Devices, systems, and methods for transcatheter treatment of valve regurgitation

Abstract

This disclosure generally provides improved medical devices, systems, and methods. [Solution] The present invention relates to a device used in transcatheter treatment of mitral valve regurgitation, specifically a system including a connecting auxiliary element implanted throughout the valve, a connecting auxiliary element and anchor for implantation, a system including a connecting auxiliary element and a delivery catheter, and a method for transcatheterally implanting the connecting element throughout the heart valve.

Description

Technical Field

[0001] Cross - reference to Related Applications This application is a continuation of U.S. Application No. 16 / 275,665, filed on February 14, 2019, which is a continuation - in - part of U.S. Application No. 16 / 129,194, filed on September 12, 2018. The above applications are hereby incorporated by reference in their entirety. In the application data sheet filed with this application, all applications identified as the subject of foreign or domestic priority claims are hereby incorporated by reference in accordance with 37 C.F.R. § 1.57.

[0002] The present disclosure generally provides improved medical devices, systems, and methods for treating heart valve diseases and / or modifying the properties of one or more valves in the body. Embodiments include implants for treating mitral valve regurgitation.

[0003] The human heart receives blood from organs and tissues via veins, passes the blood through the lungs where the oxygen content of the blood is increased, and propels the oxygen - enriched blood from the heart into the arteries so that the body's organ systems can extract oxygen for proper functioning. The oxygen - depleted blood is returned to the heart and then sent back to the lungs again.

[0004] The heart includes four heart chambers: the right atrium (RA), the right ventricle (RV), the left atrium (LA), and the left ventricle (LV). The pumping actions on the left and right sides of the heart generally occur simultaneously throughout the cardiac cycle.

[0005] The heart has four valves, which are collectively configured to selectively transmit blood flow in the correct direction during the cardiac cycle. The valves that separate the atria from the ventricles are called atrioventricular (AV) valves. The AV valve between the left atrium and left ventricle is the mitral valve. The AV valve between the right atrium and right ventricle is the tricuspid valve. The pulmonary valve directs blood flow to the pulmonary artery and from there to the lungs, and the blood returns to the left atrium via the pulmonary vein. The aortic valve directs blood to the aorta and from there to the periphery. Normally, the ventricles and atria are not directly connected.

[0006] Mechanical heartbeats are initiated by electrical impulses that spread throughout the heart tissue. The opening and closing of heart valves can occur primarily as a result of pressure differences between the heart chambers, which are brought about by passive filling or contraction of the chambers. For example, the opening and closing of the mitral valve can occur as a result of pressure differences between the left atrium and the left ventricle.

[0007] At the beginning of ventricular filling (diastole), the aortic and pulmonary valves are closed, preventing backflow from the arteries into the ventricles. Shortly after, the AV valves open, allowing unobstructed flow from the atria to the corresponding ventricles. Immediately after, ventricular systole (i.e., the ventricles become empty) begins, and the tricuspid and mitral valves usually close to form a seal, thereby preventing backflow from the ventricles to the corresponding atria.

[0008] Unfortunately, AV valves can be damaged or otherwise fail to function properly, resulting in improper closure. AV valves are complex structures, generally including annulus, leaflets, ligaments, and supporting structures. Each atrium is connected to its valve via the atrial vestibule. The mitral valve has two leaflets, and the tricuspid valve, a similar structure, has three leaflets. The juxtaposition or engagement of the corresponding surfaces of the leaflets relative to each other helps to close or seal the valve, preventing blood from flowing in the wrong direction. The inability of the leaflets to seal during ventricular systole is known as symmetry, where blood flows backward through the valve (regurgitation). Valve regurgitation can have serious consequences for a patient, often resulting in heart failure, reduced blood flow, hypotension, and / or reduced oxygen flow to the body's tissues. Mitral regurgitation can also cause congestion by causing blood to flow backward from the left atrium into the pulmonary veins. If severe valve regurgitation is left untreated, it can lead to permanent disability or death. [Background technology]

[0009] Various therapies are applied to treat mitral regurgitation, and other therapies have been proposed, but these are not used in actual patient treatment. Some of the known therapies have been found to be effective in at least some patients, but more options would be desirable. For example, medications (such as diuretics and vasodilators) can be used in patients with mild mitral regurgitation to help reduce the amount of blood flowing back into the left atrium. However, medications do not always achieve sufficient patient compliance. A significant number of patients may occasionally (or even regularly) forget to take their medication, despite the potential seriousness of the worsening of chronic and / or progressive mitral regurgitation. Pharmacological treatments for mitral regurgitation can also be inconvenient, often ineffective (especially as symptoms worsen), and may be associated with significant side effects (such as hypotension).

[0010] Various surgical options have also been proposed and / or employed to treat mitral regurgitation. For example, open cardiac surgery can replace or repair a dysfunctional mitral valve. In annular repair by annuloplasty, optionally, the size of the annular portion of the posterior leaflet of the mitral valve can be reduced along its circumference by passing sutures through a mechanical surgical annuloplasty sewing ring to create a joint. Open surgery may also attempt to reshape the leaflets and / or modify the supporting structures. In any case, open mitral valve surgery is a highly invasive procedure, generally performed under general anesthesia with a chest incision using cardiopulmonary bypass. Complications are common, and given the morbidity (and potentially mortality) of open surgery, timing is a concern; patients with more severe conditions may require surgery but are less likely to tolerate it. The success of open mitral valve surgery can depend heavily on the skill and experience of the surgeon.

[0011] Given the morbidity and mortality rates of open cardiac surgery, inventors have sought minimally invasive surgical treatments. Procedures using robots and endoscopes often remain highly invasive, time-consuming, expensive, and, in some cases, highly dependent on the skill of the surgeon. It would be desirable to further reduce trauma to these potentially fragile patients so that therapies can be successfully implemented by a large number of physicians using widely available technologies. To this end, numerous techniques and strategies described as minimally invasive have been proposed. These include devices that attempt to reconstruct the mitral annulus within the coronary sinus, devices intended to reconstruct the annulus by tightening either above or below the natural annulus, devices that fuse the valve leaflets (mimicking the Alfieri suture), and devices that reconstruct the left ventricle.

[0012] Perhaps the most widely known are the various mitral valve replacement implants that have been developed. These implants generally replace (or displace) the natural valve leaflets, and the surgically implanted structure relies on controlling the blood flow pathways between the cardiac chambers. While these various approaches and tools have met varying levels of tolerance, none are widely recognized as the ideal treatment for most or all patients with mitral regurgitation.

[0013] Due to known challenges and disadvantages of minimally invasive mitral valve regurgitation therapy and implants, further alternative treatments have been proposed. Some of these alternative proposals have sought implanted structures that remain within the valve annulus throughout the entire cardiac cycle. One group of these proposals includes cylindrical balloons that remain embedded on anchors or rigid rods extending between the atria and ventricles through the valve opening. Another group relies on arched ring structures, often combined with buttresses or other structural transverse members extending across the valve to secure the implant. Unfortunately, sealing between the natural valve leaflets and the entire circumference of the balloon or other coaxial body has proven difficult, but significant contraction around the natural valve annulus with each heartbeat, even when it is possible to flex the buttresses or anchors interconnecting the transverse members, can lead to serious fatigue failure problems during long-term implantation. Furthermore, significant movement of valve tissue can make it difficult to precisely position the implant, regardless of whether it is rigid or flexible.

[0014] In light of the above, it would be desirable to provide improved medical devices, systems, and methods. It would be particularly desirable to provide new techniques for treating mitral regurgitation and other heart valve diseases, as well as / or modifying the properties of one or more other valves in the body. There is still a need for devices that can directly improve the fusion of valve leaflets (rather than indirectly by reconstructing the annulus or ventricle), without destroying the anatomical structure of the leaflets by fusion or the like, and that can be deployed easily, reliably, and without excessive cost or surgical time. It would be especially beneficial if these new techniques could be implemented using minimally invasive measures, without stopping the heart or relying on cardiopulmonary bypass for deployment, and without relying on the exceptional skill of the operator to provide improved valve and / or cardiac function. [Prior art documents] [Patent Documents]

[0015] [Patent Document 1] U.S. Patent Application No. 13 / 099,532 [Patent Document 2] U.S. Patent Application No. 13 / 531,407 [Patent Document 3] U.S. Patent Application No. 14 / 313,975 [Patent Document 4] U.S. Patent Application No. 14 / 742,199 [Patent Document 5] U.S. Patent Application No. 14 / 749,344 [Patent Document 6] U.S. Patent Application No. 10 / 419,706 [Patent Document 7] U.S. Patent No. 8,888,843 [Overview of the project] [Means for solving the problem]

[0016] This disclosure generally provides improved medical devices, systems, and methods. Novel junction assist elements, systems, and methods for treating mitral valve regurgitation and other valve diseases are disclosed. The junction assist element may remain within the blood flow pathway as the valve moves back and forth between an open configuration and a closed configuration. The junction assist element may be a relatively thin, elongated (along the blood flow pathway), and / or shape-conforming structure that extends laterally through part, most, or all of the width of the valve opening, enabling junction between at least one of the natural valve leaflets and the junction assist element. The devices described herein can be used with any valve of the human body, including valves having two or three leaflets.

[0017] In some embodiments, an advantage is that the joining auxiliary element can be recovered. In some embodiments, the joining auxiliary element has a single anchor that can engage with or disengage from tissue. In some embodiments, the anchor is captive within the annular hub of the joining auxiliary element. In some embodiments, the captive anchor is removed simultaneously with the removal of the joining auxiliary element. In some embodiments, the joining auxiliary element may include an auxiliary anchor. In some embodiments, the joining auxiliary element may include a passive anchor. In some embodiments, one or more passive anchors are positioned to engage with tissue by engaging the anchor with tissue. In some embodiments, an advantage is that the joining auxiliary element can be recovered during the procedure. In some embodiments, the joining auxiliary element can be repositioned during the surgical procedure. In some embodiments, the joining auxiliary element can be removed from the patient during a subsequent surgical procedure. In some embodiments, the joining auxiliary element can be replaced by another device during a subsequent surgical procedure. In some embodiments, the ability to recover the joining auxiliary element is facilitated by a single annular anchor. In some embodiments, the ability to recover the joining auxiliary element is facilitated by the position of the annular anchor. In some embodiments, the ability to fold the joining support element using a drawstring suture, as described herein, facilitates the ability to retrieve the joining support element.

[0018] In some embodiments, the advantage lies in the connection between the connecting auxiliary element and the delivery catheter. In some embodiments, the connecting auxiliary element includes an annular hub with features for engaging with the delivery catheter. In some embodiments, the connecting auxiliary element and the delivery catheter are removably coupled, allowing the connecting auxiliary element to be released from the delivery catheter during the procedure. In some embodiments, after the connecting auxiliary element has been released from the delivery catheter, one or more auxiliary structures couple the connecting auxiliary element and the delivery catheter. In some embodiments, one or more auxiliary structures include a purse-string suture as described herein. In some embodiments, one or more auxiliary structures facilitate the folding and / or expansion of the connecting auxiliary element. In some embodiments, the connecting auxiliary element and the delivery catheter are fixed in a rotational direction relative to each other once coupled. In some embodiments, the connecting auxiliary element moves due to the relative movement of the delivery catheter.

[0019] In some embodiments, an advantage is that the hub can be delivered in an orientation that precedes the hub. In some uses, the annular hub can be moved into position relative to the anatomical structure. In some uses, the ventricular end of the junctional auxiliary can be retained within the delivery catheter until the annular hub is positioned. In some uses, once the annular hub and / or annular anchor engage with the tissue, the junctional auxiliary can be expanded. In some uses, once the annular hub and / or annular anchor engage with the tissue, the ventricular end of the junctional auxiliary can be positioned.

[0020] In some embodiments, an advantage is that the struts can deliver the joining assist element in a leading orientation. In this use, one or more of the struts of the joining assist element can be moved into place relative to the anatomical structure before positioning the valve annulus hub. In some uses, the joining assist element can be expanded or partially expanded before engaging the valve annulus anchor. In some uses, the valve annulus hub can be retained within the delivery catheter until one or more of the struts are positioned. In some uses, once the struts are positioned, the valve annulus anchor can be engaged with the tissue.

[0021] In some embodiments, an advantage is that the valve annulus anchor can be rotated independently of the joining assist element. As described herein, the joining assist element is coupled to a portion of the delivery catheter. As described herein, the valve annulus anchor is independently coupled to another portion of the delivery catheter, such as a driver deployed with the delivery catheter. The valve annulus anchor can be rotated independently of the valve annulus hub. When rotating the valve annulus anchor to engage the tissue, the valve annulus hub can remain stationary. With the delivery catheter retaining the position of the valve annulus hub, the valve annulus anchor can be driven into the tissue.

[0022] In some embodiments, an advantage is that the connecting support element can be folded. In some embodiments, the connecting support element is fully folded. A fully folded configuration can be an insertion configuration or a low-profile configuration. In some embodiments, the connecting support element is partially folded. A partially folded configuration can be a partially deployed configuration. A partially folded configuration can allow for selective deployment of the connecting support element within the heart. A partially folded configuration can allow for movement of the connecting support element into place within the heart. The configuration of the connecting support element can be monitored, for example, by ensuring proper deployment with imaging. In some embodiments, one or more purse-string sutures, or a portion thereof, are tensioned to fold or partially fold the connecting support element. In some embodiments, a partially folded configuration can allow for rotation of the connecting support element. In some embodiments, a fully folded configuration can allow for rotation of the connecting support element. In some embodiments, the connecting support element can be rotated together with the delivery catheter or a portion thereof. In some embodiments, the connecting support element can be rotated around a central position, such as the annular hub.

[0023] In some embodiments, an advantage is that the joining assist element can be expanded. In some embodiments, one or more drawstring sutures, or portions thereof, are released to expand the joining assist element. In some embodiments, releasing the drawstring suture enables one or more struts to assume a neutral configuration. In some embodiments, releasing the drawstring suture enables one or more struts to assume a preformed curve. In some embodiments, one or more struts comprise NiTi. In some embodiments, the drawstring suture is subjected to repeated tensioning and / or released. In some embodiments, the drawstring suture is capturable within the joining assist element. In some embodiments, the drawstring suture is tensioned to remove the joining assist element from the patient. In some embodiments, the drawstring suture is released to deploy the joining assist element within the patient's heart. In some embodiments, the drawstring suture is selectively deployed to expand a portion of the joining assist element while leaving another portion of the joining assist element folded or partially folded.

[0024] In some embodiments, an advantage is that the joining assist element can be adjusted. In some embodiments, the joining assist element can be held by a central position. In some embodiments, the central position is an anchor. In some embodiments, the central position is a hub. In some embodiments, the hub and / or anchor is located near approximately the midpoint of the diameter of the joining assist element. In some embodiments, the hub and / or anchor is located near approximately the midpoint and / or central position of the annular portion of the joining assist element. In some embodiments, the joining assist element can be held in a neutral position. In some embodiments, the joining assist element can be rotated by rotating a delivery catheter connected to the valve annulus hub. In some embodiments, the joining assist element can be longitudinally moved by a corresponding longitudinal movement of a delivery catheter connected to the valve annulus hub.

[0025] In some embodiments, an advantage is that the connecting support element can be retained by the delivery catheter after it has been positioned. In some embodiments, the connecting support element can remain anchored to the delivery catheter even after it has been fully deployed within the mitral valve. In some embodiments, the connecting support element can be adjusted after it has been fully deployed within the mitral valve. In some embodiments, the connecting support element can be rotated around the hub after it has been fully deployed. In some embodiments, the anchor can be disengaged from and / or re-engaged with the tissue after the connecting support element has been fully deployed. In some embodiments, the purse-string suture can be folded and / or expanded after the connecting support element has been fully deployed. In some embodiments, the connecting support element can be re-captured after it has been fully deployed. In some embodiments, the connecting support element can be removed after it has been fully deployed.

[0026] In some embodiments, the advantage is that the connecting auxiliary element does not require ventricular attachment. In some embodiments, the connecting auxiliary element requires only the attachment of the annulus. In some embodiments, the connecting auxiliary element requires only the attachment of the annular anchor through the annular hub. In some embodiments, the connecting auxiliary element requires only the attachment of the annular anchor through the annular hub and the annular return. In some embodiments, the connecting auxiliary element requires only the attachment of the annular anchor through the annular hub, the annular return, and / or the commissure return.

[0027] In some embodiments, the advantage is a radially extending frame. In some embodiments, the frame comprises an annular hub and one or more struts. In some embodiments, the struts extend radially from the annular hub. In some embodiments, the frame is constructed from a single flat sheet material. In some embodiments, the frame is precisely cut using water jetting, laser etching, or similar techniques. In some embodiments, the frame is constructed by forming the annular hub at the edge of the frame. In some embodiments, the flat sheet material is formed into a loop, which becomes the annular hub. In some embodiments, the struts are bent into a desired configuration. In some embodiments, the struts are evenly spaced around the circumference of the annular hub. In some embodiments, the struts are unevenly spaced around the circumference of the annular hub. In some embodiments, a strut extending along a portion of the circumference of the annular hub is different from a strut extending along another portion of the circumference of the annular hub. In some embodiments, one or more designated portions of the struts are designed to be located near the annular region of the heart. In some embodiments, one or more designated portions of the struts are designed to be located near the commissure region of the heart. In some embodiments, one or more designated portions of the struts are designed to be located near the ventricular region of the heart. In some embodiments, the struts of the radially outward-facing frame do not intersect. In some embodiments, the struts of the radially outward-facing frame do not form a mesh. In some embodiments, the struts of the radially outward-facing frame extend linearly from the hub to the edge of the joining auxiliary element. In some embodiments, the struts of the radially outward-facing frame have a pointed edge. In some embodiments, the pointed edge extends linearly from the edge of the joining auxiliary element. In some embodiments, the pointed edge is integrally formed within the strut. In some embodiments, the struts of the radially outward-facing frame have one or more radii of curvature. In some embodiments, the struts of the radially outward-facing frame can be concave, convex, or both concave and convex along the length of the strut. In some embodiments, the struts of the radially outward-facing frame have one or more inflection points.

[0028] In some embodiments, the advantage is the curvature of the frame. In some embodiments, the annular hub extends radially. In some embodiments, the annular hub extends from the connecting auxiliary element in a direction away from the annular. In some embodiments, the annular hub extends from the surface of the connecting auxiliary element above the flat surface of the strut. In some embodiments, the edge of the connecting auxiliary element is curved. In some embodiments, one or more struts may be curved laterally from the annular hub toward the upper edge. In some embodiments, the upper edge of the connecting auxiliary element can be curved upward from the annular. In some embodiments, the upper edge of the connecting auxiliary element can be curved upward from the rear point. In some embodiments, the upper edge of the connecting auxiliary element can be curved downward toward the annular. In some embodiments, the upper edge of the connecting auxiliary element can be curved downward toward the rear point. In some embodiments, one or more struts may be curved laterally from the annular hub toward the lower edge. In some embodiments, the lower edge of the connecting auxiliary element can be curved away from the rear point. In some embodiments, the lower edge of the connecting auxiliary element can be curved toward the rear point.

[0029] In some embodiments, a jointing aid is provided for treating a heart valve insufficiency. The heart valve has an annulus. The jointing aid may include a body comprising an annular compartment and a joint compartment. In some embodiments, the annular compartment is configured to be embedded in the heart above the annulus. In some embodiments, the joint compartment is configured to be embedded in the heart, traversing the surface of the annulus. The jointing aid may include a first joint surface and a second surface opposite to it. In some embodiments, each surface is bounded by a first transverse edge, a second transverse edge, a lower edge, and an upper edge. In some embodiments, the upper edge forms a lip and is cupped downward toward the lower edge or upward toward the annular compartment. The jointing aid may include a hub and an anchor coupled to the hub and held in the annular compartment. In some embodiments, the anchor is selectively deployable at a first target position. The jointing aid may include a plurality of struts extending radially outward from the hub. In some embodiments, the multiple supports comprise at least a first support located within an annular section and a second support extending from the annular section to a joint section, the second support having a longer overall length than the first support, for example, approximately or at least approximately 110%, 120%, 130%, 140%, 150%, 160%, 170%, 180%, 190%, 200%, 225%, 250%, or more, of the overall length of the first support. In some embodiments, the overall length of the second support is approximately 125% to approximately 300%, or approximately 125% to approximately 200%, of the overall length of the first support.

[0030] In some embodiments, at least one of the multiple struts has a pointed tip configured to engage with tissue. In some embodiments, the multiple struts contain nitinol. In some embodiments, the anchor is helical. The bonding auxiliary element may include one or more additional anchors. In some embodiments, one or more additional anchors are active anchors. In some embodiments, the hub includes a cross pin configured to extend through the helix of the anchor. In some embodiments, the hub is configured to entangle with a delivery catheter, which is configured to position the hub near the initial target location. In some embodiments, the delivery catheter is configured to rotate the anchor independently of the hub. The bonding auxiliary element may include radiopaque markers. The bonding auxiliary element may include multiple radiopaque markers near the upper edge. In some embodiments, the upper edge forming the lip is cupped downward toward the lower edge. In some embodiments, the upper edge forming the lip is cupped upward toward the annular compartment. In some embodiments, the hub extends upward toward the annular compartment. In some embodiments, the lower edge curves backward toward the hub.

[0031] In some embodiments, methods are provided for treating cardiac valve malposition in a patient. The cardiac valve has an annulus. The annulus further defines a valve plane, which separates the atrium proximally and the ventricle distally. The method may include coupling a delivery catheter to the hub of a malpositioning element. The method may include positioning the hub near the annulus. The method may include rotating an anchor through the hub and inserting it into cardiac tissue distal to the annulus. The method may include expanding the malpositioning element by extending a plurality of struts radially outward from the hub.

[0032] In some embodiments, the joining aid is suspended such that its joining surface joins with the first valve leaflet and its leaflet surface overlaps with the second valve leaflet, thereby reducing joining failure. The method may include engaging the pointed end of one of a plurality of supports with the distal cardiac tissue of the valve annulus. The method may include monitoring the position of the joining aid using one or more markers. The method may include monitoring the position of the joining aid using a plurality of markers near the upper edge of the joining aid. In some embodiments, the tip of the anchor is inserted into the hub while the hub is positioned near the valve annulus.

[0033] In some embodiments, a jointing aid is provided for treating a heart valve failure. The jointing aid may include a first joint surface and a second surface opposite to it. The jointing aid may include a first transverse edge, a second transverse edge, a lower edge, and an upper edge. The jointing aid may include an upper section and a lower section. In some embodiments, the upper section is configured to be in the plane of the annulus of the heart valve. In some embodiments, the lower section comprises a second surface opposite to the first joint surface. In some embodiments, the lower section comprises a laminate so that the thickness of the lower section is greater than the thickness of a portion of the upper section.

[0034] In some embodiments, the laminate contains ePTFE. In some embodiments, the thickness of the lower section is at least about 25% thicker than the thickness of a portion of the upper section. In some embodiments, the thickness of the lower section is at least about 50% thicker than the thickness of a portion of the upper section. In some embodiments, the periphery of the bonding auxiliary element includes a raised non-traumatic rim that partially surrounds the bonding auxiliary element. In some embodiments, the periphery of the bonding auxiliary element includes a raised non-traumatic rim that surrounds only the lower section of the bonding auxiliary element. In some embodiments, the raised rim includes sutures. In some embodiments, the periphery of the bonding auxiliary element includes a separated barb that extends radially outward from the periphery of the upper section of the bonding auxiliary element. The bonding auxiliary element may include a hub separated inward from each of the first transverse edge, second transverse edge, lower edge, and upper edge. The joining auxiliary element may include an active anchor configured to bond to a hub and to be rotated relative to the hub to selectively deploy the active anchor at an initial target position. The joining auxiliary element may include a plurality of struts spaced apart around the hub and extending outward from the hub, each strut comprising at least a first strut configured to be embedded in the heart such that a first bonding surface bonds to a first leaflet of a heart valve and a second opposite surface overlaps a second leaflet of the heart valve, and a second strut configured to be embedded in the heart. In some embodiments, the joining auxiliary element comprises a mesh layer.

[0035] In some embodiments, a jointing auxiliary element delivery system is provided for treating heart valve malposition. In some embodiments, the heart valve has an annulus. The jointing auxiliary element delivery system may include a jointing auxiliary element having a first surface and a second surface opposite to it. In some embodiments, each surface is bounded by a first transverse edge, a second transverse edge, a lower edge, and an upper edge. The jointing auxiliary element may include a hub. The jointing auxiliary element delivery system may include a main anchor disposed within a main anchor housing. In some embodiments, the main anchor is configured to extend through the hub and engage with the annulus. The jointing auxiliary element delivery system may include a release wire that extends through the main anchor housing and is configured to be positioned adjacent to the annulus.

[0036] The joining auxiliary element delivery system may include a main anchor driver disposed within the main anchor housing. In some embodiments, the main anchor driver is configured to rotate relative to the main anchor housing but not to translate. In some embodiments, the main anchor driver has two extensions, the two extensions configured to engage with the crossbar of the main anchor. The joining auxiliary element delivery system may include two release wires extending through the main anchor housing. In some embodiments, the two release wires are positioned adjacent to the valve ring and configured to extend in opposite directions from the hub. In some embodiments, the two release wires intersect. The joining auxiliary element delivery system may include an auxiliary anchor mooring device extending through the joining auxiliary element. In some embodiments, the auxiliary anchor mooring device extends around the release wire. The joining auxiliary element delivery system may include at least two auxiliary anchor mooring devices extending through the joining auxiliary element. In some embodiments, at least two auxiliary anchor mooring devices extend around the release wire. In some embodiments, at least one auxiliary anchor mooring device extends around the release wire, and at least one auxiliary anchor mooring device extends around a second release wire. The joining auxiliary element delivery system may include an auxiliary anchor guide rail. In some embodiments, the auxiliary anchor guide rail is configured to lock an auxiliary anchor driver to an auxiliary anchor. In some embodiments, the auxiliary anchor guide rail is configured to prevent entanglement between the auxiliary anchor and an adjacent auxiliary anchor mooring device. In some embodiments, the auxiliary anchor guide rail is configured to slide along the auxiliary anchor mooring device to deliver the auxiliary anchor. The joining auxiliary element delivery system may include an auxiliary anchor driver. In some embodiments, the auxiliary anchor driver comprises at least one locking tab configured to engage with a window in the auxiliary anchor. The joining auxiliary element delivery system may include an auxiliary anchor.In some embodiments, the auxiliary anchor is configured to be delivered by sliding it along an auxiliary anchor mooring device that is looped around a release wire. In some embodiments, the auxiliary anchor is configured to rotate and engage with the valve ring. In some embodiments, the auxiliary anchor has a smaller diameter than the primary anchor. In some embodiments, the release wire is configured to retract after the primary anchor has engaged with the valve ring. In some embodiments, the release wire is configured to retract after the primary anchor and at least one auxiliary anchor have engaged with the valve ring. In some embodiments, the primary anchor housing is configured to retract after the release wire has retracted, and the primary anchor driver retracts together with the primary anchor housing. In some embodiments, the trajectory of the primary anchor passes through a hub. In some embodiments, a cross pin of the hub is configured to connect the primary anchor to a joining auxiliary element. In some embodiments, at least one auxiliary anchor is configured to have two or more trajectories. In some embodiments, the trajectory of at least one auxiliary anchor is determined by the orientation of each auxiliary anchor guide rail. In some embodiments, the auxiliary anchor guide rail has a curved distal end, and the curved distal end defines the trajectory. The jointing auxiliary element delivery system may include a proximal assembly configured to lock the position of the auxiliary anchor guide rail relative to the auxiliary anchor, thereby preventing entanglement of the auxiliary anchor mooring device. The jointing auxiliary element delivery system may include a proximal assembly configured to lock the position of the auxiliary anchor guide rail relative to the auxiliary anchor driver, thereby facilitating the coupling of the auxiliary anchor driver to the auxiliary anchor. The jointing auxiliary element delivery system may include a proximal assembly configured to lock the position of the auxiliary anchor mooring device, which is coupled to a release wire. The jointing auxiliary element delivery system may include a proximal assembly configured to lock the position of the auxiliary anchor mooring device, thereby applying tension to the auxiliary anchor mooring device and defining the trajectory of the auxiliary anchor. The jointing auxiliary element delivery system may include an anti-rotation mechanism.In some embodiments, the auxiliary anchor is equipped with a rotation prevention mechanism.

[0037] In some embodiments, a jointing aid is provided for treating a heart valve insufficiency. In some embodiments, the heart valve has an annulus. The jointing aid may include a first surface and a second surface opposite to it, each surface being bounded by a first transverse edge, a second transverse edge, a lower edge, and an upper edge. The jointing aid may include a hub. The jointing aid may include a plurality of struts spaced apart around the hub and extending outward from the hub, the struts comprising at least a first strut configured to be embedded in the heart above the annulus and a second strut configured to be embedded in the heart across the surface of the annulus.

[0038] In some embodiments, the bonding auxiliary element comprises at least one ePTFE layer. In some embodiments, the bonding auxiliary element comprises at least one mesh layer. In some embodiments, the bonding auxiliary element comprises at least one UHMWPE mesh layer. In some embodiments, the bonding auxiliary element comprises at least one fabric layer. In some embodiments, the bonding auxiliary element comprises at least one polyester fabric layer. In some embodiments, the first surface is reinforced. In some embodiments, the second surface is reinforced. In some embodiments, the ventricular surface is reinforced. In some embodiments, the bonding surface is reinforced. In some embodiments, the anchor area is reinforced. In some embodiments, at least one edge includes a raised edge. In some embodiments, the bonding auxiliary element is configured to minimize contact with the posterior leaflet. In some embodiments, the bonding auxiliary element is configured to engage with and be embedded within the annulus.

[0039] In some embodiments, a method for delivering a bonding auxiliary element is provided. The method may include delivering the bonding auxiliary element to a patient's heart. In some embodiments, the bonding auxiliary element is coupled to a bonding auxiliary element delivery system. In some embodiments, the bonding auxiliary element delivery system comprises a main anchor disposed within a main anchor housing. In some embodiments, the bonding auxiliary element delivery system comprises at least one release wire. The method may include expanding the bonding auxiliary element within the heart. The method may include securing the bonding auxiliary element to the annulus of the heart by rotating the main anchor.

[0040] The method may include rotating the main anchor driver within the main anchor housing. In some embodiments, at least one release wire is coupled to the main anchor housing and extends beneath the joining auxiliary element when the joining auxiliary element is expanded. In some embodiments, at least one auxiliary anchor anchor extends through the joining auxiliary element when the joining auxiliary element is expanded. In some embodiments, at least one auxiliary anchor anchor anchor forms a loop around at least one release wire when the joining auxiliary element is expanded. In some embodiments, the joining auxiliary element is delivered in a low-profile configuration. In some embodiments, at least one release wire is configured to maintain the position of the main anchor housing relative to the joining auxiliary element. In some embodiments, at least one release wire is configured to maintain the position of at least one auxiliary anchor anchor relative to the joining auxiliary element. In some embodiments, the joining auxiliary element is delivered via a delivery catheter. In some embodiments, an extension function is configured to position the joining auxiliary element relative to a position in which the main anchor engages with the valve ring. The method may include rotating the main anchor to engage with the valve ring. The method may include rotating the main anchor driver within the main anchor housing, wherein the main anchor driver is configured to rotate relative to the main anchor housing but not to translate. The method may include sliding the auxiliary anchor assembly toward the valve ring along the auxiliary anchor mooring device. The method may include maintaining engagement between the auxiliary anchor driver and the auxiliary anchor using an auxiliary anchor guide rail. The method may include preventing entanglement between the auxiliary anchor and the auxiliary anchor mooring device using an auxiliary anchor guide rail. The method may include coupling the auxiliary anchor driver to the auxiliary anchor. The method may include partially retracting the auxiliary anchor guide rail before the auxiliary anchor engages with the tissue. The method may include retracting the auxiliary anchor guide rail after the auxiliary anchor has engaged with the tissue.The method may include retracting the auxiliary anchor guide rail, followed by retracting the auxiliary anchor driver. The method may also include retracting at least one release wire.

