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

Abstract

The invention relates to a device for transcatheter treatment of mitral valve regurgitation, in particular to a coaptation aid element for implantation through a valve; a system including the apposition aid element and an anchor for implantation; a system including the apposition aid element and a delivery catheter; and a method for transcatheter implantation of an apposition element through a heart valve.

Description

[0001] This application is a divisional application with application number 201980059862.2, entry date March 12, 2021, and invention name “Device, system and method for transcatheter treatment of valvular regurgitation”. Background Art

[0002] field

[0003] The present disclosure generally provides improved medical devices, systems, and methods typically used to treat heart valve disease and / or to alter the characteristics of one or more valves of the body.Embodiments include implants for treating mitral regurgitation.

[0004] The human heart receives blood from organs and tissues via veins, pumps the blood through the lungs where it becomes enriched with oxygen, and pushes the oxygenated blood away from the heart to the arteries so that the body's organ systems can extract oxygen for proper function. The deoxygenated blood flows back to the heart where it is pumped again to the lungs.

[0005] The heart consists of four chambers: the right atrium (RA), the right ventricle (RV), the left atrium (LA), and the left ventricle (LV). The pumping action of the left and right sides of the heart generally occurs synchronously during the overall cardiac cycle.

[0006] The heart has four valves that are generally configured to selectively direct blood flow in the correct direction during the cardiac cycle. The valves that separate the atria from the ventricles are called the atrioventricular (or AV) valves. The AV valve between the left atrium and the left ventricle is the mitral valve. The AV valve between the right atrium and the right ventricle is the tricuspid valve. The pulmonary valve directs blood flow to the pulmonary artery and thence to the lungs; blood returns to the left atrium via the pulmonary veins. The aortic valve directs blood flow through the aorta and thence to the periphery. There is usually no direct connection between the ventricles or between the atria.

[0007] Mechanical heart beats are triggered by electrical impulses that propagate throughout the heart tissue. The opening and closing of heart valves can occur primarily due to pressure differences between chambers, which are generated by passive filling or chamber contraction. For example, the opening and closing of the mitral valve can occur due to pressure differences between the left atrium and the left ventricle.

[0008] At the beginning of ventricular filling (diastole), the aortic and pulmonary valves close to prevent backflow from the arteries into the ventricles. Immediately thereafter, the AV valves open to allow unimpeded flow from the atria into the respective ventricles. Immediately after the beginning of ventricular systole (i.e., ventricular emptying), the tricuspid and mitral valves normally close, forming a seal that prevents backflow from the ventricles into the respective atria.

[0009] Unfortunately, the AV valves may become damaged or may not function properly, resulting in improper closure. The AV valves are complex structures, typically including an annulus, leaflets, chordae, and supporting structures. Each atrium is connected to its valve via the atrial vestibule. The mitral valve has two leaflets; the similar structure of the tricuspid valve has three leaflets, and the apposition or engagement of the corresponding surfaces of the leaflets facing each other helps provide closure or sealing of the valve to prevent blood from flowing in the wrong direction. The failure of the leaflets to seal during ventricular systole is called malcoaptation, and may allow blood to flow back through the valve (regurgitation). Heart valve regurgitation can have serious consequences for the patient, typically resulting in heart failure, decreased blood flow, hypotension, and / or decreased oxygen flow to body tissues. Mitral valve regurgitation may also cause blood to flow back from the left atrium into the pulmonary veins, resulting in congestion. Severe valvular regurgitation, if left untreated, can lead to permanent disability or death.

[0010] Related technical description

[0011] A variety of therapies have been applied to treat mitral regurgitation, and other therapies are still being proposed but have not yet been actually used to treat patients. Although several known therapies have been found to provide benefits to at least some patients, further options are still needed. For example, agents (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 may lack patient compliance. Many patients may occasionally (or even regularly) fail to take medications despite the potential severity of chronic and / or worsening mitral regurgitation. Pharmacological treatment of mitral regurgitation may also be inconvenient, often ineffective (especially as the condition worsens), and may be associated with serious side effects (such as hypotension).

[0012] Various surgical options have also been proposed and / or used to treat mitral regurgitation. For example, open-heart surgery can replace or repair a dysfunctional mitral valve. In an annuloplasty ring repair, the size of the posterior mitral annulus along its circumference can be reduced, optionally using sutures passed through a mechanical annuloplasty suture ring to provide coaptation. Open surgery may also seek to reshape the leaflets and / or modify the supporting structures. In any case, open mitral valve surgery is typically a very invasive treatment that is performed on a heart-lung machine while the patient is under general anesthesia and the chest is opened. Complications can be common, and given the morbidity (and potential mortality) of open-heart surgery, scheduling becomes a problem - sicker patients may be in great need of surgery, but are less able to withstand surgery. Successful open mitral valve surgery results may also be very dependent on surgical skill and experience.

[0013] Given the morbidity and mortality associated with open-heart surgery, innovators have sought less invasive surgical therapies. Approaches performed robotically or through an endoscope are still generally quite invasive, and can also be time consuming, expensive, and, in at least some cases, very dependent on the skill of the operator. It would be ideal to inflict even less trauma on these sometimes frail patients, and it would be equally ideal to provide a therapy that could be successfully performed by a large number of physicians using widely varying techniques. To this end, a variety of purportedly less invasive techniques and methods have been proposed. These include devices that seek to reshape the mitral annulus from within the coronary sinus; devices that attempt to reshape the annulus by tying the native annulus from top to bottom; devices that fuse the leaflets (mimicking the Alfieri suture); devices that reshape the left ventricle, and the like.

[0014] A variety of mitral valve replacement implants, perhaps the most well-known, have been developed, which generally replace (or displace) the native valve leaflets and rely on a surgically implanted structure to control the blood flow path between the heart chambers. While these various methods and tools have met varying levels of approval, none has been widely recognized as the ideal treatment for most or all patients suffering from mitral regurgitation.

[0015] Due to the difficulties and shortcomings of known minimally invasive mitral regurgitation therapies and implants, alternative treatments have been proposed. Some alternative proposals require that the implanted structure remain within the annulus throughout the cardiac cycle. One group of these proposals includes a cylindrical balloon or the like that is maintained implanted on a rope or rigid rod extending between the atrium and ventricle through the valve opening. Another group relies on an arched ring structure or the like, often in combination with a buttress or structural cross member extending through the valve to anchor the implant. Unfortunately, the seal between the entire periphery of the native leaflet and the balloon or other coaxial body can prove to be challenging, and if the buttress or the retainer interconnecting cross member is bent, the significant contraction around the native annulus during each heartbeat may lead to significant fatigue failure of the tissue during long-term implantation. In addition, the significant movement of the valve tissue may make it difficult to accurately position the implant, regardless of whether the implant is rigid or flexible.

[0016] In view of the above, it would be desirable to provide improved medical devices, systems, and methods. It would be particularly desirable to provide new technologies for treating mitral regurgitation and other valvular heart disease, and / or for altering the characteristics of one or more of the body's other valves. There remains a need for devices that can directly enhance leaflet coaptation (rather than indirectly via annular or ventricular reshaping) and that do not disrupt leaflet anatomy via fusion or otherwise, but that can be deployed simply and reliably and without excessive cost or surgical time. It would be particularly advantageous if these new technologies could be implemented using less invasive methods, without the need to stop the heart or rely on a heart-lung machine for deployment, and without relying on the excellent skill of the operator, thereby providing improved valve and / or heart function. Summary of the invention

[0017] The present disclosure generally provides improved medical devices, systems and methods. New apposition assist elements, systems and methods for treating mitral regurgitation and other valvular diseases are disclosed. The apposition assist element can remain within the blood flow path when the valve moves back and forth between an open valve configuration and a closed valve configuration. The apposition assist element can be a thin, elongated (along the blood flow path) and / or conforming structure that extends laterally through some, most or all of the width of the valve opening, allowing apposition between at least one of the native leaflets and the apposition assist element. The devices described herein can be used for any valve of the human body, including valves with two leaflets or three leaflets.

[0018] In some embodiments, an advantage is the ability to retract the apposition auxiliary element. In some embodiments, the apposition auxiliary element has a single anchor that can engage or disengage tissue. In some embodiments, the anchor is captured in the annular hub of the apposition auxiliary element. In some embodiments, the captured anchor is removed while removing the apposition auxiliary element. In some embodiments, the apposition auxiliary element may include a secondary anchor. In some embodiments, the apposition auxiliary element may include a passive anchor. In some embodiments, the engagement of the anchor with the tissue arranges one or more passive anchors to engage with the tissue. In some embodiments, an advantage is to retract the apposition auxiliary element during the procedure. In some embodiments, the apposition auxiliary element can be rearranged during the surgical procedure. In some embodiments, the apposition auxiliary element can be removed from the patient during a subsequent surgical procedure. In some embodiments, the apposition auxiliary element can be replaced by another device during a subsequent surgical procedure. In some embodiments, a single annular anchor is conducive to the ability to retract the apposition auxiliary element. In some embodiments, the position of the annular anchor is conducive to the ability to retract the apposition auxiliary element. In some embodiments, the ability to collapse the apposition assist element using a purse-string suture as described herein facilitates the ability to retract the apposition assist element.

[0019] In some embodiments, an advantage is the connection between the mate auxiliary element and the delivery catheter. In some embodiments, the mate auxiliary element includes an annular hub having the feature of engaging the delivery catheter. In some embodiments, the mate auxiliary element and the delivery catheter are removably coupled so that the mate auxiliary element can be released from the delivery catheter during the procedure. In some embodiments, after the mate auxiliary element is released from the delivery catheter, one or more secondary structures couple the mate auxiliary element and the delivery catheter. In some embodiments, one or more secondary structures include a purse-shaped drawstring suture as described herein. In some embodiments, one or more secondary structures facilitate the collapse and / or expansion of the mate auxiliary element. In some embodiments, the mate auxiliary element and the delivery catheter are rotationally fixed relative to each other when coupled. In some embodiments, the relative movement of the delivery catheter causes the movement of the mate auxiliary element.

[0020] In some embodiments, an advantage is that the apposition assist element can be delivered with a hub-guided orientation. In some methods of use, the annular hub can be moved into a position relative to the anatomical structure. In some methods of use, the ventricular end of the apposition assist element can remain in the delivery catheter until the annular hub is deployed. In some methods of use, once the annular hub and / or annular anchor engage with the tissue, the apposition assist element can be deployed. In some methods of use, once the annular hub and / or annular anchor engage with the tissue, the ventricular end of the apposition assist element can be deployed.

[0021] In some embodiments, an advantage is that the apposition auxiliary element can be delivered with a strut-guided orientation. In this method of use, one or more of the struts of the apposition auxiliary element can be moved into a position relative to the anatomical structure before the placement of the annular hub. In some methods of use, the apposition auxiliary element can be deployed or partially deployed before the engagement of the annular anchor. In some methods of use, the annular hub can remain in the delivery catheter until one or more of the struts are deployed. In some methods of use, once the struts are deployed, the annular anchor can engage with the tissue.

[0022] In some embodiments, an advantage is that the annular anchor can be rotated independently of the apposition auxiliary element. As described herein, the apposition auxiliary element is coupled to a portion of the delivery catheter. As described herein, the annular anchor is independently coupled to another portion of the delivery catheter, such as a driver provided with the delivery catheter. The annular anchor can be rotated independently of the annular hub. When the annular anchor is rotated to engage the tissue, the annular hub can remain fixed. The annular anchor can be driven into the tissue while the delivery catheter maintains the position of the annular hub.

[0023] In some embodiments, an advantage is the ability to collapse the apposition auxiliary element. In some embodiments, the apposition auxiliary element collapses completely. The fully collapsed configuration can be an insertion configuration or an unnoticeable (low profile) configuration. In some embodiments, the apposition auxiliary element partially collapses. The partially collapsed configuration can be a partially deployed configuration. The partially collapsed configuration can make the apposition auxiliary element selectively deployed in the heart. The partially collapsed configuration can move the apposition auxiliary element to a position in the heart. The configuration of the apposition auxiliary element can be monitored, for example, by imaging to ensure proper deployment. In some embodiments, tighten one or more purse strings or portions thereof to collapse or partially collapse the apposition auxiliary element. In some embodiments, the partially collapsed configuration can allow the rotation of the apposition auxiliary element. In some embodiments, the fully collapsed configuration can allow the rotation of the apposition auxiliary element. In some embodiments, the apposition auxiliary element can rotate with the delivery catheter or a portion thereof. In some embodiments, the apposition auxiliary element can rotate around a central position such as an annular hub.

[0024] In some embodiments, one advantage is the ability to deploy the apposition auxiliary element. In some embodiments, one or more purse-bag draw-string sutures or portions thereof are relaxed to deploy the apposition auxiliary element. In some embodiments, the relaxation of the purse-bag draw-string sutures causes one or more pillars to take an intermediate configuration. In some embodiments, the relaxation of the purse-bag draw-string sutures causes one or more pillars to take a preformed curve. In some embodiments, one or more pillars comprise NiTi. In some embodiments, the purse-bag draw-string sutures can be repeatedly tightened and / or relaxed. In some embodiments, the purse-bag draw-string sutures are captured in the apposition auxiliary element. In some embodiments, the purse-bag draw-string sutures are tightened to remove the apposition auxiliary element from the patient. In some embodiments, the purse-bag draw-string sutures are relaxed to deploy the apposition auxiliary element in the patient's heart. In some embodiments, the purse-bag draw-string sutures can be selectively deployed to deploy a portion of the apposition auxiliary element while another portion of the apposition auxiliary element remains collapsed or partially collapsed.

[0025] In some embodiments, an advantage is the ability to adjust the auxiliary element for coupling. In some embodiments, the auxiliary element for coupling can be supported 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 are generally located near the diameter midpoint of the auxiliary element for coupling. In some embodiments, the hub and / or anchor are generally located near the midpoint and / or central position of the annular portion of the auxiliary element for coupling. In some embodiments, the auxiliary element for coupling can be supported at a middle position. In some embodiments, the auxiliary element for coupling can be rotated by rotating the delivery catheter connected to the annular hub. In some embodiments, the auxiliary element for coupling can be moved longitudinally by the corresponding longitudinal movement of the delivery catheter connected to the annular hub.

[0026] In some embodiments, one advantage is that after the apposition auxiliary element is arranged, the apposition auxiliary element can be maintained by the delivery catheter. In some embodiments, the apposition auxiliary element can be fully deployed in the mitral valve, but still tethered to the delivery catheter. In some embodiments, after the apposition auxiliary element is fully deployed in the mitral valve, the apposition auxiliary element can be adjusted. In some embodiments, after the apposition auxiliary element is fully deployed, the apposition auxiliary element can be rotated around the hub. In some embodiments, after the apposition auxiliary element is fully deployed, the anchor can be disengaged from the tissue and / or reengaged with the tissue. In some embodiments, after the apposition auxiliary element is fully deployed, the purse-string suture can collapse and / or unfold the apposition auxiliary element or a portion thereof. In some embodiments, after the apposition auxiliary element is fully deployed, the apposition auxiliary element can be recaptured. In some embodiments, after the apposition auxiliary element is fully deployed, the apposition auxiliary element can be removed.

[0027] In some embodiments, one advantage is that the apposition assist element does not require ventricular attachment. In some embodiments, the apposition assist element requires only annular attachment. In some embodiments, the apposition assist element requires only attachment of the annular anchor through the annular hub. In some embodiments, the apposition assist element requires only attachment of the annular anchor through the annular hub and the annular barbs. In some embodiments, the apposition assist element requires only attachment of the annular anchor through the annular hub, the annular barbs, and / or the commissure barbs.

[0028] In some embodiments, an advantage is a radially extending frame. In some embodiments, the frame includes 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 composed of a single planar sheet of material. In some embodiments, the frame is precisely cut using a water jet, laser etching or similar technology. In some embodiments, the frame is constructed by forming an annular hub with the edge of the frame. In some embodiments, the planar sheet of material is formed into a ring, 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, the struts extending along a portion of the circumference of the annular hub are different from the struts 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 placed near the annular region of the heart. In some embodiments, one or more designated portions of the struts are designed to be placed near the commissural region of the heart. In some embodiments, one or more designated portions of the struts are designed to be placed near the ventricular region of the heart. In some embodiments, the struts of the radially outward frame do not intersect. In some embodiments, the struts of the radially outward frame do not form a net. In some embodiments, the struts of the radially outward frame extend along a line from the hub to the edge of the mate auxiliary element. In some embodiments, the struts of the radially outward frame have sharp edges. In some embodiments, the sharp edge extends along a straight line starting from the edge of the mate auxiliary element. In some embodiments, the sharp edge is formed integrally within the strut. In some embodiments, the struts of the radially outward frame have one or more radii of curvature. In some embodiments, the struts of the radially outward frame can be concave or convex or both concave and convex along the length of the strut. In some embodiments, the struts of the radially outward frame have one or more inflection points.

[0029] In some embodiments, one advantage is the bending of the frame. In some embodiments, the annular hub extends radially. In some embodiments, the annular hub extends away from the valve ring from the apposition auxiliary element. In some embodiments, the annular hub extends from the surface of the apposition auxiliary element above the plane of the pillar. In some embodiments, the edge of the apposition auxiliary element is curved. In some embodiments, one or more pillars can bend laterally from the annular hub toward the upper edge. In some embodiments, the upper edge of the apposition auxiliary element can be bent upward from the valve ring. In some embodiments, the upper edge of the apposition auxiliary element can be bent upward from the posterior leaflet. In some embodiments, the upper edge of the apposition auxiliary element can be bent downward toward the valve ring. In some embodiments, the upper edge of the apposition auxiliary element can be bent downward toward the posterior leaflet. In some embodiments, one or more pillars can bend laterally from the annular hub toward the lower edge. In some embodiments, the lower edge of the apposition auxiliary element can be bent away from the posterior leaflet. In some embodiments, the lower edge of the apposition auxiliary element can be bent toward the posterior leaflet.

[0030] In some embodiments, a coaptation auxiliary element for treating poor coaptation of a heart valve is provided. The heart valve has a valve ring. The coaptation auxiliary element may include a main body, the main body including an annular portion and a coaptation portion. In some embodiments, the annular portion is configured to be implanted in the heart above the valve ring. In some embodiments, the coaptation zone is configured to be implanted in the heart and to cross the plane of the valve ring. The coaptation auxiliary element may include a first coaptation surface and an opposite second coaptation surface. In some embodiments, each surface is limited by a first lateral edge, a second lateral 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 cupped upward from the annular portion. The coaptation auxiliary element may include a hub and an anchor coupled to the hub and supported by the annular portion. In some embodiments, the anchor may be selectively deployable at a first target position. The coaptation auxiliary element may include a plurality of struts extending radially outward from the hub. In some embodiments, the plurality of struts include at least a first strut located within the annular portion and a second strut extending from the annular portion to the apposition portion, wherein the second strut has a total length that is longer than the total length of the first strut, such as, for example, a total length of about or at least about 110%, 120%, 130%, 140%, 150%, 160%, 170%, 180%, 190%, 200%, 225%, 250% or more of the total length of the first strut. In some embodiments, the total length of the second strut is about 125% to about 300%, or about 125% to 200% of the total length of the first strut.

[0031] In some embodiments, at least one of the plurality of pillars has a sharp tip configured to engage tissue. In some embodiments, the plurality of pillars comprises Nitinol. In some embodiments, the anchor is spiral. The auxiliary element for apposition may include one or more additional anchors. In some embodiments, one or more additional anchors are active anchors. In some embodiments, the hub comprises a transverse pin configured to extend through the spiral structure of the anchor. In some embodiments, the hub is configured to cooperate with a delivery catheter, wherein the delivery catheter is configured to arrange the hub near the first target position. In some embodiments, the delivery catheter is configured to rotate the anchor independently of the hub. The auxiliary element for apposition may include a radiopaque marker. The auxiliary element for apposition may include a plurality of radiopaque markers near the upper edge. In some embodiments, the upper edge of the lip is formed into a cup shape downward toward the lower edge. In some embodiments, the upper edge of the lip is formed into a cup shape upward from the annular portion. In some embodiments, the hub extends upward from the annular portion. In some embodiments, the lower edge is bent backward toward the hub.

[0032] In some embodiments, a method for treating malalignment of a patient's heart valve is provided. The heart valve has an annulus. The annulus also defines a valve plane that separates the proximal atrium and the distal ventricle. The method includes coupling a delivery catheter to a hub of an alignment assist element. The method may include arranging the hub near the annulus. The method may include rotating an anchor through the hub and into cardiac tissue distal to the annulus. The method may include deploying the alignment assist element by deploying a plurality of struts radially outward from the hub.

[0033] In some embodiments, the coaptation aid body is suspended so that the coaptation surface is in coaptation with the first leaflet, and the leaflet surface of the coaptation aid body covers the second leaflet so that the malcoaptation is reduced. The method may include engaging the sharp tip of a strut among the plurality of struts with cardiac tissue distal to the annulus. The method may include monitoring the position of the coaptation aid element using one or more markers. The method may include monitoring the position of the coaptation aid element using multiple markers near the upper edge of the coaptation aid element. In some embodiments, the tip of the anchor is recessed into the hub during placement of the hub near the annulus.

[0034] In some embodiments, a coaptation auxiliary element for treating poor coaptation of a heart valve is provided. The coaptation auxiliary element may include a first coaptation surface and an opposite second surface. The coaptation auxiliary element may include a first lateral edge, a second lateral edge, a lower edge, and an upper edge. The coaptation auxiliary element may include an upper region and a lower region. In some embodiments, the upper region is configured to be located in the plane of the annulus of the heart valve. In some embodiments, the lower region includes a first coaptation surface and an opposite second surface. In some embodiments, the lower region includes a laminated layer so that the thickness of the lower region is greater than the thickness of a portion of the upper region.

[0035] In some embodiments, the laminate layer includes ePTFE. In some embodiments, the thickness of the lower region is at least about 25% thicker than the thickness of a part of the upper region. In some embodiments, the thickness of the lower region is at least about 50% thicker than the thickness of a part of the upper region. In some embodiments, the peripheral edge of the apposition auxiliary element includes a non-traumatic edge of the protrusion that only partially surrounds the apposition auxiliary element. In some embodiments, the peripheral edge of the apposition auxiliary element includes a non-traumatic edge of the protrusion that only surrounds the lower region of the apposition auxiliary element. In some embodiments, the edge of the protrusion includes sutures. In some embodiments, the peripheral edge of the apposition auxiliary element includes only the spaced barbs extending radially outward from the peripheral edge of the upper region of the apposition auxiliary element. The apposition auxiliary element may include a hub spaced inwardly from each of the first lateral edge, the second lateral edge, the lower edge and the upper edge. The apposition auxiliary element may include an active anchor, which is configured to be connected to the hub and is configured to rotate relative to the hub to selectively deploy the active anchor at the first target position. The coaptation assist element may include a plurality of struts spaced about and extending outwardly from the hub, the plurality of struts including at least a first strut and a second strut, the first strut being configured to be implanted within the heart, the second strut being configured to be implanted within the heart such that a first coaptation surface engages a first leaflet of a heart valve and an opposing second surface covers a second leaflet of the heart valve. In some embodiments, the coaptation assist element includes a mesh layer.

[0036] In some embodiments, a coaptation assist element delivery system for treating poor coaptation of a heart valve is provided. In some embodiments, the heart valve has a valve ring. The coaptation assist element delivery system may include a coaptation assist element, which includes a first surface and an opposite second surface. In some embodiments, each surface is defined by a first lateral edge, a second lateral edge, a lower edge, and an upper edge. The coaptation assist element may include a hub. The coaptation assist element delivery system may include a main anchor disposed in a main anchor housing. In some embodiments, the main anchor is configured to extend through the hub to engage the valve ring. The coaptation assist element delivery system may include a release line extending through the main anchor housing and configured to be positioned adjacent to the valve ring.

[0037] The apposition 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 includes two extensions, wherein the two extensions are configured to engage a crossbar of the main anchor. The apposition auxiliary element delivery system may include two release lines extending through the main anchor housing. In some embodiments, the two release lines are configured to be positioned adjacent to the annulus, extending from the hub in opposite directions. In some embodiments, the two release lines cross. The apposition auxiliary element delivery system may include a secondary anchor bolt fastener extending through the apposition auxiliary element. In some embodiments, the secondary anchor bolt fastener extends around the release line. The apposition auxiliary element delivery system may include at least two secondary anchor bolt fasteners extending through the apposition auxiliary element. In some embodiments, at least two secondary anchor bolt fasteners extend around the release line. In some embodiments, at least one secondary anchor bolt fastener extends around the release line, and at least one secondary anchor bolt fastener extends around the second release line. The apposition auxiliary element delivery system may include a secondary anchor rail. In some embodiments, the secondary anchor rail is configured to lock the secondary anchor driver to the secondary anchor. In some embodiments, the secondary anchor rail is configured to prevent entanglement between the secondary anchor and the adjacent secondary anchor tether. In some embodiments, the secondary anchor rail is configured to slide along the secondary anchor tether to deliver the secondary anchor. The apposition auxiliary element delivery system may include a secondary anchor driver. In some embodiments, the secondary anchor driver includes at least one locking piece, and the at least one locking piece is configured to engage the window of the secondary anchor. The apposition auxiliary element delivery system may include a secondary anchor. In some embodiments, the secondary anchor is configured to be delivered by allowing the secondary anchor to be along the secondary anchor tether wrapped around the release line. In some embodiments, the secondary anchor is configured to rotate to engage the valve ring. In some embodiments, the secondary anchor has a smaller diameter than the main anchor. In some embodiments, the release line is configured to be retracted after the main anchor engages the valve ring. In some embodiments, the release line is configured to be retracted after the main anchor and at least one secondary anchor engage the valve ring. In some embodiments, the primary anchor housing is configured to be retracted after the release line is retracted, wherein the primary anchor driver is retracted together with the primary anchor housing. In some embodiments, the trajectory of the primary anchor passes through the hub. In some embodiments, the cross pin of the hub is configured to connect the primary anchor to the matching auxiliary element. In some embodiments, at least one secondary anchor is configured to have two or more trajectories. In some embodiments, the trajectory of at least one secondary anchor is determined by the orientation of the corresponding secondary anchor guide. In some embodiments, the secondary anchor guide includes a curved distal end, wherein the curved distal end defines the trajectory.The apposition auxiliary element delivery system may include a proximal assembly configured to lock the position of the secondary anchor guide relative to the secondary anchor to prevent entanglement of the secondary anchor bolt. The apposition auxiliary element delivery system may include a proximal assembly configured to lock the position of the secondary anchor guide relative to the secondary anchor driver so as to facilitate connecting the secondary anchor driver to the secondary anchor. The apposition auxiliary element delivery system may include a proximal assembly configured to lock the position of the secondary anchor bolt, wherein the secondary anchor bolt is connected to the release line. The apposition auxiliary element delivery system may include a proximal assembly configured to lock the position of the secondary anchor bolt to apply tension to the secondary anchor bolt, thereby defining the trajectory of the secondary anchor. The apposition auxiliary element delivery system may include an anti-rotation feature. In some embodiments, the secondary anchor includes an anti-rotation feature.

[0038] In some embodiments, a coaptation assist element for treating poor coaptation of a heart valve is provided. In some embodiments, the heart valve has a valve ring. The coaptation assist element may include a first surface and an opposite second surface, each surface being defined by a first lateral edge, a second lateral edge, a lower edge, and an upper edge. The coaptation assist element may include a hub. The coaptation assist element may include a plurality of struts, the plurality of struts being spaced apart around the hub and extending outwardly from the hub, the plurality of struts including at least a first strut and a second strut, the first strut being configured to be implanted in the heart above the valve valve ring, and the second strut being configured to be implanted in the heart and pass through the plane of the valve valve ring.

[0039] In some embodiments, the apposition aid element comprises at least one layer of ePTFE. In some embodiments, the apposition aid element comprises at least one layer of mesh. In some embodiments, the apposition aid element comprises at least one layer of UHMWPE mesh. In some embodiments, the apposition aid element comprises at least one layer of fabric. In some embodiments, the apposition aid element comprises at least one layer of polyester fabric. 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 apposition surface is reinforced. In some embodiments, the anchoring area is reinforced. In some embodiments, at least one edge comprises a raised edge. In some embodiments, the apposition aid element is configured to minimize contact with the posterior leaflet. In some embodiments, the apposition aid element is configured to engage the leaflet and be embedded in the annulus.

[0040] In some embodiments, a method for delivering an apposition assist element is provided. The method may include delivering the apposition assist element to the patient's heart. In some embodiments, the apposition assist element is coupled to an apposition assist element delivery system. In some embodiments, the apposition assist element delivery system includes a main anchor disposed within a main anchor housing. In some embodiments, the apposition assist element delivery system includes at least one release line. The method may include expanding the apposition assist element within the heart. The method may include anchoring the apposition assist element to the annulus of a heart valve by rotating the main anchor.

[0041] The method may include rotating a primary anchor driver within a primary anchor housing. In some embodiments, the at least one release line is coupled to the primary anchor housing, and when the apposition auxiliary element is expanded, the at least one release line extends below the apposition auxiliary element. In some embodiments, when the apposition auxiliary element is expanded, at least one secondary anchor tether extends through the apposition auxiliary element. In some embodiments, when the apposition auxiliary element is expanded, at least one secondary anchor tether surrounds at least one release line. In some embodiments, the apposition auxiliary element is delivered in an unobtrusive configuration. In some embodiments, the at least one release line is configured to maintain a position of the primary anchor housing relative to the apposition auxiliary element. In some embodiments, the at least one release line is configured to maintain a position of at least one secondary anchor tether relative to the apposition auxiliary element. In some embodiments, the apposition auxiliary element is delivered via a delivery catheter. In some embodiments, the telescoping action is configured to position the apposition auxiliary element relative to a position for engaging the primary anchor with the valve annulus. The method may include rotating the primary anchor to engage the valve annulus. The method may include rotating the primary anchor driver within the primary anchor housing, wherein the primary anchor driver is configured to rotate relative to the primary anchor housing and cannot translate. The method may include sliding the secondary anchor assembly toward the annulus along the secondary anchor tether. The method may include maintaining engagement between the secondary anchor driver and the secondary anchor with a secondary anchor guide. The method may include preventing entanglement between the secondary anchor and the secondary anchor tether with the secondary anchor guide. The method may include coupling the secondary anchor driver to the secondary anchor. The method may include partially retracting the secondary anchor guide before the secondary anchor engages with the tissue. The method may include retracting the secondary anchor guide after the secondary anchor engages with the tissue. The method may include retracting the secondary anchor driver after retracting the secondary anchor guide. The method may include retracting the at least one release line.

