Devices, systems and methods for transcatheter treatment of valvular regurgitation using auxiliary anchors

Abstract

The present invention relates to devices for use in the transcatheter treatment of mitral regurgitation, specifically a coaptation assist element implanted across the valve, a system including the coaptation assist element and an anchor for implantation, a system including the coaptation assist element and a delivery catheter, and a method of transcatheter implantation of the coaptation element across a heart valve.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Patent Application No. 17 / 124,160, filed December 16, 2020, the entire disclosure of which is 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 the veins, pumps it to the lungs where it is oxygenated, and pumps the oxygenated blood out of the heart into the arteries from which the body's organ systems can extract oxygen for proper functioning. 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 that are 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. Normally, there are 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 contraction of the chambers. For example, the opening and closing of the mitral valve can occur as a result of pressure differences between the left atrium and the left ventricle.

[0007] At the beginning of ventricular filling (diastole), the aortic and pulmonary valves are closed, preventing backflow from the arteries into the ventricles. Shortly thereafter, the AV valves open, allowing unimpeded flow from the atria into the corresponding ventricles. Shortly thereafter, ventricular systole (i.e., the ventricles empty) 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 fail to function properly, resulting in improper closure. AV valves are complex structures, generally including annulus, cusps, chordae, and supporting structures. Each atrium is connected to its valve via the atrial vestibule. The mitral valve has two cusps, whereas the tricuspid valve has a similar structure with three cusps, where the apposition or engagement of the corresponding surfaces of the cusps relative to one another helps close or seal the valve to prevent blood from flowing in the wrong direction. The inability of the cusps to seal during ventricular systole is known as coaptation, which allows blood to flow backwards through the valve (regurgitation). Heart valve regurgitation can have serious consequences for the patient, 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 backwards from the left atrium into the pulmonary veins, resulting in blood congestion. If left untreated, severe valve regurgitation can lead to permanent damage or death. [Background technology]

[0009] Various therapies have been applied to treat mitral regurgitation, and others have been proposed but not used to treat actual patients. Although some of the known therapies have been found to be effective in at least some patients, further options would be desirable. For example, medications (such as diuretics and vasodilators) can be used in patients with mild mitral regurgitation to help reduce the amount of blood that leaks back into the left atrium. However, medications may not provide sufficient patient compliance. A significant number of patients may occasionally (or even regularly) forget to take their medication, regardless of the potential severity of worsening chronic and / or progressive mitral regurgitation. Pharmacological therapy of mitral regurgitation can also be inconvenient, often ineffective (especially as the condition worsens), and may be associated with significant side effects (such as low blood pressure).

[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 the incompetent mitral valve. Annuloplasty annulus repair can optionally reduce the size of the annulus of the posterior mitral 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. In any case, open mitral valve surgery is a highly invasive procedure that is generally performed with the patient under general anesthesia with the chest open and on cardiopulmonary bypass. Complications are common and timing is an issue in light of the morbidity (and potential mortality) of open surgery, but sicker patients may require surgery but are more likely to not tolerate it. Successful open mitral valve surgery may depend heavily on the skill and experience of the surgeon.

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

[0012] Perhaps most widely known, a variety of mitral valve replacement implants have been developed, which generally replace (or displace) the natural valve leaflets and rely on surgically implanted structures to control the blood flow pathway between the heart's chambers. Although these various strategies and tools have met with varying levels of acceptance, none of them has been 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 regurgitation therapies and implants, further alternative treatments have been proposed. Some of the alternative proposals have sought for the implanted structure to remain within the valve annulus throughout the cardiac cycle. One group of these proposals includes cylindrical balloons that remain embedded on tethers or rigid rods that extend between the atrium and ventricle through the valve opening. 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, it has proven difficult to achieve a seal between the native leaflets and the entire circumference of the balloon or other coaxial body, 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 view 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 modifying one or more characteristics of other valves in the body. There remains a need for devices that can directly improve leaflet coaptation (rather than indirectly by remodeling the annulus or ventricle), do not destroy the leaflet anatomy by fusion or the like, and 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 the 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 Serial No. 13 / 099,532 [Patent Document 2] U.S. Patent Application Serial No. 13 / 531,407 [Patent Document 3] U.S. Patent Application Serial 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 Serial 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 regurgitation and other valve diseases. The coaptation assist element may remain in the blood flow path as the valve moves back and forth between the 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 allow 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, the 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, one or more passive anchors are positioned to engage tissue by engaging an anchor with tissue. In some embodiments, the advantage is retrieval of the coaptation assist element during a procedure. In some embodiments, the coaptation assist element can be repositioned during a 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, the 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 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 and 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 motion 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 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 that the coaptation assist element can be folded. 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 that the coaptation assist element can be expanded. 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 preformed curve. In some embodiments, one or more struts comprise NiTi. In some embodiments, the purse string sutures are repeatedly tensioned and / or released. In some embodiments, the purse string sutures are capture 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 and leave another portion of the coaptation assist element folded or partially folded.

[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 location. In some embodiments, the central location is an anchor. In some embodiments, the central location 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 location 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 a 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 the coaptation assist element is fully deployed. In some embodiments, the anchor can disengage and / or re-engage the tissue after the coaptation assist element is fully deployed. In some embodiments, the purse string suture can collapse and / or expand the coaptation assist element or a portion thereof after the coaptation assist element is fully deployed. In some embodiments, the coaptation assist element can be recaptured after the coaptation assist element is fully deployed. In some embodiments, the coaptation assist element can be removed after the coaptation assist element 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 the annulus anchor through the annulus hub. In some embodiments, the coaptation assist element only requires attachment of the annulus anchor through the annulus hub and annulus barbs. In some embodiments, the coaptation assist element only requires attachment of the annulus anchor through the annulus hub, annulus barbs, and / or commissure barbs.

[0027] In some embodiments, the 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 jet, laser etching, or similar techniques. In some embodiments, the frame is constructed by forming the annulus hub at the edge 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 that extend along a portion of the circumference of the annulus hub are different from the struts that extend 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 cross. 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 a pointed edge. In some embodiments, the pointed edge extends linearly from the edge of the coaptation assist element. In some embodiments, the pointed edge is integrally formed within the strut. 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, the advantage is the curvature of the frame. In some embodiments, the annular hub extends radially. In some embodiments, the annular hub extends from the 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 strut. 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 an 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 a 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 is provided for treating mal-coaptation of a heart valve. 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 in the heart above the annulus. In some embodiments, the coaptation section is configured to be implanted in the heart across the plane of the 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 and is cupped downwardly toward the lower edge or upwardly 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 a first target location. The coaptation assist element can include a plurality of struts extending radially outwardly 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 greater 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, etc. 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 sharp 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 the first 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 upper edge forming the lip is cupped downwardly towards 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 towards the hub.

[0031] In some embodiments, a method is provided for treating malcoaptation of a heart valve in a patient. 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 is suspended with a coaptation surface coapting with the first leaflet and a leaflet surface of the coaptation assist overlapping the second leaflet, thereby reducing malcoaptation. The method can include engaging a pointed end of one of the struts with cardiac tissue distal to the annulus. The method can include monitoring the position of the coaptation assist element with one or more markers. The method can include monitoring the position of the coaptation assist element with a plurality of markers near a top edge of the coaptation assist element. In some embodiments, the tip of the anchor is recessed into the hub while positioning the hub near the annulus.

[0033] In some embodiments, a coaptation assist element is provided for treating mal-coaptation of a heart valve of a heart. 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 comprises a first coaptation surface and an opposing second surface. In some embodiments, the lower section comprises 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 the portion of the upper section. In some embodiments, the thickness of the lower section is at least about 50% greater than the thickness of the portion of the upper section. In some embodiments, the periphery of the attachment aid element comprises a raised atraumatic edge that only partially surrounds the attachment aid element. In some embodiments, the periphery 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 periphery of the attachment aid element comprises spaced apart barbs that extend radially outward from the periphery 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 may 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 a first target location. The coaptation assist element may include a plurality of struts spaced about and extending outwardly 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 coapting with a first leaflet of the heart valve and an opposing second surface overlying 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 with 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 annulus. The coaptation assist element delivery system can include a release wire configured to extend through the primary anchor housing and be positioned adjacent the annulus.

[0036] The coaptation auxiliary 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 a crossbar of the primary anchor. The coaptation auxiliary 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 auxiliary element delivery system can include an auxiliary anchor tether extending through the coaptation auxiliary element. In some embodiments, the auxiliary anchor tether extends around the release wire. The coaptation auxiliary element delivery system can include at least two auxiliary anchor tethers extending through the coaptation auxiliary 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 auxiliary 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 auxiliary element delivery system can include an auxiliary anchor driver. In some embodiments, the auxiliary anchor driver comprises at least one locking tab configured to engage a window in the auxiliary anchor. The coaptation auxiliary 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 tether 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 the 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 track of the at least one auxiliary anchor is determined by an 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 a track. The coaptation auxiliary element delivery system may include a proximal assembly configured to lock the position of the auxiliary anchor guide rail relative to the auxiliary anchor to prevent entanglement of the auxiliary anchor anchor. The coaptation auxiliary element delivery system may include a proximal assembly configured to lock the position of the auxiliary anchor guide rail relative to the auxiliary anchor driver to facilitate coupling of the auxiliary anchor driver to the auxiliary anchor. The coaptation auxiliary 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 the release wire. The coaptation auxiliary 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 auxiliary 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 is provided for treating mal-coaptation of a heart valve. 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 around and extending outwardly 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, the 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 comprises a primary anchor disposed within the primary anchor housing. In some embodiments, the coaptation assist element delivery system comprises 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, the at least one release wire is coupled to the primary anchor housing and extends under 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 telescopic feature is configured to position the coaptation assist element relative to a position that engages 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 the auxiliary anchor assembly along the auxiliary anchor anchor toward the annulus. The method can include maintaining engagement between the auxiliary anchor driver and the auxiliary anchor with the auxiliary anchor guide rail. The method can include preventing entanglement between the auxiliary anchor and the auxiliary anchor anchor with 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 tissue. The method can include retracting the auxiliary anchor guide rail after the auxiliary anchor engages 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 is provided for treating mal-coaptation of a heart valve having an annulus. 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 a first target location. The coaptation assist element can include a plurality of struts spaced about the hub and extending outwardly from the hub. In some embodiments, the plurality of struts comprises 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 greater 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 is cupped 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, the delivery catheter configured to position the hub near the first target location. In some embodiments, the delivery catheter is configured to rotate the anchor independently of the hub. The coaptation assist element may include a radiopaque marker. The coaptation assist element may include a plurality of radiopaque markers near the top edge. In some embodiments, the lip is cupped downwardly toward the bottom edge. In some embodiments, the lip is cupped upwardly from the bottom edge. In some embodiments, the hub extends upwardly from the first coaptation surface. In some embodiments, the bottom edge curves back toward the hub. In some embodiments, the hub is tubular. In some embodiments, the post and the hub are integrally formed. In some embodiments, the coaptation assist element is configured to fold against 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 is provided for treating mal-coaptation of a heart valve having an 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. 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 disengage tissue. The coaptation assist element can include a plurality of struts spaced about the hub. In some embodiments, the plurality of struts comprises 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 is provided for treating mal-coaptation of a heart valve. 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, 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 a first target location. In some embodiments, the anchor is configured to be selectively deployed at the annulus. The coaptation assist element can include a plurality of struts spaced about the hub. In some embodiments, the plurality of struts comprises 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.

[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 comprising 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 comprises 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 to engage the annulus. The coaptation assist element delivery system can include a release wire configured to extend through the first anchor housing and be positioned adjacent the 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 that extends 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 for visualizing 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 that is looped around the release wire. In some embodiments, the second anchor is configured to be delivered by sliding the second anchor along a second anchor guide rail, the second anchor guide rail guiding the trajectory of the second anchor. In some embodiments, the second anchor is configured to rotate to engage the annulus. In some embodiments, the second anchor is configured to have two or more trajectories. In some embodiments, the trajectory of the second anchor is determined by the orientation of the respective 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, the first anchor driver 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 30-90 degree bend. In some embodiments, the bend determines the trajectory of the second anchor delivered along the second anchor guide rail. [Brief description of the drawings]

