Prosthetic heart valve

Abstract

The present disclosure relates generally to prosthetic heart valves. The prosthetic heart valve includes one or more support structures. At least one support structure of the one or more support structures defines an elongate central channel of the prosthetic valve. The prosthetic valve may also include a plurality of leaflet elements attached to the at least one of the one or more support structures and disposed within the elongate central channel for controlling fluid flow through the elongate central channel. The at least one of the one or more support structures is configured to biodynamically secure the prosthetic valve within a native valve, such as a native tricuspid valve of a heart.

Description

[0001] This application is a divisional application of the invention patent application filed on March 25, 2020, with application number 202080039131.4 (PCT / US2020 / 024765) and entitled "Artificial Heart Valve". Technical Field

[0002] This disclosure relates generally to implantable cardiac devices, and more particularly to artificial tricuspid valves. Background Technology

[0003] Significant progress has been made in transcatheter treatment of heart valve disease. Initial clinical work focused on the pulmonary valve, followed by devices focused on percutaneous aortic valve replacement to treat aortic stenosis. Simultaneously, numerous projects have been undertaken attempting to address mitral regurgitation issues through transcatheter repair techniques, and later, transcatheter mitral valve replacement.

[0004] Tricuspid valve disease is a condition in which the tricuspid valve, located between the right ventricle and right atrium of the heart, malfunctions. There are several forms of tricuspid valve disease, including tricuspid regurgitation, tricuspid stenosis, and tricuspid atresia. In tricuspid regurgitation, blood flows back from the right ventricle to the right atrium. In tricuspid stenosis, the tricuspid valve narrows, reducing blood flow from the right atrium to the right ventricle. Tricuspid atresia is a congenital absence or malformation of the tricuspid valve, thus obstructing or reducing blood flow from the right atrium to the right ventricle. Compared to aortic stenosis (which has the highest mortality rate) and mitral regurgitation (which has the highest morbidity rate), tricuspid valve disease is largely overlooked as a "milder" valvular disease.

[0005] Currently, there are very few prosthetic tricuspid valves specifically designed for the tricuspid valve. In many cases, tricuspid valve defects have been treated using repurposed aortic and mitral valves. These repurposed aortic and mitral valves for use in the tricuspid valve are rigidly fixed by applying pressure to the natural annulus of the tricuspid valve, thus immobilizing the prosthetic valve. Because the tricuspid valve is located near the heart's conduction region, this rigid fixation of the prosthetic valve within the tricuspid valve can lead to cardiac conduction block and / or other conduction abnormalities.

[0006] Due to the unique challenges associated with tricuspid valve replacement, a specially designed artificial valve is required to repair the tricuspid valve. Summary of the Invention

[0007] This invention provides an artificial tricuspid valve that is not rigidly fixed within the natural tricuspid valve. This biodynamic valve design prevents cardiac obstruction and / or other dangerous conduction abnormalities. The artificial tricuspid valve provided herein is able to remain stably in place, but also needs to be non-rigid throughout the entire cardiac cycle.

[0008] The biodynamic artificial heart valve of the present invention provides a necessary solution by allowing the necessary movement characteristic of the natural tricuspid valve. In one aspect, the invention includes an artificial heart valve having one or more support structures. At least one of the one or more support structures defines an elongated central channel. The artificial heart valve may also include a plurality of leaflet elements attached to at least one of the one or more support structures and disposed within the elongated central channel for controlling blood flow through the elongated central channel. At least one of the one or more support structures is configured to biodynamically anchor the artificial heart valve to the natural leaflet of the natural heart valve of the heart. Specifically, in some embodiments, the at least one support structure is configured to biodynamically anchor the artificial heart valve to the natural leaflet of the natural heart valve such that the at least one support structure can move within the natural annulus of the natural heart valve in response to pressure changes on one or more sides of the natural heart valve.

[0009] As mentioned herein, the term "biodynamic" in relation to artificial heart valves refers to an artificial heart valve configuration that allows it to remain axially stable within the natural heart valve while simultaneously moving within it. This allows the valve to respond to alternating pressure gradients across the natural heart valve during the cardiac cycle. This is achieved without direct attachment to the natural annulus or cords of the natural heart valve, thus preserving the natural movement of the natural annulus. Specifically, the artificial heart valve is axially stable within the natural heart valve by gripping the natural leaflets rather than by annular forces or direct annular or cord attachment. As mentioned herein, the term "axially stable" in relation to an artificial heart valve located within a natural heart valve means that a portion of the artificial heart valve is inserted between any two diametrically opposed points on the natural annulus of the natural heart valve.

[0010] Many features of the artificial heart valve described herein enable this biodynamic 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 channel of the artificial heart valve is defined by the cylindrical portion of the at least one support structure. In some embodiments, at least one of the one or more support structures includes an atrial arm assembly. Furthermore, in some embodiments, at least one of the one or more support structures includes a ventricular arm assembly. Each arm in the atrial arm assembly and the ventricular arm assembly may include a proximal segment at the proximal end of the cylindrical portion of the at least one support structure and a distal segment at the distal end of the cylindrical portion of the at least one support structure.

[0011] In some embodiments, the distal segment of each arm in the atrial arm assembly and the ventricular arm assembly may extend vertically away from the central axis of the elongated central channel. Furthermore, the atrial arm assembly may be configured to contact the atrial side of the natural leaflet of the natural heart valve, and the ventricular arm assembly may be configured to contact the ventricular side of the natural heart valve. As mentioned herein, "vertically" extending the distal segment of the arm away from the central axis of the elongated central channel means that the distal segment of the arm extends away from the central axis of the elongated central channel such that a line drawn from the point of contact between the distal segment and the target (e.g., a natural heart valve leaflet) to a 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° to the central axis of the elongated central channel. As discussed below, this approximately vertical line from the point of contact of the distal segment to the longitudinal position along the outer surface of the cylindrical portion from which the distal segment extends allows the artificial heart valve to be axially stable within the natural heart valve.

[0012] Specifically, in some embodiments, the atrial and ventricular arm assemblies are bent such that, in an implantation configuration in which the artificial heart valve is biodynamically secured to the natural leaflet of the natural heart valve by at least one support structure, if the cylindrical portion of at least one support structure moves toward the atrial side of the natural heart valve due to ventricular systolic pressure loads, one or more arms of the ventricular arm assembly resist the movement, while one or more arms of the atrial arm assembly relax to maintain contact with the atrial side of the natural leaflet. Similarly, if the cylindrical portion of at least one support structure moves toward the ventricular side of the natural heart valve due to ventricular diastolic pressure loads and / or the elimination of previously applied ventricular systolic loads, one or more arms of the atrial arm assembly resist the movement, while one or more arms of the ventricular arm assembly relax to maintain contact with the ventricular side of the natural leaflet. This also creates a trampoline effect where the ventricular systolic pressure load can be partially absorbed by the atrial movement of the natural leaflet.

[0013] In some embodiments, the arms of the atrial arm assembly and the arms of the ventricular arm assembly alternate around the circumference of a cylindrical portion of at least one support structure.

[0014] In some embodiments, overlocking may exist between the atrial arm assembly and the ventricular arm assembly. Specifically, in some embodiments, the arms of the atrial arm assembly and the arms of the ventricular arm assembly may extend across the cross-sectional plane of the cylindrical portion of at least one support structure. As mentioned herein, the “cross-sectional plane” with respect to the cylindrical portion of the at least one support structure is a cross-sectional plane of the cylindrical portion of the at least one support structure perpendicular to the central axis of the elongated central channel defined by the cylindrical portion of the at least one support structure. In some other embodiments, the distal portion of the arm of the atrial arm assembly extending vertically away from the central axis of the elongated central channel extends toward the ventricular end of the cylindrical portion of the at least one support structure, thereby enabling the distal portion of the arm of the atrial arm assembly extending vertically away from the central axis of the elongated central channel to clamp the natural leaflet on the atrial side of the natural heart valve. Alternatively, the distal segment of the arm of the ventricular arm assembly extending vertically away from the central axis of the elongated central channel may extend toward the atrial end of the cylindrical portion of the at least one support structure, thereby enabling the distal segment of the arm of the ventricular arm assembly extending vertically away from the central axis of the elongated central channel to clamp the natural leaflet on the ventricular side of the natural heart valve.

[0015] During the implantation of an artificial heart valve, the overlocking action between the atrial and ventricular arms results in additional clamping force and further tension of the natural leaflet. This is because the distal segment of the atrial arm on the atrial side of the natural leaflet is actively pushed downward toward the ventricle, while the distal segment of the ventricular arm on the ventricular side of the natural leaflet is actively pushed upward toward the atrium, effectively creating a wavy, collar-like effect within the natural leaflet. This tensioning effect, with opposing forces from either side of the natural leaflet, helps to further stabilize the artificial heart valve axially within the natural heart valve. The amount of overlocking action between the atrial and ventricular arms of the artificial heart valve determines the magnitude of the clamping force of the arms on the natural leaflet of the natural heart valve. Furthermore, the magnitude of the clamping force of the arms on the natural leaflet of the natural heart valve determines the amount of axial stability and biodynamic motion of the artificial heart valve within the natural heart valve throughout the cardiac cycle. Specifically, throughout the heart's cardiac cycle, the greater clamping force of the arm on the natural leaflets of the natural heart valve produces greater axial stability and less biodynamic motion of the artificial heart valve within the natural heart valve.

[0016] In some embodiments, the distal segments of the arms of the atrial arm assembly extending vertically away from the central axis of the elongated central channel each have a tip that bends toward the atrial end of the cylindrical portion of at least one supporting structure, thereby reducing trauma to the natural leaflets of the natural heart valve on the atrial side at the contact point of the atrial arm assembly. Furthermore, in some embodiments, the distal segments of the arms of the ventricular arm assembly extending vertically away from the central axis of the elongated central channel each have a tip that bends toward the ventricular end of the cylindrical portion of at least one supporting structure, thereby reducing trauma to the natural leaflets of the natural heart valve on the ventricular side at the contact point of the ventricular arm assembly.

[0017] In some embodiments, at least one cylindrical portion of the support structure is radially collapsible for transcatheter implantation. Furthermore, the distal segments of the atrial and ventricular arm assemblies extending vertically away from the central axis of the elongated central channel can be elastically straightened.

[0018] In some embodiments, the distal segments of one or more arms of a ventricular arm assembly (e.g., ventricular guide arms) extending vertically away from the central axis of the elongated central channel may extend toward the ventricular end of the cylindrical portion of at least one support structure, such that the distal segments of the ventricular guide arms extending vertically away from the central axis of the elongated central channel can contact a natural leaflet located on the atrial side of the natural heart valve, rather than on the ventricular side, thereby holding the natural leaflet radially outward relative to the natural heart valve in an open position. Constructing the ventricular guide arms to hold the natural leaflet radially outward relative to the natural heart valve in an open position may be useful in many different embodiments. For example, constructing the ventricular guide arms to hold the natural leaflet radially outward relative to the natural heart valve in an open position may be useful in embodiments where it is difficult to capture the natural leaflet by the arm for one reason or another (e.g., if the natural leaflet is too small or restricted). As another example, configuring the ventricular guide arm to hold the natural leaflet radially outward relative to the natural heart valve in an open position can be useful in minimizing the number of echocardiographic planes and / or viewpoints required during implantation of an artificial heart valve (thus simplifying the implantation procedure).

[0019] In some embodiments, the artificial heart valve described herein may further include one or more coverings extending within an elongated central channel and over one or more of the atrial and ventricular arm groups. In some such embodiments, a portion of the one or more coverings may include a fenestration feature. In the implantation configuration where the at least one support structure biodynamically anchors the artificial heart valve to the natural leaflet of a natural heart valve, the fenestration feature may be disposed between the elongated central channel and the natural annulus of the natural heart valve. In some embodiments, the fenestration feature may be at least one of a radiopaque marker, an opening, a magnetic element, a one-way valve, an ejector valve, a mechanically adjustable opening, and increased porosity.

[0020] In some embodiments, the atrial arm assembly of the artificial heart valve may be attached to the ventricular end of the cylindrical portion of the at least one support structure, while the ventricular arm assembly may be attached to the atrial end of the cylindrical portion of the at least one support structure. In other words, in some embodiments, the atrial and ventricular arm assemblies of the artificial heart valve may begin at opposite ends of the cylindrical portion of the at least one support structure. In these embodiments, the one or more covers may begin at and be attached to the distal segment of each arm in the atrial arm assembly, extend to and be attached to the proximal segment of each arm in the ventricular arm assembly, extend through the cylindrical portion of the at least one support structure within an elongated central channel, and extend around the cylindrical portion of the at least one support structure to be attached to the proximal segment of each arm in the atrial arm assembly. In some embodiments, the one or more covers may terminate at and attach to the proximal segment of each arm in the atrial arm group, at a common distance from the cylindrical portion of the at least one support structure. In alternative embodiments, the one or more covers may further extend to and attach to the distal segment of each arm in the ventricular arm group. In some embodiments, the one or more arms may extend asymmetrically or non-circularly within an elongated central channel and on one or more of the atrial and ventricular arm groups.

[0021] In some embodiments, the atrial arm assembly may be attached to the atrial end of the cylindrical portion of the at least one support structure, while the ventricular arm assembly may be attached to the ventricular end of the cylindrical portion of the at least one support structure. In alternative embodiments, such as those mentioned above, the atrial arm assembly may be attached to the ventricular end of the cylindrical portion of the at least one support structure, while the ventricular arm assembly may be attached to the atrial end of the cylindrical portion of the at least one support structure.

[0022] In an embodiment where the atrial arm assembly is attached to the ventricular end of the cylindrical portion of the at least one support structure and the ventricular arm assembly is attached to the atrial end of the cylindrical portion of the at least one support structure, the proximal segment of each arm in the atrial arm assembly extends from the ventricular end of the cylindrical portion of the at least one support structure along the outer surface of the cylindrical portion toward the atrial end of the cylindrical portion of the at least one support structure, and the distal segment of each arm in the atrial arm assembly extends vertically away from the central axis of the elongated central channel. Similarly, the proximal segment of each arm in the ventricular arm assembly extends from the atrial end of the cylindrical portion of the at least one support structure along the outer surface of the cylindrical portion of the at least one support structure toward the ventricular end of the cylindrical portion of the at least one support structure, and the distal segment of each arm in the ventricular arm assembly extends vertically away from the central axis of the elongated central channel.

[0023] In another embodiment where the atrial arm assembly is attached to the ventricular end of the cylindrical portion of the at least one support structure and the ventricular arm assembly is attached to the atrial end of the cylindrical portion of the at least one support structure, the distal end portion of the arm of the atrial arm assembly extending vertically away from the central axis of the elongated central channel may extend from an atrial longitudinal position along the outer surface of the cylindrical portion of the at least one support structure, and the distal end portion of the arm of the ventricular arm assembly extending vertically away from the central axis of the elongated central channel may extend from a ventricular longitudinal position along the outer surface of the cylindrical portion of the at least one support structure, wherein the atrial longitudinal position is closer to the atrial end of the cylindrical portion of the at least one support structure than the ventricular longitudinal position is closer to the atrial end of the cylindrical portion of the at least one support structure.

[0024] In other embodiments where the ventricular arm assembly is attached to the atrial end of the cylindrical portion of the at least one support structure in an implantation configuration where the artificial heart valve is biodynamically secured to the natural leaflet of the natural heart valve by the at least one support structure, the ventricular arm assembly may extend from the atrial end of the cylindrical portion of the at least one support structure, pass through the natural annulus of the natural heart valve, and enter the ventricular side of the natural heart valve to contact the natural leaflet on the ventricular side of the natural heart valve.

[0025] In other embodiments where the atrial arm assembly is attached to the ventricular end of the cylindrical portion of the at least one support structure in an implantation configuration where the artificial heart valve is biodynamically secured to the natural leaflet of the natural heart valve by the at least one support structure, the atrial arm assembly may extend from the ventricular end of the cylindrical portion of the at least one support structure, through the natural annulus of the natural heart valve, and into the atrium of the heart to contact the natural leaflet on the atrial side of the natural heart valve.

[0026] These various embodiments, in which the atrial arm assembly is attached to the ventricular end of the cylindrical portion of the at least one support structure and the ventricular arm assembly is attached to the atrial end of the cylindrical portion of the at least one support structure, are used to provide further overlocking between the atrial and ventricular arms, as described above. Furthermore, these various embodiments, in which the atrial arm assembly is attached to the ventricular end of the cylindrical portion of the at least one support structure and the ventricular arm assembly is attached to the atrial end of the cylindrical portion of the at least one support structure, can improve the distribution of forces received through the atrial and ventricular arms across the entire artificial heart valve, thereby reducing the fragility of the artificial heart valve, and particularly the fragility of the atrial and ventricular arms.

[0027] In some embodiments, the cylindrical portion of the at least one support structure may be a cylindrical cage-like structure with openings. In these embodiments, at least some portions and openings of the cylindrical cage-like structure may be configured to receive bends in the at least one arm of the atrial and ventricular arm assemblies at locations where the arms extend vertically away from the elongated central channel. By configuring the cylindrical portion of the at least one support structure to receive bends in the at least one arm of the atrial and ventricular arm assemblies at locations where the arms extend vertically away from the elongated central channel, the at least one support structure can provide additional support to the atrial and ventricular arm assemblies and can improve the load distribution across the entire artificial heart valve, thereby reducing the fragility of the artificial heart valve, and particularly the fragility of the atrial and ventricular arms. This improved load distribution across the entire artificial heart valve is particularly important in the biodynamic artificial heart valves disclosed herein, because the continuous biodynamic movement of the artificial heart valve and the natural heart valve during the cardiac cycle can increase the load on the artificial heart valve and thus increase the likelihood of its fragility. Furthermore, by providing additional support to the atrial and ventricular arm groups, the arms can be further stabilized when in contact with the leaflets of the natural heart valve, thereby enabling the artificial heart valve to be axially stable within the natural heart valve.

[0028] In some embodiments, an artificial heart valve may include a single support structure. However, in alternative embodiments, to further improve the load distribution of the artificial heart valve, it may include more than one support structure. In such embodiments, the artificial heart valve may include two, three, or more than three support structures. In such multi-support structure embodiments of the artificial heart valve, the multiple support structures may be configured to fit together (e.g., snap-fit) such that one or more of the multiple support structures receive support and load distribution benefits from one or more of the other multiple support structures, as described above. In some embodiments, to configure the multiple support structures of the artificial heart valve to fit together, the minimum inner diameter of the cylindrical portion defining the elongated central channel of at least one support structure may be smaller than the maximum outer diameter of the elongated central channel. In additional embodiments, the minimum diameter of the radius of curvature of each bend of one or more arms of the atrial or ventricular arm assembly at a location where the arm extends vertically away from the central axis of the elongated central channel may be smaller than the maximum outer diameter of the elongated central channel.

[0029] In another aspect, the present invention includes an artificial heart valve having one or more support structures and a valve structure, wherein the one or more support structures define an elongated central channel, and the valve structure is attached to at least one of the one or more support structures and arranged within the elongated central channel for controlling blood flow through the elongated central channel. The at least one of the one or more support structures includes a plurality of arms extending away from the elongated central channel for attaching the at least one support structure to a natural leaflet of a natural heart valve of the heart.

[0030] In some embodiments, the plurality of arms may include an atrial arm group and a ventricular arm group, wherein the atrial arm group extends from the atrial end of the at least one support structure before bending to extend away from the elongated central channel, and the ventricular arm group extends from the ventricular end of the at least one support structure before bending to extend away from the elongated central channel. In some such embodiments, the atrial and ventricular arms may be configured to cooperate to retain the natural leaflets of the natural heart valve, thereby retaining the elongated central channel within the natural annulus of the natural heart valve without requiring direct attachment to the natural valve annulus or the natural cord-like structures associated with the natural heart valve.

[0031] In another aspect, the present invention includes an artificial heart valve having one or more support structures and a plurality of leaflet elements, wherein the one or more support structures define an elongated central channel, and the plurality of leaflet elements are attached to at least one of the one or more support structures and arranged within the elongated central channel. At least one of the one or more support structures is configured to biodynamically anchor the artificial heart valve within and separate it from the natural annulus of the heart's natural heart valve.