[0042] In some embodiments, a coaptation assist element for treating poor coaptation of a heart valve is provided, the heart valve having a valve ring. The coaptation assist element may include a first coaptation surface and an opposite second surface, each surface being defined by a first lateral edge, a second lateral edge, a lower edge, and an upper edge. The coaptation assist element may include a hub. The coaptation assist element may include an anchor, the anchor being coupled to the hub and being configured to rotate relative to the hub to selectively deploy the anchor at a first target position. The coaptation assist element may include a plurality of pillars spaced apart around the hub and extending outwardly from the hub. In some embodiments, the plurality of pillars include at least a first pillar and a second pillar, the first pillar being configured to be implanted in the heart above the valve ring, and the second pillar being configured to be implanted in the heart and passing through the plane of the valve ring.

[0043] In some embodiments, the second strut has a total length that is longer than the total length of the first strut. In some embodiments, the hub is radially spaced inward from each of the first lateral edge, the second lateral edge, the lower edge, and the upper edge. In some embodiments, a plurality of struts are spaced circumferentially around the hub. In some embodiments, the upper edge forms a lip that is cupped downward toward the lower edge or cupped upward from the lower edge. In some embodiments, at least one of the plurality of struts has a sharp tip configured to engage tissue. In some embodiments, the plurality of struts include nitinol. In some embodiments, the anchor is helical. The apposition auxiliary element may include one or more additional anchors. In some embodiments, the one or more additional anchors are active anchors. In some embodiments, the hub includes a traverse pin that is configured to extend through a spiral of the anchor. In some embodiments, the hub is configured to cooperate with a delivery catheter, wherein the delivery catheter is configured to position the hub near a first target location. In some embodiments, the delivery catheter is configured to rotate the anchor independently of the hub. The apposition auxiliary element may include a radiopaque marker. The apposition auxiliary element may include a plurality of radiopaque markers near the 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 mating surface. In some embodiments, the lower edge is bent 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 mating auxiliary element is configured to collapse relative to the hub. In some embodiments, the active anchor is configured to selectively connect and disconnect with tissue.

[0044] In some embodiments, a coaptation auxiliary element for treating poor coaptation of a heart valve is provided, and the heart valve has a valve ring. The coaptation auxiliary element may include a first coaptation surface and an opposite second surface. In some embodiments, each surface is defined by a first lateral edge, a second lateral edge, a lower edge, and an upper edge. The coaptation auxiliary element may include a hub. The coaptation auxiliary element may include an anchor connected to the hub. In some embodiments, the anchor is configured to rotate in a first direction to selectively deploy an active anchor to engage tissue. In some embodiments, the active anchor is configured to rotate in a second direction opposite to the first direction to selectively disengage from tissue. The coaptation auxiliary element may include a plurality of pillars spaced apart around the hub. In some embodiments, the plurality of pillars include at least a first pillar and a second pillar, the first pillar being configured to be implanted in the heart above the valve ring, and the second pillar being configured to be implanted in the heart and pass through the plane of the valve ring.

[0045] In some embodiments, a kind of apposition auxiliary element for treating the bad apposition of heart valve is provided.In some embodiments, the heart valve has valve ring, front valve leaflet and back valve leaflet.The apposition auxiliary element may include a first apposition surface and an opposite second surface.In some embodiments, each surface is defined by a first lateral edge, a second lateral edge, a lower edge and an upper edge.The apposition auxiliary element may include a hub.The apposition auxiliary element may include an anchor, which is connected to the hub and is configured to rotate relative to the hub to selectively deploy the anchor at a first target position.In some embodiments, the anchor is configured to be selectively deployed in the ring.The apposition auxiliary element may include a plurality of pillars spaced apart around the hub.In some embodiments, the plurality of pillars include at least a first pillar and a second pillar, the first pillar being configured to be implanted in the heart above the valve ring, and the second pillar being configured to be implanted in the heart and pass through the plane of the valve ring.

[0046] In some embodiments, a coaptation assist element delivery system for treating poor coaptation of a heart valve is provided, the heart valve having a valve ring. The coaptation assist element delivery system may include a coaptation assist element, the coaptation assist element including a first surface and an opposing second surface. In some embodiments, each surface is defined by a first side edge, a second side edge, a lower edge, and an upper edge. In some embodiments, the coaptation assist element includes a hub. The coaptation assist 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 to engage the valve ring. The coaptation assist element delivery system may include a release line extending through the first anchor housing and configured to be positioned adjacent to the valve ring.

[0047] In some embodiments, the apposition auxiliary element delivery system may include a radiopaque marker. In some embodiments, the apposition auxiliary element delivery system may include a second anchor bolt fastener, which extends through the apposition auxiliary element and surrounds the release line. In some embodiments, the radiopaque marker is crimped to the second anchor bolt fastener. In some embodiments, the radiopaque marker is configured to be used for visual confirmation of the anchoring depth of the second anchor. In some embodiments, the apposition auxiliary element delivery system may include a second anchor. In some embodiments, the second anchor includes a first helical portion having a first pitch and a second helical portion having a smaller second pitch. In some embodiments, the second helical portion is configured to lock with the apposition auxiliary element. In some embodiments, the second anchor includes a locking segment and an anchoring segment, and the locking segment includes a pitch smaller than the anchoring segment. In some embodiments, the second anchor is configured to be delivered by sliding the second anchor along the second anchor bolt fastener surrounding the release line. In some embodiments, the second anchor is configured to be delivered by sliding the second anchor along the second anchor rail, wherein the second anchor rail guides the trajectory of the second anchor. In some embodiments, the second anchor is configured to be rotated to engage the valve annulus. 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 the corresponding second anchor guide. In some embodiments, the apposition auxiliary element delivery system may include a first anchor driver disposed in a first anchor housing, wherein the first anchor driver is configured to rotate but not translate relative to the first anchor housing. In some embodiments, the apposition auxiliary element delivery system may include a second anchor guide. In some embodiments, the second anchor guide is configured to lock the second anchor driver to the second anchor. In some embodiments, the second anchor guide is configured to slide along the second anchor bolt to deliver the second anchor. In some embodiments, the second anchor guide includes a distal portion having a bend between 30 degrees and 90 degrees. In some embodiments, the bend determines the trajectory of the second anchor delivered along the second anchor guide. BRIEF DESCRIPTION OF THE DRAWINGS

[0048] Figures 1A-1F Some of the tissues of the heart and mitral valve are schematically illustrated, as described in the Background section and below, and which may interact with the implants and systems described herein.

[0049] Figure 2A A simplified cross-section of the heart is shown schematically showing mitral valve function during diastole.

[0050] Figure 2BA simplified cross-section of the heart is shown schematically showing mitral valve function during systole.

[0051] Figure 3A-3B A simplified cross-section of the heart is illustrated schematically showing mitral regurgitation during systole in the setting of malcoaptation of the mitral valve leaflets.

[0052] Figure 4A A stylized cross-section of the heart is illustrated, showing mitral valve malcoaptation in the setting of functional mitral regurgitation.

[0053] Figure 4B A stylized cross-section of the heart is illustrated, showing mitral valve malcoaptation in the setting of degenerative mitral regurgitation.

[0054] Figure 5A A perspective view of one embodiment of an aligning assist element is shown.

[0055] Figure 5B Picture shows Figure 5A Top view of the involution auxiliary element.

[0056] Figure 5C-5D One embodiment of a strut for an apposition assist element is illustrated.

[0057] Figure 5E-5G The figure shows the annular anchoring site Figure 5A of the auxiliary components for the incorporation.

[0058] Figures 5H-5J Illustration of the valve with leaflet anchoring sites Figure 5A of the auxiliary components for the incorporation.

[0059] Figure 5K Picture shows Figure 5A The dimensions of the auxiliary elements for mating.

[0060] Figure 6 A perspective view of one embodiment of an aligning assist element is shown.

[0061] Fig. 7A A perspective view of one embodiment of a coaptation assist element is illustrated showing a first surface positioned toward a malapposed native valve leaflet.

[0062] Figure 7B Picture shows Fig. 7A Another perspective view of the mate assist element, showing the second surface that may include the mate surface.

[0063] Figure 7C Picture shows Fig. 7A Top view of the involution auxiliary element.

[0064] Fig.7DThe image shows the implantation of the mitral valve model. Fig. 7A of the auxiliary components for the incorporation.

[0065] Fig. 7E The image shows the implantation of the mitral valve model. Fig. 7A Top view of the involution auxiliary element.

[0066] Fig. 8A One embodiment of a control handle of a delivery system for transcatheter techniques is schematically illustrated.

[0067] Figure 8B Schematically illustrates the Fig. 8A Top and side views of a delivery system coupled to an involution assist element.

[0068] Figure 8C The connection between the annular hub of the apposition assist element and the tip of the delivery catheter is schematically illustrated.

[0069] Fig.9A Schematically illustrates Fig. 8A Anchoring operation of the delivery system.

[0070] Figure 9B-9E The connection between the ring anchor and the driver is schematically illustrated.

[0071] Fig.10 A method for a transcatheter technique is schematically illustrated, showing transseptal crossing.

[0072] Fig.11 A method for a transcatheter technique is schematically illustrated showing initial apposition assist element advancement.

[0073] Fig.12 A method for a transcatheter technique is schematically illustrated showing a partial opening of an apposition assist element.

[0074] Fig.13 A method for a transcatheter technique is schematically illustrated showing the apposition assist element collapsed.

[0075] Fig.14 A method for a transcatheter technique is schematically illustrated showing a cross-sectional view of an apposition assist element.

[0076] Fig.15 An approach for a transcatheter technique is schematically illustrated, showing secondary anchor placement.

[0077] Fig.16 A method for implant delivery is shown, wherein loading of the implant is shown;

[0078] Fig.17A method for inserting an introducer is shown;

[0079] Fig.18 Shown is the Fig.17 Method of connecting the introducer to the transseptal sheath;

[0080] Fig.19 Shown is the Fig.18 of the transseptal sheath advancement method;

[0081] Fig. 20 Shown is the method for positioning Fig.18 Transseptal approach

[0082] Fig.21 A method for delivering an anchor is shown;

[0083] Figures 22A-22D A method for deploying an implant is shown;

[0084] Fig.23 A method for using a guidewire with one or more secondary anchors is shown;

[0085] Fig.24 A method for removing an anchor driver is shown;

[0086] Fig.25 A method for advancing a secondary anchor rail is shown;

[0087] Fig.26 A method for delivering a secondary anchor is shown;

[0088] Fig. 27 A method for inserting a secondary anchor is shown;

[0089] Fig.28 A method for delivering another secondary anchor is shown;

[0090] Fig.29 An implant with a guide wire is shown anchored;

[0091] Fig.30 The anchored implant is shown;

[0092] Figures 31A-31F A method for removing an implant is shown;

[0093] Fig.32 A method for inserting a secondary anchor is shown;

[0094] Fig.33 A method for delivering another secondary anchor is shown;

[0095] Fig.34 A method for inserting another secondary anchor is shown;

[0096] Fig.35 The anchored implant is shown;

[0097] Fig.36 An embodiment of a laminate is shown;

[0098] Fig.37 An embodiment of a laminate is shown;

[0099] Fig.38 An embodiment of 3D shaping is shown;

[0100] Fig.39 An embodiment of 3D shaping is shown;

[0101] Fig.40 The implant is shown;

[0102] Fig.41 An embodiment of a barb is shown;

[0103] Figures 42A-42I An embodiment of an implant delivery system is shown;

[0104] Figures 43A-43E An embodiment of an implant delivery system is shown;

[0105] Figures 44A-44E An embodiment of an implant delivery system is shown;

[0106] Figures 45A-45K An embodiment of an implant delivery system is shown;

[0107] Figures 46A-46C An embodiment of an anchor delivery system is shown;

[0108] Figures 47A-47E A view showing an embodiment of an occlusion assist element;

[0109] Fig.48 An embodiment of an implant structure is shown;

[0110] Fig.49 An embodiment of an implant delivery system is shown;

[0111] Fig.50 The method of conveying is shown;

[0112] Fig.51 An embodiment of a primary anchor driver is shown;

[0113] Fig.52 An embodiment of a secondary anchor rail is shown;

[0114] Figures 53A-53B An embodiment of a secondary anchor rail that prevents entanglement is shown;

[0115] Fig.54 An embodiment of a secondary anchor rail is shown, which is used to assist in the tracking of the anchor;

[0116] Figures 55A-55C An embodiment of a proximal assembly is shown;

[0117] Fig.56 An embodiment of an anti-rotation feature is shown; and

[0118] Figures 57A-57B An embodiment of posterior leaflet augmentation and restoration is shown.

[0119] Figures 58A-58J An embodiment of an implant delivery system is shown.

[0120] Figures 59A-59B An embodiment of a secondary anchor is shown.

[0121] Fig.60 Shows Fig.59A Embodiments of secondary anchors and implants.

[0122] Fig.61 An embodiment of the mitral valve is shown in systole and diastole.

[0123] Figures 62A-62C An embodiment of an implant is shown.

[0124] Fig.63 Shows Fig.62A An embodiment of an implant that is positioned in the mitral valve during systole and diastole.

[0125] Figures 64A-64D An embodiment of an implant is shown.

[0126] Fig.65 Shown is the mitral valve positioned in systole and diastole Fig.64A Embodiments of implants.

[0127] Figures 66A-66D An embodiment of an implant is shown.

[0128] Figures 67A-67B Delivered to the mitral valve Fig.66A Embodiments of implants.

[0129] Fig.68 Shown is the location of the mitral valve in systole and diastole Fig.66A Embodiments of the implant. DETAILED DESCRIPTION

[0130] The present invention, in some embodiments, generally provides improved medical devices, systems and methods that are generally used to treat mitral regurgitation and other valvular diseases (including tricuspid regurgitation). Although the following description includes reference to a valve having two leaflets, such as the anterior leaflet in the mitral valve, it should be understood that the "anterior leaflet" can refer to one or more leaflets in a valve having multiple leaflets. For example, the tricuspid valve has three leaflets, so "front" can refer to one or two of the medial leaflet, the lateral leaflet, and the posterior leaflet. The apposition assist element described herein will generally include an apposition assist body (sometimes referred to as a valve body in this article), which is generally along the blood flow path when the leaflets of the valve move back and forth between an open valve configuration (the anterior leaflet is separated from the valve body) and a closed valve configuration (the anterior leaflet is engaged with the opposing valve body surface). The valve body will be positioned between the native leaflets to close the gap caused by poor coaptation of the native leaflets by providing a surface for coaptation of at least one of the native leaflets while effectively replacing a second native leaflet in the valve area that would be occluded during systole if it were functioning properly. The gap can be lateral (e.g., it can be caused by a dilated left ventricle and / or mitral annulus) and / or axial (e.g., when one leaflet prolapses or is pushed out of the annulus by fluid pressure when the valve should be closed). In some embodiments, the coaptation assist element can fully assist one, two or more leaflets, or in some embodiments partially assist the leaflets, for example, covering only one or more of the A1, A2 and / or A3 sectors of the anterior leaflet, and / or one or more of the P1, P2 and / or P3 sectors of the posterior leaflet.

[0131] The coaptation assist elements and methods described herein can be configured to treat functional and / or degenerative mitral regurgitation (MR) by forming at least one sealable artificial or new coaptation region in the native mitral valve leaflet therein, and can also be used for other purposes. The structures and methods herein will be largely tailored to this application, although alternative embodiments can be configured for other valves of the heart and / or body, including valves of the tricuspid valve, peripheral vascular system, inferior vena cava, etc.

[0132] See also Figures 1A-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 disposed between the left atrium 10 and the left ventricle 30. Also shown are the tricuspid valve 50 (which separates the right atrium 20 and the right ventricle 40), the aortic valve 80, and the pulmonary valve 70. The mitral valve 60 is composed of two leaflets, the anterior leaflet 12 and the posterior leaflet 14. In a healthy heart, the two leaflets are apposed at the apposition area 16 during systole.

[0133] A fibrous annulus 120, which is part of the heart frame, provides attachment for the two leaflets of the mitral valve, known as the anterior leaflet 12 and the posterior leaflet 14. The leaflets are supported axially by attachment to chordae tendineae 32. The chordae, in turn, are attached to one or both of the papillary muscles 34, 36 of the left ventricle. In a healthy heart, the chordae support structure tethers the mitral valve leaflets, allowing the leaflets to open easily during diastole but to withstand the high pressures generated during ventricular systole. In addition to the tethering effect of the support structure, the shape and tissue consistency of the leaflets help promote effective sealing or apposition. The leading edges of the anterior and posterior leaflets meet along a funnel-shaped apposition zone 16, with a lateral cross-section 160 of the three-dimensional apposition zone (CZ) schematically shown in FIG. Figure 1E middle.

[0134] The anterior and posterior mitral leaflets have different shapes. The anterior leaflet is more firmly attached to the annulus covering the central fibrous body (heart frame) and is slightly stiffer than the posterior leaflet, which is attached to the more mobile posterior mitral annulus. Approximately 80% of the closed area is the anterior leaflet. Adjacent to the commissures 110, 114, above or in front of the annulus 120, there are left (lateral) and right (septal) fibrous triangular prisms 124, 126, which are formed at the fusion of the mitral annulus with the base of the non-coronary cusp of the aorta ( Figure 1F ). The fiber triangular ribs 124, 126 form the septal and lateral extents of the central fiber body 128. In some embodiments, the fiber triangular ribs 124, 126 can have advantages, such as providing a secure area for stable engagement with one or more annular anchors (archor) or atrial anchors. The commissure CL between the leaflets 12, 14 is not a simple line, but a curved funnel-shaped surface interface. The first commissure 110 (lateral or left) and the second commissure 114 (septal or right) are where the anterior leaflet 12 meets the posterior leaflet 14 at the annulus 120. As in Figure 1C , 1DAs most clearly seen in the axial views of the atria in FIGS. 1A and 1F, axial cross-sections of the coaptation zone typically display a curved line CL that is separated from the centroid CA of the annulus and from the opening through the valve during diastole CO. In addition, the leaflet edges are scalloped, more so for the posterior leaflet than for the anterior leaflet. Malcoaptation may occur between one or more of these AP (anterior-posterior) segment pairs A1 / P1, A2 / P2, and A3 / P3, such that the malcoaptation characteristics may vary along the curve of the coaptation zone CL.

[0135] View now Figure 2A , a properly functioning mitral valve 60 of the heart is open during diastole to allow blood to flow along flow path FP from the left atrium to the left ventricle 30 and thereby fill the left ventricle. Figure 2B As shown in , first passively and then actively by the rise in ventricular pressure, the functioning mitral valve 60 closes during systole and effectively separates the left ventricle 30 from the left atrium 10, thereby allowing the heart tissue surrounding the left ventricle to contract and thereby propel blood through the vascular system.

[0136] See also Figure 3A-3B 4A-4B, there are several conditions or disease states in which the leaflet edges of the mitral valve fail to adequately coapt and thereby allow blood to surge back from the ventricle into the atrium during systole. Regardless of the specific etiology for a particular patient, the failure of the leaflets to seal during ventricular systole is referred to as malcoaptation and causes mitral regurgitation.

[0137] Typically, malapposition can be caused by over-tethering of the support structures of one or both leaflets, or by over-stretching or tearing of the support structures. Other less common causes include heart valve infection, congenital anomalies, and trauma. Valve malfunction can be caused by stretching of the chordae tendineae (known as mitral valve prolapse), and in some cases, tearing of the chordae tendineae 215 or papillary muscles (known as flail leaflets 220), as in Figure 3A Alternatively, if the leaflet tissue itself is redundant, the valve may prolapse so that the height of the coaptation occurs higher into the atrium, opening the valve higher in the atrium during ventricular systole 230. Either of the leaflets may prolapse or become flail. This condition is sometimes referred to as degenerative mitral regurgitation.

[0138] In such Figure 3BIn the overtethering shown in , the leaflets of a structurally normal valve may not function properly due to annular enlargement or shape change (so-called annular enlargement 240). Such functional mitral regurgitation is often caused by myocardial failure and concomitant ventricular enlargement. And the excessive volume load caused by functional mitral regurgitation may itself aggravate heart failure, ventricular and annular enlargement, and thereby worsen mitral regurgitation.

[0139] Figure 4A-4B The diagram shows the functional mitral regurgitation during systole ( Figure 4A ) and degenerative mitral regurgitation ( Figure 4B )The return flow of blood BF. Figure 4A The increased size of the mid-valve annulus, coupled with increased tethering due to hypertrophy of the ventricle 320 and papillary muscles 330, prevents the anterior and posterior leaflets 312, 314 from apposing, thereby preventing coaptation. Figure 4B In the embodiment of the present invention, tearing of the chordae tendineae 215 causes the posterior leaflet 344 to prolapse upward into the left atrium, which prevents apposition with the anterior leaflet 342. In either case, the result is a backflow of blood into the atrium, which reduces the effectiveness of left ventricular compression.

[0140] Additional descriptions of mate assist elements, tools, anchors, features, systems, and methods that may be utilized in conjunction with the disclosure herein may be found in the following applications, each of which is incorporated by reference in its entirety: U.S. patent application Ser. No. 13 / 099,532, filed May 3, 2011; U.S. patent application Ser. No. 13 / 531,407, filed June 22, 2012; U.S. patent application Ser. No. 14 / 313,975, filed June 24, 2014; U.S. patent application Ser. No. 14 / 742,199, filed June 17, 2015; U.S. patent application Ser. No. 14 / 749,344, filed June 24, 2015; and U.S. patent application Ser. No. 10 / 419,706, filed April 18, 2003.

[0141] In some embodiments, the apposition assist element described herein can be deployed to cover the posterior leaflet, chordae tendineae, and papillary muscles. In some embodiments, the apposition assist element is attached to the rear of the valve ring above and to the rear of the left ventricle below via annular anchors and / or ventricular anchors. In other embodiments, more than one annular anchor and / or more than one ventricular anchor can be used to attach the apposition assist element. In some devices, one or more annular anchors can be replaced by one or more atrial or commissural anchors or supplemented with one or more atrial or commissural anchors, which can be annular in some embodiments. The apposition assist element can be attached to the upper surface of the posterior valve ring, the posterior atrial wall, or the valve ring itself. An apposition zone has been established between the apposition assist element and the natural anterior leaflet. Similar apposition assist elements can be used for both functional and degenerative mitral regurgitation, because regardless of the mechanism behind the dysfunction, failure of leaflet apposition occurs in both. In some embodiments, coaptation assist elements of different sizes may be positioned so that the native anterior valve leaflet opposes the coaptation element at a properly established coaptation point, blocking blood flow during ventricular systole.

[0142] By making the dimensions configured for a variety of anatomies different, a variety of sizes of the coaptation aid element can be provided. For example, there may be a height measured from the upper annular attachment site of the coaptation aid element to the lowest edge in a plane substantially perpendicular to the plane defined by the annulus of the valve, a depth between the coaptation point and the upper attachment site, and a bulge between the rear wall and the coaptation point at the height of the coaptation point. There are also inner and outer diameters of the coaptation aid element, which are typically larger in functional MR. During diastole, the coaptation aid element can stay in substantially the same position while movement of the natural anterior leaflet opens the valve, allowing blood to flow from the left atrium to the left ventricle with minimal restriction. In some embodiments, the surface of the coaptation aid element can be ballooned or stretched upward during ventricular systole while the anchor remains stationary. This can be advantageous because the seal between the front or coaptation surface of the device at the coaptation zone and the native leaflet is enhanced during systole. During diastole, the surface can return toward the anterior leaflet to its initial position where it was earlier. This may provide an improved blood flow path between the atria and ventricles during diastole, thereby improving outflow from the atria through the coaptation assist element.

[0143] In some methods of use, the native posterior leaflet is left in place and the coaptation assist element is attached to the posterior valve annulus or adjacent atrial wall from above. A variety of possible alternative embodiments may have different attachment mechanisms. In other methods of use, the posterior leaflet does not exist, has been surgically removed or removed due to disease. In some methods of use, the autologous leaflet is attached to the posterior surface of the coaptation assist element. In some methods of use, the coaptation assist element may be attached to the anterior surface of the posterior leaflet, rather than the annulus or atrial wall. These are some examples of variations, but other options are still considered. In some methods of use, an anchoring structure (not shown) may pass from the coaptation assist element through the atrial wall into the coronary sinus, wherein the anchoring structure is attached to a mating structure in the coronary sinus. In some methods of use, an anchoring structure, which may be a mechanical structure or a simple suture, may pass through the atrial wall and be anchored on the epicardial surface of the heart by a knot or mechanical unit such as a clip. Similarly, the inferior attachment may reach the ventricular myocardium, through the apex into the epicardium or pericardium, and be secured from the outside or at other attachment sites using an alternative attachment unit.

[0144] The apposition assist elements described herein can exhibit a variety of desired characteristics. Some embodiments do not have to rely on reshaping of the mitral annulus (such as through thermal shrinkage of the annular tissue, implantation of an annular prosthesis, and / or placement of a gripping mechanism above or below the valve plane or in the coronary sinus or associated vessels). Advantageously, they also do not have to destroy the leaflet structure or rely on locking or fusion of the mitral leaflets together. Multiple embodiments can avoid dependence on ventricular reshaping and exhibit passive implant devices with limited excursion after implantation, which can produce very long fatigue life. Therefore, the apposition assist element can be fastened through the posterior leaflet while otherwise leaving the native heart (e.g., ventricular, mitral annulus, etc.) anatomically intact.

[0145] Relief of mitral valve malcoaptation can be effective regardless of which leaflet portion or portions exhibit malcoaptation. The treatment described herein will utilize coaptation aid elements that can be rearranged during the process and even removable after full deployment and / or tissue response begins or is completed, typically without damaging the valve structure. Nevertheless, the coaptation aid elements described herein can be combined with one or more therapies that do rely on one or more of the above-excluded properties. Coaptation aid elements can exhibit benign tissue healing and rapid endothelialization, which inhibits migration, thromboembolism, infection and / or erosion. In some cases, the coaptation aid element will not exhibit endothelialization, but its surface will remain inert, which can also inhibit migration, thromboembolism, infection and / or erosion.

[0146] Figure 5A-5BTwo views of one embodiment of a coaptation assist element 500 are shown. Coaptation assist element 500 may include a first surface 505 that is disposed toward a poorly coapted native leaflet (in the case of a mitral valve, the posterior leaflet), and a second surface 515 that may be disposed toward the anterior leaflet. Second surface 515 may include coaptation surface 560. An upper edge 540 of coaptation assist element 500 may be curved to match the general shape of the annulus or adjacent atrial wall, as described herein. Upper edge 540 may be curved downward toward the posterior leaflet, as described herein. Figure 5A or curved upward toward the atrial wall to match the overall shape of the left atrial wall, as shown in Figure 6 As shown in and described herein.

[0147] The apposition auxiliary element 500 can have a geometric structure that allows it to cross-cut the valve between the attachment sites in the atrium and ventricle. In some embodiments, the attachment site is only in the atrium. In some embodiments, the attachment site is only near the valve ring and commissure of the valve. The apposition auxiliary element 500 can be unattached near the lower edge 580. The apposition auxiliary element 500 does not require ventricular attachment. In some embodiments, the geometric structure of the apposition auxiliary element 500 helps to maintain the position of the apposition auxiliary element 500 in the valve. In some embodiments, the apposition auxiliary element 500 is bent to make the rear leaflet cup-shaped. In some embodiments, the apposition auxiliary element 500 is bent backward toward the upper edge 540. The apposition auxiliary element 500 can provide an apposition surface 560 for apposition of the front leaflet. Figure 5A and 5B This geometry is illustrated.

[0148] In some methods of use, the posterior leaflet can remain intact. The apposition auxiliary element 500 can be attached to the atrium or the valve ring so that it effectively closes the posterior leaflet. In some methods of use, the posterior leaflet can be removed. In the case where the posterior leaflet is removed or has been removed, the apposition auxiliary element 500 can replace the posterior leaflet. In some embodiments, the apposition auxiliary element 500 only requires valve ring attachment. In some embodiments, the apposition auxiliary element 500 only requires attachment at a single point. The single point can be the central position of the apposition auxiliary element 500, for example, a centrally located hub. In some embodiments, the apposition auxiliary element 500 can be attached to the atrium or valve ring along the edge. In some embodiments, the apposition auxiliary element 500 can be attached to the atrium or valve ring at a position separated from the edge of the apposition auxiliary element 500, for example, at a centrally located hub.

[0149] The apposition auxiliary element 500 may include an annular hub 520 that engages the annular anchor 800. The annular anchor 800 may be engaged at the proximal end by a driver described herein. The annular anchor 800 may include a sharp tip to engage tissue. In some methods of use, the tip of the annular anchor 800 is in the annular hub 520 during delivery of the apposition auxiliary element 500. In some methods of use, the tip of the annular anchor 800 is above the annular portion 510 during delivery. The tip of the annular anchor 800 may remain recessed in the annular hub 520 until the annular anchor 800 is rotated to engage tissue. In some embodiments, the apposition auxiliary element 500 may be assembled in vitro, the annular anchor 800 is engaged with the apposition auxiliary element 500 via the annular hub 520 and the driver is engaged with the annular anchor 800. The driver may then be retracted into the delivery catheter, wherein the apposition auxiliary element 500 is in a collapsed position. The driver may be manipulated individually by an operator to place the annular anchor 800 in a suitable position. Alternatively, the annular anchor 800 may be sequentially engaged with the coaptation assist element 500 and / or the actuator before or after deployment via the delivery catheter. The coaptation assist element 500 after placement may completely cover the posterior leaflet so that the coaptation assist element 500 coapts with the anterior leaflet during systole and maintains the valve seal at the annulus together with the native anterior leaflet.

[0150] In some embodiments, the annular anchor 800 is an active anchor. The user can selectively engage or disengage the annular anchor 800 with the tissue. Unlike barbs or other passive anchors, the active anchor 800 can be activated, for example, by rotation to engage the tissue. The annular anchor 800 allows the placement of the apposition auxiliary element 500 before the engagement of the annular anchor 800. The apposition auxiliary element 500 can contact the tissue without any attachment of the annular anchor 800. In some embodiments, the annular anchor 800 and the corresponding hub 520 are centrally located on the apposition auxiliary element 500. The annular anchor 800 and the corresponding hub 520 are spaced apart from any edge of the apposition auxiliary element 500. The position of the annular anchor 800 and the corresponding hub 520 can be in the middle center to prevent the swaying of the apposition auxiliary element 500 when the apposition auxiliary element 500 is supported by the annular hub 520. The corresponding hub 520 provides a convenient position to support and move the apposition auxiliary element 500.

