Valve ring forming implant delivery system and method

Abstract

An exemplary system for delivering an annuloplasty implant includes a long internal catheter assembly, a manifold attached to the proximal portion of the internal catheter, a steering knob assembly coupled to the manifold, a torque control knob assembly coupled to the manifold, and a central lead extending from the proximal portion of the torque control knob assembly to the distal portion of the internal catheter assembly. The manifold is configured to provide an inner driver tube, an outer driver tube, an inner lead, an outer lead, an inner tether pull portion, and an outer tether pull portion to a surgeon. Additional annuloplasty implant instruments and methods of use are also disclosed.

Description

Technical Field

[0001] (Cross - Reference to Related Applications) This disclosure claims the benefit of U.S. Provisional Application No. 63 / 364,290, filed May 6, 2022, entitled “Mitral Annulus Forming Implant Delivery System and Method,” the entire disclosure of which is hereby incorporated by reference herein.

[0002] (Incorporation by Reference) All publications and patent applications mentioned in this specification are hereby incorporated by reference herein 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 valve 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, mitral valve 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 can occur due to dilation of the left ventricle, for example, resulting from infarction. As a result of the dilation of the left ventricle, the papillary muscles will constantly 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: valvular 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, 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, a lateral (sometimes referred to as left) triangle, and an inner (sometimes referred to as right) triangle. The anterior leaflet includes three segments A1, A2, A3. Similarly, the posterior leaflet also includes three segments P1, P2, P3. According to aspects of the present disclosure, in some implementations, the device anchors can be placed 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 according to aspects of the present disclosure is shown. As will be described in more detail later, the posterior bar 210 is configured to be implanted in the mitral valve adjacent to the posterior leaflet or near it and 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 can have a thin shape that minimizes the amount of atrial irregularities that can be sites of thrombosis as shown in the figure. In this exemplary embodiment, the posterior bar 210 has a non-invasive edge that limits the potential for tissue damage and is coated with a polyethylene terephthalate (PET) fabric that aids in in-tissue growth.

[0011] In this exemplary embodiment, the rear 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 / torque application of the rear bar 210 during delivery. In some embodiments, as will be described later herein, 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 relative to the rear bar 210 so as to be movable from a retracted state to a deployed state. In the retracted state, the anchor guides may extend generally parallel to the bar 210 so 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 a tissue anchor through the hole of the bar 210 to an 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 feature 216 may extend substantially from the rear bar 210 so as to be easily fitted with one or more tension members / snares, and may be configured to prevent the disengagement of the tension member during operation. In some embodiments, the snare feature 216 may be easily imaged by fluoroscopy and echocardiography to assist in positioning the rear bar 210 during delivery and attachment to the tissue, and may be configured to assist in connecting a tension member to the snare feature 216.

[0013] The rear bar 210 may be designed to load 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 and have a contour adapted to the body structure of a particular subject, the bar may further comprise some level of flexibility. The flexibility of the rear bar 210 may also help to bend 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) laterally with respect 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 that a more uniform tension is applied to the posterior side of the mitral annulus.

[0015] Referring to FIG. 3, an exemplary front pad 310 constructed in accordance with aspects of the present disclosure is shown. As will be described in more detail later, the front pad 310 is configured to be implanted adjacent to or near the mitral annulus adjacent to the anterior cusp, particularly in the triangular portion, into the left atrium. In this exemplary embodiment, the front pad 310 is generally a flat structure with four petal portions 312 extending radially from a central portion. In other embodiments, more or fewer petal portions may be provided, or no petal portions may be provided. The major tissue anchor 314 may be disposed at the center of the front pad 310. In some embodiments, additional tissue anchors 316, such as additional anchors 316 near the center of each petal portion 312 as shown in the figure, may be provided. In some embodiments, the major 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 front pad 310 during delivery. The petal portions 312 may be designed to be folded into a small configuration for delivery of the front pad 310 within a catheter.

[0016] To minimize the amount of atrial irregularities that can be a potential site of thrombosis, the front pad may have a thin profile as shown in the figure. In this exemplary embodiment, the front 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 in-tissue growth.

