Devices, systems and methods for transcatheter treatment of valvular regurgitation

Abstract

Devices for use in transcatheter treatment of mitral regurgitation are disclosed, specifically coaptation assist elements and edge-to-edge devices for implantation across the mitral valve.Methods for reducing mitral regurgitation at low and high left ventricular pressures during a cardiac cycle are disclosed.Devices for use in transcatheter treatment of mitral regurgitation are disclosed, specifically coaptation assist elements for implantation across the mitral valve with adaptive coaptation elements.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Application No. 17 / 358,567, filed June 25, 2021, the entire contents of which are incorporated herein by reference.

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

[0003] The human heart receives blood from organs and tissues via veins, pumps it to the lungs where it becomes oxygenated, and then pumps the oxygenated blood out of the heart into the arteries from which the body's organ systems can extract oxygen for proper function. Deoxygenated blood is returned to the heart, where it is pumped again to the lungs.

[0004] The heart contains 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 simultaneously during the entire cardiac cycle.

[0005] The heart has four valves, collectively configured to selectively direct blood flow in the proper direction during the cardiac cycle. The valves that separate the atria from the ventricles are called atrioventricular (AV) valves. The AV valve between the left atrium and left ventricle is the mitral valve. The AV valve between the right atrium and right ventricle is the tricuspid valve. The pulmonary valve directs blood flow to the pulmonary artery and from there to the lungs, where blood returns to the left atrium via the pulmonary veins. The aortic valve directs blood into the aorta and from there to the periphery. There are usually no direct connections between the ventricles and atria.

[0006] The mechanical heartbeat is initiated by an electrical impulse that spreads throughout the cardiac tissue. The opening and closing of the heart valves can occur primarily as a result of pressure differences between the heart chambers, which are brought about by passive filling or by chamber contraction. For example, the opening and closing of the mitral valve can occur as a result of pressure differences between the left atrium and left ventricle.

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

[0008] Unfortunately, AV valves can become damaged or otherwise malfunction, resulting in improper closure. AV valves are complex structures, generally 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, while the tricuspid valve, like its analogous structure, has three leaflets. The apposition or engagement of corresponding surfaces against each other helps close or seal the valve to prevent blood from flowing in the wrong direction. The failure of the leaflets to seal during ventricular systole is known as coaptation, which allows blood to flow backward through the valve (regurgitation). Heart valve regurgitation can have serious consequences for patients, often resulting in heart failure, reduced blood flow, low blood pressure, and / or reduced oxygen flow to the body's tissues. Mitral valve regurgitation can also cause blood to flow backward from the left atrium into the pulmonary veins, resulting in blood congestion. Severe valve regurgitation, if left untreated, can lead to permanent damage or death. [Background technology]

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

[0010] Various surgical options have also been proposed and / or employed for the treatment of mitral regurgitation. For example, open heart surgery can replace or repair a dysfunctional mitral valve. Annuloplasty repair can optionally reduce the size of the annulus of the posterior mitral valve leaflet along its circumference by passing sutures through a mechanical surgical annuloplasty sewing ring to effect coaptation. Open surgery may also attempt to reshape the leaflets and / or modify the supporting structures. Regardless, open mitral valve surgery is a highly invasive procedure, typically performed with the patient under general anesthesia and an open chest using cardiopulmonary bypass. Complications are common, and timing is an issue given the morbidity (and potential mortality) of open surgery. Sicker patients may require surgery but are less likely to tolerate it. The success of open mitral valve surgery can be highly dependent on the skill and experience of the surgeon.

[0011] Given the morbidity and mortality associated with open cardiac surgery, inventors have sought minimally invasive surgical treatments. Robotic and endoscopic procedures often remain highly invasive and can be time-consuming, expensive, and, at least in some cases, highly dependent on the skill of the practitioner. It would be desirable to further reduce the trauma to these potentially frail patients so that a therapy could be successfully implemented by a large number of physicians using widespread technology. Toward that end, numerous techniques and strategies have been proposed that are said to be minimally invasive. These include devices that attempt to reshape the mitral annulus within the coronary sinus, devices intended to reshape the annulus by clamping either above or below the native annulus, devices that fuse the leaflets (mimicking the Alfieri suture), and devices that reshape the left ventricle.

[0012] Perhaps most widely known, various mitral valve replacement implants have been developed, but these implants generally replace (or displace) the natural valve leaflets and rely on surgically implanted structures to control the pathways of blood flow between the heart's chambers. While these various strategies and tools have met varying levels of acceptance, none of them is widely recognized as the ideal therapy for most or all patients with mitral regurgitation.

[0013] Due to the challenges and disadvantages of known minimally invasive mitral valve regurgitation therapies and implants, further alternative treatments have been proposed. Some alternative proposals have sought to ensure that the implanted structure remains within the valve annulus throughout the cardiac cycle. One group of these proposals includes cylindrical balloons that remain implanted on tethers or rigid rods that extend through the valve orifice between the atrium and ventricle. Another group relies on arcuate ring structures, often combined with buttresses or other structural cross members that extend across the valve to secure the implant. Unfortunately, achieving a seal between the native valve leaflets and the entire circumference of the balloon or other coaxial body has proven difficult, and if the buttresses or anchors interconnecting the cross members are allowed to flex, significant contraction around the native annulus with each heartbeat can lead to significant fatigue failure issues during long-term implantation. Furthermore, significant movement of the valve tissue can make it difficult to accurately position the implant, whether it is rigid or flexible.

[0014] In light of the above, it would be desirable to provide improved medical devices, systems, and methods. It would be particularly desirable to provide new techniques for treating mitral regurgitation and other heart valve diseases and / or altering one or more characteristics of other valves in the body. There remains a need for devices that can directly improve valve leaflet coaptation (rather than indirectly by reshaping the annulus or ventricle), that do not disrupt the anatomy of the leaflets, such as by fusion, and that can be deployed simply, reliably, and without excessive cost or surgical time. It would be particularly beneficial if these new techniques could be achieved using minimally invasive approaches, without stopping the heart or relying on cardiopulmonary bypass for deployment, and without relying on exceptional skill of the practitioner to provide improved valve and / or heart function. [Prior art documents] [Patent documents]

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

[0016] The present disclosure generally provides improved medical devices, systems, and methods. New coaptation assist elements, systems, and methods are disclosed for treating mitral valve regurgitation and other valve diseases. The coaptation assist element may remain within the blood flow path as the valve moves back and forth between open and closed configurations. The coaptation assist element may be a relatively thin, elongated (along the blood flow path), and / or conformal structure that extends laterally through some, most, or all of the width of the valve opening to enable coaptation between at least one of the native valve leaflets and the coaptation assist element. The devices described herein can be used with any valve in the human body, including valves with two or three leaflets.

[0017] In some embodiments, an advantage is the ability to retrieve the coaptation assist element. In some embodiments, the coaptation assist element has a single anchor that can engage or disengage tissue. In some embodiments, the anchor is captive within the annular hub of the coaptation assist element. In some embodiments, the captive anchor is removed simultaneously with removal of the coaptation assist element. In some embodiments, the coaptation assist element can include an auxiliary anchor. In some embodiments, the coaptation assist element can include a passive anchor. In some embodiments, engaging an anchor with tissue positions one or more passive anchors to engage with tissue. In some embodiments, an advantage is retrieval of the coaptation assist element during the procedure. In some embodiments, the coaptation assist element can be repositioned during the surgical procedure. In some embodiments, the coaptation assist element can be removed from the patient during a subsequent surgical procedure. In some embodiments, the coaptation assist element can be replaced by another device during a subsequent surgical procedure. In some embodiments, the ability to retrieve the coaptation assist element is facilitated by a single annular anchor. In some embodiments, the ability to retrieve the coaptation assist element is facilitated by the location of the annular anchor. In some embodiments, the ability to collapse the coaptation assist element using a purse string suture, as described herein, facilitates the ability to retrieve the coaptation assist element.

[0018] In some embodiments, an advantage is the connection between the coaptation assist element and the delivery catheter. In some embodiments, the coaptation assist element includes an annulus hub with features that engage with the delivery catheter. In some embodiments, the coaptation assist element and the delivery catheter are removably coupled, allowing the coaptation assist element to be released from the delivery catheter during the procedure. In some embodiments, one or more assist structures couple the coaptation assist element to the delivery catheter after the coaptation assist element is released from the delivery catheter. In some embodiments, the one or more assist structures include a purse string suture as described herein. In some embodiments, the one or more assist structures facilitate folding and / or expansion of the coaptation assist element. In some embodiments, the coaptation assist element and the delivery catheter are rotationally fixed relative to one another when coupled. In some embodiments, relative movement of the delivery catheter causes movement of the coaptation assist element.

[0019] In some embodiments, an advantage is that the coaptation assist element can be delivered in a hub-leading orientation. In some methods of use, the annulus hub can be moved into position relative to the anatomy. In some methods of use, the ventricular end of the coaptation assist element can be retained within the delivery catheter until the annulus hub is positioned. In some methods of use, the coaptation assist element can be expanded once the annulus hub and / or annulus anchor are engaged with tissue. In some methods of use, the ventricular end of the coaptation assist element can be positioned once the annulus hub and / or annulus anchor are engaged with tissue.

[0020] In some embodiments, an advantage is that the coaptation assist element can be delivered in a strut-leading orientation. In this method of use, one or more of the struts of the coaptation assist element can be moved into position relative to the anatomy before positioning the annulus hub. In some methods of use, the coaptation assist element can be expanded or partially expanded before engaging with the annulus anchor. In some methods of use, the annulus hub can be retained within the delivery catheter until one or more of the struts are positioned. In some methods of use, the annulus anchor can be engaged with tissue once the struts are positioned.

[0021] In some embodiments, an advantage is that the annulus anchor can be rotated independently of the coaptation assist element. As described herein, the coaptation assist element is coupled to a portion of the delivery catheter. As described herein, the annulus anchor is independently coupled to another portion of the delivery catheter, such as a driver deployed with the delivery catheter. The annulus anchor can be rotated independently of the annulus hub. The annulus hub can remain stationary as the annulus anchor is rotated to engage tissue. The annulus anchor can be driven into tissue while the delivery catheter holds the annulus hub in place.

[0022] In some embodiments, an advantage is the ability to fold the coaptation assist element. In some embodiments, the coaptation assist element is fully folded. The fully folded configuration can be an insertion configuration or a low-profile configuration. In some embodiments, the coaptation assist element is partially folded. The partially folded configuration can be a partially deployed configuration. The partially folded configuration can allow the coaptation assist element to be selectively deployed within the heart. The partially folded configuration can allow the coaptation assist element to be moved into position within the heart. The configuration of the coaptation assist element can be monitored, such as by ensuring proper deployment with imaging. In some embodiments, one or more purse string sutures, or portions thereof, are tensioned to fold or partially fold the coaptation assist element. In some embodiments, the partially folded configuration can allow rotation of the coaptation assist element. In some embodiments, the fully folded configuration can allow rotation of the coaptation assist element. In some embodiments, the coaptation assist element can be rotated with the delivery catheter or a portion thereof. In some embodiments, the coaptation assist element can be rotated about a central location, such as the annulus hub.

[0023] In some embodiments, an advantage is the ability to expand the coaptation assist element. In some embodiments, one or more purse string sutures, or portions thereof, are released to expand the coaptation assist element. In some embodiments, releasing the purse string sutures allows one or more struts to assume a neutral configuration. In some embodiments, releasing the purse string sutures allows one or more struts to assume a pre-formed curve. In some embodiments, one or more struts comprise NiTi. In some embodiments, the purse string sutures are cyclically tensioned and / or released. In some embodiments, the purse string sutures are captivating within the coaptation assist element. In some embodiments, the purse string sutures are tensioned and the coaptation assist element is removed from the patient. In some embodiments, the purse string sutures are released and the coaptation assist element is deployed within the patient's heart. In some embodiments, the purse string sutures can be selectively deployed to expand a portion of the coaptation assist element while leaving another portion of the coaptation assist element collapsed or partially collapsed.

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

[0025] In some embodiments, an advantage is that the coaptation assist element can be retained by the delivery catheter after it is positioned. In some embodiments, the coaptation assist element can remain tethered to the delivery catheter even when fully deployed within the mitral valve. In some embodiments, the coaptation assist element can be adjusted after it is fully deployed within the mitral valve. In some embodiments, the coaptation assist element can be rotated about the hub after it is fully deployed. In some embodiments, the anchor can disengage and / or reengage tissue after it is fully deployed. In some embodiments, the purse string suture can collapse and / or expand the coaptation assist element, or a portion thereof, after it is fully deployed. In some embodiments, the coaptation assist element can be recaptured after it is fully deployed. In some embodiments, the coaptation assist element can be removed after it is fully deployed.

[0026] In some embodiments, an advantage is that the coaptation assist element does not require ventricular attachment. In some embodiments, the coaptation assist element only requires annular attachment. In some embodiments, the coaptation assist element only requires attachment of an annular anchor through the annular hub. In some embodiments, the coaptation assist element only requires attachment of an annular anchor through the annular hub and annular barbs. In some embodiments, the coaptation assist element only requires attachment of annular anchors through the annular hub, annular barbs, and / or commissure barbs.

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

[0028] In some embodiments, an advantage is the curvature of the frame. In some embodiments, the annular hub extends radially. In some embodiments, the annular hub extends from the coaptation assist element in a direction away from the annulus. In some embodiments, the annular hub extends from a surface of the coaptation assist element above the flat surface of the struts. In some embodiments, the edges of the coaptation assist element are curved. In some embodiments, one or more struts may curve laterally from the annular hub toward their upper edge. In some embodiments, the upper edge of the coaptation assist element may curve upward from the annulus. In some embodiments, the upper edge of the coaptation assist element may curve upward from the posterior leaflet. In some embodiments, the upper edge of the coaptation assist element may curve downward toward the annulus. In some embodiments, the upper edge of the coaptation assist element may curve downward toward the posterior leaflet. In some embodiments, one or more struts may curve laterally from the annular hub toward their lower edge. In some embodiments, the lower edge of the coaptation assist element may curve away from the posterior leaflet. In some embodiments, the lower edge of the coaptation assist element may curve toward the posterior leaflet.

[0029] In some embodiments, a coaptation assist element for treating malcoaptation of a heart valve is provided. The heart valve has an annulus. The coaptation assist element can include a body including an annular section and a coaptation section. In some embodiments, the annular section is configured to be implanted within the heart above the valve annulus. In some embodiments, the coaptation section is configured to be implanted within the heart transverse to the plane of the valve annulus. The coaptation assist element can include a first coaptation surface and an opposing second surface. In some embodiments, each surface is bounded 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 that cups downward toward the lower edge or upward from the annular section. The coaptation assist element can include a hub and an anchor coupled to the hub and retained in the annular section. In some embodiments, the anchor is selectively deployable at an initial target location. The coaptation assist element can include a plurality of struts extending radially outward from the hub. In some embodiments, the plurality of struts comprises at least a first strut within the annular section and a second strut extending from the annular section to the junction section, the second strut having a longer overall length than the first strut, e.g., an overall length of about or at least about 110%, 120%, 130%, 140%, 150%, 160%, 170%, 180%, 190%, 200%, 225%, 250%, or more, of the overall length of the first strut. In some embodiments, the overall length of the second strut is about 125% to about 300%, or about 125% to 200%, of the overall length of the first strut.

[0030] In some embodiments, at least one of the plurality of struts has a pointed tip configured to engage tissue. In some embodiments, the plurality of struts comprises nitinol. In some embodiments, the anchor is helical shaped. The coaptation assist element can include one or more additional anchors. In some embodiments, the one or more additional anchors are active anchors. In some embodiments, the hub comprises a cross pin configured to extend through the helix of the anchor. In some embodiments, the hub is configured to mate with a delivery catheter, the delivery catheter configured to position the hub near an initial target location. In some embodiments, the delivery catheter is configured to rotate the anchor independently of the hub. The coaptation assist element can include a radiopaque marker. The coaptation assist element can include a plurality of radiopaque markers near an upper edge. In some embodiments, the upper edge forming a lip is cupped downwardly toward the lower edge. In some embodiments, the upper edge forming the lip is cupped upwardly from the annular section. In some embodiments, the hub extends upwardly from the annular section. In some embodiments, the lower edge curves back toward the hub.

[0031] In some embodiments, a method for treating malcoaptation of a heart valve in a patient is provided. The heart valve has an annulus. The annulus further defines a valve plane, the valve plane separating the atrium proximally and the ventricle distally. The method can include coupling a delivery catheter to a hub of a coaptation assist element. The method can include positioning the hub near the annulus. The method can include rotating an anchor through the hub and into cardiac tissue distal to the annulus. The method can include expanding the coaptation assist element by expanding a plurality of struts radially outward from the hub.

[0032] In some embodiments, the coaptation assist element is suspended such that the coaptation surface coapts with the first leaflet and the leaflet surface of the coaptation assist element overlies the second leaflet, thereby reducing malcoaptation. The method can include engaging a pointed end of one of the plurality of struts with cardiac tissue distal to the annulus. The method can include monitoring the position of the coaptation assist element using one or more markers. The method can include monitoring the position of the coaptation assist element using a plurality of markers near an upper edge of the coaptation assist element. In some embodiments, the tip of the anchor is recessed within the hub while the hub is positioned near the annulus.

[0033] In some embodiments, a coaptation assist element for treating malcoaptation of a heart valve is provided. The coaptation assist element can include a first coaptation surface and an opposing second surface. The coaptation assist element can include a first lateral edge, a second lateral edge, a lower edge, and an upper edge. The coaptation assist element can include an upper section and a lower section. In some embodiments, the upper section is configured to be in the plane of the annulus of the heart valve. In some embodiments, the lower section includes a first coaptation surface and an opposing second surface. In some embodiments, the lower section includes a laminate, such that the thickness of the lower section is greater than the thickness of a portion of the upper section.

[0034] In some embodiments, the laminate comprises ePTFE. In some embodiments, the thickness of the lower section is at least about 25% greater than the thickness of a portion of the upper section. In some embodiments, the thickness of the lower section is at least about 50% greater than the thickness of a portion of the upper section. In some embodiments, the peripheral edge of the attachment aid element comprises a raised atraumatic edge that only partially surrounds the attachment aid element. In some embodiments, the peripheral edge of the attachment aid element comprises a raised atraumatic edge that only surrounds the lower section of the attachment aid element. In some embodiments, the raised edge comprises a suture. In some embodiments, the peripheral edge of the attachment aid element comprises spaced barbs extending radially outward from the peripheral edge of the upper section of the attachment aid element. The attachment aid element can include a hub spaced inward from each of the first lateral edge, the second lateral edge, the lower edge, and the upper edge. The coaptation assist element can include an active anchor configured to couple to the hub and configured to be rotated relative to the hub to selectively deploy the active anchor at an initial target location. The coaptation assist element can include a plurality of struts spaced about and extending outward from the hub, the plurality of struts comprising at least a first strut configured to be implanted within the heart with a first coaptation surface that coapts with a first leaflet of the heart valve and an opposing second surface that overlies a second leaflet of the heart valve, and a second strut configured to be implanted within the heart. In some embodiments, the coaptation assist element comprises a mesh layer.

[0035] In some embodiments, a coaptation assist element delivery system for treating malcoaptation of a heart valve is provided. In some embodiments, the heart valve has an annulus. The coaptation assist element delivery system can include a coaptation assist element having a first surface and an opposing second surface. In some embodiments, each surface is bounded by a first lateral edge, a second lateral edge, a lower edge, and an upper edge. The coaptation assist element can include a hub. The coaptation assist element delivery system can include a primary anchor disposed within a primary anchor housing. In some embodiments, the primary anchor is configured to extend through the hub to engage the valve annulus. The coaptation assist element delivery system can include a release wire extending through the primary anchor housing and configured to be positioned adjacent the valve annulus.

[0036] The coaptation assist element delivery system can include a primary anchor driver disposed within the primary anchor housing. In some embodiments, the primary anchor driver is configured to rotate but not translate relative to the primary anchor housing. In some embodiments, the primary anchor driver includes two extensions, the two extensions configured to engage with crossbars of the primary anchor. The coaptation assist element delivery system can include two release wires extending through the primary anchor housing. In some embodiments, the two release wires are configured to extend in opposite directions from the hub, positioned adjacent the annulus. In some embodiments, the two release wires cross. The coaptation assist element delivery system can include an auxiliary anchor tether extending through the coaptation assist element. In some embodiments, the auxiliary anchor tether extends around the release wire. The coaptation assist element delivery system can include at least two auxiliary anchor tethers extending through the coaptation assist element. In some embodiments, the at least two auxiliary anchor tethers extend around the release wire. In some embodiments, at least one auxiliary anchor tether extends around the release wire and at least one auxiliary anchor tether extends around a second release wire. The coaptation assist element delivery system can include an auxiliary anchor guide rail. In some embodiments, the auxiliary anchor guide rail is configured to lock the auxiliary anchor driver to the auxiliary anchor. In some embodiments, the auxiliary anchor guide rail is configured to prevent entanglement of the auxiliary anchor with an adjacent auxiliary anchor anchor. In some embodiments, the auxiliary anchor guide rail is configured to slide along the auxiliary anchor anchor to deliver the auxiliary anchor. The coaptation assist element delivery system can include an auxiliary anchor driver. In some embodiments, the auxiliary anchor driver includes at least one locking tab configured to engage with a window in the auxiliary anchor. The coaptation assist element delivery system can include an auxiliary anchor.In some embodiments, the auxiliary anchor is configured to be delivered by sliding the auxiliary anchor along an auxiliary anchor anchor looped around a release wire. In some embodiments, the auxiliary anchor is configured to be rotated to engage the annulus. In some embodiments, the auxiliary anchor has a smaller diameter than the primary anchor. In some embodiments, the release wire is configured to be retracted after the primary anchor engages the annulus. In some embodiments, the release wire is configured to be retracted after the primary anchor and at least one auxiliary anchor engage the annulus. In some embodiments, the primary anchor housing is configured to be retracted after retracting the release wire, and the primary anchor driver retracts with the primary anchor housing. In some embodiments, the track of the primary anchor passes through the hub. In some embodiments, a cross pin of the hub is configured to couple the primary anchor to the coaptation auxiliary element. In some embodiments, the at least one auxiliary anchor is configured to have two or more tracks. In some embodiments, the trajectory of the at least one auxiliary anchor is determined by the orientation of a respective auxiliary anchor guide rail. In some embodiments, the auxiliary anchor guide rail comprises a curved distal end, the curved distal end defining the track. The coaptation assist element delivery system may include a proximal assembly configured to lock the position of the auxiliary anchor guide rail relative to the auxiliary anchor to prevent entanglement of the auxiliary anchor anchor. The coaptation assist element delivery system may include a proximal assembly configured to lock the position of the auxiliary anchor guide rail relative to the auxiliary anchor driver to facilitate coupling of the auxiliary anchor driver to the auxiliary anchor. The coaptation assist element delivery system may include a proximal assembly configured to lock the position of the auxiliary anchor anchor, the auxiliary anchor anchor being coupled to a release wire. The coaptation assist element delivery system may include a proximal assembly configured to lock the position of the auxiliary anchor anchor to apply tension to the auxiliary anchor anchor to define a trajectory of the auxiliary anchor. The coaptation assist element delivery system may include an anti-rotation mechanism.In some embodiments, the auxiliary anchor comprises an anti-rotation mechanism.

[0037] In some embodiments, a coaptation assist element for treating malcoaptation of a heart valve is provided. In some embodiments, the heart valve has an annulus. The coaptation assist element can include a first surface and an opposing second surface, each surface being bounded by a first lateral edge, a second lateral edge, a lower edge, and an upper edge. The coaptation assist element can include a hub. The coaptation assist element can include a plurality of struts spaced about and extending outward from the hub, the plurality of struts including at least a first strut configured to be implanted in the heart above the annulus and a second strut configured to be implanted in the heart across the plane of the annulus.

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

[0039] In some embodiments, a method of delivering a coaptation assist element is provided. The method can include delivering the coaptation assist element to the patient's heart. In some embodiments, the coaptation assist element is coupled to a coaptation assist element delivery system. In some embodiments, the coaptation assist element delivery system includes a primary anchor disposed within a primary anchor housing. In some embodiments, the coaptation assist element delivery system includes at least one release wire. The method can include expanding the coaptation assist element within the heart. The method can include securing the coaptation assist element to the heart annulus by rotating the primary anchor.

[0040] The method can include rotating a primary anchor driver within the primary anchor housing. In some embodiments, at least one release wire is coupled to the primary anchor housing and extends beneath the coaptation assist element when the coaptation assist element is expanded. In some embodiments, the at least one auxiliary anchor anchor extends through the coaptation assist element when the coaptation assist element is expanded. In some embodiments, the at least one auxiliary anchor anchor loops around the at least one release wire when the coaptation assist element is expanded. In some embodiments, the coaptation assist element is delivered in a low-profile configuration. In some embodiments, the at least one release wire is configured to maintain a position of the primary anchor housing relative to the coaptation assist element. In some embodiments, the at least one release wire is configured to maintain a position of the at least one auxiliary anchor anchor relative to the coaptation assist element. In some embodiments, the coaptation assist element is delivered via a delivery catheter. In some embodiments, the telescoping feature is configured to position the coaptation assist element to engage the primary anchor with the annulus. The method can include rotating the primary anchor to engage the annulus. The method can include rotating a primary anchor driver within the primary anchor housing, the primary anchor driver configured to rotate but not translate relative to the primary anchor housing. The method can include sliding an auxiliary anchor assembly along the auxiliary anchor anchor toward the valve annulus. The method can include maintaining engagement between the auxiliary anchor driver and the auxiliary anchor using an auxiliary anchor guide rail. The method can include preventing entanglement between the auxiliary anchor and the auxiliary anchor anchor using the auxiliary anchor guide rail. The method can include coupling the auxiliary anchor driver to the auxiliary anchor. The method can include partially retracting the auxiliary anchor guide rail before the auxiliary anchor engages the tissue. The method can include retracting the auxiliary anchor guide rail after the auxiliary anchor engages the tissue.The method can include retracting the auxiliary anchor driver after retracting the auxiliary anchor guide rail. The method can include retracting at least one release wire.

[0041] In some embodiments, a coaptation assist element for treating malcoaptation of a heart valve having an annulus is provided. The coaptation assist element can include a first coaptation surface and an opposing second surface, each surface being bounded by a first lateral edge, a second lateral edge, a lower edge, and an upper edge. The coaptation assist element can include a hub. The coaptation assist element can include an anchor coupled to the hub and configured to be rotated relative to the hub to selectively deploy the anchor at an initial target location. The coaptation assist element can include a plurality of struts spaced about the hub and extending outward from the hub. In some embodiments, the plurality of struts includes at least a first strut configured to be implanted in the heart above the annulus and a second strut configured to be implanted in the heart across the plane of the annulus.

[0042] In some embodiments, the second strut has a longer overall length than the first strut. In some embodiments, the hub is spaced radially inward from each of the first lateral edge, the second lateral edge, the lower edge, and the upper edge. In some embodiments, the plurality of struts are spaced circumferentially around the hub. In some embodiments, the upper edge forms a lip that cups downward toward the lower edge or upward from the lower edge. In some embodiments, at least one strut of the plurality of struts has a pointed tip configured to engage tissue. In some embodiments, the plurality of struts comprises nitinol. In some embodiments, the anchor is helical shaped. The coaptation assist element can include one or more additional anchors. In some embodiments, the one or more additional anchors are active anchors. In some embodiments, the hub comprises a cross pin configured to extend through the helix of the anchor. In some embodiments, the hub is configured to mate with a delivery catheter, and the delivery catheter is configured to position the hub near an initial target location. In some embodiments, the delivery catheter is configured to rotate the anchor independently of the hub. The coaptation assist element can include a radiopaque marker. The coaptation assist element can include a plurality of radiopaque markers near the upper edge. In some embodiments, the lip cups downward toward the lower edge. In some embodiments, the lip cups upward from the lower edge. In some embodiments, a hub extends upward from the first coaptation surface. In some embodiments, the lower edge curves back toward the hub. In some embodiments, the hub is tubular. In some embodiments, the strut and hub are integrally formed. In some embodiments, the coaptation assist element is configured to fold relative to the hub. In some embodiments, the active anchor is configured to selectively couple to and separate from tissue.

[0043] In some embodiments, a coaptation assist element for treating malcoaptation of a heart valve having an annulus is provided. The coaptation assist element can include a first coaptation surface and an opposing second surface. In some embodiments, each surface is bounded by a first lateral edge, a second lateral edge, a lower edge, and an upper edge. The coaptation assist element can include a hub. The coaptation assist element can include an anchor coupled to the hub. In some embodiments, the anchor is configured to be rotated in a first direction to selectively deploy an active anchor to engage tissue. In some embodiments, the active anchor is configured to be rotated in a second direction opposite the first direction to selectively detach tissue. The coaptation assist element can include a plurality of struts spaced about the hub. In some embodiments, the plurality of struts includes at least a first strut configured to be implanted in the heart above the annulus and a second strut configured to be implanted in the heart across the plane of the annulus.

[0044] In some embodiments, a coaptation assist element for treating malcoaptation of a heart valve is provided. In some embodiments, the heart valve has an annulus, an anterior leaflet, and a posterior leaflet. The coaptation assist element can include a first coaptation surface and an opposing second surface. In some embodiments, each surface is bounded by a first lateral edge, a second lateral edge, an inferior edge, and an superior edge. The coaptation assist element can include a hub. The coaptation assist element can include an anchor coupled to the hub and configured to be rotated relative to the hub to selectively deploy the anchor at an initial target location. In some embodiments, the anchor is configured to be selectively deployed at the valve annulus. The coaptation assist element can include a plurality of struts spaced about the hub. In some embodiments, the plurality of struts includes at least a first strut configured to be implanted in the heart above the valve annulus and a second strut configured to be implanted in the heart across the plane of the valve annulus.

[0045] In some embodiments, a coaptation assist element delivery system for treating malcoaptation of a heart valve having an annulus is provided. The coaptation assist element delivery system can include a coaptation assist element having a first surface and an opposing second surface. In some embodiments, each surface is bounded by a first lateral edge, a second lateral edge, a lower edge, and an upper edge. In some embodiments, the coaptation assist element includes a hub. The coaptation assist element delivery system can include a first anchor disposed within a first anchor housing. In some embodiments, the first anchor is configured to extend through the hub and engage the valve annulus. The coaptation assist element delivery system can include a release wire extending through the first anchor housing and configured to be positioned adjacent the valve annulus.

