artificial heart valve

Abstract

The present disclosure generally relates to an artificial valve and to methods and systems for deploying, positioning, and recapturing the same. The artificial valve comprises one or more support structures. At least one of the one or more support structures defines an elongated central passage of the artificial valve. The artificial valve may also comprise a plurality of valve leaflet elements attached to at least one of the one or more support structures and disposed within the elongated central passage for controlling fluid flow through the elongated central passage. At least one of the one or more support structures is configured to biomechanically secure the artificial valve within a natural valve, such as, for example, the natural tricuspid valve of the heart.

Description

Technology Field

[0001] The present invention generally relates to an implantable heart device, and more specifically to an artificial tricuspid valve. Background Technology

[0002] Significant progress has been made in transcatheter treatment of heart valve disease. Early clinical efforts focused on pulmonary valves, and subsequent devices focused on percutaneous replacement of aortic valves to treat aortic stenosis. In parallel, there were numerous programs to resolve mitral regurgitation through transcatheter repair techniques, and later through transcatheter mitral valve replacement.

[0003] Tricuspid disease is a condition in which the tricuspid valve, located between the right ventricle and the right atrium of the heart, fails to function properly. There are various forms of tricuspid disease, including, for example, tricuspid regurgitation, where blood flows backward from the right ventricle to the right atrium; tricuspid stenosis, where the tricuspid valve narrows, reducing blood flow from the right atrium to the right ventricle; and tricuspid atresia, where blood flow from the right atrium to the right ventricle is blocked or reduced due to congenital malformation or malformation of the tricuspid valve. Tricuspid disease has generally been overlooked as a "less significant" valvular disease compared to aortic stenosis (highest mortality rate) and mitral regurgitation (highest prevalence).

[0004] Currently, there are very few artificial tricuspid valves specifically designed for the tricuspid valve. In many cases, tricuspid defects have been treated using repurposed artificial aortic and mitral valves. Artificial aortic and mitral valves repurposed for tricuspid use are firmly fixed by applying pressure to the tricuspid valve's natural ring, thereby immobilizing the artificial valve. Because the tricuspid valve is located in close proximity to the heart's conductive region, the rigid fixation of the artificial valve within the tricuspid valve can lead to cardiac occlusion and / or other conduction abnormalities. The problem to be solved

[0005] Because the replacement of the tricuspid valve presents unique challenges, an artificial valve specially designed for repair is required. means of solving the problem

[0006] The present invention provides an artificial tricuspid valve that is not rigidly fixed within the natural tricuspid valve. This biomechanical valve design prevents cardiac occlusion and / or other dangerous conduction abnormalities. The artificial tricuspid valve provided herein can be stably held in place, but it is also necessary to remain loose throughout the heart's cardiac cycle.

[0007] The biomechanical artificial heart valve of the present invention provides a necessary solution by enabling the necessary movement that characterizes a natural tricuspid valve. In one embodiment, the present invention comprises an artificial heart valve having one or more support structures. At least one of the one or more support structures defines an elongated central passage. The artificial heart valve may also have a plurality of valve leaflet elements attached to at least one of the one or more support structures and disposed within the elongated central passage for controlling blood flow through the elongated central passage. At least one of the one or more support structures is configured to biomechanically secure the artificial heart valve to the natural valve leaflet of the natural heart valve of the heart. Specifically, in some embodiments, at least one support structure is configured to biomechanically secure the artificial heart valve to the natural valve leaflet of the natural heart valve so that at least one support structure can move within the natural ring of the natural heart valve in response to pressure changes at one or more sides of the natural heart valve.

[0008] As referred to herein, the term “biomechanical” in relation to an artificial heart valve refers to a configuration of the artificial heart valve that enables the artificial heart valve to maintain axial stabilization within the natural heart valve and also to move within the natural heart valve. This allows the valve to respond to alternating pressure differences on both sides of the natural heart valve during the heart’s cardiac cycle. This is achieved without direct attachment to the natural ring or natural chord of the natural heart valve, thereby preserving the natural movement of the natural ring. Specifically, the artificial heart valve is axially stabilized within the natural heart valve by gripping the natural valve leaflets of the natural heart valve rather than relying on annular forces or direct annular or chordate attachment. As referred to herein, the term “axial stabilization” in relation to an artificial heart valve placed within a natural heart valve refers to a portion of the artificial heart valve being interposed between any two opposite points on the natural ring of the natural heart valve.

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

[0010] In some embodiments, the distal segment of each arm of the atrial arm set and the ventricular arm set may extend vertically away from the central axis of the slender central passage. Additionally, the atrial arm set may be configured to contact the natural valve leaflet on the atrial side of the natural heart valve, and the ventricular arm set may be configured to contact the natural valve leaflet on the ventricular side of the natural heart valve. As referred to herein, the distal segment of the arm extending "vertically" away from the central axis of the slender central passage refers to the distal segment of the arm extending away from the central axis of the slender central passage such that a line drawn from the point of contact between the object (e.g., natural heart valve leaflet) and the distal segment to a longitudinal position along the outer surface of the cylindrical portion of at least one supporting structure from which the distal segment extends is oriented approximately 90° + / - 45° from the central axis of the slender central passage. As discussed below, this approximate perpendicularity of the line from the contact point of the distal segment to the longitudinal position along the outer surface of the cylindrical portion extending from the distal segment enables axial stabilization of the artificial heart valve within the natural heart valve.

[0011] Specifically, in some embodiments, in an implanted configuration where at least one support structure biomechanically secures the artificial heart valve to the natural leaflet of the natural heart valve, when the cylindrical portion of at least one support structure moves toward the atrial side of the natural heart valve due to a ventricular systolic pressure load, one or more arms of the ventricular arm set are bent to resist the movement, while one or more arms of the atrial arm set are bent to relax in order to maintain contact with the atrial side of the natural leaflet. Similarly, when the cylindrical portion of at least one support structure moves toward the ventricular side of the natural heart valve due to a ventricular diastolic pressure load and / or the removal of a previously applied ventricular systolic load, one or more arms of the atrial arm set are bent to resist the movement, while one or more arms of the ventricular arm set are relaxed in order to maintain contact with the ventricular side of the natural leaflet. This also creates a trampoline effect in which the ventricular systolic pressure load can be partially absorbed by the atrial movement of the natural leaflet.

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

[0013] In some embodiments, there may be an overbite between the atrial arm set and the ventricular arm set. Specifically, in some embodiments, the arms of the atrial arm set and the arms of the ventricular arm set may extend across the cross-sectional plane of the cylindrical portion of at least one support structure. As referred to herein, the “cross-sectional plane” for the cylindrical portion of at least one support structure is the cross-sectional plane of the cylindrical portion of at least one support structure perpendicular to the central axis of the slender central passage formed in the cylindrical portion of at least one support structure. In some additional embodiments, the distal segment of the arm of the atrial arm set extending vertically away from the central axis of the slender central passage extends toward the ventricular end of the cylindrical portion of at least one support structure, thereby enabling the distal segment of the arm of the atrial arm set extending vertically away from the central axis of the slender central passage to clamp the atrial natural valve leaflet of the natural heart valve. Additionally, the distal segment of the arm of the ventricular arm set extending vertically away from the central axis of the slender central passage can extend toward the atrial end of the cylindrical portion of at least one supporting structure, thereby enabling the distal segment of the arm of the ventricular arm set extending vertically away from the central axis of the slender central passage to clamp the ventricular natural valve leaflet of the natural heart valve.

[0014] Upon implantation of an artificial heart valve, this vertical overlap between the atrial and ventricular arms will result in additional clamping action and tension on the natural valve leaflets. This is because the distal segment of the atrial arm on the atrial side of the natural valve leaflets will actively push toward the ventricles of the heart, while the distal segment of the ventricular arm on the ventricular side will actively push toward the atria of the heart, effectively creating a corrugated effect similar to a wavy collar on the natural valve leaflets. This tensional effect, caused by opposing forces on both sides of the natural valve leaflets, will help to further stabilize the artificial heart valve axially within the natural heart valve. The amount of vertical overlap between the atrial and ventricular arms of the artificial heart valve determines the magnitude of the arm's clamping force on the natural valve leaflets of the natural heart valve. Furthermore, the magnitude of the arm's clamping force on the natural valve leaflets of the natural heart valve determines the amount of axial stabilization and biomechanical motion of the artificial heart valve within the natural heart valve throughout the cardiac cycle. Specifically, a greater clamping force of the arm on the natural valve leaflets of the natural heart valve results in greater axial stabilization of the artificial heart valve within the natural heart valve and less biomechanical movement throughout the cardiac cycle.

[0015] In some embodiments, each distal segment of an arm of an atrial arm set extending vertically away from the central axis of a slender central passage is curved toward the atrial end of a cylindrical portion of at least one support structure and has a tip that reduces trauma to the atrial-side natural valve leaflet of a natural heart valve at the point of contact of the atrial arm set. Additionally, in some embodiments, each distal segment of an arm of a ventricular arm set extending vertically away from the central axis of a slender central passage is curved toward the ventricular end of a cylindrical portion of at least one support structure and has a tip that reduces trauma to the ventricular-side natural valve leaflet of a natural heart valve at the point of contact of the ventricular arm set.

[0016] In some embodiments, a cylindrical portion of at least one support structure can be folded radially for catheter-transplantation. Additionally, a distal segment of the atrial and ventricular arm set extending vertically away from the central axis of the slender central passage can be elastically straightened.

[0017] In a specific embodiment, the distal segment of one or more arms of a set of ventricular arms (e.g., ventricular-directing arms) extending vertically away from the central axis of the slender central passage may extend toward the ventricular end of a cylindrical portion of at least one supporting structure, so that the distal segment of the ventricular-directing arm extending vertically away from the central axis of the slender central passage may contact one of the natural valve leaflets located on the atrial side of the natural heart valve rather than the ventricular side of the natural heart valve, thereby holding the natural valve leaflet radially lateral to the natural heart valve in an open position. Configuring the ventricular-directing arm to hold the natural valve leaflet radially lateral to the natural heart valve in an open position may be useful in various other embodiments. For example, configuring a ventricular-directing arm to retain the natural valve leaflet radially laterally from the natural heart valve in an open position may be useful in embodiments where the natural valve leaflet is difficult to capture by the arm for one reason or another (e.g., if the natural valve leaflet is too small or restricted). As another example, configuring a ventricular-directing arm to retain the natural valve leaflet radially laterally from the natural heart valve in an open position may be useful for minimizing the number of echocardiographic planes and / or views required during the implantation of an artificial heart valve (thereby simplifying the implantation procedure).

[0018] In some embodiments, the artificial heart valve described herein may further comprise one or more covers extending across one or more of the atrial arm set and the ventricular arm set within an elongated central passage. In some of these embodiments, a portion of one or more covers may comprise fenestration features. In an implanted configuration in which at least one support structure biomechanically secures the artificial heart valve to the natural leaflet of a natural heart valve, the fenestration features may be positioned between the elongated central passage and the natural ring of the natural heart valve. In some embodiments, the fenestration features may be at least one of a radiopaque marker, an opening, a magnetic element, a one-way valve, a pop-up valve, a mechanically sizable opening, and increased porosity.

[0019] In certain embodiments, the atrial arm set of the artificial heart valve may be attached to the ventricular end of the cylindrical portion of at least one support structure, while the ventricular arm set may be attached to the atrial end of the cylindrical portion of at least one support structure. In other words, in certain embodiments, the atrial arm set and the ventricular arm set of the artificial heart valve may originate from opposite ends of the cylindrical portion of at least one support structure. In these embodiments, one or more covers begin at the distal segment of each arm of the atrial arm set and are attached thereto, extend to the proximal segment of each arm of the ventricular arm set and are attached thereto, extend through the cylindrical portion of at least one support structure within the slender central passage, extend around the cylindrical portion of at least one support structure and are attached to the proximal segment of each arm of the atrial arm set. In some embodiments, one or more covers may terminate at a location along the proximal segment of each arm of the atrial arm set, which is a common distance from the cylindrical portion of at least one support structure, and be attached thereto. In an alternative embodiment, one or more covers may extend further to the distal segment of each arm of the ventricular arm set and be attached thereto. In some embodiments, one or more covers may extend asymmetrically and / or non-circularly within the slender central passage and across one or more of the atrial arm set and the ventricular arm set.

[0020] In some embodiments, the atrial arm set may be attached to the atrial end of the cylindrical portion of at least one support structure, while the ventricular arm set may be attached to the ventricular end of the cylindrical portion of at least one support structure. In alternative embodiments such as the above-described embodiments, the atrial arm set may be attached to the ventricular end of the cylindrical portion of at least one support structure, while the ventricular arm set may be attached to the atrial end of the cylindrical portion of at least one support structure.

[0021] In an embodiment in which an atrial arm set is attached to the ventricular end of a cylindrical portion of at least one support structure and a ventricular arm set is attached to the atrial end of a cylindrical portion of at least one support structure, the proximal segment of each arm of the atrial arm set may extend along the outer surface of the cylindrical portion of at least one support structure from the ventricular end of the cylindrical portion of at least one support structure toward the atrial end of the cylindrical portion of at least one support structure, and the distal segment of each arm of the atrial arm set may extend vertically away from the central axis of the slender central passage. Likewise, the proximal segment of each arm of the ventricular arm set may extend along the outer surface of the cylindrical portion of at least one support structure from the atrial end of the cylindrical portion of at least one support structure toward the ventricular end of the cylindrical portion of at least one support structure, and the distal segment of each arm of the ventricular arm set may extend vertically away from the central axis of the slender central passage.

[0022] In a further embodiment in which an atrial arm set is attached to the ventricular end of a cylindrical portion of at least one support structure and a ventricular arm set is attached to the atrial end of a cylindrical portion of at least one support structure, the distal segment of the arm of the atrial arm set extending vertically away from the central axis of the slender central passage may extend along the outer surface of the cylindrical portion of at least one support structure from an atrial longitudinal position, and the distal segment of the arm of the ventricular arm set extending vertically away from the central axis of the slender central passage may extend along the outer surface of the cylindrical portion of at least one support structure from a ventricular longitudinal position, wherein the atrial longitudinal position is closer to the atrial end of the cylindrical portion of at least one support structure than the ventricular longitudinal position is closer to the atrial end of the cylindrical portion of at least one support structure.

[0023] In an additional embodiment in which a ventricular arm set is attached to the atrial end of a cylindrical portion of at least one support structure, in an implanted configuration in which at least one support structure biomechanically fixes an artificial heart valve to a natural valve leaflet of a natural heart valve, the ventricular arm set may extend from the atrial end of the cylindrical portion of at least one support structure through the natural ring of the natural heart valve to the ventricular side of the natural heart valve and come into contact with the ventricular side natural valve leaflet of the natural heart valve.

[0024] In an additional embodiment in which an atrial arm set is attached to the ventricular end of a cylindrical portion of at least one support structure, in an implanted configuration in which at least one support structure biomechanically fixes an artificial heart valve to a natural valve leaflet of a natural heart valve, the atrial arm set may extend from the ventricular end of the cylindrical portion of at least one support structure through the natural ring of the natural heart valve into the atrium of the heart and come into contact with the atrial natural valve leaflet of the natural heart valve.

[0025] These various embodiments, in which an atrial arm set is attached to the ventricular end of the cylindrical portion of at least one support structure and a ventricular arm set is attached to the atrial end of the cylindrical portion of at least one support structure, serve to provide additional vertical overlap between the atrial arm and the ventricular arm as described above. Furthermore, these various embodiments, in which an atrial arm set is attached to the ventricular end of the cylindrical portion of at least one support structure and a ventricular arm set is attached to the atrial end of the cylindrical portion of at least one support structure, enable improved distribution of forces received by the atrial and ventricular arms across the entire artificial heart valve, thereby reducing the possibility of failure of the artificial heart valve, particularly the atrial and ventricular arms.

[0026] In a specific embodiment, a cylindrical portion of at least one support structure may be a cylindrical cage structure having an opening. In such an embodiment, at least a portion of the cylindrical cage structure and the opening may be configured to accommodate a bend of one or more arms of an atrial arm set and a ventricular arm set, and these arms extend vertically away from the central axis of the slender central passage. By configuring the cylindrical portion of at least one support structure to accommodate a bend of one or more arms of an atrial arm set and a ventricular arm set extending vertically away from the central axis of the slender central passage, the at least one support structure may provide additional support to the atrial arm set and the ventricular arm set, enable improved load distribution across the entire artificial heart valve, and thus reduce the risk of failure of the artificial heart valve, particularly the atrial and ventricular arms. This improved load distribution across the entire artificial heart valve is particularly important in the biomechanical artificial heart valve disclosed herein, because the continuous biomechanical movement of the artificial heart valve in conjunction with the natural heart valve during the heart cycle can increase the load on the artificial heart valve and thus increase the chance of the artificial heart valve failing. Additionally, by providing additional support to the atrial arm set and the ventricular arm set, these arms can be more stabilized when in contact with the natural heart valve leaflets, thereby enabling axial stabilization of the artificial heart valve within the natural heart valve.

[0027] In some embodiments, the artificial heart valve may have a single support structure. However, in alternative embodiments, to further improve the load distribution of the artificial heart valve, the artificial heart valve may have more than one support structure. In these embodiments, the artificial heart valve may have two, three, or more than three support structures. In these multiple support structure embodiments of the artificial heart valve, the multiple support structures may be configured to be fitted together (e.g., snapped in place) so that one or more of the multiple support structures receive support and distribution benefits from one or more of the other multiple support structures, as previously described. In some embodiments, to configure the multiple support structures of the artificial heart valve to be fitted together, the minimum inner diameter of the cylindrical portion of at least one support structure defining the slender central passage may be smaller than the maximum outer diameter of the slender central passage. In an additional embodiment, as one or more arms of an atrial arm set and a ventricular arm set, the minimum diameter of the radius of curvature of each bend of an arm extending vertically away from the central axis of a slender central passage may be smaller than the maximum outer diameter of the slender central passage.

[0028] In another embodiment, the present invention comprises an artificial heart valve having one or more support structures defining an elongated central passage, and a valve structure attached to at least one of the one or more support structures and disposed within the elongated central passage for controlling blood flow through the elongated central passage. At least one of the one or more support structures has a plurality of arms extending away from the elongated central passage to attach at least one support structure to a natural valve leaflet of a natural heart valve of the heart.

[0029] In some embodiments, a plurality of arms may comprise a set of atrial arms extending from the atrial end of at least one support structure before being curved away from the slender central passage, and a set of ventricular arms extending from the ventricular end of at least one support structure before being curved away from the slender central passage. In some of these embodiments, the atrial arms and ventricular arms may be configured to hold the natural valve leaflets of the natural heart valve in cooperation to maintain the slender central passage to the natural loop of the natural heart valve without any direct attachment to the natural cord or natural loop associated with the natural heart valve.

[0030] In another embodiment, the present invention comprises one or more support structures defining an elongated central passage, and an artificial heart valve having a plurality of valve leaflet elements attached to at least one of the one or more support structures and disposed within the elongated central passage. At least one of the one or more support structures is configured to biomechanically fix the artificial heart valve within the natural ring of the heart's natural heart valve, separated therefrom.

[0031] In some embodiments, at least one of the one or more support structures comprises a cylindrical portion including an atrial end and a ventricular end. An elongated central passage may be defined by the cylindrical portion of at least one support structure. Additionally, the cylindrical portion of at least one support structure may be expanded to a maximum radial width smaller than the minimum radial width of the natural ring of a natural heart valve.

[0032] In some embodiments, to biomechanically fix the artificial heart valve within the natural ring of the natural heart valve and separate it from it, at least one of the one or more support structures of the artificial heart valve is configured to grasp the natural valve leaflet of the natural heart valve without being directly attached to the natural ring or natural cord associated with the natural heart valve.