[0151] The annular hub 520 may have a built-in or coupled annular anchor 800. In some embodiments, the annular anchor 800 may be retained in the annular hub 520 by a transverse pin as described herein. The transverse pin may pass through the spiral structure of the annular anchor 800 to prevent the annular anchor 800 from being removed from the annular hub 520 by blunt force. The annular anchor 800 may include a spiral structure 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 rope or other attachment unit extending from the apex of the apex to the right ventricle. The annular anchor 800 may be in the form of a rope or other attachment unit extending through the apex to the epicardium or pericardium. The annular anchor 800 may be fastened from outside the heart in a combined endo / epi procedure. When spiral anchors are used, they may contain bioinert materials such as platinum / Ir, nitinol and / or stainless steel.

[0152] In some embodiments, the apposition assist element 500 may include a single central annular anchor 800 inside the annular hub 520. The apposition assist element 500 may be delivered percutaneously by attachment of a delivery catheter to the annular hub 520 as described herein. The apposition assist element 500 may be configured to be adjustably arranged by removing and reattaching the annular anchor 800. The apposition assist element 500 may be recaptured by removal of the annular anchor 800 and retraction of the apposition assist element 500. The apposition assist element 500 may also include secondary anchors, including commissural anchors, ventricular anchors, annular anchors, barbs, ropes, or any other known fixation devices.

[0153] like Figure 5A-5BAs can be seen in FIG. 5 , the apposition assist element 500 may include a plurality of struts 530. In some embodiments, one or more of the struts 530 have an end that terminates at the hub 520 and another end that radially extends outward toward one of the upper edge 540, the lateral edges 570 and 575, and the lower edge 580 of the apposition assist element 500. The struts 530 may extend outward from the hub 520 in various directions and may be spaced apart from adjacent struts 530 at regular or irregular intervals. In some embodiments, adjacent struts 530 extend outward from the hub at an angle of about 5 degrees to about 45 degrees, about 10 degrees to about 30 degrees, or about 5, 10, 15, 20, 25, or 30 degrees relative to adjacent struts 530. The struts 530 may be arranged generally parallel to the longitudinal axis of the apposition assist element 500 to help maintain the shape of the apposition assist element 500 when placed. The struts 530 may enable the apposition assist element 500 to take a reduced configuration for deployment through a catheter. In some embodiments, struts 530 that form part of the apposition zone of the implant 500 have a greater maximum length than struts 530 that form only part of the annular zone of the implant. In some embodiments, struts 530 that form part of the apposition zone of the implant can be, for example, at least about 10%, 20%, 30%, 40%, 50%, 75%, 100%, 125%, or 150% longer than struts 530 that form part of the annular zone of the implant.

[0154] Figure 5A A view of an apposition assist element 500 is shown having an annular anchoring site 535. The annular anchoring site 535 may be a portion of the strut 530. The annular anchoring site 535 may be located at Figure 5A 500 as extending downwardly from the coaptation assist element 500. In other embodiments, the annulus anchoring site 535 can extend from the coaptation assist element 500 in other directions to engage tissue. In some embodiments, the annulus anchoring site 535 includes one or more barbs with sharp tips. The annulus anchoring site 535 can be a passive anchor.

[0155] In some embodiments, the apposition auxiliary element 500 may include one or more retractable barbs. For example, the barbs may be retracted during the delivery of the apposition auxiliary element 500. For example, the barbs may be advanced after the apposition auxiliary element 500 is arranged relative to the anatomical structure. In some embodiments, the barbs are actively retracted and / or advanced. For example, the delivery catheter described herein may include a mechanism coupled to the barbs designed to retract and / or advance the barbs. In other embodiments, the barbs are passively advanced and / or retracted. In some embodiments, the apposition auxiliary element 500 is delivered with the barbs in a retracted state. In some embodiments, the barbs may be covered by a valve body covering as described herein. In some embodiments, the interface between the tissue and the valve body covering pushes the valve body covering back and exposes the barbs. In some embodiments, the tissue dissolves and / or absorbs a portion of the valve body covering and exposes the barbs. In some embodiments, the movement of the purse-mouth draw-close rope-type suture described herein advances the barbs. In some embodiments, movement of the purse-string suture causes movement of the valve body covering to expose the barbs.Other configurations are contemplated.

[0156] The annular anchoring site 535 may define Figure 5B The diameter D1 shown in the figure may correspond to the distance between the inner and outer commissures of the native valve or the intracommissural distance (ICD) in some embodiments. D1 may be 20-60 mm, and in some embodiments, a preferred length is 35-45 mm, which most closely corresponds to the widest range of the human mitral valve ICD. In some embodiments, D1 may be the distance from the right fibrous triangle to the left fibrous triangle.

[0157] The coaptation aid element 500 may include a generally annular portion 510. When the coaptation aid element 500 is deployed, the annular portion 510 may be disposed above the native leaflets. In some embodiments, the annular portion 510 may be curved toward or away from the annulus. The annular portion 510 may be concave. In other embodiments, the annular portion 510 may be substantially flat relative to the annulus. One or more of the struts 530 may bend laterally from the hub 520 toward the upper edge 540 to help maintain the shape of the annular portion 510 of the coaptation aid element 500 when deployed. The coaptation aid element 500 may bend downward from the hub 520 toward the annular anchoring site 535. In some embodiments, the coaptation aid element 500 does not lean against the posterior leaflet. In some embodiments, the annular anchoring site 535 is the only point of contact between the posterior annulus of the mitral valve and the coaptation aid element 500. The upper edge 540 may include an annular radius of curvature. The annular radius of curvature may be curved toward the annulus. The annular radius of curvature may be curved toward the coaptation surface 560. In some embodiments, the radius of curvature of the annulus may be 0 mm-5 mm, 5 mm-10 mm, 10 mm-15 mm, 15 mm-20 mm, 20 mm-25 mm, 25 mm-30 mm, etc.

[0158] The support 530 can be made of a radiopaque material. In some embodiments, the support 530 is made of an elastically deformable material such as a shape memory metal, for example, nitinol or a shape memory polymer. In some embodiments, the material is Elgiloy. In other embodiments, the support 530 can be made of other materials, including stainless steel, polypropylene, high-density polyethylene (PE), polyester, acellular collagen matrix such as SIS, or other plastics. In other embodiments, the support 530 can be a combination, such as a high-density PE sheath around a core of ePTFE, polyester and / or polypropylene. The support 530 can have a circular cross-section, an oval cross-section, or a ribbon. In some embodiments, the support 530 is a coil spring or a zigzag shape. The support 530 can have a constant stiffness. In some embodiments, one or more support 530 can have different stiffness along the length of the one or more support 530. The support 530 can be harder at the end of the valve ring than at the ventricular end of the apposition auxiliary element 500. The support 530 can be less stiff at the end of the valve ring than at the ventricular end of the apposition auxiliary element 500. The support 530 may be stiffer at a midpoint, such as at an inflection point or curve. The support 530, together with one or more other support structures, may form a frame. In some embodiments, one or more support structures may be provided that extend parallel to the upper edge 540 of the apposition auxiliary element 500 and help maintain the shape of the upper edge 540. In some embodiments, the support 530 and / or other support structures of the frame may be laser cut from a nitinol tube.

[0159] The body covering 550 of the auxiliary element for apposition can be made of materials such as ePTFE. Other materials for the body covering 550 of the auxiliary element for apposition include polyester, polyurethane foam, polycarbonate foam, biological tissue (such as porcine pericardium, processed bovine pericardium, pleura, peritoneum), silicone, polyester, non-cellular collagen matrix, etc. In some embodiments, the body covering 550 of the auxiliary element for apposition can include a foam material surrounded by ePTFE. The use of sponge or foam material enhances the ability of the auxiliary element 500 to be folded to a diameter small enough to pass through the catheter. In some embodiments, the body covering 550 of the auxiliary element for apposition has no holes. In other embodiments, the body covering 550 of the auxiliary element for apposition can have micropores to enhance endothelialization and cell attachment. The body covering 550 of the auxiliary element for apposition can also include radiopaque materials or echo-enhanced materials for better visualization. Any supporting structure of the auxiliary element 500 including the support interface of the pillar 530 or the hub 520 can be coated with radiopaque materials such as gold or platinum, or impregnated with barium. The apposition surface 560 can be coated with an echogenic material. The apposition auxiliary element body covering 550 can be coated with a material that inhibits thrombosis, such as a heparin-bonded compound or a quinoline and quinoxaline compound, or with a material that accelerates endothelialization, or with an antibiotic that inhibits infection. In some embodiments, the purse-mouth drawstring suture 1010 described herein can include a radiopaque material or an echogenic material for better visualization.

[0160] In some embodiments, the struts 530 can be sandwiched between layers of the apposition aid element body covering 550. The apposition aid element body covering 550 can be composed of the same material on the first surface 505 and the second surface 515. The apposition aid element body covering 550 can be composed 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 struts 530 can be attached to or embedded in the first surface 505 or the second surface 515 of a single layer of the apposition aid element body covering 550. In some embodiments, the struts 530 can be "sutured" through the apposition aid element body covering 550. The annulus anchoring site 535 can be the exposed end of the strut 530 from the apposition aid element body covering 550.

[0161] The apposition assisting element 500 may include a purse-mouth drawstring suture 1010. The purse-mouth drawstring suture 1010 may extend along a portion of the apposition assisting element 500. The purse-mouth drawstring suture 1010 may extend along the upper edge 540 or a portion thereof. The purse-mouth drawstring suture 1010 may extend along the lateral edge 570 or a portion thereof. The purse-mouth drawstring suture 1010 may extend along the lateral edge 575 or a portion thereof. The purse-mouth drawstring suture 1010 may extend along the lower edge 580 or a portion thereof. The purse-mouth drawstring suture 1010 may extend along the circumference of the apposition assisting element 500 or a portion thereof. The purse-mouth drawstring suture 1010 may extend along one or more pillars 530. The purse-mouth drawstring suture 1010 may extend in a straight path, a non-straight path, a curve, a semicircle, or any open or closed shape.

[0162] In some embodiments, the purse-string suture 1010 can be sandwiched between the layers of the valve body covering 550. For example, the purse-string suture 1010 can be disposed in a cavity between the layers of the apposition aid body covering 550. In some embodiments, the purse-string suture 1010 can be attached to or embedded in the first surface 505 or the second surface 515 of a single layer of the valve body covering 550. In some embodiments, the purse-string suture 1010 can be "sewn" through the apposition aid body covering 550. The purse-string suture 1010 can pass through the first surface 505 to the second surface 515 and back to the first surface 505. The purse-string suture 1010 can include one or more exposed ends from the apposition aid body covering 550. In embodiments where the purse-string suture 1010 is a loop, the purse-string suture may include one or more exposed portions of the loop from the valve body covering.

[0163] The apposition assisting element 500 can be collapsed by tightening the purse-mouth draw-string suture 1010. The apposition assisting element 500 can be expanded by relaxing the purse-mouth draw-string suture 1010. One or more exposed ends or loops can be manipulated by a delivery catheter or other tool to tighten or relax the purse-mouth draw-string suture 1010. The ability to collapse or expand the apposition assisting element 500 can facilitate the recapture of the apposition assisting element 500 and / or the rearrangement of the apposition assisting element 500.

[0164] The apposition assist element 500 can be rotated by tightening one or more purse-mouth draw-string sutures 1010 and / or loosening one or more purse-mouth draw-string sutures 1010. For example, tightening one or more purse-mouth draw-string sutures 1010 on the lateral edge 570 and / or loosening one or more purse-mouth draw-string sutures 1010 on the lateral edge 575 can rotate the apposition assist element 500. One or more purse-mouth draw-string sutures 1010 can be coupled to the apposition assist element 500 to achieve multi-directional rotation.

[0165] The apposition assist element 500 can be deployed by relaxing the purse-string suture 1010. One or more exposed ends or loops can be manipulated by a delivery catheter or other tool to tighten or relax the purse-string suture 1010. The ability to collapse or expand the apposition assist element 500 can facilitate recapture of the apposition assist element 500 and / or rearrangement of the apposition assist element 500.

[0166] The apposition surface 560 of the apposition assist element 500 can be adjusted by movement of the purse-string suture 1010. One or more exposed ends or loops can be manipulated by a delivery catheter or other tool to tighten or loosen the purse-string suture 1010 to change the curvature of the apposition surface 560 in situ. The ability to adjust the curvature of the apposition assist element 500 can be advantageous in conforming to the geometry of the heart, including the geometry of the anterior leaflet.

[0167] The annular size of the coaptation assist element 500 can be adjusted by movement of the purse-string suture 1010. One or more exposed ends or loops can be manipulated by a delivery catheter or other tool to tighten or loosen the purse-string suture 1010 to change one or more dimensions of the coaptation assist element 500 in situ. The ability to adjust the size of the coaptation assist element 500 can be advantageous in conforming to the geometry of the heart.

[0168] The aligning aid element 500 may include one or more purse-mouth draw-string sutures 1010. In some embodiments, the aligning aid element 500 includes one purse-mouth draw-string suture, two purse-mouth draw-string sutures, three purse-mouth draw-string sutures, four purse-mouth draw-string sutures, five purse-mouth draw-string sutures, six purse-mouth draw-string sutures, seven purse-mouth draw-string sutures, eight purse-mouth draw-string sutures, nine purse-mouth draw-string sutures, ten purse-mouth draw-string sutures, etc. For example, the purse-mouth draw-string sutures 1010 may extend along each edge of the aligning aid element 500. When a plurality of purse-mouth draw-string sutures are provided, the purse-mouth draw-string sutures 1010 may be used together to change the configuration of the aligning aid element 500. When multiple purse-string sutures are provided, the purse-string sutures 1010 can be used independently to change the configuration of the apposition assist element 500.

[0169] Figure 5A Further illustrated is the coaptation element height, which corresponds to the distance between the lower edge 580 and the annular hub 520 measured perpendicular to the plane defined by the annulus of the valve. The coaptation element height of some embodiments can be 10-80 mm, while some embodiments are 40-55 mm. The coaptation element height can be 10-20 mm, 20-30 mm, 30-40 mm, 40-50 mm, 50-60 mm, 60-70 mm, 70-80 mm, etc.

[0170] Figure 5A The generally triangular shape of the aligning aid element 500 is illustrated, such that the aligning aid element 500 has an upper edge 540, lateral edges 570 and 575, and a lower edge 580. In some embodiments, the upper edge 540 has a length greater than the length of the lower edge 580, such that the lateral distance between the lateral edges 570 and 575 generally decreases from the upper portion to the lower portion on the aligning aid element 500. For example, the length of the upper edge 540 may be in the range of 15-50 mm or 25-35 mm, while the length of the lower edge 580 may be in the range of 1-15 mm or 2-6 mm.

[0171] The annular hub 520 can be a hub, an eyelet, or any other tethering location known in the art. In some embodiments, the annular hub 520 is located at the midpoint of the distance D1. In some embodiments, the annular hub 520 is located at the center of the middle to prevent the swaying of the apposition assistance element 500 when the apposition assistance element 500 is supported by the annular hub 520. In other embodiments, the annular hub 520 is located at one of the commissures. Although only one annular anchor 800 is shown, in other embodiments, more than two annular hubs 520 may be provided.

[0172] In some embodiments, the pillar 530 may include a NiTi tube. In some embodiments, the pillar 530 may be laser cut from the tube. In some embodiments, a frame including one or more pillars 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 pillars 530, an annular hub 520, and / or one or more support structures may be integrally formed. In some embodiments, the body covering 550 of the apposition auxiliary element includes an ePTFE laminate. The laminate may surround one or more of the pillars 530 and / or one or more support structures (e.g., one side, two sides, first side 505, second side 515). The pillars 530 and / or one or more support structures may be surrounded by more than two laminated layers. The periphery of the annular portion 510 of the apposition auxiliary element 500 may be cupped downward. The periphery of the annular portion 510 of the apposition auxiliary element 500 may be cupped upward. The periphery of the annular portion 510 of the apposition auxiliary element 500 may include a secondary anchor such as an annular anchoring site 535.

[0173] In some embodiments, the annular anchor 800 and the annular hub 520 form a single central anchoring system. In some embodiments, the apposition auxiliary element 500 is fixed to the tissue by only one annular anchor 800 passing through the hub 520. In other embodiments, additional fixation is included. In some embodiments, the apposition auxiliary element 500 is fixed to the tissue by the annular anchor 800 passing through the hub 520 and the annular anchoring site 535 as described herein. The system may include features that allow rotational adjustment of the apposition auxiliary element 500. For example, the hub 520 and / or the annular anchor 800 can be coupled to the delivery catheter to allow axial movement and / or transmission of torque. The apposition auxiliary element 500 can be fixedly grasped by the delivery catheter so that the rotation of the features of the delivery catheter such as the handle causes the rotation of the apposition auxiliary element 500. The apposition auxiliary element 500 can be fixedly grasped by the delivery catheter so that the axial movement of the features of the delivery catheter such as the drive shaft causes the axial movement of the apposition auxiliary element 500.

[0174] In some embodiments, the hub 520 is located at an intermediate position on the coaptation assist element 500. The intermediate position can be a central position on the annular portion 510. The intermediate position can be between the lateral edges 505, 515. The intermediate position can be between the upper edge 540 and the coaptation surface 560. The intermediate position can enhance the stability of the coaptation assist element 500 when the coaptation assist element 500 is grasped at a single location such as the hub 520 and / or the annular anchor 800. The intermediate position can be aligned with the structure of the mitral valve. The intermediate position can be aligned along the coaptation zone.

[0175] In some embodiments, the apposition assisting element 500 is delivered percutaneously as described herein. In some embodiments, the apposition assisting element 500 is adjustable via a delivery catheter. For example, the apposition assisting element 500 can be expanded and / or collapsed by a delivery catheter. For example, the apposition assisting element 500 can rotate around a fixed position of the annular hub 520. For example, the apposition assisting element 500 can be recaptured. For example, the apposition assisting element 500 can be engaged and reengaged by a delivery catheter. For example, the annular anchor 800 can be detached from the tissue, and the delivery catheter can recapture the apposition assisting element 500.

[0176] Figure 5C-5D Embodiments of a frame 565 of the apposition assist element 500 are illustrated. These figures illustrate a flattened version of the frame 565 prior to bending and / or shape fixing. In some embodiments, the frame 565 is cut from a tubular stock. In other embodiments, the frame 565 is cut from a flat stock such as a flat sheet of material. The frame 565, including portions thereof, may be laser cut. The frame 565 may include one or more struts 530. In Figure 5D In the embodiment shown in , the frame 565 includes twenty struts 530, but other configurations are contemplated (e.g., one strut, two struts, three struts, four struts, five struts, five to ten struts, ten to fifteen struts, fifteen to twenty struts, twenty to twenty-five struts, twenty-five to thirty struts, between twenty-five and thirty struts, between two and thirty struts, between five and thirty struts, etc.). In some embodiments, the frame 565 can include about, at least about, or no more than about 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 range including any two of the above values. In some embodiments, the length of the struts extending to the upper upward or downward cup-shaped lip is less than the longest lower extending struts, for example less than about 80%, 70%, 60%, 50%, 40%, 30%, 20% or less.

[0177] In some embodiments, one, two, or more struts 530 are coupled to a backing 585. In some embodiments, the backing 585 is transverse to the direction of the struts 530. In the illustrated embodiment, the backing 585 is vertical or substantially vertical, and the struts 530 are horizontal or substantially horizontal. In some embodiments, the backing 585 is an annular hub 520. For example, the two ends of the backing 585 can be connected using methods known in the art to form the annular hub 520. For example, if the frame 565 is cut from a flat billet, the two ends are connected. In other embodiments, the frame 565 is formed from a tubular billet. The backing 585 can be a portion of an uncut tubular billet. If the frame 565 is formed from a tubular billet, it may not be necessary to connect the two ends of the backing 585. The uncut tubular billet can form the annular hub 520. As Figure 5D The pattern (patters) of the frame 565 shown in can be cut from a tubular blank, thereby eliminating the need to connect the two ends of the backing. Other manufacturing patterns are considered to form the frame 565. In other embodiments, the backing 585 forms at least a portion of the annular hub 520. In some embodiments, the backing 585 surrounds at least a portion of the annular hub 520. In some manufacturing methods, the backing 585 can be formed into a circle. In some manufacturing methods, once the backing 585 is formed into a circle, the pillars 530 extend radially outward from the backing 585. The backing 585 may include one or more openings designed to accommodate a cross pin, as disclosed herein. In some manufacturing methods, the backing 585 is removed.

[0178] Reference Figure 5A and 5C , a plurality of struts 530 can extend from the annular hub 520 to a lower end 580. In some embodiments, these struts 530 are longer than other struts 530 of the frame 565. In some embodiments, the struts 530 can include anchors or barbs that interact with subvalvular structures, including the ventricular wall. In some embodiments, these struts engage the posterior leaflet or other anatomical structures. In some embodiments, the ventricular anchoring is passive.

[0179] Reference Figures 5A-5D , a plurality of struts 530 can extend from the annular hub 520 to an upper end 540. In some embodiments, these struts 530 are shorter than other struts 530 of the frame 565. In some embodiments, these struts 530 form an atrial anchor and / or an annular anchoring site 535 as described herein. In some embodiments, these struts engage the annulus or other anatomical structure. In some embodiments, the annular anchoring is passive.

[0180] Reference Figure 5A and 5D, a plurality of struts 530 can extend from the annular hub 520 to lateral edges 570 and 575. In some embodiments, the struts 530 have an intermediate length between the ventricular struts and the atrial struts. In some embodiments, the struts engage the commissures or other anatomical structures. In some embodiments, the commissure anchoring is passive.

[0181] The support column 530 can have a variety of lengths based on the desired shape of the apposition assist element 500. Figure 5C-5D As shown in , the two or more pillars 530 have different lengths. Figure 5C-5D As shown in FIG. 5 , two or more struts 530 have the same length. Figure 5C A schematic diagram of a frame 565 is shown. One or more of the upper three struts may form a mating surface 560 and extend to the lower edge. One or more of the lower three struts may form an annular portion and extend to the upper edge. The struts 530 may be laser cut from a tube. The length may be measured from the annular hub 520 to the edge of the mating auxiliary element 500. The strut length may range from 1 mm to 50 mm. For the annular portion 510, the strut length may range from 5 mm to 35 mm. For the annular portion 510, the strut length may be approximately 15 mm. For the mating surface 560, the strut length may range from 20 mm to 35 mm. For the mating surface 560, the strut length may be approximately 30 mm. Other configurations of ranges of strut lengths are contemplated, such as 5mm to 45mm, 10mm to 40mm, 15mm to 35mm, about 5mm, about 10mm, about 15mm, about 20mm, about 25mm, about 30mm, about 35mm, about 40mm, about 45mm, about 50mm, about 55mm, about 60mm, 1mm to 10mm, 5mm to 15mm, 10mm to 20mm, 15mm to 25mm, 20mm to 30mm, 25mm to 35mm, 30mm to 40mm, etc.

[0182] The width can be measured perpendicular to the length of the pillar. The range of the pillar width can be 0.1mm to 2mm. One or more pillars can have an outer diameter or width of about 0.1mm, 0.2mm, 0.3mm, 0.4mm, 0.5mm, 0.6mm, 0.7mm, 0.8mm, 0.9mm, 1mm, 1.1mm, 1.2mm, 1.3mm, 1.4mm, 1.5mm, 1.6mm, 1.7mm, 1.8mm, 1.9mm, 2mm, less than .5mm, less than 1mm, less than 1.5mm, less than 2mm, etc. One or more pillars 530 can have a variable width along the length of the pillar. In some embodiments, one or more pillars 530 taper near the edge of the auxiliary element 500. In some embodiments, one or more pillars 530 taper near the annular hub 520. One or more pillars 530 may include a reduced diameter or taper at the connection between one or more pillars 530 and the annular hub 520. The tapering near the annular hub 520 can help collapse the coaptation assist element 500. The tapering near the annular hub 520 can facilitate insertion of the coaptation assist element 500 into a delivery catheter. The tapering can reduce stress and / or strain in the struts 530 during collapse. In some embodiments, the tapering can contribute to a longer fatigue life. In some embodiments, one or more struts 530 include a tapering of varying width. The width of the struts 530 can vary along the length of the struts 530. One or more struts 530 can include eyelets along the length of the struts 530. In some embodiments, the eyelets can reduce stress in the struts 530. In some embodiments, the eyelets can promote attachment between the struts 530 and the valve body covering 550.

[0183] The thickness can be measured perpendicular to the strut length and strut width. The thickness can be determined by the material thickness of the frame, as described herein. The strut thickness can range from 0.2 mm to 0.5 mm. One or more struts can have a thickness of about 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.

[0184] One or more pillars 530 may include barbs. In some embodiments, the barbs may be configured to be placed near the ventricular end of the apposition auxiliary element 500. In some embodiments, the barbs may be bent out of the plane of the pillar 530. In some embodiments, the barbs may have a bayonet configuration. In some embodiments, the barbs may have a sharp tip. In some embodiments, one or more pillars 530 may be bifurcated. In some embodiments, one or more pillars 530 may include one or more zigzag portions. In some embodiments, the zigzag portions reduce the stress of the pillar 530 and / or increase its flexibility. In some embodiments, the zigzag portions promote the attachment between the pillar 530 and the apposition auxiliary element body covering 550.

[0185] In some embodiments, one or more pillars 530 may include supplementary barbs. In some embodiments, the supplementary barbs may be bent out of the plane of the pillar 530. In some embodiments, one or more portions of the pillar length are bent out of the surface of the pillar. For example, a portion of the pillar may be twisted or bent during manufacture. In some embodiments, the portion bent out of the plane is shaped to engage tissue. In some embodiments, one or more pillars 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 for engaging a delivery catheter as described herein. In some embodiments, the backing 585 may include one or more notches designed to be connected to a locking tab or other feature of a delivery catheter as described herein. In some embodiments, one or more pillars 530 may include a width greater than that of other pillars 530. In some embodiments, the frame 565 includes two or more pillars 530 having a width greater than that of other pillars 530. Two or more pillars 530 may facilitate visualization of the apposition auxiliary element 500. In some embodiments, two or more pillars 530 having a larger width are designed to be placed near the commissure when the apposition auxiliary element 500 is deployed. In some embodiments, one or more struts 530 may have a smaller width than one or more other struts. In some embodiments, each strut 530 has the same width near the annular hub 520. The backing 585 may be modified to connect to a delivery catheter, as described herein. The backing 585 may be designed to allow independent rotation of the anchor 800 within the hub of the apposition assist element 500.

[0186] Figure 5E , 5F and 5G show an embodiment of the mate assist element 500 without the barbs. Figure 5E A three-dimensional schematic diagram of the alignment auxiliary element 500 is shown. Fig. 5F A perspective schematic diagram is shown of a first surface 505 disposed toward a mal-apposed native valve leaflet. Figure 5GA schematic cross-sectional view including an anchor 800 is shown.

[0187] Figure 5H , 5I 5J show an embodiment of a coaptation assist element 500 having a leaflet anchoring site 545. Figure 5A As shown in , the annulus anchoring sites 535 such as barbs can extend along the edge of the coaptation assist element 500. Figure 5H , 5I 5J illustrate one embodiment of a coaptation assist element 500 having a leaflet anchoring site 545 extending from a first surface 505 positioned toward the mal-coapted native leaflets.

[0188] Figure 5H A perspective schematic diagram of the coaptation assist element 500 is shown, including an enlarged portion showing the leaflet anchoring site 545. Fig.5I A perspective schematic diagram is shown of a first surface 505 disposed toward a mal-apposed native valve leaflet. Figure 5J A schematic cross-sectional view including an anchor 800 is shown.

[0189] In some embodiments, the leaflet anchoring site 545 includes one or more barbs with a sharp tip. The leaflet anchoring site 545 can be a passive anchor. In some embodiments, the apposition auxiliary element 500 can include one or more retractable barbs. For example, the leaflet anchoring site 545 can be retracted during the delivery of the apposition auxiliary element 500. For example, the leaflet anchoring site 545 can be advanced after the apposition auxiliary element 500 is arranged relative to the anatomical structure. In some embodiments, the leaflet anchoring site 545 actively retracts and / or advances. For example, the delivery catheter described herein may include a mechanism coupled to the leaflet anchoring site 545 that is designed to retract and / or advance the barbs. In other embodiments, the leaflet anchoring site 545 passively advances and / or retracts. In some embodiments, the leaflet anchoring site 545 can be covered by a valve body covering as described herein. In some embodiments, the interface between the tissue and the valve body covering pushes the valve body covering back and exposes the leaflet anchoring site 545. In some embodiments, the tissue dissolves and / or absorbs a portion of the valve body covering and exposes the leaflet anchoring sites 545. In some embodiments, movement of the purse-string suture described herein advances the leaflet anchoring sites 545. In some embodiments, movement of the purse-string suture causes movement of the valve body covering to expose the leaflet anchoring sites 545. Other configurations are contemplated.

[0190] One or more struts 530 can have one or more barbs along the length of the struts 530. In the illustrated embodiment, five struts 530 each have four leaflet anchoring sites 545 along the length of the strut. Other configurations are contemplated that vary the number of struts 530 (e.g., one strut, two struts, three struts, four struts, five struts, six struts, seven struts, eight struts, nine struts, ten struts, etc.) and the number of leaflet anchoring sites 545 / strut 530 (e.g., one barb, two barbs, three barbs, four barbs, five barbs, six barbs, seven barbs, eight barbs, nine barbs, ten barbs, etc.). One or more struts 530 can have the same number of leaflet anchoring sites 545. More than two struts 530 can have different numbers of leaflet anchoring sites 545. The leaflet anchoring sites 545 can be configured to engage the posterior leaflet.

[0191] In some embodiments, the struts 530 can be sandwiched between layers of the valve body covering 550. In some embodiments, the struts 530 can be attached to or embedded in the first surface 505 or the second surface 515 of a single layer of the valve body covering 550. In some embodiments, the struts 530 can be "sewn" through the valve body covering 550. The first surface 505 can include one or more openings for the leaflet anchoring sites 545. In other embodiments, the leaflet anchoring sites 545 can pass through the valve body covering 550. The leaflet anchoring sites 545 can have a preset curve that can exert force on the first surface 505. The leaflet anchoring sites 545 can be sharpened to penetrate the valve body covering 550.