[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 be able 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 such that the anchors are loaded 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 posterior 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 posterior 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 traversing 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 a 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 into 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 so as 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. Then, 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 implementations 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 its 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 against 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 the drive tube (or another drive tube 522 with another helical tissue anchor 524) can be slid in the lead 518 attached to the tissue anchor guide 214 disposed near the outer end of the rear bar 210. 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 against the mitral valve annulus tissue, the drive tube 522 can be rotated to screw the outer tissue anchor 524 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 the drive tube (or another drive tube 522 with another helical tissue anchor 524) can be slid in the lead 518 attached to the intermediate tissue anchor guide 212. 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 against 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 leads removed from the end tissue anchor guide by extraction or the like.

[0023] It should be noted that in step 416, after the first anchor is installed, torque control of the implant 210 performed 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 anchors 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 internal 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 the third member) is positioned from the distal end of the catheter 514. In some implementations, as shown in FIG. 14, the front pad 310 is steered into the inner triangle by the steerable internal catheter 520. (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 having a single anchor 314 is fixed to the inner triangle. A drive tube (not shown) can be used within the steerable internal 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 internal 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 tie 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., the first member) and a front pad 310 (i.e., the 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 tie 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 dogbone) 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 predefined 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 predefined 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 tension 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 alleviation of mitral valve regurgitation when the tension members 526 and 530 are fastened.

[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 internal 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 a 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 "Annular Formation System and Method," filed by the applicant and co-pending.

[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 region. 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 prior to being deployed from the catheter. In this embodiment, the anterior implant 612 is first implanted, and its tether 614 is passed through the posterior implant 610 prior to 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 in place by the anchor 616, tension can be applied to the tether 614 and secured 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 - rotation 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 its 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 are also provided for rotatably holding the eyelet assembly 620 (shown in FIGS. 23 and 24). 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 heads 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 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 can 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 top of the upper ring 644 and the bottom 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 rear 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 rear 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 has 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 with respect to the spinner assembly 624, and the spinner assembly spins with respect to the posterior implant 610 (shown in FIGS. 23, 24, and 37). Thus, the anchor lead 622 is generally flat against the implant 610 when pre-loaded into the delivery catheter (as shown in FIG. 44) and can extend in an orthogonal direction 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 connecting rod 664, the lead nut 666, and the anchor lead 622 (shown in FIGS. 24 and 37) can be placed more flatly on 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 that five spinner assemblies are attached to the posterior implant 610 and two are attached to each of the two anterior implants 612.

[0048] Referring to FIGS. 37 - 39, the structure and operation of the implantable 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 comprise 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 comprise a releasable mating feature or clasp 676 in the shape of a cylindrical hook. Identical and / or complementary engaging features or clasps 676 may be provided at the distal end of the driver head 628. When the implant is assembled and pre - loaded into 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 are 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 flexure portions or living hinges. These flexure portions relieve pressure and allow the clasps 676 to more easily engage and disengage with each other when axial misalignment is seen or a lateral moment is applied to the driver head 628. In other embodiments (not shown), instead of a rigid tube with or without flexure portions, a hollow braided cable may be used.

[0049] As also depicted in FIG. 37, the torque head 630 may include a flared distal end configured to fit into the central spinner assembly 624 when a tab 678 extending distally to steer the implant 610 fits into a slot 636. The torque head 630 may also include 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 a torque tube (not shown) distally while pulling the proximal end of the central anchor lead 622 (shown in FIG. 23) proximally. The torque tube needs to be rotated until the tab 678 mates with 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 front implant 612 are shown. FIG. 42 shows the exposed front implant base plate 680 with only the tether assembly 682 attached. Since the two front 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, depending on the orientation of the spinner assembly 624. 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 outer front implant 612 (shown on the left side in 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 (such that the lead nut 666 is downward as opposed to that shown in FIG. 43), the inner front implant 612 (shown on the right side in FIGS. 23 and 24) is formed.

