Posterior positioning type prosthetic mitral valve

Abstract

Apparatuses and methods are described that include a delivery device that delivers a valve frame (120) to a native mitral valve and positions the valve frame (120) such that the center of the valve frame (120) is off-centered with respect to the center of an annular plane of the annulus and is positioned towards a posterior side of the annular plane. The arms (124) of the valve frame (120) are deployed between chordae tendineae of the native mitral valve. The valve frame (120) is rotated to cause the arms (124) to pull the leaflets of the native valve radially inward. The frame body (121) of the valve frame (120) expands radially to capture the native leaflet and cause the valve frame (120) to be deployed off-center with respect to the center of the annular plane. Other applications are also described herein.

Description

Cross Reference to Related Applications

[0001] This application claims priority to U.S. Provisional Patent Application 63 / 451,261 to Shimel, entitled “Positioning of prosthetic mitral valve,” filed March 10, 2023, which is incorporated by reference herein. TECHNICAL FIELD

[0002] The present invention relates to medical devices and methods, and in particular to devices and methods for percutaneously delivering a medical device to a deployment location in a subject, such as an atrioventricular valve. BACKGROUND

[0003] The human heart is a muscular organ that pumps deoxygenated blood through the lungs to oxygenate the blood and to pump the oxygenated blood to other parts of the body through contractions of four chambers.

[0004] After circulating in the body, deoxygenated blood in the body enters the right atrium through the vena cava. In a healthy subject, the right atrium contracts, thereby pumping blood through the tricuspid valve into the right ventricle. The right ventricle contracts, thereby pumping blood through the pulmonary valve into the pulmonary artery, which divides into two branches, one for each lung. The blood is oxygenated as it flows through the lungs and reenters the heart through the left atrium. The left atrium contracts, pumping the oxygenated blood through the mitral valve into the left ventricle. The left ventricle contracts, thereby pumping the oxygenated blood through the aortic valve into the aorta for distribution to other parts of the body. The tricuspid valve closes during right ventricular contraction, thereby preventing backflow of blood into the right atrium. Similarly, the mitral valve closes during left ventricular contraction, thereby preventing backflow of blood into the left atrium. The mitral and tricuspid valves are referred to as atrioventricular valves, each of which controls blood flow between an atrium and a ventricle.

[0005] In the mitral valve, the mitral annulus defines a mitral orifice. Anterior and posterior leaflets extend from the mitral annulus. The leaflets are connected to papillary muscles within the left ventricle by chordae tendinae. During ventricular diastole, in a healthy subject, the left atrium contracts to pump blood through the mitral orifice into the left ventricle. The blood flows through the orifice, pushing the leaflets apart and into the left ventricle with little resistance. In a healthy subject, the leaflets of the aortic valve are held closed by blood pressure in the aorta.

[0006] During ventricular systole, the left ventricle contracts to pump blood through the aortic valve into the aorta, the leaflets of which are pushed open by the blood flow. In healthy subjects, 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 coapted surface that constitutes a seal. The blood pressure in the left ventricle pushes against the ventricular surface of the leaflets, pressing the leaflets tightly together at the coapted surface, thereby forming a tight, leak-proof seal.

[0007] Effective sealing of the mitral valve during ventricular systole depends on a sufficient degree of coaptation. Improper coaptation can result from a number of physical abnormalities that either allow the leaflets to prolapse (e.g., chordae elongation or rupture, or papillary muscle weakness) or prevent coaptation (e.g., chordae shortening, or leaflet smallness). There are also pathologies that cause mitral insufficiency, including collagen vascular disease, ischemic mitral regurgitation (e.g., caused by myocardial infarction, chronic heart failure, or failure / unsuccessful surgical or catheter-based revascularization), leaflet myxomatous degeneration, and rheumatic heart disease. Mitral regurgitation leads to a number of 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.

[0008] There are various medical devices configured to be delivered in a minimally invasive procedure, where a delivery device is used to deliver the device percutaneously (by puncturing the skin) to a deployment location where the device is to be deployed. Many such medical devices are deployed within a subject’s vasculature and / or within the subject’s heart. For example, such medical devices can include prosthetic valves (e.g., prosthetic mitral valves, prosthetic aortic valves, and / or prosthetic tricuspid valves), valve repair devices (e.g., valvuloplasty rings or edge-to-edge devices such as mitral valve leaflet clips), stents, hole closure devices, and / or intravascular simulation devices. Typically, larger medical devices are inserted into a subject’s vasculature via the femoral vein or artery, depending on the deployment location, while smaller devices can also be inserted via the radial vein or artery or another vein or artery. During delivery of the medical device to the deployment location, the medical device is typically maintained in a radially constrained (i.e., crimped) configuration within the delivery device. The medical device radially expands to its deployed configuration when disposed at the deployment location. In some cases, the medical device is configured to self-expand, while in other cases the medical device is radially expanded in an active manner (e.g., via a balloon expansion).

[0009] Various medical devices are configured to be implanted at the atrioventricular valve, such as the mitral valve, and / or within the left ventricle. For example, a prosthetic mitral valve can be deployed to replace the native mitral valve. Alternatively, a mitral valve repair device, such as an annuloplasty ring or a mitral valve leaflet clip, can be used to repair an unhealthy mitral valve. Some such devices are implanted during open surgical procedures. Others are implanted in a minimally invasive procedure, in which a delivery device is used to percutaneously deliver the device to the mitral valve and / or left ventricle. One method of percutaneously delivering a device to the mitral valve and / or left ventricle is the transeptal approach. Using the transeptal approach, the delivery device is typically inserted into the femoral vein, then advanced through the subject's vena cava, and from the vena cava through the right atrium and to the interatrial septum. The delivery device then penetrates the interatrial septum, and is guided from within the left atrium toward the mitral valve.

[0010] Despite the many prosthetic mitral valves and mitral valve repair devices being developed for treating damaged mitral valves, to date there has been no effective transcatheter mitral valve replacement technology, and transcatheter mitral valve repair tends to produce imperfect results. Surgical procedures, whether a mitral valve replacement or repair, have significant side effects and are not suitable for all patients. Moreover, with current treatment modalities, even if mitral regurgitation is corrected, left ventricular function, as measured using parameters such as ejection fraction, tends not to improve, and can even worsen. SUMMARY OF EMBODIMENTS

[0011] According to some applications of the present application, the delivery device is advanced from the subject's vena cava (e.g., via the inferior vena cava or via the superior vena cava) into the subject's right atrium, and from the right atrium via the interatrial septum into the subject's left atrium. The distal end of the delivery device is advanced toward the native mitral valve, and is typically advanced through the leaflets of the native mitral valve and into the left ventricle. Typically, the delivery device is used to deliver a prosthetic mitral valve to be deployed at the subject's native mitral valve.

[0012] For certain applications, the prosthetic mitral valve includes a valve frame having a valve frame body, the valve frame being deployed with a center of the valve frame offset from a center of an annular plane of the annulus, and toward a posterior side of the annular plane. Typically, the prosthetic mitral valve is thereby configured such that blood flow therethrough is offset from the center of the annular plane. Alternatively or additionally, the valve frame body is angularly deployed toward a posterior side of the left ventricle, wherein a plane defined by a ventricular end of the valve frame faces at least partially toward a posterior wall of the left ventricle. Typically, the prosthetic mitral valve is thereby configured such that blood flow therethrough is directed toward the posterior wall of the left ventricle.

[0013] It should be noted that prior art prosthetic mitral valves are typically implanted (via open-heart surgery or via a trans-catheter approach) at the center of the annular plane, such that blood flow through the prosthetic mitral valve is centered with respect to the center of the annular plane. Typically, by deploying the valve frame of the present disclosure at the subject's mitral valve such that the center of the valve frame is positioned toward the posterior side of the annular plane, blood flow from the atrium through the leaflets to the left ventricle is off-center with respect to the center of the annular plane. Blood flow from the atrium to the left ventricle that is off-center with respect to the center of the annular plane results in efficient blood flow from the left ventricle to the aorta (in a manner similar to blood flow through a healthy native mitral valve).

[0014] Typically, by deploying the valve frame of the present disclosure at the subject's mitral valve such that the valve frame is angled toward the posterior side of the left ventricle, where a plane defined by the ventricular end of the valve frame faces at least partially toward the posterior wall of the left ventricle, a majority of blood flow from the atrium to the left ventricle through the leaflets is directed toward the posterior wall of the left ventricle. Blood flow from the atrium to the left ventricle that is directed toward the posterior wall results in efficient blood flow from the left ventricle to the aorta (in a manner similar to blood flow through a healthy native mitral valve).

[0015] For some applications, the subject's native anatomy is used to facilitate one or both of the above techniques. Typically, the valve frame is anchored to the subject's native mitral valve by, among other things, rotating at least a portion of the valve frame to pull the leaflets of the native valve radially inward with the arms, by recruiting at least a portion of the native mitral valve's chordae tendinae, and subsequently, radially expanding the frame body of the valve frame so as to capture the native leaflets. Typically, both the anterior native leaflet and the posterior native leaflet are captured by the valve frame. Due to the posterior leaflet being shorter than the anterior leaflet, in some cases, its anchoring serves as a pivot and results in the valve frame being: (a) deployed off-center with respect to the center of the annular plane, and the valve frame being positioned toward the posterior side of the annular plane, and / or (b) deployed angularly toward the posterior side of the left ventricle, where a plane defined by the ventricular end of the valve frame faces at least partially toward the posterior wall of the left ventricle.

[0016] According to some embodiments of the present invention, there is thus provided an apparatus for use with a prosthetic valve configured to be deployed within a native mitral valve of a mammalian subject, the native mitral valve comprising an annulus, leaflets, chordae tendinae, and papillary muscles, the apparatus comprising: a valve frame configured to support the prosthetic valve within the native mitral valve, the valve frame comprising a frame body and a plurality of arms configured to extend from the frame body; and a delivery device configured to: - deliver the valve frame to the native mitral valve; - positioning the valve frame such that a center of the valve frame is off-center relative to a center of the annular plane of the annulus and is positioned toward a posterior side of the annular plane; - subsequently, deploying the arms between the chords of the native mitral valve; - subsequently, rotating at least a portion of the valve frame so as to cause the arms to pull the leaflets of the native valve radially inward by enlisting at least a portion of the chords of the native mitral valve; and - subsequently, causing the frame body of the valve frame to radially expand so as to capture the native leaflets and cause the valve frame to be deployed in a manner in which a center of the valve frame is off-center relative to a center of the annular plane and is positioned toward a posterior side of the annular plane.