[0033] In some embodiments, the natural heart valve may be a tricuspid heart valve.

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

[0035] A method for catheter-based implantation of an artificial heart valve comprises the step of guiding the artificial heart valve through the patient's vein into the patient's natural heart valve while the artificial heart valve is in a contractile structure in which the artificial heart valve has an elongated central passage having an atrial diameter, and each arm of a plurality of ventricular arms is held against the outer surface of the cylindrical portion of at least one support structure by a sheath, and each arm of a plurality of atrial arms is held against the outer surface of the cylindrical portion of at least one support structure within the sheath by each restraint of a plurality of restraints. The method further comprises the step of retracting the sheath so that each arm of a plurality of ventricular arms can be flexed such that the distal segment of each arm of a plurality of ventricular arms extends away from the cylindrical portion of at least one support structure. The method further comprises the step of retracting the artificial heart valve with the sheath until the distal segment of each arm of a plurality of ventricular arms contacts the natural valve leaflet of the natural heart valve on the ventricular side of the natural heart valve. The method further comprises the step of expanding a cylindrical portion of at least one support structure from a contractile structure having an atrial diameter to an expandable structure having a larger ventricular diameter to form an elongated central passage. The method further comprises the step of advancing a plurality of restraints so that each arm of a plurality of atrial arms can be flexed such that the distal segment of each arm of a plurality of atrial arms extends away from the cylindrical portion of at least one support structure and captures the natural valve leaf of a natural heart valve on the atrial side of the natural heart valve against the distal segment of a plurality of ventricular arms that contacts the natural valve leaf of a natural heart valve on the ventricular side of the natural heart valve.

[0036] In some embodiments, the step of retracting a sheath so that each arm of a plurality of ventricular arms can be flexed such that the distal segment of each arm of a plurality of ventricular arms extends away from the cylindrical portion of at least one support structure further comprises the step of flexing each arm of a plurality of ventricular arms so that the proximal segment of each arm of a plurality of ventricular arms extends along the outer surface of the cylindrical portion of at least one support structure. Additionally, in these embodiments, the step of advancing a plurality of restraints so that each arm of a plurality of atrial arms can be flexed such that the distal segment of each arm of a plurality of atrial arms extends away from the cylindrical portion of at least one support structure further comprises the step of flexing each arm of a plurality of atrial arms so that the proximal segment of each arm of a plurality of atrial arms extends along the outer surface of the cylindrical portion of at least one support structure.

[0037] In some embodiments, the method may further comprise the step of separating a plurality of restraints from a plurality of atrial arms.

[0038] In some embodiments, the method may further comprise the step of repositioning an artificial heart valve within a natural heart valve by pushing at least one support structure toward the ventricular side of the natural heart valve with a plurality of spreader arms, retracting a plurality of restraints from a plurality of atrial arms, and straightening each arm of the plurality of atrial arms against the outer surface of the cylindrical portion of at least one support structure to release the natural valve leaflets of the natural heart valve.

[0039] In some embodiments, the method may further comprise the step of recapturing and removing the artificial heart valve from the natural heart valve by advancing the sheath to remove the artificial heart valve from the natural heart valve through the patient's vein while the artificial heart valve is in a contractile structure, straightening each arm of a plurality of ventricular arms, and compressing a cylindrical portion of at least one support structure.

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

[0041] In some embodiments, a plurality of spreader arms may extend from an intermediate layer within a sheath. In certain embodiments, each of the plurality of restraints may extend from a sheath between a pair of the plurality of spreader arms. In certain embodiments, each of the plurality of spreader arms may have an interlocking mechanism that maintains contact with an atrial end of a cylindrical portion of at least one support structure. Brief explanation of the drawing

[0042] The accompanying drawings, included to provide further understanding and incorporated into this specification and constituting a part thereof, serve to illustrate the disclosed embodiments and explain the principles of the disclosed embodiments together with the detailed description. FIG. 1 is a schematic perspective view of a support structure for an artificial heart valve according to an embodiment. FIG. 2 is a schematic cross-sectional perspective view of an artificial heart valve according to an embodiment. FIG. 3 is another schematic cross-sectional perspective view of an artificial heart valve according to an embodiment. FIG. 4 through 8 are illustrations of an artificial heart valve at various stages of implantation according to an embodiment. FIG. 9 through 12 are illustrations of an artificial heart valve at various stages of removal according to an embodiment. FIG. 13 is a plan view of an artificial heart valve according to an embodiment. FIG. 14 illustrates various implantation paths for an artificial heart valve according to an embodiment. FIG. 15 and FIG. 16 illustrate a part of a support structure for an artificial heart valve according to an embodiment. FIG. 17 is another schematic cross-sectional perspective view of an artificial heart valve according to an embodiment. FIG. 18 is an artificial heart according to an embodiment This is another schematic cross-sectional perspective view of the valve. FIG. 19 is a diagram illustrating another exemplary support structure for an artificial heart valve according to an embodiment. FIG. 20 illustrates various forces that may be applied during the implantation of an artificial heart valve according to an embodiment. FIG. 21 and FIG. 22 illustrate various realizations of a part of the support structure for an artificial heart valve according to an embodiment. FIG. 23 illustrates various delivery structures for an artificial heart valve according to an embodiment. FIG. 24 is a side view of a pair of arms extending from a cylindrical part of the support structure of an artificial heart valve according to an embodiment. FIG. 25 and FIG. 26 illustrate various nose cones and guidewires for the implantation of an artificial heart valve according to an embodiment. FIG. 27 through FIG. 30 illustrate various embodiments of an artificial heart valve having different support structures according to an embodiment. FIG. 31 through FIG. 34 illustrate various other embodiments of an artificial heart valve considered herein according to an embodiment.FIG. 35 is a perspective view of a support structure for an artificial heart valve interfacing with a delivery system according to an embodiment. FIG. 36 is a perspective view of the spreader arm of FIG. 35 according to various aspects of the present invention according to an embodiment. FIG. 37 is a wider perspective view of a support structure for an artificial heart valve interfacing with a delivery system according to various aspects of the present invention according to an embodiment. FIG. 38 is a perspective view of a part of the intermediate layer of a delivery system for an artificial heart valve according to an embodiment. FIG. 39 is a perspective view of an artificial heart valve interfacing with a delivery system according to an embodiment. FIG. 40 is a partially transparent perspective view of a support structure for an artificial heart valve interfacing with a delivery system according to an embodiment. FIG. 41 is a perspective view of a support structure for an artificial heart valve before a bend is formed in an arm extending from a cylindrical part according to an embodiment. FIG. 42a is an artificial tricuspid valve implanted in the natural tricuspid valve of the heart during diastolic filling of the ventricle of the heart according to an embodiment. FIG. 42b illustrates an artificial tricuspid valve implanted into the natural tricuspid valve of the heart during systole of the heart ventricle according to an embodiment. FIG. 43a illustrates another embodiment of a support structure for an artificial tricuspid valve in a contractile structure defining an elongated central passage having a first diameter according to an embodiment. FIG. 43b illustrates another embodiment of a support structure for an artificial tricuspid valve in an inflated structure defining an elongated central passage having a second diameter larger than the first diameter according to an embodiment. FIG. 44a is a drawing of a flat support structure of an artificial tricuspid valve having one support structure according to an embodiment. FIG. 44b is a side view of an artificial tricuspid valve configured to be implanted into a natural tricuspid valve having one support structure according to an embodiment. FIG. 45a is a CAD drawing of a side view of an artificial tricuspid valve having one support structure according to an embodiment. FIG. 45b is a CAD drawing of a top-down drawing of an artificial tricuspid valve having one support structure according to an embodiment.FIG. 45c is a CAD drawing of an inclined side view of an artificial tricuspid having a single support structure according to an embodiment. FIG. 45d is a CAD drawing of a side view of an artificial tricuspid having a single support structure according to an embodiment. FIG. 46a is a drawing of an artificial tricuspid having a flat support structure and two support structures according to an embodiment. FIG. 46b is a side view of an artificial tricuspid having two support structures and configured to be implanted into a natural tricuspid according to an embodiment. FIG. 47a is a CAD drawing of an inclined side view of a support structure of an artificial tricuspid having two support structures according to an embodiment. FIG. 47b is a CAD drawing of an inclined side view of a support structure of an artificial tricuspid having two support structures according to an embodiment. FIG. 47c is a CAD drawing of a side view of an artificial tricuspid having two support structures according to an embodiment. FIG. 47d is a CAD drawing of a downward view of an artificial tricuspid having two support structures according to an embodiment. FIG. 47e is a CAD drawing of two support This is a CAD drawing of an inclined side view of an artificial tricuspid having a structure. FIG. 47f is a CAD drawing of another side view of an artificial tricuspid having two support structures according to an embodiment. FIG. 48a is a drawing of a flat support structure of an artificial tricuspid having two support structures according to an embodiment. FIG. 48b is a side view of an artificial tricuspid having two support structures and configured to be implanted into a natural tricuspid according to an embodiment. FIG. 49a is a CAD drawing of an inclined side view of a support structure of an artificial tricuspid having two support structures according to an embodiment. FIG. 49b is a CAD drawing of an inclined side view of a support structure of an artificial tricuspid having two support structures according to an embodiment. FIG. 49c is a CAD drawing of a side view of an artificial tricuspid having two support structures according to an embodiment. FIG. 49d is a CAD drawing of a downward view of an artificial tricuspid having two support structures according to an embodiment.FIG. 49e is a CAD drawing of an inclined side view of an artificial tricuspid having two support structures according to an embodiment. FIG. 49f is a CAD drawing of another side view of an artificial tricuspid having two support structures according to an embodiment. FIG. 50a is a drawing of a flat support structure of an artificial tricuspid having two support structures according to an embodiment. FIG. 50b is a side view of an artificial tricuspid having two support structures and configured to be implanted into a natural tricuspid according to an embodiment. FIG. 51a is a CAD drawing of an inclined side view of a support structure of an artificial tricuspid having two support structures according to an embodiment. FIG. 51b is a CAD drawing of an inclined side view of a support structure of an artificial tricuspid having two support structures according to an embodiment. FIG. 51c is a CAD drawing of a side view of an artificial tricuspid having two support structures according to an embodiment. FIG. 51d is a CAD drawing of a downward view of an artificial tricuspid having two support structures according to an embodiment. FIG. 51e is a CAD drawing of two This is a CAD drawing of an inclined side view of an artificial tricuspid having a support structure. FIG. 51f is a CAD drawing of another side view of an artificial tricuspid having two support structures according to an embodiment. FIG. 52a is a drawing of a flat support structure of an artificial tricuspid having three support structures according to an embodiment. FIG. 52b is a side view of an artificial tricuspid having three support structures and configured to be implanted into a natural tricuspid according to an embodiment. FIG. 53a is a CAD drawing of an inclined side view of a support structure of an artificial tricuspid having three support structures according to an embodiment. FIG. 53b is a CAD drawing of an inclined side view of a support structure of an artificial tricuspid having three support structures according to an embodiment. FIG. 53c is a CAD drawing of an inclined side view of a support structure of an artificial tricuspid having three support structures according to an embodiment. FIG. 53d is a CAD drawing of a side view of an artificial tricuspid having three support structures according to an embodiment.FIG. 53e is a CAD drawing of a downward view of an artificial tricuspid valve having three support structures according to an embodiment. FIG. 53f is a CAD drawing of an inclined side view of an artificial tricuspid valve having three support structures according to an embodiment. FIG. 53g is a CAD drawing of another side view of an artificial tricuspid valve having three support structures according to an embodiment. FIG. 54a is a side view of the vertical overlap between the atrial arm and the ventricular arm of an artificial tricuspid valve in a resting state according to an embodiment. FIG. 54b is a side view of the atrial arm and the ventricular arm of an artificial tricuspid valve when the artificial tricuspid valve is implanted into a natural tricuspid valve according to an embodiment. FIG. 55 is a CAD drawing of a cross-sectional side view of an artificial tricuspid valve having three support structures according to an embodiment. FIG. 56a is a prototype clamped on a sheet of paper oriented approximately perpendicularly (e.g., 90° + / - 45°) to the central axis of the elongated central passage of an artificial tricuspid valve according to an embodiment. FIG. 56 is a bottom-up view of an image of an artificial tricuspid. FIG. 56 is a bottom-up view of an image of a prototype artificial tricuspid clamped onto a sheet of paper oriented approximately perpendicularly (e.g., 90° + / - 45°) to the central axis of the elongated central passage of the artificial tricuspid according to an embodiment. FIG. 56 is a side view of an image of a prototype artificial tricuspid clamped onto a sheet of paper oriented approximately perpendicularly (e.g., 90° + / - 45°) to the central axis of the elongated central passage of the artificial tricuspid according to an embodiment. FIG. 57 is a top-up view of an image of a prototype artificial tricuspid according to an embodiment. FIG. 58 is a CAD drawing of an inclined side view of an artificial tricuspid having three support structures according to an embodiment. FIG. 59 is a view of a flat support structure of an artificial tricuspid according to an embodiment. FIG. 60 is a view of a support structure of an artificial tricuspid according to an embodiment. The loading, locking, and unlocking of the interlocking mechanism are illustrated. FIG. 61 is an illustration of a flat support structure configured to form the ventricular arm of an artificial tricuspid valve according to an embodiment.FIG. 62a is an image of a prototype support structure forming the ventricular arm of an artificial tricuspid valve according to an embodiment. FIG. 62b is an image of a prototype support structure forming the ventricular arm and ventricular-directing arm of an artificial tricuspid valve according to an embodiment. FIG. 63a is a downward view of a CAD drawing of a support structure forming the ventricular arm of an artificial tricuspid valve according to an embodiment. FIG. 63b is a side view of a CAD drawing of a support structure forming the ventricular arm of an artificial tricuspid valve according to an embodiment. FIG. 64a is a downward view of a CAD drawing of a support structure forming the ventricular arm and ventricular-directing arm of an artificial tricuspid valve according to an embodiment. FIG. 64b is a side view of a CAD drawing of a support structure forming the ventricular arm and ventricular-directing arm of an artificial tricuspid valve according to an embodiment. FIG. 65 is a drawing of a flat support structure configured to form the atrial arm of an artificial tricuspid valve according to an embodiment. FIG. 66 is an artificial This is a CAD drawing of a side view of a tricuspid valve. Fig. 67a is a side view of a relatively small amount of vertical overlap between the atrial arm and the ventricular arm of an artificial tricuspid valve according to an embodiment. Fig. 67b is a side view of a relatively moderate amount of vertical overlap between the atrial arm and the ventricular arm of an artificial tricuspid valve according to an embodiment. Fig. 67c is a side view of a relatively large amount of vertical overlap between the atrial arm and the ventricular arm of an artificial tricuspid valve according to an embodiment. Fig. 68a illustrates the symmetrical realization of an atrial seal skirt according to an embodiment. Fig. 68b illustrates the asymmetrical realization of an atrial seal skirt according to an embodiment. Fig. 69a is an image of an upward view of a support structure of a prototype artificial tricuspid valve according to an embodiment. Fig. 69b is an image of a side view of a support structure of a prototype artificial tricuspid valve according to an embodiment. Fig. 70a is an image of an upward view of a support structure of a prototype artificial tricuspid valve according to an embodiment. Fig. 70b is, according to an embodiment, This is an image of a side view of the support structure of a prototype artificial tricuspid.FIG. 71 is a downward view image of a support structure of a prototype artificial tricuspid valve according to an embodiment. FIG. 72a is a downward view image of a support structure of a prototype artificial tricuspid valve according to an embodiment. FIG. 72b is a side view image of a support structure of a prototype artificial tricuspid valve according to an embodiment. FIG. 73 is a diagram of an atrial sealing skirt having a ventricular arm sleeve configured to enclose the ventricular arm of a support structure according to an embodiment. FIG. 74 is a side view image of a prototype artificial tricuspid valve according to an embodiment. FIG. 75 is a diagram of load distribution in an artificial tricuspid valve having one support structure according to an embodiment. FIG. 76 is a diagram of load distribution in an artificial tricuspid valve having two support structures according to an embodiment. FIG. 77 is a diagram of load distribution in an artificial tricuspid valve having two support structures according to an embodiment. FIG. 78 is a diagram of load distribution in an artificial tricuspid valve having two support structures according to an embodiment. FIG. 79 is FIG. 80 is a CAD drawing of a cross-sectional side view of an artificial tricuspid having three support structures according to an embodiment. Specific details for implementing the invention

[0043] The detailed description provided below describes various configurations of the present technology and is not intended to represent the only configuration in which the present technology may be implemented. The detailed description includes specific details to provide a thorough understanding of the present technology. Accordingly, dimensions may be provided as non-limiting examples in relation to specific embodiments. However, it will be apparent to a person skilled in the art that the present technology can be implemented without such specific details. In some cases, well-known structures and components are shown in block diagram form to avoid obscuring the concept of the present technology.

[0044] It should be understood that the present invention includes examples of the technology and does not limit the scope of the appended claims. Various aspects of the technology will now be disclosed according to specific but non-limiting examples. The various embodiments described in the present invention may be carried out in various ways and variations depending on the desired use or realization.

[0045] In the following detailed description, many specific details are presented to provide a complete understanding of the invention. However, it will be apparent to those skilled in the art that embodiments of the invention may be practiced without some of these specific details. In other examples, well-known structures and technologies are not described in detail so as not to obscure the invention.

[0046] Since aortic and mitral valve replacements have generally been the focus of device development, the need for a solution to tricuspid regurgitation (TR) remains unresolved, particularly because TR is associated with higher mortality and there is increasing evidence showing that TR should not remain untreated even after other heart valves have been resolved.

[0047] Like the mitral valve, the tricuspid valve is located in the atrial-ventricular position. Therefore, it might be expected that mitral valve replacement devices could be repurposed for use in the tricuspid position. However, the anatomical structure of the tricuspid valve and specific characteristics of the surrounding anatomical structures (e.g., the larger size of the tricuspid valve and its proximity to the heart's conduction zone) make a dedicated solution more desirable than repurposing such mitral valve devices.

[0048] According to an embodiment of the present invention, a biomechanical artificial tricuspid is provided herein. As mentioned above, the term “biomechanical” in relation to the artificial tricuspid as used herein refers to a configuration of the artificial tricuspid that allows the artificial tricuspid to maintain axial stabilization within the natural tricuspid of the heart, but to move within the natural tricuspid in response to alternating pressure differences on both sides of the natural tricuspid during the cardiac cycle without being directly attached to the natural ring or natural chordae tendineae of the natural tricuspid, thereby preserving the natural movement of the natural ring. Specifically, the artificial tricuspid is axially stabilized within the natural tricuspid by grasping the natural valve leaflets of the natural tricuspid rather than relying on annular forces or direct annular or chordae tendineae attachment. In relation to the artificial tricuspid placed within the natural tricuspid as used herein, the term “axial stabilization” refers to a portion of the artificial tricuspid being interposed between any two opposite points on the natural ring of the natural tricuspid.

[0049] The artificial tricuspid valve comprises one or more supporting structures. For example, as discussed in more detail below, the artificial tricuspid valve may comprise one, two, three, or more than three supporting structures. At least one of the one or more supporting structures comprises a cylindrical portion having an atrial end and a ventricular end. The cylindrical portion of at least one supporting structure defines the slender central passage of the artificial tricuspid valve. The central axis of the slender central passage extends within the slender central passage from the atrial end of the cylindrical portion to the ventricular end of the cylindrical portion. When the artificial tricuspid valve is in a configuration implanted in the natural tricuspid of the heart, blood flows from the atria of the heart to the ventricles of the heart through the slender central passage of the artificial tricuspid valve, along the central axis of the slender central passage. Additionally, a plurality of valve leaflet elements are attached to at least one supporting structure and positioned within the slender central passage to control blood flow through the slender central passage.

