ANNULOPLASTY SYSTEM AND METHOD WITH PRELOADED TETHERS

Abstract

An exemplary method of performing an annuloplasty procedure includes introducing a catheter into the left atrium of the heart, deploying first and second members from the catheter to secure the anterior side of the mitral valve, and deploying a third member from the catheter to secure the posterior side of the mitral valve. The first member has a first flexible tensioning member attached thereto, and the second member has a second flexible tensioning member attached thereto. When deployed, the third member slidably advances over the first and second flexible tensioning members. Tension is applied to the first and second tensioning members to draw the first and second members toward the third member, thereby further approximating the posterior and anterior sides of the mitral annulus. Annuloplasty systems, devices, and components are also disclosed.

Description

[Technical field]

[0001] (CROSS REFERENCE TO RELATED APPLICATIONS) This disclosure claims priority to U.S. Provisional Application No. 63 / 364,256, filed May 5, 2022, entitled "Annuloplasty System and Method with Preloaded Tethers," the entire disclosure of which is incorporated herein by reference.

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

[0003] FIELD OF THE DISCLOSURE Embodiments of the present disclosure relate generally to implantable medical devices. In particular, some implementations of the present invention relate to apparatus and methods for repairing the mitral valve. [Background technology]

[0004] The mitral valve is located at the junction between the left atrium and left ventricle of the heart. During diastole, the valve opens to allow blood to flow from the left atrium to the left ventricle. During systole, the valve closes to prevent blood from flowing back into the left atrium as the left ventricle pumps blood to the body via the aorta. The mitral valve consists of two leaflets, the posterior and anterior, which sit in the mitral annulus, a ring that forms the junction between the left atrium and left ventricle. The mitral valve leaflets are anchored to the papillary muscles of the left ventricle via chordae tendineae. The chordae tendineae prevent the mitral valve leaflets from deflecting into the left atrium during systole.

[0005] Mitral regurgitation is a condition in which the mitral valve does not close completely, resulting in the backflow of blood from the left ventricle to the left atrium. In some cases, regurgitation occurs due to dilatation of the mitral annulus, particularly due to an increase in the anterior-posterior diameter of the mitral annulus. Alternatively or additionally, mitral regurgitation occurs due to dilatation of the left ventricle, which may result from, for example, an infarction. Dilatation of the left ventricle results in the papillary muscles tethering the mitral valve leaflets in a permanent open configuration via the chordae tendineae.

[0006] Prior art methods and devices exist for treating mitral regurgitation. These involve replacing or repairing the mitral valve. Valve replacement is typically performed either transapically or transseptally. Valve repair generally falls into one of four categories: leaflet clip, direct annuloplasty, indirect annuloplasty, or chordal repair. Both direct and indirect annuloplasty require reshaping the subject's mitral annulus and / or left ventricle so that the anterior and posterior leaflets are properly coapted. For some annuloplasty applications, a ring is implanted near the mitral annulus (e.g., on or behind the mitral valve). The purpose of the ring is to reduce the circumference of the mitral annulus. Summary of the Invention [Problem to be solved by the invention]

[0007] In view of the above prior art, it would be desirable to provide an improved system and method for treating mitral regurgitation. [Brief description of the drawings]

[0008] A better understanding of the features and advantages of the present disclosure will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the disclosure are utilized. [Figure 1] FIG. 1 is a generally cranial-to-caudal view showing aspects of the human mitral valve. [Diagram 2] FIG. 1 is a perspective view of an exemplary rear bar constructed in accordance with aspects of the present disclosure. [Diagram 3] FIG. 1 illustrates a top view of an exemplary front pad constructed in accordance with aspects of the present disclosure. [Figure 4] 1 is a flow chart that generally illustrates an exemplary method of performing an annuloplasty procedure in accordance with aspects of the present disclosure. [Diagram 5] ~ [Figure 22] 5 is a series of perspective views looking generally caudally through the left atrium of the mitral valve and illustrating the steps of the exemplary method outlined in FIG. 4. [Figure 23]FIG. 1 is a perspective view of a second exemplary embodiment of an annuloplasty system constructed and implanted in accordance with aspects of the present disclosure. [Figure 24] FIG. 24 is a perspective view showing the annuloplasty system of FIG. 23 along with some of the instruments that may be used to implant the system. [Diagram 25] 24 is a top view of the plate of the posterior implant of the annuloplasty system of FIG. 23. [Figure 26] FIG. 24 is a perspective view of a posterior implant of the annuloplasty system of FIG. 23. [Figure 27] FIG. 27 is a top view of the posterior implant of FIG. 26. [Figure 28] FIG. 27 is a side view of the posterior implant of FIG. 26. [Figure 29] FIG. 27 is a bottom view of the posterior implant of FIG. 26. [Diagram 30] FIG. 24 is a perspective view of an eyelet assembly of the annuloplasty system of FIG. 23. [Diagram 31] FIG. 31 is a side view of the eyelet assembly of FIG. 30. [Diagram 32] FIG. 31 is a top view of the eyelet assembly of FIG. 30. [Diagram 33] FIG. 24 is a side view of a spinner assembly of the annuloplasty system of FIG. 23. [Diagram 34] FIG. 34 is an orthogonal side view of the spinner assembly of FIG. [Diagram 35] FIG. 34 is a bottom view of the spinner assembly of FIG. [Diagram 36] FIG. 34 is a top view of the spinner assembly of FIG. [Figure 37] FIG. 24 is a perspective view of a posterior implant of the annuloplasty system of FIG. 23 along with some of the instruments that may be used to implant the system. [Figure 38] FIG. 38 is a perspective view of a portion of the posterior implant of FIG. 37 and instrumentation before the anchors are implanted. [Figure 39] FIG. 38 is a perspective view of a portion of the posterior implant of FIG. 37 after the anchors have been implanted and separated, and the instrumentation. [Diagram 40]FIG. 38 is a perspective view of a portion of the posterior implant and instrumentation of FIG. 37. [Diagram 41] FIG. 41 is an enlarged perspective view of a portion of the posterior implant and instrumentation of FIG. 40 with some of the components shown in cross-section. [Diagram 42] 24 is a top view of the plate of the anterior implant of the annuloplasty system of FIG. 23. [Diagram 43] FIG. 24 is a perspective view showing the anterior implant of the annuloplasty system of FIG. 23 along with some instruments that may be used to implant the implant. [Diagram 44] FIG. 24 is a side view showing the posterior implant of the annuloplasty system of FIG. 23 preloaded into an implant loader. [Diagram 45] FIG. 24 is a side view showing the anterior implant of the annuloplasty system of FIG. 23 preloaded into an implant loader. [Diagram 46] FIG. 46 is a side view showing an anterior implant being deployed from the implant loader of FIG. 45. [Figure 47A] 1 is a flow chart that generally illustrates a second exemplary method of performing an annuloplasty procedure in accordance with aspects of the present disclosure. [Figure 47B] FIG. 24 is a perspective view showing the annuloplasty system of FIG. 23 implanted in the mitral valve according to an exemplary procedure of the present disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0009] Referring to FIG. 1, the elements of the mitral valve are shown. Specifically, the mitral valve includes an anterior leaflet, a posterior leaflet, an anterior lateral commissure, a posteromedial commissure, a lateral (sometimes referred to as left) trigone, and a medial (sometimes referred to as right) trigone. The anterior leaflet includes three segments A1, A2, and A3. Similarly, the posterior leaflet includes three segments P1, P2, and P3. According to aspects of the present disclosure, in some implementations, device anchors may be placed at or near each of the target locations T as shown.

