Posteriorly Positioned Prosthetic Mitral Valve

Abstract

Apparatus and methods are described including a delivery device that delivers a valve frame (120) to a native mitral valve and positions the valve frame (120) such that a center of the valve frame (120) is off center with respect to a center of an annular plane of the valve annulus, and is positioned toward a posterior side of the annular plane. Arms (124) of the valve frame (120) are deployed among the chords of the native mitral valve. The valve frame (120) is rotated, such as to cause the arms (124) to pull the leaflets of the native valve radially inwards. A frame body (121) of the valve frame (120) radially expands, such as to trap the native valve leaflets, and such that the valve frame (120) is deployed off center with respect to the center of the annular plane. Other applications are also described.

Description

1 / 67 Prosthetic Mitral Valve with Posterior Positioning. Cross-References to Related Applications.

[001] This application claims priority from Provisional Patent Application No. US63 / 451,261 by Shimel, filed March 10, 2023, entitled Positioning of prosthetic mitral valve, which is incorporated herein by reference. Field of Invention Modalities

[002] The present invention relates to medical apparatus and methods and, specifically, to apparatus and methods for percutaneously dispensing a medical device to an implantation site within an individual's body, such as an atrioventricular valve. Fundamentals

[003] The human heart is a muscular organ that pumps deoxygenated blood through the lungs to oxygenate the blood and pumps oxygenated blood to the rest of the body by contractions of four chambers.

[004] After circulating throughout the body, deoxygenated blood enters the right atrium via the vena cava(s). In a healthy individual, the right atrium contracts, pumping blood through the tricuspid valve into the right ventricle. The right ventricle contracts, pumping blood through the pulmonary semilunar valve into the pulmonary artery, which divides into two branches, one for Petition 870250101878, dated 06 / 11 / 2025, page 9 / 88 2 / 67 each lung. Blood is oxygenated as it passes through the lungs and re-enters the heart through the left atrium. The left atrium contracts, pumping oxygenated blood through the mitral valve into the left ventricle. The left ventricle contracts, pumping oxygenated blood through the aortic valve into the aorta to be distributed to the rest of the body. The tricuspid valve closes during the contraction of the right ventricle, so that backflow of blood into the right atrium is prevented. Similarly, the mitral valve closes during the contraction of the left ventricle, so that backflow of blood into the left atrium is prevented. The mitral valve and the tricuspid valve are known as atrioventricular valves, where each of these valves controls the flow of blood between an atrium and a ventricle.

[005] In the mitral valve, the mitral annulus defines a mitral valve orifice. An anterior leaflet and a posterior leaflet extend from the mitral annulus. The leaflets are connected by chordae tendineae to the papillary muscles within the left ventricle. During ventricular diastole, in a healthy individual, the left atrium contracts to pump blood into the left ventricle through the mitral valve orifice. Blood flows through the orifice, pushing the leaflets apart and entering the left ventricle with little resistance. In a healthy individual, the aortic valve leaflets are held closed by blood pressure in the aorta. Petition 870250101878, dated 06 / 11 / 2025, p. 10 / 88 3 / 67

[006] During ventricular systole, the left ventricle contracts to pump blood into the aorta through the aortic valve, whose leaflets are opened by the blood flow. In a healthy individual, the mitral annulus contracts, pushing the leaflets inward and reducing the area of ​​the mitral valve orifice by about 20% to 30%. The leaflets coapt to accommodate the excess leaflet surface area, producing a coaptation surface that constitutes a seal. The blood pressure in the left ventricle pushes the ventricular surfaces of the leaflets together, pressing the leaflets firmly together at the coaptation surface to form a tight, leak-proof seal.

[007] Effective mitral valve sealing during ventricular systole depends on a sufficient degree of coaptation. Inadequate coaptation can be caused by any number of physical abnormalities that allow leaflet prolapse (e.g., elongated or ruptured chordae tendineae or weak papillary muscles) or impede coaptation (e.g., short chordae tendineae or small leaflets). There are also pathologies that lead to mitral valve insufficiency, including collagen vascular disease, ischemic mitral regurgitation (resulting, for example, from myocardial infarction, chronic heart failure, or unsuccessful / failed surgical or catheter revascularization), degeneration Petition 870250101878, dated 06 / 11 / 2025, page 11 / 88 4 / 67 Myxomatous leaflet regurgitation and rheumatic heart disease. Mitral valve regurgitation leads to many complications, including arrhythmia, atrial fibrillation, heart palpitations, chest pain, congestive heart failure, fainting, fatigue, low cardiac output, orthopnea, paroxysmal nocturnal dyspnea, pulmonary edema, shortness of breath, and sudden death.

[008] There are several medical devices that are configured to be dispensed in a minimally invasive procedure, in which a dispensing device is used to dispense the device percutaneously (through a puncture in the skin) to an implantation site where the device is to be implanted. Many of these medical devices are implanted in the individual's vasculature and / or the individual's heart. For example, these medical devices may include prosthetic valves (e.g., a prosthetic mitral valve, a prosthetic aortic valve, and / or a prosthetic tricuspid valve), valve repair devices (e.g., an annuloplasty ring or an end-to-end device such as a mitral leaflet clip), stents, orifice closure devices, and / or intravascular simulation devices.Typically, depending on the implantation site, larger medical devices are inserted into the individual's vasculature via the femoral vein or femoral artery, while other devices... Petition 870250101878, dated 06 / 11 / 2025, page 12 / 88 5 / 67 smaller devices can also be inserted through the radial vein or radial artery, or another vein or artery. During dispensing of medical devices to the implantation site, the medical devices are typically held in a radially restricted (i.e., crimped) configuration within the dispensing device. The medical devices are radially expanded to their implantation configurations when dispensed at the implantation site. In some cases, the medical devices are configured to self-expand, while in other cases the medical devices are actively radially expanded, for example, through balloon expansion.

[009] There are several medical devices that are configured to be implanted in an atrioventricular valve (such as the mitral valve) and / or within the left ventricle. For example, a prosthetic mitral valve can be implanted to replace the native mitral valve. Or, a mitral valve repair device, such as an annuloplasty ring or a mitral leaflet clip, can be implanted to repair an unhealthy mitral valve. Some of these devices are implanted in an open surgical procedure. Others are implanted in a minimally invasive procedure, in which a dispensing device is used to dispense the device percutaneously to the mitral valve and / or the left ventricle. One approach to Petition 870250101878, dated 06 / 11 / 2025, p. 13 / 88 6 / 67 Percutaneous delivery of a device into the mitral valve and / or left ventricle is the transseptal approach. Using the transseptal approach, the delivery device is typically inserted into the femoral vein and then passed through the individual's vena cava and from there, through the right atrium and into the interatrial septum. The delivery device then penetrates the interatrial septum and is directed to the mitral valve from within the left atrium.

[0010] Although many prosthetic mitral valves and mitral valve repair devices are under development for the treatment of compromised mitral valves, to date, there is no effective transcatheter mitral valve replacement technology, and percutaneous mitral valve repair tends to produce imperfect results. Surgery (whether mitral valve replacement or repair) carries substantial side effects and is not suitable for all patients. Furthermore, with current treatment modalities, even if mitral regurgitation is corrected, left ventricular function (measured by parameters such as ejection fraction) tends not to improve and may even worsen. Summary of Modalities

[0011] According to some applications of the present invention, a dispensing device conducted in the vena cava of an individual (e.g., through the vena cava) Petition 870250101878, dated 06 / 11 / 2025, p. 14 / 88 7 / 67 inferior or through the superior vena cava) to the individual's right atrium and, from there, to the individual's left atrium, through the interatrial septum. The distal end of the dispensing device is guided toward the native mitral valve and typically through the leaflets of the native mitral valve and into the left ventricle. Typically, the dispensing device is used to dispense a prosthetic mitral valve to be implanted into the individual's native mitral valve.

[0012] For some applications, the prosthetic mitral valve includes a valve structure with a valve structure body, which is implanted with the center of the valve structure off-center relative to the center of an annular plane of the valve ring and facing the posterior side of the annular plane. Typically, the prosthetic mitral valve is configured to cause blood flow to be off-center relative to the center of the annular plane. Alternatively or additionally, the valve structure body is implanted angled toward the posterior side of the left ventricle, with a plane defined by a ventricular end of the valve structure, at least partially, facing a posterior wall of the left ventricle. Typically, the prosthetic mitral valve is configured to cause blood flow to be directed toward the posterior wall of the left ventricle. Petition 870250101878, dated 06 / 11 / 2025, page 15 / 88 8 / 67

[0013] It is observed that the prosthetic mitral valves of the prior art are typically implanted (via open-heart surgery or via a transcatheter approach) in the center of the annular plane, so that blood flow through the prosthetic mitral valve is not off-center relative to the center of the annular plane. Typically, with the valve structure of the present disclosure, which is implanted in the individual's mitral valve so that the center of the valve structure faces the posterior side of the annular plane, blood flow through the valve leaflets from the atrium to the left ventricle is off-center relative to the center of the annular plane. The off-center blood flow from the atrium to the left ventricle 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, by the valve structure of the present disclosure which is implanted in the mitral valve of the individual, so that the valve structure is inclined towards the posterior side of the left ventricle, with the plane defined by the ventricular end of the valve structure at least partially facing the posterior wall of the left ventricle, much of the blood flow through the valve leaflets from the atrium to the left ventricle is Petition 870250101878, dated 06 / 11 / 2025, page 16 / 88 9 / 67 directed toward the posterior wall of the left ventricle. The blood flow from the atrium to the left ventricle that is 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] For some applications, the individual's native anatomy is used to facilitate one or both of the techniques described above. Typically, the valve frame is anchored to the individual's native mitral valve, inter alia, by rotating at least a portion of the valve frame so that the arms pull the native valve leaflets radially inward, recruiting at least a portion of the chords of the native mitral valve, and subsequently causing the valve frame body to expand radially so as to clamp the native valve leaflets. Typically, the anterior and posterior native leaflets are clamped by the valve frame.Since the posterior cusp is shorter than the anterior cusp, in some cases, its anchoring acts as a pivot and causes the valve frame to (a) be implanted off-center relative to the center of the annular plane, with the valve frame positioned toward the posterior side of the annular plane, and / or (b) be implanted at an angle toward the posterior face of the left ventricle with the plane defined by the ventricular end of the. Petition 870250101878, dated 06 / 11 / 2025, p. 17 / 88 10 / 67 valve structure at least partially facing the posterior wall of the left ventricle.