[0192] The frame 565 can have many advantages. The frame 565 can be formed from a flat pattern. The frame 565 can include an edge forming an annular hub 520. The edge can include a longitudinal strip or backing 585. One or more struts 530 can extend from the backing 585. Figure 5C and 5D In the illustrated embodiment of the present invention, one or more struts 530 are perpendicular to the longitudinal strips. The struts 530 are generally parallel. In some embodiments, the struts 530 are generally perpendicular to the backing 585 forming the annular hub 520. In some embodiments, the struts 530 form an angle with the backing 585. For example, the longitudinal axis of the struts 530 can form an acute angle with the backing 585. The angle helps to collapse the struts 530 into the delivery catheter.

[0193] The frame 565 can be made of a single planar sheet of material. The frame 565 can be precisely cut using a water jet, laser etching or similar technology. The details of the support 530 including the barbs can be machined into the support 530. The frame 565 can be bent and / or shaped to obtain the desired geometry. In some embodiments, the backing 585 is folded to form an annulus. The frame 565 can be rolled into a tubular shape. The backing 585 can be welded or fastened. When fastened end to end to form an annulus, the backing 565 can be considered to be an annular hub 520.

[0194] The pillars 530 are bent into a desired configuration. The pillars 530 may form one or more curves. The pillars 530 may have one or more inflection points. The pillars 530 may have a concave portion and / or a convex portion. One or more pillars 530 may include a radially outward taper (flare) starting at the inflection point. In some embodiments, the upper edge 540 is bent upward away from the lower edge 580. In some embodiments, the upper edge 540 is bent downward toward the lower edge 580. In some embodiments, one or more pillars 530 may be substantially flat. The pillars 530 near the commissure may be substantially flat. In some embodiments, the lower edge 580 is bent backward toward the upper edge 540. In some embodiments, the lower edge 580 is bent forward away from the upper edge 540.

[0195] The struts 530 may be evenly spaced around the circumference of the annular hub 520. The struts 530 may be unevenly spaced around the circumference of the annular hub 520. The struts 530 extending along a portion of the circumference of the annular hub 520 are different from the struts extending along another portion of the circumference of the annular hub 520. One or more designated portions of the struts 530 may be designed to be placed near the annular region of the heart. One or more designated portions of the struts 530 may be designed to be placed near the commissural region of the heart. One or more designated portions of the struts 530 may be designed to be placed near the ventricular region of the heart. The geometry of the radially extending struts 530 may be shaped to match the geometry of the patient. In some embodiments, the geometry is patient-specific. The operator may shape one or more struts 530 based on the geometry of the heart. The operator may change the shape of one or more struts 530 based on the geometry of the patient.

[0196] Figure 5KThe dimensions of the apposition auxiliary element 500 are illustrated. The apposition auxiliary element 500 may include a dimension A. Dimension A may be a linear projection dimension or a rear projection. In some embodiments, the range of dimension A may be 1 mm to 40 mm. In some embodiments, the range of dimension A may be 4 mm to 24 mm. Other configurations of the range of dimension A are considered, such as 5 mm to 35 mm, 10 mm to 30 mm, 15 mm to 25 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, 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 apposition auxiliary element 500 is straight, dimension A may be 0 mm.

[0197] The auxiliary element 500 for aligning may include a dimension B. In some embodiments, the dimension B may be a radius of curvature. The radius of curvature may be concave or convex, as described herein. In some embodiments, the range of the dimension B may be 1 / 16 inch to 1 / 2 inch. In some embodiments, the range of the dimension B may be 1.5mm to 13mm. In some embodiments, the range of the dimension B may be 1 / 4 inch to 3 / 8 inch. In some embodiments, the range of the dimension B may be 6mm to 9.5mm. In some embodiments, the range of the dimension B may be 1mm to 15mm. Other configurations of the range of the dimension B are considered, such as 2mm to 14mm, 3mm to 13mm, 4mm to 12mm, 5mm to 11mm, 6mm to 10mm, 7mm to 9mm, about 1mm, about 2mm, about 3mm, about 4mm, about 5mm, about 6mm, about 7mm, about 8mm, about 9mm, about 10mm, 1mm to 10mm, 5mm to 15mm, 10mm to 20mm, etc. If there is no bend, for example if the apposition assist element 500 is straight, dimension B may be 0 mm.

[0198] The apposition assist element 500 can include a dimension C. In some embodiments, the dimension C can be a radius of curvature near the upper edge 540. In some embodiments, the range of the dimension C can be 1 mm to 10 mm. In some embodiments, the range of the dimension C can be 1 mm to 5 mm. Other configurations of the range of the dimension C are contemplated, such as 2 mm to 9 mm, 3 mm to 8 mm, 4 mm to 7 mm, 5 mm to 6 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, 1 mm to 15 mm, 5 mm to 10 mm, 3 mm to 9 mm, etc. If there is no bend, for example, if the apposition assist element 500 is straight, the dimension C can be 0 mm.

[0199] The coaptation assist element 500 may include a dimension D. The dimension D may be the coaptation element height. The dimension D may correspond to the distance between the lower edge 580 and the atrial anchoring site or annular hub 520 as measured perpendicular to the plane defined by the annulus of the valve. In some embodiments, the dimension D may range from 10 mm to 80 mm. In some embodiments, the dimension D may range from 40 mm to 55 mm. Other configurations of the range of dimension D are considered, such as 5mm to 105mm, 10mm to 100mm, 15mm to 95mm, 20mm to 90mm, 25mm to 85mm, 30mm to 80mm, 35mm to 75mm, 40mm to 70mm, 45mm to 65mm, 50mm to 60mm, about 10mm, about 20mm, about 30mm, about 40mm, about 50mm, about 60mm, about 70mm, about 80mm, about 90mm, about 100mm, 10mm to 50mm, 20mm to 60mm, 30mm to 70mm, 40mm to 80mm, 50mm to 90mm, 60mm to 100mm, 70mm to 110mm, etc.

[0200] The auxiliary element 500 may include a dimension E. The dimension E may be a linear projection dimension or a front projection. In some embodiments, the range of the dimension E may be 2mm to 20mm. In some embodiments, the range of the dimension E may be 5mm to 10mm. Other configurations of the range of the dimension E are considered, such as 0mm to 25mm, 5mm to 20mm, 10mm to 15mm, about 1mm, about 2mm, about 3mm, about 4mm, about 5mm, about 6mm, about 7mm, about 8mm, about 9mm, about 10mm, about 11mm, about 12mm, about 13mm, about 14mm, about 15mm, about 16mm, about 17mm, about 18mm, about 19mm, about 20mm, 1mm to 10mm, 5mm to 15mm, 10mm to 20mm, 15mm to 25mm, 20mm to 30mm, 25mm to 35mm, 30mm to 40mm, etc. If there is no front projection, the dimension E may be 0mm.

[0201] The support 530 of the apposition auxiliary element 500 can form a rear curve of the apposition surface 560. The rear bend can have a bending length of 30-100% of the distal end of the support. In some embodiments, the rear bend can have a bending length of at least 40% of the distal end of the support. Relative to the longitudinal axis of the apposition auxiliary element 500, the angle of the rear bend can be in the range of 0 to 90 degrees. In some embodiments, the angle of the rear bend can be in the range of 45 to 90 degrees.

[0202] Figure 6 One embodiment of an aligning aid element 600 is illustrated. The aligning aid element 600 may be similar to the aligning aid element 500 and include any of the features of the aligning aid element 500 described herein, with certain additional features described below.

[0203] The apposition assist element 600 may include an annular hub 620 that engages an annular anchor (not shown). The annular hub 620 may have a built-in 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 apposition assist element 600 may include a single annular anchor inside the annular hub 620. The apposition assist element 600 may be delivered percutaneously by attachment of a delivery catheter to the annular hub 620 as described herein.

[0204] like Figure 6As can be seen in the figure, the apposition assistance element 600 may include a strut 630. In some embodiments, one, two or more struts 630 have one end terminating at the annular hub 620 and another end extending radially outward toward the upper edge 640, the lateral edges 670 and 675, and the lower edge 680 of the apposition assistance element 600. The struts 630 may extend outward from the hub 620. The struts 630 may be arranged generally parallel to the longitudinal axis of the apposition assistance element 600 to help maintain the shape of the apposition assistance element 600 when placed. The struts 630 may enable the apposition assistance element 600 to adopt a reduced configuration for deployment through a catheter.

[0205] The coaptation aid element 600 may include an annular portion 610. When the coaptation aid element 600 is deployed, the annular portion 610 may be disposed above the annulus of the native leaflet and form a lip as shown. In some embodiments, the annular portion 610 may be curved upward, for example away from the annulus and in a direction substantially opposite and substantially parallel to the coaptation surface 660, and form the uppermost portion of the coaptation aid element 600 when implanted. The annular portion 610 may be convex. In other embodiments, the annular portion 610 may be substantially flat relative to the annulus. One or more of the struts 630 may bend laterally from the annular hub 620 toward the upper edge 640 to help maintain the shape of the annular portion 610 of the coaptation aid element 600 when deployed. The coaptation aid element 600 may be bent upward from the annular portion 620. In some embodiments, the upper edge 640 does not lean against the posterior leaflet. The upper edge 640 may include an annular radius of curvature. The annular radius of curvature may be curved away from the annulus. The annular radius of curvature may be curved toward the coaptation surface 660. In some embodiments, the annular radius of curvature can be 0mm-5mm, 5mm-10mm, 10mm-15mm, 15mm-20mm, 20mm-25mm, 25mm-30mm, etc., or a range including any two of the foregoing values. The apposition assist element body cover 650 can be similar to the apposition assist element body cover 550 described herein.

[0206] In some embodiments, the perimeter of the annular portion 610 is cupped upward and in a direction substantially opposite to the longitudinal axis of the apposition surface 660. In some embodiments, the apposition aid element 600 includes an annular anchoring site similar to the annular anchoring site 535. In other embodiments, the apposition aid element 600 does not include an annular anchoring site such as Figure 6 The annular anchoring site is shown in .

[0207] Figures 7A-7E One embodiment of an apposition assist element 700 is illustrated. The apposition assist element 700 may be similar to the apposition assist element 500 or 600 and include any of the features described herein, with certain elements described below.

[0208] The alignment assist element 700 may include a first surface 705 and a second surface 715 . Fig. 7A A perspective view of a first surface 705 or lower surface positioned toward a mal-approximated native leaflet (in the case of a mitral valve, the posterior leaflet) is shown. Figure 7B The diagram shows a perspective view of a second surface 715 or upper surface that can be disposed toward the anterior leaflet. The second surface 715 can include an apposition surface 760. The upper edge 740 of the apposition assist element 700 can be curved to match the overall shape of the annulus or adjacent atrial wall. The upper edge 740 can be curved downward toward the posterior leaflet, such as Figure 7B as shown in . Figure 7C A top view of the alignment assist element 700 is shown.

[0209] Figures 7A-7C A view of an apposition assist element 700 having an annular hub 720 is shown. The apposition assist element 700 can include an annular hub 720 designed to engage an annular anchor 800. The annular anchor 800 can be engaged at the proximal end by a driver as described herein. The annular hub 720 can have an annular anchor 800 built in or coupled. The annular anchor 800 can include a helix rotatable relative to the annular hub 720. The apposition assist element 700 can be delivered percutaneously by attachment of a delivery catheter to the annular hub 720 as described herein.

[0210] like Figures 7A-7C As can be seen in the figure, the mate assist element 700 can include a strut 730. In some embodiments, one or more struts 730 have one end terminating at the annular hub 720 and a Figure 7B The upper edge 740, lateral edges 770 and 775, and the other end of the lower edge 780 of the apposition auxiliary element 700 shown in FIG. Figure 7B 700 is shown extending downwardly from the body of the coaptation assist element 700. The annular anchor 800 can be an active anchor. The annular anchoring site 735 can be a passive anchor, such as a barb. The annular anchoring site 735 can be at the distal end of one or more struts 730.

[0211] When the apposition assist element 700 is deployed, the annular portion 710 can be arranged above the native leaflet. In some embodiments, the annular portion 710 can be bent toward the annulus or atrial wall. One or more of the struts 730 can be bent laterally from the hub 720 toward the upper edge 740 to help maintain the shape of the annular portion 710 of the apposition assist element 700 during deployment. The apposition assist element 700 can be bent downward from the annular hub 720 toward the annular anchoring site 735. The annular portion 710 can be concave. In some embodiments, one or more support structures extending parallel to the upper edge 740 of the apposition assist element 700 and helping to maintain the shape of the upper edge 740 can be provided. In some embodiments, the struts 730 and / or other support structures of the frame can be laser cut from a nitinol tube. The valve body covering 750 can be made of materials as described herein.

[0212] In some embodiments, the apposition assist element 700 includes an active anchor such as the annular anchor 800. In some embodiments, the apposition assist element 700 includes a passive anchor such as the annular anchoring site 735. The annular anchoring site 735 can include a barb at the tip of one or more struts 730.

[0213] The apposition aid element 700, as well as the apposition aid elements 500, 600 described herein, may include one or more markers 900. The markers 900 may be disposed on the apposition aid element 500, 600, 700 or any of its elements, such as the struts 530, 630, 730, the annular hub 520, 620, 720, the purse string suture 1010, and / or any portion of the annular anchoring site 535, 735. In some embodiments, the marker 900 is disposed on the annular anchor 800. In other embodiments, the marker 900 is integrally formed with the apposition aid element 500, 600, 700 or the annular anchor 800. Multiple markers 900 may be disposed on the apposition aid element in a particular pattern to provide a fluoroscopic visual aid for the operator to accurately orient and position the apposition aid element 500, 600, 700 and / or the annular anchor 800 within the patient's heart.

[0214] In some embodiments, the marker 900 may not be radiopaque, or they may be covered by radiographic markers. During the delivery process of the apposition auxiliary element 500, 600, 700 and / or the annular anchor 800, if a fluoroscope is used, the marker 900 may be visualized. The marker 900 may help to arrange the apposition auxiliary element 500, 600, 700 and / or the annular anchor 800 in the patient's heart. In some embodiments, a torque may be applied to the annular anchor 800 so that the annular anchor 800 is driven into the tissue. In order to provide feedback on whether the annular anchor 800 is properly tightened, a fluoroscopic marker 900 may be present on the annular anchor 800. The marker may be located at the proximal end. These markers 900 may inform the medical team how far the annular anchor 800 may have traveled toward the annular hub 520, 620, 720, and provide information about the appropriate tightening of the annular anchor 800 in place. In some embodiments, to ensure that the proper torque is applied, the torque level at the handle can be quickly increased as the annular anchor 800 bottoms out on the annular hub 520, 620, 720. The systems described herein can include one or more markers 900 (e.g., one, two, three, four, five, six, seven, eight, nine, ten, more than one, more than two, more than three, more than four, etc.). The systems described herein can include more than two different markers 900. The different markers can indicate different components of the system, different portions of the apposition assist element 500, 600, 700, or placement points such as the proximal point, the distal point, the midline, etc.

[0215] Figure 7D-7E One embodiment of a coaptation assist element 700 deployed within a heart mitral valve model is illustrated. Figure 1F The CL between the leaflets is not a simple line, but Figure 7C The first 110 (antero-lateral or left) and second 114 (posterio-medial or right) commissures are where the anterior leaflet 12 meets the posterior leaflet at the apposition area, forming the apposition line (CL). Fig.7D As most clearly visible in an axial view of the atria of the heart, an axial cross-section of the coaptation zone typically shows a curved line CL that is separated from the centroid of the annulus and from the opening through the valve during diastole. In addition, the leaflet edges are scalloped, more so for the posterior leaflet than the anterior leaflet. Malcoaptation may occur between one or more of these AP (anterior-posterior) segment pairs A1 / P1, A2 / P2, and A3 / P3, such that the malcoaptation characteristics may vary along the curve of the coaptation zone CL, as shown in FIG. Figure 1F as shown in .

[0216] In some embodiments, the apposition assist element 700 is placed above the posterior leaflet to create a new surface on which the native leaflet (here the anterior leaflet) can be appositioned. The mitral valve is shown with an anterior leaflet 12. An apposition zone exists between the anterior leaflet 12 and the apposition surface 760 of the apposition assist element 700.

[0217] Now refer to Fig. 8A , illustrating aspects of a delivery catheter 1000. The delivery catheter 1000 may include a control handle. The delivery catheter 1000 may include a tip deflection control 1001. The tip deflection control 1001 may deflect the distal portion of the delivery catheter 1000. This may facilitate placement of the apposition assist 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 also include one or more ports 1002, such as flushing, irrigation and / or aspiration ports, to remove air from the system and allow fluids such as saline or contrast media to be injected into the implantation site. The catheter 1000 may include a catheter shaft 1006. The catheter 1000 may include an implant inserter 1007.

[0218] The delivery catheter 1000 may include an implant control handle 1003. The implant control handle 1003 may control the movement of the coaptation assist element 500, 600, 700. The implant control handle 1003 may achieve the collapse of the coaptation assist element 500, 600, 700. The implant control handle 1003 may achieve the deployment of the coaptation assist element 500, 600, 700. Arrow 1003a indicates the direction of movement of the implant control handle 1003 for collapsing the coaptation assist element 500, 600, 700 by the delivery catheter 1000 and / or deploying the coaptation assist element 500, 600, 700 by the delivery catheter 1000. The implant control handle 1003 may achieve the rotation of the coaptation assist element 500, 600, 700. Arrow 1003b indicates the direction of movement of the implant control handle 1003 for rotating the coaptation assist element 500, 600, 700.

[0219] The implant control handle 1003 can be internally connected to the apposition auxiliary element 500,600,700 to allow axial movement and / or transmission of torque. For example, the implant control handle 1003 of the delivery catheter 1000 can be coupled to the annular hub 520,620,720. For example, the implant control handle 1003 can be connected to one or more purse-bag draw-rope type sutures 1010 that can control the deployment of the apposition auxiliary element 500,600,700. The purse-bag draw-rope type suture 1010 can promote the collapse and / or expansion of the apposition auxiliary element 500,600,700 as described herein. The purse-bag draw-rope type suture 1010 can promote the rotation of the apposition auxiliary element 500,600,700 as described herein. In some embodiments, the delivery catheter 1000 releasably engages the coaptation assist element 500 , 600 , 700 such that axial movement and torque can be transmitted from the delivery catheter 1000 to the coaptation assist element 500 , 600 , 700 .

[0220] In some embodiments, the tip 1300 of the delivery catheter 1000 is releasably coupled to the annular hub 520, 620, 720. For example, the tip 1300 of the delivery catheter 1000 can be locked to the annular hub 520, 620, 720 so that movement of the delivery catheter 1000 causes movement of the coaptation assist element 500, 600, 700. In some embodiments, the system includes a release mechanism between the delivery catheter 1000 and the annular hub 520, 620, 720.

[0221] The annular hub 520, 620, 720 may have features that may be locked with the tip 1300 of the delivery catheter 1000. Figures 5A-7E , the annular hub 520, 620, 720 may include one or more features for engaging a portion of the delivery catheter 1000. The features may include, for example, Figure 5A One or more notches in the hub 520 of the implant as shown in FIG. Such features may include, for example, Fig.9A The features may include a window accessible from the outside of the hub 520, 620, 720, such as Figure 8CAs shown in . The features may include any structure or mechanism capable of coupling the annular hub 520, 620, 720 and a portion of the delivery catheter 1000. In some embodiments, the annular hub 520, 620, 720 and the delivery catheter 1000 are coupled via a bolt mechanism. For example, the annular hub 520, 620, 720 may include a female thread and the distal end of the delivery catheter 1000 may include a male thread. In some embodiments, the annular hub 520, 620, 720 and the delivery catheter 1000 are coupled via a lasso and pin configuration. For example, the annular hub 520, 620, 720 may include a pin such as an outwardly extending pin, and the distal end of the delivery catheter 1000 may include a ring or lasso designed to be tightened around the pin. Other configurations are contemplated.

[0222] Figure 8B Apposition assist elements 500, 600, 700 are shown coupled to delivery catheter 1000. Apposition assist elements 500, 600, 700 can be collapsed or expanded as shown in dashed lines by moving along arrow 1003a. Apposition assist elements 500, 600, 700 can be rotated as shown in dashed lines by moving along arrow 1003b.

[0223] Reference Figure 8C , the delivery catheter 1000 may include a tip 1300. The distal end of the tip 1300 may include a distal locking tab. In some embodiments, the tip 1300 includes a plurality of pre-bent or shaped locking tabs. In some embodiments, the tip includes two locking tabs, three locking tabs, four locking tabs, five locking tabs, a plurality of locking tabs, a plurality of locking tabs, and the like. The "AT-lock" (axial torsional lock) may include a nitinol locking tab on the tip 1300. In some embodiments, the locking tab of the tip 1300 may be driven by a sheath 1350. In some embodiments, the sheath 1350 is hollow to allow movement of other components described herein, such as a driver. Movement of the sheath 1350 may force the locking tabs inwardly to engage with the annular hub 520, 620, 720. In some embodiments, the locking tab of the tip 1300 engages a feature such as a window or lip of the annular hub 520, 620, 720. In some embodiments, movement of the sheath 1350 in the opposite direction can cause the release of the annular hub 520, 620, 720 from the tip. In other embodiments, the locking tabs of the tip 1300 can be driven by a central pin (not shown) inserted into the tip 1300. In some embodiments, the central pin is hollow to allow movement of other components described herein, such as a driver. Movement of the central pin can force the locking tabs outwardly to engage the annular hub 520, 620, 720.

[0224] In some embodiments, the distal end of the tip 1300 can be driven to lock the delivery catheter 1000 to the annular hub 520, 620, 720. In some embodiments, the distal end of the tip 1300 can be driven to unlock the delivery catheter 1000 from the annular hub 520, 620, 720. As described herein, after the annular hub 520, 620, 720 is released from the tip 1300, the secondary structure, such as a purse-string suture, can remain coupled to the apposition assist element 500, 600, 700. In some embodiments, when the delivery catheter 1000 is unlocked, one or more secondary structures, such as a purse-string suture, described herein can remain in relative position between the delivery catheter 1000 and the annular hub 520, 620, 720. During the procedure, the tip 1300 can be repeatedly locked and unlocked.

[0225] Reference Fig. 8A , the delivery catheter 1000 can include an anchor control handle 1004. In some embodiments, the anchor control handle 1004 can enable release of the annular anchor 800 and / or the coaptation assist element 500, 600, 700. In some embodiments, the anchor control handle 1004 can enable engagement of the annular anchor 800, for example to rotate the annular anchor 800 and / or axially move the annular anchor 800. In some embodiments, the anchor control handle 1004 can enable disengagement of the annular anchor 800. In some embodiments, the anchor control handle 1004 can control a driver 1200 configured to apply torque. In some embodiments, the anchor control handle 1004 can control a driver 1200 configured to apply tension and / or release the coaptation assist element 500, 600, 700. In some embodiments, the anchor control handle 1004 can control a driver 1200 configured to apply tension and torque.

[0226] The anchor control handle 1004 of the delivery catheter 1000 can be coupled to the annular anchor 800 to allow for the transmission of torque to the annular anchor 800. The anchor control handle 1004 can enable simple manipulation of the torque or position of the annular anchor 800. Arrow 1004a indicates the direction of movement of the anchor control handle 1004 for engaging or disengaging the annular anchor 800. For example, moving the anchor control handle 1004 toward the annular anchor 800 can engage the driver 1200 with the annular anchor 800. Arrow 1004b indicates the direction of movement of the anchor control handle 1004 for transmitting torque to the annular anchor 800. In some embodiments, arrow 1004b indicates the direction of release of the annular anchor 800. For example, additional application of torque can twist the driver 1200 out of engagement with the annular anchor 800.

[0227] One embodiment of the annular anchor 800 is Fig.9ADetailed diagram in the figure. Fig.9A 1000, such as the components that engage the annular hub 520, 620, 720. The annular anchor 800 can be coupled to the driver 1200 in a variety of ways, as described herein. The annular anchor 800 can be coupled to the coaptation assist element 500, 600, 700 in a variety of ways. In some embodiments, the annular hub 520, 620, 720 can have a transverse pin 820. The transverse pin 820 can provide a location around which the helical structure 815 of the annular anchor 800 as shown can be coiled. The annular anchor 800 can have a shoulder 805. The shoulder 805 can be mounted around the outside of the driver 1200 of the delivery catheter 1000.

[0228] In some embodiments, the driver 1200 is releasably coupled to the annular anchor 800. The driver 1200 can be coupled and / or controlled by the anchor control handle 1004 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 support and / or release the annular anchor 800. In some embodiments, a single driver 1200 delivers torque and tension. In other embodiments, two or more drivers 1200 deliver torque and tension. For example, the driver 1200 can be locked to the annular anchor 800 so that movement of the driver 1200 causes movement of the annular anchor 800. 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 driven to lock the driver 1200 to the annular anchor 800. In some embodiments, the distal end of the driver 1200 can be driven to unlock the driver 1200 from the annular anchor 800. In some embodiments, when the actuator 1200 is unlocked, one or more secondary structures, such as a purse-string suture, can maintain the relative position between the delivery catheter 1000 and the annular anchor 800. During the procedure, the actuator 1200 can be repeatedly locked and unlocked.

[0229] Fig. 9BAn embodiment of a driver 1200 is illustrated. The driver 1200 may include a torque shaft 1205. The torque shaft 1205 may include a ring 1210. The ring 1210 may engage a pin 1215, extend and loop around a tension transverse pin 1270 and through the anchor 800. The rotation of the torque shaft 1205 may cause torque to be applied to the torque transverse pin 1275, thereby causing rotation of the annular anchor 800. In some embodiments, the annular anchor 800 may include a torque transverse pin and a tension transverse pin. Another driver (not shown) may apply torque to the tension transverse pin to apply tension to the annular anchor 800. One or more drivers 1200 may engage the annular anchor 800 to deliver torque. One or more drivers 1200 may engage the annular anchor 800 to deliver tension. In some embodiments, the delivery of the annular anchor 800 is independent of the rotation of the apposition assist element 500, 600, 700.

[0230] Fig. 9C One embodiment of a driver 1200 is illustrated. The driver 1200 can include a torque shaft 1220. The torque shaft 1220 can include an anchor butt cap 1225. The anchor butt cap 1225 can engage the annular anchor 800 in a single orientation or one of a plurality of orientations. In some embodiments, the annular anchor 800 includes a protrusion 1230, and the anchor butt cap 1225 is designed to receive the protrusion 1230. In other embodiments, the annular anchor 800 includes a recess (not shown) to receive a mating protrusion (not shown) on the anchor butt cap 1225. Rotation of the torque shaft 1220 can cause torque to be applied to the annular anchor 800. Another driver 1235 can apply tension to the annular anchor 800. In some embodiments, the driver 1235 can include a release bolt. In other embodiments, the annular anchor 800 can be used. Fig. 9B The ring and pin release mechanism described in . The release bolt can be rotated to release the ring anchor 800. One or more drivers 1200 can engage the ring anchor 800 to deliver torque. One or more drivers 1200 can engage the ring anchor 800 to deliver tension.

[0231] Fig.9DAn embodiment of a driver 1200 and an annular anchor 800 is illustrated. The driver 1200 may include a torque shaft 1220. The torque shaft 1220 may include an anchor butt cap 1225. In some embodiments, the annular anchor 800 includes a protrusion 1230, and the anchor butt cap 1225 is designed to accommodate the protrusion 1230. In other embodiments, the annular anchor 800 includes a recess (not shown) to accommodate a mating protrusion (not shown) on the anchor butt cap 1225. Two or more wires 1240, 1245 can apply tension to the annular anchor 800. In some embodiments, the wire 1240 acts as a pin and the wire 1245 terminates with a ball. In the retained state, the wires 1240, 1245 are both arranged in an opening in the annular anchor 800. The opening is too small to allow the pin and ball ends of the wires 1240, 1245 to pass side by side. In some methods of use, the wire 1240 is first retracted. The retraction of wire 1240 creates space sufficient to allow retraction of wire 1245. Wires 1240, 1245 may be driven to release annular anchor 800. One or more drivers 1200 may engage annular anchor 800 to deliver torque. One or more drivers 1200 may engage annular anchor 800 to deliver tension.

[0232] Fig.9E One embodiment of a driver 1200 is illustrated. The driver 1200 may include a torque shaft 1255. The shoulder 805 may have features such as a window 810 that may be locked 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 shape-set NiTi clip. The distal locking tabs 1265 may be pushed outward into the windows 810 by a driver 1260. The driver 1260 acts as a release mechanism. Longitudinal movement of the driver 1260 toward the annular anchor 800 may push the distal locking tabs 1265 outward toward the windows 810. Longitudinal movement of the driver 1260 away from the annular anchor 800 may cause the distal locking tabs 1265 to resume an intermediate configuration and disengage from the windows 810. The distal locking tabs 1265 engaged with the windows 810 of the annular anchor 800 may allow axial movement transmission between the torque shaft 1255 and the annular anchor 800. The distal locking tab 1265 engaged with the window 810 of the annular anchor 800 can allow torque transmission between the torque shaft 1255 and the annular anchor 800. In embodiments where the annular anchor 800 is embedded in or captured by the annular hub 520, 620, 720, the distal locking tab 1265 engaged with the window 810 can allow axial movement transmission between the delivery catheter and the apposition assist element 500, 600, 700.

[0233] In some embodiments, one advantage is that the annular anchor 800 can be rotated independently of the coaptation assist element 500, 600, 700. As described herein, the coaptation assist element 500, 600, 700 is 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 hub 520, 620, 720. When the annular anchor 800 is rotated to engage tissue, the annular hub 520, 620, 720 can remain fixed.

[0234] In some methods, the annular anchor 800 can be preloaded onto the apposition auxiliary element 500, 600, 700 and coupled to the driver 1200 during the process of mounting the apposition auxiliary element 500, 600, 700 onto the delivery catheter 1000. This can occur before the apposition auxiliary element 500, 600, 700 is pulled into another part of the implant sheath and / or the delivery catheter 1000 and is ready for insertion into the femoral vein. As disclosed herein, a torque can be applied so that the annular anchor 800 is driven into the tissue. In some embodiments, to ensure that appropriate torque is applied, the torque level at the handle can rise rapidly when the annular anchor 800 drops to the lowest point on the annular hub 520, 620, 720. The increased torque level can be felt at the handle, providing feedback that the torque has been properly applied. In other embodiments, radiopaque markings can help visually determine the level of anchor engagement in the tissue. In some embodiments, markings may be located on the annular anchor 800 and / or the apposition assist element 500 , 600 , 700 .