[0052] In this exemplary embodiment, the same components as 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 of the torque head 630 (only one tab 678 is visible in FIG. 43). 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 end 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 rigidity for high-response tightening while ensuring full in vivo loading 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 (shown in FIG. 45) configured to slide at the distal end of an internal steering catheter (not shown). 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 the placement of the implant, 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 substantially 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. Only four of the anchors 616 are visible since the fifth anchor is located inside the torque head 630.

[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 pushed out 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, 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 details that are the same between the two methods is not 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 such that 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 helical 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 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. 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 placed 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, a separate steerable internal catheter that is pre-loaded and pre-sterilized is 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 on 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 placed 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 posterior implant 610 (sometimes referred to herein as the third member) is placed in the heart. As with the first and second members, a third member pre-loaded on a unique steerable internal catheter may be provided to the surgeon. In some embodiments, prior to the introduction of the third internal catheter into the external catheter, a tether or tension member 614 extending from the first and second members is passed through an eyelet assembly 620 of the posterior implant 610 and the third internal catheter. An anchor lead 622 and the internal catheter may be used to push the anterior implant 612 within the external delivery catheter and deploy it from its distal end. After the posterior 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 posterior 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 posterior 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 a distally extending tab 678 fits into a 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 engages 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 turning 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 device, 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. When 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 their attached tethers, and at least one subsequently placed implant advances along the tether when being placed and attached to the heart tissue. For example, first the posterior implant can be implanted with two tethers pre-attached to both end portions of the implant. And then the inner anterior implant can be placed and 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 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 the present 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 implementations, 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 installation of each implant is 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 of tension members 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. And when activated, it cuts the tension member and is 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 clinically most to be reduced, as opposed to changing other dimensions of the valve annulus simultaneously, it is advantageous to directly affect this dimension. This can be achieved by a reduction in the clamping force, as it is a direct A-P direction movement rather than the large forces generally required for circumferential remodeling. A reduction in the clamping force can generally be equated 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 is related 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 one 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 install the components and simplifying the implantation procedure. 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 previously described devices according to aspects of the present disclosure.

[0074] First referring to FIG. 48A, an exemplary adjustable base system is presented for slidably supporting some or all of the proximal ends of the above - mentioned 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 - apart vertical plates 753 extending upwardly 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 the 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 can 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 can be adjusted and the handle 758 re - tightened.

[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 can be adjusted to any angle between a minus 10 - degree angle and a plus 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 for applying a specific friction (such as ball indentation, etc.) can be used to achieve a linear guide that allows smooth linear movement but prevents 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 has 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 in 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 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 inside the patient.

[0078] As described later, the inner bore 785 can 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 can 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 can 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 can also be provided so that the loading tool can be quickly inserted into or withdrawn from the handle assembly 778 with minimal blood loss. The handle assembly 778 can 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) can 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 implanted in the 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, allowing 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 an implant loading tool assembly 762 in use installed at the proximal end of an outer steerable catheter 760. The handle assembly of the outer catheter 778 is omitted in FIG. 50D for clarity. The compression knob 804 is fastened, and a loading tool 762 is shown attached to the distal end of an inner steerable catheter 766 with the previously described posterior implant 610 pre-loaded in the tool 762. The proximal end of the outer steerable catheter 760 may be enlarged as shown so that when the loading tool 762 is installed therein, the inner diameter of the tool 762 is substantially the same as the inner diameter of the main portion of the outer catheter 760. Separate loading tools 762 may be provided for each inner steerable 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 the 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 a 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 external catheter assembly, can be provided to provide a frictional fit that provides tactile feedback such as intermittent resistance when the internal catheter control housing 812 is rotated, keeping 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 operated 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. While one steering cable pulls on one side of the distal tip, 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 representing "inner" may be marked on one side of the wing portion 816, and an L representing "outer" 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 includes 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 includes 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 shape. The linear arrangement of the driver and the tether allows the relationship between the driver at the proximal end and its placement at the implant to be intuitively grasped.