[0016] Therefore, according to some embodiments of the present invention, an apparatus is provided for use with a prosthetic valve configured to be implanted within a native mitral valve of a mammal, the native mitral valve including a valve ring, valve leaflets, chordae tendineae and papillary muscles, wherein the apparatus includes: A valve structure configured to support the prosthetic valve within the native mitral valve, wherein the valve structure includes a frame body and a plurality of arms configured to extend from the frame body; and a dispensing device configured to: to dispense with the valve structure to the native mitral valve; Position the valve structure so that one center of the valve structure is off-center relative to the center of an annular plane of the valve ring and faces a posterior side of the annular plane; Subsequently, use the arms between the chords of the native mitral valve; Subsequently, rotate at least a portion of the valve structure so that the arms pull the valve leaflets of the native valve radially inward, recruiting at least a portion of the valve chords. Petition 870250101878, dated 06 / 11 / 2025, p. 18 / 88 11 / 67 native mitral valve; and subsequently, cause the body of the valve structure to expand radially, so as to secure the leaflets of the native valve, and so that the valve structure is employed with the center of the valve structure off-center with respect to the center of the annular plane and is positioned towards the posterior side of the annular plane.

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

[0018] In some embodiments, the dispensing device is configured to cause blood flow through the prosthetic valve to be off-center relative to the center of the annular plane, causing the valve structure body to expand radially, so that the valve structure is implanted with the center of the valve structure off-center relative to the center of the annular plane, and is positioned towards the posterior side of the annular plane.

[0019] In some embodiments, the dispensing device is configured to position the valve structure so that the center of the valve structure is Petition 870250101878, dated 06 / 11 / 2025, page 19 / 88 12 / 67 approximately aligned with a line of coaptation of the anterior and posterior leaflets native to the individual's mitral valve.

[0020] In some embodiments, by positioning the valve structure so that the center of the valve structure is approximately aligned with the coaptation line of the native leaflets of the anterior and posterior mitral valves of the individual, the dispensing device is configured to cause approximately equal numbers of anterior and posterior chords to be captured when the valve structure portion is rotated.

[0021] In some embodiments, the dispensing device is configured to: Position the valve structure so that the valve structure is angled toward a posterior side of the left ventricle with a plane defined by a ventricular end of the valve structure at least partially facing a posterior wall of the left ventricle; and cause the body of the valve structure to expand radially, so that the valve structure is employed at an angle toward the posterior side of the left ventricle with the plane defined by the ventricular end of the valve structure at least partially facing the posterior wall of the left ventricle.

[0022] In some forms, the device of Petition 870250101878, dated 06 / 11 / 2025, page 20 / 88 The 13 / 67 dispensation is configured to cause blood flow through the prosthetic valve to be directed toward the posterior wall of the left ventricle, causing the body of the valve structure to expand radially, so that the valve structure is implanted at an angle toward the posterior side of the left ventricle with the plane defined by the ventricular end of the valve structure at least partially facing the posterior wall of the left ventricle.

[0023] In some embodiments, the dispensing device is configured to cause the valve structure body to expand radially, so that the plane defined by the ventricular end of the valve structure forms an angle with respect to the annular plane of more than 5 degrees.

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

[0025] In some embodiments, the dispensing device is configured to cause the body of the valve structure to expand radially, so that the plane defined by the ventricular end of the Petition 870250101878, dated 06 / 11 / 2025, page 21 / 88 14 / 67 valve structure forms an angle with respect to the annular plane between 5 and 40 degrees.

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

[0027] A method is further provided, according to some embodiments of the present invention, for use with a prosthetic valve configured to be implanted within a native mitral valve of a mammalian heart, the native mitral valve including a valve ring, valve leaflets, chordae tendineae and papillary muscles, wherein the method includes: to place a valve structure within the individual's heart, wherein the valve structure includes a valve structure body and a plurality of arms that are configured to extend from the valve structure body; Position the valve structure so that one center of the valve structure is off-center relative to the center of an annular plane of the valve ring and is positioned toward a rear side of the annular plane; Subsequently, use the arms between the chords of the native mitral valve; subsequently, rotate at least a portion of the Petition 870250101878, dated 06 / 11 / 2025, p. 22 / 88 15 / 67 valve structure, so as to cause the arms to pull the leaflets of the native valve radially inward, recruiting at least a portion of the chords of the native mitral valve; and subsequently, to cause the body of the valve structure to expand radially, so as to secure the leaflets of the native valve, and so that the valve structure is employed with the center of the valve structure off-center relative to the center of the annular plane and positioned toward the posterior side of the annular plane, wherein the valve structure supports the prosthetic valve within the native mitral valve.

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

[0029] In some embodiments, causing the valve structure body to expand radially, so that the valve structure is implanted with the center of the structure Petition 870250101878, dated 06 / 11 / 2025, p. 23 / 88 16 / 67 of the valve being off-center relative to the center of the annular plane and positioned toward the posterior side of the annular plane involves causing blood flow through the prosthetic valve to be off-center relative to the center of the annular plane.

[0030] In some embodiments, positioning the valve structure so that the center of the valve structure is off-center with respect to the center of the annular plane of the valve ring and positioned toward the posterior side of the annular plane includes positioning the valve structure so that the center of the valve structure is approximately aligned with a line of coaptation of the native anterior and posterior valve leaflets of the individual's mitral valve.

[0031] In some embodiments, positioning the valve structure so that the center of the valve structure is approximately aligned with the coaptation line of the native anterior and posterior mitral valve leaflets of the individual includes causing an approximately equal number of anterior and posterior chordae tendineae to be captured when the valve structure portion is rotated.

[0032] In some forms, the method additionally includes: position the valve structure so that the structure Petition 870250101878, dated 06 / 11 / 2025, p. 24 / 88 17 / 67 of the valve is angled toward a posterior side of a left ventricle of the individual's heart with a plane defined by a ventricular end of the valve structure at least partially facing a posterior wall of the left ventricle; and cause the body of the valve structure to expand radially, so that the valve structure is employed angled toward the posterior side of the left ventricle with the plane defined by the ventricular end of the valve structure at least partially facing the posterior wall of the left ventricle.

[0033] In some embodiments, causing the valve structure body to expand radially, so that the valve structure is implanted at an angle towards the posterior side of the left ventricle, includes causing blood flow through the prosthetic valve to be directed towards the posterior wall of the left ventricle.

[0034] In some embodiments, causing the valve structure body to expand radially so that the valve structure is implanted at an angle toward the posterior side of the left ventricle includes causing the valve structure body to expand radially so that the plane defined by the ventricular end of the valve structure forms an angle with respect to the annular plane of more than 5 degrees. Petition 870250101878, dated 06 / 11 / 2025, p. 25 / 88 18 / 67

[0035] In some embodiments, causing the valve structure body to expand radially so that the valve structure is implanted at an angle toward the posterior side of the left ventricle includes causing the valve structure body to expand radially so that the plane defined by the ventricular end of the valve structure forms an angle with respect to the annular plane of more than 15 degrees.

[0036] In some embodiments, causing the valve structure body to expand radially so that the valve structure is implanted at an angle toward the posterior side of the left ventricle includes causing the valve structure body to expand radially so that the plane defined by the ventricular end of the valve structure forms an angle with respect to the annular plane between 5 and 40 degrees.

[0037] In some embodiments, causing the valve structure body to expand radially so that the valve structure is implanted at an angle toward the posterior side of the left ventricle includes causing the valve structure body to expand radially so that the plane defined by the ventricular end of the valve structure forms an angle with respect to the annular plane between 15 and 25 degrees.

[0038] It is additionally provided, in accordance with some Petition 870250101878, dated 06 / 11 / 2025, p. 26 / 88 19 / 67 embodiments of the present invention, an apparatus for use with a prosthetic valve configured to be implanted within a native mitral valve of a mammal, wherein the native mitral valve includes a valve ring, valve leaflets, chordae tendineae and papillary muscles, the apparatus including: a valve structure configured to support the prosthetic valve within the native mitral valve, wherein the valve structure includes a structure body and a plurality of arms configured to extend from the structure body; and a dispensing device configured to: dispense the valve structure to the native mitral valve; position the valve structure so that the valve structure is angled toward a posterior side of the left ventricle with a plane defined by a ventricular end of the valve structure at least partially facing a posterior wall of the left ventricle; Subsequently, use the arms between the chords of the native mitral valve; Subsequently, rotate at least a portion of the valve structure so as to cause the arms to pull the leaflets of the native mitral valve radially inward, recruiting at least a portion of the chordae tendineae of the native mitral valve; and subsequently, cause the body of the structure of Petition 870250101878, dated 06 / 11 / 2025, p. 27 / 88 20 / 67 valve structure expands radially so as to secure the leaflets of the native valve, and so that the valve structure is employed angled toward the posterior side of the left ventricle with the plane defined by the ventricular end of the valve structure at least partially facing the posterior wall of the left ventricle.

[0039] In some embodiments, the dispensing device is configured to use a native posterior leaflet as a pivot to cause the valve structure to be implanted angled toward the posterior side of the left ventricle with the plane defined by the ventricular end of the valve structure at least partially facing the posterior wall of the left ventricle.

[0040] In some embodiments, the dispensing device is configured to cause blood flow through the prosthetic valve to be directed toward the posterior wall of the left ventricle, causing the body of the valve structure to expand radially, so that the valve structure is implanted at an angle toward the posterior side of the left ventricle with the plane defined by the ventricular end of the valve structure at least partially facing the posterior wall of the left ventricle.

[0041] In some embodiments, the dispensing device is configured to cause the body of Petition 870250101878, dated 06 / 11 / 2025, page 28 / 88 21 / 67 valve structure expands radially, so that the plane defined by the ventricular end of the valve structure forms an angle with respect to the annular plane of more than 5 degrees.

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

[0043] In some embodiments, the dispensing device is configured to cause the valve structure body to expand radially, so that the plane defined by the ventricular end of the valve structure forms an angle with respect to the annular plane between 5 and 40 degrees.

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

[0045] In some embodiments, the dispensing device is configured to: position the valve structure so that a center Petition 870250101878, dated 06 / 11 / 2025, page 29 / 88 22 / 67 of the valve structure is off-center relative to the center of an annular plane of the valve ring and is positioned toward a posterior side of the annular plane; and cause the body of the valve structure to expand radially so that the valve structure is employed with the center of the valve structure off-center relative to the center of the annular plane and is positioned toward the posterior side of the annular plane.

[0046] In some embodiments, the dispensing device is configured to cause blood flow through the prosthetic valve to be off-center relative to the center of the annular plane, causing the valve structure body to expand radially, so that the valve structure is implanted with the center of the valve structure off-center relative to the center of the annular plane, and is positioned towards the posterior side of the annular plane.

[0047] In some embodiments, the dispensing device is configured to position the valve structure so that the center of the valve structure is approximately aligned with a line of coaptation of the anterior and posterior leaflets native to the individual's mitral valve.

