Prosthetic heart valve

Abstract

The prosthetic heart valve may be delivered to a target native heart valve site via one or more delivery catheters. In some embodiments, the prosthetic heart valve includes structural features that securely anchor the prosthetic heart valve to an anatomical structure at a native heart valve site. Such structural features may provide robust resistance to migration. In addition, the prosthetic heart valve may include structural features that improve sealing between the prosthetic valve and native valve anatomy to mitigate perivalvular leakage. In particular embodiments, the prosthetic heart valve occupies a small delivery profile, facilitating a smaller delivery catheter system for advancement to the heart. Some delivery catheter systems may include a curved inner catheter to facilitate deployment of the prosthetic heart valve to the native tricuspid valve site via either the superior vena cava or the inferior vena cava.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the benefit of U.S. Patent Application No. 18 / 122,407, filed March 16, 2023, which is a divisional application of U.S. Patent Application No. 17 / 986,597, filed November 14, 2022, which claims the benefit of U.S. Provisional Application Serial No. 63 / 390,810, filed July 20, 2022. This application also claims the benefit of U.S. Patent Application No. 18 / 124,684, filed March 22, 2023, which is a divisional application of U.S. Patent Application No. 17 / 986,607 (now U.S. Patent No. 11,638,643), filed November 14, 2022, which claims the benefit of U.S. Provisional Application Serial No. 63 / 390,810, filed July 20, 2022. The disclosure of the prior application is considered to be part of the disclosure of the present application (and is incorporated into the disclosure of the present application by reference). Technical Field

[0003] The present disclosure relates generally to prosthetic heart valve systems. For example, the present disclosure relates to transcatheter deliverable prosthetic heart valves suitable for use in replacing suboptimally functioning native heart valves, including but not limited to the tricuspid valve. Background Art

[0004] The human heart includes four types of heart valves, which are arranged to ensure that blood flows in a specific direction: the mitral valve, the tricuspid valve, the aortic valve, and the pulmonary valve. The aortic valve and the pulmonary valve are semilunar valves that are located in the arteries leaving the heart and, when closed, prevent blood from flowing back into the left and right ventricles, respectively. The mitral valve and the tricuspid valve are atrioventricular valves that are located between the atria and ventricles and, when closed, prevent blood from flowing back into the left and right atria, respectively. The conditions of stenosis (when the valve is not fully open) and regurgitation / dysfunction (when the valve does not close properly, resulting in leakage) are considered to be important contributors to mortality and morbidity.

[0005] Some valve replacement systems include a valve prosthesis that is compressed into a delivery catheter, also known as a transcatheter valve, to avoid open heart surgery. Many transcatheter valve prostheses have a tubular frame that may or may not be axisymmetric and include two or more leaflets. Although these transcatheter valve prostheses can be compressed into a catheter, they may still require a large delivery system (e.g., a required catheter size of 45 French). This is particularly true in the case of mitral valve replacement systems and tricuspid valve replacement systems, which typically require valve prostheses with larger profiles. Summary of the invention

[0006] Some embodiments described herein include a prosthetic heart valve that can be delivered to a target native heart valve site via one or more delivery catheters. In some embodiments, the prosthetic heart valve includes structural features that firmly anchor the prosthetic heart valve to the anatomical structure at the native heart valve site. Such structural features can provide robust anti-migration. In addition, the prosthetic heart valve can include structural features that improve the seal between the prosthetic valve and the native valve anatomical structure to reduce paravalvular leakage. In a specific embodiment, the prosthetic heart valve occupies a small delivery profile, thereby facilitating a smaller delivery catheter system to advance to the heart. Some delivery catheter systems can include a curved inner catheter to facilitate deployment of the prosthetic heart valve to the native tricuspid valve site via the superior vena cava or the inferior vena cava.

[0007] In one aspect, the present disclosure relates to a prosthetic heart valve, the prosthetic heart valve comprising a body and an occluder, the body comprising an inflow end portion and an outflow end portion, the occluder extending between the inflow end portion and the outflow end portion and comprising valve leaflets attached to the body in an arrangement that: (i) allows blood to flow through the occluder along a central axis of the occluder in a direction from the inflow end portion toward the outflow end portion, and (ii) prevents blood from flowing through the occluder in a direction from the outflow end portion toward the inflow end portion. The prosthetic heart valve also includes: a first front leaflet extending from the outflow end portion in a first direction transverse to the central axis; a rear leaflet extending from the outflow end portion in a second direction opposite to the first direction; and a rear arm extending from the inflow end portion in the second direction.

[0008] Such a prosthetic heart valve may optionally include one or more of the following features. The prosthetic heart valve may also include a forearm extending from the inflow end portion in the first direction. The prosthetic heart valve may also include a second front flap extending from the outflow end portion in the first direction. The first front flap and the second front flap may overlap each other. The cross-sectional shape of the first front flap and the second front flap taken perpendicular to the first direction may be arcuate.

[0009] On the other hand, the present disclosure relates to another prosthetic heart valve. The prosthetic heart valve includes a body and an occluder, the body including an inflow end portion and an outflow end portion, the occluder extending between the inflow end portion and the outflow end portion and including valve leaflets, the valve leaflets attached to the body in the following arrangement: (i) allowing blood to flow through the occluder along the central axis of the occluder in a direction from the inflow end portion toward the outflow end portion, and (ii) preventing blood from flowing through the occluder in a direction from the outflow end portion toward the inflow end portion. The prosthetic heart valve also includes a front leaflet extending from the outflow end portion in a first direction transverse to the central axis; a rear leaflet extending from the outflow end portion in a second direction opposite to the first direction; and a forearm extending from the inflow end portion in the first direction.

[0010] On the other hand, the present disclosure relates to another prosthetic heart valve. The prosthetic heart valve includes a main body and an occluder, the main body includes an inflow end portion and an outflow end portion, the occluder extends between the inflow end portion and the outflow end portion and includes valve leaflets, and the valve leaflets are attached to the main body in the following arrangement: (i) allowing blood to flow through the occluder along the central axis of the occluder in a direction from the inflow end portion toward the outflow end portion, and (ii) preventing blood from flowing through the occluder in a direction from the outflow end portion toward the inflow end portion. The prosthetic heart valve also includes: a first front leaflet, the first front leaflet extending from the outflow end portion in a first direction transverse to the central axis; and a second front leaflet, the second front leaflet extending from the outflow end portion in the first direction. The cross-sectional shape of the first front leaflet and the second front leaflet taken perpendicular to the first direction is arcuate from the outer edge of the first front leaflet to the outer edge of the second front leaflet.

[0011] On the other hand, the present disclosure relates to another prosthetic heart valve. The prosthetic heart valve includes a body and an occluder, the body including an inflow end portion and an outflow end portion, the occluder extending between the inflow end portion and the outflow end portion and including valve leaflets, the valve leaflets attached to the body in the following arrangement: (i) allowing blood to flow through the occluder along the central axis of the occluder in a direction from the inflow end portion toward the outflow end portion, and (ii) preventing blood from flowing through the occluder in a direction from the outflow end portion toward the inflow end portion. The prosthetic heart valve also includes: a first front leaflet, the first front leaflet extending from the outflow end portion in a first direction transverse to the central axis; a second front leaflet, the second front leaflet extending from the outflow end portion in the first direction; a first rear leaflet, the first rear leaflet extending from the outflow end portion in a second direction opposite to the first direction; and a second rear leaflet, the second rear leaflet extending from the outflow end portion in the second direction. The channel is defined between the first rear leaflet and the second rear leaflet. The first rear leaflet and the second rear leaflet extend farther from the outflow end portion than the first front leaflet and the second front leaflet.

[0012] In another aspect, the present disclosure relates to a method of deploying a prosthetic heart valve. The method includes engaging any prosthetic heart valve described herein with the anatomy of a native tricuspid valve. The lateral anterior flap extends into the right ventricular outflow tract (RVOT) and engages with the lateral wall of the RVOT to provide anchoring during diastole.

[0013] In another aspect, the present disclosure relates to another method of deploying a prosthetic heart valve. The method includes engaging any prosthetic heart valve described herein with the anatomical structure of a native tricuspid valve. The distal portion of the posterior arm abuts against the inner wall of the inferior vena cava or the coronary sinus or the right atrium.

[0014] In another aspect, the present disclosure relates to another method of deploying a prosthetic heart valve. The method includes engaging any prosthetic heart valve described herein with the anatomy of a native tricuspid valve. The distal portion of the forearm abuts against an inner wall of the right atrial appendage.

[0015] Various types of deployment systems can be used in conjunction with the prosthetic tricuspid valve described herein. In some embodiments described herein, such a deployment system may include an outer sheath defining a first lumen; an intermediate deflectable catheter slidably disposed in the first lumen and defining a second lumen, the intermediate deflectable catheter including a selectively deflectable distal portion having at least one deflection plane; and an internal control catheter slidably disposed in the second lumen and including one or more control wires that configure the internal control catheter to releasably couple with the prosthetic heart valve. The internal control catheter includes a distal portion that elastically transitions to a naturally curved configuration when the internal control catheter transitions from radially constrained to radially unconstrained. In some embodiments, when in the naturally curved configuration, the distal portion defines an internal angle of less than 135 degrees.

[0016] In another aspect, the present disclosure relates to another method for deploying a prosthetic heart valve. The method includes advancing a prosthetic heart valve toward a native tricuspid valve via the jugular vein and the superior vena cava, while the prosthetic heart valve is releasably coupled to a prosthetic heart valve deployment system and is constrained in diameter in a low-profile delivery configuration. The prosthetic heart valve deployment system includes an outer sheath defining a first lumen; an intermediate deflectable catheter slidably disposed in the first lumen and defining a second lumen, the intermediate deflectable catheter including a selectively deflectable distal portion; and an internal control catheter slidably disposed in the second lumen and including one or more control wires releasably coupled to the prosthetic heart valve. The internal control catheter includes a distal portion constrained in the first lumen. The method also includes retracting the outer sheath relative to the inner control catheter to allow the distal portion of the inner control catheter to become radially unconstrained and elastically transition to a bent configuration; and deflecting the selectively deflectable distal portion of the intermediate deflectable catheter so that the inner control catheter and the intermediate deflectable catheter are combined to bend at least 90° relative to the outer sheath.

