of customization to a particular biological structure. This relates to the provision of individual components that are installed separately and the ability to adjust the inner and outer sides separately. Each of the separate components is easier to implant compared to a single large structure. Each of the components can be retrieved prior to anchor removal. The systems and methods have in-vivo adjustability, reducing the accuracy required to implant the components and simplifying the implantation surgery. A reduction in the number of implant sizes and configurations can also be achieved. In addition to applying tension to the device during the new procedure, additional tensioning devices may be added later, or at a later date, and / or the existing device may be re-tensioned to further reduce the A-P dimension.

[0073] Referring to FIGS. 48A - 62F, details of an exemplary surgical instrument are presented that can be constructed and used to embed the devices already described according to aspects of the present disclosure.

[0074] Referring first to FIG. 48A, an exemplary adjustable base system is presented for slidably supporting some or all of the proximal ends of the above-described instruments. The exemplary system includes a weighted base 752 configured to be placed on an operating table, cart, stool, or other stand adjacent to the patient undergoing surgery. A clamp (not shown) may be used to hold the base 752 to the underlying stand to prevent movement during surgery, or the base 752 may be made to have sufficient self-weight. The base 752 may include a pair of spaced vertical plates 753 extending upward from the base as shown in the figure. The plates 753 may be configured to slidably receive therebetween a bracket 754 having a linear guide rail 768 attached to an upper portion of an adjustable bracket 754. Slots 756 and 757 may be provided in the bracket 754 for receiving a threaded shaft from a clamp handle 758. In this mechanism, the clamp handle 758 may be loosened to releasably fix the orientation of the rail 768 relative to the base 752 and the patient, and the height and / or angle of the rail 768 may be adjusted such that the handle 758 is re-fastened.

[0075] Referring to FIGS. 48B - 48E, the exemplary adjustable base system of FIG. 48A is shown in various orientations. Specifically, FIG. 48B shows the rail 768 in a downward position at a slightly negative angle (i.e., tilted downward away from the patient). FIG. 48C shows the rail 768 in a downward position at a slightly positive angle (i.e., tilted downward toward the patient). FIG. 48D shows the rail 768 in an upward position at a gentle positive angle. FIG. 48E shows the rail 768 in an upward position at a steep positive angle. Many other orientations are possible with the base system. In some embodiments, the base system may be adjustable to any angle between a negative 10 - degree angle and a positive 45 - degree angle. In some embodiments, the height adjustment range is at least 3 inches.

[0076] Referring to FIG. 48F, several proximal ends of the previously described instruments are shown as being configured for use during surgery. The system 750 includes an external steerable catheter assembly 760, an implant loading tool assembly 762, a tether retainer yoke 764, and an internal steerable catheter assembly 766. Each of the external steerable catheter assembly 760, the tether retainer 764, and the internal steerable catheter assembly 766 can be slidably mounted on a linear guide rail 768 by a separate carriage assembly 770. In some implementations, the guide rail 768 is a drylin® T standard guide rail with a width of 30 mm, and the carriage assembly 770 is a drylin® T standard recirculating ball bearing carriage, both manufactured by Igus, GmbH of Cologne, Germany. In another embodiment, the carriage assembly has an internal contour that conforms to the contour of the guide rail. In other embodiments, the carriage fits onto the guide rail at any point along its length without the need to slide the carriage at the ends of the rail. The carriage assembly 770 can include a locking knob that can be moved between a locked state where the carriage is fixed in its current position on the rail 768 and a free state where the carriage can be moved on the rail. In other embodiments, means (such as ball indentations) for applying a specific friction can be used to achieve the desired pressure in the linear guide to allow smooth linear movement but prevent unexpected sliding. In some implementations, the guide rail 768 has a length of 60 to 190 cm and is inclined at an angle of 0 to 45 degrees from the horizontal. In some implementations, the guide rail has a length of 120 cm and an angle of 15 degrees. In the exemplary embodiment shown in FIG. 48F, the linear guide rail 768 includes an upper proximal end 772 and a lower distal end 774.

[0077] Referring to FIGS. 49A - 49C, an external steerable catheter assembly 760 is shown. The catheter assembly 760 includes a catheter section 776 (to be described in more detail later) and a handle assembly 778. The handle assembly 778 includes a mounting groove portion 780 for removably attaching the handle 778 to the rail carriage assembly 770 shown in FIGS. 48A - 48C. The handle 778 can be rotatably mounted so that a surgeon can rotate the external catheter assembly 760 relative to the rail carriage assembly. Thus, the surgeon can rotatably orient the distal end (not shown) of the catheter section 776 within the patient's circulatory system and heart. In this exemplary embodiment, a single pull cable for pulling the distal end of the catheter section 776 from a substantially straight orientation to a curved orientation extends between a pull ring at the distal end of the catheter section 776 and the handle assembly 778. A rotation lock 782 can be provided on the handle assembly 778 as shown in the figure to indicate to the surgeon the radial / rotational orientation of the external catheter 760 and releasably lock this orientation at a desired location. A ball detent 783 can be provided as shown in FIG. 49C to provide a tactile feedback when the handle assembly 778 is rotated and to impart a friction fit to hold the handle in the current rotational orientation. A steering knob 784 is provided at the distal end of the handle assembly 778 and is coupled to an internal lead screw mechanism for pulling the proximal end of the pull cable as shown in FIG. 49C. In this mechanism, the more the steering knob 784 is turned, the more the distal end of the external catheter 776 curves for guiding within the patient.

[0078] As described below, the internal bore 785 may be configured to receive the distal end of the implant loading tool assembly 762. A cam-acting collar seal 786 for tightening the hourglass valve 788 (shown in FIG. 49C) by longitudinally compressing may be provided at the proximal end of the handle assembly 778. In this exemplary embodiment, the collar 786 and the valve 788 form a hemostatic seal configured to minimize blood loss during surgery. The collar 786 may be used to fully close the valve 788 only when the tether passes through the handle. In this exemplary embodiment, the collar 786 is rotated 180 degrees as it moves from the open position to the closed position, and the words "open" and "closed" are molded on both sides of the collar 786. As shown in FIG. 49C, a cross-slit valve 789 may also be provided so that the loading tool is quickly inserted into or withdrawn from the handle assembly 778 with minimal blood loss. The handle assembly 778 may also include a flush port (not shown).

[0079] Referring to FIGS. 50A-50C, three views of an exemplary implant loading tool assembly 762 similar to the implant loader shown in FIGS. 44-46 are presented. FIG. 50A is a perspective view showing the tool 762 in an assembled state, FIG. 50B is an exploded view showing the components of the tool 762, and FIG. 50C is an enlarged perspective view of the proximal end of the tool 762 showing internal features. As most clearly seen in FIG. 50B, the loading tool 762 includes a rigid cannula 790, a main housing 792 attached to the proximal end of the cannula 790, a hemostatic seal 794 disposed inside the housing 792 during assembly, and a compression hub section 796 that seals the proximal end of the housing 792. The compression hub section 796 includes a stationary hub 798, compression gaskets 800 and 802, and a compression knob 804. Three screws (not shown) may be used to attach the stationary hub 798 to the main housing 792.

[0080] The cannula 790 of the implant loading tool assembly 762 is configured to be received within the proximal end of the outer catheter 760, and the tool 762 is configured such that the inner steerable catheter assembly 766 can pass through it to the outer catheter 760. In some implementations, separate inner steerable catheter assemblies and loading tool assemblies 762 are used to introduce each device to be implanted in a patient's body. Compression gaskets 800 and 802 serve to seal around the outside of the inner catheter assembly or other instruments installed within the loading tool 762. First, the compression knob 804 is tightened to compress the gaskets 800 and 802 to provide a good seal and may prevent rotation of the inner catheter relative to the loading tool 762. After the loading tool 762 is loaded onto the proximal handle of the outer catheter, the compression knob 804 is loosened to allow the inner catheter to rotate and slide easily within and out of the outer catheter. As shown in the figure, the main housing 792 may also be provided with a flush port 806.

[0081] Referring to FIG. 50D, the longitudinal cross-sectional view schematically shows the implant loading tool assembly 762 in use installed at the proximal end of the outer steering catheter 760. The handle assembly of the outer catheter 778 is omitted in FIG. 50D for clarity. The compression knob 804 is fastened, and the loading tool 762 is shown attached to the distal end of the inner steering catheter 766 with the previously described rear implant 610 pre-loaded in the tool 762. The proximal end of the outer steering catheter 760 may be enlarged as shown so that the inner diameter of the tool 762 is substantially the same as the inner diameter of the main portion of the outer catheter 760 when the tool 762 is installed therein. Separate loading tools 762 may be provided for each inner steering catheter 766. With the implant pre-loaded in the tool 762, each tool may be enclosed at the distal end of the inner catheter assembly. This mechanism allows for easy replacement of the inner catheter and implant within the outer catheter 760, without the need for the implant to fit within the inner catheter assembly. The implant only needs to fit within the inner diameter portion of the main portion of the outer catheter assembly 760, and the inner catheter assembly 766 also slides therein.

[0082] During operation, the implant loading tool assembly 762 may be enclosed in a releasably attached state to the distal end of the inner catheter 766 by the compression hub 796. The compression hub 796 holds the tool 762 in a state attached to the inner catheter assembly 766 and prevents the tool from rotating relative to the inner catheter assembly 766 so that the implant 610 and its lead do not rotate. After unsealing, the loading tool 762 and the distal end of the inner catheter 766 may be inserted into the proximal end of the outer catheter 760. Then, when the compression hub 796 is loosened, the inner catheter 766 and the implant 610 may be slid distally within the outer catheter 760.