[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 at its distal end (FIG. 24) to a central spinner assembly 624 (not shown). 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-actuating mechanism 828. The spring-actuating mechanism 828 serves to bias the central lead 622 in the proximal direction by an elastic spring force when the lever 826 is engaged. This mechanism helps to hold the implant 610 at the torquer head 630 (shown in FIG. 24) when operating the implant 610 by 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 fixed. 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 and 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 previously 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 mated with the torque head 630 as shown in FIG. 24). As previously described, the torque control knob / housing 832 needs to be rotated slightly to ensure that the tabs of the torque head 630 mate with the slots of the implant plate. When the torque head 630 is fully mated with the implant, the spring actuating 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 a mated 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 actuating 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 detaching from the implant when the implant is rotated by the torque control assembly 830.

[0091] In some embodiments, the torque control assembly 830 comprises 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 regarding how fast the control unit and the 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 comprises 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 inner 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), 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 inner 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 (and in some embodiments all) of the forward and backward positioning. When implanting a triangular implant, the inner steerable catheter is more "active" in the forward and backward directions, along with 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 inner system prevents the tethers from winding around each other within the biological structure and / or inside the external guide by the surgeon. A detent mechanism may 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 may 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 tethering portion 694 as shown in the figure. When prepared in the operating room, two tethering 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 in the inner catheter assembly 766. The distal end of the tethering 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 embodiments, as will be described in more detail later, both front implants are first implanted and their tethers extend from the proximal end of the outer catheter. The distal end of the tether puller may have different colors, different lengths marked with characters, and / or other distinguishing 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 embodiments, the inner catheter 766 is inserted into the outer catheter while a light tension is applied to the tether. In another embodiment, the tether can be fixed to a linear guide. This would avoid the need for the surgeon 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 thread 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 outer guide.In these embodiments, a tether puller is used to maintain a light tension during advancement. In other embodiments, the tether is short enough such that it is not present 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 puller 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 and a second set of driver tubes 818 and anchor leads 622 extending from the inner wing portion 816 or the side wing portion 816 suitable for a particular implant, as already described for the assembly 766. The control housing 812 may be configured and function as already described for the internal catheter assembly 766 in each case. 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, therefore, 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 direct the torquer to a predetermined location on the implant and assist in its retention there. An anterior implant can comprise a single anchor that is 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 can include a central anchor and two outer anchors.

[0097] Referring to FIG. 59A, an exploded view showing the internal components of the internal steerable catheter assembly 766 is presented. FIG. 59B is a longitudinal cross-sectional view showing the internal components of the internal steerable 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 catheters 810' / 810" of the inner catheter assemblies 766' / 766". Referring first to FIG. 59F, the inner catheter 810 may comprise a multi-lumen extruded body (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 a laser-cut steering shaft 835, a torque driver tube 692, an anchor driver tube 818, an anchor lead 622, a tether 614, a tether pull 694, and / or a 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 the overall torque transmission of the internal system. 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 between the control housing and its distal end that is steered by a pull wire from the control housing and extends 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 extruded body 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 coaxial leads and drivers. 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 hypo - tubes and three laser - cut patterns. The proximal - most section 836 is a small - diameter section that extends over approximately the length of the MLE834 and has a laser - cut pattern that allows flexibility of the internal catheter within the vasculature. The small - diameter section 836 that extends into the MLE834 results in the MLE being small - diameter, and thus the overall system is low - profile. The exposed segment of the proximal hypo - tube 836 (long small - diameter section) has a cut pattern that allows flexibility in all directions, and it is assumed that the distal end of this section will be substantially aligned with the curved portion of the outer guide when the internal catheter advances into the atrium. The distal - most section hypo - tube 837 has a larger diameter and has a laser - cut pattern that allows curvature in one plane (primary curvature). The larger diameter of the distal - most section 837 results in a larger diameter, and the torquer is 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 the 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 imparts a curvature that is somewhat perpendicular to the primary curvature. This pattern can be used in a triangular - based system to 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 non - existent. 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 distally, 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 curve to a considerable extent in the primary direction and to a slight extent in a secondary direction generally perpendicular to the primary direction. In this exemplary embodiment, the inner catheter is steered by two guide wires (i.e., can curve alternately in opposite directions), while the outer catheter is steered by a single guide wire (i.e., can curve in a single direction). In some embodiments, the laser-cut hypotube 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 hypotube 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 an 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, a tether, a tether pull portion, and / or a 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 above 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 above 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-described elements. The clip 841 may be formed from a polymer or other elastic material such that the inwardly projecting tabs 849 can flex outwardly when the clip 841 is installed on the inner steering shaft. And the tabs 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 as to be movable 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 to have 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 location to temporarily store the proximal end of the tether extending 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 can be 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, for example, 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, an M representing the inner side and an L representing the outer side can be marked on both 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 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 an 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, an 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 through the septum of the subject to the left atrium of the subject using a transseptal approach. Once the external catheter 760 is positioned at a 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 embedding each device and an 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 embed the inner front implant, followed by the internal catheter assembly 766'' (FIG. 58) to embed the outer front implant, and then the internal catheter assembly 766 (FIG. 56) to embed 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 therefrom 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. 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 subject's left atrium 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 inner front implant has been implanted as previously described, 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 end of the tether extending from the implanted inner implant protrudes from the proximal end of the external catheter and can be attached to the inner clip of the tether holding yoke 764. Then, an internal catheter assembly 766'' (FIG. 58) for the outer implant can be attached to the carriage assembly 770 used for the internal catheter. As shown in FIG. 58, the internal catheter assembly 766'' can include a tether 614 that is attached to the outer implant and extends from the outer wing portion 816. The internal catheter assembly 766'' can also include a tether pulling portion 694 that extends from the inner wing portion 816. Then, the distal end of the tether pulling portion 694 can be attached to the proximal end of the aforementioned tether from the implanted inner front implant as previously described. The tether pulling portion 694 can be pulled proximally from the internal catheter assembly 766'' along with the tether and removed from the tether, such as by excising the most proximal end of the tether. After the tether for the inner implant has 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'' advances along the tether without the tether loosening within the external catheter.

