Prosthetic heart valve

Abstract

To provide a disclosure relating generally to prosthetic valves and methods and systems for deploying, positioning, and recapturing the same.SOLUTION: A prosthetic valve includes one or more support structures. At least one of the one or more support structures defines an elongate central passageway of the prosthetic valve. The prosthetic valve can also include a plurality of leaflet elements attached to at least one of the one or more support structures and disposed within the elongate central passageway for control of fluid flow through the elongate central passageway. At least one of the one or more support structures is configured to biodynamically fix the prosthetic valve within a native valve such as, for example, a native tricuspid valve of a heart.SELECTED DRAWING: Figure 80

Description

Technical Field

[0001] The present disclosure generally relates to implantable cardiac devices, and more particularly to artificial tricuspid valves.

Background Art

[0002] Significant progress has been made in the transcatheter treatment of heart valve diseases. The first clinical efforts focused on the pulmonary valve, and subsequently on devices for the percutaneous replacement of the aortic valve to treat aortic stenosis. In parallel, there were a number of programs that attempted to address mitral regurgitation by transcatheter treatment techniques and, later, transcatheter mitral valve replacement.

[0003] Tricuspid valve disease is a condition in which the tricuspid valve, located between the right ventricle and the right atrium of the heart, does not function properly. For example, there are multiple forms of tricuspid valve disease such as tricuspid regurgitation (blood flowing backward from the right ventricle to the right atrium), tricuspid stenosis (the tricuspid valve becomes narrow, thereby reducing blood flow from the right atrium to the right ventricle), tricuspid atresia (congenital non-formation or malformation of the tricuspid valve, thereby blocking or reducing blood flow from the right atrium to the right ventricle). Tricuspid valve disease has been largely ignored as a "lesser" valve disease compared to aortic stenosis (highest level of mortality) and mitral regurgitation (highest morbidity).

[0004] Currently, there are few artificial tricuspid valves dedicated to the tricuspid valve. In many cases, tricuspid valve defects are treated using artificial aortic and mitral valves that are for other uses. Artificial aortic and mitral valves for other uses, when used for the tricuspid valve, exert pressure on the natural annulus of the tricuspid valve and are rigidly fixed by immobilizing the artificial valve. Since the tricuspid valve is close to the cardiac conduction region, this rigid fixation of the artificial valve within the tricuspid valve can lead to heart block and / or other conduction abnormalities.

[0005] Because the replacement of the tricuspid valve presents unique problems, there is a need for an artificial valve specifically designed for the treatment of the tricuspid valve.

Summary of the Invention

Means for Solving the Problem

[0006] The present invention provides an artificial tricuspid valve that is not rigidly fixed inside the native tricuspid valve. This biomechanical design prevents cardiac obstruction and / or other dangerous conduction abnormalities. The artificial tricuspid valve provided herein is not rigidly fixed throughout the cardiac cycle of the heart, but can stably remain in a predetermined position.

[0007] The biomechanical artificial heart valve of the present invention provides the necessary solution by allowing the movements necessary to characterize the native tricuspid valve. In one aspect, the present invention comprises an artificial heart valve including one or more support structures. At least one of the one or more support structures defines an elongate central passageway. The artificial heart valve can also include a plurality of leaflet elements mounted to at least one of the one or more support structures and disposed within the elongate central passageway to control blood flow through the elongate central passageway. At least one of the one or more support structures is configured to biomechanically fix the artificial heart valve to the native leaflets of the heart's native heart valve. Specifically, in some embodiments, at least one support structure is configured to biomechanically fix the artificial heart valve to the native leaflets of the native heart valve, such that at least one support structure is movable within the native annulus of the native heart valve in response to changes in pressure on one or more sides of the native heart valve.

[0008] As referred to herein, the term "biomechanics" with respect to an artificial heart valve refers to the configuration of an artificial heart valve that enables the artificial heart valve to maintain axial stabilization within the natural heart valve of the heart, while allowing it to move within the natural heart valve. Thereby, the valve becomes responsive to the alternating pressure differences on both sides of the natural heart valve during the cardiac cycle of the heart. This is achieved without directly attaching to the natural valve annulus or the natural cords (chordae tendineae) of the natural heart valve, thereby maintaining the natural movement of the natural valve annulus. Specifically, the artificial heart valve is axially stabilized within the natural heart valve by gripping the natural leaflets of the natural heart valve, rather than relying on circumferential forces or direct circumferential or cord attachment. As referred to herein, the term "axial stabilization" with respect to an artificial heart valve disposed within a natural heart valve refers to a portion of the artificial heart valve intervening between two diametrically opposed points on the natural valve annulus of the natural heart valve.

[0009] Many of the features of the artificial heart valve described herein enable this biomechanical movement of the artificial heart valve. In some embodiments, at least one of the one or more support structures of the artificial heart valve includes a cylindrical portion having an atrial end and a ventricular end. The elongated central passage of the artificial heart valve is defined by the cylindrical portion of at least one support structure. In some embodiments, at least one of the one or more support structures comprises an atrial arm set. Further, in some embodiments, at least one of the one or more support structures comprises a ventricular arm set. Each arm of the atrial arm set and the ventricular arm set can include a proximal segment that is proximal to the cylindrical portion of at least one support structure and a distal segment that is distal to the cylindrical portion of at least one support structure.

[0010] In some embodiments, the distal segments of each arm of the atrial arm set and the ventricular arm set can extend away perpendicularly from the central axis of the elongated central passageway. Further, the atrial arm set can be configured to contact the native leaflets on the atrial side of the native heart valve, and the ventricular arm set can be configured to contact the native leaflets on the ventricular side of the native heart valve. As referred to herein, the distal segment of an arm that extends "perpendicularly" away from the central axis of the elongated central passageway refers to the distal segment of an arm that extends away from the central axis of the elongated central passageway, such that a line drawn from the contact point of the distal segment with an object (e.g., a native heart valve leaflet) to the longitudinal position along the outer surface of the cylindrical portion of at least one support structure from which the distal segment extends is oriented at approximately 90° ± 45° from the central axis of the elongated central passageway. As described below, this approximate perpendicularity of the line from the contact point of the distal segment to the longitudinal position along the outer surface of the cylindrical portion from which the distal segment extends enables axial stabilization of the prosthetic heart valve within the native heart valve.

[0011] Specifically, in some embodiments, the atrial arm set and the ventricular arm set are flexed such that, in a transplanted configuration in which at least one support structure biomechanically secures the prosthetic heart valve to the native leaflets of the native heart valve, when the cylindrical portion of at least one support structure moves toward the atrial side of the native heart valve due to ventricular systolic pressure loading, one or more arms of the ventricular arm set resist this movement while one or more arms of the atrial arm set relax to maintain contact with the atrial side of the native leaflets. Similarly, when the cylindrical portion of at least one support structure moves toward the ventricular side of the native heart valve due to ventricular diastolic pressure loading and / or when the previously applied ventricular systolic load is removed, one or more arms of the atrial arm set resist this movement while one or more arms of the ventricular arm set relax to maintain contact with the ventricular side of the native leaflets. This creates a trampoline effect whereby the ventricular systolic pressure load can be partially absorbed by the atrial movement of the native leaflets.

[0012] In some embodiments, the arms of the atrial arm set are interleaved with the arms of the ventricular arm set around the cylindrical portion of at least one support structure.

[0013] In some embodiments, overbite can exist between the atrial arm set and the ventricular arm set. Specifically, in some embodiments, the arms of the atrial arm set and the ventricular arm set can extend across the cross-section of the cylindrical portion of at least one support structure. As referred to herein, the "cross-section" with respect to the cylindrical portion of at least one support structure is a cross-section of the cylindrical portion of at least one support structure that is perpendicular to the central axis of the elongated central passage defined by the cylindrical portion of at least one support structure. In some further embodiments, the distal segment of the arm of the atrial arm set that extends perpendicular away from the central axis of the elongated central passage extends towards the ventricular end of the cylindrical portion of at least one support structure, thereby enabling the distal segment of the arm of the atrial arm set that extends perpendicular away from the central axis of the elongated central passage to clamp the native leaflet to the atrial side of the native heart valve. Further, the distal segment of the arm of the ventricular arm set that extends perpendicular away from the central axis of the elongated central passage can extend towards the atrial end of the cylindrical portion of at least one support structure, thereby enabling the distal segment of the arm of the ventricular arm set that extends perpendicular away from the central axis of the elongated central passage to clamp the native leaflet to the ventricular side of the native heart valve.

[0014] During the implantation of the artificial heart valve, the overbite between the atrial arm and the ventricular arm creates an additional clamping effect and an additional tension on the native leaflets. The reason is that the distal segment of the atrial arm on the atrial side of the native leaflet is actively pushed down towards the ventricle of the heart, while the distal segment of the ventricular arm on the ventricular side of the native leaflet is actively pushed up towards the atrium of the heart, thereby effectively generating a waveform effect in the native leaflet, like a frilled flap. This tension effect from the opposing forces on both sides of the native leaflet helps to further axially stabilize the artificial heart valve within the native heart valve. The amount of overbite between the atrial arm and the ventricular arm of the artificial heart valve determines the magnitude of the clamping force of the arms in the native leaflet of the native heart valve. Furthermore, the magnitude of the clamping force of the arms in the native leaflet of the native heart valve determines the amount of axial stabilization and biomechanical movement of the artificial heart valve within the native heart valve over the entire cardiac cycle of the heart. Specifically, a greater clamping force of the arms in the native leaflet of the native heart valve results in greater axial stabilization and less biomechanical movement of the artificial heart valve within the native heart valve over the entire cardiac cycle of the heart.

[0015] In some embodiments, the distal segments of the arms of the atrial arm set extending away perpendicularly from the central axis of the elongated central passage each have a tip that curves towards the atrial end of the cylindrical portion of at least one support structure, thereby reducing trauma to the native leaflets on the atrial side of the native heart valve at the contact points of the atrial arm set. Further, in some embodiments, the distal segments of the arms of the ventricular arm set extending away perpendicularly from the central axis of the elongated central passage each have a tip that curves towards the ventricular end of the cylindrical portion of at least one support structure, thereby reducing trauma to the native leaflets on the ventricular side of the native heart valve at the contact points of the ventricular arm set.

[0016] In some embodiments, the cylindrical portion of at least one support structure is radially collapsible for transcatheter implantation. Further, the distal segments of the atrial arm set and the ventricular arm set that extend away from the central axis of the elongated central passage can be elastically straightened.

[0017] In certain embodiments, the distal segments of one or more arms of a ventricular arm set (e.g., ventricular-directed arms) that extend away from the central axis of the elongated central passage can extend toward the ventricular end of the cylindrical portion of at least one support structure, such that the distal segments of the ventricular-directed arms that extend away from the central axis of the elongated central passage contact one of the native leaflets on the atrial side rather than the ventricular side of the native heart valve, thereby holding the native leaflet in a radially outward open position away from the native heart valve. Configuring the ventricular-directed arms to hold the native leaflet in a radially outward open position away from the native heart valve can be useful in embodiments where it is difficult for the native leaflet to be captured by the arms for one reason or another (e.g., if the native leaflet is too small or restricted). As another example, configuring the ventricular-directed arms to hold the native leaflet in a radially outward open position away from the native heart valve can be useful for minimizing the number of echocardiographic planes and / or viewpoints required during implantation of an artificial heart valve (thereby simplifying the implantation procedure).

[0018] In some embodiments, the artificial heart valve described herein can further include one or more covers that extend across one or more of the atrial arm set and the ventricular arm set within the elongated central passageway. In some such embodiments, a portion of the one or more covers can include a fenestration mechanism. In an implantation configuration in which at least one support structure biomechanically secures the artificial heart valve to the native leaflets of the native heart valve, the fenestration mechanism can be disposed between the elongated central passageway and the native annulus of the native heart valve. In some embodiments, the fenestration mechanism can be at least one of a radiopaque marker, an aperture, a magnetic element, a one-way valve, a pop-up valve, a mechanically size-adjustable aperture, and increased porosity.

[0019] In certain embodiments, the atrial arm set of the artificial heart valve can be attached to the ventricular end of the cylindrical portion of at least one support structure, while the ventricular arm set can be attached to the atrial end of the cylindrical portion of at least one support structure. In other words, in certain embodiments, the atrial arm set and the ventricular arm set of the artificial heart valve can originate from opposite ends of the cylindrical portion of at least one support structure. In such embodiments, one or more covers can originate from and be attached to the distal segment of each arm of the atrial arm set, extend to and be attached to the proximal segment of each arm of the ventricular arm set, extend through the cylindrical portion of at least one support structure within the elongated central passageway, extend around the cylindrical portion of at least one support structure, and be attached to the proximal segment of each of the atrial arm sets. In some embodiments, one or more covers terminate at and are attached to a location along the proximal segment of each arm of the atrial arm set that is at a common distance from the cylindrical portion of at least one support structure. In alternative embodiments, one or more covers can further extend to and be attached to the distal segment of each arm of the ventricular arm set. In some embodiments, one or more covers can extend asymmetrically and / or non-circularly within the elongated central passageway and over one or more of the atrial arm set and the ventricular arm set.

[0020] In some embodiments, the atrial arm set can be attached to the atrial end of the cylindrical portion of at least one support structure, while the ventricular arm set can be attached to the ventricular end of the cylindrical portion of at least one support structure. In alternative embodiments, for example, in the embodiments described above, the atrial arm set can be attached to the ventricular end of the cylindrical portion of at least one support structure, while the ventricular arm set can be attached to the atrial end of the cylindrical portion of at least one support structure.

[0021] In embodiments where the atrial arm set is attached to the ventricular end of the cylindrical portion of at least one support structure and the ventricular arm set is attached to the atrial end of the cylindrical portion of at least one support structure, the proximal segment of each arm of the ventricular arm set can extend from the ventricular end of the cylindrical portion of at least one support structure along the outer surface of the cylindrical portion of at least one support structure, and the distal segment of each arm of the atrial arm set can extend away perpendicularly from the central axis of the elongated central passage. Similarly, the proximal segment of each arm of the ventricular arm set can extend from the atrial end of the cylindrical portion of at least one support structure along the outer surface of the cylindrical portion of at least one support structure toward the ventricular end of the cylindrical portion of at least one support structure, and the distal segment of each arm of the ventricular arm set can extend away perpendicularly from the central axis of the elongated central passage.

[0022] In a further embodiment, the atrial arm set is attached to the ventricular end of the cylindrical portion of at least one support structure, the ventricular arm set is attached to the atrial end of the cylindrical portion of at least one support structure, and the distal segment of the arm of the atrial arm set that extends perpendicular to the central axis of the elongated central passage can extend along the outer surface of the cylindrical portion of at least one support structure from a certain atrial longitudinal position, and the distal segment of the arm of the ventricular arm set that extends perpendicular to the central axis of the elongated central passage can extend along the outer surface of the cylindrical portion of at least one support structure from a certain ventricular longitudinal position, and the atrial longitudinal position is closer to the atrial end of the cylindrical portion of at least one support structure than the ventricular longitudinal position.

[0023] In a further embodiment, the ventricular arm set is attached to the atrial end of the cylindrical portion of at least one support structure. In a transplantation configuration where at least one support structure biodynamically fixes the artificial heart valve to the natural leaflets of the natural heart valve, the ventricular arm set extends from the atrial end of the cylindrical portion of at least one support structure through the natural valve annulus of the natural heart valve to the ventricular side of the natural heart valve and contacts the natural leaflets on the ventricular side of the natural heart valve.

[0024] In a further embodiment, the atrial arm set is attached to the ventricular end of the cylindrical portion of at least one support structure. In a transplantation configuration where at least one support structure biodynamically fixes the artificial heart valve to the natural leaflets of the natural heart valve, the atrial arm set extends from the ventricular end of the cylindrical portion of at least one support structure through the natural valve annulus of the natural heart valve into the atrium of the heart and contacts the natural leaflets on the atrial side of the natural heart valve.

[0025] In these various embodiments, the atrial arm set is attached to the ventricular end of the cylindrical portion of at least one support structure, and the ventricular arm set is attached to the atrial end of the cylindrical portion of at least one support structure, providing a further overbite between the atrial arm and the ventricular arm as described above. Further, in these various embodiments where the atrial arm set is attached to the ventricular end of the cylindrical portion of at least one support structure and the ventricular arm set is attached to the atrial end of the cylindrical portion of at least one support structure, it enables an improved distribution of the forces received by the atrial and ventricular arms across the entire artificial heart valve, thereby reducing the likelihood of failure of the artificial heart valve, particularly the atrial and ventricular arms.

[0026] In certain embodiments, the cylindrical portion of at least one support structure can be a cylindrical cage structure with an opening. In such embodiments, at least some portions of the cylindrical cage structure and the opening can be configured to receive the bends of one or more arms of the atrial arm set and the ventricular arm set, and the arms extend perpendicular to the central axis of the elongated central passage. By configuring the cylindrical portion of at least one support structure such that the arms extend perpendicular to the central axis of the elongated central passage to receive the bends of one or more arms of the atrial arm set and the ventricular arm set, at least one support structure can provide additional support to the atrial arm set and the ventricular arm set, enabling an improved load distribution across the entire artificial heart valve, thereby reducing the likelihood of failure of the artificial heart valve, particularly the atrial and ventricular arms. This improved load distribution across the entire artificial heart valve is particularly important in the biomechanical artificial heart valves disclosed herein. The reason is that the continuous biomechanical movement of the artificial heart valve with a natural heart valve during the cardiac cycle of the heart increases the load on the artificial heart valve and increases the chance of failure of the artificial heart valve. Further, by providing additional support to the atrial arm set and the ventricular arm set, the arms can be further stabilized when they contact the natural heart valve leaflets, thereby enabling axial stabilization of the artificial heart valve within the natural heart valve.

[0027] In some embodiments, the artificial heart valve can include one support structure. However, in alternative embodiments, to further improve the load distribution of the artificial heart valve, the artificial heart valve can include one or more support structures. In such embodiments, the artificial heart valve can include two, three, or more support structures. In such multi-support structure embodiments of the artificial heart valve, the plurality of support structures can be configured to fit together (e.g., snap fit into place) such that one or more of the plurality of support structures receive the benefit of support and load distribution from one or more of the other plurality of support structures, as described above. To configure the plurality of support structures of the artificial heart valve to fit together, the minimum inner diameter of the cylindrical portion of at least one support structure that defines the elongated central passageway can be less than the maximum outer diameter of the elongated central passageway. In additional embodiments, the minimum diameter of the radius of curvature of each bend of one or more arms of the atrial arm set and the ventricular arm set (the arms extending away perpendicularly from the central axis of the elongated central passageway) can be less than the maximum outer diameter of the elongated central passageway.

[0028] In other aspects, the present invention provides an artificial heart valve comprising one or more support structures that define an elongated central passageway, and a valve structure mounted to at least one of the one or more support structures and disposed within the elongated central passageway to control blood flow through the elongated central passageway. At least one of the one or more support structures includes a plurality of arms that extend away from the elongated central passageway for attachment of at least one of the support structures to a natural leaflet of a natural heart valve of the heart.

[0029] In some embodiments, the plurality of arms can include an atrial arm set extending from the atrial end of at least one support structure and a ventricular arm set extending from the ventricular end of at least one support structure before curving away from the elongated central passage. In some such embodiments, the atrial and ventricular arms are configured to cooperate to hold the natural leaflets of the native heart valve and maintain the elongated central passage within the native annulus of the native heart valve, and can be configured not to be directly attached to the native annulus or native cord associated with the native heart valve.