[0050] A ventricular arm extending from a first end of a cylindrical portion of at least one support structure extends into the ventricle of the heart and contacts the ventricular surface of a natural valve leaflet, whereas an atrial arm extending from a second end opposite to the first end of a cylindrical portion of at least one support structure extends into the atrium and contacts the atrial surface of a natural valve leaflet. Various features of the artificial tricuspid valve constitute the valve for catheter-transplantation, repositioning, and / or removal. The artificial tricuspid valve described herein can be easily placed and deployed in a wide range of patients while maintaining the ability to control deployment, evaluate full function, and recapture and remove the implant before foil release.

[0051] Although various examples configured to replace a natural tricuspid valve are described herein, it should be understood that appropriate modifications may be made to use the artificial tricuspid disclosed herein to replace other natural heart valves and / or any other non-heart valves.

[0052] FIG. 1 illustrates an exemplary artificial tricuspid valve (100) according to an embodiment of the present invention. In the example of FIG. 1, the artificial tricuspid valve (100) comprises a support structure (102) having a cylindrical portion (116) defining an elongated central passage (104). The cylindrical portion (116) has an atrial end (118) configured to be positioned in the atrium of the heart and a ventricular end (120) configured to be positioned in the ventricle of the heart. The central axis of the elongated central passage (104), along which blood flows from the atrium of the heart to the ventricle of the heart, is shown as a dotted line in FIG. 1.

[0053] Although the cylindrical portion (116) is depicted as a solid cylindrical structure, it should be understood that the cylindrical portion (116) may be formed into other structures, such as a radially expandable and compressible cylindrical cage structure having openings that can be balloon-inflated or self-inflated, for example. In this embodiment, the cylindrical cage structure may be manufactured from laser-cut metal, polymer tubes, and / or wire-formed materials. In this example, some of the openings (not shown in FIG. 1; see FIG. 15, FIG. 16, FIG. 21 or FIG. 22) may be positioned to accommodate one or more bends of one or more arms (106) described below, to maintain uniformity and symmetry during loading and recapturing of the artificial tricuspid (100), and / or to enable load distribution from one or more arms (106) across the entire support structure (102) of the artificial tricuspid (100). In various structural realizations, the cylindrical portion (116) can be radially folded [e.g., into an elongated central passage (104)] for catheter-through implantation.

[0054] The cylindrical portion (116) is smaller in size compared to the natural tricuspid ring so as not to apply any radial force to the ring. Specifically, in the example of FIG. 1 and various other examples described herein, the cylindrical portion (116) may be expanded to a maximum radial width smaller than the minimum radial width of the natural ring of the natural tricuspid. As described in detail below, the arm (106) is configured to hold the natural leaflet of the natural tricuspid by cooperating to maintain the slender central passage (104) in the natural ring of the natural tricuspid without any direct attachment to the natural ring or natural cord, so that the artificial tricuspid (100) is biomechanically fixed within the natural ring of the natural tricuspid, separated from it. However, it should be noted that some portions of the artificial tricuspid (100) may extend into or beyond the natural ring. For example, as will be discussed in more detail below, the artificial tricuspid (100) may be provided with an atrial sealing skirt that extends into or beyond the natural ring to secure and / or completely cover the hole of the natural tricuspid to prevent leakage.

[0055] Although the cylindrical portion (116) is depicted in FIG. 1 as having a circular cross-section, it should be noted that the cylindrical portion (116) may have a generally cylindrical shape rather than 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 shape), and may be configured so that one artificial tricuspid size accommodates all patients [e.g., having different sizes only for the arm (106) and the atrial seal skirt described later] or may have various artificial tricuspid sizes depending on the patient's anatomical structure.

[0056] Although not illustrated in FIG. 1, a plurality of valve leaflet elements may be attached to a support structure (102) and placed within the slender central passage (104) to control blood flow through the slender central passage. These valve leaflet elements replace the function of natural valve leaflets when an artificial tricuspid valve (100) is installed.

[0057] As illustrated in FIG. 1, the artificial tricuspid valve (100) is biomechanically fixed within the natural ring of the natural tricuspid valve, separated from it, by fixing the artificial tricuspid valve (100) to the natural leaflet of the natural tricuspid valve using a plurality of ventricular arms (106-1) and atrial arms (106-2). Specifically, the plurality of ventricular arms (106-1) extend from a first end of the cylindrical portion (116) of the support structure (102) and contact the ventricular side of the natural leaflet of the natural tricuspid valve. Likewise, the plurality of atrial arms (106-2) extend from a second end opposite to the first end of the cylindrical portion (116) of the support structure (102) and contact the atrial side of the natural leaflet of the natural tricuspid valve. As shown in FIG. 1, 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).

[0058] Each arm (106) includes a proximal segment and a distal segment. The proximal segment of each arm (106) is proximal to the cylindrical portion (116) of the support structure (102). Specifically, the proximal segment of each arm (106) is a segment of the arm (106) that is attached to the cylindrical portion (116) of the support structure (102). The proximal segment of each arm (106) extends from its point of attachment in the cylindrical portion (116) along the outer surface (147) of the cylindrical portion (116) and terminates at a secondary bend that leads the distal segment of the arm away from the central axis of the elongated central passage (104) and perpendicular to the central axis (and is provided with a secondary bend). The secondary bend guides the distal segment of the arm in a longitudinal position along the outer surface (147) of the cylindrical portion (116) away from the central axis of the elongated central passage (104) and perpendicular to the central axis. In some embodiments [e.g., an embodiment of the artificial tricuspid device (100) of FIG. 1], the proximal segment of each arm (106) also has an initial bend that guides the proximal segment of the arm (106) along the outer surface (147) of the cylindrical portion (116).

[0059] Each atrial arm (106-1) has a proximal segment (112) and each ventricular arm (106-2) has a proximal segment (108). As illustrated in FIG. 1 and discussed in more detail below, the optional initial bend of the proximal segment (112) of each atrial arm (106-1) is the initial bend (128), and the secondary bend of the proximal segment (112) of each atrial arm (106-1) is the secondary bend (130). Likewise, the optional initial bend of the proximal segment (108) of each ventricular arm (106-2) is the initial bend (124), and the secondary bend of the proximal segment (108) of each ventricular arm (106-2) is the secondary bend (126).

[0060] The distal segment of each arm (106) is distal to the cylindrical portion (116) of at least one support structure (102). Specifically, the distal segment of each arm (106) is a segment of the arm (106) that contacts a target (e.g., a natural leaflet of a natural tricuspid valve). The distal segment of the arm (106) contacts the target (e.g., a 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 the secondary bend of the arm (106) (which is not provided), extends away from the central axis of the elongated central passage (104) and perpendicular to the central axis, and terminates at a tip (and is provided). As mentioned above, the distal segment of the arm extends from a longitudinal position along the outer surface (147) of the cylindrical part (116) far from the central axis of the elongated central passage (104) and perpendicular to the central axis.

[0061] In some embodiments described below in detail with reference to FIG. 24, the distal segment of each arm may have an extended segment having a third bend. Each atrial arm (106-1) has a distal segment (114) and each ventricular arm (106-2) has a distal segment (110). As described below in more detail, 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).

[0062] In the example of FIG. 1, the proximal segment (108) of each ventricular arm (106-2) extends from the atrial end (118) of the cylindrical portion (116) and has an initial bend (124) of 180°+ / - 45° that guides the proximal segment (108) of the ventricular arm (106-2) along the outer surface (147) of the cylindrical portion (116), through a natural loop [located outside the elongated central passage (104)], and toward the ventricular end (120). Subsequently, following the secondary bend (126) in the proximal segment (108) of the ventricular arm (106-2), the distal segment (110) of the ventricular arm (106-2) extends from a longitudinal position along the outer surface (147) of the cylindrical portion (116) far from the central axis of the elongated central passage (104) and perpendicular to the central axis.

[0063] FIG. 1 also illustrates a method in which 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° that sufficiently guides the proximal segment (112) of the atrial arm (106-1) along the outer surface (147) of the cylindrical portion (116), through a natural loop [located outside the elongated central passage (104)], and toward the atrial end (118) of the cylindrical portion (116). Subsequently, following the secondary bend (130) in the proximal segment (112) of the atrial arm (106-1), the distal segment (114) of the atrial arm (106-1) extends from a longitudinal position along the outer surface (147) of the cylindrical portion (116) far from the central axis of the slender central passage (104) and perpendicular to the central axis. As mentioned above, in some embodiments, one or more proximal segments of arms (106) do not have an initial bend.

[0064] As mentioned above, the distal segment of each arm (106) extends vertically away from the central axis of the elongated central passage (104) to attach the support structure (102) to the natural leaflet of the natural tricuspid valve. As referred to herein, the distal segment of the arm (106) extending "vertically" from the central axis of the elongated central passage (104) refers to the distal segment of the arm (160) extending away from the central axis of the elongated central passage (104) such that a line drawn from the point of contact between the target (e.g., natural leaflet of the tricuspid valve) and the distal segment to a longitudinal position along the outer surface (147) of the cylindrical portion (116) of the at least one support structure (102) from which the distal segment extends is oriented at approximately 90°+ / - 45° from the central axis of the elongated central passage (104). In some embodiments, the contact point of the distal segment of the arm (106) may be the tip (140 or 142) of the arm (106). In an alternative embodiment in which the distal segment of the arm (106) has an extended segment having a third bend, the contact point of the distal segment of the arm may be the extended segment of the arm (106) or, more specifically, the third bend. The contact point of the distal segment of the arm (106) may be any other part of the distal segment of the arm (106). As will be discussed in more detail below, this approximate perpendicularity of the 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 axial stabilization of the artificial tricuspid within the natural tricuspid.

[0065] The distal segment (114) of each atrial arm (106-1) and the distal segment (110) of each ventricular arm (106-2), which extend vertically away from the central axis of the elongated central passage (104), can be elastically straightened [e.g., with respect to the outer surface (147) of the cylindrical portion (116) of the support structure (102)] without extending beyond or not extending beyond the length of the cylindrical portion (116). In this way, the artificial tricuspid valve (100) is configured to have a reduced length to facilitate navigation of the curve or bend along the insertion path [e.g., into the patient's vascular system (e.g., vein or artery) and into the heart].

[0066] In the example of FIG. 1, the ventricular arm (106-2) extends from the atrial end (118) of the cylindrical portion (116), the atrial arm (106-1) extends from the ventricular end (120) of the cylindrical portion (116), and the relative positions of the secondary bends (126, 130) are set so that the position of the secondary bend (126) of each ventricular arm (106-2) is closer to the ventricular end (120) of the cylindrical portion (116) than the position of the secondary bend (130) of each atrial arm (106-1). In other words, in the example of FIG. 1, the atrial arm (106-1) and the ventricular arm (106-2) extend across the cross-sectional plane of the cylindrical portion (116) of at least one support structure (102) so that there is a vertical overlap between the atrial arm (106-1) and the ventricular arm (106-2) across the cross-sectional plane. As referred to herein, the “cross-sectional plane” regarding the cylindrical portion of at least one support structure is the cross-sectional plane of the cylindrical portion of at least one support structure perpendicular to the central axis of the elongated central passage defined by the cylindrical portion of at least one support structure. As a result of this vertical overlap between the atrial arm (106-1) and the ventricular arm (106-2), in vivo, the ventricular arm (106-2) extending from the atrial end (118) of the cylindrical portion (116) extends downward into the ventricle of the heart and contacts the ventricular surface of the natural valve leaflet, whereas the atrial arm (106-1) extending from the ventricular end (120) of the cylindrical portion (116) extends upward into the atrium of the heart and contacts the atrial surface of the natural valve leaflet.

[0067] Additionally, in some embodiments, the relative bending angle of the secondary bends (126, 130) may be slightly greater than 90° for each or either one, so 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 configuration further contributes to the vertical overlap of the aforementioned atrial arms (106-1) and ventricular arms (106-2). Upon implantation, this vertical overlap of the atrial arm (106-1) and the ventricular arm (106-2) will result in additional clamping action and additional tension on the natural valve leaflet because the distal segment (114) of the atrial arm (106-1) on the atrial side of the natural valve leaflet will actively push toward the ventricle of the heart, while the distal segment (110) of the ventricular arm (106-2) on the ventricular side of the natural valve leaflet will actively push toward the atrium of the heart, effectively creating a corrugated effect similar to a wavy collar on the natural valve leaflet. This tension effect caused by opposing forces on both sides of the natural valve leaflet will help to axially stabilize the artificial tricuspid valve (100) within the natural tricuspid valve.

[0068] Fixing the artificial tricuspid valve (100) to both sides of the natural valve leaflets in this way also creates a trampoline effect in which the ventricular systolic pressure load can be partially absorbed by the upward (atrial) movement and tension of the natural valve leaflets. Specifically, in this example, the arm (106) is bent so 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 this movement, while the atrial arm (106-1) is flexed to relax in order to maintain contact with the atrial side of the natural valve leaflet. Additionally, 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 this movement, while the ventricular arm (106-2) relaxes to maintain contact with the ventricular side of the natural valve leaflet. Furthermore, as a result of the trampoline effect, the force from the distal segment (110) of each ventricular arm (106-2) toward the ventricular side of the natural valve leaflet can be further distributed across the entire atrial sealing skirt to minimize the risk of corrosion through the natural valve leaflet. In this way, the artificial tricuspid valve (100) is biomechanically fixed within the natural tricuspid valve during the cardiac cycle.

[0069] In FIG. 2, the tip (140, 142) of the arm (106-2, 106-1) is depicted as having a square cross-section, but it should be noted that in other embodiments, the cross-sectional configuration of the tip (140, 142) of the arm (106-2, 106-1) may have a circular or other non-circular shape (for example, to provide improved attachment and / or leak prevention, such as in the case where an atrial sealing skirt is present, as will be discussed in more detail below). The relative lengths of the distal segment (114) of the atrial arm (106-1) and / or the distal segment (110) of the ventricular arm (106-2) may also be modified for improved attachment and / or leak prevention.

[0070] FIG. 2 illustrates an example of a cover (200) that may be provided over a support structure (102). The cover (200) may be made of bio-artificial tissue (e.g., cow, pig, etc.) or may be made of synthetic material (e.g., polyurethane, ePTFE, proprietary hydrogel material). As illustrated, the cover (200) may have a cylindrical portion (202) to which an artificial valve leaflet element (not illustrated) can be attached, defining an elongated central passage (104). The cover (200) may also have an atrial sealing skirt (204) that extends over the atrial end (118) of the support structure (102) and extends at least partially over the atrial arm (106-1).

[0071] The atrial sealing skirt (204) can also facilitate the recapturable properties 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 to recapture the ventricular arm (106-2) in contact with the ventricular side of the natural valve leaflet of the natural tricuspid valve and to completely reposition or remove the implant before final release, after which the outer sheath (see 406 in FIG. 4) can be advanced toward the ventricular side of the natural tricuspid valve.

[0072] In these examples, the portion of the atrial seal skirt (204) located relatively proximal to the atrial side of the natural tricuspid valve may be attached to the proximal segment (108) of each ventricular arm (106-2) (see, for example, FIG. 17), and the portion of the atrial seal skirt (204) located relatively distal to the atrial side of the natural tricuspid valve may be attached to the distal segment (114) of each atrial arm (106-1). The cover (200) may extend downward through the cylindrical portion (116) of the support structure (102) within the elongated central passage (104). In the examples of FIGS. 2 and 3, the portion (202) of the cover (200) extending downward through the cylindrical portion (116) of the support structure (102) to help define the elongated central passage (104) terminates at or near the ventricular end (120) of the cylindrical portion (116). However, in some embodiments (e.g., see FIGS. 17 and 18), the cover (200) wraps around the ventricular end (120) of the cylindrical portion (116) and terminates along the proximal segment (112) of each atrial arm (106-1) [e.g., just before the secondary bend (130)]. In other examples not explicitly illustrated, 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 embodiment, the cover (200) may form a continuous "webbing" of the atrial sealing skirt (204) at the atrial end (118) of the cylindrical portion (116) of the support structure (102), which helps to create a seal and also acts as a backstop against pressure from the ventricular arm (106-2) on the ventricular side of the natural tricuspid valve leaflet, preventing the ventricular arm (106-2) from corroding through the natural valve leaflet.The atrial sealing skirt (204) can be extended to or beyond the natural ring of the natural tricuspid to secure it and to completely cover the hole of the natural tricuspid to sufficiently prevent leakage.

[0073] In various examples, the atrial seal skirt (204) may start at the distal segment (114) of each atrial arm (106-1) and be attached thereto, then be transitioned to be attached to the proximal segment (108) of each ventricular arm (106-2), then be extended downward around the proximal segment (112) of each atrial arm (106-1) through the elongated central passage (104), and 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 of the cylindrical portion (116)], or in various embodiments may be further extended to the distal segment (110) of each ventricular arm (106-2) before being terminated.

[0074] In some embodiments, the cover (200) may extend asymmetrically and / or non-circularly within the elongated central passage (104) and across one or more of the atrial arms (106-1) and / or ventricular arms (106-2). For example, in some embodiments, the cover (200) may extend in a "D" shape within the elongated central passage (104) and across one or more of the atrial arms (106-1) and / or ventricular arms (106-2).

[0075] FIG. 3 also illustrates a method in which an artificial tricuspid (100) may be provided with an opening feature (300) (see FIG. 13) in a part of the cover (200). The opening feature (300) may include, for example, a radiopaque marker, an opening, a magnetic element, a one-way valve, a pop-up valve, a mechanically scalable opening, and increased porosity. In an implanted configuration in which a support structure (102) biomechanically fixes the artificial tricuspid (100) to the natural valve leaflet of a natural tricuspid, the opening feature (300) may be positioned between the elongated central passage (104) and the natural ring of the natural tricuspid.

[0076] The opening feature (300) may be a hole or vent that allows, for example, a guidewire and an auxiliary device (e.g., a pacing lead, an ICD lead, or other device) to move into the ventricle through the cover (200) and / or natural tricuspid valve (e.g., for right ventricle and / or pulmonary artery access and beyond). In this way, the additional device can access the right ventricle and / or pulmonary artery without needing to pass through the elongated central passage (104) of the artificial tricuspid valve (100) to avoid dysfunction, the risk of thrombosis and / or valve damage.

[0077] The opening feature (300) may have a hole identified by a radiopaque marker. The opening feature (300) may have a magnetic element or other mechanism to assist in the alignment and coupling of a secondary system (e.g., similar to a transseptal puncture needle) to pass through the atrial sealing skirt (204) and the natural tricuspid valve to reach the ventricle and beyond. The opening feature (300) may be formed of the same material as the atrial sealing skirt (204) or a different material (e.g., ePTFE, silicone, etc.) to facilitate sealing of the opening feature (300) before and after passage of the device. Likewise, the opening feature (300) may have a one-way valve that separates from the valve structure (e.g., a valve leaflet element) in the elongated central passage (104). In some realizations, the opening feature (300) may be initially sealed and configured to be easily identifiable and perforated. In another embodiment, the entire atrial seal skirt (204) may be made of a material that allows perforation by a standard or custom auxiliary device and subsequently maintains a seal sufficient to prevent undesirable backflow after a lead or other catheter passes through.

[0078] Additionally, it should be noted that one or more other features of the opening feature (300) and / or the atrial sealing skirt (204) may be positioned to allow a controlled amount of backflow through it permanently or temporarily [e.g., to permanently or temporarily relieve an increase in pressure within the ventricle that may be caused by sealing the natural tricuspid valve by the artificial tricuspid valve (100)].