[0017] In some embodiments, the delivery device is configured to use the native posterior leaflet as a pivot to cause the valve frame to be deployed in a manner in which a center of the valve frame is off-center relative to a center of the annular plane and is positioned toward a posterior side of the annular plane.

[0018] In some embodiments, the delivery device is configured to cause blood flowing through the prosthetic valve to be off-center relative to a center of the annular plane by causing the frame body of the valve frame to radially expand so as to cause the valve frame to be deployed in a manner in which a center of the valve frame is off-center relative to a center of the annular plane and is positioned toward a posterior side of the annular plane.

[0019] In some embodiments, the delivery device is configured to position the valve frame such that a center of the valve frame is approximately aligned with a line of coaptation of the native anterior and posterior leaflets of the mitral valve of the subject.

[0020] In some embodiments, the delivery device is configured to cause approximately equal numbers of anterior and posterior chords to be captured when a portion of the valve frame is rotated by positioning the valve frame such that a center of the valve frame is approximately aligned with a line of coaptation of the native anterior and posterior leaflets of the mitral valve of the subject.

[0021] In some embodiments, the delivery device is further configured to: position the valve frame such that the valve frame is angled toward a posterior side of the left ventricle, wherein a plane defined by a ventricular end of the valve frame at least partially faces a posterior wall of the left ventricle; and cause the frame body of the valve frame to radially expand so as to cause the valve frame to be deployed in an angled manner toward a posterior side of the left ventricle, wherein a plane defined by a ventricular end of the valve frame at least partially faces a posterior wall of the left ventricle.

[0022] In some embodiments, the delivery device is configured to radially expand the frame body of the valve frame such that the blood flow through the prosthetic valve is directed toward the posterior wall of the left ventricle.

[0023] In some embodiments, the delivery device is configured to radially expand the frame body of the valve frame such that a plane defined by the ventricular end of the valve frame forms an angle greater than 5 degrees relative to the annular plane.

[0024] In some embodiments, the delivery device is configured to radially expand the frame body of the valve frame such that a plane defined by the ventricular end of the valve frame forms an angle greater than 15 degrees relative to the annular plane.

[0025] In some embodiments, the delivery device is configured to radially expand the frame body of the valve frame such that a plane defined by the ventricular end of the valve frame forms an angle between 5 degrees and 40 degrees relative to the annular plane.

[0026] In some embodiments, the delivery device is configured to radially expand the frame body of the valve frame such that a plane defined by the ventricular end of the valve frame forms an angle between 15 degrees and 25 degrees relative to the annular plane.

[0027] According to some embodiments of the application, there is also provided a method for use with a prosthetic valve configured to be deployed within a native mitral valve of a heart of a mammalian subject, the native mitral valve comprising an annulus, leaflets, chordae tendineae, and papillary muscles, the method comprising: placing a valve frame within the heart of the subject, the valve frame comprising a frame body and a plurality of arms configured to extend from the frame body; positioning the valve frame such that a center of the valve frame is off-center relative to a center of the annular plane of the annulus and is positioned toward a posterior side of the annular plane; subsequently, deploying the arms between the chordae tendineae of the native mitral valve; subsequently, rotating at least a portion of the valve frame to cause the arms to radially pull inward the leaflets of the native valve by recruiting at least a portion of the chordae tendineae of the native mitral valve; and subsequently, radially expanding the frame body of the valve frame so as to capture the native leaflets and such that the valve frame is deployed off-center relative to the center of the annular plane and is positioned toward the posterior side of the annular plane, wherein the valve frame supports the prosthetic valve within the native mitral valve.

[0028] In some embodiments, radially expanding the frame body of the valve frame so that the valve frame is deployed off-center with a center of the valve frame from a center of the annular plane and positioned toward a posterior side of the annular plane includes using the native posterior leaflet as a pivot to radially expand the frame body of the valve frame so that the valve frame is deployed off-center with a center of the valve frame from a center of the annular plane and positioned toward a posterior side of the annular plane.

[0029] In some embodiments, radially expanding the frame body of the valve frame so that the valve frame is deployed off-center with a center of the valve frame from a center of the annular plane and positioned toward a posterior side of the annular plane includes: causing blood flow through the prosthetic valve to be off-center from a center of the annular plane.

[0030] In some embodiments, positioning the valve frame so that a center of the valve frame is off-center from a center of an annular plane of the annulus and positioned toward a posterior side of the annular plane includes positioning the valve frame so that the center of the valve frame is approximately aligned with a line of coaptation of native anterior and posterior leaflets of the subject's mitral valve.

[0031] In some embodiments, positioning the valve frame so that a center of the valve frame is approximately aligned with a line of coaptation of native anterior and posterior leaflets of the subject's mitral valve includes causing approximately equal numbers of anterior and posterior chordae to be captured when portions of the valve frame are rotated.

[0032] In some embodiments, the method further comprises: positioning the valve frame so that the valve frame is angled toward a posterior side of a left ventricle of the subject's heart, wherein a plane defined by a ventricular end of the valve frame faces at least partially toward a posterior wall of the left ventricle; and radially expanding the frame body of the valve frame so that the valve frame is deployed off-center with a center of the valve frame from a center of the annular plane and positioned toward a posterior side of the annular plane includes: causing blood flow through the prosthetic valve to be off-center from a center of the annular plane.

[0033] In some embodiments, radially expanding the frame body of the valve frame so that the valve frame is deployed off-center with a center of the valve frame from a center of the annular plane and positioned toward a posterior side of the annular plane includes: causing blood flow through the prosthetic valve to be off-center from a center of the annular plane.

[0034] In some embodiments, radially expanding the frame body of the valve frame so that the valve frame is deployed off-center with a center of the valve frame from a center of the annular plane and positioned toward a posterior side of the annular plane includes: causing blood flow through the prosthetic valve to be off-center from a center of the annular plane.

[0035] In some embodiments, radially expanding the frame body of the valve frame so that the valve frame is angularly deployed toward the posterior side of the left ventricle includes radially expanding the frame body of the valve frame so that a plane defined by the ventricular end of the valve frame forms an angle greater than 15 degrees relative to the annular plane.

[0036] In some embodiments, radially expanding the frame body of the valve frame so that the valve frame is angularly deployed toward the posterior side of the left ventricle includes radially expanding the frame body of the valve frame so that a plane defined by the ventricular end of the valve frame forms an angle between 5 degrees and 40 degrees relative to the annular plane.

[0037] In some embodiments, radially expanding the frame body of the valve frame so that the valve frame is angularly deployed toward the posterior side of the left ventricle includes radially expanding the frame body of the valve frame so that the plane defined by the ventricular end of the valve frame forms an angle between 15 degrees and 25 degrees relative to the annular plane.

[0038] According to some embodiments of the application, there is also provided an apparatus for use with a prosthetic valve configured to be deployed within a native mitral valve of a mammalian subject, the native mitral valve comprising an annulus, leaflets, chordae tendineae, and papillary muscles, the apparatus comprising: a valve frame configured to support the prosthetic valve within the native mitral valve, the valve frame comprising a frame body and a plurality of arms configured to extend from the frame body; and a delivery device configured to: - deliver the valve frame to the native mitral valve; - position the valve frame so that the valve frame is angularly deployed toward the posterior side of the left ventricle, wherein a plane defined by the ventricular end of the valve frame at least partially faces the posterior wall of the left ventricle; and - subsequently, deploy the arms between the chordae tendineae of the native mitral valve; - subsequently, rotate at least a portion of the valve frame to cause the arms to radially pull inward the leaflets of the native valve by enlisting at least a portion of the chordae tendineae of the native mitral valve; and - subsequently, radially expand the frame body of the valve frame so as to capture the native leaflets and so that the valve frame is angularly deployed toward the posterior side of the left ventricle, wherein a plane defined by the ventricular end of the valve frame at least partially faces the posterior wall of the left ventricle.

[0039] In some embodiments, the delivery device is configured to use the native posterior leaflet as a pivot to angularly deploy the valve frame toward the posterior side of the left ventricle, wherein a plane defined by the ventricular end of the valve frame at least partially faces the posterior wall of the left ventricle.

[0040] In some embodiments, the delivery device is configured to cause the frame body of the valve frame to radially expand such that the valve frame is angularly deployed toward a posterior side of the left ventricle with a plane defined by the ventricular end of the valve frame facing at least partially toward a posterior wall of the left ventricle, causing blood flow through the prosthetic valve to be directed toward the posterior wall of the left ventricle.

[0041] In some embodiments, the delivery device is configured to cause the frame body of the valve frame to radially expand such that a plane defined by the ventricular end of the valve frame forms an angle greater than 5 degrees relative to the annular plane.

[0042] In some embodiments, the delivery device is configured to cause the frame body of the valve frame to radially expand such that a plane defined by the ventricular end of the valve frame forms an angle greater than 15 degrees relative to the annular plane.

[0043] In some embodiments, the delivery device is configured to cause the frame body of the valve frame to radially expand such that a plane defined by the ventricular end of the valve frame forms an angle between 5 degrees and 40 degrees relative to the annular plane.

[0044] In some embodiments, the delivery device is configured to cause the frame body of the valve frame to radially expand such that a plane defined by the ventricular end of the valve frame forms an angle between 15 degrees and 25 degrees relative to the annular plane.

[0045] In some embodiments, the delivery device is further configured to: position the valve frame such that a center of the valve frame is off-center relative to a center of the annular plane of the annulus and is positioned toward a posterior side of the annular plane; and cause the frame body of the valve frame to radially expand such that the valve frame is deployed off-center relative to the center of the annular plane with the center of the valve frame and is positioned toward the posterior side of the annular plane.