[0032] In some embodiments, at least one of the one or more support structures includes a cylindrical portion having an atrial end and a ventricular end. An elongated central channel may be defined by the cylindrical portion of the at least one support structure. Furthermore, the cylindrical portion of the at least one support structure may extend to a maximum radial width smaller than the minimum radial width of the natural annulus of a natural heart valve.

[0033] In some embodiments, in order to biodynamically anchor the artificial heart valve within and separate it from the natural annulus of the natural heart valve, at least one of the one or more support structures of the artificial heart valve is configured to grasp the natural leaflet of the natural heart valve without requiring direct attachment to the natural annulus or the natural cord-like structures associated with the natural heart valve.

[0034] In some implementations, a natural heart valve can be an artificial heart valve.

[0035] In another aspect, the present invention includes a method of 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 channel 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 of the plurality of atrial arms includes a proximal segment at the proximal end of the cylindrical portion of the at least one support structure and a distal segment at the distal end of 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 of the plurality of ventricular arms includes a proximal segment at the proximal end of the cylindrical portion of the at least one support structure and a distal segment at the distal end of the cylindrical portion of the at least one support structure.

[0036] A method for transcatheter implantation of an artificial heart valve includes guiding the artificial heart valve via a patient's vein into the natural valve of the patient's heart while the artificial heart valve is in a contractile configuration. In the contractile configuration: an elongated central channel having an atrial diameter; each of a plurality of ventricular arms being held by a sheath against the outer surface of a cylindrical portion of at least one support structure; and each of the plurality of atrial arms being held within the sheath and against the outer surface of the cylindrical portion of the at least one support structure by a corresponding constraint of a plurality of constraints. The method further includes retracting the sheath to allow each of the plurality of ventricular arms to bend such that the distal portion of each of the plurality of ventricular arms extends away from the cylindrical portion of the at least one support structure. The method further includes retracting the artificial heart valve together with the sheath until the distal portion of each of the plurality of ventricular arms contacts the natural leaflet on the ventricular side of the natural heart valve. The method further includes expanding the cylindrical portion of the at least one support structure from a contractile configuration having an atrial diameter to an expanded configuration having a larger ventricular diameter to form the elongated central channel. The method further includes advancing the plurality of restraints to allow each of the plurality of atrial arms to bend 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 and captures the natural leaflet of the natural heart valve on the atrial side of the natural heart valve against the distal segment of the plurality of ventricular arms, thereby contacting the natural leaflet of the natural heart valve on the ventricular side of the natural heart valve.

[0037] In some embodiments, retracting the sheath to allow each of the plurality of ventricular arms to bend such that the distal portion of each of the plurality of ventricular arms extends away from the cylindrical portion of the at least one support structure also includes allowing each of the plurality of ventricular arms to bend such that the proximal portion of each of the plurality of ventricular arms extends along the outer surface of the cylindrical portion of the at least one support structure. Furthermore, in such embodiments, advancing the plurality of restraints to allow each of the plurality of atrial arms to bend such that the distal portion of each of the plurality of atrial arms extends away from the cylindrical portion of the at least one support structure may also include allowing each of the plurality of atrial arms to bend such that the proximal portion of each of the plurality of atrial arms extends along the outer surface of the cylindrical portion of the at least one support structure.

[0038] In some embodiments, the method may further include separating the plurality of restraints from the plurality of atrial arms.

[0039] In some embodiments, the method may further include repositioning the artificial heart valve within the natural heart valve by retracting the plurality of restraints from the plurality of atrial arms to straighten each of the plurality of atrial arms against the outer surface of the cylindrical portion of the at least one support structure to release the natural leaflet of the natural heart valve, while simultaneously pushing the at least one support structure toward the ventricular side of the natural heart valve with the plurality of expansion arms.

[0040] In some embodiments, the method may further include recapturing and removing the artificial heart valve from the natural heart valve by advancing the sheath to straighten each of the plurality of ventricular arms and compressing the cylindrical portion of the at least one support structure for removing the artificial heart valve from the natural heart valve via a vein in the patient while the artificial heart valve is in a contractile configuration.

[0041] In some embodiments, advancing the plurality of constraints may include advancing the constraints while simultaneously maintaining contact with the at least one support structure via a plurality of expansion arms.

[0042] In some embodiments, the plurality of expansion arms may extend from an intermediate layer within the sheath. In some embodiments, each of the plurality of restraints may extend from the sheath between a pair of expansion arms. In some embodiments, each of the plurality of expansion arms may include an interlocking mechanism that maintains contact with the atrial end of the cylindrical portion of the at least one support structure. Attached Figure Description

[0043] The accompanying drawings, which are included to provide a further understanding of the specification and are incorporated in and form part of this specification, illustrate the disclosed embodiments and, together with the description, serve to explain the principles of the disclosed embodiments. In the drawings:

[0044] Figure 1 This is a schematic perspective view of a support structure for an artificial heart valve according to an embodiment.

[0045] Figure 2 This is a schematic cross-sectional perspective view of an artificial heart valve according to an embodiment.

[0046] Figure 3 This is another schematic cross-sectional perspective view of an artificial heart valve according to an embodiment.

[0047] Figures 4 to 8 The illustration shows artificial heart valves at various implantation stages according to various embodiments.

[0048] Figures 9 to 12 The illustration shows artificial heart valves at various removal stages according to various embodiments.

[0049] Figure 13 The illustration shows a top view of an artificial heart valve according to an embodiment.

[0050] Figure 14 The illustrations depict various implantation routes for artificial heart valves according to embodiments.

[0051] Figure 15 and Figure 16 The illustration shows a portion of a support structure for an artificial heart valve according to an embodiment.

[0052] Figure 17 This is another schematic cross-sectional perspective view of an artificial heart valve according to an embodiment.

[0053] Figure 18 This is another schematic cross-sectional perspective view of an artificial heart valve according to an embodiment.

[0054] Figure 19 The illustration shows another example support structure for an artificial heart valve according to an embodiment.

[0055] Figure 20 The illustration shows various forces that can be applied during the implantation of an artificial heart valve according to an embodiment.

[0056] Figure 21 and Figure 22 The illustrations show various implementations of a portion of a support structure for an artificial heart valve according to embodiments.

[0057] Figure 23 The illustrations depict various delivery structures for artificial heart valves according to embodiments.

[0058] Figure 24 The illustration shows a side view of a pair of arms extending from the cylindrical portion of the support structure of the artificial heart valve, according to an embodiment.

[0059] Figure 25 and Figure 26 Various views of the nasal cone and guidewire for implantation of an artificial heart valve are illustrated according to embodiments.

[0060] Figures 27 to 30 The illustration shows various aspects of an artificial heart valve with another support structure according to an embodiment.

[0061] Figures 31 to 34 Other aspects of the artificial heart valve contemplated herein according to embodiments are illustrated.

[0062] Figure 35The illustration shows a perspective view of a support structure for an artificial heart valve connected to a delivery system, according to an embodiment.

[0063] Figure 36 The illustrations depict various aspects of the subject matter art according to the embodiments. Figure 35 A three-dimensional view of the expansion arm.

[0064] Figure 37 The illustration shows a larger perspective view of a support structure for an artificial heart valve connected to a delivery system, according to an embodiment and various aspects of the subject matter.

[0065] Figure 38 The illustration shows a perspective view of a portion of the intermediate layer of a delivery system for an artificial heart valve according to an embodiment.

[0066] Figure 39 The illustration shows a perspective view of an artificial heart valve connected to a delivery system according to an embodiment.

[0067] Figure 40 The illustration shows a partial transparent perspective view of a support structure for an artificial heart valve connected to a delivery system, according to an embodiment.

[0068] Figure 41 The illustration shows a perspective view of a support structure for an artificial heart valve before a bend is formed in an arm extending from a cylindrical portion, according to an embodiment.

[0069] Figure 42A The illustration shows an artificial tricuspid valve, according to an embodiment, being implanted into the heart's natural tricuspid valve during ventricular diastolic filling.

[0070] Figure 42B The illustration shows an artificial tricuspid valve, according to an embodiment, implanted into the heart's natural tricuspid valve during ventricular systole.

[0071] Figure 43A The illustration shows another implementation of a support structure for an artificial tricuspid valve in a contracted configuration that defines an elongated central channel with a first diameter, according to an embodiment.

[0072] Figure 43B The illustration shows another implementation of a support structure for an artificial tricuspid valve in an extended configuration that defines an elongated central channel having a second diameter greater than the first diameter.

[0073] Figure 44A The illustration shows a view of a flat support structure for an artificial tricuspid valve with a support structure according to an embodiment.

[0074] Figure 44BThe illustration shows a side view of an artificial tricuspid valve having a support structure and configured for implantation into a natural tricuspid valve, according to an embodiment.

[0075] Figure 45A The illustration shows a CAD drawing of a side view of an artificial tricuspid valve with a support structure according to an embodiment.

[0076] Figure 45B The illustration shows a CAD drawing of a top view of an artificial tricuspid valve with a support structure according to an embodiment.

[0077] Figure 45C The illustration shows a CAD drawing of an inclined side view of an artificial tricuspid valve with a support structure according to an embodiment.

[0078] Figure 45D The illustration shows a CAD drawing of a side view of an artificial tricuspid valve with a support structure according to an embodiment.

[0079] Figure 46A The illustration shows a view of a flat support structure for an artificial tricuspid valve with two support structures according to an embodiment.

[0080] Figure 46B The illustration shows a side view of an artificial tricuspid valve having two support structures and configured for implantation into a natural tricuspid valve, according to an embodiment.

[0081] Figure 47A The illustration shows a CAD drawing of an inclined side view of the support structure of an artificial tricuspid valve with two support structures according to an embodiment.

[0082] Figure 47B The illustration shows a CAD drawing of an inclined side view of the support structure of an artificial tricuspid valve with two support structures according to an embodiment.

[0083] Figure 47C The illustration shows a CAD drawing of a side view of an artificial tricuspid valve with two support structures according to an embodiment.

[0084] Figure 47D The illustration shows a CAD drawing of a top view of an artificial tricuspid valve with two support structures according to an embodiment.

[0085] Figure 47E The illustration shows a CAD drawing of an inclined side view of an artificial tricuspid valve with two support structures according to an embodiment.

[0086] Figure 47F The illustration shows a CAD drawing of another side view of an artificial tricuspid valve with two support structures according to an embodiment.

[0087] Figure 48AThe illustration shows a view of a flat support structure for an artificial tricuspid valve with two support structures according to an embodiment.

[0088] Figure 48B The illustration shows a side view of an artificial tricuspid valve having two support structures and configured for implantation into a natural tricuspid valve, according to an embodiment.

[0089] Figure 49A The illustration shows a CAD drawing of an inclined side view of the support structure of an artificial tricuspid valve with two support structures according to an embodiment.

[0090] Figure 49B The illustration shows a CAD drawing of an inclined side view of the support structure of an artificial tricuspid valve with two support structures according to an embodiment.

[0091] Figure 49C The illustration shows a CAD drawing of a side view of an artificial tricuspid valve with two support structures according to an embodiment.

[0092] Figure 49D The illustration shows a top view CAD drawing of an artificial tricuspid valve with two support structures according to an embodiment.

[0093] Figure 49E The illustration shows a CAD drawing of an inclined side view of an artificial tricuspid valve with two support structures according to an embodiment.

[0094] Figure 49F The illustration shows a CAD drawing of another side view of an artificial tricuspid valve with two support structures according to an embodiment.

[0095] Figure 50A The illustration shows a view of a flat support structure for an artificial tricuspid valve with two support structures according to an embodiment.

[0096] Figure 50B The illustration shows a side view of an artificial tricuspid valve having two support structures and configured for implantation into a natural tricuspid valve, according to an embodiment.

[0097] Figure 51A The illustration shows a CAD drawing of an inclined side view of the support structure of an artificial tricuspid valve with two support structures according to an embodiment.

[0098] Figure 51B The illustration shows a CAD drawing of an inclined side view of the support structure of an artificial tricuspid valve with two support structures according to an embodiment.

[0099] Figure 51C The illustration shows a CAD drawing of a side view of an artificial tricuspid valve with two support structures according to an embodiment.

[0100] Figure 51D The illustration shows a CAD drawing of a top view of an artificial tricuspid valve with two support structures according to an embodiment.

[0101] Figure 51E The illustration shows a CAD drawing of an inclined side view of an artificial tricuspid valve with two support structures according to an embodiment.

[0102] Figure 51F The illustration shows a CAD drawing of another side view of an artificial tricuspid valve with two support structures according to an embodiment.

[0103] Figure 52A The illustration shows a view of a flat support structure for an artificial tricuspid valve with three support structures according to an embodiment.

[0104] Figure 52B The illustration shows a side view of an artificial tricuspid valve having three support structures and configured for implantation into a natural tricuspid valve, according to an embodiment.

[0105] Figure 53A The illustration shows a CAD drawing of an inclined side view of the support structure of an artificial tricuspid valve with three support structures according to an embodiment.

[0106] Figure 53B The illustration shows a CAD drawing of an inclined side view of the support structure of an artificial tricuspid valve with three support structures according to an embodiment.

[0107] Figure 53C The illustration shows a CAD drawing of an inclined side view of the support structure of an artificial tricuspid valve with three support structures according to an embodiment.

[0108] Figure 53D The illustration shows a CAD drawing of a side view of an artificial tricuspid valve with three support structures according to an embodiment.

[0109] Figure 53E The illustration shows a CAD drawing of a top view of an artificial tricuspid valve with three support structures according to an embodiment.

[0110] Figure 53F The illustration shows a CAD drawing of an inclined side view of an artificial tricuspid valve with three support structures according to an embodiment.

[0111] Figure 53G The illustration shows a CAD drawing of another side view of an artificial tricuspid valve with three support structures according to an embodiment.

[0112] Figure 54A The illustration shows a side view of the overbite between the atrial and ventricular arms of an artificial tricuspid valve at rest, according to an embodiment.

[0113] Figure 54B The illustration shows a side view of the atrial and ventricular arms of the artificial tricuspid valve when the artificial tricuspid valve is implanted into the natural tricuspid valve, according to an embodiment.

[0114] Figure 55 The illustration shows a CAD drawing of a cross-sectional side view of an artificial tricuspid valve with three support structures according to an embodiment.

[0115] Figure 56A It is a top view of an image of the original artificial tricuspid valve, which is placed on paper according to the embodiment and oriented substantially perpendicular (e.g., 90° + / - 45°) to the central axis of the elongated central channel of the artificial tricuspid valve.

[0116] Figure 56B It is a bottom view of an image of the original artificial tricuspid valve, which is placed on paper according to the embodiment and oriented substantially perpendicular (e.g., 90° + / - 45°) to the central axis of the elongated central channel of the artificial tricuspid valve.

[0117] Figure 56C It is a side view of an image of the original artificial tricuspid valve, which is placed on paper according to the embodiment and oriented substantially perpendicular (e.g., 90° + / - 45°) to the central axis of the elongated central channel of the artificial tricuspid valve.

[0118] Figure 57 This is a bottom view of the original artificial tricuspid valve image according to the implementation method.

[0119] Figure 58 The illustration shows a CAD drawing of an inclined side view of an artificial tricuspid valve with three support structures according to an embodiment.

[0120] Figure 59 The illustration shows a view of the flat support structure of an artificial tricuspid valve according to an embodiment.

[0121] Figure 60 The diagram illustrates the loading, locking, and releasing of the interlocking mechanism of the support structure of the artificial tricuspid valve according to an embodiment.

[0122] Figure 61 The illustration shows a view of a flat support structure configured to form the ventricular arm of an artificial tricuspid valve according to an embodiment.

[0123] Figure 62A This is an image of the original support structure of the ventricular arm that forms the artificial tricuspid valve according to the embodiment.

[0124] Figure 62B This is an image of the original support structure for forming the ventricular arm and ventricular guide arm of the artificial tricuspid valve according to the embodiment.

[0125] Figure 63AThe illustration shows a top view of a CAD drawing of the support structure for forming the ventricular arm of an artificial tricuspid valve according to an embodiment.

[0126] Figure 63B The illustration shows a side view of a CAD drawing of the support structure for forming the ventricular arm of an artificial tricuspid valve according to an embodiment.

[0127] Figure 64A The illustration shows a top view of a CAD drawing of the support structure for forming the ventricular arm and ventricular guide arm of an artificial tricuspid valve according to an embodiment.

[0128] Figure 64B The illustration shows a side view of a CAD drawing of the support structure for forming the ventricular arm and ventricular guide arm of an artificial tricuspid valve according to an embodiment.

[0129] Figure 65 The illustration shows a view of a flat support structure configured to form the atrial arm of an artificial tricuspid valve according to an embodiment.

[0130] Figure 66 The illustration shows a CAD drawing of a side view of an artificial tricuspid valve according to an embodiment.

[0131] Figure 67A The illustration shows a side view of a relatively small amount of overbite between the atrial and ventricular arms of an artificial tricuspid valve according to an embodiment.

[0132] Figure 67B The illustration shows a side view of the relative amount of overbite between the atrial and ventricular arms of an artificial tricuspid valve according to an embodiment.

[0133] Figure 67C The illustration shows a side view of the relatively large overbite between the atrial and ventricular arms of an artificial tricuspid valve according to an embodiment.

[0134] Figure 68A The illustration shows a symmetrical implementation of the atrial sealing skirt according to an embodiment.

[0135] Figure 68B The illustration shows an asymmetric implementation of the atrial sealing skirt according to an embodiment.

[0136] Figure 69A This is a bottom view image of the support structure of the original artificial tricuspid valve according to the embodiment.

[0137] Figure 69B This is an image of the side view of the support structure of the original artificial tricuspid valve according to the embodiment.

[0138] Figure 70A This is a bottom view image of the support structure of the original artificial tricuspid valve according to the embodiment.

[0139] Figure 70B This is an image of the side view of the support structure of the original artificial tricuspid valve according to the embodiment.

[0140] Figure 71 This is a top view image of the support structure of the original artificial tricuspid valve according to the embodiment.

[0141] Figure 72A This is a top view image of the support structure of the original artificial tricuspid valve according to the embodiment.

[0142] Figure 72B This is an image of the side view of the support structure of the original artificial tricuspid valve according to the embodiment.

[0143] Figure 73 The illustration shows an atrial sealing skirt including a ventricular arm sleeve according to an embodiment, the ventricular arm sleeve being configured to encapsulate the ventricular arm of the support structure.

[0144] Figure 74 This is an image of a side view of the original artificial tricuspid valve according to the implementation method.

[0145] Figure 75 The illustration shows the load distribution for an artificial tricuspid valve having a support structure according to an embodiment.

[0146] Figure 76 The illustration shows the load distribution for an artificial tricuspid valve with two support structures according to an embodiment.

[0147] Figure 77 The illustration shows the load distribution for an artificial tricuspid valve with two support structures according to an embodiment.

[0148] Figure 78 The illustration shows the load distribution for an artificial tricuspid valve with two support structures according to an embodiment.

[0149] Figure 79 The illustration shows the load distribution for an artificial tricuspid valve with three support structures according to an embodiment.

[0150] Figure 80 The illustration shows a CAD drawing of a cross-sectional side view of an artificial tricuspid valve according to an embodiment. Detailed Implementation

[0151] The detailed description below describes various configurations of the subject matter and is not intended to represent only configurations of the subject matter that can be practiced. The detailed description includes specific details to provide a thorough understanding of the subject matter. Therefore, dimensions regarding certain aspects may be provided as non-limiting examples. However, it will be apparent to those skilled in the art that the subject matter can be practiced without these specific details. In some cases, well-known structures and components are shown in block diagram form to avoid confusion with the concepts of the subject matter.

[0152] It should be understood that this disclosure includes examples of the subject matter and does not limit the scope of the appended claims. Various aspects of the subject matter will now be disclosed based on specific, but not limiting, examples. The various embodiments described in this disclosure can be implemented in different ways and variations, and depending on the desired application or implementation.

[0153] In the following detailed description, numerous specific details are set forth 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 have not been shown in detail so as not to obscure this disclosure.

