Annular formation systems and methods

Abstract

One exemplary method of performing an annuloplasty procedure includes introducing a catheter into the left atrium of the heart, deploying a first member from the catheter, anchoring the first member to a posterior side of the mitral valve annulus in the left atrium, deploying a second member from the catheter, anchoring the second member to an anterior side of the mitral valve annulus in the left atrium, deploying a flexible tensioning member from the catheter, attaching the tensioning member to both the first and second members, and tensioning the tensioning member to draw the first and second members toward each other and approximate the posterior and anterior sides of the mitral valve annulus. Annuloplasty systems and components are also disclosed.

Description

[Technical field]

[0001] Literature citations 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.

[0002] FIELD OF THE DISCLOSURE Embodiments of the present disclosure relate generally to implantable medical devices. In particular, some embodiments of the present invention relate to apparatus and methods for repairing a mitral valve. [Background technology]

[0003] The mitral valve is located at the junction of the left atrium and left ventricle of the heart. The mitral valve opens during diastole, allowing blood to flow from the left atrium to the left ventricle. During systole, when the left ventricle pumps blood through the aorta to the body, the mitral valve closes to prevent blood from flowing back into the left atrium. The mitral valve consists of two leaflets, the posterior and anterior leaflets, which are located in the mitral annulus. The mitral annulus is a ring that forms the junction of the left atrium and left ventricle. The mitral valve leaflets are attached to the papillary muscles of the left ventricle by chordae tendineae. The chordae tendineae prevent the mitral valve leaflets from deflecting into the left atrium during systole.

[0004] Mitral regurgitation is a condition in which the mitral valve does not close completely, allowing blood to flow backward from the left ventricle into the left atrium. In some cases, regurgitation is due to dilatation of the mitral annulus, specifically due to an increase in the anterior-posterior diameter of the mitral annulus. Alternatively or additionally, mitral regurgitation is due to dilatation of the left ventricle, which may be due to, for example, an infarction. When the left ventricle dilates, the papillary muscles constantly pull the mitral valve leaflets into an open configuration with their chordae tendineae.

[0005] Methods and devices exist in the prior art to treat mitral regurgitation. They include replacing or repairing the mitral valve. Valve replacement is typically performed transapically or transseptally. Valve repair typically falls into one of four categories: leaflet clip, direct annuloplasty, indirect annuloplasty, or chordal repair. Both direct and indirect annuloplasty involve reshaping the patient's mitral annulus and / or left ventricle so that the anterior and posterior leaflets are properly coapted. In some applications of annuloplasty, a ring is implanted near (e.g., above or behind) the mitral annulus. The purpose of the ring is to reduce the circumference of the mitral annulus.

[0006] In light of the above prior art, it would be desirable to provide improved systems and methods for treating mitral regurgitation. Summary of the Invention [Problem to be solved by the invention]

[0007] The present invention has been made to solve the problems in the conventional techniques described above. [Means for solving the problem]

[0008] According to aspects of the present disclosure, systems and methods for performing an annuloplasty procedure are provided. In some embodiments, a method includes introducing a catheter into a left atrium of a heart, deploying a first member from the catheter, anchoring the first member to a posterior side of a mitral valve annulus in the left atrium, deploying a second member from the catheter, anchoring the second member to an anterior side of the mitral valve annulus in the left atrium, deploying a flexible tensioning member from the catheter, attaching the tensioning member to both the first and second members, and tensioning the tensioning member to draw the first and second members toward each other and approximate the posterior and anterior sides of the mitral valve annulus.

[0009] In some embodiments, a method of performing an annuloplasty procedure includes introducing a catheter into a left atrium of the heart and deploying a first member from the catheter. The first member is anchored to a posterior side of the mitral valve annulus in the left atrium. A second member is deployed from the catheter and anchored to an anterior side of the mitral valve annulus in the left atrium. A flexible tensioning member is deployed from the catheter and attached to both the first and second members. A tensioning force is applied to the tensioning member to draw the first and second members toward each other, approximating the posterior and anterior sides of the mitral valve annulus.

[0010] In some embodiments, the second member is deployed and anchored separately from the first member. The step of anchoring the first member may include screwing and attaching at least two separate anchors to the annulus. The method may further include deploying a separate third member from the catheter, anchoring the third member to the anterior side of the mitral annulus in the left atrium, attaching a tensioning member to both the first member and the third member, and tensioning the tensioning member attached between the first member and the third member to approximate the posterior and anterior sides of the mitral annulus. In some embodiments, the third member is deployed and anchored separately from the first member and the second member. The tensioning member attached between the first member and the second member and the tensioning member attached between the first member and the third member may be two separate tensioning members. In some embodiments, the two separate tensioning members are tensioned separately.

[0011] In some embodiments, the second member is anchored toward the lateral side of the mitral annulus and the third member is anchored toward the medial side of the mitral annulus. The second member may have at least one anchor proximate the lateral trigon and the third member may have at least one anchor proximate the medial trigon. In some embodiments, at least one of the steps of anchoring the second member and anchoring the third member includes threadedly attaching at least two separate anchors to the annulus. In some embodiments, the anterior-posterior dimension of the mitral annulus may be different on the lateral side and the medial side.

[0012] In some embodiments, the tensioning member is not attached to either the first or second member until it is deployed from the catheter in vivo. In some embodiments, the separate tensioning members are not attached to either the first, second, or third member until it is deployed from the catheter in vivo. The tensioning member is pre-attached to at least one of the first and second members before the first or second member is deployed from the catheter. In some embodiments, the first member includes a protruding feature configured to engage the tensioning member. In some embodiments, the second member includes a protruding feature configured to engage the tensioning member. Deploying the flexible tensioning member from the catheter may include capturing the first and second members with the tensioning member one at a time. In some embodiments, the first member has an elongated shape, and the method further includes rotating the elongated first member to a desired position to anchor it behind the mitral valve annulus. Two or more leads may be attached to the elongated first member during the rotating step.