[0113] As already 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, an 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 pulling portion 694 extending from the inner wing portion 816 and a second tether pulling portion 694 extending from the outer wing portion 816. As already described, the distal ends of the tether pulling portions 694 can be attached to the proximal ends of the above-described tethers from the implanted inner and outer front implants. The tether pulling portions 694 can be pulled proximally from the internal catheter assembly 766 along with the tethers and can be removed from the tethers, such as by excising the most proximal end of the tethers. 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 in the tethers to ensure that the internal catheter 766 and the associated rear implant advance along the tethers without the tethers loosening within the external catheter.

[0114] As already 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 and 24) can be advanced one at a time along the tethers. Another instrument (not shown, but more fully disclosed in a later application by the applicant) 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 taken to evaluate the tether tensioning as it is being performed. Once the desired tension is achieved, another instrument (not shown, but more fully disclosed in a later application by the applicant) 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 just 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] When a feature or element is referred to herein as being "on" another feature or element, it may be directly on the other feature or element or intervening features and / or elements may be present. In contrast, when a feature or element is referred to as being "directly on" another feature or element, no intervening features or elements are present. It will also be understood that when a feature or element is referred to as being "connected", "attached", or "coupled" to another feature or element, it may be directly connected, attached, or coupled to the other feature or element or intervening features or elements may be present. In contrast, when a feature or element is referred to as being "directly connected", "directly attached", or "directly coupled" to another feature or element, no intervening features or elements are present. Although an embodiment has been described or illustrated, the features and elements so described or illustrated may also apply to other embodiments. 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.

[0118] 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 as well, unless the context clearly dictates 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, as used in this specification, the term "and / or" includes any and all combinations of one or more of the associated listed items and may be abbreviated with " / ".

[0119] 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 then 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 explicitly stated otherwise.

[0120] The terms "first" and "second" may be used in this specification 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.

[0121] Throughout this specification and the claims that follow, unless the context requires otherwise, the word "comprise", and its variations "comprises" and "comprising", mean that various components can be employed collaboratively in a method and an article (e.g., a composition, an apparatus including devices, and a method). For example, it will be understood that the term "comprising" means including any of the recited elements or steps but not excluding any other element or step.