[0154] Because aortic and mitral valve replacements are typically the focus of device development, the need for solutions to tricuspid regurgitation (TR) remains unresolved. In particular, given the growing evidence linking TR to higher mortality rates, TR should not be left untreated even if other heart valves have been treated.

[0155] Like the mitral valve, the tricuspid valve is located in the atrioventricular position. Therefore, it is expected that mitral valve replacement can be repurposed for the tricuspid valve position. However, specific aspects of the tricuspid valve anatomy and surrounding anatomy (such as the larger size of the tricuspid valve and its proximity to the conduction zone of the heart) make dedicated solutions more advantageous than such repurposed mitral valve devices.

[0156] According to various aspects of this disclosure, this document provides a biodynamic artificial tricuspid valve. As mentioned herein, the term "biodynamic" with respect to an artificial tricuspid valve means that the configuration of the artificial tricuspid valve allows it to remain axially stable within the natural tricuspid valve of the heart without direct attachment to the natural annulus or cords of the natural tricuspid valve, while allowing it to move within the natural tricuspid valve in response to alternating pressure gradients across the natural heart valve during the cardiac cycle, thereby preserving the natural motion of the natural annulus. Specifically, the artificial tricuspid valve is axially stable within the natural tricuspid valve by gripping the natural leaflets of the natural tricuspid valve rather than by annular forces or direct annular or cord attachment. As referred to herein, the term "axially stable" with respect to an artificial tricuspid valve located within the natural tricuspid valve means that a portion of the artificial tricuspid valve is inserted between any two diametrically opposed points on the natural annulus of the natural tricuspid valve.

[0157] An artificial tricuspid valve includes one or more support structures. For example, as discussed in further detail below, an artificial tricuspid valve may include one, two, three, or more than three 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 channel of the artificial tricuspid valve. The central axis of the elongated central channel extends within the elongated central channel from the atrial end of the cylindrical portion to the ventricular end of the cylindrical portion. When the artificial tricuspid valve is in implantation configuration in a natural tricuspid valve, blood flows from the atria of the heart through the elongated central channel of the artificial tricuspid valve to the ventricles of the heart along the central axis of the elongated central channel. In addition, a plurality of leaflet elements are attached to at least one support structure and disposed within the elongated central channel to control blood flow through the elongated central channel.

[0158] A ventricular arm extending from a first end of the cylindrical portion of at least one support structure extends into the ventricle of the heart to contact the ventricular surface of the natural leaflet, while an atrial arm extending from a second end opposite to the first end of the cylindrical portion of at least one support structure extends into the atrium to contact the atrial surface of the natural leaflet. Various features of the prosthetic tricuspid valve facilitate transcatheter implantation, repositioning, and / or removal of the valve. The prosthetic tricuspid valve described herein can be easily positioned and deployed in a wide variety of patients, and such a prosthetic tricuspid valve possesses the ability to control deployment, assess full function, and retain the ability to be recaptured and removed before complete release.

[0159] Although various examples of artificial tricuspid valves constructed for replacement of natural tricuspid valves are described herein, it should be understood that suitable modifications can be made for use with the artificial tricuspid valves disclosed herein to replace other natural heart valves, and / or modifications can be made in any other non-heart valve.

[0160] Figure 1 An example artificial tricuspid valve 100 according to various aspects of this disclosure is illustrated. Figure 1 In the example, the artificial 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 positioned within the atria of the heart and a ventricular end 120 configured to be positioned within the ventricles of the heart. Figure 1 The central axis of the elongated central channel 104 is depicted with a dashed line, along which blood flows from the atria of the heart to the ventricles.

[0161] Although the cylindrical portion 116 is shown as a solid cylindrical structure, it should be understood that the cylindrical portion 116 is formed of other structures, such as radially expandable and compressible cylindrical cage structures having openings that can be expandable or self-expanding balloons. In these embodiments, the cylindrical cage structure can be made of laser-cut metal, polymer tubing, and / or wire-formed materials. In this example, some of the openings ( Figure 1 Not shown in the image, see [link / reference]. Figure 15 , Figure 16 , Figure 21 or Figure 22 The arm 106 can be positioned to receive one or more bends as described below in order to maintain consistency and symmetry during loading and recapture of the artificial tricuspid valve 100, and / or to allow the load to be distributed from one or more arms 106 to the entire support structure 102 of the artificial tricuspid valve 100. In various implementations of the structure, the cylindrical portion 116 is radially collapsible (e.g., collapses into an elongated central channel 104) for transcatheter implantation.

[0162] The cylindrical portion 116 is smaller than the natural tricuspid valve annulus size so as not to exert any radial force on the annulus. Specifically, in Figure 1In the examples and various other examples described herein, the cylindrical portion 116 may extend to a maximum radial width less than the minimum radial width of the natural annulus of the natural tricuspid valve. As detailed below, the arm 106 is configured to engage to retain the natural annulus of the natural tricuspid valve, thereby holding the elongated central channel 104 within the natural annulus of the natural tricuspid valve without requiring direct attachment to the natural annulus or cord-like structure, such that the artificial tricuspid valve 100 is biodynamically secured within and separated from the natural annulus of the natural tricuspid valve. However, it should be understood that certain portions of the artificial tricuspid valve 100 may extend into or beyond the natural annulus. For example, and as discussed further in detail below, the artificial tricuspid valve 100 may include an atrial sealing skirt that extends into or beyond the natural annulus for anchoring and / or extends to completely cover the commissure of the natural tricuspid valve to prevent leakage.

[0163] Cylindrical section 116 in Figure 1 While depicted as having a circular cross-section, it should be understood that the cylindrical portion 116 may have a generally cylindrical shape without a perfectly circular cross-section. For example, the cylindrical portion 116 may have a circular or non-circular cross-section (e.g., D-shaped, triangular, elliptical, or any other cross-sectional geometry) and may be configured such that one prosthetic tricuspid valve size is suitable for all patients (e.g., having different sizes only for arm 106 and the atrial sealing skirt, which will be described below) or a range of prosthetic tricuspid valve sizes are available depending on the patient's anatomy.

[0164] Despite Figure 1 Although not shown, multiple leaflet elements can be attached to the support structure 102 and arranged within the elongated central channel 104 to control blood flow through the elongated central channel. Once the artificial tricuspid valve 100 is installed, these leaflet elements will replace the function of the natural leaflets.

[0165] like Figure 1 As shown, the artificial tricuspid valve 100 is fixed to the natural leaflet of the natural tricuspid valve using multiple ventricular arms 106-1 and atrial arms 106-2. The artificial tricuspid valve 100 is biodynamically fixed within and separated from the natural annulus of the natural tricuspid valve. Specifically, the multiple ventricular arms 106-1 extend from the first end of the cylindrical portion 116 of the support structure 102 and contact the ventricular side of the natural leaflet of the natural tricuspid valve. Similarly, the multiple atrial arms 106-2 extend from the second end of the cylindrical portion 116 of the support structure 102 opposite to the first end and contact the atrial side of the natural leaflet of the natural tricuspid valve. Figure 1 As shown, the atrial arm 106-1 can alternate with the ventricular arm 106-2 around the circumference of the cylindrical portion 116 of the support structure 102.

[0166] Each arm 106 includes a proximal section and a distal section. The proximal section of each arm 106 is close to the cylindrical portion 116 of the support structure 102. Specifically, the proximal section of each arm 106 is the portion of the arm 106 attached to the cylindrical portion 116 of the support structure 102. The proximal section of each arm 106 extends from its attachment point at the cylindrical portion 116 along the outer surface 147 of the cylindrical portion 116 and terminates at (and includes) a second bend that guides the distal section of the arm away from the central axis of the central channel 104 and perpendicular to the central axis of the elongated central channel 104. The second bend guides the distal section of the arm away from the central axis of the central channel 104 and perpendicular to the central axis of the elongated central channel 104 at a longitudinal position along the outer surface 147 of the cylindrical portion 116. In some embodiments (e.g., Figure 1 In an embodiment of the artificial tricuspid valve 100, the proximal segment of each arm 106 also includes an initial bend that guides the proximal segment of the arm 106 along the outer surface 147 of the cylindrical portion 116.

[0167] Each atrial arm 106-1 has a proximal segment 112, and each ventricular arm 106-2 has a proximal segment 108. (As...) Figure 1 As shown and discussed in further detail below, the optional initial curvature of the proximal segment 112 of each atrial arm 106-1 is an initial curvature 128, and the second curvature of the proximal segment 112 of each atrial arm 106-1 is a second curvature 130. Similarly, the optional initial curvature of the proximal segment 108 of each ventricular arm 106-2 is an initial curvature 124, and the second curvature of the proximal segment 108 of each ventricular arm 106-2 is a second curvature 126.

[0168] The distal segment of each arm 106 is located at the distal end of the cylindrical portion 116 of at least one support structure 102. Specifically, the distal segment of each arm 106 is the portion of the arm 106 that contacts a target (e.g., the natural leaflet of a natural tricuspid valve). The distal segment of the arm 106 contacts the target (e.g., the natural leaflet of a natural tricuspid valve) at a contact point along the distal segment of the arm 106. The distal segment of each arm 106 extends from (and does not include) the second bend of the arm 106, extends away from the central axis of the central channel 104 and perpendicular to the central axis of the elongated central channel 104, and terminates at (and includes) a tip. As mentioned above, the distal segment of the arm extends from a longitudinal position along the outer surface 147 of the cylindrical portion 116 away from the central axis of the central channel 104 and perpendicular to the central axis of the elongated central channel 104.

[0169] In the following text about Figure 24In some embodiments discussed in detail, the distal segment of each arm may include an extension 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 discussed in further detail below, the tip of the distal segment 114 of each atrial arm 106-1 is a tip 142, and the tip of the distal segment 110 of each ventricular arm 106-2 is a tip 140.

[0170] exist Figure 1 In the example, 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 at 180° + / - 45°, which guides the proximal segment 108 of the ventricular arm 106-2 along the outer surface 147 of the cylindrical portion 116, through the natural valve annulus (outside the elongated central channel 104), and fully toward the ventricular end 120. Then, a second bend 126 in the proximal segment 108 of the ventricular arm 106-2, and the distal segment 110 of the ventricular arm 106-2 extend from a longitudinal position along the outer surface 147 of the cylindrical portion 116 away from the central axis of the elongated central channel 104 and perpendicular to the central axis of the elongated central channel 104.

[0171] Figure 1 It is also shown how the proximal segment 112 of each atrial arm 106-1 extends from the ventricular end 120 of the cylindrical portion 116 and has an initial bend 128 of 180° + / - 45°, which guides the proximal segment 112 of the atrial arm 106-1 along the outer surface 147 of the cylindrical portion 116, through the natural valve annulus (outside the elongated central channel 104), and sufficiently toward the atrial end 118 of the cylindrical portion 116. Then, a second bend 130 located in the proximal segment 112 of the atrial arm 106-1, and a distal segment 114 of the atrial arm 106-1, extend from a longitudinal position along the outer surface 147 of the cylindrical portion 116 away from the central axis of the central channel 104 and perpendicular to the central axis of the elongated central channel 104. As described above, in some embodiments, the proximal segment of one or more arms 106 does not include the initial bend.

[0172] As described above, the distal end segment of each arm 106 extends vertically away from the central axis of the elongated central channel 104 for attaching the support structure 102 to the natural leaflet of the natural tricuspid valve. As mentioned herein, "vertically" extending the distal end segment of the arm 106 away from the central axis of the elongated central channel 104 means that the distal end segment of the arm 160 extends away from the central axis of the elongated central channel 104 such that a line drawn from the point of contact between the distal end segment and the target (e.g., the natural tricuspid leaflet) to a longitudinal position along the outer surface 147 of the cylindrical portion 116 of at least one support structure 102 from which the distal end segment extends is oriented at approximately 90° + / - 45° to the central axis of the elongated central channel 104. In some embodiments, the contact point of the distal end segment of the arm 106 may be the tip 140 or 142 of the arm 106. In an alternative embodiment where the distal segment of arm 106 includes an extension segment with a third bend, the contact point of the distal segment of arm 106 may be the extension segment of arm 106, or more specifically, the third bend of arm 106. The contact point of the distal segment of arm 106 may also be any other portion of the distal segment of arm 106. As discussed in further detail below, this approximately perpendicular line from the contact point of the distal segment to a longitudinal position along the outer surface 147 of the cylindrical portion 116 from which the distal segment extends enables the artificial tricuspid valve to be axially stable within the natural tricuspid valve.

[0173] The distal segments 114 of each atrial arm 106-1 extending vertically away from the central axis of the elongated central channel 104 and the distal segments 110 of each ventricular arm 106-2 extending vertically away from the central axis of the elongated central channel 104 are resiliently straightened (e.g., abutting against the outer surface 147 of the cylindrical portion 116 of the support structure 102) with or without extending beyond the length of the cylindrical portion 116. In this way, the artificial tricuspid valve 100 is configured with a reduced length to navigate bends or curves along the patient's insertion path (e.g., the patient's vascular system (e.g., veins or arteries) and into the heart).

[0174] exist Figure 1 In the example, ventricular arm 106-2 extends from the atrial end 118 of the cylindrical portion 116, atrial arm 106-1 extends from the ventricular end 120 of the cylindrical portion 116, and the relative positions of the second bend 126 and the second bend 130 are such that 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 Figure 1In the example, the atrial arm 106-1 and the ventricular arm 106-2 extend through the cross-sectional plane of the cylindrical portion 116 of at least one support structure 102 such that there is an overbite between the atrial arm 106-1 and the ventricular arm 106-2 in the cross-sectional plane. As mentioned herein, the “cross-sectional plane” with respect to the cylindrical portion of the at least one support structure is the cross-sectional plane of the cylindrical portion of the at least one support structure perpendicular to the central axis of the elongated central channel defined by the cylindrical portion of the at least one support structure. Due to this overbite between the atrial arm 106-1 and the ventricular arm 106-2 in vivo, the ventricular arm 106-2 extending downward from the atrial end 118 of the cylindrical portion 116 extends into the ventricle of the heart to contact the ventricular surface of the natural leaflet, while the atrial arm 106-1 extending upward from the ventricular end 120 of the cylindrical portion 116 extends into the atrium of the heart to contact the atrial surface of the natural leaflet.

[0175] Furthermore, in some embodiments, the relative bending angles of the second bend 126 and the second bend 130 may each be slightly greater than 90° or both may 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 also facilitates the overbite-overbite of the atrial arms 106-1 and ventricular arms 106-2 as described above. During implantation, this overbite-overbite of the atrial arms 106-1 and ventricular arms 106-2 will result in additional clamping action and further tension of the natural leaflet, as the distal segment 114 of the atrial arm 106-1 on the atrial side of the natural leaflet will be 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 natural leaflet will be actively pushed upward toward the atrium of the heart, thereby effectively creating a pleated effect like a collar in the natural leaflet. The tension effect of opposing forces from either side of the natural leaflet will help stabilize the artificial tricuspid valve 100 axially within the natural tricuspid valve.

[0176] Secured to either side of the natural leaflet in this manner, the artificial tricuspid valve 100 also creates a trampoline effect, where the ventricular systolic pressure load can be partially absorbed by the upward (atrial) movement and tension of the natural leaflet. Specifically, in this example, arm 106 is bent such that when the cylindrical portion 116 of the support structure 102 moves toward the atrial side 118 of the natural tricuspid valve (e.g., due to the ventricular systolic pressure load), the ventricular arm 106-2 resists movement while the atrial arm 106-1 relaxes to maintain atrial side contact with the natural leaflet. Furthermore, when the cylindrical portion 116 of the support structure 102 moves toward the ventricular side 120 of the natural tricuspid valve, the atrial arm 106-1 resists movement while the ventricular arm 106-2 relaxes to maintain ventricular side contact with the natural leaflet. Furthermore, due to the trampoline effect, the forces from the distal segments 110 of the ventricular side of each ventricular arm 106-2 abutting against the natural leaflet can be further distributed throughout the atrial sealing skirt to minimize the risk of erosion through the natural leaflet. In this way, the artificial tricuspid valve 100 is biodynamically secured within the natural tricuspid valve during the cardiac cycle.

[0177] It should be understood that, although the tip 140 of arm 106-2 and the tip 142 of arm 106-1 are... Figure 1 While depicted as having a square cross-section, in other embodiments, the cross-sectional configuration of the tip 140 of arm 106-2 and the tip 142 of arm 106-1 may have a circular or other non-circular shape (e.g., to provide improved attachment and / or leak-proofing, for example, in the presence of an atrial sealing skirt, as discussed further in detail below). The relative lengths of the distal segment 114 of atrial arm 106-1 and / or the distal segment 110 of ventricular arm 106-2 may also be modified for improved attachment and / or leak-proofing.

[0178] Figure 2 An example of a cover 200 that can be disposed on a support structure 102 is shown. The cover 200 may be made of artificial biological tissue (e.g., bovine, porcine, etc.) or may be made of synthetic materials (e.g., polyurethane, ePTFE, proprietary hydrogel materials, etc.). As shown, the cover 200 may include a cylindrical portion 202 defining an elongated central channel 104, to which an artificial leaflet element (not shown) may be attached. The cover 200 may also include an atrial sealing skirt 204 that extends at the atrial end 118 of the support structure 102 and at least partially on the atrial arm 106-1.

[0179] The atrial sealing skirt 204 also facilitates the recapture property of the artificial tricuspid valve 100. For example, reducing the length of the atrial arm 106-1 while maintaining contact with the atrial end 118 of the cylindrical portion 116 of the support structure 102 allows the atrial sealing skirt 204 to be folded, and allows the outer sheath (see reference) to be folded. Figure 4 The 406) is advanced toward the ventricular side of the natural tricuspid valve in order to recapture the ventricular arm 106-2 which is in contact with the ventricular side of the natural leaflet of the natural tricuspid valve, and to completely reposition or remove the implant before final release.

[0180] In these examples, a portion of the atrial side of the atrial sealing skirt 204, relatively close to the natural tricuspid valve, may be attached to the proximal segment 108 of each ventricular arm 106-2 (e.g., see reference). Figure 3 Furthermore, a portion of the atrial sealing skirt 204, relatively distant from the natural tricuspid valve on the atrial side, can be attached to the distal segment 114 of each atrial arm 106-1. The cover 200 can extend downward within the elongated central channel 104 through the cylindrical portion 116 of the support structure 102. Figure 2 and Figure 3 In one example, the downward extension of the cover 200 through the cylindrical portion 116 of the support structure 102 to help define the portion 202 of the elongated central channel 104 terminates at or near the ventricular end 120 of the cylindrical portion 116. However, in some implementations (see, for example...) Figure 17 and Figure 18 The cover 200 surrounds 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 before 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 “band” atrial sealing skirt 204 on the atrial end 118 of the cylindrical portion 116 of the support structure 102, which helps to form a seal and also serves as a support for pressure on the ventricular arms 106-2 from the ventricular side of the natural tricuspid leaflet and prevents the ventricular arms 106-2 from eroding through the natural leaflet. The atrial sealing skirt 204 can extend to or beyond the natural annulus of the natural tricuspid valve for anchoring and to fully cover the commissure of the natural tricuspid valve for adequate leakage prevention.

[0181] In various examples, the atrial sealing skirt 204 may begin at the distal segment 114 of each atrial arm 106-1 and attach to the distal segment of each atrial arm, then switch to attach to the proximal segment 108 of each ventricular arm 106-2, then extend downward around the proximal segment 112 of each atrial arm 106-1 through the elongated central channel 104, or terminate before the second bend 130 of each atrial arm 106-1 (e.g., along the proximal segment of each atrial arm 106-1 at a common distance from the cylindrical portion 116), or in various implementations extend further to the distal segment 110 of each ventricular arm 106-2 before termination.

[0182] In some embodiments, the cover 200 may extend asymmetrically or non-circularly within the elongated central channel 104 and over one or more of the atrial arms 106-1 and / or ventricular arms 106-2. For example, in some implementations, the cover 200 may extend in a “D-shape” within the elongated central channel 104 and over one or more of the atrial arms 106-1 and / or ventricular arms 106-2.