[0235] Figure 10-15 A variety of methods are shown that may be performed during a method of using the coaptation aid element 500, 600, 700. The method may include collapsing the coaptation aid element 500, 600, 700. The method may include coupling the coaptation aid element 500, 600, 700 to the delivery catheter 1000. The method may include coupling the locking tab 1265 to the annular anchor 800 and / or the coaptation aid element 500, 600, 700. The method may include any of the methods disclosed herein for making the coaptation aid element 500, 600, 700.

[0236] In some embodiments, one advantage is that the coaptation assist element 500, 600, 700 can be delivered using a hub-guided orientation. In this method of use, the annular hub 520, 620, 720 can be moved into a position relative to the anatomical structure before another portion of the coaptation assist element 500, 600, 700. In some methods of use, the ventricular end of the coaptation assist element 500, 600, 700 can remain in the delivery catheter 1000 until the annular hub 520, 620, 720 is deployed. In some methods of use, once the annular hub 520, 620, 720 and / or the annular anchor 800 engages with the tissue, the coaptation assist element 500, 600, 700 can be deployed. In some methods of use, once the annular hub 520, 620, 720 and / or the annular anchor 800 engages with the tissue, the ventricular end of the coaptation assist element 500, 600, 700 can be deployed.

[0237] In some embodiments, one advantage is that the coaptation assist element 500, 600, 700 can be delivered using a strut-guided orientation. In this method of use, one or more of the struts 530, 630, 730 of the coaptation assist element 500, 600, 700 can be moved to a position relative to the anatomical structure before another portion of the coaptation assist element 500, 600, 700. In some methods of use, the coaptation assist element 500, 600, 700 can be deployed or partially deployed before the placement of the annular hub 520, 620, 720. In some methods of use, the annular hub 520, 620, 720 can remain in the delivery catheter until one or more of the struts 530, 630, 730 are deployed. In some methods of use, once the struts 530, 630, 730 are deployed, the annular anchor 800 engages with the tissue.

[0238] Fig.10 An embodiment of transseptal crossing is illustrated. The method may include femoral vein entry. Entry may be achieved through a blood vessel such as the femoral vein to reach a cardiac chamber such as the right atrium 1300. The left ventricle 1380 and its papillary muscle 1360 are also shown. The method may include transseptal puncture and crossing to the left atrium 1320 using a standard transseptal kit 1330. The method may include exchanging a custom transseptal sheath and delivery catheter 1000, as described herein. The transseptal puncture kit may be replaced with a transseptal sheath and a dilator, and the dilator may be replaced with an implant delivery catheter, which may be disclosed herein and in U.S. Pat. No. 8,888,843 to Khairkhahan et al., which is incorporated by reference in its entirety. The method may include removing the dilator. The method may include advancing the delivery catheter 1000. However, other approaches such as transapical, transatrial, femoral, brachial, etc. are also within the scope of the present invention.

[0239] Fig.11 Initial advancement of the coaptation assist element 500, 600, 700 is illustrated. The method may include advancing the coaptation assist element 500, 600, 700 inside a retraction sheath. The retraction sheath may include a tip having a plurality of petals emanating from a central hub 1420. The retraction sheath may be disposed 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 portion 510, 610, 710 toward the annulus before advancing the coaptation surface 560, 660, 760 toward the annulus. The method may include deploying the ventricular end or lower surface 580 after deploying the annular portion 510.

[0240] Fig.12 The local deployment of the apposition auxiliary element 500, 600, 700 is illustrated. The apposition auxiliary element 500, 600, 700 can be advanced close to the target position under imaging guidance such as ultrasound or fluoroscopy. The annular anchor 800 coupled to the apposition auxiliary element 500, 600, 700 is engaged in the tissue. The anchor torque shaft 1540 can rotate internally and independently of the rotation of the implant torque shaft (not shown). The controlled release of the purse-mouth draw-closed rope suture 1010 around the periphery of the apposition auxiliary element 500, 600, 700 can cause the apposition auxiliary element 500, 600, 700 to be deployed. Before the apposition auxiliary element 500, 600, 700 is fully deployed, the rotation adjustment of the apposition auxiliary element 500, 600, 700 can be performed to align the internal (ventricular) portion of the apposition auxiliary element 500, 600, 700 with the valve opening 1580.

[0241] The method may include advancing the apposition assist element 500, 600, 700 toward the target location. The method may include advancing the annular hub 520, 620, 720 toward the target location. The method may include advancing the annular anchor 800 coupled to the annular hub 520, 620, 720 toward the target location. The method may include echogenic or fluoroscopic guidance of the annular anchor 800, the hub 520, 620, 720, and / or the apposition assist element 500, 600, 700. The method may include engaging the annular anchor 800 in the tissue. The method may include rotating the anchor control handle 1004 to rotate the annular anchor 800. The method may include independent rotation of the valve anchor 800 relative to the hub 520, 620, 720. The method may include keeping the hub 520, 620, 720 fixed during the rotation of the annular anchor 800. The method may include controlled release of the purse-mouth draw-string suture 1010. Release can cause the apposition assistance element 500, 600, 700 to unfold. A purse-string suture 1010 can be set within the apposition assistance element 500, 600, 700 and / or along the periphery of the apposition assistance element 500, 600, 700. The purse-string suture 1010 can promote the collapse and / or unfolding of the apposition assistance element 500, 600, 700. The method may include rotationally adjusting the apposition assistance element 500, 600, 700 so that the lower edge 580, 680, 780 or the ventricular portion of the apposition assistance element 500, 600, 700 is aligned with the valve opening. The method may include rotationally adjusting the apposition assistance element 500, 600, 700 so that the lower edge 580, 680, 780 or the ventricular portion is aligned around the posterior leaflet.

[0242] Fig.13 The recapture of the apposition assist element 500, 600, 700 is illustrated. The apposition assist element 500, 600, 700 can be recaptured by tightening the purse-mouth draw-string suture 1010 around a portion of the periphery 1620 of the apposition assist element 500, 600, 700 to collapse the apposition assist element 500, 600, 700. The periphery may include any edge, any combination of edges, or all edges described herein. The recapture sheath and the transseptal sheath 1600 can advance over the collapsed apposition assist element 500, 600, 700. The recapture sheath petals diverging from the central hub can reverse the apposition assist element 500, 600, 700, so that the apposition assist element 500, 600, 700 is retracted into the transseptal sheath. The annular anchor 800 can be unscrewed or released, and the system can be removed. Coaptation assist elements 500, 600, 700 by recapture of the prolapsed or partially encapsulated sheath petals may be another mode of delivery.The encapsulation first mode of delivery may be contrasted with the hub first and strut first modes of delivery described herein.

[0243] In some methods, recapture is an optional method. The method may include tightening the purse-string suture 1010. The tightening may collapse the apposition auxiliary element 500, 600, 700. The method may include advancing the recapture sheath and / or the transseptal sheath over the collapsed apposition auxiliary element 500, 600, 700. The recapture sheath may be folded outward to flip the apposition auxiliary element 500, 600, 700. The method may include retracting the apposition auxiliary element 500, 600, 700 into the transseptal sheath. The method may include rotating the annular anchor 800 to disengage from the tissue. The method may include removing the apposition auxiliary element 500, 600, 700 and the annular anchor 800.

[0244] Fig.14 A cross-sectional view of a deployed coaptation assist element 500, 600, 700 is illustrated. The method may include releasing the coaptation assist element 500, 600, 700. The method may include retracting the delivery catheter 1000.

[0245] Fig.15 The deployment of secondary anchors is illustrated. In some methods, the deployment of secondary anchors is an optional method. The method may include engaging the annulus attachment site 535, 735 with the annulus. The method may include engaging the ventricular anchor. The method may include engaging the commissure anchor 1650. The method may include deploying markers at strategic locations on the apposition aid element 500, 600, 700 and / or the annular anchor 800. The method may include detecting markers, such as detecting radiopaque markers. The method may include facilitating the placement of the anchor 800 under fluoroscopy. The method may include positioning radiopaque markers along the periphery of the apposition aid element 500, 600, 700 to indicate the shape of the apposition aid element 500, 600, 700.

[0246] In some embodiments, the manufacturer provides instructions for use of the system including one or more of the steps disclosed herein, or any steps previously described or inherent in the figures.

[0247] Figure 16-30 Various methods are shown that can be performed during the method of using the apposition assist element 500, 600, 700. According to some embodiments of the present invention, the method can include any of the steps disclosed herein. The method can include any of the steps disclosed herein for manufacturing and / or deploying the apposition assist element 500, 600, 700. The method can include collapsing the apposition assist element 500, 600, 700.

[0248] Fig.16A method for implant delivery is shown, which shows the loading of the coaptation assist element 500, 600, 700. As described herein, the coaptation assist element 500, 600, 700 can be collapsed. The collapsed coaptation assist element 500, 600, 700 can be loaded into a transseptal sheath introducer 1700. The transseptal sheath introducer 1700 can include a sheath having a lumen to accommodate the collapsed coaptation assist element 500, 600, 700. The collapsed coaptation assist element 500, 600, 700 can be inverted within the transseptal sheath introducer 1700. The annular hub 520, 620, 720 can be positioned near the edge 1705 of the transseptal sheath introducer 1700. The transseptal sheath introducer 1700 can include a multi-lumen catheter 1710 connected to the coaptation assist element 500, 600, 700. The method may include loading the apposition assist element 500 , 600 , 700 into the transseptal sheath introducer 1700 .

[0249] Fig.17 A method for inserting a transseptal sheath introducer 1700 into a transseptal sheath 1715 is shown. 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 may be coupled to the transseptal sheath 1715. The proximal end of the transseptal sheath 1715 is located at Fig.17 is shown in Fig.17 In FIG, the transseptal sheath introducer 1700 is not connected to the transseptal sheath 1715. Fig.18 In the embodiment of the present invention, 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 the assembly including the coaptation assist element 500, 600, 700 to the transseptal sheath 1715.

[0250] Fig.19 A method for advancing a transseptal sheath introducer 1700 is shown. The transseptal sheath introducer 1700 can be advanced to the distal end of a transseptal sheath 1715. The coaptation assist element 500, 600, 700 can be advanced through the transseptal sheath 1715. When advanced through the transseptal sheath 1715, the collapsed coaptation assist element 500, 600, 700 can be inverted. Fig.19 In the embodiment, the coaptation assisting elements 500 , 600 , 700 are located at the distal end of the transseptal sheath 1715 .

[0251] Fig. 20A method for positioning the transseptal sheath 1715 is shown. During positioning, the coaptation aid element 500, 600, 700 can be located at the distal end of the transseptal sheath 1715. The transseptal sheath 1715 can be positioned in the annulus. The transseptal sheath 1715 can be positioned above the posterior leaflet. The transseptal sheath 1715 can be centered on P2 as described herein. The method can include positioning the coaptation aid element 500, 600, 700 to the posterior leaflet. The method can include positioning the coaptation aid element 500, 600, 700 to be centered on P2. The method can include positioning the coaptation aid element 500, 600, 700 in the annulus. The transseptal sheath 1715 can be rotated as shown by the arrows. The transseptal sheath 1715 can position the coaptation aid element 500, 600, 700 by rotation. The transseptal sheath 1715 can correct the direction of the atria / ventricle. The transseptal sheath 1715 may include one or more markings / markings 1725. The markings 1725 may enable a user to guide the rotation of the transseptal sheath 1715. The markings 1725 may enable a user to provide a correct orientation of the ring portion of the coaptation assist element 500, 600, 700. The markings 1725 may enable a user to provide a correct orientation of the ventricular portion of the coaptation assist element 500, 600, 700. In some embodiments, the markings 1725 may include radiopaque markings. Fig. 20 The coaptation assist elements 500, 600, 700 and the transseptal sheath 1715 are shown centered on P2 in the annulus of the mitral valve. Fig. 20 Rotation of the apposition assist elements 500, 600, 700 and the transseptal sheath 1715 is shown.

[0252] Fig.21A method for delivering an anchor 800 is shown. The anchor 800 may include any of the features of the anchors described herein. Based on the position of the anchor 800 after deployment, the anchor 800 may be considered a P2 anchor. As described herein, the anchor 800 may extend through the annular hub 520, 620, 720. The method may include delivering the anchor 800 while the apposition assist element 500, 600, 700 is within the transseptal sheath 1715. In some embodiments, the anchor 800 is coupled to the annular hub 520, 620, 720 of the apposition assist element 500, 600, 700 before loading into the transseptal sheath 1715. In some embodiments, the anchor 800 is coupled to the annular hub 520, 620, 720 of the apposition assist element 500, 600, 700 while within the transseptal sheath 1715. In some embodiments, after the transseptal sheath 1715 is positioned within the annulus, the anchor 800 is coupled to the annular hub 520, 620, 720 of the coaptation aid element 500, 600, 700. The method may include delivering the anchor 800 while the coaptation aid element 500, 600, 700 is within the transseptal sheath 1715. During delivery of the anchor 800, the coaptation aid element 500, 600, 700 may be centered on P2 in the annulus. As described herein, the anchor 800 may be inserted by rotating the anchor 800 into the tissue of the annulus.

[0253] Figures 22A-22D A method for deploying a coaptation assist element 500, 600, 700 is shown. The coaptation assist element 500, 600, 700 can be deployed by retracting the transseptal sheath 1715. The transseptal sheath 1715 can be retracted by moving the transseptal sheath 1715 proximally from the anchor 800. The coaptation assist element 500, 600, 700 can be inverted within the transseptal sheath 1715. In some embodiments, the coaptation assist element 500, 600, 700 can be inverted within the transseptal sheath 1715. Fig.22A As shown, the annular portion of the coaptation assist element 500, 600, 700 near the annular hub 520, 620, 70 is first deployed. In some embodiments, the ventricular portion of the coaptation assist element 500, 600, 700 can then be deployed, such as Fig. 22B As shown. The apposition assisting elements 500, 600, 700 can be inverted so that the ventricular portion extends proximally from the annular portion. Fig. 22C When the apposition assist element 500, 600, 700 is deployed as shown, the apposition assist element 500, 600, 700 can be expanded outward from P2. The apposition assist element 500, 600, 700 can be inverted so that the ventricular portion extends proximally from the annular portion. The apposition assist element 500, 600, 700 can be inverted so that the ventricular portion extends toward the transseptal sheath 1715.

[0254] In some embodiments, the aligning auxiliary elements 500, 600, 700 can be as follows: Fig.22D The apposition assist element 500, 600, 700 can be reversed from the initial deployment configuration so that the ventricular portion extends distally from the annular portion. The apposition assist element 500, 600, 700 can be positioned so that the ventricular portion extends away from the transseptal sheath 1715. The method can include deploying the apposition assist element 500, 600, 700 by retracting the transseptal sheath 1715. Figures 22A-22D The deployment of involution assist elements 500 , 600 , 700 is shown.

[0255] Figure 23-30 Deployment of one or more secondary anchors 850 is shown. Secondary anchors 850 may include any of the features of anchor 800. Secondary anchors 850 may include a helical or spiral-like structure. Secondary anchors 850 may be designed to engage tissue of the heart, such as tissue of the annulus. Secondary anchors 850 may include a bioinert material, such as platinum / Ir, Nitinol alloy, and / or stainless steel.

[0256] Fig.23 A method utilizing one or more secondary anchor guidewires is shown. The coaptation aid element 500, 600, 700 may include one or more secondary anchor guidewires. In the illustrated embodiment, the coaptation aid element 500, 600, 700 may include a first guidewire 1730 and a second guidewire 1735. In some embodiments, the coaptation aid element 500, 600, 700 may include any number of secondary anchor guidewires (e.g., approximately or at least approximately one, two, three, four, five, etc.). In some embodiments, the number of secondary anchor guidewires corresponds to (equal to) the number of secondary anchors (e.g., one guidewire is used for one secondary anchor, two guidewires are used for two secondary anchors, etc.). Fig.23 An embodiment of a docking tube 1740 is shown. The docking tube 1740 may include any of the features described herein, including Figures 42A-45K Those features shown.

[0257] Fig.23 A tethered mode is shown. The tethered mode may correspond to one or more methods of evaluating the coaptation assist element 500, 600, 700. The tethered mode may correspond to one or more methods for evaluating the function of the coaptation assist element 500, 600, 700 without one or more delivery systems. In some embodiments, the tethered mode may correspond to one or more methods for evaluating the function of the coaptation assist element 500, 600, 700 without the transseptal sheath 1715. The tethered mode may evaluate function without attaching a large delivery system. Fig.23The deployed apposition assist elements 500, 600, 700 are shown. Fig.23 The apposition assist element 500, 600, 700 is shown entering a tethered mode by retracting the implant shaft. Fig.23 The apposition assist element 500 , 600 , 700 is shown entering a tethered mode by retracting the transseptal sheath 1715 .

[0258] Fig.24 Methods are shown in connection with a docking tube 1740. The docking tube 1740 may include internal threads. The docking tube 1740 may include an internally threaded DS hub for coupling to the externally threaded portion 525, 625, 725 of the annular hub 520, 620, 720. The docking tube 1740 may include an internally threaded hub for connecting to the mate assist element 500, 600, 700. In some methods of use, the docking tube 1740 is removed for the tethered mode. Fig.24 The coaptation assist element 500 , 600 , 700 is shown entering a tethered mode by retracting the docking tube 1740 .

[0259] Fig.24 A method is shown in connection with an anchor driver 1745. The anchor driver 1745 may be disposed within the docking tube 1740. The anchor driver 1745 may include any of the features described herein, including Figures 42A-45K Those features shown. Fig.21 During the method shown, the anchor driver 1745 can rotate the anchor 800. The anchor driver 1745 can rotate the anchor 800 through the annular hub 520, 620, 720. In some methods of use, the anchor driver 1745 is removed for the tethered mode. Fig.24 The apposition assist element 500 , 600 , 700 is shown entering a tethered mode by retracting the anchor driver 1745 .

[0260] The anchor driver 1745 may include a tether rail 1750. The tether rail 1750 may include any of the features described herein, including Figures 42A-45KThose shown in . The tethered guide 1750 can be fixed to the anchor 800. Before releasing the apposition assist element 500, 600, 700, the tethered guide 1750 can allow a minimum force assessment of the effectiveness of the apposition assist element 500, 600, 700. As an example, the user can verify that the apposition assist element 500, 600, 700 is functional. As an example, the user can verify that the native valve leaflet is appositioned with the apposition assist element 500, 600, 700. As an example, the user can verify that the force applied to the apposition assist element 500, 600, 700 is within an acceptable range. As an example, the user can verify that the apposition assist element 500, 600, 700 will not deform under the force of the native valve leaflet. As an example, the user can verify that the apposition assist element 500, 600, 700 is deployed. As an example, the user can verify that the apposition assist element 500, 600, 700 spans the mitral valve. The docking tube 1740 can be retracted as shown. Fig.24 As shown, the tether rail 1750 can remain coupled to the anchor 800 during the tethered mode.

[0261] Fig.25 A method for advancing a secondary anchor rail is shown. In the illustrated embodiment, the method may include a first rail 1755 and a second guidewire 1760. In some embodiments, the mate assist element 500, 600, 700 may include any number of secondary anchor rails (e.g., one, two, three, four, five, etc.). In some embodiments, the number of secondary anchor rails corresponds to the number of secondary guidewires (e.g., one rail for one secondary guidewire, two rails for two secondary guidewires, etc.). The first rail 1755 may be advanced along the first guidewire 1730. The second rail 1760 may be advanced along the second guidewire 1735. The method may include advancing the two secondary anchor rails 1755, 1760. In Fig.25 In the embodiment of the present invention, the secondary anchor rails 1755, 1760 are located on the guide wires 1730, 1735.

[0262] The distal end 1765 of each secondary anchor rail 1755, 1760 can be threaded. In some embodiments, the distal end 1765 of each secondary anchor rail 1755, 1760 engages tissue in the annulus. The distal end 1765 can be threaded to temporarily secure the secondary anchor to the rail 1755, 1760 during delivery. In some embodiments, the distal end 1765 of each secondary anchor rail 1755, 1760 can reduce the likelihood of the secondary anchor inadvertently disengaging from the secondary anchor rail 1755, 1760. The secondary anchor rail 1755, 1760 can reduce the likelihood of the secondary anchor becoming entangled with the guidewire 1730, 1735. In some embodiments, the diameter of the secondary anchor rail 1755, 1760 is greater than or equal to the secondary anchor pitch.

[0263] In some methods of use, the docking tube 1740 can be coupled to the apposition assist element 500, 600, 700. This attachment can allow for recessing of the anchor 800 during delivery of the apposition assist element 500, 600, 700. In some embodiments, the secondary anchor rails 1755, 1760 are advanced over the guidewires 1730, 1735 prior to deployment of the anchor 800. In some embodiments, the secondary anchor rails 1755, 1760 are advanced over the guidewires 1730, 1735 after deployment of the anchor 800. Fig.25 The coaptation aid element 500 , 600 , 700 is shown secured to the annulus using an anchor 800 , with a secondary anchor rail advanced to the surface of the coaptation aid element 500 , 600 , 700 .

[0264] Fig.26 A method for delivering a secondary anchor 1770 is shown. The secondary anchor 1770 is advanced on the first rail 1755. The secondary anchor 1770 can be advanced toward the apposition assist element 500, 600, 700. The secondary anchor 1770 can be installed by a driver 1775. The driver 1775 can translate the secondary anchor 1770 along the first rail 1755.

[0265] Fig. 27 A method for inserting a secondary anchor 1770 is shown. A driver 1775 can rotate the secondary anchor 1770 along the first guide rail 1755. The secondary anchor 1770 can pass through the apposition assist element 500, 600, 700. The secondary anchor 1770 can be rotated to engage tissue beneath the apposition assist element 500, 600, 700. Fig.26 The apposition assist elements 500, 600, 700 are shown secured to the annulus with the anchor 800 when the secondary anchor 1770 is delivered. Fig.2617 shows the auxiliary anchor 1770 inserted into the tissue, the auxiliary elements 500, 600, 700 are fixed to the valve ring by the anchor 800. The driver 1775 is still as Fig. 27 The secondary anchor 1770 can be located on the medial side of the anchor 800.

[0266] Fig.28 A method for delivering a secondary anchor 1780 is shown. The secondary anchor 1780 is advanced over the second rail 1760. The secondary anchor 1780 can be advanced toward the apposition assist element 500, 600, 700. In some methods of use, the secondary anchor 1780 can be installed with a driver 1775. In some methods of use, the driver 1775 can be retracted along the first rail 1755 before being advanced along the second rail 1760. In other methods of use, the secondary anchor 1780 is installed with a different driver than the secondary anchor 1770. The driver 1775 can translate the secondary anchor 1780 along the first rail 1760. In some methods of use, the secondary anchor 1770 can be pre-inserted into the tissue.

[0267] The driver 1775 can rotate the secondary anchor 1780 along the second guide rail 1760. The secondary anchor 1780 can pass through the apposition assist element 500, 600, 700. The secondary anchor 1780 can be rotated to engage tissue beneath the apposition assist element 500, 600, 700. Fig.28 Apposition assist elements 500, 600, 700 are shown secured to the annulus by anchor 800 and secondary anchor 1770 when secondary anchor 1780 is delivered. Fig.26 The apposition assist element 500, 600, 700 is shown secured to the annulus by the anchor 800 and the secondary anchor 1770 when the secondary anchor 1780 is inserted into the tissue. The secondary anchor 1780 can be a lateral anchor. The secondary anchor 1780 can be positioned on the lateral side of the anchor 800.

[0268] Fig.29The apposition assist element 500, 600, 700 with the secondary anchor guide wire 1730, 1735 is shown. The tether rail 1750 can remain coupled to the anchor 800. The secondary anchor guide wires 1730, 1735 remain connected. The delivery system can be reattached. In some methods of use, one or more rails 1755, 1760 can be reattached. In some methods of use, the driver 1775 is reattached. One or more secondary anchors 1770, 1780 can be removed. One or more secondary 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 secondary anchors 1770, 1780 can be removed. The alignment assisting elements 500 , 600 , 700 may be retracted. Fig.29 The apposition assist elements 500, 600, 700 are shown deployed and anchored, with the secondary anchor guidewires 1730, 1735 and tether rail 1750 retained to allow for removal.

[0269] Fig.30 Anchored coaptation assist elements 500, 600, 700 are shown. Secondary anchor guidewires 1730, 1735 are removed. Tether rail 1750 is removed. In some embodiments, tether rail 1750 is rotated and retracted. Coaptation assist elements 500, 600, 700 are shown fully deployed and anchored. In some methods of use, removal is no longer possible. In some methods of use, by Figures 31A-31F Removal by the method described in is no longer possible.

[0270] Figures 31A-31F A method for removing the coaptation aid element 500, 600, 700 is shown. The coaptation aid element 500, 600, 700 can be removed through the transseptal sheath 1715. In some methods of use, the coaptation aid element 500, 600, 700 can be removed after the anchor 800 is removed without the secondary anchors 1770, 1780. In some methods of use, the coaptation aid element 500, 600, 700 can be removed after the anchor 800 and all secondary anchors 1770, 1780 are removed. Figures 31A-31F In some methods of use, the apposition assisting element 500, 600, 700 is removed through the septal sheath 1715. In some methods of use, removal is optional. In some methods of use, removal occurs during Fig.29 After the method shown and Fig.30 Before the method shown.

[0271] Figure 32-35A method for installing one or more secondary anchors is shown. One or more methods can be used in combination with the methods described herein. One or more methods can be used as an alternative to the methods described herein. As an example, Figure 32-35 One or more of the methods shown in Figure 23-30 One or more methods shown in . The secondary anchors described herein can be delivered using guidewires and / or guide rails with a variety of different designs. In some embodiments, each secondary anchor can have a dedicated lumen (e.g., two secondary anchors use two lumens; four secondary anchors use four lumens, etc.). In some embodiments, each secondary anchor can have a dedicated guidewire (e.g., two secondary anchors use two guidewires, four secondary anchors use four guidewires, etc.). In some embodiments, two secondary anchors share a lumen (e.g., two secondary anchors in one lumen, four secondary anchors in two lumens; two guidewires in one lumen, four guidewires in two lumens, etc.). In some embodiments, each of the two guidewires in the shared lumen is covered by a guide rail. The guide rail can reduce the entanglement of the secondary anchor. The guide rail can reduce the entanglement of the secondary anchor with two or more guidewires in the lumen.

[0272] Fig.32 A method for inserting a secondary anchor is shown. In some methods of use, the secondary anchor 1770 is inserted as described herein. The guide wire 1735 can extend from the secondary anchor 1770. The guide wire 1735 can extend into a lumen or a shared lumen. In some methods of use, the secondary anchor 1770 is inserted as described herein. One or more secondary anchors 1170, 1780 can be inserted.

[0273] In some embodiments, one guidewire 1735 can be used for two secondary anchors. In some methods of use, in order to facilitate the removal of the guidewire 1735 after the first secondary anchor 1770 is delivered, the guidewire 1735 can be captured (snared) and removed. In some embodiments, the guidewire 1735 forms a loop. In some embodiments, a portion of the loop of the guidewire 1735 is contained in the apposition auxiliary element 500, 600, 700. In some embodiments, the loop passes through (thread through) the apposition auxiliary element 500, 600, 700. In some embodiments, the catcher 1785 can be positioned along the guidewire 1735. In some embodiments, the catcher 1785 forms a loop. In some embodiments, a portion of the loop of the guidewire 1735 is contained in the loop of the catcher 1785. The method may include the use of the catcher 1785. The catcher 1785 can be used to unthread the guidewire 1735. The catcher 1785 can be retracted. The catcher 1785 can be pulled toward the proximal end through the lumen.

[0274] Fig.33 A method for delivering a secondary anchor 1790 is shown. Capture 1785 has been retracted into the lumen. Capture 1785 has pulled guidewire 1735 toward the proximal end. In some embodiments, driver 1775 or another driver can advance secondary anchor 1790 along guidewire 1735. In some embodiments, secondary anchor 1790 will be delivered with guidewire 1735 removed from anchor 1770 with capture 1785.

[0275] Fig.34 A method for inserting a secondary anchor 1790 is shown. The secondary anchor 1790 can be rotated. The secondary anchor 1790 can be threaded through the apposition assist element 500, 600, 700. The secondary anchor 1790 can be rotated to engage tissue beneath the apposition assist element 500, 600, 700. Fig.34 The apposition assist element 500, 600, 700 is shown being secured to the annulus by the anchor 800 and the secondary anchor 1770 when the secondary anchor 1790 is delivered. The secondary anchor 1790 can be a medial anchor. The secondary anchor 1790 can be positioned on the medial side of the anchor 800. The secondary anchor 1790 can be positioned between the anchor 800 and the secondary anchor 1770.

[0276] Fig.35 Anchored apposition auxiliary elements 500, 600, 700 are shown. The method can be repeated to install one or more additional secondary anchors. For example, one or more additional secondary anchors can be located between secondary anchor 1780 and anchor 800, such as Fig.30 For example, one or more additional secondary anchors may be located between secondary anchor 1770 and anchor 800, such as Fig.30 For example, one or more additional secondary anchors may be located anywhere on the annular portion of the apposition assist element 500 , 600 , 700 .

[0277] Fig.36 and Fig.37 An embodiment of a 2D stack is shown. Fig.38 and Fig.39The embodiment of 3D forming is shown. In some embodiments, the auxiliary element 500, 600, 700 is included in the multilayer laminate on the entire auxiliary element or on only a part of the auxiliary element. In some embodiments, the multilayer laminate may include two or more layers of laminates (e.g., two layers, three layers, four layers, five layers, etc.). Two or more layers of the multilayer laminate may include the same material. Two or more layers of the multilayer laminate may include different materials. Two or more layers of the multilayer laminate may have the same size (e.g., length, width, thickness, diameter, etc.). Two or more layers of the multilayer laminate may include one or more different sizes. According to the region of the auxiliary element 500, 600, 700, the laminate may be variable. In some embodiments, the aligning area may have an additional protective layer. In some embodiments, the aligning surface 560, 660, 760, compared to another part of the aligning auxiliary element 500, 600, 700, includes one or more additional layers. Fig.38 An additional layer 1795 is shown located only in the apposition region (e.g., the lower region) of the apposition aid element 500, 600, 700. Thus, the lower apposition region can be thicker than the upper region of the apposition aid element located near the heart valve annulus, such as at least about 10%, 25%, 50%, 75%, 100%, 150%, 200%, 250%, 300% or more thicker than the upper region, or a range including any two of the above values.

