Artificial heart valve

Abstract

Described herein are prosthetic heart valves and methods for improving the function of a native heart valve. Exemplary prosthetic heart valves can include one or more support structures, at least one of which defines an elongated central passage having a longitudinal direction. The prosthetic heart valve can include a plurality of leaflet elements attached to the at least one support structure and positioned within the elongated central passage for controlling blood flow through the elongated central passage. The at least one support structure can be configured to biomechanically secure the prosthetic heart valve to the native leaflets of a native heart valve of the heart.

Description

Technical Field

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

Background Art

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

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

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

Summary of the Invention

Problems to be Solved by the Invention

[0005] Therefore, because tricuspid valve replacement presents unique challenges, there is a need for prosthetic valves specifically designed for the treatment of tricuspid valves. Furthermore, innovative forms of tricuspid-specific prosthetic valves can offer improvements over heart valves designed for other atrioventricular valves (i.e., mitral valves). [Means for solving the problem]

[0006] This section describes an embodiment of an artificial heart valve configured for the treatment of tricuspid valve disease.

[0007] In one embodiment, the disclosure features an artificial heart valve comprising one or more support structures, at least one of which defines an elongated central passage having a longitudinal axis, the at least one support structure being asymmetrical with respect to at least one viewpoint about the longitudinal axis, and comprising a plurality of leaflet elements mounted on the at least one support structure and positioned within the elongated central passage for controlling blood flow through the elongated central passage, the at least one support structure being configured to biomechanically fix the artificial heart valve to the natural leaflet of the natural heart valve of the heart.

[0008] Various embodiments of the artificial heart valve may include one or more of the following features:

[0009] At least one support structure can be configured to biomechanically fix the artificial heart valve to the natural leaflet, so that at least one support structure is movable within the natural annulus of the natural heart valve in response to pressure changes on one or more sides of the natural heart valve. At least one support structure can include a cylindrical portion including the atrial and ventricular ends, and an elongated central passage is defined by the cylindrical portion of at least one support structure. At least one support structure can include an atrial arm set, each arm of the atrial arm set including a proximal atrial segment proximal to the cylindrical portion and a distal atrial segment distal to the cylindrical portion, and at least one of the size, shape, or angle of the first atrial arm of the atrial arm set is different from the corresponding size, shape, or angle of the second atrial arm of the atrial arm set. The angle may also be the angle of the distal atrial segment and / or proximal atrial segment with respect to the longitudinal axis.

[0010] The size of the first atrial arm may be larger than the size of the second atrial arm. The first atrial arm may have a first length in a direction parallel to the longitudinal axis, and the second atrial arm may have a second length in a direction parallel to the longitudinal axis, and the first length may be greater than the second length. When the artificial heart valve is implanted in the heart, the first length may be greater than the second length. The distal atrial segment of the first atrial arm has a first distal end at a first distance from the longitudinal axis, the distal atrial segment of the second atrial arm has a second distal end at a second distance from the longitudinal axis, and the distal atrial segment of the first atrial arm extends with respect to the longitudinal axis such that the first distance is less than the second distance.

[0011] The artificial heart valve may include an atrial cover comprising multiple distal atrial covers configured to be positioned adjacent to the distal atrial segment of the atrial arm set. Each distal atrial cover may include one or more pleats, and as a result, the distal atrial cover is configured to expand or contract as the length of the corresponding atrial arm set increases or decreases. The atrial arm set may be mounted on the ventricular end of the cylindrical portion of at least one support structure.

[0012] At least one support structure may include a ventricular arm set, each arm of the ventricular arm set including a proximal ventricular segment proximal to the cylindrical portion and a distal ventricular segment distal to the cylindrical portion, wherein at least one of the size, shape, or angle of the first ventricular arm differs from the corresponding size, shape, or angle of the second ventricular arm. The angle may also be the angle of the distal atrial segment and / or proximal atrial segment with respect to the longitudinal axis.

[0013] The size of the first ventricular arm may be larger than the size of the second ventricular arm. The first ventricular arm has a first length in a direction parallel to the longitudinal axis, and the second ventricular arm has a second length in a direction parallel to the longitudinal axis, with the first length being greater than the second length. When the artificial heart valve is implanted in the heart, the first length may be greater than the second length. In the implanted configuration, a first subset of the ventricular arm set is adjacent to the ventricular side of the first of the natural leaflets, and a second subset of the ventricular arm set is adjacent to the atrial side of the second of the natural leaflets. In the implanted configuration, at least one arm of the third subset of the ventricular arm set is adjacent to at least one of the commissures of the natural heart or the atrial side of the first natural leaflet.

[0014] At least one arm of the third subset may have a first length in a direction parallel to the longitudinal axis, and the other arms of the third subset may have a second length in a direction parallel to the longitudinal axis, the first length being greater than the second length. Each arm of the first subset is configured such that, in the implanted configuration, the arms of the first subset do not come into contact with the natural annulus of the heart, thereby reducing trauma to the heart. A ventricular cover may be positioned adjacent to the periphery of the proximal ventricular segment, which is on the opposite side of the cylindrical portion. The ventricular cover may be positioned adjacent to the proximal ventricular segment of the ventricular arm set. A portion of the ventricular cover may extend to be positioned adjacent to the distal ventricular segment of a subset of the ventricular arm set. The ventricular arm set may be attached to the atrial end of the cylindrical portion of at least one support structure. The cylindrical portion of at least one support structure may be radially foldable for transcatheter implantation.

[0015] In other embodiments, the present disclosure features a method for improving the function of a natural heart valve of the heart. The method may include the step of positioning an artificial heart valve within a natural heart valve, the at least one of which defines an elongated central passage having a longitudinal axis, the at least one of which is asymmetrical with respect to at least one viewpoint about the longitudinal axis, and includes a plurality of leaflet elements attached to the at least one of which are positioned within the elongated central passage to control blood flow through the elongated central passage, the at least one of which is which biomechanically secures the artificial heart valve to the natural leaflet of the natural heart valve.

[0016] In other embodiments, the disclosure features an artificial heart valve comprising one or more support structures, at least one of which defines an elongated central passage having a longitudinal axis, and at least one support structure is configured to biomechanically secure the artificial heart valve to the natural leaflet of a natural heart valve of the heart. The artificial heart valve comprises a plurality of leaflet elements mounted on at least one support structure and positioned within the elongated central passage for controlling blood flow through the elongated central passage, and a cover configured to be positioned between a portion of at least one support structure and at least one atrial side of the natural leaflet. When the artificial heart valve is implanted in a natural heart valve, the cover is configured to reduce leakage around the artificial heart valve. [Brief explanation of the drawing]

[0017] Non-limiting embodiments of the present invention are described by reference to the accompanying drawings, which are schematic and not intended to be drawn to scale. In the drawings, each identical or substantially identical component shown is typically represented by a single number. For clarity, not all components are labeled in all drawings, and not all components of each embodiment of the present invention are shown, and illustrations are not necessary for those skilled in the art to understand the present invention.

[0018] [Figure 1] This is a cross-sectional view of the heart illustrating the biological structure of the right side of the heart during normal physiological activity and in a diseased state of tricuspid valve regurgitation. [Figure 2] This is a front view of the tricuspid valve biostructure, which exhibits a heterogeneous or asymmetrical shape. [Figure 3] This is a perspective CAD drawing of two support structures for an artificial heart valve according to one embodiment. [Figure 4A] This is a side view CAD drawing of two support structures for an artificial heart valve according to one embodiment. [Figure 4B] This is a side view CAD drawing of two support structures for an artificial heart valve according to one embodiment. [Figure 5] This is a top view CAD drawing of two support structures for an artificial heart valve according to one embodiment. [Figure 6] Cross-sectional front CAD drawing of two support structures for an artificial heart valve according to one embodiment. [Figure 7] Shows a top view of an artificial heart valve within a native tricuspid valve annulus according to one embodiment. [Figure 8A] Shows a side view of an artificial heart valve within a native tricuspid valve annulus according to one embodiment. [Figure 8B] Side view of points of contact with the native heart by atrial arms and / or ventricular arms. [Figure 9] Side CAD drawing of a support structure for an artificial heart valve according to one embodiment. [Figure 10A] Shows variations of a ventricular arm set according to some embodiments. [Figure 10B] Shows variations of a ventricular arm set according to some embodiments. [Figure 10C] Shows variations of a ventricular arm set according to some embodiments. [Figure 11] Top CAD drawing of a cover for an atrial arm set according to one embodiment. [Figure 12] Perspective photograph of an exemplary atrial cover mounted on an exemplary atrial arm set according to one embodiment. [Figure 13] Shows the change in arm length of an atrial arm set between a compressed configuration and an expanded configuration according to one embodiment. [Figure 14] Shows some variations of one or more members extending from a cover for an atrial arm set according to one embodiment. [Figure 15] Shows an opening in a cover for an atrial arm set according to one embodiment. [Figure 16] Top CAD drawing of a cover for a ventricular arm set according to one embodiment. [Figure 17] Top view of a ventricular cover for a ventricular arm set including two covers according to one embodiment. [Figure 18] CAD drawing of a top view of a cover for a ventricular arm set according to other embodiments. [Figure 19] This is a perspective view of a cover for a ventricular arm set in a deployed configuration according to one embodiment. [Figure 20A] The deployment sequence of an artificial heart valve having a cover for a ventricular arm set with pleats, according to one embodiment, is shown. [Figure 20B] The deployment sequence of an artificial heart valve having a cover for a ventricular arm set with pleats, according to one embodiment, is shown. [Figure 20C] The deployment sequence of an artificial heart valve having a cover for a ventricular arm set with pleats, according to one embodiment, is shown. [Figure 20D] The deployment sequence of an artificial heart valve having a cover for a ventricular arm set with pleats, according to one embodiment, is shown. [Figure 21] An artificial heart valve with a support structure having a flared ventricular end according to one embodiment is shown. [Figure 22A] This shows the radial expansion of a ventricular arm set during deployment, according to one embodiment. [Figure 22B] This shows the radial expansion of a ventricular arm set during deployment, according to one embodiment. [Figure 22C] This shows the radial expansion of a ventricular arm set during deployment, according to one embodiment. [Figure 22D] This shows the radial expansion of a ventricular arm set during deployment, according to one embodiment. [Figure 23] This shows a sewing pattern for attaching the arms of a ventricular arm set to a cover for the ventricular set, according to one embodiment. [Figure 24] The image shows a side view of a cover attached to an atrial arm set, a cover attached to a ventricular arm set, and a cover attached to the cylindrical portion of the elongated central passage of an artificial heart valve, according to one embodiment. [Figure 25] This is a cross-sectional view of a pad attached to an arm set according to one embodiment. [Figure 26]This is a side cross-sectional view of an artificial heart valve according to one embodiment, which has an atrial arm set, a ventricular arm set, and one or more covers attached to the atrial arm set and the ventricular set. [Figure 27] This is a top view CAD drawing of a leaflet for an artificial heart valve according to one embodiment. [Figure 28] This is a top view CAD drawing of a cylinder cover for an artificial heart valve according to one embodiment. [Figure 29] This is a perspective view of a cylinder cover for an artificial heart valve according to one embodiment. [Figure 30] This is a perspective view of three leaflets attached to a cylinder cover for an artificial heart valve according to one embodiment. [Figure 31] This is a perspective view of a cylinder cover for an artificial heart valve, including three covers, according to one embodiment. [Figure 32] Various diagrams of an artificial heart valve, according to one embodiment, which includes one or more brackets on the inner portion of the artificial heart valve, are shown. [Figure 33] Various diagrams of an artificial heart valve, according to one embodiment, which includes one or more brackets on the inner portion of the artificial heart valve, are shown. [Figure 34] Various diagrams of an artificial heart valve, according to one embodiment, which includes one or more brackets on the inner portion of the artificial heart valve, are shown. [Figure 35] Various diagrams of an artificial heart valve, according to one embodiment, which includes one or more brackets on the inner portion of the artificial heart valve, are shown. [Figure 36] Various diagrams of an artificial heart valve, according to one embodiment, which includes one or more brackets on the inner portion of the artificial heart valve, are shown. [Figure 37] A CAD drawing of a bracket for an artificial heart valve according to one embodiment is shown. [Figure 38] Figure 28 is a top view of the cylinder cover that communicates with the bracket and artificial leaflet of an artificial heart valve, according to one embodiment. [Figure 39] This is an upper cross-sectional view of a bracket for an artificial heart valve having two frame sleeves according to one embodiment. [Figure 40] This is a side view of a bracket for an artificial heart valve having two frame sleeves according to one embodiment. [Figure 41] Figure 40 is a cross-sectional view of the bracket according to one embodiment, where the frame sleeve is installed on the inner portion of the cylindrical part of the artificial heart valve. [Figure 42] Figure 40 is an upper cross-sectional view of the bracket according to one embodiment, where the frame sleeve is positioned on the outer portion of the cylindrical part of the artificial heart valve. [Figure 43A] The following are embodiments of a bracket for an artificial heart valve having one or more frame sleeves, according to several embodiments. [Figure 43B] The following are embodiments of a bracket for an artificial heart valve having one or more frame sleeves, according to several embodiments. [Figure 43C] The following are embodiments of a bracket for an artificial heart valve having one or more frame sleeves, according to several embodiments. [Figure 44A] The following are embodiments of an artificial heart valve bracket according to several embodiments, in which the frame portion of the bracket does not form a continuous loop. [Figure 44B] The following are embodiments of an artificial heart valve bracket according to several embodiments, in which the frame portion of the bracket does not form a continuous loop. [Figure 44C] The following are embodiments of an artificial heart valve bracket according to several embodiments, in which the frame portion of the bracket does not form a continuous loop. [Figure 45A] A diagram of the bracket for an artificial heart valve according to one embodiment is shown. [Figure 45B] A diagram of the bracket for an artificial heart valve according to one embodiment is shown. [Figure 46] This is a top view of the bracket of an artificial heart valve according to one embodiment. [Figure 47A] Two embodiments of an artificial heart valve bracket, which is attached to the cylinder cover of the artificial heart valve, are shown. [Figure 47B]Two embodiments of an artificial heart valve bracket attached to the cylinder cover of the artificial heart valve are shown according to two embodiments. [Figure 48] This shows a bracket for an artificial heart valve that is attached to a support structure for an artificial heart valve according to one embodiment. [Figure 49] A perspective view of an artificial heart valve bracket, which is attached to a support structure for the artificial heart valve according to one embodiment, is shown. [Figure 50] This is a perspective view of a support structure for an artificial heart valve, according to one embodiment, in which the bracket shown in Figure 37 is installed adjacent to the outer surface of the support structure. [Figure 51] This is an upper cross-sectional view of two leaflet tabs passing through a bracket according to one embodiment, where the bracket is positioned outside the elongated central passage of the artificial heart valve. [Figure 52] A part of a support structure for an artificial heart valve having one or more slots, according to one embodiment, is shown. [Figure 53] The following is a perspective view of several covers attached to a support structure for an artificial heart valve according to one embodiment. [Figure 54] Another perspective view is shown of several covers attached to the support structure of an artificial heart valve according to one embodiment. [Figure 55] This is a top view of an artificial heart valve having an atrial arm set including three arms, according to one embodiment. [Figure 56] This is a perspective view of an artificial heart valve having an atrial arm set including three arms, according to one embodiment. [Figure 57] The following are some diagrams of one arm of a ventricular arm set configured to contact the spontaneous leaflet on the ventricular side of the leaflet and on the atrial side of the spontaneous leaflet, according to one embodiment. [Figure 58] This is a side view showing one arm of a ventricular arm set, according to one embodiment, which is mounted on a support structure and configured to contact the natural leaflet on the ventricular side of the leaflet and on the atrial side of the natural leaflet. [Figure 59A]CAD drawings of several embodiments of the arm hooks of an atrial arm set according to one embodiment are shown. [Figure 59B] CAD drawings of several embodiments of the arm hooks of an atrial arm set according to one embodiment are shown. [Figure 60] This is a perspective view of an artificial heart valve in an extended configuration having a threaded element according to one embodiment. [Figure 61] This is a side cross-sectional view of two support structures for an artificial heart valve according to one embodiment. [Figure 62A] Several diagrams of covers for ventricular arm sets according to two embodiments are shown. [Figure 62B] Several diagrams of covers for ventricular arm sets according to two embodiments are shown. [Figure 63A] Several diagrams of the two arms of a ventricular arm set, according to different embodiments, are shown. [Figure 63B] Several diagrams of the two arms of a ventricular arm set, according to different embodiments, are shown. [Figure 63C] Several diagrams of the two arms of a ventricular arm set, according to different embodiments, are shown. [Figure 63D] Several diagrams of the two arms of a ventricular arm set, according to different embodiments, are shown. [Figure 64] A side view of a ventricular arm set according to one embodiment is shown. [Figure 65] This is a side view of the folding arm and the extended arm of a ventricular arm set according to one embodiment. [Modes for carrying out the invention]

