Annuloplasty System and Method

Abstract

Exemplary methods of performing an annuloplasty procedure include introducing a catheter into the left atrium of the heart, deploying a first member from the catheter, anchoring the first member to the posterior side of the mitral valve annulus in the left atrium, deploying a second member from the catheter, anchoring the second member to the anterior side of the mitral valve annulus in the left atrium, deploying a flexible tension member from the catheter, attaching the tension member to both the first member and the second member, and applying tension to the tension member to pull the first member and the second member toward each other and bring the posterior and anterior sides of the mitral valve annulus closer together. Annuloplasty systems and components are also disclosed.

Description

[0001] Incorporation by reference

[0002] All publications and patent applications mentioned in this specification are hereby 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. Field of the Invention

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

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

[0005] Mitral regurgitation is a condition in which the mitral valve does not close completely, resulting in blood flowing back from the left ventricle to the left atrium. In some cases, the regurgitation is caused by dilation of the mitral annulus, particularly an increase in the anteroposterior diameter of the mitral annulus. Alternatively or additionally, mitral regurgitation is caused by dilation of the left ventricle, which may be caused by, for example, an infarction. Dilation of the left ventricle causes the papillary muscles to continuously hold the mitral valve leaflets in an open configuration via the chordae tendineae.

[0006] There are existing art methods and devices for treating mitral regurgitation. They involve replacing or repairing the mitral valve. Replacement of the valve is typically performed via the apex or transseptally. Repair of the valve generally falls into one of four categories: leaflet clip; direct annuloplasty; indirect annuloplasty or chordae tendineae repair. Both direct and indirect annuloplasty involve shaping the mitral annulus and / or the left ventricle of the subject to cause the anterior and posterior leaflets to engage properly. For some annuloplasty applications, a ring is implanted near the mitral annulus (e.g., above or posterior to the mitral annulus). The purpose of the ring is to reduce the circumference of the mitral annulus.

[0007] In view of the above prior art, there is a desire to provide improved systems and methods for treating mitral regurgitation. Summary of the Invention

[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 the left atrium of a heart; deploying a first member from the catheter; anchoring the first member to the posterior side of the mitral annulus in the left atrium; deploying the second member from the catheter; anchoring the second member to the anterior side of the mitral annulus in the left atrium; deploying a flexible tensile member from the catheter, attaching the tensile member to the first member and the second member, and applying tension to the tensile member to pull the first member and the second member toward each other and bring the posterior and anterior sides of the mitral annulus closer together.

[0009] In some embodiments, a method of performing an annuloplasty procedure includes the steps of: introducing a catheter into the left atrium of a heart and deploying a first member from the catheter. The first member is anchored to the posterior side of the mitral annulus in the left atrium. A second member is deployed from the catheter and the second member is anchored to the anterior side of the mitral annulus in the left atrium. A flexible tensile member is deployed from the catheter and attached to both the first member and the second member. Tension is applied to the tensile member to pull the first member and the second member toward each other and bring the posterior and anterior sides of the mitral annulus closer together.

[0010] In some embodiments, the second member is deployed and anchored separately from the first member. The step of anchoring the first member can include attaching at least two separate anchors by screwing the at least two separate anchors into the annulus. The method can 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 the tensile member to both the first member and the third member; and applying tension to the tensile member attached between the first member and the third member to bring the posterior and anterior sides of the mitral annulus closer together. In some embodiments, the third member is deployed and anchored separately from the first and second members. The tensile member attached between the first and second members and the tensile member attached between the first and third members can be two separate tensile members. In some embodiments, tension is applied independently to the two separate tensile members.

[0011] In some embodiments, the second member is anchored toward the outer side of the mitral annulus, and the third member is anchored toward the inner side of the mitral annulus. The second member can have at least one anchor near the outer trigone, and the third member can have at least one anchor near the inner trigone. In some embodiments, at least one of the steps of anchoring the second and third members includes attaching at least two separate anchors by screwing separate anchors into the annulus. In some embodiments, the amount of reduction in the size of the mitral annulus in the anterior-posterior direction can be different on the outer and inner sides.

[0012] In some embodiments, the tensile member is not attached to the first member or the second member until the tensile member is deployed from the catheter in vivo. In some embodiments, the separate tensile members are not attached to any of the first member, the second member, or the third member until the tensile members are deployed from the catheter in vivo. Prior to deploying the first member or the second member from the catheter, at least one of the first member and the second member may be pre-attached with a tensile member. In some embodiments, the first member includes an extension feature configured to engage the tensile member. In some embodiments, the second member includes an extension feature configured to engage the tensile member. The step of deploying the flexible tensile member from the catheter may include: snaring the first member and the second member one at a time with the tensile member. In some embodiments, the first member has an elongated shape, and the method further includes rotating the elongated first member to a desired position before anchoring the elongated first member to the posterior side of the mitral annulus. During the rotation step, more than one lead may be attached to the elongated first member.

[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 flexible first tensile member. At least one first member anchor is configured to anchor the first member to the posterior side of the mitral annulus in the left atrium of the heart. At least one second member anchor is configured to anchor the second member to the anterior side of the mitral annulus in the left atrium. The flexible first tensile member is configured to span between the first member and the second member such that tension can be applied to the first tensile member to pull the first member and the second member toward each other and bring the posterior and anterior sides of the mitral annulus closer together. All elements of the annuloplasty system are configured to be deployed into the left atrium through a catheter.

[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, the at least one third member anchor being configured to anchor the third member to the anterior side of the mitral annulus in the left atrium. The annuloplasty system may further include a flexible second tensile member configured to span between the first member and the third member such that tension can be applied to the second tensile member to pull the first member and the third member toward each other and bring the posterior and anterior sides of the mitral annulus closer together. In some embodiments, the first member includes at least two extension features, each extension feature being configured to engage the first tensile member or the second tensile member. BRIEF DESCRIPTION OF THE DRAWINGS

[0015] A better understanding of the features and advantages of the present disclosure will be obtained by referring to the detailed description of illustrative embodiments set forth below, which utilize the principles of the present disclosure and whose accompanying drawings include:

[0016] Figure 1 is a superior-inferior overall view showing various aspects of the human mitral valve.