[0122] When used in the specification and claims, including use in the examples, and unless otherwise specified, all numbers should be interpreted as if the words "about" or "approximately" were prefixed to them, even if these words are not explicitly stated. The words "about", "approximately", or "generally" may be used to describe a magnitude and / or a position so as to indicate that the recited values and / or positions are 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 a value of "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 a 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 a range 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 will be understood 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, as well as between 10 and 15 are disclosed. It 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.

[0123] 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 method steps may be omitted altogether. Any feature of the various device and system embodiments may be included in some embodiments and not in others. Accordingly, the foregoing description has been made primarily for purposes of illustration and should not be construed as limiting the scope of the disclosure as claimed.

[0124] The examples and illustrations included herein are shown as examples and not as limitations of 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 the present disclosure. Such embodiments of the inventive subject matter, when one or more are actually disclosed, may be referred to herein individually or collectively by the term "invention" merely for convenience and not with the intention of voluntarily limiting the scope of this application to a single invention or inventive concept. Thus, although specific embodiments have been illustrated and described herein, any arrangement devised to achieve the same purpose may be substituted for the specific embodiments shown. The present disclosure is intended to embrace any and all modifications or variations of the various embodiments. Combinations of the above embodiments and other embodiments not specifically described herein will be apparent to those skilled in the art upon reviewing the above description.

Description of the Reference Numerals

[0125] 210 Rear bar 212 Intermediate tissue anchor guide 214 End tissue anchor guide 216 Snare feature 310 Front pad 312 Petal portion 314 Main tissue anchor 316 Additional tissue anchor 510 Left atrium 512 Mitral valve 514 Catheter 516 Septum 518 Anchor lead 520 Steering internal catheter 522 Drive tube 524 Spiral tissue anchor 526 First tension member 528 Snare sheath 530 Second tension member 532 Snare sheath 600 Valve annulus formation system 610 Posterior implant 612 Anterior implant 614 Tether 616 Anchor 618 Tether lock 620 Swivel eyelet assembly 622 Anchor lead 624 Spinner assembly 626 Posterior implant plate 628 Driver head 630 Torque head 632 Through hole 634 Hole 636 Slot 638 Through hole 640 Scallop 642 Cylindrical core 644 Upper ring 646 Bottom ring 648 Eyelet 650 Wedge or filler material 652 Eyelet coating portion 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 pull portion 696 Lumen 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” Internally steerable 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 portion 782 Rotation lock 783 Ball detent 784 Steering knob 785 Internal bore 786 Cam-acting collar seal 788 Hourglass-shaped 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 portion 817 Steering knob 818 Anchor driver tube 820 Control knob 822 Control knob 824 Concave portion 826 Lever 828 Spring actuating mechanism 830 Torquer control assembly 832 Torquer control knob 833 Flash port 834, 834’ MLE (Multi-lumen extruded body) 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 T Target position A1, A2, A3 Front tip section P1, P2, P3 Rear tip section