[0048] In some embodiments, by positioning the valve structure so that the center of the valve structure Petition 870250101878, dated 06 / 11 / 2025, p. 30 / 88 23 / 67 is approximately aligned with the coaptation line of the native leaflets of the anterior and posterior mitral valve of the individual, the dispensing device is configured to cause approximately equal numbers of anterior and posterior chords to be captured when the portion of the valve structure is rotated.

[0049] A method is further provided, according to some embodiments of the present invention, for use with a prosthetic valve configured to be implanted within a native mitral valve of a mammalian heart, the native mitral valve including a valve ring, valve leaflets, chordae tendineae and papillary muscles, wherein the method includes: to place a valve structure within the individual's heart, wherein the valve structure includes a valve structure body and a plurality of arms that are configured to extend from the valve structure body; Position the valve structure so that it is angled toward a posterior side of the left ventricle of the individual's heart, with a plane defined by a ventricular end of the valve structure at least partially facing a posterior wall of the left ventricle; Subsequently, use the arms between the chords of the native mitral valve; subsequently, rotate at least a portion of the Petition 870250101878, dated 06 / 11 / 2025, p. 31 / 88 24 / 67 valve structure, so as to cause the arms to pull the leaflets of the native valve radially inward, recruiting at least a portion of the chords of the native mitral valve; and subsequently, to cause the body of the valve structure to expand radially, so as to ensnare the leaflets of the native valve, and so that the valve structure is employed angled toward the posterior side of the left ventricle with the plane defined by the ventricular end of the valve structure at least partially facing the posterior wall of the left ventricle, wherein the valve structure supports the prosthetic valve within the native mitral valve.

[0050] In some embodiments, causing the valve structure body to expand radially so that the valve structure is implanted at an angle toward the posterior side of the left ventricle with the plane defined by the ventricular end of the valve structure at least partially facing the posterior wall of the left ventricle includes the use of a native posterior leaflet as a pivot to cause the valve structure to be implanted at an angle toward the posterior side of the left ventricle with the plane defined by the ventricular end of the valve structure at least partially facing the posterior wall of the left ventricle. Petition 870250101878, dated 06 / 11 / 2025, page 32 / 88 25 / 67

[0051] In some embodiments, causing the valve structure body to expand radially, so that the valve structure is implanted at an angle towards the posterior side of the left ventricle, includes causing blood flow through the prosthetic valve to be directed towards the posterior wall of the left ventricle.

[0052] In some embodiments, causing the valve structure body to expand radially so that the valve structure is implanted at an angle toward the posterior side of the left ventricle includes causing the valve structure body to expand radially so that the plane defined by the ventricular end of the valve structure forms an angle with respect to the annular plane of more than 5 degrees.

[0053] In some embodiments, causing the valve structure body to expand radially so that the valve structure is implanted at an angle toward the posterior side of the left ventricle includes causing the valve structure body to expand radially so that the plane defined by the ventricular end of the valve structure forms an angle with respect to the annular plane of more than 15 degrees.

[0054] In some embodiments, causing the valve structure body to expand radially, so that the valve structure is deployed at an angle towards the Petition 870250101878, dated 06 / 11 / 2025, p. 33 / 88 26 / 67 posterior side of the left ventricle, includes causing the body of the valve structure to expand radially, so that the plane defined by the ventricular end of the valve structure forms an angle with respect to the annular plane between 5 and 40 degrees.

[0055] In some embodiments, causing the valve structure body to expand radially so that the valve structure is implanted at an angle toward the posterior side of the left ventricle includes causing the valve structure body to expand radially so that the plane defined by the ventricular end of the valve structure forms an angle with respect to the annular plane between 15 and 25 degrees.

[0056] In some forms, the method additionally includes: Position the valve structure so that a center of the valve structure is off-center with respect to the center of an annular plane of the valve ring and is positioned toward a posterior side of the annular plane; and cause the body of the valve structure to expand radially so that the valve structure is employed with the center of the valve structure off-center with respect to the center of the annular plane and is positioned toward the posterior side of the annular plane.

[0057] In some modalities, causing the body to Petition 870250101878, dated 06 / 11 / 2025, page 34 / 88 27 / 67 valve structure expands radially, so that the valve structure is implanted with the center of the valve structure off-center relative to the center of the annular plane and positioned towards the posterior side of the annular plane, including causing the blood flow through the prosthetic valve to be off-center relative to the center of the annular plane.

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

[0059] In some embodiments, positioning the valve structure so that the center of the valve structure is approximately aligned with the coaptation line of the native anterior and posterior mitral valve leaflets of the individual's mitral valve includes causing an approximately equal number of anterior and posterior chordae tendineae to be captured when the valve structure portion is rotated.

[0060] The present invention will be more fully understood from the following detailed description of Petition 870250101878, dated 06 / 11 / 2025, p. 35 / 88 28 / 67 its applications, taken together with the drawings, in which: Brief Description of the Drawings Figures 1A and 1B are schematic illustrations showing a dispensing device being guided toward the left ventricle of an individual, according to some applications of the present invention; Figures 2A, 2B and 2C are schematic illustrations of internal and external steerable catheters of a dispensing device, according to some applications of the present invention; Figures 3A and 3B are schematic illustrations showing a capsule of a dispensing device, according to some applications of the present invention; Figures 4A, 4B and 4C are schematic illustrations of the proximal and distal capsule portions of the dispensing device, according to some applications of the present invention; Figure 5 is a schematic illustration of a stage and a handle portion of the dispensing device, according to some applications of the present invention; Figures 6A and 6B are schematic illustrations of a dispensing device, according to some applications of the present invention; Figures 7A, 7B, 7C, and 7D are schematic illustrations. Petition 870250101878, dated 06 / 11 / 2025, page 36 / 88 29 / 67 of a valve structure configured to support a prosthetic valve within the native atrioventricular valve of an individual, the figures showing the valve structure arranged in a non-radially constrained configuration, according to some applications of the present invention; Figures 8A, 8B, 8C, 8D and 8E are schematic illustrations of the respective steps in the implantation of a mitral valve prosthesis via a transseptal approach, according to some applications of the present invention; Figure 9A is a schematic illustration showing an anterior-posterior cross-section of the left ventricle of an individual; Figure 9B is a schematic illustration of an anterior-posterior cross-section of the left ventricle of an individual with a prosthetic mitral valve structure, which supports valve leaflets, implanted in the mitral valve, such that the center of the valve structure is off-center relative to the center of the annular plane and is positioned towards the posterior side of the annular plane, according to some applications of the present invention; and Figure 9C is a schematic illustration of an anterior-posterior cross-section of the left ventricle of an individual, with a prosthetic mitral valve structure supporting valve leaflets implanted in the mitral valve, so that the valve structure is inclined towards the Petition 870250101878, dated 06 / 11 / 2025, p. 37 / 88 30 / 67 posterior side of the left ventricle (that is, so that the leaflets point towards the posterior wall of the left ventricle), according to some applications of the present invention. Detailed description of the modalities

[0061] Reference is now made to Figures 1A and 1B, which are schematic illustrations showing the conduction of a dispensing device 20 towards the native mitral valve of an individual 46 and / or left ventricle 54, by means of a transseptal dispensing approach, according to some applications of the present invention. As shown in Figure 1A, the distal end of the dispensing device 20 is typically conducted from the vena cava 42 of the individual to the right atrium 43 of the individual, and from there to the left atrium 50 of the individual, through the interatrial septum 52. The distal end of the dispensing device is conducted towards the native mitral valve and typically conducted through the leaflets 58 of the native mitral valve and into the left ventricle 54, as shown in Figure 1B. For some applications, the dispensing device 20 is guided towards the individual's native mitral valve 46 over a guide wire 48.Typically, the dispensing device is used to dispense a percutaneously implantable medical device, such as a prosthetic mitral valve (as shown schematically in the Figures). Petition 870250101878, dated 06 / 11 / 2025, p. 38 / 88 31 / 67 7A-8C), a mitral valve repair device (such as an annuloplasty ring or a mitral leaflet clip), artificial chordae tendineae, and / or a different percutaneously implantable medical device.

[0062] For some applications, the dispensing device includes the capsule 40 at its distal end. Typically, the percutaneously implantable medical device is held in a crimped (i.e., radially constrained) configuration within the capsule during dispensing of the medical device to the individual's mitral valve and / or left ventricle. Additionally, typically, to implant the device into the individual's mitral valve and / or left ventricle, the medical device is released from the capsule, as described in further detail below in this document. For some applications, the medical device is a self-expanding medical device configured to expand radially upon release from the capsule. For example, the medical device may include a shape-memory alloy (such as nitinol) that is set to a desired radially expanded configuration.Alternatively or additionally, the device can be actively expanded radially after being released from the capsule (e.g., by balloon expansion). For some applications, a distal portion of the medical device is released from the capsule first, followed by a proximal portion. Petition 870250101878, dated 06 / 11 / 2025, page 39 / 88 32 / 67 subsequently released from the capsule, as described in further detail below in this document.

[0063] Reference is now made to Figures 2A, 2B and 2C, which are schematic illustrations of an externally steerable catheter 22 and an internally steerable catheter 24 of the dispensing device 20, according to some applications of the present invention. Figures 2A and 2B show side views and Figure 2C shows a cross-sectional view of the externally and internally steerable catheters. As shown in the transition from Figure 2A to Figure 2B, typically the internally steerable catheter is axially slidable relative to the externally steerable catheter. Typically, during the conduction of the dispensing device 20 from the individual's vena cava 42 to the individual's left atrium 50, through the interatrial septum 52 (anatomy shown in Figures 1A-B), the distal end of the internally steerable catheter is disposed within the externally steerable catheter, as shown in Figure 2A.Furthermore, typically, once the distal end of the externally steerable catheter is positioned within the left atrium, the internally steerable catheter is guided out of the distal end of the externally steerable catheter (i.e., the configuration shown in Figure 2B) and then directed toward the mitral valve and / or left ventricle of the individual. For some applications, the catheter... Petition 870250101878, dated 06 / 11 / 2025, p. 40 / 88 The 33 / 67 internal steerable catheter is configured to be steered independently of the external steerable catheter, once the internal steerable catheter has been guided out of the distal end of the external steerable catheter.

[0064] For some applications, the external steerable catheter includes first and second directional deflection cables 26 that are configured to be operated by a user to direct the distal end of the external catheter through a first external steerable catheter deflection plane, toward the individual's interatrial septum. Alternatively (embodiment not shown), the external catheter includes only a single directional deflection cable 26 that is configured to be operated by a user to direct the distal end of the external steerable catheter through the first external steerable catheter deflection plane toward the individual's interatrial septum. Typically, in addition to one or more directional deflection cables 26, the external catheter includes a height adjustment deflection cable 28.Typically, the height-adjustable deflection cable 28 is configured to be operated by a user to deflect the distal end of the externally steerable catheter from within the left atrium toward the roof of the left atrium, directing the tip of the externally steerable catheter through a second externally steerable catheter deflection plane. Typically, the second... Petition 870250101878, dated 06 / 11 / 2025, page 41 / 88 34 / 67 The deflection plane of the external steerable catheter is perpendicular to the first deflection plane of the external steerable catheter. Consequently, the height adjustment deflection cable 28 is typically arranged at a 90-degree angle to the direction deflection cable(s) 26, as shown in Figure 2C.

