atrioventricular valve replacement

Abstract

Devices and methods including a frame (20) configured to support a prosthetic valve within a native atrioventricular valve are described. The frame (20) includes an atrial portion (26) and a cylindrical portion (22) to which prosthetic valve leaflets (23) are coupled. A plurality of chordal recruitment arms (24) extend radially from at least a ventricular end of the cylindrical portion (22). The chordal recruitment arms (24) are coupled to the ventricular end of the cylindrical portion by a suture (82), and the suture (82) is configured to act as a hinge such that, when released from a radially constrained configuration, the chordal recruitment arms (24) are configured to extend radially outward by pivoting about the suture (82) relative to the cylindrical portion (22) while the cylindrical portion (22) is held in at least a partially radially constrained configuration. Other applications are also described herein.

Description

[0001] Cross-reference to related applications

[0002] This application claims priority to Agian's U.S. Provisional Patent Application 62 / 886,366, filed August 14, 2019, entitled "Atrioventricular valve replacement," which is incorporated herein by reference. Field of embodiments of the invention

[0003] This invention relates to medical devices and methods, and more particularly to devices and methods for implanting an artificial valve at the atrioventricular valve. background

[0004] The human heart is a muscular organ that pumps oxygenated blood through the lungs by the contraction of its four chambers, and then pumps the oxygenated blood to other parts of the body.

[0005] After circulating in the body, the deoxygenated blood enters the right atrium through the vena cava. In healthy subjects, the right atrium contracts, pumping blood through the tricuspid valve into the right ventricle. The right ventricle contracts, pumping blood through the pulmonary semilunar valve into the pulmonary artery, which branches into two arteries, one for each lung. The blood is oxygenated as it flows through the lungs and re-enters the heart through the left atrium. The left atrium contracts, pumping oxygenated blood through the mitral valve into the left ventricle. The left ventricle contracts, pumping oxygenated blood through the aortic valve into the aorta, from where it is distributed to the rest of the body. The tricuspid valve closes during right ventricular contraction to prevent backflow into the right atrium. Similarly, the mitral valve closes during left ventricular contraction to prevent backflow into the left atrium. The mitral and tricuspid valves are called the atrioventricular valves, and each of these valves controls blood flow between the atria and ventricles.

[0006] In the mitral valve, the mitral annulus defines the mitral orifice. The anterior and posterior leaflets extend from the mitral annulus. The leaflets are connected to the papillary muscles in the left ventricle via chordae tendineae.

[0007] During ventricular diastole, in healthy subjects, the left atrium contracts to pump blood through the orifice of the mitral valve into the left ventricle. As blood flows through the orifice, it pushes the leaflets apart and allows them to enter the left ventricle with minimal resistance. In healthy subjects, the leaflets of the aortic valve are kept closed by blood pressure in the aorta.

[0008] During ventricular contraction, the left ventricle contracts to pump blood through the aortic valve, the leaflets of which are pushed open by the blood flow. In a healthy subject, the mitral annulus contracts to push the leaflets inward and reduce the area of the mitral orifice by about 20% to 30%. The leaflets coapt to accommodate the excess leaflet surface area, creating a coaptation surface that constitutes a seal. Blood pressure in the left ventricle pushes the ventricular surface of the leaflets together tightly at the coaptation surface, thereby forming a tight, leak-proof seal.

[0009] Effective sealing of the mitral valve during ventricular contraction depends on a sufficient degree of coaptation. Improper coaptation can result from many physical abnormalities that allow the leaflets to prolapse (e.g., chordae elongation or rupture, or papillary muscle weakness) or prevent coaptation (e.g., chordae shortening, or leaflets small). There are also pathologies that cause mitral regurgitation, including collagen vascular disease, ischemic mitral regurgitation (e.g., caused by myocardial infarction, chronic heart failure, or failure / unsuccessful surgical or catheter-based revascularization), myxomatous degeneration of the leaflets, and rheumatic heart disease. Mitral regurgitation leads to many complications, including arrhythmias, atrial fibrillation, palpitations, chest pain, congestive heart failure, syncope, fatigue, low cardiac output, orthopnea, paroxysmal nocturnal dyspnea, pulmonary edema, shortness of breath, and sudden death.

[0010] The tricuspid valve includes three leaflets: the septal leaflet, the anterior leaflet, and the posterior leaflet. Each valve leaflet is attached to the tricuspid annulus, which defines the tricuspid orifice. The leaflets are connected to the papillary muscles within the right ventricle by chordae tendinae. In a healthy subject, the tricuspid valve controls the direction of blood flow from the right atrium to the right ventricle in a manner similar to the way the mitral valve controls blood flow on the left side of the heart. During ventricular diastole, the tricuspid valve opens to allow blood to flow from the right atrium to the right ventricle, and during ventricular systole, the leaflets of the tricuspid valve coapt to prevent blood from flowing from the right ventricle to the right atrium.

[0011] Tricuspid regurgitation occurs when the tricuspid valve fails to close properly. This causes blood to flow back into the right atrium when the right ventricle contracts. The most common cause of tricuspid regurgitation is dilation of the right ventricle, which causes the tricuspid annulus to dilate, causing the valve leaflets to fail to coapt properly. SUMMARY OF EMBODIMENTS

[0012] For some applications of the present invention, a frame for use with a prosthetic valve is provided, the prosthetic valve configured to be deployed within a native atrioventricular valve (e.g., a mitral valve or a tricuspid valve). The frame typically includes a frame body, the frame body including a cylindrical section and an atrial section. Typically, the cylindrical section is configured to support the prosthetic valve within the native atrioventricular valve. For example, the leaflets of the prosthetic valve can be sutured to the cylindrical section, and / or can be otherwise coupled to the cylindrical section. Typically, the atrial section is configured to be at least partially deployed within the atrium of a subject. Further, typically, the cylindrical section is configured to be at least partially deployed within the ventricle of a subject.

[0013] For some applications, the atrial section includes a disc portion (also referred to herein as a flange) and a frustoconical portion. Typically, the disc portion of the atrial section is configured to seal the frame against tissue on the atrial side of the native atrioventricular annulus, and is further configured to prevent migration of the frame into the ventricle. The frustoconical portion typically extends from the disc portion of the atrial section to an outer surface of the cylindrical section. For some applications, including the frustoconical portion between the disc portion and the cylindrical section (as opposed to coupling the disc portion directly to the cylindrical section) reduces the likelihood of regurgitation around the outside of the cylindrical section.

[0014] For some applications, a plurality of chord-recruiting arms (e.g., more than two and / or less than twelve arms) extend from a portion of the frame body configured to be placed within the ventricle of a subject. For example, four chord-recruiting arms or six chord-recruiting arms can extend from the frame body. For some applications, a single chord-recruiting arm extends from a portion of the frame body configured to be placed within the ventricle of a subject. Typically, the chord-recruiting arms extend from the cylindrical section of the frame body. Further, typically, the chord-recruiting arms extend from the ventricular end of the cylindrical section (i.e., the end of the frame body configured to be placed within the ventricle). Typically, the arms extend radially from the frame body in addition to extending axially from the ventricular end of the frame body toward the atrial end of the frame body (i.e., the end of the frame body configured to be placed within the atrium). Further, typically, the arms are curved in a given circumferential direction around the outside of the frame body.

[0015] It should be noted that descriptions herein of an arm extending in a given direction from a frame body should not be interpreted as excluding the arm being oriented in another direction. Rather, an arm being described (or claimed) as extending radially from a frame body should be interpreted as meaning that the orientation of the arm relative to the frame body includes a radial component. Typically, the arm is circumferentially curved in addition to extending radially from the frame body, and in some cases, the orientation of the arm includes an axial component. For some applications, at least along a portion of the arm, and at least in certain configurations of the arm, the arm is disposed tangentially relative to the frame body.

[0016] Typically, the frame having the prosthetic valve leaflets disposed therein is delivered to the native atrioventricular valve by a delivery device (e.g., a delivery catheter), and the delivery device is configured to hold the frame and the prosthetic valve in a radially constrained configuration (i.e., a "crimped" configuration) during delivery. Depending on the respective application, the frame is delivered transapically (i.e., via the apex of the left ventricle), transseptally (i.e., via the vena cava, right atrium, and interatrial septum), and / or via a different delivery path. For some applications, the chordae-harvesting arms are deployed among the chordae tendinae of the native atrioventricular valve when the distal end of the delivery device is disposed within the ventricle of the subject.

[0017] Typically, the chordae-harvesting arms are deployed among the chordae tendinae of the native atrioventricular valve by releasing the chordae-harvesting arms from the delivery device, the shape of the chordae-harvesting arms being set to extend from the frame body when released from the delivery device. For some applications, additional techniques are used in order to deploy the chordae-harvesting arms among the chordae tendinae of the native atrioventricular valve by releasing the chordae-harvesting arms from the delivery device. For example, the frame can include a lever element configured to cause the chordae-harvesting arms to extend radially. Alternatively or additionally, the arms are coupled to the cylindrical portion of the frame by a suture portion, the suture portion acting as a hinge such that the arms pivot about the suture portion relative to the cylindrical portion, as described below. Typically, the chordae-harvesting arms are released from the delivery device while the frame body is still held in the at least partially radially constrained configuration by the delivery device. Moreover, typically, in this configuration of the frame body (i.e., the chordae-harvesting arms have been released from the delivery device, but the frame body is still held in the at least partially radially constrained configuration by the delivery device), the chordae-harvesting arms assume a configuration described herein as the "rotated configuration" of the chordae-harvesting arms.

[0018] After the chordae-harvesting arms are deployed among the chordae tendinae of the native atrioventricular valve (and typically, while the frame body is still held in the at least partially radially constrained configuration by the delivery device), at least a portion of the frame is rotated, thereby causing the chordae-harvesting arms to (a) pull the native atrioventricular valve radially inward toward the frame, and (b) twist the native atrioventricular valve around the frame, by harvesting and deflecting at least a portion of the chordae tendinae.

[0019] Typically, when the arms are deployed in the chordae tendinae (i.e., when the arms are set in their rotated configuration), and when the frame body is allowed to radially expand (i.e., when the frame assumes its non-radially constrained configuration), the chordae-harvesting arms are configured to bend in a given circumferential direction relative to the longitudinal axis of the frame, as described in further detail below. For example, the arms can bend in a clockwise direction or a counterclockwise direction relative to the longitudinal axis of the frame. Typically, after the chordae-harvesting arms are deployed in the chordae tendinae of the native atrioventricular valve (and typically, while the frame body is still held in the at least partially radially constrained configuration by the delivery device), the frame is rotated in the same circumferential direction as the circumferential bending direction of the arms. For some applications, the frame is rotated in the opposite circumferential direction before being rotated in the same circumferential direction as the circumferential bending direction of the arms. For example, if the arms bend in a clockwise circumferential direction, then, after the arms are deployed in the chordae tendinae, the frame can first be rotated in a counterclockwise direction, and then rotated in a clockwise direction. For some applications, rotating the frame in this manner facilitates harvesting of a greater portion of the chordae tendinae than if the frame were rotated only in the circumferential bending direction of the arms.

[0020] As noted in the paragraph above, for some applications, the frame is rotated in the opposite circumferential direction before being rotated in the same circumferential direction as the circumferential bending direction of the arms. For some applications, the delivery device is configured such that the frame is initially rotated a given angle in the circumferential direction opposite the circumferential bending direction of the arms, and then rotated through a predetermined angle in the circumferential bending direction of the arms. For some applications, in the rotated configuration of the chordae-harvesting arms, the outer surface of each arm has a smooth convex curvature that extends along substantially the entire length of the arm, such that, during the initial rotation (against the circumferential bending direction of the arms), the chordae tendinae slide over the outer surface of the arms without being harvested or caught by the arms, or damaged by the arms in any way. For some applications, because the arms are shaped in this manner, the initial rotation of the frame results in a relatively large amount of the chordae tendinae being positioned such that they are harvested by each arm in the subsequent rotation step. During the subsequent rotation of the frame (in the circumferential bending direction of the arms), the chordae tendinae are harvested and deflected (e.g., inwardly deflected) by the arms. Typically, in the rotated configuration of the chordae-harvesting arms, the inner surface of the arms has a concave curvature, and, during the subsequent rotation of the frame, the chordae tendinae are harvested within the space defined by the concave curvature.

[0021] For some applications, a plurality of struts extend from the outside of the cylindrical portion of the frame. Typically, the atrial portion is coupled to the cylindrical portion, for example via suturing or welding, through the atrial portion. It is noted that typically, during crimping of the frame, there is a significant amount of strain at the junctions where the extending struts extend from the cylindrical portion, as the struts pivot around these junctions. If the atrial portion is directly coupled to the cylindrical portion at these junctions, then this would mean that these points on the frame where there is relatively large strain are also the points where the two pieces are coupled to each other, which would make the frame susceptible to fatigue damage at these points. In contrast, since the cylindrical portion includes the extending struts, and the atrial portion is coupled to the cylindrical portion through the struts, there is a separation between the points of high strain and the points where the atrial portion is coupled to the cylindrical portion.

[0022] It is also noted that typically, the extending struts extend from an axial location along the cylindrical portion that is at the lower 90% (e.g., lower 70%, or lower 50%) of the height of the cylindrical portion. Typically, the cylindrical portion has a height of at least 15 mm, in order to accommodate the coupling of the valve leaflets to the cylindrical portion. If the extending struts extend from the top of the cylindrical portion (or if the atrial portion is directly coupled to the cylindrical portion at the top of the cylindrical portion), then the entire height of the cylindrical portion would be disposed below the atrial portion. In contrast, since the extending struts extend from the lower 90% (e.g., lower 70%, or lower 50%) of the height of the cylindrical portion, there is typically an axial overlap along the height of the cylindrical portion between the atrial portion and the cylindrical portion of the frame. Typically, in the absence of an axial overlap between the atrial portion and the cylindrical portion of the frame, this results in a smaller portion of the height of the cylindrical portion extending into the ventricle of the subject. In turn (when the frame is configured to be placed within the left ventricle of the subject), this typically reduces the obstruction of the left ventricular outflow tract relative to if a larger portion of the height of the cylindrical portion extends into the ventricle of the subject. In this case, it is noted that, as described above, the chordal recruitment arm is typically configured to (a) pull the native atrioventricular valve radially inward toward the frame, and (b) twist the native atrioventricular valve around the frame, by recruiting and deflecting at least a portion of the chordae tendinae of the native atrioventricular valve. Typically, recruiting and deflecting the chordae tendinae in this manner serves to prevent the left ventricular outflow tract from being partially obstructed by the native mitral valve device.

[0023] According to some applications of the present application, there is thus provided an apparatus for use with an artificial valve leaflet configured to be deployed within a native atrioventricular valve disposed between an atrium and a ventricle of a heart of a mammalian subject, the native atrioventricular valve comprising an annulus, valve leaflets, chordae tendinae, and papillary muscles, the apparatus comprising:

[0024] a frame configured to support a prosthetic valve within an native atrioventricular valve, the frame comprising:

[0025] an atrial section comprising a disc-shaped portion configured to be deployed on an atrial side of the annulus;

[0026] a cylindrical section to which the prosthetic valve leaflets are coupled, the cylindrical section configured to be deployed such that a ventricular end of the cylindrical section is disposed within the ventricle;

[0027] a plurality of chord-recruiting arms configured to extend radially at least from the ventricular end of the cylindrical section, the chord-recruiting arms being coupled to the ventricular end of the cylindrical section by sutures, and the sutures being configured to act as hinges such that, when the chord-recruiting arms are released from a radially constrained configuration, the chord-recruiting arms are configured to extend radially outward by pivoting about the sutures relative to the cylindrical section while the cylindrical section is held in the at least partially radially constrained configuration.

