Prosthetic mitral valve for posterior positioning

Abstract

Apparatus and methods are described that include a delivery device. The delivery device delivers a valve frame (120) to a native mitral valve and positions the valve frame (120) so that the center of the valve frame (120) is eccentric relative to the center of the annular surface of the valve annulus and positioned near the posterior side of the annular surface. The arms (124) of the valve frame (120) are deployed between the 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) radially expands to capture the leaflets of the native valve, causing the valve frame (120) to be deployed eccentrically relative to the center of the annular surface. Other uses are also described.

Description

[Technical Field]

[0001] (CROSS-REFERENCE TO RELATED APPLICATIONS) This application claims priority to U.S. Provisional Application No. 63 / 451,261 to Shimel, entitled "Positioning of prosthetic mitral valve," filed March 10, 2023, which is incorporated herein by reference.

[0002] The present invention relates to medical devices and methods, and more particularly to devices and methods for percutaneously delivering medical devices, such as atrioventricular valves, to a deployment location within a subject's body. [Background technology]

[0003] The human heart is a muscular organ with four chambers that contract to pump deoxygenated blood to the lungs to oxygenate the blood, and then pump oxygenated blood to the rest of the body.

[0004] After circulating throughout the body, deoxygenated blood from the body enters the right atrium through one or more venae cavae. In healthy individuals, the right atrium contracts and pumps blood into the right ventricle through the tricuspid valve. The right ventricle contracts and pumps blood into the pulmonary artery through the pulmonary semilunar valve. The pulmonary artery divides into two branches, one for each lung. Blood is oxygenated as it passes through the lungs and re-enters the heart through the left atrium. The left atrium contracts and pumps oxygenated blood into the left ventricle through the mitral valve. The left ventricle contracts and pumps oxygenated blood into the aorta through the aortic valve, distributing oxygenated blood to the rest of the body. The tricuspid valve closes during right ventricular contraction, preventing blood from flowing backward into the right atrium. Similarly, the mitral valve closes during left ventricular contraction, preventing blood from flowing backward into the left atrium. The mitral and tricuspid valves are known as atrioventricular valves, and these valves control blood flow between the atria and ventricles, respectively.

[0005] In the mitral valve, the mitral annulus defines the mitral valve opening. Extending from the annulus are anterior and posterior leaflets. These leaflets are connected by chordae tendineae to the papillary muscles in the left ventricle. During ventricular diastole, in a healthy individual, the left atrium contracts, forcing blood into the left ventricle through the mitral valve opening. Blood flows through the opening, with little resistance, pushing the leaflets apart and into the left ventricle. In a healthy individual, the aortic valve leaflets are kept closed by blood pressure in the aorta.

[0006] During ventricular systole, the left ventricle contracts, pumping blood through the aortic valve into the aorta. The aortic valve leaflets are forced apart by blood flow. In healthy individuals, the mitral valve annulus contracts, pushing the leaflets inward and reducing the area of ​​the mitral valve opening by approximately 20% to 30%. The leaflets coapt to accommodate the excess leaflet surface area and create a coaptation surface that forms a seal. Blood pressure within the left ventricle presses against the ventricular surfaces of the leaflets, forcing them together at their coaptation surfaces, creating a leak-proof seal.

[0007] Effective sealing of the mitral valve during ventricular systole depends on adequate coaptation. Inadequate coaptation can be caused by a variety of physical abnormalities that allow leaflet prolapse (e.g., stretched or ruptured chordae or weak papillary muscles) or prevent coaptation (e.g., short chordae or small leaflets). Other pathologies that cause insufficient mitral valve function include collagen disease, ischemic mitral regurgitation (e.g., resulting from myocardial infarction, chronic heart failure, or failed surgical or catheter revascularization), myxomatous degeneration of the valve leaflets, and rheumatic heart disease. Mitral regurgitation can lead to numerous 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] Various medical devices exist that are configured to be delivered in minimally invasive procedures. In minimally invasive procedures, a delivery device is used to deliver the medical device percutaneously (through puncture of the skin) to a deployment location where the medical device is deployed. Many such medical devices are deployed within a subject's vasculature and / or within the subject's heart. For example, such medical devices include prosthetic valves (e.g., prosthetic mitral valves, prosthetic aortic valves, and / or prosthetic tricuspid valves), valve repair devices (e.g., edge-to-edge devices such as annuloplasty rings or mitral valve leaflet clips), stents, foramen closure devices, and / or endovascular simulation devices. Typically, depending on the deployment location, larger medical devices are inserted into a subject's vasculature via the femoral vein or femoral artery, while smaller devices can be inserted via the radial vein or artery or via 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. Once positioned at the deployment location, the medical device is radially expanded to its deployed configuration. In some instances, the medical device is configured to self-expand, while in other instances, the medical device is actively radially expanded, for example, by balloon expansion.

[0009] Various medical devices exist that are configured to be implanted into an atrioventricular valve (such as the mitral valve) and / or into the left ventricle. For example, a prosthetic mitral valve can be deployed to replace a native mitral valve. Alternatively, a mitral valve repair device, such as an annuloplasty ring or a mitral valve leaflet clip, can be deployed to repair an unhealthy mitral valve. Some such devices are implanted via open surgical procedures, while others are implanted via minimally invasive procedures. In minimally invasive procedures, a delivery device is used to deliver the medical device percutaneously to the mitral valve and / or left ventricle. One technique for percutaneously delivering a device to the mitral valve and / or left ventricle is the transseptal approach. Using the transseptal approach, a delivery device is typically inserted into the femoral vein and then advanced through the subject's vena cava, from there through the right atrium to the interatrial septum. The delivery device is then pierced through the interatrial septum and directed from within the left atrium toward the mitral valve.

[0010] Although many prosthetic mitral valves and mitral valve repair devices are currently under development to treat dysfunctional mitral valves, no effective transcatheter mitral valve replacement techniques exist, and transcatheter mitral valve repair tends to produce incomplete results. Surgery (whether mitral valve replacement or repair) is associated with significant side effects and is not suitable for all patients. Furthermore, current treatments tend to fail to improve or even deteriorate left ventricular function (as measured using parameters such as ejection fraction), even when mitral regurgitation is corrected. Summary of the Invention

[0011] According to some applications of the present invention, a delivery device is advanced from a 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 there through the atrial septum to the subject's left atrium. The distal end of the delivery device is advanced toward the native mitral valve, typically 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 that is deployed in the subject's native mitral valve.

[0012] For some applications, the mitral valve prosthesis includes a valve frame having a valve frame body. The valve frame is deployed with the center of the valve frame eccentric to the center of the annular surface of the valve annulus and near the posterior side of the annular surface. Typically, the mitral valve prosthesis is configured such that blood flow through the mitral valve prosthesis is eccentric to the center of the annular surface. Alternatively or additionally, the valve frame body is deployed at an angle toward the posterior side of the left ventricle, with a plane defined by the ventricular end of the valve frame at least partially facing the posterior wall of the left ventricle. Typically, the mitral valve prosthesis is configured such that blood flow through the mitral valve prosthesis is directed toward the posterior wall of the left ventricle.

[0013] It should be noted that prior art mitral valve prostheses are typically implanted (via open-heart surgery or a transcatheter approach) in the center of the annular plane so that blood flow through the prosthetic mitral valve is not eccentric relative to the center of the annular plane. Typically, the valve frame of the present disclosure is deployed in a subject's mitral valve so that the center of the valve frame is positioned near the posterior side of the annular plane, thereby causing blood flow from the atrium through the valve leaflets to the left ventricle to be eccentric relative to the center of the annular plane. Blood flow from the atrium to the left ventricle that is eccentric relative to the center of the annular plane generates efficient blood flow from the left ventricle to the aorta (similar to blood flow through a healthy native mitral valve).

[0014] Typically, the valve frame of the present disclosure is deployed in a subject's mitral valve so that the valve frame is tilted toward the posterior side of the left ventricle, and the plane defined by the ventricular end of the valve frame faces at least partially against the posterior wall of the left ventricle, so that most of the blood flow from the atrium through the valve leaflets to the left ventricle is directed toward the posterior wall of the left ventricle. The blood flow from the atrium to the left ventricle directed toward the posterior wall generates efficient blood flow from the left ventricle to the aorta (similar to blood flow through a healthy native mitral valve).

[0015] In some applications, the subject's unique anatomy is used to facilitate one or both of the above-described techniques. Typically, the valve frame is secured to the subject's native mitral valve by, among other things, rotating at least a portion of the valve frame to cause the arms to pull the native valve leaflets radially inward and capture at least a portion of the native mitral valve's chordae tendineae, and then radially expanding the frame body of the valve frame to capture the native valve leaflets. Typically, both the anterior and posterior leaflets of the native valve are captured by the valve frame. Because the posterior leaflet is shorter than the anterior leaflet, in some instances, the securing serves as a pivot, causing the valve frame to (a) be deployed eccentrically relative to the center of the annular surface, positioning the valve frame near the posterior side of the annular surface, and / or (b) be deployed tilted toward the posterior side of the left ventricle, with the plane defined by the ventricular end of the valve frame at least partially facing the posterior wall of the left ventricle.