[0083] Referring to FIGS. 51 - 56, an exemplary steerable internal catheter 766 is shown. The internal catheter 766 can be used to deliver and implant a posterior implant 610 (shown in FIGS. 23 and 24). As most clearly seen in FIG. 51, the internal catheter 766 includes a catheter section 810 and a control housing 812 attached to the proximal end of the catheter section 810. The control housing 812 is rotatably coupled to a support structure 814, and as previously described, the support structure can be attached to a guide rail carriage 770. A ball detent or another detent mechanism, as previously described for the outer catheter assembly, can be provided to provide tactile feedback such as intermittent resistance when the internal catheter control housing 812 is rotated, imparting a friction fit to hold the housing 812 in its current rotational orientation.

[0084] As most clearly seen in FIG. 52B, the distal portion of the housing 812 can include a pair of diametrically extending wings 816 on both sides. Among other functions, the wings 816 serve as an indicator for the orientation of the distal tip of the catheter section 810 when being manipulated within the patient's heart. The control housing 812 can be rotated relative to the support structure 814 during surgery to vary its radial orientation and the radial orientation of the distal tip of the catheter section 810. A steering knob 817 can be rotated by the surgeon to increase or decrease the amount of curvature of the distal tip. In this exemplary embodiment, the steering knob 817 drives an internal thread through a lead screw assembly (not shown), and the internal thread drives a pair of steering cables (not shown) that extend along the length of the catheter section 810 to its distal tip. One steering cable pulls on one side of the distal tip while the other cable relaxes the opposite side, thereby curving the distal tip in a first direction. When the steering knob 817 is rotated in the opposite direction beyond its initial neutral position, the other cable pulls on the opposite side of the distal tip, thereby curving the distal tip in the opposite direction.

[0085] As shown in the figure, an M indicating "inside" may be marked on one side of the wing portion 816, and an L indicating "outside" may be marked on the other side. The inner wing portion 816 may include a pair of internal guide slots (not shown) that guide the proximal portions of the two inner anchor driver tubes 818 outward from the catheter section 810 to a proximal position of the inner wing portion 816 that can be manipulated by the surgeon. The proximal end of the inner anchor driver tube 818 is provided with a control knob 820 for rotating the inner driver tube 818, and as already described, the inner driver tube drives the inner anchor driver head 628 shown on the right side of FIG. 24 at the distal end of the anchor driver tube. In FIG. 52B, the proximal end of the inner anchor lead 622 is shown as extending from the proximal end of the inner driver tube 818. A small-diameter control knob 822 may be provided at the proximal end of this lead to rotate the inner anchor lead 622, and as already described and shown on the right side of FIG. 24, the lead is connected to the two inner spinner assemblies 624 at its distal end.

[0086] In a manner similar to the inner wing portion 816, the outer wing portion 816 may include a pair of internal guide slots (not shown) that guide the two outer anchor driver tubes 818 outward from the catheter section 810 to a proximal position of the outer wing portion 816 that can be manipulated by the surgeon. The proximal end of the outer anchor driver tube 818 is provided with a control knob 820 for rotating the outer driver tube 818, and as already described, the outer driver tube drives the outer anchor driver head 628 shown on the left side of FIG. 24 at the distal end of the anchor driver tube. FIG. 52B shows the proximal end of the outer anchor lead 622 extending from the proximal end of the outer driver tube 818. A small-diameter control knob 822 may be provided at the proximal end of this lead to rotate the outer anchor lead 622, and as already described and shown on the left side of FIG. 24, the lead is connected to the two outer spinner assemblies 624 at its distal end.

[0087] When the two wings 816 are brought together, they form a manifold that provides the drive tube 818, the lead 622, and the tether or tether pull portion 694 (see FIG. 56) to the surgeon in a flat, fan-shaped configuration. The linear arrangement of the driver and the tether provides an intuitive understanding of the relationship between the driver at the proximal end and its placement at the implant.

[0088] The central anchor driver tube 818 extends into the center of the housing 812 and may terminate at the control knob 820 of the concave portion 824 of the housing 812. This driver tube 818 can be used to rotate the central anchor driver head 628 shown in the center of FIG. 24, as previously described. In this exemplary embodiment, a first magnet is fixed inside the central anchor control knob 820, and an engaging second magnet is fixed inside the proximal portion of the control housing 812 to prevent the central anchor driver 818 from making an unexpected forward movement during surgery. FIG. 52B shows the proximal end of the central anchor lead 622 extending from the proximal end of the control housing 812. A small-diameter control knob 822 for rotating the central anchor lead 622 can be provided at the proximal end of this lead, and the lead is connected to a central spinner assembly 624 (not shown) at its distal end (FIG. 24). A lock lever 826 can be provided as shown in FIG. 52B to releasably couple the central lead 622 to the handle and prevent relative movement between the handle, and thus prevent relative movement between the implant and the handle. In this exemplary embodiment, the lever lock 826 is coupled to a spring-actuated mechanism 828. The spring-actuated mechanism 828 serves to bias the central lead 622 in the proximal direction by elastic spring force when the lever 826 is engaged. This mechanism helps hold the implant 610 at the torquer head 630 (shown in FIG. 24) when operating the implant 610 with the internal steerable catheter control housing 812 (shown in FIG. 52B). In some embodiments, the central anchor may be removed depending on whether other anchors are performing fixation. The torquer does not need to operate around the central anchor, and the lead nut does not need to be attached to the spinner assembly. In such embodiments, loading is facilitated when the diameter of the torquer is reduced. The inner diameter of the torquer may be even smaller to more closely match the diameter of the lead. The closer the diameter alignment between the inner diameter of the torquer and the lead, the more the left-right movement is reduced, and the torquer can be fitted to the posterior implant with fewer operations.

[0089] The control housing 812 may also include a torque control assembly 830. The housing of the torque control assembly 830 is generally C-shaped and forms the concave portion 824 as already described. A torque control knob 832 may be formed in the housing of the torque control assembly 830 to allow a surgeon to rotate and axially translate the entire housing of the torque control assembly 830 relative to other portions of the control housing 812. Internally, the torque control knob / housing 832 is connected to the proximal end of a torque tube 692 (not shown in FIG. 52B), and the distal end of the torque tube is connected to a torque head 630 as shown in FIG. 45. (The torque head 630 itself is most clearly seen in FIGS. 24 and 37.)

[0090] During operation, after the implant is placed in the left atrium, the proximal end of the central lead 622 can be pulled proximally to pull the implant relative to the torque head 630 (i.e., from a configuration where the implant 610 is separated from the torque head 630 as shown in FIG. 37 to a configuration where the implant 610 is engaged with the torque head 630 as shown in FIG. 24). As already described, the torque control knob / housing 832 needs to be rotated slightly to ensure that the tabs of the torque head 630 engage the slots of the implant plate. When the torque head 630 is fully engaged with the implant, the spring-actuated mechanism 828 is pressed distally, the lever 826 engages to bias the central lead 622 in the proximal direction, and maintains the torque head 630 in an engaged state with the implant. Then, the implant can be rotated and translated with the knob 832 to precisely position the implant inside the patient. Since the torque control assembly 830 extends around the concave portion 820 to support the spring-actuated mechanism 828, the central lead 622 rotates and translates in cooperation with the torque head and the implant. In this mechanism, the torque head is held relative to the implant when the implant is translated by the torque control assembly 830, and the central lead 622 is prevented from disengaging from the implant when the implant is rotated by the torque control assembly 830.

[0091] In some embodiments, the torque control assembly 830 includes a detent mechanism that provides intermittent resistance when the torque control assembly 830 is used to rotate the torque tube and / or when it is used to axially move the torque tube. What is meant by "intermittent resistance" is a series of stops, detents, or clicks, so that the surgeon receives feedback on how fast the control unit and implant are moving, and the implant is held in place when the torque control assembly 830 is not being moved. In some embodiments, the rotational connection of the inner catheter assembly to the carriage assembly detent mechanism has a greater rotational resistance than the torque control knob assembly detent mechanism. This helps ensure that the inner catheter assembly does not unexpectedly rotate when the torque control assembly is rotated. In this exemplary embodiment, the torque control assembly 830 includes 11 detent positions when the knob 832 is linearly / axially moved over a 10 mm stroke and 36 detent positions when the knob 832 is rotated a full revolution.

[0092] Referring to FIGS. 53 - 56, additional figures are presented showing the above - described features of the internal catheter 766. As most clearly seen in FIG. 54, the control housing 812 can be rotated towards the surgeon (in the direction of arrow A) or away from the surgeon (in the direction of arrow B), which is located above and to the left of the control housing 812. FIG. 54 shows the wing 816 moved 25 degrees towards the surgeon from the initial horizontal position. In this orientation, the distal tip of the internal catheter is moved in the forward direction within the patient's heart. When implanting a posterior implant in this exemplary embodiment, the external steerable catheter performs most (all in some embodiments) of the forward and backward positioning. When implanting a triangular implant, the internal steerable catheter is more "active" in the forward and backward as well as the inner and outer positioning. In this exemplary embodiment, the support structure 814 is configured to rotate the control housing 812 plus or minus 90 degrees. In other embodiments, rotation up to plus or minus 180 degrees is allowed. Preventing 360 - degree rotation of the internal system prevents the tethers from wrapping around each other within the biological structure and / or inside the external guide by the surgeon. A detent mechanism can be provided that allows 28 individual positions within this 180 - degree range of motion. As most clearly seen in FIG. 55, the control housing 812 can include a flush port 833 having a tube disposed in a concave groove extending between a connection at the center of the bottom of the housing and a valve attached to the bottom periphery of the inner wing 816. The support structure and the rail carriage are omitted in FIG. 56 for clarity.

[0093] Referring to FIG. 56, each wing portion 816 can be configured to support the proximal end of the tether pull portion 694 as shown in the figure. When prepared in the operating room, two tether pull portions 694 that each pass through the wing portion 816, through the inner catheter 810, and through the eyelet assembly 620 of the posterior implant 610 (both shown in FIG. 23) that is loaded into the implant loading tool 686 or 762 and extends from the distal end of the implant loading tool can be provided by the inner catheter assembly 766. The distal end of the tether pull portion can include a crimp sleeve or other attachment device for gripping the proximal end of the tether 614 (the distal end of the tether 614 shown in FIGS. 23 and 24).