[0010] Referring to FIG. 2, an exemplary posterior bar 210 constructed in accordance with aspects of the present disclosure is shown. As described in more detail below, the posterior bar 210 is configured to be implanted in the left atrium at or near the mitral valve adjacent the posterior leaflet. Thus, in this exemplary embodiment, the posterior bar 210 is an elongated tubular structure that is curved to conform to the anatomy of the mitral valve at this location. The posterior bar 210 may have a low profile shape to minimize the amount of irregularities in the atrium that may be potential sites for thrombosis, as shown. In this exemplary embodiment, the posterior bar 210 has atraumatic edges to limit the possibility of tissue damage and is covered with a polyethylene terephthalate (PET) fabric to aid in tissue ingrowth.

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

[0012] The rear bar 210 may be provided with one or more snare features 216. In this exemplary embodiment, two snare features 216 are provided, one near each end of the rear bar 210. The snare features 216 may be configured to extend beyond the rear bar 210 to facilitate engagement with one or more tensioning members / snares while preventing disengagement of the tensioning members during operation. In some embodiments, the snare features 216 may be configured to facilitate imaging with fluoroscopy and echocardiography to aid in positioning of the rear bar 210 during delivery and attachment to tissue, as well as to aid in connection of tensioning members to the snare features 216.

[0013] The posterior bar 210 can be designed to load the anchors in a manner suitable for shear and tension relative to the anatomy. Torque control features can be provided to allow for initial positioning of the posterior bar 210 and later provide the ability to move the implant to conform to the anatomy as the anchors are delivered.

[0014] The bar may further include some level of flexibility to allow in vivo adjustment of the posterior bar 210 to contour to the anatomy of a particular subject. The flexibility of the posterior bar 210 may also aid in flexing the bar during the cardiac cycle. In some embodiments, flexibility of the bar is achieved by providing a series of slits (not shown in FIG. 1 ) transverse to the longitudinal axis of the posterior bar 210. In some embodiments, the slits and / or other flexibility-imparting features may be configured to limit the minimum radius of the posterior bar 210 upon implantation to ensure a more uniform tension is applied to the posterior side of the mitral annulus.

[0015] Referring to FIG. 3, an exemplary anterior pad 310 constructed in accordance with aspects of the present disclosure is shown. As will be described in more detail below, the anterior pad 310 is configured to be implanted in the left atrium at or near the mitral annulus adjacent the anterior leaflet, specifically at the trigone. In this exemplary embodiment, the anterior pad 310 is a generally flat structure with four petals 312 extending radially from a central portion. In other embodiments, more, fewer, or no petals may be provided. A main tissue anchor 314 may be disposed in the center of the anterior pad 310. In some embodiments, additional tissue anchors 316 may be provided, such as additional anchors 316 near the center of each petal 312 as shown. In some embodiments, the main tissue anchors 314 are identical to the additional tissue anchors 316, while in other embodiments, they have different configurations, such as features that facilitate positioning of the anterior pad 310 during delivery. The petals 312 may be designed to fold into a compact configuration so that the front pad 310 can be delivered within a catheter.

[0016] The anterior pad may have a low profile as shown to minimize the amount of irregularities in the atrium that may be potential sites for thrombosis. In this exemplary embodiment, the anterior pad 310 has atraumatic edges that limit the potential for tissue damage and is covered with a polyethylene terephthalate (PET) fabric that is conducive to tissue ingrowth.

[0017] The front pad may be provided with one or more snare features. In this exemplary embodiment, the upper ends of the tissue anchors 314 and 316 are configured to mate with one or more tensioning members / snares. These snare features may be configured to extend beyond the front pad 310 to facilitate easy mating with one or more tensioning members / snares and to prevent disengagement of the tensioning members during operation. In some embodiments, the snare features and / or the entire front pad 310 are configured to be easily imaged under fluoroscopy and echocardiography to aid in positioning the front pad 310 during delivery and attachment to tissue, and to aid in connecting the tensioning members to the snare features. The front pad 310 may be designed to load the anchors in a manner suitable for shear and tension forces relative to the anatomy.

[0018] With reference to FIG. 4, an exemplary method of performing an annuloplasty procedure according to aspects of the present disclosure is shown. The steps of this exemplary method 410 are described with reference to the flow chart shown in FIG. 4 and the series of images shown in FIGS. 5-22. Each of the images shown in FIGS. 5-22 is looking generally caudal from the left atrium 510 toward the mitral valve 512, with the medial direction generally to the right. In some implementations of the method, one posterior bar 210 and one, two, or more anterior 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 locations T shown in FIG. 1.

[0019] In some implementations of the method 410, the first step 412 of the method is to introduce the distal end of a delivery catheter into the left atrium 510 of the subject. This may be performed using a transseptal approach, a left atrial approach, or other methods to gain access to the left atrium. The images shown in Figures 5-22 depict a transseptal approach in which the distal end of the 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) is disposed at the distal end of the catheter 514 to cross the septum.

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

[0021] 6, as the trailing bar 210 emerges from the distal end of the catheter 514, the lead 518 attached to one end is pushed and the other is pulled from the proximal end of the catheter 514 to pivot the trailing bar 210 to an orientation that is generally perpendicular to the catheter 514 as shown. The inner catheter 520 may be slid distally on the intermediate lead 518 until features (such as recesses and / or walls, not shown) mate with engagement features on the trailing bar 210 to prevent the bar 210 from rotating relative to the steerable inner catheter 520. The steerable inner catheter 520 may then be used to position and rotate the trailing bar 210 until it is steered to the desired implantation location and orientation, as shown in FIG. 7. In some implementations, a torque driver disposed coaxially between the lead 518 and the steerable inner catheter 520 may be used to apply torque to the trailing bar 210. Such implementations are described below in connection with FIGS. 40-46.

[0022] 4 and 8-11, step 416 of the exemplary method 410 is described. In this step, the posterior bar 210 (i.e., the first member) is secured to the posterior side of the mitral valve 512. As shown in FIG. 8, this may be accomplished by first sliding a drive tube 522 with a helical tissue anchor 524 disposed at its distal end on a lead 518 attached to a tissue anchor guide 214 disposed near the medial end of the posterior bar 210. As seen in FIG. 9, while a steerable inner catheter 520 holds the posterior bar 210 against the mitral annulus tissue, the drive tube 522 is rotated to thread the medial anchor 522 through the posterior bar 210 and into the underlying tissue. 9, the drive tube 522 may be removed from the medial anchor 214 and the drive tube (or another drive tube 522 with another helical tissue anchor 524) may be slid over the lead 518 attached to the tissue anchor guide 214 disposed near the outer end of the posterior bar 210. As seen in FIG. 10, the drive tube 522 may be rotated to thread the outer tissue anchor 524 through the bar 210 and into the tissue below while the medial anchor 524 and steerable inner catheter 520 (and in some implementations a torque driver inside the catheter 520) hold the posterior bar 210 to the mitral annulus tissue. Then, as shown in FIG. 11, the drive tube 522 may be removed from the outer anchor 524 and the drive tube (or another drive tube 522 with another helical tissue anchor 524) may be slid over the lead 518 attached to the intermediate tissue anchor guide 212. In some implementations, the steerable inner catheter 520 may be left in place on the posterior bar 210 when the central anchor is deployed (as shown in FIG. 10), or may be removed from the posterior bar 210 prior to sliding the drive tube 522 and intermediate anchor 524 into engagement with the intermediate tissue anchor guide 212 (as shown in FIG. 11). While the medial and lateral anchors 524 hold the posterior bar 210 against the mitral annulus tissue, the drive tube 522 may be rotated to screw the intermediate anchor 524 through the bar 210 and into the underlying tissue.10 and 11 show the rear bar 210 after the lead has been removed from the end tissue anchor guide, such as by extraction.