[0046] In some embodiments, the coaptation assist element delivery system can include a radiopaque marker. In some embodiments, the coaptation assist element delivery system can include a second anchor anchor extending through the coaptation assist element and around the release wire. In some embodiments, the radiopaque marker is crimped to the second anchor anchor. In some embodiments, the radiopaque marker is configured to visually confirm the fixation depth of the second anchor. In some embodiments, the coaptation assist element delivery system can include a second anchor. In some embodiments, the second anchor comprises a first helical portion having a first pitch and a second helical portion having a second, smaller pitch. In some embodiments, the second helical portion is configured to lock with the coaptation assist element. In some embodiments, the second anchor includes a locking segment and a fixation segment, the locking segment having a smaller pitch than the fixation segment. In some embodiments, the second anchor is configured to be delivered by sliding the second anchor along the second anchor anchor looped around the release wire. In some embodiments, the second anchor is configured to be delivered by sliding the second anchor along a second anchor guide rail, where the second anchor guide rail guides the trajectory of the second anchor. In some embodiments, the second anchor is configured to be rotated to engage with 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 each second anchor guide rail. In some embodiments, the coaptation assist element delivery system can include a first anchor driver disposed within the first anchor housing, where the first anchor driver is configured to rotate but not translate relative to the first anchor housing. In some embodiments, the coaptation assist element delivery system can include a second anchor guide rail. In some embodiments, the second anchor guide rail is configured to lock the second anchor driver to the second anchor.In some embodiments, the second anchor guide rail is configured to slide along the second anchor anchor to deliver the second anchor. In some embodiments, the second anchor guide rail comprises a distal section having a bend of 30 to 90 degrees. In some embodiments, the bend determines the trajectory of the second anchor delivered along the second anchor guide rail.

[0047] In some embodiments, a coaptation assist system for treating malcoaptation of a heart valve is provided. The coaptation assist system can include a coaptation assist element having a first surface and an opposing second surface, a first lateral edge, a second lateral edge, a lower edge, and an upper edge, and an implant clip section extending from the lower edge. The coaptation assist system can include an edge-to-edge device configured to be positioned within the implant clip section to clip one or more valve leaflets.

[0048] In some embodiments, the coaptation assist system can include radiopaque markers along the implant clip section. In some embodiments, the edge-to-edge device is formed separately from the coaptation assist element. In some embodiments, the coaptation assist element comprises an implant anterior overhang of 7 mm to 40 mm. In some embodiments, the coaptation assist element comprises an implant anterior overhang of 10 mm to 30 mm. In some embodiments, the coaptation assist element comprises an implant inter-commissure distance of 20 mm to 60 mm. In some embodiments, the coaptation assist element comprises an implant inter-commissure distance of 30 mm to 50 mm. In some embodiments, the coaptation assist element comprises a coaptation section angle of 30 degrees to 90 degrees. In some embodiments, the coaptation assist element comprises a coaptation section angle of approximately 70 degrees. In some embodiments, the implant clip section comprises a membrane. In some embodiments, the membrane comprises ePTFE, and the membrane has a thickness of 0.001 inches to 0.020 inches.

[0049] In some embodiments, a method for treating malcoaptation of a heart valve of a heart is provided. The method can include positioning a coaptation assist element. The coaptation assist element can include a first surface and an opposing second surface, a first lateral edge, a second lateral edge, a lower edge, an upper edge, and an implant clip section extending from the lower edge. The method can include positioning an edge-to-edge device within the implant clip section to clip one or more valve leaflets.

[0050] In some embodiments, clipping one or more leaflets includes clipping only the anterior leaflet, and the coaptation assist element overlies the posterior leaflet. In some embodiments, clipping one or more leaflets includes clipping the anterior leaflet to a first surface of the coaptation assist element. In some embodiments, the coaptation zone angle, implant anterior protrusion, or implant intercommissural distance is designed to facilitate coaptation between the anterior leaflet and the coaptation assist element. In some embodiments, the coaptation zone of the coaptation assist element contacts the anterior leaflet as the mitral valve begins to close, thereby reducing mitral regurgitation at low ventricular pressures. In some embodiments, as left ventricular pressure increases, pressure on the anterior leaflet and the coaptation assist element is increased, pressing the coaptation assist element and anterior leaflet together, thereby increasing contact between the anterior leaflet and the coaptation assist element and reducing mitral regurgitation at high left ventricular pressures. In some embodiments, the coaptation assist element facilitates the creation of a better seal. In some embodiments, the method can include selecting a coaptation assist element from a plurality of coaptation assist elements having different sizes with respect to coaptation zone angle, implant anterior protrusion, or implant intercommissural distance to provide optimal coaptation during the cardiac cycle, hi some embodiments, the method can include considering the patient's anatomy to select the optimal size of the coaptation assist element.

[0051] In some embodiments, a coaptation assist element for treating malcoaptation of a heart valve is provided, the heart valve having an annulus. The coaptation assist element can include a first surface and an opposing second surface, each surface being bounded by a first lateral edge, a second lateral edge, a lower edge, and an upper edge, the second surface comprising a coaptation surface. The coaptation assist element can include a hub spaced radially inward from each of the first lateral edge, the second lateral edge, the lower edge, and the upper edge. The coaptation assist element can include a plurality of struts, the plurality of struts being spaced circumferentially around the hub and extending radially outward from the hub. In some embodiments, the plurality of struts includes at least a first plurality of struts and a second plurality of struts, the first plurality of struts configured to be implanted in the heart above the annulus, and the second plurality of struts configured to be implanted in the heart and transverse to the plane of the annulus. The coaptation assist element can include an implant clip section extending from the lower edge. In some embodiments, the implant clip section comprises a radiopaque marker. In some embodiments, the coaptation assist element comprises an implant anterior protrusion. In some embodiments, the coaptation assist element comprises an implant intercommissural distance. In some embodiments, the coaptation assist element comprises a coaptation section angle. In some embodiments, the implant anterior protrusion, implant intercommissural distance, and coaptation section angle provide optimal coaptation during the cardiac cycle.

[0052] In some embodiments, the coaptation assist element can include a coaptation assist element body cover. In some embodiments, the plurality of struts include nitinol. In some embodiments, the upper edge is cupped upward from the lower edge. In some embodiments, the implant clip section is spaced inward from the first and second lateral edges. In some embodiments, the implant anterior protrusion is between 7 mm and 40 mm. In some embodiments, the implant intercommissural distance is between 20 mm and 60 mm. In some embodiments, the coaptation section angle is between 30 degrees and 90 degrees. In some embodiments, the coaptation assist element is configured to reduce mitral regurgitation at low and high left ventricular pressures. In some embodiments, the coaptation assist element can include an edge-to-edge device configured to be positioned within the implant clip section.

[0053] In some embodiments, a coaptation assist element for treating malcoaptation of a heart valve of a heart is provided, the coaptation assist element can include a first surface and an opposing second surface, a first lateral edge, a second lateral edge, a lower edge, and an upper edge, and an adaptive coaptation element configured to expand during systole and contract during diastole.

[0054] In some embodiments, the adaptive coaptation element comprises ePTFE or a bioinert fabric. In some embodiments, the coaptation assist element can include implant wings configured to seal over the commissures of the valve leaflets. In some embodiments, the implant wings comprise ePTFE or a bioinert fabric. In some embodiments, the implant wings are configured to cover the opening during upward and downward movement of the coaptation assist element. In some embodiments, the adaptive coaptation element expands with an increase in left ventricular pressure and blood flow toward the left atrium. In some embodiments, the adaptive coaptation element contracts with a decrease in left ventricular pressure and blood flow toward the left ventricle. In some embodiments, the adaptive coaptation element forms an opening. In some embodiments, the adaptive coaptation element expands up to 15 mm. In some embodiments, the adaptive coaptation element comprises a material having a porosity between 10 microns and 200 microns. [Brief explanation of the drawings]

[0055] [Figure 1A] FIG. 1 is a schematic diagram illustrating portions of the heart and mitral valve anatomy that may interact with the implants and systems described herein, as described in the Background section and below. [Figure 1B] FIG. 1 is a schematic diagram illustrating portions of the heart and mitral valve anatomy that may interact with the implants and systems described herein, as described in the Background section and below. [Figure 1C] FIG. 1 is a schematic diagram illustrating portions of the heart and mitral valve anatomy that may interact with the implants and systems described herein, as described in the Background section and below. [Figure 1D] FIG. 1 is a schematic diagram illustrating portions of the heart and mitral valve anatomy that may interact with the implants and systems described herein, as described in the Background section and below. [Figure 1E] FIG. 1 is a schematic diagram illustrating portions of the heart and mitral valve anatomy that may interact with the implants and systems described herein, as described in the Background section and below. [Figure 1F] FIG. 1 is a schematic diagram illustrating portions of the heart and mitral valve anatomy that may interact with the implants and systems described herein, as described in the Background section and below. [Figure 2A] FIG. 1 is a simplified cross-sectional view of a heart illustrating mitral valve function during diastole. [Figure 2B] FIG. 1 is a simplified cross-sectional view of a heart illustrating mitral valve function during systole. [Figure 3A] FIG. 1 is a simplified cross-sectional view of the heart illustrating mitral valve regurgitation during systole in the setting of malcoaptation of the mitral valve leaflets. [Figure 3B] FIG. 1 is a simplified cross-sectional view of the heart illustrating mitral valve regurgitation during systole in the setting of malcoaptation of the mitral valve leaflets. [Figure 4A] FIG. 1 is a stylized cross-sectional view of the heart showing mitral valve dyscotation in the setting of functional mitral regurgitation. [Figure 4B] FIG. 1 is a stylized cross-sectional view of the heart showing mitral valve dyscotation in the setting of degenerative mitral regurgitation. [Figure 5A] FIG. 1 is a perspective view showing one embodiment of a joint assist element. [Figure 5B] FIG. 5B is a top view showing the joining assist element of FIG. 5A. [Figure 5C] 10A and 10B show an embodiment of the posts of the coaptation assist element. [Figure 5D] 10A and 10B show an embodiment of the posts of the coaptation assist element. [Figure 5E] FIG. 5B shows the coaptation assist element of FIG. 5A without the annulus anchor portion. [Figure 5F] FIG. 5B shows the coaptation assist element of FIG. 5A without the annulus anchor portion. [Figure 5G] FIG. 5B shows the coaptation assist element of FIG. 5A without the annulus anchor portion. [Figure 5H] FIG. 5B shows the coaptation assist element of FIG. 5A including a leaflet anchor site. [Figure 5I] FIG. 5B shows the coaptation assist element of FIG. 5A including a leaflet anchor site. [Figure 5J]FIG. 5B shows the coaptation assist element of FIG. 5A including a leaflet anchor site. [Figure 5K] FIG. 5B is a diagram showing the dimensions of the joining assist element of FIG. 5A. [Figure 6] FIG. 10 is a perspective view showing an embodiment of a joint assist element. [Figure 7A] FIG. 1C is a perspective view of one embodiment of a coaptation assist element showing a first surface disposed toward the mal-coapted native valve leaflets. [Figure 7B] 7B is another perspective view of the coaptation assist element of FIG. 7A showing a second surface that may include a coaptation surface. [Figure 7C] 7B is a top view showing the joining assist element of FIG. 7A. FIG. [Figure 7D] FIG. 7B shows the coaptation assist element of FIG. 7A implanted within a model of a mitral valve. [Figure 7E] FIG. 7B is a top view showing the coaptation assist element of FIG. 7A implanted within a model of a mitral valve. [Figure 8A] FIG. 1 is a schematic diagram illustrating one embodiment of a control handle of a delivery system for transcatheter techniques. [Figure 8B] 8B and 8C are schematic top and side views of a coaptation assist element coupled to the delivery system of FIG. 8A. [Figure 8C] FIG. 10 is a schematic diagram showing the connection of the coaptation assist element annulus hub to the tip of the delivery catheter. [Figure 9A] 8B is a schematic diagram illustrating anchoring operation of the delivery system of FIG. 8A. [Figure 9B] 10A-10C are schematic diagrams illustrating an embodiment of a connection between an annulus anchor and a driver. [Figure 9C] 10A-10C are schematic diagrams illustrating an embodiment of a connection between an annulus anchor and a driver. [Figure 9D] 10A-10C are schematic diagrams illustrating an embodiment of a connection between an annulus anchor and a driver. [Figure 9E] 10A-10C are schematic diagrams illustrating an embodiment of a connection between an annulus anchor and a driver. [Figure 10] FIG. 1 is a schematic diagram illustrating a transcatheter technique method showing transseptal crossing. [Figure 11]FIG. 10 is a schematic diagram illustrating a transcatheter technique method showing advancement of an initial coaptation assist element. [Figure 12] 10A-10C are schematic diagrams illustrating a transcatheter technique method showing the release of a partial coaptation assist element. [Figure 13] 10A-10C are schematic diagrams illustrating a method of transcatheter technique showing folding of the coaptation assist element. [Figure 14] 1 is a schematic diagram illustrating a transcatheter technique method showing a cross-sectional view of a coaptation assist element. [Figure 15] 1 is a schematic diagram illustrating a transcatheter technique method showing placement of an auxiliary anchor. [Figure 16] 1A-1C illustrate a method of implant delivery showing the loading of the implant. [Figure 17] 10A-10C illustrate a method of inserting the introducer. [Figure 18] 18A and 18B show a method of connecting the introducer of FIG. 17 to a transseptal sheath. [Figure 19] 19A-19C illustrate a method of advancing the transseptal sheath of FIG. 18. [Figure 20] 20A-20C illustrate a method of positioning the transseptal sheath of FIG. 19. [Figure 21] FIG. 1 illustrates a method for delivering an anchor. [Figure 22A] 1A-1C illustrate a method of deploying an implant. [Figure 22B] 1A-1C illustrate a method of deploying an implant. [Figure 22C] 1A-1C illustrate a method of deploying an implant. [Figure 22D] 1A-1C illustrate a method of deploying an implant. [Figure 23] 10A-10C illustrate a method utilizing one or more auxiliary anchor guidewires. [Figure 24] FIG. 1 illustrates a method for removing an anchor driver. [Figure 25] 10A and 10B are diagrams illustrating a method for advancing the auxiliary anchor guide rail. [Figure 26]10A-10C illustrate a method of delivering auxiliary anchors. [Figure 27] 10A-10C illustrate a method for inserting an auxiliary anchor. [Figure 28] 10A-10C illustrate a method of delivering another auxiliary anchor. [Figure 29] FIG. 1 shows a fixed implant including a guidewire. [Figure 30] FIG. 1 shows a fixed implant. [Figure 31A] FIG. 1 illustrates a method for retrieving an implant. [Figure 31B] FIG. 1 illustrates a method for retrieving an implant. [Figure 31C] FIG. 1 illustrates a method for retrieving an implant. [Figure 31D] FIG. 1 illustrates a method for retrieving an implant. [Figure 31E] FIG. 1 illustrates a method for retrieving an implant. [Figure 31F] FIG. 1 illustrates a method for retrieving an implant. [Figure 32] 10A-10C illustrate a method for inserting an auxiliary anchor. [Figure 33] 10A-10C illustrate a method of delivering another auxiliary anchor. [Figure 34] 10A-10C illustrate a method of inserting another auxiliary anchor. [Figure 35] FIG. 1 shows a fixed implant. [Figure 36] FIG. 1 illustrates one embodiment of a stack. [Figure 37] FIG. 1 illustrates one embodiment of a stack. [Figure 38] FIG. 1 illustrates one embodiment of 3D molding. [Figure 39] FIG. 1 illustrates one embodiment of 3D molding. [Figure 40] FIG. 1 shows an implant. [Figure 41] FIG. 1 illustrates one embodiment of a barb. [Figure 42A] FIG. 1 illustrates one embodiment of an implant delivery system. [Figure 42B] FIG. 1 illustrates one embodiment of an implant delivery system. [Figure 42C] FIG. 1 illustrates one embodiment of an implant delivery system. [Figure 42D] FIG. 1 illustrates one embodiment of an implant delivery system. [Figure 42E] FIG. 1 illustrates one embodiment of an implant delivery system. [Figure 42F] FIG. 1 illustrates one embodiment of an implant delivery system. [Figure 42G] FIG. 1 illustrates one embodiment of an implant delivery system. [Figure 42H] FIG. 1 illustrates one embodiment of an implant delivery system. [Figure 42I] FIG. 1 illustrates one embodiment of an implant delivery system. [Figure 43A] FIG. 1 illustrates one embodiment of an implant delivery system. [Figure 43B] FIG. 1 illustrates one embodiment of an implant delivery system. [Figure 43C] FIG. 1 illustrates one embodiment of an implant delivery system. [Figure 43D] FIG. 1 illustrates one embodiment of an implant delivery system. [Figure 43E] FIG. 1 illustrates one embodiment of an implant delivery system. [Figure 44A] FIG. 1 illustrates one embodiment of an implant delivery system. [Figure 44B] FIG. 1 illustrates one embodiment of an implant delivery system. [Figure 44C] FIG. 1 illustrates one embodiment of an implant delivery system. [Figure 44D] FIG. 1 illustrates one embodiment of an implant delivery system. [Figure 44E] FIG. 1 illustrates one embodiment of an implant delivery system. [Figure 45A] FIG. 1 illustrates one embodiment of an implant delivery system. [Figure 45B] FIG. 1 illustrates one embodiment of an implant delivery system. [Figure 45C] FIG. 1 illustrates one embodiment of an implant delivery system. [Figure 45D] FIG. 1 illustrates one embodiment of an implant delivery system. [Figure 45E] FIG. 1 illustrates one embodiment of an implant delivery system. [Figure 45F] FIG. 1 illustrates one embodiment of an implant delivery system. [Figure 45G] FIG. 1 illustrates one embodiment of an implant delivery system. [Figure 45H] FIG. 1 illustrates one embodiment of an implant delivery system. [Figure 45I] FIG. 1 illustrates one embodiment of an implant delivery system. [Figure 45J] FIG. 1 illustrates one embodiment of an implant delivery system. [Figure 45K] FIG. 1 illustrates one embodiment of an implant delivery system. [Figure 46A] FIG. 1 illustrates one embodiment of an anchor delivery system. [Figure 46B] FIG. 1 illustrates one embodiment of an anchor delivery system. [Figure 46C] FIG. 1 illustrates one embodiment of an anchor delivery system. [Figure 47A] 10A and 10B show an embodiment of a joint assist element. [Figure 47B] 10A and 10B show an embodiment of a coaptation assist element. [Figure 47C] 10A and 10B show an embodiment of a coaptation assist element. [Figure 47D] 10A and 10B show an embodiment of a coaptation assist element. [Figure 47E] 10A and 10B show an embodiment of a coaptation assist element. [Figure 48] FIG. 1 illustrates one embodiment of an implant construction. [Figure 49] FIG. 1 illustrates one embodiment of an implant delivery system. [Figure 50] FIG. 1 illustrates a delivery method. [Figure 51] 1 illustrates one embodiment of a main anchor driver. FIG. [Figure 52] 13A-13C illustrate an embodiment of an auxiliary anchor guide rail. [Figure 53A] 10A-10C illustrate an embodiment of an auxiliary anchor guide rail to prevent entanglement. [Figure 53B] 10A-10C illustrate an embodiment of an auxiliary anchor guide rail to prevent entanglement. [Figure 54] 10A-10C illustrate an embodiment of an auxiliary anchor guide rail that facilitates the trajectory of the auxiliary anchor. [Figure 55A] FIG. 1 illustrates one embodiment of a proximal assembly. [Figure 55B] FIG. 1 illustrates one embodiment of a proximal assembly. [Figure 55C] FIG. 1 illustrates one embodiment of a proximal assembly. [Figure 56] 10A-10C illustrate an embodiment of an anti-rotation mechanism. [Figure 57A] FIG. 1 illustrates one embodiment of posterior leaflet expansion and reconstruction. [Figure 57B] FIG. 1 illustrates one embodiment of posterior leaflet expansion and reconstruction. [Figure 58A] FIG. 1 illustrates one embodiment of an implant delivery system. [Figure 58B] FIG. 1 illustrates one embodiment of an implant delivery system. [Figure 58C] FIG. 1 illustrates one embodiment of an implant delivery system. [Figure 58D] FIG. 1 illustrates one embodiment of an implant delivery system. [Figure 58E] FIG. 1 illustrates one embodiment of an implant delivery system. [Figure 58F] FIG. 1 illustrates one embodiment of an implant delivery system. [Figure 58G] FIG. 1 illustrates one embodiment of an implant delivery system. [Figure 58H]FIG. 1 illustrates one embodiment of an implant delivery system. [Figure 58I] FIG. 1 illustrates one embodiment of an implant delivery system. [Figure 58J] FIG. 1 illustrates one embodiment of an implant delivery system. [Figure 59A] 1A-1C illustrate an embodiment of an auxiliary anchor. [Figure 59B] 1A-1C illustrate an embodiment of an auxiliary anchor. [Figure 60] 59B shows an embodiment of the auxiliary anchor and implant of FIG. 59A. [Figure 61] 1A-1C illustrate an embodiment of a mitral valve in systole and diastole. [Figure 62A] 1 illustrates one embodiment of an implant. [Figure 62B] 1 illustrates one embodiment of an implant. [Figure 62C] 1 illustrates one embodiment of an implant. [Figure 63] 62B shows one embodiment of the implant of FIG. 62A positioned within the mitral valve during systole and diastole. [Figure 64A] 1 illustrates one embodiment of an implant. [Figure 64B] 1 illustrates one embodiment of an implant. [Figure 64C] 1 illustrates one embodiment of an implant. [Figure 64D] 1 illustrates one embodiment of an implant. [Figure 65] 64B shows one embodiment of the implant of FIG. 64A positioned within the mitral valve during systole and diastole. [Figure 66A] 1 illustrates one embodiment of an implant. [Figure 66B] 1 illustrates one embodiment of an implant. [Figure 66C] 1 illustrates one embodiment of an implant. [Figure 66D] 1 illustrates one embodiment of an implant. [Figure 67A] FIG. 66B illustrates one embodiment of the implant of FIG. 66A delivered to the mitral valve. [Figure 67B] FIG. 66B illustrates one embodiment of the implant of FIG. 66A delivered to the mitral valve. [Figure 68] 66B shows one embodiment of the implant of FIG. 66A positioned within the mitral valve during systole and diastole. [Figure 69A] 1 illustrates one embodiment of an implant. [Figure 69B] 1 illustrates one embodiment of an implant. [Figure 70A] 1 illustrates one embodiment of an implant. [Figure 70B] 1 illustrates one embodiment of an implant. [Figure 71] 1A-1C illustrate an embodiment of an implant and an edge to edge device. [Figure 72] FIG. 72 illustrates one embodiment of the implant of FIG. 71. [Figure 73A] 1 illustrates one embodiment of an implant. [Figure 73B] 1 illustrates one embodiment of an implant. [Figure 73C] 1 illustrates one embodiment of an implant. [Figure 74A] 1 illustrates one embodiment of an implant. [Figure 74B] 1 illustrates one embodiment of an implant. [Figure 75A] 74A-74B show an embodiment of the implant. [Figure 75B] 74A-74B show an embodiment of the implant. [Figure 76] 74B-75B. FIG. [Figure 77A] 1 illustrates one embodiment of an implant. [Figure 77B] 1 illustrates one embodiment of an implant. [Figure 77C] 1 illustrates one embodiment of an implant. [Figure 77D] 1 illustrates one embodiment of an implant. [Figure 78A] 77A-77D illustrate an embodiment of the implant and edge-to-edge device. [Figure 78B] 77A-77D illustrate an embodiment of the implant and edge-to-edge device. [Figure 79A] 78A-78B show an embodiment of the implant. [Figure 79B] 78A-78B show an embodiment of the implant. [Figure 79C] 78A-78B show an embodiment of the implant. [Figure 80] FIG. 1 is a schematic diagram of the cardiac cycle. [Figure 81] FIG. 1 illustrates the cardiac cycle. [Figure 82A] 77A-77D show the implants of FIGS. 77A-77D. [Figure 82B] 77A-77D show the implants of FIGS. 77A-77D. [Figure 82C] 77A-77D show the implants of FIGS. 77A-77D. [Figure 83] 78A-78B show an embodiment of the implant. [Figure 84] FIG. 1 illustrates the cardiac cycle. [Figure 85] FIG. 1 illustrates two phases of the cardiac cycle. [Figure 86A] 1 illustrates one embodiment of an implant. [Figure 86B] 1 illustrates one embodiment of an implant. [Figure 87A] 86A-86B illustrate an embodiment of the implant and edge-to-edge device. [Figure 87B] 86A-86B illustrate an embodiment of the implant and edge-to-edge device. [Figure 88A] 1 illustrates one embodiment of an implant. [Figure 88B] 1 illustrates one embodiment of an implant. [Figure 89A] 88A-88B show the implant of FIG. [Figure 89B] 88A-88B show the implant of FIG. [Figure 89C] 88A-88B show the implant of FIG. [Figure 89D] 88A-88B show the implant of FIG. [Figure 90A] 88A-88B show the implant of FIG. [Figure 90B] 88A-88B show the implant of FIG. [Figure 90C] 88A-88B show the implant of FIG. [Figure 91A] 88A-88B show the implant of FIG. [Figure 91B] 88A-88B show the implant of FIG. DETAILED DESCRIPTION OF THE INVENTION

[0056] The present invention, in some embodiments, generally provides improved medical devices, systems, and methods, often for the treatment of other valvular diseases, including mitral regurgitation and tricuspid regurgitation. While the following description includes reference to the anterior leaflet of a valve, such as a two-leaflet mitral valve, it is understood that "anterior leaflet" may refer to one or more leaflets of a multi-leaflet valve. For example, since the tricuspid valve has three leaflets, "anterior leaflet" may refer to one or two of the medial, lateral, and posterior leaflets. The coaptation assist elements described herein generally include a coaptation assist body (sometimes referred to herein as a valve body) that generally follows the blood flow path as the valve leaflets move back and forth between an open configuration (the anterior leaflet is separated from the valve body) and a closed configuration (the anterior leaflet is engaged with the opposing surface of the valve body). The disc is disposed between the native leaflets to provide a surface for at least one of the native leaflets to coapt, while effectively displacing a second native leaflet in an area of ​​the valve that would normally be occluded during systole, thereby closing the gap caused by malcoaptation of the native leaflets. The gap may be lateral (such as may be caused by a dilated left ventricle and / or mitral annulus) and / or axial (such as when one leaflet is prolapsed or pushed beyond the annulus by fluid pressure when the valve is to close). In some embodiments, the coaptation assist element may fully assist one, two, or more leaflets, or in some embodiments, partially assist the leaflets, covering, for example, only one or more of the A1, A2, and / or A3 sails of the anterior leaflets and / or only one or more of the P1, P2, and / or P3 sails of the posterior leaflets.

[0057] Among other applications, the coaptation assist elements and methods described herein may be configured to treat functional and / or degenerative mitral regurgitation (MR) by creating an artificial or novel coaptation area within which at least one of the native mitral valve leaflets can be sealed. While the structures and methods herein are largely tailored to this application, alternative embodiments may be configured for use with other valves of the heart and / or body, including the tricuspid valve, valves of the peripheral vasculature, the inferior vena cava, etc.

[0058] 1A-1D, the four chambers of the heart are shown: left atrium 10, right atrium 20, left ventricle 30, and right ventricle 40. A mitral valve 60 is disposed between the left atrium 10 and the left ventricle 30. Also shown are the tricuspid valve 50, the aortic valve 80, and the pulmonary valve 70, which separate the right atrium 20 and the right ventricle 40. The mitral valve 60 is composed of two leaflets: an anterior leaflet 12 and a posterior leaflet 14. In a healthy heart, the two leaflets are apposed at a coaptation area 16 during systole.

[0059] Portions of the fibrous annulus 120 of the cardiac skeleton attach to the two leaflets of the mitral valve, called the anterior leaflet 12 and the posterior leaflet 14. The leaflets are supported axially by attachment to chordae tendineae 32. The chordae, in turn, attach to one or both of the papillary muscles 34, 36 of the left ventricle. In a healthy heart, the chordae support structures anchor the mitral valve leaflets, allowing them to open easily during diastole yet resist the high pressures generated during ventricular systole. In addition to the anchoring effect of the support structures, the consistent shape and organization of the leaflets help promote effective sealing, or coaptation. The anterior edges of the anterior and posterior leaflets meet along a funnel-shaped coaptation zone 16, a three-dimensional cross-section of the coaptation zone (CZ) 160 is shown schematically in Figure 1E.

[0060] The anterior and posterior mitral valve leaflets are shaped differently. The anterior leaflet is firmly attached by the annulus overlying the central fibrous body (cardiac skeleton) and is somewhat stiffer than the posterior leaflet, which is attached to the more mobile posterior mitral annulus. Approximately 80 percent of the closure area is in the anterior leaflet. Adjacent to the commissures 110, 114, on or anterior to the annulus 120, are the left (lateral) fibrous trigone 124 and the right (septal) fibrous trigone 126, which form where the mitral annulus fuses with the base of the non-coronary leaflet of the aorta (FIG. 1F). The fibrous trigone 124, 126 form the septal and lateral extents of the central fibrous body 128. In some embodiments, the fibrous trigone 124, 126 may have the advantage of providing a secure area for stable engagement with one or more annular or atrial anchors. The coaptation area CL between the leaflets 12, 14 is not a simple line but rather a curved, funnel-shaped interface. The first commissure 110 (lateral or left) and second commissure 114 (septal or right) are where the anterior leaflet 12 meets the posterior leaflet 14 at the annulus 120. As can be seen most clearly in the atrial axial views of Figures 1C, 1D, and 1F, an axial cross-section of the coaptation zone generally shows a curved line CL that is separated from the annular center CA and from the opening CO through the valve during diastole. In addition, the leaflet edges are wavy, with the posterior leaflet being more wavy than the anterior leaflet. Because malcoaptation can occur between one or more of these AP (anterior-posterior) segment pairs A1 / P1, A2 / P2, and A3 / P3, the characteristics of the malcoaptation may vary along the curved line CL of the coaptation zone.

[0061] 2A, a properly functioning mitral valve 60 of the heart is open during diastole, allowing blood to flow along a flow path FP from the left atrium toward the left ventricle 30, thereby filling the left ventricle. As shown in FIG. 2B, during systole, a functioning mitral valve 60 first passively and then actively closes due to increased ventricular pressure, effectively sealing the left ventricle 30 from the left atrium 10, thereby allowing contraction of the cardiac tissue surrounding the left ventricle to propel blood throughout the vascular system.