[0017] On the other hand, the present disclosure relates to another method for deploying a prosthetic heart valve. The method includes advancing the prosthetic heart valve toward the native tricuspid valve via the femoral vein and the inferior vena cava, while the prosthetic heart valve is releasably connected to a prosthetic heart valve deployment system and is constrained in diameter in a low-profile delivery configuration. The prosthetic heart valve deployment system includes an outer sheath defining a first inner cavity; an intermediate deflectable catheter, which is slidably disposed in the first inner cavity and defines a second inner cavity, the intermediate deflectable catheter including a selectively deflectable distal portion; and an internal control catheter, which is slidably disposed in the second inner cavity and includes one or more control wires releasably connected to the prosthetic heart valve. The internal control catheter includes a curved distal portion, which is bent less than 20° when constrained in the first inner cavity. The method also includes advancing the inner control catheter relative to the outer sheath to allow the curved distal portion to become unconstrained and elastically transition to a curved configuration that is bent at least 45° relative to the outer sheath; and deflecting the selectively deflectable distal portion of the intermediate deflectable catheter so that the inner control catheter and the intermediate deflectable catheter are combined to bend at least 90° relative to the outer sheath.

[0018] In another aspect, the present disclosure relates to a method of deploying a prosthetic heart valve, such as any of the prosthetic heart valves described herein. The method includes deploying a lateral anterior flap of the prosthetic heart valve such that the lateral anterior flap extends into the right ventricular outflow tract (RVOT) and engages with the sidewall of the RVOT. In this position, sidewall tissue may be present on both sides of the lateral anterior flap (e.g., on the superior side and the inferior side, or on the atrial-oriented side and the ventricular-oriented side) to provide anchoring during diastole.

[0019] Any of the prosthetic heart valves described herein may optionally include one or more of the following additional features. In some embodiments, portions of the first anterior flap and the second anterior flap overlap each other. The prosthetic tricuspid valve may also include a posterior flap that extends laterally from the end of the body in a direction opposite to the first anterior flap and the second anterior flap. In some embodiments, the first anterior flap and the second anterior flap extend laterally farther than the posterior flap. In a particular embodiment, the combined first anterior flap and the second anterior flap are wider than the posterior flap (in the septal to lateral direction). The frame of the prosthetic tricuspid valve (which includes the body, the first anterior flap and the second anterior flap, and the posterior flap) may be made of a single integral material that is cut and expanded. In some embodiments, the distal end portion of the posterior flap extends along an axis that is at a non-zero angle relative to the portion of the posterior flap that extends directly from the body. In some examples, overlapping portions of the first anterior flap and the second anterior flap increases the bending resistance of the combination of the first anterior flap and the second anterior flap compared to the first anterior flap and the second anterior flap alone. Making portions of the first anterior flap and the second anterior flap as separate components can configure the prosthetic tricuspid valve to allow a pacemaker lead to pass through the prosthetic tricuspid valve between the first anterior flap and the second anterior flap. The prosthetic tricuspid valve may also include one or more additional anterior flaps extending laterally from the end of the main body in the same direction as the first anterior flap and the second anterior flap. The prosthetic tricuspid valve may also include two or more posterior flaps extending laterally from the end of the main body in a direction opposite to the first anterior flap and the second anterior flap. Making portions of the first posterior flap and the second posterior flap as separate components can construct the prosthetic tricuspid valve so that a pacemaker lead passes through the prosthetic tricuspid valve between the first posterior flap and the second posterior flap. In some embodiments, the cross-section of the main body has an elliptical outer contour defining a major diameter and a minor diameter. The minor diameter is shorter than the major diameter. The occluder may have a circular cross-sectional shape, and the anterior flap and the posterior flap may extend transversely to the major diameter. The prosthetic heart valve may also include a leaflet engagement member extending from the main body, a portion of the leaflet engagement member extending toward the inflow end portion and terminating at a free end. The leaflet engagement member may extend in a second direction. The posterior flap may extend farther away from the main body than the leaflet engagement member. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] Figure 1A cross-sectional view of a human heart is shown including four heart valves (mitral valve, tricuspid valve, aortic valve and pulmonary valve) that allow blood to flow through specific paths. The mitral valve and tricuspid valve are arranged to prevent blood from flowing back into the left atrium and right atrium, respectively, when the left ventricle and the right ventricle, respectively, contract, respectively.

[0021] Figure 2 Shows Figure 1 The tricuspid valve is shown in top view and includes three native leaflets: the anterior leaflet, the posterior leaflet, and the septal leaflet.

[0022] Figure 3 Another cross-sectional view of a human heart is shown, which includes four chambers (right atrium, right ventricle, left atrium, and left ventricle) and the major conduits that deliver blood to and away from the heart.

[0023] Figure 4 Shows some natural anatomical structures Figure 3 Schematic diagram of the right side of the heart, including the right atrium ("RA"), right ventricle ("RV"), and right ventricular outflow tract ("RVOT").

[0024] Figure 5 Shows some natural anatomical structures Figure 3 Another schematic diagram of the right side of the heart, including the RA, RV, and RVOT.

[0025] Figure 6 Shown is a side view of an exemplary prosthetic heart valve according to some embodiments described herein.

[0026] Figure 7 Shown coapted within the native tricuspid valve Figure 6 Side view of a prosthetic heart valve.

[0027] Figure 8 Shows Figure 6 Top view of a prosthetic heart valve.

[0028] Fig. 9 Shown is a top view of a frame of another exemplary prosthetic heart valve, according to some embodiments described herein.

[0029] Fig.10 The native tricuspid annulus and RVOT are schematically shown in a transverse plane.

[0030] Fig.11 Schematically shows Figure 6 Top view of a prosthetic heart valve.

[0031] Fig.12 Schematically shows the Fig.10 The native tricuspid annulus and RVOT coaptation Fig.11 prosthetic heart valves.

[0032] Fig.13 Schematically illustrates the Fig.12 A cross-sectional view of the cutting plane 13 - 13 taken along and including the anterior leaflet and RVOT of the prosthetic heart valve.

[0033] Fig.14 Schematically depicted are longitudinal plane cross-sectional views of the anterior portion of a native tricuspid valve annulus and the anterior leaflet of a prosthetic heart valve described herein.

[0034] Fig.15 is an anterior view of a prosthetic heart valve described herein, illustrating the cross-sectional shape of the anterior leaflet.

[0035] Fig.16 Shown are top views of some of the prosthetic heart valves described herein.

[0036] Fig.17 A plan view of an exemplary prosthetic heart valve deployment system is shown in accordance with some embodiments.

[0037] Fig.18 Shows Fig.17 An expanded view of the distal portion of a prosthetic heart valve deployment system.

[0038] Fig.19 A side view of a prosthetic tricuspid valve as described herein is schematically shown.

[0039] Fig. 20 Schematically shows the Fig.17 Prosthetic Heart Valve Deployment System Connected Fig.19 prosthetic tricuspid valve.

[0040] Figures 21 to 30 Shows the use of Fig.17 An example transjugular approach to deploying a prosthetic tricuspid valve described herein using a prosthetic heart valve deployment system.

[0041] Fig.31 Schematically illustrated is a top view of another exemplary prosthetic heart valve according to some embodiments described herein.

[0042] Figure 32-37 Schematic depiction of the use Fig.17 Prosthetic Heart Valve Deployment System to deploy Fig.31 An example of a transfemoral approach to a prosthetic heart valve.

[0043] Fig.38 is a perspective view of an example frame that can be used with the prosthetic heart valves described herein.

[0044] Fig.39yes Fig.38 A top view of the frame.

[0045] Fig.40 yes Fig.38 Side view of the frame.

[0046] Fig.41 is a perspective view of another example frame that can be used with the prosthetic heart valves described herein.

[0047] Fig.42 yes Fig.41 A top view of the frame.

[0048] Fig.43 yes Fig.41 Side view of the frame. DETAILED DESCRIPTION

[0049] Some embodiments described herein include a prosthetic heart valve that can be delivered to a target native heart valve site via one or more delivery catheters. In some embodiments, the prosthetic heart valve includes structural features that firmly anchor the prosthetic heart valve to the anatomical structure at the native heart valve site. Such structural features can provide robust anti-migration during diastole and systole. In addition, the prosthetic heart valve can include structural features that improve the seal between the prosthetic valve and the native valve anatomical structure to alleviate paravalvular leakage. In a specific embodiment, the prosthetic heart valve occupies a small delivery profile, thereby facilitating a smaller delivery catheter system to advance to the heart. Some catheter-based prosthetic heart valve deployment systems may include a curved inner catheter to facilitate deployment of the prosthetic heart valve to the native tricuspid valve site via the superior vena cava or the inferior vena cava.

[0050] refer to Figure 1 Certain aspects of the concepts described herein for heart valve replacement systems may be implemented in prosthetic valve designs intended for use with any of the four heart valves that allow blood to flow through a specific path: the mitral valve, the tricuspid valve, the aortic valve, and the pulmonary valve. Figure 2 A target site is depicted, for example, at the tricuspid valve 10 of the heart. The tricuspid valve 10 includes anterior leaflets 11a, posterior leaflets 11p, and septal leaflets 11s, and a valve annulus 12. In some cases, the tricuspid valve 10 may experience stenosis or anatomical changes that lead to tricuspid regurgitation, such as a situation in which the distance between the anterior septal commissure and the anterior and posterior commissures of the native tricuspid valve increases as the diseased state progresses due to dilation of the annulus 12 of the tricuspid valve 10.

[0051] Figure 3A longitudinal cross-sectional view of a human heart 1 is shown, showing the four chambers (right atrium, right ventricle, left atrium, and left ventricle) and the major conduits that deliver blood to and from the heart 1. The tricuspid valve 10 is located between the right atrium and the right ventricle. Blood enters the right atrium from the superior vena cava and the inferior vena cava. Blood flows from the right atrium to the right ventricle through the tricuspid valve 10. Blood leaves the right ventricle and enters the main pulmonary artery ("MPA") via the RVOT adjacent to the tricuspid valve 10.