[0017] Figure 2 is a perspective view showing an exemplary posterior bar constructed in accordance with aspects of the present disclosure;

[0018] Figure 3 is a perspective view showing an exemplary anterior pad constructed in accordance with aspects of the present disclosure;

[0019] Figure 4 is a flowchart schematically showing an exemplary method of performing an annuloplasty procedure in accordance with aspects of the present disclosure;

[0020] Figure 5-22 is a series of perspective views from a perspective along a generally caudal direction through the left atrium at the mitral valve and showing the Figure 4 steps of the exemplary method outlined therein;

[0021] Figure 23-33B is a perspective view showing additional examples of posterior bar and loop kit features;

[0022] Figure 34-37 is a perspective view showing other examples of the anterior pad.

[0023] Figure 38-40 is a side view showing other examples of the helical tissue anchor;

[0024] Figure 41-44 is a top view showing other exemplary embodiments of an annuloplasty system constructed in accordance with aspects of the present disclosure;

[0025] Figure 45-51 is a perspective view showing an exemplary embodiment of torque control of the posterior bar; and

[0026] Figure 52-53 is a perspective view showing an exemplary embodiment of a collapsible implant.

[0027] Figure 54-55 is a top view showing other examples of the tensile member loop kit. Specific Embodiments

[0028] Reference Figure 1, showing elements of the mitral valve. In particular, the mitral valve includes an anterior leaflet, a posterior leaflet, an anterior-lateral commissure, a posterior-medial commissure, a lateral triangle (sometimes referred to as the left side), and a medial triangle (sometimes referred to as the right side). The anterior leaflet includes three segments A1, A2, and A3. Similarly, the posterior leaflet also includes three segments P1, P2, and P3. In accordance with aspects of the present disclosure, in some embodiments, the device anchor can be placed at or near each of the target locations T as shown.

[0029] Reference Figure 2 , showing an exemplary posterior rod 210 constructed in accordance with aspects of the present disclosure. The posterior rod 210 is configured to be implanted in the left atrium on or near the mitral annulus adjacent to the posterior leaflet, as will be described in more detail subsequently. Thus, in this exemplary embodiment, the posterior rod 210 is an elongated tubular structure that is curved to match the anatomy of the mitral annulus at that location. The posterior rod 210 is configured to have a low profile as shown to minimize the number of irregular structures that could potentially be sites of thrombus formation in the atrium. In this exemplary embodiment, the posterior rod 210 is provided with a non-invasive edge to limit the likelihood of tissue damage and is covered with a polyethylene terephthalate (PET) fabric to assist in tissue ingrowth.

[0030] In this exemplary embodiment, the posterior rod 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 the same as the end tissue anchor guides 214, while in other embodiments, the central tissue anchor guide 212 is constructed differently from the end tissue anchor guides 214, with the central tissue anchor guide 212 having features such as facilitating manipulation / twisting of the posterior rod 210 during delivery. In some embodiments, as will be described subsequently herein, there may be no central tissue anchor guide, and there may be more or fewer than the three tissue anchor guides provided in this exemplary embodiment. The anchor guides 212 and 214 can be configured to pivot relative to the posterior rod 210 such that they can move from a retracted state to a deployed state. In the retracted state, the anchor guides 212 and 214 can extend generally parallel to the rod 210 such that they and the rod 210 can pass through the lumen of a catheter together. In the deployed state, as Figure 2 shown, the anchor guides 212 and 214 can extend generally perpendicular to the rod 210 such that they can be used to screw tissue anchors above the guides through holes in the rod 210 into adjacent tissue to fix the rod 210 to the tissue.

[0031] One or more loop kit features 216 may be provided on the posterior shaft 210. In this exemplary embodiment, two loop kit features 216 are provided, each near an end of the posterior shaft 210. The loop kit features 216 may be configured to project prominently from the posterior shaft 210 such that they may be easily engaged with one or more tensile members / loop kits and also prevent the tensile members from coming off during operation. In some embodiments, the snare features 216 are configured to be easily imaged under fluoroscopy and echocardiography to assist in positioning the posterior shaft 210 during delivery and attachment to tissue and to facilitate connecting the tensile members to the loop kit features 216.

[0032] The posterior shaft 210 may be designed to preferably load the anchor with shear rather than tensile forces in an anatomical sense. Torque control features may be provided to allow the posterior shaft 210 to have an initial positioning and to allow the implant to be moved to match the anatomy when subsequent anchors are delivered.

[0033] The posterior shaft 210 may also be provided with a degree of flexibility to allow in vivo adjustment of the shaft to accommodate the anatomy of a particular target. The flexibility of the posterior shaft 210 may also be used to allow the shaft to bend during the cardiac cycle. In some embodiments, the flexibility of the posterior shaft 210 is created by providing a series of slits ( Figure 1 not shown in the figures) that are transverse to the longitudinal axis of the shaft. In some embodiments, the slits and / or other flexibility-providing features may be configured to limit the minimum radius of the posterior shaft 210 at the time of implantation to ensure that it applies a more uniform tension to the posterior side of the mitral annulus.

[0034] Referring Figure 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 on or near the mitral annulus adjacent to the anterior leaflet in the left atrium, particularly on the trigone, as will be described in more detail subsequently. In this exemplary embodiment, the anterior pad 310 is a generally flat structure having four petal portions 312 that extend radially from a central portion. In other embodiments, more, fewer, or no petal portions may be provided. The main tissue anchor 314 may be located at 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 portion 312 as shown. In some embodiments, the main tissue anchor 314 is the same as the additional tissue anchors 316, while in other embodiments, the main tissue anchor and the additional tissue anchors may have different configurations, with the main tissue anchor having features, for example, that facilitate positioning of the anterior pad 310 during delivery. The petal portions 312 may be designed to fold into a compact configuration such that the anterior pad 310 may be delivered through a catheter.