[0062] 3A-3B and 4A-4B, there are several conditions or pathological states in which the leaflet edges of the mitral valve fail to adequately oppose, thereby allowing blood to flow backward from the ventricle to the atrium during systole. Regardless of the specific etiology in a particular patient, the failure of the leaflets to seal during ventricular systole is known as coaptation and results in mitral valve regurgitation.

[0063] Generally, malcoaptation can occur due to excessive tethering of one or both leaflets by their supporting structures, or due to excessive stretching or rupture of the supporting structures. Other less common causes include infection, congenital anomalies, and trauma to the heart valve. Valve malfunction can occur due to elongation of the chordae tendineae, known as mitral valve prolapse, or, in some cases, rupture of the chordae 215 or papillary muscles, known as flail leaflet 220, as shown in FIG. 3A. Alternatively, if the leaflet tissue itself is redundant, the valve can prolapse; the greater the degree of coaptation, the greater the opening of the valve within the atrium during ventricular systole 230. Either leaflet can prolapse or flail. This condition is sometimes known as degenerative mitral regurgitation.

[0064] In the case of excessive tethering, as shown in Figure 3B, the leaflets of a normally anatomic valve may not function properly due to an enlargement or change in shape of the valve annulus, known as annular dilation 240. Such functional mitral regurgitation is generally caused by myocardial impairment and associated ventricular dilation. Additionally, the excessive amount of stress caused by functional mitral regurgitation may itself exacerbate heart failure, ventricular dilation, and annular dilation, which in turn exacerbates mitral regurgitation.

[0065] 4A-4B illustrate the regurgitation of blood during systole (BF) in functional mitral regurgitation (FIG. 4A) and degenerative mitral regurgitation (FIG. 4B). In FIG. 4A, the increased size of the annulus, combined with increased tethering due to hypertrophy of the ventricle 320 and papillary muscles 330, prevents apposition of the anterior leaflet 312 and posterior leaflet 314, thereby preventing coaptation. In FIG. 4B, rupture of the chordae 215 causes the posterior leaflet 344 to prolapse upward into the left atrium, preventing apposition against the anterior leaflet 342. In either situation, the result is a backflow of blood into the atrium, thereby reducing the effectiveness of left ventricular compression.

[0066] Further description of articulation assist elements, tools, anchors, features, systems, and methods that can be utilized in conjunction with the disclosure herein can be found in the following applications, which are incorporated by reference in their entireties: U.S. Patent Application No. 13 / 099,532, filed May 3, 2011, U.S. Patent Application No. 13 / 531,407, filed June 22, 2012, U.S. Patent Application No. 14 / 313,975, filed June 24, 2014, U.S. Patent Application No. 14 / 742,199, filed June 17, 2015, U.S. Patent Application No. 14 / 749,344, filed June 24, 2015, and U.S. Patent Application No. 10 / 419,706, filed April 18, 2003.

[0067] In some embodiments, the coaptation assist elements described herein may be deployed to overlie the posterior leaflet, chordae, and papillary muscles. In some embodiments, the coaptation assist element attaches to the posterior surface of the annulus from above and to the posterior surface of the left ventricle from below via an annular anchor and / or a ventricular anchor. In other embodiments, more than one annular anchor and / or more than one ventricular anchor may be used to attach the coaptation assist element. In some elements, one or more annular anchors may be replaced or supplemented by one or more atrial or commissural anchors, which in some embodiments may be annular. The coaptation assist element may attach to the superior surface of the posterior annulus, the posterior atrial wall, or the annulus itself. A coaptation zone is established between the coaptation assist element and the native anterior leaflet. Because leaflet dyscopiation occurs in both functional and degenerative mitral regurgitation, regardless of the mechanism underlying the dysfunction, similar coaptation assist elements can be used in both. In some embodiments, different sized coaptation assist elements can be positioned so that the native anterior leaflet apposes the coaptation element at the properly established coaptation point, inhibiting blood flow during ventricular contraction.

[0068] Coaptation assist elements may be provided in various sizes, with different dimensions adapted to accommodate various anatomical structures. For example, there may be a height measured from the upper annulus attachment site to the lowermost edge of the coaptation assist element in a plane essentially perpendicular to the plane defined by the valve annulus, a depth between the coaptation point and the upper attachment site, and a protrusion between the posterior wall and the coaptation point at the level of the coaptation point. There may also be an inner-outer diameter of the coaptation assist element, which is generally larger in cases of functional MR. During diastole, the coaptation assist element may remain in substantially the same position, while movement of the native anterior leaflet opens the valve, allowing blood flow from the left atrium to the left ventricle with minimal restriction. In some embodiments, during ventricular systole, the surface of the coaptation assist element may bulge or stretch upward, while the anchor remains stationary. This may be advantageous because it improves the seal between the anterior surface of the element and the native valve leaflets in the coaptation zone during systole. During diastole, the surface may return to its original position, more anterior toward the anterior leaflet. This may improve the blood flow pathway between the atrium and ventricle during diastole, improving outflow from the atrium over the coaptation assist element.

[0069] In some methods of use, the natural posterior leaflet is left in place, and the coaptation assist element is attached from above to the posterior annulus or adjacent atrial wall. Many possible alternative embodiments may have different attachment mechanisms. In other methods of use, the posterior leaflet is not present and has been removed surgically or as a result of disease. In some methods of use, the natural 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 to the annulus or atrial wall. These are just a few variations, but others are envisioned. In some methods of use, an anchoring structure (not shown) can pass from the coaptation assist element through the atrial wall and into the coronary sinus, where the anchoring structure attaches to a mating structure within the coronary sinus. In some methods of use, the anchoring structure can be a mechanical structure or a simple suture that penetrates the atrial wall and is secured by a mechanical element, such as a knot or clip, on the epicardial surface of the heart. Similarly, attachment from below may be to the ventricular muscle, through the apex into the epicardium or pericardium and secured from the outside, or at other attachment sites using alternative attachment means.

[0070] The coaptation assist elements described herein may exhibit a number of desirable characteristics. Some embodiments do not require reshaping of the mitral valve annulus (such as by heat shrinking the annular tissue, implanting a prosthetic annular ring, and / or placing a fastening mechanism above or below the valve plane or within the coronary sinus or associated vessels). Advantageously, no disruption of the leaflet structure is required, nor is reliance on locking or fusing the mitral valve leaflets together. Many embodiments represent passive implant devices that can avoid reliance on ventricular reshaping and, after implantation, may have a limited range of motion, resulting in a very long fatigue life. Thus, the coaptation assist element can be secured across the posterior leaflet, leaving otherwise intact the anatomy of the native heart (e.g., ventricles, mitral annulus, etc.).

[0071] Alleviation of mitral valve malcoaptation may be effective regardless of which leaflet segments are malcoapted. The treatments described herein utilize coaptation assist elements that can be repositioned during the procedure and even removed after full deployment and / or after tissue response has begun or completed, often without damaging the valve structure. Nevertheless, the coaptation assist elements described herein may be combined with one or more therapies that rely on one or more of the attributes described above to be obviated. The coaptation assist elements can exhibit benign tissue healing and rapid endothelialization, thereby inhibiting dislocation, thromboembolism, infection, and / or erosion. In some cases, the coaptation assist elements do not exhibit endothelialization, and their surfaces remain inert, thereby also inhibiting dislocation, thromboembolism, infection, and / or erosion.

[0072] 5A-5B show two views of one embodiment of a coaptation assist element 500. The coaptation assist element 500 can include a first surface 505 that is disposed toward the malcoapted native valve leaflet, which in the case of the mitral valve is the posterior leaflet, and a second surface 515 that can be disposed toward the anterior leaflet. The second surface 515 can include a coaptation surface 560. The upper edge 540 of the coaptation assist element 500 can be curved to conform to the overall shape of the valve annulus or adjacent atrial wall, as described herein. The upper edge 540 can be curved downward toward the posterior leaflet, as shown in FIG. 5A, or upward toward the atrial wall to conform to the overall shape of the left atrial wall, as shown in FIG. 6 and described herein.

[0073] The coaptation assist element 500 can have a geometry that allows it to traverse the valve between attachment sites in the atrium and the ventricle. In some embodiments, the attachment sites are only in the atrium. In some embodiments, the attachment sites are only near the annulus and commissures of the valve. The coaptation assist element 500 can be free of attachment near the lower edge 580. The coaptation assist element 500 does not require ventricular attachment. In some embodiments, the geometry of the coaptation assist element 500 helps maintain its position within the valve. In some embodiments, the coaptation assist element 500 is curved to cover the posterior leaflet. In some embodiments, the coaptation assist element 500 is curved posteriorly toward the upper edge 540. The coaptation assist element 500 may provide a coaptation surface 560 against which the anterior leaflet coapts. Figures 5A and 5B illustrate this geometry.

[0074] In some methods of use, the posterior leaflet can be left intact. The coaptation assist element 500 can be attached to the atrium or annulus to effectively seal the posterior leaflet. In some methods of use, the posterior leaflet can be removed. The coaptation assist element 500 can replace the posterior leaflet if the leaflet is to be removed or has already been removed. In some embodiments, the coaptation assist element 500 only requires attachment to the annulus. In some embodiments, the coaptation assist element 500 only requires attachment at a single point. The single point can be a central location on the coaptation assist element 500, such as a centrally located hub. In some embodiments, the coaptation assist element 500 can be attached to the atrium or annulus along its edges. In some embodiments, the coaptation assist element 500 can be attached to the atrium or annulus at a location away from the edges of the coaptation assist element 500, such as a centrally located hub.

[0075] The coaptation assist element 500 can include an annulus hub 520 that engages with the annulus anchor 800. The annulus anchor 800 can be engaged at its proximal end by a driver, as described herein. The annulus anchor 800 can include a pointed tip that engages tissue. In some methods of use, the tip of the annulus anchor 800 is within the annulus hub 520 during delivery of the coaptation assist element 500. In some methods of use, the tip of the annulus anchor 800 is above the annular compartment 510 during delivery. The tip of the annulus anchor 800 can remain recessed within the annulus hub 520 until the annulus anchor 800 is rotated to engage tissue. In some embodiments, the coaptation assist element 500 can be assembled outside the body, and the annulus anchor 800 and the driver can be engaged to the coaptation assist element 500 via the annulus hub 520. The driver can then be retracted into the delivery catheter with the coaptation assist element 500 in its collapsed position. The driver may be separately manipulated by the practitioner to position the annulus anchor 800 in the appropriate position. Alternatively, the annulus anchor 800 may be sequentially engaged with the coaptation assist element 500 and / or the driver before or after deployment through the delivery catheter. Once deployed, the coaptation assist element 500 completely covers the posterior leaflet, allowing the coaptation assist element 500 to coapt with the anterior leaflet during systole, maintaining valve sealing at the annular ring with the natural anterior leaflet.

[0076] In some embodiments, the annulus anchor 800 is an active anchor. A user can selectively engage or disengage the annulus anchor 800 from tissue. Unlike barbs or other passive anchors, active anchors can be activated, such as by rotation, to engage tissue. The annulus anchor 800 allows the coaptation assist element 500 to be positioned prior to engagement with the annulus anchor 800. The coaptation assist element 500 can contact tissue without any adhesion to the annulus anchor 800. In some embodiments, the annulus anchor 800 and corresponding hub 520 are centered on the coaptation assist element 500. The annulus anchor 800 and corresponding hub 520 are spaced apart from any edges of the coaptation assist element 500. The position of the annulus anchor 800 and corresponding hub 520 can be neutrally centered, which prevents rocking of the coaptation assist element 500 when held by the annulus hub 520. A corresponding hub 520 provides a convenient location for holding and moving the coaptation assist element 500 .

[0077] The annulus hub 520 may have an integrated or attached annulus anchor 800. In some embodiments, the annulus anchor 800 can be retained within the annulus hub 520 by a cross-pin, as described herein. The cross-pin may penetrate the helical structure of the annulus anchor 800 to prevent blunt force from disengaging the annulus anchor 800 from the annulus hub 520. The annulus anchor 800 may include a helix that is rotatable relative to the annulus hub 520. In some embodiments, other anchors may be used. The annulus anchor 800 may be in the form of a tether or other attachment means that extends from the coaptation assist element 500 through the interventricular septum to the right ventricle. The annulus anchor 800 may be in the form of a tether or other attachment means that extends through the apex into the epicardium or pericardium. The annulus anchor 800 may be secured from outside the heart in a combined endocardial / epicardial procedure. If a helical anchor is used, it may comprise a bioinert material such as platinum / Ir, nitinol alloy, and / or stainless steel.

[0078] In some embodiments, the coaptation assist element 500 can include a single central annulus anchor 800 within the annulus hub 520. The coaptation assist element 500 can be delivered percutaneously as described herein by attaching a delivery catheter to the annulus hub 520. The coaptation assist element 500 can be configured for adjustable positioning by removing and reattaching the annulus anchor 800. The coaptation assist element 500 can be recaptureable by removing the annulus anchor 800 and retracting the coaptation assist element 500. The coaptation assist element 500 can also include auxiliary anchors, including commissural anchors, ventricular anchors, annular anchors, barbs, tethers, or any other known fixation devices.

[0079] 5A-5B, the coaptation assist element 500 can include multiple struts 530. In some embodiments, one or more of the struts 530 have one end that terminates at the hub 520 and another end that extends radially outward toward one of the upper edge 540, the lateral edges 570 and 575, and the lower edge 580 of the coaptation assist element 500. The struts 530 can extend outward from the hub 520 in various directions and can 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 between about 5 degrees and about 45 degrees, between about 10 degrees and about 30 degrees, or at an angle of about 5, 10, 15, 20, 25, or 30 degrees relative to the adjacent struts 530. The struts 530 may be aligned generally parallel to the longitudinal axis of the coaptation assist element 500 to help maintain the shape of the coaptation assist element 500 during deployment. The struts 530 may allow the coaptation assist element 500 to assume a reduced configuration for deployment through a catheter. In some embodiments, the struts 530 forming a portion of the coaptation zone of the implant 500 have a longer maximum length than the struts 530 forming only a portion of the annular zone of the implant. In some embodiments, the struts 530 forming a portion of the coaptation zone of the implant can be, for example, at least about 10%, 20%, 30%, 40%, 50%, 75%, 100%, 125%, or 150% longer than the struts 530 forming a portion of the annular zone of the implant.

[0080] FIG. 5A shows a view of a coaptation assist element 500 having an annulus anchor portion 535. The annulus anchor portion 535 can be a portion of a strut 530. The annulus anchor portion 535 is shown extending downward from the coaptation assist element 500 in FIG. 5A. In other embodiments, the annulus anchor portion 535 may extend in other directions from the coaptation assist element 500 to engage tissue. In some embodiments, the annulus anchor portion 535 comprises one or more barbs with sharp tips. The annulus anchor portion 535 may be a passive anchor.

[0081] In some embodiments, the coaptation assist element 500 can include one or more retractable barbs. For example, the barbs can be retracted during delivery of the coaptation assist element 500. For example, the barbs can be advanced after the coaptation assist element 500 has been positioned relative to the anatomy. In some embodiments, the barbs are actively retracted and / or advanced. For example, the delivery catheters described herein can include mechanisms 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 coaptation assist element 500 is delivered with the barbs in a retracted state. In some embodiments, the barbs can be covered by a valve disc cover as described herein. In some embodiments, the interface between the tissue and the valve disc cover pushes back the valve disc cover, exposing the barbs. In some embodiments, the tissue dissolves and / or absorbs a portion of the valve disc cover, exposing the barbs. In some embodiments, the barbs are advanced by movement of a purse string suture as described herein. In some embodiments, movement of the purse string suture moves the valve disc cover, exposing the barbs. Other configurations are contemplated.

[0082] The annulus anchoring site 535 may define a diameter D1, shown in FIG. 5B, which in some embodiments may correspond to the distance between the medial and lateral commissures of the native valve, i.e., the intracommissural distance (ICD). D1 may range from 20 to 60 mm, and in some embodiments, a preferred length is 35 to 45 mm, which most closely approximates the ICD of the widest range of human mitral valves. In some embodiments, D1 may be the distance from the right fibrous trigone to the left fibrous trigone.

[0083] The coaptation assist element 500 can include a generally annular section 510. The annular section 510 can be positioned above the native valve leaflets when the coaptation assist element 500 is deployed. In some embodiments, the annular section 510 can be curved toward or away from the annulus. The annular section 510 can be concave. In other embodiments, the annular section 510 can be substantially flat relative to the annulus. One or more of the struts 530 can curve laterally from the hub 520 toward the upper edge 540 to help maintain the shape of the annular section 510 of the coaptation assist element 500 during deployment. The coaptation assist element 500 can curve downward from the hub 520 toward the annulus anchor site 535. In some embodiments, the coaptation assist element 500 does not contact the posterior leaflet. In some embodiments, the annulus anchor site 535 is the only point of contact between the coaptation assist element 500 and the posterior annulus of the mitral valve. The upper edge 540 can include an annular radius of curvature. The annular curve radius can curve towards the annulus. The annular curve radius can curve towards the coaptation surface 560. In some embodiments, the annular curve radius can be between 0 mm and 5 mm, between 5 mm and 10 mm, between 10 mm and 15 mm, between 15 mm and 20 mm, between 20 mm and 25 mm, between 25 mm and 30 mm, etc.

[0084] The struts 530 may be constructed of a radiopaque material. In some embodiments, the struts 530 are constructed of an elastically deformable material, such as a shape memory metal, e.g., Nitinol, or a shape memory polymer. In some embodiments, the material is Elgiloy. In other embodiments, the struts 530 may be constructed of other materials, such as stainless steel, polypropylene, high-density polyethylene (PE), Dacron, an acellular collagen matrix such as SIS, or other plastics. In other embodiments, the struts 530 may be a combination of a high-density PE sheath surrounded by a core of ePTFE, Dacron, and / or polypropylene. The struts 530 may have a circular or elliptical cross-section, or may be ribbon-shaped. In some embodiments, the struts 530 are coil spring or zigzag shaped. The struts 530 may have consistent stiffness. In some embodiments, one or more struts 530 may have different stiffnesses along the length of the one or more struts 530. The struts 530 may be stiffer at the annulus end than at the ventricular end of the coaptation assist element 500. The struts 530 may be less stiff at the annulus end than at the ventricular end of the coaptation assist element 500. The struts 530 may be stiffer at their midpoints, such as at inflection points or curves. The struts 530, together with one or more other support structures, can form a frame. In some embodiments, one or more support structures may be provided that run parallel to the upper edge 540 of the coaptation assist element 500 and help maintain the shape of the upper edge 540. The struts 530 and / or other support structures of the frame, in some embodiments, can be laser cut from a nitinol tube.

[0085] The attachment assist element body cover 550 may be constructed of a material such as ePTFE. Other materials for the attachment assist element body cover 550 include polyester, polyurethane foam, polycarbonate foam, biological tissue such as porcine pericardium, processed bovine pericardium, pleura, peritoneum, silicone, Dacron, acellular collagen matrix, and the like. In some embodiments, the attachment assist element body cover 550 may comprise a foam material surrounded by ePTFE. The use of a sponge or foam material improves the ability of the attachment assist element 500 to be collapsed to a diameter small enough to pass through a catheter. In some embodiments, the attachment assist element body cover 550 is imperforate. In other embodiments, the attachment assist element body cover 550 may have pores to improve endothelialization and cell attachment. The attachment assist element body cover 550 may also incorporate a radiopaque or echo-enhancing material for better visualization. Any support structure of the coaptation assist element 500, including the support interface of the struts 530 or hub 520, may be coated with a radiopaque material such as gold or platinum or barium-impregnated material. The coaptation surface 560 may be coated with an echo-enhancing material. The coaptation assist element body cover 550 may be coated with a material that inhibits thrombosis, such as heparin-binding or quinoline and quinoxaline compounds, or with a material that accelerates endothelialization, or with an antibiotic to inhibit infection. In some embodiments, the purse string sutures 1010 described herein can incorporate radiopaque or echo-enhancing materials for better visualization.

[0086] In some embodiments, the struts 530 may be sandwiched between layers of the coaptation assist element body cover 550. The coaptation assist element body cover 550 may be composed of the same material on the first surface 505 and the second surface 515. The coaptation assist element body cover 550 may 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 may be attached to or embedded in the first surface 505 or the second surface 515 of a single layer of the coaptation assist element body cover 550. In some embodiments, the struts 530 may be "sewn" through the coaptation assist element body cover 550. The annulus anchor sites 535 can be the ends of the struts 530 exposed from the coaptation assist element body cover 550.

[0087] The application assist element 500 may include a purse string suture 1010. The purse string suture 1010 may extend along a portion of the application assist element 500. The purse string suture 1010 may extend along the top edge 540 or a portion thereof. The purse string suture 1010 may extend along the lateral edge 570 or a portion thereof. The purse string suture 1010 may extend along the lateral edge 575 or a portion thereof. The purse string suture 1010 may extend along the bottom edge 580 or a portion thereof. The purse string suture 1010 may extend along the periphery of the application assist element 500 or a portion thereof. The purse string suture 1010 may extend along one or more struts 530. The purse string suture 1010 may extend in a straight path, a non-straight path, a curve, a semicircle, or any open or closed shape.

[0088] In some embodiments, the purse string suture 1010 may be sandwiched between layers of the valve body cover 550. For example, the purse string suture 1010 may be disposed within a lumen between layers of the coaptation assist element body cover 550. In some embodiments, the purse string suture 1010 may be attached to or embedded in the first surface 505 or the second surface 515 of a single layer of the valve body cover 550. In some embodiments, the purse string suture 1010 may be “sewn” through the coaptation assist element body cover 550. The purse string suture 1010 may pass from the first surface 505 to the second surface 515 and return to the first surface 505. The purse string suture 1010 may include one or more ends exposed from the coaptation assist element body cover 550. In embodiments in which the purse string suture 1010 is a loop, the purse string suture may include one or more exposed sections of the loop from the valve body cover.

[0089] The coaptation assist element 500 may be collapsed by tightening the purse string suture 1010. The coaptation assist element 500 may be expanded by loosening the purse string suture 1010. One or more exposed ends or loops can be manipulated by tightening or loosening the purse string suture 1010 with a delivery catheter or other tool. The ability to collapse or expand the coaptation assist element 500 may be beneficial for recapturing and / or repositioning the coaptation assist element 500.

[0090] The coaptation assist element 500 may be rotated by tightening one or more purse string sutures 1010 and / or loosening one or more purse string sutures 1010. For example, the coaptation assist element 500 may be rotated by tightening one or more purse string sutures 1010 at the lateral edges 570 and / or loosening one or more purse string sutures 1010 at the lateral edges 575. The one or more purse string sutures 1010 may be coupled to the coaptation assist element 500 to allow for multi-directional rotation.

[0091] The coaptation assist element 500 may be expanded by loosening the purse string suture 1010. One or more exposed ends or loops can be manipulated by tightening or loosening the purse string suture 1010 with a delivery catheter or other tool. The ability to collapse or expand the coaptation assist element 500 can be beneficial for recapturing and / or repositioning the coaptation assist element 500.

[0092] The coaptation surface 560 of the coaptation assist element 500 may be adjusted by movement of the purse string suture 1010. One or more exposed ends or loops can be manipulated by tightening or loosening the purse string suture 1010 with a delivery catheter or other tool to change the curvature of the coaptation surface 560 in situ. The ability to adjust the curvature of the coaptation assist element 500 can be beneficial to conform to the geometry of the heart, including the geometry of the anterior leaflet.

[0093] The annular dimension of the coaptation assist element 500 may be adjusted by movement of the purse string suture 1010. One or more exposed ends or loops can be manipulated by tightening or loosening the purse string suture 1010 with a delivery catheter or other tool to change one or more dimensions of the coaptation assist element 500 in situ. The ability to adjust the dimensions of the coaptation assist element 500 can be beneficial for conforming to the geometry of the heart.

[0094] The application assist element 500 can include one or more purse string sutures 1010. In some embodiments, the application assist element 500 includes one purse string suture, two purse string sutures, three purse string sutures, four purse string sutures, five purse string sutures, six purse string sutures, seven purse string sutures, eight purse string sutures, nine purse string sutures, ten purse string sutures, etc. For example, a purse string suture 1010 can extend along each edge of the application assist element 500. When multiple purse string sutures are provided, the purse string sutures 1010 can act together to change the configuration of the application assist element 500. When multiple purse string sutures are provided, the purse string sutures 1010 can act independently to change the configuration of the application assist element 500.

[0095] 5A further illustrates the coaptation element height, which corresponds to the distance between the lower edge 580 and the annulus hub 520 measured perpendicular to the plane defined by the annulus. The coaptation element height in some embodiments may be 10-80 mm, and in some embodiments, ranges from 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.

[0096] 5A illustrates a generally triangular shape of the coaptation aid element 500, such that the coaptation 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 longer length than the lower edge 580, such that the transverse distance between the lateral edges 570 and 575 decreases overall from the top to the bottom of the coaptation aid element 500. For example, the length of the upper edge 540 may be in the range of 15 to 50 mm or 25 to 35 mm, and the length of the lower edge 580 may be in the range of 1 to 15 mm or 2 to 6 mm.

[0097] The annulus hub 520 may be a hub, an eyelet, or any other anchoring site known in the art. In some embodiments, the annulus hub 520 is located at the midpoint of the distance D1. In some embodiments, the annulus hub 520 is located at a neutral center that prevents rocking of the coaptation assist element 500 when held by the annulus hub 520. In other embodiments, the annulus hub 520 is located at one of the commissures. While only one annulus anchor 800 is shown, in other embodiments, two or more annulus hubs 520 may be provided.

[0098] In some embodiments, the struts 530 can comprise NiTi tubing. In some embodiments, the struts 530 can be laser cut from tubing. In some embodiments, a frame including one or more struts 530 and / or one or more support structures can be laser cut from a single piece of material. In some embodiments, a frame including one or more struts 530, annulus hub 520, and / or one or more support structures can be integrally formed. In some embodiments, the coaptation assist element body cover 550 comprises an ePTFE laminate. The laminate can surround one or more (e.g., one side, two sides, first side 505, second side 515) of the struts 530 and / or one or more support structures. The struts 530 and / or one or more support structures can be encapsulated by two or more layers of laminate. The periphery of the annular section 510 of the coaptation assist element 500 can be cup-shaped facing downward. The periphery of the annular section 510 of the coaptation assist element 500 can be cup-shaped facing upward. The periphery of the annular section 510 of the coaptation assist element 500 can include an auxiliary anchor, such as annulus anchor site 535 .

[0099] In some embodiments, the annulus anchor 800 and the annulus hub 520 form a single, central anchor system. In some embodiments, the coaptation assist element 500 is anchored to tissue by only one annulus anchor 800 passing through the hub 520. In other embodiments, additional fixation is included. In some embodiments, the coaptation assist element 500 is anchored to tissue by one anchor 800 passing through the hub 520 and the annulus anchor site 535, as described herein. The system can include features that allow for rotational adjustment of the coaptation assist element 500. For example, the hub 520 and / or the annulus anchor 800 can be coupled to a delivery catheter to allow axial movement and / or torque transmission. The coaptation assist element 500 can be immovably grasped by the delivery catheter such that rotation of a feature of the delivery catheter, such as a handle, causes rotation of the coaptation assist element 500. The coaptation assist element 500 can be immovably grasped by the delivery catheter such that axial movement of a feature of the delivery catheter, such as a drive shaft, causes axial movement of the coaptation assist element 500 .

[0100] In some embodiments, the hub 520 is located in a neutral position on the coaptation assist element 500. The neutral position can be a central position of the annular section 510. The neutral position can be between the lateral edges 505, 515. The neutral position can be between the upper edge 540 and the coaptation surface 560. The neutral position can improve the stability of the coaptation assist element 500 when the coaptation assist element 500 is grasped at a single position, such as the hub 520 and / or the annulus anchor 800. The neutral position can be aligned with the structure of the mitral valve. The neutral position can be aligned along the coaptation area.

[0101] In some embodiments, the coaptation assist element 500 is delivered percutaneously as described herein. In some embodiments, the coaptation assist element 500 is adjustable via a delivery catheter. For example, the coaptation assist element 500 can be expanded and / or collapsed via the delivery catheter. For example, the coaptation assist element 500 can be rotated around a fixed position on the annulus hub 520. For example, the coaptation assist element 500 can be recaptureable. For example, the coaptation assist element 500 can be engaged and reengaged via the delivery catheter. For example, the annulus anchor 800 can be detached from tissue, and the delivery catheter can recapture the coaptation assist element 500.

[0102] 5C-5D illustrate embodiments of a frame 565 of the joining support element 500. These figures show the flattened pattern of the frame 565 before bending and / or shaping. In some embodiments, the frame 565 is cut from a tubular stock material. In other embodiments, the frame 565 is cut from a flat stock material, such as a flat sheet of material. The frame 565, including its portions, can be laser cut. The frame 565 can include one or more struts 530. In the embodiment shown in FIG. 5D, the frame 565 includes 20 struts 530, although other configurations are contemplated (e.g., 1 strut, 2 struts, 3 struts, 4 struts, 5 struts, 5-10 struts, 10-15 struts, 15-20 struts, 20-25 struts, 25-30 struts, 2-30 struts, 5-30 struts, etc.). In some embodiments, the frame 565 can include about, at least about, or at most 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 incorporating any two of the foregoing values. In some embodiments, the length of the struts extending upwardly or downwardly to the cupped upper lip is shorter, such as by less than about 80%, 70%, 60%, 50%, 40%, 30%, 20%, or less, than the longest strut extending downwardly.

[0103] 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 nearly vertical, and the struts 530 are horizontal or nearly horizontal. In some embodiments, the backing 585 is annulus hub 520. For example, two ends of the backing 585 can be joined using methods known in the art to form the annulus hub 520. The two ends are joined, for example, when the frame 565 is cut from a flat stock. In other embodiments, the frame 565 is formed from a tubular stock. The backing 585 can be a portion of an uncut tubular stock. The two ends of the backing 585 may not need to be joined if the frame 565 is formed from a tubular stock. The uncut tubular stock can form the annulus hub 520. The pattern for the frame 565, as shown in FIG. 5D , can be cut from a tubular stock material, thereby eliminating the need to join the two ends of the backing. Other manufacturing modes for forming the frame 565 are envisioned. In other embodiments, the backing 585 forms at least a portion of the annulus hub 520. In some embodiments, the backing 585 surrounds at least a portion of the annulus hub 520. In some manufacturing methods, the backing 585 can be formed in a circular shape. In some manufacturing methods, the struts 530 extend radially outward from the backing 585 when the backing 585 is shaped into a circle. The backing 585 can include one or more openings designed to receive a cross pin, as described herein. In some manufacturing methods, the backing 585 is removed.