[0046] In some embodiments, the delivery device is configured to cause blood flow through the prosthetic valve to be off-center relative to the center of the annular plane by causing the frame body of the valve frame to radially expand such that the valve frame is deployed off-center relative to the center of the annular plane with the center of the valve frame and is positioned toward the posterior side of the annular plane.

[0047] In some embodiments, the delivery device is configured to position the valve frame such that a center of the valve frame is approximately aligned with a line of coaptation of native anterior and posterior leaflets of a mitral valve of the subject.

[0048] In some embodiments, the delivery device is configured to cause approximately equal numbers of anterior and posterior chordae to be captured when portions of the valve frame are rotated by positioning the valve frame such that a center of the valve frame is approximately aligned with a line of coaptation of native anterior and posterior leaflets of a mitral valve of the subject.

[0049] There is also provided, in accordance with some embodiments of the present application, a method for use with a prosthetic valve configured to be deployed within a native mitral valve of a heart of a mammalian subject, the native mitral valve comprising an annulus, leaflets, chordae tendinae and papillary muscles, the method comprising: placing a valve frame within the heart of the subject, the valve frame comprising a valve frame body and a plurality of arms configured to extend from the valve frame body; positioning the valve frame such that the valve frame is angled towards a posterior side of a left ventricle of the heart of the subject, wherein a plane defined by a ventricular end of the valve frame faces at least partially towards a posterior wall of the left ventricle; subsequently, deploying the arms between the chordae tendinae of the native mitral valve; subsequently, rotating at least a portion of the valve frame to cause the arms to pull the leaflets of the native valve radially inward by recruiting at least a portion of the chordae tendinae of the native mitral valve; and subsequently, causing the frame body of the valve frame to radially expand so as to capture the native leaflets and such that the valve frame is deployed angled towards the posterior side of the left ventricle, wherein a plane defined by a ventricular end of the valve frame faces at least partially towards a posterior wall of the left ventricle, wherein the valve frame supports the prosthetic valve within the native mitral valve.

[0050] In some embodiments, causing the frame body of the valve frame to radially expand so that the valve frame is deployed angled towards the posterior side of the left ventricle, wherein a plane defined by a ventricular end of the valve frame faces at least partially towards a posterior wall of the left ventricle, comprises using the native posterior leaflet as a pivot to cause the valve frame to be deployed angled towards the posterior side of the left ventricle, wherein a plane defined by a ventricular end of the valve frame faces at least partially towards a posterior wall of the left ventricle.

[0051] In some embodiments, causing the frame body of the valve frame to radially expand so that the valve frame is deployed angled towards the posterior side of the left ventricle comprises causing blood flow through the prosthetic valve to be directed towards the posterior wall of the left ventricle.

[0052] In some embodiments, causing the frame body of the valve frame to radially expand so that the valve frame is deployed angled towards the posterior side of the left ventricle comprises causing the frame body of the valve frame to radially expand so that a plane defined by a ventricular end of the valve frame forms an angle of greater than 5 degrees with respect to an annular plane.

[0053] In some embodiments, causing the frame body of the valve frame to radially expand so that the valve frame is deployed angled towards the posterior side of the left ventricle comprises causing the frame body of the valve frame to radially expand so that a plane defined by a ventricular end of the valve frame forms an angle of greater than 15 degrees with respect to an annular plane.

[0054] In some embodiments, radially expanding the frame body of the valve frame so that the valve frame is angularly deployed toward the posterior side of the left ventricle includes radially expanding the frame body of the valve frame so that a plane defined by the ventricular end of the valve frame forms an angle of between 5 degrees and 40 degrees relative to the annular plane.

[0055] In some embodiments, radially expanding the frame body of the valve frame so that the valve frame is angularly deployed toward the posterior side of the left ventricle includes radially expanding the frame body of the valve frame so that a plane defined by the ventricular end of the valve frame forms an angle of between 15 degrees and 25 degrees relative to the annular plane.

[0056] In some embodiments, the method further includes: positioning the valve frame so that a center of the valve frame is off-center relative to a center of the annular plane of the annulus and is positioned toward a posterior side of the annular plane; and radially expanding the frame body of the valve frame so that the valve frame is deployed off-center relative to a center of the annular plane of the annulus and is positioned toward a posterior side of the annular plane.

[0057] In some embodiments, radially expanding the frame body of the valve frame so that the valve frame is deployed off-center relative to a center of the annular plane of the annulus and is positioned toward a posterior side of the annular plane includes biasing blood flow through the prosthetic valve off-center relative to the center of the annular plane.

[0058] In some embodiments, positioning the valve frame so that a center of the valve frame is off-center relative to a center of the annular plane of the annulus and is positioned toward a posterior side of the annular plane includes positioning the valve frame so that the center of the valve frame is approximately aligned with a line of coaptation of the native anterior and posterior leaflets of the mitral valve of the subject.

[0059] In some embodiments, positioning the valve frame so that a center of the valve frame is approximately aligned with a line of coaptation of the native anterior and posterior leaflets of the mitral valve of the subject includes causing approximately equal numbers of anterior and posterior chordae to be captured as portions of the valve frame rotate.

[0060] 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 FIG. 1A and FIG. 1B are schematic illustrations showing delivery devices advanced toward the left ventricle of a subject in accordance with some applications of the present application; FIG. 2A , FIG. 2B and FIG. 2Cis a schematic illustration of an inner steerable catheter and an outer steerable catheter of a delivery device according to some applications of the present invention; FIG. 3A and FIG. 3B is a schematic illustration of a capsule of a delivery device according to some applications of the present invention; FIG. 4A , FIG. 4B and FIG. 4C is a schematic illustration of a proximal capsule portion and a distal capsule portion of a delivery device according to some applications of the present invention; FIG. 5 is a schematic illustration of a gantry and handle portion of a delivery device according to some applications of the present invention; FIG. 6A and FIG. 6B is a schematic illustration of a delivery device according to some applications of the present invention; FIG. 7A , FIG. 7B , FIG. 7C and FIG. 7D is a schematic illustration of a valve frame configured to support a prosthetic valve within a subject's native atrioventricular valve according to some applications of the present invention, the illustration showing the valve frame disposed in a non-radially constrained configuration; FIG. 8A , FIG. 8B , FIG. 8C , FIG. 8D and FIG. 8E is a schematic illustration of respective steps of deploying a prosthetic mitral valve via a trans-septal approach according to some applications of the present invention; FIG. 9A is a schematic illustration showing an anterior-posterior cross-section of a subject's left ventricle; FIG. 9B is a schematic illustration of an anterior-posterior cross-section of a subject's left ventricle in which a prosthetic mitral valve frame (which supports valve leaflets) is deployed at the mitral valve such that a center of the valve frame is offset from a center of the annular plane and is positioned towards a posterior side of the annular plane, according to some applications of the present invention; and FIG. 9C is a schematic illustration of an anterior-posterior cross-section of a subject's left ventricle in which a prosthetic mitral valve frame (which supports valve leaflets) is deployed at the mitral valve such that the valve frame is angled towards a posterior side of the left ventricle (i.e., such that the valve leaflets are angled towards a posterior wall of the left ventricle), according to some applications of the present invention. DETAILED DESCRIPTION

[0061] Reference is now made to FIG. 1A and FIG. 1B , FIG. 1A and FIG. 1Bare schematic illustrations showing advancement of a delivery device 20 toward a subject's native mitral valve 46 and / or left ventricle 54 via a transseptal delivery method in accordance with some applications of the present application. As shown in FIG. 1A the distal end of the delivery device 20 is advanced from the subject's vena cava 42 to the subject's right atrium 43 and from the right atrium 43 into the subject's left atrium 50 via the interatrial septum 52. As shown in FIG. 1B the distal end of the delivery device is advanced toward the native mitral valve and is typically advanced through the leaflets 58 of the native mitral valve into the left ventricle 54. For some applications, the delivery device 20 is guided over a guidewire 48 toward the subject's native mitral valve 46. Typically, the delivery device is used to deliver a percutaneously implantable medical device such as a prosthetic mitral valve (e.g., as shown in FIG. 7A to FIG. 8C ), a mitral valve repair device (such as an annuloplasty ring or a mitral valve leaflet clip), a prosthetic chordae, and / or another percutaneously implantable medical device.

[0062] For some applications, the delivery device includes a capsule 40 at its distal end. Typically, during delivery of the medical device to the subject's mitral valve and / or left ventricle, the percutaneously implantable medical device is held within the capsule in a coiled (i.e., radially constrained) configuration. Also, typically, to deploy the device at the subject's mitral valve and / or left ventricle, the medical device is released from the capsule as described in further detail below. For some applications, the medical device is a self-expanding medical device that is configured to radially self-expand upon release from the capsule. For example, the medical device can include a shape memory alloy (such as Nitinol) that is shape set to a desired radially expanded configuration. Alternatively or additionally, the device can be actively radially expanded (e.g., via a balloon) upon release from the capsule. For some applications, a distal portion of the medical device is released from the capsule first and a proximal portion of the medical device is subsequently released from the capsule as described in further detail below.