[0094] In some implementations, as will be described in more detail later, both front implants are first implanted and their tethers extend from the proximal end of the external catheter. The distal end of the tether puller may have different colors, different lengths marked with characters, and / or other identifying characteristics so that the inner and outer tethers can be distinguished from each other at their distal ends. Then, by inserting the tether from the inner implant into the crimp sleeve and crimping it, etc., the proximal end of this tether can be attached to the distal end of the inner tether puller 694. In other embodiments, the interior of the crimp sleeve is provided with a proximally directed protrusion that grips the tether in the sleeve without the need for crimping. Additionally, a peel-away-funnel may be provided to assist in guiding the tether into the sleeve. The outer tether can be attached to the outer tether puller 694 in the same or a similar manner. And the two tethers can be pulled through the implant and the inner catheter by the tether puller 694 until they extend from the proximal side of the wing portion 816. And they can be cut or separated in other ways from the tether puller 694. And in some implementations, the inner catheter 766 is inserted into the outer catheter with a light tension applied to the tether. In another embodiment, the tether can be fixed to a linear guide. This way, the surgeon will be avoided the need to apply a light tension to the tether. This may require directly clamping the tether to the linear guide or providing an additional carriage with a tether locking feature. The tether locking feature rotates to wind up or further increase the length of the tether to further fine-tune the tension of the tether and / or its relative length to the system. This mechanism allows the inner catheter 766, the implant loader, and the loaded implant to be provided in the operating room ready for insertion into the outer catheter without the need to remove the implant and first pass the tether through it. This mechanism also prevents the tethers from crossing or tangling when the rear implant advances along the tether during implantation. In other embodiments, the tether is shorter and remains inside the lumen and most of the internal system is not present in the manifold until most of it is inserted into the external guide.In these embodiments, a tether pull is used to maintain a light tension during advancement. In other embodiments, the tether is short enough that it does not exist in the manifold even when the internal system is fully inserted.

[0095] Referring to FIGS. 57 and 58, an exemplary internal catheter assembly 766' configured to implant an inner front implant 612 (shown in FIG. 23) and an exemplary internal catheter assembly 766'' configured to implant an outer front implant 612 (also shown in FIG. 23) are shown respectively. In some implementations, the internal catheter assemblies 766' and 766'' are the same as or similar to the catheter assembly 766 configured to implant a rear implant 610 (shown in FIG. 23) shown in FIG. 56, but have fewer anchor driver tubes 818 and anchor leads 622 to be inserted, and the tether pull 694 is less or not provided. Each of these two internal catheter assemblies 766' and 766'' may include a driver tube 818 and an anchor lead 622 extending to the center of the control housing 812 as already described for the assembly 766, and a second set of driver tubes 818 and anchor leads 622 extending from an inner wing 816 or a lateral wing 816 suitable for a particular implant. The control housing 812 may be configured and function in each case as already described for the internal catheter assembly 766. Each internal catheter assembly 766' and 766'' may also include an implant loader 686 or 762 (not shown) loaded with a front implant in the same manner as the mechanism for the rear implant described above.

[0096] In some embodiments (not shown), the instrument described above can be modified to deliver an implant having fewer or more anchors than the implants already described. For example, a posterior implant has only one inner anchor and one outer anchor, and thus does not require all of the leads and driver tubes described above. Regardless of the number of inner and outer anchors, a central anchor may or may not be included. When the central anchor is omitted from the posterior implant, the central lead can still be used, as already described, to guide the torquer to a predetermined location on the implant and assist in its retention there. An anterior implant may comprise a single anchor provided within or separated from the torquer. Even when the anchor is not disposed in the torquer, a lead can be used with the torquer. In some embodiments, the anterior implant is similar to the posterior implant and may include a central anchor and two outer anchors.

[0097] Referring to FIG. 59A, an exploded view showing the internal components of the internal steering catheter assembly 766 is presented. FIG. 59B is a longitudinal cross-sectional view showing the internal components of the internal steering catheter assembly 766, again. FIG. 59C is an enlarged cross-sectional view showing the distal / left side portion of FIG. 59B. FIG. 59D is an enlarged cross-sectional view showing the middle portion of FIG. 59B. FIG. 59E is an enlarged cross-sectional view showing the proximal / right side portion of FIG. 59B.

[0098] Referring to FIGS. 59F and 59G, cross-sections of the inner catheter are shown. FIG. 59F shows the inner catheter 810 of the inner catheter assembly 766, and FIG. 59G shows the inner catheter 810' / 810'' of the inner catheter assemblies 766' / 766''. First referring to FIG. 59F, the inner catheter 810 may comprise a multi-lumen extrudate (MLE) 834 having at least seven lumens. In this exemplary embodiment, a large hole is disposed at the bottom of the MLE 834 with a series of small holes disposed in a crescent shape at the top. As shown in FIGS. 60A and 60B, each of the holes is configured to accommodate at least one of the laser-cut steering shaft 835, torque driver tube 692, anchor driver tube 818, anchor lead 622, tether 614, tether pull 694, and / or tether router 840. The tether router 840 can provide a consistent lumen for the tether and / or tether pull to cross the system, particularly from the rear of the MLE 834 to the manifold outlet. The MLE 834 can enhance responsiveness during operation by preventing the above-listed articles from becoming entangled or twisted with each other. The MLE can significantly improve torque transmission of the internal system as a whole. In this exemplary embodiment, the proximal end of the MLE 834 is coupled to the control housing. The proximal end of the laser-cut steering shaft 835 is also coupled to the control housing and its distal end steered by a pull wire from the control housing, extending beyond the distal end of the MLE 834. FIG. 60B presents the dimensions of the above articles in this exemplary embodiment, and FIG. 60C shows the gap extending therebetween. Referring again to FIG. 59G, the multi-lumen extrudate 834' configured for use with the inner catheter assemblies 766' / 766'' may be similar to the MLE 834 with the same articles inserted as shown in FIGS. 59F, 60A, 60B, but has only one lumen at the top for accommodating the coaxial lead and driver. The lumen of the MLE 834' for the steering shaft and for the tether / tether pull may be larger than the corresponding lumen of the MLE 834 as shown in the figure.

[0099] Referring to FIGS. 60D - 60F, details of an exemplary laser cut internally steerable shaft 835 are shown. The steerable segments of the internally steerable shaft 835 are constructed from two stainless steel hypodermic tubes and three laser cut patterns. The proximal most section 836 is a small diameter section that extends over approximately the length of the MLE 834 and has a laser cut pattern that allows for flexibility of the inner catheter within the vasculature. The small diameter section 836 that extends into the MLE 834 results in the MLE being small diameter and thus the overall system being low profile. The exposed segment of the proximal hypodermic tube 836 (long small diameter section) has a cut pattern that allows for flexibility in all directions and the distal end of this section is assumed to be approximately aligned with the curved portion of the outer guide when the inner catheter advances into the atrium. The distal most section hypodermic tube 837 has a larger diameter and has a laser cut pattern that allows for curvature in one plane (primary curvature). The larger diameter of the distal most section 837 results in a larger diameter and a torquer being recessed into the steerable assembly. This provides support to the torquer. The large diameter tube 837 increases the torsional stiffness of the curved distal section (due to the large moment of inertia) and thus enhances control of the distal end. In some embodiments, the distal most section of the laser cut portion has a spine 838 that is helical. This provides some curvature that is approximately perpendicular to the primary curvature. This pattern can be used in a triangular system and tilt the distal end forward of a single primary curvature. This helical pattern (or the opposite pattern) can also be used in a posterior system to increase or decrease the (anteroposterior) approach angle of the implant to the valve annulus. In this exemplary embodiment, two spines 838 are provided in the distal section 837 and are spaced 180 degrees apart. The maximum flexure of the distal section 837 occurs between the two spines 838 and the flexure along the spines is minimal or no flexure occurs. Two pull wires 839 are also provided in the distal section 837 and are spaced 180 degrees apart from each other. As most clearly seen in FIG. 60D, the pull wire 839 (only one is visible) originates at the proximal end of the distal section 837 that is 90 degrees away from the spine 838.Since the spine 838 extends in the distal direction, it is helical in one direction, while the pull wire 839 is helical in the opposite direction and intersects the spine 838 before reaching the distal end of the distal section 837. With this mechanism, the distal section 837 can be curved to a considerable extent in the primary direction and to a slight extent in the secondary direction that is generally perpendicular to the primary direction. In this exemplary embodiment, the inner catheter is steered by two guide wires (i.e., it can be curved alternately in opposite directions), while the outer catheter is steered by a single guide wire (i.e., it can be curved in a single direction). In some embodiments, the laser-cut hypo tube is coated with a braided outer sheath and / or a polymeric coating. In some embodiments, the pull wire is clamped between the outer diameter portion of the hypo tube assembly and the braided outer sheath. FIG. 60F shows the laser-cut pattern of the distal tube 837 as if it were lying flat on a sheet.

[0100] FIGS. 60D and 60E also show an exemplary guide clip 841 that can be used in the outer triangular system. The guide clip 841 is configured to be attached to the inner steering shaft 835 and has an elliptical opening 843 that extends distally from the MLE 834 and is configured to guide a coaxial anchor driver tube / anchor lead, tether, tether pull, and / or spring lumen (not shown) to prevent their twisting or entanglement. In some embodiments, the guide clip 841 is disposed approximately 60 mm proximal to the distal tip of the steering shaft 835 and approximately 35 mm distal to the distal end of the MLE 834. In this exemplary embodiment, the opening 843 is aligned with the small lumen at the top of the MLE 834 as shown in the figure. In some embodiments (not shown), the opening 843 is rotated approximately 90 degrees counterclockwise from the small opening at the top of the MLE 834 (as viewed from the proximal end of the instrument).