[0016] Thus, according to some embodiments of the present invention, there is provided a device for use with a prosthetic valve configured to be deployed within a native mitral valve of a mammalian subject, the native mitral valve including a valve annulus, leaflets, chordae tendineae, and papillary muscles. a valve frame configured to support a prosthetic valve within a native mitral valve, the valve frame including a frame body and a plurality of arms configured to extend from the frame body; A delivery device comprising: Delivering the valve frame to the native mitral valve; positioning the valve frame so that the center of the valve frame is eccentric to the center of the annular surface of the valve annulus and positioned near the posterior side of the annular surface; Then, the arms are deployed between the chordae of the native mitral valve. Then, at least a portion of the valve frame is rotated to capture at least a portion of the chordae tendineae of the native mitral valve, thereby causing the arms to pull the leaflets of the native valve radially inward; Then, the frame body of the valve frame is radially expanded to capture the leaflets of the native valve, and the valve frame is deployed with the center of the valve frame eccentric to the center of the annular surface and positioned near the posterior side of the annular surface. a delivery device configured to Equipped with.

[0017] In some embodiments, the delivery device is configured to deploy the valve frame eccentrically with the center of the valve frame relative to the center of the annular surface and position the valve frame near the posterior side of the annular surface using the natural posterior leaflet as an axis.

[0018] In some embodiments, the delivery device is configured to cause blood flow through the prosthetic valve to be eccentric relative to the center of the annular surface by radially expanding the frame body of the valve frame such that the valve frame is deployed with the center of the valve frame eccentric relative to the center of the annular surface and positioned near the posterior side of the annular surface.

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

[0020] In some embodiments, by positioning the valve frame so that the center of the valve frame is approximately aligned with the coaptation line of the subject's own anterior and posterior leaflets of the mitral valve, the delivery device is configured to capture approximately equal numbers of anterior and posterior chordae when a portion of the valve frame is rotated.

[0021] In some embodiments, the delivery device further comprises: positioning the valve frame so that the valve frame is tilted toward the posterior side of the left ventricle such that a plane defined by the ventricular end of the valve frame faces at least partially against a posterior wall of the left ventricle; radially expanding a frame body of the valve frame such that the valve frame is tilted toward the posterior side of the left ventricle and a plane defined by the ventricular end of the valve frame faces at least partially against the posterior wall of the left ventricle; It is structured as follows.

[0022] In some embodiments, the delivery device is configured to direct blood flow through the prosthetic valve toward the posterior wall of the left ventricle by radially expanding the frame body of the valve frame such that the valve frame is deployed at an angle toward the posterior side of the left ventricle and a plane defined by the ventricular end of the valve frame at least partially faces 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 so that a plane defined by the ventricular end of the valve frame forms an angle of greater than 5 degrees with the annular plane.

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

[0025] In some embodiments, the delivery device is configured to radially expand 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 with respect to the annular plane.

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

[0027] Further, according to some embodiments of the present invention, there is provided a method for use with a prosthetic valve configured to be deployed within a native mitral valve of a mammalian subject's heart, the native mitral valve including a valve annulus, valve leaflets, chordae tendineae, and papillary muscles. placing a valve frame within the subject's heart, 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 so that the center of the valve frame is eccentric to the center of the annular surface of the valve annulus and positioned near the posterior side of the annular surface; Then, deploying the arms between the chordae of the native mitral valve; Then, rotating at least a portion of the valve frame to capture at least a portion of the chordae tendineae of the native mitral valve, thereby causing the arms to pull the leaflets of the native valve radially inward; Then, radially expanding the frame body of the valve frame to capture the leaflets of the native valve, the valve frame being deployed with the center of the valve frame eccentric to the center of the annular surface and positioned near the posterior side of the annular surface to support the prosthetic valve within the native mitral valve; Includes:

[0028] In some embodiments, radially expanding the frame body of the valve frame such that the valve frame is deployed eccentrically with respect to the center of the annular surface and positioned near the posterior side of the annular surface includes using the natural posterior leaflet as an axis to deploy the valve frame such that the center of the valve frame is eccentrically with respect to the center of the annular surface and positioned near the posterior side of the annular surface.

[0029] In some embodiments, radially expanding the frame body of the valve frame such that the valve frame is deployed with the center of the valve frame eccentric to the center of the annular surface and positioned near the posterior side of the annular surface includes causing blood flow through the prosthetic valve to be eccentric to the center of the annular surface.

[0030] In some embodiments, positioning the valve frame so that the center of the valve frame is eccentric to the center of the annular surface of the valve annulus and positioned near the posterior side of the annular surface includes positioning the valve frame so that the center of the valve frame is approximately aligned with the coaptation line of the subject's own anterior and posterior leaflets of the mitral valve.

[0031] In some embodiments, positioning the valve frame so that the center of the valve frame is approximately aligned with the coaptation line of the subject's own anterior and posterior leaflets of the mitral valve includes capturing approximately equal numbers of anterior and posterior chordae when a portion of the valve frame is rotated.

[0032] In some embodiments, the method comprises: positioning the valve frame such that the valve frame is tilted toward a posterior side of the left ventricle of the subject's heart such that a plane defined by a ventricular end of the valve frame at least partially faces a posterior wall of the left ventricle; radially expanding a frame body of the valve frame such that the valve frame is deployed at an angle toward the posterior side of the left ventricle and a plane defined by a ventricular end of the valve frame at least partially faces a posterior wall of the left ventricle; Further includes:

[0033] In some embodiments, radially expanding the frame body of the valve frame such that the valve frame is deployed at an angle toward the posterior side of the left ventricle includes directing blood flow through the prosthetic valve toward the posterior wall of the left ventricle.

[0034] In some embodiments, radially expanding the frame body of the valve frame such that the valve frame is deployed at an angle toward the posterior side of the left ventricle comprises radially expanding the frame body of the valve frame such that a plane defined by the ventricular end of the valve frame forms an angle of greater than 5 degrees with respect to the annular plane.

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

[0036] In some embodiments, radially expanding the frame body of the valve frame such that the valve frame is deployed at an angle toward the posterior side of the left ventricle comprises radially expanding the frame body of the valve frame such that a plane defined by the ventricular end of the valve frame forms an angle of 5 degrees to 40 degrees with respect to the annular plane.

[0037] In some embodiments, radially expanding the frame body of the valve frame such that the valve frame is deployed at an angle toward the posterior side of the left ventricle comprises radially expanding the frame body of the valve frame such that a plane defined by the ventricular end of the valve frame forms an angle of 15 to 25 degrees with respect to the annular plane.

[0038] Further, in accordance with some embodiments of the present invention, there is provided a device for use with a prosthetic valve configured to be deployed within a native mitral valve of a mammalian subject, the native mitral valve including a valve annulus, valve leaflets, chordae tendineae, and papillary muscles. a valve frame configured to support a prosthetic valve within a native mitral valve, the valve frame including a frame body and a plurality of arms configured to extend from the frame body; A delivery device comprising: Delivering the valve frame to the native mitral valve; positioning the valve frame so that the valve frame is tilted toward the posterior side of the left ventricle such that a plane defined by the ventricular end of the valve frame faces at least partially against a posterior wall of the left ventricle; Then, the arms are deployed between the chordae of the native mitral valve. Then, at least a portion of the valve frame is rotated to capture at least a portion of the chordae tendineae of the native mitral valve, thereby causing the arms to pull the leaflets of the native valve radially inward; Then, the frame body of the valve frame is radially expanded to capture the leaflets of the native valve, and the valve frame is deployed at an angle toward the posterior side of the left ventricle so that a plane defined by the ventricular end of the valve frame at least partially faces the posterior wall of the left ventricle. a delivery device configured to Equipped with.

[0039] In some embodiments, the delivery device is configured to deploy the valve frame by tilting it toward the posterior side of the left ventricle using the native posterior leaflet as an axis, so that the 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 direct blood flow through the prosthetic valve toward the posterior wall of the left ventricle by radially expanding the frame body of the valve frame such that the valve frame is deployed at an angle toward the posterior side of the left ventricle and a plane defined by the ventricular end of the valve frame at least partially faces the posterior wall of the left ventricle.

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

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

[0043] In some embodiments, the delivery device is configured to radially expand 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 with respect to the annular plane.

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

[0045] In some embodiments, the delivery device further comprises: positioning the valve frame so that the center of the valve frame is eccentric to the center of the annular surface of the valve annulus and positioned near the posterior side of the annular surface; radially expanding a frame body of the valve frame such that the valve frame is deployed eccentrically with respect to the center of the annular surface and positioned near the rear side of the annular surface; It is structured as follows.

[0046] In some embodiments, the delivery device is configured to cause blood flow through the prosthetic valve to be eccentric relative to the center of the annular surface by radially expanding the frame body of the valve frame such that the valve frame is deployed with the center of the valve frame eccentric relative to the center of the annular surface and positioned near the posterior side of the annular surface.