[0063] Reference is now made to FIG. 2A , FIG. 2B and FIG. 2C , FIG. 2A , FIG. 2B and FIG. 2C are schematic illustrations of the outer steerable catheter 22 and the inner steerable catheter 24 of the delivery device 20 in accordance with some applications of the present application. FIG. 2A and FIG. 2B show side views of the outer steerable catheter and the inner steerable catheter, and FIG. 2C show cross-sectional views of the outer steerable catheter and the inner steerable catheter. As shown in the transition from FIG. 2A to FIG. 2B , typically the inner steerable catheter is axially slidable relative to the outer steerable catheter. Typically, during advancement of the delivery device 20 from the subject's vena cava 42 to the subject's left atrium 50 via the interatrial septum 52 (in FIG. 1A to FIG. 1BDuring the process of entering the left atrium 50 of the subject (shown in cross-section), the distal end of the inner steerable catheter is disposed within the outer steerable catheter, as shown in FIG. 1 1. In addition, generally, once the distal end of the outer steerable catheter is disposed within the left atrium, the inner steerable catheter is pushed out of the distal end of the outer steerable catheter (i.e., the inner steerable catheter is pushed out of the outer steerable catheter's distal end), as shown in FIG. 12. Then, the inner steerable catheter is steered toward the subject's mitral valve and / or left ventricle, as shown in FIG. 13. FIG. 2A In addition, generally, once the distal end of the outer steerable catheter is disposed within the left atrium, the inner steerable catheter is pushed out of the distal end of the outer steerable catheter (i.e., the inner steerable catheter is pushed out of the outer steerable catheter's distal end), as shown in FIG. 12. Then, the inner steerable catheter is steered toward the subject's mitral valve and / or left ventricle, as shown in FIG. 13. FIG. 2B In addition, generally, once the distal end of the outer steerable catheter is disposed within the left atrium, the inner steerable catheter is pushed out of the distal end of the outer steerable catheter (i.e., the inner steerable catheter is pushed out of the outer steerable catheter's distal end), as shown in FIG. 12. Then, the inner steerable catheter is steered toward the subject's mitral valve and / or left ventricle, as shown in FIG. 13.

[0064] For some applications, the outer steerable catheter includes first and second steering deflection cables 26 configured to be operated by a user to steer the distal end of the outer catheter toward the subject's interatrial septum in a first outer steerable catheter deflection plane. Alternatively (embodiments not shown), the outer catheter includes only a single steering deflection cable 26 configured to be operated by a user to steer the distal end of the outer steerable catheter toward the subject's interatrial septum in a first outer steerable catheter deflection plane. Generally, in addition to the one or more steering deflection cables 26, the outer catheter includes a height adjustment deflection cable 28. Generally, the height adjustment deflection cable 28 is configured to be operated by a user to deflect the distal end of the outer steerable catheter from within the left atrium toward the top of the left atrium by steering the tip of the outer steerable catheter in a second outer steerable catheter deflection plane. Generally, the second outer steerable catheter deflection plane is perpendicular to the first outer steerable catheter deflection plane. Thus, the height adjustment deflection cable 28 is generally disposed at a 90 degree angle relative to the steering deflection cable(s) 26, as shown in FIG. 14. FIG. 2C

[0065] For some applications, the steering deflection cable(s) 26 are configured to steer the distal end of the outer steerable catheter through an angle between 0 degrees and greater than 60 degrees or greater than 75 degrees (e.g., 0-90 degrees) in the first outer steerable catheter deflection plane. For some applications, the height adjustment deflection cable 28 is configured to steer the distal end of the outer steerable catheter through an angle between 0 degrees and greater than 30 degrees or greater than 40 degrees (e.g., 0-45 degrees) in the second outer steerable catheter deflection plane to deflect the distal end of the outer steerable catheter from within the left atrium toward the top of the left atrium.

[0066] It is noted that in FIG. 2C each steering deflection cable is shown as being doubled. This is because generally each steering deflection cable travels first along a first path from the proximal end of the catheter to the distal end of the catheter, and then travels along a return path from the distal end of the catheter to the proximal end of the catheter.​

[0067] It is noted that within the left atrium, the inner steerable catheter typically needs to make a turn with a curve of about 90 degrees. This is because the inner steerable catheter is pushed out of the outer steerable catheter after the outer steerable catheter has penetrated the atrial septum. Thus, the tip of the inner steerable catheter is typically pushed from the outer steerable catheter facing in a lateral direction, and must be steered to face in a down- forward direction in order to be advanced toward the mitral valve. Typically, the outer steerable catheter penetrates the atrial septum below the roof of the atrium, as shown (e.g., in a posterior- inferior or posterior-superior position), because the septum is thinner and easier to penetrate at this location. As noted above, the height adjustment deflection cable 28 is configured to be operated by the user to deflect the distal end of the outer steerable catheter from within the left atrium toward the roof of the left atrium. Typically, this provides the inner steerable catheter with more height to make the turn with the curve described above, so that the curve is less sharp, and also provides height for deployment of the capsule over the annulus. FIG. 1A to FIG. 1B

[0068] Typically, the inner steerable catheter 22 includes one or more steering deflection cables 30. For some applications, the inner steerable catheter includes (a) a first set 32 of one or more (e.g., a pair) of steering deflection cables configured to be operated by the user to steer the distal end of the inner steerable catheter in a first inner steerable catheter deflection plane toward the subject’s mitral valve, and (b) a second set 34 of one or more (e.g., a pair) of steering deflection cables configured to be operated by the user to steer the distal end of the inner steerable catheter in a second inner steerable catheter deflection plane, such as to align the distal end of the inner steerable catheter with the subject’s mitral valve.

[0069] For some applications, the first set 32 of steering deflection cables is configured to steer the distal end of the inner steerable catheter in the first inner steerable catheter deflection plane through an angle between 0 degrees and more than 80 degrees or more than 100 degrees (e.g., 120 degrees). For some applications, the second set 34 of steering deflection cables is configured to steer the distal end of the inner steerable catheter in the second inner steerable catheter deflection plane through an angle between at least -45 degrees and +45 degrees, such as to align the distal end of the inner steerable catheter with the subject’s mitral valve. Typically, the set 32 of steering deflection cables is disposed at a 90 degree angle relative to the set 34 of steering deflection cables, as shown. FIG. 2C

[0070] Reference is now made to FIG. 3A and FIG. 3B , FIG. 3A and FIG. 3B ​​is a schematic view of a capsule 40 of a delivery device 20 illustrating some applications of the present application. Generally, during delivery of a medical device to a deployment location (such as the mitral valve and / or left ventricle of a subject), the medical device is held within the capsule in a crimped (i.e., radially constrained) configuration. Further, generally, to deploy the device at the deployment location, the medical device is released from the capsule. It is noted that the capsule as shown in FIG. 3A to FIG. 3B ( and FIG. 4A to FIG. 4C ) can be used with any medical device delivered to a deployment location within a subject in a crimped configuration, and is not limited to use with devices deployed within the mitral valve and / or left ventricle. For example, the capsule as shown in FIG. 3A to FIG. 3B ( and FIG. 4A to FIG. 4C ) can be used with medical devices delivered to the aorta, vena cava, tricuspid valve, right ventricle, right atrium, right ventricle, pulmonary vein, pulmonary artery, etc. of a subject.

[0071] For some applications, the capsule includes a distal capsule portion 60 configured to hold a distal portion of the medical device in a radially constrained configuration during delivery of the medical device to the deployment location, and a proximal capsule portion 62 configured to hold a proximal portion of the medical device in a radially constrained configuration during delivery of the medical device to the deployment location. Generally, the proximal and distal portions can be reversibly coupled to one another, as described in further detail below. For some applications, the capsule additionally includes a tapered distal tip 70 configured to facilitate advancement of the capsule into the vasculature of a subject, and subsequently to serve as a dilator to advance through the atrial septum. Generally, the distal tip is made of a soft material such that the tip is atraumatic and does not cause damage to the subject's tissue during advancement of the delivery device to the deployment location. The distal tip generally allows the system to advance over a guidewire, and the soft material of the distal tip is compliant to the guidewire direction.

[0072] For some applications, the outer shaft 64, the intermediate shaft 66, and the inner shaft 68 are all disposed within the inner steerable catheter 24 (as shown in FIG. 2B to FIG. 2C ). The outer shaft is generally coupled to the proximal capsule portion 62 such that axial movement of the outer shaft relative to the intermediate and inner shafts will transfer axial movement to the proximal capsule portion relative to the intermediate and inner shafts. To release the proximal portion of the medical device from within the proximal capsule portion, the outer shaft is generally withdrawn proximally axially relative to the intermediate and inner shafts, which causes the proximal capsule portion to withdraw from the proximal portion of the medical device. (It is noted that the outer shaft can not be withdrawn, but rather the relative proximal movement of the outer shaft relative to the intermediate and inner shafts is achieved by advancing the intermediate and inner shafts distally relative to the outer shaft.) The inner shaft 68 is typically coupled to the distal capsule portion 60 such that axial movement of the inner shaft imparts axial movement to the distal capsule portion. (Note that rotational movement of the distal capsule portion is typically decoupled from rotational movement of the inner shaft via the bearing mechanism 72, as described below with reference to FIG. 4A to FIG. 4C For some applications, the delivery device includes a distal device engagement portion 74 that is configured to fix the distal portion of the medical device in a fixed axial position relative to the intermediate shaft so long as the distal portion of the medical device remains within the distal capsule portion. For some applications, the distal device engagement portion is a flange that extends radially from the intermediate shaft, as shown. To release the distal portion of the medical device from within the distal capsule portion, the inner shaft is typically advanced axially and distally relative to the intermediate shaft (typically using techniques described below with reference to FIG. 4A to FIG. 4C ). This causes the distal capsule portion to advance distally relative to the distal device engagement portion. Once the proximal end of the distal capsule portion is advanced beyond the distal device engagement portion, the distal portion of the medical device is typically released from the distal device engagement portion (typically via radial self-expansion of the distal portion of the medical device, and / or by another mechanism as described above).