[0101] Referring to FIGS. 60G - 60I, an enlarged view of the guide clip 841 is shown. As most clearly seen in FIG. 60H, the guide clip 841 may include a first elliptical opening 847 for receiving the inner steering shaft 835 and a second elliptical opening 843 interconnected therewith for guiding the above - mentioned elements. The clip 841 may be formed from a polymer or other elastic material so that the inwardly projecting tab 849 can flex outwardly when the clip 841 is installed on the inner steering shaft. And the tab 849 can apply an inward pressure to maintain the clip at a predetermined location on the shaft. In this exemplary embodiment, the clip 841 has an axial width in the range of 3 - 5 mm. By shortening the width, such as to 5 mm or less, the clip 841 does not significantly affect the flexibility of the inner or outer catheter.

[0102] Referring to FIG. 61, an exemplary embodiment of the tether - holding yoke 764 is shown. As already described with respect to FIGS. 48A - 48C, the yoke 764 is configured to be mounted on a linear carriage so that it can be moved along a rail between the proximal control handles of the inner and outer catheters. In this exemplary embodiment, spring clips 842 are mounted on the upper surface of each of the upwardly and outwardly extending arms. Each spring clip 842 functions in combination with the upper surface of the lower arm and has a rounded distal tip that allows the tether to slide easily onto and off of the clip. In operation, the spring clip 842 serves as a temporary storage location for the proximal end of the tether that extends from the proximal end of the outer catheter after one instrument has been removed from the outer catheter and before another instrument is inserted. This mechanism can keep a small amount of tension on the tethers so that they do not cross. In some embodiments, letters or other markings (not shown) may be provided as shown on the inner and outer sides of the yoke 764 for holding the inner and outer tethers. In an alternative embodiment (not shown), additional clips 842 are arranged on the yoke 764 for use in procedures that require more than two tethers.

[0103] Referring to FIGS. 62A - 62C, an exemplary embodiment of a bifurcated loading tool 844 is shown. In some implementations, after all devices are implanted and the last internal catheter and the loading tool are removed from the outer catheter, a tether from the implant is passed through the loading tool 844, and the loading tool can be placed at the distal end of the outer catheter. As will be described later, the loading tool 844 can be used to load the tether onto the tool one at a time or simultaneously, such as to apply tension to the tether and cut it near the implant.

[0104] As most clearly seen in FIG. 62C, the exemplary loading tool 844 includes a pair of converging passages 845 that converge when connecting to the proximal end of the cannula section 846. As most clearly seen in FIG. 62A, M representing the inner side and L representing the outer side can be marked on two sides. As most clearly seen in FIG. 62B, the loading tool 844 includes a cannula section 846, a collet nut 848, a housing 850, a first seal pair 852, a second seal pair 854, a pair of hemostatic valves 856, a retaining plate 858, and a flush port line 860. The collet nut 848 is configured to be screwed onto the distal end of the housing 850 to fix the cannula section 846 therein. One of the first seal 852, one of the second seal 854, and one of the hemostatic valves 856 are each installed in each of the two passages 845 (FIG. 62C) and are held here by a plate 858 that can be fastened to the housing 850 by a threading fastener (not shown). The hemostatic valve 856 allows an instrument to be inserted into the passage 845 of the tool 844 and the outer catheter, but prevents unrestricted blood flow when the instrument is removed. A flush port valve (not shown) can be provided in the flush port line 860 to allow intermittent cleaning of the tool 844.

[0105] Referring to FIGS. 62D - 62F, an exemplary embodiment of a tether guide 862 for use with a bifurcated loading tool 844 is shown. The guide 862 includes two tubes 864 that are bent to conform to the internal contour of the tool 844. To facilitate insertion of the tether and to distinguish the two tubes from each other, one of the distal ends of the tubes 864 is longer than the other. The proximal ends of the tubes 864 may be joined to a connector 866. The connector 866 and / or the tubes 864 may be configured to be somewhat flexible and / or rotatable relative to each other so as to follow the bend of the passageway 845 when inserted into the loading tool 844.

[0106] As shown in FIGS. 62E and 62F, in operation, the tether guide is installed on the loading tool 844. The proximal end of the inner tether extending from the distal end of the outer catheter is inserted distally and passed through the inner tube 864. Similarly, the proximal end of the outer tether is inserted distally and passed through the outer tube 864. Then the guide 862 is removed from the proximal end of the loading tool 844 and the tool may be inserted into the proximal end of the outer catheter. In this mechanism, the inner and outer tethers can be easily inserted into the appropriate passageways of the loading tool 844 without creating a concern that they will cross each other.

[0107] In some embodiments (not shown), for use in procedures that require three or more tethers, three or more converging passageways 845 may be provided in the loading tool 844 and three or more tubes 864 may be provided in the tether guide 862.

[0108] Referring again to FIGS. 48A - 48C, the overall operation of the exemplary instrument system 750 will now be described. In some procedures, as the distal end of the external steerable catheter assembly 760 is introduced into a patient's artery and advanced toward the patient's heart, the external steerable catheter assembly 760 is moved from the upper proximal end 772 to the lower distal end 774 of the linear guide rail 768. As previously described, the internal dilator can be advanced along the guide and used to pass the distal end of the external steerable catheter assembly 760 from the septum of the heart to the left atrium of the subject using a transseptal approach. Once the external catheter 760 is positioned at the desired location, the tether retainer 764 can be installed on the guide rail 768 and / or slid to a position several inches proximal from the proximal end of the external catheter 760.

[0109] Then, a combination of a separate steerable internal catheter assembly for implanting each device and the implant loading tool 762 can be sequentially introduced into the external steerable catheter assembly 760. In some implementations, the internal catheter assembly 766’ (FIG. 57) is first used to implant the inner front implant, followed by the internal catheter assembly 766” (FIG. 58) for implanting the outer front implant, and then the internal catheter assembly 766 (FIG. 56) for implanting the rear implant. On the other hand, each of the internal catheter assemblies 766’, 766” and 766 can be fitted into the same carriage assembly 770 and then removed later.

[0110] As shown in FIG. 57, the internal catheter 766’ can include a tether 614 having a distal end pre - attached to a pre - loaded inner implant 612 (both shown in FIG. 23) and a proximal end extending from the inner wing 816.

[0111] Then the distal end of the inner steerable catheter assembly 766’ can be passed through the outer catheter 760. In this exemplary implementation, the implant loading tool assembly 762 encloses the distal end of the inner steerable catheter assembly 766’ with the inner implant pre-loaded. The carriage assembly 770 for the inner steerable catheter assembly 766’ is mounted or pre-disposed at the upper proximal end 772 of the guide rail 768 and can be moved distally until the distal end of the implant loading tool assembly 762 reaches the proximal end of the outer catheter 760. Then, after the distal end of the tool 762 is inserted into the outer catheter 760, it is locked at a predetermined location. And when the distal end of the inner steerable catheter assembly 766’ and its associated implant are introduced through the loading tool assembly 762 to the proximal end of the outer catheter 760, the proximal end of the inner steerable catheter assembly 766’ can be moved from the upper proximal end 772 to the lower distal end 774 of the linear guide rail 768. When the implant and the distal end of the inner catheter 766’ advance inside the outer catheter 760 and emerge from the distal end into the left atrium of the subject as already described, as shown in FIGS. 48A - 48C, the proximal ends of the inner catheter 766’, the loading tool 762, and the outer catheter 760 are approximately positioned relative to each other.

[0112] After the medial anterior implant has been implanted as previously described, the inner catheter assembly 766' can be withdrawn from the outer catheter assembly 760 and removed from the carriage assembly 770. At this point, the proximal end of the tether extending from the implanted inner implant protrudes from the proximal end of the outer catheter and can be attached to the inner clip of the tether holding yoke 764. Then an inner catheter assembly 766'' (FIG. 58) for the outer implant can be attached to the carriage assembly 770 used for the inner catheter. As shown in FIG. 58, the inner catheter assembly 766'' can include a tether 614 that is attached to the outer implant and extends from the outer wing portion 816. The inner catheter assembly 766'' can also include a tether pull portion 694 that extends from the inner wing portion 816. Then the distal end of the tether pull portion 694 can be attached to the proximal end of the aforementioned tether from the implanted medial anterior implant as previously described. The tether pull portion 694 can be pulled proximally from the inner catheter assembly 766'' along with the tether and removed from the tether, such as by excising the most proximal end of the tether. Then, after the tether for the inner implant has been removed from the yoke 764, the inner catheter assembly 766'' and the implant loading tool 762 attached thereto can be introduced into the outer catheter 760. Some tension should be maintained on the tether to ensure that the inner catheter 766'' advances along the tether without the tether loosening within the outer catheter.

[0113] As previously described, after the outer front implant has been implanted, the internal catheter assembly 766” can be withdrawn from the external catheter assembly 760 and removed from the carriage assembly 770. At this point, the proximal ends of the tethers extending from the implanted inner and outer implants project from the proximal end of the external catheter and can be attached to the inner and outer clips of the tether holding yoke 764, respectively. Then, the internal catheter assembly 766 (FIG. 56) for the rear implant can be attached to the carriage assembly 770 used for the internal catheter. As shown in FIG. 56, the internal catheter assembly 766’ can include a first tether pull portion 694 extending from the inner wing portion 816 and a second tether pull portion 694 extending from the outer wing portion 816. As previously described, the distal end of the tether pull portion 694 can be attached to the proximal ends of the aforementioned tethers from the implanted inner and outer front implants. The tether pull portion 694 can be pulled proximally from the internal catheter assembly 766 along with the tether and can be removed from the tether, such as by excising the most proximal end of the tether. After the tethers for the inner and outer implants have been removed from the yoke 764, the internal catheter assembly 766 and the implant loading tool 762 attached thereto can be introduced into the external catheter 760. Some tension should be maintained on the tether to ensure that the internal catheter 766 and the associated rear implant advance along the tether without the tether loosening within the external catheter.