[0079] In another embodiment, one or more opening features comprising the opening feature (300) may be radially positioned along the elongated central passage (104) in a location that allows a controlled amount of backflow through it while bypassing the cover (200). For example, the opening feature (300) may be realized as a permanent opening of a predetermined size or a mechanically controllable opening (e.g., an aperture or other opening having a diameter, width, or other dimensions that are mechanically controllable at and / or after implantation). As another example, the opening feature (300) may be a portion of the atrial seal skirt (204) that is more porous than other portions of the atrial seal skirt (204). The opening feature (300), realized as part of an atrial seal skirt (204) having increased porosity, may have permanently increased porosity or may be formed of a material having porosity that initially increases in the implanted environment but decreases over time (e.g., endothelialization) to enable a controlled reduction of regurgitation. Alternatively, the entire atrial seal skirt (204) may be porous to control the amount of regurgitation, and / or may enable a decrease in porosity over time (e.g., through endothelialization) to gradually reduce regurgitation. In some realizations, the opening feature (300) may have a pressure-controlled component, such as a pop-up valve, that allows regurgitation when the pressure within the ventricle rises above a predetermined threshold.

[0080] FIGS. 4 through 8 illustrate various artificial tricuspid valves (100) at different stages of implantation into the natural tricuspid valve of a patient's heart. In the example of FIG. 4, the artificial tricuspid valve (100) is compressed within the delivery sheath (406) such that the cylindrical portion (116) of the support structure (102) (realized as a cage structure in this example) is compressed radially within the sheath (406), and the distal segment (114) of each atrial arm (106-1) and the distal segment (110) of each ventricular arm (106-2) are not extended beyond the length of the cylindrical portion (116) and are straightened against the outer surface (147) of the cylindrical portion (116).

[0081] FIG. 4 also illustrates an intermediate layer (404) within a sheath (406), a plurality of restraints (410), each of which is attached to the distal segment (114) of an atrial arm (106-1), an inner nose cone (402), and an outer nose cone (400) [e.g., a pigtail nose cone configured to be guided along a guide wire (408) and / or separated from the guide wire (408)]. A guide wire (408) can be used to guide the artificial tricuspid valve (100) through the patient's vein to the patient's natural tricuspid valve while the artificial tricuspid valve (100) is in the contractile structure of FIG. 4, in which the cylindrical portion (116) has a first diameter, each ventricular arm (106-2) is held against the outer surface (147) of the cylindrical portion (116) by a sheath (406), 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 restraint (410).

[0082] As illustrated in FIG. 5, the sheath (406) can be retracted to allow the ventricular arm (106-2) to be bent so 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). In FIG. 5, the artificial tricuspid valve (100) is inserted into the natural tricuspid valve. In FIG. 5, the natural valve leaflets (500) and natural chordae tendineae (502) of the natural tricuspid valve can be seen.

[0083] As illustrated in FIG. 6, the artificial tricuspid valve (100) can subsequently 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 valve leaflet (500) of the natural tricuspid valve. In FIG. 6, it can be seen that the cylindrical portion (116) expands from the contracted structure of FIG. 4, which has a first diameter (e.g., due to its shape memory features, balloon expansion, etc.), to an expanded structure, which has a larger second diameter, in order to form an elongated central passage (104) (see FIG. 7 and FIG. 8).

[0084] As illustrated in FIGS. 7 and 8, the restraint (410) can then be advanced so 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 valve leaflet (500), thereby allowing the atrial arm (106-1) to bend so as to capture the natural valve leaflet (500) against the distal segment (110) of the ventricular arm (106-2).

[0085] The restraint (410) may be composed of sutures, polymers, metals, and / or other materials and may serve as a controllably expandable connector from the delivery system to the tip of the atrial arm (106-1) on the atrial side of the natural valve leaflet (500). In this way, the atrial arm (106-1) may be extended and expanded as a final stage of deployment before evaluating valve function, and the connection to the delivery system is maintained at full diameter. If the result is undesirable and recapture is required, the restraint (410) may be operated in reverse to pull the tip of the atrial arm (106-1) toward the delivery system to relocate and / or recapture the implant. When positioning and valve function are required, the restraint (410) may be released, and the implant may be fully deployed.

[0086] For example, when the artificial tricuspid valve (100) is preferably placed on the natural tricuspid valve, the restraint (410) can be separated from the atrial arm (106-1) to release the artificial tricuspid valve (100) in a fully implanted configuration. FIG. 8 illustrates a method in which a support structure (102) [equipped with arms (106-1, 106-2)] is configured to biomechanically fix the artificial tricuspid valve (100) by separating it from the natural ring or natural chordae associated with the natural tricuspid valve by grasping the natural leaflet (500) of the natural tricuspid valve without being directly attached to it.

[0087] However, if it is required to relocate or remove the artificial tricuspid valve (100) from the configuration of FIG. 8, FIG. 9 to 12 illustrate a method in which the restraint (410) can be retracted to straighten the atrial arm (106-1) against the outer surface (147) of the cylindrical portion (116) for releasing the natural valve leaflet (500) (Fig. 9), and a method in which the sheath (406) can be advanced to straighten the ventricular arm (106-2) and compress the central cylindrical portion (116) for removing the artificial tricuspid valve (100) (Fig. 10 to 12).

[0088] FIGS. 4 through 12 also illustrate the vertical overlap arrangement of the arms (106) during the capture of the natural valve leaflet (500). Specifically, as shown in FIGS. 4 through 12, the atrial arm (106-1) extends from the ventricular end (120) of the cylindrical portion (116) and the ventricular arm (106-2) extends from the atrial end (118) of the cylindrical portion (116). Both the atrial arm (106-1) and the ventricular arm (106-2) extend across the cross-sectional plane of the cylindrical portion (116) of at least one support structure (102) so that there is a vertical overlap between the atrial arm (106-1) and the ventricular arm (106-2) across the cross-sectional plane during the capture of the natural valve leaflet (500). The support structure (102) may be realized as an arm (106) that does not cross the cross-sectional plane and thus does not show vertical overlap [e.g., an atrial arm (106-1) extending from the atrial end (118) of the cylindrical portion (116) and a ventricular arm (106-2) extending from the ventricular end (120) of the cylindrical portion (116), but the vertical overlap arrangement described herein (e.g., see FIGS. 1 to 12) in which the atrial arm (106-1) and the ventricular arm (106-2) cross twice with respect to the cross-sectional plane of the cylindrical portion (116) has the advantage of promoting a more robust seal on the natural valve leaflet (500) to prevent perivalvular leakage, and also enables proper unfolding sequencing [the atrial following the ventricular arm (106-2)] that allows for complete evaluation and recapture of the artificial tricuspid valve (100). It has the advantage of promoting [Aam (106-1)].Additionally, allowing the atrial arm (106-1) and ventricular arm (106-2) to extend from opposite ends of the cylindrical portion (116) allows each set of arms (106-1, 106-2) to be compressed against the cylindrical portion (116) itself [without needing to be fully extended beyond each end of the cylindrical portion (116)], thereby significantly reducing the overall length of the artificial tricuspid valve (100) during delivery, and thereby improving flexibility and ease of positioning and deployment.

[0089] FIG. 13 is a plan view of an artificial tricuspid (100) in which a valve leaflet element (1300) within an elongated central passage (104) can be seen forming the interior of the artificial tricuspid (100). In the example of FIG. 13, the valve leaflet element (1300) is joined to form a complete seal in the closed structure of the artificial tricuspid (100). However, as previously described in relation to FIG. 3, in some scenarios it may be desirable to allow a controlled amount of backflow through the artificial tricuspid (100) permanently or temporarily. In the example of FIG. 3, various realizations of the opening feature (300) to enable such controlled backflow are described. However, in other realizations, the valve leaflet element (1300) may be provided with a feature or restraint that provides the desired backflow. For example, tension lines or other mechanical or material features (not shown) may be provided to prevent one or more valve leaflet elements (1300) from being completely joined to another valve leaflet element (1300), thereby enabling a controlled amount of backflow between valve leaflet elements (1300) permanently or temporarily. To reduce or eliminate backflow, the tension lines may later be removed, relaxed, or materially altered.

[0090] An artificial tricuspid valve (100) can be delivered from the inferior vena cava, which extends to the superior vena cava, to the natural tricuspid valve. The distal portion of the delivery system can be extended so that the capsule extends away from the main axis of the delivery system at a preset curvature and can bend toward the natural tricuspid valve for axial alignment and positioning. In this example, if it is extended further toward the inferior vena cava, the curve will increase, and if the distal portion is pulled back, the curve will be minimized. FIG. 14 illustrates the delivery paths from the inferior vena cava and the superior vena cava.

[0091] The delivery system for this catheter-via-tricuspid implant (100) may come out from the superior vena cava via the jugular vein, subclavian vein, or some other vessel, or from the inferior vena cava via the femoral vein or other entry point. Alternatively, access may be achieved by surgical access through the right atrium of the heart.

[0092] For example, the development sequence may allow partial development within the atrium before advancing into the ventricle to complete localization and development, or the development sequence may allow full advancing and localization into the natural tricuspid valve before initiating development.

[0093] The delivery system may be passive or may have multiple planes of steering elements. In some embodiments, depth control may be provided by providing a steering mechanism of the delivery system that can reciprocate proximally or distally with respect to the handle of the delivery system. An example of reciprocating the steering mechanism includes allowing tension of the steering mechanism (e.g., relative movement between a base laser-cut hypotube and a tension wire mounted on the distal end of the hypotube) within a sub-part of the delivery system handle that can itself be translated linearly within the handle, while maintaining the same relative tension between the steering mechanisms.

[0094] In some scenarios, the delivery system is advanced from the inferior vena cava through the right atrium to the superior vena cava along a guide wire extending beyond the superior vena cava, with the artificial tricuspid valve (100) effectively accommodated in a portion of the delivery system placed within the right atrium. Subsequently, the distal portion of the delivery system is extended upward into the superior vena cava so that the distal portion of the delivery system is released from the proximal portion, and may be bent from the main axis of the delivery system toward the natural tricuspid ring. The degree to which the distal portion of the delivery system extends away from the proximal portion of the delivery system controls the magnitude of the angle between the proximal portion of the distal portion of the delivery system [where the artificial tricuspid valve (100) is accommodated] 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 ring. The delivery feature is further illustrated in FIGS. 25 and 26, which illustrate the separation of the pigtail nose cone (400) from the guide wire (408).

[0095] In another example, the delivery system may access the right atrium from the superior vena cava via a guidewire extending downward into the inferior vena cava (see, for example, lower left of FIG. 33). In this example, as the tip of the delivery system approaches the right atrium, the delivery system may be detached from the guidewire and thus guided toward the ring of the natural tricuspid valve either passively or by active steering. In this way, the guidewire can still be used for stability without needing to advance into the right ventricle, which could cause complications (e.g., perforation, entanglement, conduction problems, etc.). In this example or in another example, the outer nose cone (400) of the delivery system may be blunt and rounded like a dome or long and flexible in the shape of a pigtail so as to advance non-traumatically into the right ventricle without getting entangled in the chordae tendineae of the natural tricuspid valve.

[0096] FIGS. 15 and FIGS. 16 respectively illustrate wide-field and near-field views of a portion of a support structure (102) in which a cylindrical portion (116) is formed by a foldable cage structure [e.g., having a V-shaped support (2200) for capturing the secondary bend (130) of the atrial arm 106-1). In the example of FIGS. 15 and FIGS. 16, the arm (106) is shown before the bend (126, 124, 128, 130) is formed therein.

[0097] FIGS. 17 and FIGS. 18 illustrate different arrangements for the aforementioned cover (200).

[0098] FIG. 19 illustrates a method in which the vertical overlap of the atrial arm (106-1) and the ventricular arm (106-2) can be formed closer to the ventricular end (120) of the cylindrical portion (116) than shown in FIG. 1. In other words, FIG. 19 illustrates a method in which the cross-sectional plane of the cylindrical portion (116) to which the atrial arm (106-1) and the ventricular arm (106-2) extend can be formed closer to the ventricular end (120) of the cylindrical portion (116) than shown in FIG. 1.

[0099] FIG. 20 illustrates a method in which a force (2000) [e.g., by an intermediate layer (404)] can be applied to the cylindrical portion (116) of the support structure (102) of the artificial tricuspid valve (100) against a restraining force (2002) on the atrial arm (106-1) of the support structure (102) for the control of natural valve leaflet capture.

[0100] FIG. 21 illustrates a method in which a V-shaped support (2200) may be formed over a secondary bend (130) of an atrial arm (106-1) that contacts a cylindrical portion (116) of a support structure (2100) [e.g., support structure (102)], in contrast to the realization of FIG. 22 in which a V-shaped support (2200) is formed under a secondary bend (2202) of an atrial arm (106-1) [e.g., secondary bend (130)] and receives the secondary bend (2202) to stabilize the position of the atrial arm (106-1).

[0101] FIG. 23 illustrates a spreader arm (2300) configured to extend from an intermediate layer (404) to provide the force (2000) of FIG. 20 against the restraining force of the restraint (410). Further details regarding the arrangement of the spreader arm (2300) and the restraint (410) are provided later in connection with FIG. 35 through FIG. 40.

[0102] FIG. 24 is a side view of a pair of atrial arms (106-1) and ventricular arms (106-2) and illustrates a vertical overlap arrangement of a pair of atrial arms (106-1) and ventricular arms (106-2) for grasping natural valve leaflets as in FIG. 8. As shown in FIG. 24, the distal segment (114) of each atrial arm (106-1), which extends vertically away from the central axis of the elongated central passage (104), extends along the cylindrical portion (116) of the support structure (102) from the first longitudinal position (2421). Likewise, the distal segment (110) of each ventricular arm (106-2) extending away from the central axis of the elongated central passage (104) extends along the cylindrical portion (116) of the support structure (102) from the second longitudinal position (2420). As shown in FIG. 24, the first longitudinal position (2421) is closer to the atrial end (118) of the cylindrical portion (116) of the support structure (102) than the second longitudinal position (2420) is closer to the atrial end (118) of the cylindrical portion (116) of the support structure (102).

[0103] In an implanted configuration of the artificial tricuspid valve (100) in which a supporting structure (102) of the artificial tricuspid valve (100) biomechanically fixes the artificial tricuspid valve (100) to the natural valve leaflet (500) of the natural tricuspid valve, the ventricular arm (106-2) in the example of FIG. 24 extends from the atrial end (118) of the cylindrical portion (116) into the ventricle of the heart through the natural loop of the natural tricuspid valve and contacts the ventricular surface of the natural valve leaflet (500). In this implanted configuration, the atrial arm (106-1) extends from the ventricular end (120) of the cylindrical portion (116) into the atrium of the heart through the natural loop of the natural tricuspid valve and contacts the atrial surface of the natural valve leaflet (500).

[0104] FIG. 24 also illustrates a method in which the bends (126, 130) may be greater than 90° so that the distal segment (114) of each atrial arm (106-1), which extends vertically away from the central axis of the elongated central passage (104), extends toward the ventricular end (120) of the cylindrical part (116), and the distal segment (110) of each ventricular arm (106-2), which extends vertically away from the central axis of the elongated central passage (104), extends toward the atrial end (118) of the cylindrical part (116).

[0105] FIG. 24 also shows that the distal segment (114) of each atrial arm (106-1) extending vertically away from the central axis of the elongated central passage (104) has a tip (142), and the distal segment (110) of each ventricular arm (106-2) extending vertically away from the central axis of the elongated central passage (104) has a tip (140), and the tip (142) is closer to the ventricular end (120) of the cylindrical part (116) than the tip (140) is usually closer to the ventricular end (120) of the cylindrical part (116). However, as illustrated in FIG. 24, the distal segment (114) of each atrial arm (106-1) [e.g., the tip (142) of each atrial arm (106-1)] may have an extended segment (2400) having a third bend toward the atrial end (118) of the cylindrical portion (116) for a more non-traumatic connection to the atrial surface of the natural valve leaflet if necessary. It should also be noted that the distal segment (110) of each ventricular arm (106-2) [e.g., the tip (140) of each ventricular arm (106-2)] may have an extended segment having a third bend [similar to the third bend of the extended segment (2400) of each atrial arm (106-1)] toward the ventricular end (120) of the cylindrical portion (116) for a more non-traumatic connection to the ventricular surface of the natural valve leaflet if necessary. It should also be noted that the third bend may reduce the frictional force applied to the inner surface of the outer sheath (406) by the artificial tricuspid valve (100) by guiding the tip of the arm (106) away from the inner surface of the outer sheath (406) during loading, delivery, and recapture of the artificial tricuspid valve (100).

[0106] Referring again to FIGS. 25 and 26, the delivery system may emerge from a guidewire (2500) [e.g., guidewire (408)] leading from the inferior vena cava to the superior vena cava or from the superior vena cava to the inferior vena cava, where the nose cone (400) and the distal portion of the delivery system enter the right atrium without the guidewire (2500), pass through the natural tricuspid loop, and separate from the wire track of the guidewire (2500) to enter the right ventricle. This enables the utilization of the stability of the guidewire (2500) following a straight section without the risk of having the guidewire in the right ventricle, which could stimulate the heart's electrical system and cause conduction abnormalities. When the guidewire (2500) is pulled, the nose cone (400) can return to a flexible "pigtail" shaped tip that can easily pass through the natural tricuspid loop without getting entangled in the cord of the natural tricuspid valve. In another embodiment, the guidewire (2500) may extend from the superior vena cava or inferior vena cava into the right atrium, and the delivery system may be advanced so that the nose cone (400) returns to its "pig tail" shape before entering the right ventricle.

[0107] FIGS. 27 through 29 illustrate other embodiments of a support structure (2702) [e.g., support structure (102)] for an artificial tricuspid valve (2700), wherein both the atrial arm (2701-1) [e.g., atrial arm (106-1)] and the ventricular arm (2701-2) [e.g., ventricular arm (106-2)] may initially extend from the ventricular end of the support structure (2702), and each arm (2701) has an initial bend of 180°+ / - 45° that guides the arm (2701) back toward the atrial end of the support structure (2702). In this example, each atrial arm (2701-1) extends through the ring of the natural tricuspid valve and has a secondary bend closer to the atrial end of the support structure (2720) than the secondary bend of each ventricular arm (2701-2). The secondary bend of each arm (2702) is sufficient to position the distal segment of the arm (2702) perpendicular to the central axis of the slender central passage formed in the support structure (2702) beyond the secondary bend of the arm (2702). However, in this example, the degree of the secondary bend of the arm (2702) is configured so that the tip of the atrial arm (2701-1) is closer to the ventricular end of the support structure (2702) than the tip of the ventricular arm (2701-2). Therefore, the placement of the atrial arm (2701-1) and ventricular arm (2701-2) above and below the natural valve leaflet will result in a corrugated, wavy-collar configuration to ensure tight sealing and more stable positioning of the artificial tricuspid valve (2700).

[0108] In another embodiment, the atrial arm (2701-1) and the ventricular arm (2701-2) both initially extend from the atrial end of the support structure (2702). The valve leaflet element (1300) described in relation to the artificial tricuspid valve (100) may also be used with the alternative support structure (2702) of FIGS. 27 through 30 as shown in FIG. 29. In an exemplary embodiment shown in FIG. 30, each atrial arm (2701-1) may be folded against the outer surface (147) of the support structure (2702) during loading, and each ventricular arm (2701-2) may be extended downward toward and beyond the ventricular end of the support structure (2702) during loading.

[0109] FIGS. 31 to 34 illustrate various features of an artificial tricuspid valve in which the atrial and ventricular arms originate and extend from opposite ends of the cylindrical portion of the supporting structure of the artificial tricuspid valve (e.g., the ventricular arm originates and extends from the atrial end of the cylindrical portion of the supporting structure, and the atrial arm originates and extends from the ventricular end of the cylindrical portion of the supporting structure). These various features may be applied to any of the embodiments described above or below if necessary.