[0104] 5A and 5C, multiple struts 530 can extend from the annulus hub 520 to the lower edge 580. In some embodiments, these struts 530 are longer than the other struts 530 of the frame 565. In some embodiments, the struts 530 may include anchors or barbs that interact with the valve substructure, including the ventricular wall. In some embodiments, the struts engage the posterior leaflet or another anatomical structure. In some embodiments, the ventricular fixation is passive.

[0105] 5A-5D , a plurality of struts 530 can extend from the annulus hub 520 to the upper edge 540. In some embodiments, these struts 530 are shorter than the other struts 530 of the frame 565. In some embodiments, these struts 530 form atrial anchors and / or annulus anchor sites 535 as described herein. In some embodiments, these struts engage the annulus or another anatomical structure. In some embodiments, the annulus fixation is passive.

[0106] 5A and 5D, multiple struts 530 can extend from the annulus hub 520 to the lateral edges 570 and 575. In some embodiments, these struts 530 have a length intermediate between the ventricular and atrial struts. In some embodiments, these struts engage with commissures or another anatomical structure. In some embodiments, commissural fixation is passive.

[0107] The struts 530 can have various lengths based on the desired shape of the coaptation assist element 500. As shown in FIGS. 5C-5D, two or more struts 530 have different lengths. As shown in FIGS. 5C-5D, two or more struts 530 have the same length. FIG. 5C shows a schematic model of a frame 565. One or more of the top three struts can form the coaptation surface 560 and extend to the lower edge. One or more of the bottom three struts can form the annular portion and extend to the upper edge. The struts 530 can be laser cut from tubing. The length can be measured from the annulus hub 520 to the edge of the coaptation assist element 500. The strut length can range from 1 mm to 50 mm. For the annular portion 510, the strut length can range from 5 mm to 35 mm. For the annular portion 510, the strut length can be approximately 15 mm. For interface surface 560, the range of strut lengths can be 20 mm to 35 mm. For interface surface 560, the strut length can be about 30 mm. Other configurations of strut length ranges are envisioned, such as 5 mm to 45 mm, 10 mm to 40 mm, 15 mm to 35 mm, about 5 mm, about 10 mm, about 15 mm, about 20 mm, about 25 mm, about 30 mm, about 35 mm, about 40 mm, about 45 mm, about 50 mm, about 55 mm, about 60 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.

[0108] The width can be measured perpendicular to the strut length. Strut widths can range from 0.1 mm to 2 mm. One or more struts can have an outer diameter or width of approximately 0.1 mm, 0.2 mm, 0.3 mm, 0.4 mm, 0.5 mm, 0.6 mm, 0.7 mm, 0.8 mm, 0.9 mm, 1 mm, 1.1 mm, 1.2 mm, 1.3 mm, 1.4 mm, 1.5 mm, 1.6 mm, 1.7 mm, 1.8 mm, 1.9 mm, 2 mm, less than 5 mm, less than 1 mm, less than 1.5 mm, less than 2 mm, etc. One or more struts 530 can have a width that varies along the strut length. In some embodiments, one or more struts 530 taper near the edge of the coaptation assist element 500. In some embodiments, one or more struts 530 taper near the annulus hub 520. One or more struts 530 may include a reduced diameter or taper at the connection between one or more struts 530 and the annulus hub 520. The taper near the annulus hub 520 may aid in the collapse of the coaptation assist element 500. The taper near the annulus hub 520 may facilitate insertion of the coaptation assist element 500 into a delivery catheter. The taper may reduce stress and / or strain in the struts 530 during collapse. In some embodiments, the taper may facilitate a longer fatigue life. In some embodiments, one or more struts 530 include a taper with varying width. The width of the struts 530 may vary along the length of the struts 530. One or more struts 530 may include an eyelet along the length of the strut 530. In some embodiments, the eyelet may reduce stress on the struts 530. In some embodiments, the eyelet may facilitate adhesion between the struts 530 and the valve body cover 550.

[0109] The thickness can be measured perpendicular to the strut length and strut width. The thickness can be determined by the thickness of the frame material, 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.

[0110] One or more of the struts 530 can include barbs. In some embodiments, the barbs can be configured to be positioned near the ventricular end of the coaptation assist element 500. In some embodiments, the barbs can be bent outward from the plane of the struts 530. In some embodiments, the barbs can have a bayonet configuration. In some embodiments, the barbs can have pointed tips. In some embodiments, one or more of the struts 530 can be bifurcated. In some embodiments, one or more of the struts 530 can include one or more zigzag sections. In some embodiments, the zigzag sections reduce stress and / or increase flexibility of the struts 530. In some embodiments, the zigzag sections facilitate adhesion between the struts 530 and the coaptation assist element body cover 550.

[0111] In some embodiments, one or more struts 530 may include complementary barbs. In some embodiments, the complementary barbs may be bent out of the plane of the struts 530. In some embodiments, one or more portions of the strut length are bent out of the plane of the struts. For example, a portion of the strut may be twisted or bent during manufacturing. In some embodiments, the portion bent out of the plane is shaped to engage tissue. In some embodiments, one or more struts 530 may include an increased width to compensate for electropolishing or other post-manufacturing processes. In some embodiments, the backing 585 may include one or more features that engage with a delivery catheter as described herein. In some embodiments, the backing 585 may include one or more notches designed to interface with locking tabs or other features of a delivery catheter as described herein. In some embodiments, one or more struts 530 may include a wider width than the other struts 530. In some embodiments, the frame 565 includes two or more struts 530 having a wider width than the other struts 530. The two or more struts 530 may facilitate visualization of the coaptation assist element 500. In some embodiments, two or more struts 530 having a wider width are designed to be located near the commissures when the coaptation assist element 500 is deployed. In some embodiments, one or more struts 530 can have a narrower width compared to one or more other struts. In some embodiments, each strut 530 has the same width near the annulus hub 520. The backing 585 can be modified to interface with the delivery catheter, as described herein. The backing 585 can be designed to allow independent rotation of the anchor 800 within the hub of the coaptation assist element 500.

[0112] Figures 5E, 5F, and 5G illustrate one embodiment of a barbless coaptation assist element 500. Figure 5E shows a schematic perspective view of the coaptation assist element 500. Figure 5F shows a schematic perspective view of the first surface 505 disposed toward the mal-coapted native leaflets. Figure 5G shows a schematic cross-sectional view including an anchor 800.

[0113] Figures 5H, 5I, and 5J illustrate an embodiment of a coaptation assist element 500 having leaflet anchoring sites 545. As shown in Figure 5A, the annulus anchoring sites 535, such as barbs, can extend along the edge of the coaptation assist element 500. Figures 5H, 5I, and 5J illustrate an embodiment of a coaptation assist element 500 having leaflet anchoring sites 545 extending from a first surface 505 disposed toward the mal-coapted native leaflets.

[0114] Figure 5H shows a schematic perspective view of coaptation assist element 500, including an enlarged cross-section showing leaflet anchor site 545. Figure 51 shows a schematic perspective view of first surface 505 disposed toward the mal-coapted native leaflet. Figure 5J shows a schematic cross-section including anchor 800.

[0115] In some embodiments, the leaflet anchor site 545 comprises one or more barbs having a pointed tip. The leaflet anchor site 545 may be a passive anchor. In some embodiments, the coaptation assist element 500 may include one or more retractable barbs. For example, the leaflet anchor site 545 may be retracted during delivery of the coaptation assist element 500. For example, the leaflet anchor site 545 may be advanced after the coaptation assist element 500 is positioned relative to the anatomy. In some embodiments, the leaflet anchor site 545 is actively retracted and / or advanced. For example, the delivery catheters described herein may include a mechanism coupled to the leaflet anchor site 545 designed to retract and / or advance the barbs. In other embodiments, the leaflet anchor site 545 is passively advanced and / or retracted. In some embodiments, the leaflet anchor site 545 may be covered by a valve disc cover as described herein. In some embodiments, the interface between the tissue and the disc cover pushes back the disc cover, exposing the leaflet anchor site 545. In some embodiments, the tissue dissolves and / or absorbs a portion of the valve body cover, exposing the leaflet anchor site 545. In some embodiments, movement of the purse string sutures described herein advances the leaflet anchor site 545. In some embodiments, movement of the purse string sutures moves the valve body cover, exposing the leaflet anchor site 545. Other configurations are envisioned.

[0116] One or more struts 530 may have one or more barbs along the length of the strut 530. In the illustrated embodiment, five struts 530 each have four leaflet anchor sites 545 along the length of the strut. Other configurations are envisioned, including different numbers of struts 530 (e.g., 1 strut, 2 struts, 3 struts, 4 struts, 5 struts, 6 struts, 7 struts, 8 struts, 9 struts, 10 struts, etc.) and different numbers of leaflet anchor sites 545 per strut 530 (e.g., 1 barb, 2 barbs, 3 barbs, 4 barbs, 5 barbs, 6 barbs, 7 barbs, 8 barbs, 9 barbs, 10 barbs, etc.). One or more struts 530 can have the same number of leaflet anchor sites 545. Two or more struts 530 can have different numbers of leaflet anchor sites 545. The leaflet anchoring site 545 can be disposed to engage the posterior leaflet.

[0117] In some embodiments, the struts 530 may be sandwiched between layers of the disc cover 550. In some embodiments, the struts 530 may be attached to or embedded in the first surface 505 or second surface 515 of a single layer of the disc cover 550. In some embodiments, the struts 530 may be "sewn" through the disc cover 550. The first surface 505 may include one or more openings for the leaflet anchor sites 545. In other embodiments, the leaflet anchor sites 545 may pass through the disc cover 550. The leaflet anchor sites 545 may have a predetermined curve that can exert a force on the first surface 505. The leaflet anchor sites 545 may be sharpened to cut through the disc cover 550.

[0118] The frame 565 can have many advantages. The frame 565 can be formed from a flattened pattern. The frame 565 can include an edge that forms the annulus hub 520. The edge can include a longitudinal strip or backing 585. One or more struts 530 can extend from the backing 585. In the illustrated embodiment of FIGS. 5C and 5D , the one or more struts 530 are perpendicular to the longitudinal strip. The struts 530 are approximately parallel. In some embodiments, the struts 530 are approximately perpendicular to the backing 585 that forms the annulus 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 can aid in folding the struts 530 into a delivery catheter.

[0119] The frame 565 can be constructed from a single flat sheet of material. The frame 565 can be precision cut using water jetting, laser etching, or similar techniques. The details of the struts 530, including barbs, can be machined into the struts 530. The frame 565 can be bent and / or shaped to achieve a desired geometry. In some embodiments, the backing 585 is folded to form a loop. The frame 565 can be rolled into a tubular shape. The backing 585 can be welded or otherwise secured. When the backing 585 is secured together at its ends to form a loop, it can be considered the annulus hub 520.

[0120] The struts 530 are bent into a desired configuration. The struts 530 can form one or more curves. The struts 530 can have one or more inflection points. The struts 530 can have concave and / or convex portions. One or more struts 530 can include a radially outward flare beginning at an inflection point. In some embodiments, the upper edge 540 is curved upward away from the lower edge 580. In some embodiments, the upper edge 540 is curved downward toward the lower edge 580. In some embodiments, one or more struts 530 can be substantially flat. The struts 530 near the commissures can be substantially flat. In some embodiments, the lower edge 580 is curved backward toward the upper edge 540. In some embodiments, the lower edge 580 is curved forward away from the upper edge 540.

[0121] The struts 530 can be evenly spaced around the circumference of the annulus hub 520. The struts 530 can be unevenly spaced around the circumference of the annulus hub 520. The struts 530 extending along one portion of the circumference of the annulus hub 520 are different from the struts extending along another portion of the circumference of the annulus hub 520. One or more designated portions of the struts 530 can be designed to be located near annular regions of the heart. One or more designated portions of the struts 530 can be designed to be located near commissure regions of the heart. One or more designated portions of the struts 530 can be designed to be located near ventricular regions of the heart. The geometry of the radially extending struts 530 can be shaped to match the geometry of a patient. In some embodiments, the geometry is patient-specific. A practitioner can shape one or more struts 530 based on the geometry of the heart. The practitioner can modify the shape of one or more of the struts 530 based on the patient's geometry.

[0122] FIG. 5K shows the dimensions of the coaptation assist element 500. The coaptation assist element 500 can include a dimension A. Dimension A can be a linear protruding dimension or a rear projection. In some embodiments, dimension A can range from 1 mm to 40 mm. In some embodiments, dimension A can range from 4 mm to 24 mm. Other ranges for dimension A are contemplated, such as 5 mm to 35 mm, 10 mm to 30 mm, 15 mm to 25 mm, approximately 1 mm, approximately 2 mm, approximately 3 mm, approximately 4 mm, approximately 5 mm, approximately 6 mm, approximately 7 mm, approximately 8 mm, approximately 9 mm, approximately 10 mm, 1 mm to 10 mm, 5 mm to 15 mm, 10 mm to 20 mm, 15 mm to 25 mm, 20 mm to 30 mm, 25 mm to 35 mm, and 30 mm to 40 mm. If there is no rear projection, for example, if the coaptation assist element 500 is linear, dimension A can be 0 mm.

[0123] The coaptation assist element 500 can include a dimension B. In some embodiments, dimension B can be a radius of curvature. The radius of curvature can be concave or convex, as described herein. In some embodiments, dimension B can range from 1 / 16 inch to 1 / 2 inch. In some embodiments, dimension B can range from 1.5 mm to 13 mm. In some embodiments, dimension B can range from 1 / 4 inch to 3 / 8 inch. In some embodiments, dimension B can range from 6 mm to 9.5 mm. In some embodiments, dimension B can range from 1 mm to 15 mm. Other configurations for the range of dimension B are envisioned, such as 2 mm to 14 mm, 3 mm to 13 mm, 4 mm to 12 mm, 5 mm to 11 mm, 6 mm to 10 mm, 7 mm to 9 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, etc. If there is no curvature, for example if the joining assist element 500 is straight, dimension B can be 0 mm.

[0124] The coaptation 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 dimension C can range from 1 mm to 10 mm. In some embodiments, the dimension C can range from 1 mm to 5 mm. Other ranges for 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. In the absence of curvature, for example, if the coaptation assist element 500 is straight, the dimension C can be 0 mm.

[0125] The coaptation assist element 500 can include a dimension D. Dimension D can be the coaptation element height. Dimension D can correspond to the distance between the lower edge 580 and the atrial anchor site or annulus hub 520, measured perpendicular to a plane defined by the annulus. In some embodiments, dimension D can range from 10 mm to 80 mm. In some embodiments, dimension D can range from 40 mm to 55 mm. Other configurations of ranges for dimension D are envisioned, 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.

[0126] The coaptation assist element 500 can include a dimension E. Dimension E can be a linear protruding dimension or an anterior protrusion. In some embodiments, dimension E can range from 2 mm to 20 mm. In some embodiments, dimension E can range from 5 mm to 10 mm. Other configurations for the range of dimension E are contemplated, such as 0 mm to 25 mm, 5 mm to 20 mm, 10 mm to 15 mm, about 1 mm, about 2 mm, about 3 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, about 11 mm, about 12 mm, about 13 mm, about 14 mm, about 15 mm, about 16 mm, about 17 mm, about 18 mm, about 19 mm, about 20 mm, 1 mm to 10 mm, 5 mm to 15 mm, 10 mm to 20 mm, 15 mm to 25 mm, 20 mm to 30 mm, 25 mm to 35 mm, 30 mm to 40 mm, etc. If there is no front protrusion, dimension E can be 0 mm.

[0127] The struts 530 of the coaptation assist element 500 can form a backbend of the coaptation surface 560. The backbend can have a bend length of 30-100% distal to the strut. In some embodiments, the backbend can have a bend length of at least 40% distal to the strut. The angle of the backbend can range from 0 degrees to 90 degrees relative to the longitudinal axis of the coaptation assist element 500. In some embodiments, the angle of the backbend can range from 45 degrees to 90 degrees.

[0128] 6 illustrates one embodiment of coaptation assist element 600. Coaptation assist element 600 can be similar to coaptation assist element 500 and can include any of the features of coaptation assist element 500 described herein, as well as certain additional features described below.

[0129] The coaptation assist element 600 can include an annulus hub 620 that engages with an annulus anchor (not shown). The annulus hub 620 can have an integral or coupled annulus anchor, such as annulus anchor 800 described herein. The annulus anchor can include a helix that is rotatable relative to the annulus hub 620. In some embodiments, the coaptation assist element 600 can include a single annulus anchor within the annulus hub 620. The coaptation assist element 600 can be delivered percutaneously as described herein by attaching a delivery catheter to the annulus hub 620.

[0130] As can be seen in FIG. 6 , the coaptation assist element 600 can include struts 630. In some embodiments, one, two, or more struts 630 have one end that terminates at the annulus hub 620 and another end that extends radially outward toward the upper edge 640, the lateral edges 670 and 675, and the lower edge 680 of the coaptation assist element 600. The struts 630 can extend outward from the hub 620. The struts 630 can be aligned generally parallel to the longitudinal axis of the coaptation assist element 600 to help maintain the shape of the coaptation assist element 600 during deployment. The struts 630 can enable the coaptation assist element 600 to adopt a reduced configuration for deployment through a catheter.

[0131] The coaptation assist element 600 may include an annular segment 610. When the coaptation assist element 600 is deployed and forms a lip as shown, the annular segment 610 may be positioned above the annulus of the native valve leaflet. In some embodiments, the annular segment 610 may curve upward, e.g., away from the annulus, in a direction substantially opposite and substantially parallel to the coaptation surface 660, and may form the uppermost portion of the coaptation assist element 600 when implanted. The annular segment 610 may be convex. In other embodiments, the annular segment 610 may be substantially flat relative to the annulus. One or more of the struts 630 may curve laterally from the annular hub 620 toward the upper edge 640 to help maintain the shape of the annular segment 610 of the coaptation assist element 600 during deployment. The coaptation assist element 600 may curve upward from the annular hub 620. In some embodiments, the upper edge 640 does not contact the posterior leaflet. The upper edge 640 may include an annular radius of curvature. The annular curve radius can curve away from the annulus. The annular curve radius can curve toward the coaptation surface 660. In some embodiments, the annular curve radius can be between 0 mm and 5 mm, between 5 mm and 10 mm, between 10 mm and 15 mm, between 15 mm and 20 mm, between 20 mm and 25 mm, between 25 mm and 30 mm, etc., or a range incorporating any two of the foregoing values. The coaptation assist element body cover 650 can be similar to the coaptation assist element body cover 550 described herein.

[0132] In some embodiments, the periphery of the annular section 610 is cupped upward and in a direction substantially opposite the longitudinal axis of the coaptation surface 660. In some embodiments, the coaptation assist element 600 includes an annulus anchor site similar to the annulus anchor site 535. In other embodiments, the coaptation assist element 600 does not include an annulus anchor site as shown in FIG.

[0133] 7A-7E illustrate one embodiment of coaptation assist element 700. Coaptation assist element 700 can be similar to coaptation assist elements 500 or 600 and can include any of the features described herein, with certain elements described below.

[0134] The coaptation assist element 700 can include a first surface 705 and a second surface 715. FIG. 7A shows a perspective view of the first surface 705, i.e., the lower surface that is disposed toward the mal-coapted native valve leaflet, or in the case of the mitral valve, the posterior leaflet. FIG. 7B shows a perspective view of the second surface 715, i.e., the upper surface that may be disposed toward the anterior leaflet. The second surface 715 can include a coaptation surface 760. The upper edge 740 of the coaptation assist element 700 can be curved to match the overall shape of the valve annulus or the adjacent atrial wall. The upper edge 740 can be curved downward toward the posterior leaflet, as shown in FIG. 7B. FIG. 7C shows a top view of the coaptation assist element 700.

[0135] 7A-7C show views of a coaptation assist element 700 having an annulus hub 720. The coaptation assist element 700 can include an annulus hub 720 designed to engage an annulus anchor 800. The annulus anchor 800 can be engaged at its proximal end by a driver, as described herein. The annulus hub 720 can have an integrated or coupled annulus anchor 800. The annulus anchor 800 can include a helix that is rotatable relative to the annulus hub 720. The coaptation assist element 700 can be delivered percutaneously, as described herein, by attaching a delivery catheter to the annulus hub 720.

[0136] As can be seen in Figures 7A-7C, the coaptation assist element 700 can include struts 730. In some embodiments, one or more struts 730 have one end that terminates at the annulus hub 720 and another end that extends radially outward toward the upper edge 740, lateral edges 770 and 775, and lower edge 780 of the coaptation assist element 700 shown in Figure 7B. The annulus anchor region 735 is shown extending downward from the body of the coaptation assist element 700 in Figure 7B. The annulus anchor 800 can be an active anchor. The annulus anchor region 735 can be a passive anchor, such as a barb. The annulus anchor region 735 can be at the distal end of one or more struts 730.

[0137] The annular segment 710 can be positioned above the native valve leaflets when the coaptation assist element 700 is deployed. In some embodiments, the annular segment 710 can be curved toward the valve annulus or atrial wall. One or more of the struts 730 can be curved laterally from the hub 720 toward the upper edge 740 to help maintain the shape of the annular segment 710 of the coaptation assist element 700 during deployment. The coaptation assist element 700 can be curved downward from the annulus hub 720 toward the annulus anchor site 735. The annular segment 710 can be concave. In some embodiments, one or more support structures can be provided that extend parallel to the upper edge 740 of the coaptation assist element 700 and help maintain the shape of the upper edge 740. The struts 730 and / or other support structures of the frame can be laser cut from a nitinol tube in some embodiments. The valve body cover 750 can be constructed of materials as described herein.

[0138] In some embodiments, coaptation assist element 700 includes an active anchor, such as annulus anchor 800. In some embodiments, coaptation assist element 700 includes a passive anchor, such as annulus anchor site 735. Annulus anchor site 735 can include barbs at the tips of one or more struts 730.

[0139] Coaptation assist element 700, like any of the coaptation assist elements 500, 600 described herein, can include one or more markers 900. Markers 900 can be positioned on any portion of coaptation assist element 500, 600, 700, or on any portion of any element of the coaptation assist element, such as struts 530, 630, 730, annulus hub 520, 620, 720, purse string suture 1010, and / or annulus anchor site 535, 735. In some embodiments, marker 900 is positioned on annulus anchor 800. In other embodiments, marker 900 is integrally formed with coaptation assist element 500, 600, 700, or annulus anchor 800. Multiple markers 900 can be arranged in a particular pattern on the coaptation assist element to provide a fluoroscopic visual aid for the practitioner to accurately orient and position the coaptation assist element 500, 600, 700 and / or annulus anchor 800 within the patient's heart.

[0140] In some embodiments, the markers 900 may be radiopaque or may be covered with a radiographic marker. The markers 900 may be visualized when a fluoroscope is used during the process of delivering the coaptation assist elements 500, 600, 700 and / or the annulus anchor 800. The markers 900 may aid in positioning the coaptation assist elements 500, 600, 700 and / or the annulus anchor 800 within the patient's heart. In some embodiments, a torque may be applied to the annulus anchor 800 to drive it into the tissue. Fluoroscopic markers 900 may be present on the annulus anchor 800 to provide feedback on whether the annulus anchor 800 is properly secured. The markers may be located on the proximal end. These markers 900 may inform the medical team how far the annulus anchor 800 has traveled toward the annulus hub 520, 620, 720 and may be informative as to when the annulus anchor 800 is safely in place. In some embodiments, to ensure proper torque is applied, the amount of torque at the handle may increase sharply when the annulus anchor 800 is lowest on the annulus hub 520, 620, 720. The systems described herein can include one or more markers 900 (e.g., 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, more than 1, more than 2, more than 3, more than 4, etc.). The systems described herein can include two or more different markers 900. The different markers can indicate different components of the system, different portions of the coaptation assist element 500, 600, 700, or positioning points such as the proximal-most point, the distal-most point, the midline, etc.

[0141] Figures 7D-7E show one embodiment of a coaptation assist element 700 deployed within a mitral heart valve model. Referring again to Figure 1F, the coaptation area CL between the valve leaflets is not a simple line but rather a curved, funnel-shaped surface interface as shown in Figure 7C. The first commissure 110 (anterolateral or left) and second commissure 114 (posteromedial or right) are where the anterior leaflet 12 meets the posterior leaflet at the coaptation area, forming the coaptation line (CL). As can be seen most clearly in the axial view from the atrium in Figure 7D, an axial cross-section of the coaptation area generally shows the curved line CL, which is separate from the center of the annulus and from the opening through the valve during diastole. Additionally, the leaflet edges are wavy, with the posterior leaflet being more wavy than the anterior leaflet. Because dyssynchrony can occur between one or more of these AP (anterior-posterior) segment pairs, A1 / P1, A2 / P2, and A3 / P3, the characteristics of dyssynchrony can vary along the junctional curve CL, as shown in Figure 1F.

[0142] In some embodiments, the coaptation assist element 700 is placed over the posterior leaflet to create a new surface onto which the native leaflet, here the anterior leaflet, can coapt. The mitral valve is shown with the anterior leaflet 12. The coaptation area occurs between the anterior leaflet 12 and the coaptation surface 760 of the coaptation assist element 700.

[0143] Referring next to FIG. 8A , an embodiment of a delivery catheter 1000 is shown. The delivery catheter 1000 can include a control handle. The delivery catheter 1000 can include a tip deflection control 1001. The tip deflection control 1001 can allow a distal portion of the delivery catheter 1000 to bend. This can be advantageous for positioning the coaptation assist element 500, 600, 700 within the mitral valve. The delivery catheter 1000 can 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 can further 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, to be infused into the implantation site. The catheter 1000 can include a catheter shaft 1006. The catheter 1000 can include an implant inserter 1007.

[0144] The delivery catheter 1000 may include an implant control knob 1003. The implant control knob 1003 may control the movement of the coaptation assist elements 500, 600, 700. The implant control knob 1003 may be configured to collapse the coaptation assist elements 500, 600, 700. The implant control knob 1003 may be configured to expand the coaptation assist elements 500, 600, 700. Arrow 1003a indicates the direction of movement of the implant control knob 1003 in which the coaptation assist elements 500, 600, 700 are collapsed and / or expanded by the delivery catheter 1000. The implant control knob 1003 may be configured to rotate the coaptation assist elements 500, 600, 700. Arrow 1003b indicates the direction of movement of the implant control knob 1003 in which the coaptation assist elements 500, 600, 700 are rotated.

[0145] The implant control knob 1003 can be internally connected to the coaptation assist elements 500, 600, 700 to allow for axial movement and / or torque transmission. For example, the implant control knob 1003 of the delivery catheter 1000 can be coupled to the annulus hub 520, 620, 720. For example, the implant control knob 1003 can be connected to one or more purse string sutures 1010, which can control deployment of the coaptation assist elements 500, 600, 700. The purse string sutures 1010 can facilitate folding and / or expansion of the coaptation assist elements 500, 600, 700, as described herein. The purse string sutures 1010 can facilitate rotation of the coaptation assist elements 500, 600, 700, as described herein. In some embodiments, the delivery catheter 1000 releasably engages the coaptation assist elements 500 , 600 , 700 such that axial movement and torque can be transferred from the delivery catheter 1000 to the coaptation assist elements 500 , 600 , 700 .

[0146] In some embodiments, the tip 1300 of the delivery catheter 1000 is releasably coupled to the annulus hub 520, 620, 720. For example, the tip 1300 of the delivery catheter 1000 can be locked onto the annulus hub 520, 620, 720 such that movement of the delivery catheter 1000 moves the coaptation assist element 500, 600, 700. In some embodiments, the system includes a release mechanism between the delivery catheter 1000 and the annulus hub 520, 620, 720.

[0147] The annulus hub 520, 620, 720 may have features that allow it to lock onto the tip 1300 of the delivery catheter 1000. Referring again to FIGS. 5A-7E, the annulus hub 520, 620, 720 may include one or more features that engage with a portion of the delivery catheter 1000. The features may include one or more notches in the hub 520 of the implant, as shown in FIG. 5A. The features may include an internal lip, as shown in FIG. 9A. The features may include a window accessible from the outside of the hub 520, 620, 720, as shown in FIG. 8C. The features may include any structure or mechanism that allows the annulus hub 520, 620, 720 to couple to a portion of the delivery catheter 1000. In some embodiments, the annulus hub 520, 620, 720 and the delivery catheter 1000 are coupled via a threaded mechanism. For example, the annulus hub 520, 620, 720 can include female threads, and the distal end of the delivery catheter 1000 can include male threads. In some embodiments, the annulus hub 520, 620, 720 and the delivery catheter 1000 are coupled via a noose and pin configuration. For example, the annulus hub 520, 620, 720 can include a pin, such as an outwardly extending pin, and the distal end of the delivery catheter 1000 can include a loop or hoop designed to tighten around the pin. Other configurations are envisioned.

[0148] 8B shows the coaptation assist elements 500, 600, 700 coupled to a delivery catheter 1000. The coaptation assist elements 500, 600, 700 can be collapsed as shown or expanded as shown by the dashed lines by movement along arrow 1003a. The coaptation assist elements 500, 600, 700 can be rotated as shown by the dashed lines by movement along arrow 1003b.

[0149] 8C , the delivery catheter 1000 can include a tip 1300. The distal end of the tip 1300 can include distal locking tabs. In some embodiments, the tip 1300 includes multiple pre-bent or shaped locking tabs. In some embodiments, the tip includes two locking tabs, three locking tabs, four locking tabs, five locking tabs, multiple locking tabs, multiple locking tabs, etc. This “AT Lock” (axial-torsional lock) can include nitinol locking tabs on the tip 1300. In some embodiments, the locking tabs on the tip 1300 can be actuated by a sheath 1350. In some embodiments, the sheath 1350 is hollow to allow movement of other components, such as the drivers described herein. Movement of the sheath 1350 can force the locking tabs inward to engage the annulus hub 520, 620, 720. In some embodiments, the locking tabs on the tip 1300 engage features such as windows or lips on the annulus hub 520, 620, 720. In some embodiments, movement of the sheath 1350 in the opposite direction can release the annulus hub 520, 620, 720 from the tip. In other embodiments, the locking tabs on the tip 1300 can be actuated by a central pin (not shown) inserted within the tip 1300. In some embodiments, the central pin is hollow to allow for movement of other components, such as a driver as described herein. Movement of the central pin can force the locking tabs outward to engage the annulus hub 520, 620, 720.