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

[0048] In some embodiments, by positioning the valve frame so that the center of the valve frame is approximately aligned with the coaptation line of the subject's own anterior and posterior leaflets of the mitral valve, the delivery device is configured to capture approximately equal numbers of anterior and posterior chordae when a portion of the valve frame is rotated.

[0049] Further, according to some embodiments of the present invention, there is provided a method for use with a prosthetic valve configured to be deployed within a native mitral valve of a mammalian subject's heart, the native mitral valve including a valve annulus, valve leaflets, chordae tendineae, and papillary muscles. placing a valve frame within the subject's heart, 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 tilted toward a posterior side of the left ventricle of the subject's heart such that a plane defined by a ventricular end of the valve frame at least partially faces a posterior wall of the left ventricle; Then, deploying the arms between the chordae of the native mitral valve; Then, rotating at least a portion of the valve frame to capture at least a portion of the chordae tendineae of the native mitral valve, thereby causing the arms to pull the leaflets of the native valve radially inward; Then, radially expanding the frame body of the valve frame to capture the leaflets of the native valve, the valve frame is tilted toward the posterior side of the left ventricle and deployed so that a plane defined by the ventricular end of the valve frame at least partially faces the posterior wall of the left ventricle, and the valve frame supports the prosthetic valve within the native mitral valve; Includes:

[0050] In some embodiments, radially expanding the frame body of the valve frame so that the valve frame is deployed at an angle toward the posterior side of the left ventricle and a plane defined by the ventricular end of the valve frame at least partially faces the posterior wall of the left ventricle includes using the native posterior leaflet as an axis to deploy the valve frame at an angle toward the posterior side of the left ventricle and a plane defined by the ventricular end of the valve frame at least partially faces the posterior wall of the left ventricle.

[0051] In some embodiments, radially expanding the frame body of the valve frame such that the valve frame is deployed at an angle toward the posterior side of the left ventricle includes directing blood flow through the prosthetic valve toward the posterior wall of the left ventricle.

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

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

[0054] In some embodiments, radially expanding the frame body of the valve frame such that the valve frame is deployed at an angle toward the posterior side of the left ventricle comprises radially expanding the frame body of the valve frame such that a plane defined by the ventricular end of the valve frame forms an angle of 5 degrees to 40 degrees with respect to the annular plane.

[0055] In some embodiments, radially expanding the frame body of the valve frame such that the valve frame is deployed at an angle toward the posterior side of the left ventricle comprises radially expanding the frame body of the valve frame such that a plane defined by the ventricular end of the valve frame forms an angle of 15 to 25 degrees with respect to the annular plane.

[0056] In some embodiments, the method comprises: positioning the valve frame so that the center of the valve frame is eccentric to the center of the annular surface of the valve annulus and positioned near the posterior side of the annular surface; radially expanding a frame body of the valve frame such that the valve frame is deployed eccentrically with respect to the center of the annular surface and positioned near a posterior side of the annular surface; Further includes:

[0057] In some embodiments, radially expanding the frame body of the valve frame such that the valve frame is deployed with the center of the valve frame eccentric to the center of the annular surface and positioned near the posterior side of the annular surface includes causing blood flow through the prosthetic valve to be eccentric to the center of the annular surface.

[0058] In some embodiments, positioning the valve frame so that the center of the valve frame is eccentric to the center of the annular surface of the valve annulus and positioned near the posterior side of the annular surface includes positioning the valve frame so that the center of the valve frame is approximately aligned with the coaptation line of the subject's own anterior and posterior leaflets of the mitral valve.

[0059] In some embodiments, positioning the valve frame so that the center of the valve frame is approximately aligned with the coaptation line of the subject's own anterior and posterior leaflets of the mitral valve includes capturing approximately equal numbers of anterior and posterior chordae when a portion of the valve frame is rotated.

[0060] The invention will be more fully understood from the following detailed description of its application, taken together with the drawings. [Brief explanation of the drawings]

[0061] [Figure 1A-1B] 1 is a schematic diagram showing a delivery device being advanced toward the left ventricle of a subject, in accordance with some applications of the present invention. [Figures 2A-2C] 1 is a schematic diagram of inner and outer steerable catheters of a delivery device according to some applications of the present invention. [Figure 3A-3B] 1 is a schematic diagram illustrating a capsule of a delivery device according to some applications of the present invention. [Figures 4A-4C]1 is a schematic diagram of proximal and distal capsule portions of a delivery device according to some applications of the present invention. [Figure 5] 1 is a schematic diagram of a stage and handle portion of a delivery device according to some applications of the present invention. [Figures 6A-6B] 1 is a schematic diagram of a delivery device according to some applications of the present invention. [Figures 7A-7D] FIG. 1 is a schematic diagram of a valve frame configured to support a prosthetic valve within a subject's native atrioventricular valve, in accordance with some applications of the present invention, showing the valve frame disposed in a radially unconstrained configuration. [Figures 8A-8E] 1A-1D are schematic diagrams of steps in the deployment of a prosthetic mitral valve via a transseptal approach, in accordance with some applications of the present invention. [Figure 9A] 1 is a schematic diagram showing an anterior-posterior cross section of the left ventricle of a subject. [Figure 9B] FIG. 1 is a schematic illustration of an anterior-posterior cross section of a subject's left ventricle, in accordance with some applications of the present invention, in which a prosthetic mitral valve frame supporting the valve leaflets is deployed in the mitral valve such that the center of the valve frame is eccentric to the center of the annular surface and positioned near the posterior side of the annular surface. [Figure 9C] 1 is a schematic illustration of an anterior-posterior cross section of a subject's left ventricle, in accordance with some applications of the present invention, in which a prosthetic mitral valve frame supporting the valve leaflets is deployed in the mitral valve such that the valve frame is tilted toward the posterior side of the left ventricle (i.e., the leaflets are pointing toward the posterior wall of the left ventricle). DETAILED DESCRIPTION OF THE INVENTION

[0062] Reference is now made to Figures 1A and 1B, which are schematic diagrams illustrating a delivery device 20 being advanced toward a subject's native mitral valve 46 and / or left ventricle 54 via a transseptal delivery approach, in accordance with some applications of the present invention. As shown in Figure 1A, the distal end of the delivery device 20 is typically advanced from the subject's vena cava 42 into the subject's right atrium 43, and thence through the atrial septum 52 into the subject's left atrium 50. As shown in Figure 1B, the distal end of the delivery device is advanced toward the native mitral valve, typically through the leaflets 58 of the native mitral valve and into the left ventricle 54. In 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 (shown schematically in Figures 7A to 8C), a mitral valve repair device (such as annuloplasty ring or mitral valve leaflet clip), an artificial chordae tendineae, and / or a different percutaneously implantable medical device.

[0063] In some applications, the delivery device includes a capsule 40 at its distal end. Typically, a percutaneously implantable medical device is held in a crimped (i.e., radially constrained) configuration within the capsule during delivery of the medical device to the subject's mitral valve and / or left ventricle. More typically, the medical device is released from the capsule to deploy the device in the subject's mitral valve and / or left ventricle, as described in more detail below. In some applications, the medical device is a self-expanding medical device configured to radially self-expand upon release from the capsule. For example, the medical device may include a shape memory alloy (such as nitinol) that is shape-set to a desired radially expanded configuration. Alternatively, or additionally, the device may be actively radially expanded (e.g., by balloon expansion) after release from the capsule. In some applications, a distal portion of the medical device is released from the capsule first, followed by a proximal portion of the medical device, as described in more detail below.

[0064] Reference is now made to Figures 2A, 2B, and 2C, which are schematic illustrations of the outer steerable catheter 22 and the inner steerable catheter 24 of a delivery device 20 according to some applications of the present invention. Figures 2A and 2B show side views of the outer and inner steerable catheters, and Figure 2C shows a cross-sectional view thereof. As shown in the transition from Figure 2A to Figure 2B, the inner steerable catheter is typically axially slidable relative to the outer steerable catheter. Typically, while the delivery device 20 is advanced from the subject's vena cava 42 through the atrial septum 52 and into the subject's left atrium 50 (anatomy shown in Figures 1A-1B), the distal end of the inner steerable catheter is positioned within the outer steerable catheter, as shown in Figure 2A. More typically, once the distal end of the outer steerable catheter is positioned within the left atrium, the inner steerable catheter is advanced out of the distal end of the outer steerable catheter (i.e., the configuration shown in Figure 2B) and then steered toward the subject's mitral valve and / or left ventricle. For some applications, the inner steerable catheter is configured to be steered independently of the outer steerable catheter once advanced out the distal end of the outer steerable catheter.