[0030] In other aspects, the present invention provides an artificial heart valve comprising one or more support structures defining an elongated central passage and a plurality of leaflet elements attached to at least one of the one or more support structures and disposed within the elongated central passage. At least one of the one or more support structures is configured to biodynamically fix the artificial heart valve inside and away from the native annulus of the native heart valve of the heart.

[0031] In some embodiments, at least one of the one or more support structures comprises a cylindrical portion including an atrial end and a ventricular end. The elongated central passage can be defined by the cylindrical portion of the at least one support structure. Further, the cylindrical portion of the at least one support structure can be expandable to a maximum radial width smaller than the minimum radial width of the native annulus of the native heart valve.

[0032] In some embodiments, to biodynamically fix the artificial heart valve inside and separated from the native annulus of the native heart valve, at least one of the one or more support structures of the artificial heart valve is configured to grip the natural leaflets of the native heart valve without directly attaching to the native annulus or native cord associated with the native heart valve.

[0033] In some embodiments, the native heart valve can be a tricuspid heart valve.

[0034] In another aspect, the present invention comprises a method for transcatheter implantation of an artificial heart valve. The artificial heart valve includes at least one support structure having a cylindrical portion. The cylindrical portion of the at least one support structure defines an elongated central passage of the artificial heart valve. The artificial heart valve also includes a plurality of atrial arms extending from the ventricular end of the cylindrical portion of the at least one support structure. Each arm of the plurality of atrial arms includes a proximal segment proximate to the cylindrical portion of the at least one support structure and a distal segment distal to the cylindrical portion of the at least one support structure. The artificial heart valve also includes a plurality of ventricular arms extending from the atrial end of the cylindrical portion of the at least one support structure. Each arm of the plurality of ventricular arms includes a proximal segment proximate to the cylindrical portion of the at least one support structure and a distal segment distal to the cylindrical portion of the at least one support structure.

[0035] The transcatheter implantation method of an artificial heart valve includes guiding the artificial heart valve through a patient's vein into the natural valve of the patient's heart. The artificial heart valve has a contracted configuration with an elongated central passage having an atrial diameter, and each arm of the plurality of ventricular arms is held by a sheath against the outer surface of the cylindrical portion of at least one support structure. Each arm of the plurality of atrial arms is held by the individual restraint of the plurality of restraints inside the sheath against the outer surface of the cylindrical portion of at least one support structure. The method further includes retracting the sheath to bend each arm of the plurality of ventricular arms such that the distal segment of each arm of the plurality of ventricular arms extends away from the cylindrical portion of at least one support structure. The method further includes retracting the artificial heart valve together with the sheath until the distal segment of each arm of the plurality of ventricular arms contacts the natural leaflet of the natural heart valve on the ventricular side of the natural heart valve. The method further includes expanding the cylindrical portion of at least one support structure from a contracted configuration to an expanded configuration with a larger ventricular diameter to form an elongated central passage. The method includes advancing the plurality of restraints to bend each arm of the plurality of atrial arms such that the distal segment of each arm of the plurality of atrial arms extends away from the cylindrical portion of at least one support structure and captures against the distal segments of the plurality of ventricular arms that contact the natural leaflet of the natural heart valve on the atrial side of the natural heart valve at the natural leaflet of the natural heart valve on the atrial side of the natural heart valve.

[0036] In some embodiments, the step of retracting the sheath to bend each of the plurality of ventricular arms such that the distal segment of each of the plurality of ventricular arms extends away from the cylindrical portion of the at least one support structure further includes bending each of the plurality of ventricular arms such that the proximal segment of each of the plurality of ventricular arms extends along the outer surface of the cylindrical portion of the at least one support structure, and the step of advancing the plurality of restraints to bend each of the plurality of atrial arms such that the distal segment of each of the plurality of atrial arms extends away from the cylindrical portion of the at least one support structure further includes bending each of the plurality of atrial arms such that the proximal segment of each of the plurality of atrial arms extends along the outer surface of the cylindrical portion of the at least one support structure.

[0037] In some embodiments, the method can further include removing the plurality of restraints from the plurality of atrial arms.

[0038] In some embodiments, the method further includes repositioning the prosthetic heart valve within the native heart valve by retracting the plurality of restraints from the plurality of atrial arms, straightening each of the plurality of atrial arms relative to the outer surface of the cylindrical portion of the at least one support structure, and pressing the at least one support structure toward the ventricular side of the native heart valve using the plurality of spreader arms while releasing the native leaflets of the native heart valve.

[0039] In some embodiments, the method further includes advancing the sheath to straighten each of the plurality of ventricular arms and recapturing and removing the prosthetic heart valve from the native heart valve by compressing the cylindrical portion of the at least one support structure to remove the prosthetic heart valve through the patient's vein while the prosthetic heart valve is in a collapsed configuration.

[0040] In some embodiments, advancing the plurality of restraints can include advancing the restraints while maintaining contact with at least one support structure using a plurality of spreader arms.

[0041] In some embodiments, the plurality of spreader arms can extend from a mid layer within the sheath. In certain embodiments, each restraint of the plurality of restraints can extend from the sheath between a pair of the plurality of spreader arms. In certain embodiments, each spreader arm of the plurality of spreader arms can include an interlock mechanism that maintains contact with the atrial end of the cylindrical portion of at least one support structure.

Brief Description of the Drawings

[0042] The accompanying drawings, which are incorporated in and constitute a part of this specification, are included to provide a further understanding and illustrate the disclosed embodiments and, together with the description, serve to explain the principles of the disclosed embodiments.

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Mode for Carrying Out the Invention

[0044] The detailed description that follows describes various configurations of the present technology and is not intended to represent the only configuration by which the present technology can be practiced. The detailed description includes specific details for the purpose of providing a thorough understanding of the present technology. Accordingly, dimensions may be provided with respect to specific embodiments as non-limiting examples. However, it will be apparent to those skilled in the art that the present technology can be practiced without these specific details. In some instances, well-known structures and components are shown in block diagram form in order to avoid obscuring the concepts of the present technology.

[0045] It should be understood that this disclosure includes examples of the present technology and does not limit the scope of the appended claims. Various aspects of the present technology are disclosed in accordance with specific non-limiting examples. The various embodiments described in this disclosure can be implemented in various ways and variations, in accordance with the desired application or implementation example.

[0046] In the following detailed description, numerous specific details are set forth in order to provide a thorough understanding of this disclosure. However, it will be apparent to those skilled in the art that embodiments of this disclosure can be practiced without some of these specific details. In other instances, well-known structures and techniques are not shown in detail so as not to obscure this disclosure.

[0047] Generally, because aortic and mitral valve replacements have been the focus of device development, the need for a solution for tricuspid regurgitation (TR) has remained unresolved. In particular, evidence is increasing that shows TR is associated with higher mortality rates and should not be left untreated even when other heart valves are addressed.

[0048] Similar to the mitral valve, the tricuspid valve is in an atrioventricular position. As a result, it might be expected that mitral valve replacements could be diverted for use in the tricuspid valve position. However, specific aspects of the tricuspid valve's anatomical structure and the surrounding anatomical structure (e.g., the tricuspid valve's larger size and proximity to the heart's conduction regions) favor a dedicated solution over such diversion of mitral valve devices.

[0049] According to aspects of the present disclosure, a biomechanical artificial tricuspid valve is provided herein. As described above, as referred to herein, the term "biomechanical" with respect to an artificial tricuspid valve refers to a configuration of an artificial tricuspid valve that can maintain axial stabilization within the natural tricuspid valve of the heart, can move within the natural tricuspid valve in response to an interactive pressure differential on both sides of the natural tricuspid valve, and can preserve the natural movement of the natural valve annulus without directly attaching to the natural valve annulus or natural cords (chordae tendineae) of the natural tricuspid valve. Specifically, the artificial tricuspid valve is axially stabilized within the natural tricuspid valve by gripping the natural leaflets of the natural tricuspid valve, rather than relying on annulus forces or direct annular or cord attachments. As referred to herein, the term "axial stabilization" with respect to an artificial tricuspid valve installed within the natural tricuspid valve refers to a portion of the artificial tricuspid valve intervening between two diametrically opposed points on the natural valve annulus of the natural tricuspid valve.

[0050] The artificial tricuspid valve includes one or more support structures. For example, as will be described in more detail below, the artificial tricuspid valve can include one, two, three, or four or more support structures. At least one of the one or more support structures includes a cylindrical portion having an atrial end and a ventricular end. The cylindrical portion of at least one support structure defines an elongated central passage of the artificial tricuspid valve. A central axis of the elongated central passage extends within the elongated central passage from the atrial end of the cylindrical portion to the ventricular end of the cylindrical portion. When the artificial tricuspid valve is in a configuration implanted within the natural tricuspid valve of the heart, blood flows through the elongated central passage of the artificial tricuspid valve from the atrium of the heart to the ventricle of the heart along the central axis of the elongated central passage. Further, a plurality of leaflet elements are attached to at least one support structure and are disposed within the elongated central passage for controlling blood flow through the elongated central passage.

[0051] The ventricular arms extending from the first end of the cylindrical portion of the at least one support structure extend into the ventricle of the heart and contact the ventricular surface of the native leaflets, while the atrial arms extending from the second end of the cylindrical portion of the at least one support structure opposite the first end extend into the atrium and contact the atrial surface of the native leaflets. The various mechanisms of the prosthetic tricuspid valve constitute a valve for transcatheter implantation, repositioning, and / or removal. The prosthetic tricuspid valve described herein can be easily positioned and deployed in a wide range of patients, has the ability to control deployment and evaluate complete functionality, and can maintain the ability to recapture and remove the implant before complete release.

[0052] Although various examples of prosthetic tricuspid valves configured for replacement of the native tricuspid valve are described herein, it should be understood that appropriate modifications can be made to use the prosthetic tricuspid valve disclosed herein for replacement of other native heart valves and / or other non-heart valves.

[0053] FIG. 1 shows an exemplary prosthetic tricuspid valve 100 according to an aspect of the present disclosure. In the example of FIG. 1, the prosthetic tricuspid valve 100 includes a support structure 102 having a cylindrical portion 116 that defines an elongated central passage 104. The cylindrical portion 116 has an atrial end 118 configured to be disposed within the atrium of the heart and a ventricular end 120 configured to be disposed within the ventricle of the heart. The central axis of the elongated central passage 104 through which blood flows from the atrium of the heart to the ventricle of the heart is shown as a dotted line in FIG. 1.

[0054] The cylindrical portion 116 is shown as a rigid cylindrical structure, but it should be understood that the cylindrical portion 116 can be formed of other structures, such as a radially expandable and compressible cylindrical cage structure with an expandable balloon or self-expanding openings, for example. In such embodiments, the cylindrical cage structure can be fabricated from laser cut metal, polymer tubing, and / or wire forming materials. In this example, some of the openings (not shown in FIG. 1; see FIGS. 15, 16, 21 or 22) can be positioned to receive one or more bends of one or more of the arms 106 described below, maintaining uniformity and symmetry during loading and recapture of the native tricuspid valve 100, and / or enabling load distribution from one or more arms 106 across the support structure 102 of the prosthetic tricuspid valve 100. In various structural examples, the cylindrical portion 116 can be radially collapsible (e.g., into the elongated central passageway 104) for transcatheter implantation.

[0055] The cylindrical portion 116 is sized small relative to the native tricuspid valve annulus so as not to impart a radial force to the annulus. Specifically, in the example of FIG. 1 and various other examples described herein, the cylindrical portion 116 is expandable to a maximum radial width that is less than the minimum radial width of the native annulus of the native tricuspid valve. As will be described in more detail below, the arms 106 are configured to cooperate to hold the native leaflets of the native tricuspid valve and maintain the elongated central passageway 104 within the native annulus of the native tricuspid valve, such that the prosthetic tricuspid valve 100 is biomechanically secured within and separated from the native annulus of the native tricuspid valve. However, it should be understood that some portions of the prosthetic tricuspid valve 100 can extend up to or beyond the native annulus. For example, as will be described in more detail below, the prosthetic tricuspid valve 100 may include an atrial sealing skirt that extends up to or beyond the native annulus for anchor fixation and / or to completely cover the commissure of the native tricuspid valve for leak prevention.

[0056] The cylindrical portion (116) is shown in FIG. 1 as having a circular cross-section, but it should be understood that the cylindrical portion 116 may have a generally cylindrical shape that is not a perfect circular cross-section. For example, the cylindrical portion 116 can have a cross-section that is circular or non-circular (e.g., D-shaped, triangular, elliptical or any other cross-sectional geometry), and can be configured such that the size of one prosthetic tricuspid valve fits all patients (e.g., with different size settings only for the arm 106 and the atrial sealing skirt described below), or within a range of prosthetic tricuspid valve sizes according to the patient's anatomy.

[0057] Although not shown in FIG. 1, a plurality of leaflet elements can be attached to the support structure 102 and disposed inside the elongated central passage 104 to control blood flow through the elongated central passage. These leaflet elements replace the function of the natural leaflets once the prosthetic tricuspid valve 100 is implanted.

[0058] As shown in FIG. 1, the prosthetic tricuspid valve 100 is biomechanically fixed inside the native valve annulus of the native tricuspid valve by separating therefrom and fixing the prosthetic tricuspid valve 100 to the native leaflets of the native tricuspid valve using a plurality of ventricular arms 106-1 and a plurality of atrial arms 106-2. Specifically, the plurality of ventricular arms 106-1 extend from a first end of the cylindrical portion 116 of the support structure 102 and contact the ventricular side of the native leaflets of the native tricuspid valve. Similarly, the plurality of atrial arms 106-2 extend from a second end of the cylindrical portion 116 of the support structure 102 opposite the first end and contact the atrial side of the native leaflets of the native tricuspid valve. As shown in FIG. 1, the atrial arms 106-1 may be alternately arranged with the ventricular arms 106-2 around the circumference of the cylindrical portion 116 of the support structure 102.

[0059] Each arm 106 includes a proximal segment and a distal segment. The proximal segment of each arm 106 is adjacent to the cylindrical portion 116 of the support structure 102. Specifically, the proximal segment of each arm 106 is the segment of the arm 106 that is attached to the cylindrical portion 116 of the support structure 102. The proximal segment of each arm 106 extends along the outer surface 147 of the cylindrical portion 116 from its attachment point at the cylindrical portion 116 and ends (including this) at a second bend that directs the distal segment of the arm away from the central axis of the elongated central passage 104 and perpendicular thereto. The second bend directs the distal segment of the arm away from the central axis of the elongated central passage (104) at a longitudinal position along the outer surface 147 of the cylindrical portion 116 and perpendicular thereto. In some embodiments (e.g., the embodiment of the artificial tricuspid device 100 in FIG. 1), the proximal segment of each arm 106 also includes an initial bend that directs the proximal segment of the arm 106 along the outer surface 147 of the cylindrical portion 116.

[0060] Each atrial arm 106-1 has a proximal segment 112, and each ventricular arm 106-2 has a proximal segment 108. As shown in FIG. 1 and described in more detail hereinafter, any initial bend of the proximal segment 112 of each atrial arm 106-1 is the initial bend 128, and the second bend of the proximal segment 112 of each atrial arm 106-1 is the second bend 130. Similarly, any initial bend of the proximal segment 108 of each ventricular arm 106-2 is the initial bend 124, and the second bend of the proximal segment 108 of each ventricular arm 106-2 is the second bend 126.

[0061] The distal segment of each arm 106 is distal to the cylindrical portion 116 of at least one support structure 102. Specifically, the distal segment of each arm 106 is the segment of the arm 106 that contacts an object (e.g., a native leaflet of a native tricuspid valve). The distal segment of the arm 106 contacts the object (e.g., a native leaflet of a native tricuspid valve) at a contact point along the distal segment of the arm 106. The distal segment of each arm 106 extends from (but does not include) the second bend of the arm 106 and extends perpendicularly to the central axis of the elongated central passage 104 so as to be away from the central axis of the elongated central passage 104 and ends (including this) at the tip. As described above, the distal segment of the arm extends perpendicularly to the central axis of the elongated central passage 104 so as to be away from the central axis of the elongated central passage 104 from the longitudinal position along the outer surface 147 of the cylindrical portion 116.

[0062] In some embodiments described in detail with respect to FIG. 24, the distal segment of each arm can include an extended segment having a third bend. Each atrial arm 106-1 has a distal segment 114, and each ventricular arm 106-2 has a distal segment 110. As will be described in more detail later, the tip of the distal segment 114 of each atrial arm 106-1 is the tip 142, and the tip of the distal segment 110 of each ventricular arm 106-2 is the tip 140.

[0063] In the example of FIG. 1, the proximal segment 108 of each ventricular arm 106-2 extends from the atrial end 118 of the cylindrical portion 116 and has an initial bend 124 of 180° ± 45° that directs the proximal segment 108 of the ventricular arm 106-2 to face sufficiently toward the ventricular end 120 via the native valve annulus (outside the elongated central passage 104) along the outer surface 147 of the cylindrical portion 116. Then, following the second bend 126 in the proximal segment 108 of the ventricular arm 106-2, the distal segment 110 of the ventricular arm 106-2 extends perpendicularly away from the central axis of the elongated central passage 104 from the longitudinal position along the outer surface 147 of the cylindrical portion 116.

[0064] FIG. 1 also shows how the proximal segment 112 of each atrial arm 106-1 extends from the ventricular end 120 of the cylindrical portion 116, and how the proximal segment 112 of the atrial arm 106-1 has an initial bend 128 of 180° ± 45° that orients the proximal segment 112 of the atrial arm 106-1 sufficiently toward the atrial end 118 of the cylindrical portion 116 via a natural valve annulus (outside the elongated central passage 104) along the outer surface 147 of the cylindrical portion 116. And following a second bend 130 in the proximal segment 112 of the atrial arm 106-1, the distal segment 114 of the atrial arm 106-1 extends perpendicularly away from the central axis of the elongated central passage 104 from a longitudinal position along the outer surface 147 of the cylindrical portion 116. As described above, in some embodiments, the proximal segments of one or more of the arms 106 do not include an initial bend.

[0065] As described above, the distal segment of each arm 106 extends perpendicularly away from the central axis of the elongated central passage 104 for attachment of the support structure 102 to the native leaflets of the native tricuspid valve. As referred to herein, the distal segment of the arm 106 that extends "perpendicularly" away from the central axis of the elongated central passage 104 refers to the distal segment of the arm 160 that extends away from the central axis of the elongated central passage 104, such that a line drawn from the point of contact of the distal segment with an object (e.g., a native heart valve leaflet) to the longitudinal position along the outer surface 147 of the cylindrical portion 116 of at least one support structure 102 from which the distal segment extends is oriented at approximately 90° ± 45° from the central axis of the elongated central passage. In some embodiments, the point of contact of the distal segment of the arm 106 can be at the tip 140 or 142 of the arm 106. In an alternative embodiment where the distal segment of the arm 106 includes an extended segment having a third bend, the point of contact of the distal segment of the arm can be at the extended segment of the arm (106), particularly at the third bend. The point of contact of the distal segment of the arm 106 can be at any other portion of the distal segment of the arm 106. As will be described in more detail below, this approximate perpendicularity of the line from the point of contact of the distal segment to the longitudinal position along the outer surface 147 of the cylindrical portion 116 from which the distal segment extends enables axial stabilization of the prosthetic tricuspid valve within the native tricuspid valve.