[0023] It should be noted that in step 416, after the first anchor is placed, torque control of the implant 210 provided by the steerable inner catheter 520 (or in some implementations a torque driver disposed within the catheter 520) can be used to guide subsequent placement of anchors in the implant 210. This avoids the need for non-guided anchor placement after the first anchor is placed. Figure 12 shows the posterior bar 210 with three anchors placed and all leads removed.

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

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

[0026] It should be noted that in step 420, after the initial anchor is placed, the lead may be left in place within the steerable inner catheter 520 such that the lead and catheter 520 may be used to guide subsequent placement of anchors in the implant 310. This avoids the need for non-guided anchor placement after the initial anchor is placed.

[0027] 4 and 14, steps 422 and 424 of an exemplary method 410 are described. In these steps, another anterior pad 310 (sometimes referred to herein as a third member) is placed from the distal end of a catheter 514. In some implementations, the anterior pad 310 is steered to the medial trigone by a steerable inner catheter 520, as shown in FIG. 14. (The medial trigone is also shown in FIG. 1.) The anterior pad 310 may then be secured to the anterior side of the mitral valve 512. In some implementations, the anterior pad 310, shown with a single anchor 314, is secured to the medial trigone. A drive tube (not shown) may be used within the steerable inner catheter 520 to screw the anchor 314 into place. As with the lateral anterior pad 310, additional anchors may be used to further secure the medial anterior pad 310 to the medial trigone.

[0028] It should be noted that in step 424, after the initial anchor is placed, the lead may be left in place within the steerable inner catheter 520 such that the lead and catheter 520 may be used to later guide the placement of an anchor in the implant 310. This avoids the need for non-guided anchor placement after the initial anchor is placed.

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

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

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

[0032] 4 and 20-22, step 432 of the 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 anterior pad 310 (i.e., the third member). As shown in FIG. 20, a steerable inner catheter 520 and a snare sheath 532 may be utilized to guide the second tension member 530 to the inner snare feature 216 of the bar 210. As shown in FIG. 21, the second tension member 530 may then be guided to the main tissue anchor 314 of the anterior pad 310. As shown in FIG. 22, a small amount of tension may be applied to the second tension member 530 by the snare sheath 532 to keep it mated with the bar 210 and pad 310. In some implementations, the snare shape may be configured to more easily mate with the snare feature of the implant. For example, each snare may form a D-shape that contacts the outside or inside of the atrium. The walls of the atrium are then used to guide the snare to the lower annulus and then clamp, 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 predetermined diameter, and the remainder of the snare has generally parallel tension members that form a gap between them that is smaller than the loop diameter. The distal loop 552 may be exposed first to engage with a first snare feature of the implant, followed by the proximal loop 554 to capture a second snare feature of the implant. In some embodiments, two snares 560 and 562, each with a predetermined shape, are loaded in parallel, as depicted in FIG. 55. The individual snares 560 and 562 may be connected with a coupler 564 and may slide independently to separately mate with the snare features of the implant.

[0033] Once both the first tensioning member 526 and the second tensioning member 530 are in place, additional tension can be applied to both to further approximate the anterior and posterior sides of the mitral valve 512. In some implementations, the tension of the members 526 and 530 can be increased simultaneously. In some implementations, the tension can be increased incrementally alternating between the members 526 and 530 until a desired tension and / or valve approximation is reached. In some implementations, the final tension and / or tissue approximation of each tensioning member 526 and 530 is approximately the same. In some implementations, the final tension and / or tissue approximation of each tensioning member 526 and 530 is different. The inner and outer tightening can be performed independently, allowing for more latitude in the placement of each bar. This is generally true for all of the systems disclosed herein. In some implementations, real-time echocardiography of the mitral valve is used to monitor the relief of mitral regurgitation as the tensioning members 526 and 530 are tightened.

[0034] After the desired tension and / or tissue approximation is achieved, tensioning members 526 and 530 may be ligated. In some implementations, a reversible lock configured to permanently retain the position of the tensioning members may be used during the tightening process. A cutting member may be used to separate the snare from the delivery system, or a portion of the tensioning member may be cut to release it. Catheter 514, along with steerable inner catheter 520 and snare sheaths 528 and 532, may then be withdrawn from the left atrium (step 436 shown in FIG. 4). In addition to tensioning the devices during a new procedure, additional tensioning devices may be added later or at a later date, and / or 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 the applicant's co-pending U.S. Patent Application Publication No. 2021 / 0052387, entitled "Annuloplasty Systems and Methods."

[0036] 23-47B, a second exemplary embodiment of an annuloplasty system 600 constructed and implanted according to aspects of the present disclosure is shown. Referring to FIG. 23, annuloplasty system 600 is constructed and functions in a manner similar to the previously described systems. It also includes an elongated posterior implant 610 configured to be implanted in the left atrium at or near the mitral annulus adjacent the posterior leaflet, and two anterior implants 612, each configured to be implanted in the left atrium at or near the mitral annulus adjacent the anterior leaflet, specifically at the trigone. However, in this second exemplary embodiment, instead of attaching a tension member or tether to the implant after it is deployed, a tether 614 is pre-attached to the anterior implant 612 before it is deployed from the catheter. In this embodiment, the anterior implant 612 is implanted first, and its tether 614 is threaded through the posterior implant 610 before it is deployed from the catheter. The posterior implant 610 then follows the tether 614 as it is deployed from the catheter and placed on the posterior side of the mitral annulus. As will be described in more detail below, after the posterior implant 610 is anchored in place by the anchor 616, the tether 614 can be tensioned and secured with the lock 618. This arrangement saves significant time during surgery as each implant does not have to be captured by a tether. It also ensures a more consistent and reliable tether attachment point.

[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 runs down the tether 614 and provides a backstop for the tether lock 618.

[0038] Referring to FIG. 24, another perspective view of the system 600 is provided showing the anchors 616 at various stages of insertion. Each anchor 616 is guided into place by its own lead 622 which is removably connected to a spinner assembly 624. Each spinner assembly 624 is rotatably mounted to a posterior implant plate 626. A separate driver head 628 is removably connected to the top of each anchor 616. When the driver head 628 is rotated by a proximally extending driver tube (not shown), the attached anchor 616 is driven through the spinner assembly 624 and into the underlying cardiac tissue until it engages with its spinner assembly 624, thereby anchoring 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 driven in longitudinal rotation by a proximally extending torque tube (not shown) to engage with a respective implant and drive the implant into position for fixation.