[0073] Reference is now made to FIG. 4A , FIG. 4B and FIG. 4C , FIG. 4A , FIG. 4B and FIG. 4C are schematic illustrations of a proximal capsule portion 62 and a distal capsule portion 60 of a delivery device according to some applications of the present application, in various stages of advancement of the distal capsule portion 60 relative to the proximal capsule portion 62. In some cases, it is desirable to advance the distal capsule portion 60 relative to the proximal capsule portion 62 in a precisely controlled manner. For example, when used with a prosthetic mitral valve frame as shown in FIG. 7A to FIG. 7D , it can be desirable to initially release the intermediate portion of the valve frame (e.g., the radially expandable arms of the valve frame) so that it is not covered by the distal capsule portion, without fully releasing the entire distal portion of the valve frame. Typically, in order to allow the physician to maintain precise control over the advancement of the distal capsule portion 60 relative to the proximal capsule portion 62, the physician uses a rotational control mechanism (e.g., a knob 70) that is coupled to the inner shaft 68, as shown in FIG. 5The mechanism 108 shown converts the rotational motion of the rotational control mechanism into axial motion of the inner shaft 68 (coupled to the distal capsule portion). In some such applications, the conversion from rotational motion to axial motion of the inner shaft 68 is achieved at the distal end of the inner shaft, and typically within the capsule. It should be noted that if the conversion from rotational motion to axial motion of the inner shaft is achieved at the proximal end of the inner shaft 68, the axial motion of the inner shaft will need to be transmitted along its entire length before being transmitted to the distal capsule portion, which may result in inaccurate transmission of the axial motion to the distal capsule portion. In contrast, by converting the rotational motion into axial motion of the inner shaft 68 at the distal end of the inner shaft (according to some applications of the invention), the axial motion does not need to be transmitted along its entire length before being transmitted to the distal capsule portion. Instead, the axial motion is transmitted from within the capsule to the distal capsule portion.

[0074] For some applications, the inner shaft 68 defines a threaded outer surface 76 at its distal end, and the inner surfaces of the distal device engagement 74 (typically a flange as described above) and / or the intermediate shaft 66 are correspondingly threaded. The threaded inner surfaces of the distal device engagement 74 and / or the intermediate shaft 66 act as nuts, such that rotation of the distal end of the inner shaft causes the inner shaft to advance distally relative to the distal device engagement 74. As described above, typically, the distal device engagement 74 secures the distal end of the medical device, and further typically, axial movement of the inner shaft is transmitted to the distal capsule portion. Therefore, advancement of the inner shaft relative to the distal device engagement 74 causes advancement of the distal capsule portion relative to the distal end of the medical device. As described above, for some applications, the distal capsule portion includes a support mechanism 72. The support mechanism is configured to separate the rotational movement of the distal capsule portion from the rotational movement of the inner shaft. Therefore, rotation of the inner shaft causes the distal capsule portion to be advanced distally relative to the distal end of the medical device, but does not cause rotation of the distal capsule portion.

[0075] Typically, once the medical device has been released from capsule 40, the proximal and distal portions of the capsule are recoupled to each other before withdrawal from the subject. For some applications, the capsule includes a guide portion defined by at least one of the distal and proximal capsule portions. The guide portion is configured to guide the distal and proximal capsule portions back to their coupled configuration after the medical device has been deployed. For example, as... FIG. 4B to FIG. 4CAs shown, for some applications, the proximal capsule portion defines a lip 80 at its distal end, and the distal capsule portion defines a corresponding lip 82 at its proximal end, the lips 80 and 82 being shaped to slide into place relative to one another. Alternatively, only one of the capsule portions defines a lip, and the lip is configured to receive the other capsule portion (embodiments not shown). Typically, when the proximal and distal portions are properly coupled to one another, they are shaped to define a substantially smooth outer surface. In this manner, during advancement of the capsule to the medical device deployment location, the capsule is atraumatic and does not cause damage to the subject's tissue. Similarly, during withdrawal of the capsule from the medical device deployment location, the capsule is atraumatic and does not cause damage to the subject's tissue or to the deployed medical device. For some applications, the above-described lip is shaped as a complete ring (as shown). For some applications (not shown), the lip, generally as described above, is divided into a plurality of separate arcuate segments. For example, the lip can be formed of 4 arcuate segments that are spaced 90 degrees apart from one another, and each arcuate segment covers an arc of 30 degrees. In this manner, the medical device can be released before the entire capsule is removed, thus saving the height required to release the medical device.

[0076] FIG. 5 is a schematic view of a gantry 90 and handle portion 92 of a delivery device according to some applications of the present application. For some applications, the handle portion includes a first handle 94 configured to control steering of the outer steerable catheter 22, a second handle 96 configured to control steering of the inner steerable catheter 24, and a deployment handle 98 configured to control release of the medical device from the capsule 40.

[0077] Typically, the first handle 94 includes a first rotary control mechanism 100 for controlling the steering deflection cables 26 that are configured to be operated by the user to steer the distal end of the outer steerable catheter toward the subject's atrial septum in a first outer steerable catheter deflection plane. In addition, typically, the first handle 94 includes a second rotary control mechanism 102 for controlling the height adjustment deflection cable 28 that is configured to be operated by the user to deflect the distal end of the outer steerable catheter from the left atrium toward the roof of the left atrium by steering the tip of the outer steerable catheter in a second outer steerable catheter deflection plane.

[0078] In general, the second handle 96 includes a first rotation control mechanism 104 for controlling a first set 32 of steering deflection cables configured to be operated by a user to steer the distal end of the inner steerable catheter within a first inner steerable catheter deflection plane toward the subject's mitral valve. In addition, in general, the second handle 96 includes a second rotation control mechanism 106 for controlling a second set 34 of steering deflection cables configured to be operated by a user to steer the distal end of the inner steerable catheter within a second inner steerable catheter deflection plane to align the distal end of the inner steerable catheter with the subject's mitral valve.

[0079] As noted above, the deployment handle generally includes a rotation control mechanism 108 for controlling axial movement of the distal capsule portion 60. In addition, in general, the deployment handle includes a second rotation control mechanism 110 for controlling axial movement of the proximal capsule portion 62. In general, the handle portion includes a plurality of flush ports via which respective catheters and shafts are flushed.

[0080] In general, the stand 90 is configured to position and allow adjustment of the position of the handle portion 92. For some applications, the stand is configured to facilitate quick attachment of the handle portion to the stand, e.g., via a snap-lock mechanism, without requiring any screws. For some applications, the stand is configured to facilitate modification of the orientation of the handle portion during a procedure to allow realignment of the handle portion relative to a percutaneous access point.

[0081] Reference is now made to FIG. 6A and FIG. 6B , FIG. 6A and FIG. 6B are schematic illustrations showing delivery devices 20 according to some applications of the present application. Generally, FIG. 6A and FIG. 6B the delivery device 20 shown is similar to the delivery device shown in FIG. 1A to FIG. 5 except for the differences described below. For some applications, the proximal end of the proximal capsule portion 62 defines a recess 118. In general, the recess is sized such that the proximal capsule portion can overlap with the distal end of a delivery catheter (e.g., the inner steerable catheter 24 of the delivery device 20 described above with reference to FIG. 2A to FIG. 2C In general, if there is no such recess, there must be a gap between the distal end of the delivery catheter and the proximal capsule portion in order to enable the proximal capsule portion to be withdrawn relative to the delivery catheter (e.g., in order to release the proximal end of the implantable device). In contrast, when the proximal capsule portion includes the recess 118, the proximal capsule portion is generally disposed in close proximity to the distal end of the delivery catheter, even before the proximal capsule portion is withdrawn (as shown in FIG. 6).FIG. 6A Alternatively, the proximal capsule portion partially overlaps the distal end portion of the delivery catheter, even before the proximal capsule portion is withdrawn (embodiment not shown). Subsequently, as the proximal capsule portion 62 is withdrawn, the proximal end of the proximal capsule portion is overlapped (or further overlapped) with the distal end of the delivery catheter by the recess sliding over the distal end of the delivery catheter. Generally, by eliminating the need for a gap between the distal end of the delivery catheter and the proximal capsule portion, the recess 118 allows the device to occupy less space (e.g., a smaller height) within the left atrium than would otherwise be required.

[0082] Reference is now made to FIG. 7A , FIG. 7B and FIG. 7C which are schematic illustrations of respective views of a valve frame 120 according to some applications of the present application, showing the valve frame in its non-radially constrained configuration. FIG. 7A shows a side view of the valve frame, FIG. 7B shows a bottom view (i.e., a view from the ventricular end of the valve frame), and FIG. 7C shows a top view (i.e., a view from the atrial end of the valve frame). Reference is also made to FIG. 7D which is a schematic illustration of a valve frame 120 according to some applications of the present application, with leaflets 123 coupled to the valve frame.

[0083] Generally, the valve frame includes a valve frame body 121. For some applications, the valve frame body 121 includes a cylindrical section 122 and an atrial section 126. Generally, the cylindrical section is configured to support the prosthetic valve within the native atrioventricular valve. For example, leaflets 123 of the prosthetic valve can be sewn to the cylindrical section, and / or can be coupled to the cylindrical section in other ways, e.g., as shown in FIG. 7D Generally, the atrial section 126 is configured to be at least partially deployed within the atrium of a subject. For some applications, the atrial section 126 includes a disc-shaped portion 128 (also referred to herein as a flange) and a frustoconical portion 130.

[0084] Generally, the disc-shaped portion of the atrial section is configured to seal the valve frame against tissue on the atrial side of the mitral annulus, and is further configured to prevent migration of the valve frame into the left ventricle. The frustoconical portion generally extends from the disc-shaped portion of the atrial section to the outer surface of the cylindrical section. For some applications, including 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.

[0085] 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 shaped piece.

[0086] Generally, the valve frame 120 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 132 (as FIG. 7D shown), such as a fabric and / or a polymer (such as expanded polytetrafluoroethylene (ePTFE), or a woven, knitted, mesh, and / or braided polyester). Generally, the shape memory material of the cylindrical section 122 and the atrial section 126 is shaped into a stent-like structure that includes struts and / or cells of shape memory material. The covering material is generally coupled to the shape memory material by sutures 134 (as FIG. 7D shown). It should be noted that, for illustrative purposes, FIG. 7A to FIG. 7C the valve frame 120 is shown in the absence of the leaflets 123 and the covering material 132. However, the leaflets 123 and the covering material 132 can be observed in FIG. 7D .