[0028] In some applications, the atrial section further comprises a frustoconical portion, and the frustoconical portion of the atrial section is coupled to the cylindrical section such that there is axial overlap between at least the frustoconical portion of the atrial section and the cylindrical section.

[0029] In some applications, the atrial section further comprises a frustoconical portion, the frame further comprising a plurality of protruding struts configured to protrude from an outer side of the cylindrical section, and the frustoconical portion of the atrial section is coupled to the cylindrical section by the protruding struts.

[0030] In some applications, the apparatus further comprises a delivery device configured to:

[0031] deliver the frame to the native atrioventricular valve,

[0032] subsequently deploy the plurality of chord-recruiting arms among the chords of the native atrioventricular valve, and

[0033] subsequently rotate at least a portion of the frame so as to (a) pull the native atrioventricular valve radially inward toward the frame and (b) twist the native atrioventricular valve around the frame by recruiting and deflecting at least a portion of the chords.

[0034] In some applications:

[0035] the delivery device is configured to deploy the plurality of chord-recruiting arms among the chords of the native atrioventricular valve while maintaining the cylindrical section in the at least partially radially constrained configuration such that the chord-recruiting arms assume a rotated configuration in which the chord-recruiting arms extend radially at least from the ventricular end of the cylindrical section and are bent circumferentially around the cylindrical section in a given circumferential direction, and

[0036] The delivery device is configured to rotate at least a portion of the valve frame when the chordae tendinae recruitment arms are disposed in the rotated configuration.

[0037] In some applications, after rotating at least a portion of the valve frame,

[0038] The delivery device is configured to release the atrial section and the cylindrical section of the valve frame, thereby causing the native atrioventricular valve to remain (a) radially inward toward the valve frame, and (b) twisted about the valve frame, by causing at least a portion of the native atrioventricular valve to be captured within the valve frame.

[0039] In some applications, when the atrial section and the cylindrical section of the valve frame have been released by the delivery device, the chordae tendinae recruitment arms are configured to define pockets, and the pockets defined by the chordae tendinae recruitment arms are configured to accommodate the captured portions of the native atrioventricular valve.

[0040] In some applications:

[0041] First, the delivery device is configured to rotate at least a portion of the valve frame in a circumferential direction opposite a circumferential bending direction of the chordae tendinae recruitment arms; and

[0042] Subsequently, the delivery device is configured to rotate at least a portion of the valve frame in the circumferential bending direction of the chordae tendinae recruitment arms, thereby causing the plurality of chordae tendinae recruitment arms to (a) pull the native atrioventricular valve radially inward toward the valve frame, and (b) twist the native atrioventricular valve about the valve frame, by recruiting and deflecting at least a portion of the chordae tendinae.

[0043] In some applications, in the rotated configuration of the chordae tendinae recruitment arms:

[0044] The outer surface of each of the chordae tendinae recruitment arms has a smooth convex curvature extending along substantially an entire length of the chordae tendinae recruitment arms, such that the chordae tendinae slide over the outer surface of the chordae tendinae recruitment arms without being recruited or caught by the chordae tendinae recruitment arms during rotation of at least a portion of the valve frame in a circumferential direction opposite a circumferential bending direction of the chordae tendinae recruitment arms; and

[0045] The inner surface of each of the chordae tendinae recruitment arms has a concave curvature, such that the chordae tendinae are recruited within a space defined by the concave curvature during rotation of at least a portion of the valve frame in the circumferential bending direction of the chordae tendinae recruitment arms.

[0046] In some applications, the disc-shaped portion of the atrial section includes struts defining cells, and at least some of the struts have a wavy pattern, the struts being configured to provide flexibility to the cells of the flange such that the disc-shaped portion is able to adjust its shape to accommodate changes in the shape of tissue on the atrial side of the annulus.

[0047] In some applications, the cells of the disc-shaped portion are circumferentially curved such that outer ends of the cells point in a given circumferential direction.

[0048] In some applications, the chordal recruitment arms are configured to circumferentially flex around the cylindrical section in a circumferential flexing direction opposite a given circumferential direction.

[0049] According to some applications of the present application, there is also provided an apparatus for use with a prosthetic valve leaflet configured to be deployed within a native atrioventricular valve disposed between an atrium and a ventricle of a heart of a mammalian subject, the native atrioventricular valve comprising an annulus, valve leaflets, chords and papillary muscles, the apparatus comprising:

[0050] a frame configured to support the prosthetic valve within the native atrioventricular valve, the frame comprising:

[0051] an atrial section comprising a disc portion and a frustoconical portion, the disc portion configured to be deployed on an atrial side of the annulus;

[0052] a cylindrical section to which the prosthetic valve leaflet is coupled, the cylindrical section configured to be deployed such that a ventricular end of the cylindrical section is disposed within the ventricle; and

[0053] a plurality of protruding struts configured to protrude from an outer side of the cylindrical section, the frustoconical portion of the atrial section being coupled to the cylindrical section by the protruding struts.

[0054] In some applications, the frustoconical portion of the atrial section is coupled to the cylindrical section such that there is an axial overlap between at least the frustoconical portion of the atrial section and the cylindrical section.

[0055] In some applications, the plurality of protruding struts protrude from the outer side of the cylindrical section from an axial location along the cylindrical section that is at a lower 70% of a height of the cylindrical section.

[0056] In some applications, the frustoconical portion of the atrial section is stitched to the protruding struts. In some applications, the frustoconical portion of the atrial section is welded to the protruding struts. In some applications, the frustoconical portion of the atrial section is glued to the protruding struts.

[0057] In some applications, due to the frustoconical portion of the atrial section being coupled to the cylindrical section by the protruding struts, a strain generated on an area of the frame where the frustoconical portion of the atrial section is coupled to the cylindrical section is reduced relative to if the frustoconical portion of the atrial section was directly coupled to the cylindrical section.

[0058] In some applications, the frame further comprises a plurality of chordal recruitment arms configured to extend radially at least from the ventricular end of the cylindrical section.

[0059] In some applications, the apparatus further comprises a delivery device configured to:

[0060] delivering the frame to an autologous atrioventricular valve,

[0061] subsequently, deploying the plurality of chordal recruitment arms among chordae tendinae of the autologous atrioventricular valve, and

[0062] subsequently, rotating at least a portion of the frame so as to cause the plurality of chordal recruitment arms (a) to pull the autologous atrioventricular valve radially inward toward the frame and (b) to twist the autologous atrioventricular valve around the frame by recruiting and deflecting at least a portion of the chordae tendinae.

[0063] In some applications, the end of each of the chordal recruitment arms is rounded so as to guide the chordae tendinae around the end of the chordal recruitment arms without damaging tissue.

[0064] In some applications, the end of each of the chordal recruitment arms is lined so as to guide the chordae tendinae around the end of the chordal recruitment arms without damaging tissue.

[0065] In some applications:

[0066] the delivery device is configured to deploy the plurality of chordal recruitment arms among chordae tendinae of the autologous atrioventricular valve while maintaining the cylindrical section in the at least partially radially constrained configuration such that the chordal recruitment arms assume a rotated configuration in which the chordal recruitment arms extend radially at least from the ventricular end of the cylindrical section and are bent circumferentially around the cylindrical section in a given circumferential direction, and

[0067] the delivery device is configured to rotate at least a portion of the frame while the chordal recruitment arms are disposed in the rotated configuration.

[0068] In some applications, after rotating at least a portion of the frame,

[0069] the delivery device is configured to release the atrial section and the cylindrical section of the frame so as to cause the autologous atrioventricular valve to remain (a) pulled radially inward toward the frame and (b) twisted around the frame by having at least a portion of the autologous atrioventricular valve captured within the frame.

[0070] In some applications, when the atrial section and the cylindrical section of the frame have been released by the delivery device, the chordal recruitment arms are configured to define a pocket, and wherein the pocket defined by the chordal recruitment arms is configured to accommodate the captured portion of the autologous atrioventricular valve.

[0071] In some applications:

[0072] first, the delivery device is configured to rotate at least a portion of the frame in a circumferential direction opposite to the circumferential bending direction of the chordal recruitment arms; and

[0073] Subsequently, the delivery device is configured to rotate at least a portion of the frame in a circumferential bending direction of the chordal recruitment arms, thereby causing the plurality of chordal recruitment arms to (a) pull the native atrioventricular valve radially inward toward the frame and (b) twist the native atrioventricular valve about the frame by recruiting and deflecting at least a portion of the chordae tendinae.

[0074] In some applications, in the rotated configuration of the chordal recruitment arms:

[0075] The outer surface of each of the chordal recruitment arms has a smooth convex curvature extending along substantially the entire length of the chordal recruitment arms, such that the chordae tendinae slide over the outer surface of the chordal recruitment arms without being recruited or caught by the chordal recruitment arms during rotation of at least a portion of the frame in a circumferential direction opposite the circumferential bending direction of the chordal recruitment arms; and

[0076] The inner surface of each of the chordal recruitment arms has a concave curvature, such that the chordae tendinae are recruited within a space defined by the concave curvature during rotation of at least a portion of the frame in the circumferential bending direction of the chordal recruitment arms.

[0077] In some applications, the disc-shaped portion of the atrial section includes struts defining the cells, and wherein at least some of the struts have a wavy pattern, the struts being configured to provide flexibility to the cells of the flange such that the disc-shaped portion is able to adjust its shape to accommodate changes in the shape of the tissue on the atrial side of the annulus.

[0078] In some applications, the cells of the disc-shaped portion are circumferentially curved such that the outer ends of the cells point in a given circumferential direction.

[0079] In some applications, the frame further includes chordal recruitment arms configured to bend circumferentially about the cylindrical section in a circumferential bending direction opposite a given circumferential direction.

[0080] According to some applications of the invention, there is also provided an apparatus for use with a prosthetic valve leaflet configured to be deployed within a native atrioventricular valve disposed between an atrium and a ventricle of a heart of a mammalian subject, the native atrioventricular valve including an annulus, valve leaflets, chordae tendinae, and papillary muscles, the apparatus comprising:

[0081] a frame configured to support the prosthetic valve within the native atrioventricular valve, the frame including:

[0082] an atrial section including a disc-shaped portion and a frustoconical portion, the disc-shaped portion being configured to be deployed on an atrial side of the annulus;

[0083] a cylindrical section to which the prosthetic valve leaflet is coupled, the cylindrical section being configured to be deployed such that a ventricular end of the cylindrical section is disposed within the ventricle,

[0084] The frustoconical portion of the atrial section is coupled to the cylindrical section such that there is axial overlap between at least the frustoconical portion and the cylindrical section of the atrial section.

[0085] In some applications, the frame further comprises a plurality of extending struts configured to extend from an outer side of the cylindrical section, the frustoconical portion of the atrial section being coupled to the cylindrical section by the extending struts.

[0086] In some applications, the frustoconical portion of the atrial section is directly coupled to the cylindrical section. In some applications, the frustoconical portion of the atrial section is coupled to the cylindrical section by suturing. In some applications, the frustoconical portion of the atrial section is coupled to the cylindrical section by welding. In some applications, the frustoconical portion of the atrial section is coupled to the cylindrical section by gluing.

[0087] In some applications, the frustoconical portion of the atrial section is coupled to the cylindrical section such that the frustoconical portion of the atrial section extends from an axial position along the cylindrical section that is at a lowest 90% of a height of the cylindrical section. In some applications, the frustoconical portion of the atrial section is coupled to the cylindrical section such that the frustoconical portion of the atrial section extends from an axial position along the cylindrical section that is at a lowest 70% of a height of the cylindrical section. In some applications, the frustoconical portion of the atrial section is coupled to the cylindrical section such that the frustoconical portion of the atrial section extends from an axial position along the cylindrical section that is at a lowest 50% of a height of the cylindrical section.

[0088] In some applications, the frame further comprises a plurality of chord recruiting arms configured to extend radially from at least a ventricular end of the cylindrical section.

[0089] In some applications, the device further comprises a delivery apparatus configured to:

[0090] deliver the frame to a native atrioventricular valve,

[0091] subsequently deploy the plurality of chord recruiting arms among chords of the native atrioventricular valve, and

[0092] subsequently rotate at least a portion of the frame, thereby causing the plurality of chord recruiting arms to (a) pull the native atrioventricular valve radially inward toward the frame and (b) twist the native atrioventricular valve around the frame by recruiting and deflecting at least a portion of the chords.

[0093] In some applications, the end of each of the chordae tendinae harvesting arms is rounded so as to guide the chordae tendinae around the end of the chordae tendinae harvesting arms without damaging tissue. In some applications, the end of each of the chordae tendinae harvesting arms is padded so as to guide the chordae tendinae around the end of the chordae tendinae harvesting arms without damaging tissue.

[0094] In some applications:

[0095] The delivery device is configured to deploy the plurality of chordae tendinae harvesting arms among the chordae tendinae of the native atrioventricular valve while maintaining the cylindrical section in the at least partially radially constrained configuration such that the chordae tendinae harvesting arms assume a rotated configuration in which the chordae tendinae harvesting arms extend radially at least from the ventricular end of the cylindrical section and are curved circumferentially around the cylindrical section in a given circumferential direction, and

[0096] The delivery device is configured to rotate at least a portion of the valve holder while the chordae tendinae harvesting arms are disposed in the rotated configuration.

[0097] In some applications, after rotating at least a portion of the valve holder,

[0098] The delivery device is configured to release the atrial section and the cylindrical section of the valve holder, thereby causing the native atrioventricular valve to be held (a) radially inward toward the valve holder, and (b) twisted around the valve holder, by causing at least a portion of the native atrioventricular valve to be captured within the valve holder.

[0099] In some applications, when the atrial section and the cylindrical section of the valve holder have been released by the delivery device, the chordae tendinae harvesting arms are configured to define pockets, and the pockets defined by the chordae tendinae harvesting arms are configured to accommodate the captured portion of the native atrioventricular valve.

[0100] In some applications:

[0101] First, the delivery device is configured to rotate at least a portion of the valve holder in a circumferential direction opposite the circumferential bending direction of the chordae tendinae harvesting arms; and

[0102] Subsequently, the delivery device is configured to rotate at least a portion of the valve holder in the circumferential bending direction of the chordae tendinae harvesting arms, thereby causing the plurality of chordae tendinae harvesting arms to (a) pull the native atrioventricular valve radially inward toward the valve holder, and (b) twist the native atrioventricular valve around the valve holder, by harvesting and deflecting at least a portion of the chordae tendinae.

[0103] In some applications, in the rotated configuration of the chordae tendinae harvesting arms:

[0104] The outer surface of each of the chordae tendinae harvesting arms has a smooth convex curvature extending along substantially the entire length of the chordae tendinae harvesting arms such that, during rotation of at least a portion of the valve holder in a circumferential direction opposite the circumferential bending direction of the chordae tendinae harvesting arms, the chordae tendinae slide over the outer surface of the chordae tendinae harvesting arms without being harvested or caught by the chordae tendinae harvesting arms; and

[0105] The inner surface of each of the chord recruiting arms has a concave curvature such that, during rotation of at least a portion of the frame in a circumferential bending direction of the chord recruiting arms, the chords are recruited within a space defined by the concave curvature.