[0039] Referring to Figure 25, the posterior implant plate 626 is shown in its bare state without any components attached for clarity. It has five through holes 632 for rotatably retaining the spinner assembly 624 (shown in Figures 23 and 24). Two holes 634 are also provided for rotatably retaining the eyelet assembly 620 (shown in Figures 23 and 24). A series of slots 636 spaced about the central spinner assembly hole 632 are provided for mating with the torque head 630 (shown in Figures 23 and 24), as will be described in more detail below. Additional through holes 638 and scallops 640 are provided as shown to reduce the amount of metal in the plate 626 for better echo imaging and tissue ingrowth.

[0040] 26-29, the posterior implant plate 626 is shown with the anchor spinner assembly 624 and the tether eyelet assembly 620 attached to the base plate 626. Figure 26 is a perspective view, Figure 27 is a top view, Figure 28 is a side view, and Figure 29 is a bottom view.

[0041] 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. (A bottom view of the eyelet assembly 620 is provided in FIG. 29.) As seen most clearly in FIG. 31, the eyelet assembly 620 may be formed from six separate components: a cylindrical core 642, a top ring 644, a bottom ring 646, an eyelet 648, a wedge or filler material 650, and an eyelet covering 652. As seen most clearly in FIGS. 31 and 32, the core 642 includes two pairs of arcuate fins 654, one pair protruding from the top of the core 642 and one pair protruding from the bottom. The top ring 644 and the bottom ring 646 may each include an engagement slot for receiving the arcuate fins 654. In some embodiments, the fins 654 are swaged, welded, epoxied, press fit, and / or fastened to the rings 644 and 646 by other suitable means. In other embodiments, there is only a slip fit between the fins 654 and the rings 644 and 646, and the rings are held in place by being clamped between the core 642 and the ends of the straight body portion of the eyelet 648 and / or by the eyelet body expanding into the ring, as described below. In some embodiments, the fins 654 may serve as a centering feature for the core 642 and / or as an anti-rotation feature to prevent the rings 644 and 646 from rotating relative to the core 642 and / or the eyelet 648. In other embodiments (not shown), features other than arcuate fins may be used.

[0042] The eyelet 648 is formed with a straight body having an elliptical or rectangular cross-section (as seen most clearly in FIG. 29). The core 642 may have a central bore with a mating elliptical or rectangular cross-section or a circular cross-section to receive the eyelet body. The straight body is split in the middle to provide a gap between the two halves. Thus, an anti-friction tube 652 can slide over one half of the body into the circular portion of the eyelet 648 as shown. In some embodiments, the tube 652 is made of or coated with polytetrafluoroethylene (PTFE) to reduce friction between the eyelet 648 and the tether passing through it. In other embodiments, the eyelet 648 may be directly dipped into PTFE or another anti-friction coating.

[0043] During assembly, the straight body of the eyelet 648 may pass through the top ring 644, the center of the core 642 (located in one of the holes 634 of the posterior implant plate 626 as shown in FIG. 25), and the bottom ring 646. A wedge or filler material 650 may then be provided between the two halves of the eyelet body so that it is 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 a resilient compressible material that is provided in the body gap prior to assembly so that it can be compressed during assembly and then exert an outward resilient force after assembly. In other embodiments, the material 650 is metal (i.e., incompressible). In some embodiments, the eyelet body includes a waist (not shown) having an axial length that is slightly longer than the distance between the top of the top ring 644 and the bottom of the bottom ring 646. This arrangement allows the core 642 and rings 644 and 646 to be constrained in the waist after the split body is radially compressed to pass other components and then radially expand. When the eyelet assembly 620 is assembled, the posterior implant plate 626 (shown in FIG. 25 ) is sandwiched between the top ring 644 and 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 may freely rotate relative to the plate 626.

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

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

[0046] In the manner described above, the lead nut 666 pivots relative to the spinner assembly 624, and the spinner assembly spins relative to the posterior implant 610 (shown in FIGS. 23, 24, and 37). Thus, the anchor lead 622 can lie generally flat on the implant 610 when preloaded into the delivery catheter (as shown in FIG. 44) and extend orthogonally or at another angle when the implant is deployed. As can be seen most clearly in FIGS. 33 and 40, one or more recesses 670 can be provided in the top of the hoop 656 to allow the connecting rod 664, lead nut 666, and anchor lead 622 (shown in FIGS. 24 and 37) to lie even flatter on the implant.

[0047] Another advantage of the spinner assembly 624 is that it ensures that the anchors 616 passing therethrough (shown in FIGS. 23 and 24) can pull the implant across the tissue without leaving any gaps 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 to each of the two anterior implants 612.

[0048] 37-39, the structure and operation of the implantable anchors 616 will be described. In this exemplary embodiment, each anchor 616 is constructed of two components: a coil 672 and an anchor head 674. The distal end of the anchor head 674 may include a helical slot to accommodate 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 anchor head 674 is hollow in the center to fit over the lead nut 666 and connecting rod 664 when the anchor 616 is implanted. The proximal end of the anchor head 674 may include a cylindrical hook-shaped releasable mating feature or clasp 676. An identical and / or complementary mating feature or clasp 676 may be disposed on the distal end of the driver head 628. The two clasps 676 may interlock with each other and be held together by the anchor lead 622 when the implant is assembled and preloaded into the delivery catheter. As shown in FIG. 38, when engaged, the clasps 676 transfer axial and rotational motion from the driver head 628 to the anchors 616 to drive the anchors through the spinner assembly 624 and into the underlying cardiac tissue. As shown in FIG. 39, after all anchors 616 of the implant have been installed, the distal end of each anchor lead 622 may be loosened from the associated lead nut 666 and withdrawn proximally through the clasps 676 to disengage each anchor driver from the anchor 616. As shown in FIGS. 38 and 39, a series of slots or laser cuts 677 may be formed in the wall thickness of the driver head 628 to form flexures or living hinges. These flexures may release pressure to allow the clasps 676 to more easily engage and disengage with one another when axial misalignment is encountered or a lateral moment is applied to the driver head 628. In other embodiments (not shown), a hollow stranded cable may be used instead of a rigid tube with or without flexures.

[0049] 37, the torque head 630 can include a flared distal end configured to fit into the central spinner assembly 624 when distally extending tabs 678 fit into slots 636 to steer the implant 610. The torque head 630 can also include a central bore large enough to accommodate the anchor 616 when installed.

[0050] 40 and 41, additional views of the torquer head 630 are shown. FIG. 40 shows the distal end of the torquer head 630 as it approaches the central spinner assembly 624. The torquer head 630 can be mated with the implant 610 by pushing the proximal end of the torquer tube (not shown) distally while pulling the proximal end of the central anchor lead 622 (shown in FIG. 23) proximally. The torquer tube must be rotated until the tabs 678 mate with the slots 636. FIG. 41 shows the distal end of the torquer head 630 and the central spinner assembly 624 with some portions cut away to show further detail of these components.