[0087] For some applications, a plurality of chordae tendinae recruitment arms 124 (e.g., more than two and / or less than twelve arms) extend from a portion of the valve frame body 121 that is configured to be placed within a ventricle of a subject. For example, four chordae tendinae recruitment arms or six chordae tendinae recruitment arms can extend from the valve frame body. For some applications, a single chordae tendinae recruitment arm 124 extends from a portion of the valve frame body 121 that is configured to be placed within a ventricle of a subject. Generally, the chordae tendinae recruitment arms extend from the cylindrical section 122 of the valve frame body 121. Further, generally, the chordae tendinae recruitment arms extend from a ventricular end of the cylindrical section (i.e., an end of the valve frame body that is configured to be placed within a ventricle). Generally, in a non-radially constrained configuration of the valve frame (the valve frame generally assumes this configuration when neither the valve frame body nor the chordae tendinae recruitment arms are constrained by a delivery device), the arms extend radially from the valve frame body in addition to extending axially from a ventricular end of the valve frame body toward an atrial end of the valve frame body (i.e., an end of the valve frame body that is configured to be placed within an atrium). Further, generally, the arms are curved around an outer side of the valve frame body in a given circumferential direction of curvature.

[0088] It should be noted that the description herein of the arms extending from the valve frame body in a given direction is not to be construed as excluding the arms being oriented in another direction. Rather, the arms are described (or claimed) as extending radially from the valve frame body should be construed as meaning that the orientation of the arms relative to the valve frame body includes a radial component. Often, in addition to extending radially from the valve frame body, the arms are also circumferentially curved, 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 valve frame body.

[0089] Typically, the valve frame 120, in which the prosthetic leaflets 123 are arranged, is delivered to the native atrioventricular valve via a delivery device 20 (typically, a delivery device as described hereinabove) and the delivery device is configured to hold the valve frame and the prosthetic valve in a radially constrained configuration (i.e., a "crimped" configuration) during delivery. Depending on the respective application, the valve frame is delivered transapically (i.e., via the apex of the left ventricle), transseptally (i.e., via the vena cava, the right atrium and the interatrial septum, as described with reference to FIG. 8A to FIG. 8C The detailed description) and / or via a different delivery path. For some applications, the chordae recruiting arms 124 are deployed between the chordae of the native atrioventricular valve when the distal end of the delivery device is disposed within the ventricle of the subject. Typically, the chordae recruiting arms are deployed between the chordae of the native atrioventricular valve by releasing the chordae recruiting arms from the delivery device, the shape of the chordae recruiting arms being set to extend from the valve frame body upon release from the delivery device. For some applications, additional techniques are used in order to deploy the chordae recruiting arms between the chordae of the native atrioventricular valve by releasing the chordae recruiting arms from the delivery device. For example, the valve frame can include a lever element configured to cause the chordae recruiting arms to extend radially. Alternatively or additionally, the arms are coupled to the cylindrical portion of the valve frame by a suture, the suture acting as a hinge such that the arms pivot about the suture relative to the cylindrical portion, as described below. Typically, the chordae recruiting arms are released from the delivery device while the valve frame body is still held in the at least partially radially constrained configuration by the delivery device. Typically, the valve frame is rotated when the chordae recruiting arms and the valve frame body are configured in the aforementioned configuration. Accordingly, in the present application, the configuration of the chordae recruiting arms when the valve frame body is still held in the at least partially radially constrained configuration by the delivery device but the chordae recruiting arms have been released from the delivery device is referred to as the "rotated configuration" of the chordae recruiting arms.

[0090] Reference is now made to FIG. 8A , FIG. 8B , FIG. 8C , FIG. 8D and FIG. 8E, which are schematic illustrations of various steps of delivering and deploying a prosthetic mitral valve through a transseptal approach in accordance with some applications of the present application. Generally, the prosthetic mitral valve includes a valve frame body as described above, prosthetic leaflets 123 sewn to the cylindrical section, and / or otherwise coupled to the cylindrical section 122 of the valve frame, e.g., as FIG. 7D illustrated. As described above, the prosthetic mitral valve is delivered through a transseptal (i.e., through the vena cava, right atrium, and interatrial septum), transapical (i.e., via the apex of the left ventricle), and / or via different delivery paths in accordance with the respective applications. FIG. 8A FIG. 8F illustrates, by way of example and not limitation, steps of delivering and deploying a prosthetic mitral valve through a transseptal approach.

[0091] Generally, the delivery device 20 is guided over a guidewire 202 towards the native mitral valve 200 of a subject. The distal end of the delivery device 20 is generally advanced into the left atrium 204 of the subject via the interatrial septum 206. As FIG. 8A illustrated, the distal end of the delivery device is advanced towards the native mitral valve and through the leaflets 208 of the native mitral valve into the left ventricle 210. When the distal end of the delivery device is disposed within the left ventricle, the chordae recruiting arms 124 are allowed to at least partially radially expand and assume their rotated configuration, as FIG. 8B illustrated. For some applications, the arms are allowed to assume the non-radially constrained configuration by releasing the arms from radial constraint by the delivery device, e.g., by partially retracting the proximal capsule portion 62, and / or by partially advancing the distal capsule portion 60. Generally, upon assuming the rotated configuration of the chordae recruiting arms, the shape of the chordae recruiting arms is set to radially extend from the valve frame body 121 and to circumferentially bend around the valve frame body (e.g., in a clockwise direction as illustrated). For some applications, the chordae recruiting arms are also configured to axially extend towards the atrium of the subject. Generally, the chordae recruiting arms are configured to be deployed between the chordae 212 of the native mitral valve upon release from the delivery device.

[0092] As FIG. 8C illustrated, after the chordae recruiting arms 124 are deployed in the chordae of the native mitral valve, at least a portion of the valve frame is rotated in the direction of the arrow 214, thereby causing the chordae recruiting arms 124 to: (a) pull the native atrioventricular valve radially inward towards the valve frame and (b) twist the native atrioventricular valve around the valve frame by recruiting and deflecting at least a portion of the chordae. Generally, the chordae recruiting arms 124 are configured to bend in a given circumferential direction relative to the longitudinal axis of the valve frame. For example, the arms can bend in a clockwise direction or in a counterclockwise direction relative to the longitudinal axis of the valve frame. Generally, after the chordae recruiting arms 124 are deployed in the chordae of the native mitral valve, the valve frame is rotated in the same circumferential direction as the circumferential bending direction of the arms. In FIG. 8CIn the illustrated example, the arms curve in a clockwise circumferential direction (viewed from the left atrium 204), and the valve frame is rotated in that direction.

[0093] For some applications, the valve frame is rotated in an opposite circumferential direction before the valve frame is rotated in the same circumferential direction as the circumferential curve direction of the arms. For some applications, the delivery device 20 is configured such that the valve frame is initially rotated a given angle against the circumferential curve direction of the arms, and subsequently rotated through a predetermined angle in the circumferential curve direction of the arms. For some applications, in the rotated configuration of the arms (as FIG. 8C to FIG. 8C As illustrated), the outer surface of each arm has a smooth convex curve extending along substantially the entire length of the arm, such that during the initial rotation (opposite the circumferential curve direction of the arms), the chordae are sliding over the outer surface of the arms without being recruited or caught by the arms. For some applications, because the arms are shaped in this way, the initial rotation of the valve frame results in a relatively large number of chordae being positioned such that they are recruited by each arm in the subsequent rotation step. During the subsequent rotation of the valve frame (in the circumferential curve direction of the arms, e.g. FIG. 8C As illustrated by the direction of the arrows 214), the chordae are recruited and deflected by the arms. Typically, in the rotated configuration of the arms (as FIG. 8B to FIG. 8C As illustrated), the inner surface of each arm has a concave curve, and during the subsequent rotation of the valve frame, the chordae are recruited within the space defined by the concave curve.

[0094] After the chordae-receptive arms 124 have been released and the valve frame 120 has been rotated, the valve frame body 121 (i.e. the cylindrical section 122 and the atrial section 126 of the valve frame) is allowed to assume its non-radially constrained configuration. For certain 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 capsule portion 62. 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 capsule portion 60. FIG. 8Dboth the cylindrical section 122 and the atrial section 126 are shown in their non-radially constrained (i.e., radially expanded) configurations. Typically, by assuming its non-radially constrained configuration, the valve frame body is configured to capture the native leaflets 208 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 leaflets between the cylindrical section and the chordae recruiting arms, and / or the atrial section can be configured to radially expand so as to capture the native leaflets between the atrial section and the chordae recruiting arms. For some applications, capturing the native leaflets 208 in a partially closed and twisted configuration is achieved by capturing the chordae (which are attached to the leaflets) in a twisted configuration. After performing the above steps, typically the delivery device 20 will then be fully withdrawn from the subject’s left atrium, as shown in FIG. 8E .

[0095] Reference is now made to FIG. 9A , which is a schematic illustration of an anterior-posterior cross-section of a healthy left ventricle 210 without any implanted devices. As is well known, the anterior leaflet 208A is significantly larger than the posterior leaflet 208P. As a result, the line of coaptation of the leaflets (i.e., the line at which the anterior and posterior leaflets coapt with each other) is off-center with respect to the center 220 of the annular plane and is located at the posterior side of the left ventricle. Typically, the fact that the line of coaptation of the leaflets is off-center with respect to the center 220 of the annular plane results in blood flow from the atrium to the left ventricle being off-center with respect to the center of the annular plane. As shown by the blood flow arrows 222 in FIG. 9A , blood flow from the atrium to the left ventricle is off-center with respect to the center of the annular plane, resulting in efficient blood flow from the left ventricle towards the aorta 224. In addition, the anterior leaflet directs most of the blood flow from the atrium to the left ventricle towards the posterior wall 225, which further results in efficient blood flow from the left ventricle towards the aorta 224.

[0096] Reference is now made to FIG. 9B , which is a schematic illustration of an anterior-posterior cross-section of a subject’s left ventricle according to some applications of the present application, in which a prosthetic mitral valve frame 120 (which supports the leaflets 123) is deployed at the mitral valve such that the center of the valve frame is off-center with respect to the center 220 of the annular plane and is positioned towards the posterior side of the annular plane. It should be noted that prior art prosthetic mitral valves are typically implanted at the center of the annular plane such that blood flow through the prosthetic mitral valve is not off-center with respect to the center of the annular plane. Typically, by deploying the valve frame of the present disclosure at the subject’s mitral valve such that the center of the valve frame is positioned towards the posterior side of the annular plane, blood flow from the atrium to the left ventricle through the leaflets is off-center with respect to the center of the annular plane. As shown by the blood flow arrows 222 in FIG. 9Bblood flow from the atrium to the left ventricle is offset from the center of the annular plane, producing efficient blood flow from the left ventricle toward the aorta 224 (in a manner similar to blood flow through a healthy native mitral valve).