[0047] [Figure 1A] FIG. 1 is a schematic diagram illustrating some of the tissues of the heart and mitral valve 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 some of the tissues of the heart and mitral valve 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 some of the tissues of the heart and mitral valve 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 some of the tissues of the heart and mitral valve 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 some of the tissues of the heart and mitral valve 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 some of the tissues of the heart and mitral valve 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 generally mitral regurgitation during systole in the setting of mal-coaptation of the mitral valve leaflets. [Figure 3B] FIG. 1 is a simplified cross-sectional view of the heart illustrating generally mitral regurgitation during systole in the setting of mal-coaptation of the mitral valve leaflets. [Figure 4A] FIG. 2 is a stylized cross-sectional view of the heart showing mitral valve dyscopiation in the setting of functional mitral regurgitation. [Figure 4B] FIG. 2 is a stylized cross-sectional view of the heart showing mitral valve dyscopiation in the setting of degenerative mitral regurgitation. [Figure 5A] FIG. 2 is a perspective view showing one embodiment of a joint auxiliary element. [Figure 5B] FIG. 5B is a top view showing the joint auxiliary element of FIG. 5A. [Figure 5C] FIG. 13 shows an embodiment of a post of the joint auxiliary element. [Figure 5D] FIG. 13 shows an embodiment of a post of the joint auxiliary 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 illustrates the coaptation assist element of FIG. 5A including a leaflet anchor site. [Figure 5I] FIG. 5B illustrates the coaptation assist element of FIG. 5A including a leaflet anchor site. [Figure 5J] FIG. 5B illustrates the coaptation assist element of FIG. 5A including a leaflet anchor site. [Figure 5K] FIG. 5B is a diagram showing the dimensions of the joint auxiliary element of FIG. 5A. [Figure 6] FIG. 13 is a perspective view showing an embodiment of a joint auxiliary element. [Figure 7A] FIG. 13 is a perspective view of one embodiment of a coaptation assist element showing a first surface disposed toward the mal-coapted native leaflet. [Figure 7B]FIG. 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] FIG. 7B is a top view showing the joint auxiliary element of FIG. 7A. [Figure 7D] FIG. 7B shows the coaptation assist element of FIG. 7A embedded within a model of the mitral valve. [Figure 7E] FIG. 7B is a top view showing the coaptation assist element of FIG. 7A embedded 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 joint assist element coupled to the delivery system of FIG. 8A. [Figure 8C] FIG. 13 is a schematic diagram showing the connection of the coaptation assist element to the annulus hub and the tip of the delivery catheter. [Figure 9A] FIG. 8B is a schematic diagram showing anchor operation of the delivery system of FIG. 8A. [Figure 9B] 1A-1C are schematic diagrams illustrating an embodiment of a connection between an annulus anchor and a driver. [Figure 9C] 1A-1C are schematic diagrams illustrating an embodiment of a connection between an annulus anchor and a driver. [Figure 9D] 1A-1C are schematic diagrams illustrating an embodiment of a connection between an annulus anchor and a driver. [Figure 9E] 1A-1C 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 method of a transcatheter technique showing transseptal crossing. [Figure 11] FIG. 13 is a schematic diagram illustrating a method of a transcatheter technique showing advancement of a first coaptation assist element. [Figure 12] FIG. 13 is a schematic diagram illustrating a transcatheter technique method showing the release of a partial coaptation assist element. [Figure 13] 13 is a schematic diagram illustrating a method of a transcatheter technique showing folding of the coaptation assist element. [Figure 14] FIG. 13 is a schematic diagram illustrating a method of a transcatheter technique showing a cross-sectional view of the coaptation assist element. [Figure 15] 1 is a schematic diagram illustrating a method of a transcatheter technique showing placement of an auxiliary anchor. [Figure 16] FIG. 1 illustrates a method of implant delivery showing the loading of the implant. [Figure 17] FIG. 1 illustrates a method for inserting an introducer. [Figure 18] 18A-18C 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. [Figure 20] 20 illustrates a method of positioning the transseptal sheath of FIG. 19. [Figure 21] FIG. 1 illustrates a method of delivering an anchor. [Figure 22A] FIG. 1 illustrates a method of deploying an implant. [Figure 22B] FIG. 1 illustrates a method of deploying an implant. [Figure 22C] FIG. 1 illustrates a method of deploying an implant. [Figure 22D] FIG. 1 illustrates a method of deploying an implant. [Figure 23] FIG. 13 illustrates a method of utilizing one or more auxiliary anchor guidewires. [Figure 24] FIG. 1 illustrates a method for removing an anchor driver. [Diagram 25] 13A and 13B are diagrams showing a method of advancing the auxiliary anchor guide rail. [Figure 26] 1 illustrates a method of delivering an auxiliary anchor. [Figure 27] 13A-13C show a method of inserting an auxiliary anchor. [Figure 28] 13A-13D illustrate a method of delivering another auxiliary anchor. [Figure 29] FIG. 1 shows a fixed implant including a guidewire. [Diagram 30] FIG. 2 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. [Fig. 31F] FIG. 1 illustrates a method for retrieving an implant. [Diagram 32] 13A-13C show a method of inserting an auxiliary anchor. [Diagram 33] 13A-13D illustrate a method of delivering another auxiliary anchor. [Diagram 34] 13A-13C show a method of inserting another auxiliary anchor. [Diagram 35] FIG. 2 shows a fixed implant. [Diagram 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. [Diagram 40] FIG. 1 shows an implant. [Diagram 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. [Fig.42D] FIG. 1 illustrates one embodiment of an implant delivery system. [Figure 42E] FIG. 1 illustrates one embodiment of an implant delivery system. [Fig.42F]FIG. 1 illustrates one embodiment of an implant delivery system. [Fig.42G] FIG. 1 illustrates one embodiment of an implant delivery system. [Fig. 42H] FIG. 1 illustrates one embodiment of an implant delivery system. [Fig.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. [Fig. 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. [Fig.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. [Fig.45F]FIG. 1 illustrates one embodiment of an implant delivery system. [Figure 45G] FIG. 1 illustrates one embodiment of an implant delivery system. [Fig. 45H] FIG. 1 illustrates one embodiment of an implant delivery system. [Fig.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] FIG. 13 shows an embodiment of a joint assist element. [Figure 47B] FIG. 13 shows an embodiment of a joint assist element. [Figure 47C] FIG. 13 shows an embodiment of a joint assist element. [Figure 47D] FIG. 13 shows an embodiment of a joint assist element. [Figure 47E] FIG. 13 shows an embodiment of a joint 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 method of delivery. [Figure 51] FIG. 1 illustrates one embodiment of a main anchor driver. [Figure 52] FIG. 13 illustrates one embodiment of an auxiliary anchor guide rail. [Figure 53A] FIG. 13 illustrates an embodiment of an auxiliary anchor guide rail to prevent entanglement. [Figure 53B]FIG. 13 illustrates an embodiment of an auxiliary anchor guide rail to prevent entanglement. [Figure 54] 13A-13C 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] 13A-13C 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. [Fig. 58D] FIG. 1 illustrates one embodiment of an implant delivery system. [Figure 58E] FIG. 1 illustrates one embodiment of an implant delivery system. [Fig. 58F] FIG. 1 illustrates one embodiment of an implant delivery system. [Figure 58G] FIG. 1 illustrates one embodiment of an implant delivery system. [Fig. 58H] FIG. 1 illustrates one embodiment of an implant delivery system. [Fig. 58I] FIG. 1 illustrates one embodiment of an implant delivery system. [Fig. 58J] FIG. 1 illustrates one embodiment of an implant delivery system. [Figure 59A] FIG. 1 illustrates an embodiment of an auxiliary anchor. [Figure 59B] FIG. 1 illustrates an embodiment of an auxiliary anchor. [Figure 60] FIG. 59B illustrates one embodiment of the auxiliary anchor and implant of FIG. 59A. [Figure 61] FIG. 1 illustrates an embodiment of an auxiliary anchor. [Figure 62A] 62 illustrates one embodiment of the auxiliary anchor and auxiliary anchor driver of FIG. 61. [Figure 62B] 62 illustrates one embodiment of the auxiliary anchor and auxiliary anchor driver of FIG. 61. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0048] The present invention, in some embodiments, generally provides improved medical devices, systems, and methods, often for the treatment of other valve diseases, including mitral regurgitation and tricuspid regurgitation. The following description includes reference to the anterior leaflet of a valve, such as the mitral valve, which has two leaflets, but it is understood that "anterior leaflet" may refer to one or more leaflets of a valve having multiple leaflets. For example, the tricuspid valve has three leaflets, so "anterior leaflet" may refer to one or two of the inner leaflet, the outer leaflet, and the posterior leaflet. The coaptation assist element described herein generally includes a coaptation assist (sometimes referred to as a valve disc) that generally follows the blood flow path as the leaflets move back and forth between an open configuration (where the anterior leaflet is separated from the valve disc) and a closed configuration (where the anterior leaflet engages the opposing surface of the valve disc). The valve 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 be closed during systole if normally functioning, thereby closing the gap caused by mal-coaptation 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 dislodged or pushed beyond the annulus by fluid pressure when the valve should be closed). In some embodiments, the coaptation assist element may fully assist one, two, or more leaflets, or in some embodiments, it may partially assist the leaflets, for example, covering 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.

[0049] 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 into 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, and the like.

[0050] 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 comprised 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.

[0051] 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 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 consistency of the leaflet shape and tissue helps promote effective sealing or coaptation. The anterior edges of the anterior and posterior leaflets meet along a funnel-shaped coaptation zone 16, a cross-section 160 of the three-dimensional coaptation zone (CZ) is shown diagrammatically in FIG. 1E.

[0052] The anterior and posterior mitral leaflets are shaped differently. The anterior leaflet is firmly attached by an 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 the anterior leaflet. Adjacent to the commissures 110, 114 and on or in front of the annulus 120 are the left (lateral) fibrous trigones 124 and the right (septal) fibrous trigones 126 (FIG. 1F), which form where the mitral annulus fuses with the base of the aortic non-coronary leaflet. The fibrous trigones 124, 126 form the septal and lateral extents of the central fibrous body 128. The fibrous trigones 124, 126 may have the advantage in some embodiments of providing a firm 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 the 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 axial atrial views of FIGS. 1C, 1D, and 1F, the axial cross-section of the coaptation area generally shows a curved line CL that is separate from the annular center CA and from the opening CO through the valve during diastole. In addition, the leaflet edges are wavy, with a greater wavy line for the posterior leaflet compared to the anterior leaflet. The characteristics of the coaptation may vary along the curved line CL of the coaptation area, as mal-coaptation may occur between one or more of these AP (anterior-posterior) segment pairs A1 / P1, A2 / P2, and A3 / P3.

[0053] 2A, a properly functioning mitral valve 60 of the heart is open during diastole to allow 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, a functioning mitral valve 60 is first passively and then actively closed during systole by an increase in 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.

[0054] 3A-3B and 4A-4B, there are a number of conditions or pathological conditions in which the leaflet edges of the mitral valve fail to adequately oppose, thereby allowing blood to flow back from the ventricle into 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 causes mitral regurgitation.

[0055] In general, malcoaptation may occur due to excessive tethering of one or both leaflets by the supporting structures, or due to excessive stretching or rupture of the supporting structures. Other less common causes include infection, congenital abnormalities, and trauma to the heart valve. Valve incompetence may occur due to elongation of the chordae tendineae, known as mitral valve prolapse, and sometimes due to rupture of the chordae 215 or papillary muscles, known as flail leaflets 220, as shown in FIG. 3A. Alternatively, the more the coaptation extends into the atrium, the greater the opening of the valve in the atrium during ventricular systole 230, since the valve may prolapse if the leaflet tissue itself is redundant. Either leaflet may prolapse or flail. This condition is sometimes known as degenerative mitral regurgitation.

[0056] In the case of excessive tethering as shown in FIG. 3B, the leaflets of a normally anatomic valve may not function properly due to an enlargement or change in shape of the valve annulus, so-called annular dilation 240. Such functional mitral regurgitation is generally brought about by impaired myocardium and associated ventricular dilation. In addition, the excessive amount of load caused by functional mitral regurgitation may itself exacerbate heart failure, ventricular dilation and annular dilation, which in turn exacerbates mitral regurgitation.

[0057] 4A-B show the regurgitation of blood during systole BF in functional (FIG. 4A) and degenerative (FIG. 4B) mitral regurgitation. The increased size of the annulus in FIG. 4A, along with increased tethering due to hypertrophy of the ventricle 320 and papillary muscles 330, prevents apposition of the anterior 312 and posterior 314 leaflets, 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.

[0058] Further description of articulation assist elements, tools, anchors, features, systems, and methods that may be utilized in conjunction with the disclosure herein may be found in the following applications, which are incorporated by reference in their entireties: U.S. Ser. No. 13 / 099,532, filed May 3, 2011, U.S. Ser. No. 13 / 531,407, filed June 22, 2012, U.S. Ser. No. 14 / 313,975, filed June 24, 2014, U.S. Ser. No. 14 / 742,199, filed June 17, 2015, U.S. Ser. No. 14 / 749,344, filed June 24, 2015, and U.S. Ser. No. 10 / 419,706, filed April 18, 2003.

[0059] 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 elements attach to the posterior aspect of the annulus from above and to the posterior aspect of the left ventricle from below via annular anchors and / or ventricular anchors. In other embodiments, more than one annular anchor and / or more than one ventricular anchor may be used to attach the coaptation assist elements. 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 elements may attach to the superior aspect 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 coaptation failure occurs in both functional and degenerative mitral regurgitation, regardless of the mechanism behind the dysfunction, similar coaptation assist elements can be used in both. In some embodiments, different sized coaptation assist elements can be positioned such that the native anterior leaflet apposes the coaptation element at the properly established coaptation point to inhibit blood flow during ventricular contraction.

[0060] Various sizes of coaptation assist elements may be provided, with different dimensions configured 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 height of the coaptation point. There may also be an inner-outer diameter of the coaptation assist element, which is generally larger in the case of functional MR. During diastole, the coaptation assist element may remain in substantially the same position, while the movement of the native anterior leaflet opens the valve to allow 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 upwards, while the anchor remains stationary. This may be advantageous as it improves the seal between the anterior or coaptation surface of the element and the native leaflets in the coaptation area during systole. During diastole, the surface may return to its original position, which is 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 across the coaptation assist element.

[0061] 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 some variations, but still others are envisioned. In some methods of use, a fixation structure (not shown) may pass from the coaptation assist element through the atrial wall and into the coronary sinus, where the fixation structure is attached to a mating structure in the coronary sinus. In some methods of use, the fixation structure may be a mechanical structure or a simple suture that passes through the atrial wall and is fixed by a mechanical element such as a knot or clip at 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.

[0062] The coaptation assist elements described herein may exhibit a number of desirable characteristics. Some embodiments do not need to rely on remodeling the mitral annulus (such as by heat shrinking the annular tissue, implanting an artificial annular ring, and / or placing a fastening mechanism above or below the valve plane or within the coronary sinus or associated vessels). Advantageously, there is no need to destroy the leaflet structure, nor to rely on locking or fusing the mitral leaflets together. Many embodiments represent passive implant devices that may avoid remodeling the ventricle, and may have a limited range of motion after implantation, resulting in a very long fatigue life. Thus, the coaptation assist elements may be fixed across the posterior leaflets, leaving otherwise native heart (e.g., ventricles, mitral annulus, etc.) anatomical structures intact.

[0063] The reduction of mitral valve mal-coaptation may be effective regardless of which leaflet segment is mal-coapted. 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 is complete, often without damaging the valve structure. Nevertheless, the coaptation assist elements described herein may be combined with one or more therapies that are obviated and rely on one or more of the attributes described above. The coaptation assist elements may exhibit benign tissue healing and rapid endothelialization, thereby inhibiting dislocation, thromboembolism, infection, and / or erosion. In some cases, the coaptation assist elements may not exhibit endothelialization and the surface may remain inert, thereby also inhibiting dislocation, thromboembolism, infection, and / or erosion.