[0114] As previously described, after the rear implant has been implanted, the internal catheter assembly 766 and its loading tool 762 can be withdrawn from the external catheter assembly 760 and removed from the carriage assembly 770. At this point, the proximal ends of the tethers extending from the implanted inner and outer front implants and passing through the implanted rear implant project from the proximal end of the external catheter and can be reattached to the inner and outer clips of the tether holding yoke 764, respectively.

[0115] Then, a bifurcated loading tool 844 (shown in FIGS. 62A-62F) can be used. As previously described, the proximal ends of the tethers from the implanted inner and outer front implants can be passed through the loading tool 844. Then, after the tethers are removed from the yoke 764, the loading tool 844 can be introduced into the proximal end of the outer catheter 760. Some tension should be maintained in the tethers to ensure that the tool 844 advances along the tethers without loosening them.

[0116] Then, additional implants and / or instruments can be passed through the bifurcated loading tool 844 and the outer catheter 760. Specifically, the tether locks 618 (shown in FIGS. 23, 24, and 63A-65D) can be advanced one at a time along the tethers. Another instrument (disclosed in more detail below) can be passed through the loading tool 844 to introduce the tether locks 618 along each tether to apply a desired amount of tension to each tether. Such instruments can be alternately provided between the tethers to apply tension and / or re-tension to the tethers until a desired amount of tension (which can be patient-specific and different for each tether) is obtained. Alternatively, two tensioning / locking instruments can be used simultaneously, one for each tether. In some implementations, imaging and / or real-time measurements can be performed to evaluate the tether tensioning as it is being performed. Once the desired tension is achieved, the tensioning / locking instrument (not shown, but disclosed in more detail in a subsequent application by the applicant) can be removed, and another instrument can be passed through the loading tool 844 and along each tether one at a time to excise the excess length of the tether, such as immediately proximal to the tether lock. After confirmation that the implant system is properly implanted, the outer catheter assembly 760 is slid proximally along the guide rail 768 to withdraw the outer catheter from the patient.

[0117] Referring to FIGS. 63A - 65D, further details of an exemplary tension member / tether lock 618 are shown. The locking device includes a lock body 30 and a movable part 40. The lock body 30 is configured for the tension member 13 to pass through, and the lock body 30 is provided with a sliding groove portion 70. The movable part 40 can be movably installed in the sliding groove portion 70. The lock body 30 is provided with an abutting portion 333, and the tension member 13 is disposed between the abutting portion 333 and the movable part 40. The movable part 40 is configured to move along the sliding groove portion 70 to the abutting portion 333 under the action of an external force, and restrict the tension member 13 at the location of the abutting portion 333.

[0118] The sliding groove portion 70 provides a guiding function for the movable part 40. The movable part 40 moves along the sliding groove portion 70 under the action of an external force and gradually approaches the abutting portion 333, thereby restricting the tension member 13 to the abutting portion 333. As shown in FIGS. 64A and 64B, the tension member 13 passes through the lock body 30 in the direction from the proximal end 11 to the distal end 12. The sliding groove portion 70 acts as a chute, and the sliding groove portion 70 extends in the direction from the proximal end 11 to the distal end 12. This direction is inclined towards the abutting portion 333. When a force in the direction from the proximal end 11 to the distal end 12 is applied to the movable part 40, the movable part 40 is driven to move along the sliding groove portion 70 to the abutting portion 333, and pressure is applied to the tension member 13 to clamp it between the abutting portion 333 and the movable part 40. Preferably, the movable member 40 is a pin 60 having an enlarged head portion at both ends that penetrates the sliding groove portion 70 and holds the pin 60 in the groove portion 70.

[0119] Furthermore, the abutting portion 333 may be provided with a sawtooth continuum on the abutting surface 72 that increases the friction between the tension member 13 and the abutting portion 333 and improves the stability of locking the tension member 13.

[0120] In some embodiments, the inner wall of the sliding groove portion 70 is provided with a limiting portion 71. When the movable member 40 moves along the sliding groove portion 70 from the proximal end portion 11 to the distal end portion 12, the movable member 40 is subjected to an external force and continues to move in the distal direction by passing through the limiting portion 71. When the member 40 moves to a predetermined position and the external force is removed, the limiting portion 71 restricts the movable member 40, and the limiting portion 71 locks the relative position between the lock body 30 and the movable member 40 by preventing the movable member 40 from returning to the proximal end portion 11. Therefore, the stability of the locking tension member 13 is improved. The limiting portion 71 may be disposed on the inner side wall of the sliding groove portion 70 away from the contact surface 72. Specifically, the limiting portion 71 may be a limiting convex point or a limiting rib or the like. Referring to FIGS. 64A and 64B, in this exemplary embodiment, the position limiting portion 71 is a limiting rib 711 extending longitudinally along the movable member 40. Further, a plurality of limiting ribs 711 are provided at the distal end portion of the inclined chute 70, and the movable portion 40 can be restricted by different limiting ribs 711 according to the thickness of the tension member 13, so that the locking device is suitable for different thicknesses. When a large number of limiting ribs 711 are provided, when the surgeon applies a proximal direction force to the traction member 13, the surgeon can press the movable portion 40 to the distal end portion without continuous force, which reduces the difficulty of the operation. Further, the proximal end portion of the inner wall of the sliding groove portion 70 may also be provided with a limiting portion 71 for preventing the movable portion 40 from moving to the distal end portion, so that the movable portion 40 is initially held at the proximal end portion of the sliding groove portion 70, which is convenient for sliding the lock body 30 along the tension member 13 without resistance.

[0121] As shown in FIGS. 65A and 65B, an external force can be applied by a sliding cylinder, a sleeve, or a collar 23. The sliding collar 23 is put on the lock body 30, and the sliding collar 23 abuts against the movable member 40. The sliding collar 23 serves as a locking driving device 20. The sleeve 23 moves from the proximal end portion 11 to the distal end portion 12 with respect to the lock body 30, thereby pressing the movable member 40 and moving it to the contact portion 333. In this exemplary embodiment, the sliding collar 23 is detachably connected to the locking device. After the locking of the tension member 13 is completed, the sliding collar 23 can be pulled out from the locking device.

[0122] In this exemplary embodiment, as shown in FIGS. 63A and 63B, the lock body 30 includes a lock body connection portion 301. The lock body connection portion 301 is disposed at the proximal end of the lock body 30 and includes at least one connection protrusion 84. The locking device also includes a chuck 80 having a connection beam 82. The connection protrusion 84 and the connection beam 82 are configured to be detachably connected. The connection beam 82 and the connection protrusion 84 are also configured to connect the protrusion 84 to a force applied in the proximal direction to prevent the lock body 30 from moving when the movable member 40 receives a force applied in the distal direction from the outside. As shown in FIGS. 63A, 63B, 65C, and 65D, the sliding collar 23 presses the movable member 40 so that the lock body 30 is fixed and moves toward the abutting portion 333 in the direction from the proximal end 11 to the distal end 12. During this process, the chuck 80 can apply a proximal force to the lock body 30 through the connection between the connection beam 82 and the connection protrusion 84 to keep the position of the lock body 30 in a stable state. The chuck 80 is connected to a pull wire 83, and a pulling force can be applied to the lock body 30 through the pull wire 83 and the chuck 80. In some embodiments, the lock body 30 remains stationary while the sliding collar 23 moves distally by a catheter to activate the lock. In some embodiments, the sliding collar 23 remains stationary while the lock body 30 moves proximally by the pull wire 83 to activate the lock.

[0123] As shown in FIGS. 65C and 65D, the chuck 80 and the lock body connection portion 301 have a detachable structure, which facilitates assembly and cooperation, and the chuck 80 is removed after the tension member 13 is locked. Specifically, the pull wire 83 is a fibrous material, belt, string, cable, rod, or suture. In some embodiments, the pull wire 83 includes a flexible and / or superelastic material, such as nitinol, polyester, stainless steel, or a cobalt-chromium alloy. In some embodiments, the pull wire 83 may be a rigid or semi-rigid rod-shaped structure, such as stainless steel.

[0124] Furthermore, the lock body connection portion 301 includes a plurality of connection protrusions 84 that are spaced apart and dispersed, and a connection groove portion 85 is provided between the plurality of connection protrusions 84. In this exemplary embodiment, the chuck 80 includes a connection post 81 fixed to the connection beam 82, and the connection post 81 is inserted into the connection groove portion 85, which facilitates a more secure connection between the chuck 80 and the lock body connection portion 301 and facilitates assembly and disassembly.

[0125] Furthermore, as shown in FIGS. 63B, 65C, and 65D, the connection protrusion 84 is configured in an L shape. The connection beam 82 includes a contact surface 821 that contacts the connection protrusion 84. The connection beam 82 and the connection column 81 form a T-shaped chuck 80. Thus, it is ensured that the lock body connection portion 301 and the chuck 80 have a large contact area, which is beneficial for transmitting the traction force.

[0126] Referring to FIGS. 66A-66D, additional features are shown that are found in an alternative embodiment of the tether lock 618. In this exemplary embodiment, the lock 618 includes a front plate 870, a back plate 872, a pair of laterally spaced ear flaps 874, a pair of laterally spaced coupling plates 876, side plates 878, an H-shaped brace 880, a serrated contact block 882, a pair of spaced anti-reversal plates 884, a pair of anti-reversal pins 886, a tether bushing 888, and a movable member / lock pin 40.

[0127] As seen in FIGS. 66C and 66D, the lock 618 may include a flexure arm 890 that forms or is adjacent to one side of the sliding groove 70. Near the free end of the flexure arm 890, inwardly projecting saw teeth 892 may be provided. In the non-flexed state shown in FIGS. 66C and 66D, the saw teeth 892 project into the sliding groove 70 and prevent the movable member / lock pin 40 (shown in FIGS. 66A and 66B) from moving from the proximal end of the groove 70 to the distal end of the groove 70. When an external force is applied to the pin 40 as previously described, the pin contacts the saw teeth 892 and flexes the arm 890 away from the groove 70, allowing the pin 40 to pass to the distal end of the groove 70. This mechanism allows the tether to slide freely within the lock 618 until the surgeon is ready to set the lock.