[0013] In some embodiments, the annuloplasty system includes a first member, at least one first member anchor, a second member, at least one second member anchor, and a first flexible tension member. The at least one first member anchor is configured to anchor the first member to a posterior side of the mitral valve annulus in the left atrium of the heart. The at least one second member anchor is configured to anchor the second member to an anterior side of the mitral valve annulus in the left atrium. The first flexible tension member is configured to span between the first member and the second member such that tension can be applied to the first flexible tension member to draw the first member and the second member toward each other and approximate the posterior and anterior sides of the mitral valve annulus. All of the elements of the annuloplasty system are configured to be deployed through a catheter into the left atrium.

[0014] In some embodiments, the first member is elongated and capable of assuming a curved shape. The first member may include a series of slits that allow the first member to flex. In some embodiments, the annuloplasty system further includes a third member and at least one third member anchor configured to anchor the third member to the anterior side of the mitral annulus of the left atrium. The annuloplasty system may further include a second flexible tensioning member configured to span between the first and third members such that tension can be applied to the second flexible tensioning member to draw the first and third members toward each other and approximate the posterior and anterior sides of the mitral annulus. In some embodiments, the first member includes at least two protruding features, each protruding feature configured to engage either the first tensioning member or the second tensioning member.

[0015] 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, and the accompanying drawings, in which: [Brief description of the drawings]

[0016] [Figure 1]FIG. 1 shows an approximately cranial to caudal view 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 one exemplary method of performing an annuloplasty procedure in accordance with aspects of the present disclosure. [Diagram 5] ~ [Figure 22] 5A-5C are a series of perspective views showing the steps of the exemplary method outlined in FIG. 4, looking generally caudally at the mitral valve through the left atrium. [Figure 23] ~ [Figure 33B] FIG. 13 is a perspective view showing another example of a rear bar and snare feature. [Diagram 34] ~ [Figure 37] FIG. 13 is a perspective view showing another example of a front pad. [Figure 38] ~ [Diagram 40] FIG. 13 is a side view of another example of a helical tissue anchor. [Diagram 41] ~ [Diagram 44] FIG. 13 is a top view illustrating another exemplary embodiment of an annuloplasty system constructed in accordance with aspects of the present disclosure. [Diagram 45] ~ [Figure 51] FIG. 13 is a perspective view showing an exemplary embodiment of a rear bar torque control. [Figure 52] ~ [Diagram 53] FIG. 1 illustrates a perspective view of an exemplary embodiment of a collapsible implant. [Figure 54] ~ [Figure 55] FIG. 13 is a top view of another example of a tension member snare. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0017] 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 trigon (sometimes referred to as the left side), and a medial trigon (sometimes referred to as the right side). 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.

[0018] Referring to FIG. 2, an exemplary posterior bar 210 constructed in accordance with aspects of the present disclosure is shown. The posterior bar 210 is configured to be implanted in the left atrium at or near the mitral annulus adjacent to the posterior leaflet, as will be described in more detail below. Thus, in this exemplary embodiment, the posterior bar 210 is an elongated tubular structure that is curved to match the anatomy of the mitral annulus at this location. The posterior bar 210 may be given a low profile as shown to minimize the amount of irregular structure within the atrium that may be a breeding ground for thrombosis. In this exemplary embodiment, the posterior bar 210 is given an atraumatic edge to limit the possibility of tissue damage and is covered with a polyethylene terephthalate (PET) fabric to support tissue ingrowth.

[0019] In this exemplary embodiment, the rear bar 210 is provided with a central tissue anchor guide 212 and two end tissue anchor guides 214. In some embodiments, the central tissue anchor guide 212 is identical to the end tissue anchor guides 214, while in other embodiments, the central tissue anchor guide 212 is configured differently, for example with features that facilitate steering / torquing of the rear bar 210 during delivery. In some embodiments, as described later in this specification, there may be no central tissue anchor guide, and the number of tissue anchor guides may be more or less than the three provided in this exemplary embodiment. The anchor guides 212 and 214 may be configured to pivot relative to the rear bar 210 to allow movement from the stored and deployed states. In the stored state, the anchor guides 212 and 214 may extend approximately parallel to the bar 210 so that they and the bar 210 can pass together through the lumen of the catheter. In the deployed state, anchor guides 212 and 214 may extend approximately perpendicular to bar 210, as shown in FIG. 2, such that they may be used to secure bar 210 to tissue by passing tissue anchors over the guides, through apertures in bar 210, and into adjacent tissue.

[0020] One or more snare features 216 may be provided on the rear bar 210. In this exemplary embodiment, two snare features 216 are provided, one near each end of the rear bar 210. The snare features 216 may be configured to protrude significantly from the rear bar 210 to allow for easy engagement with one or more tensioning members / snares and may be configured to prevent the tensioning members from disengaging during manipulation. In some embodiments, the snare features 216 are configured to be easily imaged under fluoroscopy and echocardiography to aid in positioning the rear bar 210 during delivery and attachment to tissue, and to aid in connecting tensioning members to the snare features 216.

[0021] The posterior bar 210 may be designed to preferentially load the anchors in shear rather than tension with respect to the anatomy. Torque control features may be provided to allow for initial positioning of the posterior bar 210 and to allow the implant to move as subsequent anchors are delivered to conform to the anatomy.

[0022] The posterior bar 210 may also be provided with some flexibility to allow for in vivo adjustment of the bar to contour to a particular patient's anatomy. The flexibility of the posterior bar 210 may also serve to allow the bar to flex during the cardiac cycle. In some embodiments, flexibility of the posterior bar 210 is achieved by providing a series of slits (not shown in FIG. 1 ) that traverse the longitudinal axis of the bar. In some embodiments, the slits and / or other flexibility-imparting features may be configured to limit the minimum radius of the posterior bar 210 at implantation so that tension on the posterior side of the mitral annulus is more uniform.