[0051] 42 and 43, a diagram of the components of an anterior implant 612 is shown. FIG. 42 shows an exposed anterior implant base plate 680 with only a tether thimble 682 attached. Because the two anterior implants 612 shown in FIGS. 23 and 24 are mirror images of each other, the same plate 680 and thimble 682 can be used to construct either, depending on which way the spinner assembly 624 is oriented. When the spinner assembly 624 is attached to the near side of the plate 680 shown in FIG. 42 (with the lead nut 666 facing up as shown in FIG. 43), a lateral anterior implant 612 (shown on the left side of FIGS. 23 and 24) is formed. When the spinner assembly 624 is attached to the far side of the plate 680 shown in FIG. 42 (with the lead nut 666 facing down as opposed to what is shown in FIG. 43), a medial anterior implant 612 (shown on the right side of FIGS. 23 and 24) is formed.

[0052] In this exemplary embodiment, the same components already described for the posterior implant 610 are used for the anterior implant 612, such as the spinner assembly 624, anchor 616, torque head 630, etc. As shown in FIG. 42, the spacing of the slots 636 can be the same as that used for the posterior implant plate 626 (shown in FIG. 25) to accommodate the two opposing tabs 678 of the torque head 630 (only one tab 678 is seen in FIG. 43). Because 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 tabs 678 mate with a pair of engagement slots 636.

[0053] As shown in Fig. 43, a thimble 682 and sleeve 684 may be used to terminate the distal end of the tether 614 to the beam of the anterior implant 612 so that the tether is free to pivot relative to the implant. In this way, the implant 612 with its pre-attached tether 614 may be more securely loaded into and deployed from a delivery catheter. This pivoting also allows the tether 614 to be directly aligned with the posterior implant 610 (as shown in Figs. 23 and 24) rather than imparting a rotational moment to the implanted anterior implant 612 and underlying cardiac tissue.

[0054] In some embodiments, the tether or tension member 614 has a composite construction. The continuous braided filament core may include ultra-high mechanical property polyethylene (UHMPE) fibers, such as Dyneema®, supplied by Koninklijke DSM NV, The Netherlands, combined with polyethylene terephthalate (PET) fibers. Dyneema® may be used for strength and durability, while PET improves bonding with the 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) jacketing to provide desirable handling properties, such as high column strength to thread the tether through the catheter and advance the catheter without tether collapse. In some embodiments, at least one platinum wire is placed in the distal portion of each tether 614 for radiopacity, so that the tethers are more clearly visible during imaging. Prior to insertion into the jacket, the filament core may be saturated with epoxy. This may be done to bond the composite together. In some embodiments, the jacket is passed through a necking die to reduce its diameter and compress it onto the filament. The tether 614 may be color coded to allow the surgeon to distinguish the inner tether from the outer tether. In some embodiments, the tether 614 is provided with markings every 5 mm so that tightening may be observed. Applicants have discovered that the use of the above features provides the ability to cut the tether in vivo, providing the tether with excellent longitudinal stiffness for highly responsive tightening while ensuring full in vivo loading of cardiac valve regulation, and excellent durability over the life of the implant.

[0055] 44-46, diagrams of exemplary implants preloaded into a delivery system are shown. In some embodiments, each of the implants is loaded into its own implant loader 686. The implant loader 686 has a proximal hub 688 (shown in FIG. 45) that is configured to slide over the distal end of an inner steerable catheter (not shown). The distal end 690 of the implant loader 686 may be configured to slide within the proximal end of an outer steerable catheter (not shown). During placement of the implant, the implant loader 686 remains in place in the proximal end of the outer catheter, while the implant and distal end of the inner catheter slide distally over the implant loader 686 and outer catheter.

[0056] 44 shows a posterior implant 610 preloaded into an implant loader 686. As shown, the implant 610 is generally parallel to the central axis of the implant loader 686. Each of the five anchor leads 622 is attached to the implant's spinner assembly 624 and rests generally flat on the implant 610 when preloaded. Each anchor lead 622 extends proximally within an anchor 616 and is attached to an anchor driver 628. Only four of the anchors 616 are visible, as the fifth anchor is located inside the torque head 630.

[0057] Each of a pair of tether pullers 694 may extend distally from the implant loader 686 through a spin eyelet assembly 620 of the posterior implant 610, as shown. After the anterior implant is implanted, its tether 614 may be attached to the protruding end of the tether puller 694, such as by a sleeve that may be attached to each puller and crimped to the tether. The tether may then be pulled proximally by the tether puller 694 until the proximal end of the tether emerges from the internal steerable catheter (not shown).

[0058] 45 shows a medial anterior implant 612 preloaded into an implant loader 686. As shown, the implant 612 forms an acute angle with the central axis of the implant loader 686. Two anchor leads 622 are attached to the implant's spinner assembly 624 and extend proximally through the anchor 616 and attached anchor driver 628. Only one anchor 616 is visible as the second anchor is located inside the torque head 630 and torque tube 692.

[0059] FIG. 46 shows an outer anterior implant 612 preloaded into an implant loader 686 and pushed out from its distal end 690. In this exemplary embodiment, the preloading and positioning of the outer anterior implant 612 is essentially the same as that of the inner anterior implant 612 shown in FIG. 45, but with a tether pull 694 for attachment to the proximal end of the tether from the first implanted inner anterior implant 612. In this exemplary embodiment, an axially extending spring lumen 696 is provided to guide the tether pull 694. In this embodiment, the spring lumen 696 is similar to a "curve detector" in an automobile in that it is biased back to its original straight orientation if lateral forces cause it to deviate from the straight orientation during operation. The spring lumen 696 helps to prevent the tether pull 694, and later the tether itself, from wrapping around the implant, another tether, a lead, or a tube.

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

[0061] In some implementations of method 710, the first step 712 of the method is to introduce the distal end of a steerable external delivery catheter (not shown) into the subject's left atrium. This may be performed 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) is disposed at the distal end of the steerable external delivery catheter to cross the septum. A steerable internal delivery catheter (not shown) may be placed within the external steerable delivery catheter for more precise delivery of the implant.

[0062] Once the inner delivery catheter is introduced into the outer catheter, in step 714 of this exemplary embodiment, a first anterior implant 612 (see FIG. 24 ), sometimes referred to herein as the first member, and the distal end of the inner delivery catheter may be deployed from the distal end of the outer delivery catheter into the left atrium. In this exemplary embodiment, the inner anterior device 612 is implanted first, followed by the outer anterior device 612. In other embodiments, the order of implantation may be changed. The anchor lead 622 and inner catheter may be used to push the anterior implant 612 within the outer delivery catheter to deploy it from its distal end. After the first anterior implant 612 emerges from the distal end of the outer delivery catheter, the anchor lead 622 may be manipulated from the proximal end of the inner delivery catheter to pivot the anterior implant 612 to an orientation that is generally perpendicular to the inner delivery catheter. The first anterior implant 612 emerges from the outer delivery catheter with the distal end of the tether or first tension member 614 pre-attached. The proximal end of the attached tether 614 extends through the delivery catheter and out the proximal end. The torque head 630 may be slid distally on the anchor lead 622 until the distally extending tab 678 engages with the slot 636 (see FIG. 43 ) so that the implant 612 may be steered to a desired implantation location 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 612 proximally until it engages with the torque head 630.