[0019] The detailed description below describes various configurations of the Art and is not intended to represent the only configuration in which the Art can be implemented. The detailed description includes certain details for the purpose of providing a complete understanding of the Art. Accordingly, dimensions may be provided for certain embodiments as examples that are not limited. However, it will be apparent to those skilled in the art that the Art can be implemented without these specific details. In some examples, well-known structures and components are shown in the form of block diagrams to avoid obscuring the concepts of the Art.

[0020] It should be understood that this disclosure includes examples of the Art and does not limit the scope of the appended claims. Various aspects of the Art are disclosed in accordance with certain non-limiting examples. The various embodiments described in this disclosure can be carried out in various ways and variations according to desired applications or implementations.

[0021] The detailed description below includes numerous specific details to provide a complete understanding of the disclosure. However, it will be apparent to those skilled in the art that embodiments of the disclosure can be implemented without some of these specific details. In other examples, well-known structures and techniques are not described in detail so as not to obscure the disclosure.

[0022] Generally, since device development has focused on aortic and mitral valve replacement, there is a need for a solution for tricuspid regurgitation (TR). In particular, there is growing evidence that TR is associated with higher mortality and should not be left untreated even if other heart valves are addressed.

[0023] Like the mitral valve, the tricuspid valve is located in the atrioventricular position. Consequently, it might be expected that, in some cases, mitral valve replacements could be repurposed for use in the tricuspid valve position. However, certain aspects of the anatomical structure of the tricuspid valve and the surrounding anatomical structures (e.g., the larger size of the tricuspid valve and its proximity to the cardiac conduction area) favor dedicated solutions over such repurposings of mitral valve devices. An example of an artificial tricuspid valve and a method for its implantation can be found in International Application No. PCT / US2020 / 024765 (title "PROSTHETIC HEART VALVE," filed March 25, 2020), which is incorporated here in its entirety by reference for all purposes.

[0024] Furthermore, innovative embodiments of tricuspid-specific prosthetic valves can offer improvements over heart valves designed for other atrioventricular valves (i.e., mitral valves). Therefore, the term "tricuspid valve" is used here to refer to prosthetic valves that are primarily intended for the tricuspid position but can also be used for other atrioventricular valves.

[0025] A biomechanical tricuspid valve prosthesis is provided in accordance with aspects of the present disclosure. As stated herein, the term “biomechanical” with respect to a tricuspid valve prosthesis refers to a configuration of the tricuspid valve prosthesis that allows it to maintain axial stabilization within the natural tricuspid valve of the heart, to move within the natural tricuspid valve in response to alternating pressure differences on both sides of the natural tricuspid valve, and without direct attachment (and / or contact) with the natural annulus and / or natural cords (chordae tendineae) of the natural tricuspid valve, or thereby preserving the natural movement of the natural annulus. In detail, the tricuspid valve prosthesis is axially stabilized within the natural tricuspid valve by gripping the natural leaflet of the natural tricuspid valve, rather than relying on the force of the annulus or direct attachment of the annulus or cords. As stated herein, the term “axial stabilization” with respect to a tricuspid valve prosthesis placed within a natural tricuspid valve refers to a portion of the tricuspid valve prosthesis being interposed between two diametrically opposed points on the natural annulus of the natural tricuspid valve.

[0026] In some embodiments, the prosthetic tricuspid valve includes one or more support structures. For example, as will be described in more detail later, the prosthetic tricuspid valve may include one, two, three, or four or more support structures in some cases. At least one of the one or more support structures includes a cylindrical portion having an atrial end and a ventricular end. In some embodiments, the cylindrical portion of one or more support structures defines an elongated central passage of the prosthetic tricuspid valve. In some embodiments, the central axis (also referred to as the “longitudinal axis”) of the elongated central passage extends within the elongated central passage from the atrial end of the cylindrical portion to the ventricular end of the cylindrical portion. When the prosthetic tricuspid valve is a configuration implanted in the heart’s natural tricuspid valve, blood generally flows through the elongated central passage of the prosthetic tricuspid valve from the atria to the ventricles of the heart along the central axis of the elongated central passage. Furthermore, in some additional embodiments, multiple leaflet elements are attached to one or more support structures and positioned within the elongated central passage to control blood flow through it.

[0027] In some embodiments, ventricular arms extending from a first end of a cylindrical portion of one or more support structures extend into the ventricles of the heart and contact the ventricular surface of the natural leaflet, while atrial arms extending from a second end opposite to the first end of the cylindrical portion of one or more support structures extend into the atria and contact the atrial surface of the natural leaflet. Conveniently, in some embodiments, the various mechanisms of the artificial tricuspid valve described herein constitute a valve for transcatheter implantation, repositioning and / or removal. For example, the artificial tricuspid valve described herein can be easily positioned and deployed in a wide range of patients, has the ability to control deployment and assess full functionality, and / or maintains the ability to recapture and remove the implant before complete release.

[0028] As used herein, “patient” or “subject” generally refers to any animal, such as a mammal (e.g., human). Non-limiting examples of subjects include humans, non-human primates, cattle, horses, pigs, sheep, goats, dogs, cats, or rodents (e.g., mice, rats, hamsters), birds, fish, or guinea pigs. Generally, the inventions described herein relate to use with humans. However, other subjects are also possible. In some embodiments, subjects can demonstrate, for example, a health benefit from the implantation of the valve described herein.

[0029] While various examples of how artificial tricuspid valves are configured to replace natural tricuspid valves are described here, it should be understood that appropriate modifications can be made to use the artificial tricuspid valves disclosed herein to replace other natural heart valves (e.g., other atrioventricular valves) and / or other non-heart valves.

[0030] Figure 1 shows lateral cross-sectional views of two versions 100a and 100b of an exemplary spontaneous heart. Embodiment 100a depicts the normal biostructure of a spontaneous heart, where blood flows from the right atrium 102 through the tricuspid valve 104 to the right ventricle 106 and then through the pulmonary valve to the pulmonary artery. The interatrial septum 107 separates the right atrium 102 from the rest of the heart (e.g., the left atrium). Embodiment 100b depicts a spontaneous heart with tricuspid regurgitation, where blood leaks from the right ventricle 106 through the tricuspid valve 104 to the right atrium 102. Figure 1 shows two leaflets 108 of the spontaneous tricuspid valve 104, and embodiment 100b has chordae tendineae 110 attached to the ventricular side of the leaflets, which function to control the opening of the valve 104.

[0031] Figure 2 shows an exemplary top view of a tricuspid valve 104, including the typical biostructural positioning of the three natural leaflets (septal 202, anterior 204, and posterior 206) and surrounding biostructures, such as the atrioventricular node (AV node) 208 and the coronary sinus 210. In some embodiments, the tricuspid annulus 212 circumferentially surrounds the three natural leaflets 202, 204, and 206, and in this example, the tricuspid annulus 212 has a non-circular or asymmetrical shape. The region between the anterior leaflet 204 and the septal leaflet is generally referred to as the anterior septal commissure 214. The region between the septal leaflet 202 and the posterior leaflet 206 is generally referred to as the posterior septal commissure 216.