[0065] For some applications, the directional deflection cables 26 are configured to guide the distal end of the externally steerable catheter through the first externally steerable catheter deflection plane through an angle between 0 degrees and more than 60 degrees, or more than 75 degrees (e.g., 0-90 degrees). For some applications, the height adjustment deflection cable 28 is configured to guide the distal end of the externally steerable catheter through the second externally steerable catheter deflection plane through an angle between 0 degrees and more than 30 degrees, or more than 40 degrees (e.g., 0-45 degrees), to deflect the distal end of the externally steerable catheter from within the left atrium towards the roof of the left atrium.

[0066] Note that in Figure 2C, each direction deflection cable is shown as being bent. This is because, typically, each direction deflection cable follows an initial path from a proximal end of the catheter to the distal end of the catheter, before continuing... Petition 870250101878, dated 06 / 11 / 2025, page 42 / 88 35 / 67 a return path from the distal end of the catheter to the proximal end of the catheter.

[0067] It is observed that within the left atrium, the internally steerable catheter typically needs to maneuver through a curve of approximately 90 degrees. This occurs because the internally steerable catheter is guided outward from the externally steerable catheter after the externally steerable catheter has penetrated the interatrial septum. Thus, the tip of the internally steerable catheter typically advances from the externally steerable catheter in a lateral direction and must be directed in an inferior-anterior direction to be guided toward the mitral valve. Typically, the externally steerable catheter is made to penetrate the interatrial septum below the atrial roof, as shown in Figures 1A-B (e.g., in a posterior-inferior or posterior-superior location), since the septum is thinner and more easily penetrated at this location.As described above, the height-adjusting deflection cable 28 is configured to be operated by a user to deflect the distal end of the externally steerable catheter from within the left atrium toward the roof of the left atrium. Typically, this provides the internally steerable catheter with greater height to maneuver through the curve described above, so that the curve is less sharp, and also provides height for the capsule to implant above the... Petition 870250101878, dated 06 / 11 / 2025, page 43 / 88 36 / 67 ring.

[0068] Typically, the internally steerable catheter 22 includes one or more directional deflection cables 30. For some applications, the internally steerable catheter includes (a) a first set 32 ​​of one or more (e.g., a pair of) directional deflection cables that are configured to be operated by a user to guide the distal end of the internally steerable catheter through a first plane of deflection of the internally steerable catheter, toward the individual's mitral valve, and (b) a second set 34 of one or more (e.g., a pair of) directional deflection cables configured to be operated by a user to guide the distal end of the internally steerable catheter through a second plane of deflection of the internally steerable catheter, so as to align the distal end of the internally steerable catheter with the individual's mitral valve.

[0069] For some applications, the first set of 32 direction deflection cables is configured to direct the distal end of the internal steerable catheter through the first internal steerable catheter deflection plane through an angle between 0 degrees and more than 80 degrees, or more than 100 degrees (e.g., 120 degrees). For some applications, the second set of 34 direction deflection cables is configured to direct the distal end Petition 870250101878, dated 06 / 11 / 2025, page 44 / 88 37 / 67 of the internally steerable catheter through the second deflection plane of the internally steerable catheter through an angle of at least between -45 degrees and +45 degrees, so as to align the distal end of the internally steerable catheter with the individual's mitral valve. Typically, the 32 assembly of the steerable deflection cable(s) is arranged at a 90-degree angle to the second 34 assembly of the steerable deflection cable(s), as shown in Figure 2C.

[0070] Reference is now made to Figures 3A and 3B, which are schematic illustrations showing the capsule 40 of the dispensing device 20, according to some applications of the present invention. Typically, the medical device is held in a crimped configuration (i.e., radially restricted) within the capsule during dispensing of the medical device to an implantation site (such as the mitral valve and / or left ventricle of the individual). Furthermore, typically, to implant the device at the implantation site, the medical device is released from the capsule. It is noted that a capsule as shown in Figures 3A-B (as well as in Figures 4A-C) can be used with any medical device that is dispensed to the implantation site within an individual's body in a crimped configuration and is not limited to being used with devices that are implanted within the mitral valve and / or left ventricle. For example, a capsule as shown Petition 870250101878, dated 06 / 11 / 2025, p. 45 / 88 38 / 67 in Figures 3A-B (as well as in Figures 4A-C) can be used with a medical device that is dispensed to the aorta, vena cava, tricuspid valve, right ventricle, right atrium, right ventricle, pulmonary vein, pulmonary artery, etc.

[0071] For some applications, the capsule includes a distal capsule portion 60 configured to maintain a distal portion of the medical device in a radially restricted configuration during dispensing of the medical device to the implantation site and a proximal capsule portion 62 configured to maintain a proximal portion of the medical device in a radially restricted configuration during dispensing of the medical device to the implantation site. Typically, the proximal and distal portions are reversibly attachable to each other, as described in further detail below in this document. For some applications, the capsule additionally includes a conical distal tip 70 that is configured to facilitate conduction of the capsule into the individual's vasculature and subsequently acts as a dilator for conduction through the interatrial septum.Typically, the distal tip is made of a soft material so that the tip is atraumatic and does not cause injury to the individual's tissue during the guidance of the dispensing device to the implantation site. The distal tip typically allows the system to be guided on a guidewire, and its soft material is... Petition 870250101878, dated 06 / 11 / 2025, page 46 / 88 39 / 67 conformity with the direction of the guide wire.

[0072] For some applications, an outer rod 64, a medial rod 66, and an inner rod 68 are all arranged within the steerable inner catheter 24 (shown in Figures 2B-C). The outer rod is typically coupled to proximal capsule portions 62, such that axial movement of the outer rod relative to the medial rod and the inner rod transmits axial movement to the proximal capsule portions relative to the medial rod and the inner rod. In order to release the proximal portion of the medical device from within the proximal capsule portion, the outer rod is typically retracted axially, proximally relative to the medial rod and the inner rod, which causes the proximal capsule portion to retract over the proximal portion of the medical device.(Note that, instead of retracting the outer rod, the relative proximal movement of the outer rod in relation to the medial and inner rods can be achieved by advancing the medial and inner rods distally in relation to the outer rod.)

[0073] The inner rod 68 is typically coupled to the distal capsule portion 60, so that axial movement of the inner rod transmits axial movement to the distal capsule portion. (Note that the rotational movement of the distal capsule portion is typically separated from the rotational movement of the inner rod by means of a mechanism of Petition 870250101878, dated 06 / 11 / 2025, page 47 / 88 40 / 67 bearing 72, as described in further detail below in this document with reference to Figures 4A-C.) For some applications, the dispensing device includes a distal device interface 74, which is configured to secure a distal portion of the medical device at a fixed axial location relative to the medial stem, provided that the distal portion of the medical device is kept within the distal capsule portion. For some applications, the distal device interface is a flange extending radially from the medial stem, as shown. In order to release the distal portion of the medical device from within the distal capsule portion, the inner stem is typically driven axially and distally (typically using the techniques described below with reference to Figures 4A-C) relative to the medial stem. This causes the distal capsule portion to be driven distally relative to the distal device interface.Once the proximal end of the distal capsule portion is guided 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).

[0074] Reference is now made to Figures 4A, 4B and 4C, which are schematic illustrations of the capsule portion. Petition 870250101878, dated 06 / 11 / 2025, page 48 / 88 41 / 67 proximal 62 and distal capsule portion 60 of the dispensing device in the respective stages of driving the distal capsule portion 60 relative to the proximal capsule portion 62, according to some applications of the present invention. In some cases, it is desirable to drive the distal capsule portion 60 relative to the proximal capsule portion 62 in a precisely controlled manner. For example, when used with a mitral valve prosthetic structure, as shown in Figures 7A-D, it may be desirable to initially release an intermediate portion of the valve structure (e.g., radially expandable arms of the valve structure) from being covered by the distal capsule portion, without fully releasing the entire distal portion of the valve structure.Typically, to allow a physician to maintain precise control of the conduction of the distal capsule portion 60 relative to the proximal capsule portion 62, the physician uses a rotary control mechanism (e.g., mechanism 108 shown in Figure 5), and the rotary motion of the rotary control mechanism is converted into axial motion of the internal rod 68 (which is coupled to the distal capsule portion). For some of these applications, the conversion of rotary motion to axial motion of the internal rod 68 is effected at the distal end of the internal rod and typically within the capsule. Note that if the conversion of rotary motion to axial motion of the... Petition 870250101878, dated 06 / 11 / 2025, page 49 / 88 42 / 67 inner rod 68 were effected at the proximal end of the inner rod, the axial movement of the inner rod would need to be transmitted along the entire length of the inner rod before being transmitted to the distal capsule portion, which could result in inaccurate transmission of the axial movement to the distal capsule portion. On the other hand, by converting the rotary motion to axial movement of the inner rod 68 at the distal end of the inner rod (according to some applications of the present invention), the axial movement does not need to be transmitted along the entire length of the inner rod before being transmitted to the distal capsule portion. Instead, the axial movement is transmitted from inside the capsule to the distal capsule portion.

[0075] For some applications, the inner rod 68 defines a threaded outer surface 76 at its distal end, and the inner surface of the distal device interface 74 (which is described above as typically a flange) and / or the medial rod 66 is threaded accordingly. The threaded inner surface of the distal device interface 74 and / or the medial rod 66 acts as a nut, so that rotation of the distal end of the inner rod causes the inner rod to be driven distally relative to the distal device interface 74. As described above, typically the device interface Petition 870250101878, dated 06 / 11 / 2025, page 50 / 88 43 / 67 distal 74 protects the distal end of the medical device and, moreover, typically, the axial movement of the inner rod is transmitted to the distal capsule portion. Therefore, the driving of the inner rod relative to the distal device interface 74 causes the distal capsule portion to be driven relative to a distal end of the medical device. As described above, for some applications, the distal capsule portion includes a bearing mechanism 72. The bearing mechanism is configured to separate the rotary motion of the distal capsule portion from the rotary motion of the inner rod. Thus, the rotation of the inner rod causes the distal capsule portion to be driven distally relative to the distal end of the medical device, but without causing the distal capsule portion to rotate.