[0066] The distal segment 114 of each atrial arm 106-1 and the distal segment 110 of each ventricular arm 106-2 extend perpendicularly away from the central axis of the elongated central passage 104 and can be elastically straight (e.g., with respect to the outer surface 147 of the cylindrical portion 116 of the support structure 102), and may or may not extend beyond the length of the cylindrical portion 116. Thus, the prosthetic tricuspid valve 100 is configured to have a shortened length that facilitates manipulation of bending or flexing along an insertion path (e.g., within a patient's vasculature (e.g., a vein or artery)).

[0067] In the example of FIG. 1, the ventricular arm 106-2 extends from the atrial end 118 of the cylindrical portion 116, the atrial arm 106-1 extends from the ventricular end 120 of the cylindrical portion 116, and the relative positions of the second bends 126, 130 are such that the position of the second bend 126 of each ventricular arm 106-2 is closer to the ventricular end 120 of the cylindrical portion 116 than the second bend 130 of each atrial arm 106-1. In other words, in the example of FIG. 1, the atrial arm 106-1 and the ventricular arm 106-2 extend across the cross-section of the cylindrical portion 116 of at least one support structure 102, and thus there is an overbite in the cross-section between the atrial arm 106-1 and the ventricular arm 106-2. As referred to herein, the "cross-section" with respect to the cylindrical portion of at least one support structure is the cross-section of the cylindrical portion of at least one support structure that is perpendicular to the central axis of the elongated central passage defined by the cylindrical portion of at least one support structure. As a result of this overbite between the atrial arm 106-1 and the ventricular arm 106-2, in vivo, the ventricular arm 106-2 extending from the atrial end 118 of the cylindrical portion 116 extends downward into the ventricle of the heart and contacts the ventricular surface of the native leaflet, while the atrial arm 106-1 extending from the ventricular end 120 of the cylindrical portion 116 extends upward into the atrium of the heart and contacts the atrial surface of the native leaflet.

[0068] Furthermore, in some embodiments, the relative flexion angles of the second flexion portions 126, 130 can each or both be slightly greater than 90°, such that the tip 140 of each ventricular arm 106-2 is closer to the atrial end 118 of the cylindrical portion 116 than the tip 142 of each atrial arm 106-1. This arrangement further contributes to the overbite of the atrial arm 106-1 and the ventricular arm 106-2 described above. At the time of implantation, this overbite of the atrial arm 106-1 and the ventricular arm 106-2 creates an additional clamping action and further tension of the native leaflets. The reason is that the distal segment 114 of the atrial arm 106-1 on the atrial side of the native leaflet is actively pushed downward toward the ventricle of the heart, while the distal segment 110 of the ventricular arm 106-2 on the ventricular side of the native leaflet is actively pushed upward toward the atrium of the heart, thereby effectively generating a wavy effect in the native leaflet, like a frilled flap. This tension effect from the opposing forces on both sides of the native leaflet serves to axially stabilize the prosthetic tricuspid valve 100 within the native tricuspid valve.

[0069] Fixing the artificial tricuspid valve 100 on both sides of the natural leaflets in this way also generates a trampoline effect in which the ventricular systolic pressure load can be partially absorbed by the upward (atrial) movement and the tension of the natural leaflets. Specifically, in this example, when the cylindrical portion 116 of the support structure 102 towards the atrial side 118 of the natural tricuspid valve moves (e.g., due to the ventricular systolic pressure load), the ventricular arm 106-2 resists this movement while the atrial arm 106-1 relaxes to maintain contact with the atrial side of the natural leaflet. Further, when the cylindrical portion 116 of the support structure 102 towards the ventricular side 120 of the natural tricuspid valve moves, the atrial arm 106-1 resists this movement while the ventricular arm 106-2 relaxes to maintain contact with the ventricular side of the natural leaflet. Further, as a result of the trampoline effect, the force from the distal segment 110 of each ventricular arm 106-2 to the ventricular side of the natural leaflet can be distributed across the entire atrial sealing skirt, minimizing the risk of erosion through the natural leaflet. Thus, the artificial tricuspid valve 100 is biomechanically fixed within the natural tricuspid valve even during the cardiac cycle.

[0070] The tips 140, 142 of the arms 106-2, 106-1 are shown in FIG. 1 as having a square cross-section, but in other implementation examples, the cross-sectional shapes of the tips 140, 142 of the arms 106-2, 106-1 can have a circular or other non-circular shape (e.g., to provide improved attachment and / or leak prevention, such as in the presence of an atrial sealing skirt, as will be described in more detail later). The relative lengths of the distal segment 114 of the atrial arm 106-1 and / or the distal segment 110 of the ventricular arm 106-2 can be changed for improved attachment and / or leak prevention.

[0071] Figure 2 shows an example of a cover 200 that can be placed on the support structure 102. The cover 200 can be made from biological prosthetic tissue (e.g., bovine, porcine, etc.) or from synthetic materials (e.g., polyurethane, ePTFE, dedicated hydrogel materials, etc.). As shown, the cover 200 can include a cylindrical portion 202 that defines an elongated central passage 104 and in which an artificial leaflet element (not shown) can be mounted. The cover 200 can also include an atrial sealing skirt 204 that extends over the atrial end 118 of the support structure 102 and at least partially over the atrial arm 106-1.

[0072] The atrial sealing skirt 204 can also facilitate the re-capturable nature of the artificial tricuspid valve 100. For example, the atrial sealing skirt 204 can be folded by reducing the length of the atrial arm 106-1 while maintaining contact between the atrial end 118 and the cylindrical portion 116 of the support structure 102, and allowing the outer sheath (see reference numeral 406 in FIG. 4) to advance toward the ventricular side of the native tricuspid valve, re-capturing the ventricular arm 106-2 that contacts the ventricular side of the native leaflets of the native tricuspid valve and allowing the implant to be fully repositioned or removed prior to final release.

[0073] In these examples, a portion of the atrial sealing skirt 204 that is relatively close to the atrial side of the native tricuspid valve may be attached to the proximal segment 108 of each ventricular arm 106-2 (see, e.g., FIG. 3), and a portion of the atrial sealing skirt 204 that is relatively distal to the atrial side of the native tricuspid valve may be attached to the distal segment 114 of each atrial arm 106-1. The cover 200 may extend downward through the cylindrical portion 116 of the support structure 102 within the elongated central passage 104. In the examples of FIGS. 2 and 3, a portion 202 of the cover 200 extends downward through the cylindrical portion 116 of the support structure 102 and serves to define the elongated central passage 104 at or near the ventricular end 120 of the cylindrical portion 116. However, in some implementations (see, e.g., FIGS. 17 and 18), the cover 200 wraps around the ventricular end 120 of the cylindrical portion 116 and terminates along the proximal segment 112 of each atrial arm 106-1 (e.g., just prior to the second bend 130). In other examples, not explicitly shown, the cover 200 may extend beyond the proximal segment 112 of each atrial arm 106-1 and terminate along the distal segment 110 of each ventricular arm 106-2. In any implementation, the cover 200 may form a continuous "webbing" of the atrial sealing skirt 204 on the atrial end 118 of the cylindrical portion 116 of the support structure 102 that serves to create a seal, and function as a reinforcing means against the pressure from the ventricular arm 106-2 on the ventricular side of the native tricuspid valve leaflet, preventing the ventricular arm 106-2 from eroding through the native leaflet. The atrial sealing skirt 204 may extend to or beyond the native valve annulus of the native tricuspid valve for anchor fixation and may completely cover the seam of the native tricuspid valve for adequate leak prevention.

[0074] In various examples, the atrial sealing skirt 204 starts at the distal segment 114 of each atrial arm 106-1, is attached thereto, and switches to be attached to the proximal segment 108 of each ventricular arm 106-2, and in various implementations, extends downward through the elongated central passage 104 to near the proximal segment 112 of each atrial arm 106-1 and terminates before the second bend 130 of each atrial arm 106-1 (along the proximal segment of each atrial arm 106-1 at a common distance from the cylindrical portion 116), or may extend to the distal segment 110 of each ventricular arm 106-2 before terminating.

[0075] In some embodiments, the cover 200 can extend asymmetrically and / or non-circularly within the elongated central passage 104 and across one or more of the atrial arm 106-1 and / or the ventricular arm 106-2. For example, in some embodiments, the cover 200 can extend within the elongated central passage 104 and across one or more of the atrial arm 106-1 and / or the ventricular arm 106-2.

[0076] FIG. 3 also shows how the artificial tricuspid valve 100 can include a fenestration mechanism 300 in a portion of the cover 200 (see also FIG. 13). The fenestration mechanism 300 may include, for example, a radiopaque marker, an opening, a magnetic element, a one-way valve, a pop-up valve, a mechanically size-adjustable opening, and increased porosity. In a transposition configuration where the support structure 102 biodynamically fixes the artificial tricuspid valve 100 to the natural leaflets of the natural tricuspid valve, the fenestration mechanism 300 can be disposed between the elongated central passage 104 and the natural valve annulus of the natural tricuspid valve.

[0077] The fenestration mechanism 300 may be, for example, a hole or vent that allows a guide wire and an auxiliary device (e.g., a pacing lead, an ICD lead, or other device) to pass through the cover 200 and / or the native tricuspid valve into the ventricle (e.g., the right ventricle and / or pulmonary artery access and beyond). In this way, additional devices can access the right ventricle and / or pulmonary artery without having to pass through the elongated central passage 104 of the prosthetic tricuspid valve 100, and insufficiency, thrombus risk, and / or valve damage can be avoided.

[0078] The fenestration mechanism 300 may include a hole identified by a radiopaque marker. The fenestration mechanism 300 may also have a magnetic element or other mechanism to assist in the alignment and engagement of a second system (e.g., similar to a transseptal puncture needle) to reach through the atrial sealing skirt 204 and the native tricuspid valve into the ventricle and beyond. The fenestration mechanism 300 may be formed of the same material or a different material (e.g., ePTFE, silicone, etc.) as the atrial seal skirt 204 to facilitate sealing of the fenestration mechanism 300 before and after device passage. Similarly, the fenestration mechanism 300 can include a one-way valve separate from the valve structure (e.g., leaflet elements) within the elongated central passage 104. In some implementations, the fenestration mechanism 300 may be configured to be initially sealed and easily identifiable and pierceable. In other implementations, the entire atrial sealing skirt 204 may be manufactured from a material that allows piercing by a standard or custom auxiliary device and maintains a seal sufficient to prevent unwanted backflow after a lead or other catheter has passed through.

[0079] It should also be understood that one or more other mechanisms of the fenestration mechanism 300 and / or the atrial sealing skirt 204 can be arranged to permanently or temporarily allow a controlled amount of backflow to pass through (e.g., to permanently or temporarily relieve an increase in ventricular pressure that can occur due to the sealing of the native tricuspid valve by the prosthetic tricuspid valve 100).

[0080] In other embodiments, one or more fenestration mechanisms 300, including the fenestration mechanism, may be radially disposed along the elongated central passage 104 at a position that allows a controlled amount of backflow through the central passage 104 while bypassing the cover 200. For example, the fenestration mechanism 300 may be implemented as a permanently sized opening or a mechanically controllable opening (e.g., an iris or other opening having a diameter, width, or other dimension that is mechanically controllable and / or changeable during and / or after implantation). As another example, the fenestration mechanism 300 may be a portion of the atrial sealing skirt 204 that is more porous than other portions of the atrial sealing skirt 204. The fenestration mechanism 300 implemented as a portion of the atrial sealing skirt 204 with increased porosity may have permanently increased porosity, or may be formed of a material that initially increases and then decreases (e.g., endothelializes) over time in the implanted environment, allowing for a controlled decrease in backflow. Alternatively, the entire atrial sealing skirt 204 may be porous to control the amount of backflow and / or allow for a decrease in porosity (e.g., due to endothelialization) over time, gradually reducing the backflow. In some implementations, the fenestration mechanism 300 may have a pressure control component, such as a pop-up valve that allows backflow when the pressure in the ventricle rises above a predetermined threshold.

[0081] Figures 4-8 show various prosthetic tricuspid valves 100 at various stages of implantation into a patient's native tricuspid valve. In the example of Figure 4, the prosthetic tricuspid valve 100 is compressed inside the delivery sheath 406, such that the cylindrical portion 116 of the support structure 102 (implemented as a cage structure in this example) is radially compressed within the sheath 406, and the distal segments 114 of each atrial arm 106-1 and the distal segments 110 of each ventricular arm 106-2 are straightened relative to the outer surface 147 of the cylindrical portion 116 without extending beyond the full length of the cylindrical portion 116.

[0082] FIG. 4 also shows an intermediate layer 404 inside the sheath 406, a plurality of restraints 410 each attached to the distal segment 114 of the atrial arm 106-1, an inner nose cone 402, and an outer nose cone 400 (e.g., a pigtail nose cone configured to be guided along and / or separated from the guide wire 408). The guide wire 408 can be used to guide the prosthetic tricuspid valve 100 through a patient's vein to the natural tricuspid valve of the patient's heart. The prosthetic tricuspid valve 100 is in the contracted configuration of FIG. 4 where the cylindrical portion 116 has a first diameter, and each ventricular arm 106-2 is held against the outer surface 147 of the cylindrical portion 116 by the sheath 406, and each atrial arm 106-1 is held against the interior of the sheath 406 and the outer surface 147 of the cylindrical portion 116 by individual restraints 410.

[0083] As shown in FIG. 5, the sheath 406 may retract so that the ventricular arms 106-2 can bend, such that the proximal segments 108 of each ventricular arm 106-2 extend along the outer surface 147 and the distal segments 110 of each ventricular arm 106-2 extend perpendicular to and away from the central axis of the cylindrical portion 116. In FIG. 5, the prosthetic tricuspid valve 100 is inserted into the natural tricuspid valve. In FIG. 5, the natural leaflets 500 and natural chordae tendineae 502 of the natural tricuspid valve are visible.

[0084] As shown in FIG. 6, the prosthetic tricuspid valve 100 can retract with the sheath 406 until the distal segments 110 of each ventricular arm 106-2 contact the ventricular side of the natural leaflets 500 of the natural tricuspid valve. In FIG. 6, it can be seen that the cylindrical portion 116 expands from the contracted configuration of FIG. 4 having a first diameter to an expanded configuration having a larger second diameter (e.g., due to its shape memory mechanism, balloon inflation, etc.) to form an elongated central passageway 104 (see also FIGS. 7 and 8).

[0085] As shown in FIGS. 7 and 8, subsequently, the restraint 410 advances and the atrial arm 106-1 can bend. As a result, the proximal segment 112 of each atrial arm 106-1 extends along the outer surface 147 of the cylindrical portion, and the distal segment 114 of each atrial arm 106-1 extends perpendicular to the central axis of the cylindrical portion 116 and contacts the atrial side of the native leaflet 500, thereby capturing the native leaflet 500 against the distal segment 110 of the ventricular arm 106-2.

[0086] The restraint 410 can be composed of suture, polymer, metal, and / or any other material and can function as a controllably expandable connection from the delivery system to the tip of the atrial arm 106-1 on the atrial side of the native leaflet 500. Thus, the atrial arm 106-1 can extend and expand as the final step of deployment before evaluating the valve function, and reconnection to the delivery system is maintained at full diameter. If the result is undesirable and recapture is necessary, the restraint 410 can be driven in the opposite direction, pulling the tip of the atrial arm 106-1 back towards the delivery system to reposition and / or recapture the implant. If positioning and valve function are as desired, the restraint 410 can be released and the implant can be fully deployed.

[0087] For example, when the prosthetic tricuspid valve 100 is desirably positioned relative to the native tricuspid valve, the restraint 410 may be removed from the atrial arm 106-1 for release of the prosthetic tricuspid valve in a fully implanted configuration. FIG. 8 shows how the support structure 102 (including the arms 106-1, 106-2) is configured to be biomechanically fixed within and separated from the native valve annulus of the native tricuspid valve by gripping the native leaflets 500 of the native tricuspid valve without directly attaching to the native valve annulus or native chordae tendineae attached to the native tricuspid valve.

[0088] On the one hand, when it is desirable to reposition or remove the artificial tricuspid valve 100 from the configuration of FIG. 8, FIGS. 9-12 show how to retract the restraint 410 (FIG. 9), straighten the atrial arm 106-1 against the outer surface 147 of the cylindrical portion 116, release the natural leaflet 500, and how to advance the sheath 406 (FIGS. 10-12) to straighten the ventricular arm 106-2 and compress the central cylindrical portion 116 for removal of the artificial tricuspid valve 100.

[0089] Figures 4-12 also show the overbite arrangement of the arm 106 during capture of the native leaflet 500. Specifically, as shown in Figures 4-12, the atrial arm 106-1 extends from the ventricular end 120 of the cylindrical portion 116, and the ventricular arm 106-2 extends from the atrial end 118 of the cylindrical portion 116. Both the atrial arm 106-1 and the ventricular arm 106-2 extend across the cross-section of the cylindrical portion 116 of at least one support structure 102, and thus there is an overbite across the cross-section between the atrial arm 106-1 and the ventricular arm 106-2 during capture of the native leaflet 500. The support structure 102 can be implemented using arms 106 that do not cross across the cross-section and do not exhibit an overbite (e.g., using the atrial arm 106-1 extending from the atrial end 118 of the cylindrical portion 116 and the ventricular arm 106-2 extending from the ventricular end 120 of the cylindrical portion 116), but the overbite described herein has the advantage that the atrial arm 106-1 and the ventricular arm 106-2 cross the cross-section of the cylindrical portion 116 twice, promoting a stronger seal against the native leaflet 500 and preventing paravalvular leakage, and also has the advantage of promoting an appropriate deployment sequence (the atrial arm 106-1 following the ventricular arm 106-2), enabling complete evaluation and recapture of the prosthetic tricuspid valve 100. Further, by extending the atrial arm 106-1 and the ventricular arm 106-2 from opposite ends of the cylindrical portion 116, each set of arms 106-1, 106-2 can be compressed against the cylindrical portion 116 itself (rather than having to extend completely beyond each end of the cylindrical portion 116), thereby greatly reducing the overall length of the prosthetic tricuspid valve 100 during delivery, thereby improving flexibility and ease of positioning and deployment.

[0090] Figure 13 shows a top view of the prosthetic tricuspid valve 100, with the leaflet elements 1300 within the elongated central passageway 104 appearing to form the interior of the prosthetic tricuspid valve 100. In the example of FIG. 13, the leaflet elements 1300 are joined so as to form a complete seal in the closed configuration of the prosthetic tricuspid valve 100. However, as described above in connection with FIG. 3, it may be desirable in some scenarios to permanently or temporarily allow a controlled amount of backflow through the prosthetic tricuspid valve 100. In the example of FIG. 3, various implementations of the fenestration mechanism 300 for allowing such controlled backflow are illustrated. However, in other implementations, the leaflet elements 1300 may include a mechanism or restraint for providing a desired backflow. For example, one or more of the leaflet elements 1300 may be provided with a tension line or other mechanical or material mechanism (not shown) to prevent complete joining with other leaflet elements, allowing a controlled amount of backflow between the leaflet elements 1300 permanently or temporarily. The tension line can later be removed, loosened, or substantially altered to reduce or eliminate the backflow.

[0091] The prosthetic tricuspid valve 100 can be delivered into the native tricuspid valve from the inferior vena cava, which extends up to the superior vena cava. The distal portion of the delivery system can be extended such that the capsule extends away from the main axis of the delivery system with a pre-set curvature and is allowed to bend towards the native tricuspid valve for axialization and positioning. Further extension into the inferior vena cava increases the curvature and pulls the distal portion rearward, minimizing the curvature in this example. FIG. 14 shows the delivery path from the inferior vena cava and the superior vena cava.