[0032] (Support structure) Figures 3 to 5 show several diagrams of one or more exemplary support structures 300 of an exemplary artificial heart valve, which are configured to fit inside a natural tricuspid annulus 212. However, in some embodiments, the artificial heart valve may have a generally symmetrical shape. Figure 3 shows a perspective view of the support structure 300. The exemplary support structure 300 may include an atrial support structure 302 and a ventricular support structure 304. In some embodiments, the atrial support structure 302 may include an atrial arm set 306 (also referred to as the “atrial arm”) and an atrial cylindrical portion 308. In some embodiments, the ventricular support structure 304 may include a ventricular arm set 310 (also referred to as the “ventricular arm”) and a ventricular cylindrical portion 312. In some of these embodiments, the atrial arm set 306 extends substantially above (towards the atrial direction 314) the atrial cylindrical portion 308, and the ventricular arm set 310 extends substantially below (towards the ventricular direction 316) the ventricular cylindrical portion 312. In some embodiments, the atrial support structure 302 is aligned with the ventricular support structure 304, so that the atrial cylindrical portion 308 "seats" within the ventricular cylindrical portion 312. In some embodiments, the structures 302 and 304 are interlocked, and once assembled, they can operate as a single structure. In some embodiments, the atrial support structure 302 and the ventricular support structure 304 can be shaped so that the atrial cylindrical portion 308 aligns with the ventricular cylindrical portion 312. In some embodiments, one or more atrial arms 306, atrial cylindrical portions 308, one or more ventricular arms 310 and / or ventricular cylindrical portions 312 can be shaped to ensure that the artificial heart valve has an asymmetrical shape and avoids trauma to surrounding biological structures (e.g., septa 107). In some embodiments, the artificial heart valve is substantially symmetrical in shape.

[0033] Figure 4A shows a side view of an exemplary support structure 300. As shown in this figure, one or more members of the atrial cylindrical portion 308 are aligned with one or more members of the ventricular cylindrical portion 312. In particular, the atrial cylindrical portion 308 and the ventricular cylindrical portion 312 form a cylindrical space (also referred to as an elongated central passage) around a central axis 402. In some embodiments, the distal portion 404 of one or more atrial arms 306 (e.g., atrial arm 306a) may be bent toward the central axis 402 of the elongated central passage, so that the distal end 404a of arm 306a has a maximum distance 406 to the central axis 402, which is smaller than the distance 408 to the central axis 402 of the distal end 404b of the other arms of the atrial arm set 306 (e.g., atrial arm 306b). As shown in Figure 4B, in some embodiments, the distal portion 404 of one or more atrial arms 306 (e.g., atrial arm 306a) may be bent toward the central axis 402, so that the distal end 404a of arm 306a has an angle 414a with respect to the central axis 402, which is different from the angle 414b of the distal end 404b of the other arms of the atrial arm set 306 (e.g., atrial arm 306b) with respect to the central axis 402.

[0034] As shown in Figure 4A, one or more arms of the atrial arm set 306 depicted in Figures 3 to 5 may, in some embodiments, have an axial length smaller or larger than the axial length of the other arms of the atrial arm set 306. In some cases, an arm may have a first dimension parallel to the central axis 402 (also referred to as the "axial length") and a second dimension perpendicular to the central axis 402 (also referred to as the "radial length"). For example, atrial arm 306a in Figure 4A has an axial length 410 that is greater than the axial length 412 of atrial arm 306b. In some embodiments, it may be desirable for one or more first arms of the atrial arm set to be shorter than one or more second arms of the atrial arm set in a compressed configuration, so that when deployed in a bent configuration, the first atrial arm (e.g., arm 306a) minimizes its coverage of the septum 107, which may hinder future ability to perform transseptal cardiac procedures. As shown in Figure 4A, one or more atrial arms 306 are asymmetrical with respect to at least one other atrial arm, thereby forming an asymmetrical atrial support structure 302. In some embodiments, one or more atrial arms are symmetrical with respect to at least one other atrial arm. In some embodiments, the atrial support structure is symmetrical in shape.

[0035] In some embodiments, the ventricular arm (e.g., 310a of arm 310 in Figure 4B) is configured to originate from the atrial side. In some embodiments, the ventricular arm 310b in Figure 4B is configured to originate from the atrial side 314. In some embodiments, the atrial arm (e.g., arm 306b of arm 306 in Figure 4A) is configured to originate from the ventricular side.

[0036] As shown in Figure 5, in some embodiments, the diameter 502 of the atrial cylindrical portion 308 may be smaller than the diameter 504 of the ventricular cylindrical portion 312. In some embodiments, one or more atrial arms 306 have a radial length 506 that is greater than that of one or more ventricular arms 310. For example, an atrial arm 306b has a radial length 506 that is greater than the radial length 508 of the corresponding ventricular arm 310b.

[0037] Figure 6 shows a cross-sectional front view of the support structures 302, 304. Figure 6 also shows one embodiment in which the proximal segment 702a of one or more atrial arms (e.g., arm 306c) has a first proximal curvature toward the ventricular end 316 of the atrial cylindrical portion 308 and a second distal curvature in the direction 314 toward the atrial portion of the cylindrical portion. In some such embodiments, the distal segments 704a, 704b (collectively referred to as 704) of the atrial arm (e.g., arm 306c) function to connect two adjacent proximal segments 702a, 702b (collectively referred to as 702) of the atrial arm, and the distal segment 704 of the atrial arm curves toward the central axis 402 of the elongated central passage, ensuring that the distal segment 704 is non-traumatic to the surrounding biomedical structure.

[0038] Figure 7 shows a top view of the support structure 300 of an example of an artificial heart valve in an unfolded configuration within the natural tricuspid annulus 212, forming a periphery region 800 configured such that one or more atrial arms (e.g., arms 306e, 306f, 306g) extend beyond the natural tricuspid annulus 212. In this exemplary embodiment, the distal segments 704a, 704b (collectively referred to as 704) of the atrial arms are joined to the proximal segment 702 of the atrial arm set 306 in Figure 6, beyond the internal edge of the natural tricuspid annulus 212. Thus, the atrial arm set 306 of the artificial heart valve can be configured to prevent backflow of blood from the natural ventricle 106 to the natural atrium 102 around the outside of the cylindrical portion of the artificial heart valve (indicated as region 804 within the atrial cylindrical portion 308).

[0039] In some embodiments, the ventricular arm set 310 may include three ventricular directional arms (collectively referred to as 602, for example, as shown below in Figure 9) configured to hold the natural leaflet radially outward from the natural tricuspid valve 104 in the open position. The ventricular directional arms 602 of the ventricular arm set and the arms of the atrial arm set are configured to allow the outer edges of the cylindrical portion of the prosthetic heart valve to be positioned close to the wall of the natural heart, which can help minimize paravalvular regurgitation, for example, when the natural leaflet of the natural tricuspid valve 104 is held radially outward from the natural tricuspid valve in the open position. In the example in Figure 7, the prosthetic heart valve is configured to be positioned closer to the septum 806 of the natural heart. In other sets of embodiments, the prosthetic heart valve is configured to be positioned closer to any other wall of the heart along the circumference of the natural valve annulus 212. Similarly, in the example in Figure 7, the prosthetic heart valve is configured to hold the septal leaflet radially outward from the natural tricuspid valve 104 in the open position. In other sets of embodiments, the artificial heart valve is configured, in the open position, to hold the anterior and / or posterior leaflets radially outward from the natural tricuspid valve.

[0040] In some embodiments, the ventricular arm set 310 includes three ventricular-directing arms. In other embodiments, there may be one, two, or four or more ventricular-directing arms. Similarly, in the embodiments shown in Figures 3 to 7, the atrial arm set 306 includes three arms that are asymmetrical with respect to another arm of the atrial support structure 302. However, in some embodiments, the atrial arm set includes arms that are substantially symmetrical with respect to another arm of the atrial support structure. In other embodiments, there may be one, two, or four or more arms that are asymmetrical with respect to another arm of the atrial support structure 302. Furthermore, in other embodiments, there may be no arms that are asymmetrical with respect to another arm of the atrial support structure 302.

[0041] Figure 8A shows a cross-sectional side view of the support structure 300 for an artificial heart valve implanted in a natural tricuspid valve 104, where the ventricular arm set 310 is shown to hold the leaflet 902 radially outward from the natural tricuspid valve 104 in the open position, and the atrial arm set 306 rests along the wall of the natural heart. Figure 8A also shows the distal portion 404a of the atrial arm 306a, which curves away from the wall of the natural heart 904 to be non-traumatic to the wall of the natural heart 904. In some embodiments, the ventricular arm set 310 may have distal curvature toward the central axis 402 of the elongated central passage to avoid trauma to the natural leaflet, the wall of the natural heart, and / or any other surrounding biostructure.

[0042] In some embodiments, the ventricular directional arms of the ventricular arm set 310 can be further configured to avoid obstruction of the outflow pathway of the right ventricle 106 of a natural heart.

[0043] Figure 8B also shows possible points of contact with the spontaneous heart by the ventricular arm 310. In particular, the ventricular arm 906 (of arm 310) originates from the atrial side 314 of the anterior or posterior leaflet 902 and is configured to contact the ventricular side of the leaflet 902. The ventricular arm 906 can be shaped so that it acts a force (e.g., a clamping force with arm 908) against the leaflet 902. The ventricular arm 906 can be shaped so that arm 906 does not contact the annular portion 914. The ventricular arm 908 originates from the atrial side 314 and is configured to contact the atrial side of the leaflet 902. The ventricular arm 910 originates from the atrial side 314 and is configured to contact (e.g., act a force on) the septal leaflet 912 against the septum 904.

[0044] The arms of the atrial arm set may extend from the atrial side of the atrial cylindrical portion of the support structure. The atrial arm set of the support structure may have a flat pattern.

[0045] Figure 9 shows a diagram of one embodiment of a ventricular arm set 310 of a ventricular support structure 304, in which three arms 602 have a ventricular orientation 316 and are configured to contact the natural leaflet on the atrial side of the natural leaflet, and six arms 1402 (including arms 1402e) have an atrial orientation 314 and are configured to contact the leaflet on the ventricular side of the natural leaflet. The atrial-oriented arms 1402 of the ventricular arm set can be configured to avoid contact with the natural valve annulus 212 of the natural heart. The arms of the ventricular arm set extend from the atrial side of the ventricular cylindrical portion 312 of the ventricular support structure 304. In other sets of embodiments, the ventricular arm set may include one, two, or four or more ventricular-oriented arms 602. The ventricular support structure 304 may further include a third arm set, such as an annular-oriented arm set 1404, as will be further described below.

[0046] Figure 9 also illustrates one embodiment in which the ventricular directional arms 602 (e.g., the third arm set) of the ventricular arm set 310 are configured to be non-traumatic to surrounding biomolecular structures. Each ventricular directional arm 602 of the ventricular arm set 310 has a distal segment 1406 with a first proximal curvature toward the central axis 402 of the elongated central passage, a second intermediate curvature away from the central axis 402 of the elongated central passage, and a third distal curvature toward the central axis 402 of the elongated central passage, so that the most distal portion of one or more arms 602 of the ventricular arm set is substantially parallel to the central axis 402 of the elongated central passage, thus avoiding trauma to surrounding biomolecular structures.