[0128] In this exemplary embodiment, the abutment block 882 includes a saw tooth continuum 894 to fit well with the tether when in the locked state. As previously described, the tether may have a fiber core covered by an outer covering. One large saw tooth 896 may be disposed in the saw tooth continuum as shown in the figure to reduce the possibility of damaging the outer covering of the tether and assist in gripping the fiber core. In this embodiment, the large saw tooth 896 is positioned proximal to the center of the pin when the pin 40 has slid to the end of the groove 70 and helps hold the pin in this locked position. In this embodiment, the large saw tooth 896 has a height greater than twice the height of the other saw teeth of the continuum 894.

[0129] As previously described, the passageway 70 may include several saw teeth 898 disposed on the side of the groove 70 opposite the abutment block 882 as shown in FIGS. 66C and 66D. The saw teeth 898 may allow the surgeon to move the lock pin to the locked position without having to maintain a constant force on the lock pin and may help prevent the lock pin from moving out of the locked position.

[0130] Referring to FIGS. 66E and 66F, additional features are shown that are found in another alternative embodiment of the tether lock 618. In this exemplary embodiment, the lock 618 includes a front plate 870', a back plate 872', a pair of laterally spaced ear flaps 874, a pair of laterally spaced coupling plates 876, an H-shaped side plate 880', a serrated abutment block 882, a pair of spaced anti-rotation plates 884, a pair of anti-rotation pins (not shown), a tether bushing 888', a movable member / lock pin 40, and a lock ring 40' attached to the distal end of the lock pin 40.

[0131] As most clearly seen in FIG. 66F, the lock 618 may include a flexure arm 890' that forms or is adjacent to one side of the sliding groove 70. In the non-flexed state shown in FIG. 66F, the distal end of the flexure arm 890' projects into the sliding groove 70 and prevents the movable member / lock pin 40 (shown in FIG. 66E) from moving from the proximal end of the groove 70 to the distal end of the groove 70. When an external force is applied to the pin 40 as previously described, the pin abuts against the distal end of the arm 890' and flexes it away from the groove 70 to allow the pin 40 to pass through to the distal end of the groove 70. This mechanism allows the tether to slide freely within the lock 618 until the surgeon is ready to set the lock. The flexure arm 890' shown in FIG. 66F is similar to the flexure arm 890 shown in FIG. 66D but has two significant differences. First, the arm 890' does not have serrations located at its distal end. Second, the distal end of the arm 890' generally extends towards the locking end of the sliding groove 70 rather than the non-locking end. Additionally, the locking serrations 898 shown on the side of the sliding groove 70 in FIG. 66D may be omitted in the embodiment shown in FIG. 66F. In some embodiments, these changes may increase the reliability when moving the pin 40 to the locked position. Other variations of the embodiments shown in FIGS. 66E and 66F include a reconfigured side plate 880' instead of additional braces and a curved tether bushing 888' that extends across the entire head / distal end of the lock 618.

[0132] Referring to FIGS. 67 - 72, an exemplary instrument 900 is shown that is configured to install and apply tension to the tether lock described above. First referring to FIG. 67, the proximal handle section of instrument 900 is shown. Instrument 900 includes a catheter section 910 and a main handle housing consisting of a left half 912 and a right half 914 that can be fixed together with a fastener. Handle trigger 916 may include an upper fork - shaped section that is pivotally attached to the left and right halves of the main housing as shown in the figure. A tension clamp base 918 is provided at the proximal end of the housing, and a tension clamp lever 920 can be pivotally attached to the tension clamp base by a pivot pin 922 for clamping the tether. Trigger triple lock 924 can be slidably attached to the main housing proximal to trigger 916 so as to slide transversely with respect to the longitudinal axis of the housing. Trigger push lock 926 can be slidably attached to the main housing distal to trigger 916 so as to slide transversely with respect to the longitudinal axis of the housing. A flush port 928 may also be provided at the distal end of the main housing as shown in the figure.

[0133] Referring to FIG. 68, the distal end of instrument 900 is shown. A collar 930 for slidably receiving the proximal end of tether lock 618 can be firmly attached to the distal end of catheter section 910 as shown in the figure. In some embodiments (not shown), a curved shroud or base plate may be provided at the proximal end of collar 930 to ensure that it does not catch when being withdrawn from the patient. One or more laser - cut sections 932 may be provided near the distal end as shown in the figure to increase the flexibility of the distal end of the catheter when positioning lock 618 on the implant.

[0134] Referring to FIG. 69, the proximal end of instrument 900 is shown with the components of collar 930 shown in an exploded state so that lock 618 and coupling component 80 at the end of pull wire 83 can be clearly seen.

[0135] Referring to FIG. 70A, an exploded view of the proximal handle section of instrument 900 shows its components. A straddle gear 934 can be rotatably attached between a left handle housing 912 and a right handle housing 914. In this exemplary embodiment, the straddle gear 934 (also shown in FIG. 70B) has pinion gears 936 on both sides and is configured to mate with an engagement recess 938 inside each upper end of the trigger 916. The straddle gear 934 also includes a pair of laterally spaced gear segments 940 that are arranged to drive a pinion gear 942. The pinion gear 942 is firmly attached to a drive gear 944, and all are rotatably attached to a gear shaft 946 and a bushing 947 between the left handle housing 912 and the right handle housing 914 below a gear rack 948. With this mechanism, when the trigger 916 is grasped (i.e., rotated in the proximal direction), the gear rack 948 slides proximally between the left handle housing 912 and the right handle housing 914. A pull wire 83 is coupled to the gear rack 948 by a cable lock 950 such that when the gear rack 948 slides proximally, it is pulled proximally within the catheter 910. In some embodiments, a return spring (not shown) is provided to bias the trigger 916 and the gear rack 948 to a forward neutral position.

[0136] In this exemplary embodiment, a tension clamp base 918 is screwed onto a tension lead screw 952, while the tension lead screw mates with an internal thread 954 disposed inside the left handle housing 912 and the right handle housing 914. As further described below, neodymium magnets 956 can be provided in recesses at the top of the handle housing as shown for removably coupling the housing to a linear slide carriage.

[0137] Referring to FIG. 71, a longitudinal cross-section of instrument 900 is shown.

[0138] Referring to FIG. 72, the enlarged perspective view shows the gear rack 948 from below. Also shown are the trigger triple lock 924 and the trigger push lock 926 in the unlocked position. The gear rack 948 is shown in the farthest displacement position. During operation, the gear rack 948 starts at a relatively proximal position (right side of FIG. 72), and the trigger triple lock 924 and the trigger push lock 926 are in the locked position (moved upward in FIG. 72).

[0139] When the gear rack 948 is in the starting position, the trigger triple lock stopper 958 engages with the recess 960 at the bottom of the gear rack 948, preventing the rack from moving in the proximal or distal direction until the stopper 958 slides into alignment with the groove 962 (downward in FIG. 72). If the trigger triple lock 924 re-engages after the gear rack 948 has moved in the proximal direction, when the gear rack 948 moves back in the distal direction, the slope 964 causes the stopper to return to the recess 960, locking the gear rack 948 in its starting position.

[0140] When the gear rack 948 is in the starting position, the trigger push lock stopper 966 engages with the distal surface 968 of the gear rack 948, preventing the rack from moving in the distal direction until the stopper 966 slides into alignment with the groove 970 (downward in FIG. 72). In this unlocked position, the trigger is moved in the distal direction to drive the gear rack 948 in the distal direction as shown in the figure, thereby pressing the pull wire 83 in the distal direction to disengage it from the embedded lock.

[0141] Referring to FIG. 73, the operation of the tether tensioning locking instrument 900 is described. In some implementations, the instrument 900 is configured to be disposable after being used in a single angioplasty procedure. The instrument can be provided in a sterilized package with the tether lock 618 pre-loaded at the distal end and held here by the coupling member 80 at the distal end of the pull wire 83 (shown in FIG. 69). During operation, first the instrument 900 is removed from the package. Then, as already described, the proximal end of the tether that exits the implanted front implant, passes through the implanted rear implant, through the external catheter, and through one side of the bifurcated loading tool, is passed through the pre-loaded tether lock and the instrument 900 and exits from its proximal end. As shown in FIG. 23, the distal end of the instrument 900 can be inserted into the bifurcated loading tool and the external catheter until it contacts one of the eyelet assemblies 620 of the rear implant 610 and the pre-loaded lock. As already illustrated and described, the instrument 900 can be reversibly attached to the carriage of the linear guide rail 768 as shown in the figure, such as by using a magnet disposed on the upper part of the instrument housing. In some implementations, a second instrument 900 with its own pre-loaded tether lock 618 can be advanced along a second tether in the same manner so that both instruments 900 can be used to apply tension to the tether simultaneously. Thus, real-time feedback (from echocardiogram images, etc.) about the effect of the applied tether tension on the mitral valve junction improvement is possible. The second instrument 900 can also be reversed and reversibly attached to the second carriage on the linear guide rail 768 with a magnet as shown in the figure. In some embodiments, the catheter sections 910 of two (or more) instruments 900 may have different lengths such that the positions of the instruments are alternately arranged along the same guide rail 768 as shown in the figure.