[0106] In some applications, the disc-shaped portion of the atrial section includes struts defining the cells, and at least some of the struts have a wavy pattern, the struts being configured to provide flexibility to the cells of the flange such that the disc-shaped portion can adjust its shape to accommodate changes in the shape of tissue on the atrial side of the annulus.

[0107] In some applications, the cells of the disc-shaped portion are circumferentially curved such that the outer ends of the cells point in a given circumferential direction.

[0108] In some applications, the frame further includes a chord recruiting arm configured to circumferentially bend around the cylindrical section in a circumferential bending direction opposite the given circumferential direction.

[0109] According to some applications of the invention, there is also provided an apparatus for use with a prosthetic valve leaflet configured to be deployed within a native atrioventricular valve disposed between an atrium and a ventricle of a heart of a mammalian subject, the native atrioventricular valve including an annulus, valve leaflets, chords, and papillary muscles, the apparatus comprising:

[0110] a frame configured to support the prosthetic valve within the native atrioventricular valve, the frame comprising:

[0111] an atrial section including a flange and a frustoconical portion, the flange being configured to be deployed on an atrial side of the annulus;

[0112] a cylindrical section to which the prosthetic valve leaflet is coupled, the cylindrical section being configured to be deployed such that a ventricular end of the cylindrical section is disposed within the ventricle,

[0113] the flange includes struts defining the cells, and at least some of the struts have a wavy pattern, the struts being configured to provide flexibility to the cells of the flange such that the flange can adjust its shape to accommodate changes in the shape of tissue on the atrial side of the annulus.

[0114] In some applications, the cells of the flange are circumferentially curved such that the outer ends of the cells point in a given circumferential direction.

[0115] In some applications, the frame further includes a plurality of chord recruiting arms configured to extend radially from the ventricular end of the cylindrical section and configured to circumferentially bend around the cylindrical section in a circumferential bending direction opposite the given circumferential direction.

[0116] According to some applications of the present invention, there is also provided an apparatus for use with a prosthetic valve leaflet configured to be deployed within a native atrioventricular valve disposed between an atrium and a ventricle of a heart of a mammalian subject, the native atrioventricular valve comprising an annulus, valve leaflets, chordae tendineae, and papillary muscles, the apparatus comprising:

[0117] a frame configured to support the prosthetic valve within the native atrioventricular valve, the frame comprising:

[0118] an atrial section comprising a disc-shaped portion configured to be deployed on an atrial side of the annulus;

[0119] a cylindrical section to which the prosthetic valve leaflet is coupled, the cylindrical section configured to be deployed such that a ventricular end of the cylindrical section is disposed within the ventricle;

[0120] a plurality of chordae tendineae recruitment arms configured to radially extend at least from the ventricular end of the cylindrical section, the plurality of chordae tendineae recruitment arms configured to:

[0121] deploy within the chordae tendineae of the native atrioventricular valve while the cylindrical section remains in the at least partially radially constrained configuration such that the chordae tendineae recruitment arms assume a rotated configuration in which the chordae tendineae recruitment arms radially extend at least from the ventricular end of the cylindrical section and are circumferentially curved around the cylindrical section in a given circumferential direction, and in the rotated configuration of the chordae tendineae recruitment arms:

[0122] an outer surface of each of the chordae tendineae recruitment arms has a smooth convex curvature extending along substantially an entire length of the chordae tendineae recruitment arm such that the chordae tendineae slide over the outer surface of the chordae tendineae recruitment arms without being recruited or caught by the chordae tendineae recruitment arms during rotation of at least a portion of the frame in a circumferential direction opposite to the circumferential curvature direction of the chordae tendineae recruitment arms; and

[0123] an inner surface of each of the chordae tendineae recruitment arms has a concave curvature such that the chordae tendineae are recruited within a space defined by the concave curvature during rotation of at least a portion of the frame in the circumferential curvature direction of the chordae tendineae recruitment arms.

[0124] In some applications, the outer surface of each of the chordae tendineae recruitment arms is covered with a low-friction fabric so as to allow the outer surface to move relative to the chordae tendineae without damaging tissue. In some applications, the inner surface of each of the chordae tendineae recruitment arms is covered with a low-friction fabric so as to allow the inner surface to move relative to the chordae tendineae without damaging tissue. In some applications, the tip of each of the chordae tendineae recruitment arms is rounded so as to guide the chordae tendineae around the tip of the chordae tendineae recruitment arms without damaging tissue. In some applications, the tip of each of the chordae tendineae recruitment arms is lined so as to guide the chordae tendineae around the tip of the chordae tendineae recruitment arms without damaging tissue.

[0125] In some applications, the apparatus further comprises a delivery device configured to:

[0126] deliver the frame to an native atrioventricular valve,

[0127] subsequently, deploy the plurality of chordal recruitment arms among chordae tendineae of the native atrioventricular valve while maintaining the cylindrical section in the at least partially radially constrained configuration, such that the chordal recruitment arms assume a rotated configuration, and

[0128] when the chordal recruitment arms are disposed in the rotated configuration:

[0129] first, rotate at least a portion of the frame in a circumferential direction opposite a circumferential bending direction of the chordal recruitment arms; and

[0130] subsequently, rotate at least a portion of the frame in the circumferential bending direction of the chordal recruitment arms, thereby causing the plurality of chordal recruitment arms to (a) pull the native atrioventricular valve radially inward toward the frame, and (b) twist the native atrioventricular valve around the frame, by recruiting and deflecting at least a portion of the chordae tendineae.

[0131] In some applications, after rotating at least a portion of the frame, the delivery device is configured to release the atrial section and the cylindrical section of the frame, thereby causing the native atrioventricular valve to remain (a) pulled radially inward toward the frame, and (b) twisted around the frame, by causing at least a portion of the native atrioventricular valve to be captured within the frame.

[0132] In some applications, when the atrial section and the cylindrical section of the frame have been released by the delivery device, the chordal recruitment arms are configured to define a pocket, and wherein the pocket defined by the chordal recruitment arms is configured to accommodate the captured portion of the native atrioventricular valve.

[0133] According to some applications of the present invention, there is also provided a method for use with a prosthetic valve leaflet configured to be deployed within a native atrioventricular valve disposed between an atrium and a ventricle of a heart of a mammalian subject, the native atrioventricular valve comprising an annulus, valve leaflets, chordae tendineae, and papillary muscles, the method comprising:

[0134] deploying the frame within the native atrioventricular valve by:

[0135] deploying an atrial section of the frame at least partially within the atrium of the subject, the atrial section comprising a frustoconical portion and a disc-shaped portion configured to be deployed on an atrial side of the annulus;

[0136] deploying a cylindrical section of the frame such that a ventricular end of the cylindrical section is disposed within the ventricle of the subject, the prosthetic valve leaflet being coupled to the cylindrical section,

[0137] A plurality of outwardly extending struts extend from outside the cylindrical section, the frustoconical portion of the atrial section being coupled to the cylindrical section by the extending struts.

[0138] According to some applications of the present application, there is also provided a method for use with a prosthetic valve leaflet configured to be deployed within an autologous atrioventricular valve disposed between an atrium and a ventricle of a heart of a mammalian subject, the autologous atrioventricular valve comprising an annulus, valve leaflets, chordae tendinae, and papillary muscles, the method comprising:

[0139] deploying the frame within the autologous atrioventricular valve by:

[0140] deploying an atrial section of the frame at least partially within the atrium of the subject, the atrial section comprising a frustoconical portion and a disc-shaped portion configured to be deployed on an atrial side of the annulus;

[0141] deploying a cylindrical section of the frame such that a ventricular end of the cylindrical section is disposed within the ventricle of the subject, the prosthetic valve leaflet being coupled to the cylindrical section,

[0142] the frustoconical portion of the atrial section is coupled to the cylindrical section such that there is axial overlap between at least the frustoconical portion of the atrial section and the cylindrical section.

[0143] According to some applications of the present application, there is also provided an apparatus for use with a prosthetic valve leaflet configured to be deployed within an autologous atrioventricular valve disposed between an atrium and a ventricle of a heart of a mammalian subject, the autologous atrioventricular valve comprising an annulus, valve leaflets, chordae tendinae, and papillary muscles, the apparatus comprising:

[0144] a frame configured to support the prosthetic valve within the autologous atrioventricular valve, the frame comprising:

[0145] an atrial section comprising a disc-shaped portion configured to be deployed on an atrial side of the annulus;

[0146] a cylindrical section to which the prosthetic valve leaflet is coupled, the cylindrical section being configured to be deployed such that a ventricular end of the cylindrical section is disposed within the ventricle;

[0147] a plurality of chordae tendinae recruitment arms configured to extend radially at least from the ventricular end of the cylindrical section, the chordae tendinae recruitment arms being configured to be deployed within the chordae tendinae of the autologous atrioventricular valve and, in response to rotation of the frame in a given direction, to pull the autologous atrioventricular valve (a) radially inward toward the frame and (b) twist around the frame by recruiting and deflecting at least a portion of the chordae tendinae; and

[0148] a plurality of anti-recoil elements extending from the disc-shaped portion of the atrial section of the frame, the anti-recoil elements being configured to prevent rotation of the frame in a direction opposite to the direction of rotation of the frame.

[0149] According to some applications of the present application, there is also provided a method for use with a prosthetic valve leaflet configured to be deployed within a native atrioventricular valve disposed between an atrium and a ventricle of a heart of a mammalian subject, the native atrioventricular valve comprising an annulus, valve leaflets, chordae tendinae, and papillary muscles, the method comprising:

[0150] placing a frame within the native atrioventricular valve, the frame comprising:

[0151] an atrial section configured to be deployed on an atrial side of the annulus,

[0152] a cylindrical section to which the prosthetic valve leaflet is coupled, the cylindrical section configured to be deployed such that a ventricular end of the cylindrical section is disposed within the ventricle of the subject, and

[0153] a plurality of chordae tendinae recruitment arms configured to extend radially at least from the ventricular end of the cylindrical section;

[0154] deploying the chordae tendinae recruitment arms among the chordae tendinae of the native atrioventricular valve;

[0155] rotating the frame in a given direction, thereby pulling the native atrioventricular valve radially inward toward the frame and twisting the native atrioventricular valve around the frame by recruiting and deflecting at least a portion of the chordae tendinae; and

[0156] deploying an anti-backflushing element into tissue of the atrium of the subject to prevent rotation of the frame in a direction opposite to the direction of rotation of the frame.

[0157] According to some applications of the present application, there is also provided an apparatus for use with a delivery device and a prosthetic valve leaflet configured to be deployed within a native atrioventricular valve disposed between an atrium and a ventricle of a heart of a mammalian subject, the native atrioventricular valve comprising an annulus, valve leaflets, chordae tendinae, and papillary muscles, the apparatus comprising:

[0158] a frame configured to support the prosthetic valve within the native atrioventricular valve, the frame comprising:

[0159] an atrial section comprising a disc-shaped portion configured to be deployed on an atrial side of the annulus;

[0160] a cylindrical section to which the prosthetic valve leaflet is coupled, the cylindrical section configured to be deployed such that a ventricular end of the cylindrical section is disposed within the ventricle;

[0161] a plurality of chordae tendinae recruitment arms configured to extend radially at least from the ventricular end of the cylindrical section,

[0162] The frame includes a lever element extending from the chordal recruitment arms, the lever element configured such that, when the chordal recruitment arms are deployed among chordae tendinae of the native atrioventricular valve and the lever element is held within the delivery device, the lever element causes the chordal recruitment arms to pivot radially outward.

[0163] According to some applications of the present application, there is also provided a method for use with artificial valve leaflets configured to be deployed within a native atrioventricular valve disposed between an atrium and a ventricle of a heart of a mammalian subject, the native atrioventricular valve including an annulus, valve leaflets, chordae tendinae, and papillary muscles, the method comprising:

[0164] delivering the frame to the native atrioventricular valve using a delivery device, the frame including:

[0165] an atrial section configured to be deployed on an atrial side of the annulus,

[0166] a cylindrical section to which the artificial valve leaflets are coupled, the cylindrical section configured to be deployed such that a ventricular end of the cylindrical section is disposed within the ventricle of the subject,

[0167] a plurality of chordal recruitment arms configured to extend radially at least from the ventricular end of the cylindrical section, and

[0168] a lever element extending from the chordal recruitment arms;

[0169] deploying the chordal recruitment arms among chordae tendinae of the native atrioventricular valve at least in part by holding the lever element within the delivery device, thereby causing the chordal recruitment arms to pivot radially outward; and

[0170] rotating the frame in a given direction, thereby pulling the native atrioventricular valve (a) radially inward toward the frame and (b) twisting the native atrioventricular valve around the frame by recruiting and deflecting at least a portion of the chordae tendinae.

[0171] According to some applications of the present application, there is also provided a method for use with artificial valve leaflets configured to be deployed within a native atrioventricular valve disposed between an atrium and a ventricle of a heart of a mammalian subject, the native atrioventricular valve including an annulus, valve leaflets, chordae tendinae, and papillary muscles, the method comprising:

[0172] delivering the frame to the native atrioventricular valve using a delivery device, the frame including:

[0173] an atrial section configured to be deployed on an atrial side of the annulus,

[0174] a cylindrical section to which the artificial valve leaflets are coupled, the cylindrical section configured to be deployed such that a ventricular end of the cylindrical section is disposed within the ventricle of the subject,

[0175] a plurality of chordae tendinae recruitment arms configured to extend radially at least from the ventricular end of the cylindrical section, the chordae tendinae recruitment arms coupled to the ventricular end of the cylindrical section by the sutures;

[0176] deploying the chordae tendinae recruitment arms in the chordae tendinae of the native atrioventricular valve by releasing the chordae tendinae recruitment arms from the delivery device such that the chordae tendinae recruitment arms extend radially outward by pivoting about the sutures relative to the cylindrical section; and

[0177] rotating the valve holder in a given direction thereby pulling the native atrioventricular valve (a) radially inward toward the valve holder and (b) twisting about the valve holder by recruiting and deflecting at least a portion of the chordae tendinae.

[0178] According to some applications of the invention, there is also provided a method for use with a prosthetic valve leaflet configured to be deployed within a native atrioventricular valve disposed between an atrium and a ventricle of a heart of a mammalian subject, the native atrioventricular valve comprising an annulus, valve leaflets, chordae tendinae, and papillary muscles, the method comprising:

[0179] delivering the valve holder to the native atrioventricular valve using a delivery device, the valve holder comprising:

[0180] an atrial section configured to be deployed on an atrial side of the annulus,

[0181] a cylindrical section to which the prosthetic valve leaflet is coupled, the cylindrical section configured to be deployed such that a ventricular end of the cylindrical section is disposed within the ventricle of the subject,

[0182] a plurality of chordae tendinae recruitment arms configured to extend radially at least from the ventricular end of the cylindrical section and to bend relative to a longitudinal axis of the valve holder in a given circumferential bending direction;

[0183] deploying the chordae tendinae recruitment arms in the chordae tendinae of the native atrioventricular valve by releasing the chordae tendinae recruitment arms from the delivery device;

[0184] subsequently rotating the valve holder circumferentially in a direction opposite to the circumferential bending direction of the chordae tendinae recruitment arms; and

[0185] further subsequently rotating the valve holder circumferentially in the circumferential bending direction of the chordae tendinae recruitment arms thereby pulling the native atrioventricular valve (a) radially inward toward the valve holder and (b) twisting about the valve holder by recruiting and deflecting at least a portion of the chordae tendinae.