[0063] In step 716, the anterior implant 612 (i.e., the first member) is secured to the anterior side of the mitral valve. This may be accomplished by individually turning each of the two helical tissue anchors 616 with the attached driver head 628. One drive tube may be rotated to thread the anchor 616 from the spinner assembly 624 into the tissue below while the torque head 630 holds the anterior implant 612 in the mitral annulus tissue. The torque head 630 may then be used to finely adjust / rotate the implant 612 before the second anchor 616 with the drive tube and driver head 628 is threaded into place. Proper placement of the first member may be confirmed through imaging. When the surgical staff is ready to remove the delivery instrument, the lead 622 may be loosened from the spinner assembly 624 and at least partially withdrawn through the driver head 628 and into the connected drive tube. The driver head 628 may then be disengaged from the anchor 616. Once the driver head 628 is disengaged, the attached drive tube, anchor lead 622, torque head 630 and inner catheter may be withdrawn proximally from the outer delivery catheter.

[0064] In this exemplary embodiment, steps 718 and 720 are similar to steps 714 and 716, respectively. In step 718, the outer anterior implant 612 (sometimes referred to herein as the second member) and the distal end of the inner delivery catheter may be placed into the left atrium from the distal end of the outer delivery catheter in exactly the same manner as already described for the inner anterior implant 612 in step 714. In some embodiments, a separate preloaded and presterilized steerable inner catheter is provided for each of the anterior implants 612. In some embodiments, after the inner catheter for the first member is removed, the tether 614 from the already implanted first member 612 remains on the outer catheter. To avoid entanglement, this tether 614 may be threaded through the second inner catheter before the second inner catheter is introduced into the outer steerable catheter. In this exemplary embodiment, the second member 612 is positioned with its own tether or tension member 614 attached such that the proximal ends of both the first and second tethers 614 extend through and out of the second inner catheter. In step 720, the outer anterior implant 612 (i.e., second member) is secured to the anterior side of the valve in exactly the same manner as already described for the inner anterior implant 612 (i.e., first member).

[0065] At step 722, the posterior implant 610 (sometimes referred to herein as the third member) is placed in the heart. Like the first and second members, the third member may be provided to the surgeon preloaded into its own steerable inner catheter. In some embodiments, a tether or tension member 614 extending from the first and second members is threaded through the eyelet assembly 620 of the posterior implant 610 and the third inner catheter before the third inner catheter is introduced into the outer catheter. The anchor lead 622 and inner catheter may be used to push the anterior implant 612 within the outer delivery catheter to deploy it from its distal end. After the posterior implant 610 emerges from the distal end of the outer delivery catheter, the anchor lead 622 may be manipulated from the proximal end of the inner delivery catheter to pivot the posterior implant 610 to an orientation that is generally perpendicular to the inner delivery catheter. By keeping some tension on 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 down the first and second tension members 614. One advantage of this arrangement is that the first and second tension members 614 help guide the third member 610 into the proper orientation. Pre-connecting the tension members 614 to the three implants also saves time during surgery and ensures that the tension members are properly and consistently connected to the implants. The torque head 630 can be slid distally on the central anchor lead 622 until the distally extending tab 678 engages the slot 636 (see FIG. 40 ) so that the implant 610 can be further steered to its desired implantation location 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 610 proximally until it engages the torque head 630.

[0066] In step 724, the posterior implant 610 (i.e., the third member) is secured to the posterior side of the mitral valve. This may be accomplished by individually turning each of the five helical tissue anchors 616 with their attached driver heads 628. One drive tube may be rotated to thread the anchor 616 through the spinner assembly 624 and into the tissue below, while the torque head 630 holds the posterior implant 610 to the mitral annulus tissue. The torque head 630 may then be used to finely adjust / rotate the implant 610 before the next anchor 616 with its drive tube and driver head 628 is threaded into place. Proper placement of the third member may be confirmed through imaging. When the surgical staff is ready to remove the delivery instrument, the lead 622 may be loosened from the spinner assembly 624 and at least partially withdrawn through the driver head 628 and into the connected drive tube. The driver head 628 may then be disengaged from the anchor 616. Once the driver head 628 is disengaged, the attached drive tube, anchor lead 622, torque head 630 and inner catheter may be withdrawn proximally from the outer delivery catheter.

[0067] In other embodiments, the order of placement and attachment of multiple implants may be changed. In these other embodiments, a first implant or implants may be placed with an attached tether, and at least one subsequently placed implant may follow the tether as it is placed and attached to the heart tissue. For example, a posterior implant may be implanted first with two tethers pre-attached to both ends of the implant. Then an inner anterior implant may be placed and follow one of the posterior implant's tethers. After the inner anterior implant is anchored to the underlying heart tissue, an outer anterior implant may be placed and follow the other tether of the posterior implant. In another embodiment, a single anterior implant with two tethers may be implanted first, and then a single posterior implant may be placed and follow the two tethers of the anterior implant. Other embodiments having different implant placement orders may also utilize the principles of the present disclosure.

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

[0069] In some implementations, the tension of the tension members 614 may be increased simultaneously. In some implementations, the tension at the members may be increased gradually, alternating between the two members 614 until a desired tension and / or valve proximity is reached. In some implementations, the final tension and / or tissue proximity of each tension member 614 is approximately 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, there is more tolerance for the placement of each implant. In some implementations, real-time echocardiography of the mitral valve is used to monitor mitral regurgitation as the tension members 614 are tightened. In some embodiments, one or both locks 618 may be temporarily released when it is desired to reduce the tension of the tension members 614.

[0070] After the desired tension and / or tissue approximation is achieved, the excess length of tension member 614 extending proximally from lock 618 may be severed. At step 732, a cutter assembly may be slid distally along each tension member 614 until it reaches lock 618, and is actuated to cut the tension member and then withdrawn along with the excised portion of the tension member. The outer delivery catheter may then be withdrawn from the left atrium at step 734.

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

[0072] Advantages provided by the systems and methods disclosed herein may include: A more direct reduction in the anterior-posterior (A-P) direction may be achieved. As the A-P direction is the relevant dimension that should be reduced most clinically, it is advantageous to directly affect this dimension as opposed to simultaneously altering other dimensions of the annulus. This may be achieved by reduced clamping force as it is a direct A-P motion rather than the larger forces generally required for circumferential remodeling. Reduced clamping force generally translates to fewer anchors required. The systems and methods also allow a high level of customization for a particular anatomy. This relates to the provision of individual components that are placed separately and the ability to adjust the medial and lateral separately. Each of the separate components is easier to implant compared to one large structure. Each of the components may be retrieved prior to anchor removal. The systems and methods provide in vivo adjustability, reducing the precision required to place the components and simplifying the implantation procedure. A reduction in the number of implant sizes and configurations may also be achieved. In addition to tensioning the devices during a new procedure, additional tensioning devices may be added later or at a later date, and / or existing devices may be re-tensioned to further reduce the A-P dimension.

[0073] 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 there may be intervening features and / or elements present. In contrast, when a feature or element is referred to as being "directly on" another feature or element, there are no intervening features or elements 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 there may be intervening features or elements 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, there are no intervening features or elements present. Although described or illustrated with respect to one embodiment, the features and elements so described or illustrated may apply to other embodiments. Those skilled in the art will also recognize that a reference to a structure or feature disposed "adjacent" to another feature may have portions that are above or below the adjacent feature.