[0150] In some embodiments, the distal end of the tip 1300 can be actuated to lock the delivery catheter 1000 to the annulus hub 520, 620, 720. In some embodiments, the distal end of the tip 1300 can be actuated to unlock the delivery catheter 1000 from the annulus hub 520, 620, 720. As described herein, a support structure, such as a purse string suture, may remain coupled to the coaptation assist element 500, 600, 700 after the annulus hub 520, 620, 720 is released from the tip 1300. In some embodiments, when the delivery catheter 1000 is unlocked, one or more support structures, such as a purse string suture described herein, can maintain the relative position between the delivery catheter 1000 and the annulus hub 520, 620, 720. The tip 1300 may be repeatedly locked and unlocked during the procedure.

[0151] 8A , the delivery catheter 1000 can include an anchor control knob 1004. In some embodiments, the anchor control knob 1004 can enable release of the annulus anchor 800 and / or the coaptation assist elements 500, 600, 700. In some embodiments, the anchor control knob 1004 can enable engagement of the annulus anchor 800, for example, to rotate the annulus anchor 800 and / or to move the annulus anchor 800 axially. In some embodiments, the anchor control knob 1004 can enable detachment of the annulus anchor 800. In some embodiments, the anchor control knob 1004 can control a driver 1200 configured to apply torque. In some embodiments, the anchor control knob 1004 can control a driver 1200 configured to apply tension to and / or release the coaptation assist elements 500, 600, 700. In some embodiments, the anchor control knob 1004 can control a driver 1200 configured to apply tension and torque.

[0152] The anchor control knob 1004 of the delivery catheter 1000 may be coupled to the annulus anchor 800 to allow torque to be transmitted to the annulus anchor 800. The anchor control knob 1004 may allow for simple manipulation of the torque or position of the annulus anchor 800. Arrow 1004a indicates the direction of movement of the anchor control knob 1004 to engage or disengage the annulus anchor 800. For example, moving the anchor control knob 1004 toward the annulus anchor 800 may engage the driver 1200 with the annulus anchor 800. Arrow 1004b indicates the direction of movement of the anchor control knob 1004 to transmit torque to the annulus anchor 800. In some embodiments, arrow 1004b indicates the direction to release the annulus anchor 800. For example, applying additional torque may twist the driver 1200 out of engagement with the annulus anchor 800.

[0153] One embodiment of the annulus anchor 800 is shown in detail in FIG. 9A . Other components of the delivery catheter 1000, such as components that engage the annulus hub 520, 620, 720, are not shown in FIG. 9A . The annulus anchor 800 may be coupled to the driver 1200 in various ways, as described herein. The annulus anchor 800 may be coupled to the coaptation assist element 500, 600, 700 in various ways. In some embodiments, the annulus hub 520, 620, 720 may have a cross pin 820. The cross pin 820 can provide a region around which the helical structure 815 of the annulus anchor 800 can wrap, as shown. The annulus anchor 800 can have a shoulder 805. The shoulder 805 can fit around the outside of the driver 1200 of the delivery catheter 1000.

[0154] In some embodiments, the driver 1200 is releasably coupled to the annulus anchor 800. The driver 1200 can be coupled and / or controlled by an anchor control knob 1004 described herein. One or more drivers 1200 can deliver torque to drive the annulus anchor 800 into tissue. One or more drivers 1200 can deliver tension to hold and / or release the annulus 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 lock onto the annulus anchor 800 such that movement of the driver 1200 moves the annulus anchor 800. In some embodiments, the system includes a release mechanism between the driver 1200 and the annulus anchor 800. In some embodiments, the distal end of the driver 1200 can be actuated to lock the driver 1200 onto the annulus anchor 800. In some embodiments, the distal end of driver 1200 can be actuated to unlock driver 1200 from annulus anchor 800. In some embodiments, when driver 1200 is unlocked, one or more auxiliary structures, such as a purse string suture, can maintain the relative position between delivery catheter 1000 and annulus anchor 800. During the procedure, driver 1200 may be repeatedly locked and unlocked.

[0155] FIG. 9B shows one embodiment of a driver 1200. The driver 1200 can include a torque shaft 1205. The torque shaft 1205 can include a loop 1210. The loop 1210 can engage with a pin 1215, which extends around a tension cross pin 1270 and through the anchor 800 to form a loop. Rotation of the torque shaft 1205 can cause a torque to be applied to the torque cross pin 1275, thereby rotating the annulus anchor 800. In some embodiments, the annulus anchor 800 can include a torque cross pin and a tension cross pin. A separate driver (not shown) can apply torque to the tension cross pin to apply tension to the annulus anchor 800. One or more drivers 1200 can engage with the annulus anchor 800 to deliver torque. One or more drivers 1200 can engage with the annulus anchor 800 to deliver tension. In some embodiments, delivery of the annulus anchor 800 is independent of rotation of the coaptation assist elements 500, 600, 700.

[0156] FIG. 9C illustrates one embodiment of a driver 1200. The driver 1200 can include a torque shaft 1220. The torque shaft 1220 can include an anchor docking cap 1225. The anchor docking cap 1225 can engage the annulus anchor 800 in a single orientation or one of multiple orientations. In some embodiments, the annulus anchor 800 includes a protrusion 1230, and the anchor docking cap 1225 is designed to receive the protrusion 1230. In other embodiments, the annulus anchor 800 includes a recess (not shown) that receives a mating protrusion (not shown) on the anchor docking cap 1225. Rotation of the torque shaft 1220 can cause a torque to be applied to the annulus anchor 800. A separate driver 1235 can apply tension to the annulus anchor 800. In some embodiments, the driver 1235 can include a release screw. In other embodiments, the loop and pin release mechanism described in FIG. 9B can be used. The release screw can be rotated to release the annulus anchor 800. One or more drivers 1200 can engage with the annulus anchor 800 to deliver torque. One or more drivers 1200 can engage with the annulus anchor 800 to deliver tension.

[0157] 9D shows one embodiment of a driver 1200 and annulus anchor 800. The driver 1200 can include a torque shaft 1220. The torque shaft 1220 can include an anchor docking cap 1225. In some embodiments, the annulus anchor 800 includes a protrusion 1230, and the anchor docking cap 1225 is designed to receive the protrusion 1230. In other embodiments, the annulus anchor 800 includes a recess (not shown) that receives a mating protrusion (not shown) on the anchor docking cap 1225. Two or more wires 1240, 1245 can apply tension to the annulus anchor 800. In some embodiments, the wire 1240 acts as a pin, and the wire 1245 terminates in a ball. In the retained state, both wires 1240, 1245 are positioned within an opening in the annulus anchor 800. The opening is small enough to prevent the pin and ball-shaped ends of the wires 1240, 1245 from passing side-by-side. In some methods of use, wire 1240 is retracted first. Retraction of wire 1240 provides enough room to retract wire 1245. Wires 1240, 1245 can be actuated to release annulus anchor 800. One or more drivers 1200 can engage with annulus anchor 800 to deliver torque. One or more drivers 1200 can engage with annulus anchor 800 to deliver tension.

[0158] FIG. 9E illustrates one embodiment of a driver 1200. The driver 1200 can include a torque shaft 1255. The shoulder 805 can have features, such as a window 810, that can lock with one or more distal locking tabs 1265 of the torque shaft 1255. The distal locking tabs 1265 can include a nitinol material, such as a shape-set NiTi clip. The distal locking tabs 1265 can be pushed outward into the window 810 by the driver 1260. The driver 1260 acts as a release mechanism. Longitudinal movement of the driver 1260 toward the annulus anchor 800 can push the distal locking tabs 1265 outward toward the window 810. Longitudinal movement of the driver 1260 away from the annulus anchor 800 can return the distal locking tabs 1265 to a neutral configuration and disengage from the window 810. The distal locking tab 1265 may be engaged with the window 810 of the annulus anchor 800 to allow axial movement to be transferred between the torque shaft 1255 and the annulus anchor 800. The distal locking tab 1265 may be engaged with the window 810 of the annulus anchor 800 to allow torque to be transferred between the torque shaft 1255 and the annulus anchor 800. In embodiments in which the annulus anchor 800 is embedded in or captured by the annulus hub 520, 620, 720, the distal locking tab 1265 may be engaged with the window 810 to allow axial movement to be transferred between the delivery catheter and the coaptation assist element 500, 600, 700.

[0159] In some embodiments, an advantage may be that the annulus anchor 800 can be rotated independently of the coaptation assist elements 500, 600, 700. As described herein, the coaptation assist elements 500, 600, 700 are coupled to the delivery catheter 1000. As described herein, the annulus anchor 800 is independently coupled to the driver 1200. The annulus anchor 800 can be rotated independently of the annulus hub 520, 620, 720. The annulus hub 520, 620, 720 can remain stationary as the annulus anchor 800 is rotated to engage tissue.

[0160] In some methods, the annulus anchor 800 can be pre-loaded onto the coaptation assist element 500, 600, 700 and coupled to the driver 1200 during the process of loading the coaptation assist element 500, 600, 700 onto the delivery catheter 1000. This can be done before the coaptation assist element 500, 600, 700 is retracted into the implant sheath and / or another portion of the delivery catheter 1000, ready for insertion into the femoral vein. As described herein, torque can be applied to drive the annulus anchor 800 into tissue. In some embodiments, to ensure proper torque is applied, a sudden increase in torque amount at the handle may be felt when the annulus anchor 800 is lowest on the annulus hub 520, 620, 720. This increase in torque amount may be felt at the handle to provide feedback that the proper torque is being applied. In other embodiments, radiopaque markings may help visually determine the level of engagement between the anchor and the tissue. In some embodiments, markings may be placed on the annulus anchor 800 and / or the coaptation assist element 500, 600, 700.

[0161] 10-15 illustrate various methods that may be performed during a method of using the coaptation assist element 500, 600, 700. The method may include folding the coaptation assist element 500, 600, 700. The method may include coupling the coaptation assist element 500, 600, 700 to the delivery catheter 1000. The method may include coupling the locking tab 1265 to the annulus anchor 800 and / or the coaptation assist element 500, 600, 700. The method may include any of the steps described herein for manufacturing the coaptation assist element 500, 600, 700.

[0162] In some embodiments, an advantage is that the coaptation assist element 500, 600, 700 can be delivered in a hub-leading orientation. This method of use allows the annulus hub 520, 620, 720 to be moved into position relative to the anatomy prior to other portions 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 be retained within the delivery catheter 1000 until the annulus hub 520, 620, 720 is positioned. In some methods of use, the coaptation assist element 500, 600, 700 can be expanded once the annulus hub 520, 620, 720 and / or the annulus anchor 800 is engaged with tissue. In some methods of use, the ventricular end of the coaptation assist element 500, 600, 700 can be positioned once the annulus hub 520, 620, 720 and / or the annulus anchor 800 is engaged with tissue.

[0163] In some embodiments, an advantage is that the coaptation assist element 500, 600, 700 can be delivered in a strut-leading 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 into position relative to the anatomy prior to the delivery of other portions of the coaptation assist element 500, 600, 700. In some methods of use, the coaptation assist element 500, 600, 700 can be expanded or partially expanded before the annulus hub 520, 620, 720 is positioned. In some methods of use, the annulus hub 520, 620, 720 can be retained within the delivery catheter until one or more of the struts 530, 630, 730 are positioned. In some methods of use, the annulus anchor 800 is engaged with tissue once the struts 530, 630, 730 are positioned.

[0164] FIG. 10 illustrates one embodiment of a transseptal crossing. The method may include femoral vein access. Access may be gained through a blood vessel, such as the femoral vein, to reach a chamber of the heart, such as the right atrium 1300. The left ventricle 1380 and its papillary muscles are also shown at 1360. The method may include transseptally puncturing and crossing into the left atrium 1320 using a standard transseptal kit 1330. The method may include exchanging for a custom transseptal sheath and delivery catheter 1000 as described herein. The transseptal puncture kit may be exchanged for a transseptal sheath and dilator, and the dilator may be exchanged for an implant delivery catheter as described herein and as described in U.S. Patent 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 within the scope of the present invention.

[0165] FIG. 11 illustrates the initial advancement of the coaptation assist elements 500, 600, 700. The method may include advancing the coaptation assist elements 500, 600, 700 within a retrieval sheath. The retrieval sheath may include a tip having multiple petals radiating from a central hub 1420. The retrieval sheath may be positioned within a transseptal sheath 1400. The mitral valve is shown at the base of the left atrium 1440. The method may include advancing the annular section 510, 610, 710 toward the annulus before advancing the coaptation surfaces 560, 660, 760 toward the annulus. The method may include deploying the ventricular end or lower edge 580 after deploying the annular section 510.

[0166] FIG. 12 illustrates partial deployment of the coaptation assist element 500, 600, 700. The coaptation assist element 500, 600, 700 may be advanced near the target location under imaging guidance, such as ultrasound or fluoroscopy. The annulus anchor 800 coupled with the coaptation assist element 500, 600, 700 is engaged with tissue. The anchor torque shaft 1540 may be rotated internally and independently of the rotation of the implant torque shaft (not shown). The coaptation assist element 500, 600, 700 may be expanded by controlled release of the purse string suture 1010 around the periphery of the coaptation assist element 500, 600, 700. Before the coaptation assist element 500, 600, 700 is fully expanded, rotational adjustment of the coaptation assist element 500, 600, 700 may be performed to align the internal (ventricular) section of the coaptation assist element 500, 600, 700 with the valve opening 1580.

[0167] The method may include advancing the coaptation assist element 500, 600, 700 toward the target location. The method may include advancing the annulus hub 520, 620, 720 toward the target location. The method may include advancing the annulus anchor 800 coupled to the annulus hub 520, 620, 720 toward the target location. The method may include echo or fluoroscopic guidance of the annulus anchor 800, the hub 520, 620, 720, and / or the coaptation assist element 500, 600, 700. The method may include engaging the annulus anchor 800 with tissue. The method may include rotating the anchor control knob 1004 to rotate the annulus anchor 800. The method may include rotating the annulus anchor 800 independently of the hub 520, 620, 720. The method may include holding the hub 520, 620, 720 stationary during rotation of the annulus anchor 800. The method may include controlled release of the purse string suture 1010. The release may cause the coaptation assist element 500, 600, 700 to expand. The purse string suture 1010 may be disposed within and / or along the periphery of the coaptation assist element 500, 600, 700. The purse string suture 1010 may facilitate folding and / or expansion of the coaptation assist element 500, 600, 700. The method may include rotational adjustment of the coaptation assist element 500, 600, 700 to align the lower edge 580, 680, 780 or the ventricular compartment of the coaptation assist element 500, 600, 700 with the valve opening. The method may include rotationally adjusting the coaptation assist element 500, 600, 700 to align the lower edge 580, 680, 780 or ventricular compartment about the posterior apex.

[0168] FIG. 13 illustrates the recapture of the coaptation assist element 500, 600, 700. The coaptation assist element 500, 600, 700 may be recaptured by tightening the purse string suture 1010 around a portion of the perimeter 1620 of the coaptation assist element 500, 600, 700, thereby folding the coaptation assist element 500, 600, 700. The perimeter may include any edge, any combination of edges, or all of the edges described herein. The recapture sheath and transseptal sheath 1600 may be advanced over the folded coaptation assist element 500, 600, 700. Petals of the recapture sheath radiating from a central hub may extend over the coaptation assist element 500, 600, 700, allowing the coaptation assist element 500, 600, 700 to be retracted into the transseptal sheath. The annulus anchor 800 may be unscrewed or otherwise released, and the system may be removed. Partially encapsulated coaptation assist elements 500, 600, 700 in the petals of a prolapsed or recapture sheath may be another delivery mode. An encapsulated-first delivery mode may be in contrast to a hub-first or strut-first delivery mode.

[0169] In some methods, recapture is optional. The method may include tightening the purse string suture 1010. This tightening may collapse the coaptation assist element 500, 600, 700. The method may include advancing a recapture sheath and / or a transseptal sheath over the collapsed coaptation assist element 500, 600, 700. The recapture sheath may fold outward and unfold over the coaptation assist element 500, 600, 700. The method may include retracting the coaptation assist element 500, 600, 700 into the transseptal sheath. The method may include rotating the annulus anchor 800 to disengage it from the tissue. The method may include removing the coaptation assist element 500, 600, 700 and the annulus anchor 800.

[0170] 14 shows a cross-sectional view of the deployed coaptation assist elements 500, 600, 700. The method may include releasing the coaptation assist elements 500, 600, 700. The method may include retracting the delivery catheter 1000.

[0171] FIG. 15 illustrates the deployment of auxiliary anchors. In some methods, the deployment of auxiliary anchors is optional. The method may include engaging the annulus attachment sites 535, 735 with the annulus. The method may include engaging a ventricular anchor. The method may include engaging a commissure anchor 1650. The method may include deploying markers at strategic locations on the coaptation assist elements 500, 600, 700 and / or the annulus anchor 800. The method may include detecting the markers, such as detecting radiopaque markers. The method may include facilitating placement of the anchor 800 under fluoroscopy. The method may include placing radiopaque markers along the periphery of the coaptation assist elements 500, 600, 700 to indicate the shape of the coaptation assist elements 500, 600, 700.

[0172] In some embodiments, the manufacturer provides instructions for using the system that include one or more of the steps disclosed herein or any steps previously described or specific in the drawings.

[0173] 16-30 illustrate various methods that may be performed during a method of using the coaptation assist element 500, 600, 700. The methods may include any of the steps disclosed herein, according to some embodiments of the present invention. The methods may include any of the steps disclosed herein for manufacturing and / or deploying the coaptation assist element 500, 600, 700. The methods may include folding the coaptation assist element 500, 600, 700.

[0174] 16 illustrates a method of implant delivery showing the loading of the coaptation assist elements 500, 600, 700. The coaptation assist elements 500, 600, 700 can be folded as described herein. The folded coaptation assist elements 500, 600, 700 can be loaded into a transseptal sheath introducer 1700. The transseptal sheath introducer 1700 can include a sheath having a lumen that receives the folded coaptation assist elements 500, 600, 700. The folded coaptation assist elements 500, 600, 700 can be inverted within the transseptal sheath introducer 1700. The annulus 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 can include loading the coaptation assist element 500, 600, 700 into the transseptal sheath introducer 1700.

[0175] FIG. 17 illustrates a method of inserting a transseptal sheath introducer 1700 into a transseptal sheath 1715. The transseptal sheath introducer 1700 can include a multi-lumen catheter 1710. The multi-lumen catheter 1710 and / or the transseptal sheath introducer 1700 can include a hub 1720. The hub 1720 can be connected to the transseptal sheath 1715. The proximal end of the transseptal sheath 1715 is shown in FIG. 17. In FIG. 17, the transseptal sheath introducer 1700 is not connected to the transseptal sheath 1715. In FIG. 18, the transseptal sheath introducer 1700 is connected to the transseptal sheath 1715. The method can include connecting the transseptal sheath introducer 1700 to the transseptal sheath 1715. The method can include connecting an assembly comprising the coaptation assist elements 500 , 600 , 700 to the transseptal sheath 1715 .

[0176] 19 illustrates a method of advancing the transseptal sheath introducer 1700. The transseptal sheath introducer 1700 can be advanced to the distal end of the transseptal sheath 1715. The coaptation assist elements 500, 600, 700 can be advanced through the transseptal sheath 1715. The folded coaptation assist elements 500, 600, 700 can be inverted while being advanced through the transseptal sheath 1715. In FIG. 19, the coaptation assist elements 500, 600, 700 are at the distal end of the transseptal sheath 1715.

[0177] FIG. 20 illustrates a method of positioning a transseptal sheath 1715. The coaptation assist element 500, 600, 700 can be positioned at the distal end of the transseptal sheath 1715 during positioning. The transseptal sheath 1715 can be positioned at the annulus. The transseptal sheath 1715 can be positioned over the posterior leaflet. The transseptal sheath 1715 can be centered over P2 as described herein. The method can include positioning the coaptation assist element 500, 600, 700 at the posterior leaflet. The method can include centering the coaptation assist element 500, 600, 700 over P2. The method can include positioning the coaptation assist element 500, 600, 700 within the valve annulus. The transseptal sheath 1715 can be rotated as indicated by the arrow. The transseptal sheath 1715 can be rotated to position the coaptation assist element 500, 600, 700. The transseptal sheath 1715 can modify the atrial / ventricular orientation. The transseptal sheath 1715 can include one or more markings / indicia 1725. The markings 1725 can allow a user to guide the rotation of the transseptal sheath 1715. The markings 1725 can allow a user to modify the orientation of the annular portion of the coaptation assist element 500, 600, 700. The markings 1725 can allow a user to modify the orientation of the ventricular portion of the coaptation assist element 500, 600, 700. In some embodiments, the markings 1725 can include radiopaque markers. FIG. 20 shows the coaptation assist element 500, 600, 700 and the transseptal sheath 1715 centered over P2 in the mitral annulus. FIG. 20 illustrates the rotation of the coaptation assist element 500, 600, 700 and the transseptal sheath 1715.

[0178] 21 illustrates a method of delivering an anchor 800. The anchor 800 may include any of the features of the anchors described herein. The anchor 800 may be considered a P2 anchor based on the position of the anchor 800 after deployment. The anchor 800 may extend through the annulus hub 520, 620, 720, as described herein. The method may include delivering the anchor 800 while the coaptation assist element 500, 600, 700 is within the transseptal sheath 1715. In some embodiments, the anchor 800 is coupled to the annulus hub 520, 620, 720 of the coaptation assist element 500, 600, 700 prior to loading into the transseptal sheath 1715. In some embodiments, the anchor 800 is coupled to the annulus hub 520, 620, 720 of the coaptation assist element 500, 600, 700 while within the transseptal sheath 1715. In some embodiments, the anchor 800 is coupled to the annulus hub 520, 620, 720 of the coaptation assist element 500, 600, 700 after the transseptal sheath 1715 is positioned within the valve annulus. The method can include delivering the anchor 800 while the coaptation assist element 500, 600, 700 is within the transseptal sheath 1715. The coaptation assist element 500, 600, 700 can be centered over P2 of the valve annulus during delivery of the anchor 800. The anchor 800 can be inserted into the tissue of the valve annulus by rotating the anchor 800, as described herein.

[0179] 22A-22D illustrate a method for deploying the coaptation assist elements 500, 600, 700. The coaptation assist elements 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 elements 500, 600, 700 can be inverted within the transseptal sheath 1715. In some embodiments, the annular portion of the coaptation assist element 500, 600, 700 near the annulus hub 520, 620, 720 can be deployed first, as shown in FIG. 22A. In some embodiments, the ventricular portion of the coaptation assist element 500, 600, 700 can be deployed next, as shown in FIG. 22B. The coaptation assist element 500, 600, 700 can be inverted so that the ventricular portion extends proximally from the annular portion. In some embodiments, when the coaptation assist element 500, 600, 700 is deployed as shown in FIG. 22C, the coaptation assist element 500, 600, 700 can extend outward from P2. The coaptation assist element 500, 600, 700 can be everted so that the ventricular portion extends proximally from the annular portion. The coaptation assist element 500, 600, 700 can be everted so that the ventricular portion extends toward the transseptal sheath 1715.

[0180] In some embodiments, the coaptation assist element 500, 600, 700 can be folded back, as shown in FIG. 22D. The coaptation assist element 500, 600, 700 can be inverted from an initially deployed configuration so that the ventricular portion extends distally from the annular portion. The coaptation 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 coaptation assist element 500, 600, 700 by retracting the transseptal sheath 1715. FIGS. 22A-22D illustrate the deployment of the coaptation assist element 500, 600, 700.

[0181] 23-30 illustrate the deployment of one or more auxiliary anchors 850. Auxiliary anchor 850 can include any of the features of anchor 800. Auxiliary anchor 850 can comprise a helix or spiral structure. Auxiliary anchor 850 can be designed to engage cardiac tissue, such as tissue of a valve annulus. Auxiliary anchor 850 can include a bioinert material, such as platinum / Ir, nitinol alloy, and / or stainless steel.

[0182] FIG. 23 illustrates a method utilizing one or more auxiliary anchor guidewires. The coaptation assist element 500, 600, 700 can include one or more auxiliary anchor guidewires. In the illustrated embodiment, the coaptation assist element 500, 600, 700 can include a first guidewire 1730 and a second guidewire 1735. In some embodiments, the coaptation assist element 500, 600, 700 can include any number of auxiliary anchor guidewires (e.g., about or at least about 1, 2, 3, 4, 5, etc.). In some embodiments, the number of auxiliary anchor guidewires corresponds to (is equal to) the number of auxiliary anchors (e.g., one guidewire for one auxiliary anchor, two guidewires for two auxiliary anchors, etc.). FIG. 23 illustrates one embodiment of a docking tube 1740. The docking tube 1740 can include any of the features described herein, including those shown in FIGS. 42A-45K.

[0183] FIG. 23 illustrates the anchoring mode. The anchoring mode can correspond to one or more methods for evaluating the coaptation assist element 500, 600, 700. The anchoring mode can correspond to one or more methods for evaluating the function of the coaptation assist element 500, 600, 700 without the delivery system(s). In some embodiments, the anchoring mode can correspond to one or more methods for evaluating the function of the coaptation assist element 500, 600, 700 without the transseptal sheath 1715. The anchoring mode can evaluate function without the need for a substantial delivery system. FIG. 23 illustrates the deployed coaptation assist element 500, 600, 700. FIG. 23 illustrates the coaptation assist element 500, 600, 700 entering the anchoring mode by retracting the implant body. FIG. 23 illustrates the coaptation assist element 500, 600, 700 entering the anchoring mode by retracting the transseptal sheath 1715.

[0184] FIG. 24 illustrates a method involving a docking tube 1740. The docking tube 1740 can include internal threads. The docking tube 1740 can include an internally threaded DS hub that couples to the externally threaded portion 525, 625, 725 of the annulus hub 520, 620, 720. The docking tube 1740 can include an internally threaded hub that couples to the coaptation assist element 500, 600, 700. In some methods of use, the docking tube 1740 is removed for the tethered mode. FIG. 24 illustrates that retracting the docking tube 1740 places the coaptation assist element 500, 600, 700 in the tethered mode.

[0185] FIG. 24 illustrates a method involving an anchor driver 1745. The anchor driver 1745 can be disposed within the docking tube 1740. The anchor driver 1745 can include any of the features described herein, including those shown in FIGS. 42A-45K. The anchor driver 1745 can rotate the anchor 800 during the method illustrated in FIG. 21. The anchor driver 1745 can rotate the anchor 800 through the annulus hub 520, 620, 720. In some methods of use, the anchor driver 1745 is removed when in the anchoring mode. FIG. 24 illustrates that the coaptation assist element 500, 600, 700 enters the anchoring mode by retracting the anchor driver 1745.

[0186] The anchor driver 1745 can include a tether rail 1750. The tether rail 1750 can include any of the features described herein, including those shown in FIGS. 42A-45K. The tether rail 1750 can be secured to the anchor 800. The tether rail 1750 can enable a minimal force evaluation of the effectiveness of the coaptation assist elements 500, 600, 700 before releasing the coaptation assist elements 500, 600, 700. As an example, a user can verify that the coaptation assist elements 500, 600, 700 are functional. As an example, a user can verify that the native valve leaflets are coapting to the coaptation assist elements 500, 600, 700. As an example, a user can verify that the force acting on the coaptation assist elements 500, 600, 700 is within an acceptable range. As an example, a user can verify that the coaptation assist elements 500, 600, 700 have not deformed due to the forces of the native valve leaflets. As an example, a user can verify that the coaptation assist elements 500, 600, 700 have been deployed. As an example, a user can verify that the coaptation assist elements 500, 600, 700 span the entire mitral valve. The docking tube 1740 can be retracted as shown. As shown in FIG. 24, the tether rail 1750 can remain coupled to the anchor 800 during the tethering mode.

[0187] FIG. 25 illustrates a method of advancing auxiliary anchor guide rails. In the illustrated embodiment, the method can include a first guide rail 1755 and a second guide wire 1760. In some embodiments, the coaptation auxiliary element 500, 600, 700 can include any number of auxiliary anchor guide rails (e.g., one, two, three, four, five, etc.). In some embodiments, the number of auxiliary anchor guide rails corresponds to the number of auxiliary guide wires (e.g., one guide rail per auxiliary guide wire, two guide rails per two auxiliary guide wires, etc.). The first guide rail 1755 can be advanced along the first guide wire 1730. The second guide rail 1760 can be advanced along the second guide wire 1735. The method can involve advancing both auxiliary anchor guide rails 1755, 1760. The auxiliary anchor guide rails 1755, 1760 are shown over the guide wires 1730, 1735 in FIG. 25 .

[0188] The distal end 1765 of each auxiliary anchor guide rail 1755, 1760 can be threaded. In some embodiments, the distal end 1765 of each auxiliary anchor guide rail 1755, 1760 engages tissue within the valve annulus. The distal end 1765 can be threaded to temporarily secure the auxiliary anchor to the guide rail 1755, 1760 during delivery. In some embodiments, the distal end 1765 of each auxiliary anchor guide rail 1755, 1760 can reduce the likelihood of the auxiliary anchor accidentally disengaging from the auxiliary anchor guide rail 1755, 1760. The auxiliary anchor guide rails 1755, 1760 can reduce the likelihood of the auxiliary anchor becoming entangled with the guidewire 1730, 1735. In some embodiments, the diameter of the auxiliary anchor guide rails 1755, 1760 is equal to or greater than the pitch of the auxiliary anchors.

[0189] In some methods of use, the docking tube 1740 can be coupled to the coaptation assist element 500, 600, 700. Attachment can allow the anchor 800 to be recessed during delivery of the coaptation assist element 500, 600, 700. In some embodiments, the auxiliary anchor guide rails 1755, 1760 are advanced over the guidewires 1730, 1735 prior to deploying the anchor 800. In some embodiments, the auxiliary anchor guide rails 1755, 1760 are advanced over the guidewires 1730, 1735 after deploying the anchor 800. FIG. 25 shows the coaptation assist element 500, 600, 700 secured to the annulus, with the anchor 800 advanced with the auxiliary anchor guide rails to the surface of the coaptation assist element 500, 600, 700.

[0190] 26 illustrates a method of delivering the auxiliary anchor 1770. The auxiliary anchor 1770 is advanced over the first guide rail 1755. The auxiliary anchor 1770 can be advanced toward the joint auxiliary element 500, 600, 700. The auxiliary anchor 1770 can be installed using a driver 1775. The driver 1775 can translate the auxiliary anchor 1770 along the first guide rail 1755.