[0183] Figure 3 It also shows how the artificial tricuspid valve 100 can be included in the fenestration feature 300 within a portion of the cover 200 (see also...). Figure 13 The fenestration feature 300 may include, for example, radiopaque markers, openings, magnetic elements, one-way valves, pop-out valves, mechanically adjustable openings, and increased porosity. In the implantation configuration where the artificial tricuspid valve 100 is biodynamically secured to the natural leaflet of the natural tricuspid valve in the support structure 102, the fenestration feature 300 may be positioned between the elongated central channel 104 and the natural annulus of the natural tricuspid valve.

[0184] The fenestration feature 300 may be, for example, an opening or vent that allows guidewires and auxiliary devices (such as pacing leads, ICD leads, or other devices) to pass through the cover 200 and / or the natural tricuspid valve into the ventricle (e.g., for right ventricular and / or pulmonary artery access and access). In this way, additional devices can enter the right ventricle and / or pulmonary artery without passing through the elongated central channel 104 of the artificial tricuspid valve 100, thereby avoiding the risk of dysfunction, thrombosis, and / or valve damage.

[0185] The fenestration feature 300 may include an aperture identifiable by a radiopaque marker. The fenestration feature 300 may also have magnetic elements or other mechanisms to aid in alignment and engagement with a secondary system (e.g., a transseptal puncture needle) for passage through the atrial sealing skirt 204 and the natural tricuspid valve to and beyond the ventricle. The fenestration feature 300 may be formed of the same material as or a different material (e.g., ePTFE, silicone, etc.) as the atrial sealing skirt 204 to facilitate sealing of the fenestration feature 300 before and after the device passes through it. Similarly, the fenestration feature 300 may include a one-way valve separate from the valvular structures (e.g., leaflet elements) in the elongated central channel 104. In some implementations, the fenestration feature 300 may initially be sealed and constructed in a manner that is easily identifiable and puncture-proof. In other implementations, the entire atrial sealing skirt 204 may be made of a material that allows puncture by a standard or custom-made auxiliary device and then maintains a sufficient seal to prevent unwanted backflow after the wire or other catheter has passed through.

[0186] It should also be understood that one or more other features of the fenestration feature 300 and / or the atrial sealing skirt 204 may be arranged to permanently or temporarily allow a controlled amount of backflow through them (e.g., to permanently or temporarily reduce the increase in ventricular pressure that may be caused by sealing the natural tricuspid valve by the artificial tricuspid valve 100).

[0187] In other embodiments, one or more fenestration features, including fenestration feature 300, may be radially positioned along the elongated central channel 104 in locations that allow controlled amounts of backflow to pass through while bypassing the cover 200. For example, fenestration feature 300 may be implemented as a permanent opening of a predetermined size or a mechanically controllable opening (e.g., an iris or other opening with a mechanically controllable and / or variable diameter, width, or other size at and / or after implantation). As another example, fenestration feature 300 may be a portion of the atrial sealing skirt 204 with more orifices than other portions of the atrial sealing skirt 204. Fenestration feature 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 with initially increased porosity but which decreases over time in the implantation environment (e.g., endothelialization) to allow controlled reduction of backflow. Alternatively, the entire atrial sealing skirt 204 may be porous to control the amount of backflow, and / or may allow the porosity to decrease over time (e.g., through endothelialization) to gradually reduce the backflow volume. In some implementations, the fenestration feature 300 may have pressure control components, such as a pop-out valve that allows backflow when the pressure in the ventricle rises above a predetermined threshold.

[0188] Figures 4 to 8 The illustration shows various artificial tricuspid valves 100 at different stages of implantation into a patient's heart using a natural tricuspid valve. Figure 4 In the example, the artificial tricuspid valve 100 is compressed within 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 such that the distal segment 114 of each atrial arm 106-1 and the distal segment 110 of each ventricular arm 106-2 are straightened against the outer surface 147 of the cylindrical portion 116 without extending beyond the length of the cylindrical portion 116.

[0189] Figure 4 Also shown are an intermediate layer 404 within the sheath 406, multiple restraints 410 each attached to a distal segment 114 of the atrial arm 106-1, an internal nasal cone 402, and an external nasal cone 400 (e.g., a porcine nasal cone configured to guide along and / or separate from the guidewire 408). The guidewire 408 can be used when the artificial tricuspid valve is in position... Figure 4 In the contractile configuration, the artificial tricuspid valve 100 is guided via the patient's vein into the patient's natural tricuspid valve. In the contractile configuration: the cylindrical portion 116 has a first diameter, each ventricular arm 106-2 is held by a sheath 406 against the outer surface 147 of the cylindrical portion 116, and each atrial arm 106-1 is held within the sheath 406 and against the outer surface 147 of the cylindrical portion 116 by a corresponding restraint 410.

[0190] like Figure 5 As shown, the sheath 406 can retract to allow the ventricular arms 106-2 to bend, such that the proximal segment 108 of each ventricular arm 106-2 extends along the outer surface 147, and the distal segment 110 of each ventricular arm 106-2 extends vertically away from the central axis of the cylindrical portion 116. Figure 5 In this case, an artificial tricuspid valve 100 has been inserted into the natural tricuspid valve. Figure 5 In the middle, the natural leaflet 500 and natural chordae tendineae 502 of the natural tricuspid valve are visible.

[0191] like Figure 6 As shown, the artificial tricuspid valve 100 can then be retracted together with the sheath 406 until the distal segment 110 of each ventricular arm 106-2 contacts the ventricular side of the natural leaflet 500 of the natural tricuspid valve. Figure 6 What was observed was that the cylindrical portion 116... Figure 4 The contraction configuration with a first diameter expands (e.g., due to its shape memory characteristics, balloon inflation, etc.) to an expanded configuration with a larger second diameter to form an elongated central channel 104 (see also...). Figure 7 and Figure 8 ).

[0192] like Figure 7 and Figure 8 As shown, the constraint 410 can then be advanced to allow the atrial arms 106-1 to bend such that 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 vertically away from the central axis of the cylindrical portion 116 to contact the atrial side of the natural leaflet 500, thereby capturing the natural leaflet 500 against the distal segment 110 of the ventricular arm 106-2.

[0193] The restraint 410 may be made of suture, polymer, metal, and / or any other material and may serve as a controllable extension connector from the delivery system to the atrial arm 106-1 at its atrial side on the natural leaflet 500. In this way, the atrial arm 106-1 can be extended and expanded as a final step in deployment before assessing valve function, maintaining connection to the delivery system even at its full diameter. If the outcome is undesirable and recapture is required, the restraint 410 can be actuated in the opposite direction to pull the tip of the atrial arm 106-1 back toward the delivery system for repositioning and / or recapture of the implant. If positioning and valve function are satisfactory, the restraint 410 can be released and the implant can be fully deployed.

[0194] For example, if the artificial tricuspid valve 100 is positioned in the natural tricuspid valve in the desired manner, the restraint 410 can be dissociated from the atrial arm 160-1 to release the artificial tricuspid valve 100 in a fully implanted configuration. Figure 8 The diagram illustrates how the support structure 102 (including arms 160-1 and 160-2) is configured to biodynamically fix the artificial tricuspid valve 100 within and separate it from the natural annulus of the natural tricuspid valve without direct attachment to the natural annulus or chordae tendineae associated with the natural tricuspid valve by grasping the natural leaflet 500 of the natural tricuspid valve.

[0195] However, if the desired repositioning of the artificial tricuspid valve 100 or removal of the artificial tricuspid valve 100 from... Figure 8 If the configuration is removed, then Figures 9 to 12 This shows how constraint 410 can retract ( Figure 9 This is to straighten the atrial arm 106-1 against the outer surface 147 of the cylindrical portion 116 to release the natural leaflet 500, and it is shown how the sheath 406 can be advanced. Figures 10 to 12 This allows the ventricular arm 106-2 to be straightened and the central cylindrical portion 116 to be compressed, thereby removing the artificial tricuspid valve 100.

[0196] Figures 4 to 12The overbite arrangement of arm 106 during capture of natural leaflet 500 is also illustrated. Specifically, as shown... Figures 4 to 12 As shown, 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 of the cylindrical portion 116. Both the atrial arm 106-1 and the ventricular arm 106-2 extend across the cross-sectional plane of at least one support structure 102 of the cylindrical portion 116, such that during the capture of the natural leaflet 500, there is an overbite between the atrial arm 106-1 and the ventricular arm 106-2 in the cross-sectional plane. Although the support structure 102 can be implemented with an arm 106 that does not extend across the cross-sectional plane and therefore does not exhibit an overbite (e.g., where the atrial arm 106-1 extends from the atrial end 118 of the cylindrical portion 116 and the ventricular arm 106-2 extends from the ventricular end 120 of the cylindrical portion 116), the overbite arrangement described herein (e.g., see reference) Figures 1 to 12 In the overbite arrangement, the atrial arm 106-1 and ventricular arm 106-2 traverse twice relative to the cross-sectional plane of the cylindrical portion 116—offering the advantage of a more robust seal against the natural leaflet 500 to prevent paravalvular leakage, and also the advantage of facilitating the correct deployment sequence (ventricular arm 106-2, followed by atrial arm 106-1), which allows for a comprehensive evaluation and recapture of the prosthetic tricuspid valve 100. Furthermore, extending the atrial arm 106-1 and ventricular arm 106-2 from opposite ends of the cylindrical portion 116 allows each set of arms 106-1 and 106-2 to be compressed against the cylindrical portion 116 itself (rather than having to extend completely beyond each end of the cylindrical portion 116), thereby significantly reducing the overall length of the prosthetic tricuspid valve 100 during delivery and thus improving the flexibility and ease of positioning and deployment.

[0197] Figure 13 A top view of the artificial tricuspid valve 100 is shown, in which the leaflet element 1300 within the elongated central channel 104 can be seen forming the interior of the artificial tricuspid valve 100. Figure 13 In the example, the leaflet element 1300 is closed to form a complete seal within the closed configuration of the artificial tricuspid valve 100. However, as mentioned above... Figure 3 The annotation indicates that, in some cases, it is desirable to permanently or temporarily allow a controlled amount of backflow through the artificial tricuspid valve 100. Figure 3In the example, various implementations of the window feature 300 are described as allowing such controlled backflow. However, in other implementations, the leaflet element 1300 may be provided with features or constraints that provide the desired backflow. For example, tension lines or other mechanical or material features (not shown) may be provided to prevent one or more leaflet elements 1300 from being fully closed with other leaflet elements 1300, thereby permanently or temporarily allowing a controlled amount of backflow between the leaflet elements 1300. The tension lines may subsequently be removed, loosened, or substantially altered to reduce or eliminate backflow.

[0198] The artificial tricuspid valve 100 can be delivered from the inferior vena cava, which extends into the superior vena cava. The distal portion of the delivery system can extend to allow the capsule to extend away from the main axis of the delivery system with a predetermined curvature and bend towards the natural tricuspid valve for axialization and positioning. In this example, further extension into the inferior vena cava would increase the curvature, while pulling the distal portion posteriorly would minimize it. Figure 14 The diagram illustrates the delivery pathways from the inferior vena cava and the superior vena cava.

[0199] The delivery system for the transcatheter tricuspid valve implant 100 can originate from the superior vena cava, via the jugular vein, subclavian vein, or other vessels, or from the inferior vena cava, via the femoral vein, or an alternative entry point. Alternatively, access can be achieved via a surgical incision through the right atrium of the heart.

[0200] For example, the deployment sequence may allow partial deployment within the atrium before advancing into the ventricle to complete positioning and deployment, or the deployment sequence may allow full advancement and positioning into the natural tricuspid valve before initial deployment.

[0201] The delivery system can be passive or can have multiple steering element planes. In some implementations, depth control can be provided by a steering mechanism of the delivery system that can shuttle proximally or distally relative to the handle of the delivery system. An example of shuttles for the steering mechanism includes allowing tensioning of the steering mechanism (e.g., relative movement between the underlying laser-cut sub-tube and a tension line mounted to the distal end of the sub-tube) within a sub-component of the handle of the delivery system—which itself can translate linearly within the handle—while maintaining the same relative tension between the steering mechanisms.

[0202] In some cases, the delivery system is advanced from the inferior vena cava, through the right atrium, and along a guidewire extending beyond the superior vena cava into the superior vena cava, where the artificial tricuspid valve 100 is effectively housed within a portion of the delivery system positioned within the right atrium. The distal portion of the delivery system then extends upward into the superior vena cava, such that the distal portion is released from the proximal portion and is able to bend away from the main axis of the delivery system and toward the natural tricuspid valve annulus. The extent to which the distal portion of the delivery system extends away from the proximal portion controls the angle between the proximal portion of the distal portion of the delivery system (where the artificial tricuspid valve 100 is housed) and the main axis of the proximal portion of the delivery system, until the artificial tricuspid valve 100 is coaxially aligned with the natural tricuspid valve annulus. Delivery features in Figure 25 and Figure 26 Further illustrations are provided. Figure 25 and Figure 26 The diagram shows the separation of the pig nasal cone 400 and the guide wire 408.

[0203] In another example, the delivery system can be accessed from the superior vena cava near the right atrium, where the guidewire extends downwards into the inferior vena cava (see example...). Figure 33 (Lower left). In this example, as the tip of the delivery system approaches the right atrium, the delivery system can dissociate from the guidewire, allowing it to be passively guided toward the annulus of the natural tricuspid valve or actively guided toward the annulus of the natural tricuspid valve. In this way, the guidewire can still be used for stabilization without having to be advanced into the right ventricle, where it could potentially cause complications (e.g., perforation, entanglement, conduction problems, or other issues). In this or other examples, the external nasal cone 400 of the delivery system can be non-sharp and rounded, like a dome, or it can be long and flexible in a braided shape, allowing the external nasal cone to be advanced into the right ventricle non-invasively without entanglement with the chordae tendineae of the natural tricuspid valve.

[0204] Figure 15 and Figure 16 Wide-field and close-field views of a portion of the support structure 102 are shown, respectively, wherein the cylindrical portion 116 is formed by a collapsible cage-like structure (e.g., a V-shaped strut 2200 having a second bend 130 for capturing the atrial arm 106-1). Figure 15 and Figure 16 The example shows an arm 106 before the bends 126, 124, 128 and 130 are formed in the arm 106.

[0205] Figure 17 and 18 Other arrangements for the cover 200 as described above are shown.

[0206] Figure 19 This demonstrates how the overbite of atrial arm 106-1 and ventricular arm 106-2 can be formed as a ratio Figure 1 The ventricular end 120, which is closer to the cylindrical portion 116, is illustrated in the diagram. In other words, Figure 19 The cross-sectional plane of the cylindrical portion 116—with the atrial arm 106-1 and ventricular arm 106-2 extending across this cross-sectional plane—is shown, thus illustrating how it can be formed as a ratio Figure 1 The ventricular end 120, which is closer to the cylindrical portion 116, is shown in the diagram.

[0207] Figure 20 The illustration shows how the cylindrical portion 116 of the support structure 102 of the artificial tricuspid valve 100 can provide a force 2000 (e.g., through the intermediate layer 404) opposite to the restraint force 2002 on the atrial arm 106-1 of the support structure 102 for controlling the capture of the natural leaflet.

[0208] Figure 21 It shows the relationship with Figure 22 Compared to other implementations, how can the V-shaped support 2200 be formed on the second curved portion 130 of the atrial arm 106-1 that contacts the cylindrical portion 116 of the support structure 2100 (e.g., support structure 102)? Figure 22 In the implementation, the V-shaped support 2200 is located below the second bend (e.g., the second bend 130) of the atrial arm 106-1 and receives the second bend 2202 and stabilizes the position of the atrial arm 106-1.

[0209] Figure 23 It is shown that it is configured to extend from the intermediate layer 404 to provide Figure 20 The expansion arm 2300 is opposite to the constraint force 2002 of constraint member 410. (The following text is in conjunction with...) Figures 35 to 40 Further details regarding the arrangement of the expansion arm 2300 and the constraint 410 are provided.

[0210] Figure 24 A side view of a pair of atrial arms 106-1 and ventricular arms 106-2 is shown, and the use of the pair of atrial arms 106-1 and ventricular arms 106-2 for... Figure 8 The diagram shows the grasping and overbite arrangement of natural leaflets. (Example) Figure 24 As shown, the distal segment 114 of each atrial arm 106-1, extending vertically away from the central axis of the elongated central channel 104, extends from a first longitudinal position 2421 along the cylindrical portion 116 of the support structure 102. Similarly, the distal segment 110 of each ventricular arm 106-2, extending away from the central axis of the elongated central channel 104, extends from a second longitudinal position 2420 along the cylindrical portion 116 of the support structure 102. Figure 24As shown, 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 is closer to the atrial end 118 of the cylindrical portion 116 of the support structure 102.

[0211] In the implantation configuration of the artificial tricuspid valve 100—where the support structure 102 of the artificial tricuspid valve 100 biodynamically fixes the artificial tricuspid valve 100 to the natural leaflet 500 of the natural tricuspid valve— Figure 24 In this example, the ventricular arm 106-2 extends from the atrial end 118 of the cylindrical portion 116, passes through the natural annulus of the natural tricuspid valve, and enters the ventricle of the heart to contact 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, passes through the natural annulus of the natural tricuspid valve, and enters the atrium of the heart to contact the atrial surface of the natural leaflet 500.

[0212] Figure 24 It is also shown how the bends 126 and 130 can be greater than 90°, such that the distal end segment 114 of each atrial arm 106-1 extending vertically away from the central axis of the elongated central channel 104 extends toward the ventricular end 120 of the cylindrical portion 116, and such that the distal end segment 110 of each ventricular arm 106-2 extending vertically away from the central axis of the elongated central channel 104 extends toward the atrial end 118 of the cylindrical portion 116.

[0213] Figure 24 It is also shown how the distal segment 114 of each atrial arm 106-1, extending vertically away from the central axis of the elongated central channel 104, has a tip 142, and how the distal segment 110 of each ventricular arm 106-2, extending vertically away from the central axis of the elongated central channel 104, has a tip 140, and the tip 142 is closer to the ventricular end 120 of the cylindrical portion 116 than the tip 140 is closer to the ventricular end 120 of the cylindrical portion 116. However, as Figure 24As shown, if desired, the distal segment 114 of each atrial arm 106-1 (e.g., the tip 142 of each atrial arm 106-1) may include an extension segment 2400 having a third bend toward the atrial end 118 of the cylindrical portion 116 for a more non-invasive engagement of the atrial surface of the natural leaflet. It should also be understood that, if desired, 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 extension segment having a third bend toward the ventricular end 120 of the cylindrical portion 116 (e.g., similar to the third bend of the extension segment 2400 of each atrial arm 106-1) for a more non-invasive engagement of the ventricular surface of the natural leaflet. It should be noted that the aforementioned third bend can also reduce the frictional force applied to the inner surface of the outer sheath 406 by the tip of the guide arm 106 being moved away from the inner surface of the outer sheath 406 during the loading, delivery and recapture of the artificial tricuspid valve 100.

[0214] Refer to Figure 25 and Figure 26 The delivery system may originate from a guidewire 2500 (e.g., guidewire 408) extending from the inferior vena cava to the superior vena cava or vice versa, wherein the nasal cone 400 and the distal portion of the delivery system are separated from the linear trajectory of the guidewire 2500 to enter the right atrium, pass through the natural tricuspid valve annulus, and enter the right ventricle without the guidewire 2500. This allows for the leverage of the guidewire 2500 along the straight portion without the risk of having the guidewire in the right ventricle, which could potentially irritate the heart's electrical system and cause conduction abnormalities. When the guidewire 2500 is withdrawn, the nasal cone 400 can return to a flexible "braided" tip that can easily pass through the natural tricuspid valve annulus without becoming entangled in the cord-like structure of the natural tricuspid valve. In some embodiments, the guidewire 2500 may extend from the superior or inferior vena cava into the right atrium, and the delivery system may be advanced such that the nasal cone 400 returns to its "braided" shape before entering the right ventricle.