[0092] The delivery system for this trans-catheter tricuspid valve implant 100 can exit the superior vena cava via the jugular vein, subclavian vein, or other blood vessels, or from the inferior vena cava via the femoral vein or an alternative entry point. Alternatively, access can be achieved by surgical access via the right atrium of the heart.

[0093] For example, the deployment sequence can allow for partial deployment within the atrium before advancing into the ventricle to complete positioning and deployment, or the deployment sequence can allow for complete advancement and positioning into the native tricuspid valve before starting deployment.

[0094] The delivery system can be passive and can have multiple planes of steering elements. In some implementations, depth control can be provided by including a steering mechanism of the delivery system that can reciprocate proximally or distally relative to the handle of the delivery system. An example of reciprocating the steering mechanism enables tensioning of the steering mechanism (e.g., relative movement between a base laser cut hypotube and a tension wire mounted at the distal end of the hypotube) within a sub-component of the handle of the delivery system that can translate linearly within the handle while maintaining the same relative tension between the steering mechanisms.

[0095] In some scenarios, the delivery system advances into the superior vena cava along a guide wire that extends from the inferior vena cava through the right atrium and over the superior vena cava, and the prosthetic tricuspid valve 100 is effectively housed within a portion of the positioning delivery system within the right atrium. And the distal portion of the delivery system extends into the superior vena cava, and the distal portion of the delivery system can flex toward the native tricuspid valve annulus such that the distal portion of the delivery system is released from the proximal portion and moves away from the main axis of the delivery system. The extent to which the distal portion of the delivery system extends away from the proximal portion of the delivery system controls the magnitude of the angle between the proximal portion of the distal portion of the delivery system (in which the prosthetic tricuspid valve 100 is housed) and the main axis of the proximal portion of the delivery system until the prosthetic tricuspid valve 100 is coaxially aligned with the native tricuspid valve annulus. The delivery mechanism is further illustrated in FIGS. 25 and 26, showing the separation of the pigtail nose cone 400 from the guide wire 408.

[0096] In other examples, the delivery system may approach the right atrium from the superior vena cava, with the guide wire extending downward into the inferior vena cava (see, e.g., the lower left in FIG. 33). In this example, when the tip of the delivery system approaches the right atrium, the delivery system may separate from the guide wire, such that the delivery system can be directed toward the annulus of the native tricuspid valve using passive or active steering. Thus, the guide wire may still be used for stability without the need to advance into the right ventricle, which can cause complications (perforation, entanglement, conduction problems, or otherwise). In this or other examples, the outer nose cone 400 of the delivery system may be blunt and round like a dome, or long and flexible in a pigtail shape, such that it can advance into the right ventricle without trauma and without entanglement with the chordae tendineae of the native tricuspid valve.

[0097] FIGS. 15 and 16 show wide-field and close-up views of a portion of the support structure 102, with the cylindrical portion 116 formed by a foldable cage structure (e.g., having a V-shaped strut 2200 for capturing the second bend 130 of the atrial arm 106-1). In the example of FIGS. 15 and 16, the arms 106 are shown before the bends 126, 124, 128, 130 are formed therein.

[0098] FIGS. 17 and 18 show other configurations of the cover 200 as described above.

[0099] FIG. 19 shows how the overbites of the atrial arm 106-1 and the ventricular arm 106-2 can be formed closer to the ventricular end 120 of the cylindrical portion 11 to that shown in FIG. 1. FIG. 19 shows how the cross-section of the cylindrical portion 116 over which the atrial arm 106-1 and the ventricular arm 106-2 extend can be formed closer to the ventricular end 120 of the cylindrical portion 116 than that shown in FIG. 1.

[0100] FIG. 20 shows how a force 2000 (e.g., by the intermediate layer 404) on the cylindrical portion 116 of the support structure 102 of the prosthetic tricuspid valve 100 can be provided against the restraining force 2002 at the atrial arm 106-1 of the support structure 102 for the control of natural leaflet capture.

[0101] FIG. 21 shows how a V-shaped strut 2200 can be formed above the second bend 130 of the atrial arm 106-1 that contacts the cylindrical portion 116 of the support structure 2100 (e.g., support structure 102), in contrast to the implementation example of FIG. 22 where the V-shaped strut 2200 is located below the second bend 2202 (e.g., the second bend 130) and receives the second bend 2202 to fix the position of the atrial arm 106-1.

[0102] FIG. 23 shows a spreader arm 2300 configured to extend from the intermediate layer 404 to provide the force 2000 of FIG. 20 against the restraining force 2002 of the restraint 410. Further details of the arrangement of the spreader arm 2300 and the restraint 410 are provided below in connection with FIGS. 35-40.

[0103] FIG. 24 shows a side view of a pair of atrial arm 106-1 and ventricular arm 106-2, showing an overbite arrangement of the pair of atrial arm 106-1 and ventricular arm 106-2 for gripping a natural leaflet as in FIG. 8. As shown in FIG. 24, the distal segment 114 of each atrial arm 106-1 extending away perpendicularly from the central axis of the elongated central passage 104 extends along the cylindrical portion 116 of the support structure 102 from a first longitudinal position 2421. Similarly, the distal segment 110 of each ventricular arm 106-2 extending away from the central axis of the elongated central passage 104 extends along the cylindrical portion 116 of the support structure 102 from a second longitudinal position 2420. As shown in FIG. 24, the first longitudinal position 2421 is closer to the atrial end 118 of the cylindrical portion 116 of the support structure 102 than the second longitudinal position 2420.

[0104] In the implantation configuration of the prosthetic tricuspid valve 100 in which the support structure 102 of the prosthetic tricuspid valve 100 biodynamically fixes the prosthetic tricuspid valve 100 to the natural leaflets 500 of the natural tricuspid valve, in the example of FIG. 24, the ventricular arm 106-2 extends from the atrial end 118 of the cylindrical portion 116 through the natural valve annulus of the natural tricuspid valve into the ventricle of the heart and contacts the ventricular surface of the natural leaflet 500. In this implantation configuration, the atrial arm 106-1 extends from the ventricular end 120 of the cylindrical portion 116 through the natural valve annulus of the natural tricuspid valve into the atrium of the heart and contacts the atrial surface of the natural leaflet 500.

[0105] FIG. 24 also shows how the bends 126, 130 can be greater than 90°, such that the distal segment 114 of each atrial arm 106-1 extending perpendicularly away from the central axis of the elongated central passage 104 extends toward the ventricular end 120 of the cylindrical portion 116, and the distal segment 110 of each ventricular arm 106-2 extending perpendicularly away from the central axis of the elongated central passage 104 extends toward the atrial end 118 of the cylindrical portion 116.

[0106] FIG. 24 shows how the distal segment 114 of each atrial arm 106-1, which extends away perpendicularly from the central axis of the elongated central passageway 104, has a tip 142, and the distal segment 110 of each ventricular arm 106-2 extends away perpendicularly from the central axis of the elongated central passageway 104 and has a tip 140. The tip 142 is closer to the ventricular end 120 of the cylindrical portion 116 than the tip 140. On the other hand, as shown in FIG. 24, the distal segment 114 of each atrial arm 106-1 (e.g., the tip 142 of each atrial arm 106-1) may include an expansion segment 2400 with a third bend facing the atrial end 118 of the cylindrical portion 116 for a less traumatic engagement of the natural leaflet's atrial surface if needed. It should be understood that the distal segment 110 of each ventricular arm 106-2 (e.g., the tip 140 of each ventricular arm 106-2) may also include an expansion segment with a third bend (e.g., similar to the third bend of the expansion segment 2400 of each atrial arm 106-1) facing the ventricular end 120 of the cylindrical portion 116 for a less traumatic engagement of the natural leaflet's ventricular surface if needed. It should be noted that the aforementioned third bend can reduce the frictional force acting on the prosthetic tricuspid valve 100 on the inner surface of the outer sheath 406 by directing the tip of the arm 106 away from the inner surface of the outer sheath 406 during loading, delivery, and recapture of the prosthetic tricuspid valve 100.

[0107] Referring again to FIGS. 25 and 26, the delivery system can exit from a guide wire 2500 (e.g., guide wire 408) extending from the inferior vena cava to the superior vena cava or from the superior vena cava to the inferior vena cava, and the nose cone 400 and distal portion of the delivery system are separated from the wire track of the guide wire 2500 and enter the right atrium, pass through the native tricuspid valve annulus, and enter the right ventricle without the guide wire 2500. This enables utilization of the stability of the guide wire 2500 along the straight portion without the risk of having a guide wire in the right ventricle (which can potentially excite the heart's electrical system and cause conduction abnormalities). When the guide wire 2500 is withdrawn, the nose cone 400 can return to a flexible "pigtail" tip that can easily pass through the native tricuspid valve annulus without snagging on the cords of the native tricuspid valve. In other embodiments, the guide wire 2500 can extend from either the superior vena cava or the inferior vena cava into the right atrium, and the delivery system can advance such that the nose cone 400 returns to its pigtail shape before entering the right ventricle.

[0108] Figures 27-29 show other implementation examples of a support structure 2702 (e.g., support structure 102) for an artificial tricuspid valve 2700, where both an atrial arm 270-1 (e.g., atrial arm 106-1) and a ventricular arm 270-2 (e.g., ventricular arm 106-2) may first extend from the ventricular end of the support structure 2702, and each arm 2701 has an initial bend of 180° ± 45° that reverses the direction of the arm 2701 toward the atrial end of the support structure 2702. In this example, each atrial arm 270-1 extends through the annulus of the native tricuspid valve and has a second bend closer to the atrial end of the support structure 2720 than the second bend of each ventricular arm 2701. The second bend of each arm 2702 is sufficient to position the distal segment of the arm 2702 beyond the second bend of the arm 2702 that is perpendicular to the central axis of the elongated central passage defined by the support structure 2702. On the other hand, in this example, the degree of the second bend of the arm 2702 is such that the tip of the atrial arm 270-1 is closer to the ventricular end of the support structure 2702 than the tip of the ventricular arm 2701. The arrangement of the atrial arm 2701-1 and the ventricular arm 2701-2 above and below the native leaflet again results in a wavy and frilled flap configuration, ensuring a close seal and more stable positioning of the artificial tricuspid valve 2700.

[0109] In yet another embodiment, both the atrial arm 270-1 and the ventricular arm 270-2 first extend from the atrial end of the support structure 2702. The leaflet element 1300 described in connection with the artificial tricuspid valve 100 can be used with the alternative support structure 2702 of FIGS. 27-30, as shown in FIG. 29. In one exemplary implementation, as shown in FIG. 30, each atrial arm 270-1 is foldable relative to the outer surface 147 of the support structure 2702 during loading, while each ventricular arm 270-2 can extend downward beyond and toward the ventricular end of the support structure 2702 during loading.

[0110] Figures 31 to 34 show various features of the artificial tricuspid valve, with the atrial arm and the ventricular arm extending from both ends of the cylindrical portion of the artificial tricuspid valve (for example, the ventricular arm extends starting from the atrial end of the cylindrical portion of the support structure, and the atrial arm extends starting from the ventricular end of the cylindrical portion of the support structure). These various features can be applied to any of the implementation examples described above and below if necessary.

[0111] Figure 35 shows additional features of the spreader arm 2300 described above in connection with Figure 23 (for example, to provide the forces 2000, 2002 of Figure 20 for the controlled deployment or retraction of the ventricular arm 106-2). As shown in the example of Figure 35, a plurality of spreader arms 2300 can extend from circumferentially separated locations on the intermediate layer 404 and be configured to spread radially apart upon retraction of the outer sheath 406.

[0112] Each spreader arm 2300 can be coupled to the atrial end 118 of the cylindrical portion 116 of the support structure 102, so that the spread of the spreader arm 2300 enables the cylindrical portion 116 of the artificial tricuspid valve 100 to expand radially, while the spreader arm 2300 provides a ventricular-directed force against the support structure 102 and counteracts the atrial-directed force of the restraint 410 on the atrial arm 106-1. The spreader arm 2300 may be formed of a 3D printed or molded material (such as a polymer), which is compressed within the sheath 406 and has sufficient flexibility to naturally expand back to the configuration of Figure 35 upon retraction of the sheath 406. In the example of Figure 35, each restraint 410 for each atrial arm 106-1 extends from the gap 3508 between the spreader arms 2300 through a small hole 3502 within the atrial arm 106-1 and is implemented as a suture that returns through the gap 3508 between the spreader arms 2300. Once the desired implantation position for the artificial tricuspid valve 100 is achieved, the restraint 410 can be cut and removed.

[0113] FIG. 36 shows a perspective view of a spreader arm 2300 extending from an intermediate layer 404, and an interlock mechanism 3600 for interfacing with an atrial end 118 of a cylindrical portion 116 of a support structure 102 can be seen. Each interlock mechanism 3600 is configured to maintain contact with the atrial end 118 of the cylindrical portion 116 of the support structure 102, such that the spreader arm 2300 can push at least one support structure 102 in a ventricular direction. In some embodiments, the interlock mechanism 3600 can maintain contact with the atrial end 118 of the cylindrical portion 116 of the support structure 102 during an active pushing operation of the spreader arm 2300 and during a passive stop of the spreader arm 2300. In some embodiments, the interlock mechanism 3600 can separate from the atrial end 118 of the cylindrical portion 116 of the support structure 102 during a passive stop of the spreader arm 2300 when the intermediate layer 404 moves away from the support structure 102.

[0114] As shown in FIG. 36, each spreader arm 2300 may include an extension 3602 that extends over an interlock mechanism 3600 on the spreader arm and over an atrial end 118 of a cylindrical portion 116 of at least one support structure 102. The extension 3602 can function for a plurality of purposes. First, the extension 3602 can function as a “hood” over the support structure 102 by preventing the outer sheath 406 from encountering resistance from the edge of the support structure 102 when the outer sheath 406 advances again over the edge of the support structure 102 during recapture, enabling easier recapture of the prosthetic tricuspid valve 100 with lower force. Further, the extension 3602 can facilitate pleating of the atrial sealing skirt 204, provide a hinge point for controlled bending of the atrial sealing skirt 204, and extend to reduce loads and recapture forces that would otherwise cause the atrial sealing skirt 204 to protrude non-uniformly when the atrial arm 204 is folded.

[0115] In the embodiments of FIGS. 35 and 36, the spreader arm 2300 engages at the atrial end 118 of the cylindrical portion 116 of the support structure 102 with the proximal segment 108 (e.g., the initial flexion 124 of each ventricular arm 106-2) of each ventricular arm 106-2. On the other hand, it should be understood that the spreader arm 2300 may alternatively or additionally be provided to engage the cylindrical portion 116 of the support structure 102 as shown in the examples of FIGS. 59-60.

[0116] FIG. 37 is a more extensive perspective view of the support structure 102 coupled to the retainer 410 of the central layer 404 and the spreader arm 2300, with the inner nose cone 402 and the outer nose cone 400 appearing to extend through the elongated central passage 104. The prosthetic tricuspid valve 100 may be placed in the configuration of FIG. 37 at the time of implantation and prior to removal of the inner nose cone 402, outer nose cone 400, spreader arm 2300, retainer 410, and sheath 406 to complete the implantation.

[0117] FIG. 38 shows a perspective view of a portion of the intermediate layer 404 according to an aspect of the present disclosure. As shown in FIG. 38, the suture lines forming the restraint 410 can pass through the entire length of the delivery system (e.g., inside the elongated opening 3804 in the outer layer 3800 of the intermediate layer 404). If necessary, these suture lines can be connected to the springs 3801 at the ends of the delivery system, configured to be close to the ventricular side of the native tricuspid valve, and configured to accommodate any bends at the ends of the delivery system with variable relative lengths. The spring 3801 may be mounted, for example, in the opening 3806 in the inner layer 3802 of the intermediate layer 404. From the spring 3801, the suture lines can descend through one of the arm holes 3502 (see FIG. 35) in the inner diameter and then back through the gap 3508 between the spreader arms 2300. In one exemplary implementation, nine spreader arms 2300 can be arranged alternately circumferentially with nine suture lines. One end of each suture line can extend from the intermediate layer 404 at the end of the delivery system configured to be close to the atrial side of the native tricuspid valve, so that the end can be cut and the suture line can be configured to be pulled out around the inner diameter.

[0118] In the examples of FIGS. 35 and 37, for simplicity and clarity, the support structure 102 of the prosthetic tricuspid valve 100 is shown interfacing with the spreader arms 2300 and the restraint 410 without the other parts of the prosthetic tricuspid valve 100. FIG. 39 shows the completed prosthetic tricuspid valve 100 including the leaflet element 1300 and the cover 200, and the cover 200 includes an atrial sealing skirt 204 and interfaces with the delivery system. For additional clarity, FIG. 40 shows a perspective view of the support structure 102 and the spreader arms 2300 shown partially transparent for clarity of the interface, particularly between the interlock mechanism 3600 and the bend 124 of the ventricular arm 106-2.

[0119] FIG. 41 shows a perspective view of the support structure 102 in a configuration where the atrial arm 106-1, the ventricular arm 106-2, and the cylindrical portion 116 are cut from a common structure. In the example of FIG. 41, the support structure 102 is shown in an “as-cut” state (e.g., the arm 106-1 and the ventricular arm 106-2 show the configuration of the segments 108, 110, 112, 114 before the bends 126, 124, 128, 130 are formed therein, depicting, for example, that shown in FIG. 1). FIG. 41 also shows an exemplary configuration for the ventricular arm tip 140 and the atrial arm tip 142. However, the configuration of the tips 140, 142 can be installed in a variety of different geometries to optimize the load distribution on the natural leaflets. In the configuration of FIG. 41, the cylindrical portion 116 is formed of an expandable cage structure depicted in a contracted configuration.

[0120] FIGS. 42A-42B show the prosthetic tricuspid valve 100 implanted in the native tricuspid valve of the heart 4200 through the interactive pressure differences on both sides of the native tricuspid valve 100 during the cardiac cycle of the heart 4200.

[0121] Specifically, FIG. 42A shows the prosthetic tricuspid valve 100 implanted in the native tricuspid valve of the heart 4200 during diastole filling of the ventricle 4202 of the heart 4200. During diastole filling of the ventricle 4202 of the heart 4200, blood flows from the atrium 4201 of the heart 4200 through the elongated central passage 104 of the prosthetic tricuspid valve 100 into the ventricle 4202 of the heart 4200. During diastole filling of the ventricle 4202 of the heart 4200, the pressure at the prosthetic tricuspid valve 100 is relaxed when the prosthetic tricuspid valve 100 moves slightly towards the ventricle 4202 of the heart 4200. The atrial arm 106-1 resists this movement, while the ventricular arm 106-2 relaxes to maintain contact with the ventricular side of the native tricuspid valve leaflet.

[0122] Conversely, FIG. 42B shows the artificial tricuspid valve 100 implanted in the native tricuspid valve of the heart 4200 during systolic contraction of the ventricle 4202 of the heart 4200. During systolic contraction of the ventricle 4202 of the heart 4200, blood flows out of the ventricle 4202 of the heart 4200 and into the pulmonary artery 4203 of the heart 4200. During systolic contraction of the ventricle 4202 of the heart 4200, the pressure at the artificial tricuspid valve 100 causes the artificial tricuspid valve 100 to move slightly toward the atrium 4201 of the heart 4200. The ventricular arm 106-2 resists this movement while the atrial arm 106-1 relaxes to maintain contact with the atrial side of the native tricuspid valve leaflet. This also creates a trampoline effect where the ventricular systolic pressure load can be partially absorbed by the atrial movement of the native leaflet.