[0065] In some applications, the outer steerable catheter includes first and second steering deflection cables 26 configured to be manipulated by a user to steer the distal end of the outer steerable catheter toward the subject's atrial septum through the first outer steerable catheter deflection surface. Alternatively (embodiments not shown), the outer catheter includes only one steering deflection cable 26 configured to be manipulated by a user to steer the distal end of the outer steerable catheter toward the subject's atrial septum through the first outer steerable catheter deflection surface. Typically, in addition to the one or more steering deflection cables 26, the outer catheter also includes a height adjustment deflection cable 28. Typically, the height adjustment deflection cable 28 is configured to be manipulated by a user to deflect the distal end of the outer steerable catheter from within the left atrium toward the roof of the left atrium by steering the tip of the outer steerable catheter through the second outer steerable catheter deflection surface. Typically, the second outer steerable catheter deflection surface is perpendicular to the first outer steerable catheter deflection surface, and thus, as shown in FIG. 2C, the height adjustment deflection cable 28 is typically disposed at a 90 degree angle relative to the steering deflection cable(s) 26.

[0066] In some applications, the steering deflection cable 26 is configured to steer the distal end of the outer steerable catheter at an angle between 0 degrees and greater than 60 degrees, or greater than 75 degrees (e.g., 0 to 90 degrees) within a first outer steerable catheter deflection plane. In some applications, the height adjustment deflection cable 28 is configured to steer the distal end of the outer steerable catheter at an angle between 0 degrees and greater than 30 degrees, or greater than 40 degrees (e.g., 0 to 45 degrees) within a second outer steerable catheter deflection plane to deflect the distal end of the outer steerable catheter from within the left atrium toward the roof of the left atrium.

[0067] Note that in Figure 2C, two steering deflection cables are shown because each steering deflection cable typically follows a first path from the proximal end of the catheter to the distal end of the catheter, and then follows a return path from the distal end of the catheter to the proximal end of the catheter.

[0068] It should be noted that within the left atrium, the inner steerable catheter typically must make approximately a 90-degree turn. This is because the inner steerable catheter is advanced out of the outer steerable catheter after it penetrates the atrial septum. Therefore, the tip of the inner steerable catheter typically advances out of the outer steerable catheter, which is facing laterally, and must be steered to face in an inferoanterior direction for advancement toward the mitral valve. Typically, as shown in FIGS. 1A-1B, the outer steerable catheter penetrates the atrial septum below the roof of the atrium (e.g., in a posteroinferior or posterosuperior position). This is because the atrial septum is thin and easily penetrated at this location. As described above, the height adjustment deflection cable 28 is configured to be manipulated 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 allows the inner steerable catheter to make gentler curves by providing more height for the inner steerable catheter to make the curves described above, and also provides height for the capsule to deploy above the valve annulus.

[0069] 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 manipulated by a user to steer the distal end of the inner steerable catheter toward the subject's mitral valve through a first inner steerable catheter deflection surface, and (b) a second set 34 of one or more (e.g., a pair of) steering deflection cables configured to be manipulated by a user to steer the distal end of the inner steerable catheter toward the subject's mitral valve through a second inner steerable catheter deflection surface to align the distal end of the inner steerable catheter with the subject's mitral valve.

[0070] In some applications, the first set of steering deflection cables 32 is configured to steer the distal end of the inner steerable catheter through an angle of 0 degrees to greater than 80 degrees, or greater than 100 degrees (e.g., 120 degrees) within the first inner steerable catheter deflection plane. In some applications, the second set of steering deflection cables 34 is configured to steer the distal end of the inner steerable catheter through an angle of at least -45 to +45 degrees within the second inner steerable catheter deflection plane to align the distal end of the inner steerable catheter with the subject's mitral valve. Typically, the first set of steering deflection cables 32 is positioned at a 90-degree angle relative to the second set of steering deflection cables 34, as shown in FIG. 2C .

[0071] Reference is now made to FIGS. 3A and 3B, which are schematic illustrations of a capsule 40 of a delivery device 20 according to some applications of the present invention. Typically, a medical device is held in a crimped (i.e., radially constrained) configuration within the capsule during delivery of the medical device to a deployment location (such as the mitral valve and / or left ventricle of a subject). More typically, the medical device is released from the capsule to deploy the device at the deployment location. It should be noted that capsules such as those shown in FIGS. 3A-3B (and FIGS. 4A-4C) may be used with any medical device delivered in a crimped configuration to a deployment location within a subject, and are not limited to use with devices deployed within the mitral valve and / or left ventricle. For example, the capsules shown in FIGS. 3A-3B (and FIGS. 4A-4C) may be used with medical devices delivered to a subject's aorta, vena cava, tricuspid valve, right ventricle, right atrium, right ventricle, pulmonary veins, pulmonary artery, etc.

[0072] For some applications, the capsule includes a distal capsule portion 60 configured to maintain a distal portion of the medical device in a radially constrained configuration during delivery of the medical device to a deployment location, and a proximal capsule portion 62 configured to maintain a proximal portion of the medical device in a radially constrained configuration during delivery of the medical device to a deployment location. Typically, the proximal and distal portions are reversibly couplable with one another, as described in more detail below. For some applications, the capsule further includes a tapered distal tip 70 configured to facilitate advancement of the capsule into a subject's vasculature and thereafter act as a dilator for advancement through the atrial septum. Typically, the distal tip is made of a soft material to prevent the tip from abrading or damaging the subject's tissue during advancement of the delivery device to a deployment location. The distal tip typically allows for advancement of the system over a guidewire, with the soft material following the direction of the guidewire.

[0073] In some applications, the outer shaft 64, mid-shaft 66, and inner shaft 68 are all disposed within the inner steerable catheter 24 (shown in FIGS. 2B-2C). The outer shaft is typically coupled to the proximal capsule portion 62 such that axial movement of the outer shaft relative to the mid-shaft and inner shaft transmits axial movement to the proximal capsule portion relative to the mid-shaft and inner shaft. To release the proximal portion of the medical device from within the proximal capsule portion, the outer shaft is typically retracted axially and proximally relative to the mid-shaft and inner shaft, thereby retracting the proximal capsule portion from the proximal portion of the medical device. (Note that relative proximal movement of the outer shaft relative to the mid-shaft and inner shaft may also be accomplished by advancing the mid-shaft and inner shaft distally relative to the outer shaft, rather than retracting the outer shaft.)

[0074] The inner shaft 68 is typically coupled to the distal capsule portion 60 such that axial motion of the inner shaft transfers axial motion to the distal capsule portion. (Note that rotational motion of the distal capsule portion is typically decoupled from rotational motion of the inner shaft via a bearing mechanism 72, which is described in more detail below with reference to FIGS. 4A-4C.) In some applications, the delivery device includes a distal device interface 74 configured to secure the distal portion of the medical device in a fixed axial position relative to the midshaft as long as the distal portion of the medical device is retained within the distal capsule portion. In some applications, the distal device interface is a flange extending radially from the midshaft, 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 midshaft (typically using the techniques described below with reference to FIGS. 4A-4C). This advances the distal capsule portion distally relative to the distal device interface. Once the proximal end of the distal capsule portion has advanced beyond the distal device interface, the distal portion of the medical device is typically released from the distal device interface (typically by radial self-expansion of the distal portion of the medical device and / or by another mechanism as described above).

[0075] Reference is now made to Figures 4A, 4B, and 4C, which are schematic illustrations of the proximal and distal capsule portions 62, 60, at various stages of advancement of the distal capsule portion 60 relative to the proximal capsule portion 62 of a delivery device, in accordance with some applications of the present invention. In some instances, it may be 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 such as that shown in Figures 7A-7D, it may be desirable to first release an intermediate portion of the valve frame (e.g., the radially expandable arms of the valve frame) from being covered by the distal capsule portion without fully releasing the entire distal portion of the valve frame. Typically, 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., mechanism 108 shown in Figure 5), whose rotational motion is translated into axial motion of the inner shaft 68 (coupled to the distal capsule portion). In some such applications, conversion of rotational motion to axial motion of the inner shaft 68 occurs at the distal end of the inner shaft, typically within the capsule. Note that if conversion of rotational motion to axial motion of the inner shaft 68 occurred at the proximal end of the inner shaft, the axial motion of the inner shaft would have to be transmitted along the entire length of the inner shaft before being transmitted to the distal capsule, and as a result, the transmission of axial motion to the distal capsule could be imprecise. In contrast, by converting rotational motion to axial motion of the inner shaft 68 at the distal end of the inner shaft (in accordance with some applications of the present invention), the axial motion does not have to be transmitted along the entire length of the inner shaft before being transmitted to the distal capsule. The axial motion is transmitted from within the capsule to the distal capsule.

[0076] In some applications, the inner shaft 68 defines a threaded outer surface 76 at its distal end, and the inner surface of the distal device interface 74 (described above and typically a flange) and / or the intermediate shaft 66 are correspondingly threaded. The threaded inner surface of the distal device interface 74 and / or the intermediate shaft 66 acts as a nut, such that rotation of the distal end of the inner shaft advances the inner shaft distally relative to the distal device interface 74. As described above, the distal device interface 74 typically secures the distal end of the medical device, and more typically, axial movement of the inner shaft is transferred to the distal capsule. Thus, advancement of the inner shaft relative to the distal device interface 74 advances the distal capsule relative to the distal end of the medical device. As described above, in some applications, the distal capsule includes a bearing mechanism 72. The bearing mechanism is configured to decouple rotational movement of the distal capsule from rotational movement of the inner shaft. Thus, rotation of the inner shaft advances the distal capsule portion distally relative to the distal end of the medical device, but does not rotate the distal capsule portion.