[0052] Figure 4 and Figure 5 The right side of the heart 1 is schematically shown, including the right atrium, the right ventricle and the tricuspid valve 10 therebetween. Naturally, there is anatomical variability within the population. Figure 4 and Figure 5 Some anatomical variability is depicted. In particular, Figure 4 The heart 1a is shown including the presence of the rear shelf 11. In contrast, Figure 5 A heart 1b is shown lacking any such posterior shelf. Some human hearts (e.g., heart 1a) have a posterior shelf 11, but some human hearts (e.g., heart 1b) do not have a distinct posterior shelf. The prosthetic tricuspid valve disclosed herein is designed to be implantable in a native tricuspid valve 10 of both types of anatomical structures (e.g., heart 1a with a posterior shelf 11 and heart 1b without a posterior shelf).

[0053] The posterior shelf 11 (when present) provides an anatomical structure that can be advantageously used to anchor a prosthetic tricuspid valve (as further described herein). When such a posterior shelf is not present (e.g., as Figure 5 ), secure anchoring of the prosthetic tricuspid valve at the site of the native tricuspid valve 10 is more challenging. However, and as described in U.S. patent application Ser. No. 17 / 747,507, filed May 18, 2022 (the entire contents of which are incorporated herein by reference and for all purposes), the prosthetic tricuspid valve described herein can be successfully used in this situation.

[0054] Figure 6-8 An exemplary prosthetic tricuspid valve 100 (or simply “valve 100 ”) is shown according to some exemplary embodiments of the present disclosure. Valve 100 includes a frame 102 and a covering 104 attached to frame 102 . Figure 7 The valve 100 is shown coapting with the native tricuspid valve 10 between the right atrium and the right ventricle.

[0055] The frame 102 includes a honeycomb structure that provides mechanical support for the shape and structure of the valve 100. In some embodiments, the frame 102 is made of nitinol (NiTi), stainless steel, cobalt chromium, MP35N, titanium, polymer materials, other biocompatible materials, or any combination thereof. Some or all portions of the frame 102 may be covered by a cover 104. In some embodiments, the frame 102 may be made of laser cut, expanded, and shaped materials. In some embodiments, the frame 102 is self-expanding. In some embodiments, the precursor material is tubular NiTi, NiTi sheets, or other suitable types of precursor materials.

[0056] The covering 104 can be made of a biocompatible polymer material (e.g., expanded polytetrafluoroethylene (ePTFE), UHMWPE (ultra-high molecular weight polyethylene), nylon, polyester (e.g., Dacron), or another synthetic material), natural tissue (e.g., bovine, porcine, ovine, or equine pericardium), or any combination thereof. The covering 104 can be attached to the frame 102 by suturing, using clips, adhesives, and / or any other suitable attachment process.

[0057] The valve 100 includes a body 106. The body 106 includes an occluder 110 (e.g., a one-way valve) that defines a central axis 101. The occluder 110 has flexible leaflets 111a, 111b, and 111c (collectively referred to as 111a-c), which enable the occluder 110 to function as a one-way valve (in a manner similar to a natural tricuspid valve). The occluder 110 defines a circular inlet at which the edges of the leaflets 111a-c are attached to the frame 102. The other side edges of the leaflets 111a-c are attached to the posts 112a, 112b, and 112c of the frame 102. The leaflets 111a-c also have distal free edges that can adapt to each other to facilitate opening and sealing of the occluder 110.

[0058] The body 106 of the valve 100 includes an inflow end portion 102i, an intermediate body portion 102m, and an outflow end portion 102o. The inflow end portion 102i includes a series of arcuate shapes in the frame 102, which are circumscribed with the axis 101 of the occluder 110. The occluder leaflets 111a-c allow blood to flow through the occluder 110 directionally from the inflow end portion 102i to the outflow end portion 102o. The leaflets 111a-c of the occluder 110 are closed against each other (e.g., co-adapted) to prevent blood from flowing in the other direction (to prevent blood from flowing from the outflow end portion 102o to the inflow end portion 102i).

[0059] The embodiment of the valve 100 depicted in the present disclosure adopts three occluder leaflets 111a-c, which is called a three-leaflet occluder. The occluder 110 of the valve 100 can optionally adopt a configuration other than a three-leaflet occluder. For example, a double leaflet, a four-leaflet or a mechanical valve structure can be used in some embodiments. In a specific embodiment described herein, the flexible leaflets 111a-c are made of natural tissue, such as pig or cattle or horse or sheep pericardium. In such an embodiment, glutaraldehyde or formaldehyde or other aldehydes commonly used as cross-linking agents are used to chemically cross-link the tissue. In other embodiments, the flexible leaflets 111a-c are made of polymers such as polyurethane, polyester (Dacron) or expanded polytetrafluoroethylene (ePTFE). In some embodiments, the flexible leaflets 111a-c are attached to the structural frame 102 using sutures, which can be made of materials including but not limited to UHMWPE, nylon or polyester (e.g., Dacron).

[0060] The valve 100 also includes a first anterior flap 120a (or septal anterior flap 120a), a second anterior flap 120b (or lateral anterior flap 120b), and at least one posterior flap 130. The frame 102 and the covering 104 combine to form the anterior flaps 120a-b and the posterior flap 130. The frame 102 provides the structure of the anterior flaps 120a-b and the posterior flap 130, and the covering 104 provides occlusion. Although the depicted embodiment includes two anterior flaps 120a-b, in some embodiments, one, three, four, or more than four anterior flaps may be included. Although the depicted embodiment includes a single posterior flap 130, in some embodiments, two, three, four, or more than four posterior flaps may be included. For example, Fig.31 Concerning an embodiment having two rear lobes 330a and 330b.

[0061] The front flap 120a-b and the rear flap 130 extend away from the outflow end portion 102o of the body 106 in opposite directions away from the axis 101. That is, the rear flap 130 extends in a direction opposite to the extension direction of the first and second front flaps 120a-b. In some embodiments, the rear flap 130 extends 180° opposite to the extension direction of the first and second front flaps 120a-b. In a specific embodiment, the front flap 120a-b and the rear flap 130 extend away from the outflow end portion 102o of the body 106 transversely to the axis 101 of the occluder 110.

[0062] In the depicted embodiment, the first front lobe 120a and the second front lobe 120b each include a middle body portion 124 ( Figure 6), the middle body portion 124 is bent at a certain angle so as to guide the end portions of the front lobes 120a-b toward the inlet end of the body 106. In some embodiments, the front lobes 120a-b initially extend away from the body 106 substantially perpendicular to the central axis 101 (e.g., within about 80° to 100°). Then, at the middle body portion 124, the front lobes 120a-b have a bend that defines an angle θ in the range of 20° to 60°, or 30° to 60°, or 30° to 70°, or 40° to 60°, or 40° to 70°, or 40° to 50°, but is not limited thereto.

[0063] The bend in the midbody 106 of the anterior lobes 120a-b may allow the anterior lobes 120a-b to conform to the contours of the walls defining the RVOT (eg, Figure 7 ). Thus, in some cases, the curved anterior flap 120a-b can reduce the likelihood that the anterior flap 120a-b will restrict blood flow through the RVOT.

[0064] like Figure 8 As shown, the depicted embodiment includes an opening 126a defined by the cover 104 at a distal portion of the first front lobe 120a. Additionally, the cover 104 on the second front lobe 120b defines an opening 126b at a distal portion of the second front lobe 120b.

[0065] The openings 126a-b in the ends of the front flaps 120a-b allow blood to flow through the front flaps 120a-b (via the openings 126a-b). This can be beneficial because, in some embodiments, the front flaps 120a-b extend into the RVOT. Therefore, in some cases, such openings 126a-b can reduce the likelihood that the front flaps 120a-b will restrict blood flow through the RVOT.

[0066] In the illustrated embodiment, the rear flap 130 includes a first portion 130a and a second portion 130b arranged at an angle relative to each other. The first portion 130a extends away from the outflow end portion 102o of the body 106 approximately transversely to the axis 101 of the occluder 110. The second portion 130b of the rear flap 130 extends from the first portion 130a. In the illustrated embodiment, the second portion 130b extends approximately parallel to the axis 101 of the occluder 110. The angle defined between the first portion 130a and the second portion 130b may be in the range of 80° to 100°, or 70° to 110°, or 60° to 120°, or 50° to 130°, or 40° to 140°, but is not limited thereto.

[0067] The first front flap 120a and the second front flap 120b each extend in the same direction, which is opposite to the direction in which the rear flap 130 extends. In the depicted embodiment, portions of the first front flap 120a and the second front flap 120b overlap each other. An advantage of having two separate front flaps 120a-b (rather than a single larger front flap) is that the front flap portion of the valve 100 can be radially compressed into a smaller profile for transcatheter delivery due to having two separate front flaps 120a-b (compared to having a single larger front flap).

[0068] In some embodiments, Figure 7 As shown, the first and second front flaps 120a-b extend into the RVOT, and one front flap overlaps axially on top of the other front flap. This arrangement is functionally similar to a cantilever beam arrangement. When the first and second front flaps 120a-b overlap each other, the bending resistance of the first and second front flaps 120a-b is increased (compared to a single flap or a non-overlapping flap). This arrangement enables a favorable degree of rigidity without having to use a frame member with a larger cross-section. That is, the overlapping arrangement of the first and second front flaps 120a-b allows the use of smaller frame members, which in turn importantly allows a smaller contracted delivery size (diameter). In other words, the overlapping arrangement of the first and second front flaps 120a-b provides a thicker support structure without having to use a material with a higher wall thickness (the frame is formed from it); ultimately providing bending rigidity or stiffness that keeps the valve 100 stable when RV pressure acts on the valve 100.

[0069] In the depicted embodiment, the open channel 122 (see, e.g., Fig.16 ) is defined between the first front leaflet 120a and the second front leaflet 120b. The open channel 122 can be used, for example, to pass a pacemaker lead through the valve 100 without interfering with the function of the occluder 110. Thus, the valve 100 can facilitate the passage of a pacemaker lead while still providing a seal to prevent tricuspid regurgitation from the RV to the RA. In some cases, the pacemaker lead is pre-existing and the valve 100 is subsequently implanted (wherein the open channel 122 is used to receive the pacemaker lead). In other cases, the valve 100 can be pre-existing and the pacemaker lead can be subsequently passed through the open channel 122. This can occur during the same implantation procedure, or as a subsequent procedure.