[0074] The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. For example, as used herein, the singular forms "a", "an" and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms "comprises" and / or "comprising", as used herein, specify the presence of stated features, steps, operations, elements, and / or components, but do not exclude the presence or addition of one or more other features, steps, operations, elements, components, and / or groups thereof. As used herein, the term "and / or" includes any and all combinations of one or more of the associated listed items and may be abbreviated with " / ".

[0075] Spatially relative terms such as "under," "below," "lower," "over," "upper," and the like, may be used herein to facilitate the description of the relationship of one element or feature to another element or feature depicted in the figures. It will be understood that the spatially relative terms are intended to encompass various 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 were inverted, an element described as "under" or "beneath" the other element or feature would be oriented "over" the other element or feature. Thus, by way of example, the term "under" may encompass both an above and below orientation. The device may be in other orientations (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly. Similarly, the terms "upwardly," "downwardly," "vertical," "horizontal," and other terms are used herein for descriptive purposes only, unless expressly stated to the contrary.

[0076] Although the terms "first" and "second" may be used herein to describe various features / elements (including steps), 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, a first feature / element described below may be referred to as a second feature / element, and similarly, a second feature / element described below may be referred to as a first feature / element, without departing from the teachings of the present invention.

[0077] Throughout this specification and the claims that follow, unless the context requires otherwise, the words "comprise" and variations thereof, such as "comprises" and "comprising," mean that various components may be employed cooperatively in methods and articles (e.g., compositions and apparatus, including devices, and methods). For example, it will be understood that the word "comprising" means the inclusion of any of the described elements or steps but not the exclusion of any other elements or steps.

[0078] When used in the specification and claims, including in the examples, and unless otherwise specified, all numbers may be interpreted as if preceded by the words "about" or "approximately", even if these words are not explicitly stated. The words "about" or "approximately" or "generally" may be used when describing a size and / or location to indicate that the stated value and / or location is within a reasonable expected range of value and / or location. For example, a numerical value may have a value that is + / -0.1% of the stated value (or range of values), + / -1% of the stated value (or range of values), + / -2% of the stated value (or range of values), + / -5% of the stated value (or range of values), + / -10% of the stated value (or range of values), etc. Any numerical value recited herein should be understood to include about or approximately that value, unless the context indicates otherwise. For example, when a value of "10" is disclosed, "about 10" is also disclosed. Any numerical ranges described herein are intended to include all subranges subsumed therein. It is also understood that when a value is disclosed, "less than or equal to" that value, "greater than or equal to" that value, and possible ranges between these values ​​are also disclosed, as would be well understood by one of ordinary skill in the art. For example, when a value of "X" is disclosed, "less than or equal to" as well as "greater than or equal to X" (e.g., X is a number) are also disclosed. It is also understood that data is provided throughout this application in several different formats, and that this data represents endpoints and starting points and ranges of combinations of the data points. For example, when a specific data point "10" and a specific data point "15" are disclosed, it is understood that 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, and equal to 10 and 15 are also considered to be disclosed, as well as between 10 and 15. It is also understood that each unit between two particular units is also disclosed. For example, if 10 and 15 are disclosed, then 11, 12, 13, and 14 are also disclosed.

[0079] Although various exemplary embodiments have been described above, any of several modifications may be made to the various embodiments without departing from the scope of the disclosure as set forth in the claims. For example, the order in which the various method steps described are performed is often changed in alternative embodiments, and one or more method steps may be omitted altogether in other alternative embodiments. Any feature of the various device and system embodiments may be included in some embodiments and not included in other embodiments. Therefore, the foregoing description is provided primarily for illustrative purposes and should not be construed as limiting the scope of the disclosure as set forth in the claims.

[0080] The examples and illustrations contained herein illustrate, by way of example, and not limitation, specific embodiments in which the subject matter may be practiced. As noted above, other embodiments may be utilized and derived, such 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 may be individually or collectively referred to herein by the term "invention" when one or more are actually disclosed, merely for convenience and without any intention of spontaneously limiting the scope of the present application to a single invention or inventive concept. Thus, although specific embodiments have been shown and described herein, any mechanism contrived to achieve the same purpose may be substituted for the specific embodiment shown. The present disclosure is intended to encompass any and all modifications or variations of the various embodiments. Combinations of the above embodiments, as well as other embodiments not expressly described herein, will be apparent to those skilled in the art upon reviewing the above description. [Explanation of symbols]

[0081] 210 Rear Bar 212 Intermediate Tissue Anchor Guide 214 End Tissue Anchor Guide 216 Snare Features 310 Front Pad 312 Petal 314 Major Organization Anchors 316 Additional Tissue Anchor 510 Left atrium 512 Mitral valve 514 Catheter 516 Septum 518 Anchor Lead 520 Steerable Internal Catheter 522 Drive Tube 524 Spiral Tissue Anchor 526 First Tensile Member 528 Snare Sheath 530 Second tension member 532 Snare sheath 600 Annuloplasty System 610 Posterior Implant 612 Anterior Implant 614 Tether 616 Anchor 618 Tetherlock 620 Swivel Eyelet Assembly 622 Anchor Lead 624 Spinner Assembly 626 Posterior Implant Plate 628 Driver Head 630 Torque Head 632 Through hole 634 holes 636 Slots 638 Through hole 640 Scallop 642 Cylindrical Core 644 Upper Ring 646 Bottom Ring 648 Eyelet 650 Wedge or filler material 652 Eyelet Covering Part 654 Bow Fin 656 Center Hoop 658 Upper Disc 660 Bottom Lock Ring 662 Crossbar 664 U-shaped connecting rod 666 Lead Nut 668 Flange 670 Recess 672 Coil 674 Anchorhead 676 Clasp 677 Slots 678 tabs 680 Base Plate 682 Thimble 684 Sleeve 686 Implant Loader 688 Proximal Hub 690 Distal end 692 Torque tube 694 Tether puller 696 Lumen T target position A1, A2, A3 anterior leaflet division P1, P2, P3 Posterior cusp division

Claims

1. a first member configured to be secured to an anterior side of the mitral valve; a first flexible tension member attached to the first member; a second member configured to be secured to an anterior side of the mitral valve; a second flexible tension member attached to the second member; and a third member configured to be secured to a posterior side of the mitral valve, the third member having a first attachment component configured to be slidably attached to the first flexible tensile member and a second attachment component configured to be slidably attached to the second flexible tensile member, the first and second attachment components allowing the third member to slidably advance over the first and second flexible tensile members when the third member is positioned from a catheter into the left atrium; a first lock movable between a sliding state and a locked state, the first lock configured to slide with the first flexible tension member to abut the first mounting component in the sliding state and to hold tension in the first flexible tension member in the locked state; a second lock movable between a sliding state and a locked state, the second lock configured to slide with the second flexible tension member to abut the second mounting component in the sliding state and to hold tension in the second flexible tension member in the locked state; An implantable annuloplasty system comprising:

2. 2. The implantable annuloplasty system of claim 1, wherein the first member is configured to be deployed from a catheter into the left atrium with the first flexible tension member pre-loaded thereon, and the second member is configured to be deployed from a catheter into the left atrium with the second flexible tension member pre-loaded thereon.