[0110] FIG. 35 illustrates additional features of the spreader arm (2300) described above in relation to FIG. 23 [for providing the force (2000, 2002) of FIG. 20 for controlled deployment or retraction of the ventricular arm (106-2), for example]. As illustrated in the example of FIG. 35, a plurality of spreader arms (2300) may extend from circumferentially separated positions on the intermediate layer (404) and may be configured to spread radially upon retraction of the outer sheath (406).

[0111] Each spreader arm (2300) may be coupled to the atrial end (118) of the cylindrical portion (116) of the support structure (102) so that the cylindrical portion (116) of the artificial tricuspid valve (100) can be expanded radially by the expansion of the spreader arm (2300) and the spreader arm (2300) provides a force in the ventricular direction to the support structure (102) that counteracts the atrial-directed force of the restraint (410) on the atrial arm (106-1). The spreader arm (2300) may be formed of a 3D printed or molded material (e.g., a polymer) that is flexible enough to be compressed into the sheath (406) and then naturally spread out again into the structure of FIG. 35 upon retraction of the sheath (406). In the example of FIG. 35, each restraint (410) for each atrial arm (106-1) is realized as a suture that extends from the gap (3508) between the spreader arms (2300), through the eyelet (3502) within the atrial arm (106-1), and extends back through the gap (3508) between the spreader arms (2300). When the desired implantation position for the artificial tricuspid valve (100) is achieved, the restraint (410) can be cut and removed.

[0112] FIG. 36 is a perspective view of a spreader arm (2300) extending from an intermediate layer (404), in which an interlocking mechanism (3600) for interfacing with 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) so that the spreader arm (2300) can push at least one support structure (102) toward the ventricle. In some embodiments, the interlocking mechanism (3600) may maintain contact with the atrial end (118) of the cylindrical portion (116) of the support structure (102) both during active pushing of the spreader arm (2300) and during passive rest of the spreader arm (2300). In some embodiments, the interlocking mechanism (3600) may be disengaged from the atrial end (118) of the cylindrical portion (116) of the support structure (102) during passive rest of the spreader arm (2300) when the intermediate layer (404) moves away from the support structure (102).

[0113] As illustrated in FIG. 36, each spreader arm (2300) may have an extension (3602) extending over the interlocking mechanism (3600) on the spreader arm and over the atrial end (118) of the cylindrical portion (116) of at least one support structure (102). The extension (3602) may serve for various purposes. First, the extension (3602) may serve as a "hood" over the support structure (102) to enable the artificial tricuspid (100) to be recaptured more easily with less force by preventing the outer sheath (406) from facing resistance from the edge of the support structure (102) as the outer sheath (406) advances again over the edge of the support structure (102) during recapture. Additionally, the extension (3602) may be extended to facilitate the formation of the atrial sealing skirt (204) and to provide a hinge point for controlled sliding of the atrial sealing skirt (204) in order to reduce the loading and recapturing forces that would otherwise cause the atrial sealing skirt (204) to be unevenly folded when the atrial arm (106-1) is folded upward.

[0114] In the examples of FIGS. 35 and 36, the spreader arm (2300) is coupled to the proximal segment (108) of each ventricular arm (106-2) [e.g., the initial bend (124) of each ventricular arm (106-2)] at the atrial end (118) of the cylindrical portion (116) of the support structure (102). However, it should be noted that the spreader arm (2300) may alternatively or additionally be provided to be coupled to the cylindrical portion (116) of the support structure (102) as illustrated in the examples of FIGS. 59 and 60.

[0115] FIG. 37 is a wider perspective view of a support structure (102) coupled to a restraint (410) and a spreader arm (2300) of an intermediate layer (404), where it can be seen that the inner nose cone (402) and the outer nose cone (400) extend through an elongated central passage (104). The artificial tricuspid (100) can be positioned in the configuration of FIG. 37 during implantation and before the removal of the inner nose cone (402), outer nose cone (400), spreader arm (2300), restraint (410), and sheath (406) to complete the implantation.

[0116] FIG. 38 is a perspective view of a portion of an intermediate layer (404) according to an embodiment of the present invention. As illustrated in FIG. 38, a suture forming a restraint (410) may be provided along the entire length of the delivery system [e.g., within an elongated opening (3804) of the outer layer (3800) of the intermediate layer (404)]. If necessary, these sutures may be coupled to a spring (3801) on the end of the delivery system to accommodate any bending at the end of the delivery system, which is configured to be proximal to the ventricular side of the natural tricuspid valve and whose relative length may be changed. The spring (3801) may be mounted, for example, in an opening (3806) in the inner layer (3802) of the intermediate layer (404). From the spring (3081), the suture can be extended downward into the inner diameter, through one of the arm eyelets (3502) (see FIG. 35), and then again downward through the gap (3508) between the spreader arms (2300). In one exemplary embodiment, nine spreader arms (2300) may alternate with nine sutures in the circumferential direction. One end of each suture may extend from the intermediate layer (404) at an end of the delivery system configured to be proximal to the atrial side of the natural tricuspid valve, and thus this end may be cut so that the suture can be pulled around the inner diameter.

[0117] In the examples of FIGS. 35 and 37, the support structure (102) of the artificial tricuspid valve (100) is shown interfacing with the spreader arm (2300) and restraint (410) without other parts of the artificial tricuspid valve (100) for clarity only. FIG. 39 shows a complete artificial tricuspid valve (100) having a cover (200) and valve leaflet elements (1300), having an atrial sealing skirt (204) that interfaces with a delivery system. For further clarity, FIG. 40 is a perspective view of the support structure (102) and the spreader arm (2300) shown partially transparent, particularly for clarity of the interface between the interlocking mechanism (3600) and the bend (124) of the ventricular arm (106-2).

[0118] FIG. 41 is a perspective view of a support structure (102) in a configuration in which an atrial arm (106-1), a ventricular arm (106-2), and a cylindrical portion (116) are cut from a common structure. In the example of FIG. 41, the support structure (102) is shown in a "cut state" [e.g., the atrial arm (106-1) and the ventricular arm (106-2) are shown in a state before the bends (126, 124, 128, 130) are formed therein to modify the configuration of the segments (108, 110, 112, 114) to reflect, for example, what is shown in FIG. 1]. FIG. 41 also shows an exemplary configuration for the ventricular arm tip (140) and the atrial arm tip (142). However, the configuration of the tip (140, 142) may be provided in various different geometric structures to optimize load distribution for the natural valve leaflets. In the configuration of FIG. 41, the cylindrical part (116) is formed as an expandable cage structure shown in a contracted configuration.

[0119] FIGS. 42a and FIGS. 42b illustrate an artificial tricuspid valve (100) implanted in the natural tricuspid valve of the heart (4200) throughout the alternating pressure difference on both sides of the natural tricuspid valve (100) during the heart cycle of the heart (4200).

[0120] Specifically, FIG. 42a illustrates an artificial tricuspid valve (100) implanted in the natural tricuspid valve of the heart (4200) during diastolic filling of the ventricle (4202) of the heart (4200). During diastolic filling of the ventricle (4202) of the heart (4200), blood flows from the atrium (4201) of the heart (4200) into the ventricle (4202) of the heart (4200) through the elongated central passage (104) of the artificial tricuspid valve (100). During diastolic filling of the ventricle (4202) of the heart (4200), the pressure on the artificial tricuspid valve (100) is relieved as the artificial tricuspid valve (100) moves slightly toward the ventricle (4202) of the heart (4200). The atrial arm (106-1) resists this movement, while the ventricular arm (106-2) relaxes to maintain contact with the ventricular side of the natural tricuspid valve leaflet.

[0121] Conversely, FIG. 42b illustrates an artificial tricuspid valve (100) implanted in the natural tricuspid valve of the heart (4200) during the systole of the ventricle (4202) of the heart (4200). During the systole of the ventricle (4202) of the heart (4200), blood flows from the ventricle (4202) of the heart (4200) to the pulmonary artery (4203) of the heart (4200). During the systole of the ventricle (4202) of the heart (4200), pressure on the artificial tricuspid valve (100) causes the artificial tricuspid valve (100) to move slightly toward the atrium (4201) of the heart (4200). While the ventricular arm (106-2) resists this movement, 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 ventricular systolic pressure load can be partially absorbed by the atrial movement of the natural valve leaflets.

[0122] FIGS. 43a and FIGS. 43b illustrate different realizations of a support structure (102) for an artificial tricuspid according to an embodiment. Specifically, FIG. 43a illustrates another realization of a support structure (102) for an artificial tricuspid in a contracted structure, which defines an elongated central passage having a first diameter. FIG. 43b illustrates another realization of a support structure (102) for an artificial tricuspid in an expanded structure, which defines an elongated central passage having a second diameter larger than the first diameter. For example, in the embodiments of FIGS. 43a and FIG. 43b, the first diameter of the elongated central passage may be 8 mm, and the second diameter of the elongated central passage may be 25 mm.

[0123] As discussed above, the artificial tricuspid valve described herein may have one or more support structures. For example, the artificial tricuspid valve described herein may have one, two, three, or more than three support structures. At least one of the one or more support structures has a cylindrical portion having an atrial end and a ventricular end. The cylindrical portion of at least one support structure defines the elongated central passage of the artificial tricuspid valve. The detailed description of the specific drawings above and below describes an exemplary artificial tricuspid valve having one support structure. Additionally, the detailed description of the specific drawings above and below describes an exemplary artificial tricuspid valve having more than one (e.g., two, three, or more than three) support structures. For example, the detailed description of FIGS. 46 through 53 below describes an exemplary artificial tricuspid valve having two or three support structures. However, most of the features of the artificial tricuspid valve described with reference to the artificial tricuspid valve having a specific number of support structures may be included in other artificial tricuspid valves having a different number of support structures.

[0124] FIGS. 44 to 45 are other illustrations of the realization of an artificial tricuspid (4400) having one support structure (102) according to an embodiment.

[0125] FIG. 44a is a diagram illustrating a flat support structure (102) of an artificial tricuspid (4400) having one support structure (102) according to an embodiment.

[0126] FIG. 44b is a side view of an artificial tricuspid (4400) configured to be implanted into a natural tricuspid plate having one support structure (102) according to an embodiment.

[0127] FIGS. 45a to 45d are computer-aided design (CAD) drawings of different views of an artificial tricuspid (4400) having one support structure (102) according to an embodiment. FIG. 45a is a CAD drawing of a side view of an artificial tricuspid (4400) having one support structure (102) according to an embodiment. FIG. 45b is a CAD drawing of a downward view of an artificial tricuspid (4400) having one support structure (102) according to an embodiment. FIG. 45c is a CAD drawing of an inclined side view of an artificial tricuspid (4400) having one support structure (102) according to an embodiment. FIG. 45d is a CAD drawing of a side view of an artificial tricuspid (4400) having one support structure (102) according to an embodiment.

[0128] In an embodiment of an artificial tricuspid valve (4400) having a single support structure (102), the atrial arm (106-1) and the ventricular arm (106-2) are both formed by the single support structure (102). As described throughout this specification, the single structure (102) also has a cylindrical portion (116) defining the elongated central passage (104) of the artificial tricuspid valve (4400).

[0129] Advantages of forming the artificial tricuspid (4400) as a single support structure (102) include a reduction in the diameter of the artificial tricuspid (4400) and fewer steps for assembling the artificial tricuspid (4400). However, one disadvantage of forming the artificial tricuspid (4400) as a single support structure (102) is the more complex manufacturing of the artificial tricuspid (4400). Another disadvantage of forming the artificial tricuspid (4400) as a single support structure (102) is that the artificial tricuspid (4400) may not effectively distribute the load, and therefore certain parts of the artificial tricuspid (4400) may easily fracture under stress. Specifically, as will be discussed in more detail below, forming the artificial tricuspid (4400) as a single support structure (102) may result in the artificial tricuspid (4400) having a shorter arm (106), as well as a support point occurring at the same general location as the load node, and thus generating less effective load distribution capability, and thus increasing the possibility of the artificial tricuspid (4400) being destroyed.

[0130] FIGS. 46 and FIGS. 47 are different illustrations of the realization of an artificial tricuspid (4600) having two support structures (102-1, 102-2) according to an embodiment.

[0131] FIG. 46a is a diagram illustrating a flat support structure (102-1, 102-2) of an artificial tricuspid (4600) having two support structures (102-1, 102-2) according to an embodiment.

[0132] FIG. 46b is a side view of an artificial tricuspid (4600) configured to be implanted into a natural tricuspid plate having two support structures (102-1, 102-2) according to an embodiment.

[0133] FIGS. 47a to 47f are CAD drawings of different illustrations of an artificial tricuspid (4600) having two support structures (102-1, 102-2) according to an embodiment. FIG. 47a is a CAD drawing of an inclined side view of a support structure (102-1) of an artificial tricuspid (4600) having two support structures (102-1, 102-2) according to an embodiment. FIG. 47b is a CAD drawing of an inclined side view of a support structure (102-2) of an artificial tricuspid (4600) having two support structures (102-1, 102-2) according to an embodiment. FIG. 47c is a CAD drawing of a side view of an artificial tricuspid (4600) having two support structures (102-1, 102-2) according to an embodiment. FIG. 47d is a CAD drawing of a downward view of an artificial tricuspid (4600) having two support structures (102-1, 102-2) according to an embodiment. FIG. 47e is a CAD drawing of an inclined side view of an artificial tricuspid (4600) having two support structures (102-1, 102-2) according to an embodiment. FIG. 47f is a CAD drawing of another side view of an artificial tricuspid (4600) having two support structures (102-1, 102-2) according to an embodiment.

[0134] In an embodiment of an artificial tricuspid valve (4600) having two support structures (102-1, 102-2), the atrial arm (106-1) is formed by the first support structure (102-1) and the ventricular arm (106-2) is formed by the second support structure (102-2). The two support structures (102-1, 102-2) are configured to be fitted together to form an artificial tricuspid valve (4600). As described throughout this specification, at least one of the two support structures (102-1, 102-2) has a cylindrical portion defining an elongated central passage (104) of the artificial tricuspid valve (4600). For example, in the realization of an artificial tricuspid (4600) having two support structures (102-1, 102-2) as illustrated in FIGS. 46 and 47, each of the two support structures (102-1, 102-2) has a cylindrical portion (116-1, 116-2) that defines the elongated central passage (104) of the artificial tricuspid (4600). However, in an alternative embodiment, only one of the two support structures (102-1, 102-2) may have a cylindrical portion to define the elongated central passage (104) of the artificial tricuspid (4600).

[0135] The advantage of forming the artificial tricuspid valve (4600) with two support structures (102-1, 102-2) is that the artificial tricuspid valve (4600) is made simpler. However, the disadvantage of forming the artificial tricuspid valve (4600) with two support structures is that the assembly of the artificial tricuspid valve (4600) involves an additional step of fitting the two support structures (102-1, 102-2) together to form the artificial tricuspid valve (4600). Another advantage of forming the artificial tricuspid valve with two support structures (102-1, 102-2) is improved load distribution in the ventricular arm (106-20), which is important because the ventricular arm (106-2) experiences greater force than the atrial arm (106-1) when the artificial tricuspid valve (4600) is implanted in vivo.

[0136] FIGS. 48 and FIGS. 49 are different illustrations of the realization of an artificial tricuspid (4800) having two support structures (102-1, 102-2) according to an embodiment.

[0137] FIG. 48a is a diagram illustrating a flat support structure (102-1, 102-2) of an artificial tricuspid (4800) having two support structures (102-1, 102-2) according to an embodiment.

[0138] FIG. 48b is a side view of an artificial tricuspid (4800) configured to be implanted into a natural tricuspid plate having two support structures (102-1, 102-2) according to an embodiment.

[0139] FIGS. 49a to 49f are CAD drawings of different illustrations of an artificial tricuspid (4800) having two support structures (102-1, 102-2) according to an embodiment. FIG. 49a is a CAD drawing of an inclined side view of a support structure (102-1) of an artificial tricuspid (4800) having two support structures (102-1, 102-2) according to an embodiment. FIG. 49b is a CAD drawing of an inclined side view of a support structure (102-2) of an artificial tricuspid (4800) having two support structures (102-1, 102-2) according to an embodiment. FIG. 49c is a CAD drawing of a side view of an artificial tricuspid (4800) having two support structures (102-1, 102-2) according to an embodiment. FIG. 49d is a CAD drawing of a downward view of an artificial tricuspid (4800) having two support structures (102-1, 102-2) according to an embodiment. FIG. 49e is a CAD drawing of an inclined side view of an artificial tricuspid (4800) having two support structures (102-1, 102-2) according to an embodiment. FIG. 49f is a CAD drawing of another side view of an artificial tricuspid (4800) having two support structures (102-1, 102-2) according to an embodiment.

[0140] In an embodiment of an artificial tricuspid valve (4800) having two support structures (102-1, 102-2), the ventricular arm (106-2) is formed by the first support structure (102-1) and the atrial arm (106-1) is formed by the second support structure (102-2). The two support structures (102-1, 102-2) are configured to be fitted together to form an artificial tricuspid valve (4800). As described throughout this specification, at least one of the two support structures (102-1, 102-2) has a cylindrical portion defining an elongated central passage (104) of the artificial tricuspid valve (4800). For example, in the realization of an artificial tricuspid (4800) having two support structures (102-1, 102-2) as illustrated in FIGS. 48 and 49, each of the two support structures (102-1, 102-2) has a cylindrical portion (116-1, 116-2) that defines the elongated central passage (104) of the artificial tricuspid (4800). However, in an alternative embodiment, only one of the two support structures (102-1, 102-2) may have a cylindrical portion to define the elongated central passage (104) of the artificial tricuspid (4800).

[0141] The advantage of forming the artificial tricuspid valve (4800) with two support structures (102-1, 102-2) is that the artificial tricuspid valve (4800) is made simpler to manufacture than the artificial tricuspid valve (4600). Another advantage of forming the artificial tricuspid valve (4800) with two support structures (102-1, 102-2) is that the valve leaflet element can be formed by the first support structure (102-1) forming the ventricular arm (106-2) rather than the atrial arm (106-1), and thus the aforementioned atrial sealing skirt can be formed separately from the valve leaflet element by the second support structure (102-2) forming the atrial arm (106-1). By forming the atrial sealing skirt as a second support structure (102-2) separately from the valve leaflet element formed by the first support structure (102-1), the assembly of the individual support structures (102-1, 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, 102-2) together to form the artificial tricuspid valve (4800). Another advantage of forming the artificial tricuspid valve (4800) with two supporting structures (102-1, 102-2) is that load distribution is improved, but the improvement is mainly made in the atrial arm (106-1), and this is less important because when the artificial tricuspid valve (4800) is implanted in vivo, the atrial arm (106-1) experiences less force than the ventricular arm (106-2).

[0142] FIGS. 50 to 51 are other illustrations of the realization of an artificial tricuspid (5000) having two support structures (102-1, 102-2) according to an embodiment.

[0143] FIG. 50a is a diagram illustrating a flat support structure (102-1, 102-2) of an artificial tricuspid (5000) having two support structures (102-1, 102-2) according to an embodiment.

[0144] FIG. 50b is a side view of an artificial tricuspid (5000) configured to be implanted into a natural tricuspid plate, having two support structures (102-1, 102-2) according to an embodiment.

[0145] FIGS. 51a to 51f are CAD drawings of various illustrations of an artificial tricuspid (5000) having two support structures (102-1, 102-2) according to an embodiment. FIG. 51a is a CAD drawing of an inclined side view of a support structure (102-1) of an artificial tricuspid (5000) having two support structures (102-1, 102-2) according to an embodiment. FIG. 51b is a CAD drawing of an inclined side view of a support structure (102-2) of an artificial tricuspid (5000) having two support structures (102-1, 102-2) according to an embodiment. FIG. 51c is a CAD drawing of a side view of an artificial tricuspid (5000) having two support structures (102-1, 102-2) according to an embodiment. FIG. 51d is a CAD drawing of a downward view of an artificial tricuspid (5000) having two support structures (102-1, 102-2) according to an embodiment. FIG. 51e is a CAD drawing of an inclined side view of an artificial tricuspid (5000) having two support structures (102-1, 102-2) according to an embodiment. FIG. 51f is a CAD drawing of another side view of an artificial tricuspid (5000) having two support structures (102-1, 102-2) according to an embodiment.