[0142] After the instrument 900 is placed at a predetermined location, the tension clamp lever 920, which is already installed in the vertical position, is lowered to the horizontal position (shown in FIG. 71) to lock the tether to the tension clamp base 918. Then, the tension on the tether can be increased by rotating the clamp base 918 relative to other parts of the instrument 900 so as to advance the tension clamp base 918 in the proximal direction. When the desired tension is obtained with both / all the tethers (as confirmed by the echocardiogram in some implementations), the trigger triple lock 924 can be disengaged by pressing the left end protruding from the left handle housing 912. At this time, the trigger triple lock 924 can be re-engaged by pressing the right end protruding from the right handle housing 914. As already described with reference to FIGS. 67 to 72, when the trigger triple lock 924 is disengaged, the trigger 916 can be grasped to move the gear rack 948 in the proximal direction of the pull wire 83. As already described with reference to FIGS. 63A to 66D, in this way, the lock 618 is moved from the unlocked state to the locked state. When both / all the locks 618 are locked, the desired junction of the mitral valve leaflet can be confirmed again. If it is desired to change the tension on the tether at this point for some reason, the lock 618 can also be moved from the locked state to the unlocked state. This can be achieved by pulling the tether in the proximal direction by returning the trigger 916 to its original position and rotating the tension clamp base 918, etc., to move the movable member 40 in the proximal direction away from the contact surface / block 72 / 882 (shown in FIGS. 63A to 66D).

[0143] Once the lock 618 is set, the instrument 900 can be disengaged and removed. This can be achieved by first moving the trigger push lock 926 to the unlocked state and then pressing the left end protruding from the left handle housing 912. At this time, by pressing the right end that would protrude from the right handle housing 914, the trigger pull lock 926 can be refitted. As already described with reference to FIGS. 67-72, when the trigger pull lock 926 disengages, the trigger 916 extends distally beyond the starting position and can move the pull wire 83 distally by the gear rack 948. On the other hand, as already described with reference to FIGS. 65C and 65D, this causes the T-shaped chuck / engagement member 80 to push the lock 618 out of the collar 23 and disengage it from the connection portion / engagement element 301. Then the instrument 900 is removed from the external catheter and the bifurcated loading tool, leaving the tensioned and locked tether.

[0144] After the lock 916 is installed and the instrument 900 is removed, another instrument (not shown but more fully disclosed in a later application by the applicant) is passed one at a time through each tether from the bifurcated loading tool, and the excess length of the tether is cut just proximal to the tether lock. After confirmation that the implant system is properly implanted, the external catheter assembly can be slid proximally along its guide rail to withdraw the external catheter from the patient.

[0145] Referring to FIGS. 74-77, another exemplary instrument 900' is shown that is configured to install and apply tension to the tether lock described above. Referring to FIG. 74, the proximal handle section of the instrument 900' is shown. The instrument 900' includes a catheter section 910', and a main handle housing consisting of a left half 912' and a right half 914' that can be fixed together with a fastener. As shown in the figure, trigger levers 916' can be rotatably attached to the left and right halves of the main housing. A tension clamp base 918 is provided at the proximal end of the housing, and a tension clamp lever 920 can be rotatably attached to the tension clamp base by a pivot pin 922 to clamp the tether. As shown in the figure, a flush port 928' can also be provided at the distal end of the main housing. A position or tension gauge 972 and a pull knob 974 can also be provided.

[0146] Referring to FIG. 77, the distal end of the instrument 900' is shown. The distal end of the instrument 900' is similar to the distal end of the instrument 900 shown in FIG. 68, but instead of providing one or more laser cut sections 932, at least one section of the hollow cable 932' is welded or otherwise attached between the collar 930 and the catheter section 910' as shown in the figure, or between two sections of the hypo tube 910' near the distal end of the instrument. In some embodiments, this mechanism provides good performance during compression and bending. In some embodiments, the section of the hollow cable 932' is about 4 inches in length, or less than about 6 inches, or more than about 2 inches.

[0147] Referring to FIGS. 75 and 76, an exploded view and a cross-sectional view of the proximal handle section of the instrument 900’ each show its components. As can be seen in these figures, neither a gear nor a rack is employed in the design of this embodiment. Instead, when the lever 916’ is pressed downward to urge the pull wire shuttle 978 and the pull wire in the proximal direction, the bottom curved portion 976 of the lever 916’ slides on the engagement surface of the shuttle 978. In other aspects, the instrument 900’ functions in substantially the same manner as the instrument 900 already described. Also visible in these figures are a hemostatic valve 980 and a gauge indicator 982.

[0148] As used herein, when a feature or element is referred to as being “on” another feature or element, there may be intervening features and / or elements, even if the other feature or element is directly on top. In contrast, when a feature or element is referred to as being “directly on” another feature or element, there are no intervening features or elements. It will also be understood that when a feature or element is referred to as being “connected,” “attached,” or “coupled” to another feature or element, it may be directly connected, attached, or coupled to the other feature or element, or there may be intervening features or elements. In contrast, when a feature or element is referred to as being “directly connected,” “directly attached,” or “directly coupled” to another feature or element, there are no intervening features or elements. Although an embodiment has been described or illustrated, the features and elements so described or illustrated may apply to other embodiments as well. It will also be recognized by those skilled in the art that a reference to a structure or feature disposed “adjacent” to another feature may have portions that are above or below this adjacent feature.

[0149] The terms used in this specification are for the sole purpose of describing particular embodiments and are not intended to limit the invention. For example, as used in this specification, the singular forms "a", "an", and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. The terms "comprises" and / or "comprising", when used in this specification, specify the presence of the stated features, steps, operations, elements, and / or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and / or groups thereof. It will be further understood that when used in this specification, the phrase "and / or" includes any and all combinations of one or more of the associated listed items and may be abbreviated with " / ".

[0150] Spatial relative terms such as "under", "below", "lower", "over", "upper", and the like may be used in this specification to facilitate descriptions of the relationship of one element or feature to another element or feature shown in the figures. It will be understood that the spatial relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if the device in the figures is reversed, an element described as "under" or "beneath" another element or feature will be oriented "over" the other element or feature. Thus, by way of example, the term "under" may encompass both an orientation of above and below. The device may be in other orientations (rotated 90 degrees or other orientations), and the spatial relative descriptors used in this specification will be interpreted accordingly. Similarly, the terms "upwardly", "downwardly", "vertical", "horizontal", and the like are used in this specification for descriptive purposes only, unless otherwise clearly indicated.

[0151] The terms "first" and "second" may be used herein to describe various features / elements (including steps), but these features / elements should not be limited by these terms unless the context indicates otherwise. These terms may be used to distinguish one feature / element from another. Thus, without departing from the teachings of the present invention, the first feature / element described below may be referred to as the second feature / element, and similarly, the second feature / element described below may be referred to as the first feature / element.

[0152] Throughout this specification and the claims which follow, unless the context requires otherwise, the words "comprise", "comprises" and "comprising" and variations thereof are to be construed in an inclusive sense, that is, in the sense of "including, but not limited to", such that various components may be employed in a method and article (e.g., a composition, an apparatus including devices, and a method) in a collaborative manner. For example, it will be understood that the term "comprising" means including any one of the recited elements or steps without excluding any other element or step.

[0153] When used in the specification and claims, including use in the examples, and unless otherwise specified, all numbers can be construed as if the words "about" or "approximately" were placed before them, even if these words are not explicitly stated. The words "about" or "approximately" or "generally" can be used when describing a magnitude and / or position to indicate that the recited value and / or position is within a reasonable expected range of values and / or positions. For example, a numerical value can have a value that is + / −0.1% of the recited value (or range of values), + / −1% of the recited value (or range of values), + / −2% of the recited value (or range of values), + / −5% of the recited value (or range of values), + / −10% of the recited value (or range of values), etc. Any numerical value recited herein should be understood to include about that value or approximately that value, unless the context indicates otherwise. For example, if the value "10" is disclosed, then "about 10" is also disclosed. Any numerical range recited herein is intended to include all sub-ranges subsumed therein. As will be appropriately understood by those skilled in the art, when a value is disclosed, it is also understood that the value "less than or equal to" and "greater than or equal to" that value, as well as the possible ranges between these values, are also disclosed. For example, if the value of "X" is disclosed, then "less than or equal to X" and "greater than or equal to X" (e.g., X is a numerical value) are also disclosed. Throughout this application, it is also understood that data is provided in several different formats and that this data represents ranges of endpoints and starting points and combinations of data points. For example, if a particular data point "10" and a particular data point "15" are disclosed, it goes without saying that values greater than 10 and 15, greater than or equal to 10 and 15, less than 10 and 15, less than or equal to 10 and 15, equal to 10 and 15, but between 10 and 15 are also disclosed. It also goes without saying that each unit between two particular units is also disclosed. For example, if 10 and 15 are disclosed, then 11, 12, 13, 14 are also disclosed.

[0154] Although various illustrative embodiments have been described above, various changes may be added to the various embodiments without departing from the scope of the disclosure as claimed. For example, the order in which the various method steps are performed is often changed in alternative embodiments, and in other alternative embodiments, one or more of the method steps may be omitted entirely. Any feature of the various device and system embodiments may be included in some embodiments and not in others. Therefore, the foregoing description has been made primarily for illustrative purposes and should not be construed as limiting the scope of the disclosure as claimed.

[0155] The examples and illustrations included herein are presented as examples and not as limitations of the specific embodiments in which the subject matter may be practiced. As noted above, other embodiments may be utilized and derived so that structural and logical substitutions and changes may be made without departing from the scope of this disclosure. Such embodiments of the inventive subject matter may be referred to herein individually or collectively by the term "invention" merely for convenience and without an intention to voluntarily limit the scope of this application to a single invention or inventive concept when more than one is in fact disclosed. Thus, although particular embodiments have been illustrated and described herein, any arrangement designed to achieve the same purpose may be substituted for the particular embodiments shown. This disclosure is intended to cover any and all modifications or variations of various embodiments. Combinations of the above embodiments and other embodiments not specifically described herein will be apparent to those of ordinary skill in the art upon review of the above description.