[0077] Typically, once the medical device is released from within capsule 40, the proximal and distal portions of the capsule reconnect with one another and then retract from the subject's body. 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 into their reconnected configuration after the medical device is deployed. For example, as shown in FIGS. 4B-4C , 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, with the lips 80 and 82 shaped to slide relative to one another into position. Alternatively, only one of the capsule portions defines a lip, which is configured to receive the other capsule portion (embodiment not shown). Typically, the proximal and distal portions are shaped to define a substantially smooth outer surface when properly connected to one another. In this manner, the capsule does not scratch or damage the subject's tissue as it advances toward the medical device deployment position. Similarly, the capsule does not scratch or damage the subject's tissue or the deployed medical device as it retracts from the medical device deployment position. In some applications, the lip described above is formed as a complete ring (not shown). In some applications (not shown), the lip, generally as described above, is divided into multiple separate arc-shaped segments. For example, the lip is formed from four arc-shaped segments, each corresponding to a 30-degree arc and spaced 90 degrees apart from one another. In this manner, the height required to release the medical device can be reduced because the entire capsule is removed after the medical device is released.

[0078] 5 is a schematic diagram of a stage 90 and handle portion 92 of a delivery device according to some applications of the present invention. In 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.

[0079] Typically, the first handle 94 includes a first rotation control mechanism 100 for controlling the steering deflection cables 26 (which are configured to be manipulated by a user to steer the distal end of the outer steerable catheter through a first outer steerable catheter deflection surface toward the subject's atrial septum) and, more typically, the first handle 94 includes a second rotation control mechanism 102 for controlling the height adjustment deflection cables 28 (which are configured to be manipulated by a user to steer the tip of the outer steerable catheter through a second outer steerable catheter deflection surface, thereby deflecting the distal end of the outer steerable catheter from within the left atrium toward the roof of the left atrium).

[0080] Typically, the second handle 96 includes a first rotational control mechanism 104 for controlling the first set of steering deflection cables 32 (which are configured to be operated by a user to steer the distal end of the inner steerable catheter through a first inner steerable catheter deflection surface toward the subject's mitral valve), and more typically, the second handle 96 includes a second rotational control mechanism 106 for controlling the second set of steering deflection cables 34 (which are configured to be operated by a user to steer the distal end of the inner steerable catheter through a second inner steerable catheter deflection surface to align the distal end of the inner steerable catheter with the subject's mitral valve).

[0081] As mentioned above, the deployment handle typically includes a rotational control mechanism 108 for controlling the axial movement of the distal capsule portion 60. More typically, the deployment handle includes a second rotational control mechanism 110 for controlling the axial movement of the proximal capsule portion 62. Typically, the handle portion includes multiple flushing ports through which each catheter and shaft is flushed.

[0082] Typically, the stage 90 is configured to position the handle portion 92 and allow for adjustment of the position of the handle portion. In some applications, the stage is configured to facilitate quick attachment of the handle portion to the stage, for example, via a snap-lock mechanism, without the need for screws. In some applications, the stage is configured to facilitate reorientation of the handle portion during a procedure, allowing for repositioning of the handle portion relative to the percutaneous access point.

[0083] Reference is now made to FIGS. 6A and 6B, which are schematic illustrations of a delivery device 20 according to some applications of the present invention. Generally, the delivery device 20 as shown in FIGS. 6A and 6B is similar to that shown in FIGS. 1A through 5, except for the differences described below. In some applications, the proximal end of the proximal capsule portion 62 defines a recess 118. Typically, the recess is sized to allow the proximal capsule portion to overlap a distal portion of a delivery catheter (e.g., the inner steerable catheter 24 of the delivery device 20 described above with reference to FIGS. 2A through 2C) as the proximal capsule portion is retracted. Typically, if the recess were not present, a gap would need to exist between the distal end of the delivery catheter and the proximal capsule portion to allow retraction of the proximal capsule portion relative to the delivery catheter (i.e., to release the proximal end of the implantable device). In contrast, if the proximal capsule portion includes a recess 118, the proximal capsule portion will typically be positioned adjacent to the distal end of the delivery catheter even before retraction (as shown in FIG. 6A ). Alternatively, the proximal capsule portion may partially overlap the distal end of the delivery catheter even before retraction (embodiment not shown). Subsequently, as the proximal capsule portion 62 is retracted, the recess slides over the distal end of the delivery catheter, causing the proximal end of the proximal capsule portion to overlap (or further overlap) the distal end of the delivery catheter. Typically, recess 118 eliminates the need for a gap between the distal end of the delivery catheter and the proximal capsule portion, thereby allowing the device to occupy less space (e.g., be less tall) in the left atrium than would be necessary if the recess were not present.

[0084] Reference is now made to Figures 7A, 7B, and 7C, which are schematic views of a valve frame 120 from different perspectives, according to some applications of the present invention, showing the valve frame in a radially unconstrained configuration. Figure 7A shows a side view of the valve frame, Figure 7B shows a bottom view (i.e., a view from the ventricular end of the valve frame), and Figure 7C shows a top view (i.e., a view from the atrial end of the valve frame). Reference is also made to Figure 7D, which is a schematic illustration of a valve frame 120 with valve leaflets 123 attached, according to some applications of the present invention.

[0085] Typically, the valve frame includes a valve frame body 121. In some applications, the valve frame body 121 includes a cylindrical portion 122 and an atrial portion 126. Typically, the cylindrical portion is configured to support a prosthetic valve within a native atrioventricular valve. For example, as shown in FIG. 7D , the leaflets 123 of the prosthetic valve can be sutured and / or otherwise coupled to the cylindrical portion. Typically, the atrial portion 126 is configured to be deployed at least partially within the atrium of the subject. In some applications, the atrial portion 126 includes a disk-shaped portion 128 (also referred to herein as a flange) and a frusto-conical portion 130.

[0086] Typically, the disc-shaped portion of the atrial portion is configured to seal the valve frame against tissue on the atrial side of the mitral annulus and further configured to prevent migration of the valve frame into the left ventricle. The frusto-conical portion typically extends from the disc-shaped portion of the atrial portion to the outer surface of the cylindrical portion. In some applications, including the frusto-conical portion between the disc-shaped portion and the cylindrical portion (as opposed to directly bonding the disc-shaped portion to the cylindrical portion) reduces the likelihood of regurgitation along the outer periphery of the cylindrical portion.

[0087] In some applications, the cylindrical portion and the atrial portion are formed as separate pieces and are joined together, for example, by sewing, gluing, welding, and / or other methods, or the cylindrical portion and the atrial portion are part of a single, integrally formed piece.

[0088] Typically, the valve frame 120 is made of a shape-memory material (e.g., nitinol and / or a shape-memory alloy such as copper-aluminum-nickel) and is covered on one or both sides with a cover material 132 (shown in FIG. 7D). The cover material 132 may be, for example, a fabric and / or a polymer (e.g., expanded polytetrafluoroethylene (ePTFE) or a woven, knit, mesh, and / or braided polyester). Typically, the shape-memory material in the cylindrical portion 122 and the atrial portion 126 is shaped into a stent-like structure comprising struts and / or cells of shape-memory material. The cover material is typically connected to the shape-memory material by stitches 134 (shown in FIG. 7D). Note that for illustrative purposes, FIGS. 7A-7C show the valve frame 120 without the valve leaflets 123 and cover material 132. However, the valve leaflets 123 and cover material 132 can be observed in FIG. 7D.

[0089] In some applications, multiple chordae tendineae capture arms 124 (e.g., more than two and / or less than twelve arms) extend from a portion of the valve frame body 121 configured to be placed in a ventricle of a subject. For example, four chordae tendineae capture arms or six chordae tendineae capture arms may extend from the valve frame body. In some applications, a single chordae tendineae capture arm 124 extends from a portion of the valve frame body 121 configured to be placed in a ventricle of a subject. Typically, the chordae tendineae capture arm extends from the cylindrical portion 122 of the valve frame body 121. More typically, the chordae tendineae capture arm extends from the ventricular end of the cylindrical portion (i.e., the end of the valve frame body configured to be placed in a ventricle). Typically, in the radially unconstrained configuration of the valve frame (which is the configuration the valve frame typically assumes when neither the valve frame body nor the chordae capture arms are constrained by a delivery device), the arms extend radially from the valve frame body in addition to extending axially from the ventricular end of the valve frame body toward the atrial end of the valve frame body (i.e., the end of the valve frame body configured to be disposed in the atrium). More typically, the arms curve around the circumference of the valve frame body in a given curved circumferential direction.