[0186] A more complete understanding of the present application will be afforded to those skilled in the art upon consideration of the following detailed description of the application taken in conjunction with the accompanying drawings, in which: BRIEF DESCRIPTION OF DRAWINGS

[0187] FIG. 1A ,FIG. 1B and FIG. 1C are schematic views of respective views of a frame according to some applications of the present invention, the frame being configured to support a prosthetic valve within a native atrioventricular valve of a subject, the figures showing the frame disposed in a non-radially constrained configuration;

[0188] FIG. 1D are schematic views of a frame according to some applications of the present invention in a non-radially constrained configuration FIG. 1A , FIG. 1B and FIG. 1C showing a valve leaflet attached to the frame and a covering material;

[0189] FIG. 2A and FIG. 2B are schematic views of a frame according to some applications of the present invention fully disposed within a delivery device FIG. 2A and the chordae tendinae gathering arms of the frame in a "rotated configuration" FIG. 2B , FIG. 1A , FIG. 1B and FIG. 1C showing a valve leaflet attached to the frame and a covering material;

[0190] FIG. 3A and FIG. 3B are schematic views of respective views of an atrial portion of a frame according to some applications of the present invention;

[0191] FIG. 4A and FIG. 4B are schematic views of top views of an atrial portion and a cylindrical portion of a frame according to respective applications of the present invention;

[0192] FIG. 5A are schematic views of side views of a cylindrical portion of a frame according to some applications of the present invention;

[0193] FIG. 5B are schematic views of an atrial portion of a frame coupled to a cylindrical portion of a frame according to some applications of the present invention;

[0194] FIG. 6A are schematic views of a chordae tendinae gathering arm of a frame according to some applications of the present invention;

[0195] FIG. 6B are schematic views of a chordae tendinae gathering arm coupled to a cylindrical portion of a frame according to some applications of the present invention FIG. 6A ;

[0196] FIG. 7A and FIG. 7B are schematic views of a frame disposed in a non-radially constrained configuration FIG. 7A and when the lower end of the arm remains within the delivery device but the upper end of the arm has been released from the delivery device FIG. 7Bschematic view of a tendon gathering arm of a frame;

[0197] FIG. 8A , FIG. 8B and FIG. 8C are schematic views of respective views of a frame in its non-radially constrained configuration, in accordance with some applications of the present invention;

[0198] FIG. 9A and FIG. 9B are schematic views of respective views of a frame body of a frame, in accordance with some applications of the present invention;

[0199] FIG. 10A and FIG. 10B are schematic views of an atrial section of a frame, a strut of the atrial section having a wavy pattern, in accordance with some applications of the present invention; and

[0200] FIG. 11A , FIG. 11B , FIG. 11C , FIG. 11D , FIG. 11E and FIG. 11F are schematic views of respective steps of deploying a prosthetic mitral valve through a trans-septal approach, in accordance with some applications of the present invention. DETAILED DESCRIPTION

[0201] Reference is now made to FIG. 1A , FIG. 1B and FIG. 1C , which are schematic views of respective views of a frame 20, showing the frame in its non-radially constrained configuration, in accordance with some applications of the present invention. FIG. 1A a side view of the frame is shown, FIG. 1B a bottom view (i.e., a view from the atrial end of the frame) is shown, FIG. 1C a top view (i.e., a view from the ventricular end of the frame) is shown. Reference is also made to FIG. 1D , which is a schematic view of a frame 20, with valve leaflets 23 coupled to the frame, in accordance with some applications of the present invention.

[0202] Typically, the frame includes a frame body 21. For some applications, the frame body 21 includes a cylindrical section 22 and an atrial section 26. Typically, the cylindrical section is configured to support a prosthetic valve within a native atrioventricular valve. For example, leaflets 23 of a prosthetic valve can be sutured to the cylindrical section, and / or can be coupled to the cylindrical section in other ways, for example, as shown in FIG. 1D Typically, the atrial section 26 is configured to be at least partially deployed within an atrium of a subject. For some applications, the atrial section 26 includes a disc portion 28 (also referred to herein as a flange) and a frustoconical portion 30.

[0203] Typically, the disc portion of the atrial section is configured to seal against the tissue on the atrial side of the annulus of the mitral valve, and is also configured to prevent migration of the frame into the left ventricle. The frustoconical portion typically extends from the disc portion of the atrial section to the outer surface of the cylindrical section. For some applications, including the frustoconical portion between the disc portion and the cylindrical section (as opposed to coupling the disc portion directly to the cylindrical section) reduces the likelihood of regurgitation around the outside of the cylindrical section.

[0204] For some applications, the cylindrical section and the atrial section are formed as separate pieces from one another, and are coupled to one another, for example, by suturing, gluing, welding, and / or other methods. Alternatively, the cylindrical section and the atrial section are portions of a single, unitarily formed piece, for example, as described below with reference to FIG. 8A-FIG. 8C .

[0205] Typically, the frame 20 is made of a shape memory material (e.g., a shape memory alloy, such as Nitinol and / or copper-aluminum-nickel) that is covered on one or both sides with a covering material 32 (as shown, for example, in FIGS. 1 and 2), such as a fabric and / or a polymer (such as expanded polytetrafluoroethylene (ePTFE), or a woven, knitted, mesh, and / or braided polyester). Typically, the shape memory material of the cylindrical section 22 and the atrial section 26 is shaped into a stent-like structure that includes struts and / or cells of shape memory material. The covering material is typically coupled to the shape memory material by sutures 34 (as shown, for example, in FIGS. 1 and 2). Note that, for purposes of illustration, FIG. 1D . FIG. 1D is shown without the valve leaflets 23 and the covering material 32. However, the valve leaflets 23 and the covering material 32 can be observed in FIG. 1A-FIG. 1C . FIG. 3A-FIG. 10B . FIG. 1D .

[0206] For some applications, multiple tendon-harvesting arms 24 (e.g., more than two and / or less than twelve arms) extend from a portion of the frame body 21 that is configured to be placed within a subject's ventricle. For example, four tendon-harvesting arms or six tendon-harvesting arms can extend from the frame body. For some applications, a single tendon-harvesting arm 24 extends from a portion of the frame body 21 that is configured to be placed within a subject's ventricle. Typically, the tendon-harvesting arms extend from the cylindrical section 22 of the frame body 21. Also typically, the tendon-harvesting arms extend from the ventricular end of the cylindrical section (i.e., the end of the frame body that is configured to be placed within the ventricle). Typically, in the non-radially-constrained configuration of the frame (which the frame typically assumes when neither the frame body nor the tendon-harvesting arms are constrained by a delivery device), the arms extend radially from the frame body in addition to extending axially from the ventricular end of the frame body toward the atrial end of the frame body (i.e., the end of the frame body that is configured to be placed within the atrium). Also typically, the arms are curved around the outside of the frame body in a given circumferential direction of curvature.

[0207] As noted in the SUMMARY, the description herein of the arms extending from the frame body in a given direction should not be interpreted as precluding the arms from being oriented in another direction. Rather, the arms are described (or claimed) as extending radially from the frame body should be interpreted as meaning that the orientation of the arms relative to the frame body includes a radial component. Typically, the arms are circumferentially curved in addition to extending radially from the frame body, and in some cases the orientation of the arms includes an axial component. For some applications, at least along a portion of the arms, and at least in certain configurations of the arms, the arms are disposed tangentially relative to the frame body.

[0208] Typically, the frame 20 with the prosthetic valve leaflets 23 disposed therein is delivered to the native atrioventricular valve by a delivery device 40 (e.g., a delivery catheter, as shown in FIG. 2A FIG. 1) and the delivery device is configured to maintain the frame and the prosthetic valve in a radially-constrained configuration (i.e., a "crimped" configuration) during delivery. Depending on the respective application, the frame is delivered transapically (i.e., via the apex of the left ventricle), transseptally (i.e., via the vena cava, right atrium, and interatrial septum, as described in detail with reference to FIG. 11A-FIG. 11F For some applications, the tendon-harvesting arms 24 are deployed in the chords of the native atrioventricular valve when the distal end of the delivery device is disposed within the subject's ventricle. Typically, the tendon-harvesting arms are deployed in the chords of the native atrioventricular valve by releasing the tendon-harvesting arms from the delivery device, the tendon-harvesting arms being configured to extend from the frame body upon release from the delivery device. For some applications, additional techniques are used in order to deploy the tendon-harvesting arms in the chords of the native atrioventricular valve by releasing the tendon-harvesting arms from the delivery device. For example, the frame can include a lever element that is configured to cause the tendon-harvesting arms to extend radially (e.g., as described below with reference toFIG. 7A-FIG. 7B Alternatively or additionally, the arms are coupled to the cylindrical section of the frame by sutures, which act as hinges, such that the arms pivot about the sutures relative to the cylindrical section, as described below. Typically, the chordae-harvesting arms are released from the delivery device while the frame body is still held by the delivery device in the at least partially radially constrained configuration. Typically, the frame is rotated when the chordae-harvesting arms and the frame body are configured in the aforementioned configuration. Accordingly, in the present application, the configuration of the chordae-harvesting arms when the frame body is still held by the delivery device in the at least partially radially constrained configuration but the chordae-harvesting arms have already been released from the delivery device is referred to as the "rotated configuration" of the chordae-harvesting arms.

[0209] Reference is now made to FIG. 2A and FIG. 2B . FIG. 2A is a schematic illustration of a frame 20 according to some applications of the present application, fully disposed within a delivery device 40, which typically includes a proximal sleeve 41 and a front cone 43. FIG. 2B is a schematic illustration of a frame 20 according to some applications of the present application, when the chordae-harvesting arms are disposed in their rotated configuration (i.e., when the chordae-harvesting arms 24 of the frame have been released from the delivery device 40 while the frame body 21 of the frame is still held by the delivery device in the at least partially radially constrained configuration). Note that FIG. 2B shows a delivery device and arms configured for insertion from beneath the mitral valve (e.g., via transapical insertion). For some such applications, in their rotated configuration, the arms extend axially in a distal direction from the distal end of the delivery device (i.e., the end of the delivery device further from the point of insertion of the delivery device into the body of the subject), as shown. For some applications in which the delivery device is inserted from above the mitral valve (e.g., via trans-septal insertion, as described below with reference to FIG. 11A-FIG. 11F Detailed description

[0210] After the chordae-harvesting arms 24 are deployed among the chordae of the native atrioventricular valve (and typically, while the frame body 21 is still held by the delivery device in the at least partially radially constrained configuration, as described above with reference to FIG. 2BAs shown in FIG. 1 1, at least a portion of the frame 20 is rotated, thereby causing the chordal recruitment arms 24 to (a) pull the native atrioventricular valve radially inward toward the frame by gathering and deflecting at least a portion of the chordae tendinae, and (b) twist the native atrioventricular valve about the frame. For some applications, the frame is rotated during ventricular systole, when the native atrioventricular valve is closed, such that the rotation occurs when the chordae tendinae are closest to the frame. Alternatively, the frame is rotated independent of the phase of the subject's cardiac cycle (i.e., without attempting to synchronize the rotation with a particular phase of the subject's cardiac cycle).

[0211] After the frame is rotated, the cylindrical section 22 and the atrial section 26 are typically allowed to radially expand, e.g., by releasing the cylindrical section and the atrial section from the delivery device, such that the frame assumes its non-radially constrained configuration. Typically, the frame is configured to thereby capture the native valve leaflets in the partially closed and twisted configuration, thereby at least partially sealing the space between the native atrioventricular valve and the prosthetic valve. For example, the cylindrical section can be configured to radially expand to capture the native valve leaflets between the cylindrical section and the chordal recruitment arms, and / or the atrial section can be configured to radially expand to capture the native valve leaflets between the atrial section and the chordal recruitment arms.

[0212] Typically, when the arms are deployed in the chordae tendinae (i.e., when the arms are disposed in their rotated configuration), and when the cylindrical section 22 and the atrial section 26 are allowed to radially expand (i.e., the frame assumes its non-radially constrained configuration), the chordal recruitment arms 24 are configured to bend in a given circumferential direction relative to the longitudinal axis of the frame, as described in further detail below. For example, the arms can bend in a clockwise direction or a counterclockwise direction relative to the longitudinal axis of the frame. Typically, after the chordal recruitment arms 24 are deployed in the chordae tendinae of the native atrioventricular valve (and typically, while the frame body 21 is still held in the at least partially radially constrained configuration by the delivery device (i.e., while the arms are disposed in their rotated configuration), as shown in FIG. 1 1 ), the frame is rotated in the same circumferential direction as the circumferential bending direction of the arms. For some applications, the frame is rotated in the opposite circumferential direction prior to rotating the frame in the direction of the circumferential bending of the arms. For example, if the arms bend in a clockwise circumferential direction, then, after the arms are deployed in the chordae tendinae, the frame can first be rotated in a counterclockwise direction, and then can be rotated in a clockwise direction. For some applications, rotating the frame in this manner is more conducive to gathering a greater portion of the chordae tendinae than rotating the frame only in the circumferential bending direction of the arms. FIG. 2B

[0213] ​As noted in the preceding paragraph, for some applications, the petal before being rotated in the same circumferential direction as the circumferential bending direction of the arms is rotated in the opposite circumferential direction. For some applications, the delivery device is configured such that the petal is initially rotated a given angle against the circumferential bending direction of the arms, and subsequently rotated through a predetermined angle in the circumferential bending direction of the arms. For some applications, in the rotated configuration of the chordae-harvesting arms, the outer surface of each arm has a smooth convex curvature that extends substantially along the entire length of the arm, such that during the initial rotation (against the circumferential bending direction of the arms), the chordae slide over the outer surface of the arms without being harvested or captured by the arms. For some applications, due to the arms being shaped in this manner, the initial rotation of the petal results in a relatively large amount of chordae being positioned such that they are harvested by each arm in the subsequent rotation step. During the subsequent rotation of the petal (in the circumferential bending direction of the arms), the chordae are harvested and deflected by the arms. Typically, in the rotated configuration of the chordae-harvesting arms, the inner surface of each arm has a concave curvature, and during the subsequent rotation of the petal, the chordae are harvested within the space defined by the concave curvature.

[0214] Referring again to FIG. 1D For some applications, the covering material 32 defines slits 42. Typically, when the petal 20 is disposed within the delivery device in its radially constrained configuration, the cells of the petal become axially elongated. For some applications, the slits 42 are configured such that the axial elongation of the cells of the petal is permitted without tearing the covering material by extending through the slits with the axially elongated cells. Typically, when the petal is released from the delivery device and assumes its non-radially constrained configuration, the cells reinsert themselves into the slits so as to be covered by the covering material. Note that for the purposes of illustration, in FIG. 1D the non-radially constrained configuration of the petal, the ends of the cells are shown protruding from the slits.