[0047] Figure 9 also depicts subsets (1404g and 1404i) of multiple (9 in this example) arms of a ventricular arm set (collectively referred to as 1404, e.g., the third arm set), which are configured to bring the natural leaflet into contact with the atrial side of the natural leaflet. In some embodiments, the arms have a maximum distance to the central axis of the elongated central passage, which is smaller than the maximum distance to the central axis of any of the atrial-directing arms and / or the ventricular-directing arms of the ventricular arm set. In some embodiments, the maximum distance from one or more arms to the central axis of the elongated central passage may be greater than the maximum distance to the central axis of any of the atrial-directing arms and / or ventricular-directing arms of the ventricular arm set. The arms of the ventricular arm set are shown to be arranged alternately with either the ventricular-directing arms of the ventricular arm set or the atrial-directing arms of the ventricular arm set. More specifically, the arms of the ventricular arm set may extend substantially toward the ventricular end of one or more support structures from the central axis of the elongated central passage. Referring to Figure 9, in the illustrated embodiment, the arm 1402 of the ventricular arm set has a first proximal bend that extends away from the central axis 402 of the elongated central passage, forming, for example, an angle of about 45°, and a second distal bend that extends toward the central axis 402 of the elongated central passage to prevent injury to surrounding bio-structures. In some embodiments, the most distal portion is pointed toward the central axis 402.

[0048] The arms may have varying lengths depending on the desired function of each arm. In some embodiments, one or more arms are configured to engage with the commissure of a natural heart valve to prevent valve orifice backflow through one or more openings at the commissure. Two of the arms may be longer than the others and may extend radially from the central axis of the elongated central passage to better fill the opening at the commissure. In some embodiments, three of the arms may be configured to engage with the commissure of a natural heart valve. In other sets of embodiments, all arms may be the same length.

[0049] Figure 9 shows that, in some embodiments, the distal ends of the shorter arms of the ventricular arm set extend ventricular 316 beyond the portion of the third arm set that is perpendicular to the central axis of the elongated central passage. In particular, the distal ends of the ventricular arms (e.g., arm 1404g) do not extend beyond the bend 1408 of the atrial arm (e.g., arm 1402e) in some embodiments. This configuration allows a cover (also referred to as a "skirt") (e.g., covers 2802, 3202, or 3302, which are described elsewhere) to be attached to the ventricular support structure 304, as shown in Figure 16.

[0050] In some embodiments, the distal portions of one or more arms 1404 can be configured to facilitate the attachment of one or more covers (e.g., covers 2802, 3202, or 3302, as described elsewhere) to the ventricular arm set 310 using sutures or other types of threads, strings, wires, cables, or lines. In some embodiments, one or more arms of the ventricular arm set 310 may have one or more openings located along one or more arms, which may be desirable to assist in attaching one or more covers to the ventricular arm set. In some embodiments, one or more arms have a single opening located at the distal end of each arm, and each ventricular arm has three openings of varying sizes located near the distal end of each ventricular arm. In some embodiments, the openings may be of equal size. According to some embodiments, each distal end of an arm has four protruding elements, which are useful for providing an anchoring structure to which sutures can be wrapped. Other embodiments may have fewer or more protrusions.

[0051] In some embodiments, the support structure comprises a third arm set mounted on the support structure. In some embodiments, the third arm set is a subset of the ventricular arm set. In some embodiments, the third arm set is a subset of the atrial arm set. In some embodiments, the third arm set is independent of the ventricular and atrial sets. In some embodiments, the third arm set may extend from the atrial side of the support structure. In other sets of embodiments, the third arm set extends from the ventricular side of the frame. The third arm set may, in some cases, be used to support a cover (e.g., a ventricular cover, an atrial cover) that assists in sealing the prosthetic heart valve. In an exemplary set of embodiments, the third arm set supports a ventricular cover. Conveniently, incorporating a cover such as a ventricular cover can promote a larger lavage area for the prosthetic heart valve compared to a prosthetic heart valve without a cover. While we do not wish to be constrained by theory, the increased cleaning area using the cover described herein may, in some cases, favorably lead to a reduction in areas of stagnant blood flow and / or thrombus formation adjacent to the prosthetic heart valve. As an example for illustrative purposes only, in a prosthetic heart valve where a natural leaflet is permitted to seat on the prosthetic heart valve, the cleaning area would be relatively smaller compared to the embodiment described herein.

[0052] In some embodiments, the third arm set and / or cover can conveniently hold the natural leaflet and / or natural chordae tendineae away from the central cylindrical portion of the prosthetic heart valve. In some embodiments, such a configuration can conveniently maximize the outflow diameter of the prosthetic heart valve (e.g., functioning as the outermost valve cylinder) and / or prevent the natural leaflet and / or chordae tendineae from contacting the support structure, thereby minimizing damage to the natural leaflet and / or chordae tendineae. In some embodiments, the cover may conveniently have notches and / or openings that facilitate a larger amount of cleaning area (compared to other configurations). For example, in some embodiments, the third arm set may include a ventricular cover, which can provide a larger cleaning area and / or an improved sealing surface on the ventricular cover.

[0053] In some embodiments, the atrial and ventricular arm sets are bent, and as a result, in an implantation configuration in which at least one support structure biomechanically fixes an artificial heart valve to the natural leaflet of a native heart valve, when the cylindrical portion of at least one support structure moves toward the atrial side of the native heart valve due to ventricular systolic pressure loading, one or more arms of the ventricular arm set resist this movement, and one or more arms of the atrial arm set relax to maintain contact with the atrial side of the native leaflet. Similarly, when the cylindrical portion of at least one support structure moves toward the ventricular side of the native heart valve due to ventricular diastolic pressure loading and / or removal of the previously applied ventricular systolic load, one or more arms of the atrial arm set resist this movement, and one or more arms of the ventricular arm set relax to maintain contact with the ventricular side of the native leaflet. In some embodiments, this also generates a trampoline effect, where the natural leaflet acts as a spring-like element, absorbing at least partially the applied pressure load and / or removing the previously applied pressure load.

[0054] For example, by fixing an artificial tricuspid valve to one side of the natural leaflet (e.g., the atrial or ventricular surface), a trampoline effect can be generated in some cases, allowing the ventricular systolic pressure load to be partially absorbed by the upward (atrial) motion and the tension of the natural leaflet. For instance, during the movement of the cylindrical portion of the support structure facing the atrial side of the natural tricuspid valve (e.g., due to the ventricular systolic pressure load), the ventricular arms resist this movement while the atrial arms relax, maintaining contact with the atrial side of the natural leaflet. Furthermore, during the movement of the cylindrical portion of the support structure facing the ventricular side of the natural tricuspid valve, the atrial arms resist this movement while the ventricular arms relax, maintaining contact with the ventricular side of the natural leaflet. As a result of the trampoline effect, the force from the distal segment of each ventricular arm toward the ventricular side of the natural leaflet can be further distributed across the entire atrium and / or ventricular sealing skirt (i.e., cover), minimizing the risk of erosion through the natural leaflet. In this way, for example, an artificial tricuspid valve can, in some cases, be biomechanically fixed within the natural tricuspid valve even during the cardiac cycle.

[0055] In some embodiments, the third arm set and / or cover can press against the natural leaflet of the natural heart, thereby improving sealing and / or minimizing damage to the natural leaflet of the natural heart. Conveniently, the third arm set and / or cover can function to distribute force across the prosthetic heart valve, thereby improving and / or enhancing the trampoline effect described above. The third arm set can also function to increase the overall surface area for sealing against the natural leaflet, thereby reducing the possibility of paravalvular leakage.

[0056] Figures 10A to 10C show several embodiments of a ventricular arm set 310 having arms with various orientations, lengths, and shapes. In Figure 10A, three of the arms 1902 of the ventricular arm set (also referred to as "gutter" arms) extend in the atrial direction and have distal portions that contact the natural leaflet and the ventricular side of the natural heart valve, and six of the arms 1904 (also referred to as "up" arms) have an atrial orientation with a non-traumatic distal curvature. Figure 10B shows a ventricular arm set in which three of the arms 1906 (also referred to as "down" arms) have a ventricular orientation with a non-traumatic distal curvature. Figure 10C shows a ventricular arm set in which all of the arms 1904 (e.g., nine "up" arms) have the same atrial orientation with a non-traumatic distal curvature.

[0057] (An embodiment of an atrial cover) Figure 11 is a top view of an atrial cover 2000 for an atrial arm set relating to one embodiment, and includes a central donut-shaped region and nine radial extension members. In some embodiments, the atrial cover is configured to be mounted on an atrial arm set 306. In the mounted configuration, the central donut-shaped region is configured to contact the atrial side of the atrial arm set, while the radial extension members are configured to contact the ventricular side of the atrial arm set. In the embodiment shown in Figure 11, the atrial cover also has tabs that extend perpendicularly from the edge of each radial extension member, wrap around the segments of the atrial arm set, and are mounted on the sides of the atrial cover to facilitate mounting the atrial cover to the atrial arm set. In some embodiments, the tabs are mounted to the atrial cover using sutures (or threads, strings, wires, etc.). In some embodiments, the tabs are configured to slide along at least a portion of the distal segment of the arm of the atrial arm set when attached to the atrial cover, which is advantageous in allowing the atrial cover to completely enclose the area between adjacent distal segments of the arm of the atrial arm set when the atrial arm set is in both an extended and compressed configuration. The atrial cover may have one or more openings through which sutures (or threads, strings, wires, etc.) can pass to attach the tabs of the atrial cover to the radial extension member, thereby allowing the atrial cover to be attached to the atrial arm set. In some embodiments, the atrial cover of Figure 11 can be divided into thirds to create three covers of similar or identical shape, which can be attached separately to the atrial arm set. Using two or more atrial covers is advantageous, for example, to facilitate the assembly of an artificial heart valve. In some embodiments, two or three or more atrial covers can be used.

[0058] In the embodiment shown in Figure 11, the donut-shaped portion of the atrial cover has an opening that is radially aligned with the proximal portion of the arm of the atrial arm set, and can be used to attach the atrial cover to the atrial arm set using, for example, sutures, threads, strings, wires, etc. In some embodiments, one or more vertices of the radial extension member may have one or more openings. As shown in Figure 11, each vertex of the radial extension member has a single opening 2002, which can be used to attach the atrial cover to the atrial arm set (see, for example, arm 306 in Figure 12), and by passing the hook of the distal portion of the arm of the atrial cover 2000 through the opening 2002, attachment can be temporarily facilitated or permanently enhanced.

[0059] Figure 11 also shows tabs 2004 that line the inner edge of the donut-shaped portion of the atrial cover, which can be used to allow the atrial cover to follow the atrial-oriented curve of the atrial arm set without excessively stretching the inner edge of the atrial cover. As shown in the figure, the atrial cover has 18 inner tabs 2004, but in other sets of embodiments, the atrial cover may have about two inner tabs, more than 18 inner tabs, or any other number of inner tabs, for example, nine (9), six (6), or three (3) inner tabs.

[0060] In some embodiments, the radial extension members of the atrial cover may be configured to contact the atrial side of the atrial arm set, in which case the tabs 2006 of the radial extension members may wrap around the segments of the atrial arm set and contact the ventricular side of the atrial cover to facilitate the attachment of the atrial cover to the atrial arm set.

[0061] In Figure 11, the atrial cover 2000 is depicted as being manufactured from a flat, two-dimensional pattern. In other sets of embodiments, the atrial cover can be manufactured as a three-dimensional structure by, for example, knitting, weaving, molding, forming, casting, or printing. In some embodiments, the atrial cover with a three-dimensional structure has an unfolded configuration in which its central diameter extends in the ventricular direction to create an elongated central passage, which can be configured to cover the inner surface of the cylindrical portion of the support structure for the artificial heart valve.

[0062] Figure 12 shows a photograph of an exemplary atrial cover (e.g., the atrial cover 2000 in Figure 11) according to an exemplary embodiment, which is mounted on an atrial arm set 306. In some embodiments, tabs 2006 of the radial extension members of the atrial cover 2000 are wrapped around a segment of the atrial arm set 306 and contact the ventricular side of the atrial cover 2000 to facilitate mounting the atrial cover 2000 onto the atrial arm set 306.