[0064] 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 disposed toward the mal-coapted native valve leaflet, the posterior leaflet in the case of the mitral valve, 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 match 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 curved upward toward the atrial wall to match the overall shape of the left atrial wall, as shown in FIG. 6 and described herein.

[0065] The coaptation assist element 500 may have a geometry that allows it to traverse the valve between attachment sites in the atrium and 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 may not be attached 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. FIGS. 5A and 5B show the geometry.

[0066] 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 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 may be a central location of the coaptation assist element 500, such as a centrally located hub. In some embodiments, the coaptation assist element 500 may be attached to the atrium or annulus along an edge. In some embodiments, the coaptation assist element 500 may be attached to the atrium or annulus at a location away from the edge of the coaptation assist element 500, such as a centrally located hub.

[0067] The coaptation assist element 500 can include an annulus hub 520 that engages the annulus anchor 800. The annulus anchor 800 can be engaged at a 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 section 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 can be engaged to the coaptation assist element 500 and the driver to the annulus anchor 800 via the annulus hub 520. The driver can then be retracted into the delivery catheter with the coaptation assist element 500 in the collapsed position. The driver may be separately manipulated by the practitioner to place 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 a delivery catheter. Once deployed, the coaptation assist element 500 may completely cover the posterior leaflet such that during systole, the coaptation assist element 500 coapts with the anterior leaflet and maintains valve sealing at the annular ring with the natural anterior leaflet.

[0068] 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 engaging 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 location of the annulus anchor 800 and corresponding hub 520 can be neutral center, which prevents rocking of the coaptation assist element 500 when it is held by the annulus hub 520. The corresponding hub 520 provides a convenient location for holding and moving the coaptation aid element 500 .

[0069] The annulus hub 520 may have an inbuilt or attached annulus anchor 800. In some embodiments, the annulus anchor 800 may be retained in 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 the annulus anchor 800 from being dislodged from the annulus hub 520 by blunt force. 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 ventricular 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.

[0070] 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 commissure anchors, ventricular anchors, annulus anchors, barbs, tethers, or any other known fixation devices.

[0071] As can be seen in Figures 5A-5B, the coaptation assist element 500 can include a plurality of 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 in various directions from the hub 520 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 of about 5 degrees to about 45 degrees, about 10 degrees to about 30 degrees, or about 5, 10, 15, 20, 25, or 30 degrees relative to the adjacent struts 530. The struts 530 may be arranged approximately parallel to the longitudinal axis of the coaptation assist element 500 to help maintain the shape of the coaptation assist element 500 during placement. 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.

[0072] 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 the strut 530. The annulus anchor portion 535 is shown extending downwardly 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 having a pointed tip. The annulus anchor portion 535 may be a passive anchor.

[0073] 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 is 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 body cover as described herein. In some embodiments, the interface between the tissue and the valve body cover pushes back the valve body cover, exposing the barbs. In some embodiments, the tissue dissolves and / or absorbs a portion of the valve body cover, exposing the barbs. In some embodiments, the barbs are advanced by movement of a purse string suture as described herein. In some embodiments, the valve body cover moves by movement of the purse string suture to expose the barbs. Other configurations are envisioned.

[0074] The annulus anchor 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 20-60 mm, and in some embodiments, a preferred length is 35-45 mm, which is closest to the ICD of the widest range of human mitral valves. In some embodiments, D1 may be the distance from the right fibrous trigone to the left fibrous trigone.

[0075] The coaptation assist element 500 can include a generally annular section 510. The annular section 510 can be positioned above the natural leaflets when the coaptation assist element 500 is deployed. In some embodiments, the annular section 510 can be curved toward the annulus or curved 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 be curved 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 upon deployment. The coaptation assist element 500 can be curved downward from the hub 520 toward the annular anchor site 535. In some embodiments, the coaptation assist element 500 does not contact the posterior leaflet. In some embodiments, the annular 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 be curved towards the annulus. The annular curve radius can be curved 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.

[0076] The struts 530 may be constructed of a radiopaque material. In some embodiments, the struts 530 are constructed of a material that is elastically deformable, 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, acellular collagen matrix such as SIS, or other plastics. In other embodiments, the struts 530 may be combinations such as 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 a consistent stiffness. In some embodiments, one or more struts 530 may have different stiffness 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 the midpoint, e.g., at an inflection point or curve. The struts 530, together with one or more other support structures, may form a frame. In some embodiments, one or more support structures may be provided that run parallel to the top edge 540 of the coaptation assist element 500 and help maintain the shape of the top edge 540. The struts 530 and / or other support structures of the frame may be laser cut from Nitinol tubing in some embodiments.

[0077] The coaptation assist element body cover 550 may be constructed of materials such as ePTFE. Other materials for the coaptation 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 coaptation assist element body cover 550 may include a foam material surrounded by ePTFE. The use of a sponge or foam material improves the ability of the coaptation assist element 500 to fold into a diameter small enough to pass through a catheter. In some embodiments, the coaptation assist element body cover 550 is non-porous. In other embodiments, the coaptation assist element body cover 550 may have pores to improve endothelialization and cell attachment. The coaptation assist element body cover 550 may also incorporate radiopaque or echo-enhancing materials 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 covered with a radiopaque material such as gold or platinum or barium impregnated material. The coaptation surface 560 may be covered with an echo-enhancing material. The coaptation assist element body cover 550 may be covered 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 suture 1010 described herein may incorporate radiopaque or echo-enhancing materials for better visualization.

[0078] 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 constructed of the same material on the first surface 505 and the second surface 515. The coaptation assist element body cover 550 may be constructed 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.

[0079] The attachment auxiliary element 500 may include a purse string suture 1010. The purse string suture 1010 may extend along a portion of the attachment auxiliary 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 attachment auxiliary 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.

[0080] In some embodiments, the purse string suture 1010 may be sandwiched between layers of the body cover 550. For example, the purse string suture 1010 may be disposed within a lumen between layers of the 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 body cover 550. In some embodiments, the purse string suture 1010 may be "sewn" through the body cover 550. The purse string suture 1010 may pass from the first surface 505 to the second surface 515 and back to the first surface 505. The purse string suture 1010 may include one or more ends exposed from the 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 body cover.

[0081] 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 in recapturing and / or repositioning the coaptation assist element 500.

[0082] The application assist element 500 may be rotated by tightening one or more of the purse string sutures 1010 and / or loosening one or more of the purse string sutures 1010. For example, the application assist element 500 may be rotated by tightening one or more of the purse string sutures 1010 at the lateral edge 570 and / or loosening one or more of the purse string sutures 1010 at the lateral edge 575. The one or more purse string sutures 1010 may be coupled to the application assist element 500 to allow for multi-directional rotation.

[0083] 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 in recapturing the coaptation assist element 500 and / or repositioning the coaptation assist element 500.

[0084] 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 in situ the curvature of the coaptation surface 560. 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.

[0085] The annular dimensions 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 alter in situ one or more dimensions of the coaptation assist element 500. The ability to adjust the dimensions of the coaptation assist element 500 can be beneficial to accommodate the geometry of the heart.

[0086] The coaptation assist element 500 can include one or more purse string sutures 1010. In some embodiments, the coaptation 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 coaptation assist element 500. When multiple purse string sutures are provided, the purse string sutures 1010 can act together to change the configuration of the coaptation assist element 500. When multiple purse string sutures are provided, the purse string sutures 1010 can act independently to change the configuration of the coaptation assist element 500.

[0087] 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 a 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.

[0088] 5A shows 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 generally decreases from the top to the bottom of the coaptation aid element 500. For example, the length of the upper edge 540 may range from 15 to 50 mm or 25 to 35 mm, and the length of the lower edge 580 may range from 1 to 15 mm or 2 to 6 mm.

[0089] 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 in 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. Although only one annulus anchor 800 is shown, in other embodiments, two or more annulus hubs 520 may be provided.

[0090] In some embodiments, the struts 530 can include NiTi tubing. In some embodiments, the struts 530 can be laser cut from tubing. In some embodiments, the frame including the one or more struts 530 and / or the one or more support structures can be laser cut from a single piece of material. In some embodiments, the frame including the one or more struts 530, the annulus hub 520, and / or the one or more support structures can be integrally formed. In some embodiments, the coaptation assist element body cover 550 includes 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 the one or more support structures. The struts 530 and / or the 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.

[0091] 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 fixations are 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 for axial movement and / or transmission of torque. 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 may 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.

[0092] In some embodiments, the hub 520 is located at 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.

[0093] 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 by the delivery catheter. For example, the coaptation assist element 500 can be rotated about 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 by the delivery catheter. For example, the annulus anchor 800 can be disengaged from the tissue and the delivery catheter can recapture the coaptation assist element 500.

[0094] 5C-5D show an embodiment of the frame 565 of the joint auxiliary element 500. These figures show the flat pattern of the frame 565 before bending and / or shape setting. 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 can be laser cut, including its portions. The frame 565 can include one or more struts 530. In the embodiment shown in FIG. 5D, the frame 565 includes 20 struts 530, but other configurations are envisioned (e.g., 1 strut, 2 struts, 3 struts, 4 struts, 5 struts, 5-10 struts, 10-15 struts, 15-20 struts, 20-25 struts, 25-30 struts, 2-30 struts, 5-30 struts, etc.). In some embodiments, the frame 565 can include about, at least about, or up to 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 that extend upwardly or downwardly to the cupped upper lip is less than the longest strut that extends downwardly, such as less than about 80%, 70%, 60%, 50%, 40%, 30%, 20%, or less.

[0095] In some embodiments, one, two, or more struts 530 are coupled to the 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 the annulus hub 520. For example, the 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 when the frame 565 is formed from a tubular stock. The uncut tubular stock can form the annulus hub 520. The pattern of 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 of 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 the shape of a circle. 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.

[0096] 5A and 5C, a number of 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.

[0097] 5A-5D, a number 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.

[0098] 5A and 5D, a number of struts 530 can extend from the annulus hub 520 to the lateral edges 570 and 575. In some embodiments, the struts 530 have a length intermediate between the ventricular and atrial struts. In some embodiments, the struts engage commissures or another anatomical structure. In some embodiments, the commissure fixation is passive.

[0099] The struts 530 can have various lengths based on the desired shape of the coaptation assist element 500. As shown in Figures 5C-5D, two or more struts 530 have different lengths. As shown in Figures 5C-5D, two or more struts 530 have the same length. Figure 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 bottom edge. One or more of the bottom three struts can form the annular portion and extend to the top edge. The struts 530 can be laser cut from a tube. 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 about 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.

[0100] The width can be measured perpendicular to the strut length. The strut width can range from 0.1 mm to 2 mm. One or more struts can have an outer diameter or width 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. 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 a connection between one or more struts 530 and the annulus hub 520. A taper near the annulus hub 520 may aid in collapsing of the coaptation assist element 500. A 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 collapsing. In some embodiments, the taper may aid in 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 struts 530. In some embodiments, the eyelet may reduce stress in the struts 530. In some embodiments, the eyelet may facilitate adhesion between the struts 530 and the valve body cover 550.

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

[0102] 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 out of the plane of the struts 530. In some embodiments, the barbs can have a bayonet configuration. In some embodiments, the barbs can have a pointed tip. In some embodiments, the one or more struts 530 can be bifurcated. In some embodiments, the one or more 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.

[0103] In some embodiments, one or more struts 530 can include supplemental barbs. In some embodiments, the supplemental barbs can 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 can 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 can include an increased width to compensate for electropolishing or other post-manufacturing processes. In some embodiments, the backing 585 can include one or more features that engage a delivery catheter as described herein. In some embodiments, the backing 585 can include one or more notches designed to interface with a locking tab or other feature of a delivery catheter as described herein. In some embodiments, one or more struts 530 can include a width that is wider than the other struts 530. In some embodiments, the frame 565 includes two or more struts 530 that have a width wider than the other struts 530. The two or more struts 530 can 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.

[0104] Figures 5E, 5F, and 5G show an embodiment of a coaptation assist element 500 that lacks barbs. 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.

[0105] Figures 5H, 5I, and 5J show an embodiment of a coaptation assist element 500 having leaflet anchor sites 545. As shown in Figure 5A, annulus anchor sites 535, such as barbs, can extend along the edge of the coaptation assist element 500. Figures 5H, 5I, and 5J show an embodiment of a coaptation assist element 500 having leaflet anchor sites 545 extending from a first surface 505 disposed towards the mal-coapted native leaflets.

[0106] Figure 5H shows a schematic perspective view of the coaptation assist element 500, including an enlarged cross-section showing the leaflet anchor site 545. Figure 51 shows a schematic perspective view of the first surface 505 disposed towards the mal-coapted native leaflet. Figure 5J shows a schematic cross-section including the anchor 800.

[0107] In some embodiments, the leaflet anchoring site 545 comprises one or more barbs having a sharp tip. The leaflet anchoring 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 anchoring site 545 may be retracted during delivery of the coaptation assist element 500. For example, the leaflet anchoring site 545 may be advanced after the coaptation assist element 500 is positioned relative to the anatomy. In some embodiments, the leaflet anchoring site 545 is actively retracted and / or advanced. For example, the delivery catheters described herein may include a mechanism coupled to the leaflet anchoring site 545 designed to retract and / or advance the barbs. In other embodiments, the leaflet anchoring site 545 is passively advanced and / or retracted. In some embodiments, the leaflet anchoring site 545 may 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 leaflet anchoring site 545. In some embodiments, the tissue dissolves and / or resorbs a portion of the body cover, exposing the leaflet anchor site 545. In some embodiments, movement of the purse string suture described herein advances the leaflet anchor site 545. In some embodiments, movement of the purse string suture moves the body cover to expose the leaflet anchor site 545. Other configurations are envisioned.