[0041] In some embodiments, a jointing auxiliary element is provided for treating joint failure of a heart valve having an annulus. The jointing auxiliary element may include a first jointing surface and a second surface opposite to it, each surface being bounded by a first transverse edge, a second transverse edge, a lower edge, and an upper edge. The jointing auxiliary element may include a hub. The jointing auxiliary element may include an anchor that is coupled to the hub and configured to rotate relative to the hub to selectively deploy the anchor at an initial target position. The jointing auxiliary element may include a plurality of struts that are spaced apart around the hub and extend outward from the hub. In some embodiments, the plurality of struts comprises at least a first strut configured to be embedded in the heart above the annulus and a second strut configured to be embedded in the heart across the surface of the annulus.

[0042] In some embodiments, the second support has a longer overall length than the first support. In some embodiments, the hub is radially separated inward from the first transverse edge, the second transverse edge, the lower edge, and the upper edge, respectively. In some embodiments, the multiple supports are circumferentially separated around the hub. In some embodiments, the upper edge forms a cupped lip that is downward toward the lower edge or upward toward the lower edge. In some embodiments, at least one of the multiple supports has a pointed tip configured to engage with tissue. In some embodiments, the multiple supports contain nitinol. In some embodiments, the anchor is helical. The bonding auxiliary element may include one or more additional anchors. In some embodiments, one or more additional anchors are active anchors. In some embodiments, the hub includes a cross pin configured to extend through the helix of the anchor. In some embodiments, the hub is configured to mesh with a delivery catheter, which is configured to position the hub near the initial target location. In some embodiments, the delivery catheter is configured to rotate the anchor independently of the hub. The bonding auxiliary element may include radiopaque markers. The bonding auxiliary element may include multiple radiopaque markers near its upper edge. In some embodiments, the lip is cupped downward toward the lower edge. In some embodiments, the lip is cupped upward from the lower edge. In some embodiments, the hub extends upward from the first bonding surface. In some embodiments, the lower edge curves backward toward the hub. In some embodiments, the hub is tubular. In some embodiments, the support and the hub are formed integrally. In some embodiments, the bonding auxiliary element is configured to fold relative to the hub. In some embodiments, the active anchor is configured to selectively bond to and separate from tissue.

[0043] In some embodiments, a jointing aid is provided for treating joint failure of a heart valve having an annulus. The jointing aid may include a first jointing surface and a second surface opposite to it. In some embodiments, each surface is bounded by a first transverse edge, a second transverse edge, a lower edge, and an upper edge. The jointing aid may include a hub. The jointing aid may include an anchor coupled to the hub. In some embodiments, the anchor is configured to be rotated in a first direction to selectively deploy an active anchor and engage with tissue. In some embodiments, the active anchor is configured to be rotated in a second direction opposite to the first direction to selectively engage with and disengage from tissue. The jointing aid may include a plurality of struts spaced apart around the hub. In some embodiments, the struts include at least a first strut configured to be embedded in the heart above the annulus and a second strut configured to be embedded in the heart across the surface of the annulus.

[0044] In some embodiments, a jointing aid is provided for treating a heart valve insufficiency. In some embodiments, the heart valve has an annulus, an anterior leaflet, and a posterior leaflet. The jointing aid may include a first jointing surface and a second surface opposite to it. In some embodiments, each surface is bounded by a first transverse edge, a second transverse edge, a lower edge, and an upper edge. The jointing aid may include a hub. The jointing aid may include an anchor that is coupled to the hub and configured to rotate relative to the hub to selectively deploy the anchor at an initial target position. In some embodiments, the anchor is configured to selectively deploy on the annulus. The jointing aid may include a plurality of struts spaced apart around the hub. In some embodiments, the struts include at least a first strut configured to be embedded in the heart above the annulus and a second strut configured to be embedded in the heart across the surface of the annulus.

[0045] In some embodiments, a jointing auxiliary element delivery system is provided for treating joint failure of a heart valve having an annulus. The jointing auxiliary element delivery system may include a jointing auxiliary element having a first surface and a second surface opposite to it. In some embodiments, each surface is bounded by a first transverse edge, a second transverse edge, a lower edge, and an upper edge. In some embodiments, the jointing auxiliary element includes a hub. The jointing auxiliary element delivery system may include a first anchor disposed within a first anchor housing. In some embodiments, the first anchor is configured to extend through the hub and engage with the annulus. The jointing auxiliary element delivery system may include a release wire that extends through the first anchor housing and is configured to be positioned adjacent to the annulus.

[0046] In some embodiments, the joining auxiliary element delivery system may include a radiopaque marker. In some embodiments, the joining auxiliary element delivery system may include a second anchor anchor extending through the joining auxiliary element and around the release wire. In some embodiments, the radiopaque marker is crimped onto the second anchor anchor. In some embodiments, the radiopaque marker is configured to visually confirm the fixing depth of the second anchor. In some embodiments, the joining auxiliary element delivery system may include a second anchor. In some embodiments, the second anchor comprises a first helical portion having a first pitch and a second helical portion having a second, smaller pitch. In some embodiments, the second helical portion is configured to lock into the joining auxiliary element. In some embodiments, the second anchor includes a locking segment and a fixing segment, the locking segment having a smaller pitch than the fixing segment. In some embodiments, the second anchor is configured to be delivered by sliding the second anchor along a second anchor anchor that is looped around the release wire. In some embodiments, the second anchor is configured to be delivered by sliding the second anchor along a second anchor guide rail, which guides the trajectory of the second anchor. In some embodiments, the second anchor is configured to be rotated to engage with a valve ring. In some embodiments, the second anchor is configured to have two or more trajectories. In some embodiments, the trajectory of the second anchor is determined by the orientation of each second anchor guide rail. In some embodiments, the joining auxiliary element delivery system may include a first anchor driver disposed within the first anchor housing, which is configured to rotate relative to the first anchor housing but not to translate. In some embodiments, the joining auxiliary element delivery system may include a second anchor guide rail. In some embodiments, the second anchor guide rail is configured to lock the second anchor driver to the second anchor.In some embodiments, the second anchor guide rail is configured to slide along the second anchor mooring device to deliver the second anchor. In some embodiments, the second anchor guide rail includes a distal section having a bend of 30 to 90 degrees. In some embodiments, the bend determines the trajectory of the second anchor delivered along the second anchor guide rail. [Brief explanation of the drawing]

[0047] [Figure 1A] This is a schematic diagram showing a portion of the heart and mitral valve tissue that may interact with the implants and systems described herein, as described in the Background Art section and below. [Figure 1B] This is a schematic diagram showing a portion of the heart and mitral valve tissue that may interact with the implants and systems described herein, as described in the Background Art section and below. [Figure 1C] This is a schematic diagram showing a portion of the heart and mitral valve tissue that may interact with the implants and systems described herein, as described in the Background Art section and below. [Figure 1D] This is a schematic diagram showing a portion of the heart and mitral valve tissue that may interact with the implants and systems described herein, as described in the Background Art section and below. [Figure 1E] This is a schematic diagram showing a portion of the heart and mitral valve tissue that may interact with the implants and systems described herein, as described in the Background Art section and below. [Figure 1F] This is a schematic diagram showing a portion of the heart and mitral valve tissue that may interact with the implants and systems described herein, as described in the Background Art section and below. [Figure 2A] This is a simplified cross-sectional view of the heart illustrating mitral valve function during diastole. [Figure 2B] This is a simplified cross-sectional view of the heart illustrating mitral valve function during systole. [Figure 3A]This is a simplified cross-sectional view of the heart illustrating systolic mitral regurgitation in a scenario of mitral valve leaflet insufficiency. [Figure 3B] This is a simplified cross-sectional view of the heart illustrating systolic mitral regurgitation in a scenario of mitral valve leaflet insufficiency. [Figure 4A] This is a stylized cross-sectional view of the heart showing mitral valve closure in the context of functional mitral regurgitation. [Figure 4B] This is a stylized cross-sectional view of the heart showing mitral valve closure in a setting of degenerative mitral regurgitation. [Figure 5A] This is a perspective view showing one embodiment of a joining auxiliary element. [Figure 5B] Figure 5A is a top view showing the joining auxiliary element. [Figure 5C] This figure shows one embodiment of a support column for a joining auxiliary element. [Figure 5D] This figure shows one embodiment of a support column for a joining auxiliary element. [Figure 5E] This figure shows the connecting auxiliary elements of Figure 5A, excluding the valve ring anchor portion. [Figure 5F] This figure shows the connecting auxiliary elements of Figure 5A, excluding the valve ring anchor portion. [Figure 5G] This figure shows the connecting auxiliary elements of Figure 5A, excluding the valve ring anchor portion. [Figure 5H] This figure shows the connecting auxiliary elements of Figure 5A, including the valve leaflet anchor portion. [Figure 5I] This figure shows the connecting auxiliary elements of Figure 5A, including the valve leaflet anchor portion. [Figure 5J] This figure shows the connecting auxiliary elements of Figure 5A, including the valve leaflet anchor portion. [Figure 5K] This figure shows the dimensions of the joining support element in Figure 5A. [Figure 6] This is a perspective view showing an embodiment of a joining auxiliary element. [Figure 7A] This is a perspective view showing one embodiment of a bonding aid element, with a first surface positioned toward a non-bonding natural valve leaflet. [Figure 7B]Another perspective view showing the bonding auxiliary element of Figure 7A, which has a second surface that can include a bonding surface. [Figure 7C] Figure 7A is a top view showing the joining auxiliary element. [Figure 7D] This figure shows the connecting auxiliary element of Figure 7A embedded within a model of the mitral valve. [Figure 7E] This is a top view showing the connecting auxiliary element of Figure 7A embedded within a model of the mitral valve. [Figure 8A] This is a schematic diagram showing one embodiment of a control handle for a delivery system for transcatheter technology. [Figure 8B] Figure 8A shows a schematic top view and side view of the bonding auxiliary element coupled to the delivery system. [Figure 8C] This is a schematic diagram showing the connection between the valve annular hub of the connecting auxiliary element and the tip of the delivery catheter. [Figure 9A] Figure 8A is a schematic diagram showing the anchor operation of the delivery system. [Figure 9B] This is a schematic diagram showing an embodiment of the connection between the valve ring anchor and the driver. [Figure 9C] This is a schematic diagram showing an embodiment of the connection between the valve ring anchor and the driver. [Figure 9D] This is a schematic diagram showing an embodiment of the connection between the valve ring anchor and the driver. [Figure 9E] This is a schematic diagram showing an embodiment of the connection between the valve ring anchor and the driver. [Figure 10] This is a schematic diagram illustrating the transcatheter technique, showing a transseptal cross-section. [Figure 11] This is a schematic diagram illustrating a transcatheter technique method that shows the advancement of the first jointing auxiliary element. [Figure 12] This is a schematic diagram illustrating a transcatheter technique method showing the opening of a partial joint support element. [Figure 13] This is a schematic diagram illustrating a transcatheter technique method showing the folding of the connecting support element. [Figure 14] This is a schematic diagram illustrating a transcatheter technique, showing a cross-sectional view of a connecting auxiliary element. [Figure 15] This is a schematic diagram illustrating the transcatheter technique method, showing the placement of auxiliary anchors. [Figure 16] This diagram shows the implant delivery method, including the placement of the implant. [Figure 17] This diagram shows how to insert an introducer. [Figure 18] This diagram shows how to connect the introducer shown in Figure 17 to the transseptal sheath. [Figure 19] This diagram shows the method for advancing the transseptal sheath shown in Figure 18. [Figure 20] This diagram shows the method for positioning the transseptal sheath in Figure 19. [Figure 21] This diagram shows how to deliver the anchor. [Figure 22A] This diagram shows how to deploy an implant. [Figure 22B] This diagram shows how to deploy an implant. [Figure 22C] This diagram shows how to deploy an implant. [Figure 22D] This diagram shows how to deploy an implant. [Figure 23] This diagram shows a method using one or more auxiliary anchor guidewires. [Figure 24] This diagram shows how to remove an anchor driver. [Figure 25] This diagram shows how to advance the auxiliary anchor guide rail. [Figure 26] This diagram shows how to deliver auxiliary anchors. [Figure 27] This diagram shows how to insert auxiliary anchors. [Figure 28] This diagram shows how to deliver another auxiliary anchor. [Figure 29] This diagram shows a fixed implant including a guidewire. [Figure 30] This is a diagram showing a fixed implant. [Figure 31A]This diagram shows a method for retrieving an implant. [Figure 31B] This diagram shows a method for retrieving an implant. [Figure 31C] This diagram shows a method for retrieving an implant. [Figure 31D] This diagram shows a method for retrieving an implant. [Figure 31E] This diagram shows a method for retrieving an implant. [Figure 31F] This diagram shows a method for retrieving an implant. [Figure 32] This diagram shows how to insert auxiliary anchors. [Figure 33] This diagram shows how to deliver another auxiliary anchor. [Figure 34] This diagram shows how to insert another auxiliary anchor. [Figure 35] This is a diagram showing a fixed implant. [Figure 36] This figure shows one embodiment of the lamination process. [Figure 37] This figure shows one embodiment of the lamination process. [Figure 38] This figure shows one embodiment of 3D molding. [Figure 39] This figure shows one embodiment of 3D molding. [Figure 40] This is a diagram showing an implant. [Figure 41] This figure shows one embodiment of the return mechanism. [Figure 42A] This figure shows one embodiment of an implant delivery system. [Figure 42B] This figure shows one embodiment of an implant delivery system. [Figure 42C] This figure shows one embodiment of an implant delivery system. [Figure 42D] This figure shows one embodiment of an implant delivery system. [Figure 42E] This figure shows one embodiment of an implant delivery system. [Figure 42F]This figure shows one embodiment of an implant delivery system. [Figure 42G] This figure shows one embodiment of an implant delivery system. [Figure 42H] This figure shows one embodiment of an implant delivery system. [Figure 42I] This figure shows one embodiment of an implant delivery system. [Figure 43A] This figure shows one embodiment of an implant delivery system. [Figure 43B] This figure shows one embodiment of an implant delivery system. [Figure 43C] This figure shows one embodiment of an implant delivery system. [Figure 43D] This figure shows one embodiment of an implant delivery system. [Figure 43E] This figure shows one embodiment of an implant delivery system. [Figure 44A] This figure shows one embodiment of an implant delivery system. [Figure 44B] This figure shows one embodiment of an implant delivery system. [Figure 44C] This figure shows one embodiment of an implant delivery system. [Figure 44D] This figure shows one embodiment of an implant delivery system. [Figure 44E] This figure shows one embodiment of an implant delivery system. [Figure 45A] This figure shows one embodiment of an implant delivery system. [Figure 45B] This figure shows one embodiment of an implant delivery system. [Figure 45C] This figure shows one embodiment of an implant delivery system. [Figure 45D] This figure shows one embodiment of an implant delivery system. [Figure 45E] This figure shows one embodiment of an implant delivery system. [Figure 45F]This figure shows one embodiment of an implant delivery system. [Figure 45G] This figure shows one embodiment of an implant delivery system. [Figure 45H] This figure shows one embodiment of an implant delivery system. [Figure 45I] This figure shows one embodiment of an implant delivery system. [Figure 45J] This figure shows one embodiment of an implant delivery system. [Figure 45K] This figure shows one embodiment of an implant delivery system. [Figure 46A] This figure shows one embodiment of an anchor delivery system. [Figure 46B] This figure shows one embodiment of an anchor delivery system. [Figure 46C] This figure shows one embodiment of an anchor delivery system. [Figure 47A] This figure shows one embodiment of a joining auxiliary element. [Figure 47B] This figure shows one embodiment of a joining auxiliary element. [Figure 47C] This figure shows one embodiment of a joining auxiliary element. [Figure 47D] This figure shows one embodiment of a joining auxiliary element. [Figure 47E] This figure shows one embodiment of a joining auxiliary element. [Figure 48] This figure shows one embodiment of implant construction. [Figure 49] This figure shows one embodiment of an implant delivery system. [Figure 50] This is a diagram showing the delivery method. [Figure 51] This figure shows one embodiment of a major anchor driver. [Figure 52] This figure shows one embodiment of an auxiliary anchor guide rail. [Figure 53A] This figure shows one embodiment of an auxiliary anchor guide rail to prevent entanglement. [Figure 53B]This figure shows one embodiment of an auxiliary anchor guide rail to prevent entanglement. [Figure 54] This figure shows one embodiment of an auxiliary anchor guide rail that facilitates the trajectory of the auxiliary anchor. [Figure 55A] This figure shows one embodiment of the proximal assembly. [Figure 55B] This figure shows one embodiment of the proximal assembly. [Figure 55C] This figure shows one embodiment of the proximal assembly. [Figure 56] This figure shows one embodiment of a rotation prevention mechanism. [Figure 57A] This figure shows one embodiment of posterior leaflet enlargement and reconstruction. [Figure 57B] This figure shows one embodiment of posterior leaflet enlargement and reconstruction. [Figure 58A] This figure shows one embodiment of an implant delivery system. [Figure 58B] This figure shows one embodiment of an implant delivery system. [Figure 58C] This figure shows one embodiment of an implant delivery system. [Figure 58D] This figure shows one embodiment of an implant delivery system. [Figure 58E] This figure shows one embodiment of an implant delivery system. [Figure 58F] This figure shows one embodiment of an implant delivery system. [Figure 58G] This figure shows one embodiment of an implant delivery system. [Figure 58H] This figure shows one embodiment of an implant delivery system. [Figure 58I] This figure shows one embodiment of an implant delivery system. [Figure 58J] This figure shows one embodiment of an implant delivery system. [Figure 59A] This figure shows one embodiment of an auxiliary anchor. [Figure 59B] This figure shows one embodiment of an auxiliary anchor. [Figure 60] Figure 59A shows one embodiment of the auxiliary anchor and implant. [Figure 61] This figure shows one embodiment of the mitral valve during systole and diastole. [Figure 62A] This figure shows one embodiment of an implant. [Figure 62B] This figure shows one embodiment of an implant. [Figure 62C] This figure shows one embodiment of an implant. [Figure 63] This figure shows one embodiment of the implant shown in Figure 62A, positioned within the mitral valve during systole and diastole. [Figure 64A] This figure shows one embodiment of an implant. [Figure 64B] This figure shows one embodiment of an implant. [Figure 64C] This figure shows one embodiment of an implant. [Figure 64D] This figure shows one embodiment of an implant. [Figure 65] This figure shows one embodiment of the implant shown in Figure 64A, positioned within the mitral valve during systole and diastole. [Figure 66A] This figure shows one embodiment of an implant. [Figure 66B] This figure shows one embodiment of an implant. [Figure 66C] This figure shows one embodiment of an implant. [Figure 66D] This figure shows one embodiment of an implant. [Figure 67A] This figure shows one embodiment of the implant shown in Figure 66A, delivered to the mitral valve. [Figure 67B] This figure shows one embodiment of the implant shown in Figure 66A, delivered to the mitral valve. [Figure 68] This figure shows one embodiment of the implant shown in Figure 66A, positioned within the mitral valve during systole and diastole. [Modes for carrying out the invention]

[0048] The present invention provides improved medical devices, systems, and methods, which in some embodiments are generally for the treatment of other valvular disorders, including mitral regurgitation and tricuspid regurgitation. The following description includes references to the anterior leaflet of a valve, such as a mitral valve, which has two leaflets, although it should be understood that “anterior leaflet” may refer to one or more leaflets of a valve having multiple leaflets. For example, since a tricuspid valve has three leaflets, “anterior leaflet” may refer to one or two of the medial leaflet, lateral leaflet, and posterior leaflet. The connecting aids described herein generally include a connecting aid (which may be referred to herein as the valve body) substantially along the blood flow path as the leaflet moves back and forth between an open configuration (where the anterior leaflet is separated from the valve body) and a closed configuration (where the anterior leaflet is engaged with the opposing surface of the valve body). The valve body is positioned between the natural leaflets to provide a surface for at least one of the natural leaflets to contact and join, while effectively replacing a second natural leaflet in a region of the valve that would normally be closed during systole, thereby closing the gap caused by the failure of the natural leaflets to join. The gap may be lateral (for example, caused by a dilated left ventricle and / or mitral annulus) and / or axial (for example, when one leaflet is displaced or pushed over the annulus by fluid pressure when the valve should be closed). In some embodiments, the joining aid may fully assist one, two, or more leaflets, or in some embodiments, for example, partially assist the leaflets to cover only one or more of the A1, A2, and / or A3 leaflets of the anterior leaflet and / or only one or more of the P1, P2, and / or P3 leaflets of the posterior leaflet.

[0049] Among other applications, the junction auxiliary elements and methods described herein may be configured to treat functional and / or degenerative mitral regurgitation (MR) by creating an artificial or novel junction area in which at least one of the natural mitral valve leaflets can be sealed. While the structures and methods described herein are largely adapted for this application, alternative embodiments may be configured for use in other valves of the heart and / or body, including tricuspid valves, valves of the peripheral vascular system, and inferior vena cava.

[0050] Referring to Figures 1A to 1D, the four chambers of the heart are shown: the left atrium 10, the right atrium 20, the left ventricle 30, and the right ventricle 40. The mitral valve 60 is located between the left atrium 10 and the left ventricle 30. Also shown are the tricuspid valve 50, the aortic valve 80, and the pulmonary valve 70, which separate the right atrium 20 and the right ventricle 40. The mitral valve 60 consists of two leaflets: the anterior leaflet 12 and the posterior leaflet 14. In a healthy heart, the two leaflets are juxtaposed in the junctional area 16 during systole.

[0051] The fibrous annulus 120 of the cardiac skeleton attaches to the two leaflets of the mitral valve, called the anterior leaflet 12 and the posterior leaflet 14. The leaflets are axially supported by attachment to chordae tendineae 32. The chordae then attach to one or both of the papillary muscles 34, 36 of the left ventricle. In a healthy heart, the chordal support structure anchors the mitral leaflets, allowing them to open easily during diastole but resist the high pressure generated during ventricular systole. In addition to the anchoring action of the support structure, the consistency of the leaflet shape and tissue helps to facilitate effective sealing or joining. The anterior edges of the anterior and posterior leaflets join along a funnel-shaped joining zone 16, and a cross-section 160 of the three-dimensional joining zone (CZ) is schematically shown in Figure 1E.

[0052] The anterior and posterior leaflets of the mitral valve are shaped differently. The anterior leaflet is firmly attached by the annulus that overlaps the central fibrous body (cardiac skeleton) and is somewhat rigider than the posterior leaflet, which is attached to the more mobile posterior mitral annulus. The anterior leaflet accounts for approximately 80 percent of the closure range. Adjacent to the commissures 110, 114, on or anterior to the annulus 120, are the left (lateral) fibrous triangle 124 and the right (septal) fibrous triangle 126, which are formed where the mitral annulus fuses with the base of the non-coronary cusp of the aorta (Figure 1F). The fibrous triangles 124, 126 form the septal and lateral portions of the central fibrous body 128. In some embodiments, the fibrous triangles 124, 126 may have the advantage of providing a firm region that stably engages with one or more annuls or atrial anchors. The junctional region CL between leaflets 12, 14 is not a simple line, but rather a curved, funnel-shaped interface. The first commissure 110 (lateral or left side) and the second commissure 114 (septal or right side) are where the anterior leaflet 12 joins the posterior leaflet 14 at the annulus 120. As is most clearly visible in the axial views from the atrium in Figures 1C, 1D, and 1F, the axial section of the junctional region shows a curved CL throughout, separated from the annular center CA and the opening CO through the valve during diastole. In addition, the leaflet margins are wavy, with the posterior leaflet being more wavy than the anterior leaflet. Since junctional insufficiency can occur between one or more of these AP (anterior-posterior) segments of A1 / P1, A2 / P2, and A3 / P3, the characteristics of junctional insufficiency may vary along the curved CL of the junctional region.

[0053] Next, referring to Figure 2A, a properly functioning mitral valve 60 of the heart is open during diastole, allowing blood to flow along the flow path FP from the left atrium to the left ventricle 30, thereby filling the left ventricle. As shown in Figure 2B, during systole, the functioning mitral valve 60 closes initially passively and then actively in response to the increase in ventricular pressure, effectively sealing the left ventricle 30 away from the left atrium 10, thereby allowing the cardiac tissue surrounding the left ventricle to contract and advance blood throughout the vascular system.

[0054] Referring to Figures 3A-3B and 4A-4B, there are several conditions or pathological states in which the mitral valve leaflets do not adequately oppose each other, thereby causing blood to flow backward from the ventricles to the atria during systole. Regardless of the specific etiology in a particular patient, the inability of the valve leaflets to seal during ventricular systole is known as mitral regurgitation and causes mitral regurgitation.

[0055] Generally, mitral regurgitation can result from excessive anchoring of one or both leaflets by the supporting structures, or from excessive stretching or rupture of the supporting structures. Other less common causes include infection of the heart valve, congenital abnormalities, and trauma. Valve dysfunction can result from stretching of the chordae tendineae, known as mitral prolapse, and, in some cases, from rupture of the chordae 215 or papillary muscle, known as the loose leaflet 220, as shown in Figure 3A. Alternatively, if there is excess leaflet tissue, the valve may prolapse, so the greater the degree to which the junction enters the atrium, the greater the opening of the valve in the atrium during ventricular systole 230. In some cases, one of the leaflets may prolapse or become loose. This condition is sometimes known as degenerative mitral regurgitation.

[0056] In cases of excessive tethering, as shown in Figure 3B, the leaflets of a normally structured valve may not function properly due to annular dilation or deformation, so-called annular dilation. Such functional mitral regurgitation is generally caused by myocardial damage and the associated ventricular dilation. Furthermore, the excessive load itself resulting from functional mitral regurgitation may worsen heart failure, ventricular dilation, and annular dilation, thereby exacerbating mitral regurgitation.

[0057] Figures 4A and 4B show systolic blood regurgitation (BF) in functional mitral regurgitation (Figure 4A) and degenerative mitral regurgitation (Figure 4B). In Figure 4A, the increased size of the valve annulus, along with increased tethering due to hypertrophy of the ventricle 320 and papillary muscle 330, prevents the juxtaposition of the anterior leaflet 312 and posterior leaflet 314, thereby preventing junction. In Figure 4B, rupture of ligament 215 causes the posterior leaflet 344 to protrude upward into the left atrium, preventing juxtaposition with the anterior leaflet 342. In both situations, the result is blood regurgitation into the atrium, thereby reducing the effectiveness of left ventricular compression.

[0058] Further descriptions of joining auxiliary elements, tools, anchors, features, systems, and methods, which can be used in conjunction with the disclosures herein, can be found in the following applications, which are incorporated herein by reference in their entirety: U.S. Patent Application No. 13 / 099,532 filed 3 May 2011, U.S. Patent Application No. 13 / 531,407 filed 22 June 2012, U.S. Patent Application No. 14 / 313,975 filed 24 June 2014, U.S. Patent Application No. 14 / 742,199 filed 17 June 2015, U.S. Patent Application No. 14 / 749,344 filed 24 June 2015, and U.S. Patent Application No. 10 / 419,706 filed 18 April 2003.

[0059] In some embodiments, the symmetry auxiliary elements described herein may be positioned to overlap the posterior leaflet, ligaments, and papillary muscles. In some embodiments, the symmetry auxiliary elements are attached to the posterior surface of the annulus from above and to the posterior surface of the left ventricle from below via annular anchors and / or ventricular anchors. In other embodiments, one or more annular anchors and / or one or more ventricular anchors may be used to attach the symmetry auxiliary elements. In some elements, one or more annular anchors may be replaced or supplemented by one or more atrial or commissure anchors, which may be annular in some embodiments. The symmetry auxiliary elements may be attached to the superior surface of the posterior annulus, the posterior atrial wall, or the annulus itself. A symmetry area is established between the symmetry auxiliary element and the natural anterior leaflet. Since leaflet symmetry insufficiency occurs in both functional and degenerative mitral regurgitation, regardless of the underlying mechanism of the dysfunction, similar symmetry auxiliary elements can be used in both. In some embodiments, symmetry auxiliary elements of different sizes can be positioned so as to obstruct blood flow during ventricular contraction, with the natural anterior leaflet juxtaposed with the symmetry element at a well-established symmetry point.

[0060] Various sizes of junctional auxiliary elements may be provided, with different dimensions configured to accommodate various anatomical structures. For example, there may be a height measured from the upper annular attachment site to the lowest edge of the junctional auxiliary element in a plane essentially perpendicular to the plane defined by the annulus, a depth between the junction and the upper attachment site, and a projection between the posterior wall and the junction at the height of the junction. There may also be a medial-lateral diameter of the junctional auxiliary element, which is generally larger in the case of functional MR. During diastole, the junctional auxiliary element may remain substantially in the same position, while the movement of the natural anterior leaflet opens the valve, allowing blood flow from the left atrium to the left ventricle with minimal restriction. In some embodiments, during ventricular systole, the surface of the junctional auxiliary element may bulge or stretch upward, while the anchor remains stationary. This can be advantageous as it improves sealing between the anterior surface of the element or the junctional surface and the natural leaflet in the junctional region during systole. During diastole, the surface may return to its initial position, further forward toward the anterior leaflet. This may improve the blood flow pathway between the atria and ventricles during diastole, thereby improving outflow from the atria across the junctional accessory element.

[0061] In some applications, the natural posterior leaflet is left in place, and the supinating auxiliary element is attached from above to the posterior annulus or adjacent atrial wall. Many possible alternative embodiments may have different attachment mechanisms. In other applications, the posterior leaflet is absent and has been removed surgically or as a result of disease. In some applications, the natural leaflet attaches to the posterior surface of the supinating auxiliary element. In some applications, the supinating auxiliary element may attach to the anterior surface of the posterior leaflet, rather than to the annulus or atrial wall. These are some variations, but many more can be imagined. In some applications, a fixation structure (not shown) can pass from the supinating auxiliary element through the atrial wall into the coronary sinus, and the fixation structure attaches to an interlocking structure within the coronary sinus. In some applications, the fixation structure can be a mechanical structure or a simple suture, which can penetrate the atrial wall and be fixed to the epicardial surface of the heart by mechanical elements such as knots or clips. Similarly, attachment from below may be to the ventricular muscle, enter the epicardium or pericardium through the apex and be fixed from the outside, or be fixed at other attachment sites using alternative attachment means.

[0062] The connecting auxiliary elements described herein may exhibit a number of desirable properties. Some embodiments do not rely on reconstructing the mitral annulus (such as by thermal contraction of the annular tissue, implantation of an artificial annular ring, and / or placement of a tightening mechanism above or below the valve surface, or within the coronary sinus or associated blood vessel). Advantageously, there is no need to destroy the leaflet structure, nor is there any need to rely on locking or fusing the mitral leaflets together. Many embodiments can avoid reconstructing the ventricle and represent passive implantable devices that, after implantation, may have a limited range of motion and a very long fatigue life. Thus, the connecting auxiliary element can be fixed to the entire posterior leaflet, leaving the other anatomical structures of the natural heart (e.g., ventricle, mitral annulus, etc.) intact.