[0146] In an embodiment of an artificial tricuspid valve (5000) having two support structures (102-1, 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 atrial arm (106-2). In some embodiments, the second support structure (102-2) forming both the atrial arm (106-1) and the atrial arm (106-2) may be an artificial tricuspid valve (4400) having one support structure (102). The two support structures (102-1, 102-2) are configured to be fitted together to form an artificial tricuspid valve (5000). As described throughout the invention, at least one of the two support structures (102-1, 102-2) has a cylindrical portion defining the elongated central passage (104) of the artificial tricuspid (5000). For example, in an embodiment of the artificial tricuspid (5000) having two support structures (102-1, 102-2) shown in FIGS. 50 and 51, each of the two support structures (102-1, 102-2) has a cylindrical portion (116-1, 116-2) defining the elongated central passage (104) of the artificial tricuspid (5000). However, in an alternative embodiment, only one of the two support structures (102-1, 102-2) may have a cylindrical portion to define the elongated central passage (104) of the artificial tricuspid (5000).

[0147] The advantage of forming the artificial tricuspid valve (5000) with two support structures (102-1, 102-2), as with the artificial tricuspid valve (4600, 4800), includes simpler manufacturing of the artificial tricuspid valve (5000). Additionally, another advantage of forming the artificial tricuspid valve (5000) with two support structures (102-1, 102-2), as with the artificial tricuspid valve (4800), is that the valve leaflet element can be formed by the first support structure (102-1) which does not form the atrial arm (106-1), and thus the aforementioned atrial sealing skirt can be formed separately from the valve leaflet element by the second support structure (102-2) which forms the atrial arm (106-1). By forming the atrial sealing skirt as a second support structure (102-2) separately from the valve leaflet element formed by the first support structure (102-1), the assembly of the individual support structures (102-1, 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, 102-2) together to form the artificial tricuspid valve (5000). Another advantage of forming the artificial tricuspid valve (5000) with two support structures (102-1, 102-2) is that load distribution is improved because the first support structure (102-1) can provide additional reinforcement to the ventricular arm (106-2) and the atrial arm (106-1) formed by the second support structure (102-2). However, the arm (106) is not yet extended, and the support point still occurs at the same general location as the load node, resulting in less effective load distribution capability and thus causing a greater possibility of failure of the artificial tricuspid (5000).

[0148] FIGS. 52 and FIGS. 53 are different illustrations of the realization of an artificial tricuspid (5200) having three support structures (102-1, 102-2, 102-3) according to an embodiment.

[0149] FIG. 52a is a diagram illustrating a flat support structure (102-1, 102-2, 102-3) of an artificial tricuspid (5200) having three support structures (102-1, 102-2, 102-3) according to an embodiment.

[0150] FIG. 52b is a side view of an artificial tricuspid (5200) configured to be implanted into a natural tricuspid, having three support structures (102-1, 102-2, 102-3) according to an embodiment.

[0151] FIGS. 53a to 53g are CAD drawings of different illustrations of an artificial tricuspid (5200) having three support structures (102-1, 102-2, 102-3) according to an embodiment. FIG. 53a is a CAD drawing of an inclined side view of a support structure (102-1) of an artificial tricuspid (5200) having three support structures (102-1, 102-2, 102-3) according to an embodiment. FIG. 53b is a CAD drawing of an inclined side view of a support structure (102-2) of an artificial tricuspid (5200) having three support structures (102-1, 102-2, 102-3) according to an embodiment. FIG. 53c is a CAD drawing of an inclined side view of a support structure (102-3) of an artificial tricuspid (5200) having three support structures (102-1, 102-2, 102-3) according to an embodiment. FIG. 53d is a CAD drawing of a side view of an artificial tricuspid (5200) having three support structures (102-1, 102-2, 102-3) according to an embodiment. FIG. 53e is a CAD drawing of a downward view of an artificial tricuspid (5200) having three support structures (102-1, 102-2, 102-3) according to an embodiment. FIG. 53f is a CAD drawing of an inclined side view of an artificial tricuspid (5200) having three support structures (102-1, 102-2, 102-3) according to an embodiment. FIG. 53g is a CAD drawing of another side view of an artificial tricuspid (5200) having three support structures (102-1, 102-2, 102-3) according to an embodiment.

[0152] In an embodiment of an artificial tricuspid valve (5200) having three support structures (102-1, 102-2, 102-3), the first support structure (102-1) does not form an atrial arm (106-1) or a ventricular arm (106). 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, 102-3) are configured to be fitted together to form an artificial tricuspid valve (5200). As described throughout this specification, at least one of the three support structures (102-1, 102-2, 102-3) has a cylindrical portion defining an elongated central passage (104) of the artificial tricuspid (5200). In the realization of the artificial tricuspid (5200) having three support structures (102-1, 102-2, 102-3) shown in FIG. 52 and FIG. 53, each of the three support structures (102-1, 102-2, 102-3) has a cylindrical portion (116-1, 116-2, 116-3) defining an elongated central passage of the artificial tricuspid (5200). However, in an alternative embodiment, only one or two of the three support structures (102-1, 102-2, 102-3) may have a cylindrical portion to define the elongated central passage (104) of the artificial tricuspid (5200).

[0153] The advantage of forming the artificial tricuspid valve (5200) with three support structures (102-1, 102-2, 102-3), as in the artificial tricuspid valve (4600, 4800, 5000), includes simpler manufacturing of the artificial tricuspid valve (5200). Additionally, another advantage of forming the artificial tricuspid valve (5200) with three support structures (102-1, 102-2, 102-3), as in the artificial tricuspid valve (4800, 5000), is that the valve leaflet element can be formed by the first support structure (102-1) which does not form the atrial arm (106-1), and thus the aforementioned atrial sealing skirt can be formed separately from the valve leaflet element by the third support structure (102-3) which forms the atrial arm (106-1). By forming the atrial sealing skirt as a third support structure (102-3) separately from the valve leaflet element formed by the first support structure (102-1), the assembly of the individual support structures (102-1, 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, 102-3) together to form the artificial tricuspid valve (5200). Another advantage of forming the artificial tricuspid valve (5200) with three support structures (102-1, 102-2, 102-3) is that load distribution is improved 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).In addition, unlike the artificial tricuspid (4600, 4800, 5000) described above, the arm (106) is extended so that the support point occurs at a plurality of different locations spaced apart from the node receiving the load force, thereby effectively generating a greater load distribution and thus reducing the possibility of failure of the artificial tricuspid (5000). However, forming the artificial tricuspid (5200) into three support structures (102-1, 102-2, 102-3) has the disadvantage of causing an increase in the total volume and diameter of the artificial tricuspid (5200).

[0154] FIG. 54a is a side view of the vertical overlap between the atrial arm (106-1) and the ventricular arm (106-2) of the artificial tricuspid valve (100) during rest according to an embodiment. In other words, FIG. 54a is a side view of the vertical overlap 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.

[0155] FIG. 54b is a side view of the atrial arm (106-1) and ventricular arm (106-2) of the artificial tricuspid valve (100) when the artificial tricuspid valve (100) is implanted into a natural tricuspid valve according to an embodiment. In other words, FIG. 54b is a side view of the atrial arm (106-1) and ventricular arm (106-2) of the artificial tricuspid valve (100) when the arm (106) is clamped onto the natural valve leaflet of the natural tricuspid valve to which the artificial tricuspid valve (100) is implanted. As shown in FIG. 54a, when the artificial tricuspid valve (100) is in a resting state, the amount of vertical overlap 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 valve leaflet of the natural tricuspid valve.

[0156] FIG. 55 is a CAD drawing of a cross-sectional side view of an artificial tricuspid valve (5200) having three support structures (102-1, 102-2, 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, 102-3) are configured to be fitted together to form an artificial tricuspid valve (5200). Specifically, to form an artificial tricuspid valve (5200) by fitting three support structures (102-1, 102-2, 102-3) together, the radius of curvature of the secondary bend (130) of each atrial arm (106-1) is accommodated by the V-shaped support (2200-1) of the first support structure (102-1). In addition, to form an artificial tricuspid valve (5200) by fitting three support structures (102-1, 102-2, 102-3) together, the radius of curvature of the secondary bend (126) of each ventricular arm (106-2) is accommodated by the V-shaped support (2200-1) of the support structure (102-1) and also comes into contact with the mirror V-shaped support (2200-3) of the support structure (102-3) forming the atrial arm (106-1).

[0157] Additionally, in order to enable the three support structures (102-1, 102-2, 102-3) to be fitted together to form an artificial tricuspid (5200), the dimensions of the three support structures (102-1, 102-2, 102-3) may be determined relative to one another. For example, in some embodiments, the minimum inner diameter of the cylindrical portion(s) of at least one support structure defining the elongated central passage (104) may be smaller than the maximum outer diameter of the elongated central passage (104). As previously discussed, in the realization of the artificial tricuspid (5200), each of the three support structures (102-1, 102-2, 102-3) has a cylindrical portion (116-1, 116-2, 116-3) defining the elongated central passage (104) of the artificial tricuspid (5200). Accordingly, in some embodiments, the minimum inner diameter of the cylindrical portions (116-1, 116-2, 116-3) of each of the three supporting structures (102-1, 102-2, 102-3) defining the slender central passage (104) may be smaller than the maximum outer diameter of the slender central passage (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 perpendicularly away from the central axis of the slender central passage (104)] is smaller than the maximum outer diameter of the slender central passage (104). In other words, in some embodiments, the minimum length of the radius of curvature of the secondary bend (130) of each atrial arm (106-1) and the secondary bend (126) of each ventricular arm (106-2) is smaller than the maximum outer diameter of the slender central passage (104). These relative dimensions can facilitate the three support structures (102-1, 102-2, 102-3) being fitted together to form an artificial tricuspid (5200).

[0158] FIGS. 56a to 56c are images of a prototype artificial tricuspid (5600) according to an embodiment. Specifically, FIG. 56a is a downward view of an image of a prototype artificial tricuspid (5600) clamped onto a sheet of paper oriented approximately perpendicularly (e.g., 90°+ / - 45°) to the central axis of the elongated central passage (104) of the artificial tricuspid (5600) according to an embodiment. FIG. 56b is an upward view of an image of a prototype artificial tricuspid (5600) clamped onto a sheet of paper oriented approximately perpendicularly (e.g., 90°+ / - 45°) to the central axis of the elongated central passage (104) of the artificial tricuspid (5600) according to an embodiment. FIG. 56c is a side view of an image of a prototype artificial tricuspid clamped onto a sheet of paper oriented approximately perpendicularly (e.g., 90°+ / - 45°) to the central axis of the elongated central passage of the artificial tricuspid according to an embodiment.

[0159] FIG. 57 is an upward view of an image of a prototype artificial tricuspid valve (5700) according to an embodiment. In the embodiment of the artificial tricuspid valve (5700) shown in FIG. 57, two of the ventricular arms differ from the ventricular arms (106-2) described throughout this specification. Specifically, in the embodiment of the artificial tricuspid valve (5700) shown in FIG. 57, the ventricular-directing arm (5701) is a ventricular arm modified to differ from the ventricular arm (106-2) described throughout this specification. In particular, the distal segment (110) of each ventricular-directing arm (5701) is modified to extend toward the ventricular end (120) of the cylindrical portion (116) of at least one support structure (102). Thus, the distal segment (110) of each ventricular-directing arm (5701) extends toward the ventricular end (120) of the cylindrical portion (116) of at least one support structure (102), thereby allowing the distal segment (110) of each ventricular-directing arm (5701) to come into contact with the natural valve leaflet of the natural tricuspid valve on the atrium side of the natural tricuspid valve rather than on the ventricular side of the natural tricuspid valve, so as to maintain the natural valve leaflet radially outward from the natural tricuspid valve in an open position.

[0160] Configuring the ventricular-directing arm (5701) to hold the natural valve leaflet radially laterally from the natural tricuspid valve in an open position may be useful in many different embodiments. For example, configuring the ventricular-directing arm (5701) to hold the natural valve leaflet radially laterally from the natural tricuspid valve in an open position may be useful in embodiments where it is difficult to capture the natural valve leaflet by the arm (106) for one reason or another (e.g., when the natural valve leaflet is too small or restricted). As another example, configuring the ventricular-directing arm (5701) to hold the natural valve leaflet radially laterally from the natural tricuspid valve in an open position may be useful for minimizing the number of echocardiographic planes and / or views required during the implantation of the artificial heart valve (thereby simplifying the implantation procedure). In this embodiment, rather than attempting to capture all three natural leaflets of the natural tricuspid valve, one or more natural leaflets may be pushed out as described above, and the remaining natural leaflets may be captured by the arm (106). Although the artificial tricuspid valve (5700) is equipped with two ventricular-directing arms (5701), in an alternative embodiment, the artificial tricuspid valve (5700) may be equipped with any number of ventricular-directing arms (5701), such as zero, one, two, three, or more than three ventricular-directing arms (5701).

[0161] FIG. 58 is a CAD drawing of an inclined side view of an artificial tricuspid valve (5800) having three support structures (102-1, 102-2, 102-3) according to an embodiment. The artificial tricuspid valve (5800) is similar to the artificial tricuspid valve (5200) shown in FIG. 52, FIG. 53 and FIG. 55. However, the artificial tricuspid valve (5800) is equipped with two ventricular-directing arms (5701) as previously described in relation to FIG. 57. Like the ventricular arm (106-2), the ventricular-directing arm (5701) is formed by a second support structure (102-2).

[0162] FIG. 59 is a diagram illustrating a flat support structure (102) of an artificial tricuspid valve according to an embodiment. As illustrated in FIG. 59, the support structure (102) has an atrial end (118) and a ventricular end (120). A plurality of interlocking mechanisms (5900) are provided at the atrial end (118) of the support structure (102). As discussed below in relation to FIG. 59, each interlocking mechanism (5900) of the support structure (102) is configured to interlock with a corresponding interlocking mechanism (3600) of a spreader arm (2300).

[0163] FIG. 60 illustrates the loading, locking, and unlocking of an interlocking mechanism (5900) of a support structure (102) of an artificial tricuspid according to an embodiment. Specifically, as shown in FIG. 60, each interlocking mechanism (5900) of the support structure (102) is interlocked with a corresponding interlocking mechanism (3600) of a spreader arm (2300).

[0164] The loading, locking, and unlocking of the interlocking mechanism (5900) of the support structure (102) is achieved by using the extension (3602) of each interlocking mechanism (3600) of each spreader arm (2300). Specifically, while the interlocking mechanism (5900) of the support structure (102) is loaded with the corresponding interlocking mechanism (3600) of the spreader arm (2300), the extension (3602) of the interlocking mechanism (3600) of the spreader arm (2300) is partially retracted from the interlocking mechanism (5900) of the support structure (102), thereby pushing the interlocking mechanism (3600) of the spreader arm (2300) to the side and allowing the interlocking mechanism (5900) of the support structure (102) to snap to a position where it is locked with the interlocking mechanism (3600) of the spreader arm (2300). While the interlocking mechanism (5900) of the support structure (102) is locked with the corresponding interlocking mechanism (3600) of the spreader arm (2300), the extension (3602) of the interlocking mechanism (3600) of the spreader arm (2300) is fully advanced over the interlocking mechanism (5900) of the support structure (102), thereby locking the interlocking mechanism (3600) of the spreader arm (2300) and the interlocking mechanism (5900) of the support structure (102) to the locking position. While the interlocking mechanism (5900) of the support structure (102) is released from the corresponding interlocking mechanism (3600) of the spreader arm (2300), the extension (3602) of the interlocking mechanism (3600) of the spreader arm (2300) is fully retracted from the interlocking mechanism (5900) of the support structure (102), thereby allowing the interlocking mechanism (5900) of the support structure (102) to expand and be released from the position in which it is locked with the interlocking mechanism (3600) of the spreader arm (2300).

[0165] FIG. 61 is a diagram of a flat support structure (102) configured to form the ventricular arm (106-2) of an artificial tricuspid valve according to an embodiment.

[0166] FIG. 62a is an image of a prototype support structure (102) forming the ventricular arm (106-2) of an artificial tricuspid valve according to an embodiment.

[0167] FIG. 62b is an image of a prototype support structure (102) forming the ventricular arm (106-2) and ventricular-directing arm (5701) of an artificial tricuspid valve according to an embodiment.

[0168] FIGS. 63a and FIG. 63b are CAD drawings of a support structure (102) forming a ventricular arm (106-2) of an artificial tricuspid valve according to an embodiment. Specifically, FIG. 63a is a downward view of a CAD drawing of a support structure (102) forming a ventricular arm (106-2) of an artificial tricuspid valve according to an embodiment. FIG. 63b is a side view of a CAD drawing of a support structure (102) forming a ventricular arm (106-2) of an artificial tricuspid valve according to an embodiment.

[0169] FIGS. 64a and 64b are CAD drawings of a support structure (102) forming the ventricular arm (106-2) and ventricular-directing arm (5701) of an artificial tricuspid valve according to an embodiment. Specifically, FIG. 64a is a downward view of a CAD drawing of a support structure (102) forming the ventricular arm (106-2) and ventricular-directing arm (5701) of an artificial tricuspid valve according to an embodiment. FIG. 64b is a side view of a CAD drawing of a support structure (102) forming the ventricular arm (106-2) and ventricular-directing arm (5701) of an artificial tricuspid valve according to an embodiment.

[0170] FIG. 65 is a diagram illustrating a flat support structure (102) configured to form an atrial arm (106-1) of an artificial tricuspid valve according to an embodiment. As illustrated in FIG. 65, the tip (142) of each atrial arm (106-1) may be provided with a locking mechanism (6500). Each locking mechanism (6500) of the support structure (102) is configured to be locked to a corresponding restraint (410) (e.g., a suture).

[0171] During the loading of the locking mechanism (6500), the narrow opening (6501) of each locking mechanism (6500) allows the corresponding restraint (410) to enter the locking mechanism (6500) and be locked in place. During the locking of the locking mechanism (6500), the tooth (6502) of each locking mechanism (6500) prevents the corresponding locked restraint (410) from exiting the locking mechanism (6500) through the narrow opening (6501) while the restraint (410) is under tension. During the release of the locking mechanism (6500), when the tension is removed from the restraint (410), the restraint (410) can exit the locking mechanism (6500) through the narrow opening (6501).

[0172] FIG. 66 is a CAD drawing of a side view of an artificial tricuspid valve (5800) according to an embodiment. As shown in FIG. 66, the distal segment (114) of each atrial arm (106-1) extends from the atrial end (118) of the cylindrical portion (116) of the support structure (102-1, 102-2, 102-3), but extends toward the ventricular end (120) of the cylindrical portion (116) of the support structure (102-1, 102-2, 102-3). Conversely, the distal segment (110) of each ventricular arm (106-2) extends from the ventricular end (120) of the cylindrical portion (116) of the support structure (102-1, 102-2, 102-3), but extends toward the atrial end (118) of the cylindrical portion (116) of the support structure (102-1, 102-2, 102-3). As a result, as previously mentioned, a vertical overlap occurs between the atrial arm (106-1) and the ventricular arm (106-2). The dotted line crossing the artificial tricuspid valve (5800) in FIG. 66 indicates the point of vertical overlap between the atrial arm (106-1) and the ventricular arm (106-2). As illustrated in FIG. 66, the vertical overlap between the atrial arm (106-1) and the ventricular arm (106-2) allows the atrial arm (106-1) and the ventricular arm (106-2) to clamp the natural valve leaflet (500-2) of the natural tricuspid valve between them. Conversely, as illustrated in FIG. 66, the ventricular-directing arm (5701) is configured to hold the natural valve leaflet (500-1) radially outward from the natural tricuspid valve in an open position.