[0023] Referring to FIG. 3, an exemplary anterior pad 310 constructed in accordance with aspects of the present disclosure is shown. The anterior pad 310 is configured to be implanted in the left atrium at or near the mitral annulus adjacent the anterior leaflet (specifically in the trigones), as will be described in more detail below. In this exemplary embodiment, the anterior pad 310 is a generally flat structure with four petals 312 radiating from a central portion. In other embodiments, the number of petals may be greater than four, less than four, or even zero. A primary tissue anchor 314 may be located at the center of the anterior pad 310. In some embodiments, additional tissue anchors 316 may be provided, as shown, for example, near the center of each petal 312. In some embodiments, the primary tissue anchor 314 is identical to the additional tissue anchor 316, while in other embodiments the primary tissue anchor 314 is configured differently, for example with features that facilitate positioning of the front pad 310 during delivery. The petals 312 may be designed to fold into a compact shape to allow the front pad 310 to be delivered through a catheter.

[0024] The anterior pad 310 may be given a low profile as shown to minimize the amount of irregular structure within the atrium that may harbor thrombosis. In this exemplary embodiment, the anterior pad 310 is given an atraumatic edge to limit the potential for tissue damage and is covered with a polyethylene terephthalate (PET) fabric to support tissue ingrowth.

[0025] One or more snare features may be provided on the forward pad 310. In this exemplary embodiment, the top ends of the tissue anchors 314 and 316 are configured to engage one or more tension members / snares. These snare features may be configured to protrude significantly from the forward pad 310 to allow easy engagement with one or more tension members / snares and may be configured to prevent the tension members from disengaging during manipulation. In some embodiments, the snare features and / or the entire forward pad 310 are configured to be easily imaged under fluoroscopy and echocardiography to aid in positioning the forward pad 310 during delivery and attachment to tissue and to aid in connecting the tension members to the snare features. The forward pad 310 may be designed with respect to the anatomy to preferentially load the anchors with shear rather than tension loads.

[0026] Referring to FIG. 4, an exemplary method of performing an annuloplasty procedure according to aspects of the present disclosure is shown. The steps of the exemplary method 410 are described with reference to the flow chart shown in FIG. 4 and the sequence of images shown in FIGS. 5-22. In each of the images shown in FIGS. 5-22, the line of sight is generally caudal, with the medial direction generally to the right, through the left atrium 510 toward the mitral valve 512. In some embodiments of the method, one posterior bar 210 and one, two, or more anterior pads 310 are implanted. In other embodiments, different types or numbers of devices may be used. In FIGS. 5-22, the fabric covering of the posterior bar 210 has been omitted 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.

[0027] In some embodiments of method 410, the first step 412 of the method is to introduce the distal end of a delivery catheter into the patient's left atrium 510. This may be performed via a transseptal approach, a left atrial approach, or other methods of gaining access to the left atrium. A transseptal approach is depicted in the images shown in Figures 5-22, in which the distal end of catheter 514 penetrates the septum 516 of the heart to enter the patient's left atrium 510. In some embodiments, an internal dilator (not shown) is located at the distal end of catheter 514 for crossing the septum.

[0028] 4 and 5, after 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 embodiments, the catheter 514 is first introduced into the left atrium 510 and then the rear bar assembly is loaded onto the proximal end of the catheter 514. In other embodiments, the rear bar 210, along with its tissue anchor guides 212, 214 and snare feature 216, may be preloaded onto a catheter (not shown) and advanced within the catheter 514. As seen in FIG. 5, anchor leads 518 may be removably attached to each of the tissue anchor guides 212 and 214 to push the rear bar 210 through the catheter 514 and deploy it from the distal end.

[0029] 6, once the rear bar 210 emerges from the distal end of the catheter 514, the lead 518 attached to one end of the rear bar 210 may be pushed from the proximal end of the catheter 514 and the lead 518 attached to the other end may be pulled to pivot the rear bar 210 to an orientation approximately perpendicular to the catheter 514, as shown. The steerable inner catheter 520 may be slid distally over the central lead 518 until features (e.g., recesses and / or castellations (not shown)) engage mating features on the rear bar 210 to prevent the bar 210 from rotating relative to the inner catheter 520. The steerable inner catheter 520 may then be used to position and rotate the rear bar 210 until it is steered to its desired implantation location and orientation, as shown in FIG. 7. In some embodiments, a torque driver may be used that is coaxially positioned between the lead 518 and the steerable inner catheter 520 to apply a torque to the rear bar 210. Such an embodiment is described below with respect to Figures 40-46.

[0030] 4 and 8-11, step 416 of the exemplary method 410 will be described. In this step, the posterior bar 210 (i.e., the first member) is anchored to the posterior side of the mitral valve 512. To accomplish this, first, as shown in FIG. 8, a drive tube 522 having a helical tissue anchor 524 at its distal end may be slid over a lead 518 attached to a tissue anchor guide 214 located 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 valve annulus tissue, the drive tube 522 may be rotated to thread the inner anchor 522 through the posterior bar 210 and into the underlying tissue. Next, as shown in FIG 9, the drive tube 522 may be removed from the inner anchor 214, and the drive tube 522 (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 located near the outer end of the posterior bar 210. While the inner anchor 524 and the steerable inner catheter 520 (and in some embodiments, a torque driver inside the catheter 520) hold the posterior bar 210 against the mitral annulus tissue, the drive tube 522 may be rotated to thread the outer tissue anchor 524 through the bar 210 and into the underlying tissue, as seen in FIG 10. Next, as shown in FIG 11, the drive tube 522 may be removed from the outer anchor 524, and the drive tube 522 (or another drive tube 522 with another helical tissue anchor 524) may be slid over the lead 518 attached to the central tissue anchor guide 212. In some embodiments, the steerable inner catheter 520 may remain in position holding down the rear bar 210 while the central anchor is in place (as shown in FIG. 10), or the steerable inner catheter 520 may be removed from the rear bar 210 and then the drive tube 522 and central anchor 524 may be slid over and engaged over the central tissue anchor guide 212 (as shown in FIG. 11).While the inner and outer anchors 524 hold the posterior bar 210 against the mitral valve annulus tissue, the drive tube 522 may be rotated to thread the central anchor 524 through the bar 210 and into the underlying tissue. Figures 10 and 11 show the posterior bar 210 with the leads removed, such as by unscrewing, from the end tissue anchor guides.