[0278] The multilayer laminate can be manufactured by a 2D lamination method. In some methods of use, two or more layers are combined together. These layers can be combined by heating. These layers can be combined by adhesives. These layers can be combined together by any mechanical or chemical changes. The auxiliary element 500, 600, 700 can have a roughly 2D shape. The auxiliary element 500, 600, 700 can be flat or roughly flat. In some embodiments, one or more layers include high-density polyethylene (PE), polypropylene, Dacron, acellular collagen matrix (such as SIS) or other plastics.

[0279] The multilayer laminate can be manufactured using a 3D forming method. The auxiliary element 500, 600, 700 can be formed. As described herein, the auxiliary element 500, 600, 700 can include pillars 530, 630, 730. In some embodiments, the pillars 530, 630, 730 are made of elastically deformable materials, such as shape memory metals or shape memory polymers such as nitinol. In some embodiments, the material is Elgiloy. In some embodiments, the pillar 530 can be made of other materials, including stainless steel, polypropylene, high-density polyethylene (PE), Dacron, acellular collagen matrix (e.g., SIS) or other plastics. 3D forming can involve the shape of molded pillars 530, 630, 730. 3D forming can include adjusting the shape memory metal to an appropriate shape. The shape can be set with an appropriate mold, which bends the pillars 530, 630, 730 into a desired shape. The shape setting or shape training may include constraining the auxiliary element 500, 600, 700 on a fixture or in a mold. In some methods of use, when the auxiliary element 500, 600, 700 is on a fixture or in a mold, appropriate heat treatment is applied to the auxiliary element 500, 600, 700. In some embodiments, the temperature, time and / or other parameters are adjusted to heat-set the auxiliary element 500, 600, 700. In some embodiments, the temperature of heat setting is greater than 300°C, greater than 400°C, greater than 500°C, greater than 600°C, etc. In some embodiments, the time for heat setting is 1 minute, 2 minutes, 3 minutes, 4 minutes, 5 minutes, 6 minutes, 7 minutes, 8 minutes, 9 minutes, 10 minutes, more than 2 minutes, more than 5 minutes, more than 10 minutes, etc. In some embodiments, the method may include rapid cooling. In some embodiments, the method may include rapid cooling by water or air.

[0280] Fig.40 A coaptation aid element 400 is shown. Coaptation aid element 400 may include any of the features of coaptation aid elements described herein. Coaptation aid element 400 may include an annular hub 420 to facilitate attachment to a delivery system, similar to the annular hubs described herein. An annular hub 425 may include an externally threaded portion 425. Coaptation aid element 400 may include struts 430. Struts 430 may be atrial arms that may bend in an upper and / or lower direction.

[0281] The apposition assist element 400 may include an annular anchoring portion 435. The annular anchoring portion 435 may be a portion of the support 430. In some embodiments, the annular anchoring portion 435 includes one or more barbs with sharp ends. The annular anchoring portion 435 may be a passive anchor. The barbs may be completely exposed and, as shown, Fig.40 In some embodiments, the barbs extend from the multilayer laminate. The barbs can be the free ends of the struts 430. In some embodiments, the barbs can be located on the surface of the apposition assist element 400. In some embodiments, the barbs can engage tissue by pushing back the laminate. For example, Fig.41 As shown, the multilayer laminate can be pushed back. Fig.41 An embodiment of a barb is shown. In some methods of use, engagement of the barbs with tissue can cause the multi-layer laminate to push back.

[0282] The apposition auxiliary element 400 may include a knotless suture edge 455. The edge can reduce trauma to autologous tissue. The apposition auxiliary element 400 may include one or more rounded edges that reduce trauma. In some embodiments, the lateral edges of the apposition auxiliary element 400 are rounded. In some embodiments, the upper edge of the apposition auxiliary element 400 is rounded. In some embodiments, the lower edge of the apposition auxiliary element 400 is rounded.

[0283] The apposition assist element 400 may include an apposition surface 460. The apposition surface 460 may include an additional protective layer. In some embodiments, the apposition surface 460 may include one or more additional layers of a multilayer laminate. In some embodiments, the apposition surface 460 may include one or more different layers of a multilayer laminate. One or more layers of the apposition surface 460 may be designed to facilitate long-term use of the apposition assist element 400. One or more layers of the apposition surface 460 may be designed to facilitate apposition with the native leaflet.

[0284] Figures 42A-45K Embodiments of implant delivery systems are shown. The implant delivery system may include any of the coaptation assist elements described herein. The implant delivery system may be designed to position the coaptation assist element 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 anchor with tissue. The implant delivery system may be designed to rotate the anchor.

[0285] Fig.42A-42i shows an embodiment of an implant delivery system 1800. The implant delivery system 1800 can include a butt joint tube 1805. The butt joint tube 1805 is connected to an implant torque shaft 1810. In some embodiments, the implant torque shaft 1810 can be rigidly coupled to the butt joint tube 1805. In some embodiments, the implant torque shaft 1810 is welded or brazed to the butt joint tube 1805. The implant torque shaft 1810 can transmit torque to the butt joint tube 1805, as described herein. The butt joint tube 1805 can be coupled to the butt joint auxiliary element 400, 500, 600, 700. In the illustrated embodiment, only a portion of the pillars 430, 530, 630, 730 are shown.

[0286] Reference now Figures 42A-42B , the butt joint tube 1805 may include one or more slots 1815 (slots). In the illustrated embodiment, the butt joint tube 1805 may include one slot 1815, but other configurations are contemplated (e.g., two slots, three slots, four slots, two diametrically opposed slots, four radially spaced slots, etc.). The slot 1815 may extend through the butt joint tube 1815. In some embodiments, the butt joint tube 1805 may include one or more grooves that do not extend through the butt joint tube. The slot 1815 may extend along the length of the butt joint tube 1805 or a portion thereof. The slot 1815 may extend between the distal end and the proximal end of the butt joint tube 1805.

[0287] The docking tube 1805 can include a pin 1820 disposed within a slot 1815. In some embodiments, the docking tube 1805 can include a spring 1825 disposed within the slot 1815. The pin 1820 can be coupled to a pull wire 1830. The pull wire 1830 can move the pin 1820 within the slot 1815, as described herein. The annular hub 420, 520, 620, 720 can include a groove 1835. The groove 1835 in the annular hub 420, 520, 620, 720 can be aligned with the groove 1815 in the docking tube 1805. The pin 1820 can be disposed within the groove 1835.

[0288] The annular hub 420, 520, 620, 720 may include an externally threaded portion 425, 525, 625, 725. The butt joint tube 1805 may include an internally threaded portion 1840. In some methods of use, the butt joint tube 1805 is rotated to engage the butt joint tube 1805 to the annular hub 420, 520, 620, 720. The internally threaded portion 1840 engages with the externally threaded portion 425, 525, 625, 725. The groove 1835 may be cut on the outer diameter of the threads on the externally threaded portion 425, 525, 625, 725. The groove 1815 may be cut on the inner diameter of the internally threaded portion 1840 of the butt joint tube 1805. The groove 1815 may be aligned with the groove 1835. In some embodiments, when the docking tube 1805 reaches the lowest point against the docking assist element 400 , 500 , 600 , 700 , the slot 1815 may be aligned with the groove 1835 .

[0289] Figures 42A-42B The neutral position of the pin 1820 is shown. The spring 1825 biases the pin 1820 downward and engages the pin 1820 with the groove 1835. The pin 1835 spans between the butt joint 1805 and the annular hub 420, 520, 620, 720. The natural state is that the pin 1820 is forward. In this state, the pin 1820 locks the threaded connection between the internal threaded portion 1840 of the butt joint 1805 and the external threaded portion 425, 525, 625, 725 of the annular hub 420, 520, 620, 720. The pin 1820 allows the user to twist the apposition auxiliary element 400, 500, 600, 700 in two directions through the butt joint 1805 and the implant torque shaft 1810. The pin 1820 allows the user to rotate the apposition auxiliary element 400, 500, 600, 700 clockwise or counterclockwise by rotating the butt joint 1805. In some methods of use, the pin 1820 can be used to mate the auxiliary element 400, 500, 600, 700 through the docking tube 1805. When the slot 1815 and the groove 1835 are aligned, the spring-loaded pin 1820 can slide into the groove 1835 and substantially capture the threads. Fig.42A The pin 1820 is shown forward so that the docking tube 1805 and the mate assist element 400, 500, 600, 700 are locked together. Fig.42B A cross-sectional view of the locking pin 1820 is shown in its natural forward position.

[0290] Figures 42C-42DThe release of the pin 1820 is shown. The pin 1820 can be pulled back via the pull wire 1830. The pin 1820 can compress the spring 1825. The pin 1820 can be removed from the groove 1835. The pin 1820 slides along the slot 1815. In this position, the docking tube 1805 can be unscrewed from the mate auxiliary element 400, 500, 600, 700. The internal threaded portion 1840 can be disengaged from the external threaded portion 425, 525, 625, 725 by rotating the docking tube 1805. Fig.42C A cross-sectional view of the retracted pin 1820 is shown. With the pin 1820 retracted, the docking tube 1805 can be unscrewed from the annular hub 420, 520, 620, 720. Figures 42A-42D It is shown that a docking hub 1805 can be coupled to the alignment assist element 400 , 500 , 600 , 700 in order to position the alignment assist element 400 , 500 , 600 , 700 . Figures 42A-42D It is shown that a docking hub 1805 may be coupled to the mate assist element 400 , 500 , 600 , 700 in order to rotate the mate assist element 400 , 500 , 600 , 700 .

[0291] Fig.42E -42i shows the use of anchor 800 with implant delivery system 1800. Fig.42E As shown, the anchor 800 is located within the docking hub 1805. The anchor 800 is in a retracted state within the docking hub 1805. The anchor 800 is internal relative to the locking mechanism or pin 1820. The docking hub 1805 is shown in line form, or is drawn in line form. For clarity, Fig.42E The docking hub 1805 and implant torque shaft 1810 shown in FIG. Fig.42F was removed.

[0292] As described herein, anchor 800 can be screwed onto the posterior leaflet at the anatomical P2 position. Anchor 800 can be considered a P2 anchor. Anchor 800 can be driven by driver 1845. Figure 42G A close-up view of the driver 1845 is shown. The driver 1845 has driven the anchor 800 completely into the tissue and down onto the annular hub 420, 520, 620, 720 of the apposition assist element 400, 500, 600, 700. The driver 1845 is connected to the internal torque shaft 1850. The driver 1845 and the anchor 800 are completely contained within the docking hub 1805, as described herein. The internal torque shaft 1850 can extend through the implant torque shaft 1810, see Fig.42E .

[0293] Figure 42HAn internal cross-sectional view of the anchor 800 is shown. To ensure a secure connection with the driver 1845, the anchor 800 can be tensioned on the driver 1845 by a tether rail 1855. The tether rail 1855 can include a guide wire having a small screw or an externally threaded portion 1860 at the distal end. The externally threaded portion 1860 of the tether rail 1855 is configured to engage the internally threaded portion 1865 of the anchor device 800. Figure 42H An interior view of the tether rail 1855 and the connection between the anchor 800 and the annular hub 420, 520, 620, 720 is shown.

[0294] Figure 42H Also shown is a 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 in the head of the anchor 800. Other designs for mating the anchor 800 and the driver 1845 are also contemplated (e.g., any non-circular shape, polygonal, hexagonal, Philips, oval, etc.).

[0295] Anchor 800 may include shoulder 1875. Once anchor 800 is fully driven into tissue, shoulder 1875 of anchor 800 pushes annular hub 420, 520, 620, 720 downward to secure apposition assist element 400, 500, 600, 700. Fig. 42i shows a view of an apposition assist element 400, 500, 600, 700 being anchored.

[0296] Figures 43A-43E An embodiment of an implant delivery system 1900 is shown. The implant delivery system 1900 can include a butt joint tube 1905. The butt joint tube 1905 can be cylindrical. The butt joint tube 1905 is connected to an implant torque shaft 1910. In some embodiments, the implant torque shaft 1910 can be rigidly connected to the butt joint tube 1905. In some embodiments, the implant torque shaft 1910 is welded or brazed to the butt joint tube 1905. The implant torque shaft 1910 can transmit torque to the butt joint tube 1905, as described herein. The butt joint tube 1905 can be coupled to the butt joint auxiliary element 400, 500, 600, 700. In the illustrated embodiment, only a portion of the pillars 430, 530, 630, 730 are shown.

[0297] The butt joint 1905 may include two or more hypotubes 1915 embedded in the wall. The hypotube 1915 may include a lumen. The hypotube 1915 may be diametrically opposed. The hypotube 1915 may be spaced 180° apart. The hypotube 1915 may extend within the groove. The hypotube 1915 may extend along a portion of the length of the butt joint 1905. In some embodiments, the butt joint 1905 includes two or more lumens. In some embodiments, the lumen is integrally or integrally formed with the butt joint 1905. In the illustrated embodiment, the butt joint 1905 may include two hypotubes 1915, but other configurations are also contemplated (e.g., four hypotubes, etc.).

[0298] The docking tube 1905 may include a tether 1920 disposed within the lower tube 1915. In some embodiments, the tether 1920 may be looped through opposing gaps in the apposition assist element 400, 500, 600, 700. In some embodiments, the tether 1920 may be passed between struts 430, 530, 630, 730 in the apposition assist element 400, 500, 600, 700. The tether 1920 may extend through one lower tube 1915, through the apposition assist element 400, 500, 600, 700, below the annular hub 420, 520, 620, 720, through the apposition assist element 400, 500, 600, 700, and through another lower tube 1915. The tether 1920 may be looped through the apposition assist element 400, 500, 600, 700. The tether 1920 may be looped through the apposition assist element 400, 500, 600, 700 and back to the proximal or handle end of the system.

[0299] Figures 43A-43B The initial position of the tether 1920 is shown. In this state, the tether 1920 holds the butt joint tube 1905 and the apposition auxiliary element 400, 500, 600, 700 together. The tether 1920 allows the user to twist the apposition auxiliary element 400, 500, 600, 700 in two directions through the butt joint tube 1905 and the implant torque shaft 1910. The tether 1920 allows the user to rotate the apposition auxiliary element 400, 500, 600, 700 clockwise or counterclockwise by rotating the butt joint tube 1905. In some methods of use, the tether 1920 can be used for the movement of the apposition auxiliary element 400, 500, 600, 700 through the butt joint tube 1905. The tether 1920 can be released. When the tether 1920 is released, the butt joint tube 1905 can be disengaged from the annular hub 420, 520, 620, 720. Figures 43A-43BIt is shown that a docking hub 1905 can be coupled to the alignment assist element 400 , 500 , 600 , 700 in order to position the alignment assist element 400 , 500 , 600 , 700 . Figures 43A-43B It is shown that the docking hub 1805 can be coupled to the mate assist element 400 , 500 , 600 , 700 in order to rotate the mate assist element 400 , 500 , 600 , 700 .

[0300] Figures 43C-43E Anchor 800 is shown for use with implant delivery system 1900. Fig.43C As shown, the anchor 800 is located within the docking hub 1905. The anchor 800 is in a retracted state within the docking hub 1905. The anchor 800 is located internally relative to the locking mechanism or tether 1920. The docking hub 1905 is in a retracted state. Fig.43B It is shown in line form.

[0301] As described herein, anchor 800 can be screwed in at the anatomical P2 location on the posterior leaflet. Anchor 800 can be considered a P2 anchor. Anchor 800 can be driven by driver 1945. Fig.43D A close-up view of the driver 1945 is shown. The driver has driven the anchor 800 completely into the tissue and down onto the annular hub 420, 520, 620, 720 of the apposition assist element 400, 500, 600, 700. The driver 1945 is connected to the internal torque shaft 1950. In some embodiments, the internal torque shaft 1950 is welded or brazed to the driver 1945. The driver 1945 and the anchor 800 are completely contained within the docking hub 1905. The internal torque shaft 1950 can extend through the implant torque shaft 1910. Fig.43C Advancement of the anchor 800 is shown before the anchor 800 is fully seated. Fig.43D Anchor 800 is shown screwed down into tissue.

[0302] Fig.43C Also shown is an internal cross-sectional view of the anchor 800. To ensure a secure connection with the driver 1945, the anchor 800 can be tensioned against the driver 1945 by a tether rail 1955. The tether rail 1955 can include a guide wire having a small screw or externally threaded portion 1960 at the distal end. The externally threaded portion 1960 of the tether rail 1955 is configured to engage the internally threaded portion 1965 of the anchor device 800. Fig.42CAn internal view of the tether rail 1955 and the connection between the anchor 800 and the annular hub 420, 520, 620, 720 is shown. The tether rail 1955 can allow for a minimum force assessment of the effectiveness of the aligning aid element 400, 500, 600, 700 before releasing the tether 1920. The tether rail 1955 can allow for a minimum force assessment of the effectiveness of the aligning aid element 400, 500, 600, 700 before releasing the tether 1920. Fig.43C A cross-sectional view showing the path of tether 1920 is shown.

[0303] Fig.43E A view of an implanted anchor 800 is shown. Fig.42E Also shown is 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 in the head of the anchor 800. Other designs for mating the anchor 800 and the driver 1945 are also contemplated (e.g., any non-circular, polygonal, hexagonal, Phillips, elliptical, etc.). The anchor 800 may include an anchor hub. The hub may include an internally threaded portion 1965 of the anchor 800 to allow connection to the tie-down rail 1955. The anchor 800 may include an anchoring spiral. The anchoring spiral may include a bottom end for optimal tissue penetration.

[0304] The tethered auxiliary element 400, 500, 600, 700 may include some cutouts to minimize the sliding friction of the tethered member 1920. The anchor 800 may be screwed into the tissue and bottomed out on the hub 420, 520, 620, 720. The user may retract the docking tube 1905, leaving both ends of the tethered member 1920. The tethered member may be connected by connecting the inner torque shaft. If the user is satisfied with the performance of the tethered auxiliary element 400, 500, 600, 700, the user may remove the tethered member 1920. If the user is not satisfied with the performance of the tethered auxiliary element 400, 500, 600, 700, the user may re-docking the implant delivery system 1900 with the tethered member 1920. If the user is not satisfied with the performance of the tethered auxiliary element 400, 500, 600, 700, the user may pass the tethered member 1920 through the lower tube 1915. If the user is not satisfied with the performance of the apposition aid element 400 , 500 , 600 , 700 , the user may remove the anchor 800 and / or remove the apposition aid element 400 , 500 , 600 , 700 entirely.

[0305] Figures 44A-44EAn embodiment of an implant delivery system 2000 is shown. The implant delivery system 2000 may include a butt joint tube 2005. The butt joint tube 2005 may be a desired shape, such as a cylindrical shape. The butt joint tube 2005 is connected to an implant torque shaft 2010. In some embodiments, the implant torque shaft 2010 may be rigidly coupled to the butt joint tube 2005. In some embodiments, the implant torque shaft 2010 is welded or brazed to the butt joint tube 2005. The implant torque shaft 2010 may transfer torque to the butt joint tube 2005, as described herein. The butt joint tube 2005 may include a butt end cap 2015.

[0306] The butt joint tube 2005 may include one, two or more retaining arms 2020 cut out at the distal end. The one, two or more retaining arms 2020 may allow the transmission of torque and push / thrust to the butt joint auxiliary element 400, 500, 600, 700 via the implant torque shaft 2010. The butt joint tube 2005 may include three retaining arms 2020. The retaining arms 2020 may be spaced equidistantly around the butt joint tube 2005. The retaining arms 2020 may be spaced approximately, at least approximately, or no more than approximately 120 ° or another desired angle. The retaining arms 2020 may extend along a portion of the length of the butt joint tube 2005. In some embodiments, the retaining arms 2020 are integrally or integrally formed with the butt joint tube 2005. In the illustrated embodiment, the butt joint tube 2005 may include three retaining arms 2020, but other configurations are also contemplated (e.g., one retaining arm, two retaining arms, four retaining arms, five retaining arms, etc.). The retaining arm 2020 may be formed by a U-shaped cutout in the butt tube 2005 .

[0307] Figures 44B-44C The initial position of the retaining arm 2020 is shown. In this state, the retaining arm 2020 holds the butt joint tube 2005 and the apposition auxiliary element 400, 500, 600, 700 together. The retaining arm 2020 allows the user to twist the apposition auxiliary element 400, 500, 600, 700 in two directions through the butt joint tube 2005 and the implant torque shaft 2010. The retaining arm 2020 allows the user to rotate the apposition auxiliary element 400, 500, 600, 700 clockwise or counterclockwise by rotating the butt joint tube 2005. In some methods of use, the retaining arm 2020 can be used for the movement of the apposition auxiliary element 400, 500, 600, 700 via the butt joint tube 2005.

[0308] Reference Fig.44E, the retaining arm 2020 engages a window 2025 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 annular hub 420, 520, 620, 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 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 can include an inwardly facing tab 2030. The tab 2030 can have an increased thickness relative to the retaining arm 2020. The tab 2030 can be shaped to engage with the window 2025. The tab 2030 can be a distal inner portion of the retaining arm 2020.

[0309] Figures 44B-44D Anchor 800 is shown for use with implant delivery system 2000. Fig.44B As shown, the anchor 800 is located within the docking hub 2005. The anchor 800 is in a retracted state within the docking hub 2005. The anchor 800 is located internally relative to the tab 2030 of the locking mechanism or retaining arm 2020. Fig.44B It is shown in line form. Fig.44C Advancement of the anchor 800 is shown. Fig.44C Advancement of the anchor 800 is shown before the anchor 800 is fully seated and before the retaining arms 2020 are bent.

[0310] As described herein, anchor 800 can be screwed in, for example, at the anatomical P2 location on the posterior leaflet. Anchor 800 can be considered a P2 anchor. Anchor 800 can be driven by driver 2045. Fig.44D A close-up view of the driver 2045 is shown. The driver 2045 has driven the anchor 800 completely into the tissue and down onto the annular hub 420, 520, 620, 720 of the apposition assist element 400, 500, 600, 700. The driver 2045 is connected to the internal torque shaft 2050. In some embodiments, the internal torque shaft 2050 is welded or brazed to the driver 2045. The driver 2045 and the anchor 800 are completely contained within the docking hub 2005, as shown in FIG. Fig.44B The internal torque shaft 2050 can extend through the implant torque shaft 2010.

[0311] Fig.44DAn internal cross-sectional view of the anchor 800 is shown. To ensure a secure connection with the driver 2045, the anchor 800 can be tensioned against the driver 2045 by a tie rail 2055. The tie rail 2055 can include a guide wire having a small screw or external threaded portion 2060 at the distal end. The external threaded portion 2060 of the tie rail 2055 is configured to engage the internal threaded portion 2065 of the anchor 800. Fig.44D An internal view of the tether guide 2055 and the connection between the anchor 800 and the annular hub 420, 520, 620, 720 is shown. The tether guide 2055 can allow for a minimum force assessment of the effectiveness of the aligning aid element 400, 500, 600, 700 before releasing the aligning aid element 400, 500, 600, 700. The tether guide 2055 can allow for a minimum force assessment of the effectiveness of the aligning aid element 400, 500, 600, 700 before releasing the retaining arm 2020.

[0312] Fig.44D A cross-sectional view showing the release of the retention arm 2020 is shown. When the anchor 800 is screwed into tissue, the annular hub 420, 520, 620, 720 contacts the tab 2030 of the retention arm 2020. Due to the distal movement of the annular hub 420, 520, 620, 720, the retention arm 2020 can bend outward from the window 2025 of the anchor 800. The tab 2030 may include an angled face 2035 that allows the docking tube 2005 to be easily removed from the annular hub 420, 520, 620, 720 when the retention arm 2020 is bent outward. Fig.44D Advancement of the anchor 800 is shown, with the retaining arms 2020 flexing outwardly as the anchor 800 is driven fully in.

[0313] With the retaining arms 2020 bent outwardly, the docking tube 2005 may be decoupled from the annular hub 420 , 520 , 620 , 720 . Fig.44D It is shown that the docking hub 2005 can be disconnected from the mate assist element 400 , 500 , 600 , 700 . Figures 44A-44C It is shown that the docking hub 2005 can be coupled to the mate assist element 400 , 500 , 600 , 700 in order to position the mate assist element 400 , 500 , 600 , 700 . Figures 44A-44C It is shown that the docking hub 2005 can be coupled to the mate assist element 400 , 500 , 600 , 700 in order to rotate the mate assist element 400 , 500 , 600 , 700 .

[0314] Fig.44E A view of an implanted anchor 800 is shown. Fig.44EAlso shown is a square recess 2070 of the head of the anchor 800. The driver 2045 may include a square portion (not shown) configured to engage the square recess 2070 in the head of the anchor 800. Other designs for mating the anchor 800 and the driver 2045 are also contemplated (e.g., any non-circular shape, polygonal, hexagonal, Phillips, elliptical, etc.). The anchor 800 may include an anchor hub. The hub may include an internal threaded portion 2065 of the anchor 800 to allow connection to the tie-down rail 2055. The anchor 800 may include an anchor spiral. The anchor 800 may include a window 2025. The window 2025 allows the retaining arm 2020 to snap and remain on the annular hub 420, 520, 620, 720. The window 2025 allows the retaining arm 2020 to remain on the annular hub 420, 520, 620, 720 in compression, tension, and torsion.

[0315] Figures 45A-45K 1 shows an embodiment of an implant delivery system 2100. The implant delivery system 2100 can include a butt joint tube 2105. The butt joint tube 2105 can be cylindrical. The butt joint tube 2105 is connected to an implant torque shaft 2110. In some embodiments, the implant torque shaft 2110 can be rigidly connected to the butt joint tube 2105. In some embodiments, the implant torque shaft 2110 is welded or brazed to the butt joint tube 2105. As described herein, the implant torque shaft 2110 can transmit torque to the butt joint tube 2105. The butt joint tube 2105 can include a butt end cap 2115.

[0316] The butt joint pipe 2105 may include one or more grooves 2120 cut out at the distal end. The groove 2120 may be a bayonet slot. The groove 2120 may have a bayonet configuration. The one or more grooves 2120 may allow the torque and the transmission of the thrust / thrust force to the butt joint auxiliary element 400, 500, 600, 700 through the implant torque shaft 2110. The butt joint pipe 2105 may include three grooves 2120. The grooves 2120 may be spaced equidistantly around the butt joint pipe 2105. The grooves 2120 may be spaced 120° apart. The grooves 2120 may extend along a portion of the length of the butt joint pipe 2105. In some embodiments, the grooves 2120 are integrally or integrally formed with the butt joint pipe 2105. In the illustrated embodiment, the butt joint pipe 2105 may include three grooves 2120, but other configurations (e.g., one groove, two grooves, four grooves, five grooves, etc.) may also be considered. The grooves 2120 may be formed by a J-shaped cutout in the butt joint pipe 2105.

[0317] The docking tube 2105 may include Fig.45BThe flare ring 2125 shown. The flare ring 2125 can ensure that the groove 2120 does not weaken the distal end of the butt tube 2105. The flare ring 2125 can ensure easy re-docking. The flare ring 2125 can be welded or brazed to the distal end of the butt tube 2105.

[0318] Reference Fig.45F , the groove 2120 engages the retaining pin 2030 within the head of the anchor 800. In some embodiments, the retaining pin 2030 protrudes a sufficient amount to ensure proper engagement with the groove 2120 at the end of the docking tube 2105. In some embodiments, the retaining pin 2030 extends radially outward from the annular hub 420, 520, 620, 720. In some embodiments, the retaining pin 2030 is cylindrical. The number of retaining pins 2030 can correspond to the number of grooves 2120. In some embodiments, each groove 2120 engages a retaining pin 2025. The groove 2120 can be shaped to receive and guide the retaining pin 2030.

[0319] Figures 45B-45C The initial position of the slot 2120 relative to the retaining pin 2030 is shown. In this state, the slot 2120 and the retaining pin 2030 hold the butt joint tube 2005 and the joint auxiliary element 400, 500, 600, 700 together. The slot 2120 and the retaining pin 2030 allow the user to twist the joint auxiliary element 400, 500, 600, 700 in two directions through the butt joint tube 2005 and the implant torque shaft 2010. The slot 2120 and the retaining pin 2030 allow the user to rotate the joint auxiliary element 400, 500, 600, 700 clockwise or counterclockwise by rotating the butt joint tube 2005. In some methods of use, the slot 2120 and the retaining pin 2030 can be used for the movement of the joint auxiliary element 400, 500, 600, 700 through the butt joint tube 2105.

[0320] Figures 45B-45E Anchor 800 is shown for use with implant delivery system 2100. Fig.45B As shown, the anchor 800 is located within the docking hub 2105. The anchor 800 is in a retracted state within the docking hub 2105. The anchor 800 is located internally relative to the locking mechanism or groove 2120. The docking hub 2105 is in Fig.45B It is shown in line form. Fig.45C Advancement of the anchor 800 is shown.

[0321] As described herein, anchor 800 can be screwed in at the anatomical P2 location on the posterior leaflet. Anchor 800 can be considered a P2 anchor. Anchor 800 can be driven by driver 2145. Fig.45DA close-up view of the driver 2145 is shown. The driver 2145 has driven the anchor 800 completely into the tissue and down onto the annular hub 420, 520, 620, 720 of the apposition assist element 400, 500, 600, 700. The driver 2145 is connected to the internal torque shaft 2150. In some embodiments, the internal torque shaft 2150 is welded or brazed to the driver 2145. Fig.45B As shown, the driver 2145 and anchor 800 are fully contained within the docking hub 2105. The internal torque shaft 2150 can extend through the implant torque shaft 2110.

[0322] Fig.45E An internal cross-sectional view of the anchor 800 is shown. To ensure a secure connection with the driver 2145, the anchor 800 can be tensioned against the driver 2145 by a tether rail 2155. The tether rail 2155 includes a guide wire having a small screw or externally threaded portion 2160 at the distal end. The externally threaded portion 2160 of the tether rail 2155 is configured to engage the internally threaded portion 2165 of the anchor 800. Fig.45E An internal view of the tether rail 2055 and the connection between the anchor device 800 and the annular hub 420, 520, 620, 720 is shown. The tether rail 2155 can allow for a minimum force assessment of the effectiveness of the mate assist element 400, 500, 600, 700 before releasing the mate assist element 400, 500, 600, 700. The tether rail 2155 can allow for a minimum force assessment of the effectiveness of the mate assist element 400, 500, 600, 700 before releasing the retaining pin 2030.