Description of Reference Numerals

[0156] 11 Proximal end 12 Distal end 13 Tensile member 23 Sliding collar 30 Lock body 40 Movable part / Locking pin 40’ Lock ring 60 Pin 70 Sliding groove 71 Limiting portion 72 butt joint 80 chuck 81 connection post 82 connection beam 83 pull wire 84 connection protrusion 85 connection groove 210 rear bar 212 intermediate tissue anchor guide 214 end tissue anchor guide 216 snare feature 301 lock body connection part 310 front pad 312 petal part 314 main tissue anchor 316 additional tissue anchor 333 contact part 510 left atrium 512 mitral valve 514 catheter 516 septum 518 anchor lead 520 steerable internal catheter 522 drive tube 524 helical tissue anchor 526 first tension member 528 snare sheath 530 second tension member 532 snare sheath 600 valve annulus formation system 610 rear implant 612 front implant 614 tether 616 anchor 618 tether lock 620 swivel eyelet assembly 622 anchor lead 624 spinner assembly 626 rear implant plate 628 driver head 630 torque head 632 through hole 634 hole 636 slots 638 through holes 640 scallops 642 cylindrical core 644 upper ring 646 bottom ring 648 eyelet 650 wedge or filler material 652 eyelet coating part 654 arcuate fin 656 central hoop 658 upper disk 660 bottom lock ring 662 crossbar 664 U-shaped connecting rod 666 lead nut 668 flange 670 recess 672 coil 674 anchor head 676 clasp 677 slot 678 tab 680 base plate 682 thimble 684 sleeve 686 implant loader 688 proximal hub 690 distal end 692 torque tube 694 tether pulling part 696 lumen 711 limiting rib 750 system 752 base 753 vertical plate 754 bracket 756 slot 757 slot 758 clamp handle 760 externally steerable catheter assembly 762 implant loading tool assembly 764 tether retainer yoke 766, 766’, 766” Internal Steering Catheter Assembly 768 Guide Rail 770 Carriage Assembly 772 Upper Proximal End 774 Lower Distal End 776 Catheter Section 778 Handle Assembly 780 Mounting Groove 782 Rotation Lock 783 Ball Detent 784 Steering Knob 785 Internal Bore 786 Cam-Actuated Collar Seal 788 Hourglass Valve 789 Cross-Slit Valve 790 Rigid Cannula 792 Housing 794 Hemostatic Seal 796 Compression Hub Section 798 Stationary Hub 800 Compression Gasket 802 Compression Gasket 804 Compression Knob 806 Flash Port 810, 810’, 810” Catheter Section 812 Control Housing 814 Support Structure 816 Wing 817 Steering Knob 818 Anchor Driver Tube 820 Control Knob 821 Contact Surface 822 Control Knob 824 Concave Portion 826 Lever 828 Spring-Actuated Mechanism 830 Torque Control Assembly 832 Torque Control Knob 833 Flash Port 834, 834’ MLE (Multi-Lumen Extrusion) 835 Steering Shaft 836 Proximal section 837 Distal tube 838 Spine 839 Pull wire 840 Tether router 841 Guide clip 842 Spring clip 843 Second opening 844 Loading tool 845 Converging passage 846 Cannula section 847 First opening 848 Collet nut 849 Tab 850 Housing 852 First seal pair 854 Second seal pair 856 Hemostatic valve 858 Retaining plate 860 Flash port line 862 Tether guide 864 Tube 866 Connector 870, 870’ Front plate 872, 872’ Back plate 874 Ear flap 876 Coupling plate 878 Side plate 880, 880’ H-shaped brace / side plate 882 Serrated abutment block 884 Anti-reversal plate 886 Anti-reversal pin 888, 888’ Tether bushing 890, 890’ Flexure arm 892 Inwardly projecting serrations 894 Serrated continuum 896 Large serrations 898 Serrations 900, 900’ Instrument 910 Catheter section 910’ Catheter section / hypotube 912, 912' Left half body 914, 914' Right half body 916 Trigger 916' Lever 918 Tension clamp base 920 Tension clamp lever 922 Swivel pin 924 Trigger triple lock 926 Trigger push lock 928, 928' Flash port 930 Color 932 Laser cutting section 932' Hollow cable 934 Straddle gear 936 Pinion gear 938 Engagement recess 940 Gear segment 942 Pinion gear 944 Drive gear 946 Gear shaft 947 Bush 948 Gear rack 950 Cable lock 952 Tension lead screw 954 Internal thread 956 Neodymium magnet 958 Trigger triple lock stopper 960 Recess 962 Groove 964 Inclined plane 966 Trigger push lock stopper 968 Distant plane 970 Groove 972 Tension gauge 974 Pull knob 976 Bottom curved part 978 Pull wire shuttle 980 Hemostatic valve 982 Gauge indicator

Claims

1. A locking system for transcatheter annuloplasty, comprising: An implantable lock body configured to pass an implant tether, the lock body having a slot; A movable member slidably received in the lock body slot configured to move between a proximal unlocked position and a distal locked position upon application of an external force to the lock body; A tether abutting portion disposed on the lock body and configured such that the tether can freely pass between the abutting portion and the movable member when the movable member is in the unlocked position, and the tether is pressed by the movable member against the abutting portion to prevent movement relative to the abutting portion when the movable member is in the locked position; A coupling element disposed at the proximal portion of the lock body; A pull wire having a coupling member disposed at the distal portion and configured to detachably engage the coupling element of the lock body; A flexible catheter having a central lumen configured to slidably receive a portion of the pull wire; A collar disposed at the distal portion of the catheter and having a recess at the distal end configured to slidably receive the proximal portion of the lock body, the collar having a cam surface configured to apply an external force to the movable member to move the member to the locked position; Comprising: The pull wire and the catheter can be extruded together in the distal direction to advance the lock body along the tether, and the pull wire is pulled in the proximal direction relative to the catheter to move the movable member to the locked position to lock the tether to the lock body; A locking system.

2. The locking system according to claim 1, wherein the collar is configured to releasably restrain the coupling member to the coupling element.

3. The locking system according to claim 2, wherein the collar is configured to releasably surround the coupling member and the coupling element until the pull wire is used to extrude the lock body from the collar to release the coupling member from the coupling element.

4. The locking system according to claim 1, wherein the pull wire, the catheter, and the collar are configured to be detached from the lock body and withdrawn from the patient, leaving the lock body implanted.

5. The latching system of claim 1, wherein the coupling element comprises a distal ramp configured to release the coupling member from the coupling element by laterally biasing the coupling member away from the coupling element when the coupling member is pressed distally against the coupling element.

6. The latching system of claim 1, wherein the coupling member comprises a T-shaped end.

7. The latching system of claim 1, wherein the lock body comprises at least one flexure arm adjacent to the lock body slot, and the at least one flexure arm is configured to prevent the movable member from moving to the distal latching position until an external force acts on the movable member to flex the flexure arm out of the path.

8. The latching system of claim 1, wherein the tether contact portion comprises a sawtooth continuum, and one of the sawteeth of the continuum has a height at least twice as large as the height of the other sawteeth of the continuum.

9. The latching system of claim 8, wherein the lock body comprises a pair of spikes on a side opposite the one sawtooth having a height at least twice as large as the height of the other sawteeth of the continuum with respect to the lock body slot, and the spikes are configured to assist in holding the movable member in the distal latching position.

10. The latching system of claim 1, further comprising a handle section coupled to the proximal end of the flexible catheter.

11. The latching system of claim 10, wherein the handle section comprises a tension clamp lever configured to releasably clamp the tether to a tension clamp base, and the tension clamp base and the tension clamp lever are movable in a proximal direction in an adjustable manner to increase the tension of the tether.

12. The latching system of claim 11, wherein the tension clamp base is coupled to a lead screw, and rotation of the lead screw relative to the handle section can move the tension clamp base and the tension clamp lever in the proximal direction to increase the tension of the tether.

13. The latching system of claim 10, wherein the handle section comprises a trigger lever coupled to the pull wire and configured to pull and extrude the pull wire from an initial position.

14. When the trigger lever pulls the pull wire proximally with respect to the catheter, the movable member can be moved to the locking position to lock the tether to the lock body. When the trigger lever pushes the pull wire distally with respect to the catheter, the lock body can be released from the collar and the catheter by disengaging the coupling member from the coupling element. The locking system according to claim 13.

15. The locking system according to claim 14, wherein the trigger lever is coupled to the pull wire through a gear rack mechanism.

16. The locking system according to claim 15, further comprising a trigger pull lock movable between a locking position where the gear rack is prevented from moving and an unlocking position where the gear rack can be moved by the trigger lever.

17. The locking system according to claim 15, further comprising a trigger push lock movable between a locking position where the gear rack is prevented from moving distally beyond the starting position and an unlocking position where the gear rack can be moved distally beyond the starting position by the trigger lever to release the lock body from the collar and the catheter.

18. A method of installing an embedded tether lock, comprising: Passing a tether through an embedded device; Embedding the embedded device; Providing an embedded tether lock disposed at the distal end of a tension applying locking device; Passing the tether through the embedded tether lock and the device; Advancing the tether lock along the tether using the device until the tether lock contacts the embedded device; Increasing the tension of the tether by clamping the tether using a tension applying clamp disposed on the device and pulling the clamp proximally with respect to the tether lock; Actuating a trigger of the device to move a pull wire extending between the embedded lock and the device proximally to lock the tether lock to the tether. A method including the above steps.

19. The method according to claim 18, further comprising disengaging a trigger pull lock before actuating the trigger to move the pull wire in the proximal direction.

20. The method of claim 18, further comprising activating the trigger of the instrument to move the pull wire in the distal direction and disengaging the pull wire from the tether lock. **Claim 21** The method of claim 20, further comprising disengaging a trigger push lock before activating the trigger to move the pull wire in the distal direction. **Claim 22** The method of claim 18, wherein moving the pull wire in the proximal direction includes further pulling the proximal end of the tether lock toward a collar disposed at the distal end of the instrument, the collar serving to move a movable member of the tether lock distally relative to the tether. **Claim 23** The method of claim 20, wherein moving the pull wire in the distal direction serves to push out the proximal end of the tether lock from a collar disposed at the distal end of the instrument.

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