[0123] FIGS. 43A-43B show other implementation examples of the support structure 102 for the artificial tricuspid valve according to one embodiment. Specifically, FIG. 43A shows another embodiment of the support structure 102 for the artificial tricuspid valve in a contracted configuration, defining an elongated central passage having a first diameter. FIG. 43B shows another embodiment of the support structure 102 for the artificial tricuspid valve in an expanded configuration, defining an elongated central passage having a second diameter larger than the first diameter. For example, in the embodiments of FIGS. 43A-43B, the first diameter of the elongated central passage can be 8 mm and the second diameter of the elongated central passage can be 25 mm.

[0124] As described above, the prosthetic tricuspid valve described herein can include one or more support structures. For example, the prosthetic tricuspid valve described herein can include one, two, three, or more support structures. At least one of the one or more support structures includes a cylindrical portion having an atrial end and a ventricular end. The cylindrical portion of the at least one support structure defines an elongated central passage of the prosthetic tricuspid valve. The detailed description of the specific figures above and below describes an exemplary prosthetic tricuspid valve including one support structure. Further, the detailed description of the specific figures above and below describes exemplary prosthetic tricuspid valves including more than one (e.g., two, three, or more than three) support structures. For example, the detailed description of FIGS. 46-53 below describes exemplary prosthetic tricuspid valves having two or three support structures. However, many of the mechanisms of the prosthetic tricuspid valve described with reference to a prosthetic tricuspid valve having a particular number of support structures may be included in other prosthetic tricuspid valves having different numbers of support structures.

[0125] FIGS. 44-45 show different views of an example implementation of a prosthetic tricuspid valve 4400 having one support structure 102 according to one embodiment.

[0126] FIG. 44A shows a view of the flattened support structure 102 of a prosthetic tricuspid valve 4400 having one support structure 102 according to one embodiment.

[0127] FIG. 44B shows a side view of a prosthetic tricuspid valve 4400 having one support structure 102 according to one embodiment and configured for implantation in a native tricuspid valve.

[0128] Figures 45A - 45D show computer - aided design (CAD) drawings of various views of an artificial tricuspid valve 4400 having one support structure 102 according to one embodiment. Figure 45A shows a CAD drawing of a side view of an artificial tricuspid valve 4400 having one support structure 102 according to one embodiment. Figure 45B shows a CAD drawing of a plan view of an artificial tricuspid valve 4400 having one support structure 102 according to one embodiment. Figure 45C shows a CAD drawing of an inclined side view of an artificial tricuspid valve 4400 having one support structure 102 according to one embodiment. Figure 45D shows a CAD drawing of a side view of an artificial tricuspid valve 4400 having one support structure 102 according to one embodiment.

[0129] In an embodiment of an artificial tricuspid valve 4400 having one support structure 102, both the atrial arm 106 - 1 and the ventricular arm 106 - 2 are formed by one support structure 102. As will be described throughout this disclosure, one support structure 102 also includes a cylindrical portion 116 that defines an elongated central passage 104 of the artificial tricuspid valve 4400.

[0130] Advantages of forming the artificial tricuspid valve 4400 with one support structure 102 include a reduction in the diameter of the artificial tricuspid valve 4400 and fewer steps for assembling the artificial tricuspid valve 4400. However, one disadvantage of forming the artificial tricuspid valve 4400 with one support structure 102 is the more complex manufacturing of the artificial tricuspid valve 4400. Another disadvantage of forming the artificial tricuspid valve 4400 with one support structure 102 is that the artificial tricuspid valve 4400 does not effectively distribute the load, and thus certain parts of the artificial tricuspid valve 4400 may be easily broken under stress. Specifically, as will be described in more detail later, forming the artificial tricuspid valve 4400 with one support structure 102 results in an artificial tricuspid valve 4400 having shorter arms 106, providing a fulcrum point occurring at approximately the same location as the load node, with a smaller ability for load distribution, thus resulting in a greater likelihood of failure of the artificial tricuspid valve 4400.

[0131] Figures 46 - 47 show different views of an implementation example of an artificial tricuspid valve 4600 having two support structures 102 - 1, 102 - 2 according to one embodiment.

[0132] Figure 46A shows a diagram of the flattened support structures 102-1 and 102-2 of the artificial tricuspid valve 4600 having two support structures 102-1 and 102-2 according to one embodiment.

[0133] Figure 46B shows a side view of the artificial tricuspid valve 4600 having two support structures 102-1 and 102-2 and configured for implantation in a native tricuspid valve according to one embodiment.

[0134] Figures 47A to 47F show CAD drawings of various views of the artificial tricuspid valve 4600 having two support structures 102-1 and 102-2 according to one embodiment. Figure 47A shows a CAD drawing of an inclined side view of the support structure 102-1 of the artificial tricuspid valve 4600 having two support structures 102-1 and 102-2 according to one embodiment. Figure 47B shows a CAD drawing of an inclined side view of the support structure 102-2 of the artificial tricuspid valve 4600 having two support structures 102-1 and 102-2 according to one embodiment. Figure 47C shows a CAD drawing of a side view of the support structure 102-1 of the artificial tricuspid valve 4600 having two support structures 102-1 and 102-2 according to one embodiment. Figure 47D shows a CAD drawing of a plan view of the support structure 102-1 of the artificial tricuspid valve 4600 having two support structures 102-1 and 102-2 according to one embodiment. Figure 47E shows a CAD drawing of an inclined side view of the artificial tricuspid valve 4600 having two support structures 102-1 and 102-2 according to one embodiment. Figure 47F shows a CAD drawing of another side view of the artificial tricuspid valve 4600 having two support structures 102-1 and 102-2 according to one embodiment.

[0135] In an embodiment of the prosthetic tricuspid valve 4600 having two support structures 102-1, 102-2, the atrial arm 106-1 is formed by the first support structure 102-1 and the ventricular arm 106-2 is formed by the second support structure 102-2. The two support structures 102-1, 102-2 are configured to fit together to form the prosthetic tricuspid valve 4600. As will be described throughout the present disclosure, at least one of the two support structures 102-1, 102-2 includes a cylindrical portion that defines the elongated central passage 104 of the prosthetic tricuspid valve 4600. For example, in an implementation of the prosthetic tricuspid valve 4600 having two support structures 102-1, 102-2 depicted in FIGS. 46-47, each support structure of the two support structures 102-1, 102-2 includes a cylindrical portion 116-1, 116-2 that defines the elongated central passage 104 of the prosthetic tricuspid valve 4600, respectively. On the other hand, in an alternative embodiment, only one of the two support structures 102-1, 102-2 may include a cylindrical portion that defines the elongated central passage 104 of the prosthetic tricuspid valve 4600.

[0136] Advantages of forming the prosthetic tricuspid valve 4600 with the two support structures 102-1, 102-2 include easier manufacture of the prosthetic tricuspid valve 4600. On the other hand, a disadvantage of forming the prosthetic tricuspid valve 4600 with the two support structures 102-1, 102-2 is that the assembly of the prosthetic tricuspid valve 4600 includes an additional step of fitting the two support structures 102-1, 102-2 together to form the prosthetic tricuspid valve 4600. Another advantage of forming the prosthetic tricuspid valve 4600 with the two support structures 102-1, 102-2 is that there is an improved load distribution in the ventricular arm 106-2, which is important because the ventricular arm 106-2 receives a greater force than the atrial arm 106-1 when the prosthetic tricuspid valve 4600 is implanted in vivo.

[0137] FIGS. 48-49 show various views of an implementation of a prosthetic tricuspid valve 4800 having two support structures 102-1, 102-2 according to an embodiment.

[0138] FIG. 48A shows a view of the flattened support structures 102-1, 102-2 of a prosthetic tricuspid valve 4800 having two support structures 102-1, 102-2 according to an embodiment.

[0139] FIG. 48B shows a side view of an artificial tricuspid valve 4800 having two support structures 102-1 and 102-2 according to an embodiment and configured for implantation in a native tricuspid valve.

[0140] FIGS. 49A to 49F show CAD drawings of various views of an artificial tricuspid valve 4800 having two support structures 102-1 and 102-2 according to an embodiment. FIG. 49A shows a CAD drawing of an inclined side view of the support structure 102-1 of the artificial tricuspid valve 4800 having two support structures 102-1 and 102-2 according to an embodiment. FIG. 49B shows a CAD drawing of an inclined side view of the support structure 102-2 of the artificial tricuspid valve 4800 having two support structures 102-1 and 102-2 according to an embodiment. FIG. 49C shows a CAD drawing of a side view of the artificial tricuspid valve 4800 having two support structures 102-1 and 102-2 according to an embodiment. FIG. 49D shows a CAD drawing of a plan view of the artificial tricuspid valve 4800 having two support structures 102-1 and 102-2 according to an embodiment. FIG. 49E shows a CAD drawing of an inclined side view of the artificial tricuspid valve 4800 having two support structures 102-1 and 102-2 according to an embodiment. FIG. 49F shows a CAD drawing of another side view of the artificial tricuspid valve 4800 having two support structures 102-1 and 102-2 according to an embodiment.

[0141] In an embodiment of the prosthetic tricuspid valve 4800 having two support structures 102-1, 102-2, the ventricular arm 106-2 is formed by the first support structure 102-1, and the atrial arm 106-1 is formed by the second support structure 102-2. The two support structures 102-1, 102-2 are configured to fit together to form the prosthetic tricuspid valve 4800. As will be described throughout the present disclosure, at least one of the two support structures 102-1, 102-2 includes a cylindrical portion that defines the elongated central passage 104 of the prosthetic tricuspid valve 4800. For example, in the implementation of the prosthetic tricuspid valve 4800 having two support structures 102-1, 102-2 depicted in FIGS. 48-49, each support structure of the two support structures 102-1, 102-2 includes a cylindrical portion 116-1, 116-2 that defines the elongated central passage 104 of the prosthetic tricuspid valve 4800, respectively. On the other hand, in an alternative embodiment, only one of the two support structures 102-1, 102-2 may include a cylindrical portion that defines the elongated central passage 104 of the prosthetic tricuspid valve 4800.

[0142] The advantages of forming the prosthetic tricuspid valve 4800 with the two support structures 102-1, 102-2 include, similar to the prosthetic tricuspid valve 4800, easier manufacture of the prosthetic tricuspid valve 4800. Another advantage of forming the prosthetic tricuspid valve 4800 with the two support structures 102-1, 102-2 is that the leaflet element can be formed with the first support structure 102-1 that forms the ventricular arm 106-2 rather than the atrial arm 106-1, whereby the atrial sealing skirt as described above can be formed with the second support structure 102-2 that forms the atrial arm 106-1 so as to be separated from the leaflet element. By forming the atrial sealing skirt with the second support structure 102-1 so as to be separated from the leaflet element formed with the first support structure 102-1, the assembly of the individual support structures 102-1, 102-2 is easier and the atrial sealing skirt can be laminated. On the other hand, the assembly of the prosthetic tricuspid valve 4800 includes an additional step of fitting the two support structures 102-1, 102-2 together to form the prosthetic tricuspid valve 4800. Another advantage of forming the prosthetic tricuspid valve 4800 with the two support structures 102-1, 102-2 is the existence of improved load distribution, but mainly in the atrial arm 106-1. When the prosthetic tricuspid valve 4800 is implanted in vivo, the atrial arm 106-1 receives a smaller force than the ventricular arm 106-2, so it is less important.

[0143] Figures 50-51 show various views of the implementation of a prosthetic tricuspid valve 5000 having two support structures 102-1, 102-2 according to one embodiment.

[0144] Figure 50A shows a view of the flattened support structures 102-1, 102-2 of a prosthetic tricuspid valve 5000 having two support structures 102-1, 102-2 according to one embodiment.

[0145] Figure 50B shows a side view of a prosthetic tricuspid valve 5000 having two support structures 102-1, 102-2 according to one embodiment and configured for implantation in a native tricuspid valve.

[0146] Figures 51A to 51F show CAD drawings of various views of an artificial tricuspid valve 5000 having two support structures 102-1 and 102-2 according to an embodiment. Figure 51A shows a CAD drawing of an inclined side view of the support structure 102-1 of the artificial tricuspid valve 5000 having two support structures 102-1 and 102-2 according to an embodiment. Figure 51B shows a CAD drawing of an inclined side view of the support structure 102-2 of the artificial tricuspid valve 5000 having two support structures 102-1 and 102-2 according to an embodiment. Figure 51C shows a CAD drawing of a side view of the artificial tricuspid valve 5000 having two support structures 102-1 and 102-2 according to an embodiment. Figure 51D shows a CAD drawing of a plan view of the artificial tricuspid valve 5000 having two support structures 102-1 and 102-2 according to an embodiment. Figure 51E shows a CAD drawing of an inclined side view of the artificial tricuspid valve 5000 having two support structures 102-1 and 102-2 according to an embodiment. Figure 51F shows a CAD drawing of another side view of the artificial tricuspid valve 5000 having two support structures 102-1 and 102-2 according to an embodiment.

[0147] In an embodiment of the prosthetic tricuspid valve 5000 having two support structures 102-1, 102-2, the first support structure 102-1 does not form either the atrial arm 106-1 or the ventricular arm 106-2. The second support structure 102-2 forms both the atrial arm 106-1 and the atrial arm 106-1. In some embodiments, the second support structure 102-2 that forms both the atrial arm 106-1 and the atrial arm 106-1 can be made into the prosthetic tricuspid valve 4400 having one support structure 102. The two support structures 102-1, 102-2 are configured to fit together to form the prosthetic tricuspid valve 5000. As described throughout this disclosure, at least one of the two support structures 102-1, 102-2 includes a cylindrical portion that defines the elongated central passage 104 of the prosthetic tricuspid valve 5000. For example, in the implementation of the prosthetic tricuspid valve 5000 having two support structures 102-1, 102-2 depicted in FIGS. 50-51, each support structure of the two support structures 102-1, 102-2 includes a cylindrical portion 116-1, 116-2 that defines the elongated central passage 104 of the prosthetic tricuspid valve 5000, respectively. On the other hand, in an alternative embodiment, only one of the two support structures 102-1, 102-2 may include a cylindrical portion that defines the elongated central passage 104 of the prosthetic tricuspid valve 5000.

[0148] Similar to the prosthetic tricuspid valves 4600, 4800, the advantages of forming the prosthetic tricuspid valve 5000 with two support structures 102-1, 102-2 include easier manufacture of the prosthetic tricuspid valve 5000. Further, similar to the prosthetic tricuspid valve 4800, another advantage of forming the prosthetic tricuspid valve 5000 with two support structures 102-1, 102-2 is that the leaflet elements can be formed with the first support structure 102-1 that does not form the atrial arm 106-1, whereby the atrial sealing skirt as described above can be formed to be separated from the leaflet elements with the second support structure 102-2 that forms the atrial arm 106-1. By forming the atrial sealing skirt with the second support structure 102-2 to be separated from the leaflet elements formed with the first support structure 102-1, the assembly of the individual support structures 102-1, 102-2 is easier and the atrial sealing skirt can be laminated. On the other hand, the assembly of the prosthetic tricuspid valve 5000 includes an additional step of fitting the two support structures 102-1, 102-2 together to form the prosthetic tricuspid valve 4800. Another advantage of forming the prosthetic tricuspid valve 5000 with two support structures 102-1, 102-2 is that there is an improved load distribution because the first support structure 5000-1 can provide additional reinforcement to the atrial arm 106-1 and the ventricular arm 106-2 formed with the second support structure 5000-2. On the other hand, the arm 106 has not yet expanded, the pivot point still occurs at roughly the same location as the load node, the ability for load distribution is smaller, thus resulting in a greater likelihood of failure of the prosthetic tricuspid valve 5000.

[0149] Figures 52-53 show various views of the implementation of a prosthetic tricuspid valve 5200 having three support structures 102-1, 102-2, 102-3 according to an embodiment.

[0150] Figure 52A shows a view of the flattened support structures 102-1, 102-2, 102-3 of a prosthetic tricuspid valve 5200 having three support structures 102-1, 102-2, 102-3 according to an embodiment.

[0151] FIG. 52B shows a side view of an artificial tricuspid valve 5200 having three support structures 102-1, 102-2, 102-3 according to an embodiment and configured for implantation in a native tricuspid valve.

[0152] FIGS. 53A-53G show CAD drawings of various views of an artificial tricuspid valve 5200 having three support structures 102-1, 102-2, 102-3 according to an embodiment. FIG. 53A shows a CAD drawing of an inclined side view of support structure 102-1 of an artificial tricuspid valve 5200 having three support structures 102-1, 102-2, 102-3 according to an embodiment. FIG. 53B shows a CAD drawing of an inclined side view of support structure 102-2 of an artificial tricuspid valve 5200 having three support structures 102-1, 102-2, 102-3 according to an embodiment. FIG. 53C shows a CAD drawing of an inclined side view of support structure 102-3 of an artificial tricuspid valve 5200 having three support structures 102-1, 102-2, 102-3 according to an embodiment. FIG. 53D shows a CAD drawing of a side view of an artificial tricuspid valve 5200 having three support structures 102-1, 102-2, 102-3 according to an embodiment. FIG. 53E shows a CAD drawing of a plan view of an artificial tricuspid valve 5200 having three support structures 102-1, 102-2, 102-3 according to an embodiment. FIG. 53F shows a CAD drawing of an inclined side view of an artificial tricuspid valve 5200 having three support structures 102-1, 102-2, 102-3 according to an embodiment. FIG. 53G shows a CAD drawing of another side view of an artificial tricuspid valve 5200 having three support structures 102-1, 102-2, 102-3 according to an embodiment.

[0153] In an embodiment of the prosthetic tricuspid valve 5200 having three support structures 102-1, 102-2, 102-3, the first support structure 102-1 does not form either the atrial arm 106-1 or the ventricular arm 106-2. The second support structure 102-2 forms the ventricular arm 106-2. The third support structure 102-3 forms the atrial arm 106-1. The three support structures 102-1, 102-2, 102-3 are configured to fit together to form the prosthetic tricuspid valve 5200. As will be described throughout the present disclosure, at least one of the three support structures 102-1, 102-2, 102-3 includes a cylindrical portion that defines the elongated central passage 104 of the prosthetic tricuspid valve 5200. For example, in an implementation of the prosthetic tricuspid valve 5200 having three support structures 102-1, 102-2, 102-3 depicted in FIGS. 52-53, each support structure of the three support structures 102-1, 102-2, 102-3 includes a cylindrical portion 116-1, 116-2, 116-3 that defines the elongated central passage 104 of the prosthetic tricuspid valve 5200. On the other hand, in an alternative embodiment, only one or two of the three support structures 102-1, 102-2, 102-3 may include a cylindrical portion that defines the elongated central passage 104 of the prosthetic tricuspid valve 5200.