[0191] FIG. 27 illustrates a method of inserting the auxiliary anchor 1770. The driver 1775 can rotate the auxiliary anchor 1770 along the first guide rail 1755. The auxiliary anchor 1770 can be threaded through the coaptation assist element 500, 600, 700. The auxiliary anchor 1770 can be rotated to engage tissue beneath the coaptation assist element 500, 600, 700. FIG. 26 illustrates the coaptation assist element 500, 600, 700 secured to the annulus with the anchor 800 as the auxiliary anchor 1770 is delivered. FIG. 26 illustrates the coaptation assist element 500, 600, 700 secured to the annulus with the anchor 800 as the auxiliary anchor 1770 is inserted into tissue. The driver 1775 remains attached as shown in FIG. 27. The auxiliary anchor 1770 can be an internal anchor. The auxiliary anchor 1770 can be positioned internal to the anchor 800.

[0192] 28 illustrates a method of delivering the auxiliary anchor 1780. The auxiliary anchor 1780 is advanced over the second guide rail 1760. The auxiliary anchor 1780 can be advanced toward the coaptation auxiliary element 500, 600, 700. In some methods of use, the auxiliary anchor 1780 can be installed using a driver 1775. In some methods of use, the driver 1775 can be retracted along the first guide rail 1755 before being advanced along the second guide rail 1760. In other methods of use, the auxiliary anchor 1780 is installed using a different driver than the auxiliary anchor 1770. The driver 1775 can translate the auxiliary anchor 1780 along the first guide rail 1760. In some methods of use, the auxiliary anchor 1770 can be previously inserted into tissue.

[0193] The driver 1775 can rotate the auxiliary anchor 1780 along the second guide rail 1760. The auxiliary anchor 1780 can be threaded through the coaptation assist element 500, 600, 700. The auxiliary anchor 1780 can be rotated to engage tissue underneath the coaptation assist element 500, 600, 700. FIG. 28 shows the coaptation assist elements 500, 600, 700 secured to the annulus with anchor 800 and auxiliary anchor 1770 as the auxiliary anchor 1780 is delivered. FIG. 26 shows the coaptation assist elements 500, 600, 700 secured to the annulus with anchor 800 and auxiliary anchor 1770 as the auxiliary anchor 1780 is inserted into tissue. The auxiliary anchor 1780 can be an outer anchor. The auxiliary anchor 1780 can be positioned outside the anchor 800.

[0194] FIG. 29 shows the joint auxiliary elements 500, 600, 700 including auxiliary anchor guide wires 1730, 1735. The tether rail 1750 can remain coupled to the anchor 800. The auxiliary anchor guide wires 1730, 1735 remain connected. The delivery system can be reattached. In some uses, one or more of the guide rails 1755, 1760 can be reattached. In some uses, the driver 1775 is reattached. One or more of the auxiliary anchors 1770, 1780 can be removed. One or more of the auxiliary anchors 1770, 1780 can be repositioned. In some uses, the docking tube 1740 can be reattached. In some uses, the anchor driver 1745 can be reattached. The anchor 800 can be removed. The anchor 800 can be repositioned. The anchor 800 and the auxiliary anchors 1770, 1780 can be removed. The articulation assist elements 500, 600, 700 can be retrieved. Figure 29 shows the deployed and secured articulation assist elements 500, 600, 700 with the auxiliary anchor guide wires 1730, 1735 and tether rails 1750 remaining to allow for retrieval.

[0195] FIG. 30 shows the articulation assist element 500, 600, 700 secured. The auxiliary anchor guide wires 1730, 1735 have been removed. The tether rail 1750 has been removed. In some embodiments, the tether rail 1750 has been rotated and retracted. The articulation assist element 500, 600, 700 is shown fully deployed and secured. In some methods of use, retrieval is no longer possible. In some methods of use, retrieval by the methods described in FIGS. 31A-31F is no longer possible.

[0196] 31A-31F illustrate a method for retrieving the coaptation assist elements 500, 600, and 700. The coaptation assist elements 500, 600, and 700 can be retrieved through the transseptal sheath 1715. In some methods of use, the coaptation assist elements 500, 600, and 700 can be retrieved after anchor 800 is removed, without the auxiliary anchors 1770 and 1780. In some methods of use, the coaptation assist elements 500, 600, and 700 can be retrieved after anchor 800 and all auxiliary anchors 1770 and 1780 are removed. In FIGS. 31A-31F, the coaptation assist elements 500, 600, and 700 are retrieved through the transseptal sheath 1715. In some methods of use, retrieval is optional. In some methods of use, retrieval occurs after the method shown in FIG. 29 but before the method shown in FIG. 30.

[0197] 32-35 illustrate methods for placing one or more auxiliary anchors. One or more methods can be used in conjunction with the methods described herein. One or more methods can be alternatives to the methods described herein. As an example, one or more methods shown in FIGS. 32-35 can be substituted for one or more methods shown in FIGS. 23-30. The auxiliary anchors described herein can be delivered using guidewires and / or guiderails of various designs. In some embodiments, each auxiliary anchor can have a dedicated lumen (e.g., two auxiliary anchors using two lumens, four auxiliary anchors using four lumens, etc.). In some embodiments, each auxiliary anchor can have a dedicated guidewire (e.g., two auxiliary anchors using two guidewires, four auxiliary anchors using four guidewires, etc.). In some embodiments, two auxiliary anchors share a lumen (e.g., two auxiliary anchors in one lumen, four auxiliary anchors in two lumens, two guidewires in one lumen, four guidewires in two lumens, etc.). In some embodiments, the two guidewires in the shared lumen are each covered by a guiderail. The guiderails can reduce entanglement of the auxiliary anchors. The guiderails can reduce entanglement of the auxiliary anchors with two or more guidewires in the lumen.

[0198] 32 illustrates a method of inserting an auxiliary anchor. In some methods of use, an auxiliary anchor 1770 is inserted as described herein. A guidewire 1735 can extend from the auxiliary anchor 1770. The guidewire 1735 can extend into a lumen or a shared lumen. In some methods of use, the auxiliary anchor 1770 is inserted as described herein. One or more auxiliary anchors 1170, 1780 can be inserted.

[0199] In some embodiments, one guidewire 1735 can be used for two auxiliary anchors. In some methods of use, to facilitate removal of the guidewire 1735 after delivering the first auxiliary anchor 1770, the guidewire 1735 can be captured and removed with a snare. In some embodiments, the guidewire 1735 forms a loop. In some embodiments, a portion of the loop of the guidewire 1735 is housed within the coaptation assist element 500, 600, 700. In some embodiments, the loop passes through the coaptation assist element 500, 600, 700. In some embodiments, a snare 1785 can be positioned along the guidewire 1735. In some embodiments, the snare 1785 forms a loop. In some embodiments, a portion of the loop of the guidewire 1735 is housed within the loop of the snare 1785. The method can include using the snare 1785. The snare 1785 can be for unwinding the guidewire 1735. The snare 1785 can be retracted. The snare 1785 can be pulled proximally through the lumen.

[0200] 33 shows a method of delivering auxiliary anchor 1790. Snare 1785 is retracted into the lumen. Snare 1785 pulls guidewire 1735 proximally. In some embodiments, driver 1775 or a separate driver can advance auxiliary anchor 1790 along guidewire 1735. In some embodiments, auxiliary anchor 1790 should be delivered with guidewire 1735 removed from anchor 1770 using snare 1785.

[0201] FIG. 34 illustrates a method of inserting the auxiliary anchor 1790. The auxiliary anchor 1790 can be rotated. The auxiliary anchor 1790 can be threaded through the coaptation assist element 500, 600, 700. The auxiliary anchor 1790 can be rotated to engage tissue underneath the coaptation assist element 500, 600, 700. FIG. 34 illustrates the coaptation assist elements 500, 600, 700 secured to the annulus with anchor 800 and auxiliary anchor 1770 as the auxiliary anchor 1790 is delivered. The auxiliary anchor 1790 can be an inner anchor. The auxiliary anchor 1790 can be positioned inner to anchor 800. The auxiliary anchor 1790 can be positioned between anchor 800 and auxiliary anchor 1770.

[0202] FIG. 35 shows secured joint support elements 500, 600, 700. The method can be repeated to install one or more additional auxiliary anchors. For example, one or more additional auxiliary anchors can be positioned between auxiliary anchor 1780 and anchor 800, as shown in FIG. 30. For example, one or more additional auxiliary anchors can be positioned between auxiliary anchor 1770 and anchor 800, as shown in FIG. 30. For example, one or more additional auxiliary anchors can be positioned anywhere in the annular portion of joint support elements 500, 600, 700.

[0203] 36 and 37 show 2D laminated embodiments. 38 and 39 show 3D molded embodiments. In some embodiments, the joining assist element 500, 600, 700 includes a multilayer laminate over the entirety or only a portion of the joining assist element. In some embodiments, the multilayer laminate can include two or more laminate layers (e.g., two, three, four, five, etc.). Two or more layers of the multilayer laminate can include the same material. Two or more layers of the multilayer laminate can include different materials. Two or more layers of the multilayer laminate can include the same dimensions (e.g., length, width, thickness, diameter, etc.). Two or more layers of the multilayer laminate can include one or more different dimensions. The laminate can be variable depending on the area of ​​the joining assist element 500, 600, 700. In some embodiments, the joining area can have an additional protective layer. In some embodiments, the joining surface 560, 660, 760 includes one or more additional layers than other portions of the joining assist element 500, 600, 700. 38 illustrates an additional layer 1795 that is present only in the coaptation zone (e.g., lower zone) of the coaptation assist element 500, 600, 700. As such, the lower coaptation zone can be thicker than the upper zone of the coaptation assist element, which is located closer to the heart valve annulus, and can be at least about 10%, 25%, 50%, 75%, 100%, 150%, 200%, 250%, 300% or more, or a range incorporating any two of the foregoing values, thicker than the upper zone.

[0204] The multilayer laminate can be made by a 2D lamination method. In some applications, two or more layers are bonded together. The layers can be bonded by heat. The layers can be bonded by an adhesive. The layers can be bonded together by any mechanical or chemical change. The attachment assist element 500, 600, 700 can have an overall 2D shape. The attachment assist element 500, 600, 700 can be flat or nearly flat. In some embodiments, one or more layers comprise high-density polyethylene (PE), polypropylene, Dacron, an acellular collagen matrix such as SIS, or other plastics.

[0205] The multilayer laminate can be fabricated using a 3D shape-forming method. The articulation support elements 500, 600, 700 can be molded. As described herein, the articulation support elements 500, 600, 700 can include struts 530, 630, 730. In some embodiments, the struts 530, 630, 730 are made of an elastically deformable material, such as a shape memory metal, e.g., Nitinol, or a shape memory polymer. In some embodiments, the material is Elgiloy. In some embodiments, the struts 530 may be made of other materials, such as stainless steel, polypropylene, high-density polyethylene (PE), Dacron, acellular collagen matrices such as SIS, or other plastics. 3D molding can involve casting the shape of the struts 530, 630, 730. 3D molding can include molding a shape memory metal to the appropriate shape. The shape can be set using an appropriate mold that bends the struts 530, 630, 730 into the desired shape. Shape setting or shape adjustment may include confining the joining assist element 500, 600, 700 on a fixture or in a mold. In some methods of use, a suitable heat treatment is applied to the joining assist element 500, 600, 700 while it is on the fixture or in the mold. In some embodiments, the temperature, time, and / or other parameters are adjusted to heat cure the joining assist element 500, 600, 700. In some embodiments, the heat cure temperature is greater than 300°C, greater than 400°C, greater than 500°C, greater than 600°C, etc. In some embodiments, the heat cure time is greater than 1 minute, 2 minutes, 3 minutes, 4 minutes, 5 minutes, 6 minutes, 7 minutes, 8 minutes, 9 minutes, 10 minutes, greater than 2 minutes, greater than 5 minutes, greater than 10 minutes, etc. In some embodiments, the method can include quenching. In some embodiments, the method can include water or air quenching.

[0206] 40 shows a coaptation assist element 400. The coaptation assist element 400 can include any of the features of the coaptation assist elements described herein. The coaptation assist element 400 can include an annulus hub 420, similar to the annulus hubs described herein, to facilitate attachment to a delivery system. The annulus hub 420 can include an externally threaded portion 425. The coaptation assist element 400 can include struts 430. The struts 430 can be atrial arms that may be bent in an upward and / or downward direction.

[0207] The coaptation assist element 400 can include an annulus anchor portion 435. The annulus anchor portion 435 can be a portion of the struts 430. In some embodiments, the annulus anchor portion 435 comprises one or more barbs having a pointed tip. The annulus anchor portion 435 can be a passive anchor. The barbs can be fully exposed and shaped as shown in FIG. 40. In some embodiments, the barbs extend from the multi-layer laminate. The barbs can be free ends of the struts 430. In some embodiments, the barbs can be on a surface of the coaptation assist element 400. In some embodiments, the barbs can engage tissue by pushing back the laminate. For example, the multi-layer laminate can be pushed back as shown in FIG. 41. FIG. 41 illustrates one embodiment of a barb. In some methods of use, the multi-layer laminate can be pushed back by engagement of the barbs with tissue.

[0208] The coaptation assist element 400 can include knotless suture edges 455. The edges can reduce trauma to the native tissue. The coaptation assist element 400 can include one or more rounded edges to reduce trauma. In some embodiments, the lateral edges of the coaptation assist element 400 are rounded. In some embodiments, the top edge of the coaptation assist element 400 is rounded. In some embodiments, the bottom edge of the coaptation assist element 400 is rounded.

[0209] Coaptation assist element 400 can include a coaptation surface 460. Coaptation surface 460 can include an additional protective layer. In some embodiments, coaptation surface 460 can include one or more additional layers of a multi-layer stack. In some embodiments, coaptation surface 460 can include one or more different layers of a multi-layer stack. One or more layers of coaptation surface 460 can be designed to promote the longevity of coaptation assist element 400. One or more layers of coaptation surface 460 can be designed to promote coaptation with the native valve leaflets.

[0210] 42A-45K illustrate embodiments of an implant delivery system. The implant delivery system can include any of the coaptation assist elements described herein. The implant delivery system can be designed to position the coaptation assist element within the heart. The implant delivery system can include any of the anchors described herein. The implant delivery system can be designed to engage the anchor with tissue. The implant delivery system can be designed to rotate the anchor.

[0211] 42A-42I illustrate one embodiment of an implant delivery system 1800. The implant delivery system 1800 can include a docking tube 1805. The docking tube 1805 is connected to an implant torque shaft 1810. In some embodiments, the implant torque shaft 1810 can be rigidly coupled to the docking tube 1805. In some embodiments, the implant torque shaft 1810 is welded or soldered to the docking tube 1805. The implant torque shaft 1810 can transmit torque to the docking tube 1805, as described herein. The docking tube 1805 can be coupled to an articulation assist element 400, 500, 600, 700. In the illustrated embodiment, only a portion of the struts 430, 530, 630, 730 are shown.

[0212] 42A-42B, the docking tube 1805 can include one or more slots 1815. In the illustrated embodiment, the docking tube 1805 can include one slot 1815, although other configurations are envisioned (e.g., two slots, three slots, four slots, two diametrically opposed slots, four diametrically opposed slots, etc.). The slot 1815 can extend entirely through the docking tube 1805. In some embodiments, the docking tube 1805 can include one or more grooves that do not extend entirely through the docking tube. The slot 1815 can extend along the length of the docking tube 1805 or a portion thereof. The slot 1815 can extend between the distal and proximal ends of the docking tube 1805.

[0213] The docking tube 1805 can include a pin 1820 disposed within the 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 allows the pin 1820 to move within the slot 1815, as described herein. The annulus hub 420, 520, 620, 720 can include a groove 1835. The groove 1835 in the annulus hub 420, 520, 620, 720 can align with the slot 1815 in the docking tube 1805. The pin 1820 can be disposed within the groove 1835.

[0214] The annulus hub 420, 520, 620, 720 can include an externally threaded portion 425, 525, 625, 725. The docking tube 1805 can include an externally threaded portion 1840. In some methods of use, the docking tube 1805 is rotated to engage the docking tube 1805 with the annulus hub 420, 520, 620, 720. The internally threaded portion 1840 engages with the externally threaded portion 425, 525, 625, 725. A groove 1835 can be cut into the outer diameter of the threads of the externally threaded portion 425, 525, 625, 725. A slot 1815 can be cut into the inner diameter of the internally threaded portion 1840 of the docking tube 1805. The slot 1815 can be aligned with the groove 1835. In some embodiments, when the docking tube 1805 contacts the bottom of the coaptation assist element 400 , 500 , 600 , 700 , the slot 1815 can align with the groove 1835 .

[0215] 42A-42B show the neutral position of the pin 1820. The spring 1825 biases the pin 1820 downward, engaging the groove 1835. The pin 1820 spans between the docking tube 1805 and the annulus hub 420, 520, 620, 720. The neutral state is where the pin 1820 is forward. In this state, the pin 1820 locks the threaded connection between the internally threaded portion 1840 of the docking tube 1805 and the externally threaded portion 425, 525, 625, 725 of the annulus hub 420, 520, 620, 720. The pin 1820 allows the user to apply torque to the coaptation assist element 400, 500, 600, 700 in both directions via the docking tube 1805 and the implant torque shaft 1810. The pin 1820 allows a user to rotate the coaptation assist element 400, 500, 600, 700 clockwise or counterclockwise by rotating the docking tube 1805. In some uses, the pin 1820 can facilitate movement of the coaptation assist element 400, 500, 600, 700 through the docking tube 1805. When the slot 1815 and groove 1835 are aligned, the spring-loaded pin 1820 can slide into the groove 1835, essentially sealing the threads. FIG. 42A shows the pin 1820 in a forward position so that the docking tube 1805 and coaptation assist element 400, 500, 600, 700 are locked together. FIG. 42B shows a cross-sectional view of the locking pin 1820 in a neutral forward position.

[0216] 42C-42D show the release of the pin 1820. The pin 1820 can be retracted via the pull wire 1830. The pin 1820 can include a 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 disengaged from the coaptation assist element 400, 500, 600, 700. The internally threaded portion 1840 can be disengaged from the externally threaded portion 425, 525, 625, 725 by rotating the docking tube 1805. FIG. 42C shows a cross-sectional view of the retracted pin 1820. Retracting the pin 1820 allows the docking tube 1805 to be disengaged from the annulus hub 420, 520, 620, 720. 42A-42D illustrate that a docking hub 1805 can be coupled to the coaptation assist element 400, 500, 600, 700 to position the coaptation assist element 400, 500, 600, 700. 42A-42D illustrate that a docking hub 1805 can be coupled to the coaptation assist element 400, 500, 600, 700 to rotate the coaptation assist element 400, 500, 600, 700.

[0217] 42E-42I illustrate the use of anchor 800 with implant delivery system 1800. Anchor 800 is placed within docking hub 1805 as shown in FIG. 42E. Anchor 800 is in a retracted state within docking hub 1805. Anchor 800 resides within locking mechanism or pin 1820. Docking hub 1805 is shown in linear form, i.e., written out. Docking hub 1805 and implant torque axis 1810, shown in FIG. 42E, have been removed from FIG. 42F for clarity.

[0218] The anchor 800 can be screwed into the anatomical P2 position on the posterior leaflet as described herein. The anchor 800 can be considered a P2 anchor. The anchor 800 can be driven by a driver 1845. FIG. 42G shows a close-up of the driver 1845. The driver 1845 drives the anchor 800 completely into the tissue and down onto the annulus hub 420, 520, 620, 720 of the coaptation assist element 400, 500, 600, 700. The driver 1845 is connected to an internal torque shaft 1850. The driver 1845 and anchor 800 are fully housed within the docking hub 1805 as described herein. The internal torque shaft 1850 can extend through the implant torque shaft 1810. See FIG. 42E.

[0219] Figure 42H shows an internal cross-sectional view of anchor 800. To ensure a secure connection of driver 1845, anchor 800 can be tensioned against driver 1845 by tether rail 1855. Tether rail 1855 can include a small screw or a guidewire having an externally threaded portion 1860 at its distal tip. The externally threaded portion 1860 of tether rail 1855 is configured to engage with an internally threaded portion 1865 of anchor 800. An internal view of tether rail 1855 and the connection between anchor 800 and annulus hub 420, 520, 620, 720 is shown in Figure 42H.

[0220] 42H also shows a square recess 1870 in the head of anchor 800. Driver 1845 may include a square portion (not shown) configured to engage square recess 1870 in the head of anchor 800. Other designs for mating anchor 800 and driver 1845 are envisioned (e.g., any non-circular shape, polygonal, hexagonal, Phillips, oval, etc.).

[0221] The anchor 800 can include a shoulder 1875. When the anchor 800 is fully driven into the tissue, the shoulder 1875 of the anchor 800 presses down on the annulus hub 420, 520, 620, 720, securing the coaptation assist element 400, 500, 600, 700. Figure 421 shows a view of the secured coaptation assist element 400, 500, 600, 700.

[0222] 43A-43E illustrate one embodiment of an implant delivery system 1900. The implant delivery system 1900 can include a docking tube 1905. The docking tube 1905 can be cylindrical. The docking tube 1905 is connected to an implant torque shaft 1910. In some embodiments, the implant torque shaft 1910 can be rigidly coupled to the docking tube 1905. In some embodiments, the implant torque shaft 1910 is welded or soldered to the docking tube 1905. The implant torque shaft 1910 can transmit torque to the docking tube 1905, as described herein. The docking tube 1905 can be coupled to an articulation assist element 400, 500, 600, 700. In the illustrated embodiment, only a portion of the struts 430, 530, 630, 730 are shown.

[0223] The docking tube 1905 can include two or more hypotubes 1915 embedded in the wall. The hypotubes 1915 can include lumens. The hypotubes 1915 can be diametrically opposed. The hypotubes 1915 can be 180° apart. The hypotubes 1915 can extend within a slot. The hypotubes 1915 can extend along a portion of the length of the docking tube 1905. In some embodiments, the docking tube 1905 comprises two or more lumens. In some embodiments, the lumens are monolithic or integrally formed with the docking tube 1905. In the illustrated embodiment, the docking tube 1905 can include two hypotubes 1915, although other configurations are envisioned (e.g., four hypotubes, etc.).

[0224] The docking tube 1905 can include a tether 1920 disposed within the hypotube 1915. In some embodiments, the tether 1920 can be looped through opposing gaps in the coaptation assist elements 400, 500, 600, 700. In some embodiments, the tether 1920 can be threaded between the struts 430, 530, 630, 730 of the coaptation assist elements 400, 500, 600, 700. The tether 1920 can extend through one hypotube 1915, through the coaptation assist element 400, 500, 600, 700, underneath the annulus hub 420, 520, 620, 720, through the coaptation assist element 400, 500, 600, 700, and back through the other hypotube 1915. The tether 1920 can be looped through the articulation assist element 400, 500, 600, 700. The tether 1920 can be looped back up through the articulation assist element 400, 500, 600, 700 and to the proximal or handle end of the system.

[0225] 43A-43B show the initial position of the anchor 1920. In this state, the anchor 1920 holds the docking tube 1905 and the coaptation assist element 400, 500, 600, 700 together. The anchor 1920 allows a user to apply torque to the coaptation assist element 400, 500, 600, 700 in both directions via the docking tube 1905 and the implant torque shaft 1910. The anchor 1920 allows a user to rotate the coaptation assist element 400, 500, 600, 700 clockwise or counterclockwise by rotating the docking tube 1905. In some uses, the anchor 1920 can facilitate movement of the coaptation assist element 400, 500, 600, 700 via the docking tube 1905. The anchor 1920 can be released. The tether 1920 can be released to separate the docking tube 1905 from the annulus hub 420, 520, 620, 720. Figures 43A-43B show that the docking hub 1905 can be coupled to the coaptation assist elements 400, 500, 600, 700 to position the coaptation assist elements 400, 500, 600, 700. Figures 43A-43B show that the docking hub 1805 can be coupled to the coaptation assist elements 400, 500, 600, 700 to rotate the coaptation assist elements 400, 500, 600, 700.

[0226] 43C-43E illustrate the use of anchor 800 with implant delivery system 1900. Anchor 800 is placed within docking hub 1905 as shown in FIG. 43C. Anchor 800 is in a retracted state within docking hub 1905. Anchor 800 resides within locking mechanism or tether 1920. Docking hub 1905 is shown in linear form in FIG. 43B.

[0227] The anchor 800 can be screwed into the anatomical P2 position on the posterior leaflet as described herein. The anchor 800 can be considered a P2 anchor. The anchor 800 can be driven by a driver 1945. FIG. 43D shows a close-up of the driver 1945. The driver drives the anchor 800 completely into the tissue and down onto the annulus hub 420, 520, 620, 720 of the coaptation assist element 400, 500, 600, 700. The driver 1945 is connected to an internal torque shaft 1950. In some embodiments, the internal torque shaft 1950 is welded or soldered to the driver 1945. The driver 1945 and anchor 800 are fully housed within the docking hub 1905. The internal torque shaft 1950 can extend through the implant torque shaft 1910. FIG. 43C shows the advancement of the anchor 800 prior to full seating. FIG. 43D shows anchor 800 screwed into tissue.

[0228] FIG. 43C also shows an internal cross-sectional view of anchor 800. To ensure a secure connection of driver 1945, anchor 800 can be tensioned against driver 1945 by tether rail 1955. Tether rail 1955 can include a guidewire having a small thread or externally threaded portion 1960 at its distal tip. The externally threaded portion 1960 of tether rail 1955 is configured to engage with the internally threaded portion 1965 of anchor 800. An internal view of tether rail 1955 and the connection between anchor 800 and annulus hub 420, 520, 620, 720 is shown in FIG. 42C. Tether rail 1955 can allow for minimal-force assessment of the effectiveness of coaptation assist elements 400, 500, 600, 700 before releasing them. The tether rail 1955 can allow for a minimum force assessment of the effectiveness of the articulation assist elements 400, 500, 600, 700 before releasing the tether 1920. Figure 43C shows a cross section showing the path of the tether 1920.

[0229] FIG. 43E shows a view of the implanted anchor 800. FIG. 42E also shows the square recess 1970 in the head of the anchor 800. The driver 1945 can include a square portion (not shown) configured to engage the square recess 1970 within the head of the anchor 800. Other designs for mating the anchor 800 and driver 1945 are envisioned (e.g., any non-circular shape, polygonal, hexagonal, Phillips, oval, etc.). The anchor 800 can include an anchor hub. The hub can include an internally threaded portion 1965 of the anchor 800 that allows for connection to the mooring rail 1955. The anchor 800 can include an anchor helix. The anchor helix can include a gland tip for optimal tissue penetration.

[0230] The coaptation assist element 400, 500, 600, 700 may include several cutouts to minimize sliding friction of the anchor 1920. The anchor 800 may be screwed into tissue and contact the bottom of the hub 420, 520, 620, 720. The user may retract the docking tube 1905, leaving two edges of the anchor 1920 behind. The anchor may be connected via a connecting inner torque shaft. If the user is satisfied with the performance of the coaptation assist element 400, 500, 600, 700, the user may remove the anchor 1920. If the user is not satisfied with the performance of the coaptation assist element 400, 500, 600, 700, the user may redock the implant delivery system 1900 with the anchor 1920. If the user is not satisfied with the performance of the coaptation assist element 400, 500, 600, 700, the user can thread the tether 1920 through the hypotube 1915. If the user is not satisfied with the performance of the coaptation assist element 400, 500, 600, 700, the user can remove the anchor 800 and / or remove the coaptation assist element 400, 500, 600, 700 entirely.

[0231] 44A-44E illustrate one embodiment of an implant delivery system 2000. The implant delivery system 2000 can include a docking tube 2005. The docking tube 2005 can be any desired shape, such as, for example, cylindrical. The docking tube 2005 is connected to an implant torque shaft 2010. In some embodiments, the implant torque shaft 2010 can be rigidly coupled to the docking tube 2005. In some embodiments, the implant torque shaft 2010 is welded or soldered to the docking tube 2005. The implant torque shaft 2010 can transmit torque to the docking tube 2005, as described herein. The docking tube 2005 can include a docking end cap 2015.

[0232] The docking tube 2005 can include one, two, or more retaining arms 2020 cut into its distal end. The one, two, or more retaining arms 2020 can allow for torque transmission via the implant torque shaft 2010 and for pushing / pushing the articulation assist element 400, 500, 600, 700 therethrough. The docking tube 2005 can include three retaining arms 2020. The retaining arms 2020 can be evenly spaced around the docking tube 2005. The retaining arms 2020 can be spaced apart by an angle of about 120°, at least about 120°, or less than or equal to 120°, or another desired angle. The retaining arms 2020 can extend along a portion of the length of the docking tube 2005. In some embodiments, the retaining arms 2020 are monolithic or integrally formed with the docking tube 2005. In the illustrated embodiment, the docking tube 2005 may include three retaining arms 2020, although other configurations are envisioned (e.g., one retaining arm, two retaining arms, four retaining arms, five retaining arms, etc.) The retaining arms 2020 may be formed by cutting a U-shape into the docking tube 2005.

[0233] 44B-44C show the initial position of the retaining arm 2020. In this state, the retaining arm 2020 holds the docking tube 2005 and the coaptation assist element 400, 500, 600, 700 together. The retaining arm 2020 allows a user to apply torque to the coaptation assist element 400, 500, 600, 700 in both directions via the docking tube 2005 and the implant torque shaft 2010. The retaining arm 2020 allows a user to rotate the coaptation assist element 400, 500, 600, 700 clockwise or counterclockwise by rotating the docking tube 2005. In some uses, the retaining arm 2020 can facilitate movement of the coaptation assist element 400, 500, 600, 700 via the docking tube 2005.

[0234] 44E, the retaining arms 2020 engage with windows 2025 in the head of the anchor 800. In some embodiments, the windows 2025 are laser-cut windows. In some embodiments, the windows 2025 extend through the annulus hub 420, 520, 620, 720. In some embodiments, the windows 2025 are slots or grooves. The number of windows 2025 can correspond to the number of retaining arms 2020. In some embodiments, each retaining arm 2020 engages with a window 2025. The windows 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 inward-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 the distal inner section of the retaining arm 2020 .

[0235] 44B-44D illustrate the use of anchor 800 with implant delivery system 2000. Anchor 800 is placed within docking hub 2005 as shown in FIG. 44B. Anchor 800 is in a retracted state within docking hub 2005. Anchor 800 resides within locking mechanism or tab 2030 of retaining arm 2020. Docking hub 2005 is shown in linear form in FIG. 44B. FIG. 44C illustrates the advancement of anchor 800. FIG. 44C illustrates the advancement of anchor 800 before anchor 800 is fully seated and before retaining arm 2020 is flexed.