[0031] At step 416, it is notable that after the initial anchor is placed, torque control of the implant 210 performed by the steerable inner catheter 520 (or in some embodiments, a torque driver located within the catheter 520) can guide the placement of subsequent anchors in the implant 210. This eliminates the need for unguided placement of anchors after the initial anchor is placed. Figure 12 shows the posterior bar 210 with three anchors placed and all leads removed.

[0032] 4 and 12, step 418 of the exemplary method 410 will be described. In this step, the anterior pad 310 (sometimes referred to herein as the second member) is deployed from the distal end of the catheter 514. In some embodiments, the anterior pad 310 is steered toward the lateral triangle by a steerable inner catheter 520, as shown in FIG. 12 (the lateral triangle is also shown in FIG. 1).

[0033] 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 a second member) is anchored to the anterior side of the mitral valve 512. In some embodiments, the anterior pad 310 is anchored to the lateral trigon with a single anchor 314 as shown. The anchor 314 may be screwed into place using a drive tube (not shown) within the steerable inner catheter 520. One or more additional anchors 316 may be used to further secure the anterior pad 310 to the lateral trigon, as shown in FIG.

[0034] At step 420, it should be noted that after the initial anchor is placed, the lead may remain in place through the steerable inner catheter 520, such that the lead and catheter 520 can be used to guide the placement of subsequent anchors in the implant 310. This eliminates the need for unguided placement of anchors after the initial anchor is placed.

[0035] 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 deployed from the distal end of a catheter 514. In some embodiments, the anterior pad 310 is steered toward the medial trigon by a steerable inner catheter 520, as shown in FIG. 14 (the medial triangle is also shown in FIG. 1). The anterior pad 310 may then be anchored to the anterior side of the mitral valve 512. In some embodiments, the anterior pad 310 is secured to the medial trigon with a single anchor 314 as shown. 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, one or more additional anchors may be used to further secure the medial anterior pad 310 to the medial trigon.

[0036] At step 424, it should be noted that after the initial anchor is placed, the lead may remain in place through the steerable inner catheter 520, such that the lead and catheter 520 can be used to guide the placement of subsequent anchors in the implant 310. This eliminates the need for unguided placement of anchors after the initial anchor is placed.

[0037] 4 and 15, step 426 of the exemplary method 410 will be described. In this step, as shown, a first tensioning member or snare 526 is deployed from the distal end of the catheter 514 through the steerable inner catheter 520. A snare sheath 528 may be used to direct the first tensioning member 526 toward the implant feature. The snare sheath 528 may also be used to tighten the tensioning member 526 around the implant feature by drawing the first tensioning member 526 proximally out of the sheath 528.

[0038] 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 anterior pad 310 (i.e., second member). As shown in FIG. 16, a steerable inner catheter 520 and a snare sheath 528 may be utilized to guide the first tensioning member 526 over the outer snare feature 216 of the bar 210. The first tensioning member 526 may then be guided over the primary tissue anchor 314 of the anterior pad 310, as shown in FIG. 17. A small amount of tension may then be applied to the first tensioning member 526 by the snare sheath 528 to maintain engagement of the first tensioning member 526 with the bar 210 and pad 310, as shown in FIG. 18.

[0039] 4 and 19, step 430 of the exemplary method 410 will be described. In this step, as shown, a second tensioning member or snare 530 is deployed from the distal end of the catheter 514 through the steerable inner catheter 520. A snare sheath 532 may be used to direct the second tensioning member 530 toward the implant feature. The snare sheath 532 may also be used to tighten the tensioning member 530 around the implant feature by drawing the second tensioning member 530 proximally out of the sheath 532.

[0040] 4 and 20-22, step 432 of the exemplary method 410 is described. In this step, a second tensioning member or snare 530 is attached to the posterior bar 210 (i.e., the first member) and adjacent 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 tensioning member 530 over the inner snare feature 216 of the bar 210. The second tensioning member 530 may then be guided over the primary tissue anchor 314 of the anterior pad 310, as shown in FIG. 21. The second tensioning member 530 may then be slightly tensioned by the snare sheath 532 to maintain engagement of the second tensioning member 530 with the bar 210 and pad 310, as shown in FIG. 22. In some embodiments, the snare shape may be configured to more easily engage a snare feature on 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 and cinch the snare to the annulus, but not necessarily to guide the snare to each snare feature. In some embodiments, the snare is dumbbell-shaped (or dog-bone-shaped), such as the exemplary snare 550 shown in FIG. 54. The snare 550 has a distal loop 552 and a proximal loop 554 with predefined diameters, and the rest of the snare has substantially parallel tension members with a gap between the tension members smaller than the loop diameter. The distal loop 552 may be exposed first to engage a first snare feature on the implant, and then the proximal loop 554 may be exposed to capture a second snare feature on the implant. In some embodiments, as shown in FIG. 55, two snares 560 and 562 are loaded in parallel, each with a predefined shape. The individual snares 560 and 562 may be connected by a coupler 564 and can be slid independently of one another to separately engage snare features on the implant.

[0041] Once both the first tensioning member 526 and the second tensioning member 530 are in place, further tension may be applied to both to pull the anterior and posterior sides of the mitral valve 512 closer together. In some embodiments, the tension on members 526 and 530 may be increased simultaneously. In some embodiments, the tension on members 526 and 530 may be increased in increments in alternation until the desired tension and / or valve approximation is reached. In some embodiments, the final tension and / or tissue approximation of each tensioning member 526 and 530 is approximately the same. In some embodiments, the final tension and / or tissue approximation of each tensioning member 526 and 530 is different. This is because the inner and outer cinching may be performed independently of each other, allowing for greater differences in how each bar is placed. This is generally true for all of the systems disclosed herein. In some embodiments, a real-time echocardiogram of the mitral valve is performed to monitor the reduction in mitral regurgitation as tensioning members 526 and 530 are cinched.

[0042] Once the desired tension and / or tissue approximation is achieved, tensioning members 526 and 530 may be tied off. In some embodiments, a reversible lock configured to permanently hold the position of the tensioning members during the cinching process may be used. A detachment member may be used to detach the snare from the delivery system, or a portion of the tensioning member may be cut and released. Catheter 514 may then be withdrawn from the left atrium along with steerable inner catheter 520 and snare sheaths 528 and 532 (step 436 shown in FIG. 4). In addition to tensioning the devices during the de novo procedure, additional tensioning devices may be added later and / or tension of existing devices may be readjusted to further shorten the AP dimension.