[0108] 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 with a different number 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 a different number 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 anchor site 545 can be disposed to engage the posterior leaflet.

[0109] 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 pre-set curve that may exert a force on the first surface 505. The leaflet anchor sites 545 may be sharpened to cut through the disc cover 550.

[0110] The frame 565 can have many advantages. The frame 565 can be formed from a flattened pattern. The frame 565 can include edges that form the annulus hub 520. The edges 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.

[0111] The frame 565 can be constructed from a single flat sheet of material. The frame 565 can be precision cut using water jet, 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 with the ends to form a loop, it can be considered the annulus hub 520.

[0112] 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, the 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.

[0113] 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 that extend along one portion of the circumference of the annulus hub 520 are different from the struts that extend 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 an annulus region of the heart. One or more designated portions of the struts 530 can be designed to be located near a commissure region of the heart. One or more designated portions of the struts 530 can be designed to be located near a ventricular region 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 the 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.

[0114] FIG. 5K shows the dimensions of the joint auxiliary element 500. The joint auxiliary element 500 can include a dimension A. The dimension A can be a linear protruding dimension or a rear protrusion. In some embodiments, the dimension A can range from 1 mm to 40 mm. In some embodiments, the dimension A can range from 4 mm to 24 mm. Other configurations of the range of the dimension A are envisioned, such as 5 mm to 35 mm, 10 mm to 30 mm, 15 mm to 25 mm, about 1 mm, about 2 mm, about 3 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, 1 mm to 10 mm, 5 mm to 15 mm, 10 mm to 20 mm, 15 mm to 25 mm, 20 mm to 30 mm, 25 mm to 35 mm, 30 mm to 40 mm, etc. In the absence of a rear protrusion, for example when the joint auxiliary element 500 is a straight line, the dimension A can be 0 mm.

[0115] The joint assist element 500 can include a dimension B. In some embodiments, the dimension B can be a radius of curvature. The radius of curvature can be concave or convex, as described herein. In some embodiments, the dimension B can range from 1 / 16 inch to 1 / 2 inch. In some embodiments, the dimension B can range from 1.5 mm to 13 mm. In some embodiments, the dimension B can range from 1 / 4 inch to 3 / 8 inch. In some embodiments, the dimension B can range from 6 mm to 9.5 mm. In some embodiments, the 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. In the absence of curvature, e.g., if the joint assist element 500 is straight, dimension B can be 0 mm.

[0116] The joint auxiliary 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 configurations of the range of the dimension C are envisioned, 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 when the joint auxiliary element 500 is straight, the dimension C can be 0 mm.

[0117] 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.

[0118] The joint assist element 500 can include a dimension E. The dimension E can be a linear protruding dimension or an anterior protrusion. In some embodiments, the dimension E can range from 2 mm to 20 mm. In some embodiments, the dimension E can range from 5 mm to 10 mm. Other configurations of the range of the dimension E are envisioned, 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.

[0119] The struts 530 of the coaptation assist element 500 can form a back curvature of the coaptation surface 560. The back bend can have a bend length of 30-100% distal to the strut. In some embodiments, the back bend can have a bend length of at least 40% distal to the strut. The angle of the back bend 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 back bend can range from 45 degrees to 90 degrees.

[0120] 6 illustrates one embodiment of a 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, with certain additional features described below.

[0121] The coaptation assist element 600 can include an annulus hub 620 that engages 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.

[0122] As can be seen in FIG. 6 , the coaptation assist element 600 can include struts 630. In some embodiments, the 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 assume a reduced configuration for deployment through a catheter.

[0123] The coaptation assist element 600 may include an annular section 610. When the coaptation assist element 600 is deployed and forms a lip as shown, the annular section 610 may be positioned above the annulus of the native leaflet. In some embodiments, the annular section 610 may be curved 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 section 610 may be convex. In other embodiments, the annular section 610 may be substantially flat relative to the annulus. One or more of the struts 630 may be curved laterally from the annular hub 620 toward the upper edge 640 to help maintain the shape of the annular section 610 of the coaptation assist element 600 upon deployment. The coaptation assist element 600 may be curved 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 be curved away from the annulus. The annular curve radius can be curved towards the coaptation surface 660. In some embodiments, the annular curve radius can be 0 mm to 5 mm, 5 mm to 10 mm, 10 mm to 15 mm, 15 mm to 20 mm, 20 mm to 25 mm, 25 mm to 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.

[0124] In some embodiments, the periphery of the annular section 610 is cupped upwardly 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.

[0125] 7A-7E show one embodiment of coaptation assist element 700. Coaptation assist element 700 can be similar to coaptation assist element 500 or 600 and can include any of the features described herein, with certain elements described below.

[0126] 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, which is disposed toward the mal-coapted native leaflet, 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, which 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.

[0127] 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 a proximal end by a driver, as described herein. The annulus hub 720 can have an inbuilt or attached 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.

[0128] 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 site 735 is shown extending downwardly from the body of the coaptation assist element 700 in Figure 7B. The annulus anchor 800 can be an active anchor. The annulus anchor site 735 can be a passive anchor, such as a barb. The annulus anchor site 735 can be at a distal end of one or more struts 730.

[0129] The annular section 710 can be positioned above the natural leaflets when the coaptation assist element 700 is deployed. In some embodiments, the annular section 710 can be curved toward the annulus or atrial wall. One or more of the struts 730 can be curved laterally from the hub 720 toward the top edge 740 to help maintain the shape of the annular section 710 of the coaptation assist element 700 upon deployment. The coaptation assist element 700 can be curved downward from the annulus hub 720 toward the annulus anchor site 735. The annular section 710 can be concave. In some embodiments, one or more support structures can be provided that run parallel to the top edge 740 of the coaptation assist element 700 and help maintain the shape of the top 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.

[0130] In some embodiments, the coaptation assist element 700 includes an active anchor, such as annulus anchor 800. In some embodiments, the coaptation assist element 700 includes a passive anchor, such as annulus anchor site 735. The annulus anchor site 735 can include barbs at the tips of one or more struts 730.

[0131] The coaptation assist element 700, like any of the coaptation assist elements 500, 600 described herein, can include one or more markers 900. The markers 900 can be positioned on any portion of the coaptation assist element 500, 600, 700, or on any portion of any element of the coaptation assist element, such as the struts 530, 630, 730, the annulus hub 520, 620, 720, the purse string suture 1010, and / or the annulus anchor site 535, 735. In some embodiments, the markers 900 are positioned on the annulus anchor 800. In other embodiments, the markers 900 are integrally formed with the coaptation assist element 500, 600, 700, or the 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 precisely orient and position the coaptation assist element 500, 600, 700 and / or annulus anchor 800 within the patient's heart.

[0132] In some embodiments, the markers 900 may be radiopaque or may be covered with a radiographic marker. The markers 900 may be visualized if 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 so that it is driven 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 at the proximal end. These markers 900 may inform the medical team how far the annulus anchor 800 has traveled towards the annulus hub 520, 620, 720 and may be informative as to when the annulus anchor 800 is safely in place. In some embodiments, the amount of torque at the handle may increase sharply when the annulus anchor 800 is at its lowest position on the annulus hub 520, 620, 720 to ensure that the proper torque is applied. 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 parts of the coaptation assist element 500, 600, 700, or positioning points such as the most proximal point, the most distal point, the midline, etc.

[0133] 7D-7E show one embodiment of the coaptation assist element 700 deployed in a mitral heart valve model. Referring again to FIG. 1F, the coaptation area CL between the leaflets is not a simple line, but rather a curved, funnel-shaped surface interface as shown in FIG. 7C. The first commissure 110 (anterolateral or left side) and the second commissure 114 (posteromedial or right side) are where the anterior leaflet 12 meets the posterior leaflet at the coaptation area, which form the coaptation line (CL). As can be seen most clearly in the axial view from the atrium in FIG. 7D, an axial cross-section of the coaptation area generally shows a curved line CL that is separate from the center of the annulus as well as from the opening through the valve during diastole. In addition, 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 the dyssynchrony can vary along the junctional curve CL, as shown in Figure 1F.

[0134] 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.

[0135] 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 in 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, that allow air to be removed from the system and fluids, such as saline or contrast, to be injected into the implantation site. The catheter 1000 can include a catheter shaft 1006. The catheter 1000 can include an implant inserter 1007.

[0136] The delivery catheter 1000 may include an implant control knob 1003. The implant control knob 1003 may control the movement of the articulation assist element 500, 600, 700. The implant control knob 1003 may allow the articulation assist element 500, 600, 700 to be folded. The implant control knob 1003 may allow the articulation assist element 500, 600, 700 to be expanded. Arrow 1003a indicates the direction of movement of the implant control knob 1003 in which the articulation assist element 500, 600, 700 is folded by the delivery catheter 1000 and / or expanded by the delivery catheter 1000. The implant control knob 1003 may allow the articulation assist element 500, 600, 700 to be rotated. Arrow 1003b indicates the direction of movement of the implant control knob 1003 in which the articulation assist element 500, 600, 700 is rotated.

[0137] The implant control knob 1003 may 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 may be coupled to the annulus hub 520, 620, 720. For example, the implant control knob 1003 may be connected to one or more purse string sutures 1010, which may control the deployment of the coaptation assist elements 500, 600, 700. The purse string sutures 1010 may facilitate folding and / or expansion of the coaptation assist elements 500, 600, 700, as described herein. The purse string sutures 1010 may 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 .

[0138] 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.

[0139] The annulus hub 520, 620, 720 may have features that can lock with the tip 1300 of the delivery catheter 1000. Referring again to FIGS. 5A-7E, the annulus hub 520, 620, 720 can include one or more features that engage a portion of the delivery catheter 1000. The features can include one or more notches in the hub 520 of the implant as shown in FIG. 5A. The features can include an internal lip as shown in FIG. 9A. The features can include a window accessible from the outside of the hub 520, 620, 720 as shown in FIG. 8C. The features can include any structure or mechanism that can couple the annulus hub 520, 620, 720 and 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 screw 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.

[0140] 8B shows the coaptation assist elements 500, 600, 700 coupled to a delivery catheter 1000. The coaptation assist elements 500, 600, 700 can be folded as shown or expanded as shown in dashed lines by movement along arrow 1003a. The coaptation assist elements 500, 600, 700 can be rotated as shown in dashed lines by movement along arrow 1003b.

[0141] 8C, the delivery catheter 1000 can include a tip 1300. The distal end of the tip 1300 can include a distal locking tab. In some embodiments, the tip 1300 can include multiple pre-bent or shaped locking tabs. In some embodiments, the tip can include 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 a nitinol locking tab on the tip 1300. In some embodiments, the locking tab 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 driver 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 into the tip 1300. In some embodiments, the central pin is hollow to allow for movement of other components such as drivers as described herein. Movement of the central pin can force the locking tabs outward to engage the annulus hub 520, 620, 720.

[0142] 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 support 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, as described herein, can maintain the relative position between the delivery catheter 1000 and the annulus hub 520, 620, 720. During the procedure, the tip 1300 may be repeatedly locked and unlocked.

[0143] Referring again to FIG. 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 disengagement 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 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.

[0144] An anchor control knob 1004 of the delivery catheter 1000 may be coupled to the annulus anchor 800 to allow for torque to be transferred 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 a direction of movement of the anchor control knob 1004 in which the annulus anchor 800 is engaged or disengaged. For example, moving the anchor control knob 1004 towards the annulus anchor 800 may engage the driver 1200 with the annulus anchor 800. Arrow 1004b indicates a direction of movement of the anchor control knob 1004 in which torque is transferred to the annulus anchor 800. In some embodiments, arrow 1004b indicates a direction to release the annulus anchor 800. For example, applying more torque may twist the driver 1200 out of engagement with the annulus anchor 800.

[0145] 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 a variety of ways, as described herein. The annulus anchor 800 may be coupled to the coaptation assist element 500, 600, 700 in a variety of ways. In some embodiments, the annulus hub 520, 620, 720 may have a cross pin 820. The cross pin 820 may provide a portion around which the helical structure 815 of the annulus anchor 800 may wrap as shown. The annulus anchor 800 may have a shoulder 805. The shoulder 805 may fit around the outside of the driver 1200 of the delivery catheter 1000.

[0146] In some embodiments, the driver 1200 is releasably coupled to the 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 the driver 1200 can be actuated to unlock the driver 1200 from the annulus anchor 800. In some embodiments, when the driver 1200 is unlocked, one or more auxiliary structures, such as a purse string suture, can maintain the relative position between the delivery catheter 1000 and the annulus anchor 800. During the procedure, the driver 1200 may be repeatedly locked and unlocked.

[0147] 9B illustrates 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 a pin 1215 that extends through the anchor 800 around the tension cross pin 1270 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 the annulus anchor 800 to deliver torque. One or more drivers 1200 can engage 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.

[0148] FIG. 9C illustrates one embodiment of the 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 result in a torque being 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 the annulus anchor 800 to deliver torque. One or more drivers 1200 can engage the annulus anchor 800 to deliver tension.

[0149] 9D shows one embodiment of the driver 1200 and the 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, the wires 1240, 1245 are both positioned within an opening in the annulus anchor 800. The opening is small so that the pin and ball-shaped ends of the wires 1240, 1245 cannot pass side-by-side. In some methods of use, the wire 1240 is retracted first. Retraction of the wire 1240 provides enough room to retract the wire 1245. The wires 1240, 1245 can be actuated to release the annulus anchor 800. One or more drivers 1200 can engage the annulus anchor 800 to deliver torque. One or more drivers 1200 can engage the annulus anchor 800 to deliver tension.

[0150] 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. The driver 1260 can move longitudinally toward the annulus anchor 800 to push the distal locking tabs 1265 outward toward the window 810. The driver 1260 can move longitudinally away from the annulus anchor 800 to 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.

[0151] In some embodiments, an advantage may be that the annulus anchor 800 may 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 may be rotated independently of the annulus hub 520, 620, 720. The annulus hub 520, 620, 720 may remain stationary as the annulus anchor 800 is rotated to engage tissue.