[0035] The anterior pad 310 may be provided with a low profile as shown to minimize the number of irregular structures in the atrium that may be potential sites for thrombus formation. In this exemplary embodiment, the anterior pad 310 is provided with a trauma-free edge to limit the possibility of tissue damage, and the anterior pad 310 is covered with a polyethylene terephthalate (PET) fabric to assist in tissue ingrowth.

[0036] One or more loop kit features may be provided on the anterior pad 310. In this exemplary embodiment, the tips of the tissue anchors 314 and 316 are configured to engage with one or more tensile members / loop kits. These loop kit features may be configured to project prominently from the anterior pad 310 such that they can be easily engaged with one or more tensile members / loop kits and also prevent the tensile members from detaching during manipulation. In some embodiments, the loop kit features and / or the entire anterior pad 310 are configured to be easily imaged under fluoroscopy and echocardiography to assist in positioning the anterior pad 310 during delivery and attachment to tissue and to assist in connecting the tensile members to the loop kit features. The anterior pad 310 may be designed to preferably load the anchors with shear force rather than tensile force in an anatomical sense.

[0037] Referring Figure 4 , an exemplary method of performing an annuloplasty procedure in accordance with aspects of the present disclosure is shown. The steps of the exemplary method 410 will be described with reference to Figure 4 the flowchart shown and Figures 5 to 22 a series of images shown in Figures 5 to 22 . In each image shown in Figure 5-22 , the perspective is along a generally caudal direction through the left atrium 510 towards the mitral valve 512, where the medial direction is generally to the right. In some embodiments of the method, a posterior rod 210 and one, two, or more anterior pads 310 are implanted. In other embodiments, different types or numbers of devices may be used. In Figure 5-22 , for clarity, the posterior rod 210 is shown without a fabric covering. In this exemplary embodiment, at least one device anchor is placed at or near each of the five target positions T shown in Figure 1 .

[0038] In some embodiments 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 a subject. This can be achieved using methods such as a transseptal approach, a left atrial approach, or other methods to access the left atrium. In the image shown in Figure 5-22 , a transseptal approach is depicted, where the distal end of the catheter 514 passes through the septum 516 of the heart and into the left atrium 510 of the subject. In some embodiments, an internal dilator (not shown) is located in the distal end of the catheter 514 for passing through the septum.

[0039] Reference Figure 4 and Figure 5 , once the distal end of catheter 514 is introduced into the left atrium 510, in step 414, the posterior rod 210 (sometimes referred to herein as the first member) can be deployed from the distal end of catheter 514. In some embodiments, catheter 514 is first introduced into the left atrium 510 before loading the posterior rod assembly onto the proximal end of catheter 514. In other embodiments, the posterior rod 210 and its tissue anchor guides 212, 214, and loop kit features 216 can be pre-loaded into a catheter (not shown) and advanced through catheter 514. As Figure 5 shown, the anchor leads 518 can be removably attached to each of the tissue anchor guides 212 and 214 to push the posterior rod 210 through catheter 514 and deploy it from the distal end.

[0040] Reference Figure 6 , once the posterior rod 210 extends from the distal end of catheter 514, the lead 518 attached to one end thereof can be pushed while the other lead 518 is pulled from the proximal end of catheter 514 to pivot the posterior rod 210 to an orientation generally perpendicular to catheter 514 as shown. The steerable inner catheter 520 can slide distally on the intermediate lead 518 until features (such as recesses and / or castellated portions, not shown) engage mating features on the posterior rod 210 to prevent rotation of the rod 210 relative to the inner catheter 520. Then the steerable inner catheter 520 can be used to position and rotate the posterior rod 210 until it is turned to the desired implantation position and orientation as Figure 7 shown. In some embodiments, a torque driver coaxially located between the lead 518 and the steerable inner catheter 520 can be used to apply torque to the posterior rod 210. This embodiment will be described subsequently with reference to Figures 40 to 46 .

[0041] Reference Figure 4 and Figures 8 to 11 , step 416 of the exemplary method 410 will be described. In this step, the posterior rod 210 (i.e., the first member) is anchored to the posterior side of the mitral valve 512. This can be achieved by first sliding the drive tube 522 on the lead 518 attached to the tissue anchor guide 214 near the inner end of the posterior rod 210, as Figure 8 shown, the drive tube 522 having a helical tissue anchor 524 located at its distal end. When the steerable inner catheter 520 holds the posterior rod 210 against the mitral annulus tissue, the drive tube 522 can be rotated to screw the inner anchor 524 through the posterior rod 210 into the underlying tissue, as Figure 9As shown. Then, the drive tube 522 can be removed from the inner anchor 524 and slid (or another drive tube 522 with another helical tissue anchor 524) onto the lead 518 attached to the tissue anchor guide 214 near the outer end of the rear rod 210, as Figure 9 shown. When the inner anchor 524 and the steerable inner catheter 520 (and in some embodiments, the torque driver within the catheter 520) hold the rear rod 210 against the mitral annulus tissue, the drive tube 522 can be rotated to screw the outer tissue anchor 524 through the rod 210 into the underlying tissue, as Figure 10 shown. Then, the drive tube 522 can be removed from the outer anchor 524 and slid (or another drive tube 522 with another helical tissue anchor 524) onto the lead 518 attached to the middle tissue anchor guide 212, as Figure 11 shown. In some embodiments, when the central anchor is placed, the steerable inner catheter 520 can remain in a position against the rear rod 210 (as Figure 10 shown), or the steerable inner catheter 520 can be removed from the rear rod 210 (as Figure 11 shown) before the drive tube 522 and the middle anchor 524 slide into engagement on the middle tissue anchor guide 212. When the inner and outer anchors 524 hold the rear rod 210 against the mitral annulus tissue, the drive tube 522 can be rotated to screw the middle anchor 524 through the rod 210 into the underlying tissue. Figure 10 and Figure 11 show the rear rod 210 with the leads removed from the end tissue anchor guides, such as by being screwed out.