[0043] Referring to Figures 23-33B, another example of a rear bar and snare feature is shown. The rear bar shown in Figure 23 is similar to bar 210 already described, but has four tissue anchors and no central anchor. In addition, it has a snare feature in the form of a hook at each end.

[0044] 24 shows a boomerang shaped posterior bar with five tissue anchors, the center anchor being larger than the other four and used to torque the implant. In this embodiment, the anchors may be used as snare features. In some embodiments (not shown), the bar shape has a compound radius of curvature that gets tighter the further the bar extends away from the posterior side to match the curvature of the annulus.

[0045] The rear bar shown in Figure 25 has no fabric covering. There are three apertures with a cross bar spanning each aperture for pivotally attaching a tissue anchor guide similar to the apertures in rear bar 210. As shown, hook-like slots may be provided at each end for capturing a snare. The tubes may be laser cut with interlocking shapes as shown to allow the bar to have flexibility with a limited amount of bending and stretching.

[0046] Figure 26 shows a low profile posterior bar molded from laser cut sheet. This implant provides similar functionality to the bar of Figure 23 and has a central torque control feature. A similar implant (not shown) can be molded from wire. Such an implant can be very robust, can have spring-like flexibility, and can include a more pronounced snare feature.

[0047] FIG. 27 shows an implant similar to that shown in FIG. 26, both with and without a fabric covering.

[0048] 28 shows another similar implant 610 with a helical snare feature 612 on both ends, a lead nut tab 614 at each of five anchor locations 616, a torque control attachment 618, and a tab 620 configured to center a lead nut / anchor guide (not shown) at the central anchor location. The helical snare feature 612 can be raised against the face of the posterior bar 610 to allow easier engagement with the tension member. A tab at the tip of the helix can be provided to enhance visibility under fluoroscopy and echocardiography. The tab can be configured to help retain the tension member.

[0049] 29 shows a configuration with a recessed rear bar 630 and two front pads 632. The rear bar 630 includes a fabric covering, five anchors 634, and two snare features 636 that extend generally longitudinally from the fabric covering in opposing directions.

[0050] 30 shows two rear bars 640, one with a fabric covering and one without. The bar 640 includes five anchor locations 642 and a triangular overlapping truss configuration.

[0051] 31 shows two rear bars 650, one with a fabric covering and one without, Bar 650 includes two snare features 652 that extend in a generally radially inward direction and toward each other.

[0052] 32, 33A, and 33B show exemplary wire ends that can be used as snare features. In some embodiments, a ball at the tip of the snare feature may be configured to enhance visibility under fluoroscopy and echocardiography. The gap between the ball tip of the snare feature and the body of the implant may be configured such that the snare feature flexes slightly to allow the tension member to slide over the snare feature, which then recoils to hold the tension member on the snare feature.

[0053] In some embodiments, the posterior bar is curved to conform to the anatomy of the mitral annulus adjacent the posterior leaflet. The posterior bar may be configured to be low profile to minimize the amount of irregularities in the atrium that may harbor thrombosis.

[0054] With reference to Figures 34-37, further examples of anterior pads are shown. The anterior pad shown in Figure 34 is similar to pad 310 already shown, but has three petals. The anterior pad shown in Figure 35 has a central tower with three snare features attached to it. The circular pad shown in Figure 36 has no petals and has a stepped snare feature. The circular pad shown in Figure 37 has no petals and has a snare feature on top of a protruding tissue anchor.

[0055] In some embodiments, the anterior pad allows for targeted further anchoring after the primary anchor is placed. The anterior pad may be low profile to minimize the amount of irregularities in the atrium that may harbor thrombosis. The edges of the pad may be configured to be atraumatic to limit the potential for tissue damage. In some embodiments, the anterior pad is covered with PET fabric to support tissue ingrowth. The pad may be configured to preferentially load the anchor in shear over tension with respect to the anatomy. A prominent snare feature may be provided to prevent the snare from disengaging during manipulation of the implant. In some embodiments, the pad may be configured to be easily imaged under fluoroscopy and echocardiography.

[0056] In other embodiments (not shown), the location of the bar and pads may be reversed, with a bar placed on the anterior side of the mitral annulus and two pads placed on the posterior side. In some embodiments, the posterior element may be two separate pieces, one on the lateral side and one on the medial side, so there may be four pads around the valve and no bar. In some embodiments, one snare or tensioning member may be used to link and adjust all of the implanted components. Also, individual snares may be used to individually engage each snare feature, and two snares on each side (i.e., four snares total) may be tensioned together. Additionally, a separate tensioning member may be placed between the two triangular pads for further stabilization of the tissue as well as full circumferential engagement. Such a system, or any of the systems disclosed herein, may be used as an anchoring system during valve replacement.

[0057] 38-40, further examples of helical tissue anchors are shown. The anchor shown in FIG. 38 has a straight gapless interface feature located at the top of the anchor. This feature allows the anchor to spin freely within the implant once the anchor is inserted and traveled, eliminating any gaps between the implant and the tissue. An implant retention tab 660 may be located at the top of the straight section, allowing the coil to continue to drive into the tissue while the straight section spins freely within the implant until the implant makes intimate contact with the tissue. The anchor shown in FIG. 39 has a low profile head. The low profile of the anchor minimizes the amount of irregular structures within the atrium that may be a breeding ground for thrombosis. Each anchor in the pair of anchors shown in FIG. 40 is attached with a head for actuating the anchor. In some embodiments, the anchors are configured for strong attachment to tissue, configured for removal when needed, and configured for easy imaging under fluoroscopy and echocardiography.