[0173] Additionally, as illustrated in FIG. 66, the tip (142) of each atrial arm (106-1) is provided with an extended segment (2400) having a third bend toward the atrial end (118) of the cylindrical portion (116) of the support structure (102-1, 102-2, 102-3) for more non-traumatic attachment to the atrial surface of the natural valve leaflet. Likewise, as illustrated in FIG. 66, the tip (140) of the ventricle-directing arm (5701) may be provided with an extended segment having a third bend toward the ventricular end (120) of the cylindrical portion (116) of the support structure (102-1, 102-2, 102-3) for more non-traumatic attachment to the atrial surface of the natural valve leaflet (500-1). These third bends of the atrial arm (106-1) and the ventricular-directing arm (5701) can also prevent the atrial arm (106-1) and the ventricular-directing arm (5701) from being embedded within the tissue of the natural valve leaflet.

[0174] FIGS. 67a to 67c are side views of the vertical overlap between the atrial arm (106-1) and the ventricular arm (106-2) of an artificial tricuspid valve according to an embodiment. Specifically, FIGS. 67a to 67c are side views of various vertical overlap amounts between the atrial arm (106-1) and the ventricular arm (106-2) of an artificial tricuspid valve according to an embodiment. The amount of vertical overlap between the atrial arm (106-1) and the ventricular arm (106-2) of the artificial tricuspid valve determines the magnitude of the clamping force of the arm (106) against the natural valve leaflet of the natural tricuspid valve. Additionally, the magnitude of the clamping force of the arm (106) against the natural valve leaflet of the natural tricuspid valve determines the amount of biomechanical movement of the artificial tricuspid valve within the natural tricuspid valve throughout the heart's cardiac cycle.

[0175] FIG. 67a is a side view of a relatively small amount of vertical overlap between the atrial arm (106-1) and the ventricular arm (106-2) of an artificial tricuspid valve according to an embodiment. As a result of this relatively small amount of vertical overlap between the atrial arm (106-1) and the ventricular arm (106-2) of the artificial tricuspid valve in FIG. 67a, a relatively small amount of tension can be applied to the natural valve leaflets clamped between the atrial arm (106-1) and the ventricular arm (106-2). Additionally, as a result of this relatively small amount of tension applied to the natural valve leaflets clamped between the atrial arm (106-1) and the ventricular arm (106-2), the artificial tricuspid valve can exhibit a relatively large amount of biomechanical movement within the natural tricuspid valve throughout the heart's cardiac cycle.

[0176] FIG. 67b is a side view of a relatively moderate amount of vertical overlap between the atrial arm (106-1) and the ventricular arm (106-2) of an artificial tricuspid valve according to an embodiment. As a result of this relatively moderate amount of vertical overlap between the atrial arm (106-1) and the ventricular arm (106-2) of the artificial tricuspid valve in FIG. 67b, a relatively moderate amount of tension can be applied to the natural valve leaflets clamped between the atrial arm (106-1) and the ventricular arm (106-2). Additionally, as a result of this relatively moderate amount of tension applied to the natural valve leaflets clamped between the atrial arm (106-1) and the ventricular arm (106-2), the artificial tricuspid valve can exhibit a relatively moderate amount of biomechanical movement within the natural tricuspid valve throughout the heart's cardiac cycle.

[0177] FIG. 67c is a side view of a relatively large amount of vertical overlap between the atrial arm (106-1) and the ventricular arm (106-2) of an artificial tricuspid valve according to an embodiment. As a result of this relatively large amount of vertical overlap between the atrial arm (106-1) and the ventricular arm (106-2) of the artificial tricuspid valve in FIG. 67, a relatively large amount of tension can be applied to the natural valve leaflets clamped between the atrial arm (106-1) and the ventricular arm (106-2). Additionally, as a result of this relatively large amount of tension applied to the natural valve leaflets clamped between the atrial arm (106-1) and the ventricular arm (106-2), the artificial tricuspid valve may exhibit a relatively small amount of biomechanical movement within the natural tricuspid valve throughout the heart's cardiac cycle.

[0178] FIGS. 68a and FIG. 68b illustrate different realizations of an atrial seal skirt (204) according to an embodiment. Specifically, FIG. 68a illustrates a symmetric realization of an atrial seal skirt (204) according to an embodiment. FIG. 68b illustrates an asymmetric realization of an atrial seal skirt (204) according to an embodiment.

[0179] The symmetrical atrial seal skirt (204) shown in FIG. 68a can be used in a symmetrical artificial tricuspid device such as the artificial tricuspid device shown in FIG. 62a and FIG. 64a-64b. Specifically, the symmetrical atrial seal skirt (204) shown in FIG. 68a can be used in an artificial tricuspid device having a symmetrical ventricular arm (e.g., ventricular arm 106-2000).

[0180] Conversely, the asymmetric atrial seal skirt (204) shown in FIG. 68b can be used in an asymmetric artificial tricuspid device such as the artificial tricuspid device shown in FIG. 62b and FIG. 65a-65b. Specifically, the asymmetric atrial seal skirt (204) shown in FIG. 68b can be used in an artificial tricuspid device having an asymmetric ventricular arm [e.g., ventricular arm (106-2) and ventricular-directing arm(s) (5701)].

[0181] The tab of the atrial sealing skirt (204) lined along the slender central passage (104) can be folded downward to be joined to another part of the cover (200) that extends along the interior of the cylindrical portion (116) of at least one support structure (102) of the artificial tricuspid valve. The opening (300) of the atrial sealing skirt (204) may allow space for the ventricular arm (106-2) to pass through the atrial sealing skirt (204) during the assembly of the artificial tricuspid valve, so that when the artificial tricuspid valve is assembled, the ventricular arm (106-2) is positioned outside the slender central passage of the artificial tricuspid valve. In some embodiments, the asymmetric portion of the asymmetric atrial sealing skirt (204) of FIG. 68b may also have an additional opening (300) to be positioned within the natural ring of the natural tricuspid valve when the artificial tricuspid valve is implanted into the natural tricuspid valve.

[0182] FIGS. 69a and 69b are images of a support structure (102-2, 102-3) of a prototype artificial tricuspid (6900) according to an embodiment. Specifically, FIG. 69a is an upward view image of a support structure (102-2, 102-3) of a prototype artificial tricuspid (6900) according to an embodiment. FIG. 69b is a side view image of a support structure (102-2, 102-3) of a prototype artificial tricuspid (6900) according to an embodiment.

[0183] The artificial tricuspid valve (6900) is similar to the prototype artificial tricuspid valve (5600) of FIGS. 56a through 56c and is equipped with three support structures (102-1, 102-2, 102-3) (shown in FIG. 74). However, the images in FIGS. 69a and 69b show only the support structures (102-2, 102-3) of the prototype artificial tricuspid valve (6900). As will be discussed below, 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). As shown in FIGS. 69a and 69b, the symmetric atrial seal skirt (204) of FIG. 68a covers the support structures (102-2, 102-3) of the symmetric prototype artificial tricuspid (6900).

[0184] FIGS. 70a and 70b are images of a support structure (102-2, 102-3) of a prototype artificial tricuspid (7000) according to an embodiment. Specifically, FIG. 70a is an upward view image of a support structure (102-2, 102-3) of a prototype artificial tricuspid (7000) according to an embodiment. FIG. 70b is a side view image of a support structure (102-2, 102-3) of a prototype artificial tricuspid (7000) according to an embodiment.

[0185] The prototype artificial tricuspid (7000) is similar to the prototype artificial tricuspid (5700) of FIG. 57 and has three support structures (102-1, 102-2, 102-3). However, the images in FIG. 70a and FIG. 70b show only the support structures (102-2, 102-3) of the prototype artificial tricuspid (7000). As shown in FIG. 70a and FIG. 70b, the asymmetric atrial sealing skirt (204) of FIG. 68b covers the support structures (102-2, 102-3) of the symmetric prototype artificial tricuspid (7000).

[0186] FIG. 71 is an image of a downward view of a support structure (102-3) of a prototype artificial tricuspid valve (6900) according to an embodiment. As shown in FIG. 71, the atrial sealing skirt (204) of the support structure (102-3) of the artificial tricuspid valve (6900) is provided with an opening (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), so that when the artificial tricuspid valve (6900) is assembled, the ventricular arm (106-2) is positioned outside the elongated central passage (104) of the artificial tricuspid valve (6900).

[0187] FIGS. 72a and 72b are images of a support structure (102-2, 102-3) of a prototype artificial tricuspid (6900) according to an embodiment. Specifically, FIG. 72a is a top-down view image of a support structure (102-2, 102-3) of a prototype artificial tricuspid (6900) according to an embodiment. FIG. 72b is a side view image of a support structure (102-2, 102-3) of a prototype artificial tricuspid (6900) according to an embodiment.

[0188] As discussed above in relation to FIGS. 69a and 69b, the artificial tricuspid valve (6900) is equipped with three support structures (102-1, 102-2, 102-3) (shown in FIG. 74). However, the images in FIG. 72a and 72b show only the support structures (102-2, 102-3) of the prototype artificial tricuspid valve (6900). As discussed below, 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).

[0189] Three support structures (102-1, 102-2, 102-3) are configured to be fitted together to form an artificial tricuspid valve (6900). Specifically, to fit the three support structures (102-1, 102-2, 102-3) together to form an artificial tricuspid valve (6900), the radius of curvature of the secondary bend (130) of each atrial arm (106-1) is accommodated by the V-shaped support (2200-1) (shown in FIG. 74) of the first support structure (102-1). Additionally, to form an artificial tricuspid valve (6900) by fitting three support structures (102-1, 102-2, 102-3) together, the radius of curvature of the secondary bend (126) of each ventricular arm (106-2) is accommodated by the V-shaped support (2200-1) (shown in FIG. 74) of the support structure (102-1) and also comes into contact with the mirror V-shaped support (2200-3) of the support structure (102-3) forming the atrial arm (106-1).

[0190] It should be noted that while the artificial tricuspid (6900) is configured to also have a support structure (102-1) (shown in FIG. 74) in addition to the support structures (102-2, 102-3), some embodiments do not require three support structures for the artificial tricuspid. Rather, in some embodiments such as the embodiments of the artificial tricuspid (4600, 4800, 5000), the artificial tricuspid may have only two support structures. In these embodiments, as described in detail above and below, the reinforcement for the arm (106) of the artificial tricuspid will simply be reduced.

[0191] FIG. 73 illustrates an atrial sealing skirt (204) having a ventricular arm sleeve (7300) configured to enclose a ventricular arm (106-2) of a support structure (102) according to an embodiment. As illustrated in FIG. 73, in some embodiments, the atrial sealing skirt (204) may have one or more ventricular arm sleeves (7300), each ventricular arm sleeve (7300) configured to enclose a corresponding ventricular arm (106-2) of the support structure (102). Each ventricular arm sleeve (7300) may be configured, for example, as a ribbon extending from the atrial sealing skirt (204) covering the support structure (102). To enclose the ventricular arm (106-2), a ribbon extending from the atrial sealing skirt (204) is folded over the ventricular arm (106-2) and can be sutured closed around the ventricular arm (106-2).

[0192] Encapsulation of the ventricular arm (106-2) by the ventricular arm sleeve (7300) can facilitate the internal growth of the ventricular arm (106-2) within the natural tricuspid valve leaflet when the artificial tricuspid valve is implanted. Encapsulation of the ventricular arm (106-2) by the ventricular arm sleeve (7300) can also provide non-traumatic contact between the ventricular arm (106-2) and the natural tricuspid valve leaflet when the artificial tricuspid valve is implanted. Furthermore, encapsulation of the ventricular arm (106-2) by the ventricular arm sleeve (7300) can act as a safety device to prevent embolism in the event that the ventricular arm (106-2) fractures when the artificial tricuspid valve is implanted.

[0193] FIG. 74 is an image of a side view of a prototype artificial tricuspid valve (6900) according to an embodiment. As discussed above in relation to FIG. 69a and FIG. 69b, the artificial tricuspid valve (6900) has three support structures (102-1, 102-2, 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).

[0194] Three support structures (102-1, 102-2, 102-3) are configured to be fitted together to form an artificial tricuspid valve (6900). Specifically, to fit the three support structures (102-1, 102-2, 102-3) together to form an artificial tricuspid valve (6900), the radius of curvature of the secondary bend (130) of each atrial arm (106-1) is accommodated by the V-shaped support (2200-1) of the first support structure (102-1). In addition, to form an artificial tricuspid valve (6900) by fitting three support structures (102-1, 102-2, 102-3) together, the radius of curvature of the secondary bend (126) of each ventricular arm (106-2) is accommodated by the V-shaped support (2200-1) of the support structure (102-1) and also comes into contact with the mirror V-shaped support (2200-3) of the support structure (102-3) forming the atrial arm (106-1).

[0195] Additionally, in order to form an artificial tricuspid valve (6900) by mutually fixing three support structures (102-1, 102-2, 102-3), each support structure (102-2, 102-3) is fixed to support structure (102-1). Specifically, as shown in FIG. 74, in order to fix support structure (102-3) to support structure (102-1), the eyelet (3502) (shown in FIG. 35) of each atrial arm (106-1) formed by support structure (102-3) is fixed to the corresponding eyelet of support structure (102-1). Also, as shown in FIG. 74, in order to fix support structure (102-2) to support structure (102-1), the three-point node of support structure (102-2) is fixed to support structure (102-1).

[0196] FIGS. 75 to 79 illustrate different realizations of an artificial tricuspid having different numbers of support structures according to an embodiment. Specifically, FIGS. 75 to 79 illustrate differential load distribution in different realizations of an artificial tricuspid having different numbers of support structures according to an embodiment.

[0197] As illustrated in each of FIGS. 75 through 79, when an artificial tricuspid valve is implanted into a natural tricuspid valve throughout the heart's cardiac cycle, an atrial-directing force (7501) is generated by the ventricular arm (106-2) of each artificial tricuspid valve as a result of the ventricular systolic pressure load from the heart. Conversely, a ventricular-directing force (7500) is generated by the atrial arm (106-1) of each artificial tricuspid valve as a result of the natural valve leaflets of the natural tricuspid valve being stretched in response to the ventricular systolic pressure load. As indicated by the size of the arrows of the forces (7500, 7501), the atrial-directing force (7501) generated by the ventricular arm (106-2) is much larger in magnitude than the ventricular-directing force (7500) generated by the atrial arm (106-1). As a result, as discussed below, the dispersion of the atrial-directed force (7501) generated by the ventricular arm (106-2) is more essential than the dispersion of the ventricular-directed force (7500) generated by the atrial arm (106-1) in maintaining the integrity of the artificial tricuspid valve.

[0198] Depending on the configuration of the artificial tricuspid, particularly depending on the number of supporting structures including the artificial tricuspid, the load nodes (7502) and support points (7503) may be differentially distributed over the entire artificial tricuspid, and thus the force (7500, 7501) may be differentially distributed over the entire artificial tricuspid. Different configurations of the artificial tricuspid, its load nodes (7502) and support points (7503), and the distribution of the force (7500, 7501) accordingly are illustrated in FIGS. 75 to 79.

[0199] FIG. 75 illustrates load distribution in an artificial tricuspid valve (4400) having a single support structure (102) according to an embodiment. In an embodiment of the artificial tricuspid valve (4400) having a single support structure (102), both the atrial arm (106-1) and the ventricular arm (106-2) are formed by a single support structure (102).

[0200] As illustrated in FIG. 75, the artificial tricuspid valve (4400) has a single load node (7502) and a single support point (7503) located at the same general position of a single support structure (102). Additionally, there is no additional support structure supporting the ventricular arm (106-2). Therefore, the dispersion of the atrial-directed force (7501) generated by the ventricular arm (106-2) is minimized, effectively resulting in a greater possibility of destruction of the artificial tricuspid valve (4400).

[0201] FIG. 76 illustrates load distribution in an artificial tricuspid valve (4800) having two support structures (102-1, 102-2) according to an embodiment. In an embodiment of the artificial tricuspid valve (4800) having two support structures (102-1, 102-2), the ventricular arm (106-2) is formed by the first support structure (102-1) and the atrial arm (106-1) is formed by the second support structure (102-2).

[0202] As illustrated in FIG. 76, the artificial tricuspid valve (4800) has a load node (7502) located on each of the two support structures (102-1, 102-2). Both load nodes (7502) are located at the same common location of a single support point (7503). Additionally, the support structure (102-1) supports the atrial arm (106-1) formed by the support structure (102-2) rather than the ventricular arm (1061-2). Thus, most of the improved load distribution in the artificial tricuspid valve (4800) occurs in the atrial arm (106-1), which is less significant because, as previously discussed, the atrial arm (106-1) experiences less force than the ventricular arm (106-2) when the artificial tricuspid valve (4800) is implanted in vivo. The dispersion of the atrial-directed force (7501) generated by the ventricular arm (106-2) is not improved compared to the artificial tricuspid valve (4400).

[0203] FIG. 77 illustrates load distribution in an artificial tricuspid valve (5000) having two support structures (102-1, 102-2) according to an embodiment. In an embodiment of the artificial tricuspid valve (5000) having two support structures (102-1, 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 atrial arm (106-2).

[0204] As illustrated in FIG. 77, the artificial tricuspid valve (5000) has a load node (7502) located on each of the two support structures (102-1, 102-2). Both load nodes (7502) are located at the same common location of a single support point (7503). However, unlike the artificial tricuspid valve (4800), the dispersion of the atrial-directed force (7501) generated by the ventricular arm (106-2) is improved compared to the artificial tricuspid valve (4400) because the support structure (102-1) provides additional support to the ventricular arm (106-2) formed by the support structure (102-2). The support structure (102-1) also provides additional support to the atrial arm (106-1) formed by the support structure (102-2).

[0205] FIG. 78 illustrates load distribution in an artificial tricuspid valve (4600) having two support structures (102-1, 102-2) according to an embodiment. In an embodiment of the artificial tricuspid valve (4600) having two support structures (102-1, 102-2), the atrial arm (106-1) is formed by the first support structure (102-1) and the ventricular arm (106-2) is formed by the second support structure (102-2).

[0206] As illustrated in FIG. 78, the artificial tricuspid valve (4600) has a load node (7502) located on each of the two support structures (102-1, 102-2). However, unlike the artificial tricuspid valve (4800, 5000), the two load nodes (7502) are not located in the same general position. A single support point (7503) is located in the same general position of only one of the two load nodes (7502). Additionally, the support structure (102-1) provides additional support to the ventricular arm (106-2) formed by the support structure (102-2). As a result, the dispersion of the atrial-directed force (7501) generated by the ventricular arm (106-2) and the ventricular-directed force (7500) generated by the atrial arm (106-1) is improved compared to the artificial tricuspid valve (4400, 4800, 5000).

[0207] FIG. 79 illustrates load distribution in an artificial tricuspid valve (5200) having three support structures (102-1, 102-2, 102-3) according to an embodiment. In an embodiment of the artificial tricuspid valve (5200) having three support structures (102-1, 102-2, 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).

[0208] As illustrated in FIG. 79, the artificial tricuspid valve (5200) has a load node (7502) located at each of the three support structures (102-1, 102-2, 102-3). The three load nodes (7502) are not located at the same general location of a single support point (7503). Additionally, the first support structure (102-1) can provide additional reinforcement to the atrial arm (106-1) formed by the third support structure (102-3), and both the first support structure (102-1) and the third support structure (102-3) can provide additional reinforcement to the ventricular arm (106-2) formed by the second support structure (102-2). As a result, the dispersion of the atrial-directed force (7501) generated by the ventricular arm (106-2) and the ventricular-directed force (7500) generated by the atrial arm (106-1) is most improved in the artificial tricuspid valve (5200) compared to the artificial tricuspid valves (4400, 4800, 5000, 4600).