[0323] As the anchor 800 is screwed into tissue, the retaining pins 2030 of the annular hub 420, 520, 620, 720 move proximally within the slots 2120. The docking tube 2005 can be rotated, thereby causing the retaining pins 2030 of the annular hub 420, 520, 620, 720 to move laterally within the slots 2120. The docking tube 2005 can be moved proximally, thereby causing the retaining pins 2030 of the annular hub 420, 520, 620, 720 to move distally within the slots 2120. Further proximal movement of the docking tube 2005 can release the docking tube 2105 from the annular hub 420, 520, 620, 720. Figures 45A-45C It is shown that a docking hub 2005 may be coupled to the mate assist element 400 , 500 , 600 , 700 in order to position the mate assist element 400 , 500 , 600 , 700 . Figures 45A-45C It is shown that the docking hub 2105 can be coupled to the mate assist element 400 , 500 , 600 , 700 in order to rotate the mate assist element 400 , 500 , 600 , 700 .

[0324] Figures 45E-45F A view of an implanted anchor 800 is shown. Fig.45E Also shown is 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 in the head of the anchor 800. Other designs for matching the anchor 800 and the driver 2145 are also contemplated (e.g., any non-circular shape, polygonal, hexagonal, Philips-shaped, elliptical, etc.). The anchor 800 may include an anchor hub. The hub may include an internal threaded portion 2165 of the anchor 800 to allow connection to the tethered rail 2155. The anchor 800 may include an anchor spiral. In some embodiments, the annular hub 420, 520, 620, 720 may include three laser cut holes for receiving three retaining pins 2130. The retaining pins 2130 may be welded to the holes. In some embodiments, the retaining pins 2130 are nitinol. Figure 45G-45K Additional views are shown.

[0325] Figures 45A-45C Deployment of one or more secondary anchors 850, 1770, 1780 is shown. The secondary anchors 850, 1770, 1780 may include any of the features of the anchor 800. The secondary anchors 850, 1770, 1780 may include a spiral or helical structure 852. The secondary anchors 850, 1770, 1780 may be designed to engage tissue of the heart, such as tissue of the annulus. The secondary anchors 850, 1770, 1780 may include a tip 854 that is designed to engage tissue. The tip 854 may be sharpened. The tip 854 may be ground for optimal penetration. The secondary anchors 850, 1770, 1780 may include a hub 856. The hub 856 may be an annular hub having any of the features of the annular hubs 420, 520, 620, 720 described herein. The hub 856 may include one or more mating features 858. The mating features 858 may be cutouts. The mating feature 858 may form two semicircular portions at different heights. The mating feature 858 may include a first circular portion and a second circular portion. The first circular portion and the second circular portion may be separated by a vertical cut. The mating feature 858 may include any configuration that allows torque to be transmitted to the secondary anchors 850, 1770, 1780.

[0326] Figures 46A-46CA delivery catheter 860 designed to deploy one or more secondary anchors 850, 1770, 1780 is shown. The distal end of the delivery catheter 860 is shown. The delivery catheter 860 may include a proximal end outside the patient's body. The proximal end may include one or more controls for manipulating the delivery catheter 860. The delivery catheter 860 may include a torque shaft 862. In some embodiments, the torque shaft 862 may rotate the secondary anchors 850, 1770, 1780 in either direction. The torque shaft 862 may include a chamber 864. The torque shaft 862 may include a spiral or helical structure 866. The spiral or helical structure 866 of the torque shaft 862 may have the same or similar features as the spiral or helical structure 852 of the one or more secondary anchors 850, 1770, 1780. The spiral or helical structure 866 of the torque shaft 862 may have the same pitch as the spiral or helical structure 852 of the one or more secondary anchors 850, 1770, 1780. The helical or spiral structure 866 of the torque shaft 862 can have the same diameter as the helical or spiral structure 852 of the one or more secondary anchors 850, 1770, 1780. The helical or spiral structure 866 of the torque shaft 862 can have the same wire diameter as the helical or spiral structure 852 of the one or more secondary anchors 850, 1770, 1780.

[0327] 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 mating features 870. The mating feature 870 may be designed to lock with the mating feature 858 of the hub 856. The mating feature 870 may form two semicircular portions at different heights. The mating feature 870 may include a first circular portion and a second circular portion. The first circular portion and the second circular portion may be separated by a vertical cut. The mating feature 870 may include any configuration that allows torque to be transmitted to the hub 856 of the one or more secondary anchors 850, 1770, 1780. The locking hub 868 may be coupled to a locking shaft 872.

[0328] Fig.46A A configuration is shown in which the delivery catheter 860 is not engaged with the secondary anchors 850, 1770, 1780. Fig.46BA configuration is shown in which a delivery catheter 860 is engaged with a secondary anchor 850, 1770, 1780. In some embodiments, a spiral or helical structure 866 can engage a spiral or helical structure 852 of a secondary anchor 850, 1770, 1780. In some embodiments, the two spirals can have the same pitch and diameter. Because the two spirals have the same pitch and diameter, the combined profile will be the same as the profile of the secondary anchor 850, 1770, 1780. The spiral or helical structure 866 can interlock with the spiral or helical structure 852 of the secondary anchor 850, 1770, 1780. The spiral or helical structure 866 can fit within the void of the spiral or helical structure 852 of the secondary anchor 850, 1770, 1780. The diameter of the combined structure can be the same as the diameter of the spiral or helical structure 852 of the secondary anchor 850, 1770, 1780. In some embodiments, the torque shaft 862 can be rotated to engage the helical or spiral structure 866 with the helical or spiral structure 852 of the secondary anchor 850, 1770, 1780. In some embodiments, the secondary anchor 850, 1770, 1780 can be rotated to engage the helical or spiral structure 852 of the secondary anchor 850, 1770, 1780 with the helical or spiral structure 866. Fig.46B The engaged helices are shown.

[0329] In some embodiments, the locking hub 868 engages with the hub 856 of the secondary anchor 850, 1770, 1780. In some embodiments, the locking hub 868 can be translated within the chamber 864 of the torque shaft 862 toward the secondary anchor 850, 1770, 1780. The mating feature 870 of the locking hub 868 can interlock with the mating feature 858 of the hub 565 of the secondary anchor 850, 1770, 1780. The locking hub 868 can engage with the secondary anchor 850, 1770, 1780. The hub 856 of the secondary anchor 850, 1770, 1780 and the locking hub 868 are engaged to connect the secondary anchor 850, 1770, 1780 to the delivery catheter 860. In some embodiments, the locking shaft 872 can advance or retract the locking hub 868.

[0330] Fig.46CA locking hub 868 is shown engaged with the hub 856 of the secondary anchor 850, 1770, 1780. The locking hub 868 engaged with the hub 856 allows the secondary anchor 850, 1770, 1780 to rotate. In some embodiments, the locking hub 868 engaged with the hub 856 can reduce the likelihood that the delivery catheter 860 will disengage from the secondary anchor 850, 1770, 1780 during delivery. In some embodiments, the locking hub 868 engaged with the hub 856 allows the secondary anchor 850, 1770, 1780 to rotate counterclockwise without disengaging from the delivery catheter 860. The secondary anchor 850, 1770, 1780 can be rotated counterclockwise to be driven into tissue.

[0331] Once the secondary anchor 850, 1770, 1780 is driven into the tissue, the delivery catheter 860 can be disengaged from the secondary anchor 850, 1770, 1780. In some embodiments, the locking hub 868 can be disengaged from the hub 856 of the secondary anchor 850, 1770, 1780. The locking hub 868 can be translated away from the secondary anchor 850, 1770, 1780 within the chamber 864 of the torque shaft 862. The locking shaft 872 can retract the locking hub 868. In some embodiments, the torque shaft 862 can be rotated to disengage the spiral. In some embodiments, the torque shaft 862 can be rotated to disengage the spiral or spiral structure 866 from the spiral or spiral structure 852 of the secondary anchor 850, 1770, 1780.

[0332] In some embodiments, the apposition auxiliary element 400, 500, 600, 700 may include an annular section configured to be implanted in the heart above the valve annulus. In some embodiments, the apposition auxiliary element 400, 500, 600, 700 may include a plurality of struts, the struts including at least a first strut and a second strut, the first strut being located in the annular section, the second strut having a total length greater than the total length of the first strut. In some embodiments, the apposition auxiliary element 400, 500, 600, 700 may include an upper edge that is cup-shaped and carried by the annular section. In some embodiments, the apposition auxiliary element 400, 500, 600, 700 may improve the apposition of the entire length without destroying the anatomical structure. In some embodiments, the apposition auxiliary element 400, 500, 600, 700 may include a plurality of radial struts. In some embodiments, the apposition auxiliary element 400, 500, 600, 700 may include a plurality of radial struts, the radial struts including a first strut and a second strut, the first strut being located in the annular section, the second strut having a total length greater than the total length of the first strut. In some embodiments, the coaptation aid element 400, 500, 600, 700 includes an upper edge that is cup-shaped. In some embodiments, the coaptation aid element 400, 500, 600, 700 may include a hub positioned near the annulus. In some embodiments, the coaptation aid element 400, 500, 600, 700 may include a radially extended strut. In some embodiments, the coaptation aid element 400, 500, 600, 700 may include improved coaptation of the strut over the entire length without interfering with the anatomical structure. In some embodiments, the coaptation aid element 400, 500, 600, 700 may be extended via the strut.

[0333] In some methods, the method may include positioning the hub near the annulus. In some methods, the struts are radially expanded. In some methods, the method may include improving the apposition of the struts over the entire length without disrupting the anatomical structure. In some methods, the method may include expanding the apposition elements carried by the struts extending radially outward. In some methods, the method may include expanding the apposition elements carried by the struts extending radially outward to form an annulus section. In some methods, the method may include expanding the apposition elements carried by the struts to form an annulus section.

[0334] In some embodiments, the annular hub 420, 520, 620, 720 is spaced inwardly from the lateral edges of the apposition assistance element 400, 500, 600, 700. In some embodiments, the annular hub 420, 520, 620, 720 is spaced inwardly from the upper edge of the apposition assistance element 400, 500, 600, 700. In some embodiments, the annular hub 420, 520, 620, 720 is spaced inwardly from the lower edge of the apposition assistance element 400, 500, 600, 700. In some embodiments, the annular hub 420, 520, 620, 720 is not expandable. In some embodiments, the annular hub 420, 520, 620, 720 has a fixed circumference. In some embodiments, the annular hub 420, 520, 620, 720 maintains shape during expansion of the apposition assistance element 400, 500, 600, 700. In some embodiments, the annular hub 420, 520, 620, 720 is formed by a tube. The pillars 430, 530, 630, 730 can be laser cut from the tube. The cut can extend from one end of the tube to the second end. The uncut portion of the tube can be the annular hub 420, 520, 620, 720. In some embodiments, the apposition auxiliary element 400, 500, 600, 700 can be formed by a sheet. The sheet can be laser cut to include the pillars 430, 530, 630, 730. The sheet can be rolled to form a tube. The tube can be welded or otherwise held together. The uncut portion of the sheet can form the annular hub 420, 520, 620, 720.

[0335] In some embodiments, the anchor 800 is an active anchor. The anchor 800 can be coupled to the annular hub 420, 520, 620, 720. The anchor 800 can be coupled to the annular hub 420, 520, 620, 720 by interlocking the helix of the anchor 800 with the structure of the annular hub 420, 520, 620, 720. The anchor 800 can be configured to rotate relative to the annular hub 420, 520, 620, 720. The anchor 800 is configured to rotate relative to the annular hub 420, 520, 620, 720 when coupled to the annular hub 420, 520, 620, 720. The anchor 800 is configured to rotate to be selectively deployed. The anchor 800 is configured to rotate to engage tissue. The anchor 800 is configured to rotate to engage the valve annulus. The anchor 800 is configured to rotate through the valve annulus. The anchor 800 is configured to rotate relative to the annular hub 420, 520, 620, 720 in a first direction. The anchor 800 is configured to rotate in a first direction to selectively deploy the anchor 800. The anchor 800 is configured to rotate to deploy the anchor 800 at a first target location. The anchor 800 is configured to rotate to engage tissue in the annulus. The anchor 800 can be selectively deployed in the annulus. When the anchor 800 rotates to engage tissue, the annular hub 420, 520, 620, 720 can remain fixed. When the anchor 800 rotates to engage tissue, the non-expandable annular hub 420, 520, 620, 720 can remain fixed.

[0336] In some embodiments, the anchor 800 is configured to rotate relative to the annular hub 420, 520, 620, 720 in a second direction. The anchor 800 is configured to rotate in the second direction to selectively disengage the anchor 800. The anchor 800 is configured to rotate to disengage the anchor 800 from the first target position. The anchor 800 is configured to rotate to disengage tissue in the annulus. When the anchor 800 rotates to disengage tissue, the annular hub 420, 520, 620, 720 can remain fixed. When the anchor 800 rotates to disengage tissue, the non-expandable annular hub 420, 520, 620, 720 can remain fixed. The second direction can be opposite to 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.

[0337] In some embodiments, the plurality of struts 430, 530, 630, 730 are spaced circumferentially around the annular hub 420, 520, 620, 720. In some embodiments, the plurality of struts 430, 530, 630, 730 are evenly spaced around the annular hub 420, 520, 620, 720. In some embodiments, the plurality of struts 430, 530, 630, 730 are unevenly spaced around the annular hub 420, 520, 620, 720. In some embodiments, the struts 430, 530, 630, 730 that include an annular portion are evenly spaced around the annular hub 420, 520, 620, 720. In some embodiments, the struts 430, 530, 630, 730 that include an annular portion are unevenly spaced around the annular hub 420, 520, 620, 720. In some embodiments, the struts 430, 530, 630, 730 forming the upper edge are evenly spaced around the annular hub 420, 520, 620, 720. In some embodiments, the struts 430, 530, 630, 730 forming the upper edge are unevenly spaced around the annular hub 420, 520, 620, 720. In some embodiments, the struts 430, 530, 630, 730 comprising the ventricular portion are evenly spaced around the annular hub 420, 520, 620, 720. In some embodiments, the struts 430, 530, 630, 730 comprising the ventricular portion are unevenly spaced around the annular hub 420, 520, 620, 720. In some embodiments, the struts 430, 530, 630, 730 forming the lower edge are evenly spaced around the annular hub 420, 520, 620, 720. In some embodiments, the struts 430, 530, 630, 730 forming the lower edge are unevenly spaced about the annular hub 420, 520, 620, 720. In some embodiments, two or more struts 430, 530, 630, 730 are evenly spaced about the annular hub 420, 520, 620, 720. In some embodiments, two or more struts 430, 530, 630, 730 are unevenly spaced about the annular hub 420, 520, 620, 720.

[0338] In some embodiments, the plurality of pillars 430, 530, 630, 730 extend outward from the annular hub 420, 520, 620, 720. In some embodiments, the plurality of pillars 430, 530, 630, 730 have a portion proximal to the annular hub 420, 520, 620, 720, wherein the portion is radial. In some embodiments, the plurality of pillars 430, 530, 630, 730 are placed along a radius. In some embodiments, the plurality of pillars 430, 530, 630, 730 diverge from a center. In some embodiments, the plurality of pillars 430, 530, 630, 730 diverge from the annular hub 420, 520, 620, 720. In some embodiments, the plurality of pillars 430, 530, 630, 730 are uniformly formed around a central axis. In some embodiments, the plurality of pillars 430, 530, 630, 730 are formed uniformly around the annular hub 420, 520, 620, 720. In some embodiments, the plurality of pillars 430, 530, 630, 730 are formed uniformly around the anchor 800. In some embodiments, the plurality of pillars 430, 530, 630, 730 may form spokes. In some embodiments, the plurality of pillars 430, 530, 630, 730 extend outward from the center. In some embodiments, the plurality of pillars 430, 530, 630, 730 extend inward from the edge of the apposition auxiliary element 400, 500, 600, 700. In some embodiments, the plurality of pillars 430, 530, 630, 730 are branched. In some embodiments, the plurality of pillars 430, 530, 630, 730 are outspread. In some embodiments, the plurality of pillars 430, 530, 630, 730 are radial. In some embodiments, the plurality of pillars 430, 530, 630, 730 are spread out. In some embodiments, the plurality of pillars 430, 530, 630, 730 may include an inflection point. In some embodiments, the pillars 430, 530, 630, 730 may include an inflection point. In some embodiments, the plurality of pillars 430, 530, 630, 730 may include a curved shape. In some embodiments, the pillars 430, 530, 630, 730 may include a curved shape. In some embodiments, the pillars 430, 530, 630, 730 may include a U-shaped curve. In some embodiments, the pillars 430, 530, 630, 730 may include a C-shaped curve. In some embodiments, the pillars 430, 530, 630, 730 may include an S-shaped curve. In some embodiments, the pillars 430, 530, 630, 730 may include an L-shaped curve.

[0339] In some embodiments, the plurality of struts 430, 530, 630, 730 increase the volume of the apposition auxiliary element 400, 500, 600, 700 when deployed. In some embodiments, the plurality of struts 430, 530, 630, 730 increase the thickness of the apposition auxiliary element 400, 500, 600, 700 when deployed. In some embodiments, the plurality of struts 430, 530, 630, 730 increase the length of the apposition auxiliary element 400, 500, 600, 700 when deployed. In some embodiments, the plurality of struts 430, 530, 630, 730 increase the height of the apposition auxiliary element 400, 500, 600, 700 when deployed. In some embodiments, the plurality of struts 430, 530, 630, 730 increase the width of the apposition auxiliary element 400, 500, 600, 700 when deployed.

[0340] In some embodiments, a plurality of pillars 430, 530, 630, 730 may include a first pillar. The first pillar may be configured to be implanted in the heart above the annulus. The first pillar may be an annular pillar. In some embodiments, a plurality of pillars 430, 530, 630, 730 may include a second pillar. The second pillar may be configured to be implanted in the heart below the annulus. The second pillar may be a ventricular pillar. The second pillar may traverse the mitral valve. The second pillar may traverse the plane of the annulus. In some embodiments, the first pillar and the second pillar have different lengths. In some embodiments, the second pillar is longer than the first pillar.

[0341] In some embodiments, the upper edge of the mate assist element 400, 500, 600, 700 forms a curve. In some embodiments, the upper edge forms a lip. In some embodiments, the upper edge is cupped downward toward the lower edge. In some embodiments, the upper edge is cupped upward from the lower edge. In some embodiments, the annular hub 420, 520, 620, 720 extends upward from the lower edge. In some embodiments, the annular hub 420, 520, 620, 720 extends upward from the upper edge. In some embodiments, the annular hub 420, 520, 620, 720 extends upward from the annular portion of the mate assist element 400, 500, 600, 700. In some embodiments, the annular hub 420, 520, 620, 720 extends upward from the mate surface of the mate assist element 400, 500, 600, 700. In some embodiments, the annular hub 420, 520, 620, 720 is tubular. In some embodiments, the annular hub 420, 520, 620, 720 forms a circle. In some embodiments, the annular hub 420, 520, 620, 720 has a ring shape. In some embodiments, the hub 420, 520, 620, 720 is non-annular. In some embodiments, the hub 420, 520, 620, 720 forms a polygon (e.g., a triangle, square, rectangle, hexagon, octagon, etc.). In some embodiments, the hub 420, 520, 620, 720 forms a non-circular shape. In some embodiments, the hub 420, 520, 620, 720 forms an elliptical shape.

[0342] Figures 47A-47E Examples of implant features are shown. Figures 47A-47E Some non-restrictive potential clinically relevant aspects of implants are shown. Although the apposition auxiliary element 400 is shown, any apposition auxiliary element described herein can include features described herein. In addition, for example, the apposition auxiliary element 400 can include any features of the apposition auxiliary element described herein about other embodiments.

[0343] As described herein, the coaptation aid element 400 can include an annular hub 420 that can be relatively centrally positioned. The coaptation aid element 400 can have a generally elongated shape, but other shapes are also contemplated, such as polygonal, circular, elliptical, rounded, rectangular, triangular, etc. The coaptation aid element 400 can have an upper edge 440, lateral edges 470 and 475, and a lower edge 480. In some embodiments, the upper edge 440 has a length greater than the length of the lower edge 480, so that the lateral distance between the lateral edges 470 and 475 decreases generally from top to bottom on the coaptation aid element 400. The upper edge 440 of the coaptation aid element 400 can be curved to match the general shape of the annulus or adjacent atrial wall.

[0344] The apposition assist element 400 may include a first surface 405 and a second surface 415, wherein the first surface 405 is configured to be disposed toward the poorly appositioned native leaflet during use, and the second surface 415 is configured to be disposed toward the anterior leaflet. The second surface 415 may include an apposition surface 460. The apposition assist element 400 may include one or more struts 430. The plurality of struts 430 may provide structural support for the apposition assist element 400. The plurality of struts 430 may provide a deployment shape for the apposition assist element 400. As described herein, the plurality of struts may include a shape memory material, such as a shape memory metal or plastic.

[0345] In some embodiments, a first strut 430 of the plurality of struts extends from the annular hub 420 to or toward the upper edge 440. In some embodiments, a second strut 430 of the plurality of struts extends from the annular hub 420 to or toward the lower edge 480. In some embodiments, a third strut 430 of the plurality of struts extends from the annular hub 420 to or toward the lateral edge 470. In some embodiments, a fourth strut 430 of the plurality of struts extends from the annular hub 420 to or toward the lateral edge 475. Any two or more of the first, second, third, or fourth struts may include the same features, including material, length, width, thickness, configuration, preformed bend, curvature, etc. Any two or more of the first, second, third, or fourth struts may include different features, including material, length, width, thickness, configuration, preformed bend, curvature, etc. In some embodiments, at least one of the struts, such as in the superior region of the implant, can extend radially outward from the cover 450 of the implant 400 and protrude from the cover 450 to serve as spaced barbs and can assist in anchoring and / or ingrowth of tissue in the valve annulus. In some embodiments, the barbs extend only in the annular region of the implant (e.g., the superior region), but are not present in the inferior (leaflet) coaptation region, which in some embodiments is atraumatic. In some embodiments, the entire peripheral edge of the implant can be atraumatic.

[0346] In some embodiments, the pillar 430 may be covered with one, two or more layers of the auxiliary element body covering 450. The auxiliary element body covering 450 may include one or more layers (e.g., one, two, three, four, five or more layers, or a range including any two of the foregoing 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 multiple layers may include the same or different features, including material, length, width, thickness, etc. In some embodiments, one or more layers extend along the entirety or only a portion of the first surface 405. In some embodiments, one or more layers extend along the entirety or only a portion of the second surface 415. The layers may be formed by any process described herein.

[0347] The apposition assist element body covering 450 may include a material such as a polymer (e.g., ePTFE). Other materials for the apposition assist element body covering 450 include polyester, polyurethane foam, polycarbonate foam, biological tissue (e.g., porcine pericardium, processed bovine pericardium, pleura, peritoneum), silicone, Dacron, acellular collagen matrix, and combinations thereof. In some embodiments, the apposition assist element body covering 450 may include a foam material surrounded by ePTFE.

[0348] In some embodiments, the struts 430 may be formed with or embedded with one or more layers of the apposition aid element body covering 450. In some embodiments, the struts 430 may be surrounded or at least partially surrounded by the apposition aid element body covering 450. In some embodiments, a portion of the struts 430 may extend from the apposition aid element body covering 450 to engage tissue, as described elsewhere herein. Figures 47A-47E Features are shown that may facilitate interaction between the apposition assist element 400, or a portion thereof, and native anatomical structures.

[0349] Fig.47A A coaptation surface 460 is shown, which can define a relatively lower area of ​​the implant. The anterior ventricular coaptation surface can be reinforced. As described herein, the coaptation surface 460 can contact the patient's valve leaflet. The coaptation assist element 400 can completely cover the posterior valve leaflet after placement, so that the anterior valve leaflet is coapted with the coaptation surface 460 during heart contraction. The coaptation assist element 400 and the anterior valve leaflet can maintain the valve seal at the annular ring.

[0350] In some embodiments, the second surface 415 or a portion thereof is reinforced. In some embodiments, the mating surface 460 is reinforced. The second surface 415, including but not limited to the mating surface 460, can be reinforced by one or more additional layers. The one or more additional layers can extend over the second surface 415 or a portion thereof. The one or more additional layers can extend over the mating surface 460 or a portion thereof. The one or more additional layers can extend over a portion of the second surface 415 including the mating surface 460. The one or more additional layers can extend over a portion of the second surface 415 that is larger than the mating surface 460.

[0351] The mate surface 460 may be reinforced by any material described herein. The mate surface 460 may be reinforced by ePTFE. The mate surface 460 may be reinforced by any material of the mate auxiliary element body cover 450 (e.g., ePTFE, Dacron, and / or polypropylene).

[0352] Fig.47B A first surface 405 is shown. The posterior ventricular coaptation surface may be reinforced. As described herein, the first surface 405 may contact the patient's valve leaflets. After placement, the coaptation assist element 400 may completely cover the posterior valve leaflets with the first surface 405. The first surface 405 may be opposite to the second surface 415 including the coaptation surface 460.

[0353] In some embodiments, the first surface 405 or a portion thereof is reinforced. The first surface 405 can be reinforced by one or more additional layers. The one or more additional layers can extend over the first surface 405 or a portion thereof. The one or more additional layers can be diametrically opposed to the one or more additional layers extending over the second surface 415. The one or more additional layers can extend over a portion of the first surface 405 that is opposite to the apposition surface 460. The one or more additional layers can extend over a portion of the first surface 405 that is larger than the contact area with the posterior leaflet.

[0354] The first surface 405 can be reinforced by any material described herein. The first surface 405 or a portion thereof can be reinforced by ePTFE. The first surface 405 can be reinforced by any material of the apposition aid element cover 450 (e.g., ePTFE, Dacron and / or polypropylene), which can advantageously produce a non-traumatic surface, thereby reducing the risk of native leaflet trauma caused by repeated apposition against the apposition surface of the apposition aid body.

[0355] Figures 47C-47DThe edge of the apposition auxiliary element 400 is shown. As described herein, the apposition auxiliary element 400 may include a reinforced edge with an increased thickness, such as a knotless stitching edge 455. The upper edge 440, lateral edges 470 and 475, and / or the lower edge 480 of the apposition auxiliary element 400 may include a raised edge or ridge. In some embodiments, only one, two or more edges in the upper edge 440, lateral edges 470 and 475, or the lower edge 480 may include a raised edge or ridge. In some embodiments, the raised edge or ridge may include Gore-Tex. In some embodiments, the raised edge or ridge surrounds the periphery of the lower region or the periphery of the entire engagement auxiliary body in the circumferential direction or at least partially in the circumferential direction.

[0356] The raised edge or protuberance can be formed by sutures. Sutures can be wrapped around the edge to form a raised edge or protuberance. The raised edge or protuberance can have features such as increased thickness and / or softness, for example reducing trauma to native tissue. The raised edge or protuberance can reduce the contact between the apposition auxiliary element 400 and the patient's anatomical structure. In the case of a mitral valve, the raised edge or protuberance can reduce the contact between the apposition 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 protuberance can be located at or near the edge of the first surface 405 or the second surface 415. The raised edge or protuberance can be spaced inward from the first surface 405 or the second surface 415. Fig.47C The rear surface is shown. Fig.47D The front surface is shown.

[0357] The raised edge or ridge may include one or more rounded edges that reduce contact between the apposition assist element 400 and the underlying patient anatomy. In some embodiments, contact between the apposition assist element 400 and the posterior leaflet is reduced. In some embodiments, contact between the apposition assist element 400 and the annulus is not reduced. In some embodiments, the apposition assist element 400 is configured to minimize contact with the posterior leaflet but maximize contact with the annulus. Other configurations are also contemplated.

[0358] Fig.47EAn anchoring region is shown. The apposition auxiliary element 400 may include a generally annular upper portion 410. The anchoring region may be located within the annular portion 410 and may include two portions spaced apart from the hub 420 and extending laterally from the hub 420. When the apposition auxiliary element 400 is deployed, the annular portion 410 may be positioned relative to the valve annulus. In some embodiments, the annular portion 410 may be bent toward the valve annulus or away from the valve annulus. In other embodiments, the annular portion 410 may be substantially flat relative to the valve annulus. The annular portion 410 may be configured to receive one or more secondary anchors. The secondary anchor may be advanced on a guide rail that may be coupled to the apposition auxiliary element 400 as described herein. The secondary anchor may be rotated to penetrate the annular portion 410. The secondary anchor may engage tissue located below the apposition auxiliary element 400.

[0359] The annular portion 410, such as the anchoring zone, can be reinforced to have an increased thickness relative to the rest of the upper region and greater than, equal to, or less than the thickness of the lower apposition zone of the implant. The annular portion 410 can be reinforced in an area configured to receive one, two, three, four or more secondary anchors. As described herein, after the apposition auxiliary element 400 is placed in the patient's heart, the first surface 405 of the apposition auxiliary element 400 can be against the valve ring. The second surface 415 can face upward from the valve ring. In some embodiments, the annular portion 410 or a portion thereof is reinforced. The annular portion 410 can be reinforced by one or more additional layers. One or more additional layers can extend on the annular portion 410 or a portion thereof. One or more additional layers can be opposite in the diameter direction relative to the annular hub 420. One or more additional layers can extend on a portion of the first surface 405. One or more additional layers can extend on a portion of the second surface 415. The anchoring zone can be close to the annular hub 420. The anchoring zone can include one or more separate areas.

[0360] The annular portion 410 may be reinforced by any material described herein. The annular portion 410 or a portion thereof may be reinforced by ePTFE. The annular portion 410 or a portion thereof may be reinforced by velour. The annular portion 410 may be reinforced by any material of the auxiliary element body cover 450 (e.g., ePTFE, Dacron, and / or polypropylene). One or more additional layers may extend outwardly from the annular hub 420. The one or more additional layers may be of any shape sufficient to cover an area larger than the area engaged by the one or more secondary anchors.

[0361] In some embodiments, the annular portion 410 may include an edge that is sharper than another edge of the apposition auxiliary element 400. In some embodiments, the upper edge 440 is thinner and / or sharper than another edge of the apposition auxiliary element 400 (e.g., the lateral edge 470, the lateral edge 474, or the lower edge 480). In some embodiments, the annular portion 410 and / or the upper edge 440 can stimulate tissue or engage with tissue. In some embodiments, the annular portion 410 is configured to be implanted near the valve 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 ingrowth of tissue.