[0058] 41-44, another exemplary embodiment constructed in accordance with aspects of the present disclosure is shown. In these embodiments, two structures or "bars" are placed on either side of the mitral annulus, one on the posterior side and one on the anterior side. The two inner ends of each bar are joined together and the two outer ends are joined together. The sides may then be brought closer together to shorten the AP dimension of the valve. This focuses the annular change in the AP direction. As shown, the cinching mechanism may be covered with PET material, which may form pleats as the implant is tightened. The two bars join together to form a complete "ring" structure. As shown in FIG. 41, the posterior bar may be curved to match the shape of the annulus. The anterior bar may be straighter, as it bridges the lateral and medial triangles. This is because the medial and lateral cinching may be performed independently of each other, allowing for greater variation in how each bar is placed. Again, this is generally true for all of the systems disclosed herein. As shown in Figures 42-44, one or more anchors may be placed on the sides of the ring.

[0059] An exemplary embodiment of torque control of the rear bar will now be described with reference to Figures 45-51. In this embodiment, a torque driver 710 is provided. The torque driver 710 includes a head 712 located at its distal end and a flexible shaft 714 attached to the head, the proximal end of which extends outside the patient's body to allow the surgeon to manipulate the head 712. As best seen in Figures 48 and 50, the torque driver 710, in use, resides coaxially between the central lead 518 and the steerable catheter 520. As best seen in Figure 45, the head 712 includes a transverse slot 716 configured to engage a central tab 718 of the rear bar 720. As best seen in FIG. 46, when the torque driver 710 is rotationally aligned and pushed distally against the rear bar 720, the slots 716 engage the tabs 718, allowing the torque driver 710 to precisely control the direction of rotation of the rear bar 720 even if rotational resistance is encountered. (For clarity, FIGS. 45 and 46 omit the fabric covering, lead nuts, leads, etc. of the rear bar 720.)

[0060] In some embodiments, the head 712 has a square cross-sectional shape as shown. In other embodiments (not shown), the cross-sectional shape of the torque driver head may be circular or other shapes. In some embodiments, the outer dimensions of the head 712 are sized to fit snugly inside a mating feature on the rear bar 720 (e.g., a ring as shown in FIG. 46) to restrict lateral movement of the head 712 relative to the bar 720. In other embodiments (not shown), other centering features may be provided to restrict lateral movement.

[0061] 47-51 show one exemplary method of using the torque driver 710. The rear bar 722 shown in FIG. 47 has been deployed from the outer guide or catheter 514. The torque driver 710 shown in FIG. 48 is advanced through the inner steerable sheath 520 (not visible in FIG. 48) and over the central lead 518. The torque driver 710 shown in FIG. 49 is engaged with the rear bar 722 as described above. In some embodiments, the surgeon applies tension by pulling back on the central lead 518 while holding the torque driver 710 in place. Once the torque driver 710 engages the center of the bar 722, the position of the torque driver 710 may be locked to the rear (proximal) end of the inner steerable catheter 520. In FIG. 50, the torque driver 710 is now securely locked to the bar 722. The inner steerable catheter 520 is shown ahead of the outer guide 514. The inner steerable catheter 520, shown in Figure 51, has been advanced over the torque driver until it reaches the bar 722. At this point the rear bar 722 can be steered into position by the torque driver 710 and / or the steerable catheter 520.

[0062] 52 and 53, another exemplary embodiment is shown in which a foldable rear bar is provided. The foldable bar 810 may be configured to aid in loading the device into a catheter (not shown) and to facilitate manipulation within the left atrium. In this exemplary embodiment, the rear bar 810 includes three separate sections: a central section 814, a right section 816, and a left section 818. The right section 816 and the left section 818 are each hinged to either side of the central section 814, as shown. In this embodiment, the right section 816 and the left section 818 may each rotate between a stored position (as shown) and a deployed position (not shown), and the right section 816 and the left section 818 are each approximately coplanar with the central section 814. One or more leads 820 may be coupled to each of the right section 816 and the left section 818 to aid in unfolding the folded sections. Each section 816 and 818 may rotate through approximately 90 degrees when moving between the stowed and deployed positions. In some embodiments, the right section 816 and the left section 818 may be configured to be locked in the open position after deployment. In other embodiments (not shown), only two sections may be provided, or four or more sections may be provided that fold relative to one another.

[0063] As with the previous embodiment, five anchors 822 may be provided on the rear bar 810, one for the central section 814, two for the right section 816, and two for the left section 818. In some embodiments, the central anchor may be placed first (whether the side sections 816 and / or 818 are in a stowed or deployed state), while in other embodiments the side anchors may be placed first. As with the previous embodiment, a torque driver, steerable sheath 812, or a combination thereof may be provided to assist in maneuvering the device to the desired implantation site.

[0064] In some embodiments, the systems and methods disclosed herein, or portions thereof, may be utilized with any atrioventricular valve as well.

[0065] Advantages provided by the systems and methods disclosed herein include: A more direct reduction in the anterior-posterior (AP) direction can be achieved. This can be achieved with less cinching force since it acts directly in the AP direction, rather than the larger forces typically required for circumferential reshaping. Typically, less cinching force requires fewer anchors. The systems and methods also allow a high level of customization to fit a particular anatomy. This is related to the independent placement of the different components and the ability to adjust medially and laterally separately. Each component being independent makes each easier to implant than a single superstructure. The systems and methods allow for in vivo adjustments, reducing the precision required for placement of each component and simplifying the implantation procedure. A smaller number of implant sizes and configurations can be accommodated. In addition to tensioning the device during the de novo procedure, additional tensioning devices may be added later and / or tensioning of existing devices may be readjusted to further shorten the AP dimension.

[0066] In this specification, when a feature or element is referred to as being "on" another feature or element, the feature or element may be directly adjacent to the other feature or element, or there may be intervening features and / or elements. In contrast, when a feature or element is referred to as being "directly on" another feature or element, there are no intervening features and / or elements. It should also be understood that when a feature or element is referred to as being "connected," "attached," or "coupled" to another feature or element, the feature or element may be directly connected, attached, or coupled to the other feature or element, or there may be intervening features or elements. In contrast, when a feature or element is referred to as being "directly connected," "directly attached," or "directly coupled" to another feature or element, there are no intervening features or elements. Features and elements so described or illustrated may be described or illustrated with respect to one embodiment, but may also apply to other embodiments. Also, as will be understood by those skilled in the art, when a structure or feature is referred to as being "adjacent" to another feature, the reference may include portions that overlap or underlie the adjacent feature.