[0063] In some embodiments, one or more radial extension members of the atrial cover may have one or more pleats configured to allow the atrial cover to increase or decrease the length of one or more radial extension members. In some embodiments, the radial extension members of the cover may have a single pleat including an atrial peak and a ventricular valley. In some embodiments, the pleats of the atrial cover allow the atrial cover to lengthen, and when mounted on an atrial arm set, each arm of the atrial arm set lengthens, as shown in Figure 13. In some embodiments, the radial extension members 2502 of the cover for the atrial arm set 306 may have, for example, half pleats (one peak or one valley), two full pleats (two peaks and two valleys), two and a half pleats (two peaks and three valleys, or three peaks and two valleys), etc. Once folded over the atrial arm, the tabs on the radial extension member are configured, in some embodiments, to form a sleeve. The sleeve and pleats may cooperate to conform to the atrial arm as the arm extends and retracts.

[0064] In some embodiments, one or more radial extension members may be configured to attach to a delivery system for an artificial heart valve to assist in the deployment, positioning, repositioning, and / or recapture of the artificial heart valve. Figure 14 shows some embodiments of an atrial cover in which one or more radial extension members extend further radially. In one set of embodiments, one or more radial extension members 2600 may have one or more openings located distally to facilitate attachment to the delivery system. In another set of embodiments, a radial extension member 2602 may have two or more further extending members. In one such embodiment, a radial extension member may have three further extending members, which may be braided together to form a single further extending member 2604. In other embodiments, one further extending member 2606 may be looped through some mechanism of the delivery system and may be attached to itself, for example, using sutures, threads, strings, wires, adhesives, cables, or other attachment means.

[0065] In some embodiments, the atrial cover 2700 may further include one or more openings 2702 within the donut-shaped region of the atrial cover. In the embodiment shown in Figure 15, the openings are formed by connecting two edges of the donut-shaped region, so as to form an opening between the connecting regions of the edges.

[0066] (Embodiment of ventricular cover) Figure 16 is a top view of a ventricular cover 2802 for a ventricular arm set relating to one set of embodiments, including a central ventricular-facing flap portion 2804 and nine atrial-facing tabs 2806. In some embodiments, the ventricular cover 2802 is configured to contact the outer surface of the ventricular arm set 310. The ventricular cover 2802 shown in Figure 16 has a first side and a second side, which are arranged adjacent to each other to form a continuous circumference, which can be positioned on the outer surface of the ventricular arm set 310. In some embodiments, the ventricular cover 2802 can be configured to contact the inner surface of the ventricular arm set 310. The ventricular cover 2802 may have one or more openings through which a suture (or thread, string, wire, etc.) can pass to attach the ventricular cover 2802 to the ventricular arm set 310.

[0067] The ventricular flap portion 2804 of the ventricular cover 2802 is configured to contact the outer surface of one or more ventricular arms 602 of the ventricular arm set. In the embodiment shown in Figure 16, the central ventricular flap portion of the ventricular cover 2802 is configured to cover three ventricular arms 602 of the ventricular arm set. In some embodiments, the ventricular cover 2802 can be configured to cover one, two, or three or more ventricular arms 602 of the ventricular arm set. In some embodiments, the flap portion 2804 may not be centrally located, but rather closer to the first side of the ventricular arm set, or closer to the second side of the ventricular arm set.

[0068] In some embodiments, the ventricular cover 2802 may include two or more covers. For example, in the embodiment shown in Figure 17, the ventricular cover may include a first cover 3202 including a ventricular-oriented flap and a second cover 3204 including one or more atrial-oriented tabs extending from a single strip-like member. In some such embodiments, the first cover 3202 may be positioned on the outer surface of the second cover 3204, and the second cover 3204 may be positioned on the outer surface of the ventricular arm set 310. In other embodiments, the first cover 3202 may be positioned on the outer surface of the ventricular arm set 310, and the second cover 3204 may be positioned on the outer surface of the first cover 3202. In other sets of embodiments, the first cover 3202 and / or the second cover 3204 may be positioned on the inner surface of the ventricular arm set 310, and the two covers 3202, 3204 and the ventricular arm set 310 may be arranged to constitute any combination of the configurations described above.

[0069] The ventricular cover 3302 may further include a ventricular-oriented tab 3304, as shown in Figure 18. The ventricular-oriented tab 3304 in Figure 18 can be configured to attach to a cylindrical portion of one or more support structures of the artificial heart valve, which can conveniently provide additional structural support to the ventricular arm set or stabilize one or more ventricular covers.

[0070] In some embodiments, the atrial-facing tabs of the ventricular cover each have a vertex, which helps minimize the amount of cover material used in the construction of the artificial heart valve and reduce the overall external size in the compression configuration.

[0071] In some exemplary embodiments, the ventricular cover is depicted as being manufactured from a flat, two-dimensional pattern; however, in other sets of embodiments, the ventricular cover can be manufactured as a three-dimensional structure by, for example, knitting, weaving, molding, forming, casting, or printing. For example, the three-dimensional structure may include, at least in part, plastic, metal, cloth, etc. In some embodiments, the ventricular cover may have a three-dimensional structure in an unfolded configuration in which its central portion extends in the ventricular direction to form an elongated central passage, which can be configured to cover the inner surface of the cylindrical portion of the support structure of the artificial heart valve.

[0072] Figure 19 shows one embodiment of the ventricular cover 3702, in which the ventricular end of the ventricular cover extends further ventrally beyond the ventricular-facing portion of one or more arms of the ventricular arm set. The ventricular cover 3702 in Figure 19 further shows a plurality of windows 3704 configured so that one or more arms of the ventricular arm set can pass through the windows, preventing blood leakage from the windows.

[0073] (Cover spread) In some embodiments, one or more atrial covers are combined with one or more ventricular covers in the deployed configuration. For example, in some embodiments, the atrial cover 2000 of Figure 11 is combined with the ventricular cover 2802 of Figure 16. As another example, in some embodiments, the atrial cover 2000 of Figure 11 is combined with one of the two ventricular covers 3202, 3204 shown in Figure 17. The atrial and ventricular covers of the artificial heart valve may include any combination of the embodiments described above, as well as other embodiments not disclosed herein.

[0074] In some embodiments, the ventricular cover may further include one or more pleats configured to expand radially when the ventricular cover moves from a compressed configuration to an unfolded configuration. The one or more pleats may be configured to organize the ventricular cover into a compressed configuration that minimizes the maximum radial thickness of the ventricular cover, which may be desirable to minimize the external size of the prosthetic heart valve. As shown in Figures 20A to 20D, the ventricular cover 3902 may have one, two, three, four, or more than four pleats, which extend circumferentially around the body of the ventricular cover 3902 and expand radially when the ventricular arm set 310 transitions to an unfolded configuration. In other sets of embodiments, the pleats may extend axially along the ventricular cover, so that when compressed, the pleats curve radially inward and / or outward in a controlled manner that facilitates crimping to a smaller external size. For example, the ventricular cover may have nine symmetrically oriented and axially oriented pleats, but in other embodiments, the ventricular cover may have one, two, three or more axially oriented pleats, and may include more than nine axially oriented pleats. In some embodiments, the ventricular cover may have both axially oriented and circumferentially oriented pleats.

[0075] Figure 21 shows an embodiment in which the artificial heart valve has a flared ventricular end of the support structure of the artificial heart valve, which may be desirable to further reduce valve orifice blood flow and / or lead to a reduction in the area of ​​stagnant blood flow and / or thrombus formation adjacent to the artificial heart valve.

[0076] As described herein, in some embodiments, the valve includes a third arm set. In some embodiments, the third arm set provides support to the cover. In some embodiments, the third arm set may be an annularly oriented atrial arm set. In some embodiments, the third arm set may be an annularly oriented ventricular arm set. In some embodiments, the third arm set may be an annularly oriented independent arm set. In some embodiments, the third arm set may be an atrially oriented atrial arm set. In some embodiments, the third arm set may be an atrially oriented ventricular arm set. In some embodiments, the third arm set may be an atrially oriented independent arm set.

[0077] In some embodiments, for example, one or more of the third arm sets are configured to contact the spontaneous leaflet on the ventricular side of the spontaneous heart valve at a time prior to when one or more of the third arm sets contact the spontaneous leaflet on the atrial side of the spontaneous heart. In some embodiments, this contact (e.g., contact between the ventricular cover and the spontaneous leaflet) creates an external seal. In some embodiments, the third arm sets do not contact the spontaneous leaflet. In some such embodiments, the third arm sets are configured to extend the cover (e.g., the ventricular cover that contacts the atrial side of the spontaneous leaflet).

[0078] In some embodiments, the ventricular arm set and / or third arm set can apply a clamping force to the natural leaflet. Conveniently, such clamps can, in some embodiments, provide an additional or alternative means for biomechanically securing the artificial heart valve to the natural leaflet.

[0079] For example, in the embodiments shown in Figures 22A to 22D, the flexed region of the distal segment of a third arm set 1402 (e.g., a ventricular arm set) extending perpendicularly away from the central axis 402 of the elongated central passage is closer to the ventricular end of the cylindrical portion of one or more support structures than the flexed region of one or more arms of a third set 1404 of the ventricular arm set, which is configured to contact a natural leaflet on the atrial side of the natural heart, extending substantially toward the ventricular end of one or more support structures. In some embodiments, by staggering the positions of the flexed regions in this way, a clamping force 4104 can act on the natural leaflet 4102 due to the opposing forces applied to the natural leaflet by arms 1402 and 1404.

[0080] Figure 23 shows a side view of one arm 1404 of the third arm set of Figure 9, with a distal window, and a suture pattern drawn around it. One or more ventricular covers can be attached using one or more sutures 4202, so that only one knot is tied at the distal end of arm 1404. In some embodiments, this may have one or more windows, for example, two windows located at the distal end, which allows for better fixation of the suture.

[0081] Figure 24 shows the support structure 300 for the artificial heart valve of Figures 3 to 7, which further includes an atrial cover 4302, a ventricular cover 4304, a cylinder cover 4306 configured to cover the inner surface of the cylindrical portion of the artificial heart valve, and several sleeves 4308 configured to cover each of the third arm set of Figure 9. The sleeves can provide a more non-traumatic surface to further prevent damage to the natural leaflet (e.g., perforation due to wear over time). In a preferred embodiment, the artificial heart valve includes a sleeve 4308 covering each of the atrial-facing arms. In other sets of embodiments, the artificial heart valve may include fewer than six or more sleeves 4308. For example, nine sleeves 4308 can be used to cover six atrial-facing arms and three ventricular-facing arms. In other sets of embodiments, each sleeve 4308 may be configured to cover only a portion of one or more arms of the ventricular arm set, for example, only the distal portion of the atrial-facing arms. The sleeve may have an open distal end or a closed distal end. In some embodiments, the sleeve may be connected to an atrial cover, a ventricular cover, and / or a cylinder cover.

[0082] Either of the aforementioned covers or sleeves can be fabricated from biocompatible polymer materials, such as polyester, nylon, or polytetrafluoroethylene; elastomer materials, such as silicone rubber; biological tissues, such as pig or bovine tissue; or any other flexible biocompatible material. The cover or sleeve can be attached to any or more parts of the artificial heart valve by using sutures, threads, strings, wires, or other types of lines; by welding, staking, or using heat to melt the cover or sleeve material; by using hook-and-loop connections; or by any other means.

[0083] In some embodiments, one or more pads may be attached to the ventricular arm set. As shown in Figure 25, the pad 4350 can be attached to the atrial surface of the ventricular arm to prevent direct contact between the ventricular arm and the natural leaflet. In some embodiments, the pad may wrap around the distal end of the ventricular arm so as to contact at least a portion of the ventricular surface of the ventricular arm. The pad can be made of any kind of flexible material, such as polyurethane foam, silicone, hydrogel, other polymer foams, bioabsorbable materials, polyester cloth, etc. In some embodiments, the pad may be attached to the ventricular arm using sutures or other forms of wire or line. In some embodiments, the ventricular skirt may have one or more extensions that extend to the distal end of one or more ventricular arms. One or more extensions may cover one or more whole or partial portions of the ventricular arms. One or more extensions may be used in combination with a pad or sleeve, or by themselves. One or more extensions can assist in the recapture of the ventricular arm into the delivery catheter by preventing the mechanism on the ventricular arm (e.g., a pad on the distal end) from catching on the edge of the delivery catheter. While the above description generally relates to one or more pads attached to a ventricular arm set, those skilled in the art will understand, based on the teachings herein, that one or more pads can be attached to a ventricular arm set, an atrial arm set, and / or a third arm set.