[0076] Typically, once the medical device has been released from within the capsule 40, the proximal and distal portions of the capsule are reattached to each other before being retracted from within the individual'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 to their attached configuration after the medical device has been implanted. For example, as shown in Figure 4B-C, for some Petition 870250101878, dated 06 / 11 / 2025, p. 51 / 88 In applications 44 / 67, 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, wherein lips 80 and 82 are shaped to slide into place relative to each other. Alternatively, only one of the capsule portions defines a lip, and the lip is configured to receive the other capsule portion (embodiment not shown). Typically, when the proximal and distal portions are correctly coupled together, they are shaped to define a substantially smooth outer surface. In this way, during the conduction of the capsule to the medical device implantation site, the capsule is atraumatic and does not cause damage to the individual's tissue. Similarly, during the retraction of the capsule from the medical device implantation site, the capsule is atraumatic and does not cause damage to the individual's tissue or the implanted medical device.For some applications, the aforementioned lip is formed as a complete ring (as shown). For some applications (not shown), a lip that is generally as described above is divided into multiple separate, arc-shaped segments. For example, the lip may be formed from 4 arc-shaped segments, spaced 90 degrees apart and each covering a 30-degree arc. In this way, the medical device can be released. Petition 870250101878, dated 06 / 11 / 2025, page 52 / 88 45 / 67 before the entire capsule is removed, thus saving the height required to release the medical device.

[0077] Figure 5 is a schematic illustration of a stage 90 and loop portion 92 of the dispensing device, according to some applications of the present invention. For some applications, the loop portion includes a first loop 94 configured to control the direction of the external steerable catheter 22, a second loop 96 configured to control the direction of the internal steerable catheter 24, and an implantation loop 98 configured to control the release of the medical device from the capsule 40.

[0078] Typically, the first loop 94 includes a first rotary control mechanism 100 to control the direction deflection cables 26 (which are configured to be operated by a user to direct the distal end of the externally steerable catheter through a first externally steerable catheter deflection plane toward the individual's interatrial septum). Additionally, typically, the first loop 94 includes a second rotary control mechanism 102 to control the height adjustment deflection cable 28 (which is configured to be operated by a user to deflect the distal end of the externally steerable catheter from within the left atrium toward the roof of the left atrium, directing the tip of the externally steerable catheter through a second plane). Petition 870250101878, dated 06 / 11 / 2025, page 53 / 88 46 / 67 deflection of the external steerable catheter).

[0079] Typically, the second loop 96 includes a first rotary control mechanism 104 to control the first set 32 ​​of directional deflection cables (which are configured to be operated by a user to direct the distal end of the internally steerable catheter through a first internally steerable catheter deflection plane, toward the individual's mitral valve). Additionally, typically, the second loop 96 includes a second rotary control mechanism 106 to control the second set 34 of directional deflection cables (which are configured to be operated by a user to orient the distal end of the internally steerable catheter through a second internally steerable catheter deflection plane, so as to align the distal end of the internally steerable catheter with the individual's mitral valve).

[0080] As described above, the implantation loop typically includes a rotary control mechanism 108 to control the axial movement of the distal capsule portion 60. In addition, the implantation loop typically includes a second rotary control mechanism 110 to control the axial movement of the proximal capsule portion 62. Typically, the loop portion includes a plurality of flush ports, through which the respective catheter and Petition 870250101878, dated 06 / 11 / 2025, page 54 / 88 47 / 67 the stems are washed.

[0081] Typically, stage 90 is configured to position loop portion 92 and allows for position adjustments of the loop portion. For some applications, the stage is configured to facilitate quick attachment of the loop portion to the stage without the need for screws, for example, by means of a pressure-locking mechanism. For some applications, the stage is configured to facilitate modification of the loop portion orientation during the procedure to allow for realignment of the loop portion relative to the percutaneous access point.

[0082] Reference is now made to Figures 6A and 6B, which are schematic illustrations of the dispensing device 20, according to some applications of the present invention. In general, the dispensing device 20, as shown in Figures 6A and 6B, is similar to that shown in Figures 1A-5, except for the differences described below. For some applications, the proximal end of the proximal capsule portion 62 defines a cutout 118. Typically, the cutout is sized so that, as the proximal capsule portion is retracted, the proximal capsule portion is able to overlap a distal end of a dispensing catheter (e.g., the internally steerable catheter 24 of the dispensing device 20, described above with reference to Figures 2A-C). Typically, if it were not for the cutout, Petition 870250101878, dated 06 / 11 / 2025, page 55 / 88 48 / 67 it would be necessary for there to be a space between the distal end of the dispensing catheter and the proximal capsule portion in order to allow the proximal capsule portion to be retracted relative to the dispensing catheter (e.g., to release the proximal end of the implantable device). On the other hand, when the proximal capsule portion includes the cutout 118, the proximal capsule portion is typically disposed adjacent to the distal end of the dispensing catheter, even before the proximal capsule portion is retracted (as shown in Figure 6A). Alternatively, the proximal capsule portion partially overlaps the distal end of the dispensing catheter even before the proximal capsule portion is retracted (embodiment not shown).Subsequently, when the proximal capsule portion 62 is retracted, the proximal end of the proximal capsule portion is made to overlap (or further overlap) with the distal end of the dispensing catheter, by the cutout that slides over the distal end of the dispensing catheter. Typically, the cutout 118 allows the device to occupy less space (i.e., less height) within the left atrium than would otherwise be necessary, removing the need for a space between the distal end of the dispensing catheter and the proximal capsule portion.

[0083] Reference is now made to Figures 7A, 7B, 7C, Petition 870250101878, dated 06 / 11 / 2025, p. 56 / 88 Figures 49 / 67 are schematic illustrations of the respective views of a valve structure 120, wherein the Figures show the valve structure in its non-radially constrained configuration, according to some applications of the present invention. Figure 7A shows a side view of the valve structure, Figure 7B shows a bottom view (i.e., a view of a ventricular end of the valve structure), and Figure 7C shows a top view (i.e., a view of an atrial end of the valve structure). Reference is also made to Figure 7D, which is a schematic illustration of the valve structure 120, with valve leaflets 123 coupled to the valve structure, according to some applications of the present invention.

[0084] Typically, the valve structure includes a valve structure body 121. For some applications, the valve structure body 121 includes a cylindrical portion 122 as well as an atrial portion 126. Typically, the cylindrical portion is configured to support the prosthetic valve within the native atrioventricular valve. For example, the leaflets 123 of the prosthetic valve may be sutured to the cylindrical portion and / or may be coupled to the cylindrical portion, for example, as shown in Figure 7D. Typically, the atrial portion 126 is configured to be implanted at least partially in the individual's atrium. For some applications, the atrial portion 126 includes a disc-shaped portion 128 Petition 870250101878, dated 06 / 11 / 2025, page 57 / 88 50 / 67 (also referred to herein as flange) and a truncated conical portion 130.

[0085] Typically, the disc-shaped portion of the atrial part is configured to seal the valve structure from the tissue on the atrial side of the mitral annulus and is configured to prevent migration of the valve structure into the left ventricle. The truncated cone portion typically extends from the disc-shaped portion of the atrial part to the outer surface of the cylindrical part. For some applications, the inclusion of the truncated cone portion between the disc-shaped portion and the cylindrical part (as opposed to direct coupling of the disc-shaped portion to the cylindrical part) reduces the likelihood of regurgitation around the outer part of the cylindrical part.

[0086] For some applications, the cylindrical part and the atrial part are formed as separate pieces from each other and are joined together, for example, by stitching, gluing, welding and / or other method. Alternatively, the cylindrical part and the atrial part are portions of a single piece formed integrally.

[0087] Typically, the valve structure 120 is made of a shape memory material (for example, a shape memory alloy such as nitinol and / or copper-aluminum-nickel), which is covered on one or both sides with a covering material 132 (shown in Figure 7D), for example, a Petition 870250101878, dated 06 / 11 / 2025, pp. 58 / 88 51 / 67 fabric and / or a polymer (such as expanded polytetrafluoroethylene (ePTFE), or woven, knitted, meshed and / or braided polyester). Typically, the shape memory material of the cylindrical portion 122 and the atrial portion 126 is conformed to a stent-like structure comprising struts and / or cells of the shape memory material. The cover material is typically coupled to the shape memory material by means of points 134 (shown in Figure 7D). Note that Figures 7A-C show the valve structure 120 in the absence of valve leaflets 123 and cover material 132 for illustrative purposes. However, the valve leaflets 123 and cover material 132 can be seen in Figure 7D.

[0088] For some applications, a plurality of chordal recruitment arms 124 (e.g., more than two and / or less than twelve arms) extend from a portion of the valve structure body 121 that is configured to be placed within the individual's ventricle. For example, four chordal recruitment arms or six chordal recruitment arms may extend from the valve structure body. For some applications, a single chordal recruitment arm 124 extends from a portion of the valve structure body 121 that is configured to be placed within the individual's ventricle. Typically, the chordal recruitment arms extend from the part Petition 870250101878, dated 06 / 11 / 2025, page 59 / 88 52 / 67 cylindrical 122 of the valve structure body 121. In addition, typically, the chord recruitment arms extend from a ventricular end of the cylindrical part (i.e., the end of the valve structure body that is configured to be placed inside the ventricle). Typically, in a non-radially restricted configuration of the valve structure (which the valve structure typically assumes when neither the valve structure body nor the chord recruitment arms are restricted by the dispensing device), the arms extend radially from the valve structure body, in addition to extending axially from the ventricular end of the valve structure body toward an atrial end of the valve structure body (i.e., the end of the valve structure body that is configured to be placed inside the atrium).In addition, typically, the arms curve outward from the valve body structure in a specific circumferential direction of curvature.

[0089] Note that descriptions in this document of arms extending from the valve structure body in a given direction should not be interpreted as excluding additional directions in which the arms are oriented. Instead, arms described (or claimed) as extending radially from the valve structure body should be interpreted as Petition 870250101878, dated 06 / 11 / 2025, p. 60 / 88 53 / 67 meaning that the orientation of the arms relative to the valve body includes a radial component. Typically, in addition to extending radially from the valve body, the arms curve circumferentially and, in some cases, the orientation of the arms includes an axial component. For some applications, at least along a portion of the arms, and at least in certain arm configurations, the arms are arranged tangentially relative to the valve body.