[0070] Fig.31Another exemplary prosthetic valve 300 is shown. Valve 300 defines an open channel 332 between rear leaves 330a and 330b, which can be used, for example, to pass a pacemaker lead through valve 300 without interfering with the function of occluder 310. In some cases, the pacemaker lead is pre-existing and valve 300 is subsequently implanted (wherein the open channel 322 is used to receive the pacemaker lead). In other cases, valve 300 can be pre-existing and the pacemaker lead can be subsequently passed through open channel 322.

[0071] Still reference Figure 6-8 , the valve 100 also includes one or more leaflet engagement members 140. In the depicted embodiment, the valve 100 includes two leaflet engagement members: a first leaflet engagement member 140a and a second engagement member 140b. In the depicted embodiment, the leaflet engagement members 140a-b extend from the outflow end portion 102o of the body 106. In some embodiments, the leaflet engagement members 140a-b extend from the middle body portion 102m of the body 106.

[0072] The leaflet engagement members 140a-b extend from the frame 102 and bend toward the inflow end portion 102i of the body 106. In other words, a portion of each leaflet engagement member 140a-b extends toward the inflow end portion 102i of the body 106. A space, groove, or slot is defined between the leaflet engagement members 140a-b and the outer surface of the frame 102 (the cover 104 is present on the frame 102 and the leaflet engagement members 140a-b). As further described below, the space, groove, or slot receives and mechanically captures / holds a portion of the native leaflet (e.g., the posterior leaflet 11p and / or the septal leaflet 11s) to provide anti-migration properties to the valve 100.

[0073] In the depicted embodiment, the leaflet engagement members 140a-b extend from the frame 102 of the body 106 in the same direction as the posterior lobe 130. The posterior lobe 130 extends farther away from the body 106 than the leaflet engagement members 140a-b. Various other arrangements of the leaflet engagement members 140a-b and the posterior lobe 130 are also contemplated and are within the scope of the present disclosure.

[0074] The leaflet engagement members 140a - b can be U-shaped wire loops, as in the depicted embodiment. The wire loops making up the leaflet engagement members 140a - b can be continuous with the wire members of the frame 102 .

[0075] In the depicted embodiment, the leaflet engagement members 140a-b terminate at free ends. Thus, the leaflet engagement members 140a-b are directed toward the inflow end portion 102i of the body 106, with the free ends of the leaflet engagement members 140a-b closest to the inflow end portion 102i. This arrangement defines a space, recess, or slot that receives and mechanically captures / holds a portion of the native leaflet to provide resistance to migration for the valve 100.

[0076] The depicted embodiment of the valve 100 includes an optional posterior arm 150. The posterior arm 150 includes a wire member (e.g., an elongated ring) that extends from the frame 102 and includes a free end 150e (which can also be said to be located at the distal portion of the posterior arm 150). In some embodiments, the posterior arm 150 is a wire member that is integrally constructed with the wire member of the frame 120. Therefore, it can be said that the posterior arm 150 is part of the frame 120. In the illustrated embodiment, the covering 104 is attached to the posterior arm 150, including the free end 150e.

[0077] In the illustrated embodiment, the rear arm 150 extends from the inflow end portion 102i of the frame 102. The rear arm 150 extends in a direction that is the same as or substantially (e.g., + / - 20°) parallel to the direction in which the rear petal 130 extends. In some embodiments, the rear arm 150 extends from the middle body portion 102m of the frame 102. The free end 150e is located within a transverse plane (e.g., taken perpendicular to the axis 101) that intersects the middle body portion 102m of the frame 102 or the inflow end portion 102i of the frame 102.

[0078] The posterior arm 150 provides additional anchoring and resistance to migration for the valve 100. Figure 7 As shown, when the valve 100 is engaged in the native tricuspid valve 10, the free end 150e of the posterior arm 150 abuts against the anatomical structure. In some cases, the free end 150e of the posterior arm 150 abuts against the inner wall of the inferior vena cava or the coronary sinus or the right atrium or another anatomical structure. The location of its abutment can be largely based on variable anatomical structures from patient to patient. During diastole when the occluder 110 opens to allow blood to flow from the right atrium to the right ventricle via the occluder 110, the anti-migration provided by the posterior arm 150 can be particularly advantageous.

[0079] Also refer to Fig. 9In some embodiments, the frame 102 may include a forearm 160. The forearm 160 may also be covered similarly to the rear arm 150. The forearm 160 includes a wire member (e.g., an elongated loop) extending from the frame 102 and including a free end 160e (which may also be said to be located at a distal portion of the rear arm 160). In some embodiments, the forearm 160 is a wire member integrally constructed with the wire member of the frame 120. Therefore, it can be said that the forearm 160 is part of the frame 120. In the illustrated embodiment, the cover 104 is attached to the forearm 160, including the free end 160e.

[0080] In the illustrated embodiment, the front arm 160 extends from the inflow end portion 102i of the frame 102. The front arm 160 extends away from the axis 101 in a forward direction (e.g., in a direction substantially the same as the direction in which the front lobes 120a-b extend). In some embodiments, the front arm 160 extends from the middle body portion 102m of the frame 102. The free end 160e is located in a transverse plane (e.g., taken perpendicular to the axis 101) that intersects the middle body portion 102m of the frame 102 or the inflow end portion 102i of the frame 102.

[0081] The forearm 160 provides additional anchoring and anti-migration for the valve 100. When the valve 100 is engaged in the native tricuspid valve 10, the free end 160e of the forearm 160 abuts against the anatomical structure. In some cases, the free end 160e of the forearm 160 abuts against the inner wall of the right atrial appendage or another anatomical structure. The location where the forearm 160 lands relative to the anatomical structure can vary based on patient-to-patient variability. The anti-migration provided by the forearm 160 can be particularly advantageous during diastole when the occluder 110 opens to allow blood to flow from the right atrium to the right ventricle via the occluder 110.

[0082] Some embodiments of the valve 100 include the posterior arm 150, but not the anterior arm 160. Other embodiments of the valve 100 include the anterior arm 160, but not the posterior arm 150. Other embodiments of the valve 100 include both the posterior arm 150 and the anterior arm 160.

[0083] Fig.10 Schematically shown is a transverse plane view of a native tricuspid valve 10. The native tricuspid valve 10 comprises a valve annulus 12. The RVOT extends away from the native tricuspid valve 10 along an arcuate path.

[0084] Fig.11 The top view of the valve 100 is schematically shown. The valve 100 includes a main body 106, an occluder 110, a septal front leaflet 120a, a lateral front leaflet 120b, a rear leaflet 130, and a rear arm 150.

[0085] Fig.12 Schematically shows the coaptation to the native tricuspid valve 10 (which is also Fig.10 1 and 2. The valve 100 is shown in the anatomical structure of FIG. 1 (shown in FIG. 1 ). In this illustration, it can be seen how the anterior septal leaflet 120a and the lateral anterior leaflet 120b extend into the RVOT. In addition, it can be seen that the edge of the lateral anterior leaflet 120b abuts against and extends along the side wall 14 of the RVOT.

[0086] Fig.13 A cross-sectional view of the RVOT and the distal portion of the anterior flap 120a-b is schematically shown. Fig.12 The cutting plane 13--13 shown is intercepted. It can be seen that the edge of the front flap 120b abuts against the anatomical topography of the side wall 14 of the RVOT and engages therewith. The docking relationship between the front flap 120b and the side wall 14 of the RVOT provides anchoring and anti-migration of the valve 100 relative to the native tricuspid valve 10. For example, there is a frictional anti-migration aspect provided by the normal force exerted by the edge of the front flap 120b against the side wall 14 of the RVOT. In addition, in some embodiments, supplemental anti-migration is provided because the edge of the front flap 120b can be placed against certain anatomical topographic features of the side wall 14 of the RVOT. In such a case, the side wall 14 physically supports the front flap 120b and resists movement of the valve 10 relative to the native tricuspid valve 10 and the anatomical structure of the RVOT. The abutting relationship between the anterior lateral leaflet 120b and the lateral wall 14 of the RVOT provides anchoring and resistance to migration of the valve 100 relative to the native tricuspid valve 10, which is particularly beneficial during diastole when the occluder 110 opens to allow blood to flow from the right atrium to the right ventricle via the occluder 110.

[0087] Reference again Fig.10 , the shape of the annulus 12 of many tricuspid valves 10 is not circular. Typically, as depicted here, the shape of the annulus 12 is oblong or oval (elliptical). That is, the distance between the posterior region and the anterior region of the annulus 12 is longer than the distance between the septal region and the lateral region of the annulus 12. Therefore, it can be said that the annulus 12 defines a major diameter 16 between the posterior and anterior regions of the annulus 12, and a minor diameter 18 between the septal region and the lateral region of the annulus 12.

[0088] Also refer to Fig.12In this embodiment of the valve 100, the body 106 has an oval outer cross-sectional shape. In contrast, the occluder 110 within the body 106 has a circular cross-sectional shape. The elliptical body 106 of the valve 100 has a major diameter 108 and a minor diameter 109. The front leaflets 120a-b and the rear leaflet 130 extend from the body 106 in a direction transverse to the major diameter 108 of the elliptical body 106. In some embodiments, the front leaflets 120a-b and / or the rear leaflet 130 extend from the body 106 substantially orthogonal or perpendicular (e.g., 90°+ / -5°, 90°+ / -10°, 90°+ / -15°, or 90°+ / -20°) to the major diameter 108 of the elliptical body 106.

[0089] In some embodiments, Fig.12 As shown, the body 106 is smaller than the entire size / area of ​​the annulus 12. Therefore, the front flaps 120a-b can be used to fill the internal area defined by the annulus 12 that is not occupied by the body 106. The circular cross-sectional area occupied by the occluder 110 is smaller than the cross-sectional area of ​​the body 106, which is sufficient for the hemodynamics of blood flow between the atria and ventricles. In some embodiments, the percentage of the internal area defined by the annulus 12 occupied by the body 106 is about 50% (the remaining about 50% of the area of ​​the annulus 12 is covered by the front flaps 120a-b). In some embodiments, the percentage of the area of ​​the annulus 12 occupied by the body 106 is in the range of about 50% to 60%, or 55% to 65%, or 60% to 70%, or 65% to 75%, or 70% to 80%, or 75% to 85%, or 60% to 80%, but not limited thereto, wherein the front flaps 120a-b cover the remaining area of ​​the annulus 12. In some embodiments, the anterior flaps 120a - b cover at least 50%, or at least 40%, or at least 30%, or at least 20%, or at least 10%, or at least 5% of the interior area defined by the annulus 12 .