[0152] 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 in preparation for insertion into the femoral vein. As described herein, a torque can be applied to drive the annulus anchor 800 into the tissue. In some embodiments, to ensure proper torque is applied, a sudden increase in the amount of torque at the handle can occur when the annulus anchor 800 is at its lowest position on the annulus hub 520, 620, 720. This increase in the amount of torque can be felt at the handle to provide feedback that the proper torque is being applied. In other embodiments, radiopaque markings can help visually determine the level of engagement of the anchor with the tissue. In some embodiments, markings may be placed on the annulus anchor 800 and / or the coaptation assist element 500, 600, 700.

[0153] 10-15 illustrate various methods that may be performed during a method of use of 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 a delivery catheter 1000. The method may include coupling a 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.

[0154] In some embodiments, an advantage is that the coaptation assist element 500, 600, 700 can be delivered in a hub-leading orientation. In this method of use, the annulus hub 520, 620, 720 can be moved into position relative to the anatomy prior to another portion of the coaptation assist element 500, 600, 700. In some methods of use, the ventricular end of the coaptation assist element 500, 600, 700 can 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.

[0155] 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 another portion 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.

[0156] FIG. 10 illustrates one embodiment of a transseptal traverse. The method may include femoral vein access. Access may be obtained through a blood vessel, such as the femoral vein, to reach a heart chamber, such as the right atrium 1300. The left ventricle 1380 and its papillary muscles are also shown at 1360. The method may include puncturing transseptally with a standard transseptal kit 1330 and traversing to the left atrium 1320. 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, which 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.

[0157] 11 shows the initial advancement of the coaptation assist element 500, 600, 700. The method may include advancing the coaptation assist element 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 surface 560, 660, 760 toward the annulus. The method may include deploying the ventricular end or lower edge 580 after deploying the annular portion 510.

[0158] 12 shows 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 to 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 circumference of the coaptation assist element 500, 600, 700. Before the coaptation assist element 500, 600, 700 is fully expanded, a 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.

[0159] The method may include advancing the coaptation assist element 500, 600, 700 towards the target location. The method may include advancing the annulus hub 520, 620, 720 towards the target location. The method may include advancing the annulus anchor 800 coupled to the annulus hub 520, 620, 720 towards 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 rotationally adjusting the coaptation assist element 500, 600, 700 to align the lower edge 580, 680, 780 or 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.

[0160] 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 to collapse 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 collapsed 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 to allow 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 dislodged or recapture sheath may be another delivery mode. An encapsulated-first delivery mode may be contrasted with a hub-first or strut-first delivery mode.

[0161] In some methods, recapture is an optional method. 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 outwardly 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 the tissue. The method may include removing the coaptation assist element 500, 600, 700 and the annulus anchor 800.

[0162] 14 shows a cross-sectional view of the deployed coaptation assist element 500, 600, 700. The method may include releasing the coaptation assist element 500, 600, 700. The method may include retracting the delivery catheter 1000.

[0163] FIG. 15 illustrates the deployment of an auxiliary anchor. In some methods, the deployment of an auxiliary anchor is an optional method. The method may include engaging an annulus attachment site 535, 735 to 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 element 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 circumference of the coaptation assist element 500, 600, 700 to indicate the shape of the coaptation assist element 500, 600, 700.

[0164] 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.

[0165] 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.

[0166] 16 illustrates a method of implant delivery showing the loading of the coaptation assist element 500, 600, 700. The coaptation assist element 500, 600, 700 can be folded as described herein. The folded coaptation assist element 500, 600, 700 can be loaded into a transseptal sheath introducer 1700. The transseptal sheath introducer 1700 can include a sheath having a lumen that receives the folded coaptation assist element 500, 600, 700. The folded coaptation assist element 500, 600, 700 can be inverted within the transseptal sheath introducer 1700. The annulus hub 520, 620, 720 can be positioned near an 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.

[0167] 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. A 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 .

[0168] 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 element 500, 600, 700 can be advanced through the transseptal sheath 1715. The folded coaptation assist element 500, 600, 700 can be inverted while being advanced through the transseptal sheath 1715. In FIG. 19, the coaptation assist element 500, 600, 700 is at the distal end of the transseptal sheath 1715.

[0169] FIG. 20 illustrates a method of positioning the 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 in the 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 shows the rotation of the coaptation assist element 500, 600, 700 and the transseptal sheath 1715.

[0170] 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 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 annulus during delivery of the anchor 800. The anchor 800 can be inserted into tissue of the annulus by rotating the anchor 800 as described herein.

[0171] 22A-22D illustrate a method of deploying the coaptation assist element 500, 600, 700. The coaptation assist element 500, 600, 700 can be deployed by retracting the transseptal sheath 1715. The transseptal sheath 1715 can be retracted by moving the transseptal sheath 1715 proximally from the anchor 800. The coaptation assist element 500, 600, 700 can be inverted within the transseptal sheath 1715. In some embodiments, the 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 such 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 such that the ventricular portion extends proximally from the annular portion. The coaptation assist element 500, 600, 700 can be everted such that the ventricular portion extends toward the transseptal sheath 1715.

[0172] 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 such that the ventricular portion extends distally from the annular portion. The coaptation assist element 500, 600, 700 can be positioned such 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 show the deployment of the coaptation assist element 500, 600, 700.

[0173] 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 the valve annulus. Auxiliary anchor 850 can include a bioinert material, such as platinum / Ir, nitinol alloy, and / or stainless steel.

[0174] FIG. 23 illustrates a method utilizing one or more auxiliary anchor guidewires. The coaptation auxiliary element 500, 600, 700 can include one or more auxiliary anchor guidewires. In the illustrated embodiment, the coaptation auxiliary element 500, 600, 700 can include a first guidewire 1730 and a second guidewire 1735. In some embodiments, the coaptation auxiliary 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 (is equal) to the number of auxiliary anchors (e.g., 1 guidewire for 1 auxiliary anchor, 2 guidewires for 2 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 illustrated in FIGs. 42A-45K.

[0175] FIG. 23 illustrates the anchoring mode. The anchoring mode can correspond to one or more methods of evaluating the coaptation assist element 500, 600, 700. The anchoring mode can correspond to one or more methods of evaluating the function of the coaptation assist element 500, 600, 700 without the delivery system or systems. In some embodiments, the anchoring mode can correspond to one or more methods of evaluating the function of the coaptation assist element 500, 600, 700 without the transseptal sheath 1715. The anchoring mode can evaluate the function without attaching the majority of the 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.

[0176] FIG. 24 illustrates the method involving the docking tube 1740. The docking tube 1740 can include an internal thread. 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 when in the tethered mode. FIG. 24 illustrates that the coaptation assist element 500, 600, 700 enters the tethered mode by retracting the docking tube 1740.

[0177] 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 FIG. 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.

[0178] 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 allow for a minimal force evaluation of the effectiveness of the coaptation assist element 500, 600, 700 prior to releasing the coaptation assist element 500, 600, 700. As an example, a user can verify that the coaptation assist element 500, 600, 700 is functional. As an example, a user can verify that the native leaflets are coapting to the coaptation assist element 500, 600, 700. As an example, a user can verify that the force acting on the coaptation assist element 500, 600, 700 is within an acceptable range. As an example, the user can verify that the coaptation assist elements 500, 600, 700 have not deformed under the forces of the native leaflets. As an example, the user can verify that the coaptation assist elements 500, 600, 700 have been deployed. As an example, the user can verify that the coaptation assist elements 500, 600, 700 span the 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.

[0179] FIG. 25 illustrates a method of advancing the 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 on one auxiliary guide wire, two guide rails on 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 over the guide wires 1730, 1735 in FIG. 25.

[0180] The distal end 1765 of each auxiliary anchor guide rail 1755, 1760 can be threaded. In some embodiments, the distal end 1765 of each auxiliary anchor guide rail 1755, 1760 engages 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 dislodging from the auxiliary anchor guide rail 1755, 1760. The auxiliary anchor guide rail 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 rail 1755, 1760 is equal to or greater than the pitch of the auxiliary anchor.

[0181] 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.

[0182] 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 towards the articulation 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.

[0183] 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 underneath 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 a medial anchor. The auxiliary anchor 1770 can be positioned medial to the anchor 800.

[0184] 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 joint auxiliary element 500, 600, 700. In some methods of use, the auxiliary anchor 1780 can be placed 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 placed 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.

[0185] 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 auxiliary element 500, 600, 700. The auxiliary anchor 1780 can be rotated to engage tissue underneath the coaptation auxiliary element 500, 600, 700. FIG. 28 shows the coaptation auxiliary element 500, 600, 700 secured to the annulus with the anchor 800 and the auxiliary anchor 1770 as the auxiliary anchor 1780 is delivered. FIG. 26 shows the coaptation auxiliary element 500, 600, 700 secured to the annulus with the anchor 800 and the 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.

[0186] FIG. 29 shows the joint auxiliary elements 500, 600, 700 including the 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 arthroplasty assist element 500, 600, 700 can be retrieved. Figure 29 shows the arthroplasty assist element 500, 600, 700 deployed and secured, with the auxiliary anchor guidewires 1730, 1735 and tether rails 1750 remaining to allow for retrieval.

[0187] FIG. 30 shows the arthritic assist element 500, 600, 700 secured in place. The auxiliary anchor guidewires 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 arthritic 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.

[0188] 31A-31F show a method of retrieving the coaptation assist elements 500, 600, 700. The coaptation assist elements 500, 600, 700 can be retrieved through the transseptal sheath 1715. In some methods of use, the coaptation assist elements 500, 600, 700 can be retrieved after the anchor 800 is removed, without the auxiliary anchors 1770, 1780. In some methods of use, the coaptation assist elements 500, 600, 700 can be retrieved after the anchor 800 and all auxiliary anchors 1770, 1780 are removed. In FIG. 31A-31F, the coaptation assist elements 500, 600, 700 are retrieved through the transseptal sheath 1715. In some methods of use, the retrieval is optional. In some methods of use, the retrieval is performed after the method shown in FIG. 29 and before the method shown in FIG. 30.

[0189] 32-35 illustrate methods of 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 anchor. The guiderails can reduce entanglement of the auxiliary anchor with two or more guidewires in the lumen.

[0190] 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, an auxiliary anchor 1770 is inserted as described herein. One or more auxiliary anchors 1170, 1780 can be inserted.

[0191] In some embodiments, one guidewire 1735 can be used for two auxiliary anchors. In some methods of use, the guidewire 1735 can be captured and removed with a snare to facilitate removal of the guidewire 1735 after delivery of the first auxiliary anchor 1770. In some embodiments, the guidewire 1735 forms a loop. In some embodiments, a portion of the loop of the guidewire 1735 is contained within the coaptation auxiliary element 500, 600, 700. In some embodiments, the loop passes through the coaptation auxiliary element 500, 600, 700. In some embodiments, the 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 contained 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.

[0192] 33 illustrates a method of delivering an auxiliary anchor 1790. The snare 1785 is retracted into the lumen. The snare 1785 pulls the guidewire 1735 proximally. In some embodiments, the driver 1775 or a separate driver can advance the auxiliary anchor 1790 along the guidewire 1735. In some embodiments, the auxiliary anchor 1790 should be delivered with the guidewire 1735 removed from the anchor 1770 using the snare 1785.

[0193] 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 auxiliary element 500, 600, 700. The auxiliary anchor 1790 can be rotated to engage tissue underneath the coaptation auxiliary element 500, 600, 700. FIG. 34 illustrates the coaptation auxiliary element 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 a medial anchor. The auxiliary anchor 1790 can be positioned medial to the anchor 800. The auxiliary anchor 1790 can be positioned between the anchor 800 and the auxiliary anchor 1770.

[0194] FIG. 35 shows the secured coaptation auxiliary element 500, 600, 700. The method can be repeated to place 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 the coaptation auxiliary element 500, 600, 700.

[0195] 36 and 37 show an embodiment of 2D lamination. FIG. 38 and 39 show an embodiment of 3D molding. In some embodiments, the joining auxiliary element 500, 600, 700 comprises a multi-layer laminate on the entirety or only a portion of the joining auxiliary element. In some embodiments, the multi-layer laminate can include two or more laminate layers (e.g., two, three, four, five, etc.). Two or more layers of the multi-layer laminate can include the same material. Two or more layers of the multi-layer laminate can include different materials. Two or more layers of the multi-layer laminate can include the same dimension (e.g., length, width, thickness, diameter, etc.). Two or more layers of the multi-layer laminate can include one or more different dimensions. The laminate can be variable depending on the area of ​​the joining auxiliary 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 another part of the joining auxiliary element 500, 600, 700. 38 illustrates an additional layer 1795 that is 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 that 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.

[0196] The multi-layer 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 adhesives. The layers can be bonded together by any mechanical or chemical change. The joint support element 500, 600, 700 can have an overall 2D shape. The joint support element 500, 600, 700 can be flat or nearly flat. In some embodiments, one or more layers include high density polyethylene (PE), polypropylene, Dacron, acellular collagen matrix such as SIS, or other plastics.

[0197] The multi-layered laminate can be made by a 3D shape forming method. The joint support element 500, 600, 700 can be molded. As described herein, the joint support element 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 matrix such as SIS, or other plastics. 3D molding can involve casting the shape of the struts 530, 630, 730. 3D molding can include forming a shape memory metal into a suitable shape. The shape can be set using a suitable 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 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 temperature of heat cure is greater than 300° C., greater than 400° C., greater than 500° C., greater than 600° C., etc. In some embodiments, the time of heat cure 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 may include quenching. In some embodiments, the method may include quenching with water or air.

[0198] 40 illustrates a coaptation assist element 400. The coaptation assist element 400 may include any of the features of the coaptation assist elements described herein. The coaptation assist element 400 may include an annulus hub 420, similar to the annulus hubs described herein, that facilitates attachment to a delivery system. The annulus hub 420 may include an externally threaded portion 425. The coaptation assist element 400 may include struts 430. The struts 430 may be atrial arms that may be bent in an upward and / or downward direction.