[0215] Referring now to FIG. 3A and FIG. 3B , FIG. 3A and FIG. 3B are schematic illustrations of respective views of the atrial section 26 according to some applications of the present invention. FIG. 3A a three-dimensional side view is shown, FIG. 3BAn overhead view is shown. As noted above, the atrial section 26 is typically configured to be at least partially deployed within the atrium of a subject. For some applications, the atrial section 26 includes a disc-shaped portion 28 (also referred to herein as a flange) and a frustoconical portion 30. The disc-shaped portion is typically configured to rest on the native mitral annulus, and the frustoconical portion extends from the disc-shaped portion of the atrial section to the cylindrical section 22. Typically, the disc-shaped portion of the atrial section is configured to seal against the tissue on the atrial side of the mitral annulus, and is also configured to prevent the valve frame from migrating into the left ventricle. For some applications, the cells of the flange include spring portions 44. The spring portions are configured to provide flexibility to the cells, such that during heart motion, the flange is able to adjust its shape to accommodate changes in the shape of the atrial tissue that the flange contacts. Alternatively or additionally, the cells of the flange provide flexibility due to the undulating pattern of struts of the cells themselves, as described in further detail below with reference to FIG. 10A-FIG. 10B Further detail is described below. For some applications, the inclusion of the frustoconical portion between the disc-shaped portion and the cylindrical section (as opposed to coupling the disc-shaped portion directly to the cylindrical section) reduces the likelihood of regurgitation around the outside of the cylindrical section. Note that according to respective applications, the flange is disposed in a plane that is perpendicular to the longitudinal axis defined by the cylindrical section, or is disposed at an angle to this plane. For example, the flange can define an upward angle or a downward angle relative to a plane that is perpendicular to the longitudinal axis defined by the cylindrical section, to best match the different anatomies around the native atrioventricular valve in the atrium or ventricle.

[0216] For some applications, the frustoconical portion defines holes 50 at the base of at least some of the cells of the frustoconical portion. Typically, these holes are configured to facilitate suturing of the atrial section to the cylindrical section of the valve frame. For some applications, pairs 52 of struts 54 extend from respective cells of the disc-shaped portion 28 of the atrial section. The pairs of struts converge to a point 56. For some applications, the pairs of struts are configured to pierce tissue of the subject's heart (e.g., tissue of the annulus) at the point 56. As noted above, typically, the valve frame is rotated to recruit chordae tendinae of the native valve, and subsequently, the valve frame body is allowed to radially expand. In some cases, the valve frame tends to experience recoil, and to rotate in a direction opposite to its rotation direction. Typically, by piercing the tissue of the subject's heart at the point 56 (and then becoming embedded within the tissue), the pairs of struts are configured to act as anti-recoil elements by preventing the valve frame from rotating in a direction opposite to its rotation direction.

[0217] Reference is now made to FIG. 4A and FIG. 4B which are overhead schematic views of the atrial section 26 and the cylindrical section 22 according to respective applications of the present application. As reference is made to FIG. 3A and FIG. 3BFor some applications, pairs 52 of struts 54 extend from a corresponding cell of the disc portion 28 of the atrial section. Typically, pairs of struts are configured to function as anti-recoil elements by preventing the frame from rotating in a direction opposite to its direction of rotation. For some applications, pairs of struts additionally help anchor the atrial section to autologous tissue.

[0218] As FIG. 4A shown, for some applications, pairs of struts are curved in a circumferential direction relative to the axis of the frame. Typically, the curvature of pairs of struts is configured to facilitate the anti-recoil function by the struts curving to face in a direction in which the frame has a tendency to rotate. For example, in the example shown in FIG. 4A , the frame is configured to initially rotate in a clockwise direction (when viewed from the top, as shown in FIG. 4A ). In some cases, the frame thus has a tendency to recoil and rotate in a counterclockwise direction. The curvature of pairs 52 of struts 54 is such that when the frame begins to rotate in the counterclockwise direction, the points 56 of pairs 52 of struts 54 pierce tissue of the subject's heart (and become at least partially embedded within the tissue), thereby preventing further rotation of the frame.

[0219] Typically, each strut 54 of a given pair 52 is configured to extend from a strut of a corresponding side (i.e., left or right) of a cell of the disc portion 28 of the atrial section. As FIG. 4A shown, for some applications, each strut 54 of a given pair 52 is configured to extend from a strut of a corresponding side of an outer half of a cell of the disc portion 28 of the atrial section. Optionally, as FIG. 4B shown, each strut 54 of a given pair 52 is configured to extend from a strut of a corresponding side (i.e., left or right) of an inner half of a cell of the disc portion 28 of the atrial section.

[0220] For some applications, in addition to being curved (as described with reference to FIG. 4A , pairs 52 of struts 54 are twisted relative to the cell from which they extend. For example, as FIG. 4B shown, strut 58 is coupled to strut 60, which is on the left inner side of a cell of the disc portion 28 of the atrial section. Strut 62 is coupled to strut 64, which is on the right inner side of a cell of the disc portion 28 of the atrial section. Struts 60 and 64 form a junction 66 with one another. Strut 58 is coupled to strut 60 at a location closer to junction 66 than the location of the coupling between strut 62 and strut 64. This results in pairs 52 of struts 58 and 62 being twisted relative to the disc portion 28 of the atrial section. For some applications, the twisting of pairs 52 of struts is configured to facilitate the anti-recoil function of the pair of struts by the struts becoming more deeply embedded within tissue of the subject's heart (in response to the frame beginning to experience recoil) than they would be if the struts did not have the twisted configuration. For some applications, frame 20 does not includeFIG. 4A-FIG. 4B The anti-backlash element.

[0221] Reference is now made to FIG. 5A FIG. 5A is a schematic illustration of a side view of a cylindrical section 22 according to some applications of the present application. Reference is also made to FIG. 5B FIG. 5B is a schematic illustration of an atrial section 26 coupled to the cylindrical section 22 according to some applications of the present application. For some applications, a plurality of struts 61 extend from the outer side of the cylindrical section 22. For some applications, the struts extend from the outer side of the cylindrical section 22 such that the orientation of the struts relative to the cylindrical section has a radial and an axial component. For some applications, along at least a portion of the struts, the struts are disposed tangentially relative to the cylindrical section. Typically, the atrial section is coupled to the cylindrical section by the atrial section being coupled to the extending struts 61. For example, as described above, the frusto-conical portion 30 of the atrial section 26 can define holes 50 at the base of at least some of the cells of the frusto-conical portion. For some applications, the extending struts 61 also define holes 65, and the atrial section is coupled to the cylindrical section by suturing through the holes 50 defined by the atrial section and the corresponding holes 65 defined by the extending struts 61 of the cylindrical section 22. Alternatively or additionally, the atrial section is coupled to the extending struts by other means, for example by welding (such as laser welding), gluing and / or different methods.

[0222] Note that typically, during crimping of the frame, there is a significant amount of strain at the junctions where the extending struts 61 extend from the cylindrical section, as the struts pivot around these junctions. If the atrial section is directly coupled to the cylindrical section at these junctions, then this would mean that the points on the frame where there is relatively large strain are also the points where the two pieces are coupled to each other, which would make the frame susceptible to fatigue at these points. In contrast, since the cylindrical section includes extending struts 61 and the atrial section is coupled to the cylindrical section by the struts, there is a separation between the points of high strain and the points where the atrial section is coupled to the cylindrical section.

[0223] ​​It is also noted that typically the projecting struts project from an axial location along the cylindrical section that is at the lowermost 90% (e.g., lowermost 70%, or lowermost 50%) of the height of the cylindrical section. Typically, the cylindrical section has a height of at least 15 mm in order to accommodate the coupling of the valve leaflets to the cylindrical section. If the projecting struts project from the top of the cylindrical section (or if the atrial section is directly coupled to the cylindrical section at the top of the cylindrical section), then the entire height of the cylindrical section would be disposed below the atrial section. In contrast, because the projecting struts project from the lowermost 90% (e.g., lowermost 70%, or lowermost 50%) of the height of the cylindrical section, there is typically an axial overlap along the height of the cylindrical section between the atrial section and the cylindrical section of the frame. Typically, then, if there is no axial overlap between the atrial section and the cylindrical section of the frame (which results in a smaller portion of the height of the cylindrical section projecting into the subject's ventricle by reducing the ventricular nature of the cylindrical section), this results in less restriction of the left ventricular outflow tract if a larger portion of the height of the cylindrical section projects into the subject's ventricle. In turn (when the frame 20 is configured to be placed within the subject's left ventricle), this typically reduces obstruction of the left ventricular outflow tract relative to if a larger portion of the height of the cylindrical section projects into the subject's ventricle. In this case, it is noted that, as described above, by recruiting and deflecting at least a portion of the native atrioventricular valve chordae tendinae, the chordae tendinae recruiting arms 24 are typically configured to (a) pull the native atrioventricular valve radially inward toward the frame, and (b) twist the native atrioventricular valve around the frame. Typically, recruiting and deflecting the chordae tendinae in this manner serves to prevent obstruction of the left ventricular outflow tract by the portion of the native mitral valve device.

[0224] For some applications (not shown), the atrial section is directly coupled to the cylindrical section (i.e., not via a projecting strut). For example, the atrial section can be directly coupled to the cells and / or cell junctions of the cylindrical section. For some applications, the atrial section is directly coupled to the cylindrical section using sutures. For some such applications, the sutures act as hinges, enabling the atrial section to move relative to the cylindrical section.

[0225] Alternatively, the atrial section is directly coupled to the cylindrical section using a different method, such as welding, gluing, or a different method. Typically, in this case, the coupling is such that there is an axial overlap along the height of the cylindrical section between the atrial section and the cylindrical section of the frame, as described above. That is, typically, the frustoconical portion of the atrial section is coupled to the cylindrical section such that the frustoconical portion of the atrial section extends from an axial location along the cylindrical section that is at the lowermost 90% (e.g., lowermost 70%, or lowermost 50%) of the height of the cylindrical section.

[0226] Reference is now made to FIG. 6A , FIG. 6Ais a schematic view of a tendon recruiting arm 24 of a frame 20 in accordance with some applications of the present application. Reference is also made to FIG. 6B which is a schematic view of a tendon recruiting arm coupled to a cylindrical section 22 of a frame. As described above, for some applications, a plurality of tendon recruiting arms 24 (e.g., more than two and / or less than twelve arms) extend from a portion of the frame body 21 configured to be placed within a subject's ventricle. For example, four tendon recruiting arms or six tendon recruiting arms can extend from the frame body. For some applications, a single tendon recruiting arm 24 extends from a portion of the frame body 21 configured to be placed within a subject's ventricle. Typically, as shown, the tendon recruiting arms extend from a cylindrical section 22 of the frame body 21. FIG. 6B

[0227] For some applications, each tendon recruiting arm 24 is defined by a pair 70 of struts 72 extending from a respective junction at the ventricular end of the cylindrical section 22. Typically, the struts are bent so as to intersect one another and form a junction at the end 74 of the arm. For some applications, all of the tendon recruiting arms are cut from a single piece 76 of shape memory material (e.g., a shape memory alloy such as Nitinol and / or Copper Aluminum Nickel). The piece of shape memory material defining the arms is typically coupled to the cylindrical section of the frame, as described in further detail below. Typically, the arms are covered by a covering material 32 (as shown, for example, in FIG. 2), such as, for example, a fabric and / or a polymer (such as ePTFE and / or polyester). FIG. 2B

[0228] Typically, the tendon recruiting arms 24 of the frame are configured to be released from the delivery device 40 while the frame body 21 of the frame is still held by the delivery device in an at least partially radially constrained configuration, as described above with reference to FIG. 2B In this first configuration of the tendon recruiting arms (herein referred to as the rotated configuration of the tendon recruiting arms), the arms are configured to be deployed among the chords of the native atrioventricular valve, and then by recruiting and deflecting at least a portion of the chords, the arms are configured to (a) pull the native atrioventricular valve radially inwardly toward the frame, and (b) twist the native atrioventricular valve around the frame. Subsequently, by releasing the frame body from the delivery device, the frame body is allowed to assume its non-radially constrained configuration. Typically, the non-radially constrained configuration assumed by the frame body results in a change in the configuration of the tendon recruiting arms from their first configuration (i.e., their rotated configuration) to a second configuration different from the first configuration. In this second configuration, the tendon recruiting arms 24 are configured to trap the chords and / or native valve leaflets between the arms and portions of the frame body. Typically, the second configuration of the arms ensures a secure anchoring of the trapped chords and / or native valve leaflets relative to the frame body and the artificial valve leaflets.

[0229] ​​Typically, the first strut of the pair 70 that includes the chord-harvesting arm is longer than the second strut of the pair of struts. The pair of struts is configured such that when the base of the struts are held together (when the arms are in their rotated configuration), the arms are relatively long and thin such that the arms deploy among and subsequently harvest and deflect a relatively large amount of chordae. For some applications, in this configuration, each arm has a length, measured along the axis of the arm, that is greater than 10 mm (e.g., greater than 20 mm, or greater than 25 mm). Typically, the arms are configured such that when the arms are in the rotated configuration, (a) the arms extend radially from the frame body, (b) the arms extend axially from the ventricular end of the frame body (i.e., the end of the frame body that is configured to be placed within the ventricle) toward the atrial end of the frame body (i.e., the end of the frame body that is configured to be placed within the atrium), and (c) the arms are curved around the outside of the cylindrical section in a given circumferential bending direction. As noted above, for some applications, in their rotated configuration, the chord-harvesting arms are configured to extend radially from the frame and to be curved circumferentially around the frame, but not to extend axially in either the proximal or distal direction. Rather, for such applications, in their rotated configuration, the arms extend in the radial direction from the frame, and the arms are disposed in a single plane in the axial direction.

[0230] Further, as noted above, for some applications, in the rotated configuration of the chord-harvesting arms, the outer surface of each arm has a smooth convex curvature that extends along substantially the entire length of the arm such that during the initial rotation of the frame (against the circumferential bending direction of the arms), chordae slide over the outer surface of the arms without being harvested or caught by the arms, nor damaged by the arms. For some applications, due to the arms being shaped in this way, the initial rotation of the frame results in a relatively large amount of chordae being positioned such that they are harvested by each arm in a subsequent rotation step. During the subsequent rotation of the frame (in the circumferential bending direction of the arms), the chordae are harvested and deflected by the arms. Typically, in the rotated configuration of the chord-harvesting arms, the inner surface of the arms has a concave curvature, and during the subsequent rotation of the frame, the chordae are harvested within the space defined by the concave curvature.

[0231] Typically, the arms are configured such that in the second configuration of the arms (i.e., in the non-radially-constrained configuration of the frame), due to the base of the struts being separated from one another, the arms become shorter and the arms become wider (at least at the base of the arms). Typically, the arms define the three aforementioned curvatures in the second configuration. That is, when the arms assume the second configuration, (a) the arms extend radially from the frame body, (b) the arms extend axially from the ventricular end of the frame body (i.e., the end of the frame body that is configured to be placed within the ventricle) toward the atrial end of the frame body (i.e., the end of the frame body that is configured to be placed within the atrium), and (c) the arms are curved around the outside of the cylindrical section in a given circumferential bending direction.