[0067] The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the disclosure. For example, the singular forms "a," "an," and "the" as used herein are intended to include the plural forms as well, unless the context clearly contradicts otherwise. It is further understood that the words "comprises" and / or "comprising," as used herein, specify the presence of stated features, steps, operations, elements, and / or components, and do not exclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and / or groups thereof. As used herein, the term "and / or" includes any combination of one or more of the associated listed items and may be abbreviated as " / ."

[0068] Spatially relative terms such as "under," "below," "lower," "over," "upper," and the like may be used herein for ease of description when describing the relationship of one element or feature to another element or feature as depicted in the figures. It should be understood that these spatially relative terms are intended to encompass other 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 being "under" or "beneath" another element or feature would be oriented "over" that other element or feature. Thus, for example, the term "under" may encompass both an orientation of "over" and "under." The device may be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly. Similarly, terms such as "upwardly," "downwardly," "vertical," "horizontal," etc. are used herein for descriptive purposes only, unless otherwise specified.

[0069] The terms "first" and "second" may be used herein to describe various features / elements (including steps), but these features / elements should not be limited by these terms unless the context indicates otherwise. These terms may be used to distinguish one feature / element from another. Thus, a first feature / element may be referred to as a second feature / element below, and similarly, a second feature / element may be referred to as a first feature / element below, without departing from the teachings of the present disclosure.

[0070] Throughout this specification and the claims that follow, unless otherwise stated, the term "comprise" and its variations "comprises," "comprising," and the like, mean that various components may be used in conjunction with one another in methods and articles (e.g., devices and method-containing compositions and apparatus). For example, the word "comprising" should be understood to imply the inclusion of all stated elements or steps, but not the exclusion of any other elements or steps.

[0071] As used in the present specification and claims, including in the examples, and unless otherwise specified, any numerical value may be read as if it is preceded by the word "about" or "approximately", even if the word is not explicitly present. The words "about", "approximately", or "generally", when describing a size and / or location, may be used to indicate that the stated value and / or location falls within a reasonable expected range of values ​​and / or locations. For example, a numerical value may be ±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), or other such values. Any numerical value given herein should be understood to encompass the approximate values ​​before and after that value, unless the context contradicts. For example, if the value "10" is disclosed, "about 10" is also disclosed. Any numerical range described herein is intended to encompass all subranges encompassed therein. It should also be understood that when a value is disclosed, values ​​"less than" that value, values ​​"greater than" that value, and possible ranges therebetween, as would be properly understood by one of ordinary skill in the art. For example, when a value "X" is disclosed, values ​​"less than" X and values ​​"greater than or equal to X" (e.g., where X is a number) are also disclosed. It should also be understood that throughout this application, data is provided in several different formats, and that this data represents endpoints and starting points, with ranges covering any combination of these data points. For example, if a specific data point "10" and a specific data point "15" are disclosed, values ​​between 10 and 15 are considered to be disclosed, as well as values ​​greater than, equal to, less than, less than, and equal to 10 and 15. It is also understood that each number between the two specific numbers is also disclosed.For example, if 10 and 15 are disclosed, then 11, 12, 13, and 14 are also disclosed.

[0072] Although various exemplary embodiments have been described above, any of a number of modifications may be made to the various embodiments without departing from the scope of the invention as set forth in the claims. For example, the order in which the various method steps described are performed may often be changed in alternative embodiments, and in some alternative embodiments, one or more method steps may be skipped altogether. Optional features of the various embodiments of the apparatus and systems may be included in some embodiments and not included in other embodiments. Thus, the above description is primarily for illustrative purposes and should not be construed as limiting the scope of the invention as set forth in the claims.