[0090] Typically, the valve structure 120 with prosthetic valve leaflets 123 arranged thereon is dispensed to the native atrioventricular valve by means of the dispensing device 20 (which is typically described above), and the dispensing device is configured to maintain the valve structure and the prosthetic valve in radially restricted configurations (i.e., crimped configurations) during dispensing. According to the respective applications, the valve structure is dispensed transapically (i.e., through the apex of the left ventricle), transseptally (i.e., through the vena cava, right atrium, and interatrial septum, as described in detail with reference to Figures 8A-C), and / or through a different dispensing path. For some applications, when a distal end of the device is Petition 870250101878, dated 06 / 11 / 2025, pp. 61 / 88 54 / 67 dispensing is disposed within the individual's ventricle, the 124 chordal recruitment arms are implanted between the chords of the native atrioventricular valve. Typically, the chordal recruitment arms are implanted between the chords of the native atrioventricular valve by releasing the chordal recruitment arms from the dispensing device, wherein the chordal recruitment arms are adjusted to extend from the valve structure body upon being released from the dispensing device. For some applications, additional techniques are used to cause the chordal recruitment arms to be implanted between the chords of the native atrioventricular valve by releasing the chordal recruitment arms from the dispensing device. For example, the valve structure may include lever elements, which are configured to cause the chordal recruitment arms to extend radially.Alternatively or additionally, the arms are coupled to the cylindrical part of the valve structure by means of points, wherein the points act as hinges, so that the arms rotate about the points relative to the cylindrical part, as described below. Typically, the cord recruitment arms are released from the dispensing device while the valve structure body is still held in a configuration at least partially radially constrained by the device. Petition 870250101878, dated 06 / 11 / 2025, page 62 / 88 55 / 67 dispensing. Typically, the valve structure is rotated while the string recruitment arms and valve structure body are configured in the aforementioned configuration. Therefore, in the present application, the configuration of the string recruitment arms when the valve structure body is still held in a configuration at least partially radially restricted by the dispensing device, but the string recruitment arms have been released from the dispensing device, is termed the string recruitment arm rotation configuration.

[0091] Reference is now made to Figures 8A, 8B, 8C, 8D and 8E, which are schematic illustrations of the respective steps in dispensing and implanting a mitral valve prosthesis via a transseptal approach, according to some applications of the present invention. Typically, the prosthetic mitral valve includes a valve structure body as described above, with prosthetic valve leaflets 123 sutured to the cylindrical part and / or otherwise coupled to the cylindrical part 122 of the valve structure, for example, as shown in Figure 7D. As described above, according to the respective applications, the prosthetic mitral valve is administered transseptally (i.e., through the vena cava, right atrium and interatrial septum), or transapically (i.e., through the apex of the ventricle). Petition 870250101878, dated 06 / 11 / 2025, p. 63 / 88 56 / 67 left) and / or through a different dispensing route. Figures 8A-E show the dispensing and implantation steps of a mitral valve prosthesis via the transseptal approach, for illustrative purposes only and not as a limitation.

[0092] Typically, the dispensing device 20 is guided toward the individual's native mitral valve 200 over a guidewire 202. The distal end of the dispensing device 20 is typically guided into the individual's left atrium 204, through the interatrial septum 206. The distal end of the dispensing device is guided toward the native mitral valve and through the leaflets 208 of the native mitral valve and into the left ventricle 210, as shown in Figure 8A. When the distal end of the dispensing device is positioned within the left ventricle, the chordal recruitment arms 124 can expand at least partially radially and assume their rotational configurations, as shown in Figure 8B.For some applications, the arms are allowed to assume non-radially restricted configurations by freeing the arms from being radially restricted by the dispensing device, for example, by partially retracting the proximal capsule portion 62 and / or partially advancing the distal capsule portion 60. Typically, cord recruitment arms are shaped to extend radially from the body. Petition 870250101878, dated 06 / 11 / 2025, p. 64 / 88 57 / 67 of valve structure 121 and curve circumferentially around the valve structure body (e.g., clockwise, as shown), assuming its rotational configurations. For some applications, the chordal recruitment arms are configured to extend axially toward the individual's atrium. Typically, the chordal recruitment arms are configured to be deployed between the chords 212 of the native mitral valve upon release from the dispensing device.

[0093] As shown in Figure 8C, after the chordal recruitment arms 124 are implanted between the chordae tendineae of the native mitral valve, at least a portion of the valve structure is rotated in the direction of arrow 214, so as to cause the chordal recruitment arms 124 to (a) pull the native atrioventricular valve radially inward toward the valve structure, and (b) twist the native atrioventricular valve around the valve structure, recruiting and deflecting at least a portion of the chordae tendineae. Typically, the chordal recruitment arms 124 are configured to bend in a particular circumferential direction relative to the longitudinal geometric axis of the valve structure. For example, the arms may bend clockwise or counterclockwise relative to the longitudinal geometric axis of the valve structure. Typically, after the chordal recruitment arms 124 are Petition 870250101878, dated 06 / 11 / 2025, p. 65 / 88 58 / 67 implanted between the chordae of the native mitral valve, the valve structure is rotated in the same circumferential direction as the direction of the circumferential curvature of the arms. In the example shown in Figure 8C, the arms curve circumferentially in a clockwise direction (as seen from the left atrium 204), and the valve structure is rotated in that direction.

[0094] For some applications, before rotating the valve structure in the same circumferential direction as the direction of the circumferential curvature of the arms, the valve structure is rotated in the opposite circumferential direction. For some applications, the dispensing device 20 is configured so as to automatically perform the initial rotation of the valve structure through a given angle against the direction of the circumferential curvature of the arm and subsequently rotate the valve structure through a predetermined angle in the direction of the circumferential curvature of the arms.For some applications, in the arm rotation configuration (shown in Figures 8BC), the outer surfaces of each arm have a smooth, convex curvature that extends substantially along the entire length of the arm, so that during the initial rotation (against the direction of the arm's circumferential curvature) the strings slide over the outer surfaces of the arm without being recruited or captured by the arm. For some applications, by virtue of... Petition 870250101878, dated 06 / 11 / 2025, pp. 66 / 88 59 / 67 of the arms being shaped in this way, the initial rotation of the valve structure causes a relatively large number of chords to be positioned so as to be recruited by each of the arms in the subsequent rotation step. During the subsequent rotation of the valve structure (in the direction of the circumferential curvature of the arms, for example, the direction of arrow 214 as shown in Figure 8C), the chords are recruited and deflected by the arms. Typically, in the arm rotation configuration (shown in Figures 8B-C), the inner surface of the arm has a concave curvature and the chords are recruited within the space defined by the concave curvature during the subsequent rotation by the valve structure.

[0095] After the chordal recruitment arms 124 have been released and the valve structure 120 has been rotated, the valve structure body 121 (i.e., cylindrical part 122 and atrial part 126 of the valve structure) can assume its non-radially restricted configurations. For some applications, the atrial part is allowed to assume its non-radially restricted configuration by releasing the atrial part from the dispensing device, for example, by retracting the proximal capsule portion 62. For some applications, the cylindrical part is allowed to assume its non-radially restricted configuration by releasing the cylindrical part from the dispensing device, for example, by leading the portion Petition 870250101878, dated 06 / 11 / 2025, pp. 67 / 88 60 / 67 of distal capsule 60. Figure 8D shows the cylindrical portion 122 and the atrial portion 126 in their non-radially restricted (i.e., radially expanded) configurations. Typically, by the valve structure body assuming its non-radially restricted configuration, the valve structure body is configured to enclose the native valve leaflets 208 in a partially closed and twisted configuration, thus at least partially sealing a gap between the native mitral valve and the prosthetic valve. For example, the cylindrical portion may be configured to expand radially so as to enclose the native valve leaflets between the cylindrical portion and the chordal recruitment arms, and / or the atrial portion may be configured to expand radially so as to enclose the native valve leaflets between the atrial portion and the chordal recruitment arms.For some applications, trapping the leaflets of the native valve 208 in a partially closed and twisted configuration is achieved by trapping the cords (which are attached to the leaflets) in twisted configurations. Subsequently, after the steps described above have been performed, the dispensing device 20 is typically fully retracted from the individual's left atrium, as shown in Figure 8E.

[0096] Reference is now made to Figure 9A, which is a schematic illustration of a previous cross-section. Petition 870250101878, dated 06 / 11 / 2025, pages 68 / 88 61 / 67 posterior of a healthy left ventricle 210, in the absence of any implanted device. As is well known, the anterior cusp 208A is substantially larger than the posterior cusp 208P. As a result, the leaflet coaptation line (i.e., the line where the anterior and posterior leaflets coapt to each other) is off-center relative to the center 220 of the annular plane and is positioned on the posterior side of the left ventricle. Typically, the fact that the leaflet coaptation line is off-center relative to the center 220 of the annular plane causes the blood flow from the atrium to the left ventricle to be off-center relative to the center of the annular plane. As indicated by the blood flow arrow 222 in Figure 9A, the off-center blood flow from the atrium to the left ventricle relative to the center of the annular plane generates efficient blood flow from the left ventricle to the aorta 224.Furthermore, the anterior cusp directs much of the blood flow from the atrium to the left ventricle towards the posterior wall 225, which additionally generates efficient blood flow from the left ventricle and to the aorta 224.

[0097] Reference is now made to Figure 9B, which is a schematic illustration of an anterior-posterior cross-section of the left ventricle of an individual with a prosthetic mitral valve structure 120 (which supports leaflets Petition 870250101878, dated 06 / 11 / 2025, pp. 69 / 88 62 / 67 of valve 123) implanted in the mitral valve, so that the center of the valve structure is off-center relative to the center 220 of the annular plane, and is positioned towards the posterior side of the annular plane, according to some applications of the present invention. It is observed that prior art prosthetic mitral valves are typically implanted in the center of the annular plane, so that blood flow through the prosthetic mitral valve is not off-center relative to the center of the annular plane. Typically, by the valve structure of the present disclosure that is implanted in the individual's mitral valve, so that the center of the valve structure is positioned towards the posterior side of the annular plane, blood flow through the valve leaflets from the atrium to the left ventricle is off-center relative to the center of the annular plane.As indicated by the blood flow arrow 222 in Figure 9B, blood flow from the atrium to the left ventricle that is off-center relative to the center of the annular plane generates efficient blood flow from the left ventricle and toward the aorta 224 (similar to blood flow through a healthy native mitral valve).

[0098] Reference is now made to Figure 9C, which is a schematic illustration of an anterior-posterior cross-section of the left ventricle of an individual, with the prosthetic structure of the mitral valve 120 (which supports the Petition 870250101878, dated 06 / 11 / 2025, pp. 70 / 88 63 / 67 valve leaflets 123) implanted in the mitral valve, so that the valve structure is inclined towards the posterior side of the left ventricle (i.e., so that the leaflets open towards the posterior wall of the left ventricle), according to some applications of the present invention. It is observed that the prior art prosthetic mitral valves are typically implanted so that the plane defined by the valve structure is substantially parallel to the annular plane 228, so that blood flow through the prosthetic mitral valve is not directed towards the posterior wall. Typically, by the valve structure of the present disclosure that is implanted in the individual's mitral valve, so that the valve structure is inclined towards the posterior side of the left ventricle, a large part of the blood flow through the valve leaflets from the atrium to the left ventricle is directed towards the posterior wall 225.As indicated by the blood flow arrow 222 in Figure 9C, blood flow from the atrium to the left ventricle that is directed towards the posterior wall generates efficient blood flow from the left ventricle and to the aorta 224 (similar to blood flow through a healthy native mitral valve). For some applications, the valve structure is positioned and implanted at an angle towards the posterior side of the left ventricle, so that a plane 221 is defined by the extremity. Petition 870250101878, dated 06 / 11 / 2025, pp. 71 / 88 64 / 67 ventricular end of the valve structure is at least partially oriented towards a posterior wall of the left ventricle. For some applications, the valve structure is angled towards the posterior side of the left ventricle, so that plane 221 defined by the ventricular end of the valve structure forms an angle alpha with respect to the annular plane 228 of more than 5 degrees (e.g., more than 15 degrees) and / or less than 40 degrees (e.g., less than 25 degrees), for example, 5-40 degrees or 15-25 degrees.