Claims

Claim 1 A system for delivering an annulus-forming implant, comprising a long internal catheter assembly having a proximal portion and a distal portion; a manifold attached to the proximal portion of the internal catheter assembly; a steerable knob assembly configured to apply tension to at least one pull wire coupled to the manifold and connected to the distal portion of a steerable internal catheter extending from the proximal portion to the distal portion of the long internal catheter assembly, thereby steering the distal portion of the steerable internal catheter; a torque control knob assembly coupled to the manifold and configured to rotate a torque tube extending from the torque control knob assembly to the distal portion of the steerable internal catheter, the torque tube having a torque head disposed at the distal portion configured to releasably engage an engagement feature of the implant to rotate the implant with the torque control knob assembly after the implant is positioned in a patient; at least one inner driver tube, each extending from a first side of the manifold to the distal portion of the internal catheter assembly and having a distal portion including a mating feature configured to releasably mate with an inner anchor of the implant when the implant is disposed adjacent to the distal portion of the steerable internal catheter, each inner driver tube having a proximal portion including an inner driver knob configured to rotate the inner anchor within the inner driver tube; At least one outer driver tube, each extending from a second side of the manifold to the distal portion of the inner catheter assembly, each having a distal portion including mating features configured to releasably engage an outer anchor of the implant when the implant is disposed adjacent to the distal portion of the steerable inner catheter, and each having a proximal portion including an outer driver knob configured to rotate the outer anchor within the outer driver tube. A central lead extending from a proximal portion of the torque control knob assembly to the distal portion of the steerable inner catheter, having a distal portion including mating features configured to releasably engage a central portion of the implant when the implant is disposed adjacent to the distal portion of the steerable inner catheter, and having a proximal portion including a central lead knob configured to disengage the central lead from the implant by rotating the central lead. At least one inner lead, each extending from the distal portion to the proximal portion into one of the at least one inner driver tubes, each having a distal portion including mating features configured to releasably engage an inner portion of the implant when the implant is disposed adjacent to the distal portion of the steerable inner catheter, and each having a proximal portion including an inner lead knob configured to disengage the inner lead from the implant by rotating the inner lead. At least one outer lead, each being at least one outer lead extending from the distal portion to the proximal portion into one of the at least one outer driver tubes, and having a distal portion including a mating feature configured to removably mate with an outer portion of the implant when the implant is disposed adjacent to the distal portion of the steerable inner catheter, and each having a proximal portion including an outer lead knob configured to disengage the outer lead from the implant by rotating the outer lead. An inner tether puller extending from the first side of the manifold to the distal portion of the inner catheter assembly, configured to slidably mate with an inner mounting component of the implant when the implant is disposed adjacent to the distal portion of the steerable inner catheter, and having a distal portion configured to grip a proximal portion of the inner implant tether and pull the tether with the inner mounting component, the inner catheter assembly, and the manifold. An outer tether puller extending from the second side of the manifold to the distal portion of the inner catheter assembly, configured to slidably mate with an outer mounting component of the implant when the implant is disposed adjacent to the distal portion of the steerable inner catheter, and having a distal portion configured to grip a proximal portion of the outer implant tether and pull the tether with the outer mounting component, the inner catheter assembly, and the manifold. A system comprising the above.

2. The implant delivery system of claim 1, wherein each of the distal portions of the inner tether puller and the outer tether puller comprises a tube configured to be crimped to one of the proximal portions of the implant tether.

3. The implant delivery system of claim 1, further comprising an outer catheter assembly configured to receive the distal portion of the elongate inner catheter therein.

4. The implant delivery system of claim 3, comprising a second steering knob assembly configured to steer the distal portion of the outer catheter by applying tension to at least one second pull wire connected to the distal portion of the elongate outer catheter.

5. The implant delivery system of claim 3, wherein each of the inner catheter assembly and the outer catheter assembly is coupled to a separate carriage assembly so as to be movable independently along the guide rail.

6. The implant delivery system of claim 1, further comprising an implant loading tool assembly configured to slidably cover the implant and the distal portion of the inner catheter assembly, the implant loading tool assembly having a distal portion configured to be received in the proximal portion of the outer catheter such that the implant and the distal portion of the inner catheter assembly can be slid by the implant loading tool assembly and the outer catheter.

7. The implant delivery system of claim 6, further comprising the implant.

8. The implant delivery system of claim 7, wherein the implant is pre-loaded into the implant loading tool assembly, while the implant loading tool assembly is releasably fixed to the distal portion of the inner catheter assembly, and the implant, the implant loading tool assembly, and the inner catheter assembly are all provided in a single sterilized package.

9. The implant delivery system of claim 1, wherein the inner catheter assembly is coupled to a carriage assembly so as to be movable along the guide rail, and the rotational connection of the inner catheter assembly to the carriage assembly comprises a detent mechanism that imparts intermittent resistance when the inner catheter assembly is rotated relative to the carriage assembly.

10. The implant delivery system of claim 1, wherein the torque control knob assembly comprises a detent mechanism that imparts intermittent resistance when used to rotate the torque tube.

11. The torque control knob assembly comprises a detent mechanism that imparts intermittent resistance when used to rotate the torque tube, and the rotational connection of the inner catheter assembly to the carriage assembly detent mechanism has a higher rotational resistance than the torque control knob assembly detent mechanism, the implant delivery system of claim 9.