[0236] The anchor 800 can be screwed into the anatomical structure at the P2 position on the posterior leaflet, for example, as described herein. The anchor 800 can be considered a P2 anchor. The anchor 800 can be driven by a driver 2045. FIG. 44D shows a close-up of the driver 2045. The driver 2045 drives the anchor 800 completely into the tissue and down onto the annulus hub 420, 520, 620, 720 of the coaptation 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 soldered to the driver 2045. The driver 2045 and anchor 800 are fully housed within the docking hub 2005, as shown in FIG. 44B. The internal torque shaft 2050 can extend through the implant torque shaft 2010.

[0237] FIG. 44D shows an internal cross-sectional view of anchor 800. To ensure a secure connection of driver 2045, anchor 800 can be tensioned against driver 2045 by tether rail 2055. Tether rail 2055 can include a guidewire having a small thread or externally threaded portion 2060 at its distal tip. The externally threaded portion 2060 of tether rail 2055 is configured to engage with the internally threaded portion 2065 of anchor 800. An internal view of tether rail 2055 and the connection between anchor 800 and annulus hub 420, 520, 620, 720 is shown in FIG. 44D. Tether rail 2055 can allow for minimal-force assessment of the effectiveness of coaptation assist elements 400, 500, 600, 700 before releasing them. The tether rail 2055 can allow for a minimum force assessment of the effectiveness of the articulation assist elements 400 , 500 , 600 , 700 before releasing the retention arm 2020 .

[0238] Figure 44D shows a cross-sectional view illustrating the release of the retaining arms 2020. As the anchor 800 is threaded into tissue, the annulus hub 420, 520, 620, 720 contacts the tabs 2030 on the retaining arms 2020. The retaining arms 2020 can bend outward from the windows 2025 in the anchor 800 by distally moving the annulus hub 420, 520, 620, 720. The tabs 2030 can include angled surfaces 2035 that allow the docking tube 2005 to be easily removed from the annulus hub 420, 520, 620, 720 when the retaining arms 2020 are bent outward. Figure 44D shows the advancement of the anchor 800 with the anchor 800 fully driven, causing the retaining arms 2020 to bend outward.

[0239] When the retaining arms 2020 are bent outward, the docking tube 2005 can be separated from the annulus hub 420, 520, 620, 720. FIG. 44D illustrates that the docking hub 2005 can be separated from the coaptation assist element 400, 500, 600, 700. FIGS. 44A-44C illustrate that the docking hub 2005 can be coupled to the coaptation assist element 400, 500, 600, 700 to position the coaptation assist element 400, 500, 600, 700. FIGS. 44A-44C illustrate that the docking hub 2005 can be coupled to the coaptation assist element 400, 500, 600, 700 to rotate the coaptation assist element 400, 500, 600, 700.

[0240] FIG. 44E shows a view of the implanted anchor 800. FIG. 44E also shows the square recess 2070 in the head of the anchor 800. The driver 2045 can 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 driver 2045 are envisioned (e.g., any non-circular shape, polygonal, hexagonal, Phillips, oval, etc.). The anchor 800 can include an anchor hub. The hub can include an internally threaded portion 2065 of the anchor 800 that allows for connection to the tether rail 2055. The anchor 800 can include an anchor helix. The anchor 800 can include a window 2025. The window 2025 allows the retention arm 2020 to snap on and retain on the annulus hub 420, 520, 620, 720. The apertures 2025 allow the retention arms 2020 to be held on the annulus hub 420, 520, 620, 720 in a compressed, tensioned, or twisted state.

[0241] 45A-45K illustrate one embodiment of an implant delivery system 2100. The implant delivery system 2100 can include a docking tube 2105. The docking tube 2105 can be cylindrical. The docking tube 2105 is connected to an implant torque shaft 2110. In some embodiments, the implant torque shaft 2110 can be rigidly coupled to the docking tube 2105. In some embodiments, the implant torque shaft 2110 is welded or soldered to the docking tube 2105. The implant torque shaft 2110 can transmit torque to the docking tube 2105, as described herein. The docking tube 2105 can include a docking end cap 2115.

[0242] The docking tube 2105 can include one or more slots 2120 cut into its distal end. The slots 2120 can be bayonet slots. The slots 2120 can have a bayonet configuration. The one or more slots 2120 can allow for torque transmission via the implant torque shaft 2110 and for pushing / pushing the coaptation assist element 400, 500, 600, 700. The docking tube 2105 can include three slots 2120. The slots 2120 can be evenly spaced around the docking tube 2105. The slots 2120 can be spaced 120 degrees apart. The slots 2120 can extend along a portion of the length of the docking tube 2105. In some embodiments, the slots 2120 are monolithically or integrally formed with the docking tube 2105. In the illustrated embodiment, the docking tube 2105 may include three slots 2120, although other configurations are envisioned (e.g., one slot, two slots, four slots, five slots, etc.). The slots 2120 may be formed by cutting a J-shape into the docking tube 2105.

[0243] The docking tube 2105 can include a flared ring 2125, shown in FIG. 45B. The flared ring 2125 can ensure that the slot 2120 does not weaken the distal end of the docking tube 2105. The flared ring 2125 can ensure easy re-docking. The flared ring 2125 can be welded or soldered to the distal end of the docking tube 2105.

[0244] 45F, the slots 2120 engage with retaining pins 2030 on the head of the anchor 800. In some embodiments, the retaining pins 2030 protrude at the tip of the docking tube 2105 a sufficient amount to ensure proper interfacing with the slots 2120. In some embodiments, the retaining pins 2030 extend radially outward from the annulus hub 420, 520, 620, 720. In some embodiments, the retaining pins 2030 are cylindrical. The number of retaining pins 2030 can correspond to the number of slots 2120. In some embodiments, each slot 2120 engages with a retaining pin 2025. The slots 2120 can be shaped to receive and guide the retaining pins 2030.

[0245] 45B-45C show the initial position of the slot 2120 relative to the retaining pin 2030. In this state, the slot 2120 and retaining pin 2030 hold the docking tube 2005 and the coaptation assist element 400, 500, 600, 700 together. The slot 2120 and retaining pin 2030 allow the user to apply torque to the coaptation assist element 400, 500, 600, 700 in both directions via the docking tube 2005 and implant torque shaft 2010. The slot 2120 and retaining pin 2030 allow the user to rotate the coaptation assist element 400, 500, 600, 700 in either a clockwise or counterclockwise direction by rotating the docking tube 2005. In some uses, the slots 2120 and retaining pins 2030 can facilitate movement of the coaptation assist elements 400 , 500 , 600 , 700 through the docking tube 2105 .

[0246] 45B-45E illustrate the use of anchor 800 with implant delivery system 2100. Anchor 800 is placed within docking hub 2105 as shown in FIG. 45B. Anchor 800 is in a retracted state within docking hub 2105. Anchor 800 resides within locking mechanism or slot 2120. Docking hub 2105 is shown in linear form in FIG. 45B. FIG. 45C illustrates the advancement of anchor 800.

[0247] The anchor 800 can be screwed into the anatomical P2 position on the posterior leaflet as described herein. The anchor 800 can be considered a P2 anchor. The anchor 800 can be driven by a driver 2145. FIG. 45D shows a close-up of the driver 2145. The driver 2145 drives the anchor 800 completely into the tissue and down onto the annulus hub 420, 520, 620, 720 of the coaptation assist element 400, 500, 600, 700. The driver 2145 is connected to an internal torque shaft 2150. In some embodiments, the internal torque shaft 2150 is welded or soldered to the driver 2145. The driver 2145 and anchor 800 are fully housed within the docking hub 2105, as shown in FIG. 45B. The internal torque shaft 2150 can extend through the implant torque shaft 2110.

[0248] FIG. 45E shows an internal cross-sectional view of anchor 800. To ensure a secure connection of driver 2145, anchor 800 can be tensioned against driver 2145 by tether rail 2155. Tether rail 2155 can include a guidewire having a small thread or externally threaded portion 2160 at its distal tip. The externally threaded portion 2160 of tether rail 2155 is configured to engage with the internally threaded portion 2165 of anchor 800. An internal view of tether rail 2155 and the connection between anchor 800 and annulus hub 420, 520, 620, 720 is shown in FIG. 45E. Tether rail 2155 can allow for minimal-force assessment of the effectiveness of coaptation assist elements 400, 500, 600, 700 before releasing them. The tether rail 2155 may allow for a minimum force assessment of the effectiveness of the articulation assist elements 400 , 500 , 600 , 700 before releasing the retaining pin 2030 .

[0249] As the anchor 800 is threaded into tissue, the retaining pins 2030 of the annulus hubs 420, 520, 620, 720 move proximally within the slots 2120. The docking tube 2005 can be rotated, causing the retaining pins 2030 of the annulus hubs 420, 520, 620, 720 to move laterally within the slots 2120. The docking tube 2005 can be moved proximally, causing the retaining pins 2030 of the annulus hubs 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 annulus hub 420, 520, 620, 720. 45A-45C show that a docking hub 2005 can be coupled to the coaptation assist element 400, 500, 600, 700 to position the coaptation assist element 400, 500, 600, 700. FIGS. 45A-45C show that a docking hub 2105 can be coupled to the coaptation assist element 400, 500, 600, 700 to rotate the coaptation assist element 400, 500, 600, 700.

[0250] 45E-45F show views of the implanted anchor 800. FIG. 45E also shows the square recess 2170 in the head of the anchor 800. The driver 2145 can include a square portion (not shown) configured to engage the square recess 2170 within the head of the anchor 800. Other designs for mating the anchor 800 and driver 2145 are envisioned (e.g., any non-circular shape, polygonal, hexagonal, Phillips, oval, etc.). The anchor 800 can include an anchor hub. The hub can include an internally threaded portion 2165 of the anchor 800 that allows for connection to the tether rail 2155. The anchor 800 can include an anchor helix. In some embodiments, the annulus hub 420, 520, 620, 720 can include three laser-cut holes that accept three retaining pins 2130. The retaining pins 2130 can be welded into the holes. In some embodiments, the retaining pin 2130 is Nitinol. Figures 45G-45K show additional views.

[0251] 45A-45C illustrate the deployment of one or more auxiliary anchors 850, 1770, 1780. The auxiliary anchors 850, 1770, 1780 can include any of the features of anchor 800. The auxiliary anchors 850, 1770, 1780 can include a helix or spiral structure 852. The auxiliary anchors 850, 1770, 1780 can be designed to engage cardiac tissue, such as tissue of a valve annulus. The auxiliary anchors 850, 1770, 1780 can include a tip 854 designed to engage tissue. The tip 854 can be sharpened. The tip 854 can be ground for optimal penetration. The auxiliary anchors 850, 1770, 1780 can include a hub 856. The hub 856 can be an annulus hub having any of the features of the annulus hubs 420, 520, 620, 720 described herein. The hub 856 can include one or more interlocking features 858. The interlocking feature 858 can be a cutout. The interlocking feature 858 can create two semicircular sections of different heights. The interlocking feature 858 can include a first circular section and a second circular section. The first and second circular sections can be separated by a vertical cut. The interlocking feature 858 can include any configuration that allows torque to be transmitted to the auxiliary anchor 850, 1770, 1780.

[0252] 46A-46C illustrate a delivery catheter 860 designed to deploy one or more auxiliary anchors 850, 1770, 1780. The distal end of the delivery catheter 860 is shown in the drawings. The delivery catheter 860 can include a proximal end that is outside the patient's body. The proximal end can include one or more controls that operate the delivery catheter 860. The delivery catheter 860 can include a torque shaft 862. In some embodiments, the torque shaft 862 can rotate the auxiliary anchors 850, 1770, 1780 in either direction. The torque shaft 862 can include a lumen 864. The torque shaft 862 can include a helix or helical structure 866. The helix or helical structure 866 of the torque shaft 862 can have the same or similar characteristics as the helix or helical structure 852 of the one or more auxiliary anchors 850, 1770, 1780. The helix or helical structure 866 of the torque shaft 862 can have the same pitch as the helix or helical structure 852 of one or more auxiliary anchors 850, 1770, 1780. The helix or helical structure 866 of the torque shaft 862 can have the same diameter as the helix or helical structure 852 of one or more auxiliary anchors 850, 1770, 1780. The helix or helical structure 866 of the torque shaft 862 can have the same wire diameter as the helix or helical structure 852 of one or more auxiliary anchors 850, 1770, 1780.

[0253] The delivery catheter 860 can include a locking hub 868. The locking hub 868 can be an annulus hub. The locking hub 868 can include one or more mating features 870. The mating feature 870 can be designed to lock with the mating feature 858 of the hub 856. The mating feature 870 can create two semicircular sections of different heights. The mating feature 870 can include a first circular section and a second circular section. The first and second circular sections can be separated by a vertical cut. The mating feature 870 can include any configuration that allows torque to be transmitted to the hub 856 of the one or more auxiliary anchors 850, 1770, 1780. The locking hub 868 can be coupled to a locking shaft 872.

[0254] FIG. 46A shows a configuration in which the delivery catheter 860 is not engaged with the auxiliary anchors 850, 1770, 1780. FIG. 46B shows a configuration in which the delivery catheter 860 is engaged with the auxiliary anchors 850, 1770, 1780. In some embodiments, the helix or helical structure 866 can engage with the helix or helical structure 852 of the auxiliary anchors 850, 1770, 1780. In some embodiments, both helices can have the same pitch and diameter. Because both helices have the same pitch and diameter, the combined profile is the same as the profile of the auxiliary anchors 850, 1770, 1780. The helix or helical structure 866 can couple with the helix or helical structure 852 of the auxiliary anchors 850, 1770, 1780. The helix or helical structure 866 can fit within a void in the helix or helical structure 852 of the auxiliary anchors 850, 1770, 1780. The diameter of the combined structure can be the same as the diameter of the helix or helical structure 852 of the auxiliary anchor 850, 1770, 1780. In some embodiments, the torque shaft 862 can be rotated to engage the helix or helical structure 866 with the helix or helical structure 852 of the auxiliary anchor 850, 1770, 1780. In some embodiments, the auxiliary anchor 850, 1770, 1780 can be rotated to engage the helix or helical structure 852 of the auxiliary anchor 850, 1770, 1780 with the helix or helical structure 866. Figure 46B shows the engaged helices.

[0255] In some embodiments, the locking hub 868 is engaged with the hub 856 of the auxiliary anchor 850, 1770, 1780. In some embodiments, the locking hub 868 can be translated within the lumen 864 of the torque shaft 862 towards the auxiliary anchor 850, 1770, 1780. The mating feature 870 of the locking hub 868 can be coupled with the mating feature 858 of the hub 856 of the auxiliary anchor 850, 1770, 1780. The locking hub 868 can be engaged with the auxiliary anchor 850, 1770, 1780. The hub 856 of the auxiliary anchor 850, 1770, 1780 can be engaged with the locking hub 868 to connect the auxiliary anchor 850, 1770, 1780 to the delivery catheter 860. In some embodiments, the locking shaft 872 can advance or retract the locking hub 868.

[0256] 46C shows a locking hub 868 engaged with a hub 856 of an auxiliary anchor 850, 1770, 1780. Engaging the locking hub 868 with the hub 856 allows rotation of the auxiliary anchor 850, 1770, 1780. In some embodiments, engaging the locking hub 868 with the hub 856 can reduce the likelihood of the delivery catheter 860 disengaging from the auxiliary anchor 850, 1770, 1780 during delivery. In some embodiments, engaging the locking hub 868 with the hub 856 allows the auxiliary anchor 850, 1770, 1780 to be rotated counterclockwise without disengaging from the delivery catheter 860. The auxiliary anchor 850, 1770, 1780 can be rotated counterclockwise to drive it into tissue.

[0257] Once the auxiliary anchors 850, 1770, 1780 are driven into tissue, the delivery catheter 860 can be disengaged from the auxiliary anchors 850, 1770, 1780. In some embodiments, the locking hub 868 can be disengaged from the hub 856 of the auxiliary anchors 850, 1770, 1780. The locking hub 868 can be translated within the lumen 864 of the torque shaft 862 in a direction away from the auxiliary anchors 850, 1770, 1780. The locking shaft 872 can retract the locking hub 868. In some embodiments, the torque shaft 862 can be rotated to disengage the helix. In some embodiments, the torque shaft 862 can be rotated to disengage the helix or helical structure 866 from the helix or helical structure 852 of the auxiliary anchors 850, 1770, 1780.

[0258] In some embodiments, the coaptation assist element 400, 500, 600, 700 can include an annulus segment configured to be implanted within the heart above the valve annulus. In some embodiments, the coaptation assist element 400, 500, 600, 700 can include multiple struts, including a first strut within the annulus segment and a second strut having a longer overall length than the first strut. In some embodiments, the coaptation assist element 400, 500, 600, 700 can include a cupped upper edge that is retained by the annulus segment. In some embodiments, the coaptation assist element 400, 500, 600, 700 can improve overall coaptation without disrupting the anatomy. In some embodiments, the coaptation assist element 400, 500, 600, 700 can include multiple radial struts. In some embodiments, the coaptation assist element 400, 500, 600, 700 can include multiple radial struts, with a first strut located within the annulus compartment and a second strut having a longer overall length than the first strut. In some embodiments, the coaptation assist element 400, 500, 600, 700 can include a cupped upper edge. In some embodiments, the coaptation assist element 400, 500, 600, 700 can include a hub positioned near the annulus. In some embodiments, the coaptation assist element 400, 500, 600, 700 can include radially expanding struts. In some embodiments, the coaptation assist element 400, 500, 600, 700 can include struts that improve coaptation of the struts over their entire length without disrupting the anatomy. In some embodiments, the coaptation assist element 400, 500, 600, 700 can expand through the struts.

[0259] In some methods, the method can include positioning a hub near the annulus. In some methods, the struts are radially expanded. In some methods, the method can include improving strut coaptation along the entire length without disrupting the anatomy. In some methods, the method can include expanding coaptation elements held via the radially outward extending struts. In some methods, the method can include expanding coaptation elements held via the radially outward extending struts to form annulus compartments. In some methods, the method can include expanding coaptation elements held via the struts to form annulus compartments.

[0260] In some embodiments, the annulus hub 420, 520, 620, 720 is spaced inward from the lateral edges of the coaptation assist element 400, 500, 600, 700. In some embodiments, the annulus hub 420, 520, 620, 720 is spaced inward from the upper edge of the coaptation assist element 400, 500, 600, 700. In some embodiments, the annulus hub 420, 520, 620, 720 is spaced inward from the lower edge of the coaptation assist element 400, 500, 600, 700. In some embodiments, the annulus hub 420, 520, 620, 720 is non-expandable. In some embodiments, the annulus hub 420, 520, 620, 720 may have a fixed circumference. In some embodiments, the annulus hub 420, 520, 620, 720 retains its shape during expansion of the coaptation assist element 400, 500, 600, 700. In some embodiments, the annulus hub 420, 520, 620, 720 is formed from a tube. The struts 430, 530, 630, 730 can be laser cut from the tube. The cut can extend from one end of the tubing toward the second end. The uncut portion of the tubing can be the annulus hub 420, 520, 620, 720. In some embodiments, the coaptation assist element 400, 500, 600, 700 can be formed from a sheet of material. The sheet can be laser cut to include the struts 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 annulus hub 420, 520, 620, 720.

[0261] In some embodiments, the anchor 800 is an active anchor. The anchor 800 can be coupled to the annulus hub 420, 520, 620, 720. The anchor 800 can be coupled to the annulus hub 420, 520, 620, 720 by interlocking the helix of the anchor 800 with structure of the annulus hub 420, 520, 620, 720. The anchor 800 can be configured to rotate relative to the annulus hub 420, 520, 620, 720. The anchor 800 can be configured to rotate relative to the annulus hub 420, 520, 620, 720 when coupled to the annulus hub 420, 520, 620, 720. The anchor 800 can be configured to be selectively deployed by rotation. The anchor 800 can be configured to rotate to engage tissue. The anchor 800 can be configured to rotate to engage the annulus. The anchor 800 can be configured to rotate through the valve annulus. The anchor 800 can be configured to rotate in a first direction relative to the annulus hub 420, 520, 620, 720. The anchor 800 is configured to be rotated in a first direction to selectively deploy the anchor 800. The anchor 800 is configured to be rotated to deploy the anchor 800 at an initial target location. The anchor 800 is configured to be rotated to engage tissue within the valve annulus. The anchor 800 can be selectively deployed into the valve annulus. The annulus hub 420, 520, 620, 720 can remain stationary as the anchor 800 is rotated to engage tissue. The non-expandable annulus hub 420, 520, 620, 720 can remain stationary as the anchor 800 is rotated to engage tissue.

[0262] In some embodiments, the anchor 800 is configured to rotate in a second direction relative to the annulus hub 420, 520, 620, 720. The anchor 800 is configured to be rotated in the second direction to selectively engage and disengage the anchor 800. The anchor 800 is configured to be rotated to engage and disengage the anchor 800 from an initial target location. The anchor 800 is configured to be rotated to disengage from tissue within the annulus. The annulus hub 420, 520, 620, 720 can remain stationary when the anchor 800 is rotated to engage tissue. The non-expandable annulus hub 420, 520, 620, 720 can remain stationary when the anchor 800 is rotated to engage tissue. 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.

[0263] In some embodiments, the plurality of struts 430, 530, 630, 730 are circumferentially spaced around the annulus hub 420, 520, 620, 720. In some embodiments, the plurality of struts 430, 530, 630, 730 are evenly spaced around the annulus hub 420, 520, 620, 720. In some embodiments, the plurality of struts 430, 530, 630, 730 are unevenly spaced around the annulus hub 420, 520, 620, 720. In some embodiments, the struts 430, 530, 630, 730 comprising the annulus segments are evenly spaced around the annulus hub 420, 520, 620, 720. In some embodiments, the struts 430, 530, 630, 730 comprising the annulus compartment are unevenly spaced around the annulus hub 420, 520, 620, 720. In some embodiments, the struts 430, 530, 630, 730 forming the upper edge are evenly spaced around the annulus hub 420, 520, 620, 720. In some embodiments, the struts 430, 530, 630, 730 forming the upper edge are unevenly spaced around the annulus hub 420, 520, 620, 720. In some embodiments, the struts 430, 530, 630, 730 comprising the ventricular compartment are evenly spaced around the annulus hub 420, 520, 620, 720. In some embodiments, the struts 430, 530, 630, 730 comprising the ventricular compartment are unevenly spaced around the annulus hub 420, 520, 620, 720. In some embodiments, the struts 430, 530, 630, 730 forming the lower edge are evenly spaced around the annulus hub 420, 520, 620, 720. In some embodiments, the struts 430, 530, 630, 730 forming the lower edge are unevenly spaced around the annulus hub 420, 520, 620, 720. In some embodiments, two or more struts 430, 530, 630, 730 are evenly spaced around the annulus hub 420, 520, 620, 720. In some embodiments, two or more struts 430 , 530 , 630 , 730 are unevenly spaced around the annulus hub 420 , 520 , 620 , 720 .

[0264] In some embodiments, the plurality of struts 430, 530, 630, 730 extend outward from the annulus hub 420, 520, 620, 720. In some embodiments, the plurality of struts 430, 530, 630, 730 can have a radial portion near the annulus hub 420, 520, 620, 720. In some embodiments, the plurality of struts 430, 530, 630, 730 are arranged along a radius. In some embodiments, the plurality of struts 430, 530, 630, 730 diverge from a center. In some embodiments, the plurality of struts 430, 530, 630, 730 diverge from the annulus hub 420, 520, 620, 720. In some embodiments, the plurality of struts 430, 530, 630, 730 are uniformly distributed about a central axis. In some embodiments, the plurality of struts 430, 530, 630, 730 are uniformly distributed around the annulus hub 420, 520, 620, 720. In some embodiments, the plurality of struts 430, 530, 630, 730 are uniformly distributed around the anchor 800. In some embodiments, the plurality of struts 430, 530, 630, 730 can form spokes. In some embodiments, the plurality of struts 430, 530, 630, 730 extend outward from a center. In some embodiments, the plurality of struts 430, 530, 630, 730 extend inward from an edge of the coaptation assist element 400, 500, 600, 700. In some embodiments, the plurality of struts 430, 530, 630, 730 are branched. In some embodiments, the plurality of struts 430, 530, 630, 730 are splayed. In some embodiments, the plurality of struts 430, 530, 630, 730 are radial. In some embodiments, the plurality of struts 430, 530, 630, 730 splay outward. In some embodiments, the plurality of struts 430, 530, 630, 730 can include an inflection point. In some embodiments, the struts 430, 530, 630, 730 can include an inflection point. In some embodiments, the plurality of struts 430, 530, 630, 730 can include a curved shape. In some embodiments, the struts 430, 530, 630, 730 can include a curved shape.In some embodiments, the struts 430, 530, 630, 730 can include a U-shaped curve. In some embodiments, the struts 430, 530, 630, 730 can include a C-shaped curve. In some embodiments, the struts 430, 530, 630, 730 can include an S-shaped curve. In some embodiments, the struts 430, 530, 630, 730 can include an L-shaped curve.

[0265] In some embodiments, the plurality of struts 430, 530, 630, 730 increases the volume of the coaptation assist element 400, 500, 600, 700 when deployed. In some embodiments, the plurality of struts 430, 530, 630, 730 increases the thickness of the coaptation assist element 400, 500, 600, 700 when deployed. In some embodiments, the plurality of struts 430, 530, 630, 730 increases the length of the coaptation assist element 400, 500, 600, 700 when deployed. In some embodiments, the plurality of struts 430, 530, 630, 730 increases the height of the coaptation assist element 400, 500, 600, 700 when deployed. In some embodiments, the plurality of struts 430, 530, 630, 730 increases the width of the coaptation assist element 400, 500, 600, 700 when deployed.

[0266] In some embodiments, the plurality of struts 430, 530, 630, 730 can include a first strut. The first strut can be configured to be implanted within the heart above the valve annulus. The first strut can be an annular strut. In some embodiments, the plurality of struts 430, 530, 630, 730 can include a second strut. The second strut can be configured to be implanted within the heart below the valve annulus. The second strut can be a ventricular strut. The second strut can traverse the mitral valve. The second strut can traverse the plane of the valve annulus. In some embodiments, the first strut and the second strut have different lengths. In some embodiments, the second strut is longer than the first strut.

[0267] In some embodiments, the upper edge of the coaptation assist element 400, 500, 600, 700 forms a curve. In some embodiments, the upper edge forms a lip. In some embodiments, the upper edge cups downward toward the lower edge. In some embodiments, the upper edge cups upward from the lower edge. In some embodiments, the annulus hub 420, 520, 620, 720 extends upward from the lower edge. In some embodiments, the annulus hub 420, 520, 620, 720 extends upward from the upper edge. In some embodiments, the annulus hub 420, 520, 620, 720 extends upward from the annular portion of the coaptation assist element 400, 500, 600, 700. In some embodiments, the annulus hub 420, 520, 620, 720 extends upward from the coaptation surface of the coaptation assist element 400, 500, 600, 700. In some embodiments, the annulus hub 420, 520, 620, 720 is tubular. In some embodiments, the annulus hub 420, 520, 620, 720 forms a circle. In some embodiments, the annulus hub 420, 520, 620, 720 has the form of a ring. In some embodiments, the hub 420, 520, 620, 720 is non-annular. In some embodiments, the hub 420, 520, 620, 720 forms a polygonal shape (e.g., a triangle, a square, a rectangle, a hexagon, an 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 ellipse.

[0268] 47A-47E illustrate an embodiment of an implant mechanism. Figures 47A-47E illustrate some non-limiting, potentially clinically relevant aspects of the implant. While coaptation assist element 400 is shown, any of the coaptation assist elements described herein can include the features described herein. In addition, coaptation assist element 400 can include any of the features of the coaptation assist elements described herein for other embodiments, for example.

[0269] As described herein, the coaptation assist element 400 can include a valve annulus hub 420, which can be relatively centrally located. The coaptation assist element 400 can have an overall elongated shape, although other shapes are contemplated, such as polygonal, circular, oval, rounded, rectangular, triangular, etc. The coaptation assist 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 longer length than the lower edge 480, such that the transverse distance between the lateral edges 470 and 475 generally decreases from the top to the bottom of the coaptation assist element 400. The upper edge 440 of the coaptation assist element 400 can be curved to conform to the overall shape of the valve annulus or the adjacent atrial wall.

[0270] The coaptation assist element 400 can include a first surface 405 configured to be disposed toward the mal-coapted native valve leaflet during use and a second surface 415 configured to be disposed toward the anterior leaflet. The second surface 415 can include a coaptation surface 460. The coaptation assist element 400 can include one or more struts 430. The plurality of struts 430 can provide structural support to the coaptation assist element 400. The plurality of struts 430 can provide a deployed shape for the coaptation assist element 400. As described herein, the plurality of struts can include a shape memory material, such as a shape memory metal or plastic.

[0271] In some embodiments, a first strut 430 of the plurality of struts extends from the annulus hub 420 to or towards the superior edge 440. In some embodiments, a second strut 430 of the plurality of struts extends from the annulus hub 420 to or towards the inferior edge 480. In some embodiments, a third strut 430 of the plurality of struts extends from the annulus hub 420 to or towards the lateral edge 470. In some embodiments, a fourth strut 430 of the plurality of struts extends from the annulus hub 420 to or towards the lateral edge 475. Any two or more of the first strut, second strut, third strut, or fourth strut can comprise the same characteristics, including material, length, width, thickness, configuration, preformed bend, curvature, etc. Any two or more of the first strut, second strut, third strut, or fourth strut can comprise different characteristics, including material, length, width, thickness, configuration, preformed bend, curvature, etc. In some embodiments, at least one of the struts, for example in the upper section of the implant, extends radially outward from and protrudes from the cover 450 of the implant 400, and can act as spaced-apart barbs to assist in annular fixation and / or tissue ingrowth within the annulus. In some embodiments, the barbs extend only in the annular section of the implant (e.g., the upper section) and are absent from the lower (leaflet) coaptation section, which in some embodiments are atraumatic. In some embodiments, the entire periphery of the implant can be atraumatic.

[0272] In some embodiments, the support posts 430 can be covered with one, two, or more layers of the attachment support element body cover 450. The attachment support element body cover 450 can include one layer or multiple layers (e.g., one layer, two layers, three layers, four layers, five layers, or more, or a range incorporating any two of the foregoing values). In some embodiments, the first surface 405 can include one or more layers. In some embodiments, the second surface 415 can include one or more layers. Any two or more of the multiple layers can include the same or different characteristics, including material, length, width, thickness, etc. In some embodiments, one or more layers extend along all or only a portion of the first surface 405. In some embodiments, one or more layers extend along all or only a portion of the second surface 415. The layers can be formed from any process described herein.