[0090] The fact that the front flaps 120a-b cover at least a portion of the area defined within the annulus 12 may be beneficial for additional reasons. For example, if at some point in the future after the valve 100 has been implanted in the annulus 12, a pacemaker lead needs to pass through the annulus 12, a location on the front flaps 120a-b can be punctured to allow the pacemaker lead to pass through the front flaps 120a-b. The puncture can be at the open channel 122, or at another location on the front flaps 120a-b. The ability to pass a pacemaker lead through the front flaps 120a-b is advantageous because doing so does not affect the function of the occluder 110. This is a possible advantage because the front flaps 120a-b cover at least a portion of the area of ​​the annulus 12.

[0091] like Fig.12As shown in the example of , since in some cases a portion of the elliptical annulus 12 is covered by the front flap 120a-b, the body 106 does not need to be circular and can be configured to have various types of cross-sectional shapes. In some cases, an elliptical shape (as shown) may be preferred because it can be radially compressed well to fit in a low-profile delivery catheter because it can have a smaller circumference since the small diameter 109 of the body 106 is shorter than the large diameter 108. For example, if the body 106 has a circular cross-sectional shape with a diameter equal to the major diameter 108, the body 106 cannot be radially squeezed / compressed to a size as small as the depicted elliptical body 106. Therefore, if the body 106 is circular (compared to the oval shape shown), a larger delivery sheath will be required.

[0092] Interestingly, in Fig.12 In the example shown, although the annulus 12 of the tricuspid valve 10 and the body 106 of the valve 100 are both oblong or elliptical, when the valve 100 is implanted in the tricuspid valve 10, the orientation of their major and minor diameters is offset relative to each other by approximately 90° (e.g., 90°+ / -10°). That is, the major diameter 108 of the elliptical body 106 is substantially parallel (e.g., + / -10°) relative to the minor diameter 18 of the annulus 12. In addition, the minor diameter 109 of the elliptical body 106 is substantially parallel (e.g., + / -10°) relative to the major diameter 16 of the annulus 12. These geometric relationships are beneficial because the annulus 12 is completely occluded by the valve 100, and the diameter of the radially compressed delivery configuration of the valve 100 can be reduced (compared to having the body 106 fill a larger area of ​​the annulus 12).

[0093] Again, in Fig.12 As is apparent from the illustration, the opening defined by the native annulus 12 is not completely filled by the body 106. Instead, the laterally extending first and second front flaps 120a-b help cover and fluid-seal the native tricuspid valve opening, which in this example is not circular (e.g., where the native valve opening is oblong or irregularly shaped). In other words, in conjunction with the body 106 of the valve 100, the first and second front flaps 120a-b (and the laterally extending posterior anchoring flap 130 in some cases) help cover and fluid-seal the native tricuspid valve opening, which in some cases is not circular. In addition, the end portions of the first and second front flaps 120a-b extend into the RVOT to provide anchoring and anti-migration. Thus, the first and second front flaps 120a-b perform both sealing and anchoring.

[0094] In some cases, the shape of the patient's natural annulus 12 is generally circular. In this case, the valve 100 can still provide many of the benefits described above. For example, the body 106 can still have an oblong or elliptical outer cross-sectional shape that occupies less than the entire circular area of ​​the natural valve annulus 12 (with the first and second front flaps 120a-b occupying the remainder). In this case, the valve 100 is implanted in the natural valve annulus 12 so that the central axis 101 of the occluder 110 is laterally offset (e.g., in the posterior direction) from the geometric center of the generally circular natural valve annulus 12. In addition, the major diameter 108 of the body 106 can be shorter than the diameter of the natural valve annulus 12. For example, in some embodiments, the length of the major diameter 108 of the body 106 is approximately 60% to 80% of the diameter of the natural valve annulus 12, or approximately 70% to 90% of the diameter of the natural valve annulus 12, or approximately 80% to 95% of the diameter of the natural valve annulus 12, but is not limited thereto.

[0095] Fig.14 A longitudinal plane cross-sectional view (e.g., generally parallel to the central axis of the ring 12) near the anterior portion of the native tricuspid annulus 12 is shown. This view is from the interface between the RVOT and the native tricuspid annulus 12, looking toward the right atrium and right ventricle. In this view, it can be seen that the anterior annulus 12 is curved.

[0096] Fig.15 A front end view of the frame 102 of the valve 100 is shown (without the cover 104 in this example). In this view, the first and second front lobes 120a-b are in the foreground, and the body 106 is in the background.

[0097] The bold line 121 has been superimposed on Fig.15 The cross-sectional shape of the first and second front lobes 120a-b is shown above (when the cover 104 is attached to the frame 102). It can be seen that the cross-sectional shape of the first and second front lobes 120a-b (taken perpendicularly to the direction in which the first and second front lobes 120a-b extend from the body 106) is curved or arc-shaped. The arc extends from the outflow end portion 102o of the frame 102 toward the inflow end portion 102i, wherein the middle of the arc is the point of the arc closest to the inflow end portion 102i.

[0098] The curved or arcuate cross-sectional shape of the first and second front lobes 120a-b is beneficial because, as shown in FIG. Fig.14 As described above, the front portion of the native tricuspid annulus 12 that is connected to the first anterior flap 120a-b is also curved. Therefore, a good sealing interface between the arcuate first and second anterior flaps 120a-b and the arcuate front portion of the native tricuspid annulus 12 is generated by these complementary curved shapes. This sealing arrangement between the arcuate first and second anterior flaps 120a-b and the native tricuspid annulus 12 can be beneficial in reducing paravalvular leakage when the valve 100 is engaged with the native tricuspid valve 10.

[0099] like Fig.15 As shown, in the depicted embodiment, the arcuate cross-sectional shape of the first and second front lobes 120a-b is at least partially determined by the construction of the frame portions 128a and 128b (in Fig. 9 121). The frame portions 128a and 128b constitute interior portions of the outer edges of the first and second front flaps 120a-b, 120a-b. The frame portions 128a and 128b are arranged at a non-zero angle relative to the central axis 101 to help define the arcuate cross-sectional shape of the first and second front flaps 120a-b represented by the thick line 121. In some embodiments, the angle between the frame portions 128a and 128b and the central axis 101 is between 20° and 50°, or between 30° and 60°, or between 40° and 70°, but is not limited thereto. The frame portions 128a and 128b near the outer edges of the first and second front flaps 120a-b perform particularly advantageously to create a good seal between the first and second front flaps 120a-b and the anterior portion of the native tricuspid annulus 12, as paravalvular leaks are particularly prone to occur in those edge regions.

[0100] Fig.17 and Fig.18 An exemplary prosthetic heart valve deployment system 200 (or simply "deployment system 200") is shown. Deployment system 200 includes a control handle 210, an outer sheath 220, an intermediate deflectable catheter 230, and an inner control catheter 240. The outer sheath 220 defines a first lumen. The intermediate deflectable catheter 230 is slidably disposed in the first lumen and defines a second lumen. The inner control catheter 240 is slidably disposed in the second lumen.

[0101] The inner control catheter 240 includes a curved portion 242. The curved portion 242 is capable of elastic deformation. That is, although the curved portion 242 is within the confines of the first lumen of the outer sheath 220, the curved portion 242 is substantially linear (or at least more linear than if the curved portion 242 were radially unconstrained). When the curved portion 242 of the inner control catheter 240 is pushed distally from the confines of the first lumen of the outer sheath 220 (by pushing the inner control catheter 240 distally or by pulling the outer sheath 220 proximally), the curved portion 242 then naturally elastically reshapes to exhibit a pronounced curve (e.g., as Fig.18). Thus, it can be said that the natural shape of the internal control catheter 240 includes a curved portion 242 that defines an internal angle θ. In some embodiments, the internal angle θ may be between 130° and 160°, or between 120° and 150°, or between 110° and 140°, or between 100° and 130°, or between 90° and 120°, or between 80° and 110°, or between 80° and 100°, but is not limited thereto. In some embodiments, the internal angle θ may be less than 160°, or less than 150°, or less than 140°, or less than 135°, or less than 130°, or less than 120°, or less than 110°, or less than 100°, or less than 90°, but is not limited thereto.

[0102] The intermediate deflectable catheter 230 includes a selectively deflectable distal portion 232 having at least one deflection plane. In some embodiments, the selectively deflectable distal portion 232 is deflectable in two planes. In some embodiments, the intermediate deflectable catheter 230 includes two or more separate selectively deflectable portions in the same plane or in different planes.

[0103] In the depicted embodiment, the selectively deflectable distal portion 232 can deflect in the same plane as the plane of the curved portion 242 of the inner control catheter 240. Thus, when the selectively deflectable distal portion 232 of the intermediate deflectable catheter 230 is deflected, the combined curvature of the intermediate deflectable catheter 230 and the inner control catheter 240 relative to the axis of the outer sheath 220 increases beyond the curvature of the inner angle θ alone. In some embodiments, the combined curvature of the intermediate deflectable catheter 230 and the inner control catheter 240 relative to the axis of the outer sheath 220 can define an inner angle between 90° and 110°, or between 80° and 100°, or between 70° and 90°, or between 60° and 80°, or between 50° and 70°, or between 30° and 60°, or between 0° and 30°, but is not limited thereto. As further described below, such a high degree of curvature can be beneficial during deployment of a prosthetic valve (such as the valve 100) using the deployment system 200.

[0104] The inner control catheter 240 may also include mechanical features for releasably coupling with a prosthetic valve, such as valve 100. For example, in the illustrated embodiment, the inner control catheter 240 includes one or more control wires and / or release pins 244 that may releasably couple the valve 100 to the inner control catheter 240 in a low-profile delivery configuration.