[0084] Figure 26 shows a side cross-sectional view of an embodiment in which the atrial arm set 306 has an atrial cover 4402 configured to contact the ventricular side of the atrial arm set 306. The ventricular arm set 310 has a ventricular cover 4404 configured to contact the outer surface of the ventricular arm set 310 and surround one or more arms of the ventricular arm set 310. The ventricular cover 4404 is further configured to expand radially when moved to a deployed configuration. In some such embodiments, as shown, the atrial arm set 306 extends from a cylindrical portion of the support structure for the artificial heart valve, which has a cylinder cover 4406 configured to cover the inner surface of the cylindrical portion.

[0085] (Artificial leaflet) Figure 27 shows a top view of an artificial leaflet 4500 for an artificial heart valve disclosed herein, which comprises a main semicircular body, a first lateral extension tab 4502a, a second lateral extension tab 4502b (the tabs are collectively referred to as 4502), and one or more openings, which can be used as assembly aids or to facilitate the attachment of the tabs to a portion of the artificial heart valve using, for example, sutures, threads, strings, wires, etc.

[0086] In some embodiments, the artificial heart valve may further include a second artificial valve having a first lateral extension tab and a second lateral extension tab, and a third artificial valve having a first lateral extension tab and a second lateral extension tab. According to some embodiments, the first lateral extension tab of the first artificial leaflet is configured to contact the second lateral extension tab of the third artificial leaflet, the second lateral extension tab of the first artificial leaflet is configured to contact the first lateral extension tab of the second artificial leaflet, and the first lateral extension tab of the third artificial leaflet is configured to contact the second lateral extension tab of the second artificial leaflet.

[0087] (Cylinder cover) Figure 28 shows a top view of a two-dimensional cylinder cover 4700 configured to contact the inner surface of the cylindrical portion of one or more support structures 300 of an artificial heart valve. Although described as "cylindrical," the cylinder cover 4700 may or may not have a cylindrical shape. For example, the cylinder cover 4700 may have an elliptical, oblong, or crescent-shaped cross-section. The cylinder cover 4700 includes a first side and a second side, which are arranged adjacent to each other, as shown in Figure 29, to create a continuous circumference. The cylinder cover 4700 is configured to be positioned on the inner surface of the cylindrical portion of one or more support structures 300. In some embodiments, the cylinder cover 4700 may be configured to contact the outer surface of the cylindrical portion of one or more support structures 300. The cylinder cover 4700 may have one or more openings through which sutures (or threads, strings, wires, etc.) can pass, allowing the cylinder cover to be attached to one or more support structures 300. The one or more openings can also assist in the alignment of mating components during assembly.

[0088] In some embodiments, the artificial leaflet can be configured to contact the inner surface of the cylinder cover 4700 in Figure 29, and the tab of the artificial valve leaflet 4500 is configured to extend through one or more openings in the cylindrical skirt 4700, as shown in Figure 30. In the embodiment of Figure 30, sutures 4900 are shown used to attach the artificial leaflets 4500, 4600, 4602 to the cylindrical skirt 4700 substantially along the semicircular edge of the artificial leaflet. Thus, the unattached edge of the artificial leaflet can move radially inward and outward in response to blood flow when implanted in a natural heart.

[0089] Figure 31 shows an embodiment of a cylinder cover 5000, which comprises three artificial leaflets 5000a, 5000b, and 5000c, each having a first side and a second side, which together are configured to form an assembled cylinder cover. In the embodiment of Figure 31, the first side of the first artificial leaflet 5000a is configured to fit onto the second side of the third artificial leaflet 5000c, the second side of the first artificial leaflet 5000a is configured to fit onto the first side of the second artificial leaflet 5000b, and the first side of the third artificial leaflet 5000c is configured to fit onto the second side of the second artificial valve leaflet 5000b, as shown in Figure 31. Each cylinder cover may further include a first lateral extension tab and a second lateral extension tab, which may be configured to extend radially outward from the outer surface of the assembled cylinder cover, as shown in Figure 31. However, in some embodiments, the lateral extension tabs may be configured to extend radially inward toward the central axis of the elongated central passage.

[0090] In some embodiments, one cover of the three-piece cylinder cover comprises an atrial side of the cylinder cover including three vertices. In some embodiments, one cover of the three-piece cylinder cover comprises an atrial side of the cylinder cover including three vertices and a ventricular side comprising a region of less material than that shown in Figure 31, which may be desirable to prevent blood stagnation on the ventricular side of the artificial heart valve.

[0091] (Bracket for artificial leaflet) Embodiments shown in Figures 32 to 36 include a bracket 5300 configured to support the attachment of the lateral extension tab of the artificial leaflet 4500 of Figure 27 to the artificial heart valve. In a preferred embodiment, the artificial heart valve includes three brackets 5300 installed at the three commissures of the artificial heart valve. In other sets of embodiments, the artificial heart valve may include one, two, or more than three brackets 5300, depending on the desired outcome. The bracket 5300 includes a head portion 5400 with a single opening window, a neck portion 5402 that is smaller in width than the head portion 5400 and smaller in width than the frame portion 5404 and lower than the head portion 5400, a frame portion 5404 that is lower than the neck portion 5402, and an ankle portion 5500 that is smaller in width than the frame portion 5404 and smaller in width than the foot portion 5502 that is lower than the ankle portion 5500. The head portion 5400 of the bracket 5300 preferably includes a single opening, which facilitates attachment to at least one support structure by means of, for example, laser welding, riveting, sutures, mechanical connections, or other mounting means. The narrower width of the neck portion 5402 and / or ankle portion 5500 of the bracket 5300 may, conveniently, facilitate attachment of the bracket to one or more support structures by using threaded elements such as sutures. The bracket can be made of metal (e.g., nitinol, stainless steel, titanium, or gold), plastic (e.g., PTFE, PEEK, nylon, polyurethane), rubber (e.g., silicone), or other rigid material. In a preferred embodiment, the bracket 5300 can be laser-cut from a hypo tube made of nitinol or a nitinol alloy. In some embodiments, the bracket has only a frame portion. In some embodiments, the bracket may be attached directly to the cylinder skirt, for example, as a grommet.

[0092] As shown in Figures 32 to 36, the bracket 5300 can be configured to receive the lateral extension tabs 4502 of the artificial leaflet 4500 via the frame portion of the bracket 5300. For example, conveniently, passing the lateral extension tabs of the artificial leaflet through the bracket can reduce stress, otherwise the stress would be applied to the commissations of the artificial leaflet if they were directly sutured to the cylinder skirt, thus extending the life of the artificial leaflet. The bracket 5300 can further be configured to contact the outer or inner surface of a cylinder cover, such as the cover 4700 shown in Figure 28, and the circumference of the frame portion 5404 can be aligned with the window portion of the cylinder cover. In some embodiments, one or more cylinder covers 6000 may have window tabs 6002 extending into the interior of the window portion, as shown in Figure 38, which are configured to bend outward from the cylinder cover 6000 and wrap around the frame portion 5404 of the bracket 5300, which is in contact with the outer surface of the cylinder cover, as shown. In some embodiments, the bracket is advantageous by improving and securing the alignment of the artificial leaflet with the cylindrical portion of the artificial heart valve. The bracket can also improve ease of assembly or allow flexibility in the manufacturing process by making the subassembly of the artificial leaflet and bracket ready before mounting it to the cylindrical portion of the artificial heart valve.

[0093] In the embodiment shown in Figure 39, the window tab 6002 can be configured to bend inward from the cylinder cover and enclose the frame portion 5404 of the bracket 5300 that is in contact with the inner surface of the cylinder cover.

[0094] The embodiments of Figures 38 and 39 may preferably be realized by using one, two, or three cylinder covers, for example, those shown in Figures 28 and 31, or by using cylinder covers of different designs, or by using more than three cylinder covers together. A potential advantage of using cylinder covers including three cylinder covers to realize the embodiments of Figures 38 and 39 is that the aforementioned window tab 6002 may be of any length, which conveniently allows for more complete coverage of the frame surface, thereby protecting the artificial leaflet from contact with the frame.

[0095] The one or more cylinder covers described above may further include one or more atrial-facing tabs, which may be configured to bend away from the central axis of the elongated central passage and to contact the lateral extension tabs 4502 of the artificial leaflet on the outside of the cylindrical portion of the artificial heart valve. Thus, the atrial-facing tabs of the one or more cylinder covers may be configured to prevent contact between any portion of the artificial leaflet and one or more support structures of the artificial heart valve, which may conveniently reduce wear and extend the life of the artificial leaflet. In some embodiments, the atrial-facing tabs of the one or more cylinder covers may be configured to bend toward the central axis of the elongated central passage into the inner portion of the cylindrical portion of the artificial heart valve.

[0096] In some embodiments, for example as shown in Figure 28, the cylinder cover may include one or more window portions configured to allow the passage of the lateral extension tabs 4502 of the artificial leaflet. Such embodiments may further include one or more frame sleeves configured to enclose at least a portion of the cross-section of the frame portion of the bracket. The frame sleeves may be made from bioprosthetic tissue (e.g., bovine, porcine, etc.) or from synthetic materials (e.g., polyester, nylon, polyurethane, ePTFE, hydrogel, silicone rubber, etc.). Figure 40 shows an embodiment comprising two frame sleeves 6302, each of which includes a material sheet configured to enclose the vertically oriented member of the frame, so that the two opposing sides of the sheet contact each other outside the central window portion of the frame portion 5404, and the opposing sides can be attached to each other using, for example, sutures, threads, wires, lines, etc. In other sets of embodiments, one or more sleeves may enclose only a portion of one or more members of the frame without their ends contacting each other.

[0097] As shown in Figure 41, the lateral extension tab 4502 of the artificial leaflet can be configured to pass through the central window portion of the bracket in Figure 40 and contact the outer surface of one or more frame sleeves 6302, which can preferably prevent contact between the artificial leaflet and the bracket, for example, reducing wear and extending the life of the artificial leaflet. The artificial leaflet in Figure 41 can also be configured to bend in the opposite direction toward the outer surface of the cylinder cover, and in some embodiments, can be configured to contact the outer surface of the cylinder cover. In some embodiments, for example, as shown in Figure 41, the bracket 5300 and frame sleeve 6302 are installed on the inner portion of the cylindrical portion 6400 of the artificial heart valve. In some embodiments, for example, as shown in Figure 42, the bracket 5300 and frame sleeve 6302 are installed on the outer portion of the cylindrical portion 6400 of the artificial heart valve.

[0098] Figures 43A to 43C show several embodiments of the bracket 5300 and one or more frame sleeves. The embodiment in Figure 43A includes two frame sleeves 6600 that wrap around the entire perimeter of the cross section of the frame portion 5404 of the bracket 5300. The embodiment in Figure 43B includes two frame sleeves 6602 that wrap around only a portion of the perimeter of the cross section of the frame portion 5404 of the bracket 5300 and are secured in place using sutures, threads, wires, lines or similar means. The embodiment in Figure 43C depicts the bracket 5300 with one frame sleeve 6604 covering two vertically oriented members of the frame portion 5404 of the bracket 5300.