12. The implant delivery system of claim 1, wherein the torque control knob assembly comprises a detent mechanism that imparts intermittent resistance when used to axially move the torque tube.

13. The implant delivery system of claim 1, wherein the torque control knob assembly comprises a detent mechanism that imparts intermittent resistance when used to rotate the torque tube and when used to axially move the torque tube.

14. The implant delivery system of claim 1, wherein the proximal portion of the torque control knob assembly comprises a lock lever configured to releasably couple the central lead to a spring-actuated mechanism.

15. The implant delivery system of claim 14, wherein the spring-actuated mechanism is configured to elastically bias the central lead in the proximal direction with a spring force when the lock lever is engaged to hold the implant in the torque head.

16. The distal portion of the elongate inner catheter assembly is a guide clip having at least a first hole and a second hole therein, the first hole being configured to mate with the distal portion of the steerable inner catheter, and the second hole being configured to receive at least one of the tube, the lead, and / or the tether therein to prevent entanglement or twisting with each other, the implant delivery system of claim 1.

17. The implant delivery system of claim 1, further comprising a flexible spring lumen extending distally from the distal end of the multi-lumen extruded body of the inner catheter assembly and configured to receive one of the tether pulls therein, the spring lumen further being configured to maintain alignment of the tether with respect to the implant during advancement.

18. The implant delivery system of claim 16, wherein the axial width of the guide clip is about 5 mm or less so as not to reduce the flexibility of the long inner catheter.

19. The implant delivery system of claim 1, further comprising an inner clip configured to hold an inner implant tether, an outer clip configured to hold an outer implant tether, and a yoke for separating the inner tether and the outer tether.

20. The implant delivery system of claim 19, wherein each of the inner catheter assembly and the yoke is coupled to a separate carriage assembly so as to be movable independently along the guide rail.

21. The implant delivery system of claim 1, further comprising a central driver tube extending from a proximal portion of the torque control knob assembly to a distal portion of the steerable inner catheter, the central driver tube having a distal portion including a mating feature configured to removably mate with a central anchor of the implant when the implant is disposed adjacent to the distal portion of the steerable inner catheter, and the central driver tube having a proximal portion including a central driver knob configured to rotate the central anchor with the central driver tube.

22. The implant delivery system of claim 21, wherein the central lead extends into the central driver tube.

23. Two inner driver tubes, each extending from a first side of the manifold to the distal portion of the inner catheter assembly, each inner driver tube having a distal portion including a mating feature configured to removably mate with an inner anchor of the implant when the implant is disposed adjacent to the distal portion of the steerable inner catheter, and each inner driver tube having a proximal portion including an inner driver knob configured to rotate the inner anchor with the inner driver tube. Two outer driver tubes, each extending from the second side of the manifold to the distal portion of the inner catheter assembly, and each having a distal portion including mating features configured to removably mate with an outer anchor of the implant when the implant is disposed adjacent to the distal portion of the steerable inner catheter, and each having a proximal portion including an outer driver knob configured to rotate the outer anchor with the outer driver tube. Two inner leads, each extending from the distal portion to the proximal portion in one of the inner driver tubes, and each having a distal portion including mating features configured to removably mate with an inner portion of the implant when the implant is disposed adjacent to the distal portion of the steerable inner catheter, and each having a proximal portion including an inner lead knob configured to disengage the inner lead from the implant by rotating the inner lead. Two outer leads, each extending from the distal portion to the proximal portion in one of the outer driver tubes, and each having a distal portion including mating features configured to removably mate with an outer portion of the implant when the implant is disposed adjacent to the distal portion of the steerable inner catheter, and each having a proximal portion including an outer lead knob configured to disengage the outer lead from the implant by rotating the outer lead. The implant delivery system of claim 1, further comprising a system. **Claim 24** The implant delivery system of claim 23, wherein the manifold is configured to arrange the two inner driver tubes, the two outer driver tubes, the two inner leads, the two outer leads, the inner tether pulling portion, and the outer tether pulling portion in a fan shape to facilitate visual recognition and use.

Images