[0063] Mitral valve insufficiency may be effective regardless of which leaflet segment is causing the insufficiency. The treatments described herein utilize mitral valve augmentation elements that are repositionable during the procedure, and even removable after full deployment and / or after the tissue response has begun or is complete, and often do not damage the valve structure. Nevertheless, the mitral valve augmentation elements described herein may be combined with one or more therapies that depend on one or more of the attributes described above that become unnecessary. Mitral valve augmentation elements can exhibit benign tissue healing and rapid endothelialization, thereby inhibiting displacement, thromboembolism, infection, and / or erosion. In some cases, mitral valve augmentation elements do not exhibit endothelialization, and their surface remains inactive, which can also inhibit displacement, thromboembolism, infection, and / or erosion.

[0064] Figures 5A and 5B show two diagrams of one embodiment of the jointing auxiliary element 500. The jointing auxiliary element 500 may include a first surface 505 positioned toward the natural valve leaflet experiencing joint failure, or toward the posterior leaflet in the case of a mitral valve, and a second surface 515 which may be positioned toward the anterior leaflet. The second surface 515 may include a jointing surface 560. The upper edge 540 of the jointing auxiliary element 500 may be curved to conform to the overall shape of the valve annulus or adjacent atrial wall, as described herein. The upper edge 540 may be curved downward toward the posterior leaflet, as shown in Figure 5A, or curved upward toward the atrial wall to conform to the overall shape of the left atrial wall, as shown in Figure 6 and described herein.

[0065] The connecting element 500 may have a geometric shape that allows it to traverse the valve between attachment sites in the atrium and ventricle. In some embodiments, the attachment site is located only in the atrium. In some embodiments, the attachment site is located only near the valve annulus and commissure. The connecting element 500 may not be attached near the lower edge 580. The connecting element 500 does not require ventricular attachment. In some embodiments, the geometric shape of the connecting element 500 helps to maintain its position within the valve. In some embodiments, the connecting element 500 is curved to cover the posterior leaflet. In some embodiments, the connecting element 500 is curved backward toward the upper edge 540. The connecting element 500 may provide a connecting surface 560 into which the anterior leaflet contacts and connects. Figures 5A and 5B show its geometric shape.

[0066] In some uses, the posterior leaflet can be left intact. The connecting auxiliary element 500 may be attached to the atrium or annulus to efficiently seal the posterior leaflet. In some uses, the posterior leaflet can be removed. The connecting auxiliary element 500 can replace the posterior leaflet if the leaflet is removed or has already been removed. In some embodiments, the connecting auxiliary element 500 requires attachment only to the annulus. In some embodiments, the connecting auxiliary element 500 requires attachment only at a single point. The single point may be the central position of the connecting auxiliary element 500, for example, the centrally located hub. In some embodiments, the connecting auxiliary element 500 may be attached to the atrium or annulus along its edge. In some embodiments, the connecting auxiliary element 500 may be attached to the atrium or annulus at a position away from the edge of the connecting auxiliary element 500, for example, the centrally located hub.

[0067] The connecting auxiliary element 500 may include an annular hub 520 that engages with the annular anchor 800. The annular anchor 800 may be engaged at its proximal end by a driver as described herein. The annular anchor 800 may include a pointed tip that engages with tissue. In some uses, the tip of the annular anchor 800 is inside the annular hub 520 while the connecting auxiliary element 500 is being delivered. In some uses, the tip of the annular anchor 800 is above the annular compartment 510 during delivery. The tip of the annular anchor 800 may remain inside the annular hub 520 until the annular anchor 800 is rotated to engage with tissue. In some embodiments, the connecting auxiliary element 500 can be assembled in vitro to engage the annular anchor 800 with the connecting auxiliary element 500 via the annular hub 520, and the driver with the annular anchor 800. The driver can then be withdrawn into the delivery catheter with the connecting auxiliary element 500 in the folded position. The driver may be operated separately by the operator to position the annular anchor 800 in the appropriate location. Alternatively, the annular anchor 800 may be sequentially engaged with the connecting auxiliary element 500 and / or the driver before or after deployment through the delivery catheter. After deployment, the connecting auxiliary element 500 completely covers the posterior leaflet, and during systole, the connecting auxiliary element 500 connects with the anterior leaflet, allowing the natural anterior leaflet to maintain valve sealing with the annular ring.

[0068] In some embodiments, the annular anchor 800 is an active anchor. The user can selectively engage with or disengage from the annular anchor 800. Unlike a return or other passive anchor, the active anchor can be activated by rotation or other means to engage with the tissue. The annular anchor 800 allows the joining auxiliary element 500 to be positioned before engaging with the annular anchor 800. The joining auxiliary element 500 can contact the tissue without adhering to the annular anchor 800 in any way. In some embodiments, the annular anchor 800 and the corresponding hub 520 are positioned in the center on the joining auxiliary element 500. The annular anchor 800 and the corresponding hub 520 are separated from any edge of the joining auxiliary element 500. The position of the annular anchor 800 and the corresponding hub 520 can be a neutral center that prevents the joining auxiliary element 500 from shaking when it is held by the annular hub 520. The corresponding hub 520 provides a convenient position for holding and moving the connecting auxiliary element 500.

[0069] The annular hub 520 may have an internal or coupled annular anchor 800. In some embodiments, the annular anchor 800 can be secured within the annular hub 520 by a cross pin as described herein. The cross pin may penetrate the helical structure of the annular anchor 800 to prevent the annular anchor 800 from detaching from the annular hub 520 by blunt force. The annular anchor 800 may include a helix that is rotatable relative to the annular hub 520. In some embodiments, other anchors may be used. The annular anchor 800 may be in the form of a tether or other attachment means extending from the connecting auxiliary element 500 through the interventricular septum to the right ventricle. The annular anchor 800 may be in the form of a tether or other attachment means extending through the apex to the epicardium or pericardium. The annular anchor 800 may be fixed from the outside of the heart by a combined endocardial / epidcardial treatment. When helical anchors are used, they may include bioinert materials such as platinum / ir, nitinol alloy, and / or stainless steel.

[0070] In some embodiments, the joining auxiliary element 500 may include a single central annular anchor 800 inside the annular hub 520. The joining auxiliary element 500 can be delivered percutaneously as described herein by attaching a delivery catheter to the annular hub 520. The joining auxiliary element 500 may be configured for adjustable positioning by removing and reattaching the annular anchor 800. The joining auxiliary element 500 may be recaptureable by removing the annular anchor 800 and withdrawing the joining auxiliary element 500. The joining auxiliary element 500 may also include auxiliary anchors, including commissure anchors, ventricular anchors, annular anchors, returns, anchoring devices, or any other known fastening devices.

[0071] As can be seen in Figures 5A to 5B, the connecting auxiliary element 500 may include a plurality of posts 530. In some embodiments, one or more posts 530 have one end terminating at the hub 520 and the other end extending radially outward toward one of the upper edge 540, lateral edges 570 and 575, and lower edge 580 of the connecting auxiliary element 500. The posts 530 may extend outward from the hub 520 in various directions and may be spaced regularly or irregularly apart from adjacent posts 530. In some embodiments, adjacent posts 530 extend outward from the hub at angles of about 5 to about 45 degrees, about 10 to about 30 degrees, or about 5, 10, 15, 20, 25, or 30 degrees relative to the adjacent post 530. The support columns 530 may be arranged substantially parallel to the longitudinal axis of the bonding auxiliary element 500 in order to help maintain the shape of the bonding auxiliary element 500 during placement. The support columns 530 may allow the bonding auxiliary element 500 to take on a reduced configuration for deployment through a catheter. In some embodiments, the support columns 530 forming a portion of the bonding area of ​​the implant 500 have a maximum length longer than the support columns 530 forming only a portion of the annular area of ​​the implant. In some embodiments, the support columns 530 forming a portion of the bonding area of ​​the implant can be at least about 10%, 20%, 30%, 40%, 50%, 75%, 100%, 125%, or 150% longer than, for example, the support columns 530 forming a portion of the annular area of ​​the implant.

[0072] Figure 5A shows a diagram of a joining auxiliary element 500 having an annular anchor portion 535. The annular anchor portion 535 may be a part of the support column 530. The annular anchor portion 535 is shown extending downward from the joining auxiliary element 500 in Figure 5A. In other embodiments, the annular anchor portion 535 may extend in other directions from the joining auxiliary element 500 and engage with the tissue. In some embodiments, the annular anchor portion 535 has one or more barbs with pointed tips. The annular anchor portion 535 may be a passive anchor.

[0073] In some embodiments, the joining auxiliary element 500 may include one or more retractable barbs. For example, a barb may be retracted during delivery of the joining auxiliary element 500. For example, a barb may be advanced after the joining auxiliary element 500 has been positioned relative to an anatomical structure. In some embodiments, the barb is actively retracted and / or advanced. For example, the delivery catheter described herein may include a mechanism coupled to the barb that is designed to retract and / or advance the barb. In other embodiments, the barb is passively advanced and / or retracted. In some embodiments, the joining auxiliary element 500 is delivered with the barb in a retracted state. In some embodiments, the barb may be covered by a valve body cover as described herein. In some embodiments, the interface between the tissue and the valve body cover pushes the valve body cover back, exposing the barb. In some embodiments, the tissue dissolves and / or absorbs a portion of the valve body cover, exposing the barb. In some embodiments, the movement of a purse-string suture as described herein advances the barb. In some embodiments, the movement of the purse-string suture causes the valve body cover to move and expose the barb. Other configurations can be imagined.

[0074] The annular anchor portion 535 may, in some embodiments, define a diameter D1 as shown in Figure 5B, which may correspond to the distance between the internal and external commissures of the natural valve, i.e., the intracommissural distance (ICD). D1 may be in the range of 20 to 60 mm, and in some embodiments, a preferred length is 35 to 45 mm, which is closest to the ICD of the widest range of human mitral valves. In some embodiments, D1 may be the distance from the right fibrous triangle to the left fibrous triangle.

[0075] The connecting auxiliary element 500 may include a substantially annular section 510. The annular section 510 can be positioned above the natural valve leaflet when the connecting auxiliary element 500 is deployed. In some embodiments, the annular section 510 may be curved toward or away from the valve ring. The annular section 510 may be concave. In other embodiments, the annular section 510 may be substantially flat with respect to the valve ring. One or more of the struts 530 may be curved laterally from the hub 520 toward the upper edge 540 to help maintain the shape of the annular section 510 of the connecting auxiliary element 500 when deployed. The connecting auxiliary element 500 may be curved downward from the hub 520 toward the valve ring anchor portion 535. In some embodiments, the connecting auxiliary element 500 does not contact the posterior leaflet. In some embodiments, the valve ring anchor portion 535 is the only point of contact between the posterior valve ring of the mitral valve and the connecting auxiliary element 500. The upper edge 540 may include an annular radius of curvature. The annular curve radius can be curved toward the valve ring. The annular curve radius can be curved toward the joining surface 560. In some embodiments, the annular curve radius can be 0mm to 5mm, 5mm to 10mm, 10mm to 15mm, 15mm to 20mm, 20mm to 25mm, 25mm to 30mm, etc.

[0076] The support column 530 may be made of an X-ray opaque material. In some embodiments, the support column 530 is made of an elastically deformable material such as a shape memory metal, e.g., nitinol, or a shape memory polymer. In some embodiments, the material is Elgiloy. In other embodiments, the support column 530 may be made of other materials, such as stainless steel, polypropylene, high-density polyethylene (PE), Dacron, an acellular collagen matrix such as SIS, or other plastics. In other embodiments, the support column 530 may be a combination of a high-density PE sheath surrounded therein, such as an ePTFE, Dacron, and / or polypropylene core. The support column 530 may have a circular or elliptical cross-section, or it may be ribbon-shaped. In some embodiments, the support column 530 is coil spring-shaped or zigzag-shaped. The support column 530 may have a consistent stiffness. In some embodiments, one or more support columns 530 may have different stiffnesses along the length of one or more support columns 530. The support column 530 may be more rigid at the annular end of the connecting auxiliary element 500 than at the ventricular end. The support column 530 may be less rigid at the annular end of the connecting auxiliary element 500 than at the ventricular end. The support column 530 may be more rigid at its midpoint, for example, at the inflection point or curve. The support column 530 can form a frame together with one or more other support structures. In some embodiments, one or more support structures may be provided that extend parallel to the upper edge 540 of the connecting auxiliary element 500 and help maintain the shape of the upper edge 540. The support column 530 and / or other support structures of the frame can be laser-cut from nitinol tubing in some embodiments.

[0077] The bonding support element body cover 550 may be made of a material such as ePTFE. Other materials for the bonding support element body cover 550 include polyester, polyurethane foam, polycarbonate foam, biological tissue such as porcine pericardium, treated bovine pericardium, pleura, peritoneum, silicone, Dacron, and cell-free collagen matrix. In some embodiments, the bonding support element body cover 550 may include a foam material surrounded by ePTFE. The use of a sponge or foam material improves the ability of the bonding support element 500 to be folded to a diameter small enough to pass through a catheter. In some embodiments, the bonding support element body cover 550 does not have pores. In other embodiments, the bonding support element body cover 550 may have pores to improve endothelialization and cell attachment. The bonding support element body cover 550 may also incorporate radiopaque or echo-enhancing materials for better visibility. Any support structure of the joint auxiliary element 500, including the support interface of the support column 530 or hub 520, may be covered with a radiopaque material such as gold, platinum, or barium-impregnated material. The joint surface 560 may be covered with an echo-enhancing material. The joint auxiliary element body cover 550 may be covered with a thrombosis-inhibiting material such as heparin-binding or quinoline and quinoxaline compounds, or a material that accelerates endothelialization, or an antibiotic that inhibits infection. In some embodiments, the purse-string suture 1010 described herein may incorporate a radiopaque material or an echo-enhancing material for better visibility.

[0078] In some embodiments, the support post 530 may be sandwiched between layers of the joining auxiliary element body cover 550. The joining auxiliary element body cover 550 may be made of the same material on the first surface 505 and the second surface 515. The joining auxiliary element body cover 550 may be made of different materials on the first surface 505 or a portion thereof and the second surface 515 or a portion thereof. In some embodiments, the support post 530 may be attached to or embedded in the first surface 505 or the second surface 515 of a single layer of the joining auxiliary element body cover 550. In some embodiments, the support post 530 may be “stitched” through the joining auxiliary element body cover 550. The valve ring anchor portion 535 may be the end of the support post 530 exposed from the joining auxiliary element body cover 550.

[0079] The joining support element 500 may include a drawstring suture 1010. The drawstring suture 1010 may extend along a portion of the joining support element 500. The drawstring suture 1010 may extend along the upper edge 540 or a portion thereof. The drawstring suture 1010 may extend along the transverse edge 570 or a portion thereof. The drawstring suture 1010 may extend along the transverse edge 575 or a portion thereof. The drawstring suture 1010 may extend along the lower edge 580 or a portion thereof. The drawstring suture 1010 may extend around or along a portion thereof of the joining support element 500. The drawstring suture 1010 may extend along one or more supports 530. The drawstring suture 1010 may extend in a straight path, a non-straight path, a curve, a semicircle, or any open or closed shape.

[0080] In some embodiments, the drawstring suture 1010 may be sandwiched between the layers of the valve body cover 550. For example, the drawstring suture 1010 may be positioned in the lumen between the layers of the joining auxiliary element body cover 550. In some embodiments, the drawstring suture 1010 may be attached to or embedded in a first surface 505 or a second surface 515 of a single layer of the valve body cover 550. In some embodiments, the drawstring suture 1010 may be "sewn in" through the joining auxiliary element body cover 550. The drawstring suture 1010 can pass from the first surface 505 to the second surface 515 and back to the first surface 505. The drawstring suture 1010 may include one or more exposed ends from the joining auxiliary element body cover 550. In embodiments where the drawstring suture 1010 is a loop, the drawstring suture may include one or more exposed sections of the loop from the valve body cover.

[0081] The joining support element 500 may be folded by tightening the purse-string suture 1010. The joining support element 500 may be expanded by loosening the purse-string suture 1010. One or more exposed ends or loops can be manipulated by tightening or loosening the purse-string suture 1010 with a delivery catheter or other tool. The ability to fold or expand the joining support element 500 may be beneficial for recapture and / or repositioning the joining support element 500.

[0082] The joining support element 500 may be rotated by tightening and / or loosening one or more drawstring sutures 1010. For example, the joining support element 500 may be rotated by tightening one or more drawstring sutures 1010 at the transverse edge 570 and / or loosening one or more drawstring sutures 1010 at the transverse edge 575. One or more drawstring sutures 1010 may be coupled to the joining support element 500 to allow multidirectional rotation.

[0083] The joint support element 500 may be expanded by loosening the purse-string suture 1010. One or more exposed ends or loops can be manipulated by tightening or loosening the purse-string suture 1010 with a delivery catheter or other tool. The ability of the joint support element 500 to be folded or expanded may be beneficial for recapture and / or repositioning of the joint support element 500.

[0084] The joining surface 560 of the joining auxiliary element 500 may be adjusted by the movement of the purse-string suture 1010. One or more exposed ends or loops can be manipulated by tightening or loosening the purse-string suture 1010 with a delivery catheter or other tool to change the curvature of the joining surface 560 in situ. The ability to adjust the curvature of the joining auxiliary element 500 can be beneficial in conforming to the geometry of the heart, including the geometry of the anterior leaflet.

[0085] The annular dimension of the joining support element 500 may be adjusted by the movement of the purse-string suture 1010. One or more exposed ends or loops can be manipulated by tightening or loosening the purse-string suture 1010 with a delivery catheter or other tool to change one or more dimensions of the joining support element 500 in situ. The ability to adjust the dimensions of the joining support element 500 can be beneficial for conforming to the geometric shape of the heart.

[0086] The joining support element 500 may include one or more drawstring sutures 1010. In some embodiments, the joining support element 500 may include one, two, three, four, five, six, seven, eight, nine, or ten drawstring sutures. For example, the drawstring sutures 1010 may extend along each edge of the joining support element 500. When multiple drawstring sutures are provided, they can work together to change the configuration of the joining support element 500. When multiple drawstring sutures are provided, they can work independently to change the configuration of the joining support element 500.

[0087] Figure 5A further shows the joint element height, which corresponds to the distance between the lower edge 580 and the valve ring hub 520, measured perpendicular to the plane defined by the valve ring. In some embodiments, the joint element height may be 10 to 80 mm, and in some embodiments, it is in the range of 40 to 55 mm. The joint element height can be 10 to 20 mm, 20 to 30 mm, 30 to 40 mm, 40 to 50 mm, 50 to 60 mm, 60 to 70 mm, 70 to 80 mm, etc.

[0088] Figure 5A shows the substantially triangular shape of the joining auxiliary element 500, having an upper edge 540, lateral edges 570 and 575, and a lower edge 580. In some embodiments, the upper edge 540 is longer than the lower edge 580, so the transverse distance between the lateral edges 570 and 575 decreases overall from the top to the bottom of the joining auxiliary element 500. For example, the length of the upper edge 540 may be in the range of 15 to 50 mm or 25 to 35 mm, and the length of the lower edge 580 may be in the range of 1 to 15 mm or 2 to 6 mm.

[0089] The valve ring hub 520 may be a hub, an eyelet, or any other anchoring part known in the art. In some embodiments, the valve ring hub 520 is located at the midpoint of distance D1. In some embodiments, the valve ring hub 520 is located in the neutral center, preventing the joining auxiliary element 500 from swinging when the joining auxiliary element 500 is held by the valve ring hub 520. In other embodiments, the valve ring hub 520 is located at one of the linkages. Although only one valve ring anchor 800 is shown, in other embodiments, two or more valve ring hubs 520 may be provided.

[0090] In some embodiments, the support column 530 may include NiTi tubing. In some embodiments, the support column 530 may be laser-cut from tubing. In some embodiments, a frame including one or more support columns 530 and / or one or more support structures may be laser-cut from a single piece of material. In some embodiments, a frame including one or more support columns 530, a valve ring hub 520, and / or one or more support structures may be integrally formed. In some embodiments, the joint auxiliary element body cover 550 includes ePTFE laminate. The laminate may surround one or more of the support column 530 and / or one or more support structures (e.g., one face, two faces, a first face 505, a second face 515). The support column 530 and / or one or more support structures may be enclosed by two or more layers of laminate. The periphery of the annular section 510 of the joint auxiliary element 500 may be downward cup-shaped. The periphery of the annular section 510 of the joint auxiliary element 500 may be upward cup-shaped. The area around the annular section 510 of the connecting auxiliary element 500 may include auxiliary anchors such as valve ring anchor portions 535.

[0091] In some embodiments, the annular anchor 800 and the annular hub 520 form a single central anchoring system. In some embodiments, the joining auxiliary element 500 is secured to the tissue by a single annular anchor 800 that penetrates the hub 520. In other embodiments, additional fixation is included. In some embodiments, the joining auxiliary element 500 is secured to the tissue by a single anchor 800 that penetrates the hub 520 and the annular anchor portion 535, as described herein. The system may include features that allow rotational adjustment of the joining auxiliary element 500. For example, the hub 520 and / or the annular anchor 800 can be coupled to a delivery catheter to allow axial movement and / or torque transmission. The joining auxiliary element 500 can be immovably grasped by a delivery catheter so that rotation of a feature of the delivery catheter, such as a handle, causes rotation of the joining auxiliary element 500. The connecting support element 500 can be immobilized by the delivery catheter so as to cause axial movement of the connecting support element 500 by the axial movement of the features of the delivery catheter, such as the drive shaft.

[0092] In some embodiments, the hub 520 is located in a neutral position on the joining auxiliary element 500. The neutral position can be the central position of the annular section 510. The neutral position can be between the transverse edges 505, 515. The neutral position can be between the upper edge 540 and the joining surface 560. The neutral position can improve the stability of the joining auxiliary element 500 when the joining auxiliary element 500 is gripped at a single position such as the hub 520 and / or the valve ring anchor 800. The neutral position can be aligned with the structure of the mitral valve. The neutral position can be aligned along the joining area.

[0093] In some embodiments, the bonding auxiliary element 500 is delivered percutaneously as described herein. In some embodiments, the bonding auxiliary element 500 is adjustable via a delivery catheter. For example, the bonding auxiliary element 500 can be expanded and / or folded by the delivery catheter. For example, the bonding auxiliary element 500 can be rotated around a fixed position on the annular hub 520. For example, the bonding auxiliary element 500 can be recaptured. For example, the bonding auxiliary element 500 can be engaged and re-engaged by the delivery catheter. For example, the annular anchor 800 can be engaged with and disengaged from the tissue, and the delivery catheter can recapture the bonding auxiliary element 500.

[0094] Figures 5C to 5D show embodiments of the frame 565 of the joining auxiliary element 500. These figures show the flattened pattern of the frame 565 before bending and / or shaping. In some embodiments, the frame 565 is cut from a tubular material. In other embodiments, the frame 565 is cut from a flat material, such as a flat material sheet. The frame 565 can be laser cut, including its portion. The frame 565 may include one or more struts 530. In the embodiment shown in Figure 5D, the frame 565 includes 20 struts 530, but other configurations can be envisioned (e.g., 1 strut, 2 struts, 3 struts, 4 struts, 5 struts, 5-10 struts, 10-15 struts, 15-20 struts, 20-25 struts, 25-30 struts, 2-30 struts, 5-30 struts, etc.). In some embodiments, the frame 565 may include approximately, at least approximately, or at most approximately 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30 or more struts, or a number of struts in a range incorporating any two of the aforementioned values. In some embodiments, the length of struts extending to the upper lip which is cupped upward or downward is shorter than the longest strut extending downward, and is less than approximately 80%, 70%, 60%, 50%, 40%, 30%, 20%, or less.

[0095] In some embodiments, one, two, or more struts 530 are joined to a backing 585. In some embodiments, the backing 585 traverses the direction of the struts 530. In the illustrated embodiments, the backing 585 is vertical or nearly vertical, and the struts 530 are horizontal or nearly horizontal. In some embodiments, the backing 585 is a valve ring hub 520. For example, the two ends of the backing 585 can be joined using methods known in the art to form a valve ring hub 520. The two ends are joined, for example, when the frame 565 is cut from a flat material. In other embodiments, the frame 565 is formed from a tubular material. The backing 585 can be a portion of an uncut tubular material. The two ends of the backing 585 may not need to be joined when the frame 565 is formed from a tubular material. The uncut tubular material can form a valve ring hub 520. The frame 565 pattern shown in Figure 5D can be cut from a tubular material, thereby eliminating the need to join the two ends of the backing. Other manufacturing modes for forming the frame 565 can be imagined. In other embodiments, the backing 585 forms at least a portion of the valve ring hub 520. In some embodiments, the backing 585 surrounds at least a portion of the valve ring hub 520. In some manufacturing methods, the backing 585 can be formed in a circular shape. In some manufacturing methods, the support column 530 extends radially outward from the backing 585 when the backing 585 is formed in a circular shape. The backing 585 may include one or more openings designed to receive a cross pin, as described herein. In some manufacturing methods, the backing 585 is removed.

[0096] Referring to Figures 5A and 5C, multiple struts 530 can extend from the annular hub 520 to the lower edge 580. In some embodiments, these struts 530 are longer than other struts 530 of the frame 565. In some embodiments, the struts 530 may include anchors or ribs that interact with the subvalvular structure, including the ventricular wall. In some embodiments, these struts engage with the posterior leaflet or another anatomical structure. In some embodiments, ventricular fixation is passive.

[0097] Referring to Figures 5A to 5D, multiple struts 530 can extend from the annular hub 520 to the upper edge 540. In some embodiments, these struts 530 are shorter than other struts 530 of the frame 565. In some embodiments, these struts 530 form the atrial anchor and / or annular anchor portion 535 described herein. In some embodiments, these struts engage with the annulus or another anatomical structure. In some embodiments, annular fixation is passive.

[0098] Referring to Figures 5A and 5D, multiple struts 530 can extend from the annular hub 520 to the transverse edges 570 and 575. In some embodiments, these struts 530 have an intermediate length between the ventricular struts and the atrial struts. In some embodiments, these struts engage with the commissure or another anatomical structure. In some embodiments, the commissure fixation is passive.

[0099] The struts 530 can have various lengths based on the desired shape of the connecting auxiliary element 500. As shown in Figures 5C to 5D, two or more struts 530 may have different lengths. As shown in Figures 5C to 5D, two or more struts 530 may have the same length. Figure 5C shows a schematic model of the frame 565. One or more of the three upper struts may form the joining surface 560 and extend to the lower edge. One or more of the three lower struts may form an annular portion and extend to the upper edge. The struts 530 can be laser-cut from the tube. The length can be measured from the valve ring hub 520 to the edge of the connecting auxiliary element 500. The strut length can range from 1 mm to 50 mm. In the case of the annular portion 510, the strut length can range from 5 mm to 35 mm. In the case of the annular portion 510, the strut length can be approximately 15 mm. For a joint surface of 560, the column length range can be 20mm to 35mm. For a joint surface of 560, the column length can be approximately 30mm. Other configurations of the column length range can be thought of, for example, 5mm to 45mm, 10mm to 40mm, 15mm to 35mm, approximately 5mm, approximately 10mm, approximately 15mm, approximately 20mm, approximately 25mm, approximately 30mm, approximately 35mm, approximately 40mm, approximately 45mm, approximately 50mm, approximately 55mm, approximately 60mm, 1mm to 10mm, 5mm to 15mm, 10mm to 20mm, 15mm to 25mm, 20mm to 30mm, 25mm to 35mm, 30mm to 40mm, etc.

[0100] The width can be measured perpendicular to the column length. The column width can range from 0.1 mm to 2 mm. One or more columns can have an outer diameter or width such as approximately 0.1 mm, 0.2 mm, 0.3 mm, 0.4 mm, 0.5 mm, 0.6 mm, 0.7 mm, 0.8 mm, 0.9 mm, 1 mm, 1.1 mm, 1.2 mm, 1.3 mm, 1.4 mm, 1.5 mm, 1.6 mm, 1.7 mm, 1.8 mm, 1.9 mm, 2 mm, less than 5 mm, less than 1 mm, less than 1.5 mm, less than 2 mm. One or more columns 530 can have a width that varies along the column length. In some embodiments, one or more columns 530 taper near the edge of the connecting auxiliary element 500. In some embodiments, one or more columns 530 taper near the valve ring hub 520. One or more struts 530 may include a reduced diameter or taper at the connection between one or more struts 530 and the valve annulus hub 520. A taper near the valve annulus hub 520 can assist in the folding of the joining auxiliary element 500. A taper near the valve annulus hub 520 can facilitate the insertion of the joining auxiliary element 500 into the delivery catheter. The taper can reduce stress and / or strain in the strut 530 during folding. In some embodiments, the taper can contribute to a longer fatigue life. In some embodiments, one or more struts 530 include a taper with a variable width. The width of the strut 530 can vary along the length of the strut 530. One or more struts 530 may include eyelets along the length of the strut 530. In some embodiments, eyelets can reduce stress on the strut 530. In some embodiments, eyelets can facilitate adhesion between the strut 530 and the valve body cover 550.

[0101] The thickness can be measured perpendicular to the column length and column width. The thickness can be determined by the thickness of the frame material, as described herein. The column thickness can range from 0.2 mm to 0.5 mm. One or more columns can have thicknesses such as approximately 0.1 mm, 0.2 mm, 0.3 mm, 0.4 mm, 0.5 mm, 0.6 mm, 0.7 mm, 0.8 mm, 0.9 mm, 1 mm, 1.1 mm, 1.2 mm, 1.3 mm, 1.4 mm, 1.5 mm, 1.6 mm, 1.7 mm, 1.8 mm, 1.9 mm, 2 mm, less than 5 mm, less than 1 mm, less than 1.5 mm, less than 2 mm, etc.

[0102] One or more struts 530 may include a barb. In some embodiments, the barb may be configured to be positioned near the ventricular end of the connecting auxiliary element 500. In some embodiments, the barb may be bent outward from the face of the strut 530. In some embodiments, the barb may have a bayonet configuration. In some embodiments, the barb may have a pointed tip. In some embodiments, one or more struts 530 may be bifurcated. In some embodiments, one or more struts 530 may include one or more zigzag sections. In some embodiments, the zigzag sections reduce stress on the strut 530 and / or increase its flexibility. In some embodiments, the zigzag sections facilitate adhesion between the strut 530 and the connecting auxiliary element body cover 550.

[0103] In some embodiments, one or more struts 530 may include supplementary returns. In some embodiments, the supplementary returns may be bent outward from the face of the strut 530. In some embodiments, one or more portions of the strut length may be bent outward from the face of the strut. For example, a portion of the strut may be twisted or bent during manufacturing. In some embodiments, the portion bent outward from the face is shaped to engage with tissue. In some embodiments, one or more struts 530 may include an increased width to compensate for electropolishing or other post-manufacturing processes. In some embodiments, the backing 585 may include one or more features that engage with a delivery catheter as described herein. In some embodiments, the backing 585 may include one or more notches designed to contact a locking tab or other feature of a delivery catheter as described herein at its boundary. In some embodiments, one or more struts 530 may have a wider width than the other struts 530. In some embodiments, the frame 565 includes two or more struts 530 having a wider width than the other struts 530. Two or more struts 530 can facilitate the visibility of the joining auxiliary element 500. In some embodiments, two or more struts 530 having a wider width are designed to be located near the commissure when the connecting auxiliary element 500 is deployed. In some embodiments, one or more struts 530 may have a narrower width than one or more other struts. In some embodiments, each strut 530 has the same width near the valve ring hub 520. The backing 585 can be modified to contact the delivery catheter at its boundary, as described herein. The backing 585 can be designed to allow independent rotation of the anchor 800 within the hub of the connecting auxiliary element 500.