[0042] In step 416, it should be noted that after the initial anchor is placed, the torque control of the implant 210 provided by the steerable inner catheter 520 (or in some embodiments, the torque driver within the catheter 520) can be used to guide the placement of subsequent anchors of the implant 210. This eliminates the need for non-guided anchor placement after the initial anchor has been placed. Figure 12 shows the rear rod 210 with three anchors placed and all leads removed.

[0043] Reference Figure 4 and Figure 12 will be made to describe step 418 of the exemplary method 410. 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 maneuvered towards the lateral trigone through the steerable inner catheter 520, as Figure 12 shown. (The lateral trigone is also shown in Figure 1 .)

[0044] Referring to Figure 4 、 12 and 13, steps 420 of the exemplary method 410 will be described. In this step, the anterior pad 310 (sometimes referred to herein as the 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 trigone by a single anchor 314 as shown. A drive tube (not shown) can be used within the steerable inner catheter 520 to screw the anchor 314 into place. As Figure 13 shown, additional anchors 316 can be used to further secure the anterior pad 310 to the lateral trigone.

[0045] In step 420, it should be noted that after the initial anchor has been placed, its lead can be held 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 for the implant 310. This eliminates the need for non-guided anchor placement after the initial anchor has been placed.

[0046] Referring to Figure 4 and 14 , steps 422 and 424 of the exemplary method 410 will be described. In these steps, another anterior pad 310 (sometimes referred to herein as the third member) is deployed from the distal end of the catheter 514. In some embodiments, as Figure 14 shown, the anterior pad 310 is maneuvered medially into the medial trigone by the steerable inner catheter 520. (The medial trigone is also shown in Figure 1 ). The anterior pad 310 can then be anchored to the anterior side of the mitral valve 512. In some embodiments, the anterior pad 310 is anchored to the medial trigone by a single anchor 314 as shown. A drive tube (not shown) can be used within the steerable inner catheter 520 to screw the anchor 314 into place. As with the lateral anterior pad 310, additional anchors can be used to further secure the medial anterior pad 310 to the medial trigone.

[0047] In step 424, it should be noted that after the initial anchor has been placed, its lead can be held 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 for the implant 310. This eliminates the need for non-guided anchor placement after the initial anchor has been placed.

[0048] Referring to Figure 4 and 15, step 426 of the exemplary method 410 will be described. In this step, as shown, a first tensile member or loop kit 526 is deployed through the steerable inner catheter 520 from the distal end of the catheter 514. The loop kit sheath 528 can be used to direct the first tensile member 526 toward the implant feature. The loop kit sheath 528 can also be used to tighten the first tensile member 526 around the implant feature by pulling proximally on the tensile member 526 relative to the sheath 528.

[0049] Reference Figure 4 and Figures 16 to 18 , step 428 of the exemplary method 410 will be described. In this step, the first tensile member or loop kit 526 is attached to the rear rod 210 (i.e., the first member) and the front pad 310 (i.e., the second member). The steerable inner catheter 520 and the loop kit sheath 528 can be used to first direct the tensile member 526 onto the lateral loop kit feature 216 of the rod 210, as Figure 16 shown. Then, the first tensile member 526 can be directed onto the primary tissue anchor 314 of the front pad 310. Then, a small amount of tension can be applied to the first tensile member 526 with the loop kit sheath 528 to keep it engaged with the rod 210 and the pad 310, as Figure 18 shown.

[0050] Reference Figure 4 and 19 , step 430 of the exemplary method 410 will be described. In this step, as shown, a second tensile member or loop kit 530 is deployed through the steerable inner catheter 520 from the distal end of the catheter 514. The loop kit sheath 532 can be used to direct the second tensile member 530 toward the implant feature. The loop kit sheath 532 can also be used to tighten the second tensile member 530 around the implant feature by pulling proximally on the tensile member 530 relative to the sheath 532.

[0051] Refer to Figure 4 and Figures 20 to 22 , step 432 of the exemplary method 410 will be described. In this step, the second tensile member or loop kit 530 is attached to the rear rod 210 (i.e., the first member) and the next front pad 310 (i.e., the third member). As Figure 20 shown, the steerable inner catheter 520 and the loop kit sheath 532 can be used to direct the second tensile member 530 onto the medial loop kit feature 216 of the rod 210. Then, the second tensile member 530 can be directed onto the primary tissue anchor 314 of the front pad 310, as Figure 21 shown. Then, a small amount of tension can be applied to the second tensile member 530 with the loop kit sheath 532 to keep it engaged with the rod 210 and the pad 310, as Figure 22As shown. In some embodiments, the loop set shape can be configured to more easily engage loop set features on the implant. For example, each loop set can form a D shape that contacts the outer or inner side of the atrium. Then, the wall of the atrium is used to guide the loop set down to the annulus and then tie it, without having to guide the loop set to each loop set feature. In some embodiments, the loop set has a dumbbell (or dog bone) shape, such as Figure 54 the exemplary loop set 550 shown. The loop set 550 includes a distal loop 552 and a proximal loop 554 having a predetermined diameter, while the remainder of the loop set has generally parallel tension members that form a gap smaller than the loop diameter therebetween. The distal loop 552 can be exposed first to engage a first loop set feature on the implant, and then the proximal loop 554 can be exposed to capture a second loop set feature on the implant. In some embodiments, as Figure 55 shown, two loop sets 560 and 562 are loaded in parallel, and each has a predetermined shape. The respective loop sets 560 and 562 can be connected to a coupler 564 and can slide independently to engage loop set feature portions on the implant, respectively.