[0232] Typically, the shape memory material piece 76 defining the chord recruiting arms 24 is sutured to the cylindrical section of the frame at the commissure. For some applications, one of the struts of each arm intersects one of the struts of the adjacent arm at the commissure 78. For some applications, the shape memory material defines a hole 79 at the commissure through which a suture is inserted and which is used to create a suture 82 that sutures the shape memory material to the cylindrical section of the frame body.

[0233] As described above with reference to FIG. 2B Typically, the chord recruiting arms 24 of the frame are configured to be released from the delivery device 40 while the frame body 21 of the frame is still held by the delivery device in an at least partially radially constrained configuration. For some applications, the arms are sutured to the cylindrical section at an axial position of release from the delivery device, even at this stage. For some such applications, the suture serves as a hinge, such that the arms pivot about the suture relative to the cylindrical section. For some applications, this allows the arms to extend radially to a greater distance than if the suture did not provide the aforementioned hinge function. Alternatively or additionally, the frame includes a lever element configured to cause the chord recruiting arms to extend radially, as described below with reference to FIG. 7A-FIG. 7B

[0234] As shown in FIG. 6A and FIG. 6B Typically, the tips 74 of the chord recruiting arms 24 are rounded. Alternatively or additionally, a thickened layer of the covering material 32 (not shown in FIG. 6A-FIG. 6B ) is provided on the tips 74 of the chord recruiting arms, such that the tips of the arms are cushioned. For example, in FIG. 2B a cushioning piece 75 is shown at the tips 74 of the chord recruiting arms. Typically, the rounding of the tips and / or the cushioning of the tips makes the tips of the arms atraumatic. In addition, typically, this facilitates movement and rotation of the arms among the chords of the subject and allows the arms to recruit and deflect the chords without causing damage to the chords or other surrounding tissue. For some applications, the rounding of the tips and / or the cushioning allows the chords to be guided around the tips during rotation of the frame (e.g., bidirectional rotation of the frame described above). For some applications, the use of a thickened layer of the covering material 32 on the tips of the arms (i.e., providing the cushioning piece 75) facilitates fixation of the captured chords and autologous leaflets after release of the frame body from the delivery device.

[0235] For some applications, the covering material 32 (as FIG. 1D ​The various regions of the frame are configured to provide different functionality to the various regions of the frame. For example, regions of the frame that typically contact chordae (such as the chordal recruitment arms and the ventricular rim of the cylindrical portion) are typically covered with low-friction fabric (such as PTFE) to provide low friction relative to the chordae and to allow these portions to move relative to the chordae without damaging tissue. Typically, one or both of the inner and outer surfaces of the chordal recruitment arms are covered with low-friction fabric (such as PTFE) to provide low friction relative to the chordae and to allow these portions to move relative to the chordae without damaging tissue. Other regions of the frame can be covered with fabric that induces tissue ingrowth (e.g., porous fabric) to anchor these regions to the tissue of the subject. These regions typically include portions of the atrial portion 26 and / or the cylindrical portion 22 that contact the native atrioventricular valve leaflets.

[0236] Generally, the chordal recruitment arms typically define (a) a radially constrained configuration when the arms are held in a crimped configuration within a delivery device, and (b) a rotated configuration when the arms are released from the delivery device but the cylindrical portion is held in at least a partially radially constrained configuration by the delivery device, and (c) a fully deployed configuration when the entire frame body including the cylindrical portion and the atrial portion is released from the delivery device. In the rotated configuration, the arms are configured to recruit and deflect chordae. For some applications, in the rotated configuration, the arms are configured to pivot outward relative to the cylindrical portion (e.g., by the sutures 82, lever elements 80) such that the arms encompass a relatively large span, enabling recruitment of a large number of chordae during rotation of the frame. Typically, in this configuration, there is a relatively large gap between the distal ends of the arms and the frame body due to the outward pivoting of the arms relative to the cylindrical portion. Also, typically, in the fully deployed configuration (when the entire frame body including the cylindrical portion and the atrial portion is released from the delivery device), the chordal recruitment arms are configured to be disposed so as to define a relatively small gap G (hereinafter with reference to FIG. 8B the definitions) between the distal ends of the arms and the outer surface of the frame body (e.g., the outer surface of the cylindrical portion), such that leaflets of the native atrioventricular valve and / or chordae are captured between the arms and the frame body (e.g., the outer surface of the cylindrical portion). For some applications, in the fully deployed configuration, the chordal recruitment arms are configured to define spatial pockets P (as FIG. 8B shown) between the inner surfaces of the chordal recruitment arms themselves and the frame body (e.g., the outer surface of the cylindrical portion) due to the concave curvature of the inner surfaces of the arms. Typically, chordae recruited by the arms and / or the tissue of the native valve leaflets are held in these spatial pockets.

[0237] Reference is now made to FIG. 7A-FIG. 7B , FIG. 7A-FIG. 7B is a schematic illustration of a chordal recruitment arm 24 in a non-radially constrained configuration according to some applications of the application FIG. 7A), and a schematic view of the tendon-harvesting arm 24 when the lower end of the arm is held within the delivery device 40 but the upper end of the arm has been released from the delivery device FIG. 7B As with many of the other figures, for purposes of illustration, FIG. 7A-FIG. 7B the tendon-harvesting arm 24 is shown without the covering material 32. For some applications, the shape-memory alloy piece 76 that defines the tendon-harvesting arm 24 defines a lever element 80. The lever element is configured to be held within the delivery device 40 when the arm is set in its rotated configuration in which the arm is configured to deploy in the tendon, then harvest and deflect the tendon. As FIG. 7A illustrated, typically, the lever element is configured to extend at an angle from the base of the arm 24 when the frame is set in its non-radially-constrained configuration. As FIG. 7B illustrated, by being held within the delivery device, the lever element is configured to pivot the arm radially outward. This is indicated by arrows 86 and 88 in FIG. 7A As shown, by moving (or holding) the lever element in the direction of arrow 86, the tip 74 of the arm is configured to pivot radially outward in the direction of arrow 88.

[0238] Reference is now made to FIG. 8A , FIG. 8B and FIG. 8C which are schematic views of respective views of a frame 20 in accordance with some applications of the present application, these figures showing the frame in its non-radially-constrained configuration. As FIG. 8A-FIG. 8C illustrated, certain features of the frame 20 (and also as illustrated in FIG. 9A-FIG. 9B ) differ from the frame 20 described with reference to FIG. 1A-FIG. 7B , these features being described hereinafter. In all other respects, the frame 20 as illustrated in FIG. 8A-FIG. 8C (and also as illustrated in FIG. 9A-FIG. 9B ) is generally similar to the frame 20 described with reference to FIG. 1A-FIG. 7B . Certain dimensions of the frame 20 are described with respect to the frame 20 as illustrated in FIG. 8A-FIG. 8C and FIG. 9A-FIG. 9B . Typically, generally similar dimensions, mutatis mutandis, are applicable to the frame 20 as illustrated in FIG. 1A-FIG. 7B .

[0239] For some applications, the cylindrical section 22 and the atrial section 26 of the frame 20 are made from a single, unitary piece of shape-memory material, as FIG. 8A-FIG. 8C illustrated.

[0240] Reference is made to FIG. 8A-FIG. 8CFor some applications, the frame 20 is configured such that, in the absence of any forces acting on the frame (e.g., in the non-radially constrained configuration of the frame), the height H1 of each chord recruiting arm 24 is greater than 5 mm (e.g., greater than 7 mm), and / or less than 20 mm (e.g., less than 15 mm), e.g., 5-20 mm, or 7-15 mm. For some applications, in this configuration of the frame, the overall height H2 of the frame is greater than 10 mm (e.g., greater than 15 mm), and / or less than 30 mm (e.g., less than 25 mm), e.g., 10-30 mm, or 15-25 mm

[0241] Referring to FIG. 8A and FIG. 8B For some applications, the frame 20 is configured such that, in the absence of any forces acting on the frame (e.g., in the non-radially constrained configuration of the frame), the diameter D1 of the cylindrical section 22 of the frame body 21 is greater than 20 mm (e.g., greater than 25 mm), and / or less than 40 mm (e.g., less than 35 mm), e.g., 20-40 mm, or 25-35 mm. For some applications, in this configuration of the frame, the span S1 defined by the chord recruiting arms is greater than 22 mm (e.g., greater than 26 mm), and / or less than 45 mm (e.g., less than 40 mm), e.g., 22-45 mm, or 26-40 mm. For some applications, in this configuration of the frame, the gap G between the end 74 of each chord recruiting arm 24 and the outer surface of the frame body is greater than 0.1 mm (e.g., greater than 0.5 mm), and / or less than 6 mm (e.g., less than 5 mm), e.g., 0.1-6 mm, or 0.5-5 mm. For some applications, the gap G is between the end of the chord recruiting arm and the cylindrical section. Alternatively or additionally, the gap G is between the end of the chord recruiting arm and the atrial section 26 (e.g., the frustoconical portion 30 of the atrial section 26). Referring to FIG. 8B Typically, in the non-radially constrained configuration of the frame, the chord recruiting arms are configured such that, due to the concave curvature of the inner surface of the arms, a spatial pocket P is defined between the chord recruiting arms themselves and the frame body (e.g., the outer surface of the cylindrical section). Typically, the chordae tendinae recruited by the arms and / or the tissue of the native valve leaflets are held in these spatial pockets. For some applications, the frame is shaped such that, in the non-radially constrained configuration of the frame, there is no gap between the end 74 of each chord recruiting arm 24 and the outer surface of the frame body. For some applications, the arms are preloaded such that the arms exert a force on the outer surface of the frame body, e.g., by the shape setting of the arms (such that, in these applications, the gap G would be less than zero if it were not for the frame blocking the end of the arms).

[0242] Referring again to FIG. 2BFor some applications, when the chord recruiting arms 24 of the frame have been released from the delivery device 40 while the frame body 21 of the frame is still held by the delivery device in an at least partially radially constrained configuration (i.e., when the chord recruiting arms are disposed in their rotated configuration), the chord recruiting arms 24 are configured to define a span S2 that is greater than 20 mm (e.g., greater than 25 mm), and / or less than 40 mm (e.g., less than 35 mm), e.g., 20-40 mm or 25-35 mm.

[0243] Reference is now made to FIG. 9A and FIG. 9B , FIG. 9A and FIG. 9B are schematic illustrations of respective views of the frame body 21 of the frame 20 according to some applications of the present invention. For illustrative purposes, FIG. 9A-FIG. 9B the frame body is shown without the chord recruiting arms 24 of the frame.

[0244] As noted above, typically the frame body 21 is a stent-like structure that includes struts of shape memory material and is shaped to define a generally cylindrical shape. For some applications, a plurality of extensions 90 extend radially from a portion of the frame body that is configured to extend into the atrium. Typically, the extensions are configured to prevent migration of the prosthetic valve and / or the frame into the ventricle of the subject. Alternatively or additionally, the extensions are configured such that when the frame body is radially expanded, the native valve leaflets are captured between the extensions and the chord recruiting arms. For some applications, the extensions are flexible (e.g., the extensions can be shaped as springs, as shown) and are configured to adapt to the shape of the tissue of the mitral annulus on the atrial side of the mitral valve.

[0245] For some applications, the frame 20 is configured such that, in the absence of any force acting on the frame (e.g., in the non-radially constrained configuration of the frame), the atrial section 26 encompasses a radial distance D2 from the outer surface of the cylindrical section 22 that is greater than 5 mm (e.g., greater than 10 mm), and / or less than 25 mm (e.g., less than 20 mm), e.g., 5-25 mm, or 10-20 mm. Reference is again made to FIG. 8B For some applications, in this configuration of the frame, the atrial section 26 is configured to define a span S3 that is greater than 30 mm (e.g., greater than 35 mm) and / or less than 80 mm (e.g., less than 70 mm), e.g., 30-80 mm or 35-70 mm.

[0246] Reference is now made to FIG. 10A and FIG. 10B which are schematic illustrations of the atrial section 26 of the frame 20 according to some applications of the present invention, the struts 92 of which have a wavy pattern. FIG. 10A only the atrial section of the frame is shown,FIG. 10B A top view of the atrial portion of the frame coupled to the cylindrical portion 22 and the chordal recruitment arms 24 is shown. For some applications, the struts of the disc-shaped portion (i.e., flange) 28 of the atrial portion have a wavy pattern as shown. Typically, the wavy struts are configured to provide flexibility to the cells of the flange such that the flange can adjust its shape to accommodate changes in the shape of the tissue of the mitral annulus on the atrial side of the mitral valve with which the flange is in contact. For some applications, the wavy struts are configured to provide better stress and strain distribution to the cells when bent relative to straight struts. For some applications, the cells of the flange have a circumferential curvature such that the outer tips 94 of the cells point in a given circumferential direction. Typically, the circumferential curvature of the cells is in a direction opposite to the circumferential curvature direction of the chordal recruitment arms. For some applications, by defining this circumferential curvature, the cells of the flange are configured to act as an anti-recoil element and prevent the frame from rotating in a direction opposite to its rotation direction.

[0247] Reference is now made to FIG. 11A , FIG. 11B , FIG. 11C , FIG. 11D , FIG. 11E and FIG. 11F which are schematic illustrations of various steps of delivering and deploying a prosthetic mitral valve through a transseptal approach according to some applications of the present application. Typically, the prosthetic mitral valve comprises a frame body as described above, prosthetic valve leaflets 23 are sutured to the cylindrical portion, and / or are otherwise coupled to the cylindrical portion 22 of the frame, e.g., as shown in FIG. 1D . As described above, the prosthetic mitral valve is delivered transseptally (i.e., through the vena cava, right atrium and interatrial septum), transapically (i.e., through the apex of the left ventricle) and / or through different delivery paths according to the respective application. FIG. 11A-FIG. 11F Steps of delivering and deploying a prosthetic mitral valve through a transseptal approach are shown by way of illustration and not limitation.

[0248] Typically, a delivery device 40 (e.g., a delivery catheter) is guided through a guide wire 102 towards the native mitral valve 100 of a subject. As shown in FIG. 11A , the distal end of the delivery device 40 typically enters the left atrium 104 of the subject through the interatrial septum 106. As shown in FIG. 11B , the distal end of the delivery device is advanced towards the native mitral valve and passes through the leaflets 108 of the native mitral valve and into the left ventricle 110. When the distal end of the delivery device is disposed within the left ventricle, the chordal recruitment arms 24 are allowed to at least partially radially expand and assume their rotated configuration, as shown in FIG. 11CAs shown. For some applications, the arm is allowed to be in a non-radially constrained configuration by releasing the arm from the delivery device, for example by partially retracting the proximal cannula 41 and / or by partially advancing the distal anterior cone 43. Typically, in a rotational configuration of the chordae tendineae recruiting arm, the chordae tendineae recruiting arm is shaped to extend radially from the valve frame body 21 and bend circumferentially around the valve frame body (e.g., clockwise, as shown). For some applications, the chordae tendineae recruiting arm is also configured to extend axially toward the atrium of the subject. Typically, the chordae tendineae recruiting arm is configured to be deployed within the chordae tendineae 112 of the autologous mitral valve upon release from the delivery device.