[0104] Figures 5E, 5F, and 5G show one embodiment of a non-returned jointing auxiliary element 500. Figure 5E shows a schematic perspective view of the jointing auxiliary element 500. Figure 5F shows a schematic perspective view of the first surface 505 positioned toward the non-jointed natural valve leaflet. Figure 5G shows a schematic cross-sectional view including the anchor 800.

[0105] Figures 5H, 5I, and 5J show one embodiment of a joining auxiliary element 500 having a valve leaflet anchor portion 545. As shown in Figure 5A, a valve ring anchor portion 535, such as a barb, can extend along the edge of the joining auxiliary element 500. Figures 5H, 5I, and 5J show one embodiment of a joining auxiliary element 500 having a valve leaflet anchor portion 545 extending from a first surface 505 positioned toward a non-jointed natural valve leaflet.

[0106] Figure 5H shows a schematic perspective view of the jointing auxiliary element 500, including an enlarged section showing the valve leaflet anchor portion 545. Figure 5I shows a schematic perspective view of the first surface 505 positioned toward the incompletely joined natural valve leaflet. Figure 5J shows a schematic cross-sectional view including the anchor 800.

[0107] In some embodiments, the leaflet anchor portion 545 comprises one or more barbs having a pointed tip. The leaflet anchor portion 545 may be a passive anchor. In some embodiments, the joining auxiliary element 500 may include one or more retractable barbs. For example, the leaflet anchor portion 545 can be retracted during delivery of the joining auxiliary element 500. For example, the leaflet anchor portion 545 can be advanced after the joining auxiliary element 500 has been positioned relative to an anatomical structure. In some embodiments, the leaflet anchor portion 545 is actively retracted and / or advanced. For example, the delivery catheter described herein may include a mechanism coupled to the leaflet anchor portion 545 that is designed to retract and / or advance the barbs. In other embodiments, the leaflet anchor portion 545 is passively advanced and / or retracted. In some embodiments, the leaflet anchor portion 545 can be covered by a valve body cover as described herein. In some embodiments, the interface between the tissue and the valve body cover pushes back the valve body cover, exposing the leaflet anchor portion 545. In some embodiments, the tissue dissolves and / or absorbs a portion of the valve body cover, exposing the leaflet anchor portion 545. In some embodiments, the movement of the purse-string suture described herein advances the leaflet anchor portion 545. In some embodiments, the movement of the purse-string suture causes the valve body cover to move, exposing the leaflet anchor portion 545. Other configurations can be imagined.

[0108] One or more struts 530 may have one or more returns along the length of the strut 530. In the illustrated embodiment, five struts 530 each have four leaflet anchor portions 545 along the length of the strut. Other configurations can be imagined with a different number of struts 530 (e.g., one, two, three, four, five, six, seven, eight, nine, ten struts, etc.) and a different number of leaflet anchor portions 545 per strut 530 (e.g., one return, two returns, three returns, four returns, five returns, six returns, seven returns, eight returns, nine returns, ten returns, etc.). One or more struts 530 may have the same number of leaflet anchor portions 545. Two or more struts 530 may have a different number of leaflet anchor portions 545. The valve leaflet anchor portion 545 can be positioned to engage with the posterior leaflet.

[0109] In some embodiments, the support 530 may be sandwiched between layers of the valve body cover 550. In some embodiments, the support 530 may be attached to or embedded in a first surface 505 or a second surface 515 of a single layer of the valve body cover 550. In some embodiments, the support 530 may be “stitched” through the valve body cover 550. The first surface 505 may include one or more openings for the valve leaflet anchor portion 545. In other embodiments, the valve leaflet anchor portion 545 may pass through the valve body cover 550. The valve leaflet anchor portion 545 may have a preset curve that can exert force on the first surface 505. The valve leaflet anchor portion 545 may be pointed to cut through the valve body cover 550.

[0110] Frame 565 can have many advantages. Frame 565 can be formed from a flattened pattern. Frame 565 can include a rim that forms the annular hub 520. The rim can include a longitudinal strip or backing 585. One or more struts 530 can extend from the backing 585. In the embodiments illustrated in Figures 5C and 5D, one or more struts 530 are perpendicular to the longitudinal strip. The struts 530 are substantially parallel. In some embodiments, the struts 530 are substantially perpendicular to the backing 585 that forms the annular hub 520. In some embodiments, the struts 530 form an angle with the backing 585. For example, the longitudinal axis of the strut 530 can form an acute angle with the backing 585. The angle can help fold the strut 530 and insert it into the delivery catheter.

[0111] The frame 565 can be constructed from a single flat sheet material. The frame 565 can be precisely cut using water jetting, laser etching, or similar techniques. Details of the struts 530, including the return, can be machined to form the struts 530. The frame 565 can be bent and / or shaped to achieve the desired geometric shape. In some embodiments, the backing 585 is folded to form a loop. The frame 565 can be rolled into a tubular shape. The backing 585 can be welded or otherwise secured. When the ends of the backing 585 are joined and secured to form a loop, it can be considered a valve ring hub 520.

[0112] The support columns 530 are bent to form a desired configuration. The support columns 530 can form one or more curves. The support columns 530 can have one or more inflection points. The support columns 530 can have concave and / or convex portions. One or more support columns 530 can include radially outward flares starting at the inflection points. In some embodiments, the upper edge 540 is curved upward away from the lower edge 580. In some embodiments, the upper edge 540 is curved downward toward the lower edge 580. In some embodiments, one or more support columns 530 can be substantially flat. Support columns 530 near the intersection can be substantially flat. In some embodiments, the lower edge 580 is curved backward toward the upper edge 540. In some embodiments, the lower edge 580 is curved forward away from the upper edge 540.

[0113] The struts 530 can be spaced evenly around the circumference of the annular hub 520. The struts 530 can be spaced unevenly around the circumference of the annular hub 520. A strut 530 extending along one portion of the circumference of the annular hub 520 is different from a strut extending along another portion of the circumference of the annular hub 520. One or more designated portions of the struts 530 can be designed to be located near the annular region of the heart. One or more designated portions of the struts 530 can be designed to be located near the commissure region of the heart. One or more designated portions of the struts 530 can be designed to be located near the ventricular region of the heart. The geometric shape of radially extending struts 530 can be shaped to match the patient's geometric shape. In some embodiments, the geometric shape is patient-specific. The practitioner can shape one or more struts 530 based on the cardiac geometric shape. The practitioner can modify the shape of one or more support columns 530 based on the patient's geometric shape.

[0114] Figure 5K shows the dimensions of the joint auxiliary element 500. The joint auxiliary element 500 may include dimension A. Dimension A can be a linear projection or a rear projection. In some embodiments, the range of dimension A can be 1 mm to 40 mm. In some embodiments, the range of dimension A can be 4 mm to 24 mm. Other configurations of the range of dimension A can be thought of, e.g., 5 mm to 35 mm, 10 mm to 30 mm, 15 mm to 25 mm, approximately 1 mm, approximately 2 mm, approximately 3 mm, approximately 4 mm, approximately 5 mm, approximately 6 mm, approximately 7 mm, approximately 8 mm, approximately 9 mm, approximately 10 mm, 1 mm to 10 mm, 5 mm to 15 mm, 10 mm to 20 mm, 15 mm to 25 mm, 20 mm to 30 mm, 25 mm to 35 mm, 30 mm to 40 mm, etc. If there is no rear projection, for example if the joint auxiliary element 500 is straight, dimension A can be 0 mm.

[0115] The joining auxiliary element 500 may include dimension B. In some embodiments, dimension B may be the radius of curvature. The radius of curvature may be concave or convex, as described herein. In some embodiments, the range of dimension B may be 1 / 16 inch to 1 / 2 inch. In some embodiments, the range of dimension B may be 1.5 mm to 13 mm. In some embodiments, the range of dimension B may be 1 / 4 inch to 3 / 8 inch. In some embodiments, the range of dimension B may be 6 mm to 9.5 mm. In some embodiments, the range of dimension B may be 1 mm to 15 mm. Other configurations within the dimension B range can be thought of, for example, 2mm-14mm, 3mm-13mm, 4mm-12mm, 5mm-11mm, 6mm-10mm, 7mm-9mm, approximately 1mm, approximately 2mm, approximately 3mm, approximately 4mm, approximately 5mm, approximately 6mm, approximately 7mm, approximately 8mm, approximately 9mm, approximately 10mm, 1mm-10mm, 5mm-15mm, 10mm-20mm, etc. If there is no curvature, for example if the joining auxiliary element 500 is straight, dimension B can be 0mm.

[0116] The joining auxiliary element 500 may include dimension C. In some embodiments, dimension C may be the radius of curvature near the upper edge 540. In some embodiments, the range of dimension C may be 1 mm to 10 mm. In some embodiments, the range of dimension C may be 1 mm to 5 mm. Other configurations of the range of dimension C can be thought of, for example, 2 mm to 9 mm, 3 mm to 8 mm, 4 mm to 7 mm, 5 mm to 6 mm, approximately 1 mm, approximately 2 mm, approximately 3 mm, approximately 4 mm, approximately 5 mm, approximately 6 mm, approximately 7 mm, approximately 8 mm, approximately 9 mm, approximately 10 mm, 1 mm to 15 mm, 5 mm to 10 mm, 3 mm to 9 mm, etc. If there is no curvature, for example if the joining auxiliary element 500 is straight, dimension C may be 0 mm.

[0117] The connecting auxiliary element 500 may include dimension D. Dimension D may be the height of the connecting element. Dimension D may correspond to the distance between the lower edge 580 and the atrial anchor portion or annular hub 520, measured perpendicular to the plane defined by the annulus. In some embodiments, the range of dimension D may be 10 mm to 80 mm. In some embodiments, the range of dimension D may be 40 mm to 55 mm. Other configurations within the dimension range D can be thought of, such as 5mm-105mm, 10mm-100mm, 15mm-95mm, 20mm-90mm, 25mm-85mm, 30mm-80mm, 35mm-75mm, 40mm-70mm, 45mm-65mm, 50mm-60mm, approximately 10mm, approximately 20mm, approximately 30mm, approximately 40mm, approximately 50mm, approximately 60mm, approximately 70mm, approximately 80mm, approximately 90mm, approximately 100mm, 10mm-50mm, 20mm-60mm, 30mm-70mm, 40mm-80mm, 50mm-90mm, 60mm-100mm, 70mm-110mm, etc.

[0118] The joining auxiliary element 500 may include dimension E. Dimension E can be a linear projection or a front projection. In some embodiments, the range of dimension E can be 2 mm to 20 mm. In some embodiments, the range of dimension E can be 5 mm to 10 mm. Other configurations of the dimension E range can be thought of, for example, 0 mm to 25 mm, 5 mm to 20 mm, 10 mm to 15 mm, about 1 mm, about 2 mm, about 3 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, about 11 mm, about 12 mm, about 13 mm, about 14 mm, about 15 mm, about 16 mm, about 17 mm, about 18 mm, about 19 mm, about 20 mm, 1 mm to 10 mm, 5 mm to 15 mm, 10 mm to 20 mm, 15 mm to 25 mm, 20 mm to 30 mm, 25 mm to 35 mm, 30 mm to 40 mm, etc. If there is no front projection, dimension E can be 0 mm.

[0119] The support column 530 of the joining auxiliary element 500 can form a backward curve of the joining surface 560. The backward curve can have a bending length of 30-100% of the distal side of the support column. In some embodiments, the backward curve can have a bending length of at least 40% of the distal side of the support column. The angle of the backward curve can be in the range of 0-90 degrees with respect to the longitudinal axis of the joining auxiliary element 500. In some embodiments, the angle of the backward curve can be in the range of 45-90 degrees.

[0120] Figure 6 shows one embodiment of the joining auxiliary element 600. The joining auxiliary element 600 may be similar to the joining auxiliary element 500 and may include any of the features of the joining auxiliary element 500 described herein, as well as having certain additional features described later.

[0121] The connecting auxiliary element 600 may include an annular hub 620 that engages with an annular anchor (not shown). The annular hub 620 may have an internal or coupled annular anchor, such as the annular anchor 800 described herein. The annular anchor may include a helix that is rotatable relative to the annular hub 620. In some embodiments, the connecting auxiliary element 600 may include a single annular anchor inside the annular hub 620. The connecting auxiliary element 600 can be delivered percutaneously as described herein by attaching a delivery catheter to the annular hub 620.

[0122] As can be seen in Figure 6, the joining auxiliary element 600 may include struts 630. In some embodiments, one, two, or more struts 630 have one end terminating at the valve ring hub 620 and the other end extending radially outward toward the upper edge 640, lateral edges 670 and 675, and lower edge 680 of the joining auxiliary element 600. The struts 630 may extend outward from the hub 620. The struts 630 may be arranged substantially parallel to the longitudinal axis of the joining auxiliary element 600 to help maintain the shape of the joining auxiliary element 600 during placement. The struts 630 may allow the joining auxiliary element 600 to take on a reduced configuration for deployment through a catheter.

[0123] The joining auxiliary element 600 may include an annular section 610. When the joining auxiliary element 600 is deployed and forms a lip as shown, the annular section 610 can be positioned above the annulus of the natural valve leaflet. In some embodiments, the annular section 610 may be curved upward, for example away from the annulus, in a direction substantially opposite to and substantially parallel to the joining surface 660, and when embedded, may form the uppermost portion of the joining auxiliary element 600. The annular section 610 may be convex. In other embodiments, the annular section 610 may be substantially flat with respect to the annulus. One or more of the supports 630 may be curved laterally from the annulus hub 620 toward the upper edge 640 to help maintain the shape of the annular section 610 of the joining auxiliary element 600 when deployed. The joining auxiliary element 600 may be curved upward from the annulus hub 620. In some embodiments, the upper edge 640 does not touch the trailing leaflet. The upper edge 640 may include an annular radius of curvature. The annular curve radius can be curved away from the valve ring. The annular curve radius can be curved toward the joining surface 660. In some embodiments, the annular curve radius can be in a range such as 0mm to 5mm, 5mm to 10mm, 10mm to 15mm, 15mm to 20mm, 20mm to 25mm, 25mm to 30mm, or any two of the aforementioned values. The joining auxiliary element body cover 650 may be similar to the joining auxiliary element body cover 550 described herein.

[0124] In some embodiments, the periphery of the annular section 610 is cupped upward and substantially opposite to the longitudinal axis of the joining surface 660. In some embodiments, the joining auxiliary element 600 includes a valve annular anchor portion similar to the valve annular anchor portion 535. In other embodiments, the joining auxiliary element 600 does not include a valve annular anchor portion as shown in Figure 6.

[0125] Figures 7A to 7E show one embodiment of the joining auxiliary element 700. The joining auxiliary element 700 may be similar to the joining auxiliary element 500 or 600 and may include any of the features described herein, as well as certain elements described later.

[0126] The junction support element 700 may include a first surface 705 and a second surface 715. Figure 7A shows a perspective view of the first surface 705, i.e., the lower surface, which is positioned toward the incompletely junctioned natural leaflet, or the posterior leaflet in the case of a mitral valve. Figure 7B shows a perspective view of the second surface 715, i.e., the upper surface, which may be positioned toward the anterior leaflet. The second surface 715 may include a junction surface 760. The upper edge 740 of the junction support element 700 may be curved to conform to the overall shape of the annulus or adjacent atrial wall. The upper edge 740 may be curved downward toward the posterior leaflet, as shown in Figure 7B. Figure 7C shows a top view of the junction support element 700.

[0127] Figures 7A–7C show diagrams of a connecting auxiliary element 700 having an annular hub 720. The connecting auxiliary element 700 may include an annular hub 720 designed to engage with an annular anchor 800. The annular anchor 800 may be engaged at its proximal end by a driver as described herein. The annular hub 720 may have an internal or coupled annular anchor 800. The annular anchor 800 may include a helix rotatable relative to the annular hub 720. The connecting auxiliary element 700 can be delivered percutaneously as described herein by attaching a delivery catheter to the annular hub 720.

[0128] As can be seen in Figures 7A to 7C, the connecting auxiliary element 700 may include a column 730. In some embodiments, one or more columns 730 have one end terminating at the valve ring hub 720 and the other end extending radially outward toward the upper edge 740, lateral edges 770 and 775, and lower edge 780 of the connecting auxiliary element 700 shown in Figure 7B. The valve ring anchor portion 735 is shown extending downward from the body of the connecting auxiliary element 700 in Figure 7B. The valve ring anchor 800 may be an active anchor. The valve ring anchor portion 735 may be a passive anchor, such as a barb. The valve ring anchor portion 735 may be located at the distal end of one or more columns 730.

[0129] The annular section 710 can be positioned above the natural valve leaflet when the connecting auxiliary element 700 is deployed. In some embodiments, the annular section 710 may be curved toward the annulus or atrial wall. One or more of the struts 730 may be curved laterally from the hub 720 toward the upper edge 740 to help maintain the shape of the annular section 710 of the connecting auxiliary element 700 when deployed. The connecting auxiliary element 700 may be curved downward from the annular hub 720 toward the annular anchor portion 735. The annular section 710 may be concave. In some embodiments, one or more support structures may be provided that extend parallel to the upper edge 740 of the connecting auxiliary element 700 to help maintain the shape of the upper edge 740. Other support structures of the struts 730 and / or frame may, in some embodiments, be laser-cut from nitinol tubing. The valve body cover 750 may be made of a material such as those described herein.

[0130] In some embodiments, the joining auxiliary element 700 includes an active anchor such as a valve ring anchor 800. In some embodiments, the joining auxiliary element 700 includes a passive anchor such as a valve ring anchor portion 735. The valve ring anchor portion 735 may include a return at the tip of one or more support columns 730.

[0131] As with any of the connecting auxiliary elements 500, 600 described herein, the connecting auxiliary element 700 may include one or more markers 900. The markers 900 can be positioned on any part of the connecting auxiliary elements 500, 600, 700, or on any part of any element of the connecting auxiliary element, such as the support columns 530, 630, 730, the valve ring hubs 520, 620, 720, the purse-string sutures 1010, and / or the valve ring anchor portions 535, 735. In some embodiments, the markers 900 are positioned on the valve ring anchor 800. In other embodiments, the markers 900 are formed integrally with the connecting auxiliary elements 500, 600, 700, or the valve ring anchor 800. Multiple markers 900 can be arranged in a specific pattern on the bonding support element to provide a radiographic visual aid for the operator to accurately orient and position the bonding support element 500, 600, 700 and / or annular anchor 800 within the patient's heart.

[0132] In some embodiments, the marker 900 may be radiopaque or covered with a radiographic marker. If a fluoroscopy device is used during the process of delivering the bonding auxiliary elements 500, 600, 700 and / or annular anchor 800, the marker 900 may be visible. The marker 900 can help position the bonding auxiliary elements 500, 600, 700 and / or annular anchor 800 within the patient's heart. In some embodiments, torque can be applied to the annular anchor 800 to drive it into the tissue. A fluoroscopic marker 900 may be present on the annular anchor 800 to provide feedback on whether the annular anchor 800 is properly secured. The marker may be located at the proximal end. These markers 900 may inform the medical team how far the annular anchor 800 has moved toward the annular hubs 520, 620, 720, and may also be reassuring regarding when the annular anchor 800 is safely in place. In some embodiments, to ensure that appropriate torque is applied, the amount of torque in the handle may increase sharply when the valve ring anchor 800 is in its lowest position on the valve ring hubs 520, 620, 720. The systems described herein may include one or more markers 900 (e.g., one, two, three, four, five, six, seven, eight, nine, ten, one more, two more, three more, four more, etc.). The systems described herein may include two or more different markers 900. Different markers may indicate different components of the system, different parts of the joining auxiliary elements 500, 600, 700, or positioning points such as the nearest point, the farthest point, the centerline.

[0133] Figures 7D–7E show one embodiment of the junctional auxiliary element 700 deployed within a cardiac mitral valve model. Referring again to Figure 1F, the junctional area CL between the valve leaflets is not a simple line, but rather a curved, funnel-shaped surface interface as shown in Figure 7C. The first commissure 110 (anterolateral or left side) and the second commissure 114 (postomedial or right side) are where the anterior leaflet 12 joins the posterior leaflet in the junctional area, forming the junctional line (CL). As is most clearly visible in the axial view from the atrium in Figure 7D, the axial cross-section of the junctional area shows the curved CL as a whole, separated from the annular center and from the opening through the valve during diastole. In addition, the leaflet margins are wavy, with the posterior leaflet being more wavy than the anterior leaflet. Since junction failure can occur between these AP(anterior-posterior) segments and one or more of A1 / P1, A2 / P2, and A3 / P3, the characteristics of junction failure may vary along the junction area curve CL, as shown in Figure 1F.

[0134] In some embodiments, the joining auxiliary element 700 is positioned on the posterior leaflet to create a new surface upon which the natural valve leaflet, in this case the anterior leaflet, can be joined. The mitral valve is shown together with the anterior leaflet 12. The joining area is formed between the anterior leaflet 12 and the joining surface 760 of the joining auxiliary element 700.

[0135] Referring next to Figure 8A, an embodiment of the delivery catheter 1000 is shown. The delivery catheter 1000 may include a control handle. The delivery catheter 1000 may include a tip deflection control unit 1001. The tip deflection control unit 1001 may make the distal portion of the delivery catheter 1000 bendable. This may be advantageous for positioning the connecting auxiliary elements 500, 600, 700 within the mitral valve. The delivery catheter 1000 may be inserted into a transseptal sheath (not shown). The transseptal sheath allows the delivery catheter to be introduced into the left atrium. The delivery catheter 1000 may further include one or more ports 1002, such as a lavage, irrigation, and / or aspiration port, to remove air from the system and allow a fluid, such as saline or contrast agent, to be injected into the implantation site. The catheter 1000 may include a catheter axis 1006. The catheter 1000 may include an implant inserter 1007.

[0136] The delivery catheter 1000 may include an implant control knob 1003. The implant control knob 1003 can control the movement of the bonding auxiliary elements 500, 600, and 700. The implant control knob 1003 may allow the bonding auxiliary elements 500, 600, and 700 to be folded. The implant control knob 1003 may allow the bonding auxiliary elements 500, 600, and 700 to be extended. Arrow 1003a indicates the direction of movement of the implant control knob 1003, which causes the bonding auxiliary elements 500, 600, and 700 to be folded by the delivery catheter 1000 and / or extended by the delivery catheter 1000. The implant control knob 1003 may allow the bonding auxiliary elements 500, 600, and 700 to be rotated. Arrow 1003b indicates the direction of movement of the implant control knob 1003, which causes the bonding auxiliary elements 500, 600, and 700 to be rotated.

[0137] The implant control knob 1003 can be internally connected to the joining auxiliary elements 500, 600, and 700 to enable axial movement and / or torque transmission. For example, the implant control knob 1003 of a delivery catheter 1000 can be coupled to the valve annulus hubs 520, 620, and 720. For example, the implant control knob 1003 can be connected to one or more purse-string sutures 1010 that may control the deployment of the joining auxiliary elements 500, 600, and 700. The purse-string sutures 1010 may facilitate the folding and / or expansion of the joining auxiliary elements 500, 600, and 700 as described herein. The purse-string sutures 1010 may facilitate the rotation of the joining auxiliary elements 500, 600, and 700 as described herein. In some embodiments, the delivery catheter 1000 engages the connecting auxiliary elements 500, 600, and 700 in a releasable manner so that axial movement and torque can be transmitted from the delivery catheter 1000 to the connecting auxiliary elements 500, 600, and 700.

[0138] In some embodiments, the tip 1300 of the delivery catheter 1000 is releasably coupled to the annular hubs 520, 620, and 720. For example, the tip 1300 of the delivery catheter 1000 can be locked onto the annular hubs 520, 620, and 720 such that the coupling auxiliary elements 500, 600, and 700 move as the delivery catheter 1000 moves. In some embodiments, the system includes a release mechanism between the delivery catheter 1000 and the annular hubs 520, 620, and 720.

[0139] The annular hubs 520, 620, and 720 may have features that allow them to engage with the tip 1300 of the delivery catheter 1000. Referring again to Figures 5A to 7E, the annular hubs 520, 620, and 720 may include one or more features that engage with a portion of the delivery catheter 1000. The features may include one or more notches in the hub 520 of the implant, as shown in Figure 5A. The features may include an internal lip, as shown in Figure 9A. The features may include a window accessible from the outside of the hubs 520, 620, and 720, as shown in Figure 8C. The features may include any structure or mechanism that allows the annular hubs 520, 620, and 720 to connect with a portion of the delivery catheter 1000. In some embodiments, the annular hubs 520, 620, and 720 and the delivery catheter 1000 are connected via a screw mechanism. For example, the annular hubs 520, 620, and 720 may include female threads, and the distal end of the delivery catheter 1000 may include male threads. In some embodiments, the annular hubs 520, 620, and 720 and the delivery catheter 1000 are connected via a noose and pin configuration. For example, the annular hubs 520, 620, and 720 may include a pin, such as an outwardly extending pin, and the distal end of the delivery catheter 1000 may include a loop or ring designed to tighten around the pin. Other configurations can be imagined.

[0140] Figure 8B shows the connecting auxiliary elements 500, 600, and 700 coupled to the delivery catheter 1000. The connecting auxiliary elements 500, 600, and 700 can be folded as shown or expanded as indicated by the dashed line by moving along arrow 1003a. The connecting auxiliary elements 500, 600, and 700 can be rotated as indicated by the dashed line by moving along arrow 1003b.

[0141] Referring to Figure 8C, the delivery catheter 1000 may include a tip 1300. The distal end of the tip 1300 may include distal locking tabs. In some embodiments, the tip 1300 includes a plurality of pre-bent or shaped locking tabs. In some embodiments, the tip may include two locking tabs, three locking tabs, four locking tabs, five locking tabs, multiple locking tabs, numerous locking tabs, and so on. This “AT lock” (axial-torsional lock) may include nitinol locking tabs on the tip 1300. In some embodiments, the locking tabs on the tip 1300 can be actuated by a sheath 1350. In some embodiments, the sheath 1350 is hollow and allows movement of other components, such as drivers described herein. Movement of the sheath 1350 pushes the locking tabs inward and engages with the valve annular hubs 520, 620, 720. In some embodiments, the locking tab of the tip 1300 engages with features such as windows or lips on the valve ring hubs 520, 620, and 720. In some embodiments, the valve ring hubs 520, 620, and 720 can be released from the tip by moving the sheath 1350 in the opposite direction. In other embodiments, the locking tab of the tip 1300 can be actuated by a central pin (not shown) inserted into the tip 1300. In some embodiments, the central pin is hollow and allows the movement of other components such as a driver described herein. The movement of the central pin pushes the locking tab outward and engages with the valve ring hubs 520, 620, and 720.

[0142] In some embodiments, the distal end of the tip 1300 can be actuated to lock the delivery catheter 1000 to the annular hubs 520, 620, and 720. In some embodiments, the distal end of the tip 1300 can be actuated to release the delivery catheter 1000 from the annular hubs 520, 620, and 720. As described herein, auxiliary structures such as purse-string sutures may remain coupled to the connecting auxiliary elements 500, 600, and 700 after the annular hubs 520, 620, and 720 have been released from the tip 1300. In some embodiments, when the delivery catheter 1000 is released, one or more auxiliary structures such as purse-string sutures as described herein can maintain the relative position between the delivery catheter 1000 and the annular hubs 520, 620, and 720. During the procedure, the tip 1300 may be repeatedly locked and released.

[0143] Referring again to Figure 8A, the delivery catheter 1000 may include an anchor control knob 1004. In some embodiments, the anchor control knob 1004 may enable the release of the annular anchor 800 and / or the bonding auxiliary elements 500, 600, 700. In some embodiments, the anchor control knob 1004 may enable engagement of the annular anchor 800, for example, to rotate the annular anchor 800 and / or move the annular anchor 800 axially. In some embodiments, the anchor control knob 1004 may enable the engagement and disengagement of the annular anchor 800. In some embodiments, the anchor control knob 1004 may control a driver 1200 configured to apply torque. In some embodiments, the anchor control knob 1004 may control a driver 1200 configured to apply tension to the bonding auxiliary elements 500, 600, 700 and / or release them. In some embodiments, the anchor control knob 1004 may control a driver 1200 configured to apply tension and torque.

[0144] The anchor control knob 1004 of the delivery catheter 1000 may be coupled to the annular anchor 800 to enable the transmission of torque to the annular anchor 800. The anchor control knob 1004 may also enable simple manipulation of the torque or position of the annular anchor 800. Arrow 1004a indicates the direction of movement of the anchor control knob 1004 in which the annular anchor 800 is engaged or disengaged. For example, the driver 1200 may be engaged with the annular anchor 800 by moving the anchor control knob 1004 toward the annular anchor 800. Arrow 1004b indicates the direction of movement of the anchor control knob 1004 in which torque is transmitted to the annular anchor 800. In some embodiments, arrow 1004b indicates the direction in which the annular anchor 800 is released. For example, by applying further torque, the driver 1200 may be twisted and disengaged from the annular anchor 800.

[0145] One embodiment of the annular anchor 800 is shown in detail in Figure 9A. Other components of the delivery catheter 1000, such as components that engage with the annular hubs 520, 620, and 720, are not shown in Figure 9A. The annular anchor 800 may be coupled to the driver 1200 in various ways, as described herein. The annular anchor 800 may be coupled to the connecting auxiliary elements 500, 600, and 700 in various ways. In some embodiments, the annular hubs 520, 620, and 720 may have a cross pin 820. The cross pin 820 can provide a portion around which the helical structure 815 of the annular anchor 800 may wrap as shown. The annular anchor 800 may have a shoulder 805. The shoulder 805 may fit around the outside of the driver 1200 of the delivery catheter 1000.

[0146] In some embodiments, the driver 1200 is releasably coupled to the annular anchor 800. The driver 1200 can be coupled and / or controlled by an anchor control knob 1004 as described herein. One or more drivers 1200 can deliver torque to drive the annular anchor 800 into the tissue. One or more drivers 1200 can deliver tension to hold and / or release the annular anchor 800. In some embodiments, a single driver 1200 delivers both torque and tension. In other embodiments, two or more drivers 1200 deliver both torque and tension. For example, the driver 1200 can be locked onto the annular anchor 800 such that the annular anchor 800 moves as the driver 1200 moves. In some embodiments, the system includes a release mechanism between the driver 1200 and the annular anchor 800. In some embodiments, the distal end of the driver 1200 can be actuated to lock the driver 1200 onto the annular anchor 800. In some embodiments, the distal end of the driver 1200 can be actuated to release the driver 1200 from the valve annular anchor 800. In some embodiments, when the driver 1200 is released, one or more auxiliary structures, such as a purse-string suture, can maintain the relative position between the delivery catheter 1000 and the valve annular anchor 800. During the procedure, the driver 1200 may be repeatedly engaged and disengaged.

[0147] Figure 9B shows one embodiment of the driver 1200. The driver 1200 may include a torque shaft 1205. The torque shaft 1205 may include a loop 1210. The loop 1210 can engage with a pin 1215, which extends through the anchor 800 around the tension cross pin 1270 and forms a loop. Rotation of the torque shaft 1205 generates a torque that is applied to the torque cross pin 1275, thereby causing the valve ring anchor 800 to rotate. In some embodiments, the valve ring anchor 800 may include a torque cross pin and a tension cross pin. Another driver (not shown) can apply torque to the tension cross pin to apply tension to the valve ring anchor 800. One or more drivers 1200 can engage with the valve ring anchor 800 to deliver torque. One or more drivers 1200 can engage with the valve ring anchor 800 to deliver tension. In some embodiments, the delivery of the valve ring anchor 800 is independent of the rotation of the joining auxiliary elements 500, 600, and 700.