[0073] The examples and specific examples contained herein are illustrative, not limiting, of specific embodiments in which the subject matter may be practiced. As noted, other embodiments may be utilized or derived, and structural or logical substitutions or changes may be made without departing from the scope of the present disclosure. Such embodiments of the subject matter may be referred to individually herein or collectively under the term "the present invention," which is merely for convenience and is not intended to spontaneously limit the scope of the present application to any one invention or inventive concept, even if more than one is actually disclosed. Thus, although specific embodiments have been shown and described herein, the specific embodiments shown may be substituted with any configuration designed to achieve the same purpose. The present disclosure is intended to encompass any adaptations or variations of the various embodiments. Combinations of the above-described embodiments, as well as other embodiments not specifically described herein, will become apparent to those skilled in the art upon review of the above description. [Appendix 1] 1. A method of performing an annuloplasty procedure, comprising: introducing a catheter into the left atrium of the heart; deploying a first member from the catheter; anchoring the first member posterior to the mitral valve annulus of the left atrium; deploying a second member from the catheter; anchoring the second member to the left atrium anterior to the mitral valve annulus; deploying a flexible tension member from the catheter; attaching the tension member to both the first member and the second member; applying tension to the tensioning member to draw the first and second members toward one another and approximate the posterior and anterior sides of the mitral valve annulus; The method includes: [Appendix 2] 2. The method of claim 1, wherein the second member is deployed and anchored separately from the first member. [Appendix 3] 2. The method of claim 1, wherein the step of anchoring the first member includes threadably attaching at least two separate anchors to the annulus. [Appendix 4] 2. The method of claim 1, further comprising the steps of: deploying a separate third member from the catheter; anchoring the third member to an anterior side of the mitral valve annulus in the left atrium; attaching a tensioning member to both the first member and the third member; and tensioning the tensioning member attached between the first member and the third member to approximate the posterior and anterior sides of the mitral valve annulus. [Appendix 5] 5. The method of claim 4, wherein the third member is deployed and anchored separately from the first member and the second member. [Appendix 6] 5. The method of claim 4, wherein the tension member attached between the first member and the second member and the tension member attached between the first member and the third member are two separate tension members. [Appendix 7] 7. The method of claim 6, wherein the two separate tension members are tensioned separately. [Appendix 8] 5. The method of claim 4, wherein the second member is anchored toward an outer side of the mitral valve annulus and the third member is anchored toward an inner side of the mitral valve annulus. [Appendix 9] 9. The method of claim 8, wherein the second member has at least one anchor proximate the lateral triangle and the third member has at least one anchor proximate the medial triangle. [Appendix 10] 9. The method of claim 8, wherein at least one of the steps of anchoring the second member and anchoring the third member includes threadably attaching at least two separate anchors to the annulus. [Appendix 11] 9. The method of claim 8, wherein the anterior-posterior dimension of the mitral valve annulus can be reduced differently on the lateral side than on the medial side. [Appendix 12] 2. The method of claim 1, wherein the tensioning member is not attached to either the first member or the second member until deployed from the catheter in vivo. [Appendix 13] 7. The method of claim 6, wherein the separate tension members are not attached to any of the first member, the second member, or the third member until deployed from the catheter in vivo. [Appendix 14] 2. The method of claim 1, wherein the tension member is pre-attached to at least one of the first member and the second member before the first member or the second member is deployed from the catheter. [Appendix 15] 2. The method of claim 1, wherein the first member includes a protruding feature configured to engage the tension member. [Appendix 16] 2. The method of claim 1, wherein the second member includes a protruding feature configured to engage the tension member. [Appendix 17] 2. The method of claim 1, wherein the step of deploying a flexible tension member from the catheter includes capturing the first member and the second member with the tension member, one at a time. [Appendix 18] 2. The method of claim 1, wherein the first member has an elongated shape, the method further comprising rotating the elongated first member to a desired position to anchor the elongated first member to a posterior side of the mitral valve annulus. [Appendix 19] 20. The method of claim 18, wherein two or more leads are attached to the elongate first member during the rotating step. [Appendix 20] A first member; at least one first member anchor configured to anchor the first member posterior to the mitral valve annulus in the left atrium of the heart; A second member; and at least one second member anchor configured to anchor the second member to the left atrium anterior to the mitral valve annulus; a first flexible tensioning member configured to span between the first and second members such that tension can be applied to the first flexible tensioning member to draw the first and second members toward each other and approximate the posterior and anterior sides of the mitral valve annulus; An annulus forming system comprising: all of the elements of the annuloplasty system are configured to be deployed into the left atrium through a catheter. Annular formation system. [Appendix 21] 21. The annuloplasty system of claim 20, wherein the first member is elongated and capable of assuming a curved shape. [Appendix 22] 22. The annular formation system of claim 21, wherein the first member includes a series of slits that allow the first member to flex. [Appendix 23] 21. The annuloplasty system of claim 20, further comprising a third member and at least one third member anchor configured to anchor the third member to the anterior side of the mitral valve annulus of the left atrium. [Appendix 24] 24. The annuloplasty system of claim 23, further comprising a second flexible tensioning member configured to span between the first member and the third member such that tension can be applied to the second flexible tensioning member to draw the first member and the third member toward each other and approximate the posterior and anterior sides of the mitral valve annulus. [Appendix 25] 25. The annular formation system of claim 24, wherein the first member includes at least two protruding features, each protruding feature configured to engage with either the first tension member or the second tension member. [Appendix 26] 21. The annuloplasty system of claim 20, further comprising an anchor guide mounted to the first member and configured to guide the at least one first member anchor into cardiac tissue. [Appendix 27] 27. The annuloplasty system of claim 26, wherein the anchor guide is configured to guide the at least one first member anchor approximately perpendicular to the first member in an anterior-posterior direction. [Appendix 28] 27. The annuloplasty system of claim 26, wherein the anchor guide includes a lead extending from adjacent the first member through the catheter to a proximal end of the catheter. [Appendix 29] 27. The annuloplasty system of claim 26, wherein the anchor guide is foldable relative to the first member, thereby allowing the anchor guide to lie approximately flat against the first member when the first member and the anchor guide are loaded into the catheter. [Appendix 30] 21. The annular formation system of claim 20, wherein the first member includes at least one hinge, whereby the first member is foldable along at least one individual hinge axis.

Claims

1. A first member; at least one first member anchor configured to anchor the first member posterior to the mitral valve annulus in the left atrium of the heart; an anchor guide mounted to the first member and configured to guide the at least one first member anchor into cardiac tissue; A second member; and at least one second member anchor configured to anchor the second member to the anterior side of the mitral valve annulus in the left atrium; a first flexible tensioning member configured to span between the first and second members such that tension can be applied to the first flexible tensioning member to draw the first and second members toward each other and approximate the posterior and anterior sides of the mitral valve annulus; An annulus forming system comprising: all of the elements of the annuloplasty system are configured to be deployed into the left atrium through a catheter. Annular formation system.

2. The annuloplasty system of claim 1 , wherein the first member is elongated and capable of assuming a curved shape.

3. The annuloplasty system of claim 2 , wherein the first member includes a series of slits that allow the first member to flex.

4. 10. The annuloplasty system of claim 1, further comprising a third member and at least one third member anchor configured to anchor the third member to the anterior side of the mitral valve annulus of the left atrium.

5. 5. The annuloplasty system of claim 4, further comprising a second flexible tensioning member configured to span between the first member and the third member such that tension can be applied to the second flexible tensioning member to draw the first member and the third member toward each other and approximate the posterior and anterior sides of the mitral valve annulus.

6. The annular formation system of claim 5 , wherein the first member includes at least two projecting features, each projecting feature configured to engage either the first tension member or the second tension member.

7. The annuloplasty system of claim 1 , wherein the anchor guide is configured to guide the at least one first member anchor generally perpendicular to the first member in an anterior-posterior direction.

8. The annuloplasty system of claim 1 , wherein the anchor guide includes a lead extending from adjacent the first member through the catheter to a proximal end of the catheter.

9. 2. The annuloplasty system of claim 1, wherein the anchor guide is foldable relative to the first member, thereby allowing the anchor guide to lie approximately flat against the first member when the first member and the anchor guide are loaded into the catheter.

10. The annuloplasty system of claim 1 , wherein the first member includes at least one hinge whereby the first member is foldable along at least one discrete hinge axis.

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