[0090] It should be noted that a description herein of an arm extending in a given direction from a valve frame body should not be construed as excluding additional directions in which the arm may be oriented. Rather, an arm described (or claimed) as extending radially from a valve frame body should be construed to mean that the orientation of the arm relative to the valve frame body includes a radial component. Typically, in addition to extending radially from the valve frame body, the arms are curved circumferentially, and in some instances, the orientation of the arms includes an axial component. In some applications, along at least a portion of the arms, and at least in certain configurations of the arms, the arms are oriented tangentially relative to the valve frame body.

[0091] Typically, the valve frame 120 with the prosthetic valve leaflets 123 disposed therein is delivered to the native atrioventricular valve by a delivery device 20 (typically as described above), which is configured to maintain the valve frame and prosthetic valve in a radially constrained configuration (i.e., a "crimped" configuration) during delivery. Depending on the application, the valve frame is delivered transapically (i.e., through the left ventricular cusp), transseptally (i.e., through the vena cava, right atrium, and interatrial septum, as described in detail with reference to FIGS. 8A-8C ), and / or via a different delivery route. In some applications, when the distal end of the delivery device is positioned within the subject's ventricle, the chordae tendineae capture arms 124 are deployed between the chordae tendineae of the native atrioventricular valve. Typically, the chordae tendineae capture arms are deployed between the chordae tendineae of the native atrioventricular valve by being released from the delivery device. The chordae tendineae capture arms are configured to extend from the valve frame body upon release from the delivery device. In some applications, additional techniques are used to deploy the chordae capture arms between the chordae of the native atrioventricular valve by releasing them from the delivery device. For example, the valve frame can include lever elements configured to radially extend the chordae capture arms. Alternatively or additionally, as described below, the arms are coupled to the cylindrical portion of the valve frame via stitches, which act as hinges so that the arms pivot about the stitches relative to the cylindrical portion. Typically, the chordae capture arms are released from the delivery device while the valve frame body is maintained in an at least partially radially constrained configuration by the delivery device. Typically, the valve frame is rotated while the chordae capture arms and the valve frame body are configured in the above-described configuration. Accordingly, in this application, the configuration of the chordae capture arms when the valve frame body is maintained in an at least partially radially constrained configuration by the delivery device but the chordae capture arms are released from the delivery device is referred to as the "rotated configuration" of the chordae capture arms.

[0092] Reference is now made to Figures 8A, 8B, 8C, 8D, and 8E, which are schematic illustrations of steps in the delivery and deployment of a mitral valve prosthesis via a transseptal approach, according to some applications of the present invention. Typically, the mitral valve prosthesis includes a valve frame body, as described above, with the leaflets 123 of the prosthesis sutured to the cylindrical portion and / or otherwise coupled to the cylindrical portion 122 of the valve frame, as shown, for example, in Figure 7D. As described above, depending on the application, the mitral valve prosthesis may be delivered transseptally (i.e., via the vena cava, right atrium, and atrial septum), transapically (i.e., via the left ventricular apex), and / or via a different delivery route. Figures 8A through 8E illustrate, by way of example and not limitation, steps in the delivery and deployment of a mitral valve prosthesis via a transseptal approach.

[0093] Typically, the delivery device 20 is guided over a guidewire 202 toward the subject's native mitral valve 200. The distal end of the delivery device 20 is typically advanced through the atrial septum 206 and into the subject's atrium 204. The distal end of the delivery device is advanced toward the native mitral valve and, as shown in FIG. 8A , through the leaflets 208 of the native mitral valve and into the left ventricle 210. Once the distal end of the delivery device is positioned within the left ventricle, the chordae tendineae capture arms 124 can at least partially extend radially and assume a rotated configuration, as shown in FIG. 8B . In some applications, the arms can be released from radial constraint by the delivery device, e.g., by partially retracting the proximal capsule portion 62 and / or partially advancing the distal capsule portion 60, thereby adopting a radially unconstrained configuration. Typically, the chordae capture arms are configured to extend radially from the valve frame body 121 and curve circumferentially (e.g., clockwise as shown) along the valve frame body when in the rotated configuration. In some applications, the chordae capture arms are also configured to extend axially toward the atrium of the subject. Typically, the chordae capture arms are configured to deploy between the chordae 212 of the native mitral valve upon release from the delivery device.

[0094] As shown in FIG. 8C , after the chordae tendineae capture arms 124 are deployed between the chordae tendineae of the native mitral valve, by rotating at least a portion of the valve frame in the direction of arrow 214, the chordae tendineae capture arms 124 (a) pull the native atrioventricular valve radially inward toward the valve frame and (b) twist the native atrioventricular valve around the valve frame by capturing and deflecting at least a portion of the chordae tendineae. Typically, the chordae tendineae capture arms 124 are configured to curve in a given circumferential direction relative to the longitudinal axis of the valve frame. For example, the arms can curve clockwise or counterclockwise relative to the longitudinal axis of the valve frame. Typically, after the chordae tendineae capture arms 124 are deployed between the chordae tendineae of the native mitral valve, the valve frame rotates in the same circumferential direction as the direction of the circumferential curvature of the arms. In the example shown in FIG. 8C , the arms curve in a clockwise circumferential direction (as viewed from the left atrium 204), and the valve frame rotates in this direction.

[0095] In some applications, before rotating the valve frame in the same circumferential direction as the direction of the circumferential curvature of the arms, the valve frame is rotated in the opposite circumferential direction. In some applications, the delivery device 20 is configured to automatically perform an initial rotation of the valve frame through a given angle in the direction opposite to the circumferential curvature of the arms, and then rotate the valve frame through a predetermined angle in the direction of the circumferential curvature of the arms. In some applications, in the rotated configuration of the arms (shown in FIGS. 8B-8C ), the outer surface of each arm has a smooth convex curvature and extends along substantially the entire length of the arm, so that during initial rotation (in the direction opposite to the circumferential curvature of the arms), the chordae tendineae slide on the outer surface of the arm without being captured or caught by the arm. In some applications, because the arms have such a shape, the initial rotation of the valve frame positions a relatively large number of chordae tendineae to be captured by each arm in subsequent rotation steps. During subsequent rotation of the valve frame (in the direction of the circumferential curvature of the arms, e.g., in the direction of arrow 214 shown in FIG. 8C ), the chordae tendineae are captured and deflected by the arms. Typically, in the rotated configuration of the arms (shown in Figures 8B-8C), the inner surface of the arms has a concave curvature, and during subsequent rotation by the valve frame, the chordae tendineae are trapped within the space defined by this concave curvature.

[0096] After the chordae capture arms 124 are released and the valve frame 120 is rotated, the valve frame body 121 (i.e., the cylindrical portion 122 and the atrial portion 126 of the valve frame) can assume a radially unconstrained configuration. In some applications, the atrial portion can be assumed in a radially unconstrained configuration by being released from a delivery device, for example, by retracting the proximal capsule portion 62. In some applications, the cylindrical portion can be assumed in a radially unconstrained configuration by being released from a delivery device, for example, by advancing the distal capsule portion 60. FIG. 8D illustrates both the cylindrical portion 122 and the atrial portion 126 in a radially unconstrained (i.e., radially expanded) configuration. Typically, by assuming a radially unconstrained configuration, the valve frame body is configured to capture the native valve 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 portion can be configured to radially expand to capture the native valve leaflets between the cylindrical portion and the chordae tendineae capture arms, and / or the atrial portion can be configured to radially expand to capture the native valve leaflets between the atrial portion and the chordae tendineae capture arms. In some applications, capturing the native valve leaflets 208 in a partially closed, twisted configuration is achieved by capturing the chordae tendineae (attached to the leaflets) in a twisted configuration. After the above steps have been performed, the delivery device 20 is typically generally retracted from the subject's left atrium, as shown in FIG. 8E.

[0097] 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 substantially larger than the posterior leaflet 208P. As a result, the leaflet coaptation line (i.e., the line where the anterior and posterior leaflets join) is eccentric to the center 220 of the annular plane and positioned posteriorly in the left ventricle. Typically, the eccentricity of the leaflet coaptation line relative to the center 220 of the annular plane causes blood flow from the atrium to the left ventricle to be eccentric to the center of the annular plane. As indicated by the blood flow arrows 222 in FIG. 9A , blood flow from the atrium to the left ventricle that is eccentric to the center of the annular plane generates efficient blood flow from the left ventricle to the aorta 224. Furthermore, the anterior leaflet directs much of the blood flow from the atrium toward the posterior wall 225 of the left ventricle, thereby further generating efficient blood flow from the left ventricle to the aorta 224.

[0098] Referring now to FIG. 9B, this figure is a schematic illustration of an anterior-posterior cross section of a subject's left ventricle, showing that, in accordance with some applications of the present invention, a prosthetic mitral valve frame 120 (supporting valve leaflets 123) has been deployed on the mitral valve such that the center of the frame is eccentric to the center 220 of the annular surface and positioned near the posterior side of the annular surface. It should be noted that prior art prosthetic mitral valves are typically implanted in the center of the annular surface, so that blood flow through the prosthetic mitral valve is not eccentric to the center of the annular surface. Typically, the valve frame of the present disclosure is deployed on the subject's mitral valve such that the center of the frame is positioned near the posterior side of the annular surface, such that blood flow from the atrium through the valve leaflets to the left ventricle is eccentric to the center of the annular surface. As indicated by the blood flow arrows 222 in FIG. 9B, blood flow from the atrium to the left ventricle that is eccentric to the center of the annular surface generates efficient blood flow from the left ventricle to the aorta 224 (similar to blood flow through a healthy native mitral valve).