[0215] Figures 27 to 29The illustration shows another implementation of a support structure 2720 (e.g., support structure 102) for an artificial tricuspid valve 2700, wherein both atrial arms 2701-1 (e.g., atrial arm 106-1) and ventricular arms 2701-2 (e.g., ventricular arm 106-2) may initially extend from the ventricular end of the support structure 2702, each arm 2701 having an initial bend of 180° + / - 45° that guides the arm 2701 back to the atrial end of the support structure 2702. In this example, each atrial arm 2701-1 extends through the annulus of the natural tricuspid valve and has a second bend closer to the atrial end of the support structure 2702 than the second bend of each ventricular arm 2701-2. 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 perpendicular to the central axis of the elongated central channel defined by the support structure 2702. However, in this example, the degree of the second bend in arm 2702 causes the tip of atrial arm 2701-1 to be closer to the ventricular end of support structure 2702 than the tip of ventricular arm 2701-2. Therefore, the arrangement of atrial arm 2701-1 and ventricular arm 2701-2 above and below the natural leaflet will again result in a corrugated, collared configuration to ensure a tight seal and more stable positioning of the artificial tricuspid valve 2700.

[0216] In another implementation, both the atrial arm 2701-1 and the ventricular arm 2701-2 extend from the atrial end of the supporting structure 2702. For example... Figure 29 As shown, the leaflet element 1300 described in conjunction with the artificial tricuspid valve 100 can also be used with... Figures 27 to 30 It is used in conjunction with an alternative support structure 2702. In one exemplary implementation, such as Figure 30 As shown, each atrial arm 2701-1 can be folded against the outer surface 147 of the support structure 2702 during loading, while each ventricular arm 2701-2 can extend downward toward and beyond the ventricular end of the support structure 2702 during loading.

[0217] Figures 31 to 34 Various features of an artificial tricuspid valve are illustrated, wherein the atrial arm and ventricular arm begin at and extend from the opposite ends of the cylindrical portion of the support structure of the artificial tricuspid valve (e.g., wherein the ventricular arm begins at and extends from the atrial end of the cylindrical portion of the support structure, and wherein the atrial arm begins at and extends from the ventricular end of the cylindrical portion of the support structure). These various features can be applied to any implementation of the methods described above and below, if desired.

[0218] Figure 35 The diagram illustrates the combination of the above text. Figure 23Additional features of the described expansion arm 2300 (e.g., for providing) Figure 20 Force 2000 and Force 2002 are used for controlled deployment or contraction of the ventricular arm 106-2. (As in...) Figure 35 As shown in the example, multiple expansion arms 2300 can extend from circumferentially separated positions on the intermediate layer 404 and can be configured to expand radially when the outer sheath 406 contracts.

[0219] Each dilator arm 2300 can be coupled to the atrial end 118 of the cylindrical portion 116 of the support structure 102, such that the expansion of the dilator arm 2300 allows the cylindrical portion 116 of the artificial tricuspid valve 100 to expand radially, while the dilator arm 2300 provides a force against the support structure 102 in the ventricular direction, a force opposite to the atrial-oriented force of the restraint member 410 on the atrial arm 106-1. The dilator arm 2300 can be formed from a 3D-printed or molded material (e.g., a polymer) that is soft enough to be compressed into the sheath 406 and subsequently naturally flare back outward as the sheath 406 contracts. Figure 35 In the configuration. Figure 35 In the example, each restraint 410 for each atrial arm 106-1 is implemented as a suture that extends from the gap 3508 between the dilators 2300, passes through an eyelet 3502 in the atrial arm 106-1, and then returns through the gap 3508 between the dilators 2300. Once the desired implantation location for the artificial tricuspid valve 100 is achieved, the restraint 410 can be cut and removed.

[0220] Figure 36 The illustration shows a perspective view of an expansion arm 2300 extending from an intermediate layer 404, in which interlocking mechanisms 3600 for connection to the atrial end 118 of the cylindrical portion 116 of the support structure 102 can be seen. Each interlocking 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 expansion arm 2300 can push at least one support structure 102 in the ventricular direction. In some embodiments, the interlocking mechanism 3600 can maintain contact with the atrial end 118 of the cylindrical portion 116 of the support structure 102 during both active pushing and passive resting of the expansion arm 2300. In some embodiments, the interlocking mechanism 3600 can disengage from the atrial end 118 of the cylindrical portion 116 of the support structure 102 during the passive resting of the expansion arm 2300 as the intermediate layer 404 moves away from the support structure 102.

[0221] like Figure 36As shown, each dilator arm 2300 may include an extension 3602 that extends beyond the interlocking mechanism 3600 on the dilator arm and onto the atrial end 118 of the cylindrical portion 116 of at least one support structure 102. The extension 3602 can serve a variety of purposes. First, the extension 3602 can act as a “shelter” on the support structure 102, allowing for easier recapture of the artificial tricuspid valve 100 with lower force by preventing the outer sheath 406 from encountering resistance from the edges of the support structure 102 when it is pushed back along the edges of the support structure 102 during recapture. Furthermore, the extension 3602 can extend to facilitate pleating of the atrial sealing skirt 204 and provide hinge points for controlled folding of the atrial sealing skirt 204, again reducing loading and recapture forces that would otherwise cause uneven concentration of the atrial sealing skirt 204 when the atrial arm 106-1 is folded.

[0222] exist Figure 35 and Figure 36 In the example, the expansion arm 2300 engages at the atrial end 118 of the cylindrical portion 116 of the support structure 102 with the proximal segment 108 of each ventricular arm 106-2 (e.g., the initial bend 124 of each ventricular arm 106-2). However, it should be understood that, as Figures 59 to 60 As shown in the example, the expansion arm 2300 may alternatively or additionally be configured to engage with the cylindrical portion 116 of the support structure 102.

[0223] Figure 37 A larger perspective view of the support structure 102, connected to the expansion arm 2300 of the restraint 410 and the intermediate layer 404, is shown, in which the internal nasal cone 402 and the external nasal cone 400 can be seen extending through the elongated central channel 104. The artificial tricuspid valve 100 can be inserted during implantation and prior to the removal of the internal nasal cone 402, external nasal cone 400, expansion arm 2300, restraint 410, and sheath 406. Figure 37 The configuration is set up to complete the implantation.

[0224] Figure 38 A perspective view of a portion of intermediate layer 404 according to various aspects of this disclosure is shown. Figure 38As illustrated, the sutures forming the restraint 410 can extend the entire length of the delivery system (e.g., within an elongated opening 3840 in the outer layer 3800 of the intermediate layer 404). If desired, these sutures can be coupled to a spring 3801 at the end of the delivery system to accommodate any bending at the end, which is configured adjacent to the ventricular side of the natural tricuspid valve and can vary in relative length. The spring 3801 can be mounted, for example, in an opening 3806 in the inner layer 3802 of the intermediate layer 404. The sutures can extend downwards along the inner diameter from the spring 3801, passing through the armhole 3502 (see...). Figure 35 One of the arm openings 2300 is then passed down through the gap 3508 between the dilators 2300. In one example implementation, the nine dilators 2300 may be circumferentially alternating with nine sutures. One end of each suture may extend from the intermediate layer 404 at the end of the delivery system, the end being configured adjacent to the atrial side of the natural tricuspid valve, such that the end can be cut to allow the suture to be pulled outward around the inner diameter.

[0225] exist Figure 35 and Figure 37 In the example, for clarity, the support structure 102 of the artificial tricuspid valve 100 is shown as connected to the dilator arm 2300 and the restraint 410 but not to other parts of the artificial tricuspid valve 100. Figure 39 The illustration shows a complete artificial tricuspid valve 100, including a leaflet element 1300 and a cover 200, which includes an atrial sealing skirt 204 that connects to a delivery system. For greater clarity, Figure 40 The illustration shows a perspective view of the support structure 102 and the expansion arm 2300 with partial transparency, especially for clarity of the connection between the interlocking mechanism 3600 and the bend 124 of the ventricular arm 106-2.

[0226] Figure 41 The illustration shows a perspective view of the support structure 102 in a configuration where the atrial arm 106-1, ventricular arm 106-2, and cylindrical portion 116 are cut from a common structure. Figure 41 In the example, the support structure 102 is shown as a "cut" (e.g., where the atrial arm 106-1 and the ventricular arm 106-2 are shown as being formed in the atrial arm 106-1 and the ventricular arm 106-2 before the bends 126, 124, 128, and 130 are formed in the atrial arm 106-1 and the ventricular arm 106-2 to modify the configuration of segments 108, 110, 112, and 114, thus reflecting, for example...). Figure 1 (Those components shown). Figure 41Example configurations for the ventricular arm tip 140 and the atrial arm tip 142 are also illustrated. However, the configurations of tip 140 and tip 142 can be configured with various different geometries to optimize load distribution for the natural leaflets. Figure 41 In the configuration, the cylindrical portion 116 is formed by an expandable cage-like structure described in a shrinkable configuration.

[0227] Figures 42A to 42B The illustration shows the implantation of the artificial tricuspid valve 100 into the natural tricuspid valve of the heart 4200 during the entire alternating pressure gradient on either side of the natural tricuspid valve 100 during the cardiac cycle of the heart 4200.

[0228] Specifically, Figure 42A The illustration shows the implantation of an artificial tricuspid valve 100 into the natural tricuspid valve of heart 4200 during diastolic filling of ventricle 4202. During diastolic filling of ventricle 4202, blood flows from atrium 4201 of heart 4200, through the elongated central channel 104 of artificial tricuspid valve 100, and into ventricle 4202 of heart 4200. During diastolic filling of ventricle 4202, pressure on artificial tricuspid valve 100 is released with slight movement of artificial tricuspid valve 100 toward ventricle 4202 of heart 4200. Atrial arm 106-1 prevents this movement, while ventricular arm 106-2 relaxes to maintain contact with the ventricular side of the natural tricuspid valve leaflet.

[0229] On the contrary, Figure 42B The illustration shows an artificial tricuspid valve 100 implanted in the natural tricuspid valve of heart 4200 during the contraction of the ventricle 4202 of heart 4200. During the contraction of the ventricle 4202 of heart 4200, blood flows out of the ventricle 4202 of heart 4200 and into the pulmonary artery 4203 of heart 4200. During the contraction of the ventricle 4202 of heart 4200, pressure on the artificial tricuspid valve 100 causes it to move slightly toward the atrium 4201 of 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 natural tricuspid valve leaflet. This also creates a trampoline effect, in which the pressure load of ventricular contraction can be partially absorbed by the atrial movement of the natural leaflet.

[0230] Figures 43A to 43B The illustration shows another implementation of the support structure 102 for an artificial tricuspid valve according to an embodiment. Specifically, Figure 43A The illustration shows another implementation of a support structure 102 for an artificial tricuspid valve in a contracted configuration, which defines an elongated central channel having a first diameter. Figure 43BThe illustration shows another implementation of a support structure 102 for an artificial tricuspid valve in an extended configuration, wherein the support structure defines an elongated central channel having a second diameter larger than a first diameter. For example, in Figures 43A to 43B In one embodiment, the first diameter of the elongated central channel can be 8 mm, and the second diameter of the elongated central channel can be 25 mm.

[0231] As described above, the artificial tricuspid valve described herein may include one or more support structures. For example, the artificial tricuspid valve described herein may include one, two, three, or more than three 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 artificial tricuspid valve. Detailed descriptions of certain figures above and below describe an exemplary artificial tricuspid valve including one support structure. Furthermore, detailed descriptions of certain figures above and below describe exemplary artificial tricuspid valves including more than one (e.g., two, three, or more than three) support structures. For example, detailed descriptions of Figures 46 through 53 below describe an exemplary artificial tricuspid valve having two or three support structures. However, many features of the artificial tricuspid valve described with reference to an artificial tricuspid valve having a specific number of support structures may be included in other artificial tricuspid valves with different numbers of support structures.

[0232] Figures 44 and 45 illustrate different views of an implementation of an artificial tricuspid valve 4400 having a support structure 102 according to an embodiment.

[0233] Figure 44A The illustration shows a view of the flat support structure 102 of an artificial tricuspid valve 4400 having a support structure 102 according to an embodiment.

[0234] Figure 44B The illustration shows a side view of an artificial tricuspid valve 4400 having a support structure 102 and configured for implantation into a natural tricuspid valve, according to an embodiment.

[0235] Figures 45A to 45D The illustration shows computer-aided design (CAD) drawings of different views of an artificial tricuspid valve 4400 having a support structure 102 according to an embodiment. Figure 45A The illustration shows a CAD drawing of a side view of an artificial tricuspid valve 4400 having a support structure 102 according to an embodiment. Figure 45B The illustration shows a CAD drawing of a top view of an artificial tricuspid valve 4400 having a support structure 102 according to an embodiment. Figure 45CThe illustration shows a CAD drawing of an inclined side view of an artificial tricuspid valve 4400 having a support structure 102 according to an embodiment. Figure 45D The illustration shows a CAD drawing of a side view of an artificial tricuspid valve 4400 having a support structure 102 according to an embodiment.

[0236] In an embodiment of the artificial tricuspid valve 4400 having a support structure 102, both the atrial arm 106-1 and the ventricular arm 106-2 are formed by the support structure 102. As described throughout this disclosure, the support structure 102 also includes a cylindrical portion 116 defining an elongated central passage 104 of the artificial tricuspid valve 4400.

[0237] The advantages of forming the artificial tricuspid valve 4400 from a single support structure 102 include a reduced diameter of the artificial tricuspid valve 4400 and fewer steps required for assembling it. However, a disadvantage of forming the artificial tricuspid valve 4400 from a single support structure 102 is the more complex manufacturing process. Another disadvantage is that the artificial tricuspid valve 4400 may not effectively distribute loads, and therefore, certain portions of the artificial tricuspid valve 4400 may be prone to fracture under stress. Specifically, as discussed further in detail below, forming the artificial tricuspid valve 4400 from a single support structure 102 results in a shorter arm 106 and a fulcrum located at roughly the same position as the load node, which effectively produces a weaker load distribution capability and thus makes the artificial tricuspid valve 4400 more susceptible to breakage.

[0238] Figures 46 and 47 illustrate different views of the implementation of an artificial tricuspid valve 4600 with two support structures 102-1 and 102-2 according to an embodiment.

[0239] Figure 46A The illustration shows a view of the flat support structures 102-1 and 102-2 of an artificial tricuspid valve 4600 having two support structures 102-1 and 102-2 according to an embodiment.

[0240] Figure 46B The illustration shows a side view of an artificial tricuspid valve 4600 having two support structures 102-1 and 102-2 and configured for implantation into a natural tricuspid valve, according to an embodiment.

[0241] Figures 47A to 47F The illustration shows CAD drawings of different views of an artificial tricuspid valve 4600 having two support structures 102-1 and 102-2 according to an embodiment. Figure 47AThe illustration shows a CAD drawing of an inclined side view of the support structure 102-1 of an artificial tricuspid valve 4600 having two support structures 102-1 and 102-2 according to an embodiment. Figure 47B The illustration shows a CAD drawing of an inclined side view of the support structure 102-2 of an artificial tricuspid valve 4600 having two support structures 102-1 and 102-2 according to an embodiment. Figure 47C The illustration shows a CAD drawing of a side view of an artificial tricuspid valve 4600 having two support structures 102-1 and 102-2 according to an embodiment. Figure 47D The illustration shows a CAD drawing of a top view of an artificial tricuspid valve 4600 having two support structures 102-1 and 102-2 according to an embodiment. Figure 47E The illustration shows a CAD drawing of an oblique side view of an artificial tricuspid valve 4600 having two support structures 102-1 and 102-2 according to an embodiment. Figure 47F The illustration shows a CAD drawing of another side view of an artificial tricuspid valve 4600 having two support structures 102-1 and 102-2 according to an embodiment.

[0242] In an embodiment of the artificial 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. The two support structures 102-1 and 102-2 are configured to fit together to form the artificial tricuspid valve 4600. As described throughout this disclosure, at least one of the two support structures 102-1 and 102-2 includes a cylindrical portion that defines an elongated central passage 104 of the artificial tricuspid valve 4600. For example, in the implementation of the artificial tricuspid valve 4600 with two support structures 102-1 and 102-2 depicted in Figures 46 and 47, each of the two support structures 102-1 and 102-2 includes a cylindrical portion 116-1 and a cylindrical portion 116-2, respectively, which defines an elongated central passage 104 of the artificial tricuspid valve 4600. However, in an alternative embodiment, only one of the two support structures 102-1 and 102-2 may include the cylindrical portion defining the elongated central passage 104 of the artificial tricuspid valve 4600.

[0243] The advantages of forming the artificial tricuspid valve 4600 from the two support structures 102-1 and 102-2 include a simpler manufacturing process. However, a disadvantage is that assembling the artificial tricuspid valve 4600 involves fitting the two support structures 102-1 and 102-2 together to form the artificial tricuspid valve 4600. Another advantage of forming the artificial tricuspid valve 4600 from the two support structures 102-1 and 102-2 is the improved load distribution in the ventricular arm 106-2, which is important because the ventricular arm 106-2 bears greater forces than the atrial arm 106-1 when the artificial tricuspid valve 4600 is implanted.

[0244] Figures 48 and 49 illustrate different views of the implementation of an artificial tricuspid valve 4800 with two support structures 102-1 and 102-2 according to an embodiment.

[0245] Figure 48A The illustration shows a view of the flat support structures 102-1 and 102-2 of an artificial tricuspid valve 4800 having two support structures 102-1 and 102-2 according to an embodiment.

[0246] Figure 48B The illustration shows a side view of an artificial tricuspid valve 4800 having two support structures 102-1 and 102-2 and configured for implantation into a natural tricuspid valve, according to an embodiment.

[0247] Figures 49A to 49F The illustration shows CAD drawings of different views of an artificial tricuspid valve 4800 having two support structures 102-1 and 102-2 according to an embodiment. Figure 49A The illustration shows a CAD drawing of an inclined side view of the support structure 102-1 of an artificial tricuspid valve 4800 having two support structures 102-1 and 102-2 according to an embodiment. Figure 49B The illustration shows a CAD drawing of an inclined side view of the support structure 102-2 of an artificial tricuspid valve 4800 having two support structures 102-1 and 102-2 according to an embodiment. Figure 49C The illustration shows a CAD drawing of a side view of an artificial tricuspid valve 4800 having two support structures 102-1 and 102-2 according to an embodiment. Figure 49D The illustration shows a CAD drawing of a top view of an artificial tricuspid valve 4800 having two support structures 102-1 and 102-2 according to an embodiment. Figure 49E The illustration shows a CAD drawing of an oblique side view of an artificial tricuspid valve 4800 having two support structures 102-1 and 102-2 according to an embodiment. Figure 49FThe illustration shows a CAD drawing of another side view of an artificial tricuspid valve 4800 having two support structures 102-1 and 102-2 according to an embodiment.

[0248] In an embodiment of the artificial tricuspid valve 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. The two support structures 102-1 and 102-2 are configured to fit together to form the artificial tricuspid valve 4800. As described throughout this disclosure, at least one of the two support structures 102-1 and 102-2 includes a cylindrical portion defining an elongated central passage 104 of the artificial tricuspid valve 4800. For example, in the implementation of the artificial tricuspid valve 4800 having two support structures 102-1 and 102-2 depicted in Figures 48 to 49, each of the two support structures 102-1 and 102-2 includes a cylindrical portion 116-1 and a cylindrical portion 116-2, respectively, which define the elongated central passage 104 of the artificial tricuspid valve 4800. However, in an alternative implementation, only one of the two support structures 102-1 and 102-2 may include a cylindrical portion of an elongated central channel 104 for defining the artificial tricuspid valve 4800.