[0249] like FIG. 11D As shown, after the chordae tendineae recruiting arm 24 is deployed in the chordae tendineae of the autologous mitral valve, at least a portion of the valve frame 20 is rotated in the direction of arrow 114, thereby causing the chordae tendineae recruiting arm 24 to (a) pull the autologous atrioventricular valve radially inward toward the valve frame and (b) twist the autologous atrioventricular valve around the valve frame by recruiting and deflecting at least a portion of the chordae tendineae. Typically, the chordae tendineae recruiting arm 24 is configured to bend in a given circumferential direction relative to the longitudinal axis of the valve frame. For example, the arm may bend clockwise or counterclockwise relative to the longitudinal axis of the valve frame. Typically, after the chordae tendineae recruiting arm 24 is deployed in the chordae tendineae of the autologous mitral valve, the valve frame is rotated in the same circumferential direction as the circumferential bending direction of the arm. FIG. 11D In the example shown, the arm bends in a clockwise circumferential direction (viewed from the left atrium 104), and the valve stem rotates in that direction.

[0250] As described above, for some applications, the flap is rotated in the opposite circumferential direction before being rotated in the same circumferential direction as the arm's circumferential bending direction. For some applications, the delivery device 40 is configured such that the automatic execution of the flap initially rotates a given angle against the arm's circumferential bending direction, and then rotates the flap through a predetermined angle along the arm's circumferential bending direction. For some applications, in the arm's rotational configuration (such as...) FIG. 11C-FIG. 11D As shown), the outer surface of each arm has a smooth convex bend extending substantially the entire length of the arm, such that during the initial rotation (opposite to the circumferential bending direction of the arm), the tendineae slide on the outer surface of the arm without being recruited or captured by the arm. For some applications, because the arms are shaped in this way, the initial rotation of the frame results in a relatively large number of tendineae being positioned such that they are recruited by each arm in subsequent rotational steps. During subsequent rotations of the frame (in the circumferential bending direction of the arm, e.g.) FIG. 11D (As shown by arrow 114), the tendineae are attracted and deflected by the arm. Typically, in the rotational configuration of the arm (such as...) FIG. 11C-FIG. 11D As shown), the inner surface of the arm has a concave bend, and during subsequent rotation of the flap, the tendineae are gathered within the space defined by the concave bend.

[0251] After the chordae tendinae recruitment arms 24 have been released and the frame body 21 (i.e. the cylindrical section 22 and the atrial section 26 of the frame) has been rotated, the frame body 21 (i.e. the cylindrical section 22 and the atrial section 26 of the frame) is allowed to assume its non-radially constrained configuration. For some applications, the atrial section is allowed to assume its non-radially constrained configuration by releasing the atrial section from the delivery device, e.g. by retracting the proximal sleeve 41. For some applications, the cylindrical section is allowed to assume its non-radially constrained configuration by releasing the cylindrical section from the delivery device, e.g. by advancing the distal nosecone 43. FIG. 11E The cylindrical section 22 and the atrial section 26 are shown in their non-radially constrained (i.e. radially expanded) configurations. Typically, by the frame body assuming its non-radially constrained configuration, the frame body is configured to capture the native valve leaflets 108 in a partially closed and twisted configuration, thereby at least partially sealing the space between the native mitral valve and the prosthetic valve. For example, the cylindrical section can be configured to radially expand so as to capture the native valve leaflets between the cylindrical section and the chordae tendinae recruitment arms, and / or the atrial section can be configured to radially expand so as to capture the native valve leaflets between the atrial section and the chordae tendinae recruitment arms. For some applications, capturing the native valve leaflets 108 in a partially closed and twisted configuration is achieved by capturing the chordae tendinae (which are attached to the leaflets) in a twisted configuration. After the above steps have been performed, the delivery device 40 will then typically be fully retracted from the subject's left atrium, as indicated by arrow 120 in FIG. 11F

[0252] The devices and methods described herein are typically performed on the subject's mitral valve and / or the subject's tricuspid valve. Although some embodiments of the devices and methods have been described primarily with respect to the mitral valve, the scope of the present invention includes applying any of the devices and methods described above to the tricuspid valve, mutatis mutandis.

[0253] For some applications, the devices and methods described herein are performed in conjunction with the devices and methods described in Raanani's U.S. Patent 2015 / 0173897, which is incorporated herein by reference.

[0254] Those skilled in the art will realize that the present invention is not limited to the specifics set forth in the preceding description and is capable of numerous permutations and combinations of the various features described herein. Accordingly, many modifications and variations will be apparent to those skilled in the art upon reading this disclosure, which is provided by way of example.​

Claims

1. An apparatus for use with a prosthetic valve leaflet configured to be deployed within a native atrioventricular valve disposed between an atrium and a ventricle of a heart of a mammalian subject, the native atrioventricular valve including an annulus, valve leaflets, chordae tendinae, and papillary muscles, the apparatus comprising: a frame configured to support the prosthetic valve within the native atrioventricular valve, the frame including: - an atrial section including a disc-shaped portion configured to be deployed on an atrial side of the annulus; - a cylindrical section to which the prosthetic valve leaflet is coupled, the cylindrical section configured to be deployed such that a ventricular end of the cylindrical section is disposed within the ventricle; - a plurality of chordae tendinae recruitment arms configured to radially extend at least from the ventricular end of the cylindrical section, the plurality of chordae tendinae recruitment arms being coupled to the ventricular end of the cylindrical section by a suture portion, and the suture portion being configured to act as a hinge such that, when the plurality of chordae tendinae recruitment arms are released from a radially constrained configuration, the plurality of chordae tendinae recruitment arms are configured to radially extend outwardly by pivoting about the suture portion relative to the cylindrical section while the cylindrical section is held in at least a partially radially constrained configuration.

2. The apparatus according to claim 1, wherein the atrial section further includes a frustoconical portion, and wherein the frustoconical portion of the atrial section is coupled to the cylindrical section such that there is an axial overlap between at least the frustoconical portion of the atrial section and the cylindrical section.

3. The apparatus according to claim 1, wherein the atrial section further includes a frustoconical portion, wherein the frame further includes a plurality of protruding struts configured to protrude from an outer side of the cylindrical section, and wherein the frustoconical portion of the atrial section is coupled to the cylindrical section by the protruding struts.

4. The apparatus according to any one of claims 1-3, further comprising a delivery device configured to: deliver the frame to the native atrioventricular valve, subsequently, deploy the plurality of chordae tendinae recruitment arms among the chordae tendinae of the native atrioventricular valve, and subsequently, rotate at least a portion of the frame so as to (a) pull the native atrioventricular valve radially inwardly toward the frame and (b) twist the native atrioventricular valve about the frame by recruiting and deflecting at least a portion of the chordae tendinae.

5. The apparatus according to claim 4, wherein: the delivery device is configured to deploy the plurality of chordae tendinae recruitment arms among the chordae tendinae of the native atrioventricular valve while maintaining the cylindrical section in at least a partially radially constrained configuration such that the plurality of chordae tendinae recruitment arms assume a rotated configuration in which the plurality of chordae tendinae recruitment arms radially extend at least from the ventricular end of the cylindrical section and are circumferentially bent about the cylindrical section in a given circumferential direction, and the delivery device is configured to rotate at least the portion of the frame while the plurality of chordae tendinae recruitment arms are disposed in the rotated configuration.

6. The apparatus of claim 5, wherein, after rotating at least the portion of the frame, The delivery device is configured to release the atrial portion and the cylindrical portion of the frame, thereby causing the native atrioventricular valve to be held (a) radially inward toward the frame, and (b) twisted about the frame, by causing at least a portion of the native atrioventricular valve to be captured within the frame.

7. The apparatus of claim 6, wherein, The plurality of chordal recruitment arms are configured to define a pocket when the atrial portion and the cylindrical portion of the frame have been released by the delivery device, and wherein the pocket defined by the plurality of chordal recruitment arms is configured to accommodate the captured portion of the native atrioventricular valve.

8. The apparatus of claim 4, wherein: first, the delivery device is configured to rotate at least the portion of the frame in a circumferential direction opposite a circumferential bending direction of the plurality of chordal recruitment arms; and subsequently, the delivery device is configured to rotate at least the portion of the frame in the circumferential bending direction of the plurality of chordal recruitment arms, thereby causing the plurality of chordal recruitment arms to (a) pull the native atrioventricular valve radially inward toward the frame, and (b) twist the native atrioventricular valve about the frame, by recruiting and deflecting at least the portion of the chordae tendinae.

9. The apparatus of claim 8, wherein, In the rotated configuration of the plurality of chordal recruitment arms: an outer surface of each of the plurality of chordal recruitment arms has a smooth convex curvature extending along substantially an entire length of the chordal recruitment arm, such that chordae tendinae slide over the outer surface of the chordal recruitment arm without being recruited or caught by the chordal recruitment arm during rotation of at least the portion of the frame in a circumferential direction opposite the circumferential bending direction of the plurality of chordal recruitment arms; and an inner surface of each of the plurality of chordal recruitment arms has a concave curvature, such that chordae tendinae are recruited within a space defined by the concave curvature during rotation of at least the portion of the frame in the circumferential bending direction of the plurality of chordal recruitment arms.

10. The apparatus of any one of claims 1-3, wherein the disc-shaped portion of the atrial portion includes struts defining cells, and wherein at least some of the struts have a wavy pattern configured to provide flexibility to the cells of the disc-shaped portion such that the disc-shaped portion can adjust its shape to accommodate changes in the shape of tissue on the atrial side of the annulus.

11. The apparatus of claim 10, wherein the cells of the disc-shaped portion are circumferentially curved such that outer ends of the cells point in a given circumferential direction.

12. The apparatus of claim 11, wherein, The plurality of chordal recruitment arms are configured to be circumferentially curved about the cylindrical portion in a circumferential bending direction opposite the given circumferential direction.

13. An apparatus for use with a prosthetic valve leaflet configured to be deployed within a native atrioventricular valve disposed between an atrium and a ventricle of a heart of a mammalian subject, the native atrioventricular valve including an annulus, valve leaflets, chordae tendinae, and papillary muscles, the apparatus comprising: a frame configured to support the prosthetic valve within the native atrioventricular valve, the frame including: - an atrial portion including a disc-shaped portion and a frustoconical portion, the disc-shaped portion configured to be deployed on an atrial side of the annulus; - a cylindrical portion to which the prosthetic valve leaflets are coupled, the cylindrical portion configured to be deployed such that a ventricular end of the cylindrical portion is disposed within a ventricle; - a plurality of chordal recruitment arms configured to extend radially at least from the ventricular end of the cylindrical portion, the plurality of chordal recruitment arms coupled to the ventricular end of the cylindrical portion by a suture portion, and the suture portion configured to act as a hinge such that when the plurality of chordal recruitment arms are released from a radially constrained configuration, the plurality of chordal recruitment arms are configured to extend radially outward by pivoting about the suture portion relative to the cylindrical portion while the cylindrical portion is held in at least a partially radially constrained configuration, wherein the number of the plurality of chordal recruitment arms is less than twelve; and - a plurality of projecting struts configured to project from an outer side of the cylindrical portion, the frustoconical portion of the atrial portion coupled to the cylindrical portion by the projecting struts.

14. The apparatus of claim 13, wherein, The frustoconical portion of the atrial portion is coupled to the cylindrical portion such that there is axial overlap between at least the frustoconical portion of the atrial portion and the cylindrical portion.

15. The apparatus of claim 13, wherein, The plurality of projecting struts project from an outer side of the cylindrical portion from an axial location along the cylindrical portion that is at a lower 70% of a height of the cylindrical portion.

16. The apparatus of claim 13, wherein, The frustoconical portion of the atrial portion is sutured to the projecting struts.

17. The apparatus of claim 13, wherein, The frustoconical portion of the atrial portion is welded to the projecting struts.

18. The apparatus of claim 13, wherein the frustoconical portion of the atrial portion is glued to the projecting struts.

19. The apparatus of claim 13, wherein, Strain created in a region of the frame where the frustoconical portion of the atrial portion is coupled to the cylindrical portion is reduced relative to if the frustoconical portion of the atrial portion is directly coupled to the cylindrical portion.

20. The apparatus of any of claims 13-19, wherein, The number of the plurality of chordal recruitment arms is four or six.

21. The apparatus of any of claims 13-19, further comprising a delivery device configured to: deliver the frame to an autologous atrioventricular valve, subsequently, deploy the plurality of chordal recruitment arms among chordae tendinae of the autologous atrioventricular valve, and subsequently, rotate at least a portion of the frame so as to pull the autologous atrioventricular valve (a) radially inward toward the frame and (b) twist the autologous atrioventricular valve around the frame by recruiting and deflecting at least a portion of the chordae tendinae.

22. The apparatus of claim 21, wherein a tip of each of the plurality of chordal recruitment arms is rounded so as to guide chordae tendinae around the tip of that chordal recruitment arm without damaging tissue.

23. The apparatus of claim 21, wherein a tip of each of the plurality of chordal recruitment arms is lined so as to guide chordae tendinae around the tip of that chordal recruitment arm without damaging tissue.

24. The apparatus of claim 21, wherein: the delivery device is configured to deploy the plurality of chordal recruiting arms among chordae of a native atrioventricular valve while maintaining the cylindrical section in an at least partially radially constrained configuration such that the plurality of chordal recruiting arms assume a rotated configuration in which the plurality of chordal recruiting arms extend radially at least from the ventricular end of the cylindrical section and are curved circumferentially around the cylindrical section in a given circumferential direction, and the delivery device is configured to rotate at least the portion of the frame while the plurality of chordal recruiting arms are disposed in the rotated configuration.

25. The apparatus of claim 24, wherein, after rotating at least the portion of the frame, the delivery device is configured to release the atrial section and the cylindrical section of the frame, thereby causing the native atrioventricular valve to be held (a) radially inward toward the frame and (b) twisted around the frame by having at least a portion of the native atrioventricular valve captured within the frame.

26. The apparatus of claim 25, wherein, when the atrial section and the cylindrical section of the frame have been released by the delivery device, the plurality of chordal recruiting arms are configured to define a pocket, and wherein the pocket defined by the plurality of chordal recruiting arms is configured to accommodate the captured portion of the native atrioventricular valve.

27. The apparatus of claim 24, wherein: first, the delivery device is configured to rotate at least the portion of the frame in a circumferential direction opposite to a circumferential bending direction of the plurality of chordal recruiting arms; and subsequently, the delivery device is configured to rotate at least the portion of the frame in the circumferential bending direction of the plurality of chordal recruiting arms, thereby causing the plurality of chordal recruiting arms to (a) pull the native atrioventricular valve radially inward toward the frame and (b) twist the native atrioventricular valve around the frame by recruiting and deflecting at least the portion of the chordae.

28. The apparatus of claim 27, wherein, in the rotated configuration of the plurality of chordal recruiting arms: an outer surface of each of the plurality of chordal recruiting arms has a smooth convex curvature extending along substantially an entire length of the chordal recruiting arm such that, during rotation of at least the portion of the frame in a circumferential direction opposite to a circumferential bending direction of the plurality of chordal recruiting arms, chordae slide over the outer surface of the chordal recruiting arm without being recruited or caught by the chordal recruiting arm; and an inner surface of each of the plurality of chordal recruiting arms has a concave curvature such that, during rotation of at least the portion of the frame in the circumferential bending direction of the plurality of chordal recruiting arms, chordae are recruited within a space defined by the concave curvature.