[0199] The coaptation assist element 400 can include an annulus anchoring portion 435. The annulus anchoring portion 435 can be a portion of the struts 430. In some embodiments, the annulus anchoring portion 435 comprises one or more barbs having a pointed tip. The annulus anchoring 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 may be pushed back by engagement of the barbs with tissue.

[0200] 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.

[0201] The coaptation assist element 400 can include a coaptation surface 460. The coaptation surface 460 can include an additional protective layer. In some embodiments, the coaptation surface 460 can include one or more additional layers of a multi-layer stack. In some embodiments, the coaptation surface 460 can include one or more different layers of a multi-layer stack. One or more layers of the coaptation surface 460 can be designed to promote the longevity of the coaptation assist element 400. One or more layers of the coaptation surface 460 can be designed to promote coaptation with the native leaflets.

[0202] 42A-45K show an embodiment 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.

[0203] 42A-42i show 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 the joint support element 400, 500, 600, 700. In the illustrated embodiment, only a portion of the struts 430, 530, 630, 730 are shown.

[0204] 42A-B, 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 through the docking tube 1805. In some embodiments, the docking tube 1805 can include one or more grooves that do not extend 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 a distal end and a proximal end of the docking tube 1805.

[0205] 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 can allow 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 of the annulus hub 420, 520, 620, 720 can align with the slot 1815 of the docking tube 1805. The pin 1820 can be disposed within the groove 1835.

[0206] 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 so that the docking tube 1805 engages the annulus hub 420, 520, 620, 720. The internally threaded portion 1840 engages 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 articulation assist element 400 , 500 , 600 , 700 , the slot 1815 can align with the groove 1835 .

[0207] 42A-B show the neutral position of the pin 1820. The spring 1825 biases the pin 1820 downwards into engagement with the groove 1835. The pin 1820 spans between the docking tube 1805 and the annulus hub 420, 520, 620, 720. The neutral state is with the pin 1820 forward. In this state, the pin 1820 locks the threaded connection between the female threaded portion 1840 of the docking tube 1805 and the male 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 the user to rotate the coaptation assist element 400, 500, 600, 700 in a clockwise or counterclockwise direction by rotating the docking tube 1805. In some uses, the pin 1820 can facilitate the 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 and essentially block 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.

[0208] 42C-42D show the release of the pin 1820. The pin 1820 can be pulled back via the pull wire 1830. The pin 1820 can be equipped with 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 female threaded portion 1840 can be disengaged from the male threaded portion 425, 525, 625, 725 by rotation of the docking tube 1805. FIG. 42C shows a cross-sectional view of the retracted pin 1820. Retracting the pin 1820 can disengage the docking tube 1805 from the annulus hub 420, 520, 620, 720. 42A-42D show 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. FIGURES 42A-42D show 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.

[0209] Figures 42E-i illustrate the use of the anchor 800 with an implant delivery system 1800. The anchor 800 is placed into a docking hub 1805 as shown in Figure 42E. The anchor 800 is in a retracted state within the docking hub 1805. The anchor 800 resides within a locking mechanism or pin 1820. The docking hub 1805 is shown in linear form, i.e., written out. The docking hub 1805 and implant torque shaft 1810 shown in Figure 42E have been removed from Figure 42F for clarity.

[0210] The anchor 800 can be screwed at the anatomical P2 position on the posterior leaflet as described herein. The anchor 800 can be considered a P2 anchor. The anchor 800 can be driven by a driver 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 the 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.

[0211] FIG. 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 thread 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 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 FIG.

[0212] 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.).

[0213] The anchor 800 may 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 to secure the coaptation assist element 400, 500, 600, 700. Figure 42i shows a view of the secured coaptation assist element 400, 500, 600, 700.

[0214] 43A-43E show 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 support element 400, 500, 600, 700. In the illustrated embodiment, only a portion of the struts 430, 530, 630, 730 are shown.

[0215] The docking tube 1905 can include two or more hypotubes 1915 embedded in the wall. The hypotubes 1915 can include a lumen. The hypotubes 1915 can be diametrically opposed. The hypotubes 1915 can be 180° apart. The hypotubes 1915 can extend in 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.).

[0216] 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, under the annulus hub 420, 520, 620, 720, through the coaptation assist element 400, 500, 600, 700, and 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 through the articulation assist element 400, 500, 600, 700 and up to the proximal or handle end of the system.

[0217] 43A-43B show an 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 the 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 the user to rotate the coaptation assist element 400, 500, 600, 700 in a clockwise or counterclockwise direction 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 may 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 may 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 may be coupled to the coaptation assist elements 400, 500, 600, 700 to rotate the coaptation assist elements 400, 500, 600, 700.

[0218] Figures 43C-E show the use of anchor 800 with implant delivery system 1900. Anchor 800 is placed within docking hub 1905 as shown in Figure 43C. Anchor 800 is in a retracted state within docking hub 1905. Anchor 800 is within locking mechanism or anchor 1920. Docking hub 1905 is shown in a linear configuration in Figure 43B.

[0219] The anchor 800 can be screwed at the anatomical P2 position on the posterior leaflet as described herein. The anchor 800 can be considered a P2 anchor. The anchor 800 can be driven by a driver 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 the 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 before it is fully seated. FIG. 43D shows anchor 800 screwed into tissue.

[0220] 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 male threaded portion 1960 at its distal tip. The male threaded portion 1960 of tether rail 1955 is configured to engage the female 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 a minimum force assessment of the effectiveness of coaptation assist element 400, 500, 600, 700 prior to releasing coaptation assist element 400, 500, 600, 700. The tether rails 1955 can allow for a minimum force assessment of the effectiveness of the articulation assist elements 400, 500, 600, 700 prior to releasing the tether 1920. FIG. 43C shows a cross-sectional view illustrating the path of the tether 1920.

[0221] FIG. 43E shows a view of the implanted anchor 800. FIG. 42E also shows a 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 in 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 tether rail 1955. The anchor 800 can include an anchor helix. The anchor helix can include a gland tip for optimal tissue penetration.

[0222] The coaptation assist element 400, 500, 600, 700 may include some cutouts to minimize sliding friction of the anchor 1920. The anchor 800 may be screwed into the tissue and abut the bottom of the hub 420, 520, 620, 720. The user may retract the docking tube 1905 leaving behind two edges of the anchor 1920. The anchor may connect 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.

[0223] 44A-44E show 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 of 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.

[0224] The docking tube 2005 can include one, two, or more retaining arms 2020 cut into the distal end. The one, two, or more retaining arms 2020 can allow for torque transmission via the implant torque axis 2010 as well as pushing / pushing the articulation assist element 400, 500, 600, 700. 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 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 can 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 can be formed by cutting a U-shape into the docking tube 2005.

[0225] 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 joint assist element 400, 500, 600, 700 together. The retaining arm 2020 allows the user to apply torque to the joint 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 the user to rotate the joint assist element 400, 500, 600, 700 in a clockwise or counterclockwise direction by rotating the docking tube 2005. In some methods of use, the retaining arm 2020 can facilitate the movement of the joint assist element 400, 500, 600, 700 via the docking tube 2005.

[0226] 44E, the retaining arms 2020 engage 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 a window 2025. The window 2025 can be shaped to receive a portion of the retaining arm 2020, such as a tab 2030. In some embodiments, each retaining arm 2020 can include an inwardly facing tab 2030. The tab 2030 can have an increased thickness relative to the retaining arm 2020. The tab 2030 can be shaped to engage the window 2025. The tab 2030 can be a distal inner section of the retention arm 2020 .

[0227] 44B-D show the use of anchor 800 with implant delivery system 2000. Anchor 800 is placed into 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 retention arm 2020. Docking hub 2005 is shown in linear configuration in FIG. 44B. FIG. 44C shows advancement of anchor 800. FIG. 44C shows advancement of anchor 800 before anchor 800 is fully seated and before retention arm 2020 is bent.

[0228] The anchor 800 can be screwed at a P2 position on the anatomical structure 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 the 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.

[0229] FIG. 44D shows an internal cross-sectional view of the anchor 800. To ensure a secure connection of the driver 2045, the anchor 800 can be tensioned against the driver 2045 by the tether rail 2055. The tether rail 2055 can include a guidewire having a small thread or an externally threaded portion 2060 at its distal tip. The externally threaded portion 2060 of the tether rail 2055 is configured to engage the internally threaded portion 2065 of the anchor 800. An internal view of the tether rail 2055 and the connection between the anchor 800 and the annulus hub 420, 520, 620, 720 is shown in FIG. 44D. The tether rail 2055 can allow for a minimum force assessment of the effectiveness of the coaptation assist elements 400, 500, 600, 700 prior to releasing the coaptation assist elements 400, 500, 600, 700. The tether rails 2055 can allow for a minimum force assessment of the effectiveness of the articulation assist elements 400 , 500 , 600 , 700 before releasing the retention arms 2020 .

[0230] FIG. 44D shows a cross-sectional view illustrating the release of the retaining arms 2020. As the anchor 800 is screwed into tissue, the annulus hub 420, 520, 620, 720 contacts the tabs 2030 of the retaining arms 2020. The retaining arms 2020 can bend outward from the windows 2025 of the anchor 800 by the distal movement of the annulus hub 420, 520, 620, 720. The tabs 2030 can include angled surfaces 2035 that allow for easy removal of the docking tube 2005 from the annulus hub 420, 520, 620, 720 when the retaining arms 2020 are bent outward. FIG. 44D shows the advancement of the anchor 800 with the retaining arms 2020 bent outward as the anchor 800 is fully driven.

[0231] 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 relative to 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.

[0232] 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 and be held onto the annulus hub 420, 520, 620, 720. The apertures 2025 allow the retention arms 2020 to be held in a compressed, tensioned, or twisted state on the annulus hub 420, 520, 620, 720.

[0233] 45A-K show 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.

[0234] The docking tube 2105 can include one or more slots 2120 cut into the 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 as well as 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 120° apart. The slots 2120 can extend along a portion of the length of the docking tube 2105. In some embodiments, the slots 2120 are monolithic 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.

[0235] 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.

[0236] 45F, the slots 2120 engage the retaining pins 2030 on the head of the anchor 800. In some embodiments, the retaining pins 2030 protrude a sufficient amount at the tip of the docking tube 2105 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 a retaining pin 2025. The slots 2120 can be shaped to receive and guide the retaining pins 2030.

[0237] 45B-C show the initial position of the slot 2120 relative to the retaining pin 2030. In this state, the slot 2120 and the retaining pin 2030 hold the docking tube 2005 and the coaptation assist element 400, 500, 600, 700 together. The slot 2120 and the 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 the implant torque shaft 2010. The slot 2120 and the 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 methods of use, the slots 2120 and retaining pins 2030 can facilitate movement of the articulation assist elements 400 , 500 , 600 , 700 through the docking tube 2105 .

[0238] Figures 45B-E show the use of anchor 800 with implant delivery system 2100. Anchor 800 is placed into docking hub 2105 as shown in Figure 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 a linear configuration in Figure 45B. Figure 45C shows advancement of anchor 800.

[0239] The anchor 800 can be screwed at the anatomical P2 position on the posterior leaflet as described herein. The anchor 800 can be considered a P2 anchor. The anchor 800 can be driven by a driver 2145. 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 the internal torque shaft 2150. In some embodiments, the internal torque shaft 2150 is welded or soldered to the driver 2145. The driver 2145 and the 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.

[0240] FIG. 45E shows an internal cross-sectional view of the anchor 800. To ensure a secure connection of the driver 2145, the anchor 800 can be tensioned against the driver 2145 by the tether rail 2155. The tether rail 2155 can include a guidewire with a small thread or externally threaded portion 2160 at its distal tip. The externally threaded portion 2160 of the tether rail 2155 is configured to engage the internally threaded portion 2165 of the anchor 800. An internal view of the tether rail 2055 and the connection between the anchor 800 and the annulus hub 420, 520, 620, 720 is shown in FIG. 45E. The tether rail 2155 can allow for a minimum force assessment of the effectiveness of the coaptation assist elements 400, 500, 600, 700 prior to releasing the coaptation assist elements 400, 500, 600, 700. The tether rails 2155 may allow for a minimum force assessment of the effectiveness of the articulation assist elements 400 , 500 , 600 , 700 before releasing the retaining pins 2030 .

[0241] As the anchor 800 is screwed 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 hubs 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. FIGURES 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.

[0242] 45E-45F show views of the implanted anchor 800. FIG. 45E also shows a 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 in 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 anchor 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 receive the three retention pins 2130. The retention pins 2130 can be welded into the holes. In some embodiments, the retaining pin 2130 is Nitinol.Figures 45G-K show additional views.

[0243] 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 the 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 tissue of the heart, such as tissue of the 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 mating features 858. The mating feature 858 can be a cutout. The mating feature 858 can create two semicircular sections of different heights. The mating 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 mating feature 858 can include any configuration that allows for torque to be transmitted to the auxiliary anchor 850, 1770, 1780.

[0244] 46A-46C show 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 drawing. 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 the 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 the 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 the one or more auxiliary anchors 850, 1770, 1780.

[0245] 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 one or more auxiliary anchors 850, 1770, 1780. The locking hub 868 can be coupled to a locking shaft 872.

[0246] FIG. 46A illustrates a configuration in which the delivery catheter 860 is not engaged with the auxiliary anchor 850, 1770, 1780. FIG. 46B illustrates a configuration in which the delivery catheter 860 is engaged with the auxiliary anchor 850, 1770, 1780. In some embodiments, the helix or spiral structure 866 can engage the helix or spiral structure 852 of the auxiliary anchor 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 will be the same as the profile of the auxiliary anchor 850, 1770, 1780. The helix or spiral structure 866 can couple with the helix or spiral structure 852 of the auxiliary anchor 850, 1770, 1780. The helix or spiral structure 866 can fit within the void of the helix or spiral structure 852 of the auxiliary anchor 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.

[0247] 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 engage the auxiliary anchor 850, 1770, 1780. The hub 856 of the auxiliary anchor 850, 1770, 1780 and the locking hub 868 can be engaged 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.