[0099] 9C, which is a schematic illustration of an anterior-posterior cross section of a subject's left ventricle, in which, in accordance with some applications of the present invention, a prosthetic mitral valve frame 120 (supporting the valve leaflets 123) is deployed in the mitral valve so that the frame is tilted toward the posterior side of the left ventricle (i.e., so that the leaflets open toward the posterior wall of the left ventricle). It should be 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 surface 228, preventing blood flow through the prosthetic mitral valve from being directed toward the posterior wall 225. Typically, the valve frame of the present disclosure is deployed in a subject's mitral valve so that it is tilted toward the posterior side of the left ventricle, thereby directing much of the blood flow from the atrium, through the valve leaflets, and into the left ventricle toward the posterior wall 225. As shown by flow arrows 222 in FIG. 9C , blood flow from the atrium to the left ventricle, directed toward the posterior wall, generates efficient blood flow from the left ventricle toward the aorta 224 (similar to blood flow through a healthy native mitral valve). In some applications, the valve frame is positioned and deployed at an angle toward the posterior side of the left ventricle so that plane 221 defined by the ventricular end of the valve frame faces at least partially against the posterior wall of the left ventricle. In some applications, the valve frame is angled toward the posterior side of the left ventricle so that plane 221 defined by the ventricular end of the valve frame forms an angle α with 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., between 5 and 40 degrees or between 15 and 25 degrees.

[0100] 9B and 9C are combined, i.e., in some applications, the prosthetic mitral valve frame 120 is deployed in the subject's mitral valve such that (a) the center of the valve frame is eccentric to the center 220 of the annular surface and positioned near the posterior side of the annular surface, and (b) the valve frame is tilted toward the posterior side of the left ventricle.

[0101] In some applications, the subject's unique anatomy is used to facilitate one or both of the above-described techniques. As described above, the valve frame is typically secured to the subject's native mitral valve by, among other things, rotating at least a portion of the valve frame to cause the arms to pull the native valve leaflets radially inward and capture at least a portion of the native mitral valve's chordae tendineae, and then radially expanding the frame body of the valve frame to capture the native valve leaflets. Typically, both the anterior and posterior leaflets of the native valve are captured by the valve frame. Because the posterior leaflet is shorter than the anterior leaflet, in some instances, the securing acts as a pivot, causing the valve frame to (a) deploy eccentrically relative to the center of the annular surface, positioning the valve frame near the posterior side of the annular surface, and / or (b) deploy at an angle toward the posterior side of the left ventricle, with the plane defined by the ventricular end of the valve frame at least partially facing the posterior wall of the left ventricle.

[0102] In some applications, the delivery device 20 is configured to position the mitral valve frame relative to the mitral valve annulus and deploy the valve frame in a position and / or orientation as described in Figures 9B and / or 9C. In some applications, before rotating the valve frame (i.e., the step shown in Figure 8C), the delivery device is configured to position the valve frame so that the center of the valve frame is approximately aligned with the coaptation line of the anterior and posterior leaflets of the valve. Thus, when the valve frame is rotated, approximately equal numbers of anterior and posterior chordae are captured by the chordae capture arms so that when the valve frame is fully deployed, the valve frame is centered by the anterior and posterior chordae and the center of the valve frame is eccentric to the center 220 of the annular surface and positioned near the posterior side of the annular surface.

[0103] As described above with reference to delivery device 20, the inner steerable catheter 24 (shown in FIG. 2C ) typically includes a first set 32 ​​and a second set 34 of steering deflection cables. Typically, the first set 32 ​​of steering deflection cables is configured to steer the distal end of the inner steerable catheter through an angle of 0 degrees to greater than 80 degrees, or greater than 100 degrees (e.g., 120 degrees) within a first inner steerable catheter deflection plane. In 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 of at least −45 degrees to +45 degrees within a second inner steerable catheter deflection plane. In some applications, the second set of steerable catheters is configured to position the valve frame such that the valve frame is tilted toward the posterior side of the left ventricle (as described with reference to FIG. 9C ) prior to deployment of the valve frame.

[0104] Those skilled in the art will recognize that the present invention is not limited to what has been particularly shown and described above, and the scope of the present invention includes both combinations and subcombinations of the various features described above, as well as variations and modifications that would occur to those skilled in the art upon reading the foregoing description and that are not present in the prior art.

Claims

1. 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 including a valve 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 including a frame body and a plurality of arms configured to extend from the frame body; A delivery device comprising: delivering the valve frame to the native mitral valve; positioning the valve frame such that a center of the valve frame is eccentric to a center of an annular surface of the valve annulus and positioned near a posterior side of the annular surface; Thereafter, the arms are deployed between the chordae of the native mitral valve; Then, at least a portion of the valve frame is rotated to capture at least a portion of the chordae tendineae of the native mitral valve, thereby causing the arms to pull the leaflets of the native valve radially inward; Then, the frame body of the valve frame is radially expanded to capture the leaflets of the native valve, and the valve frame is deployed with the center of the valve frame eccentrically relative to the center of the annular surface and positioned near the posterior side of the annular surface. a delivery device configured to An apparatus comprising:

2. 2. The apparatus of claim 1, wherein the delivery device is configured to deploy the valve frame eccentrically with the center of the valve frame relative to the center of the annular surface and position the valve frame near the posterior side of the annular surface using a natural posterior leaflet as an axis.

3. 2. The apparatus of claim 1, wherein the delivery device is configured to radially expand the frame body of the valve frame such that the valve frame is deployed with the center of the valve frame eccentric to the center of the annular surface and positioned near the posterior side of the annular surface.

4. 4. The apparatus of claim 1, wherein the delivery device is configured to position the valve frame such that the center of the valve frame is approximately aligned with a coaptation line of the subject's own anterior and posterior leaflets of the mitral valve.

5. 5. The apparatus of claim 4, wherein the delivery device is configured to capture approximately equal numbers of anterior and posterior chordae when the portion of the valve frame is rotated by positioning the valve frame so that the center of the valve frame is approximately aligned with the coaptation line of the subject's own anterior and posterior leaflets of the mitral valve.

6. The delivery device further comprises: positioning the valve frame so that the valve frame is tilted toward the posterior side of the left ventricle such that a plane defined by a ventricular end of the valve frame at least partially faces a posterior wall of the left ventricle; the valve frame is deployed at an angle toward the posterior side of the left ventricle, radially expanding the frame body of the valve frame such that the plane defined by the ventricular end of the valve frame at least partially faces the posterior wall of the left ventricle.

4. The device according to claim 1, wherein the device is configured to:

7. 7. The apparatus of claim 6, wherein the delivery device is configured to direct blood flow through the prosthetic valve toward the posterior wall of the left ventricle by radially expanding the frame body of the valve frame such that the valve frame is deployed at an angle toward the posterior side of the left ventricle and the plane defined by the ventricular end of the valve frame at least partially faces the posterior wall of the left ventricle.

8. 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 forms an angle of greater than 5 degrees with respect to the annular plane.

9. 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 forms an angle of greater than 15 degrees with respect to the annular plane.

10. 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 forms an angle of between 5 degrees and 40 degrees with respect to the annular plane.

11. 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 forms an angle of 15 to 25 degrees with respect to the annular plane.

12. 1. A method for use with a prosthetic valve configured to be deployed within a native mitral valve of a mammalian subject's heart, the native mitral valve including a valve annulus, leaflets, chordae tendineae, and papillary muscles, the method comprising: placing a valve frame within the subject's heart, 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 a center of the valve frame is eccentric to a center of an annular surface of the valve annulus and positioned near a posterior side of the annular surface; Thereafter, deploying the arms between the chordae of the native mitral valve; Then, rotating at least a portion of the valve frame to capture at least a portion of the chordae tendineae of the native mitral valve, thereby causing the arms to pull the leaflets of the native valve radially inward; Then, radially expanding the frame body of the valve frame to capture the leaflets of the native valve, the valve frame being deployed with the center of the valve frame eccentrically relative to the center of the annular surface and positioned near the posterior side of the annular surface to support the prosthetic valve within the native mitral valve; A method comprising:

13. 13. The method of claim 12, wherein radially expanding the frame body of the valve frame such that the center of the valve frame is deployed eccentrically relative to the center of the annular surface and positioned near the posterior side of the annular surface includes using a natural posterior leaflet as an axis to deploy the valve frame such that the center of the valve frame is deployed eccentrically relative to the center of the annular surface and positioned near the posterior side of the annular surface.