[0099] Figures 44A to 44C illustrate several embodiments in which the frames of brackets 6700a, 6700b, and 6700c do not form a continuous loop by including a gap 6702 around the frame, which conveniently allows one or more frame sleeves 6704 to be easily attached to the bracket. For example, in the embodiments shown in Figures 44B and 44C, the frame sleeve 6704 includes two frame sleeves, each being a continuous cylinder, which can be attached to the frames of brackets 6700b and 6700c by passing the frame sleeve 6704 through the open end in the gap 6702 of the bracket frame. The embodiment in Figure 44C depicts bracket 6700c, in which the frame does not form a continuous loop and further includes an ankle portion below the frame portion, having a width smaller than the width of the frame portion and smaller than the width of the foot portion below the ankle portion. Including an ankle portion in the bracket without a continuous loop frame preferably facilitates the attachment of the bracket to one or more support structures of the artificial heart valve. In other sets of embodiments, the frame may have gaps in any part of the frame, or the frame may have more than one gap, and in some embodiments the gaps may be larger or smaller than those shown in Figures 44A to 44C. In some embodiments the vertical orientation members of the frame portion of the bracket are not parallel, but instead converge or diverge at an angle of about 0 to 45 degrees. In other sets of embodiments the bracket may consist of only one or two vertical orientation members.

[0100] Figures 45A and 45B show one embodiment of the bracket 6800, the head portion of which has a substantially circular external shape, which may preferably match the substantially circular shape of one or more mating portions of the support structure of the artificial heart valve. In some embodiments, the bracket 6800 may have a first surface 6902 with concave curvature and a second surface 6904 with convex curvature, as shown in Figure 46, which may preferably improve contact between a portion of the lateral extension tab of the leaflet and a portion of the artificial heart valve. In some embodiments, the ankle portion of the bracket may have an asymmetrical shape, for example, having a circular region on only one side of the ankle portion, as shown in Figures 45A and 45B, which may preferably facilitate identification of the concave and convex surfaces of the bracket.

[0101] In some embodiments, the sleeve may be constructed from multiple windings of a threaded element 7000 (e.g., suture thread), which can be used to secure the frame to one or more covers extending into an elongated central passage, as shown in Figure 47A. In other sets of embodiments, as shown in Figure 47, the frame of the bracket 5300 may have one or more openings 7002 along one or more vertical members of the frame to facilitate connection to one or more cylinder covers extending into an elongated central passage, or to facilitate direct connection to one or more support structures using, for example, a threaded element (e.g., suture thread).

[0102] As shown in the embodiment of Figure 48, the head portion of the bracket 7100 can be configured to have one or more bends, such that the surface of the head portion forms an angle of less than 180 degrees with the surface of the frame portion. The head portion may further include an opening, which can be configured to fit with a member of one or more support structures 300 of the artificial heart valve, facilitating the attachment of the bracket 7100 to one or more support structures 300.

[0103] The embodiment shown in Figure 49 illustrates a bracket 7200 including an upper frame portion and a lower frame portion, wherein the upper frame portion is configured to have one or more bends, so that the surface of the upper frame portion forms an angle with the surface of the lower frame portion that is less than 180 degrees. For example, Figure 49 shows a bracket 7200 in which the angle between the upper and lower surfaces is approximately 0 degrees, but in other embodiments, this angle may be greater than 0 degrees. In some embodiments, the bracket may be configured to engage with one or more support structures of an artificial heart valve, facilitating the mounting of the bracket to one or more support structures. In some embodiments, the distance between the second surface of the lower frame portion of the bracket and the second surface of the upper frame portion of the bracket is equal to or less than the thickness of the fitting portion of one or more support structures, which preferably creates a pressure fit between the bracket and one or more support structures to facilitate mounting.

[0104] In some embodiments, the bracket 7300 can be positioned such that the first face of the bracket closest to the central axis 402 of the elongated central passage of the cylindrical portion of one or more support structures 300 is closer to the outer edge of one or more support structures than the second face of the bracket 7300 which is further from the central axis 402 than the first face. In some such embodiments, the lateral extension tab 4502 of the artificial leaflet can be configured to extend beyond the members of one or more support structures before passing through the window portion of the bracket 7300, as shown in the top cross section of Figure 51. In some embodiments, the lateral extension tab 4502 of the artificial leaflet may be configured to contact the inner surface of one or more support structures after first passing through the window portion of the bracket, as shown in Figure 51. In other sets of embodiments, the lateral extension tab of the artificial leaflet may be configured to contact the outer surface of one or more support structures after first passing through the window portion of the bracket. In any of the embodiments described above, one or more of the frame sleeves may be configured to surround a portion of the bracket frame and / or a portion of one or more members of one or more support structures, so that the lateral extension tabs of the artificial leaflet contact one or more frame sleeves instead of directly contacting the bracket or one or more support structures.

[0105] Figure 52 shows one embodiment in which a support structure for an artificial heart valve (e.g., 302 and / or 304) includes one or more slots 7500 configured to receive a lateral extension tab 4502 of the artificial heart valve as an alternative to using the aforementioned bracket.

[0106] (Artificial heart valve assembly) Figure 53 shows a perspective view of the artificial heart valve 7600, including the support structure 300 (see Figures 3-7) and the atrial cover 2000 in Figure 11, the ventricular cover 2802 in Figure 16, the artificial leaflet 4500 in Figure 27, and the cylinder cover 4700 in Figure 28.

[0107] In some embodiments, one or more covers on one or more ventricular arms can be fitted to the atrial end of the cylindrical portion of one or more support structures 300 (e.g., along the periatrial 7602) and to the ventricular end of the cylindrical portion of one or more support structures 300 (e.g., along the portion 7702), as shown in Figure 54, to prevent blood stagnation on the ventricular side of the artificial heart valve. This embodiment can also function to enhance the attachment of the ventricular arm set and ventricular cover to the cylindrical portion or one or more support structures.

[0108] In an exemplary embodiment, the artificial heart valve includes a first support structure comprising a cylindrical portion and an atrial arm set; a second support structure comprising a ventricular arm set; a ventricular cover configured to contact the outer surface of the ventricular set; a cylinder cover configured to contact the inner surface of the cylindrical portion of the first support structure; three artificial leaflets configured to move radially inward and outward within the cylindrical portion of the first support structure to allow blood flow in only one direction; and six sleeves configured to cover each of the atrial-facing arms of the ventricular arm set.

[0109] (Additional embodiments) Figures 55 to 58 show several alternative embodiments of the artificial heart valve. In Figure 55, the atrial arm set can be configured to extend into one or more natural commissures of a natural heart valve. Figure 56 shows an embodiment in which the atrial arm set includes three arms. Figures 57 and 58 show embodiments in which one or more arms of the ventricular arm set are configured to contact the natural leaflet on the ventricular side of the natural leaflet at the distal portion of one or more arms, and to contact the natural leaflet on the atrial side of the natural leaflet at the proximal portion of one or more arms. The artificial heart valves of Figures 57 and 58 can further be configured to include one or more ventricular covers, such as the ventricular cover in Figure 16, configured to contact the natural leaflet on the atrial side of the natural leaflet.

[0110] In the embodiment shown in Figure 3, the artificial heart valve includes two support structures, the atrial end of the cylindrical portion of each support structure includes a head portion with a single window, and the two windows can be easily fitted with at least two eyelets by, for example, laser welding, riveting, suturing, or other fitting means. In some embodiments, the atrial end of the cylindrical portion of each support structure may have a bend so that the head portion is closer to the central axis of the elongated central passage of the cylindrical portion than to the inner surface of the cylindrical portion of the support structure, for example, to facilitate insertion into a catheter in a transcatheter delivery system.

[0111] In the embodiment shown in Figure 3, one or more arms of the atrial arm set may have one or more holes in the proximal or distal segment of one or more arms, for example, to facilitate deployment, positioning, or recapture of the artificial heart valve by passing sutures through the holes to control the movement of one or more arms. In some embodiments, one or more holes may be completely closed, which conveniently prevents attachment mechanisms such as sutures from disengaging from the one or more holes. In other sets of embodiments, one or more holes may be open, which conveniently allows attachment mechanisms to be easily engaged with or disengaged from the one or more holes.

[0112] Figure 59A shows one embodiment in which one or more of the most distal segments of the arms of the atrial arm set may have a curvature that extends posteriorly toward the same distal segment, so that the most distal portion is substantially parallel to the portion of the distal segment in which the curvature occurs. Thus the distal segment forms a hook, which is preferably open, allowing attachment mechanisms such as sutures to be connected to the hook. However, in some embodiments, the hook may form a closed loop in one or more of the most distal segments of the arms of the atrial arm set. In some embodiments, the hook may have two or more openings, for example, allowing attachment mechanisms such as sutures to be connected to the hook from different directions while preventing unintended disengagement from the hook. In one set of embodiments, one arm of the atrial arm set, which is shorter than the other arms of the atrial set, has a hook having the shape shown in Figure 59B, allowing sutures originating from two different directions to be attached to the hook.

[0113] In some embodiments, the artificial heart valve may include one or more threaded elements having a first end and a second end, the first end of which may be configured to be attached to a portion of the delivery system for the artificial heart valve, and the second end of which may be configured to be attached to a portion of the artificial heart valve. In the embodiment of Figure 60, one or more threaded elements are attached to hooks on the arms of the atrial arm set of the artificial heart valve. The threaded elements may be configured to transition the atrial arm set from a compression configuration to an expansion configuration, and vice versa, as shown in Figure 60. In some embodiments, the threaded elements are configured to be implanted in a natural heart together with the artificial heart valve.

[0114] In some embodiments, the threaded element can be fabricated from sutures or other types of threads, strings, wires, or lines. In some embodiments, the threaded element may be bioabsorbable. In some embodiments, the threaded element can be fabricated from a metal, such as nitinol, stainless steel, or other flexible and biocompatible metals. In some embodiments, the threaded element may be a nitinol spring, which, conveniently due to the superelastic properties of nitinol, can help resist plastic deformation of the threaded element when moving from a compression configuration to an expansion configuration or implantation configuration.

[0115] In some embodiments, the distal end of the third arm set (e.g., the ventricular arm set) extends further radially than in the embodiment of Figure 9, which can preferably provide a larger sealing surface that the natural leaflet can contact. The arms of the ventricular arm set may also be symmetrical with respect to the central axis of the elongated central passage. However, in other sets of embodiments, one or more arms of the ventricular arm set may be of different sizes, shapes, or orientations depending on the desired function.

[0116] In some embodiments, the support structure includes connecting members extending from the atrial side of the support structure toward the atrium. These connecting members can be used to connect to a delivery system to assist in the delivery of the artificial heart valve to the natural heart valve.

[0117] According to some embodiments, a ventricular cover for a ventricular arm set is configured to extend over at least one outer surface of the arms of the ventricular arm set. In some embodiments, the ventricular cover is configured to surround at least one portion of one or more third arm sets and to contact the atrial side of the natural leaflet. In some embodiments, the cover surrounds at least one portion of one or more atrial-facing arms of the ventricular arm set. For example, the cover may surround the proximal portion of one or more arms of the ventricular arm set and the intermediate U-shaped portion of one or more arms of the atrial-facing ventricular arm set distal to the proximal portion. In some embodiments, the ventricular arm set has no connecting members and has a ventricular cover surrounding the ventricular arm set.

[0118] In some embodiments, the support structure includes a cylindrical portion and an atrial arm set, all of which are of equal size, shape, and orientation. The atrial arms may be relatively short in length, which in some embodiments can conveniently reduce the overall length of the artificial heart valve when in a compression configuration, and facilitate the manipulation of the artificial heart valve in a natural heart before implantation.

[0119] Figure 61 shows an embodiment of an artificial heart valve including the support structure and ventricular arm set.

[0120] In some embodiments, the third arm set can be configured to extend ventricularly beyond the most ventricular portion of the atrial-facing arm of the ventricular arm set. In some embodiments, the ventricular cover for the ventricular arm set may be attached to the distal end of the third arm set, thereby allowing the ventricular cover to extend further ventricularly beyond the most ventricular portion of the atrial-facing arm, which conveniently increases the surface area of ​​the cover to prevent perivalvular leakage around the prosthetic heart valve.