[0105] Fig.19 A schematic diagram of valve 100 is shown. Fig. 20Schematically illustrated is a valve 100 coupled to an inner control catheter 240 and positioned within a first lumen defined by an outer sheath 220. The distal end of the intermediate deflectable catheter 230 is also visible. In this arrangement, the valve 100 is radially compressed to a low profile delivery configuration when within the outer sheath 220. In some embodiments, the valve 100 (or a portion thereof) is wrapped or folded around the inner control catheter 240. For example, in some embodiments, the front flap 120a-b is wrapped around the inner control catheter 240. The valve 100 can self-expand when it is exposed from the outer sheath 220 (e.g., by manual retraction of the outer sheath 220 relative to the intermediate deflectable catheter 230 and the inner control catheter 240).

[0106] In some embodiments, when the valve 100 is in its collapsed delivery configuration within the outer sheath 220, the portions of the valve 100 are arranged relative to each other as follows. The first and second front flaps 120a-b (which can be wrapped around each other) are at the most distal side. The occluder portion (or valve core) 110 with flexible leaflets is located proximal to the outer sheath 220. The rear anchoring flap 130 is arranged between the most distal first front flap 120a-b and the most distal occluder portion 110.

[0107] The valve 100 may be operated using one or more control wires and / or release pins 244 ( Fig.18 ) is releasably coupled to the inner control catheter 240. In some embodiments, a first control wire is releasably coupled to the proximal portion of the body 106, a second control wire is releasably coupled to the distal portion of the body 106, and a third control wire is releasably coupled to the posterior leaflet 120a-b. The control wires can be tensioned to pull radially inward and hold the relevant portion of the valve 100 against the inner control catheter 240. During deployment of the valve 100, the control wires can be individually relaxed to allow the relevant portion of the valve 100 to elastically expand toward its natural expanded shape.

[0108] Still reference Fig. 20 In this delivery configuration, the curved portion 242 of the inner control catheter 240 is constrained by the outer sheath 220 in a substantially linear configuration. However, when the inner control catheter 240 is pressed out of the outer sheath 220 (or when the outer sheath 220 is pulled proximally relative to the inner control catheter 240), the curved portion 242 will become unconstrained and will resiliently deflect to its natural curved configuration (e.g., as Fig.18 The curved configuration of the curved portion 242 facilitates the deployment process of the valve 100 to engage the native tricuspid valve 10, as further described below.

[0109] Figure 21-30A series of steps are shown for deploying a prosthetic heart valve, such as the heart valve 100 described herein in any of its variations, using the heart valve deployment system 200. The figures show a transjugular approach to the native tricuspid valve 10 (via the superior vena cava).

[0110] Fig.21 The distal portion of the deployment system 200 is shown extending into the right atrium via the superior vena cava. The deployment system 200 is advanced over a previously installed guidewire. The valve 100 (not visible) is within the outer sheath 220.

[0111] Fig. 22 The valve 100 is shown after withdrawing the outer sheath 220 and / or advancing the inner control catheter 240 and the intermediate deflectable catheter 230 (while the valve 100 is releasably coupled to the inner control catheter 240). At this stage, the curved portion 242 (not visible below the valve 100) has become unconstrained and has elastically deflected to its natural curved configuration. The natural curved configuration of the curved portion 242 helps the inner control catheter 240 to make a relatively tight turn within the right atrium to advance from the vena cava and through the annulus 12 of the native tricuspid valve 10, as shown.

[0112] Fig.23 and Fig.24 Further advancement of the valve 100 is shown (while the valve 100 is still releasably coupled to the inner control catheter 240). In these images, the intermediate deflectable catheter 230 is being deflected (in Fig.23 The first amount is deflected in Fig.24 The deflection of the intermediate deflectable catheter 230 increases the curvature of the inner control catheter 240 so that the distal end portion of the inner control catheter 240 can become directed toward the RVOT after passing through the annulus 12 (e.g., Fig.24 shown).

[0113] Figure 25 to Figure 27 The release process of the portions of the valve 100 from the internal control catheter 240 is shown. As the portions of the valve 100 are released, those portions become engaged in the target native anatomical position. The control wires and / or release pins for the front leaflets 120a-b and the rear leaflet 130 are released (eg, Fig.26 In response, the anterior leaflets 120a-b deploy into the RVOT and the posterior leaflet 130 deploys to a posterior region of the tricuspid valve 10 just below the annulus 12. In addition, as the posterior leaflet 130 deploys, one or more leaflet engagement members 140 become coupled to the posterior leaflet 11p and / or the septal leaflet 11s to provide anti-migration properties to the valve 100. At this stage, if the valve 100 includes the posterior arm 150 and / or the anterior arm 160 ( Figures 6 to 9 ), the rear arm 150 and / or the front arm 160 may also be unfolded. Fig. 27The release of the control wire coupled to the body 106 is shown. In response, the body 106 radially expands into contact with the annulus 12 and engages.

[0114] Figures 28 to 30 Retraction of the deployment system 200 is shown. When the control wires are disengaged from the valve 100, the inner control catheter 240 and the intermediate deflectable catheter 230 can then be withdrawn, leaving the valve 100 in engagement with the anatomy in and around the native tricuspid valve 100.

[0115] Fig.31 Another exemplary prosthetic heart valve 300 is shown. Valve 300 is similar to valve 100 described above, but is modified to be better suited for transfemoral delivery (via the inferior vena cava) to the native tricuspid valve 10.

[0116] The valve 300 includes an oval body 306 containing a circular occluder 310 defining a central axis 301. The occluder 310 extends between the inflow end and the outflow end portions of the body 306 and includes valve leaflets arranged as follows: (i) allowing blood to flow through the occluder 310 along the central axis 301 of the occluder 310 in a direction from the inflow end portion toward the outflow end portion, and (ii) preventing blood from flowing through the occluder 310 in a direction from the outflow end portion toward the inflow end portion. The valve 300 also includes a first front leaflet 320a extending from the outflow end portion of the body 306 in a first direction transverse to the central axis 301, and a second front leaflet 320b also extending from the outflow end portion in the first direction. The valve 300 also includes a first rear leaflet 330a extending from the outflow end portion of the body 306 in a second direction opposite to the first direction, and a second rear leaflet 330b also extending from the outflow end portion in the second direction. A channel 332 (e.g., for a pacemaker lead as described above) is defined between the first posterior leaflet 330a-b and the second posterior leaflet 330a-b. Compared to valve 100, the first and second posterior leaflets 330a-b of valve 300 extend farther (a greater distance) from the outflow end portion of the body 306 than the first and second anterior leaflets 320a-b. This arrangement biases the body 306 toward the anterior portion of the annulus 12 (see Fig.10 ), which is different from valve 100, which is biased toward the rear of the annulus 12 (see Fig.12 ).

[0117] Figure 32-37 Schematically illustrates the use of a heart valve deployment system 200 (eg, reference Fig.17 and 18 ) A series of steps for deploying a heart valve 300 (as described herein in any of its variations) into a heart 1. These figures show a transfemoral approach to the native tricuspid valve 10 (via the inferior vena cava; "IVC").

[0118] Fig.32 Deployment system 200 is shown being advanced via the IVC toward the right atrium ("RA"). Outer sheath 220 (containing heart valve 300 in its low profile delivery configuration) may be advanced over a previously placed guidewire extending via native tricuspid valve 10 into the right ventricle ("RV").

[0119] Fig.33 The heart valve 300 is shown emerging from the outer sheath 220 in the RA (eg, by pulling the outer sheath 220 proximally and / or by advancing the intermediate deflectable catheter 230 and the inner control catheter 240 distally).

[0120] Fig.34 and Fig.35 The heart valve 300 is shown advanced to a position of engagement with the native tricuspid valve 10. To achieve this, both the middle deflectable catheter 230 and the inner control catheter 240 are curved. That is, the inner control catheter 240 is naturally curved due to its curved portion 242, and the middle deflectable catheter 230 is selectively deflected by the clinician operator who is performing the procedure.

[0121] Fig.36 The release of the heart valve 300 from the internal control catheter 240 is shown, and the resulting expansion / deployment of the heart valve 300 into engagement at the location of the native tricuspid valve 10. The release of the various components / regions of the heart valve 300 can be achieved by the clinician operator manually manipulating one or more control wires and / or release pins 244 ( Fig.18 ) is performed in a controlled manner. Release of the heart valve 300 from the internal control catheter 240 causes the body 306, anterior leaflets 320a-b, and posterior leaflets 330a-b to expand into engagement with the anatomy of the native tricuspid valve 10, RV, and RVOT.

[0122] at last, Fig.37 An implanted heart valve 300 is shown engaged with the heart 1 and serving as a prosthetic tricuspid valve between the RA and RV. The deployment system 200 and guidewire have been withdrawn. Fig.31 As can be seen in the top view of the heart valve 300, the body 306 is positioned toward the front portion of the annulus 12 (see FIG. Fig.10 ) is offset in position, the anterior portion being adjacent to the RVOT. Fig.31), the laterally extending first and second posterior flaps 330a-b help cover and fluid-seal the native tricuspid valve opening within the valve ring 12, which in this example is not circular (e.g., the native valve opening is rectangular, elliptical, or irregularly shaped). In other words, in conjunction with the body 306 of the valve 300, the first posterior flap 330a-b and the second posterior flap 330a-b (and in some cases, the laterally extending anterior anchoring flap 320a-b to a lesser extent) help cover / occlude and fluid-seal the native tricuspid valve opening, which in some cases is not circular. In addition, the ends of the first and second posterior flaps 330a-b extend to align with the posterior shelf 11 ( Figure 4 ) and / or engage with the wall of the RV just below the annulus 12 to provide anchoring and resistance to migration. Thus, the first and second posterior petals 330a-b perform sealing and anchoring.

[0123] Figure 38-40 A frame 102 that can be used in some embodiments of the prosthetic heart valve described herein is shown. The frame 102 has a honeycomb structure that provides mechanical support for the shape and structure of the prosthetic heart valve. In some embodiments, the frame 102 is made of nitinol (NiTi), stainless steel, cobalt chromium, MP35N, titanium, polymer materials, other biocompatible materials, or any combination thereof. Some or all portions of the frame 102 may be covered (e.g., by the above-mentioned covering 104). In some embodiments, the frame 102 can be made of laser cut, expanded, and shaped materials. In some embodiments, the frame 102 is self-expanding. In some embodiments, the precursor material is a tubular NiTi, a NiTi sheet, or other suitable types of precursor material.