3. The implantable annuloplasty system of claim 1 , wherein each of the first and second mounting components comprises an eyelet.

4. The implantable annuloplasty system of claim 3 , wherein the eyelet is configured to rotate relative to the third member.

5. The implantable annuloplasty system of claim 1 , wherein the third member has an elongated shape and the first and second mounting components are disposed on opposing ends of the third member.

6. 2. The implantable annuloplasty system of claim 1, wherein each of the first, second, and third members comprises at least one anchor attachment point configured to be releasably attached to an anchor lead, the anchor attachment points being configured to swivel and spin relative to the first, second, and third members such that the anchor lead lies flat against the members when the members are deployed from a catheter.

7. 7. The implantable annuloplasty system of claim 6, wherein each of the attachment points comprises a lead nut configured to threadably engage one of the anchor leads, the lead nut being attached to a connecting rod that is pivotally attached to a crossbar, the crossbar bridging a central hoop that is rotatably attached to the first, second, or third member.

8. 7. The implantable annuloplasty system of claim 6, wherein each of the first, second, and third members comprises at least one anchor configured to secure the member to underlying cardiac tissue, and each of the anchors is configured to be released from the driver head when one of the anchor leads is released from its anchor attachment point and withdrawn proximally from the anchor and attached driver head.

9. The implantable annuloplasty system of claim 8 , wherein each of said anchors comprises a cylindrical hook-shaped clasp configured to releasably mate with a mating clasp on one of said driver heads.

10. The implantable annuloplasty system of claim 1 , wherein each of the first and second flexible tensile members has a braided filament core, the braided filament core being covered or coated with a polymeric covering.

11. 2. The implantable annuloplasty system of claim 1, wherein each of the first and second flexible tensile members has a continuous braided filament core including ultra-high mechanical property polyethylene (UHMPE) fibers combined with polyethylene terephthalate (PET) fibers, the continuous braided filament core being covered with a polyvinylidene fluoride (PVDF) jacketing material.

12. The implantable annuloplasty system of claim 1 , wherein the first flexible tension member includes a color different from that of the second flexible tension member such that the first flexible tension member can be distinguished from the second flexible tension member by color during a surgical procedure.

13. a first member configured to be secured to an anterior side of the mitral valve; a first flexible tensioning member attached to the first member, the first member being configured to be deployed from the catheter into the left atrium with the first flexible tensioning member pre-attached; a second member configured to be secured to an anterior side of the mitral valve; a second flexible tensioning member attached to the second member, the second member configured to be deployed from the catheter into the left atrium with the second flexible tensioning member pre-attached; an elongate third member configured to be secured to a posterior side of the mitral valve, the third member having a first eyelet configured to slidably receive the first flexible tensile member and a second eyelet configured to slidably receive the second flexible tensile member, the first and second eyelets disposed on opposite ends of the third member and each configured to rotate relative to the third member, the first and second eyelets allowing the third member to slidably advance over the first and second flexible tensile members when the third member is positioned from a catheter into the left atrium; a first lock movable between a sliding state and a locked state, the first lock configured to slide with the first flexible tension member and abut the first eyelet when in the sliding state and to hold tension in the first flexible tension member when in the locked state; a second lock movable between a sliding state and a locked state, the second lock configured to slide with the second flexible tension member and abut the second eyelet when in the sliding state and to hold tension on the second flexible tension member when in the locked state; 1. An implantable annuloplasty system comprising: each of the first, second, and third members includes at least one anchor attachment point configured to be releasably attached to an anchor lead, the anchor attachment point configured to pivot and spin relative to the first, second, and third members such that the anchor lead lies flat against the members when the members are deployed from the catheter; each of said attachment points includes a lead nut configured to threadably engage one of said anchor leads, said lead nut being attached to a connecting rod pivotally mounted to a crossbar, said crossbar bridging a central hoop rotatably mounted to said first, second or third member; each of the first, second, and third members includes at least one anchor configured to secure the member to underlying cardiac tissue, each of the anchors configured to be released from the driver head when one of the anchor leads is released from its anchor attachment point and withdrawn proximally from the anchor and attached driver head; each of the anchors includes a cylindrical hook-shaped clasp configured to releasably mate with a mating clasp on one of the driver heads; each of the first and second flexible tensile members having a braided filament core, the braided filament core being surrounded or coated with a polymeric jacket; the first flexible tension member includes a color different from that of the second flexible tension member such that the first flexible tension member may be distinguished by color from the second flexible tension member during a surgical procedure. Implantable annuloplasty system.

14. 1. A method for performing annuloplasty surgery, comprising: Introducing a catheter into the left atrium of the heart; deploying a first member from the catheter; anchoring the first member to an anterior side of the mitral valve of the left atrium, the first member having a first flexible tension member attached thereto; deploying a second member from the catheter; anchoring the second member to the left atrium anterior to the mitral valve, the second member having a second flexible tension member attached thereto; disposing a third member from the catheter, the third member slidably advancing over the first and second flexible tension members; securing the third member to the left atrium posterior to the mitral valve; applying tension to the first and second tensioning members to draw the first and second members toward the third member, thereby further approximating the posterior and anterior sides of the mitral valve annulus; The method includes:

15. 15. The method of claim 14, wherein the first member is deployed from the catheter with the first flexible tension member pre-loaded and the second member is deployed from the catheter with the second flexible tension member pre-loaded.

16. 15. The method of claim 14, wherein the step of applying tension to the first and second tension members includes placing a first lock on the first tension member and placing a second lock on the second tension member.

17. 15. The method of claim 14, further comprising the steps of severing the first tension member proximal to the first lock and severing the second tension member proximal to the second lock.

18. The method of claim 14 , wherein the step of applying tension to the first and second tension members comprises applying tension independently to two separate tension members.

19. The method of claim 14 , wherein the first member is secured to an inside of the mitral valve and the second member is secured to an outside of the mitral valve.

20. 20. The method of claim 19, wherein the first member has at least one anchor adjacent the inner triangle and the second member has at least one anchor adjacent the outer triangle.

21. 20. The method of claim 19, wherein at least one of the steps of securing the first member and the second member includes attaching at least two separate anchors by screwing separate anchors into the mitral valve annulus.

22. 20. The method of claim 19, wherein the dimensional reduction of the mitral annulus in the anterior-posterior direction can be different on the lateral side than on the medial side.

23. 15. The method of claim 14, wherein the third member has an elongated shape, the method further comprising rotating the elongated third member to a desired position prior to fixation to the posterior side of the mitral valve annulus.

24. 15. The method of claim 14, wherein each of the first member, the second member, and the third member is deployed from the catheter with at least one anchor lead attached thereto.

25. a first member configured to be secured to a first side of the heart valve; a second member configured to be secured to an opposite side of the heart valve; a flexible tensile member bridging the first and second members, the flexible tensile member having a continuous braided filament core including ultra-high mechanical property polyethylene (UHMPE) fibers combined with polyethylene terephthalate (PET) fibers, the continuous braided filament core being coated with a polyvinylidene fluoride (PVDF) jacket; An implantable cardiac therapy system comprising:

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