[0099] Note that, for some applications, the techniques described in reference to Figures 9B and 9C are combined. That is, for some applications, the mitral valve prosthetic structure 120 is implanted in an individual's mitral valve such that (a) the center of the valve structure is off-center relative to the center 220 of the annular plane and is positioned towards the posterior side of the annular plane, and (b) the valve structure is angled towards the posterior side of the left ventricle.

[00100] For some applications, the individual's native anatomy is used to facilitate one or both of the techniques described above. As described above, typically, the valve structure is anchored to the individual's native mitral valve, inter alia, by rotating at least a portion of the valve structure so that the arms pull the native valve leaflets radially inward, Petition 870250101878, dated 06 / 11 / 2025, p. 72 / 88 65 / 67 recruiting at least a portion of the chordae of the native mitral valve, and subsequently causing the valve frame body to expand radially so as to secure the native valve leaflets. Typically, the anterior and posterior native leaflets are secured by the valve frame. Since the posterior cusp is shorter than the anterior cusp, in some cases its anchoring serves as a pivot and causes the valve frame to (a) be implanted off-center relative to the center of the annular plane, with the valve frame positioned toward the posterior side of the annular plane, and / or (b) be implanted angled toward the posterior aspect 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.

[00101] For some applications, the dispensing device 20 is configured to position the mitral valve structure relative to the mitral valve annulus, so that the valve structure is deployed in a position and / or orientation as described in Figure 9B and / or Figure 9C. For some applications, before the valve structure is rotated (i.e., the step shown in Figure 8C), the dispensing device is configured to position the valve structure so that a center of the valve structure is approximately aligned with the coaptation line of the Petition 870250101878, dated 06 / 11 / 2025, pp. 73 / 88 66 / 67 anterior and posterior native valve leaflets. Thus, when the valve structure is rotated, approximately an equal number of anterior and posterior chords are recruited by the chord recruitment arms, so that when the valve structure is fully deployed, the valve structure is centered by the anterior and posterior chords, such that the center of the valve structure is off-center relative to the center 220 of the annular plane, and is positioned towards the posterior side of the annular plane.

[00102] As noted above with reference to dispensing device 20, typically the internal steerable catheter 24 (shown in Figure 2C) includes the first set 32 ​​and second set 34 of directional deflection cables. Typically, the first set 32 ​​of directional deflection cables is configured to guide the distal end of the internal steerable catheter through a first steerable catheter deflection plane through an angle between 0 degrees and more than 80 degrees, or more than 100 degrees (e.g., 120 degrees). For some applications, the second set 34 of directional deflection cables is configured to guide the distal end of the internal steerable catheter through a second steerable catheter deflection plane through an angle of at least between -45 degrees and +45 degrees. For Petition 870250101878, dated 06 / 11 / 2025, pp. 74 / 88 67 / 67 In some applications, the second set of directional deflection cables is configured to position the valve structure so that the valve structure is tilted toward the posterior side of the left ventricle (as described in reference to Figure 9C), prior to implantation of the valve structure.

[00103] It will be recognized by persons skilled in the art that the present invention is not limited to what has been specifically shown and described above in this document. Instead, the scope of the present invention includes combinations and subcombinations of the various features described above, as well as variations and modifications not in the prior art, which would occur to persons skilled in the art upon reading the preceding description. Petition 870250101878, dated 06 / 11 / 2025, pages 75 / 88

Claims

1 / 20 CLAIMS 1. An apparatus for use with a prosthetic valve configured to be employed within a native mitral valve of a mammalian individual, the native mitral valve comprising a valve ring, valve leaflets, chordae tendineae and papillary muscles, the apparatus characterized in that it comprises: a valve structure configured to support the prosthetic valve within the native mitral valve, wherein the valve structure comprises a structure body and a plurality of arms that are configured to extend from the structure body; and a dispensing device configured to: dispense the valve structure to the native mitral valve; position the valve structure so that a center of the valve structure is off-center relative to the center of an annular plane of the valve ring and is positioned toward a posterior side of the annular plane; subsequently employ the arms between the chordae tendineae of the native mitral valve;Subsequently, rotate at least a portion of the valve structure so as to cause the arms to pull the leaflets of the native valve radially inward, recruiting at least a portion of the chords of the native mitral valve; and subsequently, cause the body of the valve structure to expand radially so as to enclose the leaflets of the native valve, and so that the valve structure is employed with the center of the valve structure off-center relative to the center of the annular plane and is positioned toward the posterior side of the annular plane.

2. Apparatus, according to claim 1, characterized in that the dispensing device is configured to use a native rear leaflet as a pivot to cause the valve structure to be employed with the center of the valve structure off-center with respect to the center of the annular plane and positioned towards the rear side of the annular plane.

3. Apparatus, according to claim 1, characterized in that the dispensing device is configured to cause the blood flow through the prosthetic valve to be off-center relative to the center of the annular plane, causing the body of the valve structure to expand radially so that the valve structure is employed with the center of the valve structure off-center relative to the center of the annular plane, Petition 870250101870, 06 / 11 / 2025, p. 10 / 29 3 / 20 and is positioned towards the posterior side of the annular plane.

4. Apparatus, according to any one of claims 1 to 3, characterized in that the dispensing device is configured to position the valve structure so that the center of the valve structure is approximately aligned with a line of coaptation of native anterior and posterior valve leaflets of the individual's mitral valve.

5. Apparatus, according to claim 4, characterized in that, by positioning the valve structure so that the center of the valve structure is approximately aligned with the coaptation line of the native anterior and posterior valve leaflets of the individual's mitral valve, the dispensing device is configured to cause an approximately equal number of anterior and posterior chords to be captured when the valve structure portion is rotated.

6. Apparatus, according to any one of claims 1 to 3, characterized in that the dispensing device is additionally configured to: position the valve structure so that the valve structure is angled towards a posterior side of the left ventricle with a plane defined by a ventricular end of the valve structure at least partially facing a posterior wall of the left ventricle; and cause the body of the valve structure to expand radially, so that the valve structure is employed at an angle towards the posterior side of the left ventricle with the plane defined by the ventricular end of the valve structure at least partially facing the posterior wall of the left ventricle.

7. Apparatus, according to claim 6, characterized in that the dispensing device is configured to cause the blood flow through the prosthetic valve to be directed to the posterior wall of the left ventricle, causing the body of the valve structure to expand radially so that the valve structure is employed at an angle towards the posterior side of the left ventricle with the plane defined by the ventricular end of the valve structure at least partially facing the posterior wall of the left ventricle.

8. Apparatus, according to claim 6, characterized in that the dispensing device is configured to cause the body of the valve structure to expand radially, so that the plane defined by the ventricular end of the valve structure forms an angle with respect to the annular plane of more than 5 degrees.

9. Apparatus, according to claim 8, characterized in that the dispensing device is configured to cause the body of the valve structure to expand radially, so that the plane defined by the ventricular end of the valve structure forms an angle with respect to the annular plane of more than 15 degrees.

10. Apparatus, according to claim 8, characterized in that the dispensing device is configured to cause the body of the valve structure to expand radially, so that the plane defined by the ventricular end of the valve structure forms an angle with respect to the annular plane between 5 and 40 degrees.

11. Apparatus, according to claim 10, characterized in that the dispensing device is configured to cause the body of the valve structure to expand radially, so that the plane defined by the ventricular end of the valve structure forms an angle with respect to the annular plane between 15 and 25 degrees.

12. Method for use with a prosthetic valve configured to be employed within a native mitral valve of a mammalian heart, wherein the native mitral valve includes a valve ring, valve leaflets, chordae tendineae, and papillary muscles, the method being characterized in that it comprises: placing a valve structure within the heart of the individual, wherein the valve structure includes a valve structure body and a plurality of arms that are configured to extend from the valve structure body; positioning the valve structure so that a center of the valve structure is off-center relative to the center of an annular plane of the valve ring and is positioned toward a posterior side of the annular plane; subsequently employing the arms between the chordae tendineae of the native mitral valve;Subsequently, rotate at least part of the valve structure so as to cause the arms to pull the leaflets of the native valve radially inward, recruiting at least part of the chords of the native mitral valve; and subsequently, cause the body of the valve structure to expand radially so as to secure the leaflets of the native valve, and so that the valve structure is employed with the center of the valve structure off-center relative to the center of the annular plane and positioned toward the posterior side of the annular plane, wherein the valve structure supports the prosthetic valve within the native mitral valve.

13. Method according to claim 12, characterized in that causing the valve structure body to expand radially so that the valve structure is employed with the center of the valve structure off-center with respect to the center of the annular plane and is positioned towards the rear side of the annular plane comprises using a native rear leaflet as a pivot to cause the valve structure to be employed with the center of the valve structure off-center with respect to the center of the annular plane and positioned towards the rear side of the annular plane.

14. Method, according to claim 12, characterized in that causing the body of the valve structure to expand radially so that the valve structure is employed with the center of the valve structure off-center relative to the center of the annular plane and is positioned towards the posterior side of the annular plane comprises causing the blood flow through the prosthetic valve to be off-center relative to the center of the annular plane.

15. Method, according to any one of claims 12 to 14, characterized in that positioning the valve structure so that the center of the valve structure is off-center with respect to the center of the annular plane of the valve ring and is positioned towards the posterior side of the annular plane comprises positioning the valve structure so that the center of the valve structure is approximately aligned with a coaptation line of the native anterior and posterior valve leaflets of the individual's mitral valve.

16. Method according to claim 15, characterized in that positioning the valve structure so that the center of the valve structure is approximately aligned with the coaptation line of the native anterior and posterior valve leaflets of the individual's mitral valve comprises causing an approximately equal number of anterior and posterior chords to be captured when the valve structure portion is rotated.