14. 13. The method of claim 12, wherein radially expanding the frame body of the valve frame such that the valve frame is deployed with the center of the valve frame eccentrically relative to the center of the annular surface and positioned near the posterior side of the annular surface comprises displacing blood flow through the prosthetic valve eccentrically relative to the center of the annular surface.

15. 15. The method of claim 12, wherein positioning the valve frame so that the center of the valve frame is eccentric to the center of the annular surface of the valve annulus and positioned near the posterior side of the annular surface comprises positioning the valve frame so that the center of the valve frame is approximately aligned with a coaptation line of the subject's own anterior and posterior leaflets of the mitral valve.

16. 16. The method of claim 15, wherein positioning the valve frame so that the center of the valve frame is approximately aligned with the coaptation line of the subject's own anterior and posterior leaflets of the mitral valve comprises capturing approximately equal numbers of anterior and posterior chordae when the portion of the valve frame is rotated.

17. positioning the valve frame such that the valve frame is tilted toward a posterior side of a left ventricle of the subject's heart such that a plane defined by a ventricular end of the valve frame at least partially faces a posterior wall of the left ventricle; radially expanding the frame body of the valve frame such that the valve frame is deployed at an angle toward the posterior side of the left ventricle and the plane defined by the ventricular end of the valve frame at least partially faces the posterior wall of the left ventricle; 15. The method of any one of claims 12 to 14, further comprising:

18. 18. The method of claim 17, wherein radially expanding the frame body of the valve frame such that the valve frame is deployed at an angle toward the posterior side of the left ventricle includes directing blood flow through the prosthetic valve toward the posterior wall of the left ventricle.

19. 18. The method of claim 17, wherein radially expanding the frame body of the valve frame such that the valve frame is deployed at an angle toward the posterior side of the left ventricle comprises 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 of greater than 5 degrees with the annular plane.

20. 20. The method of claim 19, wherein radially expanding the frame body of the valve frame such that the valve frame is deployed at an angle toward the posterior side of the left ventricle comprises 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 of greater than 15 degrees with the annular plane.

21. 20. The method of claim 19, wherein radially expanding the frame body of the valve frame so that the valve frame is deployed at an angle toward the posterior side of the left ventricle comprises 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 of 5 to 40 degrees with respect to the annular plane.

22. 22. The method of claim 21, wherein radially expanding the frame body of the valve frame so that the valve frame is deployed at an angle toward the posterior side of the left ventricle comprises 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 of 15 to 25 degrees with respect to the annular plane.

23. 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 including a valve 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 including a frame body and a plurality of arms configured to extend from the frame body; A delivery device comprising: delivering the valve frame to the native mitral valve; positioning the valve frame so that the valve frame is tilted toward the posterior side of the left ventricle such that a plane defined by a ventricular end of the valve frame at least partially faces a posterior wall of the left ventricle; Thereafter, the arms are deployed between the chordae of the native mitral valve; Then, at least a portion of the valve frame is rotated to capture at least a portion of the chordae tendineae of the native mitral valve, thereby causing the arms to pull the leaflets of the native valve radially inward; Thereafter, the frame body of the valve frame is radially expanded to capture the leaflets of the native valve, and the valve frame is deployed at an angle toward the posterior side of the left ventricle so that the plane defined by the ventricular end of the valve frame at least partially faces the posterior wall of the left ventricle. a delivery device configured to An apparatus comprising:

24. 24. The apparatus of claim 23, wherein the delivery device is configured to deploy the valve frame by tilting it toward the posterior side of the left ventricle using its own posterior leaflet as an axis, so that the plane defined by the ventricular end of the valve frame at least partially faces the posterior wall of the left ventricle.

25. 24. The apparatus of claim 23, wherein the delivery device is configured to direct blood flow through the prosthetic valve toward the posterior wall of the left ventricle by radially expanding the frame body of the valve frame such that the valve frame is deployed at an angle toward the posterior side of the left ventricle and the plane defined by the ventricular end of the valve frame at least partially faces the posterior wall of the left ventricle.

26. 26. The apparatus of any one of claims 23 to 25, 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 forms an angle of greater than 5 degrees with respect to the annular plane.

27. 27. The apparatus of claim 26, 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 forms an angle of greater than 15 degrees with respect to the annular plane.

28. 27. The apparatus of claim 26, 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 forms an angle of between 5 degrees and 40 degrees with respect to the annular plane.

29. 30. The apparatus of claim 28, 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 forms an angle of 15 to 25 degrees with respect to the annular plane.

30. The delivery device further comprises: positioning the valve frame such that a center of the valve frame is eccentric to a center of an annular surface of the valve annulus and positioned near a posterior side of the annular surface; radially expanding the frame body of the valve frame such that the valve frame is deployed eccentrically with the center of the valve frame relative to the center of the annular surface and positioned near the posterior side of the annular surface.

26. The apparatus of any one of claims 23 to 25, configured to:

31. 31. The apparatus of claim 30, wherein the delivery device is configured to radially expand the frame body of the valve frame such that the valve frame is deployed with the center of the valve frame eccentric to the center of the annular surface and positioned near the posterior side of the annular surface.

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

33. 33. The apparatus of claim 32, wherein the delivery device is configured to capture approximately equal numbers of anterior and posterior chordae when the portion of the valve frame is rotated by positioning the valve frame so that the center of the valve frame is approximately aligned with the coaptation line of the subject's own anterior and posterior leaflets of the mitral valve.

34. 1. A method for use with a prosthetic valve configured to be deployed within a native mitral valve of a mammalian subject's heart, the native mitral valve including a valve annulus, leaflets, chordae tendineae, 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 tilted toward a posterior side of a left ventricle of the subject's heart such that a plane defined by a ventricular end of the valve frame at least partially faces a posterior wall of the left ventricle; Thereafter, deploying the arms between the chordae of the native mitral valve; Then, rotating at least a portion of the valve frame to capture at least a portion of the chordae tendineae of the native mitral valve, thereby causing the arms to pull the leaflets of the native valve radially inward; Then, radially expanding the frame body of the valve frame to capture the leaflets of the native valve, the valve frame is deployed at an angle toward the posterior side of the left ventricle, and the plane defined by the ventricular end of the valve frame at least partially faces the posterior wall of the left ventricle, and the valve frame supports the prosthetic valve within the native mitral valve; A method comprising:

35. 35. The method of claim 34, wherein radially expanding the frame body of the valve frame so that the valve frame is deployed at an angle toward the posterior side of the left ventricle and the plane defined by the ventricular end of the valve frame at least partially faces the posterior wall of the left ventricle comprises using a natural posterior leaflet as an axis to deploy the valve frame at an angle toward the posterior side of the left ventricle and the plane defined by the ventricular end of the valve frame at least partially faces the posterior wall of the left ventricle.

36. 35. The method of claim 34, wherein radially expanding the frame body of the valve frame such that the valve frame is deployed at an angle toward the posterior side of the left ventricle includes directing blood flow through the prosthetic valve toward the posterior wall of the left ventricle.

37. 37. The method of any one of claims 34 to 36, wherein radially expanding the frame body of the valve frame such that the valve frame is deployed at an angle toward the posterior side of the left ventricle comprises 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 of greater than 5 degrees with the annular plane.

38. 38. The method of claim 37, wherein radially expanding the frame body of the valve frame such that the valve frame is deployed at an angle toward the posterior side of the left ventricle comprises 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 of greater than 15 degrees with the annular plane.

39. 38. The method of claim 37, wherein radially expanding the frame body of the valve frame so that the valve frame is deployed at an angle toward the posterior side of the left ventricle comprises 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 of 5 degrees to 40 degrees with respect to the annular plane.

40. 40. The method of claim 39, wherein radially expanding the frame body of the valve frame so that the valve frame is deployed at an angle toward the posterior side of the left ventricle comprises 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 of 15 to 25 degrees with respect to the annular plane.

41. positioning the valve frame such that a center of the valve frame is eccentric to a center of an annular surface of the valve annulus and positioned near a posterior side of the annular surface; radially expanding the frame body of the valve frame such that the valve frame is deployed with the center of the valve frame eccentrically relative to the center of the annular surface and positioned near the posterior side of the annular surface; 37. The method of any one of claims 34 to 36, further comprising:

42. 42. The method of claim 41 , wherein radially expanding the frame body of the valve frame such that the valve frame is deployed with the center of the valve frame eccentrically relative to the center of the annular surface and positioned near the posterior side of the annular surface comprises displacing blood flow through the prosthetic valve eccentrically relative to the center of the annular surface.

43. 42. The method of claim 41, wherein positioning the valve frame so that the center of the valve frame is eccentric to the center of the annular surface of the valve annulus and positioned near the posterior side of the annular surface comprises positioning the valve frame so that the center of the valve frame is approximately aligned with a coaptation line of the subject's own anterior and posterior leaflets of the mitral valve.

44. 44. The method of claim 43, wherein positioning the valve frame so that the center of the valve frame is approximately aligned with the coaptation line of the subject's own anterior and posterior leaflets of the mitral valve comprises capturing approximately equal numbers of anterior and posterior chordae when the portion of the valve frame is rotated.

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