[0052] Once both the first tension member 526 and the second tension member 530 are in place, additional tension can be applied to both to pull the anterior and posterior sides of the mitral valve 512 closer. In some embodiments, the tension in members 526 and 530 can be increased simultaneously. In some embodiments, the tension in members 526 and 530 can be increased incrementally, and the increase occurs alternately between the two until the desired tension is reached and / or the distance between the anterior and posterior sides of the mitral valve reaches the desired value. In some embodiments, the final tension in each tension member 526 and 530 and / or the tissue approximation achieved is approximately the same. In some embodiments, the final tension in each tension member 526 and 530 and / or the tissue approximation achieved is different. Since the medial and lateral tightening can be performed independently, the placement of each rod is relatively loose. This is generally true for all systems disclosed herein. In some embodiments, real-time echocardiography of the mitral valve is used to monitor the reduction of mitral regurgitation when the tension members 526 and 530 are tightened.

[0053] After the desired tension and / or tissue approximation is obtained, the tension members 526 and 530 can be tied. In some embodiments, a reversible lock can be used during the tightening process, which is configured to permanently hold the position of the tension members. A disconnect member can be used to separate the loop set from the delivery system, or a portion of the tension member can be cut to release the tension member. Then the catheter 514 can be withdrawn from the left atrium along with the steerable inner catheter 520 and the loop set sheaths 528 and 532 ( Figure 4Step 436) as shown. In addition to tensioning the device during the de novo process, additional tensioning devices can be added at a later time or date, and / or existing devices can be re-tensioned to further reduce the A-P dimension.

[0054] Reference Figures 23 to 33B , other examples of the rear rod and loop kit features are provided. Figure 23 A rear rod similar to the previously described rod 210 is shown, but having four tissue anchors and no central anchor. Additionally, loop kit features in the form of hooks are provided at each end.

[0055] Figure 24 A boomerang-shaped rear rod having five tissue anchors is shown, with the central anchor being larger than the other four and used for torque control of the implant. In this embodiment, the anchors can serve as loop kit features. In some embodiments (not shown), the shape of the rod has a compound radius of curvature that tightens as the rod extends away from the posterior side to match the curvature of the valve annulus.

[0056] Figure 25 A rear rod without a fabric covering is shown. Similar to the holes in the rear rod 210, there is a crossbar spanning each of the three holes, which is used to pivotally attach tissue anchor guides. As shown, a hook-shaped groove can be provided at each end to capture the loop kit. As shown, the tube can be laser cut with interlocking features to allow the rod to bend with limited degrees of curvature and elongation.

[0057] Figure 26 A low-profile rear rod formed from a laser-cut sheet is shown. The implant provides a function similar to that of the Figure 23 rod and has a central torque control feature. Similar implants (not shown) can be formed from wire. Such implants can be very strong, provide spring-like flexibility, and can include more prominent loop kit features.

[0058] Figure 27 An implant similar to the implant shown in Figure 26 is shown, and is shown in both forms with and without a fabric covering.

[0059] Figure 28Another similar implant 610 is shown, which has helical coil kit features 612 disposed at both ends, lead nut lugs 614 disposed in each of five anchor positions 616, a torque control attachment 618, and a lug 620 configured to position the lead nut / anchor guide (not shown) at the center of the middle anchor position. The helical coil kit features 612 can be raised relative to the plane of the posterior bar 610 to allow easier engagement with the tensile member. The helical tip set lugs can be made more visible during fluoroscopy and echocardiography. The lugs can be configured to help hold the tensile member.

[0060] Figure 29 The posterior bar 630 and two anterior pads 632 in an implanted configuration are shown. The posterior bar 630 includes a fabric covering, five anchors 634, and two coil kit features 636 that extend from the fabric covering in opposite directions in a generally longitudinal direction.

[0061] Figure 30 Two posterior bars 640 are shown, one with a fabric covering and the other without. The bars 640 include five anchor positions 642 and an overlapping triangular truss configuration.

[0062] Figure 31 Two posterior bars 650 are shown, one with a fabric covering and the other without. The bars 650 include two coil kit features 652 that extend toward each other in a generally radially inward direction.

[0063] Figure 32 , Figure 33A and Figure 33B An exemplary wire end that can be used as a coil kit feature is shown. In some embodiments, the ball at the end of the coil kit feature is configured to enhance visibility using fluoroscopy and echocardiography. The gap between the spherical end of the coil kit feature and the body of the implant can be configured to allow the tensile member to slide onto the coil kit feature, where the coil kit feature flexes slightly. The coil kit feature then springs back to retain the tensile member on the coil kit feature.

[0064] In some embodiments, the posterior bar is bent to match the anatomy of the mitral annulus adjacent to the posterior leaflet. They can be configured to be low profile to minimize the number of irregular structures in the atrium that could potentially be sites of thrombus formation.

[0065] Reference Figure 34-37 , additional examples of the anterior pad are provided. Figure 34 An anterior pad similar to the previously described pad 310 but having three petal portions is shown. Figure 35Shows a front pad with a central tower portion attached with a three-loop kit feature. Figure 36 Shows a circular pad without petal portions and a stepped loop kit feature. Figure 37 Shows a circular pad without petal portions and a loop kit feature on top of a protruding tissue anchor.

[0066] In some embodiments, the front pad allows for targeted additional anchoring after placement of the primary anchor. They can have a low profile to minimize the number of irregular structures in the atrium that could be potential sites for thrombus formation. The pad edges can be configured to be atraumatic to limit potential tissue damage. In some embodiments, the front pad is covered with a PET fabric to assist in tissue ingrowth. The pad can be configured to preferably load the anchor in shear rather than tension in an anatomical sense. A protruding loop kit feature can be provided to prevent the loop kit from disengaging during manipulation of the implant. In some embodiments, the pad is configured to be easily imaged under fluoroscopy and echocardiography.