[0154] Similar to the prosthetic tricuspid valves 4600, 4800, 5000, the advantages of forming the prosthetic tricuspid valve 5200 with three support structures 102-1, 102-2, 102-3 include easier manufacture of the prosthetic tricuspid valve 5200. Further, similar to the prosthetic tricuspid valves 4800, 5000, another advantage of forming the prosthetic tricuspid valve 5200 with three support structures 102-1, 102-2, 102-3 is that the leaflet element can be formed with the first support structure 102-1 that does not form the atrial arm 106-1, whereby an atrial sealing skirt as described above can be formed to be separated from the leaflet element with the third support structure 102-3 that forms the atrial arm 106-1. By forming the atrial sealing skirt with the third support structure 102-3 to be separated from the leaflet element formed with the first support structure 102-1, the assembly of the individual support structures 102-1, 102-3 is easier and the atrial sealing skirt can be laminated. On the other hand, the assembly of the prosthetic tricuspid valve 5200 includes an additional step of fitting the three support structures 102-1, 102-2, 102-3 together to form the prosthetic tricuspid valve 4800. Another advantage of forming the prosthetic tricuspid valve 5200 with three support structures 102-1, 102-2, 102-3 is that the first support structure 102-1 can provide additional reinforcement to the atrial arm 106-1 formed with the third support structure 102-3, and there is an improved load distribution because both the first support structure 102-1 and the third support structure 102-3 can provide additional reinforcement to the ventricular arm 106-2 formed with the second support structure 102-2. Further, unlike the prosthetic tricuspid valves 4600, 4800, 5000 described above, the arm 106 is expanded and the fulcrum points occur at a plurality of different locations away from the nodes that receive the load forces, effectively creating a larger load distribution and thus resulting in a lower likelihood of failure of the prosthetic tricuspid valve 5200. However, disadvantageously, forming the prosthetic tricuspid valve 5200 with three support structures 102-1, 102-2, 102-3 increases the overall bulkiness and diameter of the prosthetic tricuspid valve 5200.

[0155] FIG. 54A shows a side view of the overbite between the atrial arm 106-1 and the ventricular arm 106-2 of the artificial tricuspid valve 100 at rest according to one embodiment. In other words, FIG. 54A shows a side view of the overbite between the atrial arm 106-1 and the ventricular arm 106-2 of the artificial tricuspid valve 100 when the artificial tricuspid valve 100 is not implanted in the natural tricuspid valve.

[0156] FIG. 54B shows a side view of the atrial arm 106-1 and the ventricular arm 106-2 of the artificial tricuspid valve 100 when the artificial tricuspid valve 100 is implanted in the natural tricuspid valve according to one embodiment. In other words, FIG. 54B shows a side view of the atrial arm 106-1 and the ventricular arm 106-2 of the artificial tricuspid valve 100 when the arm 106 is clamped on the natural leaflet of the natural tricuspid valve in which the artificial tricuspid valve 100 is implanted. When the artificial tricuspid valve 100 is at rest, the amount of overbite between the atrial arm 106-1 and the ventricular arm 106-2 of the artificial tricuspid valve 100 determines the magnitude of the clamping force of the arm 106 on the natural leaflet of the natural tricuspid valve, as shown in FIG. 54A.

[0157] FIG. 55 shows a CAD drawing of a cutaway side view of an artificial tricuspid valve 5200 having three support structures 102-1, 102-2, 102-3 according to an embodiment. As described above, the first support structure 102-1 does not form either the atrial arm 106-1 or the ventricular arm 106. The second support structure 102-2 forms the ventricular arm 106-2, and the third support structure 102-3 forms the atrial arm 106-1. The three support structures 102-1, 102-2, 102-3 are all configured to fit together to form the artificial tricuspid valve 5200. Specifically, for the three support structures 102-1, 102-2, 102-3 to fit together to form the artificial tricuspid valve 5200, the radius of curvature of the second bending portion 130 of each atrial arm 106-1 is received by the V-shaped strut 2200-1 of the first support structure 102-1. Further, for the three support structures 102-1, 102-2, 102-3 to fit together to form the artificial tricuspid valve 5200, the radius of curvature of the second bending portion 126 of each ventricular arm 106-2 is received by the V-shaped strut 2200-1 of the support structure 102-1 and also contacts the mirror V-shaped strut 2200-3 of the support structure 102-3 that forms the atrial arm 106-1.

[0158] Furthermore, since the three support structures 102-1, 102-2, and 102-3 can all fit together to form the artificial tricuspid valve 5200, the dimensions of the three support structures 102-1, 102-2, and 102-3 can be determined relative to each other. For example, in some embodiments, the minimum inner diameter of the cylindrical portion of at least one support structure that defines the elongated central passage 104 can be smaller than the maximum outer diameter of the elongated central passage 104. As described above, in the implementation of the artificial tricuspid valve 5200, each support structure of the three support structures 102-1, 102-2, and 102-3 includes cylindrical portions 116-1, 116-2, and 116-3 that define the elongated central passage 104 of the artificial tricuspid valve 5200, respectively. Thus, in some embodiments, the minimum inner diameter of the cylindrical portions 116-1, 116-2, and 116-3 of the three support structures 102-1, 102-2, and 102-3 that define the elongated central passage 104 can be smaller than the maximum outer diameter of the elongated central passage 104. As another example, in some embodiments, the minimum diameter of the radius of curvature of each bend of each arm 106 (the arm 106 extends perpendicularly away from the central axis of the elongated central passage 104) is smaller than the maximum outer diameter of the elongated central passage 104. In other words, in some embodiments, the minimum diameter of the radius of curvature of the second bend 130 of each atrial arm 106-1 and the second bend 126 of each ventricular arm 106-2 is smaller than the maximum outer diameter of the elongated central passage 104. These relative dimensions can facilitate the three support structures 102-1, 102-2, and 102-3 fitting together to form the artificial tricuspid valve 5200.

[0159] Figures 56A to 56Cc are images of a prototype artificial tricuspid valve 5600 according to an embodiment. Specifically, FIG. 56A is a top view of an image of the prototype artificial tricuspid valve 5600 clamped on a sheet oriented substantially perpendicular (e.g., 90° ± 45°) to the central axis of the elongated central passage 104 of the artificial tricuspid valve 5600 according to an embodiment. FIG. 56B is a bottom view of an image of the prototype artificial tricuspid valve 5600 clamped on a sheet oriented substantially perpendicular (e.g., 90° ± 45°) to the central axis of the elongated central passage 104 of the artificial tricuspid valve 5600 according to an embodiment. FIG. 56C is a side view of an image of the prototype artificial tricuspid valve 5600 clamped on a sheet oriented substantially perpendicular (e.g., 90° ± 45°) to the central axis of the elongated central passage 104 of the artificial tricuspid valve 5600 according to an embodiment.

[0160] FIG. 57 is a bottom view of an image of a prototype artificial tricuspid valve 5700 according to an embodiment. In the embodiment of the artificial tricuspid valve 5700 depicted in FIG. 57, two of the ventricular arms are different from the ventricular arm 106-2 described throughout the present disclosure. Specifically, in the embodiment of the artificial tricuspid valve 5700 shown in FIG. 57, the ventricular-directed arm 5701 is a ventricular arm that has been modified to be different from the ventricular arm 106-2 described throughout the present disclosure. In particular, the distal segment 110 of each ventricular-directed arm 5701 has been modified to extend toward the ventricular end 120 of the cylindrical portion 116 of at least one support structure 102. Such an extension of the distal segment 110 of each ventricular-directed arm 5701 toward the ventricular end 120 of the cylindrical portion 116 of at least one support structure 102 enables the distal segment 110 of each ventricular-directed arm 5701 to contact the natural leaflet of the natural tricuspid valve on the atrial side rather than the ventricular side of the natural tricuspid valve, thereby holding the natural leaflet in a radially outward open position from the natural tricuspid valve.

[0161] Configuring the ventricular-directed arm 5701 to hold the native leaflet in an open position radially outward from the native tricuspid valve can be useful in many and various embodiments. For example, configuring the ventricular-directed arm 5701 to hold the native leaflet in an open position radially outward from the native tricuspid valve can be useful in embodiments where it is difficult for the native leaflet to be captured by the arm 106 for one reason or another (e.g., the native leaflet is too small or restricted). As another example, configuring the ventricular-directed arm 5701 to hold the native leaflet in an open position radially outward from the native tricuspid valve can be useful in minimizing the number of echocardiogram planes and / or viewpoints required during implantation of the prosthetic tricuspid valve (thereby simplifying the implantation procedure). In such embodiments, rather than attempting to capture all three native leaflets of the native tricuspid valve, one or more native leaflets can be pushed aside as described above, and the remaining native leaflets can be captured by the arm 1063. The prosthetic tricuspid valve 5700 includes two ventricular-directed arms 5701), but in alternative embodiments, the prosthetic tricuspid valve 5700 can include any amount of ventricular-directed arms 5701, such as, for example, 0, 1, 2, 3, 4, or more.

[0162] FIG. 58 shows a CAD drawing of an angled side view of a prosthetic tricuspid valve 5800 having three support structures 102-1, 102-2, 102-3 according to one embodiment. The prosthetic tricuspid valve 5800 is similar to the prosthetic tricuspid valve 5200 depicted in FIGS. 52, 53, and FIG. 55. However, the prosthetic tricuspid valve 5800 includes two ventricular-directed arms 5701 as described above with respect to FIG. 57. Similar to the ventricular arm 106-2, the ventricular-directed arm 5701 is formed by the second support structure 102-2.

[0163] FIG. 59 shows a diagram of a flattened support structure 102 of an artificial tricuspid valve according to an embodiment. As shown in FIG. 59, the support structure 102 includes an atrial end 118 and a ventricular end 120. A plurality of interlock mechanisms 5900 are included in the atrial end 118 of the support structure 102. As will be described later with respect to FIG. 59, each interlock mechanism 5900 of the support structure 102 is configured to connect with a corresponding interlock mechanism 3600 of the spreader arm 2300.

[0164] FIG. 60 shows the loading, locking, and releasing of the interlock mechanism 5900 of the support structure 102 of an artificial tricuspid valve according to an embodiment. Specifically, as shown in FIG. 60, each interlock mechanism 5900 of the support structure 102 connects with a corresponding interlock mechanism 3600 of the spreader arm 2300.

[0165] The loading, locking, and releasing of the interlock mechanism 5900 of the support structure 102 are achieved using the extension 3602 of each interlock mechanism 3600 of each spreader arm 2300. Specifically, when loading the interlock mechanism 5900 of the support structure 102 together with the corresponding interlock mechanism 3600 of the spreader arm 2300, the extension 3602 of the interlock mechanism 3600 of the spreader arm 2300 partially retracts from the interlock mechanism 5900 of the support structure 102, thereby pushing the interlock mechanism 3600 of the spreader arm 2300 laterally and enabling the interlock mechanism 5900 of the support structure 102 to snap into the locking position with the interlock mechanism 3600 of the spreader arm 2300. When locking the interlock mechanism 5900 of the support structure 102 together with the corresponding interlock mechanism 3600 of the spreader arm 2300, the extension 3602 of the interlock mechanism 3600 of the spreader arm 2300 moves completely forward over the interlock mechanism 5900 of the support structure 102, thereby locking the interlock mechanism 3600 of the spreader arm 2300 and the interlock mechanism 5900 of the support structure 102 in the locking position. When releasing the interlock mechanism 5900 of the support structure 102 from the corresponding interlock mechanism 3600 of the spreader arm 2300, the extension 3602 of the interlock mechanism 3600 of the spreader arm 2300 retracts completely from the interlock mechanism 5900 of the support structure 102, thereby enabling the interlock mechanism 5900 of the support structure 102 to expand and be released from the locking position with the interlock mechanism 3600 of the spreader arm 2300.

[0166] FIG. 61 shows a view of a flattened support structure 102 configured to form a ventricular arm 106-2 of an artificial tricuspid valve according to one embodiment.

[0167] FIG. 62A is an image of a prototype support structure 102 configured to form a ventricular arm 1 with an artificial tricuspid valve according to one embodiment.

[0168] FIG. 62B is an image of a prototype support structure 102 that forms the ventricular arm 106-2 and the ventricular-directed arm 5701 of an artificial tricuspid valve according to one embodiment.

[0169] FIGS. 63A-63B show CAD drawings of a support structure 102 that forms the ventricular arm 106-2 of an artificial tricuspid valve according to one embodiment. Specifically, FIG. 63A shows a top view of the CAD drawing of the support structure 102 that forms the ventricular arm 106-2 of an artificial tricuspid valve according to one embodiment. FIG. 63B shows a side view of the CAD drawing of the support structure 102 that forms the ventricular arm 106-2 of an artificial tricuspid valve according to one embodiment.

[0170] FIGS. 64A-64B show CAD drawings of a support structure 102 that forms the ventricular arm 106-2 and the ventricular-directed arm 5701 of an artificial tricuspid valve according to one embodiment. Specifically, FIG. 64A shows a top view of the CAD drawing of the support structure 102 that forms the ventricular arm 106-2 and the ventricular-directed arm 5701 of an artificial tricuspid valve according to one embodiment. FIG. 64B shows a side view of the CAD drawing of the support structure 102 that forms the ventricular arm 106-2 and the ventricular-directed arm 5701 of an artificial tricuspid valve according to one embodiment.

[0171] FIG. 65 shows a view of a flattened support structure 102 configured to form the atrial arm 106-1 of an artificial tricuspid valve according to one embodiment. As shown in FIG. 65, the tip 142 of each atrial arm 106-1 can include a locking mechanism 6500. Each locking mechanism 6500 of the support structure 102 is configured to lock with a corresponding restraint 410 (e.g., a suture).

[0172] When loading the locking mechanism 6500, the narrow opening 6501 of each locking mechanism 6500 allows the corresponding restraint 410 to enter the locking mechanism 6500 and lock in a predetermined position. When locking the locking mechanism (6500), the teeth 6502 of each locking mechanism 6500 prevent the corresponding locked restraint 410 from exiting the locking mechanism 6500 through the narrow opening 6501 while the restraint 410 is under tension. When releasing the locking mechanism 6500, when the tension is removed from the restraint 410, the restraint 410 is allowed to exit the locking mechanism 6500 through the narrow opening 6501.

[0173] FIG. 66 shows a CAD drawing of a side view of an artificial tricuspid valve 5800 according to an embodiment. As also shown in FIG. 66, the distal segment 114 of each atrial arm 106-1 extends from the atrial end 118 of the cylindrical portion 116 of the support structures 102-1, 102-2, 102-3, but extends toward the ventricular end 120 of the cylindrical portion 116 of the support structures 102-1, 102-2, 102-3. Conversely, the distal segment 110 of each ventricular arm 106-2 extends from the ventricular end 120 of the cylindrical portion 116 of the support structures 102-1, 102-2, 102-3, but extends toward the atrial end 118 of the cylindrical portion 116 of the support structures 102-1, 102-2, 102-3. As a result, as described above, an overbite occurs between the atrial arm 106-1 and the ventricular arm 106-2. The dotted line across the artificial tricuspid valve 5800 in FIG. 66 indicates the point of overbite between the atrial arm 106-1 and the ventricular arm 106-2. As shown in FIG. 66, the overbite between the atrial arm 106-1 and the ventricular arm 106-2 enables the atrial arm 106-1 and the ventricular arm 106-2 to clamp the natural leaflet 500-2 of the natural tricuspid valve between them. Conversely, as shown in FIG. 66, the ventricle-directed arm 5701 is configured to hold the natural leaflet 500-1 in an open position radially outward from the natural tricuspid valve.

[0174] Furthermore, as shown in FIG. 66, the tip 142 of each atrial arm 106-1 includes an expansion segment 2400 having a third bend toward the atrial end 118 of the cylindrical portion 116 of the support structures 102-1, 102-2, 102-3, enabling engagement with the atrial surface of the native leaflet without trauma. Similarly, as shown in FIG. 66, the tip 140 of the ventricular indicating arm 5701 can include an expansion segment having a third bend toward the ventricular end 120 of the cylindrical portion 116 of the support structures 102-1, 102-2, 102-3, enabling engagement with the atrial surface of the native leaflet 500-1 without trauma. These third bends of the atrial arm 106-1 and the ventricular pointing arm 5701 can also prevent the atrial arm 106-1 and the ventricular pointing arm 5701 from being embedded in the tissue of the native leaflet.

[0175] FIGS. 67A-67C show side views of the overbite between the atrial arm 106-1 and the ventricular arm 106-2 of an artificial tricuspid valve according to one embodiment. Specifically, FIGS. 67A-67C show side views of the varying amount of overbite between the atrial arm 106-1 and the ventricular arm 106-2 of an artificial tricuspid valve according to one embodiment. The amount of overbite between the atrial arm 106-1 and the ventricular arm 106-2 of the artificial tricuspid valve determines the magnitude of the clamping force of the arm 106 on the native leaflets of the native tricuspid valve. Furthermore, the magnitude of the clamping force of the arm 106 on the native leaflets of the native tricuspid valve determines the biomechanical momentum of the artificial tricuspid valve within the native tricuspid valve over the cardiac cycle.

[0176] FIG. 67A shows a side view of a relatively small overbite amount between the atrial arm 106-1 and the ventricular arm 106-2 of an artificial tricuspid valve according to an embodiment. As a result of this relatively small overbite amount between the atrial arm 106-1 and the ventricular arm 106-2 of the artificial tricuspid valve in FIG. 67A, a relatively small amount of tension can act on the native leaflets clamped between the atrial arm 106-1 and the ventricular arm 106-2. Further, as a result of the relatively small amount of tension acting on the native leaflets clamped between the atrial arm 106-1 and the ventricular arm 106-2, the artificial tricuspid valve can exhibit a relatively large biomechanical momentum within the native tricuspid valve over the entire cardiac cycle.

[0177] FIG. 67B shows a side view of a relatively medium overbite amount between the atrial arm 106-1 and the ventricular arm 106-2 of an artificial tricuspid valve according to an embodiment. As a result of this relatively medium overbite amount between the atrial arm 106-1 and the ventricular arm 106-2 of the artificial tricuspid valve in FIG. 67B, a relatively medium amount of tension can act on the native leaflets clamped between the atrial arm 106-1 and the ventricular arm 106-2. Further, as a result of the relatively medium amount of tension acting on the native leaflets clamped between the atrial arm 106-1 and the ventricular arm 106-2, the artificial tricuspid valve can exhibit a relatively medium biomechanical momentum within the native tricuspid valve over the entire cardiac cycle.

[0178] Figure 67C shows a side view of a relatively large overbite amount between the atrial arm 106-1 and the ventricular arm 106-2 of an artificial tricuspid valve according to an embodiment. As a result of this relatively large overbite amount between the atrial arm 106-1 and the ventricular arm 106-2 of the artificial tricuspid valve in Figure 67C, a relatively large amount of tension can act on the native leaflets clamped between the atrial arm 106-1 and the ventricular arm 106-2. Further, as a result of the relatively large amount of tension acting on the native leaflets clamped between the atrial arm 106-1 and the ventricular arm 106-2, the artificial tricuspid valve can exhibit a relatively small biomechanical momentum within the native tricuspid valve over the entire cardiac cycle of the heart.

[0179] Figures 68A - 68B show various embodiments of an atrial sealing skirt 204 according to an embodiment. Specifically, Figure 68A shows a symmetric implementation of the atrial sealing skirt 204 according to an embodiment. Figure 68B shows an asymmetric implementation of the atrial sealing skirt 204 according to an embodiment.

[0180] The symmetric atrial sealing skirt 204 depicted in Figure 68A can be used in a symmetric artificial tricuspid valve device such as the artificial tricuspid valve devices depicted in Figures 62A and 64A - B. Specifically, the symmetric atrial sealing skirt 204 depicted in Figure 68A can be used in an artificial tricuspid valve device having symmetric ventricular arms (e.g., ventricular arm 106-2 only).

[0181] Conversely, the asymmetric atrial sealing skirt 204 depicted in Figure 68B can be used in an asymmetric artificial tricuspid valve device such as the artificial tricuspid valve devices depicted in Figures 62B and 65A - B. Specifically, the asymmetric atrial sealing skirt 204 depicted in Figure 68B can be used in an artificial tricuspid valve device having asymmetric ventricular arms (e.g., ventricular arm 106-2 and ventricular-directed arm 5701).