[0249] The advantages of forming the artificial tricuspid valve 4800 from the two support structures 102-1 and 102-2 include the simpler manufacturing process compared to the artificial tricuspid valve 4600. Another advantage of forming the artificial tricuspid valve 4800 from the two support structures 102-1 and 102-2 is that the leaflet element can be formed by the first support structure 102-1 forming the ventricular arm 106-2 instead of the atrial arm 106-1, thereby allowing the atrial sealing skirt, as described above, to be formed separately from the leaflet element by the second support structure 102-2 forming the atrial arm 106-1. By forming the atrial sealing skirt separately from the leaflet element formed by the second support structure 102-2, the assembly of the individual support structures 102-1 and 102-2 is simpler, and the atrial sealing skirt can be laminated. However, the assembly of the artificial tricuspid valve 4800 still involves the additional step of fitting the two support structures 102-1 and 102-2 together to form the artificial tricuspid valve 4800. Another advantage of forming the artificial tricuspid valve 4800 from the two support structures 102-1 and 102-2 is the improved load distribution, but this improved load distribution is mainly in the atrial arm 106-1, which is less significant because the atrial arm 106-1 experiences less force than the ventricular arm 106-2 when the artificial tricuspid valve 4800 is implanted.

[0250] Figures 50 and 51 illustrate different views of the implementation of an artificial tricuspid valve 5000 with two support structures 102-1 and 102-2 according to an embodiment.

[0251] Figure 50A The illustration shows a view of the flat support structures 102-1 and 102-2 of an artificial tricuspid valve 5000 having two support structures 102-1 and 102-2 according to an embodiment.

[0252] Figure 50B The illustration shows a side view of an artificial tricuspid valve 5000 having two support structures 102-1 and 102-2 and configured for implantation into a natural tricuspid valve, according to an embodiment.

[0253] Figures 51A to 51F The illustration shows CAD drawings of different views of an artificial tricuspid valve 5000 having two support structures 102-1 and 102-2 according to an embodiment. Figure 51A The illustration shows a CAD drawing of an inclined side view of the support structure 102-1 of an artificial tricuspid valve 5000 having two support structures 102-1 and 102-2 according to an embodiment. Figure 51B The illustration shows a CAD drawing of an inclined side view of the support structure 102-2 of an artificial tricuspid valve 5000 having two support structures 102-1 and 102-2 according to an embodiment. Figure 51C The illustration shows a CAD drawing of a side view of an artificial tricuspid valve 5000 having two support structures 102-1 and 102-2 according to an embodiment. Figure 51D The illustration shows a CAD drawing of a top view of an artificial tricuspid valve 5000 having two support structures 102-1 and 102-2 according to an embodiment. Figure 51E The illustration shows a CAD drawing of an oblique side view of an artificial tricuspid valve 5000 having two support structures 102-1 and 102-2 according to an embodiment. Figure 51F The illustration shows a CAD drawing of another side view of an artificial tricuspid valve 5000 having two support structures 102-1 and 102-2 according to an embodiment.

[0254] In an embodiment of the artificial tricuspid valve 5000 having two support structures 102-1 and 102-2, the first support structure 102-1 does not form an atrial arm 106-1 or a ventricular arm 106-2. The second support structure 102-2 forms both the atrial arm 106-1 and the ventricular arm 106-2. In some embodiments, the second support structure 102-2 forming both the atrial arm 106-1 and the ventricular arm 106-1 may be an artificial tricuspid valve 4400 having a single support structure 102. The two support structures 102-1 and 102-2 are configured to fit together to form the artificial tricuspid valve 5000. As described throughout this disclosure, at least one of the two support structures 102-1 and 102-2 includes a cylindrical portion defining an elongated central passage 104 of the artificial tricuspid valve 5000. For example, in the implementation of the artificial tricuspid valve 5000 with two support structures 102-1 and 102-2 depicted in Figures 50 and 51, each of the two support structures 102-1 and 102-2 includes a cylindrical portion 116-1 and a cylindrical portion 116-2, respectively, which defines an elongated central passage 104 of the artificial tricuspid valve 5000. However, in an alternative embodiment, only one of the two support structures 102-1 and 102-2 may include a cylindrical portion for defining the elongated central passage 104 of the artificial tricuspid valve 5000.

[0255] Like the artificial tricuspid valves 4600 and 4800, the advantages of forming the artificial tricuspid valve 5000 from two support structures 102-1 and 102-2 include a simpler manufacturing process. Furthermore, another advantage of forming the artificial tricuspid valve 5000 from two support structures 102-1 and 102-2, similar to the artificial tricuspid valve 4800, is that the leaflet element can be formed by the first support structure 102-1 without forming the atrial arm 106-1, thereby allowing the atrial sealing skirt, as described above, to be formed separately from the leaflet element by the second support structure 102-2 forming the atrial arm 106-1. By forming the atrial sealing skirt separately from the leaflet element formed by the second support structure 102-2, which is separate from the leaflet element formed by the first support structure 102-1, the assembly of the individual support structures 102-1 and 102-2 is simpler, and the atrial sealing skirt can be laminated. However, the assembly of the artificial tricuspid valve 5000 still involves the additional step of fitting the two support structures 102-1 and 102-2 together to form the artificial tricuspid valve 5000. Another advantage of forming the artificial tricuspid valve 5000 from the two support structures 102-1 and 102-2 is the improved load distribution, as the first support structure 5000-1 can provide additional reinforcement to the atrial arm 106-1 and ventricular arm 106-2 formed by the second support structure 5000-2. However, arm 106 is still not extended, and the fulcrum still appears in the same general location as the load node, which effectively results in a weaker load distribution capability and therefore makes the artificial tricuspid valve 5000 more susceptible to breakage.

[0256] Figures 52 and 53 illustrate different views of the implementation of an artificial tricuspid valve 5200 having three support structures 102-1, 102-2 and 102-3 according to an embodiment.

[0257] Figure 52A The illustration shows a view of the flat support structure 102-1, 102-2 and 102-3 of an artificial tricuspid valve 5200 having three support structures 102-1, 102-2 and 102-3 according to an embodiment.

[0258] Figure 52B The illustration shows a side view of an artificial tricuspid valve 5200 having three support structures 102-1, 102-2 and 102-3 and configured for implantation into a natural tricuspid valve, according to an embodiment.

[0259] Figures 53A to 53G The illustration shows CAD drawings of different views of an artificial tricuspid valve 5200 having three support structures 102-1, 102-2 and 102-3 according to an embodiment. Figure 53AThe illustration shows a CAD drawing of an inclined side view of the support structure 102-1 of the artificial tricuspid valve 5200 having three support structures 102-1, 102-2 and 102-3 according to an embodiment. Figure 53B The illustration shows a CAD drawing of an inclined side view of the support structure 102-2 of an artificial tricuspid valve 5200 having three support structures 102-1, 102-2 and 102-3 according to an embodiment. Figure 53C The illustration shows a CAD drawing of an inclined side view of the support structure 102-3 of an artificial tricuspid valve 5200 having three support structures 102-1, 102-2 and 102-3 according to an embodiment. Figure 53D The illustration shows a CAD drawing of a side view of an artificial tricuspid valve 5200 having three support structures 102-1, 102-2 and 102-3 according to an embodiment. Figure 53E The illustration shows a CAD drawing of a top view of an artificial tricuspid valve 5200 having three support structures 102-1, 102-2 and 102-3 according to an embodiment. Figure 53F The illustration shows a CAD drawing of an oblique side view of an artificial tricuspid valve 5200 having three support structures 102-1, 102-2 and 102-3 according to an embodiment. Figure 53G The illustration shows a CAD drawing of another side view of an artificial tricuspid valve 5200 having three support structures 102-1, 102-2 and 102-3 according to an embodiment.

[0260] In an embodiment of the artificial tricuspid valve 5200 having three support structures 102-1, 102-2, and 102-3, the first support structure 102-1 does not form an atrial arm 106-1 or a ventricular arm 106-2. The second support structure 102-2 forms a ventricular arm 106-2. The third support structure 102-3 forms an atrial arm 106-1. The three support structures 102-1, 102-2, and 102-3 are configured to fit together to form the artificial tricuspid valve 5200. As described throughout this disclosure, at least one of the three support structures 102-1, 102-2, and 102-3 includes a cylindrical portion defining an elongated central passage 104 of the artificial tricuspid valve 5200. For example, in the implementation of the artificial tricuspid valve 5200 with the three support structures 102-1, 102-2, and 102-3 depicted in Figures 52 and 53, each of the three support structures 102-1, 102-2, and 102-3 includes a cylindrical portion 116-1, 116-2, and 116-3, which defines an elongated central passage 104 of the artificial tricuspid valve 5200. However, in an alternative embodiment, only one or two of the three support structures 102-1, 102-2, and 102-3 may include a cylindrical portion for defining the elongated central passage 104 of the artificial tricuspid valve 5200.

[0261] Like the artificial tricuspid valves 4600, 4800, and 5000, the advantages of forming the artificial tricuspid valve 5200 from three support structures 102-1, 102-2, and 102-3 include a simpler manufacturing process. Additionally, another advantage of forming the artificial tricuspid valve 5200 from three support structures 102-1, 102-2, and 102-3, similar to the artificial tricuspid valves 4800 and 5000, is that the leaflet element can be formed from the first support structure 102-1 without the atrial arm 106-1, thus allowing the atrial sealing skirt, as discussed above, to be formed separately from the leaflet element by the third support structure 102-3 forming the atrial arm 106-1. By forming the atrial sealing skirt separately from the leaflet element formed by the third support structure 102-3, the assembly of the individual support structures 102-1 and 102-3 is simpler, and the atrial sealing skirt can be laminated. However, the assembly of the artificial tricuspid valve 5200 still involves the additional step of fitting the three support structures 102-1, 102-2, and 102-3 together to form the artificial tricuspid valve 5200. Another advantage of forming the artificial tricuspid valve 5200 from the three support structures 102-1, 102-2, and 102-3 is the improved load distribution, because 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. Furthermore, unlike the artificial tricuspid valves 4600, 4800, and 5000 described above, the arm 106 extends such that the fulcrum appears at multiple different locations besides the node receiving load forces, which effectively produces a larger load distribution and therefore makes the artificial tricuspid valve 5200 less prone to breakage. However, disadvantageously, the artificial tricuspid valve 5200, formed by three support structures 102-1, 102-2 and 102-3, results in an increase in the overall volume and diameter of the artificial tricuspid valve 5200.

[0262] Figure 54A The illustration shows a side view of the atrial arm 106-1 and ventricular arm 106-2 of the artificial tricuspid valve 100 in a resting state, according to an embodiment. In other words, Figure 54A The illustration 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 into the natural tricuspid valve.

[0263] Figure 54B The illustration shows a side view of the atrial arm 106-1 and ventricular arm 106-2 of the artificial tricuspid valve when the artificial tricuspid valve 100 is implanted into the natural tricuspid valve, according to an embodiment. In other words, Figure 54B The illustration shows a side view of the atrial arm 106-1 and ventricular arm 106-2 of the artificial tricuspid valve 100 when arm 106 is clamped onto the natural leaflet of the natural tricuspid valve—in which the artificial tricuspid valve 100 is implanted. Figure 54A As shown, when the artificial tricuspid valve 100 is at rest, the amount of overlocking 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.

[0264] Figure 55 The illustration shows a CAD drawing of a cross-sectional side view of an artificial tricuspid valve 5200 having three support structures 102-1, 102-2, and 102-3 according to an embodiment. As mentioned above, the first support structure 102-1 does not form an atrial arm 106-1 or a ventricular arm 106-2. The second support structure 102-2 forms a ventricular arm 106-2, and the third support structure 102-3 forms an atrial arm 106-1. The three support structures 102-1, 102-2, and 102-3 are configured to fit together to form the artificial tricuspid valve 5200. Specifically, in order to fit the three support structures 102-1, 102-2, and 102-3 together to form the artificial tricuspid valve 5200, 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. Additionally, in order to assemble the three support structures 102-1, 102-2, and 102-3 together to form an artificial tricuspid valve 5200, 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 V-shaped strut 2200-3 of the support structure 102-3 that forms the atrial arm 106-1.

[0265] Furthermore, in order for the three support structures 102-1, 102-2, and 102-3 to be fitted together to form an 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 defining the elongated central channel 104 of at least one support structure is smaller than the maximum outer diameter of the elongated central channel 104. As discussed above, in the implementation of the artificial tricuspid valve 5200, each of the three support structures 102-1, 102-2, and 102-3 includes cylindrical portions 116-1, 116-2, and 116-3, respectively, which define the elongated central channel 104 of the artificial tricuspid valve 5200. Therefore, in some embodiments, the minimum inner diameter of the three support structures 102-1, 102-2, and 102-3 defining the cylindrical portions 116-1, 116-2, and 116-3 of the elongated central channel 104 may be smaller than the maximum outer diameter of the elongated central channel 104. As another example, in some embodiments, the minimum diameter of the radius of curvature of each bend of each arm 106—wherein the arm 106 extends vertically away from the central axis of the elongated central channel 104—is smaller than the outer diameter of the elongated central channel 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 minimum diameter of the radius of curvature of the second bend 126 of each ventricular arm 106-2 is smaller than the maximum outer diameter of the elongated central channel 104. These relative dimensions can facilitate the fitting of the three support structures 102-1, 102-2, and 102-3 together to form an artificial tricuspid valve 5200.

[0266] Figures 56A to 56C This is an image of the original artificial tricuspid valve 5600 according to the implementation method. Specifically, Figure 56A It is a top view of an image of the original artificial tricuspid valve 5600 sandwiched on paper according to an embodiment, the paper being oriented substantially perpendicular (e.g., 90º+ / -45º) to the central axis of the elongated central channel 104 of the artificial tricuspid valve 5600. Figure 56B Figure 55 is a bottom view of an image of a proto-artificial tricuspid valve 5600 sandwiched on paper according to an embodiment, the paper being oriented substantially perpendicular (e.g., 90º + / - 45º) to the central axis of the elongated central channel 104 of the proto-artificial tricuspid valve 5600. Figure 56 is a side view of an image of a proto-artificial tricuspid valve 5600 sandwiched on paper according to an embodiment, the paper being oriented substantially perpendicular (e.g., 90º + / - 45º) to the central axis of the elongated central channel 104 of the proto-artificial tricuspid valve 5600.

[0267] Figure 57 This is a bottom view of the original artificial tricuspid valve 5700 according to the implementation method. Figure 57In the embodiment of the artificial tricuspid valve 5700 described herein, the two ventricular arms are different from the ventricular arms 106-2 described throughout this disclosure. Specifically, in Figure 57 In the embodiment of the artificial tricuspid valve 5700 depicted herein, the ventricular guide arm 5701 is modified to be a different ventricular arm from the ventricular arms 106-2 described throughout this disclosure. Specifically, the distal segment 110 of each ventricular guide arm 5701 has been modified to extend toward the ventricular end 120 of the cylindrical portion 116 of at least one support structure 102. This extension of the distal segment 110 of each ventricular guide arm 5701 toward the ventricular end 120 of the cylindrical portion 116 of at least one support structure 102 causes the distal segment 110 of each ventricular guide arm 5701 to contact the natural leaflet of the natural tricuspid valve on the atrial side of the natural artificial tricuspid valve, rather than on the ventricular side, thereby holding the natural leaflet in an open position radially outward relative to the natural tricuspid valve.

[0268] Configuring the ventricular guide arm 5701 to hold the natural leaflets in an open position radially outward relative to the natural tricuspid valve can be useful in many different embodiments. For example, configuring the ventricular guide arm 5701 to hold the natural leaflets in an open position radially outward relative to the natural tricuspid valve can be useful in embodiments where it is difficult to capture the natural leaflets by arm 106 for one reason or another (e.g., if the natural leaflets are too small or restricted). As another example, configuring the ventricular guide arm 5701 to hold the natural leaflets in an open position radially outward relative to the natural tricuspid valve can be useful for minimizing the number of echocardiographic planes and / or viewpoints required during implantation of the prosthetic tricuspid valve (thus simplifying the implantation procedure). In these embodiments, instead of attempting to capture all three natural leaflets of the natural tricuspid valve, one or more natural leaflets can be pushed aside as described above, and the remaining natural leaflets can be captured by arm 106. Although the artificial tricuspid valve 5700 includes two ventricular guide arms 5701, in alternative embodiments, the artificial tricuspid valve 5700 may include any number of ventricular guide arms 5701, such as zero, one, two, three or more ventricular guide arms 5701.

[0269] Figure 58 The illustration shows a CAD drawing of an oblique side view of an artificial tricuspid valve 5800 having three support structures 102-1, 102-2, and 102-3 according to an embodiment. The artificial tricuspid valve 5800 is similar to those shown in Figures 52 and 53. Figure 55 The artificial tricuspid valve 5200 is depicted in the text. However, as mentioned above... Figure 57As described, the artificial tricuspid valve 5800 includes two ventricular guide arms 5701. Like the ventricular arm 106-2, the ventricular guide arm 5701 is formed by a second support structure 102-2.

[0270] Figure 59 The illustration shows a view of the flattened support structure 102 of the artificial tricuspid valve according to an embodiment. Figure 59 As shown, the support structure 102 includes an atrial end 118 and a ventricular end 120. Multiple interlocking mechanisms 5900 are included at the atrial end 118 of the support structure 102. (See below for details.) Figure 59 As discussed, each interlocking mechanism 5900 of the support structure 102 is configured to interlock with the corresponding interlocking mechanism 3600 of the expansion arm 2300.

[0271] Figure 60 The illustration shows the loading, locking, and releasing of the interlocking mechanism 5900 of the support structure 102 of the artificial tricuspid valve according to an embodiment. Specifically, as... Figure 60 As shown, each interlocking mechanism 5900 of the support structure 102 is interlocked with the corresponding interlocking mechanism 3600 of the expansion arm 2300.

[0272] The loading, locking, and releasing of the interlocking mechanism 5900 of the support structure 102 are accomplished using the extension 3602 of each interlocking mechanism 3600 of each expansion arm 2300. Specifically, during the loading of the interlocking mechanism 5900 of the support structure 102 and the corresponding interlocking mechanism 3600 of the expansion arm 2300, the extension 3602 of the interlocking mechanism 3600 of the expansion arm 2300 is partially retracted from the interlocking mechanism 5900 of the support structure 102, thereby pushing the interlocking mechanism 3600 of the expansion arm 2300 to one side and enabling the interlocking mechanism 5900 of the support structure 102 to engage with the interlocking mechanism 3600 of the expansion arm 2300 in a locked position. During the locking of the interlock mechanism 5900 of the support structure 102 and the corresponding interlock mechanism 3600 of the expansion arm 2300, the extension 3602 of the interlock mechanism 3600 of the expansion arm 2300 is fully advanced onto the interlock mechanism 5900 of the support structure 102, thereby locking the interlock mechanism 3600 of the expansion arm 2300 and the interlock mechanism 5900 of the support structure 102 into the locked position. During the release of the interlock mechanism 5900 of the support structure 102 from the corresponding interlock mechanism 3600 of the expansion arm 2300, the extension 3602 of the interlock mechanism 3600 of the expansion arm 2300 is fully retracted from the interlock mechanism 5900 of the support structure 102, thereby allowing the interlock mechanism 5900 of the support structure 102 to expand and release from the locked position with the interlock mechanism 3600 of the expansion arm 2300.

[0273] Figure 61The illustration shows a view of a flat support structure 102 configured to form the ventricular arm 106-2 of an artificial tricuspid valve according to an embodiment.

[0274] Figure 62A This is an image of the original support structure 102 for forming the ventricular arm 106-2 of the artificial tricuspid valve according to the embodiment.

[0275] Figure 62B This is an image of the original support structure 102 that forms the ventricular arm 106-2 and ventricular guide arm 5701 of the artificial tricuspid valve according to the embodiment.

[0276] Figures 63A to 63B The illustration shows a CAD drawing of the support structure 102 for forming the ventricular arm 106-2 of the artificial tricuspid valve according to an embodiment. Specifically, Figure 63A The illustration shows a top view of a CAD drawing of the support structure 102 for forming the ventricular arm 106-2 of the artificial tricuspid valve according to an embodiment. Figure 63B The illustration shows a side view of a CAD drawing of the support structure 102 for forming the ventricular arm 106-2 of the artificial tricuspid valve according to an embodiment.