[0248] 46C shows a locking hub 868 engaged with a hub 856 of an auxiliary anchor 850, 1770, 1780. The locking hub 868 is engaged with the hub 856 to allow rotation of the auxiliary anchor 850, 1770, 1780. In some embodiments, the locking hub 868 is engaged with the hub 856 to reduce the likelihood of the delivery catheter 860 disengaging from the auxiliary anchor 850, 1770, 1780 during delivery. In some embodiments, the locking hub 868 is engaged with the hub 856 to allow 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.

[0249] Once the auxiliary anchor 850, 1770, 1780 is driven into tissue, the delivery catheter 860 can be disengaged from the auxiliary anchor 850, 1770, 1780. In some embodiments, the locking hub 868 can be disengaged from the hub 856 of the auxiliary anchor 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 anchor 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 anchor 850, 1770, 1780.

[0250] In some embodiments, the coaptation assist element 400, 500, 600, 700 can include an annulus section configured to be implanted in the heart above the annulus. In some embodiments, the coaptation assist element 400, 500, 600, 700 can include multiple struts, including a first strut that is in the annulus section and a second strut that has a greater overall length than the first strut. In some embodiments, the coaptation assist element 400, 500, 600, 700 can include a top edge that is cupped and held by the annulus section. In some embodiments, the coaptation assist element 400, 500, 600, 700 can improve overall length 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 greater 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 improving 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.

[0251] In some methods, the method can include positioning the hub near the annulus. In some methods, the struts are radially expanded. In some methods, the method can include improving coaptation of the struts over their entire length without disrupting the anatomy. In some methods, the method can include expanding coaptation elements held via the radially outwardly extending struts. In some methods, the method can include expanding coaptation elements held via the radially outwardly extending struts to form annulus compartments. In some methods, the method can include expanding coaptation elements held via the radially outwardly extending struts to form annulus compartments.

[0252] In some embodiments, the annulus hub 420, 520, 620, 720 is spaced inwardly from a lateral edge of the coaptation assist element 400, 500, 600, 700. In some embodiments, the annulus hub 420, 520, 620, 720 is spaced inwardly from an upper edge of the coaptation assist element 400, 500, 600, 700. In some embodiments, the annulus hub 420, 520, 620, 720 is spaced inwardly from a 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 portions of the sheet may form the annulus hubs 420 , 520 , 620 , 720 .

[0253] 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 a helix of the anchor 800 with a 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 rotate in a first direction to selectively deploy the anchor 800. The anchor 800 is configured to rotate to deploy the anchor 800 at a first target location. The anchor 800 is configured to rotate to engage tissue within the valve annulus. The anchor 800 can be selectively deployed to 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.

[0254] 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 rotate in a second direction to selectively engage and disengage the anchor 800. The anchor 800 is configured to rotate to engage and disengage the anchor 800 from a first target location. The anchor 800 is configured to rotate to engage and disengage 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.

[0255] 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 non-uniformly spaced around the annulus hub 420, 520, 620, 720. In some embodiments, the struts 430, 530, 630, 730 that comprise the annulus segments are evenly spaced around the annulus hub 420, 520, 620, 720. In some embodiments, the struts 430, 530, 630, 730 that comprise the annulus compartment are spaced unevenly around the annulus hub 420, 520, 620, 720. In some embodiments, the struts 430, 530, 630, 730 that form the upper edge are spaced evenly around the annulus hub 420, 520, 620, 720. In some embodiments, the struts 430, 530, 630, 730 that form the upper edge are spaced unevenly around the annulus hub 420, 520, 620, 720. In some embodiments, the struts 430, 530, 630, 730 that comprise the ventricular compartment are spaced evenly around the annulus hub 420, 520, 620, 720. In some embodiments, the struts 430, 530, 630, 730 that comprise the ventricular compartment are spaced unevenly around the annulus hub 420, 520, 620, 720. In some embodiments, the struts 430, 530, 630, 730 that form the lower edge are spaced evenly around the annulus hub 420, 520, 620, 720. In some embodiments, the struts 430, 530, 630, 730 that form the lower edge are spaced unevenly around the annulus hub 420, 520, 620, 720. In some embodiments, two or more struts 430, 530, 630, 730 are spaced evenly around the annulus hub 420, 520, 620, 720. In some embodiments, two or more struts 430 , 530 , 630 , 730 are spaced unequally around the annulus hub 420 , 520 , 620 , 720 .

[0256] In some embodiments, the plurality of struts 430, 530, 630, 730 extend outwardly from the annulus hub 420, 520, 620, 720. In some embodiments, the plurality of struts 430, 530, 630, 730 can have a portion that is radially adjacent the annulus hub 420, 520, 620, 720. In some embodiments, the plurality of struts 430, 530, 630, 730 are disposed 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 deployed around the annulus hub 420, 520, 620, 720. In some embodiments, the plurality of struts 430, 530, 630, 730 are uniformly deployed 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 radiate 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.

[0257] 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.

[0258] 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 in 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 in 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.

[0259] 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 is cupped downwardly towards the lower edge. In some embodiments, the upper edge is cupped upwardly from the lower edge. In some embodiments, the annulus hub 420, 520, 620, 720 extends upwardly from the lower edge. In some embodiments, the annulus hub 420, 520, 620, 720 extends upwardly from the upper edge. In some embodiments, the annulus hub 420, 520, 620, 720 extends upwardly from the annular portion of the coaptation assist element 400, 500, 600, 700. In some embodiments, the annulus hub 420, 520, 620, 720 extends upwardly 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 elliptical shape.

[0260] 47A-E show an embodiment of an implant mechanism. Figures 47A-E show some non-limiting, potentially clinically relevant aspects of the implant. Although 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 example, for other embodiments.

[0261] As described herein, the coaptation assist element 400 can include an annulus hub 420 that can be relatively centrally located. The coaptation assist element 400 can have a generally elongated shape, although other shapes are envisioned, such as polygonal, circular, oval, rounded, rectangular, triangular, and the like. 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 match the overall shape of the annulus or adjacent atrial wall.

[0262] The coaptation assist element 400 can include a first surface 405 configured to be disposed toward the mal-coapted native 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.

[0263] In some embodiments, a first strut 430 of the plurality of struts extends from the annulus hub 420 to or toward the upper edge 440. In some embodiments, a second strut 430 of the plurality of struts extends from the annulus hub 420 to or toward the lower edge 480. In some embodiments, a third strut 430 of the plurality of struts extends from the annulus hub 420 to or toward the lateral edge 470. In some embodiments, a fourth strut 430 of the plurality of struts extends from the annulus hub 420 to or toward the lateral edge 475. Any two or more of the first strut, second strut, third strut, or fourth strut can include the same characteristics, including material, length, width, thickness, configuration, preformed bends, curvature, etc. Any two or more of the first strut, second strut, third strut, or fourth strut can include 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, can extend radially outward of the cover 450 of the implant 400 and protrude therefrom to 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 is atraumatic. In some embodiments, the entire periphery of the implant can be atraumatic.

[0264] In some embodiments, the strut 430 can be covered with one, two, or more layers of the articulation auxiliary element body cover 450. The articulation auxiliary 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 layers of the multiple layers can include the same or different characteristics, including material, length, width, thickness, etc. In some embodiments, the one or more layers extend along all or only a portion of the first surface 405. In some embodiments, the 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.

[0265] The attachment assist element body cover 450 may be constructed of a material such as a polymer, for example, 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.

[0266] 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 natural anatomical structures.

[0267] 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 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.

[0268] 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 including the mating surface 460. The one or more additional layers can extend over a portion of the second surface 415 that is greater than the mating surface 460.

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

[0270] 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 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.

[0271] 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.

[0272] The first surface 405 may be reinforced with any of the materials described herein. The first surface 405, or a portion thereof, may be reinforced with ePTFE. The first surface 405 may be reinforced with any of the materials of the coaptation assist element body cover 450, such as ePTFE, Dacron, and / or polypropylene, which may advantageously create an atraumatic surface to reduce the risk of damaging the native leaflets from repeated coaptation to the coaptation surface of the coaptation assist body.

[0273] 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 or at least partially circumferentially around the periphery of the lower section or the entire coaptation aid body.

[0274] The raised edge or bumper can be formed from sutures. The sutures 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 that 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. The raised edge or bumper can reduce contact between the coaptation assist element 400 and the posterior leaflet in the case of a mitral valve. 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 inwardly from the first surface 405 or the second surface 415. Figure 47C shows the rear view, and Figure 47D shows the front view.

[0275] 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.

[0276] 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 comprise 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 the annulus or curved 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.

[0277] 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 in areas configured to receive one, two, three, four, or more auxiliary anchors. As described herein, the first surface 405 of the coaptation auxiliary element 400 can be positioned against the annulus after placement in 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.

[0278] 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 auxiliary element body cover 450, such as ePTFE, Dacron, and / or polypropylene. One or more additional layers can extend outwardly 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.

[0279] In some embodiments, the annular portion 410 can include an edge that is sharper than another edge of the coaptation assist element 400. In some embodiments, the upper edge 440 is thinner and / or sharper than another edge of the coaptation assist element 400 (e.g., the lateral edge 470, the lateral edge 474, or the lower edge 480). In some embodiments, the annular portion 410 and / or the upper edge 440 can irritate or engage tissue. In some embodiments, the annular portion 410 is configured to be implanted near the valve annulus. In some embodiments, the annular portion 410 is configured to promote an immune response. In some embodiments, the annular portion 410 is configured to promote tissue ingrowth.

[0280] FIG. 48 shows an exploded view of one embodiment of a cover that surrounds a portion of an implant and includes a laminate. Although an articulation assist element 400 is shown, any of the articulation assist elements described herein can include any number of 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 articulation assist element 400 can include or exclude / omit any of the articulation 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. The raised edges or bumpers are not shown. The raised edges or bumpers can be added at the final stage of assembly. The laminate 1100 described herein can form the articulation 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.

[0281] 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 compared 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 including two of the aforementioned values). The posterior layer 1102 can include an opening through which the anchor 800 extends. The posterior layer 1102 can be any shape, including a rectangle, a polygon, a triangle, a circle, and an ellipse. In some embodiments, the posterior layer 1102 is not the final shape of the coaptation assist element 400.

[0282] 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 back layer 1102. The first support structure layer 1104 can be disposed on the back side of the strut 430. The first support structure layer 1104 can include openings through which the anchors 800 extend.

[0283] The joining support 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 aforementioned 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 an opening through which the anchor 800 extends. In some embodiments, the first fabric layer 1106 extends along only a portion of the joining support element 400. In some embodiments, the first fabric layer 1106 includes a cutout portion.

[0284] 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 aforementioned 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 on the posterior side of the strut 430.

[0285] The coaptation auxiliary element 400 may include an anchor layer 1110. The anchor layer 1110 may be a reinforcing layer of 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 aforementioned values). The anchor layer 1110 may be any shape, including rectangular, polygonal, triangular, circular, elliptical, etc. In some embodiments, the coaptation auxiliary 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 forming an 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.

[0286] 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 on 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.

[0287] The joint support element 400 can include a frame 465. In some embodiments, the frame 465 is cut from a tubular stock. The frame 465 can include one or more struts 430. The frame 465 can be constructed from a single, one-piece 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 of other materials, including stainless steel, polypropylene, high density polyethylene (PE), Dacron, acellular collagen matrix such as SIS, or other plastics. In some embodiments, the struts 430 may include a shape memory material and a strut cover. The strut cover may be any material described herein and may cover the entire strut 430 or a portion thereof. In some embodiments, the struts 430 may include nitinol and LDPE tubing or a cover over each strut 430. In some embodiments, the frame 465 may be considered a layer.

[0288] The coaptation assist element 400 can include a second ventricular layer 1114. The second ventricular layer 1114 can be a reinforcing layer of the second surface 415. In some embodiments, the second ventricular layer 1114 is thicker than the other layers. In some embodiments, the second ventricular layer 1114 is ePTFE. In some embodiments, the second ventricular layer 1114 has a thickness (e.g., about 0.03 inches, about 0.035 inches, about 0.040 inches, about 0.045 inches, about 0.05 inches, or any range including two of the aforementioned values, or other thickness values ​​as described for other layers herein). The second ventricular layer 1114 can be any shape, including rectangular, polygonal, triangular, circular, elliptical, etc. The second ventricular layer 1114 can be disposed on the anterior side of the strut 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.

[0289] 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 on 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.

[0290] The joint 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 aforementioned values). In some embodiments, the second fabric layer 1118 includes a polyester fabric. The second fabric layer 1118 can be disposed on 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 an opening through which the anchor 800 extends.

[0291] The joint auxiliary 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 an opening through which the anchor 800 extends. In some embodiments, the first support structure layer 1104 and the fourth support structure layer 1120 are the same shape.

[0292] The 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 including two of the aforementioned values, or other thickness values ​​as described for other layers herein). The front layer 1122 can include an opening through which the anchor 800 extends. The front layer 1122 can be any shape, including rectangular, polygonal, triangular, circular, and elliptical. In some embodiments, the front layer 1122 is not the final shape of the coaptation assist element 400. In some embodiments, the rear layer 1102 and the front layer 1122 are the same shape.

[0293] 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 system 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.

[0294] The implant delivery system 2200 can include a primary anchor driver 2204. The primary anchor housing 2202 can be sized to fit the primary anchor driver 2204. In some embodiments, the primary anchor driver 2204 is a torque shaft. In some embodiments, the primary anchor driver 2204 is configured to rotate relative to the primary anchor housing 2202. In some embodiments, the primary anchor driver 2204 is not configured to translate relative to the primary anchor housing 2202. 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.

[0295] 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 implant surface. 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 in the primary anchor housing 2202. The release wires 2206, 2208 can be diametrically opposed within the primary anchor housing 2202.