[0182] The tabs of the atrial sealing skirt 204 that line the elongate central passageway 104 are foldable to join other portions of a cover 200 that extends along the inside of the cylindrical portion 116 of at least one support structure 102 of the prosthetic tricuspid valve. A fenestration 300 in the atrial sealing skirt 204 allows space for the ventricular arm 106-2 to pass through the atrial seal skirt 204 during assembly of the prosthetic tricuspid valve. Once the prosthetic tricuspid valve is assembled, the ventricular arm 106-2 is disposed outside the elongate central passageway 104 of the prosthetic tricuspid valve. In some embodiments, the asymmetric portion of the asymmetric atrial sealing skirt (204) of FIG. 68B can include an additional fenestration 300 that is positioned within the native annulus of the native tricuspid valve when the prosthetic tricuspid valve is implanted within the native tricuspid valve.

[0183] FIGS. 69A-69B are images of the support structures 102-2, 102-3 of a prototype prosthetic tricuspid valve 6900 according to one embodiment. Specifically, FIG. 69A is an image of a bottom view of the support structures 102-2, 102-3 of a prototype prosthetic tricuspid valve 6900 according to one embodiment. FIG. 69B is an image of a side view of the support structures 102-2, 102-3 of a prototype prosthetic tricuspid valve 6900 according to one embodiment.

[0184] The prosthetic tricuspid valve 6900 is similar to the prototype prosthetic tricuspid valve 5600 of FIGS. 56A-C and includes three support structures 102-1, 102-2, 102-3 (shown in FIG. 74). However, the images of FIGS. 69A-69B depict only the support structures 102-1, 102-3 of the prototype prosthetic tricuspid valve 6900. As will be described below, the first support structure 102-1 does not form either the atrial arm 106-1 or the ventricular arm 106-2. The second support structure 102-2 forms the ventricular arm 106-2 and the third support structure 102-3 forms the atrial arm 106-1. As shown in FIGS. 69A-69B, the symmetric atrial seal skirt 204 of FIG. 68A covers the support structures 102-2, 102-3 of the symmetric prototype prosthetic tricuspid valve 6900.

[0185] Figures 70A - 70B are images of the support structures 102-2 and 102-3 of the prototype artificial tricuspid valve 7000 according to one embodiment. Specifically, Figure 70A is an image of the bottom view of the support structures 102-2 and 102-3 of the prototype artificial tricuspid valve 7000 according to one embodiment. Figure 70B is an image of the side view of the support structures 102-2 and 102-3 of the prototype artificial tricuspid valve 7000 according to one embodiment.

[0186] The prototype artificial tricuspid valve 7000 is similar to the prototype artificial tricuspid valve 5700 of Figure 57 and includes three support structures 102-1, 102-2, and 102-3. However, the images of Figures 70A - B depict only the support structures 102-2 and 102-3 of the prototype artificial tricuspid valve 7000. As shown in Figures 70A - B, the asymmetric atrial sealing skirt 204 of Figure 68B covers the support structures 102-2 and 102-3 of the symmetric prototype artificial tricuspid valve 7000.

[0187] Figure 71 is an image of the top view of the support structure 102-3 of the prototype artificial tricuspid valve 6900 according to one embodiment. As shown in Figure 71, the atrial sealing skirt 204 of the support structure 102-3 of the artificial tricuspid valve 6900 includes a window 300 configured such that the ventricular arm 106-2 can pass through the atrial sealing skirt 204 during the assembly of the artificial tricuspid valve 6900. Thus, once the artificial tricuspid valve 6900 is assembled, the ventricular arm 106-2 is disposed outside the elongated central passage 104 of the artificial tricuspid valve 6900.

[0188] Figures 72A - 72B are images of the support structures 102-2 and 102-3 of the prototype artificial tricuspid valve 6900 according to one embodiment. Specifically, Figure 72A is an image of the top view of the support structures 102-2 and 102-3 of the prototype artificial tricuspid valve 6900 according to one embodiment. Figure 72B is an image of the side view of the support structures 102-2 and 102-3 of the prototype artificial tricuspid valve 6900 according to one embodiment.

[0189] As described above with respect to FIGS. 69A - 69B, the prosthetic tricuspid valve 6900 includes three support structures 102 - 1, 102 - 2, 102 - 3 (shown in FIG. 74). However, the images of FIGS. 72A - B show only the support structures 102 - 2, 102 - 3 of the prototype prosthetic tricuspid valve 6900. As will be described later, the first support structure 102 - 1 does not form either the atrial arm 106 - 1 or the ventricular arm 106 - 2. The second support structure 102 - 2 forms the ventricular arm 106 - 2, and the third support structure 102 - 3 forms the atrial arm 106 - 1.

[0190] The three support structures 102 - 1, 102 - 2, 102 - 3 are all configured to fit together to form the prosthetic tricuspid valve 6900. Specifically, in order for the three support structures 102 - 1, 102 - 2, 102 - 3 to fit together to form the prosthetic tricuspid valve 6900, the radius of curvature of the second bend 130 of each atrial arm 106 - 1 is received by the V - shaped strut 2200 - 1 of the first support structure 102 - 1 (shown in FIG. 74). Further, for the three support structures 102 - 1, 102 - 2, 102 - 3 to fit together to form the prosthetic tricuspid valve 6900, the radius of curvature of the second bend 126 of each ventricular arm 106 - 2 is received by the V - shaped strut 2200 - 1 of the support structure 102 - 1 (shown in FIG. 74) and also contacts the mirror V - shaped strut 2200 - 3 of the support structure 102 - 3 that forms the atrial arm 106 - 1.

[0191] In some embodiments, the prosthetic tricuspid valve 6900 is configured to include the support structure 102 - 1 (shown in FIG. 74) as an addition to the support structure 102 - 2, but it should be noted that neither the prosthetic tricuspid valve nor the three support structures are required. Rather, in some embodiments, for example, the embodiments of the prosthetic tricuspid valves 4600, 4800, 5000, etc., the prosthetic tricuspid valve can include only two support structures. In such embodiments, as will be described in detail above and below, the reinforcement for the arms 106 of the prosthetic tricuspid valve will simply be smaller.

[0192] FIG. 73 shows an atrial sealing skirt 204 including a ventricular arm sleeve 7300 configured to enclose a ventricular arm 106-2 of a support structure 102 according to one embodiment. As shown in FIG. 73, in some embodiments, the atrial sealing skirt 204 can include one or more ventricular arm sleeves 7300, and each ventricular arm sleeve 7300 is configured to enclose a corresponding ventricular arm 106-2 of the support structure 102. Each ventricular arm sleeve 7300 can be configured, for example, as a ribbon extending from the atrial sealing skirt 204 that covers the support structure 102. To enclose the ventricular arm 106-2, the ribbon extending from the atrial sealing skirt 204 is foldable over the ventricular arm 106-2 and can be closed and sutured around the ventricular arm 106-2.

[0193] Enclosure of the ventricular arm 106-2 by the ventricular arm sleeve 7300 can promote ingrowth of the ventricular arm 106-2 within the natural tricuspid valve leaflets when an artificial tricuspid valve is implanted. Enclosure of the ventricular arm 106-2 by the ventricular arm sleeve 7300 can also provide trauma-free contact between the ventricular arm 106-2 and the natural tricuspid valve leaflets when an artificial tricuspid valve is implanted. Further, enclosure of the ventricular arm 106-2 by the ventricular arm sleeve 7300 can function as a fail-safe to prevent embolization when the ventricular arm 106-2 breaks when an artificial tricuspid valve is implanted.

[0194] FIG. 74 is an image of a side view of a prototype artificial tricuspid valve 6900 according to one embodiment. As described above with reference to FIGS. 69A - B, the artificial tricuspid valve 6900 includes three support structures 102-1, 102-2, 102-3. The first support structure 102-1 does not form either an atrial arm 106-1 or a ventricular arm 106-2. The second support structure 102-2 forms the ventricular arm 106-2, and the third support structure 102-3 forms the atrial arm 106-1.

[0195] The three support structures 102-1, 102-2, and 102-3 are configured to fit together to form the prosthetic tricuspid valve 6900. Specifically, for the three support structures 102-1, 102-2, and 102-3 to fit together to form the prosthetic tricuspid valve 6900, the radius of curvature of the second bend 130 of each atrial arm 106-1 is received by the V-shaped strut 2200-1 of the first support structure 102-1. Further, for the three support structures 102-1, 102-2, and 102-3 to fit together to form the prosthetic tricuspid valve 6900, the radius of curvature of the second bend 126 of each ventricular arm 106-2 is received by the V-shaped strut 2200-1 of the support structure 102-1 and also contacts the mirror V-shaped strut 2200-3 of the support structure 102-3 that forms the atrial arm 106-1.

[0196] Furthermore, to fix the three support structures 102-1, 102-2, and 102-3 to each other to form the prosthetic tricuspid valve 6900, the support structures 102-2 and 102-3 are each fixed to the support structure 102-1. Specifically, as depicted in FIG. 74, for fixing the support structure 102-3 to the support structure 102-1, the small holes 3502 (shown in FIG. 35) of each atrial arm 106-1 formed by the support structure 102-3 are fixed to the corresponding small holes of the support structure 102-1. Also, as depicted in FIG. 74, for fixing the support structure 102-2 to the support structure 102-1, the three-point node of the support structure 102-2 is fixed to the support structure 102-1.

[0197] FIGS. 75-79 show various implementations of prosthetic tricuspid valves having different numbers of support structures according to one embodiment. Specifically, FIGS. 75-79 show the differential load distribution for various implementations of prosthetic tricuspid valves having different numbers of support structures according to one embodiment.

[0198] As shown in each of FIGS. 75 to 79, when an artificial tricuspid valve is implanted into the natural tricuspid valve over the entire cardiac cycle of the heart, as a result of the ventricular systolic pressure load from the heart, an atrial-directed force 7501 is generated by the ventricular arm 106-2 of each artificial tricuspid valve. Conversely, a ventricular-directed force 7500 is generated by the atrial arm 106-1 of each artificial tricuspid valve as a result of the tension application of the natural leaflets of the natural tricuspid valve in response to the ventricular systolic pressure load. As indicated by the magnitude of the arrows of forces 7500, 7501, the atrial-directed force 7501 generated by the ventricular arm 106-2 is much larger than the ventricular-directed force 7500 generated by the atrial arm 106-1. As a result, as will be described later, the distribution of the atrial-directed force 7501 generated by the ventricular arm 106-2 is more essential for maintaining the integrity of the artificial tricuspid valve than the distribution of the ventricular-directed force 7500 generated by the atrial arm 106-1.

[0199] Depending on the shape of the artificial tricuspid valve, particularly the number of support structures including the artificial tricuspid valve, the load nodes 7502 and the fulcrum points 7503 can be differentially distributed over the entire artificial tricuspid valve, and thus, the forces 7500, 7501 can be differentially distributed over the entire artificial tricuspid valve. The different configurations of each artificial tricuspid valve and its load nodes 7502 and fulcrum points 7503, and the distribution of the forces 7500, 7501 are depicted in FIGS. 75 to 79.

[0200] FIG. 75 shows the load distribution for an artificial tricuspid valve 4400 having one support structure 102 according to one embodiment. In the embodiment of the artificial tricuspid valve 4400 having one support structure 102, both the atrial arm 106-1 and the ventricular arm 106-2 are formed by one support structure 102.

[0201] As shown in FIG. 75, the artificial tricuspid valve 4400 has a single load node 7502 and a single fulcrum point 7503 located at the same general location of one support structure 102. Further, there is no additional support structure supporting the ventricular arm 106-2. Thus, the distribution of the atrial-directed force 7501 generated by the ventricular arm 106-2 is minimal, effectively resulting in a greater potential for failure of the artificial tricuspid valve 4400.

[0202] FIG. 76 shows the load distribution of the prosthetic tricuspid valve 4800 having two support structures 102-1 and 102-2 according to one embodiment. In the embodiment of the prosthetic tricuspid valve 4800 having two support structures 102-1 and 102-2, the ventricular arm 106-2 is formed by the first support structure 102-1, and the atrial arm 106-1 is formed by the second support structure 102-2.

[0203] As shown in FIG. 76, the prosthetic tricuspid valve 4800 has one load node 7502 disposed on each of the two support structures 102-1 and 102-2. The two load nodes 7502 are both disposed at the same approximate position of a single fulcrum point 7503. Further, the support structure 102-1 supports the atrial arm 106-1 formed by the support structure 102-2, rather than the ventricular arm 1061-2. Thus, most of the improved load distribution in the prosthetic tricuspid valve 4800 occurs in the atrial arm 106-1, which is less significant because the atrial arm 106-1 is subjected to less force than the ventricular arm 106-2 when the atrial arm 106-1 is implanted in vivo as described above. The distribution of the atrial-directed force 7501 generated by the ventricular arm 106-2 is not improved for the prosthetic tricuspid valve 4400.

[0204] FIG. 77 shows the load distribution for the prosthetic tricuspid valve 5000 having two support structures 102-1 and 102-2 according to one embodiment. In the embodiment of the prosthetic tricuspid valve 5000 having two support structures 102-1 and 102-2, the first support structure 102-1 does not form either the atrial arm 106-1 or the ventricular arm 106-1. The second support structure 102-2 forms both the atrial arm 106-1 and the atrial arm 106-1.

[0205] As shown in FIG. 77, the prosthetic tricuspid valve 5000 has one load node 7502 disposed on each of two support structures 102-1 and 102-2. The two load nodes 7502 are both disposed at the same approximate position of a single fulcrum point 7503. However, unlike the prosthetic tricuspid valve 4800, the support structure 102-1 provides additional support for the ventricular arm 106-2 formed by the support structure 102-2, so the distribution of the atrial-directed force 7501 generated by the ventricular arm 106-2 is improved with respect to the prosthetic tricuspid valve 4400. The support structure 102-1 also provides additional support for the atrial arm 106-1 formed by the support structure 102-2.

[0206] FIG. 78 shows the load distribution of a prosthetic tricuspid valve 4600 having two support structures 102-1 and 102-2 according to an embodiment. In the embodiment of the prosthetic tricuspid valve 4600 having two support structures 102-1 and 102-2, the atrial arm 106-1 is formed by the first support structure 102-1, and the ventricular arm 106-2 is formed by the second support structure 102-2.

[0207] As shown in FIG. 78, the prosthetic tricuspid valve 4600 has one load node 7502 disposed on each of two support structures 102-1 and 102-2. However, unlike the prosthetic tricuspid valves 4800 and 5000, the two load nodes 7502 are not disposed at the same approximate position. A single fulcrum point 7503 is disposed at the same approximate position of only one of the two load nodes 7502. Further, the support structure 102-1 provides additional support for the ventricular arm 106-2 formed by the support structure 102. As a result, the distribution of the atrial-directed force 7501 generated by the ventricular arm 106-2 and the ventricular-directed force 7500 generated by the atrial arm 106-1 is improved with respect to the prosthetic tricuspid valves 4400, 4800, and 5000.

[0208] FIG. 79 shows the load distribution of the prosthetic tricuspid valve 5200 having three support structures 102-1, 102-2, 102-3 according to one embodiment. In the embodiment of the prosthetic tricuspid valve 5200 having three support structures 102-1, 102-2, 102-3, the first support structure 102-1 does not form either the atrial arm 106-1 or the ventricular arm 106-2. The second support structure 102-2 forms the ventricular arm 106-2. The third support structure 102-3 forms the atrial arm 106-1.

[0209] As shown in FIG. 79, the prosthetic tricuspid valve 5200 has one load node 7502 disposed at each of the three support structures 102-1, 102-2, 102-3. The three load nodes 7502 are not disposed at the same approximate position of a single pivot point 7503. Further, the first support structure 102-1 can provide additional reinforcement to the atrial arm 106-1 formed by the third support structure 102-3, and both the first support structure 102-1 and the third support structure 102-3 can provide additional reinforcement to the ventricular arm 106-2 formed by the second support structure 102-2. As a result, the distribution of the atrial-directed force 7501 generated by the ventricular arm 106-2 and the ventricular-directed force 7500 generated by the atrial arm 106-1 is most improved in the prosthetic tricuspid valve 5200 as compared to the prosthetic tricuspid valves 4400, 4800, 5000, 4600.

[0210] FIG. 80 shows a CAD drawing of a cutaway side view of the prosthetic tricuspid valve 5200 according to one embodiment. The central axis 8000 of the elongated central passage 104 of the cylindrical portion 116 of at least one of the three support structures 102-1, 102-2, 102-3 is shown in FIG. 80.

[0211] As described in detail above, the distal segments of each arm 106 (e.g., the distal segment 114 of each atrial arm 106-1 and the distal segment 110 of each ventricular arm 106-2) extend away from the central axis 8000 of the elongated central passage 104 for attachment of the prosthetic tricuspid valve 5200 to an object (e.g., a native tricuspid valve leaflet). As referred to herein, the distal segment of the arm 106 that extends away from the central axis 8000 of the elongated central passage 104 refers to the distal segment of the arm 106 that extends away from the central axis 8000 of the elongated central passage 104, such that a line 8001 extending from the contact point 8002 of the distal segment of the arm 106 with an object (e.g., a native tricuspid valve leaflet) to the longitudinal position 8003 along the outer surface 147 of the cylindrical portion 116 of at least one of the three support structures 102-1, 102-2, 102-3 from which the distal segment extends is oriented at approximately 90° ± 45° from the central axis 8000 of the elongated central passage 1043. In some embodiments, the contact point 8002 of the distal segment of the arm 106 can be at the tip 140 or 142 of the arm 106. In alternative embodiments, the distal segment of the arm 106 includes an extended segment having a third bend, and the contact point 8002 of the distal segment of the arm 106 can be at the extended segment, particularly the third bend of the arm 106. The contact point 8002 of the distal segment of the arm 106 can be at any other portion of the distal segment of the arm 106. As will be described in more detail below, this approximate perpendicularity of the line from the contact point 8002 of the distal segment to the longitudinal position along the outer surface 147 of the cylindrical portion 116 from which the distal segment extends enables axial stabilization of the prosthetic tricuspid valve 5200 within the native tricuspid valve.

[0212] It should be understood that the particular order or hierarchy of blocks in the disclosed process is an illustration of an exemplary approach. Based on the choice of implementation, it is understood that the particular order or hierarchy of blocks in the process may be rearranged, or that not all of the illustrated blocks may be implemented. Any of the blocks may be implemented simultaneously. In one or more embodiments, multitasking and parallel processing may be advantageous. Further, the separation of various system components in the embodiments described above should not be understood as requiring such separation in all embodiments, and it should be understood that the program components and systems described may generally be integrated into a single software product or packaged into multiple software products.

[0213] The present technology is shown, for example, in accordance with the various aspects described above. The present disclosure is provided so that those skilled in the art can implement the various aspects described herein. The present disclosure provides various examples of the technology, and the technology is not limited to these examples. Various modifications to these aspects will be readily apparent to those skilled in the art, and the general principles defined herein may be applied to other aspects.

[0214] References to elements in the singular are not intended to mean "only one" unless specifically stated otherwise, but rather "one or more." Unless specifically stated otherwise, the term "some" refers to one or more. Masculine pronouns (e.g., his) include feminine and neuter forms (e.g., her, its), and vice versa. Headings and subheadings, if any, are used for convenience only and do not limit the present invention.

[0215] The word "exemplary" is used herein to mean "serving as an example or illustration." Any aspect or design described herein should not necessarily be construed as more preferred or advantageous than other aspects or designs. In one aspect, the various alternative configurations and operations described herein are considered to be at least equivalent.