[0277] Figures 64A to 64B The illustration shows a CAD drawing of the support structure 102 for forming the ventricular arm 106-2 and the ventricular guide arm 5701 of the artificial tricuspid valve according to an embodiment. Specifically, Figure 64A The illustration shows a top view of a CAD drawing of the support structure 102 formed by the ventricular arm 106-2 and the ventricular guide arm 5701 of the artificial tricuspid valve according to an embodiment. Figure 64B The illustration shows a side view of a CAD drawing of the support structure 102 that forms the ventricular arm 106-2 and the ventricular guide arm 5701 of the artificial tricuspid valve according to an embodiment.

[0278] Figure 65 The illustration shows a view of the flat support structure 102 configured to form the atrial arm 106-1 of the artificial tricuspid valve according to an embodiment. Figure 65 As shown, the tip 142 of each atrial arm 106-1 may include a locking mechanism 6500. Each locking mechanism 6500 of the support structure 102 is configured to lock in a corresponding constraint 410 (e.g., a suture).

[0279] During the loading of the locking mechanism 6500, the narrow opening 6501 of each locking mechanism 6500 allows the corresponding constraint member 410 to enter the locking mechanism 6500 and lock the corresponding constraint member in place. During the locking of the locking mechanism 6500, the teeth 6502 of each locking mechanism 6500 prevent the corresponding locking constraint member 410 from leaving the locking mechanism 6500 through the narrow opening 6501 when the constraint member 410 is under tension. During the release of the locking mechanism 6500, when the tension is removed from the constraint member 410, the constraint member 410 is allowed to leave the locking mechanism 6500 through the narrow opening 6501.

[0280] Figure 66 The illustration shows a CAD drawing of a side view of an artificial tricuspid valve 5800 according to an embodiment. Also as... Figure 66 As shown, the distal segment 116 of each atrial arm 106-1 extends from the atrial end 118 of the cylindrical portions 116 of the support structures 102-1, 102-2, and 102-3, but towards the ventricular end 120 of the cylindrical portions 116 of the support structures 102-1, 102-2, and 102-3. Conversely, the distal segment 110 of each ventricular arm 106-2 extends from the ventricular end 120 of the cylindrical portions 116 of the support structures 102-1, 102-2, and 102-3, but towards the atrial end 118 of the cylindrical portions 116 of the support structures 102-1, 102-2, and 102-3. Therefore, as discussed above, overbite occurs between the atrial arms 106-1 and the ventricular arms 106-2. Figure 66 The dashed line crossing the artificial tricuspid valve at 580° depicts the occlusal point between the atrial arm 106-1 and the ventricular arm 106-2. (As shown...) Figure 66 As shown, the overbite between atrial arm 106-1 and ventricular arm 106-2 allows atrial arm 106-1 and ventricular arm 106-2 to clamp the natural leaflet 500-2 of the natural tricuspid valve between them. Conversely, as Figure 66 As shown, the ventricular guide arm 5701 is configured to hold the natural leaflet 500-1 in the open position relative to the natural tricuspid valve radially outward.

[0281] In addition, such as Figure 66 As shown, the tip 142 of each atrial arm 106-1 includes an extension segment 2400 having a third bend at the atrial end 118 toward the cylindrical portion 116 of the support structures 102-1, 102-2, and 102-3, for a more non-invasive joining of the atrial surface of the natural leaflet. Similarly, as Figure 66As shown, the tip 140 of the ventricular guide arm 5701 includes an extension segment having a third bend at the ventricular end 120 toward the cylindrical portion 116 of the support structures 102-1, 102-2, and 102-3, for a more non-invasive engagement with the atrial surface of the natural leaflet 500-1. These third bends of the atrial arm 106-1 and the ventricular guide arm 5701 also prevent the atrial arm 106-1 and the ventricular guide arm 5701 from embedding into the tissue of the natural leaflet.

[0282] Figures 67A to 67C The illustration shows a side view of the overbite between the atrial arm 106-1 and the ventricular arm 106-2 of the artificial tricuspid valve according to an embodiment. Specifically, Figures 67A to 67C The illustration shows a side view of the variable overlocking between the atrial arm 106-1 and the ventricular arm 106-2 of the artificial tricuspid valve according to an embodiment. The amount of overlocking 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 arm 106 on the natural leaflet of the natural tricuspid valve. Furthermore, the magnitude of the clamping force of arm 106 on the natural leaflet of the natural tricuspid valve determines the amount of biodynamic motion of the artificial tricuspid valve within the natural tricuspid valve throughout the cardiac cycle.

[0283] Figure 67A The illustration shows a side view of a relatively small amount of overbite between the atrial arm 106-1 and the ventricular arm 106-2 of an artificial tricuspid valve according to an embodiment. Due to... Figure 67A The relatively small amount of overlocking between the atrial arm 106-1 and ventricular arm 106-2 of the artificial tricuspid valve allows a relatively small amount of tension to be applied to the natural leaflets sandwiched between the atrial and ventricular arms 106-1 and 106-2. Furthermore, due to this relatively small amount of tension applied to the natural leaflets sandwiched between the atrial and ventricular arms 106-1 and 106-2, the artificial tricuspid valve is able to exhibit a relatively large amount of biodynamic motion within the natural tricuspid valve throughout the entire cardiac cycle.

[0284] Figure 67B The illustration shows a side view of the relatively appropriate overbite between the atrial arm 106-1 and the ventricular arm 106-2 of the artificial tricuspid valve according to an embodiment. Due to... Figure 67B The relatively appropriate overlocking between the atrial arm 106-1 and ventricular arm 106-2 of the artificial tricuspid valve allows a relatively appropriate amount of tension to be applied to the natural leaflets sandwiched between the atrial and ventricular arms 106-1 and 106-2. Furthermore, due to this relatively appropriate tension applied to the natural leaflets sandwiched between the atrial and ventricular arms 106-1 and 106-2, the artificial tricuspid valve can exhibit a relatively appropriate amount of biodynamic motion within the natural tricuspid valve throughout the entire cardiac cycle.

[0285] Figure 67C The illustration shows a side view of the relatively large overbite between the atrial arm 106-1 and the ventricular arm 106-2 of the artificial tricuspid valve according to an embodiment. Due to... Figure 67C The relatively large overlap between the atrial arm 106-1 and the ventricular arm 106-2 of the artificial tricuspid valve allows for a relatively large amount of tension to be applied to the natural leaflets sandwiched between the atrial and ventricular arms 106-1 and 106-2. Furthermore, due to this relatively large amount of tension applied to the natural leaflets sandwiched between the atrial and ventricular arms 106-1 and 106-2, the artificial tricuspid valve can exhibit a relatively large amount of biodynamic motion within the natural tricuspid valve throughout the entire cardiac cycle.

[0286] Figures 68A to 68B The illustrations show different implementations of the atrial sealing skirt 204 according to the embodiments. Specifically, Figure 68A The illustration shows a symmetrical implementation of the atrial sealing skirt 204 according to an embodiment. Figure 68B The illustration shows an asymmetric implementation of the atrial sealing skirt 204 according to an embodiment.

[0287] Figure 68A The symmetrical atrial sealing skirt 204 depicted can be used in symmetrical artificial tricuspid valve devices, such as... Figure 62A and Figures 64A to 64B The artificial tricuspid valve device depicted in the text. Specifically, Figure 68A The symmetrical atrial sealing skirt 204 depicted can be used in artificial tricuspid valve devices with symmetrical ventricular arms (e.g., only ventricular arms 106-2).

[0288] On the contrary, Figure 68B The asymmetric atrial sealing skirt 204 described herein can be used in asymmetric artificial tricuspid valve devices, such as... Figure 62B and Figure 65 The artificial tricuspid valve device depicted in the text. Specifically, Figure 68B The asymmetric atrial sealing skirt 204 depicted can be used in artificial tricuspid valve devices with asymmetric ventricular arms (e.g., ventricular arms 106-2 and ventricular guide arms 5701).

[0289] The protrusion of the atrial sealing skirt 204 aligned with the elongated central channel 104 can be folded down to connect another portion of the cover 200 extending inside the cylindrical portion 116 of at least one support structure 102 of the prosthetic tricuspid valve. The opening 300 of the atrial sealing skirt 204 allows space for the ventricular arm 106-2 to pass through the atrial sealing skirt 204 during prosthetic tricuspid valve assembly, such that once the prosthetic tricuspid valve is assembled, the ventricular arm 106-2 is located outside the elongated central channel 104 of the prosthetic tricuspid valve. In some embodiments, Figure 68B The asymmetrical portion of the asymmetrical atrial sealing skirt 204 may also include an additional fenestration 300, which is positioned within the natural annulus of the natural tricuspid valve when the artificial tricuspid valve is implanted into the natural tricuspid valve.

[0290] Figures 69A to 69B These are images of the support structures 102-2 and 102-3 of the original artificial tricuspid valve 6900 according to the embodiment. Specifically, Figure 69A These are bottom view images of the support structures 102-2 and 102-3 of the original artificial tricuspid valve 6900 according to the embodiment. Figure 69B These are images of the side views of the support structures 102-2 and 102-3 of the original artificial tricuspid valve 6900 according to the embodiment.

[0291] Artificial tricuspid valve 6900 is similar Figures 56A to 56C The original artificial tricuspid valve 5600 includes three support structures 102-1, 102-2 and 102-3. Figure 74 (As shown in the image). However, Figures 69A to 69B The image depicts only the support structures 102-2 and 102-3 of the original artificial tricuspid valve 6900. As described below, the first support structure 102-1 does not form the atrial arm 106-2 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. Figures 69A to 69B As shown, Figure 68A The symmetrical atrial sealing skirt 204 covers the symmetrical support structures 102-2 and 102-3 of the original artificial tricuspid valve 6900.

[0292] Figures 70A to 70B These are images of the support structures 102-2 and 102-3 of the original artificial tricuspid valve 7000 according to the embodiment. Specifically, Figure 70A These are bottom view images of the support structures 102-2 and 102-3 of the original artificial tricuspid valve 7000 according to the embodiment. Figure 70B These are images of the side views of the support structures 102-2 and 102-3 of the original artificial tricuspid valve 7000 according to the embodiment.

[0293] The original artificial tricuspid valve 7000 is similar to Figure 57 The original artificial tricuspid valve 5700 includes three support structures 102-1, 102-2, and 102-3. However, Figures 70A to 70B The images in the image only depict the support structures 102-2 and 102-3 of the original artificial tricuspid valve 7000. (For example...) Figures 70A to 70B As shown, Figure 68B The asymmetrical atrial sealing skirt 204 covers the symmetrical support structures 102-2 and 102-3 of the original artificial tricuspid valve 7000.

[0294] Figure 71 This is a top view image of the support structure 102-3 of the original artificial tricuspid valve 6900 according to the embodiment. Figure 71 As shown, the atrial sealing skirt 204 of the support structure 102-3 of the artificial tricuspid valve 6900 includes a window 300 configured to allow the ventricular arm 106-2 to pass through the atrial sealing skirt 204 during the assembly of the artificial tricuspid valve 6900, such that once the artificial tricuspid valve 6900 is assembled, the ventricular arm 106-2 is located outside the elongated central passage 104 of the artificial tricuspid valve 6900.

[0295] Figures 72A to 72B These are images of the support structures 102-2 and 102-3 of the original artificial tricuspid valve 6900 according to the embodiment. Specifically, Figure 72A These are top view images of the support structures 102-2 and 102-3 of the original artificial tricuspid valve 6900 according to the embodiment. Figure 72B These are images of the side views of the support structures 102-2 and 102-3 of the original artificial tricuspid valve 6900 according to the embodiment.

[0296] As mentioned above Figures 69A to 69B The artificial tricuspid valve 6900 discussed includes three support structures 102-1, 102-2, and 102-3 ( Figure 74 (As shown in the image). However, Figures 72A to 72B The images depict only the support structures 102-2 and 102-3 of the original artificial tricuspid valve 6900. As discussed below, the first support structure 102-1 does not form 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.

[0297] Three support structures 102-1, 102-2, and 102-3 are configured to fit together to form an artificial tricuspid valve 6900. Specifically, in order to fit the three support structures 102-1, 102-2, and 102-3 together to form the artificial tricuspid valve 6900, the radius of curvature of the second bend 130 of each atrial arm 106-1 is determined by the first support structure 102-1 ( Figure 74 The V-shaped strut 2200-1 (as shown in the diagram) receives the support. Additionally, in order to assemble the three support structures 102-1, 102-2, and 102-3 together to form the artificial tricuspid valve 6900, the radius of curvature of the second bend 126 of each ventricular arm 106-2 is determined by the support structure 102-1 (…). Figure 74 The V-shaped support 2200-1 (as shown in the figure) receives and also contacts the V-shaped support 2200-3 mirror image of the support structure 102-3 forming the atrial arm 106-1.

[0298] It should be noted that although the artificial tricuspid valve 6900 is constructed to include support structure 102-1 in addition to support structures 102-2 and 102-3, it also includes support structure 102-1. Figure 74 (As shown in the diagram), but in some embodiments, the artificial tricuspid valve does not require three support structures. Instead, in some embodiments, such as those of artificial tricuspid valves 4600, 4800, and 5000, the artificial tricuspid valve may include only two support structures. In these embodiments, the arm 106 of the artificial tricuspid valve will have only less reinforcement, as described in detail above and below.

[0299] Figure 73 The illustration shows an atrial sealing skirt 204 including a ventricular arm sleeve 7300 according to an embodiment, the ventricular arm sleeve being configured to encapsulate the ventricular arm 106-2 of the support structure 102. (See illustration for further details.) Figure 73 As shown, in some embodiments, the atrial sealing skirt 204 may include one or more ventricular arm sleeves 7300, each ventricular arm sleeve 7300 configured to encapsulate a corresponding ventricular arm 106-2 of the support structure 102. For example, each ventricular arm sleeve 7300 may be configured as a strip extending from the atrial sealing skirt 204 to cover the support structure 102. To encapsulate the ventricular arm 106-2, the strip extending from the atrial sealing skirt 204 may be folded over the ventricular arm 106-2 and sewn shut around the ventricular arm 106-2.

[0300] Encapsulating the ventricular arm 106-2 with a ventricular arm cannula 7300 can promote inward growth of the ventricular arm 106-2 within the natural tricuspid valve leaflet during implantation of the prosthetic tricuspid valve. Encapsulating the ventricular arm 106-2 with a ventricular arm cannula 7300 also provides non-invasive contact between the ventricular arm 106-2 and the natural tricuspid valve leaflet during implantation of the prosthetic tricuspid valve. Furthermore, encapsulating the ventricular arm 106-2 with a ventricular arm cannula 7300 can serve as a fail-safe protection against embolism in the event of rupture of the ventricular arm 106-2 during implantation of the prosthetic tricuspid valve.

[0301] Figure 74 This is an image of a side view of the original artificial tricuspid valve 6900 according to the implementation method. (As mentioned above regarding...) Figures 69A to 69B The described artificial tricuspid valve 6900 includes three support structures 102-1, 102-2, and 102-3. The first support structure 102-1 does not form an atrial arm 106-1 or a ventricular arm 106-2. The second support structure 102-2 forms a ventricular arm 106-2, and the third support structure 102-3 forms an atrial arm 106-1.

[0302] Three support structures 102-1, 102-2, and 102-3 are configured to fit together to form an artificial tricuspid valve 6900. Specifically, for the three support structures 102-1, 102-2, and 102-3 to fit together to form the artificial 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. Furthermore, for the three support structures 102-1, 102-2, and 102-3 to fit together to form the artificial 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 V-shaped strut 2200-3 mirror image of the support structure 102-3 forming the atrial arm 106-1.

[0303] Furthermore, in order to fasten the three support structures 102-1, 102-2, and 102-3 together to form an artificial tricuspid valve 6900, support structures 102-2 and 102-3 are each fastened to support structure 102-1. Specifically, as... Figure 74 As depicted, in order to secure the support structure 102-3 to the support structure 102-1, each atrial arm 106-1 formed by the support structure 102-3 has an eyelet 3502 ( Figure 35 (As shown) it is fastened to the corresponding hole in the support structure 102-1. Also as... Figure 74 As depicted, in order to fasten the support structure 102-2 to the support structure 102-1, the three nodes of the support structure 102-2 are fastened to the support structure 102-1.

[0304] Figures 75 to 79 The illustrations depict different implementations of an artificial tricuspid valve with varying numbers of support structures, according to various embodiments. Specifically, Figures 75 to 79 The illustration shows different load distributions for different implementations of an artificial tricuspid valve with different numbers of support structures, according to various embodiments.

[0305] like Figures 75 to 79 As shown in each figure, when the artificial tricuspid valve is implanted into the natural tricuspid valve throughout the cardiac cycle, an atrial guiding force 7501 is generated by each ventricular arm 106-2 of the artificial tricuspid valve due to the ventricular systolic pressure load from the heart. Conversely, a ventricular guiding force 7500 is generated by each atrial arm 106-1 of the artificial tricuspid valve due to the tension of the natural leaflets in response to the ventricular systolic pressure load. As indicated by the size of the arrows for force 7500 and force 7501, the magnitude of the atrial guiding force 7501 generated by the ventricular arm 106-2 is much larger than the ventricular guiding force 7500 generated by the atrial arm 106-1. Therefore, as described below, the distribution of the atrial guiding force 7501 generated by the ventricular arm 106-2 is more important than the distribution of the ventricular guiding force 7500 generated by the atrial arm 106-1 for maintaining the integrity of the artificial tricuspid valve.

[0306] Depending on the configuration of the artificial tricuspid valve, and particularly depending on the number of support structures including the artificial tricuspid valve, the load nodes 7502 and fulcrum 7503 can be distributed in different ways throughout the artificial tricuspid valve, and therefore, forces 7500 and 7501 can be distributed in different ways throughout the artificial tricuspid valve. Figures 75 to 79 Each different configuration of the artificial tricuspid valve and its load node 7502 and fulcrum 7503 are depicted, and thus the distribution of its forces 7500 and 7502 is depicted.

[0307] Figure 75 The illustration shows the load distribution for an artificial tricuspid valve 4400 having a support structure 102 according to an embodiment. In this embodiment of the artificial tricuspid valve 4400 having a support structure 102, both the atrial arm 106-1 and the ventricular arm 106-2 are formed by the support structure 102.

[0308] like Figure 75 As shown, the artificial tricuspid valve 4400 has a single load node 7502 and a single fulcrum 7503 located in the same general position as a support structure 102. Furthermore, there is no additional support structure for supporting the ventricular arm 106-2. Therefore, the distribution of the atrial guiding force 7501 generated by the ventricular arm 106-2 is minimal, which effectively makes the artificial tricuspid valve more susceptible to breakage.

[0309] Figure 76 The illustration shows the load distribution for an artificial tricuspid valve 4800 having two support structures 102-1 and 102-2 according to an embodiment. In the embodiment of the artificial 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.

[0310] like Figure 76 As shown, the artificial tricuspid valve 4800 has a load node 7502 located on each of the two support structures 102-1 and 102-2. Both load nodes 7502 are located at the same general location of a single fulcrum 7503. Furthermore, support structure 102-1 supports the atrial arm 106-1 formed by support structure 102-2, but not the ventricular arm 106-2. Therefore, most of the improved load distribution in the artificial tricuspid valve 4800 occurs in the atrial arm 106-1, which is less significant because the atrial arm 106-1 experiences less force than the ventricular arm 106-2 when the artificial tricuspid valve 4800 is implanted in the body as described above. The distribution of the atrial guiding force 7501 generated by the ventricular arm 106-2 is not improved relative to the artificial tricuspid valve 4400.

[0311] Figure 77 The illustration shows the load distribution for an artificial tricuspid valve 5000 having two support structures 102-1 and 102-2 according to an embodiment. In this embodiment of the artificial tricuspid valve 5000 having two support structures 102-1 and 102-2, the first support structure 102-1 does not form an atrial arm 106-1 or a ventricular arm 106-2. The second support structure 102-2 forms both the atrial arm 106-1 and the ventricular arm 106-2.