[0148] Figure 9C shows one embodiment of the driver 1200. The driver 1200 may include a torque shaft 1220. The torque shaft 1220 may include an anchor docking cap 1225. The anchor docking cap 1225 can engage the valve ring anchor 800 in a single orientation or in one of several orientations. In some embodiments, the valve ring anchor 800 includes a projection 1230, and the anchor docking cap 1225 is designed to receive the projection 1230. In other embodiments, the valve ring anchor 800 includes a recess (not shown) that receives a meshing projection (not shown) on the anchor docking cap 1225. Rotation of the torque shaft 1220 can generate torque to be applied to the valve ring anchor 800. Another driver 1235 can apply tension to the valve ring anchor 800. In some embodiments, the driver 1235 may include a release screw. In other embodiments, a loop and pin type release mechanism shown in Figure 9B may be used. The valve ring anchor 800 can be released by rotating the release screw. One or more drivers 1200 can engage with the valve ring anchor 800 to deliver torque. One or more drivers 1200 can engage with the valve ring anchor 800 to deliver tension.

[0149] Figure 9D shows one embodiment of a driver 1200 and a valve ring anchor 800. The driver 1200 may include a torque shaft 1220. The torque shaft 1220 may include an anchor docking cap 1225. In some embodiments, the valve ring anchor 800 includes a projection 1230, and the anchor docking cap 1225 is designed to receive the projection 1230. In other embodiments, the valve ring anchor 800 includes a recess (not shown) that receives a meshing projection (not shown) on the anchor docking cap 1225. Two or more wires 1240, 1245 can apply tension to the valve ring anchor 800. In some embodiments, the wire 1240 acts as a pin, and the wire 1245 terminates with a ball. In the retaining state, both wires 1240, 1245 are positioned within the opening of the valve ring anchor 800. The opening is small, so the pin and ball-shaped ends of the wires 1240, 1245 cannot pass through side by side. In some applications, wire 1240 is retracted first. The retraction of wire 1240 provides sufficient space for wire 1245 to retract. Wires 1240 and 1245 can be actuated to release the valve ring anchor 800. One or more drivers 1200 can engage with the valve ring anchor 800 to deliver torque. One or more drivers 1200 can engage with the valve ring anchor 800 to deliver tension.

[0150] Figure 9E shows one embodiment of the driver 1200. The driver 1200 may include a torque shaft 1255. The shoulder 805 may have features such as a window 810 that can engage with one or more distal locking tabs 1265 of the torque shaft 1255. The distal locking tabs 1265 may include a nitinol material such as a shaped NiTi clip. The distal locking tabs 1265 may be pushed outward into the window 810 by the driver 1260. The driver 1260 acts as a release mechanism. The distal locking tabs 1265 may be pushed outward into the window 810 by longitudinal movement of the driver 1260 toward the valve ring anchor 800. The distal locking tabs 1265 may return to a neutral configuration and disengage from the window 810 by longitudinal movement of the driver 1260 toward the valve ring anchor 800. The distal locking tab 1265 engages with the window 810 of the annular anchor 800, thereby enabling the transmission of axial movement between the torque shaft 1255 and the annular anchor 800. The distal locking tab 1265 engages with the window 810 of the annular anchor 800, thereby enabling the transmission of torque between the torque shaft 1255 and the annular anchor 800. In embodiments in which the annular anchor 800 is housed in or captured by the annular hubs 520, 620, 720, the distal locking tab 1265 engages with the window 810, thereby enabling the transmission of axial movement between the delivery catheter and the connecting auxiliary elements 500, 600, 700.

[0151] In some embodiments, an advantage may be that the annular anchor 800 can be rotated independently of the connecting auxiliary elements 500, 600, and 700. As described herein, the connecting auxiliary elements 500, 600, and 700 are coupled to the delivery catheter 1000. As described herein, the annular anchor 800 is independently coupled to the driver 1200. The annular anchor 800 can be rotated independently of the annular hubs 520, 620, and 720. When the annular anchor 800 is rotated to engage with tissue, the annular hubs 520, 620, and 720 can remain stationary.

[0152] In some cases, the annular anchor 800 can be pre-mounted on the connecting auxiliary elements 500, 600, and 700 during the process of mounting the connecting auxiliary elements 500, 600, and 700 onto the delivery catheter 1000 and then coupled to the driver 1200. This can be done before the connecting auxiliary elements 500, 600, and 700 are retracted into the implant sheath and / or another portion of the delivery catheter 1000 and are ready for insertion into the femoral vein. As described herein, torque can be applied to drive the annular anchor 800 into the tissue. In some embodiments, to ensure that the appropriate torque is applied, the amount of torque in the handle may increase sharply when the annular anchor 800 is in its lowest position on the annular hubs 520, 620, and 720. This increase in torque may be felt in the handle to provide feedback that the appropriate torque is being applied. In other embodiments, radiopaque markings may help to visually determine the level of engagement between the anchor and the tissue. In some embodiments, the markings can be placed on the valve ring anchor 800 and / or the connecting auxiliary elements 500, 600, 700.

[0153] Figures 10 to 15 illustrate various methods that may be performed during the use of the connecting auxiliary elements 500, 600, and 700. The method may include folding the connecting auxiliary elements 500, 600, and 700. The method may include coupling the connecting auxiliary elements 500, 600, and 700 to the delivery catheter 1000. The method may include coupling the locking tab 1265 to the valve annular anchor 800 and / or the connecting auxiliary elements 500, 600, and 700. The method may include any of the steps described herein for manufacturing the connecting auxiliary elements 500, 600, and 700.

[0154] In some embodiments, an advantage is that the connecting auxiliary elements 500, 600, and 700 can be delivered in an orientation in which the hubs precede. In this method of use, the annular hubs 520, 620, and 720 can be moved into position relative to the anatomical structure prior to other parts of the connecting auxiliary elements 500, 600, and 700. In some methods of use, the ventricular ends of the connecting auxiliary elements 500, 600, and 700 can be retained within the delivery catheter 1000 until the annular hubs 520, 620, and 720 are positioned. In some methods of use, once the annular hubs 520, 620, and 720 and / or annular anchors 800 are engaged with the tissue, the connecting auxiliary elements 500, 600, and 700 can be expanded. In some methods of use, once the annular hubs 520, 620, and 720 and / or annular anchors 800 are engaged with the tissue, the ventricular ends of the connecting auxiliary elements 500, 600, and 700 can be positioned.

[0155] In some embodiments, an advantage is that the connecting auxiliary elements 500, 600, and 700 can be delivered in an orientation in which the struts precede. In this method of use, one or more of the struts 530, 630, and 730 of the connecting auxiliary elements 500, 600, and 700 can be moved to a fixed position relative to the anatomical structure prior to another part of the connecting auxiliary elements 500, 600, and 700. In some methods of use, the connecting auxiliary elements 500, 600, and 700 can be expanded or partially expanded before the annular hubs 520, 620, and 720 are positioned. In some methods of use, the annular hubs 520, 620, and 720 can be retained within the delivery catheter until one or more of the struts 530, 630, and 730 are positioned. In some methods of use, once the struts 530, 630, and 730 are positioned, the annular anchor 800 engages with the tissue.

[0156] Figure 10 shows one embodiment of a transseptal transsection. The method may include access to the femoral vein. Access may be obtained through a blood vessel such as the femoral vein to reach the cardiac chambers of the heart, such as the right atrium 1300. The left ventricle 1380 and its papillary muscle are also shown at 1360. The method may include transseptal puncture using a standard transseptal kit 1330 and transsection to the left atrium 1320. The method may include replacement with a custom transseptal sheath and delivery catheter 1000 as described herein. The transseptal puncture kit may be replaced with a transseptal sheath and dilator, the dilator may be replaced with an implantable delivery catheter as described herein and as described in U.S. Patent No. 8,888,843 of Khairkhahan et al., which is incorporated herein by reference in whole. The method may include removal of the dilator. The method may include advancing the delivery catheter 1000. However, other methods such as transapical, transatrial, femoral, and brachial artery injections are also within the scope of this invention.

[0157] Figure 11 shows the initial advancement of the joining auxiliary elements 500, 600, and 700. The method may include advancing the joining auxiliary elements 500, 600, and 700 within the retrieval sheath. The retrieval sheath may include a tip having multiple petals radiating from a central hub 1420. The retrieval sheath may be positioned within the transseptal sheath 1400. The mitral valve is shown at the base of the left atrium 1440. The method may include advancing the annular compartments 510, 610, and 710 toward the annulus before advancing the joining surfaces 560, 660, and 760 toward the annulus. The method may include deploying the ventricular end or lower edge 580 after deploying the annular portion 510.

[0158] Figure 12 shows the partial deployment of the connecting auxiliary elements 500, 600, and 700. The connecting auxiliary elements 500, 600, and 700 may be advanced near the target location under imaging guidance such as ultrasound or fluoroscopy. The annular anchor 800 coupled with the connecting auxiliary elements 500, 600, and 700 engages with the tissue. The anchor torque axis 1540 may be rotated internally and independently of the rotation of the implant torque axis (not shown). The connecting auxiliary elements 500, 600, and 700 may be expanded by controlling and releasing the purse-string suture 1010 around the connecting auxiliary elements 500, 600, and 700. Before the connecting auxiliary elements 500, 600, and 700 are fully expanded, rotational adjustments of the connecting auxiliary elements 500, 600, and 700 may be performed to align the internal (ventricular) compartment of the connecting auxiliary elements 500, 600, and 700 with the valve opening 1580.

[0159] The method may include advancing the bonding auxiliary elements 500, 600, and 700 toward the target position. The method may include advancing the annular hubs 520, 620, and 720 toward the target position. The method may include advancing the annular anchor 800 coupled to the annular hubs 520, 620, and 720 toward the target position. The method may include echo or fluoroscopic guidance of the annular anchor 800, hubs 520, 620, and / or bonding auxiliary elements 500, 600, and 700. The method may include engaging the annular anchor 800 with tissue. The method may include rotating the annular anchor 800 by rotating the anchor control knob 1004. The method may include rotating the annular anchor 800 independently of the hubs 520, 620, and 720. The method may include keeping the hubs 520, 620, and 720 stationary while the annular anchor 800 is rotating. The method may include controlling and releasing the purse-string suture 1010. Releasing it may expand the joining auxiliary elements 500, 600, and 700. The purse-string suture 1010 may be disposed within the joining auxiliary elements 500, 600, and 700, and / or around the joining auxiliary elements 500, 600, and 700. The purse-string suture 1010 can facilitate the folding and / or expansion of the joining auxiliary elements 500, 600, and 700. The method may also include rotating the joining auxiliary elements 500, 600, and 700 to align the lower edges 580, 680, and 780 of the joining auxiliary elements 500, 600, and 700, or the ventricular compartment, with the valve opening. The method may include rotating and adjusting the connecting auxiliary elements 500, 600, and 700 to align the lower edges 580, 680, and 780 or the ventricular compartment around the posterior leaflet.

[0160] Figure 13 shows the recapture of the joining auxiliary elements 500, 600, and 700. The joining auxiliary elements 500, 600, and 700 may be recaptured by tightening the purse suture 1010 around a portion of the perimeter 1620 of the joining auxiliary elements 500, 600, and 700, thereby folding the joining auxiliary elements 500, 600, and 700. The perimeter may include any edge, any combination of edges, or all of the edges as described herein. The recapture sheath and transseptal sheath 1600 may advance beyond the folded joining auxiliary elements 500, 600, and 700. Petals of the recapture sheath radiating from the central hub may extend over the joining auxiliary elements 500, 600, and 700, allowing the joining auxiliary elements 500, 600, and 700 to retract into the transseptal sheath. The valve ring anchor 800 may be loosened by screwing or otherwise released, and the system may be removed. The joint auxiliary elements 500, 600, and 700, which deviate or are partially encapsulated in the petal of the recapture sheath, may be in a different delivery mode. The encapsulated-first delivery mode may be in contrast to the hub-first or strut-first delivery modes.

[0161] In some methods, recapture is an optional method. The method may include tightening the purse-string suture 1010. This tightening may fold the bonding auxiliary elements 500, 600, and 700. The method may include advancing the recapture sheath and / or transseptal sheath beyond the folded bonding auxiliary elements 500, 600, and 700. The recapture sheath can be folded outward and spread over the bonding auxiliary elements 500, 600, and 700. The method may include retracting the bonding auxiliary elements 500, 600, and 700 into the transseptal sheath. The method may include rotating the annular anchor 800 to disengage it from the tissue. The method may include removing the bonding auxiliary elements 500, 600, and 700 and the annular anchor 800.

[0162] Figure 14 shows cross-sectional views of the deployed connecting auxiliary elements 500, 600, and 700. The method may include releasing the connecting auxiliary elements 500, 600, and 700. The method may also include retracting the delivery catheter 1000.

[0163] Figure 15 shows the deployment of auxiliary anchors. In some methods, the deployment of auxiliary anchors is an optional method. The method may include engaging the annular attachment points 535, 735 with the annulus. The method may include engaging with the ventricular anchor. The method may include engaging with the commissure anchor 1650. The method may include deploying markers at strategic locations on the bonding auxiliary elements 500, 600, 700 and / or the annular anchor 800. The method may include detecting the markers, such as detecting radiopaque markers. The method may include facilitating the positioning of the anchor 800 under fluoroscopy. The method may include deploying radiopaque markers around the bonding auxiliary elements 500, 600, 700 to indicate their shape.

[0164] In some embodiments, the manufacturer provides instructions for using the system, which include one or more of the steps disclosed herein, or any steps previously described or specific to the drawings.

[0165] Figures 16 to 30 illustrate various methods that may be performed during the use of the joining auxiliary elements 500, 600, and 700. The methods may include any steps disclosed herein according to some embodiments of the present invention. The methods may include any steps disclosed herein for manufacturing and / or deploying the joining auxiliary elements 500, 600, and 700. The methods may include folding the joining auxiliary elements 500, 600, and 700.

[0166] Figure 16 shows a method of implant delivery, illustrating the loading of the bonding auxiliary elements 500, 600, and 700. The bonding auxiliary elements 500, 600, and 700 can be folded as described herein. The folded bonding auxiliary elements 500, 600, and 700 can be loaded into the transseptal sheath introducer 1700. The transseptal sheath introducer 1700 may include a sheath having a lumen to receive the folded bonding auxiliary elements 500, 600, and 700. The folded bonding auxiliary elements 500, 600, and 700 can be inverted within the transseptal sheath introducer 1700. The annular hubs 520, 620, and 720 can be positioned near the edge 1705 of the transseptal sheath introducer 1700. The transseptal sheath introducer 1700 may include a multi-lumen catheter 1710 connected to connecting auxiliary elements 500, 600, and 700. The method may include loading the connecting auxiliary elements 500, 600, and 700 into the transseptal sheath introducer 1700.

[0167] Figure 17 shows a method for inserting a transseptal sheath introducer 1700 into a transseptal sheath 1715. The transseptal sheath introducer 1700 may include a multi-lumen catheter 1710. The multi-lumen catheter 1710 and / or the transseptal sheath introducer 1700 may include a hub 1720. The hub 1720 can be connected to the transseptal sheath 1715. The proximal end of the transseptal sheath 1715 is shown in Figure 17. In Figure 17, the transseptal sheath introducer 1700 is not connected to the transseptal sheath 1715. In Figure 18, the transseptal sheath introducer 1700 is connected to the transseptal sheath 1715. The method may include connecting the transseptal sheath introducer 1700 to the transseptal sheath 1715. The method may include connecting an assembly comprising joining auxiliary elements 500, 600, and 700 to a trans-septal sheath 1715.

[0168] Figure 19 shows how to advance the transseptal sheath introducer 1700. The transseptal sheath introducer 1700 can be advanced to the distal end of the transseptal sheath 1715. The bonding auxiliary elements 500, 600, and 700 can be advanced through the transseptal sheath 1715. The folded bonding auxiliary elements 500, 600, and 700 can be reversed while being advanced through the transseptal sheath 1715. In Figure 19, the bonding auxiliary elements 500, 600, and 700 are at the distal end of the transseptal sheath 1715.

[0169] Figure 20 shows a method for positioning the transseptal sheath 1715. The connecting auxiliary elements 500, 600, and 700 can be positioned at the distal end of the transseptal sheath 1715 during positioning. The transseptal sheath 1715 can be positioned on the annulus. The transseptal sheath 1715 can be positioned on the posterior leaflet. The transseptal sheath 1715 can be centered on P2 as described herein. The method may include positioning the connecting auxiliary elements 500, 600, and 700 on the posterior leaflet. The method may include centering the connecting auxiliary elements 500, 600, and 700 on P2. The method may include positioning the connecting auxiliary elements 500, 600, and 700 within the annulus. The transseptal sheath 1715 can be rotated as indicated by the arrows. The transseptal sheath 1715 can be positioned with the connecting auxiliary elements 500, 600, and 700 by rotation. The transseptal sheath 1715 can correct the atrial / ventricular orientation. The transseptal sheath 1715 may include one or more markings / indicators 1725. The markings 1725 may allow a user to guide the rotation of the transseptal sheath 1715. The markings 1725 may allow a user to correct the orientation of the annular portions of the junctional auxiliary elements 500, 600, 700. The markings 1725 may allow a user to correct the orientation of the ventricular portions of the junctional auxiliary elements 500, 600, 700. In some embodiments, the markings 1725 may include radiopaque markers. Figure 20 shows the junctional auxiliary elements 500, 600, 700 and the transseptal sheath 1715 centered on P2 in the annulus of the mitral valve. Figure 20 shows the rotation of the junctional auxiliary elements 500, 600, 700 and the transseptal sheath 1715.

[0170] Figure 21 shows a method for delivering anchor 800. Anchor 800 may include any of the anchor features described herein. Anchor 800 may be considered a P2 anchor based on its position after deployment. Anchor 800 may extend through the annular hubs 520, 620, 720 as described herein. The method may include delivering anchor 800 with the joining auxiliary elements 500, 600, 700 inside the trans-septal sheath 1715. In some embodiments, anchor 800 is coupled to the annular hubs 520, 620, 720 of the joining auxiliary elements 500, 600, 700 before being loaded into the trans-septal sheath 1715. In some embodiments, anchor 800 is coupled to the annular hubs 520, 620, 720 of the joining auxiliary elements 500, 600, 700 while inside the trans-septal sheath 1715. In some embodiments, the anchor 800 is coupled to the annular hubs 520, 620, 720 of the joining auxiliary elements 500, 600, 700 after the transseptal sheath 1715 has been positioned within the annulus. The method may include delivering the anchor 800 while the joining auxiliary elements 500, 600, 700 are within the transseptal sheath 1715. The joining auxiliary elements 500, 600, 700 can be centered on P2 of the annulus during the delivery of the anchor 800. The anchor 800 can be inserted into the annular tissue by rotating the anchor 800 as described herein.

[0171] Figures 22A to 22D show how to deploy the connecting auxiliary elements 500, 600, and 700. The connecting auxiliary elements 500, 600, and 700 can be deployed by retracting the transseptal sheath 1715. The transseptal sheath 1715 can be retracted by moving it proximal to the anchor 800. The connecting auxiliary elements 500, 600, and 700 can be inverted within the transseptal sheath 1715. In some embodiments, the annular portions of the connecting auxiliary elements 500, 600, and 700 near the annular hubs 520, 620, and 720 can be deployed first, as shown in Figure 22A. In some embodiments, the ventricular portions of the connecting auxiliary elements 500, 600, and 700 can be deployed next, as shown in Figure 22B. The connecting auxiliary elements 500, 600, and 700 can be inverted so that the ventricular portions extend proximal to the annular portions. In some embodiments, when the connecting auxiliary elements 500, 600, and 700 are arranged as shown in Figure 22C, the connecting auxiliary elements 500, 600, and 700 can extend outward from P2. The connecting auxiliary elements 500, 600, and 700 can be inverted so that the ventricular portion extends proximal to the annular portion. The connecting auxiliary elements 500, 600, and 700 can be inverted so that the ventricular portion extends toward the transseptal sheath 1715.

[0172] In some embodiments, the connecting auxiliary elements 500, 600, and 700 can be folded back, as shown in Figure 22D. The connecting auxiliary elements 500, 600, and 700 can be reversed from their initially deployed configuration so that the ventricular portion extends distally from the annular portion. The connecting auxiliary elements 500, 600, and 700 can be positioned so that the ventricular portion extends away from the transseptal sheath 1715. The method may include deploying the connecting auxiliary elements 500, 600, and 700 by retracting the transseptal sheath 1715. Figures 22A to 22D show the deployment of the connecting auxiliary elements 500, 600, and 700.

[0173] Figures 23 to 30 show the deployment of one or more auxiliary anchors 850. An auxiliary anchor 850 may include any of the features of the anchor 800. An auxiliary anchor 850 may have a helical or spiral structure. An auxiliary anchor 850 may be designed to engage with cardiac tissue, such as the annular tissue. An auxiliary anchor 850 may include bioinert materials such as platinum / ir, nitinol alloy, and / or stainless steel.

[0174] Figure 23 shows a method of utilizing one or more auxiliary anchor guide wires. The joining auxiliary elements 500, 600, and 700 may include one or more auxiliary anchor guide wires. In the illustrated embodiments, the joining auxiliary elements 500, 600, and 700 may include a first guide wire 1730 and a second guide wire 1735. In some embodiments, the joining auxiliary elements 500, 600, and 700 may include any number of auxiliary anchor guide wires (e.g., about or at least about one, two, three, four, five, etc.). In some embodiments, the number of auxiliary anchor guide wires corresponds to (is equal to) the number of auxiliary anchors (e.g., one guide wire for one auxiliary anchor, two guide wires for two auxiliary anchors, etc.). Figure 23 shows one embodiment of the docking tube 1740. The docking tube 1740 may include any of the features described herein, including those shown in Figures 42A to 45K.

[0175] Figure 23 shows the anchoring mode. The anchoring mode can correspond to one or more methods for evaluating the bonding auxiliary elements 500, 600, and 700. The anchoring mode can correspond to one or more methods for evaluating the function of bonding auxiliary elements 500, 600, and 700 that do not have one or more delivery systems. In some embodiments, the anchoring mode can correspond to one or more methods for evaluating the function of bonding auxiliary elements 500, 600, and 700 that do not have a transseptal sheath 1715. The anchoring mode allows for evaluation of function without attaching most of the delivery system. Figure 23 shows the deployed bonding auxiliary elements 500, 600, and 700. Figure 23 shows the bonding auxiliary elements 500, 600, and 700 entering the anchoring mode by retracting the implant body. Figure 23 shows the bonding auxiliary elements 500, 600, and 700 entering the anchoring mode by retracting the transseptal sheath 1715.

[0176] Figure 24 illustrates how the docking tube 1740 is involved. The docking tube 1740 may include a female thread. The docking tube 1740 may include a female threaded DS hub that connects to the male threaded portions 525, 625, and 725 of the valve ring hubs 520, 620, and 720. The docking tube 1740 may include a female threaded hub that connects to the connecting auxiliary elements 500, 600, and 700. In some applications, the docking tube 1740 is removed in mooring mode. Figure 24 shows that the connecting auxiliary elements 500, 600, and 700 enter mooring mode by retracting the docking tube 1740.

[0177] Figure 24 illustrates how the anchor driver 1745 is involved. The anchor driver 1745 can be positioned within the docking tube 1740. The anchor driver 1745 may include any of the features described herein, including those shown in Figures 42A to 45K. The anchor driver 1745 can rotate the anchor 800 in the manner shown in Figure 21. The anchor driver 1745 can rotate the anchor 800 through the valve ring hubs 520, 620, and 720. In some applications, the anchor driver 1745 is removed in the mooring mode. Figure 24 shows that the joining auxiliary elements 500, 600, and 700 enter the mooring mode by retracting the anchor driver 1745.

[0178] The anchor driver 1745 may include a mooring rail 1750. The mooring rail 1750 may include any of the features described herein, including those shown in Figures 42A to 45K. The mooring rail 1750 can be fixed to the anchor 800. The mooring rail 1750 can enable a minimal force evaluation of the effectiveness of the joining auxiliary elements 500, 600, and 700 before releasing them. For example, the user can verify that the joining auxiliary elements 500, 600, and 700 are functioning. For example, the user can verify that the natural valve leaflets are joined to the joining auxiliary elements 500, 600, and 700. For example, the user can verify that the forces acting on the joining auxiliary elements 500, 600, and 700 are within acceptable limits. For example, the user can verify that the connecting auxiliary elements 500, 600, and 700 are not deformed by the force of the natural valve leaflets. For example, the user can verify that the connecting auxiliary elements 500, 600, and 700 are in place. For example, the user can verify that the connecting auxiliary elements 500, 600, and 700 extend over the entire mitral valve. The docking tube 1740 can be retracted as shown. As shown in Figure 24, the mooring rail 1750 can remain coupled to the anchor 800 during the mooring mode.

[0179] Figure 25 shows a method for advancing auxiliary anchor guide rails. In the illustrated embodiments, the method may include a first guide rail 1755 and a second guide wire 1760. In some embodiments, the joining auxiliary elements 500, 600, 700 may include any number of auxiliary anchor guide rails (e.g., one, two, three, four, five, etc.). In some embodiments, the number of auxiliary anchor guide rails corresponds to the number of auxiliary guide wires (e.g., one guide rail for one auxiliary guide wire, two guide rails for two auxiliary guide wires, etc.). The first guide rail 1755 may be advanced along the first guide wire 1730. The second guide rail 1760 may be advanced along the second guide wire 1735. The method may involve advancing both auxiliary anchor guide rails 1755 and 1760. In Figure 25, the auxiliary anchor guide rails 1755 and 1760 are above the guide wires 1730 and 1735.

[0180] The distal end 1765 of each auxiliary anchor guide rail 1755, 1760 can be threaded. In some embodiments, the distal end 1765 of each auxiliary anchor guide rail 1755, 1760 engages with the tissue within the valve ring. The distal end 1765 can be threaded to temporarily secure the auxiliary anchor to the guide rail 1755, 1760 during delivery. In some embodiments, the distal end 1765 of each auxiliary anchor guide rail 1755, 1760 can reduce the possibility of the auxiliary anchor accidentally detaching from the auxiliary anchor guide rail 1755, 1760. The auxiliary anchor guide rails 1755, 1760 can reduce the possibility of the auxiliary anchor becoming entangled with the guide wire 1730, 1735. In some embodiments, the diameter of the auxiliary anchor guide rail 1755, 1760 is greater than or equal to the pitch of the auxiliary anchor.

[0181] In some applications, the docking tube 1740 can be coupled to the joining auxiliary elements 500, 600, and 700. The mounting allows the anchor 800 to recess while the joining auxiliary elements 500, 600, and 700 are being delivered. In some embodiments, the auxiliary anchor guide rails 1755 and 1760 are advanced over the guide wires 1730 and 1735 before the anchor 800 is deployed. In some embodiments, the auxiliary anchor guide rails 1755 and 1760 are advanced over the guide wires 1730 and 1735 after the anchor 800 has been deployed. Figure 25 shows the joining auxiliary elements 500, 600, and 700 fixed to a valve ring, with the anchor 800 advanced along with the auxiliary anchor guide rails to the surface of the joining auxiliary elements 500, 600, and 700.

[0182] Figure 26 shows how to deliver the auxiliary anchor 1770. The auxiliary anchor 1770 can be advanced along the first guide rail 1755. The auxiliary anchor 1770 can be advanced toward the connecting auxiliary elements 500, 600, and 700. The auxiliary anchor 1770 can be installed using a driver 1775. The driver 1775 can translate the auxiliary anchor 1770 along the first guide rail 1755.

[0183] Figure 27 shows a method of inserting the auxiliary anchor 1770. The driver 1775 can rotate the auxiliary anchor 1770 along the first guide rail 1755. The auxiliary anchor 1770 can be passed through the joining auxiliary elements 500, 600, 700. The auxiliary anchor 1770 can be rotated to engage with the tissue below the joining auxiliary elements 500, 600, 700. Figure 26 shows the joining auxiliary elements 500, 600, 700 fixed to the valve ring by the anchor 800 when the auxiliary anchor 1770 is delivered. Figure 26 shows the joining auxiliary elements 500, 600, 700 fixed to the valve ring by the anchor 800 when the auxiliary anchor 1770 is inserted into the tissue. The driver 1775 remains attached as shown in Figure 27. The auxiliary anchor 1770 can be an inner anchor. The auxiliary anchor 1770 can be positioned inside the anchor 800.

[0184] Figure 28 shows a method of delivering the auxiliary anchor 1780. The auxiliary anchor 1780 is advanced over the second guide rail 1760. The auxiliary anchor 1780 can be advanced towards the joining auxiliary elements 500, 600, 700. In some methods of use, the auxiliary anchor 1780 can be installed using the driver 1775. In some methods of use, the driver 1775 can be retracted along the first guide rail 1755 before being advanced along the second guide rail 1760. In other methods of use, the auxiliary anchor 1780 is installed using a driver different from the auxiliary anchor 1770. The driver 1775 can translate the auxiliary anchor 1780 along the first guide rail 1760. In some methods of use, the auxiliary anchor 1770 can be pre-inserted into the tissue.

[0185] Driver 1775 can rotate the auxiliary anchor 1780 along the second guide rail 1760. The auxiliary anchor 1780 can be passed through the joining auxiliary elements 500, 600, 700. By rotating the auxiliary anchor 1780, it can engage with the tissue below the joining auxiliary elements 500, 600, 700. FIG. 28 shows the joining auxiliary elements 500, 600, 700 fixed to the valve ring by the anchor 800 and the auxiliary anchor 1770 when the auxiliary anchor 1780 is delivered. FIG. 26 shows the joining auxiliary elements 500, 600, 700 fixed to the valve ring by the anchor 800 and the auxiliary anchor 1770 when the auxiliary anchor 1780 is inserted into the tissue. The auxiliary anchor 1780 can be an outer anchor. The auxiliary anchor 1780 can be positioned outside the anchor 800.

[0186] FIG. 29 shows the joining auxiliary elements 500, 600, 700 including the auxiliary anchor guide wires 1730, 1735. The mooring rail 1750 can remain coupled to the anchor 800. The auxiliary anchor guide wires 1730, 1735 can remain connected. The delivery system can be reattached. In some methods of use, one or more of the guide rails 1755, 1760 can be reattached. In some methods of use, the driver 1775 is reattached. One or more of the auxiliary anchors 1770, 1780 can be removed. One or more of the auxiliary anchors 1770, 1780 can be repositioned. In some methods of use, the docking tube 1740 can be reattached. In some methods of use, the anchor driver 1745 can be reattached. The anchor 800 can be removed. The anchor 800 can be repositioned. The anchor 800 and the auxiliary anchors 1770, 1780 can be removed. The joining auxiliary elements 500, 600, 700 can be retrieved. FIG. 29 shows the deployed and fixed joining auxiliary elements 500, 600, 700 with the auxiliary anchor guide wires 1730, 1735 and the mooring rail 1750 remaining to enable retrieval.

[0187] Figure 30 shows the fixed connecting auxiliary elements 500, 600, and 700. The auxiliary anchor guide wires 1730 and 1735 have been removed. The mooring rail 1750 has been removed. In some embodiments, the mooring rail 1750 is rotated and retracted. The connecting auxiliary elements 500, 600, and 700 are shown fully deployed and fixed. In some uses, retrieval is no longer possible. In some uses, retrieval by the methods described in Figures 31A to 31F is no longer possible.