[0067] In other embodiments (not shown), the positions of the rod and the pad can be reversed such that the rod is placed on the anterior side of the mitral annulus and the two pads are placed on the posterior side. In some embodiments, the posterior element can be two separate components, one on the outside and one on the inside, such that there are four pads around the valve without a rod. In some embodiments, a single loop kit or tensile member can be used to connect and adjust all implanted components. Also, individual loop kits can be used to independently engage each loop kit feature, and the two loop kits on each side can be tightened together (i.e., a total of four loop kits). Additionally, a separate tensioning member can be placed between the two triangular pads to achieve further tissue stabilization and circumferential engagement. Such a system or any system disclosed herein can be used as an anchoring system for valve replacement.

[0068] Reference Figures 38 to 40 , provides other examples of spiral tissue anchors. Figure 38 Shows an anchor with a straight, gapless handoff feature at its top. This feature allows the anchor to freely rotate within the implant at the end of its travel when being inserted to eliminate any gap between the implant and the tissue. The implant retaining lug 660 can be located at the top of the straight section such that when the straight section freely rotates within the implant, the coil can continue to drive into the tissue until the implant is in tight contact with the tissue. Figure 39 Shows an anchor with a low-profile head. An anchor with a low profile minimizes the number of irregular structures in the atrium that could be potential sites for thrombus formation. Figure 40A pair of anchor devices are shown, each attached to a head for driving the anchor device. In some embodiments, the anchor devices are configured to provide strong attachment strength to tissue, which can be restored if needed, and are easily imaged under fluoroscopy and echocardiography.

[0069] Reference Figure 41-44 , other exemplary embodiments constructed in accordance with aspects of the present disclosure are shown. In these embodiments, two structures or "rods" are placed on opposite sides of the mitral annulus, one on the posterior side and the other on the anterior side. The two inner ends of each rod are connected together, and the two outer ends are connected. Then each side can be brought closer together to reduce the A-P dimension of the valve. This will focus on the annular changes in the A-P direction. As shown, the tightening mechanism can be covered with PET material, which forms pleats when the implant is tightened. The connection of the two rods creates a complete "ring" structure. As Figure 41 shown, the posterior rod can be bent to match the shape of the annulus. The anterior rod may be straighter and can bridge between the lateral and medial trigones. Since the medial and lateral tightening can be performed independently, the placement of each rod is relatively loose. Similarly, this generally applies to all systems disclosed herein. As Figures 42-44 shown, one or more anchor devices can be placed on the side portion of the annulus.

[0070] Referring Figure 45-51 , an exemplary embodiment of torque control for the posterior rod will be described. In this embodiment, a torque driver 710 is provided. The torque driver 710 includes a head 712 at its distal end, and a flexible shaft 714 attached to the head, the proximal end of the flexible shaft 714 extending outside the patient's body so that the surgeon can manipulate the head 712. As Figure 48 and 50 best shown, when in use, the torque driver 710 is coaxially located between the central lead 518 and the steerable catheter 520. As Figure 45 best shown, the head 712 includes a transverse slot 716 configured to engage a central lug 718 of the posterior rod 720. As Figure 46 best shown, when the torque driver 710 is rotated into alignment and pushed distally against the posterior rod 720, the slot 716 engages the lug 718 to allow the torque driver 710 to precisely control the rotational orientation of the posterior rod 720 even when encountering rotational resistance. (For clarity, the posterior rod 720 shown in Figure 45 and 46 does not have a fabric covering, lead nut, lead, etc.).

[0071] In some embodiments, as shown, the head 712 has a square cross-sectional shape. In other embodiments (not shown), the torque driver head may have a circular or other cross-sectional shape. In some embodiments, the outer dimensions of the head 712 fit closely within mating features of the rear rod 720 (such as Figure 46 the ring shown therein) to constrain lateral movement of the head 712 relative to the rod 720. In other embodiments (not shown), other centering features may be provided to limit lateral movement.

[0072] Figures 47-51 An exemplary method of using the torque driver 710 is shown. Figure 47 The rear rod 722 deployed from an external guide or catheter 514 is shown. Figure 48 The torque driver 710 advanced through an internally manipulable sheath 520 (not shown in Figure 48 ) and over the central lead 518 is shown. As previously described, Figure 49 The torque driver 710 engaged with the rear rod 722 is shown. In some embodiments, the surgeon pulls back and applies tension on the central lead 518 while holding the torque driver 710 in place. Once the torque driver 710 is centered with the rod 722, the position of the torque driver 710 can be locked onto the rear end (proximal end) of the internally manipulable catheter 520. In Figure 50 , the torque driver 710 is now securely locked onto the rod 722. The internally manipulable catheter 520 is shown advancing from the external guide 514. Figure 51 The internally manipulable catheter 520 is shown advancing until it covers the torque driver and reaches the rod 722. The torque driver 710 and / or the manipulable catheter 520 are now ready to be used to maneuver the rear rod 722 into position.

[0073] Referring to Figure 52 and Figure 53, showing another exemplary embodiment in which a collapsible rear rod is provided. The collapsible rod 810 can be configured to facilitate loading the device into a catheter (not shown) and to facilitate manipulation within the left atrium. In this exemplary embodiment, the rear rod 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 respectively hinged to opposite sides of the central section 814, as shown. In this embodiment, the right section 816 and the left section 818 can each rotate between a retracted position (as shown) and an extended position (not shown), in which the right section 816 and the left section 818 are both substantially coplanar with the central section 814. One or more leads 820 can be coupled to each of the right section 816 and the left section 818 to assist in deploying each section. As each section 816 and 818 travels between the retracted position and the extended position, it can rotate approximately 90 degrees. In some embodiments, the right section 816 and the left section 818 can be configured to lock in the open position once extended. In other embodiments (not shown), only two sections or more than three sections that fold relative to each other can be provided.

[0074] Similar to the previously described embodiments, the rear rod 810 can be provided with five anchors 822, one anchor for the central section 814, two anchors for the right section 816, and two anchors for the left section 818. In some embodiments, the central anchor can be placed first (with the side sections 816 and / or 818 retracted or extended), and in other embodiments, the side anchors can be placed first. As in the previously described embodiments, a torque driver, a manipulable sheath 812, or a combination thereof can be provided to assist in maneuvering the device to the desired implantation position.