[0216] As used herein, the phrase "at least one" preceding a series of items accompanied by the term "or" that separates any of the items modifies the list as a whole rather than each individual item in the list. The phrase "at least one" does not require the selection of at least one item; rather, the phrase allows a meaning that includes at least one of any one of the items, and / or at least one of any combination of the items, and / or at least one of each of the items. As an example, the phrase "at least one of A, B, or C" may refer to only A, only B, or only C, or any combination of A, B, and C.

[0217] The phrase "aspect" does not mean that such an aspect is essential to the technology or that such an aspect applies to all configurations of the technology. A disclosure regarding an aspect may apply to all configurations or to one or more configurations. An aspect may provide one or more examples. Phrases such as "an aspect" may refer to one or more aspects, and vice versa. Phrases such as "embodiment" do not mean that such an embodiment is essential to the technology or that such an embodiment applies to all configurations of the technology. A disclosure regarding an embodiment may apply to all embodiments or to one or more embodiments. An embodiment may provide one or more examples. Phrases such as "an embodiment" may refer to one or more embodiments, and vice versa. The phrase "configuration" does not mean that such a configuration is essential to the technology or that such a configuration applies to all configurations of the technology. A disclosure regarding a configuration may apply to all configurations or to one or more configurations. A configuration may provide one or more examples. Phrases such as "a configuration" may refer to one or more configurations, and vice versa.

[0218] In one aspect, unless otherwise specified, all measurements, values, ratings, positions, sizes, dimensions and other specifications described in this specification (including the claims that follow) are approximate and not exact. In one aspect, they are intended to have a reasonable range that conforms to what is conventional in the functions with which they are associated and in the technical field to which they pertain.

[0219] It is understood that some or all steps, operations or processes may be performed automatically without user intervention. Method claims may be provided to present the elements of various steps, operations or processes in a sample order and are not meant to be limited to the particular order or hierarchy presented.

[0220] All structural and functional equivalents to the elements of the various aspects described throughout this disclosure that are known or later become known to those of ordinary skill in the art are hereby expressly incorporated by reference and are intended to be encompassed by the appended claims. Further, anything not disclosed herein is intended to be dedicated to the public whether or not such disclosure is expressly recited in the claims. Elements of a claim should not be construed according to the provisions of 35 USC 112, paragraph (f) unless the element is expressly recited using the phrase "means for" in the case of a method, or unless the element is expressly recited using the phrase "step for". Further, to the extent that the terms "comprising", "having", etc. are used, such terms are intended to be inclusive in a manner similar to the term "including" for the reasons that "including" is construed when used as a transitional term in a claim.

[0221] The title, background, brief description of the drawings, and claims of the present disclosure are hereby incorporated herein and provided as exemplary examples of the present disclosure, and not as a limiting description. It is contemplated with the understanding that these are not used to limit the scope or meaning of the claims. Further, in the detailed description, it will be seen that the description provides exemplary examples and various features are grouped together in various embodiments for the purpose of streamlining the disclosure. The method of this disclosure should not be construed as reflecting an intention that the claimed subject matter requires more features than are expressly recited in the claims. Rather, since the following claims reflect, the subject matter of the invention is less than all of the features of a single disclosed configuration or operation. The following claims are incorporated into the detailed description and each claim stands on its own to represent separately claimed subject matter.

[0222] The claims are not intended to be limited to the aspects described herein, but rather are intended to cover all scopes consistent with the language of the claims and to include all legal equivalents. Nevertheless, none of the claims are intended to cover subject matter that fails to meet the requirements of 35 USC 101, 102, or 103, and should not be construed in such a way.

Claims

1. An artificial heart valve, comprising: One or more support structures, wherein at least one support structure defines an elongated central passage; A plurality of leaflet elements mounted on at least one support structure and disposed within the elongated central passage for controlling blood flow therethrough; and At least one support structure is configured to biomechanically fix the artificial heart valve to the natural leaflets of the natural heart valve of the heart.

2. At least one support structure is configured to biomechanically fix the artificial heart valve to the natural leaflets, such that the at least one support structure is movable within the natural valve annulus of the natural heart valve in response to changes in pressure on one or more sides of the natural heart valve. The artificial heart valve according to claim 1.

3. At least one of the one or more support structures comprises a cylindrical portion including an atrial end and a ventricular end; The elongated central passage is defined by the cylindrical portion of at least one support structure; At least one of the one or more support structures includes an atrial arm set; At least one of the one or more support structures includes a ventricular arm set; Each arm of the atrial arm set and the ventricular arm set includes a proximal segment proximate to the cylindrical portion of at least one support structure and a distal segment distal to the cylindrical portion of at least one support structure; The distal segment of each arm of the atrial arm set and the ventricular arm set extends perpendicular to the central axis of the elongated central passage; The atrial arm set is configured to contact the natural leaflets on the atrial side of the natural heart valve; and The ventricular arm set is configured to contact the natural leaflets on the ventricular side of the natural heart valve. The artificial heart valve according to any one of claims 1 to 2.

4. The atrial arm set and the ventricular arm set are bent, such that: - In the implanted configuration, at least one support structure biomechanically fixes the artificial heart valve to the natural leaflets of the natural heart valve; - During movement of the cylindrical portion of at least one support structure facing the atrial side of the natural heart valve due to ventricular systolic pressure loading, one or more arms of the ventricular arm set resist the movement while one or more arms of the atrial arm set relax to maintain contact with the atrial side of the natural leaflets. ・Due to ventricular diastolic pressure load and / or elimination of the previously applied ventricular systolic load, during the movement of the cylindrical portion of at least one support structure facing the ventricular side of the native heart valve, one or more arms of the atrial arm set resist the movement, while one or more arms of the ventricular arm set relax to maintain contact with the ventricular side of the native leaflet. The artificial heart valve according to claim 3.

5. The arms of the atrial arm set are alternately arranged with the arms of the ventricular arm set around the cylindrical portion of at least one support structure. The arms of the atrial arm set and the arms of the ventricular arm set extend across the cross-section of the cylindrical portion of at least one support structure. The artificial heart valve according to any one of claims 3 to 4.

6. The distal segment of the arm of the atrial arm set extending perpendicularly away from the central axis of the elongated central passage extends towards the ventricular end of the cylindrical portion of at least one support structure, thereby enabling the distal segment of the arm of the atrial arm set extending perpendicularly away from the central axis of the elongated central passage to clamp the native leaflet on the atrial side of the native heart valve. The distal segment of the arm of the ventricular arm set extending perpendicularly away from the central axis of the elongated central passage extends towards the atrial end of the cylindrical portion of at least one support structure, thereby enabling the distal segment of the arm of the ventricular arm set extending perpendicularly away from the central axis of the elongated central passage to clamp the native leaflet on the ventricular side of the native heart valve. The artificial heart valve according to any one of claims 3 to 5.

7. Each distal segment of the arm of the atrial arm set extending perpendicularly away from the central axis of the elongated central passage has a tip that curves towards the atrial end of the cylindrical portion of at least one support structure, thereby reducing trauma to the native leaflet on the atrial side of the native heart valve at the contact point of the atrial arm set. Each distal segment of the arm of the ventricular arm set extending perpendicularly away from the central axis of the elongated central passage has a tip that curves towards the ventricular end of the cylindrical portion of at least one support structure, thereby reducing trauma to the native leaflet on the ventricular side of the native heart valve at the contact point of the ventricular arm set. The artificial heart valve according to any one of claims 3 to 6.

8. The cylindrical portion of at least one support structure is radially foldable for transcatheter implantation, the artificial heart valve according to any one of claims 3 to 7.

9. The distal segments of the atrial arm set and the ventricular arm set, which extend away perpendicularly from the central axis of the elongated central passage, can be elastically straightened, the artificial heart valve according to any one of claims 3 to 8.

10. The distal segments of one or more arms of the ventricular arm set, which extend away perpendicularly from the central axis of the elongated central passage, extend towards the ventricular end of the cylindrical portion of at least one support structure, whereby the distal segments of one or more arms of the ventricular arm set, which extend away perpendicularly from the central axis of the elongated central passage, can contact one of the native leaflets on the atrial side rather than the ventricular side of the native heart valve, thereby holding the native leaflet in the radially outward open position from the native heart valve, the artificial heart valve according to any one of claims 3 to 9.

11. The artificial heart valve according to any one of claims 3 to 10, further comprising one or more covers extending within the elongated central passage and over one or more of the atrial arm set and the ventricular arm set.

12. The artificial heart valve according to claim 11, further comprising a fenestration mechanism in a part of the one or more covers.

13. In an implantation configuration where at least one support structure biomechanically fixes the artificial heart valve to the native leaflets of the native heart valve, the fenestration mechanism is disposed between the elongated central passage and the native valve annulus of the native heart valve, the artificial heart valve according to claim 12.

14. The fenestration mechanism includes at least one of a radiopaque marker, an opening, a magnetic element, a one-way valve, a pop-up valve, a mechanically size-adjustable opening, and increased porosity, the artificial heart valve according to any one of claims 12 to ​ ​ ​ One or more covers start at the distal segment of each arm of the atrial arm set, are attached thereto, extend to and are attached to the proximal segment of each arm of the ventricular arm set, extend through the cylindrical portion of at least one support structure within the elongated central passageway, extend around the cylindrical portion of at least one support structure, and are attached to the proximal segment of each of the atrial arm sets, the artificial heart valve according to any one of claims 11 to 14.

16. One or more covers terminate at and are attached to a location along the proximal segment of each arm of the atrial arm set that is at a common distance from the cylindrical portion of at least one support structure, the artificial heart valve according to claim 15.

17. One or more covers further extend to and are attached to the distal segment of each arm of the ventricular arm set, the artificial heart valve according to claim 15.

18. One or more covers extend asymmetrically and / or non-circularly within the elongated central passageway and over one or more of the atrial arm set and the ventricular arm set, the artificial heart valve according to any one of claims 11 to 15, 17.

19. The atrial arm set is attached to the atrial end of the cylindrical portion of at least one support structure, The ventricular arm set is attached to the ventricular end of the cylindrical portion of at least one support structure, the artificial heart valve according to any one of claims 3 to 14.

20. The atrial arm set is attached to the ventricular end of the cylindrical portion of at least one support structure, The ventricular arm set is attached to the atrial end of the cylindrical portion of at least one support structure, the artificial heart valve according to any one of claims 3 to 18.

21. The proximal segment of each arm of the atrial arm set extends along the outer surface of the cylindrical portion of at least one support structure from the ventricular end of the cylindrical portion of at least one support structure towards the atrial end of the cylindrical portion of at least one support structure, The distal segment of each arm of the atrial arm set extends perpendicular to the central axis of the elongated central passageway, the artificial heart valve according to claim 20.

22. The proximal segment of each arm of the ventricular arm set extends along the outer surface of the cylindrical portion of at least one support structure from the atrial end of the cylindrical portion of at least one support structure towards the ventricular end of the cylindrical portion of at least one support structure, The distal segment of each arm of the ventricular arm set extends away perpendicularly from the central axis of the elongated central passageway, the artificial heart valve according to any one of claims 20-21.

23. The distal segment of each arm of the atrial arm set extends away perpendicularly from the central axis of the elongated central passageway and extends from a certain atrial longitudinal position along the outer surface of the cylindrical portion of at least one support structure, The distal segment of each arm of the ventricular arm set extends away perpendicularly from the central axis of the elongated central passageway and extends from a certain ventricular longitudinal position along the outer surface of the cylindrical portion of at least one support structure, The artificial heart valve according to any one of claims 21-22, wherein the atrial longitudinal position is closer to the atrial end of the cylindrical portion of at least one support structure than the ventricular longitudinal position.

24. In a transplant configuration where at least one support structure biodynamically fixes the artificial heart valve to the natural leaflets of the natural heart valve, the ventricular arm set extends from the atrial end of the cylindrical portion of at least one support structure, through the natural valve annulus of the natural heart valve, to the ventricular side of the natural heart valve and contacts the natural leaflets on the ventricular side of the natural heart valve, the artificial heart valve according to claim 20.

25. In a transplant configuration where at least one support structure biodynamically fixes the artificial heart valve to the natural leaflets of the natural heart valve, the atrial arm set extends from the ventricular end of the cylindrical portion of at least one support structure, through the natural valve annulus of the natural heart valve, into the atrium of the heart and contacts the natural leaflets on the atrial side of the natural heart valve, the artificial heart valve according to any one of claims 20, 24.

26. The cylindrical portion of at least one support structure includes a cylindrical cage structure with an opening, At least some portions of the cylindrical cage structure and the opening are configured to receive the bends of one or more arms of the atrial arm set and the ventricular arm set, The arm extends away perpendicularly from the central axis of the elongated central passageway, the artificial heart valve according to any one of claims 3-25.

27. The artificial heart valve according to any one of claims 1-26, wherein the one or more support structures include one support structure.

28. The artificial heart valve according to claim 26, wherein the one or more support structures include two or more support structures.

29. The one or more support structures include two support structures, the artificial heart valve according to any one of claims 26 and 28.

30. The one or more support structures include three support structures, the artificial heart valve according to any one of claims 26 and 28.

31. The minimum inner diameter of the cylindrical portion of at least one support structure that defines the elongated central passage is smaller than the maximum outer diameter of the elongated central passage, the artificial heart valve according to any one of claims 28 to 30.

32. The minimum diameter of the radius of curvature of each bend of one or more arms of the atrial arm set and the ventricular arm set is smaller than the maximum outer diameter of the elongated central passage, The arm extends perpendicular to the central axis of the elongated central passage, the artificial heart valve according to claim 31.

33. One or more support structures that define an elongated central passage, A valve structure mounted on at least one support structure and disposed within the elongated central passage to control blood flow through the elongated central passage, and At least one support structure includes a plurality of arms extending away from the elongated central passage for attachment of the at least one support structure to a natural leaflet of a natural heart valve of the heart, the artificial heart valve.

34. The plurality of arms An atrial arm set extending from the atrial end of at least one support structure before curving and extending away from the elongated central passage, and A ventricular arm set extending from the ventricular end of at least one support structure before curving and extending away from the elongated central passage, the artificial heart valve according to claim 33.

35. The atrial arm and the ventricular arm are configured to cooperatively hold a natural leaflet of a natural heart valve and maintain the elongated central passage within the natural valve annulus of the natural heart valve, and are configured not to be directly attached to the natural valve annulus or natural cord associated with the natural heart valve, the artificial heart valve according to claim 34.

36. One or more support structures that define an elongated central passage, A plurality of leaflet elements mounted on at least one support structure and disposed within the elongated central passage, and At least one support structure is configured to biodynamically fix the artificial heart valve inside and away from the natural valve annulus of a natural heart valve of the heart, the artificial heart valve.

37. At least one of the one or more support structures includes a cylindrical portion including an atrial end and a ventricular end, The elongated central passageway is defined by a cylindrical portion of at least one support structure, The cylindrical portion of the at least one support structure is expandable to a maximum radial width that is less than the minimum radial width of the natural valve annulus of the native heart valve, the artificial heart valve according to claim 36. **Claim 38** The at least one support structure is configured to biodynamically secure the artificial heart valve within and away from the natural valve annulus of the native heart valve of the heart by gripping the natural leaflets of the native heart valve without directly attaching to the natural valve annulus or natural cord related to the native heart valve, the artificial heart valve according to any one of claims 36 - 37. **Claim 39** The native heart valve is a tricuspid heart valve, the artificial heart valve according to any one of claims 36 - 38. **Claim 40** A method for transcatheter implantation of an artificial heart valve, the artificial heart valve comprising At least one support structure having a cylindrical portion, the cylindrical portion of the at least one support structure defining an elongated central passageway, at least one support structure; A plurality of atrial arms extending from the ventricular end of the cylindrical portion of the at least one support structure, each arm of the plurality of atrial arms including a proximal segment proximate to the cylindrical portion of the at least one support structure and a distal segment distal to the cylindrical portion of the at least one support structure, a plurality of atrial arms; A plurality of ventricular arms extending from the atrial end of the cylindrical portion of the at least one support structure, each arm of the plurality of ventricular arms including a proximal segment proximate to the cylindrical portion of the at least one support structure and a distal segment distal to the cylindrical portion of the at least one support structure, a plurality of ventricular arms, comprising The method comprising Guiding the artificial heart valve through the patient's vein into the native valve of the patient's heart, the artificial heart valve having the elongated central passageway in a contracted configuration, in the contracted configuration - The elongated central passageway has an atrial diameter, - Each arm of the plurality of ventricular arms is held against the outer surface of the cylindrical portion of the at least one support structure by a sheath, - Each arm of the plurality of atrial arms is held against the outer surface of the cylindrical portion of the at least one support structure by individual restraint of a plurality of restraints within the sheath, The method further comprises the steps of retracting the sheath to bend each of the plurality of ventricular arms such that the distal segment of each of the plurality of ventricular arms extends away from the cylindrical portion of the at least one support structure, retracting the artificial heart valve together with the sheath until the distal segment of each of the plurality of ventricular arms contacts the natural leaflets of the natural heart valve on the ventricular side of the natural heart valve, expanding the cylindrical portion of the at least one support structure from a contracted configuration to an expanded configuration with a larger ventricular diameter to form an elongated central passage, advancing a plurality of restraints to bend each of the plurality of atrial arms such that the distal segment of each of the plurality of atrial arms extends away from the cylindrical portion of the at least one support structure to capture the natural leaflets of the natural heart valve on the atrial side of the natural heart valve against the distal segments of the plurality of ventricular arms that contact the natural leaflets of the natural heart valve on the atrial side of the natural heart valve.

41. The step of retracting the sheath to bend each of the plurality of ventricular arms such that the distal segment of each of the plurality of ventricular arms extends away from the cylindrical portion of the at least one support structure further includes bending each of the plurality of ventricular arms such that the proximal segment of each of the plurality of ventricular arms extends along the outer surface of the cylindrical portion of the at least one support structure, The method according to claim 40, wherein the step of advancing a plurality of restraints to bend each of the plurality of atrial arms such that the distal segment of each of the plurality of atrial arms extends away from the cylindrical portion of the at least one support structure further includes bending each of the plurality of atrial arms such that the proximal segment of each of the plurality of atrial arms extends along the outer surface of the cylindrical portion of the at least one support structure.

42. The method according to any one of claims 40 to 41, further comprising the step of removing the plurality of restraints from the plurality of atrial arms.

43. By retracting a plurality of restraints from a plurality of atrial arms, repositioning an artificial heart valve within a native heart valve, straightening each arm of the plurality of atrial arms relative to an outer surface of a cylindrical portion of at least one support structure, and using a plurality of spreader arms to press at least one support structure toward the ventricular side of the native heart valve while releasing the native leaflets of the native heart valve, the method according to any one of claims 40 to 42.

44. Advancing the sheath to straighten each arm of the plurality of ventricular arms and compressing a cylindrical portion of at least one support structure to recapture and remove the artificial heart valve from the native heart valve through a patient's vein with the artificial heart valve in a collapsed configuration, the method according to any one of claims 40 to 43.

45. The step of advancing a plurality of restraints includes advancing the restraints while maintaining contact with at least one support structure using a plurality of spreader arms, the method according to any one of claims 40 to 44.

46. The plurality of spreader arms extend from an intermediate layer within the sheath, the method according to any one of claims 43, 45.

47. Each restraint of the plurality of restraints extends from a sheath between a pair of the plurality of spreader arms, the method according to claim 46.

48. Each spreader arm of the plurality of spreader arms includes an interlock mechanism that maintains contact with an atrial end of a cylindrical portion of at least one support structure, the method according to any one of claims 43, 45 to 47.

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