17. Method, according to any one of claims 12 to 14, characterized in that it further comprises: positioning the valve structure so that the valve structure is angled toward a posterior side of a left ventricle of the individual's heart with a plane defined by a ventricular end of the valve structure at least partially facing a posterior wall of the left ventricle; and causing the body of the valve structure Petition 870250101870, dated 06 / 11 / 2025, page 16 / 29 9 / 20 to expand radially, so that the valve structure is employed angled toward the posterior side of the left ventricle with the plane defined by the ventricular end of the valve structure at least partially facing the posterior wall of the left ventricle.

18. Method according to claim 17, characterized in that causing the body of the valve structure to expand radially so that the valve structure is employed at an angle towards the posterior side of the left ventricle, causes the blood flow through the prosthetic valve to be directed towards the posterior wall of the left ventricle.

19. Method according to claim 17, characterized in that causing the body of the valve structure to expand radially so that the valve structure is employed angled towards the posterior side of the left ventricle comprises causing the body of the valve structure to expand radially so that the plane defined by the ventricular end of the valve structure forms an angle with respect to the annular plane of more than 5 degrees.

20. Method, according to claim 19, characterized in that causing the body of the valve structure to expand radially, so that the valve structure is employed angled in Petition 870250101870, dated 06 / 11 / 2025, page 17 / 29 10 / 20 towards the posterior side of the left ventricle comprises causing the body of the valve structure to expand radially, so that the plane defined by the ventricular end of the valve structure forms an angle with respect to the annular plane of more than 15 degrees.

21. A method according to claim 19, characterized in that causing the body of the valve structure to expand radially, so that the valve structure is employed angled towards the posterior side of the left ventricle, comprises causing the body of the valve structure to expand radially, so that the plane defined by the ventricular end of the valve structure forms an angle with respect to the annular plane between 5 and 40 degrees.

22. Method according to claim 21, characterized in that causing the body of the valve structure to expand radially, so that the valve structure is employed angled towards the posterior side of the left ventricle, comprises causing the body of the valve structure to expand radially, so that the plane defined by the ventricular end of the valve structure forms an angle with respect to the annular plane between 15 and 25 degrees.

23. Apparatus for use with a prosthetic valve configured to be employed within a native mitral valve of a mammalian individual, the native mitral valve including a valve ring, valve leaflets, chordae tendineae and papillary muscles, the apparatus characterized in that it comprises: a valve structure configured to support the prosthetic valve within the native mitral valve, wherein the valve structure comprises a structure body and a plurality of arms that are configured to extend from the structure body; and a dispensing device configured to: dispense the valve structure to the native mitral valve; Position the valve structure so that it is angled toward a posterior side of the left ventricle, with a plane defined by a ventricular end of the valve structure at least partially facing a posterior wall of the left ventricle.subsequently, employ the arms between the chords of the native mitral valve; subsequently, rotate at least a portion of the valve structure so as to cause the arms to pull the leaflets of the native valve radially inward, recruiting at least a portion of the chords of the native mitral valve; and Petition 870250101870, dated 11 / 06 / 2025, p. 19 / 29 12 / 20 subsequently, cause the body of the valve structure to expand radially so as to enclose the leaflets of the native valve, and so that the valve structure is employed angled toward the posterior side of the left ventricle with the plane defined by the ventricular end of the valve structure at least partially facing the posterior wall of the left ventricle.

24. Apparatus, according to claim 23, characterized in that the dispensing device is configured to use a native posterior leaflet as a pivot to cause the valve structure to be employed angled towards the posterior side of the left ventricle with the plane defined by the ventricular end of the valve structure at least partially facing the posterior wall of the left ventricle.

25. Apparatus, according to claim 23, characterized in that the dispensing device is configured to cause the blood flow through the prosthetic valve to be directed to the posterior wall of the left ventricle, causing the body of the valve structure to expand radially so that the valve structure is employed angled towards the posterior side of the left ventricle with the plane defined by the ventricular end of the valve structure at least partially facing the posterior wall of the left ventricle.

26. Apparatus, according to any one of claims 23 to 25, characterized in that the dispensing device is configured to cause the body of the valve structure to expand radially, so that the plane defined by the ventricular end of the valve structure forms an angle with respect to the annular plane of more than 5 degrees.

27. Apparatus, according to claim 26, characterized in that the dispensing device is configured to cause the body of the valve structure to expand radially, so that the plane defined by the ventricular end of the valve structure forms an angle with respect to the annular plane of more than 15 degrees.

28. Apparatus, according to claim 26, characterized in that the dispensing device is configured to cause the body of the valve structure to expand radially, so that the plane defined by the ventricular end of the valve structure forms an angle with respect to the annular plane between 5 and 40 degrees.

29. Apparatus, according to claim 28, Petition 870250101870, dated 06 / 11 / 2025, pp. 21 / 29 14 / 20, characterized in that the dispensing device is configured to cause the body of the valve structure to expand radially, so that the plane defined by the ventricular end of the valve structure forms an angle with respect to the annular plane between 15 and 25 degrees.

30. Apparatus, according to any one of claims 23 to 25, characterized in that the dispensing device is additionally configured to: position the valve structure so that a center of the valve structure is off-center with respect to the center of an annular plane of the valve ring and is positioned towards a posterior side of the annular plane; and cause the body of the valve structure to expand radially so that the valve structure is employed with the center of the valve structure off-center with respect to the center of the annular plane and is positioned towards the posterior side of the annular plane.

31. Apparatus, according to claim 30, characterized in that the dispensing device is configured to cause the blood flow through the prosthetic valve to be off-center relative to the center of the annular plane, causing the body of the valve structure to expand radially so that the valve structure is employed with the center of the valve structure off-center relative to the center of the annular plane and positioned towards the posterior side of the annular plane.

32. Apparatus, according to claim 30, characterized in that the dispensing device is configured to position the valve structure so that the center of the valve structure is approximately aligned with a coaptation line of native anterior and posterior valve leaflets of the individual's mitral valve.

33. Apparatus, according to claim 32, characterized in that, positioning the valve structure so that the center of the valve structure is approximately aligned with the coaptation line of the native anterior and posterior valve leaflets of the individual's mitral valve, the dispensing device is configured to cause an approximately equal number of anterior and posterior chords to be captured when the valve structure portion is rotated.

34. Method for use with a prosthetic valve configured to be employed within a native mitral valve of a mammalian heart, wherein the native mitral valve includes a valve annulus, valve leaflets, chordae tendineae and papillary muscles, the method being characterized in that it comprises: placing a valve structure within the heart of the individual, wherein the valve structure includes a valve structure body and a plurality of arms that are configured to extend from the valve structure body; positioning the valve structure so that the valve structure is angled toward a posterior side of a left ventricle of the heart of the individual with a plane defined by a ventricular end of the valve structure at least partially facing a posterior wall of the left ventricle; Subsequently, use the arms between the chords of the native mitral valve;Subsequently, rotate at least a portion of the valve structure so that the arms pull the leaflets of the native valve radially inward, recruiting at least a portion of the chords of the native mitral valve; and subsequently, cause the body of the valve structure to expand radially so as to secure the leaflets of the native valve, and so that the valve structure is employed angled toward the posterior side of the left ventricle with the plane defined by the ventricular end of the valve structure at least partially facing the posterior wall of the left ventricle, as per Petition 870250101870, dated 06 / 11 / 2025, pp. 24 / 29 17 / 20, whereby the valve structure supports the prosthetic valve within the native mitral valve.

35. A method according to claim 34, characterized in that causing the body of the valve structure to expand radially so that the valve structure is employed angled towards the posterior side of the left ventricle with the plane defined by the ventricular end of the valve structure at least partially facing the posterior wall of the left ventricle, comprises using a native posterior leaflet as a pivot to cause the valve structure to be employed angled towards the posterior side of the left ventricle with the plane defined by the ventricular end of the valve structure at least partially facing the posterior wall of the left ventricle.

36. Method according to claim 34, characterized in that causing the body of the valve structure to expand radially, so that the valve structure is employed angled towards the posterior side of the left ventricle, comprises causing the blood flow through the prosthetic valve to be directed towards the posterior wall of the left ventricle.

37. Method, according to any one of claims 34 to 36, characterized in that making Petition 870250101870, dated 06 / 11 / 2025, page 25 / 29 18 / 20, cause the body of the valve structure to expand radially so that the valve structure is employed at an angle towards the posterior side of the left ventricle, comprises causing the body of the valve structure to expand radially so that the plane defined by the ventricular end of the valve structure forms an angle with respect to the annular plane of more than 5 degrees.

38. A method according to claim 37, characterized in that causing the body of the valve structure to expand radially, so that the valve structure is employed angled towards the posterior side of the left ventricle, comprises causing the body of the valve structure to expand radially, so that the plane defined by the ventricular end of the valve structure forms an angle with respect to the annular plane of more than 15 degrees.

39. Method according to claim 37, characterized in that causing the body of the valve structure to expand radially, so that the valve structure is employed at an angle towards the posterior side of the left ventricle, comprises causing the body of the valve structure to expand radially, so that the plane defined by the ventricular end of the valve structure forms an angle in relation to the annular plane between 5 and 40 degrees.

40. A method according to claim 39, characterized in that causing the body of the valve structure to expand radially, so that the valve structure is employed at an angle towards the posterior side of the left ventricle, comprises causing the body of the valve structure to expand radially, so that the plane defined by the ventricular end of the valve structure forms an angle with respect to the annular plane between 15 and 25 degrees.

41. A method according to any one of claims 34 to 36, characterized in that it further comprises: positioning the valve structure so that a center of the valve structure is off-center with respect to the center of an annular plane of the valve ring and is positioned toward a posterior side of the annular plane; and causing the body of the valve structure to expand radially so that the valve structure is employed with the center of the valve structure off-center with respect to the center of the annular plane and is positioned toward the posterior side of the annular plane.

42. Method, according to claim 41, characterized in that causing the body of the valve structure to expand radially, as per Petition 870250101870, dated 06 / 11 / 2025, page 27 / 29 20 / 20, so that the valve structure is employed with the center of the valve structure off-center relative to the center of the annular plane and is positioned towards the posterior side of the annular plane, comprises causing the blood flow through the prosthetic valve to be off-center relative to the center of the annular plane.

43. A method according to claim 41, characterized in that positioning the valve structure so that the center of the valve structure is off-center with respect to the center of the annular plane of the valve ring and is positioned toward the posterior side of the annular plane, comprises positioning the valve structure so that the center of the valve structure is approximately aligned with a coaptation line of the native anterior and posterior valve leaflets of the individual's mitral valve.

44. Method according to claim 43, characterized in that positioning the valve structure so that the center of the valve structure is approximately aligned with the coaptation line of the native anterior and posterior valve leaflets of the individual's mitral valve comprises causing an approximately equal number of anterior and posterior chords to be captured when the valve structure portion is rotated. Petition 870250101870, dated 06 / 11 / 2025, pp. 28 / 29

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