29. The apparatus of any of claims 13-19, wherein the disc-shaped portion of the atrial section includes struts defining cells, and wherein at least some of the struts have a wavy pattern configured to provide flexibility to the cells of the disc-shaped portion such that the disc-shaped portion can adjust its shape to accommodate changes in shape of tissue on an atrial side of an annulus.

30. The apparatus according to claim 29, wherein the cells of the disc-shaped portion are circumferentially curved such that outer ends of the cells point in a given circumferential direction.

31. The apparatus of claim 30, wherein, The plurality of chordal recruitment arms are configured to circumferentially flex about the cylindrical portion in a circumferential flexing direction opposite the given circumferential direction.

32. An apparatus for use with a prosthetic valve leaflet configured to be deployed within a native atrioventricular valve disposed between an atrium and a ventricle of a heart of a mammalian subject, the native atrioventricular valve comprising an annulus, valve leaflets, chords, and papillary muscles, the apparatus comprising: a frame configured to support the prosthetic valve within the native atrioventricular valve, the frame being made of a shape memory material, the frame comprising: - an atrial portion comprising a disc-shaped portion and a frustoconical portion, the disc-shaped portion being configured to be deployed on an atrial side of the annulus; - a cylindrical portion to which the prosthetic valve leaflet is coupled, the cylindrical portion being configured to be deployed such that a ventricular end of the cylindrical portion is disposed within the ventricle; - a plurality of chordal recruitment arms configured to extend radially at least from the ventricular end of the cylindrical portion, the plurality of chordal recruitment arms being coupled to the ventricular end of the cylindrical portion by a suture portion, and the suture portion being configured to act as a hinge such that when the plurality of chordal recruitment arms are released from a radially constrained configuration, the plurality of chordal recruitment arms are configured to extend radially outward by pivoting about the suture portion relative to the cylindrical portion while the cylindrical portion is held in at least a partially radially constrained configuration, - the frustoconical portion of the atrial portion being coupled to the cylindrical portion such that there is an axial overlap between at least the frustoconical portion of the atrial portion and the cylindrical portion.

33. The apparatus according to claim 32, wherein the frame further comprises a plurality of protruding struts configured to protrude from an outer side of the cylindrical portion, the frustoconical portion of the atrial portion being coupled to the cylindrical portion by the protruding struts.

34. The apparatus according to claim 32, wherein the frustoconical portion of the atrial portion is directly coupled to the cylindrical portion.

35. The apparatus according to claim 32, wherein the frustoconical portion of the atrial portion is coupled to the cylindrical portion by suturing.

36. The apparatus according to claim 32, wherein the frustoconical portion of the atrial portion is coupled to the cylindrical portion by welding.

37. The apparatus of claim 32, wherein, The frustoconical portion of the atrial portion is coupled to the cylindrical portion by gluing.

38. The apparatus of any one of claims 32-37, wherein, The frustoconical portion of the atrial portion is coupled to the cylindrical portion such that the frustoconical portion of the atrial portion extends from an axial position along the cylindrical portion, the axial position being at a lowermost 90% of a height of the cylindrical portion.

39. The apparatus of claim 38, wherein, The frusto-conical portion of the atrial section is coupled to the cylindrical section such that the frusto-conical portion of the atrial section extends from an axial location along the cylindrical section that is at least 70% of the height of the cylindrical section.

40. The apparatus of claim 39, wherein, The frusto-conical portion of the atrial section is coupled to the cylindrical section such that the frusto-conical portion of the atrial section extends from an axial location along the cylindrical section that is at least 50% of the height of the cylindrical section.

41. The apparatus according to any of claims 32-37, wherein the shape memory material is a shape memory alloy.

42. The apparatus according to any of claims 32-37, further comprising a delivery device configured to: deliver the frame to a native atrioventricular valve, subsequently, deploy the plurality of chordal recruitment arms among chordae tendinae of the native atrioventricular valve, and subsequently, rotate at least a portion of the frame, thereby causing the plurality of chordal recruitment arms to (a) pull the native atrioventricular valve radially inward toward the frame and (b) twist the native atrioventricular valve around the frame by recruiting and deflecting at least a portion of the chordae tendinae.

43. The apparatus according to claim 42, wherein a tip of each of the plurality of chordal recruitment arms is rounded so as to guide chordae tendinae around the tip of the chordal recruitment arm without damaging tissue.

44. The apparatus according to claim 42, wherein a tip of each of the plurality of chordal recruitment arms is lined so as to guide chordae tendinae around the tip of the chordal recruitment arm without damaging tissue.

45. The apparatus according to claim 42, wherein: the delivery device is configured to deploy the plurality of chordal recruitment arms among chordae tendinae of the native atrioventricular valve while maintaining the cylindrical section in an at least partially radially constrained configuration such that the plurality of chordal recruitment arms assume a rotated configuration in which the plurality of chordal recruitment arms extend radially at least from the ventricular end of the cylindrical section and are circumferentially bent around the cylindrical section in a given circumferential direction, and the delivery device is configured to rotate at least the portion of the frame while the plurality of chordal recruitment arms are disposed in the rotated configuration.

46. The apparatus of claim 45, wherein, after rotating at least the portion of the frame, the delivery device is configured to release the atrial section and the cylindrical section of the frame, thereby causing the native atrioventricular valve to be held (a) radially inward toward the frame and (b) twisted around the frame by having at least a portion of the native atrioventricular valve captured within the frame.

47. The apparatus of claim 46, wherein, when the atrial section and the cylindrical section of the frame have been released by the delivery device, the plurality of chordal recruitment arms are configured to define a pocket, and wherein the pocket defined by the plurality of chordal recruitment arms is configured to accommodate the captured portion of the native atrioventricular valve.

48. The apparatus according to claim 45, wherein: first, the delivery device is configured to rotate at least the portion of the frame in a circumferential direction opposite to a circumferential bending direction of the plurality of chordal recruitment arms; and Subsequently, the delivery device is configured to rotate at least the portion of the valvette in the circumferential bending direction of the plurality of chordal arms, thereby causing the plurality of chordal arms to (a) pull the native atrioventricular valve radially inward toward the valvette and (b) twist the native atrioventricular valve around the valvette by gathering and deflecting at least the portion of the chordae tendinae.

49. The apparatus of claim 48, wherein, In the rotated configuration of the plurality of chordal arms: the outer surface of each of the plurality of chordal arms has a smooth convex curvature extending along substantially the entire length of the chordal arm, such that chordae tendinae slide over the outer surface of the chordal arm without being gathered or caught by the chordal arm during rotation of at least the portion of the valvette in a circumferential direction opposite the circumferential bending direction of the plurality of chordal arms; and the inner surface of each of the plurality of chordal arms has a concave curvature, such that chordae tendinae are gathered within a space defined by the concave curvature during rotation of at least the portion of the valvette in the circumferential bending direction of the plurality of chordal arms.

50. The apparatus according to any of claims 32-37, wherein the disc-shaped portion of the atrial section includes struts defining cells, and wherein at least some of the struts have a wavy pattern configured to provide flexibility to the cells of the disc-shaped portion such that the disc-shaped portion can adjust its shape to accommodate changes in the shape of tissue on the atrial side of the annulus.

51. The apparatus according to claim 50, wherein the cells of the disc-shaped portion are circumferentially curved such that outer ends of the cells point in a given circumferential direction.

52. The apparatus of claim 51, wherein, the plurality of chordal arms are configured to bend circumferentially around the cylindrical section in a circumferential bending direction opposite the given circumferential direction.

53. An apparatus for use with a prosthetic valve leaflet configured to be deployed within a native atrioventricular valve disposed between an atrium and a ventricle of a heart of a mammalian subject, the native atrioventricular valve including an annulus, valve leaflets, chordae tendinae, and papillary muscles, the apparatus comprising: a valvette configured to support the prosthetic valve within the native atrioventricular valve, the valvette including: - an atrial section including a flange configured to be deployed on an atrial side of the annulus and a frustoconical portion; a cylindrical section to which the prosthetic valve leaflet is coupled, the cylindrical section configured to be deployed such that a ventricular end of the cylindrical section is disposed within the ventricle; a plurality of chordal arms configured to extend radially at least from the ventricular end of the cylindrical section, the plurality of chordal arms being coupled to the ventricular end of the cylindrical section by a suture portion, and the suture portion being configured to act as a hinge such that when the plurality of chordal arms are released from a radially constrained configuration, the plurality of chordal arms are configured to extend radially outward by pivoting about the suture portion relative to the cylindrical section while the cylindrical section is maintained in at least a partially radially constrained configuration, 54. The apparatus according to claim 53, wherein the plurality of chordal arms are configured to bend circumferentially around the cylindrical section in a circumferential bending direction opposite a given circumferential direction in which the cells of the disc-shaped portion point.

55. The apparatus according to claim 53 or 54, wherein the plurality of chordal arms are configured to bend circumferentially around the cylindrical section in a circumferential bending direction opposite a given circumferential direction in which the cells of the disc-shaped portion point, and wherein the plurality of chordal arms are configured to bend circumferentially around the cylindrical section in the circumferential bending direction opposite the given circumferential direction by pivoting about the suture portion relative to the cylindrical section.

56. The apparatus according to any of claims 53-55, wherein the plurality of chordal arms are configured to bend circumferentially around the cylindrical section in a circumferential bending direction opposite a given circumferential direction in which the cells of the disc-shaped portion point, and wherein the plurality of chordal arms are configured to bend circumferentially around the cylindrical section in the circumferential bending direction opposite the given circumferential direction by pivoting about the suture portion relative to the cylindrical section.

57. The apparatus according to any of claims 53-56, wherein the plurality of chordal arms are configured to bend circumferentially around the cylindrical section in a circumferential bending direction opposite a given circumferential direction in which the cells of the disc-shaped portion point, and wherein the plurality of chordal arms are configured to bend circumferentially around the cylindrical section in the circumferential bending direction opposite the given circumferential direction by pivoting about the suture portion relative to the cylindrical section.

58. The apparatus according to any of claims 53-57, wherein the plurality of chordal arms are configured to bend circumferentially around the cylindrical section in a circumferential bending direction opposite a given circumferential direction in which the cells of the disc-shaped portion point, and wherein the plurality of chordal arms are configured to bend circumferentially around the cylindrical section in the circumferential bending direction opposite the given circumferential direction by pivoting about the suture portion relative to the cylindrical section. - wherein the flange comprises struts defining cells, and wherein at least some of the struts have a wavy pattern, the struts being configured to provide flexibility to the cells of the flange so that the flange can adjust its shape to accommodate changes in the shape of tissue on the atrial side of the annulus.

54. The apparatus of claim 53, wherein, The cells of the flange are circumferentially curved so that outer ends of the cells point in a given circumferential direction.

55. The apparatus according to claim 54, wherein the plurality of chordal recruitment arms are configured to be circumferentially curved around the cylindrical portion in a circumferential curvature direction opposite the given circumferential direction.

56. An apparatus for use with a prosthetic valve leaflet configured to be deployed within a native atrioventricular valve disposed between an atrium and a ventricle of a heart of a mammalian subject, the native atrioventricular valve comprising an annulus, valve leaflets, chords, and papillary muscles, the apparatus comprising: a valve frame configured to support the prosthetic valve within the native atrioventricular valve, the valve frame comprising: - an atrial portion comprising a disc-shaped portion and a frustoconical portion, the disc-shaped portion being configured to be deployed on an atrial side of the annulus; - a cylindrical portion to which the prosthetic valve leaflet is coupled, the cylindrical portion being configured to be deployed so that a ventricular end of the cylindrical portion is disposed within the ventricle; - a plurality of chordal recruitment arms configured to extend radially at least from the ventricular end of the cylindrical portion, the plurality of chordal recruitment arms being configured to: -- be coupled to the ventricular end of the cylindrical portion by a suture portion, and the suture portion being configured to act as a hinge so that when the plurality of chordal recruitment arms are released from a radially constrained configuration, the plurality of chordal recruitment arms are configured to extend radially outward by pivoting about the suture portion relative to the cylindrical portion while the cylindrical portion is held in the at least partially radially constrained configuration; and -- be deployed among the chords of the native atrioventricular valve while the cylindrical portion is held in the at least partially radially constrained configuration so that the plurality of chordal recruitment arms assume a rotated configuration in which the plurality of chordal recruitment arms extend radially at least from the ventricular end of the cylindrical portion and are circumferentially curved around the cylindrical portion in a given circumferential direction, wherein in the rotated configuration of the plurality of chordal recruitment arms: --- an outer surface of each of the plurality of chordal recruitment arms has a smooth convex curvature extending along substantially an entire length of that chordal recruitment arm so that during rotation of at least the portion of the valve frame in a circumferential direction opposite the direction of the circumferential curvature of the plurality of chordal recruitment arms, chords slide over the outer surface of that chordal recruitment arm without being recruited or caught by that chordal recruitment arm; and --- an inner surface of each of the plurality of chordal recruitment arms has a concave curvature so that during rotation of at least the portion of the valve frame in the direction of the circumferential curvature of the plurality of chordal recruitment arms, chords are recruited within a space defined by the concave curvature.

57. The apparatus of claim 56, wherein the outer surface of each of the plurality of chord recruiting arms is covered with a low-friction fabric so as to allow the outer surface to move relative to chordae without damaging tissue.

58. The apparatus of claim 56, wherein the inner surface of each of the plurality of chord recruiting arms is covered with a low-friction fabric so as to allow the inner surface to move relative to chordae without damaging tissue.

59. The apparatus of claim 56, wherein the end of each of the plurality of chord recruiting arms is rounded so as to guide chordae around the end of the chord recruiting arm without damaging tissue.

60. The apparatus of claim 56, wherein the end of each of the plurality of chord recruiting arms is padded so as to guide chordae around the end of the chord recruiting arm without damaging tissue.

61. The apparatus of any of claims 56-60, further comprising a delivery device configured to: deliver the frame to a native atrioventricular valve, subsequently, deploy the plurality of chord recruiting arms among chordae of the native atrioventricular valve while maintaining the cylindrical section in the at least partially radially constrained configuration such that the plurality of chord recruiting arms assumes the rotated configuration, and when the plurality of chord recruiting arms are disposed in the rotated configuration: first, rotate at least a portion of the frame in a circumferential direction opposite to a direction of the circumferential curvature of the plurality of chord recruiting arms; and subsequently, rotate at least the portion of the frame in the direction of the circumferential curvature of the plurality of chord recruiting arms, thereby causing the plurality of chord recruiting arms to (a) pull the native atrioventricular valve radially inward toward the frame and (b) twist the native atrioventricular valve around the frame by recruiting and deflecting at least the portion of chordae.

62. The apparatus of claim 61, wherein, after rotating at least the portion of the frame, the delivery device is configured to release the atrial section and the cylindrical section of the frame, thereby causing the native atrioventricular valve to remain (a) radially inward toward the frame and (b) twisted around the frame by having at least a portion of the native atrioventricular valve captured within the frame.

63. The apparatus of claim 62, wherein, when the atrial section and the cylindrical section of the frame have been released by the delivery device, the plurality of chord recruiting arms are configured to define a pocket, and wherein the pocket defined by the plurality of chord recruiting arms is configured to accommodate the captured portion of the native atrioventricular valve.

Images