[0188] Figures 31A to 31F show methods for retrieving the joint auxiliary elements 500, 600, and 700. The joint auxiliary elements 500, 600, and 700 can be retrieved through the transseptal sheath 1715. In some applications, the joint auxiliary elements 500, 600, and 700 can be retrieved after anchor 800 has been removed, without auxiliary anchors 1770 and 1780. In some applications, the joint auxiliary elements 500, 600, and 700 can be retrieved after anchor 800 and all auxiliary anchors 1770 and 1780 have been removed. In Figures 31A to 31F, the joint auxiliary elements 500, 600, and 700 are retrieved through the transseptal sheath 1715. In some applications, retrieval is optional. In some applications, retrieval is performed after the method shown in Figure 29 and before the method shown in Figure 30.

[0189] Figures 32 to 35 show methods for installing one or more auxiliary anchors. One or more methods can be used in conjunction with the methods described herein. One or more methods can be alternatives to the methods described herein. For example, one or more methods shown in Figures 32 to 35 can be replaced with one or more methods shown in Figures 23 to 30. The auxiliary anchors described herein can be delivered using guidewires and / or guide rails of various designs. In some embodiments, each auxiliary anchor may have its own lumen (e.g., two auxiliary anchors using two lumens, four auxiliary anchors using four lumens, etc.). In some embodiments, each auxiliary anchor may have its own guidewire (e.g., two auxiliary anchors using two guidewires, four auxiliary anchors using four guidewires, etc.). In some embodiments, two auxiliary anchors share a lumen (e.g., two auxiliary anchors in one lumen, four auxiliary anchors in two lumens, two guidewires in one lumen, four guidewires in two lumens, etc.). In some embodiments, two guidewires within a shared lumen are each covered by a guide rail. The guide rail can reduce entanglement of auxiliary anchors. The guide rail can reduce entanglement of auxiliary anchors with two or more guidewires within the lumen.

[0190] Figure 32 shows a method for inserting auxiliary anchors. In some uses, auxiliary anchors 1770 are inserted as described herein. Guidewires 1735 can extend from auxiliary anchors 1770. Guidewires 1735 can extend into a lumen or shared lumen. In some uses, auxiliary anchors 1770 are inserted as described herein. One or more auxiliary anchors 1170, 1780 can be inserted.

[0191] In some embodiments, one guide wire 1735 can be used for two auxiliary anchors. In some uses, the guide wire 1735 can be captured and removed with a snare to facilitate removal of the guide wire 1735 after the first auxiliary anchor 1770 has been delivered. In some embodiments, the guide wire 1735 forms a loop. In some embodiments, a portion of the loop of the guide wire 1735 is housed within the joining auxiliary elements 500, 600, 700. In some embodiments, the loop passes through the joining auxiliary elements 500, 600, 700. In some embodiments, a snare 1785 can be positioned along the guide wire 1735. In some embodiments, the snare 1785 forms a loop. In some embodiments, a portion of the loop of the guide wire 1735 is housed within the loop of the snare 1785. The method may include using a snare 1785. The snare 1785 may be used to release the guide wire 1735. The snare 1785 can be retracted. The snare drum 1785 can be pulled proximally through the lumen.

[0192] Figure 33 shows how the auxiliary anchor 1790 is delivered. The snare 1785 is retracted into the lumen. The snare 1785 is pulling the guidewire 1735 proximal. In some embodiments, a driver 1775 or another driver can advance the auxiliary anchor 1790 along the guidewire 1735. In some embodiments, the auxiliary anchor 1790 should be delivered with the guidewire 1735 removed from the anchor 1770 using the snare 1785.

[0193] Figure 34 shows how to insert the auxiliary anchor 1790. The auxiliary anchor 1790 can be rotated. The auxiliary anchor 1790 can pass through the bonding auxiliary elements 500, 600, and 700. By rotating the auxiliary anchor 1790, it can engage with the tissue below the bonding auxiliary elements 500, 600, and 700. Figure 34 shows the bonding auxiliary elements 500, 600, and 700 fixed to the valve ring with anchor 800 and auxiliary anchor 1770 when the auxiliary anchor 1790 is delivered. The auxiliary anchor 1790 can be an internal anchor. The auxiliary anchor 1790 can be positioned inside anchor 800. The auxiliary anchor 1790 can be positioned between anchor 800 and auxiliary anchor 1770.

[0194] Figure 35 shows the fixed joint auxiliary elements 500, 600, and 700. The method can be repeated to install one or more additional auxiliary anchors. For example, one or more additional auxiliary anchors can be positioned between auxiliary anchor 1780 and anchor 800, as shown in Figure 30. For example, one or more additional auxiliary anchors can be positioned between auxiliary anchor 1770 and anchor 800, as shown in Figure 30. For example, one or more additional auxiliary anchors can be positioned anywhere in the annular portions of the joint auxiliary elements 500, 600, and 700.

[0195] Figures 36 and 37 show embodiments of 2D lamination. Figures 38 and 39 show embodiments of 3D molding. In some embodiments, the bonding auxiliary elements 500, 600, and 700 have a multilayer laminate on all or only a portion of the bonding auxiliary element. In some embodiments, the multilayer laminate may include two or more laminate layers (e.g., two, three, four, five, etc.). Two or more layers of the multilayer laminate may be made of the same material. Two or more layers of the multilayer laminate may be made of different materials. Two or more layers of the multilayer laminate may have the same dimensions (e.g., length, width, thickness, diameter, etc.). Two or more layers of the multilayer laminate may have one or more different dimensions. The laminate may be variable depending on the area of ​​the bonding auxiliary elements 500, 600, and 700. In some embodiments, the bonding area may have an additional protective layer. In some embodiments, the bonding surfaces 560, 660, and 760 include one or more additional layers than other parts of the bonding auxiliary elements 500, 600, and 700. Figure 38 shows an additional layer 1795 located only in the junctional region (e.g., the lower region) of the junctional auxiliary elements 500, 600, and 700. Therefore, the lower junctional region can be thicker than the upper region of the junctional auxiliary element located in close proximity to the cardiac valve annulus, and is thicker than the upper region by at least approximately 10%, 25%, 50%, 75%, 100%, 150%, 200%, 250%, 300%, or more, or incorporating any two of the aforementioned values.

[0196] Multilayer laminates can be fabricated using a 2D lamination method. In some applications, two or more layers are bonded together. Layers can be bonded by heat. Layers can be bonded by adhesive. Layers can be bonded together by any mechanical or chemical change. Bonding auxiliary elements 500, 600, 700 can have an overall 2D shape. Bonding auxiliary elements 500, 600, 700 can be flat or nearly flat. In some embodiments, one or more layers include high-density polyethylene (PE), polypropylene, Dacron, a cell-free collagen matrix such as SIS, or other plastics.

[0197] Multilayer laminates can be fabricated by 3D shaping methods. Joining auxiliary elements 500, 600, and 700 can be molded. As described herein, the joining auxiliary elements 500, 600, and 700 may comprise columns 530, 630, and 730. In some embodiments, the columns 530, 630, and 730 are composed of an elastically deformable material, such as a shape memory metal, e.g., nitinol, or a shape memory polymer. In some embodiments, the material is Elgiloy. In some embodiments, the column 530 may be composed of other materials, such as stainless steel, polypropylene, high-density polyethylene (PE), Dacron, a cell-free collagen matrix such as SIS, or other plastics. 3D molding may involve casting the shapes of the columns 530, 630, and 730. 3D molding may include shaping the shape memory metal into a suitable form. The shape can be set using a suitable mold to bend the columns 530, 630, and 730 into the desired shape. Shape setting or adjustment may include restricting the bonding auxiliary elements 500, 600, and 700 to a fixture or within a mold. In some uses, appropriate heat treatment is applied to the bonding auxiliary elements 500, 600, and 700 while they are on the fixture or within the mold. In some embodiments, temperature, time, and / or other parameters are adjusted to heat-cur the bonding auxiliary elements 500, 600, and 700. In some embodiments, the heat-curing temperature is over 300°C, over 400°C, over 500°C, over 600°C, etc. In some embodiments, the heat-curing time is 1 minute, 2 minutes, 3 minutes, 4 minutes, 5 minutes, 6 minutes, 7 minutes, 8 minutes, 9 minutes, 10 minutes, over 2 minutes, over 5 minutes, over 10 minutes, etc. In some embodiments, the method may include quenching. In some embodiments, the method may include quenching with water or air.

[0198] Figure 40 shows a connecting auxiliary element 400. The connecting auxiliary element 400 may include any of the features of connecting auxiliary elements described herein. The connecting auxiliary element 400 may include an annular hub 420 that facilitates attachment to a delivery system, similar to the annular hub described herein. The annular hub 420 may include a male threaded portion 425. The connecting auxiliary element 400 may include a strut 430. The strut 430 may be an atrial arm that may be bent in an upward and / or downward direction.

[0199] The joining auxiliary element 400 may include a valve ring anchor portion 435. The valve ring anchor portion 435 may be a part of the column 430. In some embodiments, the valve ring anchor portion 435 has one or more barbs having pointed tips. The valve ring anchor portion 435 may be a passive anchor. The barbs may be fully exposed and shaped as shown in Figure 40. In some embodiments, the barbs extend from the multilayer laminate. The barbs may be the free end of the column 430. In some embodiments, the barbs may be on the surface of the joining auxiliary element 400. In some embodiments, the barbs may engage with the tissue by pushing back the laminate. For example, the multilayer laminate may be pushed back as shown in Figure 41. Figure 41 shows one embodiment of the barbs. In some uses, the multilayer laminate may be pushed back by engagement between the barbs and the tissue.

[0200] The joining support element 400 may include a knotless suture edge 455. The edge can reduce trauma to natural tissue. The joining support element 400 may include one or more rounded edges to reduce trauma. In some embodiments, the transverse edge of the joining support element 400 is rounded. In some embodiments, the upper edge of the joining support element 400 is rounded. In some embodiments, the lower edge of the joining support element 400 is rounded.

[0201] The bonding auxiliary element 400 may include a bonding surface 460. The bonding surface 460 may include an additional protective layer. In some embodiments, the bonding surface 460 may include one or more additional layers of a multilayer laminate. In some embodiments, the bonding surface 460 may include one or more different layers of a multilayer laminate. One or more layers of the bonding surface 460 may be designed to promote the lifespan of the bonding auxiliary element 400. One or more layers of the bonding surface 460 may be designed to promote bonding with natural valve leaflets.

[0202] Figures 42A to 45K show embodiments of implant delivery systems. The implant delivery system may include any of the bonding auxiliary elements described herein. The implant delivery system may be designed to position the bonding auxiliary elements within the heart. The implant delivery system may include any of the anchors described herein. The implant delivery system may be designed to engage the anchors with tissue. The implant delivery system may be designed to rotate the anchors.

[0203] Figures 42A to 42I show one embodiment of the implant delivery system 1800. The implant delivery system 1800 may include a docking tube 1805. The docking tube 1805 is connected to an implant torque shaft 1810. In some embodiments, the implant torque shaft 1810 can be tightly coupled to the docking tube 1805. In some embodiments, the implant torque shaft 1810 is welded or soldered to the docking tube 1805. The implant torque shaft 1810 can transmit torque to the docking tube 1805 as described herein. The docking tube 1805 can be coupled to bonding auxiliary elements 400, 500, 600, and 700. In the illustrated embodiments, only portions of the supports 430, 530, 630, and 730 are shown.

[0204] Referring again to Figures 42A and 42B, the docking tube 1805 may include one or more slots 1815. In the illustrated embodiment, the docking tube 1805 may include one slot 1815, but other configurations can be envisioned (e.g., two slots, three slots, four slots, two slots in opposite directions, four slots in opposite directions, etc.). The slot 1815 may extend through the docking tube 1805. In some embodiments, the docking tube 1805 may include one or more grooves that do not extend through the docking tube. The slot 1815 may extend along the length of the docking tube 1805 or a portion thereof. The slot 1815 may extend between the distal end and the proximal end of the docking tube 1805.

[0205] The docking tube 1805 may include a pin 1820 disposed within a slot 1815. In some embodiments, the docking tube 1805 may include a spring 1825 disposed within a slot 1815. The pin 1820 can be coupled to a tension wire 1830, which allows the pin 1820 to move within the slot 1815 as described herein. The valve ring hubs 420, 520, 620, and 720 may include a groove 1835. The groove 1835 of the valve ring hubs 420, 520, 620, and 720 can be aligned with the slot 1815 of the docking tube 1805. The pin 1820 can be disposed within the groove 1835.

[0206] The valve ring hubs 420, 520, 620, and 720 may include male threaded portions 425, 525, 625, and 725. The docking tube 1805 may include a male threaded portion 1840. In some applications, the docking tube 1805 is rotated so that it engages with the valve ring hubs 420, 520, 620, and 720. The female threaded portion 1840 engages with the male threaded portions 425, 525, 625, and 725. A groove 1835 may be cut into the outer diameter of the threads of the male threaded portions 425, 525, 625, and 725. A slot 1815 may be cut into the inner diameter of the female threaded portion 1840 of the docking tube 1805. The slot 1815 can be aligned with the groove 1835. In some embodiments, when the docking tube 1805 contacts the bottom of the joining auxiliary elements 400, 500, 600, and 700, the slot 1815 can be aligned with the groove 1835.

[0207] Figures 42A - 42B show the neutral position of pin 1820. Spring 1825 biases pin 1820 downward and engages with groove 1835. Pin 1820 extends between docking tube 1805 and valve ring hubs 420, 520, 620, 720. The neutral state has pin 1820 forward. In this state, pin 1820 locks the threaded connection between the threaded portion 1840 of the female thread of docking tube 1805 and the threaded portions 425, 525, 625, 725 of the male threads of valve ring hubs 420, 520, 620, 720. By pin 1820, the user can apply torque to joining assist elements 400, 500, 600, 700 in both directions via docking tube 1805 and implant torque shaft 1810. By pin 1820, the user can rotate joining assist elements 400, 500, 600, 700 clockwise or counterclockwise by rotating docking tube 1805. In some usage methods, pin 1820 can facilitate the movement of joining assist elements 400, 500, 600, 700 via docking tube 1805. When slots 1815 and groove 1835 are aligned, the spring - loaded pin 1820 slides into groove 1835 and can essentially fill the thread. Figure 42A shows pin 1820 forward such that docking tube 1805 and joining assist elements 400, 500, 600, 700 are both locked. Figure 42B shows a cross - sectional view of locking pin 1820 in the neutral forward position.

[0208] Figures 42C to 42D show the release of pin 1820. Pin 1820 can be pulled back via the pull wire 1830. Pin 1820 may be equipped with a spring 1825. Pin 1820 can be removed from groove 1835. Pin 1820 slides along slot 1815. In this position, the docking tube 1805 can be detached from the joining auxiliary elements 400, 500, 600, and 700. The female threaded portion 1840 can be engaged with and disengaged from the male threaded portions 425, 525, 625, and 725 by rotation of the docking tube 1805. Figure 42C shows a cross-sectional view of the retracted pin 1820. Retracting pin 1820 allows the docking tube 1805 to be detached from the valve ring hubs 420, 520, 620, and 720. Figures 42A to 42D show that the docking hub 1805 can be connected to the joining auxiliary elements 400, 500, 600, and 700 in order to position the joining auxiliary elements 400, 500, 600, and 700. Figures 42A to 42D also show that the docking hub 1805 can be connected to the joining auxiliary elements 400, 500, 600, and 700 in order to rotate the joining auxiliary elements 400, 500, 600, and 700.

[0209] Figures 42E to 42I illustrate the use of the anchor 800 together with the implant delivery system 1800. The anchor 800 is positioned within the docking hub 1805, as shown in Figure 42E. The anchor 800 is in a retracted position within the docking hub 1805. The anchor 800 is located inside the locking mechanism or pin 1820. The docking hub 1805 is shown in a linear form, i.e., drawn. The docking hub 1805 and implant torque shaft 1810 shown in Figure 42E have been removed from Figure 42F for clarity.

[0210] Anchor 800 can be screwed in at the anatomical P2 position on the posterior leaflet, as described herein. Anchor 800 can be considered a P2 anchor. Anchor 800 can be driven by driver 1845. Figure 42G shows an enlarged view of driver 1845. Driver 1845 drives anchor 800 completely into the tissue and down onto the annular hubs 420, 520, 620, and 720 of the bonding auxiliary elements 400, 500, 600, and 700. Driver 1845 is connected to an internal torque shaft 1850. Driver 1845 and anchor 800 are fully housed within the docking hub 1805, as described herein. The internal torque shaft 1850 may extend through the implant torque shaft 1810. See Figure 42E.

[0211] Figure 42H shows an internal cross-sectional view of anchor 800. To ensure a secure connection of driver 1845, tension can be applied to anchor 800 by mooring rail 1855 to bring it into contact with driver 1845. Mooring rail 1855 may include a guide wire having a small thread or male threaded portion 1860 at its distal end. The male threaded portion 1860 of mooring rail 1855 is configured to engage with the female threaded portion 1865 of anchor 800. An internal view of mooring rail 1855, as well as the connection between anchor 800 and valve ring hubs 420, 520, 620, and 720, is shown in Figure 42H.

[0212] Figure 42H also shows the square recess 1870 in the head of the anchor 800. The driver 1845 may include a square portion (not shown) configured to engage the square recess 1870 within the head of the anchor 800. Other designs for meshing the anchor 800 and the driver 1845 can be imagined (e.g., any non-circular shape, polygon, hexagon, Phillips, ellipse, etc.).

[0213] Anchor 800 may include a shoulder portion 1875. Once anchor 800 is fully driven into the tissue, the shoulder portion 1875 of anchor 800 pushes down the annular hubs 420, 520, 620, and 720, firmly securing the bonding auxiliary elements 400, 500, 600, and 700. Figure 42I shows a diagram of the secured bonding auxiliary elements 400, 500, 600, and 700.

[0214] Figures 43A to 43E show one embodiment of the implant delivery system 1900. The implant delivery system 1900 may include a docking tube 1905. The docking tube 1905 may be cylindrical. The docking tube 1905 is connected to an implant torque shaft 1910. In some embodiments, the implant torque shaft 1910 may be tightly coupled to the docking tube 1905. In some embodiments, the implant torque shaft 1910 is welded or soldered to the docking tube 1905. The implant torque shaft 1910 can transmit torque to the docking tube 1905 as described herein. The docking tube 1905 may be coupled to bonding auxiliary elements 400, 500, 600, and 700. In the illustrated embodiments, only portions of the supports 430, 530, 630, and 730 are shown.

[0215] The docking tube 1905 may include two or more hypotubes 1915 embedded in the wall. The hypotubes 1915 may include lumens. The hypotubes 1915 may be opposite each other. The hypotubes 1915 may be 180° apart. The hypotubes 1915 may extend within a slot. The hypotubes 1915 may extend along a portion of the length of the docking tube 1905. In some embodiments, the docking tube 1905 comprises two or more lumens. In some embodiments, the lumens are integral with or formed integrally with the docking tube 1905. In the illustrated embodiment, the docking tube 1905 may include two hypotubes 1915, but other configurations are conceivable (e.g., four hypotubes).

[0216] The docking tube 1905 may include a mooring device 1920 disposed within the hypo tube 1915. In some embodiments, the mooring device 1920 can be looped through opposing gaps in the connecting auxiliary elements 400, 500, 600, and 700. In some embodiments, the mooring device 1920 can pass between the supports 430, 530, 630, and 730 of the connecting auxiliary elements 400, 500, 600, and 700. The mooring device 1920 may extend through one hypo tube 1915, through the connecting auxiliary elements 400, 500, 600, and 700, under the valve ring hubs 420, 520, 620, and 720, through the connecting auxiliary elements 400, 500, 600, and 700, and through the other hypo tube 1915. The mooring device 1920 can form a loop through the connecting auxiliary elements 400, 500, 600, and 700. The mooring device 1920 can form a loop by going back upward through the connecting auxiliary elements 400, 500, 600, and 700 to the proximal end or handle end of the system.

[0217] Figures 43A and 43B show the initial position of the mooring device 1920. In this state, the mooring device 1920 holds both the docking tube 1905 and the connecting auxiliary elements 400, 500, 600, and 700. The mooring device 1920 allows the user to apply torque to the connecting auxiliary elements 400, 500, 600, and 700 in both directions via the docking tube 1905 and the implant torque shaft 1910. The mooring device 1920 allows the user to rotate the connecting auxiliary elements 400, 500, 600, and 700 clockwise or counterclockwise by rotating the docking tube 1905. In some uses, the mooring device 1920 can facilitate the movement of the connecting auxiliary elements 400, 500, 600, and 700 via the docking tube 1905. The mooring device 1920 can be released. The mooring device 1920 is released, allowing the docking tube 1905 to be separated from the valve ring hubs 420, 520, 620, and 720. Figures 43A to 43B show that the docking hub 1905 can be coupled to the joining auxiliary elements 400, 500, 600, and 700 in order to position the joining auxiliary elements 400, 500, 600, and 700. Figures 43A to 43B show that the docking hub 1805 can be coupled to the joining auxiliary elements 400, 500, 600, and 700 in order to rotate the joining auxiliary elements 400, 500, 600, and 700.

[0218] Figures 43C to 43E illustrate the use of the anchor 800 together with the implant delivery system 1900. The anchor 800 is positioned within the docking hub 1905, as shown in Figure 43C. The anchor 800 is in a retracted position within the docking hub 1905. The anchor 800 is located inside the locking mechanism or mooring device 1920. The docking hub 1905 is shown in a linear form in Figure 43B.

[0219] Anchor 800 can be screwed in at the anatomical P2 position on the posterior leaflet, as described herein. Anchor 800 can be considered a P2 anchor. Anchor 800 can be driven by a driver 1945. Figure 43D shows an enlarged view of the driver 1945. The driver drives anchor 800 completely into the tissue and down onto the annular hubs 420, 520, 620, and 720 of the bonding auxiliary elements 400, 500, 600, and 700. The driver 1945 is connected to an internal torque shaft 1950. In some embodiments, the internal torque shaft 1950 is welded or soldered to the driver 1945. The driver 1945 and anchor 800 are completely housed within the docking hub 1905. The internal torque shaft 1950 may extend through an implant torque shaft 1910. Figure 43C shows the advance of anchor 800 before it is fully placed. Figure 43D shows anchor 800 screwed into the tissue.

[0220] Figure 43C also shows an internal cross-sectional view of anchor 800. To ensure a secure connection of driver 1945, tension can be applied to anchor 800 by the mooring rail 1955 to bring it into contact with driver 1945. The mooring rail 1955 may include a guide wire having a small thread or male threaded portion 1960 at its distal end. The male threaded portion 1960 of the mooring rail 1955 is configured to engage with the female threaded portion 1965 of anchor 800. An internal view of the mooring rail 1955, as well as the connection between anchor 800 and valve ring hubs 420, 520, 620, and 720, is shown in Figure 42C. The mooring rail 1955 can allow for a minimum force assessment of the effectiveness of joining auxiliary elements 400, 500, 600, and 700 before releasing the joining auxiliary elements 400, 500, 600, and 700. The mooring rail 1955 allows for minimum force evaluation of the effectiveness of the connecting auxiliary elements 400, 500, 600, and 700 before releasing the mooring device 1920. Figure 43C shows a cross-sectional view illustrating the path of the mooring device 1920.

[0221] Figure 43E shows a diagram of the embedded anchor 800. Figure 42E also shows a square recess 1970 in the head of the anchor 800. The driver 1945 may include a square portion (not shown) configured to engage the square recess 1970 within the head of the anchor 800. Other designs for meshing the anchor 800 and the driver 1945 are conceivable (e.g., any non-circular shape, polygon, hexagon, Phillips, ellipse, etc.). The anchor 800 may include an anchor hub. The hub may include a threaded portion 1965 of the anchor 800 that allows connection to the mooring rail 1955. The anchor 800 may include an anchor helix. The anchor helix may include a gland tip for optimal tissue penetration.

[0222] The bonding auxiliary elements 400, 500, 600, and 700 may include several cutouts to minimize sliding friction of the mooring device 1920. The anchor 800 can be screwed into the tissue and make contact with the bottom of the hubs 420, 520, 620, and 720. The user can retract the docking tube 1905, leaving two edges of the mooring device 1920 behind. The mooring device can be connected via an internal torque shaft. If the user is satisfied with the performance of the bonding auxiliary elements 400, 500, 600, and 700, the user can remove the mooring device 1920. If the user is not satisfied with the performance of the bonding auxiliary elements 400, 500, 600, and 700, the user can re-dock the implant delivery system 1900 with the mooring device 1920. If the user is not satisfied with the performance of the connecting auxiliary elements 400, 500, 600, and 700, the user may pass the mooring device 1920 through the hypo tube 1915. If the user is not satisfied with the performance of the connecting auxiliary elements 400, 500, 600, and 700, the user may remove the anchor 800 and / or completely remove the connecting auxiliary elements 400, 500, 600, and 700.

[0223] Figures 44A to 44E show one embodiment of the implant delivery system 2000. The implant delivery system 2000 may include a docking tube 2005. The docking tube 2005 can be of any desired shape, such as cylindrical. The docking tube 2005 is connected to an implant torque shaft 2010. In some embodiments, the implant torque shaft 2010 can be tightly coupled to the docking tube 2005. In some embodiments, the implant torque shaft 2010 is welded or soldered to the docking tube 2005. The implant torque shaft 2010 can transmit torque to the docking tube 2005 as described herein. The docking tube 2005 may include a docking end cap 2015.

[0224] The docking tube 2005 may include one, two, or more retention arms 2020 cut into its distal end. One, two, or more retention arms 2020 may enable the transmission of torque via the implant torque axis 2010, as well as the pushing / advancing of the bonding auxiliary elements 400, 500, 600, 700. The docking tube 2005 may include three retention arms 2020. The retention arms 2020 may be spaced evenly around the docking tube 2005. The retention arms 2020 may be spaced at an angle of about 120°, at least about 120°, or less than 120°, or another desired angle. The retention arms 2020 may extend along a portion of the length of the docking tube 2005. In some embodiments, the retention arms 2020 are integral with or formed integrally with the docking tube 2005. In the illustrated embodiment, the docking tube 2005 may include three retaining arms 2020, but other configurations are conceivable (e.g., one retaining arm, two retaining arms, four retaining arms, five retaining arms, etc.). The retaining arms 2020 can be formed by cutting a U-shape into the docking tube 2005.

[0225] Figures 44B to 44C show the initial position of the retention arm 2020. In this state, the retention arm 2020 holds both the docking tube 2005 and the bonding auxiliary elements 400, 500, 600, and 700. The retention arm 2020 allows the user to apply torque to the bonding auxiliary elements 400, 500, 600, and 700 in both directions via the docking tube 2005 and the implant torque shaft 2010. The retention arm 2020 allows the user to rotate the bonding auxiliary elements 400, 500, 600, and 700 clockwise or counterclockwise by rotating the docking tube 2005. In some applications, the retention arm 2020 can facilitate the movement of the bonding auxiliary elements 400, 500, 600, and 700 via the docking tube 2005.

[0226] Referring to Figure 44E, the retaining arm 2020 engages with a window 2025 located in the head of the anchor 800. In some embodiments, the window 2025 is a laser-cut window. In some embodiments, the window 2025 extends through the valve ring hubs 420, 520, 620, and 720. In some embodiments, the window 2025 is a slot or groove. The number of windows 2025 can correspond to the number of retaining arms 2020. In some embodiments, each retaining arm 2020 engages with a window 2025. The window 2025 can be shaped to receive a portion of the retaining arm 2020, such as a tab 2030. In some embodiments, each retaining arm 2020 may include an inwardly facing tab 2030. The tab 2030 may have an increased thickness relative to the retaining arm 2020. The tab 2030 can be shaped to engage with the window 2025. Tab 2030 can be the distal medial compartment of the retention arm 2020.

[0227] Figures 44B to 44D illustrate the use of anchor 800 in conjunction with the implant delivery system 2000. Anchor 800 is positioned within the docking hub 2005, as shown in Figure 44B. Anchor 800 is in a retracted position within the docking hub 2005. Anchor 800 is located within the locking mechanism or tab 2030 of the retention arm 2020. The docking hub 2005 is shown in a linear form in Figure 44B. Figure 44C shows the advancement of anchor 800. Figure 44C shows the advancement of anchor 800 before it is fully deployed and before the retention arm 2020 is bent.

[0228] The anchor 800 can be screwed in at the anatomical P2 position on the posterior leaflet, for example, as described herein. The anchor 800 can be considered a P2 anchor. The anchor 800 can be driven by a driver 2045. Figure 44D shows an enlarged view of the driver 2045. The driver 2045 drives the anchor 800 completely into the tissue and down onto the annular hubs 420, 520, 620, and 720 of the bonding auxiliary elements 400, 500, 600, and 700. The driver 2045 is connected to an internal torque shaft 2050. In some embodiments, the internal torque shaft 2050 is welded or soldered to the driver 2045. The driver 2045 and anchor 800 are completely housed within the docking hub 2005, as shown in Figure 44B. The internal torque shaft 2050 may extend through an implant torque shaft 2010.

[0229] Figure 44D shows an internal cross-sectional view of anchor 800. To ensure a secure connection of driver 2045, tension can be applied to anchor 800 by the mooring rail 2055 to bring it into contact with driver 2045. The mooring rail 2055 may include a guide wire having a small thread or male threaded portion 2060 at its distal end. The male threaded portion 2060 of the mooring rail 2055 is configured to engage with the female threaded portion 2065 of anchor 800. An internal view of the mooring rail 2055, as well as the connection between anchor 800 and valve ring hubs 420, 520, 620, and 720, is shown in Figure 44D. The mooring rail 2055 can allow for a minimum force assessment of the effectiveness of the joining auxiliary elements 400, 500, 600, and 700 before releasing them. The mooring rail 2055 allows for minimum force evaluation of the effectiveness of the connecting auxiliary elements 400, 500, 600, and 700 before releasing the retaining arm 2020.

[0230] Figure 44D shows a cross-sectional view illustrating the release of the retaining arm 2020. As anchor 800 is screwed into the tissue, the annular hubs 420, 520, 620, and 720 come into contact with the tab 2030 of the retaining arm 2020. The retaining arm 2020 can be bent outward from the window 2025 of anchor 800 as the annular hubs 420, 520, 620, and 720 move distally. The tab 2030 may include an angled surface 2035 that allows the docking tube 2005 to be easily removed from the annular hubs 420, 520, 620, and 720 when the retaining arm 2020 is bent outward. Figure 44D shows the advance of anchor 800 with the retaining arm 2020 bent outward as anchor 800 is fully engaged.

[0231] When the retaining arm 2020 is bent outward, the docking tube 2005 can be separated from the valve ring hubs 420, 520, 620, and 720. Figure 44D shows that the docking hub 2005 can be separated from the connecting auxiliary elements 400, 500, 600, and 700. Figures 44A to 44C show that the docking hub 2005 can be coupled to the connecting auxiliary elements 400, 500, 600, and 700 in order to position them. Figures 44A to 44C show that the docking hub 2005 can be coupled to the connecting auxiliary elements 400, 500, 600, and 700 in order to rotate them.

[0232] Figure 44E shows a diagram of the embedded anchor 800. Figure 44E also shows a square recess 2070 in the head of the anchor 800. The driver 2045 may include a square portion (not shown) configured to engage the square recess 2070 within the head of the anchor 800. Other designs for meshing the anchor 800 and the driver 2045 are conceivable (e.g., any non-circular shape, polygon, hexagon, Phillips, ellipse, etc.). The anchor 800 may include an anchor hub. The hub may include a female threaded portion 2065 of the anchor 800 that allows connection to the mooring rail 2055. The anchor 800 may include an anchor helix. The anchor 800 may include a window 2025. The window 2025 allows the retaining arm 2020 to be snapped in and held on the valve ring hubs 420, 520, 620, and 720. Window 2025 allows the retaining arm 2020 to be held on the valve ring hubs 420, 520, 620, and 720 in a compressed, tensed, and twisted state.