[0124] In this example, the frame 102 includes an optional posterior arm 150 having a free end 150e. The posterior arm 150 may also be referred to as a "diastolic anchoring tab" because the posterior arm 150 helps prevent the prosthetic heart valve from migrating toward the right ventricle during diastole. In this example, the frame 102 does not include a forearm 160 (see, e.g., Fig. 9 ). However, in some embodiments, the forearm 160 is included as part of the frame 102.

[0125] In this example, frame 102 does not include frame portions 128a and 128b (see, e.g., Fig. 9 ). However, in some embodiments, frame portions 128a and 128b are included as part of frame 102.

[0126] As in Fig.40As best seen in , the frame 102 includes an inflow end portion 102i and an outflow end portion 102o. In the illustrated embodiment, the honeycomb structures of the inflow end portion 102i and the outflow end portion 102o are different from each other. In particular, the size of the cells constituting the inflow end portion 102i is smaller than the size of the cells constituting the outflow end portion 102o. For example, the cells of the inflow end portion 102i have a shorter longitudinal length (e.g., measured longitudinally parallel to the longitudinal axis 101) than the cells of the outflow end portion 102o. In other words, the cells of the outflow end portion 102o are longer than the cells of the inflow end portion 102i when measured along the longitudinal direction of the frame 102.

[0127] The difference in size of the cells of the inflow end portion 102i as compared to the cells of the outflow end portion 102o results in the frame 102 advantageously having different structural properties along the longitudinal length of the frame 102. For example, the inflow end portion 102i of the frame 102 is structurally more rigid than the outflow end portion 102o, particularly with respect to radially directed forces. Conversely, the outflow end portion 102o of the frame 102 is structurally more flexible than the inflow end portion 102i. Additionally, the structure of the front lobes 120a-b is very flexible because the front lobes 120a-b are primarily made of large open areas within the peripheral frame members (see, e.g., FIG. 1 ). Fig.39 ).

[0128] It may be advantageous for the inflow end portion 102i of the frame 102 to be structurally rigid. For example, such rigidity may help retain an occluder (e.g., Figure 6-8 The circular cross-sectional shape of the occluder 110 shown in FIG. 1 is used to maintain the circular cross-sectional shape of the occluder while the myocardium contracts to pump blood. Maintaining this circular cross-sectional shape of the occluder can be used to ensure that the leaflets of the occluder maintain their relative orientation in a predictable manner. For example, this can beneficially provide robust co-adaptation between the leaflets to mitigate the occurrence of regurgitation through the occluder.

[0129] It may be advantageous for the outflow end portion 102o and the front flaps 120a-b of the frame 102 to be structurally flexible. For example, such flexibility can beneficially mitigate the amount of force applied to the anatomical structures of the heart from the frame 102. In particular, having a flexible outflow end portion 102o and flexible front flaps 120a-b reduces or eliminates the application of forces from the frame 102 to certain sensitive anatomical regions, such as the AV node, the right coronary artery, and the annulus of the heart valve, to name a few examples.

[0130] Figures 41-43Another example frame 102' is shown that can be used in some embodiments of the prosthetic heart valves described herein. This embodiment differs from frame 102 in that frame 102' includes frame portions 128a and 128b and does not include posterior arm 150 (and also does not include anterior arm 160). It should be understood that such features can be mixed and matched in any desired combination.

[0131] Frame 102' shares the cell size characteristics of frame 102 as described above. That is, the cells making up inflow end portion 102i are smaller and more rigid than the cells making up outflow end portion 102o. The cells of the front lobes 120a-b have the largest size (making them the most flexible portion of frame 102').

[0132] Alternative methods of achieving the variable stiffness characteristics described above are also contemplated. For example, the strut widths and / or thicknesses of different portions of the frame 102 may be different.

[0133] Although this specification contains many specific implementation details, these should not be interpreted as limitations on any invention or the scope that may be claimed, but rather as descriptions of features that may be specific to a particular embodiment of a particular invention. Certain features described in this specification in the context of separate embodiments may also be implemented in combination, in part or in whole, in a single embodiment. Conversely, the various features described in the context of a single embodiment may also be implemented in multiple embodiments, either individually or in any suitable sub-combination. In addition, although features may be described herein as functioning in certain combinations and / or initially claimed as such, one or more features from the claimed combination may be deleted from the combination in some cases, and the claimed combination may be directed to a sub-combination or a variation of the sub-combination.

[0134] Similarly, although operations are depicted in a particular order in the drawings, this should not be understood as requiring that the operations be performed in the particular order shown or in sequence, or that all of the operations shown be performed, to achieve the desired results. Although many embodiments have been described in detail above, other modifications are possible. For example, the steps depicted in the drawings do not require the particular order shown or sequential order to achieve the desired results. In addition, other steps may be provided, or steps may be eliminated from the described processes, and other components may be added to or removed from the described systems. Therefore, other embodiments are within the scope of the appended claims.

Claims

1. A prosthetic heart valve, comprising: a main body, the main body comprising an inflow end portion and an outflow end portion; an occluder extending between the inflow end portion and the outflow end portion and comprising valve leaflets attached to the body in an arrangement that: (i) permits blood to flow through the occluder along a central axis of the occluder in a direction from the inflow end portion toward the outflow end portion, and (ii) prevents blood from flowing through the occluder in a direction from the outflow end portion toward the inflow end portion; a first front lobe extending from the outflow end portion in a first direction transverse to the central axis; and a second front lobe extending from the outflow end portion in the first direction, Wherein, the cross-sectional shape of the first front lobe and the second front lobe taken perpendicularly to the first direction is arcuate from the outer edge of the first front lobe to the outer edge of the second front lobe.

2. The prosthetic heart valve according to claim 1, wherein: The first front lobe and the second front lobe include a frame portion extending from an outer edge of the first front lobe and an outer edge of the second front lobe, and the frame portion is arranged at a non-zero angle relative to the central axis so as to define at least a portion of an arcuate cross-sectional shape.

3. The prosthetic heart valve according to claim 2, wherein: The frame portion is positioned adjacent to the body.

4. The prosthetic heart valve according to claim 2, wherein: Each of the frame parts comprises: two elongated members extending in said first direction; A plurality of members extend between the two elongated members.

5. The prosthetic heart valve according to any one of claims 1 to 4, wherein: Parts of the first front lobe and the second front lobe overlap each other.

6. The prosthetic heart valve according to claim 5, wherein: An open space is defined between the first front lobe and the second front lobe.

7. The prosthetic heart valve of any one of claims 1 to 4, further comprising a posterior leaflet extending from the outflow end portion in a second direction opposite to the first direction.

8. A prosthetic heart valve, comprising: A frame member, the frame member comprising: an inflow end portion, the inflow end portion comprising a first unit; an outflow end portion, the outflow end portion comprising a second unit; an occluder extending between the inflow end portion and the outflow end portion and comprising valve leaflets attached to the frame member in an arrangement that: (i) permits blood to flow through the occluder along a central axis of the occluder in a direction from the inflow end portion toward the outflow end portion, and (ii) prevents blood from flowing through the occluder in a direction from the outflow end portion toward the inflow end portion; a first front lobe extending from the outflow end portion in a first direction transverse to the central axis; and a second front lobe extending from the outflow end portion in the first direction, Wherein, the first unit is smaller than the second unit.

9. The prosthetic heart valve according to claim 8, wherein: A longitudinal length of the first unit is shorter than a longitudinal length of the second unit.

10. The prosthetic heart valve according to claim 8, wherein: The first front lobe and the second front lobe define an open space that is larger than an open space defined by the first unit and larger than an open space defined by the second unit.

11. The prosthetic heart valve according to claim 8, wherein: The flexibility of the outflow end portion is greater than the flexibility of the inflow end portion.

12. The prosthetic heart valve according to any one of claims 8 to 11, wherein: The cross-sectional shape of the inflow end portion is circular, and wherein the cross-sectional shape of the outflow end portion is elliptical.

13. The prosthetic heart valve of claim 8, further comprising a posterior leaflet extending from the outflow end portion in a second direction opposite the first direction.

14. The prosthetic heart valve according to claim 13, wherein: The open space defined by the rear lobe is larger than the open space defined by the first unit and larger than the open space defined by the second unit.

15. The prosthetic heart valve of claim 13, further comprising a posterior arm extending from the inflow end portion in the second direction.

16. A prosthetic heart valve, comprising: a main body, the main body comprising an inflow end portion and an outflow end portion; an occluder extending between the inflow end portion and the outflow end portion and comprising valve leaflets attached to the body in an arrangement that: (i) permits blood to flow through the occluder along a central axis of the occluder in a direction from the inflow end portion toward the outflow end portion, and (ii) prevents blood from flowing through the occluder in a direction from the outflow end portion toward the inflow end portion; a first front lobe extending from the outflow end portion in a first direction transverse to the central axis; a rear lobe extending from the outflow end portion in a second direction opposite to the first direction; and A rear arm extends from the inflow end portion in the second direction.

17. The prosthetic heart valve of claim 16, further comprising a forearm extending from the inflow end portion in the first direction.

18. The prosthetic heart valve of claim 16 or 17, further comprising a second front leaflet extending from the outflow end portion in the first direction.

19. The prosthetic heart valve of claim 18, wherein: A cross-sectional shape of the first front lobe and the second front lobe taken perpendicularly to the first direction is arcuate.

20. The prosthetic heart valve of claim 16, wherein: The rear arm also extends toward the outflow end portion.

21. The prosthetic heart valve of claim 16, wherein: The body has an elliptical outer profile in cross-section defining a major diameter and a minor diameter, wherein the minor diameter is shorter than the major diameter, wherein the occluder has a circular cross-sectional shape, and wherein the front and rear lobes extend transversely to the major diameter.

22. The prosthetic heart valve of claim 16, further comprising a leaflet engaging member extending from the body, a portion of the leaflet engaging member extending toward the inflow end portion and terminating at a free end.