[0209] FIG. 80 is a CAD drawing of a cross-sectional side view of an artificial tricuspid (5200) according to an embodiment. The central axis (8000) of the elongated central passage (104) of at least one cylindrical part (116) of the three support structures (102-1, 102-2, 102-3) is shown in FIG. 80.

[0210] 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 passage (104) to attach the artificial tricuspid valve (5200) to the target (e.g., natural tricuspid valve leaflet). As referred to in this specification, the distal segment of the arm (106) extending "vertically" away from the central axis (8000) of the elongated central passage (104) refers to the distal segment of the arm (106) extending away from the central axis (8000) of the elongated central passage (104) such that a line (8001) drawn from the contact point (8002) between the object (e.g., natural tricuspid valve leaflet) and the distal segment of the arm (106) to a longitudinal position (8003) along the outer surface (147) of at least one of the three supporting structures (102-1, 102-2, 102-3) from which the distal segment extends is oriented at approximately 90°+ / - 45° from the central axis (8000) of the elongated central passage (104). In some embodiments, the contact point (8002) of the distal segment of the arm (106) may be the tip (140 or 142) of the arm (106). In an alternative embodiment in which the distal segment of the arm (106) has an extended segment having a third bend, the contact point (8002) of the distal segment of the arm (106) may be the extended segment of the arm (106), or more specifically, the third bend. The contact point (8002) of the distal segment of the arm (106) may also be any other part of the distal segment of the arm (106). As will be discussed in more detail below, this approximate verticality of the line (8001) from the contact point (8002) of the distal segment to the longitudinal position (8003) along the outer surface (147) of the cylindrical portion (116) from which the distal segment extends enables axial stabilization of the artificial tricuspid (5200) within the natural tricuspid.

[0211] It should be understood that any particular order or hierarchy of blocks in the disclosed process is an example of an exemplary approach. It should be understood that, based on feasibility preferences, any particular order or hierarchy of blocks in the process may be rearranged, nor may all of the depicted blocks be executed. Any of the blocks may be executed simultaneously. In one or more embodiments, multitasking and parallel processing may be advantageous. Furthermore, it should be understood that the separation of various system components in the foregoing embodiments should not be understood as requiring such separation in all embodiments, and that the described program components and systems may generally be integrated together into a single software product or packaged into multiple software products.

[0212] The present technology is described, for example, according to the various embodiments described above. The present disclosure is provided to enable a person skilled in the art to practice the various embodiments described herein. The present disclosure provides various examples of the technology, and the technology is not limited to these examples. Various modifications to these embodiments will be readily apparent to a person skilled in the art, and general principles defined herein may be applied to other embodiments.

[0213] References to singular elements are intended to mean "one or more" rather than "one and only one" unless specifically stated otherwise. Unless otherwise stated, the term "some" indicates one or more. Masculine pronouns include feminine and neuter genders, and vice versa. Where headings and subheadings exist, they are used merely for convenience and do not limit the invention.

[0214] In this specification, the word “exemplary” is used to mean “an example or serving as an example.” Any embodiment or design described as “exemplary” in this specification should not be construed as being more desirable or advantageous than any other embodiment or design. In one embodiment, various alternative configurations and operations described in this specification may be considered at least equivalent.

[0215] As used herein, the phrase “at least one” preceding a series of items modifies the entire list rather than each item in the list, together with the term “or” to separate these items. The phrase “at least one” does not require the selection of at least one item; rather, it allows for the meaning of including at least one of any one of the items, and / or at least one of any combination of the items, and / or at least one of each item. For example, the phrase “at least one of A, B, or C” may refer to A only, B only, or C only; or any combination of A, B, and C.

[0216] Phrases such as "moderation" do not imply that such moderation is essential to the present technology or that such moderation applies to all configurations of the present technology. Disclosures regarding moderation may apply to all configurations or one or more configurations. Moderation may provide one or more examples. Phrases such as "moderation" may refer to one or more moderations and vice versa. Phrases such as "example" do not imply that such example is essential to the present technology or that such example applies to all configurations of the present technology. Disclosures regarding example may apply to all example or one or more example. Example may provide one or more examples. Phrases such as "example" may refer to one or more example. Phrases such as "configuration" do not imply that such configuration is essential to the present technology or that such configuration applies to all configurations of the present technology. Disclosures regarding configuration may apply to all configurations or one or more configurations. Configuration may provide one or more examples. Phrases such as "configuration" may refer to one or more configurations and vice versa.

[0217] In one embodiment, unless otherwise specified, all measurements, numbers, grades, locations, sizes, dimensions, and other specifications described herein, including the following claims, are approximations and not accurate. In one embodiment, they are intended to have a reasonable range consistent with the function to which they relate and the customary practice in the art to which they belong.

[0218] It should be understood that some or all steps, operations, or processes may be performed automatically without user intervention. Method claims may be provided to present elements of various steps, operations, or processes in a sample order and do not imply being limited to a specific order or hierarchy presented.

[0219] All structural and functional equivalents of elements of various embodiments described throughout this specification, which are known to or will later become known to a person skilled in the art, are incorporated by reference into this specification and are intended to be included in the claims. Furthermore, nothing disclosed in this specification is intended to be dedicated to the public, regardless of whether such disclosure is specified in the claims. No claim element shall be interpreted under the provisions of 35 USC §112(f) unless the element is explicitly cited using the phrase “means for” or, in the case of a method, the element is cited using the phrase “step for”. Additionally, where terms such as “comprising”, “having”, etc. are used, such terms are intended to be inclusive in a manner similar to the term “comprising” as it is interpreted when used as a transitive word in the claims.

[0220] The title of the invention, background art, brief description of the drawings, and claims are incorporated herein by reference and are provided as exemplary examples rather than as a limiting description. These are provided with the understanding that they are not intended to limit the scope or meaning of the claims. Additionally, in the detailed description, it may be seen that the description provides exemplary examples and that various features are grouped together in various embodiments for the purpose of simplifying the disclosure. This method of disclosure should not be interpreted as reflecting an intention that the claimed essence requires more features than specified in any claim. Rather, as reflected in the claims below, the essence of the invention is within a scope smaller than all features of a single disclosed configuration or operation. The claims below are incorporated into the detailed description, and each claim exists independently to represent the essence claimed individually.

[0221] The claims are not intended to be limited to the embodiments described herein, but must follow the full scope consistent with the language of the claims and include all legal equivalents. Nevertheless, none of the claims are intended to include, nor should they be interpreted as, any content that fails to satisfy the requirements of 35 USC §101, 102, or 103.

Claims

Claim 1 A supporting structure defining an elongated central passage in an artificial heart valve; and includes a plurality of valve leaflet elements attached to the support structure and disposed within the slender central passage for controlling blood flow through the slender central passage, wherein the support structure is configured to biodynamically fix the artificial heart valve to the natural valve leaflet of the natural heart valve of the heart so that the artificial heart valve is not attached to the natural annulus of the natural heart valve, and so that the artificial heart valve maintains axial stabilization within the natural heart valve of the heart while the support structure moves within the natural heart valve during the heart cycle of the heart, wherein the support structure includes a cylindrical portion including an atrial end and a ventricular end, and the slender central passage is defined by the cylindrical portion of the support structure, and the support structure includes an atrial arm set and a ventricular arm set, wherein the distal segment of each arm of the atrial arm set and the distal segment of each arm of the ventricular arm set extend perpendicularly away from the central axis of the slender central passage, and the atrial arm set and the ventricular arm set is configured to contact the opposite side of each natural valve leaflet at a position radially inward from the natural ring so as to allow axial movement of the cylindrical portion of the support structure and the portion of each natural valve leaflet with respect to the natural ring, and during the biomechanical movement of the artificial heart valve within the natural heart valve during the cardiac cycle of the heart, the artificial heart valve is configured such that at least one of the systolic pressure load and the diastolic pressure load is absorbed at least partially by the movement of the natural valve leaflet, while the ventricular arm set maintains contact with the natural valve leaflet.An artificial heart valve configured to include at least one of the following: while the ventricular arm set maintains contact with the natural valve leaflet, the atrial arm set is configured to resist the movement. Claim 2 In claim 1, each arm of the atrial arm set and the ventricular arm set comprises an artificial heart valve having a proximal segment located proximal to the cylindrical portion of the support structure and a distal segment located distal to the cylindrical portion of the support structure. Claim 3 In claim 2, the atrial arm set and the ventricular arm set are an artificial heart valve that is bent such that, in an implanted configuration in which the support structure biomechanically fixes the artificial heart valve to the natural valve leaflet of the natural heart valve, when the cylindrical portion of the support structure moves toward the atrial side of the natural heart valve due to a ventricular systolic pressure load, one or more arms of the ventricular arm set resist movement while one or more arms of the atrial arm set relax to maintain contact with the atrial side of the natural valve leaflet, and when the cylindrical portion of the support structure moves toward the ventricular side of the natural heart valve due to at least one of a ventricular diastolic pressure load and the removal of a previously applied ventricular systolic load, one or more arms of the atrial arm set resist movement while one or more arms of the ventricular arm set relax to maintain contact with the ventricular side of the natural valve leaflet. Claim 4 In claim 2, the arms of the atrial arm set alternate with the arms of the ventricular arm set around the circumference of the cylindrical portion of the support structure, and the arms of the atrial arm set and the arms of the ventricular arm set extend across the cross-sectional plane of the cylindrical portion of the support structure further comprises at least one of these. Artificial heart valve. Claim 5 In claim 4, an artificial heart valve comprising a vertical overbite between the atrial arm set and the ventricular arm set on the cross-sectional plane of the cylindrical portion. Claim 6 In claim 2, the distal segment of the arm of the atrial arm set extends toward the ventricular end of the cylindrical portion of the support structure so that the distal segment of the arm of the atrial arm set can clamp the atrial natural valve leaflet of the natural heart valve; and the distal segment of the arm of the ventricular arm set extends toward the atrial end of the cylindrical portion of the support structure so that the distal segment of the arm of the ventricular arm set can clamp the ventricular natural valve leaflet of the natural heart valve. Claim 7 In claim 2, each distal segment of the arm of the atrial arm set is curved toward the atrial end of the cylindrical portion of the support structure and has a tip that reduces trauma to the natural valve leaflet on the atrial side of the natural heart valve at the contact point of the atrial arm set; and each distal segment of the arm of the ventricular arm set is curved toward the ventricular end of the cylindrical portion of the support structure and has a tip that reduces trauma to the natural valve leaflet on the ventricular side of the natural heart valve at the contact point of the ventricular arm set, an artificial heart valve. Claim 8 In claim 2, the cylindrical portion of the support structure is a radially collapsible artificial heart valve for transcatheter implantation. Claim 9 An artificial heart valve according to claim 2, wherein the distal segment of the ventricular arm set extends toward the ventricular end of the cylindrical portion of the support structure, so that the distal segment of the ventricular arm set contacts one of the natural valve leaflets located on the atrial side of the natural heart valve rather than the ventricular side of the natural heart valve, thereby allowing the natural valve leaflet to be maintained radially outward from the natural heart valve in an open position. Claim 10 An artificial heart valve according to claim 2, further comprising one or more covers extending within the elongated central passage and across one or more of the atrial arm set and the ventricular arm set. Claim 11 In claim 10, a portion of the one or more covers further comprises a fenestration feature. Artificial heart valve. Claim 12 In claim 11, the opening feature comprises at least one of a radiopaque marker, an opening, a magnetic element, a one-way valve, a pop-up valve, a mechanically adjustable opening, and increased porosity, in an artificial heart valve. Claim 13 In claim 10, the one or more covers are artificial heart valves that extend asymmetrically or non-circularly within the elongated central passage and across one or more of the atrial arm set and the ventricular arm set. Claim 14 An artificial heart valve according to claim 2, comprising at least one of the atrial arm set being attached to the atrial end of the cylindrical portion of the support structure, and the ventricular arm set being attached to the ventricular end of the cylindrical portion of the support structure. Claim 15 An artificial heart valve according to claim 2, comprising at least one of the atrial arm set being attached to the ventricular end of the cylindrical portion of the support structure, and the ventricular arm set being attached to the atrial end of the cylindrical portion of the support structure. Claim 16 In claim 15, the proximal segment of each arm of the atrial arm set extends along the outer surface of the cylindrical portion of the support structure from the ventricular end of the cylindrical portion of the support structure toward the atrial end of the cylindrical portion of the support structure, and the distal segment of each arm of the atrial arm set extends vertically away from the central axis of the slender central passage, an artificial heart valve. Claim 17 In claim 15, the proximal segment of each arm of the ventricular arm set extends along the outer surface of the cylindrical portion of the support structure from the atrial end of the cylindrical portion of the support structure toward the ventricular end of the cylindrical portion of the support structure, and the distal segment of each arm of the ventricular arm set extends vertically away from the central axis of the slender central passage, an artificial heart valve. Claim 18 In claim 15, in an implanted configuration in which the support structure biomechanically fixes the artificial heart valve to the natural valve leaflet of the natural heart valve, the ventricular arm set extends from the atrial end of the cylindrical portion of the support structure, through the natural ring of the natural heart valve, toward the ventricular side of the natural heart valve and contacts the ventricular side natural valve leaflet of the natural heart valve. Claim 19 In claim 15, in an implanted configuration in which the support structure biomechanically fixes the artificial heart valve to the natural valve leaflet of the natural heart valve, the atrial arm set extends from the ventricular end of the cylindrical portion of the support structure, through the natural ring of the natural heart valve, toward the atrial side of the natural heart valve and contacts the atrial natural valve leaflet of the natural heart valve. Artificial heart valve. Claim 20 In claim 2, the distal segment of the arm of the atrial arm set extends along the outer surface of the cylindrical portion of the support structure from an atrial longitudinal position, and the distal segment of the arm of the ventricular arm set extends along the outer surface of the cylindrical portion of the support structure from a ventricular longitudinal position, and the atrial longitudinal position is closer to the atrial end of the cylindrical portion of the support structure than the ventricular longitudinal position is closer to the atrial end of the cylindrical portion of the support structure, an artificial heart valve. Claim 21 In claim 2, the cylindrical portion of the support structure comprises a cylindrical cage structure having an opening, and at least a portion of the cylindrical cage structure and the opening is configured to accommodate a bend of the atrial arm set and the ventricular arm set, and the atrial arm set and the ventricular arm set extend vertically away from the central axis of the slender central passage, an artificial heart valve. Claim 22 In claim 2, the minimum inner diameter of the cylindrical portion of the support structure defining the slender central passage is smaller than the maximum outer diameter of the slender central passage, for an artificial heart valve. Claim 23 In claim 2, an artificial heart valve in which the minimum diameter of the radius of curvature of each bend of the arm extending vertically away from the central axis of the slender central passage is smaller than the maximum outer diameter of the slender central passage. Claim 24 In claim 2, the atrial arm set is configured to contact the natural valve leaflet on the atrial side of the natural heart valve, an artificial heart valve. Claim 25 In claim 2, the ventricular arm set is an artificial heart valve configured to contact the ventricular side of the natural heart valve. Claim 26 In claim 1, the artificial heart valve comprises one or more supporting structures. Claim 27 In claim 1, the support structure is configured to biomechanically fix the artificial heart valve to the natural valve leaflets of the natural heart valve of the heart so that the artificial heart valve responds to alternating pressure differences on both sides of the natural heart valve during the heart cycle. Claim 28 In claim 1, the artificial heart valve is an artificial heart valve that is biomechanically fixed within the natural heart valve so as to be movable within the natural ring of the natural heart valve. Claim 29 An artificial heart valve according to claim 1, wherein the atrial arm set and the ventricular arm set are configured to contact the opposite side of each natural valve leaflet across the cross-sectional plane of the cylindrical portion of the support structure so as to allow axial movement of the cylindrical portion of the support structure and the portion of each natural valve leaflet with respect to the natural ring, at least a portion of each natural valve leaflet is retained radially outward from the natural ring. Claim 30 In claim 1, the portion of each natural valve leaflet maintained radially away from the natural ring is oriented at 90°+ / - 45° with respect to the central axis of the elongated central passage, in an artificial heart valve. Claim 31 A supporting structure defining an elongated central passage in an artificial heart valve; and includes a plurality of valve leaflet elements attached to the support structure and disposed within the slender central passage for controlling blood flow through the slender central passage, wherein the support structure includes an atrial arm set and a ventricular arm set, and the atrial arm set and the ventricular arm set are configured to contact the opposite side of the natural valve leaflet of the natural heart valve at a position radially medial from the natural ring of the natural heart valve of the heart, so as to allow axial movement of the support structure and the portion of the natural valve leaflet relative to the natural ring, such that at least a portion of the natural valve leaflet is maintained radially away from the natural ring, and the ventricular arm set is configured to resist said movement while the atrial arm set maintains contact with the natural valve leaflet during the biomechanical movement of the artificial heart valve within the natural heart valve during the cardiac cycle of the heart; An artificial heart valve configured to include at least one of the following: while the ventricular arm set maintains contact with the natural valve leaflet, the atrial arm set is configured to resist the movement. Claim 32 An artificial heart valve according to claim 31, wherein the atrial arm set and the ventricular arm set extend across the cross-sectional plane of the cylindrical portion of the support structure, and 1) the distal segment of the atrial arm set extends perpendicularly away from the central axis of the slender central passage so as to contact the natural valve leaflet on the atrial side of the natural heart valve, and 2) the distal segment of the ventricular arm set extends perpendicularly away from the central axis of the slender central passage and extends toward the atrial end of the cylindrical portion of the support structure so as to contact the natural valve leaflet on the ventricular side of the natural heart valve. Claim 33 In claim 32, the distal segments of the atrial arm set and the ventricular arm set are an artificial heart valve that can be extended vertically away from the central axis of the slender central passage or be elastically straightened. Claim 34 In claim 31, the support structure is configured to biomechanically fix the artificial heart valve to the natural valve leaflet of the natural heart valve of the heart so that the artificial heart valve maintains axial stabilization within the natural heart valve of the heart while the support structure moves within the natural heart valve during the heart cycle of the heart. Claim 35 In claim 34, in an implanted configuration in which the support structure biomechanically fixes the artificial heart valve to the natural valve leaflet of the natural heart valve, the ventricular arm set extends from the atrial end of the cylindrical portion of the support structure, through the natural ring of the natural heart valve, toward the ventricular side of the natural heart valve and contacts the ventricular side natural valve leaflet of the natural heart valve. Claim 36 In claim 34, in an implanted configuration in which the support structure biomechanically fixes the artificial heart valve to the natural valve leaflet of the natural heart valve, the atrial arm set extends from the ventricular end of the cylindrical portion of the support structure, through the natural ring of the natural heart valve, toward the atrial side of the natural heart valve and contacts the atrial natural valve leaflet of the natural heart valve. Claim 37 In claim 31, the support structure comprises a cylindrical portion including an atrial end and a ventricular end, the slender central passage is defined by the cylindrical portion of the support structure, and the atrial arm set and ventricular arm set comprise a proximal segment proximal to the cylindrical portion of the support structure and a distal segment distal to the cylindrical portion of the support structure, an artificial heart valve. Claim 38 In claim 31, the support structure comprises an artificial heart valve including a vertical overlap between the atrial arm set and the ventricular arm set such that the atrial arm set and the ventricular arm set intersect each other in the cross-sectional plane of the cylindrical portion of the support structure. Claim 39 In claim 31, the artificial heart valve is an artificial heart valve that is axially stabilized within the natural heart valve by grasping the natural valve leaflets of the natural heart valve. Claim 40 delete Claim 41 delete Claim 42 delete Claim 43 delete Claim 44 delete Claim 45 delete Claim 46 delete Claim 47 delete Claim 48 delete

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