[0233] Figures 45A to 45K show one embodiment of the implant delivery system 2100. The implant delivery system 2100 may include a docking tube 2105. The docking tube 2105 may be cylindrical. The docking tube 2105 is connected to an implant torque shaft 2110. In some embodiments, the implant torque shaft 2110 can be tightly coupled to the docking tube 2105. In some embodiments, the implant torque shaft 2110 is welded or soldered to the docking tube 2105. The implant torque shaft 2110 can transmit torque to the docking tube 2105 as described herein. The docking tube 2105 may include a docking end cap 2115.

[0234] The docking tube 2105 may include one or more slots 2120 cut into its distal end. The slots 2120 may be bayonet slots. The slots 2120 may have a bayonet configuration. One or more slots 2120 may allow torque to be transmitted via the implant torque shaft 2110, as well as to push / advance the bonding auxiliary elements 400, 500, 600, 700. The docking tube 2105 may include three slots 2120. The slots 2120 may be evenly spaced around the docking tube 2105. The slots 2120 may be spaced 120° apart. The slots 2120 may extend along a portion of the length of the docking tube 2105. In some embodiments, the slots 2120 are integral with or formed integrally with the docking tube 2105. In the illustrated embodiment, the docking tube 2105 may include three slots 2120, but other configurations are conceivable (e.g., one slot, two slots, four slots, five slots, etc.). The slots 2120 can be formed by cutting a J-shape into the docking tube 2105.

[0235] The docking tube 2105 may include a flared ring 2125, as shown in Figure 45B. The flared ring 2125 can ensure that the slot 2120 does not weaken the distal end of the docking tube 2105. The flared ring 2125 can ensure that re-docking is easy. The flared ring 2125 can be welded or soldered to the distal end of the docking tube 2105.

[0236] Referring to Figure 45F, slot 2120 engages with a retaining pin 2030 at the head of anchor 800. In some embodiments, the retaining pin 2030 protrudes from the tip of the docking tube 2105 by a sufficient amount to ensure a proper interface connection with slot 2120. In some embodiments, the retaining pin 2030 extends radially outward from the valve ring hubs 420, 520, 620, and 720. In some embodiments, the retaining pin 2030 is cylindrical. The number of retaining pins 2030 can correspond to the number of slots 2120. In some embodiments, each slot 2120 engages with a retaining pin 2025. Slot 2120 can be shaped to receive and guide the retaining pin 2030.

[0237] Figures 45B and 45C show the initial position of the slot 2120 relative to the retention pin 2030. In this state, the slot 2120 and the retention pin 2030 hold the docking tube 2005 and the bonding auxiliary elements 400, 500, 600, and 700 together. The slot 2120 and the retention pin 2030 allow the user to apply torque to the bonding auxiliary elements 400, 500, 600, and 700 in both directions via the docking tube 2005 and the implant torque shaft 2010. The slot 2120 and the retention pin 2030 allow the user to rotate the bonding auxiliary elements 400, 500, 600, and 700 clockwise or counterclockwise by rotating the docking tube 2005. In some applications, the slots 2120 and retaining pins 2030 can facilitate the movement of the connecting auxiliary elements 400, 500, 600, and 700 via the docking tube 2105.

[0238] Figures 45B to 45E illustrate the use of the anchor 800 together with the implant delivery system 2100. The anchor 800 is positioned within the docking hub 2105, as shown in Figure 45B. The anchor 800 is in a retracted position within the docking hub 2105. The anchor 800 is located inside the locking mechanism or slot 2120. The docking hub 2105 is shown in a linear form in Figure 45B. Figure 45C shows the anchor 800 in an advanced position.

[0239] The anchor 800 can be screwed in at the anatomical P2 position on the posterior leaflet, as described herein. The anchor 800 can be considered a P2 anchor. The anchor 800 can be driven by a driver 2145. Figure 45D shows an enlarged view of the driver 2145. The driver 2145 drives the anchor 800 completely into the tissue and down onto the annular hubs 420, 520, 620, and 720 of the bonding auxiliary elements 400, 500, 600, and 700. The driver 2145 is connected to an internal torque shaft 2150. In some embodiments, the internal torque shaft 2150 is welded or soldered to the driver 2145. The driver 2145 and anchor 800 are completely housed within the docking hub 2105, as shown in Figure 45B. The internal torque shaft 2150 may extend through an implant torque shaft 2110.

[0240] Figure 45E shows an internal cross-sectional view of anchor 800. To ensure a secure connection of driver 2145, tension can be applied to anchor 800 by mooring rail 2155 to bring it into contact with driver 2145. Mooring rail 2155 may include a guide wire having a small thread or male threaded portion 2160 at its distal end. The male threaded portion 2160 of mooring rail 2155 is configured to engage with the female threaded portion 2165 of anchor 800. An internal view of mooring rail 2055, as well as the connection between anchor 800 and valve ring hubs 420, 520, 620, and 720, is shown in Figure 45E. Mooring rail 2155 can allow for a minimum force assessment of the effectiveness of joining auxiliary elements 400, 500, 600, and 700 before releasing them. The mooring rail 2155 allows for minimum force evaluation of the effectiveness of the connecting auxiliary elements 400, 500, 600, and 700 before releasing the retaining pin 2030.

[0241] As anchor 800 is screwed into the tissue, the retaining pins 2030 of the valve annular hubs 420, 520, 620, and 720 move proximal within slot 2120. The docking tube 2005 can be rotated, thereby moving the retaining pins 2030 of the valve annular hubs 420, 520, 620, and 720 laterally within slot 2120. The docking tube 2005 can be moved proximal, thereby moving the retaining pins 2030 of the valve annular hubs 420, 520, 620, and 720 distally within slot 2120. By moving the docking tube 2005 further proximal, the docking tube 2105 can be released from the valve annular hubs 420, 520, 620, and 720. Figures 45A to 45C show that the docking hub 2005 can be connected to the joining auxiliary elements 400, 500, 600, and 700 in order to position the joining auxiliary elements 400, 500, 600, and 700. Figures 45A to 45C also show that the docking hub 2105 can be connected to the joining auxiliary elements 400, 500, 600, and 700 in order to rotate the joining auxiliary elements 400, 500, 600, and 700.

[0242] Figures 45E–45F show diagrams of the embedded anchor 800. Figure 45E also shows a square recess 2170 in the head of the anchor 800. The driver 2145 may include a square portion (not shown) configured to engage the square recess 2170 within the head of the anchor 800. Other designs for meshing the anchor 800 and the driver 2145 are conceivable (e.g., any non-circular shape, polygon, hexagon, Phillips, ellipse, etc.). The anchor 800 may include an anchor hub. The hub may include a female threaded portion 2165 of the anchor 800 that allows connection to the mooring rail 2155. The anchor 800 may include an anchor helix. In some embodiments, the valve ring hubs 420, 520, 620, 720 may include three laser-cut holes that receive three retaining pins 2130. The retaining pins 2130 may be welded into the holes. In some embodiments, the retaining pin 2130 is made of nitinol. Figures 45G to 45K show additional figures.

[0243] Figures 45A to 45C show the deployment of one or more auxiliary anchors 850, 1770, and 1780. Auxiliary anchors 850, 1770, and 1780 may include any of the features of anchor 800. Auxiliary anchors 850, 1770, and 1780 may comprise a helical or helical structure 852. Auxiliary anchors 850, 1770, and 1780 may be designed to engage with cardiac tissue, such as annular tissue. Auxiliary anchors 850, 1770, and 1780 may include a tip 854 designed to engage with tissue. The tip 854 may be sharpened. The tip 854 may be ground for optimal penetration. Auxiliary anchors 850, 1770, and 1780 may include a hub 856. The hub 856 may be annular hub having any of the features of annular hubs 420, 520, 620, and 720 described herein. The hub 856 may include one or more meshing mechanisms 858. The meshing mechanism 858 may be a cutout. The meshing mechanism 858 may create two semicircular portions of different heights. The meshing mechanism 858 may include a first circular portion and a second circular portion. The first and second circular portions may be separated by a vertical cutout. The meshing mechanism 858 may include any configuration that allows torque to be transmitted to auxiliary anchors 850, 1770, and 1780.

[0244] Figures 46A to 46C show a delivery catheter 860 designed to accommodate one or more auxiliary anchors 850, 1770, and 1780. The distal end of the delivery catheter 860 is shown in the drawing. The delivery catheter 860 may include a proximal end located outside the patient's body. The proximal end may include one or more control units for operating the delivery catheter 860. The delivery catheter 860 may include a torque shaft 862. In some embodiments, the torque shaft 862 may allow the auxiliary anchors 850, 1770, and 1780 to rotate in either direction. The torque shaft 862 may include a lumen 864. The torque shaft 862 may include a helix or helical structure 866. The helix or helical structure 866 of the torque shaft 862 may have the same or similar features as the helix or helical structure 852 of one or more auxiliary anchors 850, 1770, and 1780. The helical or helical structure 866 of the torque shaft 862 may have the same pitch as the helical or helical structure 852 of one or more auxiliary anchors 850, 1770, 1780. The helical or helical structure 866 of the torque shaft 862 may have the same diameter as the helical or helical structure 852 of one or more auxiliary anchors 850, 1770, 1780. The helical or helical structure 866 of the torque shaft 862 may have the same wire diameter as the helical or helical structure 852 of one or more auxiliary anchors 850, 1770, 1780.

[0245] The delivery catheter 860 may include a locking hub 868. The locking hub 868 may be an annular hub. The locking hub 868 may include one or more meshing mechanisms 870. The meshing mechanism 870 may be designed to mesh with the meshing mechanism 858 of the hub 856. The meshing mechanism 870 may make up two semicircular portions of different heights. The meshing mechanism 870 may include a first circular portion and a second circular portion. The first and second circular portions may be separated by a vertical cut. The meshing mechanism 870 may include any configuration that allows torque to be transmitted to the hub 856 of one or more auxiliary anchors 850, 1770, 1780. The locking hub 868 may be coupled to a locking shaft 872.

[0246] Figure 46A shows a configuration in which the delivery catheter 860 is not engaged with the auxiliary anchors 850, 1770, and 1780. Figure 46B shows a configuration in which the delivery catheter 860 is engaged with the auxiliary anchors 850, 1770, and 1780. In some embodiments, the helix or helical structure 866 can engage with the helix or helical structure 852 of the auxiliary anchors 850, 1770, and 1780. In some embodiments, both helices can have the same pitch and diameter. Since both helices have the same pitch and diameter, the combined profile will be the same as the profile of the auxiliary anchors 850, 1770, and 1780. The helix or helical structure 866 can be connected to the helix or helical structure 852 of the auxiliary anchors 850, 1770, and 1780. The helix or helical structure 866 can be fitted into the gap of the helix or helical structure 852 of the auxiliary anchors 850, 1770, and 1780. The diameter of the combined structure can be the same as the diameter of the helix or helical structure 852 of the auxiliary anchors 850, 1770, and 1780. In some embodiments, the torque shaft 862 can be rotated to engage the helix or helical structure 866 with the helix or helical structure 852 of the auxiliary anchors 850, 1770, and 1780. In some embodiments, the auxiliary anchors 850, 1770, and 1780 can be rotated to engage the helix or helical structure 852 of the auxiliary anchors 850, 1770, and 1780 with the helix or helical structure 866. Figure 46B shows the engaged helix.

[0247] In some embodiments, the locking hub 868 engages with the hub 856 of the auxiliary anchors 850, 1770, and 1780. In some embodiments, the locking hub 868 can be translated toward the auxiliary anchors 850, 1770, and 1780 within the lumen 864 of the torque shaft 862. The meshing mechanism 870 of the locking hub 868 can be connected with the meshing mechanism 858 of the hub 856 of the auxiliary anchors 850, 1770, and 1780. The locking hub 868 can engage with the auxiliary anchors 850, 1770, and 1780. The hub 856 of the auxiliary anchors 850, 1770, and 1780 and the locking hub 868 can engage to connect the auxiliary anchors 850, 1770, and 1780 to the delivery catheter 860. In some embodiments, the locking shaft 872 can advance or retract the locking hub 868.

[0248] Figure 46C shows a locking hub 868 engaged with the hub 856 of auxiliary anchors 850, 1770, and 1780. The engagement of the locking hub 868 with the hub 856 allows the auxiliary anchors 850, 1770, and 1780 to rotate. In some embodiments, the engagement of the locking hub 868 with the hub 856 reduces the possibility of the delivery catheter 860 disengaging from the auxiliary anchors 850, 1770, and 1780 during delivery. In some embodiments, the engagement of the locking hub 868 with the hub 856 allows the auxiliary anchors 850, 1770, and 1780 to rotate counterclockwise without disengaging from the delivery catheter 860. The auxiliary anchors 850, 1770, and 1780 can be rotated counterclockwise to drive them into the tissue.

[0249] Once the auxiliary anchors 850, 1770, and 1780 are engaged with the tissue, the delivery catheter 860 can be engaged with and disengaged from the auxiliary anchors 850, 1770, and 1780. In some embodiments, a locking hub 868 can be engaged with and disengaged from the hub 856 of the auxiliary anchors 850, 1770, and 1780. The locking hub 868 can be translated within the lumen 864 of the torque shaft 862 in a direction away from the auxiliary anchors 850, 1770, and 1780. The locking shaft 872 can withdraw the locking hub 868. In some embodiments, the helix can be engaged and disengaged by rotating the torque shaft 862. In some embodiments, the helix or helical structure 866 can be engaged with and disengaged from the helix or helical structure 852 of the auxiliary anchors 850, 1770, and 1780 by rotating the torque shaft 862.

[0250] In some embodiments, the connecting auxiliary elements 400, 500, 600, 700 may include annular compartments configured to be embedded in the heart above the annulus. In some embodiments, the connecting auxiliary elements 400, 500, 600, 700 may include a plurality of struts, each comprising a first strut within the annular compartment and a second strut having a longer overall length than the first strut. In some embodiments, the connecting auxiliary elements 400, 500, 600, 700 may include an upper edge that is cup-shaped and held by the annular compartment. In some embodiments, the connecting auxiliary elements 400, 500, 600, 700 can improve the overall connection without disrupting the anatomical structure. In some embodiments, the connecting auxiliary elements 400, 500, 600, 700 may include a plurality of radial struts. In some embodiments, the joining auxiliary elements 400, 500, 600, 700 may include a plurality of radial struts, each comprising a first strut located within the valve annular compartment and a second strut having a longer overall length than the first strut. In some embodiments, the joining auxiliary elements 400, 500, 600, 700 may include a cup-shaped upper edge. In some embodiments, the joining auxiliary elements 400, 500, 600, 700 may include a hub positioned near the valve annulus. In some embodiments, the joining auxiliary elements 400, 500, 600, 700 may include radially extending struts. In some embodiments, the joining auxiliary elements 400, 500, 600, 700 may improve strut joining over their entire length without disrupting anatomical structures. In some embodiments, the joining auxiliary elements 400, 500, 600, 700 may extend via struts.

[0251] In some methods, the method may include positioning the hub near the valve annulus. In some methods, the strut extends radially. In some methods, the method may include improving the strut joint over its entire length without disrupting the anatomical structure. In some methods, the method may include extending the joint element held via a strut that extends radially outward. In some methods, the method may include extending the joint element held via a strut that extends radially outward to form a valve annular compartment. In some methods, the method may include extending the joint element held via a strut to form a valve annular compartment.

[0252] In some embodiments, the valve ring hubs 420, 520, 620, and 720 are separated inward from the lateral edges of the connecting auxiliary elements 400, 500, 600, and 700. In some embodiments, the valve ring hubs 420, 520, 620, and 720 are separated inward from the upper edges of the connecting auxiliary elements 400, 500, 600, and 700. In some embodiments, the valve ring hubs 420, 520, 620, and 720 are separated inward from the lower edges of the connecting auxiliary elements 400, 500, 600, and 700. In some embodiments, the valve ring hubs 420, 520, 620, and 720 are not expandable. In some embodiments, the valve ring hubs 420, 520, 620, and 720 may have a fixed circumference. In some embodiments, the valve ring hubs 420, 520, 620, 720 maintain their shape during the expansion of the joining auxiliary elements 400, 500, 600, 700. In some embodiments, the valve ring hubs 420, 520, 620, 720 are formed from tubes. The struts 430, 530, 630, 730 can be laser-cut from the tubes. The cut portion can extend from one end of the tubing material toward a second end. The uncut portion of the tubing material can be the valve ring hubs 420, 520, 620, 720. In some embodiments, the joining auxiliary elements 400, 500, 600, 700 can be formed from sheets of material. The sheets can be laser-cut to include the struts 430, 530, 630, 730. The sheets can be rolled to form tubes. The tubes can be welded together or held together by other means. The uncut portions of the seat can form valve ring hubs 420, 520, 620, and 720.

[0253] In some embodiments, the anchor 800 is an active anchor. The anchor 800 can be coupled to the valve annular hubs 420, 520, 620, and 720. The anchor 800 can be coupled to the valve annular hubs 420, 520, 620, and 720 by linking the helix of the anchor 800 to the structure of the valve annular hubs 420, 520, 620, and 720. The anchor 800 can be configured to rotate relative to the valve annular hubs 420, 520, 620, and 720 when coupled to them. The anchor 800 can be configured to rotate and be selectively deployed. The anchor 800 can be configured to rotate and engage with tissue. The anchor 800 can be configured to rotate and engage with the valve annulus. The anchor 800 can be configured to rotate through the valve ring. The anchor 800 can be configured to rotate in a first direction relative to the valve ring hubs 420, 520, 620, and 720. The anchor 800 is configured to be selectively deployed by rotating in a first direction. The anchor 800 is configured to be rotated to deploy the anchor 800 to an initial target position. The anchor 800 is configured to be rotated to engage with tissue within the valve ring. The anchor 800 can be selectively deployed on the valve ring. When the anchor 800 is rotated to engage with tissue, the valve ring hubs 420, 520, 620, and 720 can remain stationary. When the anchor 800 is rotated to engage with tissue, the non-expandable valve ring hubs 420, 520, 620, and 720 can remain stationary.

[0254] In some embodiments, the anchor 800 is configured to rotate in a second direction relative to the annular hubs 420, 520, 620, and 720. The anchor 800 is configured to selectively engage and disengage by rotating in the second direction. The anchor 800 is configured to disengage from the initial target position by rotating. The anchor 800 is configured to disengage from the tissue within the annulus by rotating. When the anchor 800 is rotated to engage with the tissue, the annular hubs 420, 520, 620, and 720 can remain stationary. When the anchor 800 is rotated to engage with the tissue, the non-expandable annular hubs 420, 520, 620, and 720 can remain stationary. The second direction can be the opposite of the first direction. In some embodiments, the first direction can be clockwise and the second direction can be counterclockwise. In some embodiments, the first direction can be counterclockwise and the second direction can be clockwise.

[0255] In some embodiments, multiple struts 430, 530, 630, 730 are spaced circumferentially around the valve ring hubs 420, 520, 620, 720. In some embodiments, multiple struts 430, 530, 630, 730 are spaced evenly around the valve ring hubs 420, 520, 620, 720. In some embodiments, multiple struts 430, 530, 630, 730 are spaced unevenly around the valve ring hubs 420, 520, 620, 720. In some embodiments, struts 430, 530, 630, 730 comprising valve ring compartments are spaced evenly around the valve ring hubs 420, 520, 620, 720. In some embodiments, the struts 430, 530, 630, 730 comprising the annular compartment are unevenly spaced around the annular hubs 420, 520, 620, 720. In some embodiments, the struts 430, 530, 630, 730 forming the upper edge are evenly spaced around the annular hubs 420, 520, 620, 720. In some embodiments, the struts 430, 530, 630, 730 forming the upper edge are unevenly spaced around the annular hubs 420, 520, 620, 720. In some embodiments, the struts 430, 530, 630, 730 comprising the ventricular compartment are evenly spaced around the annular hubs 420, 520, 620, 720. In some embodiments, the strata 430, 530, 630, and 730 comprising the ventricular compartment are unevenly spaced around the annular hubs 420, 520, 620, and 720. In some embodiments, the strata 430, 530, 630, and 730 forming the lower edge are evenly spaced around the annular hubs 420, 520, 620, and 720. In some embodiments, the strata 430, 530, 630, and 730 forming the lower edge are unevenly spaced around the annular hubs 420, 520, 620, and 720. In some embodiments, two or more strata 430, 530, 630, and 730 are evenly spaced around the annular hubs 420, 520, 620, and 720. In some embodiments, two or more support columns 430, 530, 630, 730 are unevenly spaced around the valve ring hubs 420, 520, 620, 720.

[0256] In some embodiments, the multiple struts 430, 530, 630, 730 extend outward from the valve ring hubs 420, 520, 620, 720. In some embodiments, the multiple struts 430, 530, 630, 730 may have a radial portion near the valve ring hubs 420, 520, 620, 720. In some embodiments, the multiple struts 430, 530, 630, 730 are arranged along the radius. In some embodiments, the multiple struts 430, 530, 630, 730 branch from the center. In some embodiments, the multiple struts 430, 530, 630, 730 branch from the valve ring hubs 420, 520, 620, 720. In some embodiments, the multiple struts 430, 530, 630, 730 are uniformly spread around the central axis. In some embodiments, multiple struts 430, 530, 630, 730 are uniformly distributed around the valve ring hubs 420, 520, 620, 720. In some embodiments, multiple struts 430, 530, 630, 730 are uniformly distributed around the anchor 800. In some embodiments, multiple struts 430, 530, 630, 730 can form spokes. In some embodiments, multiple struts 430, 530, 630, 730 extend outward from the center. In some embodiments, multiple struts 430, 530, 630, 730 extend inward from the edges of the connecting auxiliary elements 400, 500, 600, 700. In some embodiments, multiple struts 430, 530, 630, 730 branch out. In some embodiments, multiple struts 430, 530, 630, 730 are spread out. In some embodiments, the multiple struts 430, 530, 630, 730 are radial. In some embodiments, the multiple struts 430, 530, 630, 730 spread outward. In some embodiments, the multiple struts 430, 530, 630, 730 can include inflection points. In some embodiments, the multiple struts 430, 530, 630, 730 can include inflection points. In some embodiments, the multiple struts 430, 530, 630, 730 can include a curved shape. In some embodiments, the struts 430, 530, 630, 730 can include a curved shape.In some embodiments, the support columns 430, 530, 630, and 730 may include U-shaped curves. In some embodiments, the support columns 430, 530, 630, and 730 may include C-shaped curves. In some embodiments, the support columns 430, 530, 630, and 730 may include S-shaped curves. In some embodiments, the support columns 430, 530, 630, and 730 may include L-shaped curves.

[0257] In some embodiments, multiple support columns 430, 530, 630, 730 increase the volume of the connecting auxiliary elements 400, 500, 600, 700 when deployed. In some embodiments, multiple support columns 430, 530, 630, 730 increase the thickness of the connecting auxiliary elements 400, 500, 600, 700 when deployed. In some embodiments, multiple support columns 430, 530, 630, 730 increase the length of the connecting auxiliary elements 400, 500, 600, 700 when deployed. In some embodiments, multiple support columns 430, 530, 630, 730 increase the height of the connecting auxiliary elements 400, 500, 600, 700 when deployed. In some embodiments, multiple support columns 430, 530, 630, 730 increase the width of the connecting auxiliary elements 400, 500, 600, 700 when deployed.

[0258] In some embodiments, a plurality of struts 430, 530, 630, 730 may include a first strut. The first strut may be configured to be embedded in the heart above the valve annulus. The first strut may be an annular strut. In some embodiments, a plurality of struts 430, 530, 630, 730 may include a second strut. The second strut may be configured to be embedded in the heart below the valve annulus. The second strut may be a ventricular strut. The second strut may traverse the mitral valve. The second strut may traverse the surface of the valve annulus. In some embodiments, the first and second struts may have different lengths. In some embodiments, the second strut is longer than the first strut.

[0259] In some embodiments, the upper edges of the joining auxiliary elements 400, 500, 600, and 700 form a curve. In some embodiments, the upper edges form a lip. In some embodiments, the upper edges are cupped downward toward the lower edges. In some embodiments, the upper edges are cupped upward toward the lower edges. In some embodiments, the valve ring hubs 420, 520, 620, and 720 extend upward toward the lower edges. In some embodiments, the valve ring hubs 420, 520, 620, and 720 extend upward toward the upper edges. In some embodiments, the valve ring hubs 420, 520, 620, and 720 extend upward toward the annular portions of the joining auxiliary elements 400, 500, 600, and 700. In some embodiments, the valve ring hubs 420, 520, 620, and 720 extend upward toward the joining surfaces of the joining auxiliary elements 400, 500, 600, and 700. In some embodiments, the valve ring hubs 420, 520, 620, and 720 are tubular. In some embodiments, the valve ring hubs 420, 520, 620, and 720 form a circle. In some embodiments, the valve ring hubs 420, 520, 620, and 720 have a ring shape. In some embodiments, the hubs 420, 520, 620, and 720 are non-annular. In some embodiments, the hubs 420, 520, 620, and 720 form a polygon (e.g., triangle, quadrilateral, rectangle, hexagon, octagon, etc.). In some embodiments, the hubs 420, 520, 620, and 720 form a non-circular shape. In some embodiments, the hubs 420, 520, 620, and 720 form an ellipse.

[0260] Figures 47A to 47E illustrate embodiments of the implant mechanism. Figures 47A to 47E show several non-limiting, potentially clinically relevant embodiments of the implant. A bonding auxiliary element 400 is shown, and any of the bonding auxiliary elements described herein may include the features described herein. In addition, the bonding auxiliary element 400 may include any of the features of the bonding auxiliary elements described herein for other embodiments, for example.

[0261] As described herein, the connecting auxiliary element 400 may include an annular hub 420 which can be located relatively centrally. The connecting auxiliary element 400 may have an overall elongated shape, but other shapes such as polygons, circles, ellipses, rounded shapes, rectangles, triangles, etc., can be imagined. The connecting auxiliary element 400 may have an upper edge 440, lateral edges 470 and 475, and a lower edge 480. In some embodiments, the upper edge 440 is longer than the lower edge 480, so the transverse distance between the lateral edges 470 and 475 decreases overall from the top to the bottom of the connecting auxiliary element 400. The upper edge 440 of the connecting auxiliary element 400 may be curved to match the overall shape of the annulus or adjacent atrial wall.

[0262] The jointing support element 400 may include a first surface 405 configured to be positioned toward the natural valve leaflet experiencing joint failure during use, and a second surface 415 configured to be positioned toward the anterior leaflet. The second surface 415 may include a jointing surface 460. The jointing support element 400 may include one or more struts 430. Multiple struts 430 can structurally support the jointing support element 400. Multiple struts 430 can provide the deployed shape of the jointing support element 400. As described herein, the multiple struts may include shape memory materials such as shape memory metal or plastic.

[0263] In some embodiments, the first support 430 of the multiple supports extends from or toward the upper edge 440 of the valve ring hub 420. In some embodiments, the second support 430 of the multiple supports extends from or toward the lower edge 480 of the valve ring hub 420. In some embodiments, the third support 430 of the multiple supports extends from or toward the transverse edge 470 of the valve ring hub 420. In some embodiments, the fourth support 430 of the multiple supports extends from or toward the transverse edge 475 of the valve ring hub 420. Any two or more of the first, second, third, or fourth supports may include the same characteristics, including material, length, width, thickness, construction, pre-formed bends, curvature, etc. Any two or more of the first, second, third, or fourth struts may have different characteristics, including material, length, width, thickness, construction, pre-formed bend, curvature, etc. In some embodiments, at least one of the struts, for example, located in the upper region of the implant, may extend radially outward from the cover 450 of the implant 400 and protrude therefrom, acting as a separated barb that can support fixation of the annulus and / or endo-growth of tissue within the annulus. In some embodiments, the barb may extend only in the annular region of the implant (e.g., the upper region) and may not be present in the lower (leaflet) junction region, which in some embodiments is non-traumatic. In some embodiments, the entire periphery of the implant may be non-traumatic.

[0264] In some embodiments, the support column 430 may be covered with one, two, or more layers of the joint auxiliary element body cover 450. The joint auxiliary element body cover 450 may include one or more layers (e.g., one, two, three, four, five, or more layers, or a range incorporating any two of the aforementioned values). In some embodiments, the first surface 405 may include one or more layers. In some embodiments, the second surface 415 may include one or more layers. Any two or more of the layers may include the same or different characteristics, including material, length, width, thickness, etc. In some embodiments, one or more layers may extend along all or part of the first surface 405. In some embodiments, one or more layers may extend along all or part of the second surface 415. The layers may be formed from any process described herein.

[0265] The bonding auxiliary element body cover 450 may be made of a material such as a polymer, for example, ePTFE. Other materials for the bonding auxiliary element body cover 450 include polyester, polyurethane foam, polycarbonate foam, biological tissue such as porcine pericardium, treated bovine pericardium, pleura, peritoneum, silicone, Dacron, cell-free collagen matrix, and combinations thereof. In some embodiments, the bonding auxiliary element body cover 450 may include a foam material surrounded by ePTFE.

[0266] In some embodiments, the support 430 may be formed with or embedded in one or more layers of the bonding auxiliary element body cover 450. In some embodiments, the support 430 may be enclosed in or at least partially enclosed in the bonding auxiliary element body cover 450. In some embodiments, a portion of the support 430 may extend from the bonding auxiliary element body cover 450 and engage with tissue, as described elsewhere in this specification. Figures 47A to 47E show features that may facilitate interaction between the bonding auxiliary element 400 or a portion thereof and natural anatomical structures.

[0267] Figure 47A shows a bonding surface 460 which can define the relatively lower portion of the implant. The anterior chamber bonding surface can be reinforced. As described herein, the bonding surface 460 can be in contact with the patient's valve leaflet. After placement, the bonding auxiliary element 400 can completely cover the posterior leaflet so that the anterior leaflet bonds with the bonding surface 460 during systole. The bonding auxiliary element 400 and the anterior leaflet can maintain the valve seal in the annular ring.

[0268] In some embodiments, the second surface 415 or a portion thereof is reinforced. In some embodiments, the bonding surface 460 is reinforced. The second surface 415, including but not limited to the bonding surface 460, may be reinforced with one or more additional layers. One or more additional layers may extend over the second surface 415 or a portion thereof. One or more additional layers may extend over the bonding surface 460 or a portion thereof. One or more additional layers may extend over a portion of the second surface 415 that includes the bonding surface 460. One or more additional layers may extend over a portion of the second surface 415 that is larger than the bonding surface 460.

[0269] The bonding surface 460 can be reinforced with any material described herein. The bonding surface 460 can be reinforced with ePTFE. The bonding surface 460 can be reinforced with any material of the bonding auxiliary element body cover 450, such as ePTFE, Dacron, and / or polypropylene.

[0270] Figure 47B shows the first surface 405. The posterior ventricular joint surface can be reinforced. As described herein, the first surface 405 can be in contact with the patient's valve leaflet. After placement, the joint auxiliary element 400 can completely cover the posterior leaflet with the first surface 405. The first surface 405 may be opposite the second surface 415, which includes the joint surface 460.

[0271] In some embodiments, the first surface 405 or a portion thereof is reinforced. The first surface 405 may be reinforced with one or more additional layers. One or more additional layers may extend over the first surface 405 or a portion thereof. One or more additional layers may be directly opposite one or more additional layers extending over the second surface 415. One or more additional layers may extend over a portion of the first surface 405 on the opposite side of the bonding surface 460. One or more additional layers may extend over a portion of the first surface 405 that has a contact area greater than that with the trailing tip.