[0097] Reference is now made to FIG. 9C which is a schematic illustration of an anterior-posterior cross-section of a subject's left ventricle, in accordance with some applications of the present application, in which a prosthetic mitral valve frame 120 (which supports leaflets 123) is deployed at the subject's mitral valve such that the valve frame is angled toward the posterior side of the left ventricle (i.e., such that the leaflets open toward the posterior wall of the left ventricle). It is noted that prior art prosthetic mitral valves are typically implanted such that the plane defined by the valve frame is substantially parallel to the annular plane 228, such that blood flow through the prosthetic mitral valve is not directed toward the posterior wall. Typically, by deploying the valve frame of the present disclosure at the subject's mitral valve such that the valve frame is angled toward the posterior side of the left ventricle, a majority of the blood flow through the leaflets from the atrium to the left ventricle is directed toward the posterior wall 225. As FIG. 9C blood flow from the atrium to the left ventricle is directed toward the posterior wall, producing efficient blood flow from the left ventricle toward the aorta 224 (in a manner similar to blood flow through a healthy native mitral valve). For some applications, the valve frame is positioned and deployed angled toward the posterior side of the left ventricle such that the plane 221 defined by the ventricular end of the valve frame faces at least partially toward the posterior wall of the left ventricle. For some applications, the valve frame is angled toward the posterior side of the left ventricle such that the plane 221 defined by the ventricular end of the valve frame forms an angle a relative to the annular plane 228 that is greater than 5 degrees (e.g., greater than 15 degrees) and / or less than 40 degrees (e.g., less than 25 degrees), e.g., 5-40 degrees or 15-25 degrees.

[0098] It is noted that for some applications, the techniques described in reference to FIG. 9B and 9C are incorporated. That is, for some applications, the prosthetic mitral valve frame 120 is deployed at the subject's mitral valve such that (a) the center of the valve frame is offset from the center of the annular plane 220 and is positioned toward the posterior side of the annular plane, and (b) the valve frame is angled toward the posterior side of the left ventricle.

[0099] For some applications, the subject's native anatomy is used to facilitate one or both of the above techniques. As described above, generally, the valve frame is anchored to the subject's native mitral valve by, among other things, rotating at least a portion of the valve frame to pull the leaflets of the native valve radially inward, by recruiting at least a portion of the native mitral valve's chordae tendinae, and subsequently, radially expanding the frame body of the valve frame so as to capture the native leaflets. Generally, both the anterior native leaflet and the posterior native leaflet are captured by the valve frame. Because the posterior leaflet is shorter than the anterior leaflet, in some cases, its anchoring serves as a pivot and causes the valve frame to be: (a) deployed off-center relative to the center of the annular plane, with the valve frame positioned toward the posterior side of the annular plane, and / or (b) angularly deployed toward the posterior side of the left ventricle, with the plane defined by the ventricular end of the valve frame facing at least partially toward the posterior wall of the left ventricle.

[0100] For some applications, the delivery device 20 is configured to position the mitral valve frame relative to the mitral annulus such that the valve frame can be deployed in a position and / or orientation as described in FIG. 9B and / or FIG. 9C For some applications, prior to the step of rotating the valve frame (i.e., as shown in FIG. 8C For some applications, prior to the step of rotating the valve frame (i.e., as shown in

[0101] As described above with reference to the delivery device 20, generally, the inner steerable catheter 24 (as shown in FIG. 2C Generally, the first set 32 of steering deflection cables is configured to steer the distal end of the inner steerable catheter through an angle between 0 degrees and greater than 80 degrees or greater than 100 degrees (e.g., 120 degrees) in a first inner steerable catheter deflection plane. For some applications, the second set 34 of steering deflection cables is configured to steer the distal end of the inner steerable catheter through an angle between -45 degrees and +45 degrees in a second inner steerable catheter deflection plane. For some applications, the second set of steering deflection cables is configured to position the valve frame such that the valve frame is angularly oriented toward the posterior side of the left ventricle (as described with reference to FIG. 9C

[0102] ​Those skilled in the art will realize that the application is not limited to the examples that have been particularly shown and described hereinabove. Rather, the scope of the present application includes combinations and sub-combinations of the various features described above, as well as variations and modifications that will occur to those skilled in the art upon reading the foregoing description, which are not in the prior art.

Claims

1. An apparatus for use with a prosthetic valve configured to be deployed within a native mitral valve of a mammalian subject, the native mitral valve comprising an annulus, leaflets, chordae tendinae, and papillary muscles, the apparatus comprising: a valve frame configured to support the prosthetic valve within the native mitral valve, the valve frame comprising a frame body and a plurality of arms configured to extend from the frame body; and a delivery device configured to: - deliver the valve frame to the native mitral valve; - position the valve frame such that a center of the valve frame is off-center relative to a center of an annular plane of the annulus, and is positioned toward a posterior side of the annular plane; - subsequently deploy the arms between chordae tendinae of the native mitral valve; - subsequently rotate at least a portion of the valve frame to cause the arms to pull leaflets of the native valve radially inward by enlisting at least a portion of the chordae tendinae of the native mitral valve; and - subsequently cause the frame body of the valve frame to radially expand so as to capture the native leaflets, and such that the valve frame is deployed off-center with respect to the center of the annular plane, and is positioned toward the posterior side of the annular plane.

2. The apparatus of claim 1, wherein, the delivery device is configured to use the native posterior leaflet as a pivot to cause the valve frame to be deployed off-center with respect to the center of the annular plane, and is positioned toward the posterior side of the annular plane.

3. The apparatus of claim 1, wherein, the delivery device is configured to cause blood flow through the prosthetic valve to be off-center relative to the center of the annular plane by causing the frame body of the valve frame to radially expand so that the valve frame is deployed off-center with respect to the center of the annular plane, and is positioned toward the posterior side of the annular plane.

4. The apparatus of any one of claims 1-3, wherein, the delivery device is configured to position the valve frame such that a center of the valve frame is approximately aligned with a commissure line of native anterior and posterior leaflets of the mitral valve of the subject.

5. The apparatus of claim 4, wherein, by positioning the valve frame such that a center of the valve frame is approximately aligned with a commissure line of native anterior and posterior leaflets of the mitral valve of the subject, the delivery device is configured to cause approximately equal numbers of anterior and posterior chordae tendinae to be captured when the portion of the valve frame is rotated.

6. The apparatus of any one of claims 1-3, wherein, the delivery device is further configured to: position the valve frame such that the valve frame is angled toward a posterior side of the left ventricle, wherein a plane defined by a ventricular end of the valve frame at least partially faces a posterior wall of the left ventricle; and cause the frame body of the valve frame to radially expand so that the valve frame is deployed angled toward the posterior side of the left ventricle, wherein the plane defined by the ventricular end of the valve frame at least partially faces the posterior wall of the left ventricle.

7. The apparatus of claim 6, wherein, The delivery device is configured to radially expand the frame body of the valve frame such that the plane defined by the ventricular end of the valve frame is angled relative to the annular plane by an angle greater than 5 degrees.

8. The apparatus of claim 6, wherein, The delivery device is configured to radially expand the frame body of the valve frame such that the plane defined by the ventricular end of the valve frame is angled relative to the annular plane by an angle greater than 15 degrees.

9. The apparatus of claim 8, wherein, The delivery device is configured to radially expand the frame body of the valve frame such that the plane defined by the ventricular end of the valve frame is angled relative to the annular plane by an angle greater than 15 degrees.

10. The apparatus of claim 8, wherein, The delivery device is configured to radially expand the frame body of the valve frame such that the plane defined by the ventricular end of the valve frame is angled relative to the annular plane by an angle between 5 degrees and 40 degrees.

11. The apparatus of claim 10, wherein, The delivery device is configured to radially expand the frame body of the valve frame such that the plane defined by the ventricular end of the valve frame is angled relative to the annular plane by an angle between 15 degrees and 25 degrees.

12. A method for use with a prosthetic valve configured to be deployed within a native mitral valve of a heart of a mammalian subject, the native mitral valve comprising an annulus, leaflets, chords, and papillary muscles, the method comprising: placing a valve frame within the heart of the subject, the valve frame comprising a valve frame body and a plurality of arms configured to extend from the valve frame body; positioning the valve frame such that a center of the valve frame is off-center relative to a center of an annular plane of the annulus and is positioned toward a posterior side of the annular plane; subsequently, deploying the arms between the chords of the native mitral valve; subsequently, rotating at least a portion of the valve frame to cause the arms to radially pull inward the leaflets of the native valve by enlisting at least a portion of the chords of the native mitral valve; and subsequently, radially expanding the frame body of the valve frame so as to capture the native leaflets and such that the valve frame is deployed off-center with respect to the center of the annular plane and is positioned toward the posterior side of the annular plane, wherein the valve frame supports the prosthetic valve within the native mitral valve.

13. The method of claim 12, wherein, radially expanding the frame body of the valve frame such that the valve frame is deployed off-center with respect to the center of the annular plane and is positioned toward the posterior side of the annular plane comprises using the native posterior leaflet as a pivot to cause the valve frame to be deployed off-center with respect to the center of the annular plane and is positioned toward the posterior side of the annular plane.

14. The method of claim 12, wherein, radially expanding the frame body of the valve frame such that the valve frame is deployed angled toward a posterior side of a left ventricle, wherein the plane defined by the ventricular end of the valve frame faces at least partially toward a posterior wall of the left ventricle relative to the annular plane.

15. The method of any of claims 12-14, wherein positioning the valve frame is such that a center of the valve frame is off-center relative to a center of the annular plane of the annulus, and is positioned toward a posterior side of the annular plane, comprising: positioning the valve frame such that a center of the valve frame is approximately aligned with a line of coaptation of native anterior and posterior leaflets of a mitral valve of a subject.