[0296] The release wires 2206, 2208 can extend outside the primary anchor housing 2202. The primary anchor housing 2202 can include slots 2210, 2212 that allow the release wires 2206, 2208 to extend therethrough. The release wires 2206, 2208 can extend through the slots 2210, 2212 from the inside of the primary anchor housing 2202 to the outside of the primary anchor housing 2202 (e.g., the release wire 2206 can extend through the slot 2210 and the release wire 2208 can extend through the slot 2212).

[0297] 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.

[0298] 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 be approximately along 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.

[0299] 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 pitches, different diameters, different materials, different shoulders, different windows, 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.

[0300] 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 of the auxiliary anchor drivers 2230, 2232, 2234, 2236 are the same. In some embodiments, two or more of the 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.

[0301] In some embodiments, the auxiliary anchor drivers 2230, 2232, 2234, 2236 can be coupled to a respective auxiliary anchor 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.

[0302] The implant delivery system 2200 can include one or more auxiliary anchor guide rails 2240, 2242, 2244, 2246 (e.g., 1 auxiliary anchor guide rail, 2 auxiliary anchor guide rails, 3 auxiliary anchor guide rails, 4 auxiliary anchor guide rails (as shown), 5 auxiliary anchor guide rails, 6 auxiliary anchor guide rails, 7 auxiliary anchor guide rails, 8 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 passage therethrough. The passage can extend through the center of the helical wire of the auxiliary anchors 2220, 2222, 2224, 2226. The auxiliary anchor guide rails 2240, 2242, 2244, 2246 can be configured to extend through the respective passages.

[0303] The implant delivery system 2200 can include one or more auxiliary anchor tethers 2250, 2252, 2254, 2256 (e.g., 1 auxiliary anchor tether, 2 auxiliary anchor tethers, 3 auxiliary anchor tethers, 4 auxiliary anchor tethers (as shown), 5 auxiliary anchor tethers, 6 auxiliary anchor tethers, 7 auxiliary anchor tethers, 8 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 auxiliary element 400, 500, 600, 700. The coaptation auxiliary element 400, 500, 600, 700 can include one or more passageways that facilitate passage of the auxiliary anchor tethers 2250, 2252, 2254, 2256 therethrough.

[0304] The auxiliary anchor guide rails 2240, 2242, 2244, 2246 can include a passage therethrough. The passage can extend through the center 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 a passage therethrough. The passage can extend through the center of the auxiliary anchor drivers 2230, 2232, 2234, 2236. The auxiliary anchor tethers 2250 , 2252 , 2254 , 2256 can be configured to extend through passages of the auxiliary anchor drivers 2230 , 2232 , 2234 , 2236 .

[0305] 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 anchors 2250, 2252, 2254, 2256.

[0306] FIG. 50 illustrates a telescoping feature to access 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 through which one or more additional catheters can pass. The coaptation assist elements 400, 500, 600, 700 described herein can be delivered via a delivery catheter 1402. The coaptation assist elements 400, 500, 600, 700 can be within the delivery catheter 1402. The delivery catheter 1402 can telescoping relative to the transseptal sheath 1400. The delivery catheter 1402 can telescoping relative to the transseptal sheath 1400 to extend outwardly relative to the transseptal sheath 1400 to deliver the coaptation assist elements 400, 500, 600, 700. The coaptation assist elements 400 , 500 , 600 , 700 can be telescopic relative to the delivery catheter 1402 to extend outwardly relative to the delivery catheter 1402 to deliver the coaptation assist elements 400 , 500 , 600 , 700 .

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

[0308] The primary anchor driver 2204 can engage and rotate the primary anchor 800. The primary anchor driver 2204 can be disposed within the primary anchor housing 2202. The primary anchor 800 can be disposed within the primary anchor housing 2202. The release wires 2206, 2208 can extend through at least a portion of the primary anchor housing 2202. As the primary anchor 800 is rotated, the helix of the primary anchor passes around the release wires 2206, 2208. The release wires 2206, 2208 maintain their position as the primary anchor 800 rotates. When the coaptation assist elements 400, 500, 600, 700 are adjacent the annulus, the primary anchor 800 can be advanced to engage tissue. The primary anchor driver 2204 can include a hub 2260 and one or more extensions 2262, 2264. The primary anchor driver 2204 can include two extensions 2262, 2264, although other configurations are envisioned. The extensions 2262, 2264 can be perpendicular to the hub 2560 or extend at other angles. The primary anchor driver 2204 can be a fork driver. The primary anchor 800 can include a crossbar 802. The crossbar 802 can form a proximal portion of the primary anchor 800. The crossbar 802 can be formed from the helix of a helical anchor. The two extensions 2262, 2264 can be configured to slide within a passageway of the primary anchor 800 on either side of the crossbar 802. The crossbar 802 can be disposed between the extensions 2262, 2264. Other configurations for coupling the primary anchor driver 2204 to the primary anchor 800 are envisioned, including any of the mating configurations described herein.

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

[0310] 52 illustrates a connection between the auxiliary anchor driver 2230 and each auxiliary anchor 2220, according to some embodiments. Although the auxiliary anchor driver 2230 and auxiliary anchor 2220 are illustrated, each auxiliary anchor driver 2230, 2232, 2234, 2236 can be coupled to a respective auxiliary anchor 2220, 2222, 2224, 2226.

[0311] The auxiliary anchor 2220 can include a helical body 2270. The auxiliary anchor 2220 can include a shoulder 2272. The shoulder 2272 can be configured to engage the auxiliary anchor driver 2230. The shoulder 2272 can have features such as one or more windows 2274. The windows 2274 can be diametrically opposed, evenly spaced apart, or otherwise spaced apart. Although two windows 2274 are shown, other configurations of windows are envisioned (e.g., one window, two windows (as shown), three windows, four windows, five windows, six windows, etc.).

[0312] The auxiliary anchor driver 2230 can include an elongated shaft 2276. The elongated shaft can include a lumen through which the auxiliary anchor guide rail 2240 passes. The auxiliary anchor driver 2230 can include one or more locking tabs 2278. The locking tabs 2278 can be diametrically opposed, evenly spaced apart, or otherwise spaced apart. Although two locking tabs 2278 are shown, other configurations of locking tabs are envisioned (e.g., one locking tab, two locking tabs (as shown), three locking tabs, four locking tabs, five locking tabs, six locking tabs, etc.). The number and configuration of locking tabs can correspond to the number of windows. The locking tabs 2278 can include a shape memory material or a resilient material. The locking tabs 2278 can be designed to flex outwardly to engage the windows 2274.

[0313] The auxiliary anchor guide rails 2240 can activate a locking mechanism between the auxiliary anchor driver 2230 and the respective auxiliary anchor 2220. The locking mechanism can be an axial torsional lock. When coupled, axial movement of the auxiliary anchor driver 2230 can cause axial movement of the auxiliary anchor 2220. When coupled, torsional movement of the auxiliary anchor driver 2230 can cause torsional movement of the auxiliary anchor 2220. The auxiliary anchor guide rails 2240 can lock the auxiliary anchor driver 2230 to the auxiliary anchor 2220. This locking can be temporary. This locking can be reversible. The auxiliary anchor guide rails 2240 can push the locking tabs 2278 outward. The locking tabs 2278 can be pushed outward into the window 2274 by the auxiliary anchor guide rails 2240.

[0314] The auxiliary anchor guide rail 2240 can maintain the locking tab 2278 in an open position to keep the locking tab 2278 engaged with the window 2274 of the auxiliary anchor 2220. In some embodiments, longitudinal movement of the auxiliary anchor guide rail 2240 toward the auxiliary anchor 2220 can push the locking tab 2278 outward toward the window 2274. In some embodiments, longitudinal movement of the auxiliary anchor guide rail 2240 away from the auxiliary anchor 2220 can allow the locking tab 2278 to return to a neutral configuration and disengage from the window 2274. Engagement of the locking tab 2278 with the window 2274 of the auxiliary anchor 2220 can allow axial movement to be transferred between the auxiliary anchor driver 2230 and the auxiliary anchor 2220. The locking tab 2278 can be engaged with the window 2274 of the auxiliary anchor 2220 to allow torque to be transferred between the auxiliary anchor driver 2230 and the auxiliary anchor 2220. In some embodiments, an advantage of the auxiliary anchor 2220 can be that it can be rotated independently of the rotation of the primary anchor 800. In some embodiments, an advantage of the auxiliary anchor 2220 can be that it can be rotated independently of the rotation of one or more other auxiliary anchors 2232, 2234, 2236.

[0315] 53A-53B show the relationship between the auxiliary anchor guide rail 2240, the auxiliary anchor tether 2250, and the respective auxiliary anchor 2220, according to some embodiments. Although the auxiliary anchor guide rail 2240, the auxiliary anchor tether 2250, and the auxiliary anchor 2220 are shown, each auxiliary anchor guide rail 2240, 2242, 2244, 2246 can engage a respective auxiliary anchor 2220, 2222, 2224, 2226. The auxiliary anchor guide rail 2240 can limit or prevent engagement of the anchor and tether. FIG. 53A-53B shows the auxiliary anchor tether 2250 and the adjacent auxiliary anchor tether 2252. Each auxiliary anchor tether can include two strands and an arc between them. See auxiliary anchor tether 2252.

[0316] The auxiliary anchor 2220 can be a helical anchor. The helical anchor can include a pitch and a diameter. The helical anchor can include an open distal end. The pitch of the auxiliary anchor 2220 can be larger than the strands of the auxiliary anchor tether (e.g., auxiliary anchor tether 2252). The open end of the auxiliary anchor 2220 can be larger than the strands of the auxiliary anchor tether (e.g., auxiliary anchor tether 2252). The dimension of the open end can be defined by the pitch. This configuration can allow the auxiliary anchor 2220 and the auxiliary anchor tether 2252 to intertwine, as shown in FIG. 53A. In this figure, the auxiliary anchor guide rail 2240 is proximal, exposing the open end of the auxiliary anchor 2220, allowing the auxiliary anchor tether 2252 and the auxiliary anchor 2220 to intertwine.

[0317] FIG. 53B shows the auxiliary anchor guide rail 2240 extending through the open end of the pitch of the auxiliary anchor 2220, according to some embodiments of the present invention. The pitch of the auxiliary anchor 2220 can be smaller than the strand of the auxiliary anchor tether (e.g., auxiliary anchor tether 2252). The open end of the auxiliary anchor 2220 can be smaller than the strand of the auxiliary anchor tether (e.g., auxiliary anchor tether 2252). The space between the auxiliary anchor guide rail 2240 and the auxiliary anchor 2220 can advantageously be too small to allow entanglement of the auxiliary anchor tether 2252. This configuration may prevent the auxiliary anchor 2220 and the auxiliary anchor tether 2252 from entangling. In FIG. 53B, the open end of the auxiliary anchor is protected from entanglement.

[0318] 54 illustrates an auxiliary anchor guide rail 2240, according to some embodiments of the present invention. Although the auxiliary anchor guide rail 2240 is illustrated, one or more auxiliary anchor guide rails 2240, 2242, 2244, 2246 can be provided. The auxiliary anchor guide rails 2240, 2242, 2244, 2246 can include a preformed material. The auxiliary anchor guide rails 2240, 2242, 2244, 2246 can include a shape memory material, such as a shape memory metal or plastic. The auxiliary anchor guide rails 2240, 2242, 2244, 2246 can include any shape, including one or more linear segments and one or more non-linear segments, such as one or more curved segments. The preformation of the auxiliary anchor guide rails 2240, 2242, 2244, 2246 can facilitate the traje...

Claims

1. a joint auxiliary element having 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; and an auxiliary anchor configured to couple the coaptation assist element to the valve annulus, the auxiliary anchor configured to rotate to eliminate a gap between the coaptation assist element and an implant.

2. The joint auxiliary element delivery system of claim 1 , wherein the auxiliary anchor is a variable pitch anchor.

3. The coaptation assist element delivery system of claim 1 , wherein the auxiliary anchor comprises a window configured to be engaged by an auxiliary anchor driver.

4. The coaptation assist element delivery system of claim 1 , wherein the auxiliary anchor comprises a crown pattern configured to be engaged by an auxiliary anchor driver.

5. The coaptation auxiliary element delivery system of claim 1 , wherein the auxiliary anchor comprises an engagement mechanism.

6. The joint auxiliary element delivery system of claim 1 , wherein the auxiliary anchor comprises an anti-rotation mechanism.

7. The coaptation auxiliary element delivery system of claim 1 , wherein the auxiliary anchor comprises a first helical portion having a first pitch and a second helical portion having a second, smaller pitch.

8. 2. The coaptation auxiliary element delivery system of claim 1, wherein the auxiliary anchor comprises a fixing segment having a pitch of 0.5 mm to 1.5 mm and an auxiliary anchor locking segment having a pitch of 0.1 mm to 0.5 mm.

9. 10. The coaptation assist element delivery system of claim 1, further comprising an auxiliary anchor tether extending through the coaptation assist element, the auxiliary anchor configured to advance along the auxiliary anchor tether toward the valve annulus.

10. The coaptation assist element delivery system of claim 9, further comprising a radiopaque marker crimped to the auxiliary anchor tether.

11. 10. The coaptation assist element delivery system of claim 9, further comprising a release wire, the auxiliary anchor tether being looped around the release wire.

12. a joint auxiliary element having 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; an auxiliary anchor tether extending through the auxiliary joint element; an auxiliary anchor guide rail configured to run along the auxiliary anchor mooring device to guide the trajectory of the auxiliary anchor; and an auxiliary anchor configured to advance along the auxiliary anchor guide rail toward the annulus.

13. The joint auxiliary element delivery system of claim 12, wherein the auxiliary anchor is a variable pitch anchor.

14. The coaptation assist element delivery system of claim 12 further comprising a release wire, the auxiliary anchor tether being looped around the release wire.

15. The coaptation assist element delivery system of claim 12, further comprising a radiopaque marker coupled to the auxiliary anchor tether.

16. The joint auxiliary element delivery system of claim 12 , wherein the auxiliary anchor guide rail comprises a bend.

17. The coaptation auxiliary element delivery system of claim 12 , wherein the auxiliary anchor guide rail is configured to rotate to change the trajectory of the auxiliary anchor.