[0272] The first surface 405 can be reinforced with any material described herein. The first surface 405 or a portion thereof can be reinforced with ePTFE. The first surface 405 can be reinforced with any material of the bonding auxiliary element body cover 450, such as ePTFE, Dacron, and / or polypropylene, which advantageously can create a non-traumatic surface and reduce the risk of damage to the natural valve leaflets by repeated bonding to the bonding surface of the bonding auxiliary body.

[0273] Figures 47C–47D show the edges of the joining auxiliary element 400. As described herein, the joining auxiliary element 400 may include reinforced edges with increased thickness, such as knotless suture edges 455. The upper edge 440, transverse edges 470 and 475, and / or lower edge 480 of the joining auxiliary element 400 may include raised edges or bumpers. In some embodiments, one, two, or more of the upper edge 440, transverse edges 470 and 475, or lower edge 480 may include raised edges or bumpers. In some embodiments, the raised edges or bumpers may be made of Gore-Tex®. In some embodiments, the raised edges or bumpers may encircle or at least partially encircle the periphery of the lower area or the entire joining auxiliary body.

[0274] A raised edge or bumper can be formed from sutures. Sutures can be wrapped around the edge to form a raised edge or bumper. The raised edge or bumper may have features such as increased thickness and / or softness, for example, to reduce trauma to natural tissue. The raised edge or bumper can reduce contact between the jointing auxiliary element 400 and the patient's anatomical structure. In the case of a mitral valve, the raised edge or bumper can reduce contact between the jointing auxiliary element 400 and the posterior leaflet. In some embodiments, only the first surface 405 includes a raised edge. In some embodiments, both the first surface 405 and the second surface 415 include a raised edge. The raised edge or bumper can be on or near the edge of the first surface 405 or the second surface 415. The raised edge or bumper can be separated inward from the first surface 405 or the second surface 415. Figure 47C shows the rear view. Figure 47D shows the front view.

[0275] The raised edge or bumper may include one or more rounded edges that reduce contact between the locating element 400 and the patient's underlying anatomical structure. In some embodiments, contact is reduced between the locating element 400 and the posterior leaflet. In some embodiments, contact is not reduced between the locating element 400 and the annulus. In some embodiments, the locating element 400 is configured to minimize contact with the posterior leaflet but maximize contact with the annulus. Other configurations can be imagined.

[0276] Figure 47E shows the anchor area. The joining auxiliary element 400 may include a substantially annular upper section 410. The anchor area may be located within the annular section 410 and may comprise two sections that are spaced apart from and extend laterally from the hub 420. The annular section 410 may be positioned relative to the annular when the joining auxiliary element 400 is deployed. In some embodiments, the annular section 410 may be curved toward or away from the annular. In other embodiments, the annular section 410 may be substantially flat relative to the annular. The annular section 410 may be configured to receive one or more auxiliary anchors. The auxiliary anchors may be advanced on a guide rail, which can be coupled to the joining auxiliary element 400 as described herein. The auxiliary anchors may be rotated to penetrate the annular section 410. The auxiliary anchors may engage with tissue located beneath the joining auxiliary element 400.

[0277] The annular compartment 410, such as the anchor area, can be reinforced to have an increased thickness compared to the rest of the upper compartment, and a thickness greater than, equal to, or less than the thickness of the lower junction area of ​​the implant. The annular compartment 410 can be reinforced to the extent configured to accept one, two, three, four, or more auxiliary anchors. As described herein, the first surface 405 of the junction auxiliary element 400 can be positioned in contact with the annulus after being placed in the patient's heart. The second surface 415 can face upward from the annulus. In some embodiments, the annular compartment 410 or a portion thereof is reinforced. The annular compartment 410 can be reinforced with one or more additional layers. One or more additional layers can extend over the annular compartment 410 or a portion thereof. One or more additional layers can be directly opposite the annular hub 420. One or more additional layers can extend over a portion of the first surface 405. One or more additional layers can extend over a portion of the second surface 415. The anchor area may be located near the valve ring hub 420. The anchor area may include one or more distinct areas.

[0278] The valve ring compartment 410 can be reinforced with any of the materials described herein. The valve ring compartment 410 or a portion thereof can be reinforced with ePTFE. The valve ring compartment 410 or a portion thereof can be reinforced with velour. The valve ring compartment 410 can be reinforced with any material of the joining auxiliary element body cover 450, such as ePTFE, Dacron, and / or polypropylene. One or more additional layers can extend outward from the valve ring hub 420. One or more additional layers can be of any shape sufficient to cover an area larger than the area engaged by one or more auxiliary anchors.

[0279] In some embodiments, the annular portion 410 may include an edge that is sharper than another edge of the joining auxiliary element 400. In some embodiments, the upper edge 440 is thinner than another edge of the joining auxiliary element 400 (e.g., the transverse edge 470, transverse edge 474, or lower edge 480), and / or sharper. In some embodiments, the annular portion 410 and / or the upper edge 440 may stimulate or engage with tissue. In some embodiments, the annular portion 410 is configured to be embedded near the annulus. In some embodiments, the annular portion 410 is configured to promote an immune response. In some embodiments, the annular portion 410 is configured to promote intra-tissue growth.

[0280] Figure 48 shows an exploded view of one embodiment of a cover, including a laminate, surrounding a portion of the implant. A bonding auxiliary element 400 is shown, but any bonding auxiliary element described herein may include any number of features described herein, any of the features described herein may be excluded / omitted, or arranged in a different order relative to each other. In addition, the bonding auxiliary element 400 may include, or exclude / omit, any of the features of the bonding auxiliary elements described herein. The exploded view shows a thick reinforcing layer for the anterior and posterior chamber portions. The exploded view shows a single velour anchor area. Raised edges or bumpers are not shown. Raised edges or bumpers may be added in the final stage of assembly. The laminate 1100 described herein can form the bonding auxiliary element body cover 450. The laminate 1100 may include one or more layers as described herein. The laminate 1100 may include one or more layers in any order.

[0281] The bonding auxiliary element 400 may include a post layer 1102. The post layer may form the first surface 405. In some embodiments, the post layer 1102 is thinner than the other layers. In some embodiments, the post layer 1102 is ePTFE. In some embodiments, the post layer 1102 has a thickness (e.g., about 0.001 inches, about 0.0015 inches, about 0.002 inches, about 0.0025 inches, about 0.003 inches, or any range including two of the aforementioned values). The post layer 1102 may include an opening through which the anchor 800 extends. The post layer 1102 can be any shape, including rectangular, polygonal, triangular, circular, and elliptical. In some embodiments, the post layer 1102 is not the final shape of the bonding auxiliary element 400.

[0282] The joining auxiliary element 400 may include a first support structure layer 1104. The first support structure 1104 may be mesh. In some embodiments, the first support structure layer 1104 includes UHMPE. The first support structure 1104 may be positioned on top of a rear layer 1102. The first support structure layer 1104 may be positioned behind the support column 430. The first support structure layer 1104 may include an opening through which an anchor 800 extends.

[0283] The joining auxiliary element 400 may include a first fabric layer 1106. The first fabric layer 1106 may be relatively thin and may have a thickness (e.g., about 0.001 inches, about 0.0015 inches, about 0.002 inches, about 0.0025 inches, about 0.003 inches, about 0.004 inches, about 0.005 inches, about 0.01 inches, or any range including two of the aforementioned values). In some embodiments, the first fabric layer 1106 includes a polyester fabric. The first fabric layer 1106 may be positioned on top of the first support structure layer 1104. The first fabric layer 1106 may be positioned behind the support column 430. The first fabric layer 1106 may include an opening through which the anchor 800 extends. In some embodiments, the first fabric layer 1106 extends along only a portion of the joining auxiliary element 400. In some embodiments, the first fabric layer 1106 includes a cutout portion.

[0284] The connecting auxiliary element 400 may include a first ventricular layer 1108. The ventricular surface layer 1108 may be a reinforcing layer of the first surface 405. In some embodiments, the first ventricular layer 1108 is thicker than the other layers. In some embodiments, the first ventricular layer 1108 is ePTFE. In some embodiments, the first ventricular layer 1108 has a thickness (e.g., about 0.01 inches, about 0.02 inches, about 0.03 inches, about 0.035 inches, about 0.040 inches, about 0.045 inches, about 0.05 inches, about 0.07 inches, about 0.10 inches, or any range including two of the aforementioned values). The first ventricular layer 1108 may be any shape, including rectangles, polygons, triangles, circles, ellipses, etc. The first ventricular layer 1108 may be positioned on the rear side of the support column 430.

[0285] The joining auxiliary element 400 may include an anchor layer 1110. The anchor layer 1110 may be a reinforcing layer for one or more auxiliary anchors. In some embodiments, the anchor layer 1110 is thicker than the other layers. In some embodiments, the anchor layer 1110 is ePTFE. In some embodiments, the anchor layer 1110 is velour. In some embodiments, the anchor layer 1110 has a thickness (e.g., about 0.01 inches, about 0.02 inches, about 0.03 inches, about 0.035 inches, about 0.040 inches, about 0.045 inches, about 0.05 inches, about 0.07 inches, about 0.10 inches, or any range including two of the aforementioned values). The anchor layer 1110 may be any shape, including rectangles, polygons, triangles, circles, ellipses, etc. In some embodiments, the joining auxiliary element 400 includes a single anchor area that forms the anchor layer 1110. In some embodiments, the joining auxiliary element 400 includes two or more separate anchoring regions that form an anchoring layer 1110. The anchoring layer 1110 can be positioned on the rear side of the support column 430, as shown in the illustration. In the illustrated embodiments, the ventricular surface layer 1108 and the anchoring layer 1110 can be sandwiched between the same two adjacent layers. In some embodiments, the ventricular surface layer 1108 and the anchoring layer 1110 are separated by one or more layers.

[0286] The joint auxiliary element 400 may include a second support structure layer 1112. The second support structure layer 1112 may be a mesh. In some embodiments, the second support structure layer 1112 includes UHMPE. The second support structure layer 1112 may be positioned on top of the ventricular surface layer 1108. The second support structure layer 1112 may be positioned behind the support column 430. In some embodiments, the second support structure layer 1112 extends along only a portion of the joint auxiliary element 400. In some embodiments, the second support structure layer 1112 extends along only the ventricular portion of the joint auxiliary element 400.

[0287] The joining auxiliary element 400 may include a frame 465. In some embodiments, the frame 465 is cut from a tubular material. The frame 465 may include one or more struts 430. The frame 465 can be constructed from a single piece of material. The frame 465, including its struts 430, can be formed using any method described herein, including waterjet, laser etching, or similar techniques. Details of the struts 430, including the returns, can be machined to form the struts 430. The frame 465 can be bent and / or shaped to achieve a desired geometric shape. The frame 465, including its struts 430, may include an elastically deformable material, such as a shape memory metal, e.g., Nitinol or a shape memory polymer. In some embodiments, the material is Elgiloy. In some embodiments, the frame 465 may be made of other materials, including stainless steel, polypropylene, high-density polyethylene (PE), Dacron, cell-free collagen matrix such as SIS, or other plastics. In some embodiments, the support columns 430 may include shape memory material and support column covers. The support column covers may be any of the materials described herein and may cover all or part of the support columns 430. In some embodiments, the support columns 430 may include tubular materials or covers of nitinol and LDPE on top of each support column 430. In some embodiments, the frame 465 may be considered as layers.

[0288] The joining auxiliary element 400 may include a second ventricular layer 1114. The second ventricular layer 1114 may be a reinforcing layer of the second surface 415. In some embodiments, the second ventricular layer 1114 is thicker than the other layers. In some embodiments, the second ventricular layer 1114 is ePTFE. In some embodiments, the second ventricular layer 1114 has a thickness (e.g., about 0.03 inches, about 0.035 inches, about 0.040 inches, about 0.045 inches, about 0.05 inches, or any range including two of the aforementioned values, or other thickness values ​​as described herein for the other layers). The second ventricular layer 1114 may be any shape, including rectangular, polygonal, triangular, circular, elliptical, etc. The second ventricular layer 1114 may be positioned on the front side of the support 430. In some embodiments, the second ventricular layer 1114 extends along only a portion of the joining auxiliary element 400. In some embodiments, the second ventricular layer 1114 extends only along the ventricular portion of the connecting auxiliary element 400. In some embodiments, the first ventricular layer 1108 and the second ventricular layer 1114 have the same shape.

[0289] The connecting auxiliary element 400 may include a third support structure layer 1116. The third support structure layer 1116 may be mesh. In some embodiments, the third support structure layer 1116 may include UHMPE. The third support structure layer 1116 may be positioned on top of the second ventricular layer 1114. The third support structure layer 1116 may be positioned in front of the support column 430. In some embodiments, the third support structure layer 1116 extends along only a portion of the connecting auxiliary element 400. In some embodiments, the third support structure layer 1116 extends along only the ventricular portion of the connecting auxiliary element 400.

[0290] The joining auxiliary element 400 may include a second fabric layer 1118. The second fabric layer 1118 may be thinner than the other layers. In some embodiments, the second fabric layer 1118 has a thickness (e.g., about 0.001 inches, about 0.0015 inches, about 0.002 inches, about 0.0025 inches, about 0.003 inches, or any range including two of the aforementioned values). In some embodiments, the second fabric layer 1118 includes polyester fabric. The second fabric layer 1118 may be positioned on top of the third support structure layer 1116. The second fabric layer 1118 may be positioned in front of the support column 430. The second fabric layer 1118 may include an opening through which the anchor 800 extends.

[0291] The joining auxiliary element 400 may include a fourth support structure layer 1120. The fourth support structure layer 1120 may be mesh. In some embodiments, the fourth support structure layer 1120 may include UHMPE. The fourth support structure layer 1120 may be positioned on top of the second fabric layer 1118. The fourth support structure layer 1120 may be positioned in front of the support column 430. The fourth support structure layer 1120 may include an opening through which the anchor 800 extends. In some embodiments, the first support structure layer 1104 and the fourth support structure layer 1120 are the same shape.

[0292] The bonding auxiliary element 400 may include a front layer 1122. The front layer 1122 may form a second surface 415. In some embodiments, the front layer 1122 is thinner than the other layers. In some embodiments, the front layer 1122 is ePTFE. In some embodiments, the front layer 1122 has a thickness (e.g., about 0.001 inches, about 0.0015 inches, about 0.002 inches, about 0.0025 inches, about 0.003 inches, or any range including two of the aforementioned values, or other thickness values ​​as described herein for the other layers). The front layer 1122 may include an opening through which the anchor 800 extends. The front layer 1122 can be any shape, including rectangular, polygonal, triangular, circular, and elliptical. In some embodiments, the front layer 1122 is not the final shape of the bonding auxiliary element 400. In some embodiments, the rear layer 1102 and the front layer 1122 have the same shape.

[0293] Figure 49 shows one embodiment of the implant delivery system 2200. The implant delivery system 2200 may include any of the features of the implant delivery systems described herein. The implant delivery system 2200 may include a main anchor housing 2202. In some embodiments, the main anchor housing 2202 is a docking tube. The main anchor housing 2202 may be cylindrical. The main anchor housing 2202 may include a central lumen. The main anchor housing 2202 may be arranged around the annular hubs 420, 520, 620, 720 of the bonding auxiliary elements 400, 500, 600, 700.

[0294] The implant delivery system 2200 may include a main anchor driver 2204. The main anchor housing 2202 may be sized to fit into the main anchor driver 2204. In some embodiments, the main anchor driver 2204 is a torque shaft. In some embodiments, the main anchor driver 2204 is configured to rotate relative to the main anchor housing 2202. In some embodiments, the main anchor driver 2204 is not configured to translate relative to the main anchor housing 2202. The main anchor driver 2204 may be considered a main anchor fork driver, as described herein. The main anchor driver 2204 may be designed to engage with and rotate an anchor 800. The anchor 800 may be considered a main anchor 800 to distinguish it from one or more auxiliary anchors.

[0295] The implant delivery system 2200 may include one or more release wires 2206, 2208. In the illustrated embodiment, the implant delivery system 2200 may include two release wires 2206, 2208, but other configurations are conceivable (e.g., one release wire, two release wires, three release wires, four release wires, five release wires, six release wires, etc.). The release wires 2206, 2208 may extend proximal from the main anchor housing 2202. In some embodiments, the release wires 2206, 2208 may extend beyond the implant surface. The release wires 2206, 2208 may extend through at least a portion of the main anchor housing 2202. The release wires 2206, 2208 may extend through one or more channels or tubes within the main anchor housing 2202. The release wires 2206, 2208 may be located opposite each other within the main anchor housing 2202.

[0296] The release wires 2206 and 2208 can extend outside the main anchor housing 2202. The main anchor housing 2202 may include slots 2210 and 2212 through which the release wires 2206 and 2208 can extend. The release wires 2206 and 2208 can extend from the inside of the main anchor housing 2202 to the outside of the main anchor housing 2202 through slots 2210 and 2212 (for example, release wire 2206 can extend through slot 2210 and release wire 2208 can extend through slot 2212).

[0297] The release wires 2206 and 2208 can extend back inside the main anchor housing 2202. The main anchor housing 2202 may include slots 2214 and 2216 through which the release wires 2206 and 2208 can extend. The release wires 2206 and 2208 can extend from the outside of the main anchor housing 2202 to the inside of the main anchor housing 2202 through slots 2214 and 2216 (for example, release wire 2206 can extend through slot 2214 and release wire 2208 can extend through slot 2216). The release wires 2206 and 2208 can advance by weaving through the main anchor housing 2202. The release wires 2206 and 2208 can be coupled to the main anchor housing 2202. The release wires 2206 and 2208 can extend through anchor 800. The release wires 2206 and 2208 can cross each other.

[0298] The release wires 2206 and 2208 can extend along the joining auxiliary elements 400, 500, 600, and 700. The release wires 2206 and 2208 can extend along the annular surfaces 410, 510, 610, and 710. The release wires 2206 and 2208 can extend below the joining auxiliary elements 400, 500, 600, and 700. The release wires 2206 and 2208 can extend in opposite directions. The release wires 2206 and 2208 can be directly opposite each other. The release wires 2206 and 2208 can be coaxial. The release wires 2206 and 2208 can be approximately along the line. The release wires 2206 and 2208 can be adjacent to the valve ring. The release wires 2206 and 2208 can be in contact with the valve ring. The release wires 2206 and 2208 can facilitate coupling between the implant delivery system 2200 and the bonding auxiliary elements 400, 500, 600, and 700. The release wires 2206 and 2208 can firmly hold the main anchor housing 2202 against the annular hubs 420, 520, 620, and 720 of the bonding auxiliary elements 400, 500, 600, and 700. The release wires 2206 and 2208 can extend from the front to the rear of the bonding auxiliary elements 400, 500, 600, and 700. In some embodiments, the ends of the release wires 2206 and 2208 wrap around the bonding auxiliary elements 400, 500, 600, and 700. In some embodiments, the ends of the release wires 2206 and 2208 are curved or form a C-shape.

[0299] The implant delivery system 2200 may include one or more auxiliary anchors 2220, 2222, 2224, 2226 (e.g., one auxiliary anchor, two auxiliary anchors, three auxiliary anchors, four auxiliary anchors (as shown), five auxiliary anchors, six auxiliary anchors, seven auxiliary anchors, eight auxiliary anchors, etc.). In some embodiments, two or more auxiliary anchors 2220, 2222, 2224, 2226 are the same. In some embodiments, two or more auxiliary anchors 2220, 2222, 2224, 2226 are different (e.g., different pitches, different diameters, different materials, different shoulders, different windows, etc.). In some embodiments, the auxiliary anchors 2220, 2222, 2224, 2226 may be helical anchors. The auxiliary anchors 2220, 2222, 2224, 2226 may have a smaller diameter than the main anchor 800. Auxiliary anchors 2220, 2222, 2224, and 2226 may have a smaller pitch than the main anchor 800. Auxiliary anchors 2220, 2222, 2224, and 2226 may be configured to rotate and engage with the tissue within the valve ring.

[0300] The implant delivery system 2200 may include one or more auxiliary anchor drivers 2230, 2232, 2234, 2236 (e.g., one auxiliary anchor driver, two auxiliary anchor drivers, three auxiliary anchor drivers, four auxiliary anchor drivers (as illustrated), five auxiliary anchor drivers, six auxiliary anchor drivers, seven auxiliary anchor drivers, eight auxiliary anchor drivers, etc.). In some embodiments, two or more auxiliary anchor drivers 2230, 2232, 2234, 2236 are the same. In some embodiments, two or more auxiliary anchor drivers 2230, 2232, 2234, 2236 are different (e.g., different configurations, mirror images, different anchors coupled together, etc.). In some embodiments, the auxiliary anchor drivers 2230, 2232, 2234, 2236 are torque axes. In some embodiments, auxiliary anchor drivers 2230, 2232, 2234, and 2236 are configured to rotate their respective auxiliary anchors 2220, 2222, 2224, and 2226. In some embodiments, auxiliary anchor drivers 2230, 2232, 2234, and 2236 are configured to translate their respective auxiliary anchors 2220, 2222, 2224, and 2226.

[0301] In some embodiments, auxiliary anchor drivers 2230, 2232, 2234, and 2236 can be coupled to their respective auxiliary anchors 2220, 2222, 2224, and 2226 according to any embodiment described herein. In some embodiments, each auxiliary anchor driver 2230, 2232, 2234, and 2236 is coupled to their respective auxiliary anchors 2220, 2222, 2224, and 2226. In some embodiments, each auxiliary anchor driver 2230, 2232, 2234, and 2236 is coupled to two or more auxiliary anchors 2220, 2222, 2224, and 2226. In some embodiments, a single auxiliary anchor driver, for example 2230, is coupled to all of the auxiliary anchors 2220, 2222, 2224, and 2226.

[0302] The implant delivery system 2200 may include one or more auxiliary anchor guide rails 2240, 2242, 2244, 2246 (e.g., one auxiliary anchor guide rail, two auxiliary anchor guide rails, three auxiliary anchor guide rails, four auxiliary anchor guide rails (as shown), five auxiliary anchor guide rails, six auxiliary anchor guide rails, seven auxiliary anchor guide rails, eight auxiliary anchor guide rails, etc.). The number of auxiliary anchor guide rails 2240, 2242, 2244, 2246 may correspond to the number of auxiliary anchors 2220, 2222, 2224, 2226. The auxiliary anchors 2220, 2222, 2224, 2226 may include passages through which they pass. The passages may extend through the center of the helical wires of the auxiliary anchors 2220, 2222, 2224, 2226. The auxiliary anchor guide rails 2240, 2242, 2244, and 2246 can be configured to extend through their respective passages.

[0303] The implant delivery system 2200 may include one or more auxiliary anchor anchors 2250, 2252, 2254, 2256 (e.g., one auxiliary anchor anchor, two auxiliary anchor anchors, three auxiliary anchor anchors, four auxiliary anchor anchors (as shown), five auxiliary anchor anchors, six auxiliary anchor anchors, seven auxiliary anchor anchors, eight auxiliary anchor anchors, etc.). The number of auxiliary anchor anchors 2250, 2252, 2254, 2256 may correspond to the number of auxiliary anchors 2220, 2222, 2224, 2226. The auxiliary anchor anchors 2250, 2252, 2254, 2256 may form a loop. Each auxiliary anchor anchor 2250, 2252, 2254, 2256 may include a first strand, a second strand, and an arc between them. Each auxiliary anchor mooring device 2250, 2252, 2254, and 2256 can form a loop around their respective release wires 2206 and 2208, as described herein. The auxiliary anchor mooring devices 2250, 2252, 2254, and 2256 can extend through connecting auxiliary elements 400, 500, 600, and 700. The connecting auxiliary elements 400, 500, 600, and 700 may include one or more passages that facilitate the passage of the auxiliary anchor mooring devices 2250, 2252, 2254, and 2256 therethrough.

[0304] Auxiliary anchor guide rails 2240, 2242, 2244, and 2246 may include passages through which they pass. The passages may extend through the center of the auxiliary anchor guide rails 2240, 2242, 2244, and 2246. Auxiliary anchor mooring devices 2250, 2252, 2254, and 2256 may be configured to extend through the passages of the auxiliary anchor guide rails 2240, 2242, 2244, and 2246. In some embodiments, each auxiliary anchor mooring device 2250, 2252, 2254, and 2256 extends through its respective auxiliary anchor guide rail 2240, 2242, 2244, and 2246. Auxiliary anchor drivers 2230, 2232, 2234, and 2236 may include passages through which they pass. The passages may extend through the center of the auxiliary anchor drivers 2230, 2232, 2234, and 2236. Auxiliary anchor mooring devices 2250, 2252, 2254, and 2256 can be configured to extend through the passages of auxiliary anchor drivers 2230, 2232, 2234, and 2236.

[0305] The release wires 2206 and 2208 can maintain connections to the connecting auxiliary elements 400, 500, 600, and 700. The release wires 2206 and 2208 can maintain connections between the connecting auxiliary elements 400, 500, 600, and 700 and the main anchor 800. The release wires 2206 and 2208 can maintain connections between the connecting auxiliary elements 400, 500, 600, and 700 and the main anchor driver 2204. The release wires 2206 and 2208 can maintain connections between the connecting auxiliary elements 400, 500, 600, and 700 and the auxiliary anchor mooring devices 2250, 2252, 2254, and 2256.

[0306] Figure 50 shows an expandable / contractible function for accessing the primary anchor location according to several embodiments of the present invention. The primary anchor 800 can be positioned near the valve leaflet. The primary anchor 800 can be positioned near the valve annulus. In some methods, access is achieved using a transseptal sheath 1400. The transseptal sheath 1400 may include a lumen through which one or more additional catheters pass. The connecting auxiliary elements 400, 500, 600, and 700 described herein can be delivered via a delivery catheter 1402. The connecting auxiliary elements 400, 500, 600, and 700 may be located within the delivery catheter 1402. The delivery catheter 1402 can expand and contract relative to the transseptal sheath 1400. The delivery catheter 1402 can expand and contract relative to the transseptal sheath 1400 so as to extend outward relative to the transseptal sheath 1400 to deliver the connecting auxiliary elements 400, 500, 600, and 700. The connecting auxiliary elements 400, 500, 600, and 700 can extend outward relative to the delivery catheter 1402 to deliver the connecting auxiliary elements 400, 500, 600, and 700.

[0307] Figure 51 shows the rotation of the main anchor driver 2204 according to several embodiments of the present invention. Figure 51 shows the progression of engagement of the main anchor 800. On the left, the initial positions of the main anchor driver 2204 and the main anchor 800 are shown. The main anchor 800 can be proximal to the tissue in a proximal position. In the center, the main anchor driver 2204 is rotated to rotate the main anchor 800. The main anchor 800 rotates and translates relative to the main anchor driver 2204. The main anchor 800 engages with the tissue. On the right, the main anchor 800 is further rotated to engage with the tissue. The main anchor 800 can be reversible. The main anchor 800 can be rotated in one direction to engage with the tissue and rotated in a second opposite direction to engage with the tissue.

[0308] The main anchor driver 2204 can engage with and rotate the main anchor 800. The main anchor driver 2204 can be housed within the main anchor housing 2202. The main anchor 800 can be housed within the main anchor housing 2202. Release wires 2206 and 2208 can extend through at least a portion of the main anchor housing 2202. As the main anchor 800 is rotated, the helix of the main anchor passes around the release wires 2206 and 2208. The release wires 2206 and 2208 maintain their positions as the main anchor 800 rotates. When the joining auxiliary elements 400, 500, 600, and 700 are adjacent to the valve ring, the main anchor 800 can be advanced and engaged with the tissue. The main anchor driver 2204 may include a hub 2260 and one or more extensions 2262 and 2264. The main anchor driver 2204 may include two extensions 2262, 2264, but other configurations are conceivable. The extensions 2262, 2264 may extend perpendicular to the hub 2560 or at other angles. The main anchor driver 2204 may be a fork driver. The main anchor 800 may include a crossbar 802. The crossbar 802 may form the proximal portion of the main anchor 800. The crossbar 802 may be formed from the helix of a helical anchor. The two extensions 2262, 2264 may be configured to slide within the passage of the main anchor 800 on either side of the crossbar 802. The crossbar 802 may be positioned between the extensions 2262, 2264. Other configurations are conceivable for connecting the main anchor driver 2204 to the main anchor 800, including any of the meshing configurations described herein.

[0309] In some embodiments, the main anchor driver 2204 rotates but does not move axially. In some embodiments, the main anchor driver 2204 rotates but does not translate relative to the main anchor housing 2202. The fork of the main anchor driver 2204 rotates to drive the main anchor 800. In some embodiments, the main anchor driver 2204 does not advance axially. In some embodiments, the main anchor driver 2204 is retained within the main anchor housing 2202. In some embodiments, the advantage is to limit the translation of the main anchor driver 2204. Limiting the axial movement of the main anchor driver 2204 can reduce or prevent accidental interaction between the main anchor driver 2204 and the tissue. Limiting the axial movement of the main anchor driver 2204 can reduce or prevent accidental interaction between the main anchor driver 2204 and the release wires 2206, 2208.

[0310] Figure 52 shows the connection between the auxiliary anchor driver 2230 and each auxiliary anchor 2220 according to several embodiments. Although the auxiliary anchor driver 2230 and auxi...

Claims

1. The first surface and the second surface on the opposite side, A first horizontal edge, a second horizontal edge, a lower edge, and an upper edge, Hub and anchor, A valve leaflet juxtaposition valve element extending over at least a portion of the second surface, configured to move away from the second surface during systole and toward the second surface during diastole, A joining auxiliary element equipped with the following features.

2. The joining auxiliary element according to claim 1, wherein the valve leaflet juxtaposed valve element is configured to join with the opposing valve leaflets.

3. The joining auxiliary element according to claim 1, wherein the valve leaflet juxtaposed valve element is configured to maintain a seal with the anterior leaflet in the valve ring.

4. The joining auxiliary element according to claim 1, wherein the valve leaflet juxtaposed valve element comprises at least one fixed end and at least one free end.

5. The joining auxiliary element according to claim 1, wherein the valve leaflet juxtaposed valve element is fixed near the hub.

6. The jointing auxiliary element according to claim 1, wherein the valve leaflet juxtaposition valve element is configured to mimic a cardiac cycle by the movement of the valve leaflet juxtaposition valve element.

7. The jointing auxiliary element according to claim 1, further comprising a tendon for stabilizing the valve leaflet juxtaposed valve element.

8. The bonding auxiliary element according to claim 1, wherein the first surface comprises a polymer.

9. The bonding auxiliary element according to claim 1, wherein the second surface comprises a polymer.

10. The jointing auxiliary element according to claim 1, wherein the valve leaflet juxtaposed valve element includes the pericardium.

11. The joining auxiliary element according to claim 1, wherein the valve leaflet juxtaposed valve element includes biological tissue.

12. The joining auxiliary element according to claim 1, further comprising one or more support columns.

13. The joining auxiliary element according to claim 1, wherein the first surface is configured to be positioned toward the rear tip, and the second surface is configured to be positioned toward the front tip.

14. The joining auxiliary element according to claim 1, wherein the length of the upper edge is longer than the length of the lower edge.

15. The joining auxiliary element according to claim 1, wherein the anchor includes a helix that is rotatable relative to the hub.

16. The joining auxiliary element according to claim 1, further comprising an auxiliary anchor.

17. The joining auxiliary element according to claim 1, wherein the hub is separated inward from the first lateral edge, the second lateral edge, the lower edge, and the upper edge.

18. The joining auxiliary element according to claim 1, wherein the joining auxiliary element is configured to be held by the hub.

19. The joining auxiliary element according to claim 1, wherein the joining auxiliary element is configured to be recaptureable.

20. The joining auxiliary element according to claim 1, further comprising a raised edge.

Images