[0075] In some embodiments, the systems and methods disclosed herein, or portions thereof, can be used in a similar manner on either atrioventricular valve.

[0076] The advantages provided by the systems and methods disclosed herein may include the following advantages. A more direct reduction in the anterior-posterior (A-P) direction can be achieved. This can be accomplished with reduced tension forces because the action is directly in the A-P direction without the need for greater forces, which are typically required for circumferential remodeling. Lower tension forces generally result in fewer required anchors. The systems and methods also allow for a high level of customization to fit a particular anatomy. This involves different components placed separately, as well as the ability to adjust the medial and lateral sides separately. Each of the individual components is easier to implant compared to an entire superstructure. The systems and methods allow for in vivo adjustment, allowing for reduced precision required for placing the components and simplifying the implantation process. There is also a smaller number of implant sizes and configurations. In addition to the tensioning device during the cranial procedure, other tensioning devices can be added at a later time or date, or existing devices can be retensioned to further reduce the A-P dimension.

[0077] When a feature or element is referred to herein as being "on" another feature or element, it can be directly on the other feature or element or there can also 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 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, it can be directly connected, attached or coupled to the other feature or element or there may be intervening features or elements. In contrast, when a feature or element is referred to as being "directly connected", "directly attached" or "directly coupled" to another feature or element, there are no intervening features or elements. Although described or shown with respect to one embodiment, the features and elements so described or shown can be applied to other embodiments. Those skilled in the art will also recognize that a structure or feature referred to as being "adjacent" to another feature can have portions that overlap or are beneath the adjacent feature.

[0078] 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 also intended to include the plural forms unless the context clearly indicates otherwise. It will also be understood that when the terms "comprises" and / or "comprising" are used in this specification, they specify the presence of the stated features, steps, operations, elements, and / or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and / or combinations thereof. As used herein, the term "and / or" includes any and all combinations of one or more of the associated listed items and can be abbreviated to " / ".

[0079] For ease of description, spatial relative terms, such as "below", "beneath", "under", "above", "over", etc., may be used herein to describe the relationship of one element or feature to another (as shown in the figures). It will be understood that the spatial relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if the device in the figures is inverted, an element described as "below" or "beneath" another element or feature will then be oriented "above" the other element or feature. Thus, the exemplary term "below" can encompass both an orientation of above and below. The device may be otherwise oriented (rotated 90 degrees or in other directions), and the spatial relative descriptive terms used herein can be interpreted accordingly. Similarly, unless specifically stated otherwise, the terms "upward", "downward", "vertical", "horizontal", etc. are used herein for purposes of explanation only.

[0080] 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 otherwise indicates. These terms may be used to distinguish one feature / element from another. Thus, without departing from the teachings of the present disclosure, a first feature / element discussed herein may be referred to as a second feature / element, and similarly, a second feature / element discussed below may be referred to as a first feature / element.

[0081] Throughout the specification and the following claims, unless the context otherwise requires, the term "comprise" and variations such as "comprises" and "comprising" mean that various components (e.g., compositions and devices including apparatus and methods) can be used in a method and structure. For example, the term "comprise" will be understood to imply the inclusion of any recited element or step, but not the exclusion of any other element or step.

[0082] As used in the specification and claims, including as used in the examples, and unless otherwise expressly specified, all numbers may be understood to be prefaced by the term "about" or "approximately" even if the term does not expressly appear. When describing magnitudes and / or positions, the phrases "about," "substantially," or "generally" may be used to indicate that the described value and / or position is within a reasonable expectation range of the value and / or position. For example, the value of a numerical value may be + / −0.1% of the specified value (or range of values), + / −1% of the specified value (or range of values), + / −2% of the specified value (or range of values), + / −5% of the specified value (or range of values), + / −10% of the specified value (or range of values), etc. Any numerical value given herein should also be understood to include about or approximately that value unless the context otherwise indicates. For example, if the disclosed value is "10," then "about 10" is also disclosed. Any numerical range recited herein is intended to include all sub-ranges subsumed therein. It should also be understood that, as would be appreciated by one of ordinary skill in the art, when a disclosed value is "less than or equal to" that value, "greater than or equal to that value" and the possible ranges between values are also disclosed. For example, if the value "X" is disclosed, then "less than or equal to X" and "greater than or equal to X" (e.g., where X is a numerical value) are also disclosed. It should also be understood that throughout the application, data is provided in a variety of different formats, and that this data represents ranges of endpoints and starting points and any combination of data points. For example, if a particular data point "10" and a particular data point "15" are disclosed, it should be understood that greater than, greater than or equal to, less than, less than or equal to, equal to 10 and 15, and between 10 and 15 are all considered to be disclosed. It should also be 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.

[0083] Although the various illustrative embodiments are described above, various changes of any kind may be made to the various embodiments without departing from the scope of the disclosure as described in the claims. For example, in alternative embodiments, the order of performing the various method steps described may often be changed, and in other alternative embodiments, one or more method steps may be completely skipped. Optional features of the various apparatus and system embodiments may be included in some embodiments and not included in other embodiments. Accordingly, the foregoing description has been provided primarily for exemplary purposes and should not be construed as limiting the scope of the disclosure, as the scope of the disclosure is set forth in the claims.

[0084] The examples and illustrations included in this document show, by way of illustration and not limitation, specific embodiments in which the subject matter may be practiced. As mentioned, other embodiments may be utilized and other embodiments may be derived therefrom, such that structural and logical substitutions and changes may be made without departing from the scope of the disclosure. For convenience only, the embodiments of the subject matter of the present invention (if there are more than one such embodiment in the present invention) may be referred to herein individually or collectively by the term "invention", without intending to automatically limit the scope of the present application to any single invention or inventive concept. Thus, although specific embodiments have been illustrated and described herein, any arrangement calculated to achieve the same purpose may be substituted for the specific embodiments shown. The present disclosure is intended to cover any and all modifications or variations of various embodiments. Combinations of the above embodiments and other embodiments not specifically described herein will be apparent to those skilled in the art upon reading the above description.