[0362] Fig.48 An exploded view of an embodiment of a covering surrounding portion of an implant is shown, and includes a laminate. Although an apposition auxiliary element 400 is shown, any apposition auxiliary element described herein may include any number of features described herein, may exclude / omit any features described herein, or may be placed in a different order relative to each other. In addition, the apposition auxiliary element 400 may include or exclude / omit any features of the apposition auxiliary element described herein. The exploded view shows a thick reinforcement layer for the anterior ventricular portion and the posterior ventricular portion. The exploded view shows a monofilament anchoring area. Raised edges or ridges are not shown. Raised edges or ridges may be added in the final stage of assembly. The laminate 1100 described herein may form an apposition auxiliary element main body covering 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.

[0363] The apposition assist element 400 may include a rear layer 1102. The rear layer may form a first surface 405. In some embodiments, the rear layer 1102 is thin relative to the other layers. In some embodiments, the rear layer 1102 is ePTFE. In some embodiments, the rear layer 1102 has a thickness (e.g., about 0.001", about 0.0015", about 0.002", about 0.0025", about 0.003", or any range including two of the foregoing values). The rear layer 1102 may include an opening for the anchor 800 to extend through. The rear layer 1102 may be any shape including a rectangle, a polygon, a triangle, a circle, and an ellipse. In some embodiments, the rear layer 1102 is not the final shape of the apposition assist element 400.

[0364] The aligning assist element 400 may include a first support structure layer 1104. The first support structure layer 1104 may be a mesh. In some embodiments, the first support structure layer 1104 includes UHMPE. The first support structure layer 1104 may be disposed on the rear layer 1102. The first support structure layer 1104 may be disposed on the rear side of the pillar 430. The first support structure layer 1104 may include an opening for the anchor 800 to extend through.

[0365] The apposition auxiliary element 400 may include a first fabric layer 1106. The first fabric layer 1106 may be relatively thin and in some cases have a thickness (e.g., about 0.001", about 0.0015", about 0.002", about 0.0025", about 0.003", about 0.004", about 0.005", about 0.01", or any range including two of the foregoing values). In some embodiments, the first fabric layer 1106 includes a polyester fabric. The first fabric layer 1106 may be disposed on the first support structure layer 1104. The first fabric layer 1106 may be disposed on the rear side of the pillar 430. The first fabric layer 1106 may include an opening for extending the anchor 800 through. In some embodiments, the first fabric layer 1106 extends only along a portion of the apposition auxiliary element 400. In some embodiments, the first fabric layer 1106 includes a cut-away portion.

[0366] The apposition assist element 400 may include a first ventricular layer 1108. The ventricular surface layer 1108 may be a reinforcement layer of the first surface 405. In some embodiments, the first ventricular layer 1108 is thicker than 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", 0.02", 0.03", about 0.035", about 0.040", about 0.045", about 0.05", about 0.07", about 0.10", or any range including two of the foregoing values). The first ventricular layer 1108 may be any shape, including a rectangle, a polygon, a triangle, a circle, an ellipse, etc. The first ventricular layer 1108 may be disposed on the rear side of the support 430.

[0367] The aligning auxiliary element 400 may include an anchoring layer 1110. The anchoring layer 1110 may be a reinforcement layer for one or more secondary anchors. In some embodiments, the anchoring layer 1110 is thicker than other layers. In some embodiments, the anchoring layer 1110 is ePTFE. In some embodiments, the anchoring layer 1110 is velvet. In some embodiments, the anchoring layer 1110 has a thickness (e.g., about 0.01", 0.02", 0.03", about 0.035", about 0.040", about 0.045", about 0.05", about 0.07", about 0.10", or any range including two of the foregoing values). The anchoring layer 1110 can be any shape, including rectangular, polygonal, triangular, circular, elliptical, etc. In some embodiments, the apposition assist element 400 includes a single anchoring region forming the anchoring layer 1110. In some embodiments, the apposition assist element 400 includes two or more separate anchoring regions forming the anchoring layer 1110. The anchoring layer 1110 can be disposed on the rear side of the strut 430 as shown. In the illustrated embodiment, 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.

[0368] The apposition assist 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 disposed on the ventricular surface layer 1108. The second support structure layer 1112 may be disposed on the rear side of the struts 430. In some embodiments, the second support structure layer 1112 extends only along a portion of the apposition assist element 400. In some embodiments, the second support structure layer 1112 extends only along the ventricular portion of the apposition assist element 400.

[0369] The apposition auxiliary element 400 may include a frame 465. In some embodiments, the frame 465 is cut from a tubular raw material. The frame 465 may include one or more struts 430. The frame 465 may be formed from a single integral piece of material. The frame 465 including the struts 430 may be formed using any of the methods described herein, including water jet, laser etching, or similar techniques. Details of the struts 430, including barbs, may be machined into the struts 430. The frame 465 may be bent and / or shaped to obtain a desired geometry. The frame 465 including the 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 composed of other materials, including stainless steel, polypropylene, high-density polyethylene (PE), Dacron, acellular collagen matrix (e.g., SIS) or other plastics, etc. In some embodiments, the struts 430 may include shape memory materials and strut coverings. The strut coverings may be any material described herein and may cover the entire strut 430 or a portion thereof. In some embodiments, struts 430 may include Nitinol and LDPE tubing or coverings on each strut 430. In some embodiments, frame 465 may be considered a layer.

[0370] The apposition assist element 400 may include a second ventricular layer 1114. The second ventricular layer 1114 may be a reinforcement layer of the second surface 415. In some embodiments, the second ventricular layer 1114 is thicker relative to 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", about 0.035", about 0.040", about 0.045", about 0.05", or any range including two of the foregoing values ​​or other thickness values ​​as described with respect to other layers herein). The second ventricular layer 1114 can be any shape, including rectangular, polygonal, triangular, circular, elliptical, etc. The second ventricular layer 1114 can be disposed on the front side of the strut 430. In some embodiments, the second ventricular layer 1114 extends only along a portion of the coaptation assist element 400. In some embodiments, the second ventricular layer 1114 extends only along the ventricular portion of the coaptation assist element 400. In some embodiments, the first ventricular layer 1108 and the second ventricular layer 1114 have the same shape.

[0371] The apposition assist element 400 may include a third support structure layer 1116. The third support structure layer 1116 may be a mesh. In some embodiments, the third support structure layer 1116 may include UHMPE. The third support structure layer 1116 may be disposed on the second ventricular layer 1114. The third support structure layer 1116 may be disposed on the front side of the strut 430. In some embodiments, the third support structure layer 1116 extends only along a portion of the apposition assist element 400. In some embodiments, the third support structure layer 1116 extends only along the ventricular portion of the apposition assist element 400.

[0372] The apposition auxiliary element 400 may include a second fabric layer 1118. The second fabric layer 1118 may be thinner relative to the other layers. In some embodiments, the second fabric layer 1118 has a thickness (e.g., about 0.001", about 0.0015", about 0.002", about 0.0025", about 0.003", or any range including two of the foregoing values). In some embodiments, the second fabric layer 1118 includes a polyester fabric. The second fabric layer 1118 may be disposed on the third support structure layer 1116. The second fabric layer 1118 may be disposed on the front side of the pillar 430. The second fabric layer 1118 may include an opening for the anchor 800 to extend through.

[0373] The aligning auxiliary element 400 may include a fourth support structure layer 1120. The fourth support structure layer 1120 may be a mesh. In some embodiments, the fourth support structure layer 1120 may include UHMPE. The fourth support structure layer 1120 may be disposed on the second fabric layer 1118. The fourth support structure layer 1120 may be disposed on the front side of the pillar 430. The fourth support structure layer 1120 may include an opening for the anchor 800 to extend through. In some embodiments, the first support structure layer 1104 and the fourth support structure layer 1120 have the same shape.

[0374] The apposition assist 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 relative to 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", about 0.0015", about 0.002", about 0.0025", about 0.003", or any range including two of the foregoing values, or other thickness values ​​described for other layers herein). The front layer 1122 may include an opening for the anchor 800 to extend through. The front layer 1122 may be any shape, including a rectangle, a polygon, a triangle, a circle, and an ellipse. In some embodiments, the front layer 1122 is not the final shape of the apposition assist element 400. In some embodiments, the rear layer 1102 and the front layer 1122 have the same shape.

[0375] Fig.49 An embodiment of an implant delivery system 2200 is shown. The implant delivery system 2200 may include any of the features of the implant delivery system 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 chamber. The main anchor housing 2202 may be arranged around an annular hub 420, 520, 620, 720 of the mate auxiliary element 400, 500, 600, 700.

[0376] The implant delivery system 2200 may include a primary anchor driver 2204. The primary anchor housing 2202 may be sized to fit the primary anchor driver 2204. In some embodiments, the primary anchor driver 2204 is a torque shaft. In some embodiments, the primary anchor driver 2204 is configured to rotate relative to the primary anchor housing 2202. In some embodiments, the primary anchor driver 2204 is not configured to translate relative to the primary anchor housing 2202. As described herein, the primary anchor driver 2204 may be considered a primary anchor fork driver. The primary anchor driver 2204 may be designed to engage the anchor 800 and rotate the anchor 800. The anchor 800 may be considered a primary anchor 800 to distinguish it from one or more secondary anchors.

[0377] The implant delivery system 2200 can include one or more release wires 2206, 2208. In the illustrated embodiment, the implant delivery system 2200 can include two release wires 2206, 2208, but other configurations are contemplated (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 can extend proximally from the main anchor housing 2202. In some embodiments, the release wires 2206, 2208 can extend beyond the implant surface. The release wires 2206, 2208 can extend through at least a portion of the main anchor housing 2202. The release wires 2206, 2208 can extend through one or more channels or tubes within the main anchor housing 2202. The release wires 2206, 2208 can be diametrically opposed within the main anchor housing 2202.

[0378] The release wires 2206, 2208 can extend to the exterior of the main anchor housing 2202. The main anchor housing 2202 can include slots 2210, 2212 that allow the release wires 2206, 2208 to extend through. The release wires 2206, 2208 can extend through the slots 2210, 2212 from the interior of the main anchor housing 2202 to the exterior of the main anchor housing 2202 (e.g., the release wire 2206 can extend through the slot 2210 and the release wire 2208 can extend through the slot 2212).

[0379] The release wires 2206, 2208 can extend back into the main anchor housing 2202. The main anchor housing 2202 can include slots 2214, 2216 that allow the release wires 2206, 2208 to extend therethrough. The release wires 2206, 2208 can extend through the slots 2214, 2216 from the exterior of the main anchor housing 2202 to the interior of the main anchor housing 2202 (e.g., the release wire 2206 can extend through the slots 2214 and the release wire 2208 can extend through the slots 2216). The release wires 2206, 2208 can pass into and out of the main anchor housing 2202. The release wires 2206, 2208 can be coupled to the main anchor housing 2202. The release wires 2206, 2208 can extend through the anchor 800. The release wires 2206, 2208 can cross.

[0380] The release lines 2206, 2208 may extend along the coaptation aid element 400, 500, 600, 700. The release lines 2206, 2208 may extend along the annular surface 410, 510, 610, 710. The release lines 2206, 2208 may extend below the coaptation aid element 400, 500, 600, 700. The release lines 2206, 2208 may extend in opposite directions. The release lines 2206, 2208 may be diametrically opposed. The release lines 2206, 2208 may be coaxial. The release lines 2206, 2208 may be generally along a line. The release lines 2206, 2208 may be adjacent to the annulus. The release lines 2206, 2208 may contact the annulus. The release wires 2206, 2208 can facilitate the coupling between the implant delivery system 2200 and the coaptation assist element 400, 500, 600, 700. The release wires 2206, 2208 can rigidly hold the main anchor housing 2202 against the annular hub 420, 520, 620, 720 of the coaptation assist element 400, 500, 600, 700. The release wires 2206, 2208 can extend from the front side to the rear side of the coaptation assist element 400, 500, 600, 700. In some embodiments, the ends of the release wires 2206, 2208 wrap around the coaptation assist element 400, 500, 600, 700. In some embodiments, the ends of the release wires 2206, 2208 are curved or form a C-shaped configuration.

[0381] The implant delivery system 2200 may include one or more secondary anchors 2220, 2222, 2224, 2226 (e.g., one secondary anchor, two secondary anchors, three secondary anchors, four secondary anchors (as shown), five secondary anchors, six secondary anchors, seven secondary anchors, eight secondary anchors, etc.). In some embodiments, two or more secondary anchors 2220, 2222, 2224, 2226 are identical. In some embodiments, two or more secondary anchors 2220, 2222, 2224, 2226 are different (e.g., different pitches, different diameters, different materials, different shoulders, different windows, etc.). In some embodiments, the secondary anchors 2220, 2222, 2224, 2226 may be helical anchors. The secondary anchors 2220, 2222, 2224, 2226 may have a smaller diameter than the primary anchor 800. The secondary anchors 2220, 2222, 2224, 2226 can have a smaller pitch than the primary anchor 800. The secondary anchors 2220, 2222, 2224, 2226 can be configured to engage tissue in the annulus by rotating.

[0382] The implant delivery system 2200 may include one or more secondary anchor drivers 2230, 2232, 2234, 2236 (e.g., one secondary anchor driver, two secondary anchor drivers, three secondary anchor drivers, four secondary anchor drivers (as shown), five secondary anchor drivers, six secondary anchor drivers, seven secondary anchor drivers, eight secondary anchor drivers, etc.). In some embodiments, two or more secondary anchor drivers 2230, 2232, 2234, 2236 are identical. In some embodiments, two or more secondary anchor drivers 2230, 2232, 2234, 2236 are different (e.g., different constructions, mirror images, different anchors coupled thereto, etc.). In some embodiments, the secondary anchor drivers 2230, 2232, 2234, 2236 are torque shafts. In some embodiments, the secondary anchor drivers 2230, 2232, 2234, 2236 are configured to rotate the respective secondary anchors 2220, 2222, 2224, 2226. In some embodiments, the secondary anchor drivers 2230, 2232, 2234, 2236 are configured to translate the respective secondary anchors 2220, 2222, 2224, 2226.

[0383] In some embodiments, the secondary anchor drivers 2230, 2232, 2234, 2236 can be coupled to respective secondary anchors 2220, 2222, 2224, 2226 according to any of the embodiments described herein. In some embodiments, each secondary anchor driver 2230, 2232, 2234, 2236 is coupled to a respective secondary anchor 2220, 2222, 2224, 2226. In some embodiments, each secondary anchor driver 2230, 2232, 2234, 2236 is coupled to two or more secondary anchors 2220, 2222, 2224, 2226. In some embodiments, a single secondary anchor driver (e.g., secondary anchor driver 2230) is coupled to all secondary anchors 2220, 2222, 2224, 2226.

[0384] The implant delivery system 2200 may include one or more secondary anchor rails 2240, 2242, 2244, 2246 (e.g., one secondary anchor rail, two secondary anchor rails, three secondary anchor rails, four secondary anchor rails (as shown), five secondary anchor rails, six secondary anchor rails, seven secondary anchor rails, eight secondary anchor rails, etc.). The number of secondary anchor rails 2240, 2242, 2244, 2246 may correspond to the number of secondary anchors 2220, 2222, 2224, 2226. The secondary anchors 2220, 2222, 2224, 2226 may include a channel therethrough. The channel may extend through the middle of the helical line of the secondary anchors 2220, 2222, 2224, 2226. The secondary anchor rails 2240, 2242, 2244, 2246 may be configured to extend through the corresponding channels.

[0385] The implant delivery system 2200 may include one or more secondary anchor tethers 2250, 2252, 2254, 2256 (e.g., one secondary anchor tether, two secondary anchor tethers, three secondary anchor tethers, four secondary anchor tethers (as shown), five secondary anchor tethers, six secondary anchor tethers, seven secondary anchor tethers, eight secondary anchor tethers, etc.). The number of secondary anchor tethers 2250, 2252, 2254, 2256 may correspond to the number of secondary anchors 2220, 2222, 2224, 2226. The secondary anchor tethers 2250, 2252, 2254, 2256 may form a loop. Each secondary anchor tether 2250, 2252, 2254, 2256 may include a first strand, a second strand, and an arc portion between the first strand and the second strand. Each secondary anchor tether 2250, 2252, 2254, 2256 can loop around a corresponding release line 2206, 2208 as described herein. The secondary anchor tethers 2250, 2252, 2254, 2256 can extend through the apposition assist element 400, 500, 600, 700. The apposition assist element 400, 500, 600, 700 can include one or more passages to facilitate the passage of the secondary anchor tethers 2250, 2252, 2254, 2256 therethrough.

[0386] The secondary anchor rails 2240, 2242, 2244, 2246 may include a passage therethrough. The passage may extend through a middle portion of the secondary anchor rails 2240, 2242, 2244, 2246. The secondary anchor tethers 2250, 2252, 2254, 2256 may be configured to extend through the passages of the secondary anchor rails 2240, 2242, 2244, 2246. In some embodiments, each secondary anchor tether 2250, 2252, 2254, 2256 extends through the respective secondary anchor rails 2240, 2242, 2244, 2246. The secondary anchor drivers 2230, 2232, 2234, 2236 may include a passage therethrough. The passage may extend through a middle portion of the secondary anchor drivers 2230, 2232, 2234, 2236. The secondary anchor tethers 2250 , 2252 , 2254 , 2256 can be configured to extend through the channels of the secondary anchor drivers 2230 , 2232 , 2234 , 2236 .

[0387] The release lines 2206, 2208 may maintain a connection to the apposition assistance element 400, 500, 600, 700. The release lines 2206, 2208 may maintain a connection between the apposition assistance element 400, 500, 600, 700 and the primary anchor 800. The release lines 2206, 2208 may maintain a connection between the apposition assistance element 400, 500, 600, 700 and the primary anchor driver 2204. The release lines 2206, 2208 may maintain a connection between the apposition assistance element 400, 500, 600, 700 and the secondary anchor tethers 2250, 2252, 2254, 2256.

[0388] Fig.50A telescoping action for accessing the position of a main anchor according to some embodiments of the present invention is shown. The main anchor 800 can be positioned near the leaflet. The main anchor 800 can be positioned near the annulus. In some methods, the access is achieved using a transseptal sheath 1400. The transseptal sheath 1400 can include a chamber for passing one or more additional catheters. The apposition aid elements 400, 500, 600, 700 described herein can be delivered via a delivery catheter 1402. The apposition aid elements 400, 500, 600, 700 can be located within the delivery catheter 1402. The delivery catheter 1402 can be telescoped relative to the transseptal sheath 1400. In order to deliver the apposition aid elements 400, 500, 600, 700, the delivery catheter 1402 can be telescoped relative to the transseptal sheath 1400 to extend outward relative to the transseptal sheath 1400. In order to deliver the coaptation assist element 400 , 500 , 600 , 700 , the coaptation assist element 400 , 500 , 600 , 700 may be telescoped relative to the delivery catheter 1402 to extend outwardly relative to the delivery catheter 1402 .

[0389] Fig.51 Rotation of the primary anchor driver 2204 is shown according to some embodiments of the present invention. Fig.51 200. The progress of engaging the main anchor 800 is shown. On the left, the initial position of the main anchor driver 2204 and the main anchor 800 is shown. The main anchor 800 can be close to the tissue in a proximal position. In the middle, the main anchor driver 2204 rotates 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 the tissue. On the right, the main anchor 800 is further rotated to engage the tissue. The main anchor 800 can be reversible. The main anchor 800 can be rotated in one direction to engage the tissue, and can be rotated in an opposite second direction to disengage the tissue.

[0390] The main anchor driver 2204 can engage and rotate the main anchor 800. The main anchor driver 2204 can be disposed within the main anchor housing 2202. The main anchor 800 can be disposed within the main anchor housing 2202. Release wires 2206, 2208 can extend through at least a portion of the main anchor housing 2202. When the main anchor 800 is rotated, the helixes of the main anchor pass around the release wires 2206, 2208. When the main anchor 800 is rotated, the release wires 2206, 2208 maintain their position. When the apposition auxiliary element 400, 500, 600, 700 is adjacent to the valve annulus, the main anchor 800 can be advanced to engage the tissue. The main anchor driver 2204 can include a hub 2260 and one or more extensions 2262, 2264. The main anchor driver 2204 can include two extensions 2262, 2264, but other configurations are also contemplated. The extensions 2262, 2264 can extend perpendicular to the hub 2560 or at other angles. The main anchor driver 2204 can be a fork-shaped driver. The main anchor 800 can include a crossbar 802. The crossbar 802 can form a proximal portion of the main anchor 800. The crossbar 802 can form a spiral from a spiral anchor. The two extensions 2262, 2264 can be configured to slide in the channel of the main anchor 800 on either side of the crossbar 802. The crossbar 802 can be disposed between the extensions 2262, 2264. Other configurations of coupling the main anchor driver 2204 to the main anchor 800 are also contemplated, including any mating configurations described herein.

[0391] In some embodiments, the main anchor driver 2204 rotates but does not move in the axial direction. 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 in the main anchor housing 2202. In some embodiments, the advantage is to limit the translation of the main anchor driver 2204. The limitation associated with the axial movement of the main anchor driver 2204 can reduce or prevent the unintentional interaction of the main anchor driver 2204 with the tissue. The limitation associated with the axial movement of the main anchor driver 2204 can reduce or prevent the unintentional interaction of the main anchor driver 2204 with the release wires 2206, 2208.

[0392] Fig.52A connection between a secondary anchor driver 2230 and a corresponding secondary anchor 2220 is shown according to some embodiments. Although the secondary anchor driver 2230 and the secondary anchor 2220 are shown, each secondary anchor driver 2230, 2232, 2234, 2236 can be coupled to a corresponding secondary anchor 2220, 2222, 2224, 2226.

[0393] The secondary anchor 2220 may include a helix 2270. The secondary anchor 2220 may include a shoulder 2272. The shoulder 2272 may be configured to engage the secondary anchor driver 2230. The shoulder 2272 may have features such as one or more windows 2274. The windows 2274 may be diametrically opposed, equally spaced, or otherwise spaced. Although two windows 2274 are shown, other configurations of windows are also contemplated (e.g., one window, two windows (shown), three windows, four windows, five windows, six windows, etc.).

[0394] The secondary anchor driver 2230 may include an elongated shaft 2276. The elongated shaft may include a chamber for passing the secondary anchor rail 2240 therethrough. The secondary anchor driver 2230 may include one or more locking tabs 2278. The locking tabs 2278 may be diametrically opposed, equidistantly spaced, or otherwise spaced apart. Although two locking tabs 2278 are shown, other configurations of locking tabs are also contemplated (e.g., one locking tab, two locking tabs (shown), three locking tabs, four locking tabs, five locking tabs, six locking tabs, etc.). The number and configuration of the locking tabs may correspond to the number of windows. The locking tabs 2278 may include a shape memory or springy material. The locking tabs 2278 may be designed to bend outward to engage with the window 2274.

[0395] The secondary anchor rail 2240 can actuate a locking mechanism between the secondary anchor driver 2230 and the corresponding secondary anchor 2220. The locking mechanism can be an axial torsional lock. Once coupled, axial movement of the secondary anchor driver 2230 can cause the secondary anchor 2220 to move axially. Once coupled, torsional movement of the secondary anchor driver 2230 can cause the secondary anchor 2220 to move torsional. The secondary anchor rail 2240 can lock the secondary anchor driver 2230 to the secondary anchor 2220. This locking can be temporary. This locking can be reversible. The secondary anchor rail 2240 can push the locking tab 2278 outward. The locking tab 2278 can be pushed outward into the window 2274 by the secondary anchor rail 2240.

[0396] The secondary anchor rail 2240 can maintain the locking tab 2278 in an open position so that the locking tab 2278 remains engaged with the window 2274 in the secondary anchor 2230. In some embodiments, longitudinal movement of the secondary anchor rail 2240 toward the secondary anchor 2220 can push the locking tab 2278 outward toward the window 2274. In some embodiments, longitudinal movement of the secondary anchor rail 2240 away from the secondary anchor 2220 can allow the locking tab 2278 to return to a neutral configuration and disengage from the window 2274. The locking tab 2278 engaged with the window 2274 of the secondary anchor 2220 can allow axial motion to be transmitted between the secondary anchor driver 2230 and the secondary anchor 2220. The locking tab 2278 engaged with the window 2274 of the secondary anchor 2220 can allow torque to be transmitted between the secondary anchor driver 2230 and the secondary anchor 2220. In some embodiments, one advantage is that the secondary anchor 2220 can be rotated independently of the rotation of the primary anchor 800. In some embodiments, one advantage is that the secondary anchor 2220 can be rotated independently of the rotation of one or more other secondary anchors 2232, 2234, 2236.

[0397] Figures 53A-53B The relationship between a secondary anchor rail 2240, a secondary anchor tether 2250, and a corresponding secondary anchor 2220 is shown according to some embodiments. Although the secondary anchor rail 2240, the secondary anchor tether 2250, and the secondary anchor 2220 are shown, each secondary anchor rail 2240, 2242, 2244, 2246 can engage a corresponding secondary anchor 2220, 2222, 2224, 2226. The secondary anchor rail 2240 can limit or prevent engagement of the anchor and the tether. Figures 53A-53B Shown are a secondary anchor tether 2250 and an adjacent secondary anchor tether 2252. Each secondary anchor tether may include two strands and an arcuate portion between the two strands, see secondary anchor tether 2252.

[0398] The secondary anchor 2220 can be a helical anchor. The helical anchor can include a pitch and a diameter. The helical anchor can include an open distal end. The pitch of the secondary anchor 2220 can be larger than the strands of the secondary anchor tether (e.g., the secondary anchor tether 2252). The open end of the secondary anchor 2220 can be larger than the strands of the secondary anchor tether (e.g., the secondary anchor tether 2252). The size of the open end can be defined by the pitch. This configuration can allow the secondary anchor 2220 and the secondary anchor tether 2252 to become entangled, such as Fig.53A In this figure, because the secondary anchor rail 2240 is located at the proximal end, exposing the open end of the secondary anchor 2220, the secondary anchor tether 2252 and the secondary anchor 2220 can become entangled.

[0399] Fig.53B A secondary anchor rail 2240 is shown extending through the open end of the pitch of a secondary anchor 2220 according to some embodiments of the present invention. The pitch of the secondary anchor 2220 can be smaller than the strands of the secondary anchor tether (e.g., the secondary anchor tether 2252). The open end of the secondary anchor 2220 can be smaller than the strands of the secondary anchor tether (e.g., the secondary anchor tether 2252). The space between the secondary anchor rail 2240 and the secondary anchor 2220 can advantageously be too small to allow the secondary anchor tether 2252 to become entangled. This construction can prevent the secondary anchor 2220 and the secondary anchor tether 2252 from becoming entangled. In Fig.53B In the embodiment, the open end of the secondary anchor is protected from entanglement.

[0400] Fig.54 A secondary anchor rail 2240 is shown according to some embodiments of the present invention. Although a secondary anchor rail 2240 is shown, one or more secondary anchor rails 2240, 2242, 2244, 2246 may be employed. The secondary anchor rails 2240, 2242, 2244, 2246 may include pre-formed material. The secondary anchor rails 2240, 2242, 2244, 2246 may include a shape memory material such as a shape memory metal or plastic. The secondary anchor rails 2240, 2242, 2244, 2246 may include any shape including one or more linear segments and one or more non-linear segments, such as one or more curved segments. The pre-shape of the secondary anchor rails 2240, 2242, 2244, 2246 may facilitate the trajectory of the respective secondary anchors 2220, 2222, 2224, 2226. The preformed distal ends of the secondary anchor rails 2240, 2242, 2244, 2246 can affect the anchoring trajectory of the secondary anchor 2220. Fig.54 , the secondary anchor rail 2240 is preformed to include a distal bend. The secondary anchor rail 2240 is shown in two different orientations. The orientation of the secondary anchor rail 2240 can allow the ability to define different secondary anchor trajectories. In some embodiments, two or more trajectories can be defined by the secondary anchor rail 2240.

[0401] Figures 55A-55CA proximal assembly for a secondary anchor is shown according to some embodiments of the present invention. The proximal assembly may include one or more rail locks. The secondary anchor rails 2240, 2242, 2244, 2246 may be locked to limit or prevent axial movement. The locking of the secondary anchor rails 2240, 2242, 2244, 2246 may ensure that the secondary anchor rails 2240, 2242, 2244, 2246 will be located distally relative to the secondary anchors 2220, 2222, 2224, 2226, see Fig.53B The secondary anchor rails 2240, 2242, 2244, 2246 can be locked in a position in which at least a portion is distal to an open end of the secondary anchor 2220, 2222, 2224, 2226. The secondary anchor rails 2240, 2242, 2244, 2246 can be locked to ensure that the secondary anchors 2220, 2222, 2224, 2226 do not become entangled with the secondary anchor tethers 2250, 2252, 2254, 2256. The secondary anchor rails 2240, 2242, 2244, 2246 can be locked to ensure that the secondary anchors 2220, 2222, 2224, 2226 remain coupled to the respective secondary anchor drivers 2230, 2232, 2234, 2236. The secondary anchor rails 2240, 2242, 2244, 2246 may be locked to ensure that the secondary anchors 2220, 2222, 2224, 2226 are not released prematurely.

[0402] The proximal assembly may include one or more tether locks. The secondary anchor tethers 2250, 2252, 2254, 2256 may be locked to ensure that proper tension is maintained. In some embodiments, applying proper tension to the secondary anchor tet...

Claims

1. An apposition assisting element for treating poor apposition of a heart valve, the apposition assisting element comprising: a first surface and an opposing second surface; a first lateral edge, a second lateral edge, a lower edge, and an upper edge; as well as an upper region and a lower region, the upper region being configured to lie in the plane of the annulus of the heart valve, the lower region extending downwardly from the upper region, Therein, the inferior region includes the leaflets, such that the thickness increases during systole and decreases during diastole.

2. The alignment auxiliary element according to claim 1, wherein: The aligning auxiliary element includes a frame.

3. The alignment auxiliary element according to claim 2, wherein: The leaflets are coupled to the frame.

4. The alignment auxiliary element according to claim 2, wherein: The frame is Nitinol.

5. The alignment auxiliary element according to claim 1, wherein: The alignment assisting element comprises one or more laminate layers.

6. The alignment auxiliary element according to claim 1, wherein: At least one layer is ePTFE.

7. The alignment auxiliary element according to claim 1, wherein: The mate assist element includes an annular hub.

8. The alignment auxiliary element according to claim 1, wherein: The leaflets are inflatable.

9. The alignment auxiliary element according to claim 1, wherein: The leaflets are inflated with hydrogel, collagen or polymers.

10. The alignment auxiliary element according to claim 1, wherein: The leaflets are configured to expand and contract with each heartbeat.

Images