[0312] like Figure 77 As shown, the artificial tricuspid valve 5000 has a load node 7502 located on each of the two support structures 102-1 and 102-2. Both load nodes 7502 are located at the same general location of a single fulcrum 7503. However, unlike the artificial tricuspid valve 4800, the distribution of the atrial guiding force 7501 generated by the ventricular arm 106-2 is improved relative to the artificial tricuspid valve 4400 because the support structure 102-1 provides additional support for the ventricular arm 106-2 formed by the support structure 102-2. The support structure 102-1 also provides additional support for the atrial arm 106-1 formed by the support structure 102-2.

[0313] Figure 78The illustration shows the load distribution for an artificial tricuspid valve 4600 having two support structures 102-1 and 102-2 according to an embodiment. In the embodiment of the artificial 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.

[0314] like Figure 78 As shown, the artificial tricuspid valve 4600 has a load node 7502 located on each of the two support structures 102-1 and 102-2. However, unlike the artificial tricuspid valves 4800 and 5000, the two load nodes 7502 are not located in the same general location. A single fulcrum 7503 is located in the same general location as only one of the two load nodes 7502. Furthermore, the support structure 102-1 provides additional support for the ventricular arm 106-2 formed by the support structure 102-2. Therefore, the distribution of the atrial guiding force 7501 generated by the ventricular arm 106-2 and the distribution of the ventricular guiding force 7500 generated by the atrial arm 106-1 are improved relative to the artificial tricuspid valves 4400, 4800, and 5000.

[0315] Figure 79 The illustration shows the load distribution for an artificial tricuspid valve 5200 having three support structures 102-1, 102-2, and 102-3 according to an embodiment. In this embodiment of the artificial tricuspid valve 5200 having three support structures 102-1, 102-2, and 102-3, the first support structure 102-1 does not form the atrial arm 106-1 and 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.

[0316] like Figure 79 As shown, the artificial tricuspid valve 5200 has a load node 7502 located on each of the three support structures 102-1, 102-2, and 102-3. The three load nodes 7502 are not located at the same general location as a single fulcrum 7503. Furthermore, 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. Therefore, the distribution of the atrial guiding force 7501 generated by the ventricular arm 106-2 and the ventricular guiding force 7500 generated by the atrial arm 106-1 is maximized in the artificial tricuspid valve 5200 compared to artificial tricuspid valves 4400, 4800, 5000, and 4600.

[0317] Figure 80 The illustration shows a CAD drawing of a cross-sectional side view of an artificial tricuspid valve 5200 according to an embodiment. Figure 80 The diagram shows the central axis 8000 of the elongated central channel 104 of the cylindrical portion 116 of at least one of the three support structures 102-1, 102-2 and 102-3.

[0318] As discussed in detail above, the distal segment 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) extends vertically away from the central axis 8000 of the elongated central channel 104 for attaching the artificial tricuspid valve 5200 to a target (e.g., a natural tricuspid leaflet). As mentioned herein, the "vertical" extension of the distal segment of arm 106 away from the central axis 8000 of the elongated central channel 104 means that the distal segment of arm 160 extends away from the central axis 8000 of the elongated central channel 104, such that a line 8001 drawn from the contact point 8002 between the distal segment of arm 106 and the target (e.g., a natural tricuspid leaflet) to a 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, and 102-3—from which the distal segment extends—is oriented at approximately 90° + / - 45° to the central axis 8000 of the elongated central channel 104. In some embodiments, the contact point 8002 of the distal segment of arm 106 may be the tip 140 or 142 of arm 106. In an alternative embodiment where the distal segment of arm 106 includes an extension segment with a third bend, the contact point 8002 of the distal segment of arm 106 may be the extension segment of arm 106, or more specifically, the third bend of arm 106. The contact point 8002 of the distal segment of arm 106 may also be any other portion of the distal segment of arm 106. As discussed in further detail below, this approximately perpendicular line 8001 from the contact point 8002 of the distal segment to a longitudinal position 8003 along the outer surface 147 of the cylindrical portion 116—from which the distal segment extends—enables the artificial tricuspid valve 5200 to be axially stable within the natural tricuspid valve.

[0319] It should be understood that any particular order or hierarchy of blocks in the disclosed process is an illustration of the example method. Based on implementation preferences, it should be understood that the particular order or hierarchy of blocks in the process may be rearranged, or not all illustrated blocks may be executed. Any block may be executed concurrently. In one or more implementations, multitasking and parallel processing may be advantageous. Furthermore, the separation of the various system components in the implementations described above should not be construed as requiring such separation in all implementations, and it should be understood that the described program components and systems can generally be integrated with a single software product or packaged into multiple software products.

[0320] For example, the subject matter art is illustrated according to the various aspects described above. This disclosure is provided to enable those skilled in the art to practice the various aspects described herein. This disclosure provides various examples of the subject matter art, and the subject matter art is not limited to these examples. Various modifications with respect to these aspects will be apparent to those skilled in the art, and the general principles defined herein can be applied to other aspects.

[0321] References to singular elements are not intended to mean "one and only one," but rather "one or more." Unless otherwise specified, the term "some" refers to one or more. Masculine pronouns (e.g., his) include feminine and neuter pronouns (e.g., her and its), and feminine and neuter pronouns include masculine pronouns. Any headings and subheadings—if present—are used for convenience only and do not limit the invention.

[0322] The word “exemplary” is used herein to mean “serving as an example or illustration.” Any aspect or design described herein as “exemplary” is not necessarily to be construed as superior to or better than other aspects or designs. In one aspect, the various alternative configurations and operations described herein may be considered at least equivalent.

[0323] As used herein, the phrase "at least one of" preceding a series of items with the term "or" used to separate any items in the list modifies the list as a whole rather than each item in the list. The phrase "at least one of" does not require selection of at least one item; rather, the phrase allows for the inclusion of at least one item from any of the items in the list, and / or at least one item from any combination of items, and / or at least one item from each of the items in the list. As an example, the phrase "at least one of A, B, or C" can refer to only A, only B, or only C, or any combination of A, B, and C.

[0324] For example, phrases such as "aspect" do not imply that this aspect is essential to the subject matter or that this aspect applies to all configurations of the subject matter. Disclosures relating to an aspect may apply to all configurations or one or more configurations. An aspect may provide one or more examples. Phrases such as "one aspect" may refer to one or more aspects, and phrases such as "one or more aspects" may also refer to one aspect. Phrases such as "implementation" do not imply that such implementation is essential to the subject matter or that such implementation applies to all configurations of the subject matter. Disclosures relating to an implementation may apply to all implementations or to one or more implementations. An implementation may provide one or more examples. Phrases such as "one implementation" may refer to one or more implementations, and phrases such as "one or more implementations" may refer to one implementation. Phrases such as "configuration" do not imply that such configuration is essential to the subject matter or that such configuration applies to all configurations of the subject matter. Disclosures relating to a configuration may apply to all configurations or one or more configurations. A configuration may provide one or more examples. A phrase such as "a configuration" can refer to one or more configurations, and a phrase such as "one or more configurations" can refer to one configuration.

[0325] In one aspect, unless otherwise stated, all measurements, values, ratings, positions, sizes, dimensions, and other specifications set forth in this specification, including in the appended claims, are approximate and not precise. In one aspect, they are intended to have a reasonable range consistent with the function concerned and with the conventions of the art to which they pertain.

[0326] It should be understood that some or all of the steps, operations, or processes can be performed automatically without user intervention. Method claims may be provided to present elements of various steps, operations, or processes in an example sequence, but method claims are not intended to be limited to a particular order or hierarchy presented.

[0327] All structural and functional equivalents of the elements throughout the various aspects described in this disclosure, known or to be known by one of ordinary skill in the art, are expressly incorporated herein by reference and are intended to be covered by the appended claims. Furthermore, nothing disclosed herein is intended for public use, regardless of whether such disclosure is expressly referenced in the claims. No element of any claim shall be construed in accordance with 35 USC §112(f) unless it is expressly stated using the phrase “for a method of” or, in the case of a method, the phrase “for a step of”. Furthermore, with regard to the use of the terms “comprising,” “having,” or similar terms, such terms are intended to be inclusive rather than encompassing, as the term “comprising” is construed when used as a transitional term in a claim.

[0328] The title, background, brief description of the drawings, and claims of this disclosure are hereby incorporated in this disclosure and are provided as illustrative examples rather than as limiting descriptions. It should be understood at the time of filing that they are not intended to limit the scope or meaning of the claims. Furthermore, it will be apparent from the detailed description that it provides illustrative examples and that various features are combined in various embodiments for the purpose of simplifying the disclosure. The disclosed method should not be construed as reflecting an intention to require more features than expressly stated in any claim. Rather, as reflected in the following claims, the inventive subject matter lies in all features of fewer than those in a single disclosed configuration or operation. The following claims are hereby incorporated in the detailed description, wherein each claim independently represents a separate claimed subject matter.

[0329] The claims are not intended to limit themselves to the aspects described herein, but are given the full scope consistent with the language of the claims and include all legal equivalents. Nevertheless, none of the claims are intended to include subject matter that does not satisfy the requirements of 35 U.S.SC §101, 35 U.S.C §102, and 35 U.S.C §103, nor should they be interpreted in this manner.

Claims

1. An artificial heart valve, comprising: One or more support structures, wherein at least one support structure defines an elongated central channel; and Multiple lobular elements are attached to the at least one support structure and arranged within the elongated central channel to control blood flow through the elongated central channel. The at least one support structure is configured to biodynamically fix the artificial heart valve to the natural leaflet of the natural heart valve of the heart.

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

3. The artificial heart valve according to any one of claims 1 to 2, wherein: At least one of the one or more support structures includes a cylindrical portion, the cylindrical portion comprising an atrial end and a ventricular end. The elongated central channel is defined by the cylindrical portion of the at least one supporting structure. At least one of the one or more support structures includes an atrial arm assembly. At least one of the one or more support structures includes a ventricular arm assembly. Each arm in the atrial arm group and the ventricular arm group includes a proximal segment at the proximal end of the cylindrical portion of the at least one support structure and a distal segment at the distal end of the cylindrical portion of the at least one support structure. The distal segments of each arm in the atrial arm group and the ventricular arm group extend vertically away from the central axis of the elongated central channel. The atrial arm assembly is configured to contact the natural leaflet on the atrial side of the natural heart valve, and The ventricular arm assembly is configured to contact the natural leaflets on the ventricular side of the natural heart valve.

4. The artificial heart valve according to claim 3, wherein, The atrial arm assembly and the ventricular arm assembly are bent such that: In the at least one support structure, the artificial heart valve is biodynamically secured to the implantation configuration of the natural leaflet of the natural heart valve. If the cylindrical portion of the at least one support structure moves toward the atrial side of the natural heart valve due to ventricular systolic pressure load, one or more arms of the ventricular arm assembly resist the movement, while one or more arms of the atrial arm assembly relax to maintain contact with the atrial side of the natural leaflet, and If the cylindrical portion of the at least one support structure moves toward the ventricular side of the natural heart valve due to the elimination of ventricular diastolic pressure load and / or previously applied ventricular systolic load, one or more arms of the atrial arm group resist the movement, while one or more arms of the ventricular arm group relax to maintain contact with the ventricular side of the natural leaflet.

5. The artificial heart valve according to any one of claims 3 to 4, wherein, The arms of the atrial arm group and the arms of the ventricular arm group alternate around the circumference of the cylindrical portion of the at least one support structure, wherein the arms of the atrial arm group and the arms of the ventricular arm group extend across the cross-sectional plane of the cylindrical portion of the at least one support structure.

6. The artificial heart valve according to any one of claims 3 to 5, wherein: The distal portion of the vertically extending arm of the atrial arm assembly, away from the central axis of the elongated central channel, extends toward the ventricular end of the cylindrical portion of the at least one support structure, thereby enabling the distal portion of the vertically extending arm of the atrial arm assembly, away from the central axis of the elongated central channel, to clamp the natural leaflet onto the atrial side of the natural heart valve; and The distal end of the arm of the ventricular arm assembly extends vertically away from the central axis of the elongated central channel toward the atrial end of the cylindrical portion of the at least one support structure, thereby enabling the distal end of the arm of the ventricular arm assembly extending vertically away from the central axis of the elongated central channel to clamp the natural leaflet on the ventricular side of the natural heart valve.

7. The artificial heart valve according to any one of claims 3 to 6, wherein: Each distal segment of the vertically extending arm of the atrial arm assembly, away from the central axis of the elongated central channel, has a tip that bends toward the atrial end of the cylindrical portion of the at least one support structure, thereby reducing trauma to the atrial-side natural leaflets of the natural heart valve at the contact point of the atrial arm assembly; and Each distal segment of the arm of the ventricular arm assembly extending vertically away from the central axis of the elongated central channel has a tip that bends toward the ventricular end of the cylindrical portion of the at least one support structure, thereby reducing trauma to the natural leaflets on the ventricular side of the natural heart valve at the contact point of the ventricular arm assembly.

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

9. The artificial heart valve according to any one of claims 3 to 8, wherein, The distal segments of the atrial arm assembly and the ventricular arm assembly, which extend vertically away from the central axis of the elongated central channel, are elastically straightened.

10. The artificial heart valve according to any one of claims 3 to 9, wherein, The distal segments of one or more arms of the ventricular arm assembly extending vertically away from the central axis of the elongated central channel extend toward the ventricular end of the cylindrical portion of the at least one support structure, thereby enabling the distal segments of one or more arms of the ventricular arm assembly extending vertically away from the central axis of the elongated central channel to contact a natural leaflet located on the atrial side of the natural heart valve rather than on the ventricular side of the natural heart valve, thereby holding the natural leaflet in an open position radially outward relative to the natural heart valve.

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

12. The artificial heart valve of claim 11, further comprising a fenestration feature located in a portion of the one or more coverings.

13. The artificial heart valve according to claim 12, wherein, In the at least one support structure, the artificial heart valve is biodynamically secured to the implantation configuration of the natural leaflet of the natural heart valve, and the fenestration feature is arranged between the elongated central channel and the natural annulus of the natural heart valve.

14. The artificial heart valve according to any one of claims 12 to 13, wherein, The fenestration features include at least one of the following: a radiopaque marker, an opening, a magnetic element, a one-way valve, a pop-out valve, an opening capable of mechanical adjustment of size, and increased porosity.

15. The artificial heart valve according to any one of claims 11 to 14, wherein: The atrial arm assembly is attached to the ventricular end of the cylindrical portion of the at least one support structure. The ventricular arm assembly is attached to the atrial end of the cylindrical portion of the at least one support structure, and The one or more covers begin at and are attached to the distal segment of each arm in the atrial arm group, extend to and are attached to the proximal segment of each arm in the ventricular arm group, extend through the cylindrical portion of the at least one support structure within the elongated central channel, and extend around the cylindrical portion of the at least one support structure to be attached to the proximal segment of each arm in the atrial arm group.

16. The artificial heart valve according to claim 15, wherein, The one or more covers terminate at and are attached to a position along the proximal segment of each arm in the atrium arm group, the position being at a common distance from the cylindrical portion of the at least one support structure.

17. The artificial heart valve according to claim 15, wherein, The one or more covers further extend to and are attached to the distal segment of each arm in the ventricular arm group.

18. The artificial heart valve according to any one of claims 11 to 15 and 17, wherein, The one or more covers extend asymmetrically and / or non-circularly within the elongated channel and on one or more of the atrial arm group and the ventricular arm group.

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

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

21. The artificial heart valve according to claim 20, wherein, The proximal segment of each arm in the atrioventricular arm group extends from the ventricular end of the cylindrical portion of the at least one support structure along the outer surface of the cylindrical portion of the at least one support structure toward the atrial end of the cylindrical portion of the at least one support structure, and the distal segment of each arm in the atrioventricular arm group extends vertically away from the central axis of the elongated central channel.

22. The artificial heart valve according to any one of claims 20 to 21, wherein, The proximal segment of each arm in the ventricular arm group extends from the atrial end of the cylindrical portion of the at least one support structure along the outer surface of the cylindrical portion of the at least one support structure toward the ventricular end of the cylindrical portion of the at least one support structure, and the distal segment of each arm in the ventricular arm group extends vertically away from the central axis of the elongated central channel.

23. The artificial heart valve according to any one of claims 21 to 22, wherein: The distal segment of the arm of the atrial arm assembly extends vertically away from the central axis of the elongated central channel from a longitudinal position in the atrium along the outer surface of the cylindrical portion of the at least one support structure. The distal segment of the arm of the ventricular arm assembly, extending vertically away from the central axis of the elongated central channel, extends from a longitudinal position of the ventricle along the outer surface of the cylindrical portion of the at least one support structure, and The longitudinal position of the atrium is closer to the atrial end of the cylindrical portion of the at least one support structure than the longitudinal position of the ventricle is closer to the atrial end of the cylindrical portion of the at least one support structure.

24. The artificial heart valve according to claim 20, wherein: In the implantation configuration where the at least one support structure biodynamically anchors the artificial heart valve to the natural leaflet of the natural heart valve, the ventricular arm assembly extends from the atrial end of the cylindrical portion of the at least one support structure, passes through the natural annulus of the natural heart valve, and enters the ventricular side of the natural heart valve to contact the natural leaflet on the ventricular side of the natural heart valve.

25. The artificial heart valve according to any one of claims 20 and 24, wherein: In the implantation configuration where the at least one support structure biodynamically secures the artificial heart valve to the natural leaflet of the natural heart valve, the atrial arm assembly extends from the ventricular end of the cylindrical portion of the at least one support structure, passes through the natural annulus of the natural heart valve, and enters the atrium of the heart to contact the atrial side of the natural leaflet of the natural heart valve.

26. The artificial heart valve according to any one of claims 3 to 25, wherein, The cylindrical portion of the at least one support structure includes a cylindrical cage structure with an opening, wherein at least some portions of the cylindrical cage structure and the opening are configured to receive bends of one or more arms in the atrial arm group and the ventricular arm group at locations where the arms extend vertically away from the central axis of the elongated central channel.

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

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

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

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

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

32. The artificial heart valve according to claim 31, wherein, The minimum diameter of the radius of curvature of each bend in one or more arms of the atrial arm group and the ventricular arm group, located at a position where the arm extends vertically away from the central axis of the elongated central channel, is smaller than the maximum outer diameter of the elongated central channel.

33. An artificial heart valve, comprising: One or more support structures defining an elongated central channel; as well as A valve structure, said valve structure being attached to at least one support structure and disposed within the elongated central channel for controlling blood flow through said elongated central channel. The at least one support structure includes a plurality of arms that extend away from the elongated central channel for attaching the at least one support structure to the natural leaflets of the natural heart valves of the heart.

34. The artificial heart valve according to claim 33, wherein, The plurality of arms includes: Atrial arm assembly, the atrial arm assembly extending from the atrial end of the at least one support structure before bending into an extension away from the elongated central channel; and A ventricular arm assembly that extends from the ventricular end of the at least one support structure before bending into an extension away from the elongated central channel.

35. The artificial heart valve according to claim 34, wherein, The atrial arm and the ventricular arm are configured to cooperate to retain the natural leaflets of the natural heart valve, thereby retaining the elongated central channel within the natural annulus of the natural heart valve without requiring direct attachment to the natural valve annulus or the natural cord-like structures associated with the natural heart valve.

36. An artificial heart valve, comprising: One or more support structures defining an elongated central channel; as well as Multiple leaflet elements, which are attached to at least one support structure and arranged within the elongated central channel. The at least one support structure is configured to biodynamically fix the artificial heart valve within the natural annulus of the natural heart valve and separate it from the natural annulus of the natural heart valve.

37. The artificial heart valve according to claim 36, wherein, At least one of the one or more support structures includes a cylindrical portion comprising an atrial end and a ventricular end, the elongated central channel being defined by the cylindrical portion of the at least one support structure, and the cylindrical portion of the at least one support structure being capable of extending to a maximum radial width less than the minimum radial width of the natural annulus of the natural heart valve.

38. The artificial heart valve according to any one of claims 36 to 37, wherein, The at least one support structure is configured to biodynamically fix the artificial heart valve within and separate it from the natural annulus of the natural heart valve by grasping the natural leaflet of the natural heart valve without requiring direct attachment to the natural annulus or the natural cord-like structure associated with the natural heart valve.

39. The artificial heart valve according to any one of claims 36 to 38, wherein, The natural heart valve is the tricuspid valve.

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