[0085] Drawings:

[0086] Figure 1 , Figure 41

[0087] aortic valve

[0088] left coronary sinus

[0089] noncoronary sinus

[0090] lateral trigone

[0091] medial trigone

[0092] aortic mitral curtain

[0093] anterior commissure

[0094] posterior commissure

[0095] anterior leaflet

[0096] posterior leaflet

[0097] Figure 4

[0098] 412 Introduce the catheter into the left atrium

[0099] 414 Deploy the first member from the catheter

[0100] 416 Anchor the first component to the posterior side of the mitral valve

[0101] 418 Deploy the second component from the catheter

[0102] 420 Anchor the second component to the anterior side of the mitral valve

[0103] 422 Deploy the third component from the catheter

[0104] 424 Anchor the third component to the anterior side of the mitral valve

[0105] 426 Deploy the first tensile member

[0106] 428 Attach the first tensile member to the first and second components

[0107] 430 Deploy the second tensile member

[0108] 432 Attach the second tensile member to the first and second components

[0109] 434 Apply tension to the tensile members

[0110] 435 Lock and disengage from the tensile members

[0111] 436 Withdraw the catheter

Claims

1. An annuloplasty system, characterized in that, comprising: a first member; at least one first member anchor configured to anchor the first member to the posterior side of the mitral annulus in the left atrium of the heart; a second member, separated from the first member and configured not to directly contact the first member; at least one second member anchor configured to anchor the second member to the anterior side of the mitral annulus in the left atrium; a third member, separated from the first member and the second member and configured not to directly contact the first member and the second member; at least one third member anchor, the third member anchor configured to anchor the third member to the anterior side of the mitral annulus in the left atrium; and a flexible first tensile member configured to span linearly between the anchored first member and the anchored second member such that tension can be applied to the first tensile member to pull the first member and the second member toward each other and bring the posterior and anterior sides of the mitral annulus closer together; a flexible second tensile member configured to span between the first member and the third member such that tension can be applied to the second tensile member to pull the first member and the third member toward each other and bring the posterior and anterior sides of the mitral annulus closer together; wherein all elements of the annuloplasty system are configured to be deployed into the left atrium through a catheter.

2. The annuloplasty system according to claim 1, characterized in that, wherein, the first member is elongate and capable of assuming a curved shape.

3. The annuloplasty system according to claim 2, characterized in that, wherein, the first member includes a series of slits that permit flexure of the first member.

4. The annuloplasty system according to claim 1, characterized in that, wherein, the first member includes at least two extension features, each extension feature configured to engage the first tensile member or the second tensile member.

5. The annuloplasty system according to claim 1, characterized in that, further comprising: an anchor guide mounted to the first member and configured to guide at least one first member anchor into heart tissue.

6. The annuloplasty system according to claim 5, characterized in that, wherein, the anchor guide is configured to guide the at least one first member anchor in a manner generally perpendicular to the first member in the anteroposterior direction.

7. The annuloplasty system according to claim 5, characterized in that, wherein, the anchor guide includes a lead extending from adjacent the first member through the catheter to the proximal end of the catheter.

8. The annuloplasty system according to claim 5, characterized in that, wherein, the anchor guide is collapsible relative to the first member such that when the first member and the anchor guide are loaded into the catheter, the anchor guide is permitted to lie generally flat against the first member.

9. The annuloplasty system according to claim 1, characterized in that, wherein, The first member includes at least one hinge such that the first member is foldable along at least one discrete hinge axis.

10. The annuloplasty system according to claim 1, wherein, the first member further includes a first member body to which the at least two extension features are connected, wherein the extension features are configured as helical features.

11. The annuloplasty system according to claim 10, wherein, wherein, the helical features are configured to project from the first member body.

12. The annuloplasty system according to claim 11, wherein, wherein, the helical features are configured to be visible under fluoroscopy or ultrasound.

13. The annuloplasty system according to claim 12, wherein, wherein, the helical features include free ends provided with lugs.

14. The annuloplasty system according to claim 1, wherein, wherein, the second member includes a flat portion configured to facilitate tissue contact, and the at least one second member anchor is configured to anchor the second member to heart tissue through the flat portion.

15. The annuloplasty system according to claim 14, wherein, wherein, the flat portion is provided with petal portions radially extending from a central portion.

16. The annuloplasty system according to claim 15, wherein, wherein, the petal portions are configured to be foldable.

17. The annuloplasty system according to claim 16, wherein, wherein, the second member further includes an extension feature projecting from the flat portion, and the extension feature is configured to engage the first tensile member.

18. The annuloplasty system according to claim 1, wherein, both the first member and the second member are provided with extension features, the first tensile member includes a first ring portion, a second ring portion and a parallel portion longitudinally distributed, the first ring portion is disposed at the distal end of the first tensile member, the transverse widths of the first ring portion and the second ring portion are greater than the gap of the parallel portion, the first ring portion is configured to engage the extension feature of the first member under the guidance of the tissue wall, and the second ring portion is configured to engage the extension feature of the second member under the guidance of the tissue wall.

19. The annuloplasty system according to claim 18, wherein, wherein, the first ring portion and the second ring portion are configured as D-shaped or circular.

20. The annuloplasty system according to claim 18, wherein, wherein, the parallel portion is disposed between the first ring portion and the second ring portion, and the first ring portion, the second ring portion and the parallel portion are configured in a dumbbell or dog bone shape.

21. The annuloplasty system according to claim 18, wherein, wherein, The first tensile member includes two sub-tensile members arranged in parallel and capable of independent movement. Each sub-tensile member includes a straight portion and a loop portion located at the distal end of the straight portion. The parallel portion is formed by the straight portions of the two sub-tensile members arranged in parallel, and the first loop portion and the second loop portion are respectively formed by the loop portions of the two sub-tensile members.

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