23. The prosthetic heart valve of claim 22, wherein: The leaflet engagement members extend in the second direction.

24. The prosthetic heart valve according to claim 22 or 23, wherein: The posterior leaflet extends further away from the body than the leaflet coaptation member.

25. A method of deploying a prosthetic heart valve, the method comprising: Advancing the prosthetic heart valve toward the native tricuspid valve via the jugular vein and the superior vena cava while the prosthetic heart valve is releasably coupled to a prosthetic heart valve deployment system and diametrically constrained in a low-profile delivery configuration, wherein the prosthetic heart valve deployment system comprises: an outer sheath defining a first inner cavity; an intermediate deflectable catheter slidably disposed within the first lumen and defining a second lumen, the intermediate deflectable catheter including a selectively deflectable distal portion; and an internal control catheter slidably disposed within the second lumen and comprising one or more control wires releasably coupled to the prosthetic heart valve, wherein the inner control catheter includes a distal portion radially constrained within the first lumen; retracting the outer sheath relative to the inner control catheter to allow the distal end portion of the inner control catheter to become radially unconstrained and elastically transition to a curved configuration; and The selectively deflectable distal portion of the intermediate deflectable catheter is deflected such that the inner control catheter and the intermediate deflectable catheter, in combination, bend at least 90° relative to the outer sheath.

26. The method according to claim 25, wherein: The distal portion of the inner control catheter bends less than 20° when radially constrained within the first lumen.

27. The method of claim 25 or 26, wherein the distal portion elastically transitions to a curved configuration that curves at least 45° relative to the outer sheath when radially unconstrained.

28. The method of claim 25, wherein the prosthetic heart valve comprises: a main body, the main body comprising an inflow end portion and an outflow end portion; an occluder extending between the inflow end portion and the outflow end portion and comprising valve leaflets attached to the body in an arrangement that: (i) permits blood to flow through the occluder along a central axis of the occluder in a direction from the inflow end portion toward the outflow end portion, and (ii) prevents blood from flowing through the occluder in a direction from the outflow end portion toward the inflow end portion; a first front lobe extending from the outflow end portion in a first direction transverse to the central axis; a rear lobe extending from the outflow end portion in a second direction opposite to the first direction; and a rear arm extending from the inflow end portion in the second direction; and A leaflet engaging member extends from the body, a portion of the leaflet engaging member extending toward the inflow end portion and terminating at a free end.

29. The method according to claim 28, wherein: When the posterior valve is released from the prosthetic heart valve deployment system, a portion of a native leaflet of a native tricuspid valve is captured and retained between the leaflet engagement member and the body.

30. The method of claim 28, wherein: When the posterior arm is released from the prosthetic heart valve deployment system, the end of the posterior arm abuts against the inner wall of the inferior vena cava or the coronary sinus or the right atrium.

31. The method of any one of claims 28 to 30, further comprising a forearm extending from the inflow end portion in the first direction, and wherein, When the forearm is released from the prosthetic heart valve deployment system, the distal portion of the forearm abuts against the inner wall of the right atrial appendage.

32. A method of deploying a prosthetic heart valve, the method comprising: Engaging the prosthetic heart valve with the anatomy of a native tricuspid valve, wherein the prosthetic heart valve comprises: a main body, the main body comprising an inflow end portion and an outflow end portion; an occluder extending between the inflow end portion and the outflow end portion and comprising valve leaflets attached to the body in an arrangement that: (i) permits blood to flow through the occluder along a central axis of the occluder in a direction from the inflow end portion toward the outflow end portion, and (ii) prevents blood from flowing through the occluder in a direction from the outflow end portion toward the inflow end portion; and a lateral front flap extending from the outflow end portion in a first direction transverse to the central axis, wherein the anterior lateral valve extends into the right ventricular outflow tract (RVOT), and The edge portion of the lateral anterior flap extends along the side wall of the RVOT and abuts against the side wall of the RVOT, so that there is side wall tissue above and below the edge portion of the lateral anterior flap to provide anchoring.

33. The method of claim 32, wherein: The prosthetic heart valve also includes an anterior septal leaflet extending in the first direction.

34. The method of claim 33, wherein: The cross-sectional shape of the anterior lateral flap and the anterior septal flap taken perpendicularly to the first direction is arcuate from the outer edge of the anterior lateral flap to the outer edge of the anterior septal flap.

35. The method of claim 34, wherein: The anterior lateral flap and the anterior septal flap each include a frame portion extending from outer edges of the anterior lateral flap and the anterior septal flap, and the outer edges are arranged at a non-zero angle relative to the central axis so as to define at least a portion of an arcuate cross-sectional shape.

36. The method of claim 35, wherein: Each of the frame parts comprises: two elongated members extending in said first direction; A plurality of members extend between the two elongated members.

37. A prosthetic heart valve, comprising: a main body, the main body comprising an inflow end portion and an outflow end portion; an occluder extending between the inflow end portion and the outflow end portion and comprising valve leaflets attached to the body in an arrangement that: (i) permits blood to flow through the occluder along a central axis of the occluder in a direction from the inflow end portion toward the outflow end portion, and (ii) prevents blood from flowing through the occluder in a direction from the outflow end portion toward the inflow end portion; a front lobe extending from the outflow end portion in a first direction transverse to the central axis; a rear lobe extending from the outflow end portion in a second direction opposite to the first direction; and A forearm extends from the inflow end portion in the first direction.

38. A prosthetic heart valve, comprising: a main body, the main body comprising an inflow end portion and an outflow end portion; an occluder extending between the inflow end portion and the outflow end portion and comprising valve leaflets attached to the body in an arrangement that: (i) permits blood to flow through the occluder along a central axis of the occluder in a direction from the inflow end portion toward the outflow end portion, and (ii) prevents blood from flowing through the occluder in a direction from the outflow end portion toward the inflow end portion; a first front lobe extending from the outflow end portion in a first direction transverse to the central axis; a second front lobe extending from the outflow end portion in the first direction; a first rear lobe extending from the outflow end portion in a second direction opposite to the first direction; and a second rear lobe extending from the outflow end portion in the second direction, wherein a channel is defined between the first rear lobe and the second rear lobe, and Wherein, the first rear lobe and the second rear lobe extend further from the outflow end portion than the first front lobe and the second front lobe.

39. The prosthetic heart valve of claim 38, wherein: The body has an elliptical outer profile in cross-section defining a major diameter and a minor diameter, wherein the minor diameter is shorter than the major diameter, wherein the occluder has a circular cross-sectional shape, and wherein the front and rear lobes extend transversely to the major diameter.

40. The prosthetic heart valve of claim 38 or 39, further comprising a leaflet engaging member extending from the body, a portion of the leaflet engaging member extending toward the inflow end portion and terminating at a free end.

41. The prosthetic heart valve of claim 40, wherein: The leaflet engagement members extend in the second direction.

42. The prosthetic heart valve of claim 41, wherein: The posterior leaflet extends further away from the body than the leaflet coaptation member.

43. A method of deploying a prosthetic heart valve, the method comprising: Engaging the prosthetic heart valve with the anatomy of a native tricuspid valve, wherein the prosthetic heart valve comprises: a main body, the main body comprising an inflow end portion and an outflow end portion; an occluder extending between the inflow end portion and the outflow end portion and comprising valve leaflets attached to the body in an arrangement that: (i) permits blood to flow through the occluder along a central axis of the occluder in a direction from the inflow end portion toward the outflow end portion, and (ii) prevents blood from flowing through the occluder in a direction from the outflow end portion toward the inflow end portion; and a rear arm extending from the inflow end portion, Wherein, the distal end portion of the rear arm abuts against the inner wall of the inferior vena cava, the coronary sinus or the right atrium.

44. A method of deploying a prosthetic heart valve, the method comprising: Engaging the prosthetic heart valve with the anatomy of a native tricuspid valve, wherein the prosthetic heart valve comprises: a main body, the main body comprising an inflow end portion and an outflow end portion; an occluder extending between the inflow end portion and the outflow end portion and comprising valve leaflets attached to the body in an arrangement that: (i) permits blood to flow through the occluder along a central axis of the occluder in a direction from the inflow end portion toward the outflow end portion, and (ii) prevents blood from flowing through the occluder in a direction from the outflow end portion toward the inflow end portion; and a forearm extending from the inflow end portion, Wherein, the distal end portion of the forearm abuts against the inner wall of the right atrial appendage.

45. A prosthetic heart valve deployment system comprising: an outer sheath defining a first inner cavity; an intermediate deflectable catheter slidably disposed within the first lumen and defining a second lumen, the intermediate deflectable catheter including a selectively deflectable distal portion having at least one deflection plane; and an internal control catheter slidably disposed within the second lumen and comprising one or more control wires configuring the internal control catheter to releasably couple with a prosthetic heart valve, Wherein, the internal control catheter includes a distal portion, and when the internal control catheter is converted from radially constrained to radially unconstrained, the distal portion elastically transforms into a natural curved configuration.

46. ​​The prosthetic heart valve deployment system of claim 45, wherein: When in the naturally curved configuration, the distal portion defines an internal angle of less than 135 degrees.

47. A method of deploying a prosthetic heart valve, the method comprising: advancing the prosthetic heart valve toward the native tricuspid valve via the femoral vein and the inferior vena cava while the prosthetic heart valve is releasably coupled to a prosthetic heart valve deployment system and diametrically constrained in a low-profile delivery configuration, wherein the prosthetic heart valve deployment system comprises: an outer sheath defining a first inner cavity; an intermediate deflectable catheter slidably disposed within the first lumen and defining a second lumen, the intermediate deflectable catheter including a selectively deflectable distal portion; and an internal control catheter slidably disposed within the second lumen and comprising one or more control wires releasably coupled to the prosthetic heart valve, wherein the internal control catheter comprises a curved distal portion, wherein when constrained in the first lumen, the curved distal portion is bent by less than 20°; Advancing the inner control catheter relative to the outer sheath to allow the curved distal end portion to become unconstrained and elastically transition to a curved configuration that is bent at least 45° relative to the outer sheath; and The selectively deflectable distal portion of the intermediate deflectable catheter is deflected such that the inner control catheter and the intermediate deflectable catheter, in combination, bend at least 90° relative to the outer sheath.

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