16. The method of claim 15, wherein positioning the valve frame such that a center of the valve frame is approximately aligned with a line of coaptation of native anterior and posterior leaflets of a mitral valve of a subject comprises: approximately equal number of anterior and posterior chordae are captured as the portion of the valve frame rotates.

17. The method of any of claims 12-14, further comprising: positioning the valve frame such that the valve frame is angled toward a posterior side of a left ventricle of a heart of a subject, wherein a plane defined by a ventricular end of the valve frame faces at least partially toward a posterior wall of the left ventricle; and radially expanding the frame body of the valve frame such that the valve frame is deployed angled toward a posterior side of a left ventricle, wherein the plane defined by the ventricular end of the valve frame faces at least partially toward a posterior wall of the left ventricle relative to the annular plane.

18. The method of claim 17, wherein, radially expanding the frame body of the valve frame such that the valve frame is deployed angled toward a posterior side of a left ventricle, including causing blood flow through the prosthetic valve to be directed toward a posterior wall of the left ventricle.

19. The method of claim 17, wherein, radially expanding the frame body of the valve frame such that the valve frame is deployed angled toward a posterior side of a left ventricle, including radially expanding the frame body of the valve frame such that the plane defined by the ventricular end of the valve frame forms an angle greater than 5 degrees relative to the annular plane.

20. The method of claim 19, wherein, radially expanding the frame body of the valve frame such that the valve frame is deployed angled toward a posterior side of a left ventricle, including radially expanding the frame body of the valve frame such that the plane defined by the ventricular end of the valve frame forms an angle greater than 15 degrees relative to the annular plane.

21. The method of claim 19, wherein, radially expanding the frame body of the valve frame such that the valve frame is deployed angled toward a posterior side of a left ventricle, including radially expanding the frame body of the valve frame such that the plane defined by the ventricular end of the valve frame forms an angle between 5 degrees and 40 degrees relative to the annular plane.

22. The method of claim 21, wherein, radially expanding the frame body of the valve frame such that the valve frame is deployed angled toward a posterior side of a left ventricle, including radially expanding the frame body of the valve frame such that the plane defined by the ventricular end of the valve frame forms an angle between 15 degrees and 25 degrees relative to the annular plane.

23. An apparatus for use with a prosthetic valve configured to be deployed within a native mitral valve of a mammalian subject, the native mitral valve including an annulus, leaflets, chordae, and papillary muscles, the apparatus comprising: a valve frame configured to support the prosthetic valve within the native mitral valve, the valve frame including a frame body and a plurality of arms configured to extend from the frame body; a valve frame configured to support the prosthetic valve within the native mitral valve, the valve frame including a frame body and a plurality of arms configured to extend from the frame body; And a delivery device configured to: - deliver the valve frame to the native mitral valve; - position the valve frame such that the valve frame is angled towards the posterior side of the left ventricle, wherein a plane defined by the ventricular end of the valve frame faces at least partially towards the posterior wall of the left ventricle; - subsequently, deploy the arms between the chords of the native mitral valve; - subsequently, rotate at least a portion of the valve frame to cause the arms to pull the leaflets of the native valve radially inwards by recruiting at least a portion of the chords of the native mitral valve; And - subsequently, cause the frame body of the valve frame to radially expand so as to capture the native leaflets and cause the valve frame to be deployed angled towards the posterior side of the left ventricle, wherein the plane defined by the ventricular end of the valve frame faces at least partially towards the posterior wall of the left ventricle.

24. The apparatus of claim 23, wherein, The delivery device is configured to use the native posterior leaflet as a pivot to cause the valve frame to be deployed angled towards the posterior side of the left ventricle, wherein the plane defined by the ventricular end of the valve frame faces at least partially towards the posterior wall of the left ventricle.

25. The apparatus of claim 23, wherein, The delivery device is configured to cause the blood flow through the prosthetic valve to be directed towards the posterior wall of the left ventricle by causing the frame body of the valve frame to radially expand so that the valve frame is deployed angled towards the posterior side of the left ventricle, wherein the plane defined by the ventricular end of the valve frame faces at least partially towards the posterior wall of the left ventricle.

26. The apparatus of any one of claims 23-25, wherein, The delivery device is configured to cause the frame body of the valve frame to radially expand such that the plane defined by the ventricular end of the valve frame forms an angle of more than 5 degrees with respect to the annular plane.

27. The apparatus of claim 26, wherein, The delivery device is configured to cause the frame body of the valve frame to radially expand such that the plane defined by the ventricular end of the valve frame forms an angle of more than 15 degrees with respect to the annular plane.

28. The apparatus of claim 26, wherein, The delivery device is configured to cause the frame body of the valve frame to radially expand such that the plane defined by the ventricular end of the valve frame forms an angle of between 5 degrees and 40 degrees with respect to the annular plane.

29. The apparatus of claim 28, wherein, The delivery device is configured to cause the frame body of the valve frame to radially expand such that the plane defined by the ventricular end of the valve frame forms an angle of between 15 degrees and 25 degrees with respect to the annular plane.

30. The apparatus of any of claims 23-25, wherein, The delivery device is further configured to: position the valve frame such that the center of the valve frame is off-center with respect to the center of the annular plane of the annulus and is positioned towards the posterior side of the annular plane; And cause the frame body of the valve frame to radially expand such that the valve frame is deployed off-center with respect to the center of the annular plane and is positioned towards the posterior side of the annular plane.

31. The apparatus of claim 30, wherein, The delivery device is configured to position the valve frame such that a center of the valve frame is approximately aligned with a line of coaptation of native anterior and posterior leaflets of a mitral valve of the subject.

32. The apparatus of claim 30, wherein, The delivery device is configured to position the valve frame such that a center of the valve frame is approximately aligned with a line of coaptation of native anterior and posterior leaflets of a mitral valve of the subject.

33. The apparatus of claim 32, wherein, The delivery device is configured to position the valve frame such that a center of the valve frame is approximately aligned with a line of coaptation of native anterior and posterior leaflets of a mitral valve of the subject.

34. A method for use with a prosthetic valve configured to be deployed within a native mitral valve of a heart of a mammalian subject, the native mitral valve including an annulus, leaflets, chords, and papillary muscles, the method comprising: placing a valve frame within the heart of the subject, the valve frame including a valve frame body and a plurality of arms configured to extend from the valve frame body; positioning the valve frame such that the valve frame is angled toward a posterior side of a left ventricle of the heart of the subject, wherein a plane defined by a ventricular end of the valve frame faces at least partially toward a posterior wall of the left ventricle; subsequently, deploying the arms between chords of the native mitral valve; subsequently, rotating at least a portion of the valve frame to cause the arms to radially pull the leaflets of the native valve inward by recruiting at least a portion of the chords of the native mitral valve; and subsequently, radially expanding the frame body of the valve frame to capture the native leaflets and to cause the valve frame to be deployed angularly toward the posterior side of the left ventricle, wherein the plane defined by the ventricular end of the valve frame faces at least partially toward the posterior wall of the left ventricle, wherein the valve frame supports the prosthetic valve within the native mitral valve.

35. The method of claim 34, wherein, radially expanding the frame body of the valve frame such that the valve frame is angularly deployed toward the posterior side of the left ventricle, wherein the plane defined by the ventricular end of the valve frame faces at least partially toward the posterior wall of the left ventricle, includes using the native posterior leaflet as a pivot to cause the valve frame to be angularly deployed toward the posterior side of the left ventricle, wherein the plane defined by the ventricular end of the valve frame faces at least partially toward the posterior wall of the left ventricle.

36. The method of claim 34, wherein, radially expanding the frame body of the valve frame such that the valve frame is angularly deployed toward the posterior side of the left ventricle, includes causing blood flow through the prosthetic valve to be directed toward the posterior wall of the left ventricle.

37. The method of any one of claims 34-36, wherein, radially expanding the frame body of the valve frame such that the valve frame is angularly deployed toward the posterior side of the left ventricle, includes radially expanding the frame body of the valve frame such that the plane defined by the ventricular end of the valve frame forms an angle greater than 5 degrees relative to an annular plane.

38. The method of claim 37, wherein, radially expanding the frame body of the valve frame such that the plane defined by the ventricular end of the valve frame forms an angle greater than 15 degrees relative to the annular plane.

39. The method of claim 37, wherein, radially expanding the frame body of the valve frame such that the plane defined by the ventricular end of the valve frame forms an angle between 5 degrees and 40 degrees relative to the annular plane.

40. The method of claim 39, wherein, radially expanding the frame body of the valve frame such that the plane defined by the ventricular end of the valve frame forms an angle between 15 degrees and 25 degrees relative to the annular plane.

41. The method of any of claims 34-36, further comprising: positioning the valve frame such that a center of the valve frame is off-center relative to a center of an annular plane of an annulus and is positioned toward a posterior side of the annular plane; and radially expanding the frame body of the valve frame such that the valve frame is deployed off-center relative to a center of the annular plane and is positioned toward a posterior side of the annular plane.

42. The method of claim 41, wherein, radially expanding the frame body of the valve frame such that the valve frame is deployed off-center relative to a center of the annular plane and is positioned toward a posterior side of the annular plane, including: causing blood flow through the prosthetic valve to be off-center relative to the center of the annular plane.

43. The method of claim 41, wherein positioning the valve frame so that a center of the valve frame is off-center relative to a center of an annular plane of an annulus and positioned toward a posterior side of the annular plane comprises: positioning the valve frame such that a center of the valve frame is approximately aligned with a line of coaptation of native anterior and posterior leaflets of a mitral valve of the subject.

44. The method of claim 43, wherein positioning the valve frame such that a center of the valve frame is approximately aligned with a line of coaptation of native anterior and posterior leaflets of a mitral valve of a subject comprises: causing approximately equal numbers of anterior and posterior chordae tendinae to be captured when the portion of the valve frame is rotated. causing approximately equal numbers of anterior and posterior chordae tendinae to be captured when the portion of the valve frame is rotated.

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