[0273] The attachment assist element body cover 450 may be constructed of a material such as a polymer, e.g., ePTFE. Other materials for the attachment assist element body cover 450 include polyester, polyurethane foam, polycarbonate foam, biological tissue such as porcine pericardium, treated bovine pericardium, pleura, peritoneum, silicone, Dacron, acellular collagen matrix, combinations thereof, etc. In some embodiments, the attachment assist element body cover 450 can include a foam material surrounded by ePTFE.

[0274] In some embodiments, the posts 430 can be formed with or embedded in one or more layers of the coaptation assist element body cover 450. In some embodiments, the posts 430 can be encapsulated or at least partially encapsulated in the coaptation assist element body cover 450. In some embodiments, a portion of the posts 430 can extend from the coaptation assist element body cover 450 to engage tissue, as described elsewhere herein. Figures 47A-47E illustrate features that may facilitate interaction of the coaptation assist element 400, or portions thereof, with the natural anatomy.

[0275] 47A shows a coaptation surface 460, which can define a relatively inferior area of ​​the implant. The anterior chamber coaptation surface can be reinforced. As described herein, the coaptation surface 460 can contact the patient's valve leaflets. After deployment, the coaptation assist element 400 can entirely cover the posterior leaflet such that the anterior leaflet coapts with the coaptation surface 460 during systole. The coaptation assist element 400 and the anterior leaflet can maintain a valve seal at the annular ring.

[0276] 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 with 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 that includes 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.

[0277] The interface surface 460 can be reinforced with any of the materials described herein. The interface surface 460 can be reinforced with ePTFE. The interface surface 460 can be reinforced with any of the materials of the interface assist element body cover 450, such as ePTFE, Dacron, and / or polypropylene.

[0278] 47B shows the first surface 405. The posterior ventricular coaptation surface can be reinforced. As described herein, the first surface 405 can contact the patient's valve leaflet. After deployment, the coaptation assist element 400 can completely cover the posterior leaflet with the first surface 405. The first surface 405 can be opposite the second surface 415, which includes the coaptation surface 460.

[0279] In some embodiments, the first surface 405, or a portion thereof, is reinforced. The first surface 405 can be reinforced with 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 directly opposite the one or more additional layers that extend over the second surface 415. The one or more additional layers can extend over a portion of the first surface 405 opposite the coaptation surface 460. The one or more additional layers can extend over a portion of the first surface 405 that is greater than the contact area with the posterior leaflet.

[0280] First surface 405 can be reinforced with any of the materials described herein. First surface 405, or a portion thereof, can be reinforced with ePTFE. First surface 405 can advantageously be reinforced with any of the materials of coaptation assist element body cover 450, such as ePTFE, Dacron, and / or polypropylene, which can create an atraumatic surface to reduce the risk of damaging the native valve leaflets from repeated coaptation to the coaptation surface of the coaptation assist body.

[0281] 47C-47D show the edges of the coaptation aid element 400. As described herein, the coaptation aid element 400 can include reinforced edges of increased thickness, such as knotless stitched edges 455. The upper edge 440, the lateral edges 470 and 475, and / or the lower edge 480 of the coaptation aid element 400 can include raised edges or bumpers. In some embodiments, only one, two, or more of the upper edge 440, the lateral edges 470 and 475, or the lower edge 480 can include raised edges or bumpers. In some embodiments, the raised edges or bumpers can include Gore-Tex®. In some embodiments, the raised edges or bumpers circumferentially surround or at least partially surround the periphery of the lower section or the entire coaptation aid body.

[0282] The raised edge or bumper can be formed from suture. The suture can be wrapped around the edge to form the raised edge or bumper. The raised edge or bumper can have features such as increased thickness and / or softness, for example, to reduce trauma to the native tissue. The raised edge or bumper can reduce contact between the coaptation assist element 400 and the patient's anatomy. In the case of a mitral valve, the raised edge or bumper can reduce contact between the coaptation assist element 400 and the posterior leaflet. In some embodiments, only the first surface 405 includes a raised edge. In some embodiments, both the first surface 405 and the second surface 415 include a raised edge. The raised edge or bumper can be at or near the edge of the first surface 405 or the second surface 415. The raised edge or bumper can be spaced inward from the first surface 405 or the second surface 415. Figure 47C shows the rear view, and Figure 47D shows the front view.

[0283] The raised edges or bumpers can include one or more rounded edges that reduce contact between the coaptation assist element 400 and the underlying patient anatomy. In some embodiments, contact is reduced between the coaptation assist element 400 and the posterior leaflet. In some embodiments, contact is not reduced between the coaptation assist element 400 and the annulus. In some embodiments, the coaptation assist element 400 is configured to minimize contact with the posterior leaflet but maximize contact with the annulus. Other configurations are envisioned.

[0284] FIG. 47E illustrates the anchor section. The coaptation assist element 400 can include a generally annular upper section 410. The anchor section can be disposed within the annulus section 410 and can include two sections spaced apart from and extending laterally from the hub 420. The annulus section 410 can be positioned relative to the annulus when the coaptation assist element 400 is deployed. In some embodiments, the annulus section 410 can be curved toward or away from the annulus. In other embodiments, the annulus section 410 can be substantially flat relative to the annulus. The annulus section 410 can be configured to receive one or more auxiliary anchors. The auxiliary anchors can be advanced over guide rails, which can be coupled to the coaptation assist element 400 as described herein. The auxiliary anchors can be rotated to penetrate the annulus section 410. The auxiliary anchors can engage tissue disposed beneath the coaptation assist element 400.

[0285] The annulus section 410, such as the anchor section, can be reinforced to have an increased thickness relative to the remainder of the upper section and a thickness greater than, equal to, or less than the thickness of the lower coaptation section of the implant. The annulus section 410 can be reinforced to the extent that it is configured to accept one, two, three, four, or more auxiliary anchors. As described herein, the first surface 405 of the coaptation assist element 400 can rest against the annulus after placement within the patient's heart. The second surface 415 can face upward from the annulus. In some embodiments, the annulus section 410, or a portion thereof, is reinforced. The annulus section 410 can be reinforced with one or more additional layers. The one or more additional layers can extend over the annulus section 410, or a portion thereof. The one or more additional layers can be diametrically opposed to the annulus hub 420. The one or more additional layers can extend over a portion of the first surface 405. The one or more additional layers can extend over a portion of the second surface 415. The anchor section can be near the annulus hub 420. The anchor section can include one or more separate sections.

[0286] The annulus section 410 can be reinforced with any of the materials described herein. The annulus section 410, or a portion thereof, can be reinforced with ePTFE. The annulus section 410, or a portion thereof, can be reinforced with velour. The annulus section 410 can be reinforced with any of the materials of the coaptation assist element body cover 450, such as ePTFE, Dacron, and / or polypropylene. One or more additional layers can extend outward from the annulus hub 420. The one or more additional layers can be of any shape sufficient to cover an area larger than the area engaged by one or more auxiliary anchors.

[0287] In some embodiments, annular portion 410 can include an edge that is sharper than another edge of coaptation assist element 400. In some embodiments, upper edge 440 is thinner and / or sharper than another edge of coaptation assist element 400 (e.g., lateral edge 470, lateral edge 474, or lower edge 480). In some embodiments, annular portion 410 and / or upper edge 440 can irritate or engage tissue. In some embodiments, annular portion 410 is configured to be implanted near the valve annulus. In some embodiments, annular portion 410 is configured to promote an immune response. In some embodiments, annular portion 410 is configured to promote tissue ingrowth.

[0288] FIG. 48 shows an exploded view of one embodiment of a cover that surrounds a portion of an implant and includes a laminate. While an attachment assist element 400 is shown, any of the attachment assist elements described herein can include any number of the features described herein, can exclude / omit any of the features described herein, or can be arranged in a different order relative to each other. In addition, the attachment assist element 400 can include, exclude / omit any of the attachment assist element features described herein. The exploded view shows a thick reinforcing layer for the anterior and posterior chamber portions. The exploded view shows a single velour anchor area. A raised edge or bumper is not shown. A raised edge or bumper can be added during the final stages of assembly. The laminate 1100 described herein can form the attachment assist element body cover 450. The laminate 1100 can include one or more layers as described herein. The laminate 1100 can include one or more layers in any order.

[0289] The coaptation assist element 400 can include a posterior layer 1102. The posterior layer can form the first surface 405. In some embodiments, the posterior layer 1102 is thin relative to the other layers. In some embodiments, the posterior layer 1102 is ePTFE. In some embodiments, the posterior layer 1102 has a thickness (e.g., about 0.001 inches, about 0.0015 inches, about 0.002 inches, about 0.0025 inches, about 0.003 inches, or any range inclusive of two of the foregoing values). The posterior layer 1102 can include an opening through which the anchor 800 extends. The posterior layer 1102 can be any shape, including rectangular, polygonal, triangular, circular, and oval. In some embodiments, the posterior layer 1102 is not the final shape of the coaptation assist element 400.

[0290] The coaptation assist element 400 can include a first support structure layer 1104. The first support structure 1104 can be a mesh. In some embodiments, the first support structure layer 1104 includes UHMPE. The first support structure 1104 can be disposed on the posterior layer 1102. The first support structure layer 1104 can be disposed posterior to the strut 430. The first support structure layer 1104 can include openings through which the anchors 800 extend.

[0291] The coaptation assist element 400 can include a first fabric layer 1106. The first fabric layer 1106 can be relatively thin, and in some cases, has a thickness (e.g., about 0.001 inches, about 0.0015 inches, about 0.002 inches, about 0.0025 inches, about 0.003 inches, about 0.004 inches, about 0.005 inches, about 0.01 inches, 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 can be disposed on the first support structure layer 1104. The first fabric layer 1106 can be disposed on the rear side of the strut 430. The first fabric layer 1106 can include openings through which the anchors 800 extend. In some embodiments, the first fabric layer 1106 extends along only a portion of the coaptation assist element 400. In some embodiments, the first fabric layer 1106 includes a cutout portion.

[0292] The coaptation assist element 400 can include a first ventricular layer 1108. The ventricular surface layer 1108 can be a reinforcing layer of the first surface 405. In some embodiments, the first ventricular layer 1108 is thicker than the other layers. In some embodiments, the first ventricular layer 1108 is ePTFE. In some embodiments, the first ventricular layer 1108 has a thickness (e.g., about 0.01 inches, about 0.02 inches, about 0.03 inches, about 0.035 inches, about 0.040 inches, about 0.045 inches, about 0.05 inches, about 0.07 inches, about 0.10 inches, or any range including two of the foregoing values). The first ventricular layer 1108 can be any shape, including rectangular, polygonal, triangular, circular, elliptical, etc. The first ventricular layer 1108 can be disposed posterior to the struts 430.

[0293] The coaptation assist element 400 can include an anchor layer 1110. The anchor layer 1110 can be a reinforcing layer for one or more auxiliary anchors. In some embodiments, the anchor layer 1110 is thicker than other layers. In some embodiments, the anchor layer 1110 is ePTFE. In some embodiments, the anchor layer 1110 is velour. In some embodiments, the anchor layer 1110 has a thickness (e.g., about 0.01 inches, about 0.02 inches, about 0.03 inches, about 0.035 inches, about 0.040 inches, about 0.045 inches, about 0.05 inches, about 0.07 inches, about 0.10 inches, or any range including two of the foregoing values). The anchor layer 1110 can be any shape, including rectangular, polygonal, triangular, circular, oval, etc. In some embodiments, the coaptation assist element 400 includes a single anchor section forming the anchor layer 1110. In some embodiments, the coaptation assist element 400 includes two or more separate anchor sections that form the anchor layer 1110. The anchor layer 1110 can be disposed posterior to the struts 430, as shown. In the illustrated embodiment, the ventricular surface layer 1108 and the anchor layer 1110 can be sandwiched between the same two adjacent layers. In some embodiments, the ventricular surface layer 1108 and the anchor layer 1110 are separated by one or more layers.

[0294] The coaptation assist element 400 can include a second support structure layer 1112. The second support structure layer 1112 can be a mesh. In some embodiments, the second support structure layer 1112 includes UHMPE. The second support structure layer 1112 can be disposed over the ventricular surface layer 1108. The second support structure layer 1112 can be disposed posterior to the struts 430. In some embodiments, the second support structure layer 1112 extends along only a portion of the coaptation assist element 400. In some embodiments, the second support structure layer 1112 extends along only the ventricular portion of the coaptation assist element 400.

[0295] The articulation support element 400 can include a frame 465. In some embodiments, the frame 465 is cut from a tubular stock material. The frame 465 can include one or more struts 430. The frame 465 can be constructed from a single, monolithic piece of material. The frame 465, including its struts 430, can be formed using any method described herein, including water jet, laser etching, or similar techniques. Details of the struts 430, including barbs, can be machined into the struts 430. The frame 465 can be bent and / or shaped to achieve a desired geometry. The frame 465, including its struts 430, can 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 can be constructed from other materials, including stainless steel, polypropylene, high-density polyethylene (PE), Dacron, an acellular collagen matrix such as SIS, or other plastics. In some embodiments, the struts 430 can include a shape memory material and a strut cover. The strut cover can be any material described herein and can cover the entire strut 430 or a portion thereof. In some embodiments, the struts 430 can include nitinol and LDPE tubing or a cover over each strut 430. In some embodiments, the frame 465 can be considered a layer.

[0296] The coaptation assist element 400 can include a second ventricular layer 1114. The second ventricular layer 1114 can be a reinforcing layer on the second surface 415. In some embodiments, the second ventricular layer 1114 is thicker than the other layers. In some embodiments, the second ventricular layer 1114 is ePTFE. In some embodiments, the second ventricular layer 1114 has a thickness (e.g., about 0.03 inches, about 0.035 inches, about 0.040 inches, about 0.045 inches, about 0.05 inches, or any range incorporating two of the foregoing values, or other thickness values ​​as described for other layers herein). The second ventricular layer 1114 can be any shape, including rectangular, polygonal, triangular, circular, oval, etc. The second ventricular layer 1114 can be disposed anterior to the struts 430. In some embodiments, the second ventricular layer 1114 extends along only 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 are the same shape.

[0297] The coaptation assist element 400 can include a third support structure layer 1116. The third support structure layer 1116 can be a mesh. In some embodiments, the third support structure layer 1116 can include UHMPE. The third support structure layer 1116 can be disposed over the second ventricular layer 1114. The third support structure layer 1116 can be disposed anterior to the struts 430. In some embodiments, the third support structure layer 1116 extends along only a portion of the coaptation assist element 400. In some embodiments, the third support structure layer 1116 extends along only the ventricular portion of the coaptation assist element 400.

[0298] The coaptation assist element 400 can include a second fabric layer 1118. The second fabric layer 1118 can be thin compared to the other layers. In some embodiments, the second fabric layer 1118 has a thickness (e.g., about 0.001 inches, about 0.0015 inches, about 0.002 inches, about 0.0025 inches, about 0.003 inches, or any range including two of the foregoing values). In some embodiments, the second fabric layer 1118 comprises a polyester fabric. The second fabric layer 1118 can be disposed on top of the third support structure layer 1116. The second fabric layer 1118 can be disposed on the front side of the strut 430. The second fabric layer 1118 can include openings through which the anchors 800 extend.

[0299] The coaptation assist element 400 can include a fourth support structure layer 1120. The fourth support structure layer 1120 can be a mesh. In some embodiments, the fourth support structure layer 1120 can include UHMPE. The fourth support structure layer 1120 can be disposed on the second fabric layer 1118. The fourth support structure layer 1120 can be disposed on the front side of the support post 430. The fourth support structure layer 1120 can include openings through which the anchors 800 extend. In some embodiments, the first support structure layer 1104 and the fourth support structure layer 1120 have the same shape.

[0300] The coaptation assist element 400 can include a front layer 1122. The front layer 1122 can form the second surface 415. In some embodiments, the front layer 1122 is thin compared 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 inches, about 0.0015 inches, about 0.002 inches, about 0.0025 inches, about 0.003 inches, or any range inclusive of two of the foregoing values, or other thickness values ​​as described for other layers herein). The front layer 1122 can include openings through which the anchors 800 extend. The front layer 1122 can be any shape, including rectangular, polygonal, triangular, circular, and oval. In some embodiments, the front layer 1122 is not the final shape of the coaptation assist element 400. In some embodiments, the posterior layer 1102 and the front layer 1122 are the same shape.

[0301] 49 illustrates one embodiment of an implant delivery system 2200. The implant delivery system 2200 can include any of the features of the implant delivery systems described herein. The implant delivery system 2200 can include a primary anchor housing 2202. In some embodiments, the primary anchor housing 2202 is a docking tube. The primary anchor housing 2202 can be cylindrical. The primary anchor housing 2202 can include a central lumen. The primary anchor housing 2202 can be disposed around the annulus hub 420, 520, 620, 720 of the coaptation assist element 400, 500, 600, 700.

[0302] The implant delivery system 2200 can include a primary anchor driver 2204. The primary anchor housing 2202 can be sized to fit over 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. The primary anchor driver 2204 can be considered a primary anchor fork driver, as described herein. The primary anchor driver 2204 can be designed to engage and rotate the anchor 800. The anchor 800 can be considered a primary anchor 800 to distinguish it from one or more secondary anchors.

[0303] 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, although other configurations are envisioned (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 primary anchor housing 2202. In some embodiments, the release wires 2206, 2208 can extend beyond the surface of the implant. The release wires 2206, 2208 can extend through at least a portion of the primary anchor housing 2202. The release wires 2206, 2208 can extend through one or more channels or tubes within the primary anchor housing 2202. The release wires 2206, 2208 can be diametrically opposed within the primary anchor housing 2202.

[0304] Release wires 2206, 2208 can extend outside of primary anchor housing 2202. Primary anchor housing 2202 can include slots 2210, 2212 that allow release wires 2206, 2208 to extend therethrough. Release wires 2206, 2208 can extend through slots 2210, 2212 from the inside of primary anchor housing 2202 to the outside of primary anchor housing 2202 (e.g., release wire 2206 can extend through slot 2210 and release wire 2208 can extend through slot 2212).

[0305] The release wires 2206, 2208 can extend back inside the primary anchor housing 2202. The primary 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 outside of the primary anchor housing 2202 to the inside of the primary anchor housing 2202 (e.g., the release wire 2206 can extend through the slot 2214 and the release wire 2208 can extend through the slot 2216). The release wires 2206, 2208 can thread through the primary anchor housing 2202. The release wires 2206, 2208 can be coupled to the primary anchor housing 2202. The release wires 2206, 2208 can extend through the anchor 800. The release wires 2206, 2208 can cross.

[0306] The release wires 2206, 2208 can extend along the coaptation assist element 400, 500, 600, 700. The release wires 2206, 2208 can extend along the annular surface 410, 510, 610, 710. The release wires 2206, 2208 can extend underneath the coaptation assist element 400, 500, 600, 700. The release wires 2206, 2208 can extend in opposite directions. The release wires 2206, 2208 can be diametrically opposed. The release wires 2206, 2208 can be coaxial. The release wires 2206, 2208 can generally follow a line. The release wires 2206, 2208 can be adjacent to the annulus. The release wires 2206, 2208 can contact the annulus. The release wires 2206, 2208 can facilitate coupling between the implant delivery system 2200 and the coaptation assist element 400, 500, 600, 700. The release wires 2206, 2208 can hold the primary anchor housing 2202 firmly against the annulus hub 420, 520, 620, 720 of the coaptation assist element 400, 500, 600, 700. The release wires 2206, 2208 can extend from the anterior to the posterior 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.

[0307] The implant delivery system 2200 can include one or more auxiliary anchors 2220, 2222, 2224, 2226 (e.g., 1 auxiliary anchor, 2 auxiliary anchors, 3 auxiliary anchors, 4 auxiliary anchors (as shown), 5 auxiliary anchors, 6 auxiliary anchors, 7 auxiliary anchors, 8 auxiliary anchors, etc.). In some embodiments, two or more of the auxiliary anchors 2220, 2222, 2224, 2226 are the same. In some embodiments, two or more of the auxiliary anchors 2220, 2222, 2224, 2226 are different (e.g., different pitch, different diameter, different material, different shoulder, different window, etc.). In some embodiments, the auxiliary anchors 2220, 2222, 2224, 2226 can be helical anchors. The auxiliary anchors 2220, 2222, 2224, 2226 can have a smaller diameter than the primary anchor 800. The auxiliary anchors 2220, 2222, 2224, 2226 can have a smaller pitch than the primary anchor 800. The auxiliary anchors 2220, 2222, 2224, 2226 can be configured to rotate to engage tissue within the valve annulus.

[0308] The implant delivery system 2200 can include one or more auxiliary anchor drivers 2230, 2232, 2234, 2236 (e.g., one auxiliary anchor driver, two auxiliary anchor drivers, three auxiliary anchor drivers, four auxiliary anchor drivers (as shown), five auxiliary anchor drivers, six auxiliary anchor drivers, seven auxiliary anchor drivers, eight auxiliary anchor drivers, etc.). In some embodiments, two or more auxiliary anchor drivers 2230, 2232, 2234, 2236 are the same. In some embodiments, two or more auxiliary anchor drivers 2230, 2232, 2234, 2236 are different (e.g., different configurations, mirror images, different anchors coupled together, etc.). In some embodiments, the auxiliary anchor drivers 2230, 2232, 2234, 2236 are torque shafts. In some embodiments, the auxiliary anchor drivers 2230, 2232, 2234, 2236 are configured to rotate the respective auxiliary anchors 2220, 2222, 2224, 2226. In some embodiments, the auxiliary anchor drivers 2230, 2232, 2234, 2236 are configured to translate the respective auxiliary anchors 2220, 2222, 2224, 2226.

[0309] In some embodiments, auxiliary anchor drivers 2230, 2232, 2234, 2236 can be coupled to respective auxiliary anchors 2220, 2222, 2224, 2226 according to any embodiment described herein. In some embodiments, each auxiliary anchor driver 2230, 2232, 2234, 2236 is coupled to a respective auxiliary anchor 2220, 2222, 2224, 2226. In some embodiments, each auxiliary anchor driver 2230, 2232, 2234, 2236 is coupled to two or more auxiliary anchors 2220, 2222, 2224, 2226. In some embodiments, a single auxiliary anchor driver, for example 2230, is coupled to all of the auxiliary anchors 2220, 2222, 2224, 2226.

[0310] The implant delivery system 2200 can include one or more auxiliary anchor guide rails 2240, 2242, 2244, 2246 (e.g., one auxiliary anchor guide rail, two auxiliary anchor guide rails, three auxiliary anchor guide rails, four auxiliary anchor guide rails (as shown), five auxiliary anchor guide rails, six auxiliary anchor guide rails, seven auxiliary anchor guide rails, eight auxiliary anchor guide rails, etc.). The number of auxiliary anchor guide rails 2240, 2242, 2244, 2246 can correspond to the number of auxiliary anchors 2220, 2222, 2224, 2226. The auxiliary anchors 2220, 2222, 2224, 2226 can include a passageway therethrough. The passageway can extend through the center of the helical wire of the auxiliary anchors 2220, 2222, 2224, 2226. Auxiliary anchor guide rails 2240, 2242, 2244, 2246 can be configured to extend through the respective passages.

[0311] The implant delivery system 2200 can include one or more auxiliary anchor tethers 2250, 2252, 2254, 2256 (e.g., one auxiliary anchor tether, two auxiliary anchor tethers, three auxiliary anchor tethers, four auxiliary anchor tethers (as shown), five auxiliary anchor tethers, six auxiliary anchor tethers, seven auxiliary anchor tethers, eight auxiliary anchor tethers, etc.). The number of auxiliary anchor tethers 2250, 2252, 2254, 2256 can correspond to the number of auxiliary anchors 2220, 2222, 2224, 2226. The auxiliary anchor tethers 2250, 2252, 2254, 2256 can form a loop. Each auxiliary anchor tether 2250, 2252, 2254, 2256 can include a first strand, a second strand, and an arc therebetween. Each auxiliary anchor tether 2250, 2252, 2254, 2256 can form a loop around a respective release wire 2206, 2208, as described herein. The auxiliary anchor tethers 2250, 2252, 2254, 2256 can extend through the coaptation assist element 400, 500, 600, 700. The coaptation assist element 400, 500, 600, 700 can include one or more passageways that facilitate passage of the auxiliary anchor tethers 2250, 2252, 2254, 2256 therethrough.

[0312] The auxiliary anchor guide rails 2240, 2242, 2244, 2246 can include passages therethrough. The passages can extend through the centers of the auxiliary anchor guide rails 2240, 2242, 2244, 2246. The auxiliary anchor tethers 2250, 2252, 2254, 2256 can be configured to extend through the passages of the auxiliary anchor guide rails 2240, 2242, 2244, 2246. In some embodiments, each auxiliary anchor tether 2250, 2252, 2254, 2256 extends through a respective auxiliary anchor guide rail 2240, 2242, 2244, 2246. The auxiliary anchor drivers 2230, 2232, 2234, 2236 can include passages therethrough. The passages can extend through the centers of the auxiliary anchor drivers 2230, 2232, 2234, 2236. The auxiliary anchor tethers 2250, 2252, 2254, 2256 can be configured to extend through passages in the auxiliary anchor drivers 2230, 2232, 2234, 2236.

[0313] The release wires 2206, 2208 can maintain the connection to the coaptation assist elements 400, 500, 600, 700. The release wires 2206, 2208 can maintain the connection between the coaptation assist elements 400, 500, 600, 700 and the primary anchor 800. The release wires 2206, 2208 can maintain the connection between the coaptation assist elements 400, 500, 600, 700 and the primary anchor driver 2204. The release wires 2206, 2208 can maintain the connection between the coaptation assist elements 400, 500, 600, 700 and the secondary anchor tethers 2250, 2252, 2254, 2256.

[0314] FIG. 50 illustrates a telescoping feature for accessing the primary anchor location, according to some embodiments of the present invention. The primary anchor 800 can be positioned near the valve leaflets. The primary anchor 800 can be positioned near the valve annulus. In some methods, access is achieved using a transseptal sheath 1400. The transseptal sheath 1400 can include a lumen for passing one or more additio...

Claims

1. 1. A coaptation assist element for treating mal-coaptation of a heart valve, the coaptation assist element comprising: a first surface and an opposing second surface; a first lateral edge, a second lateral edge, a bottom edge, and a top edge; an adaptive coaptation element configured to expand during systole and contract during diastole; The joining auxiliary element comprises:

2. 10. The coaptation assist element of claim 1, further comprising an implant wing configured to seal over a commissure of a valve leaflet.

3. The coaptation assist element of claim 2 , wherein the implant wing comprises ePTFE or a bioinert fabric.

4. The coaptation assist element of claim 2 , wherein the implant wings are configured to cover the opening during upward and downward movement of the coaptation assist element.

5. 2. The coaptation assist element of claim 1, wherein the adaptive coaptation element expands with an increase in left ventricular pressure and blood flow toward the left atrium, and the adaptive coaptation element contracts with a decrease in left ventricular pressure and blood flow toward the left ventricle.

6. The joining aid element of claim 1, wherein the joining aid element is used in conjunction with an edge-to-edge device.

7. The coaptation assist element of claim 6, wherein the edge-to-edge device is configured to clip an anterior leaflet to the coaptation assist element to reduce blood reflux.

8. The coaptation assist element of claim 6, wherein the edge-to-edge device grasps only the anterior leaflet and the edge-to-edge device does not grasp the posterior leaflet.

9. The joining auxiliary element of claim 6, wherein the edge-to-edge device is configured to be embedded behind the joining auxiliary element.

10. The coaptation assist element of claim 1, wherein the coaptation assist element is configured to be fixed at one or more positions in the valve annulus, and the coaptation assist element is configured to move upwardly and downwardly during the cardiac cycle.

11. The joining auxiliary element of claim 1, wherein a joining auxiliary element body cover forms the first surface and the second surface.

12. The joint auxiliary element of claim 1, wherein the adaptive joint element has a fixed upper edge, fixed lateral edges, and a free lower edge.

13. The joint assist element of claim 1, wherein the adaptive joint element defines a pocket formed between the adaptive joint element and the second surface.

14. The joining assistance element of claim 1, wherein the adaptive joining element has a thickness at the joining surface when expanded of between 5 mm and 15 mm.

15. The coaptation assist element of claim 1, wherein the adaptive coaptation element is configured to fill to a greater thickness as a cardiac condition worsens.

16. The coaptation assist element of claim 1, further comprising one or more struts having one end terminating at the annulus hub and having another end extending radially outward.

17. The coaptation assist element of claim 1, wherein the adaptive coaptation element extends between the first lateral edge and the second lateral edge, and wherein the adaptive coaptation element extends the entire height of the ventricular portion or a portion thereof.

18. The coaptation assist element of claim 1, further comprising an annulus hub, the annulus hub being spaced inwardly from the adaptive coaptation element.

19. The coaptation assist element of claim 1, wherein during diastole, blood flow from the left atrium into the left ventricle causes the adaptive coaptation element to fold against a surface of the coaptation assist element.

20. The joining aid element of claim 1, wherein the adaptive joining element is a percentage between 70% and 100% of the width between the first lateral edge and the second lateral edge.

21. The joint assist element of claim 1, wherein the adaptive joint element is a percentage between 30% and 80% of the height of the joint assist element.

22. The joint support element of claim 1, wherein the adaptive joint element is joined along one or more sides or portions.

23. The joining assist element of claim 1, wherein the adaptive joining element expands and contracts relative to the second surface.

24. The joint auxiliary element of claim 1, further comprising implant wings, the implant wings extending along the first lateral edge and the second lateral edge or portions thereof.

25. The coaptation assist element of claim 1, further comprising implant wings, said implant wings being a percentage of between 10% and 30% of the height of said coaptation assist element.

26. The coaptation assist element of claim 1, further comprising an implant wing extending along a transition from the horizontally oriented portion to the vertically oriented portion of the coaptation assist element.

27. The joint auxiliary element of claim 1, wherein the adaptive joint element has a fixed upper edge and fixed lateral edges.

28. The joint assist element of claim 1, wherein the adaptive joint element is configured to fill from a lower end.

29. The coaptation assist element of claim 1, wherein the adaptive coaptation element is configured to expand to any thickness over a range of thicknesses until the adaptive coaptation element is stopped by the anterior leaflet.

30. The coaptation assist element of claim 21 , wherein the adaptive coaptation element comprises a material having a porosity between 10 microns and 200 microns.

Images