[0121] In some embodiments, the third arm set can be configured to extend radially beyond the distal portion of the atrial-facing arm of the ventricular arm set, as shown in Figures 62A and 62B. Figure 62A shows a top view of one embodiment of the ventricular arm set, in which the cover for the ventricular arm set has a ridged outer surface that extends radially beyond the distal portion of the atrial-facing arm between adjacent atrial-facing arms, thereby extending the ventricular cover closer to the natural leaflet, which can help prevent perivalvular leakage of the prosthetic heart valve. In some embodiments, the distal end of the third arm set has a radial distance from the central axis of the elongated central passage that is smaller than the radial distance between the distal portion of the atrial-facing arm and its central axis. In an exemplary embodiment, Figure 62A shows a side view of the atrial-facing arm of the ventricular arm set overlapping the annular-facing arm of the ventricular arm set, in which the distal end of the annular-facing arm has a radial distance from the central axis of the elongated central passage that is larger than the radial distance between the distal portion of the atrial-facing arm and its central axis. Those skilled in the art will understand, based on the teachings herein, that the arms shown in Figure 62A are not intended to be limiting, and that other arms from the third arm set may exist that are not necessarily annular or atrial.

[0122] Figures 63A to 63D show several side views of exemplary embodiments in which the atrial-oriented arms overlap the annular-oriented arms, which have different lengths, sizes, shapes, curvatures, or orientations.

[0123] In some embodiments, the distal end of the third arm set may have a different shape, such as a bifurcation, as illustrated in the embodiment of Figure 64. Depending on this embodiment, it may be desirable to provide an additional radial extension of the ventricular cover between adjacent arms of the third arm set. In some embodiments, the distal end of the third arm set may have other shapes, such as a paddle shape as shown in Figure 65. In some embodiments, the distal end of the third arm set may have more than two extensions (e.g., three or four extension members). In some embodiments, the distal end of an annular arm can be made non-traumatic to avoid damage to surrounding tissue. In some embodiments, the distal end of the arms of the third set may have one or more openings or other mechanisms to facilitate the attachment of one or more ventricular covers to the third set arms. In some embodiments, the distal end of the first arm of the third arm set may have a different length, size, shape, curvature, angle and / or orientation than the second arm of the third arm set.

[0124] While several embodiments of the present invention have been described and illustrated herein, those skilled in the art will readily conceive of various other means and / or structures for carrying out the function and / or obtaining one or more of the results and / or advantages described herein. Each of these variations and / or modifications is considered to be within the scope of the present invention. More generally, those skilled in the art will readily understand that all parameters, dimensions, materials and configurations described herein are illustrative, and that actual parameters, dimensions, materials and / or configurations will depend on the specific application in which the teachings of the present invention are used. Those skilled in the art will come to recognize or elucidate many equivalents to the specific embodiments of the present invention described herein using only a set of experiments. Accordingly, it should be understood that the embodiments described herein are presented only as examples, and that within the scope of the appended claims and their equivalents, the present invention can be carried out in ways other than those specifically described and claimed. The present invention covers the individual features, systems, articles, materials, kits and / or methods described herein. Furthermore, any combination of two or more such features, systems, articles, materials, kits and / or methods is within the scope of the present invention, provided that they are not contradictory to each other.

[0125] The indefinite articles "a" and "an" as used herein and in claims should be understood to mean "at least one" unless explicitly stated otherwise.

[0126] The phrase "and / or" as used herein and in the claims should be understood to mean "either or both" of coordinating elements, i.e., elements that are sometimes presented conjunctively and other times presented disjunctively. Other elements other than those specifically identified by the phrase "and / or" may be present as they may, regardless of whether they are related to the specifically identified elements, unless explicitly stated otherwise. Thus, as a non-restrictive example, when a reference to "A and / or B" is used in combination with open-ended phrases such as "equips, includes," in one embodiment it may refer to A without B (including other elements as may), in another embodiment it may refer to B without A (including other elements as may), and in yet another embodiment it may refer to both A and B (including other elements as may).

[0127] As used herein and in the claims, “or” should be understood to have the same meaning as “and / or” as defined above. For example, when separating items within a list, “or” or “and / or” should be interpreted as inclusive, that is, including at least one of several elements or lists of elements, but also including two or more, and including items not in any additional lists. Conversely, only terms that are clearly indicated, such as “one of” or “exactly one of” or “consisting of” as used in a claim, refer to the inclusion of exactly one of several elements or lists of elements. In general, the term “or” as used herein should be interpreted as indicating exclusive substitutes (i.e., one or the other, but not both) when preceded by terms of exclusivity, such as “either,” “one of,” “one of” or “exactly one of.” “Essentially consisting of” should have the usual meaning as used in the field of patent law when used in a claim.

[0128] As used herein and in the claims, the phrase “at least one” referring to a list of one or more elements should be understood to mean at least one element selected from any one or more of the elements in the list of elements, but not necessarily including at least one of the individual and all elements specifically described in the list of elements, but not excluding any combination of elements in the list of elements. By this definition, elements other than those specifically identified in the list of elements referred to by the phrase “at least one” may be present as necessary, regardless of whether they are related to the specifically identified elements. Thus, as a non-limiting example, “at least one of A and B” (or equivalently, “at least one of A or B” or equivalently, “at least one of A and / or B”) may refer, in one embodiment, to include at least one, optionally two or more A's, and no B (optionally including elements other than B); in another embodiment, to include at least one, optionally two or more B's, and no A (optionally including elements other than A); and in yet another embodiment, to include at least one, optionally two or more A's, and optionally two or more B's (optionally including other elements).

[0129] In the claims and the above specification, all transitional phrases, such as “equipment,” “includes,” “carry,” “have,” “contain,” “involve,” and “hold,” should be understood to be open-ended, meaning they include but are not limited to these. As stated in Section 2111.03 of the U.S. Patent and Trademark Office's Patent Examination Procedure Manual, only the transitional phrases “consist of” and “essentially consist of” should be closed or semi-closed.

[0130] For example, any terms used herein with respect to the shape, orientation, alignment and / or geometric relationships between one or more articles, structures, forces, fields, flows, directions / trajectories and / or their subcomponents and / or combinations thereof and / or any other tangible or intangible elements not listed above that are subject to such characterization should be understood as not requiring absolute conformity to the mathematical definitions of such terms unless otherwise defined or indicated, but rather should be understood as conforming to the mathematical definitions of such terms as far as possible with respect to subjects characterized in a manner that is most closely related to such subjects and understandable to those skilled in the art. Examples of these terms relating to shape, orientation and / or geometric relationships include shape (e.g., circle, square, gomboc, circular, rectangular, triangular, cylindrical, elliptical, n-gonal, etc.), angular orientation (e.g., perpendicular, orthogonal, parallel, vertical, horizontal, collinear, etc.), contour and / or trajectory (e.g., plane, coplanar, hemispherical, hemisphere, line, hyperbola, parabola, planar Descriptive terms include, but are not limited to, descriptive terms for surface, curved, straight, arched, sinusoidal, tangent / tangent, etc., direction (e.g., north, south, east, west, etc.), surface and / or bulk material properties and / or spatial / temporal resolution and / or distribution (e.g., smooth, reflective, transparent, clear, opaque, rigid, impermeable, uniform, inert, non-wetting, insoluble, stable, invariant, constant, uniform, etc.), and many other things that are obvious to those skilled in the art. As an example, a manufactured product described herein as a “square” does not require such a product to be perfectly planar or linear and have faces or sides that intersect at exactly 90-degree angles (in fact, such a product exists only as a mathematical abstraction), but rather the shape of such a product should be interpreted as approximating a mathematically defined “square” to the extent that it is typically achievable and attainable for the manufacturing technique described, as understood by those skilled in the art, or as specifically described.As another example, two or more manufactured products described herein as "aligned" do not require that such products have perfectly aligned faces or sides (in fact, such products can only exist as mathematical abstractions), and the arrangement of such products should be interpreted as approximating a mathematically defined "alignment" to the extent that is typically achievable and attainable for the manufacturing techniques described, as understood by those skilled in the art or as specifically described.

[0131] The word “exemplary” is used here to mean “serving as an example or illustration.” Any aspect or design described herein should not necessarily be interpreted as being preferable or more convenient than other aspects or designs. In one aspect, the various alternative configurations and operations described herein are considered at least equivalent.

[0132] The term "aspect" does not mean that such aspects are essential to the Art, or that such aspects apply to all configurations of the Art. Disclosure relating to a particular aspect may apply to all configurations or to one or more configurations. A particular aspect may provide one or more examples. A term such as "aspect" may refer to one or more aspects, and vice versa. The term such as "embodiment" does not mean that such embodiments are essential to the Art, or that such embodiments apply to all configurations of the Art. Disclosure relating to an embodiment may apply to all embodiments or to one or more embodiments. An embodiment may provide one or more examples. A term such as "embodiment" may refer to one or more embodiments, and vice versa. The term "configuration" does not mean that such configurations are essential to the Art, or that such configurations apply to all configurations of the Art. Disclosure relating to a configuration may apply to all configurations or to one or more configurations. A configuration may provide one or more examples. A term such as "configuration" may refer to one or more configurations, and vice versa.

[0133] It is understood that some or all of the steps, actions, or processes may be performed automatically without user intervention. The claims for the method may be provided to present elements of various steps, actions, or processes in a sample order, and are not meant to be limited to any particular order or hierarchy presented.

[0134] The title, background, brief description of the drawings, and claims of this disclosure are incorporated herein and provided as exemplary examples of the disclosure, and not as limiting descriptions. They are intended to be understood as not being used to limit the scope or meaning of the claims. Furthermore, in the detailed description, it will be found that the description provides exemplary examples, and various features are grouped together in various embodiments for the purpose of streamlining the disclosure. This method of disclosure should not be interpreted as reflecting an intention that the claimed subject matter requires more features than those explicitly stated in the claims. Rather, as reflected in the claims below, the subject matter of the invention is fewer than all features of a single disclosed configuration or operation. The claims below are incorporated in the detailed description, and each claim is based on itself to represent separately claimed subject matter.

Claims

1. It is an artificial heart valve, A support structure defining a long, narrow central passage, comprising one or more atrial arms, one or more ventricular arms, and a third arm set, Multiple leaflet elements attached to a support structure, wherein multiple leaflet elements are arranged within an elongated central passage to control blood flow through the elongated central passage, A cover, formed separately from the support structure and supported by a third arm set, is configured to contact the natural leaflets of the natural heart valves of the heart and reduce leakage around the artificial heart valve, The support structure is configured to biomechanically fix the artificial heart valve to the natural leaflet of the heart's natural heart valve, but not to the natural annulus of the heart's natural heart valve. One or more atrial arms and one or more ventricular arms extend across the cross-sectional plane of the cylindrical portion of the support structure. One or more distal segments of the atrial arms and one or more distal segments of the ventricular arms extend perpendicularly away from the central axis of the elongated central passage and contact the opposing side of each natural leaflet at a location radially inward from the natural annulus, thereby holding at least a portion of each natural leaflet radially away from the natural annulus, thereby allowing axial movement of the cylindrical portion of the support structure for the natural annulus and the portion of each natural leaflet. During the biomechanical movement of the artificial heart valve within the natural heart valve during the cardiac cycle, the ventricular arm is configured to resist this movement, while the atrial arm maintains contact with the natural leaflet, and / or the atrial arm resists this movement, while the ventricular arm maintains contact with the natural leaflet, so that the systolic and / or diastolic pressure load is at least partially absorbed by the movement of the natural leaflet.

2. At least one support structure comprises a cylindrical portion including the atrial end and the ventricular end, The artificial heart valve according to claim 1, wherein the elongated central passage is defined by a cylindrical portion of at least one support structure.

3. Each of the one or more atrial arms includes a proximal atrial segment located proximal to the cylindrical portion and a distal atrial segment located distal to the cylindrical portion. The artificial heart valve according to claim 2, wherein at least one of the size, shape, or angle of the first atrial arm of one or more atrial arms is different from the corresponding size, shape, or angle of the second atrial arm of one or more atrial arms.

4. The artificial heart valve according to claim 3, wherein the size of the first atrial arm is larger than the size of the second atrial arm.

5. The first atrial arm has a first length in a direction parallel to the longitudinal axis, and the second atrial arm has a second length in a direction parallel to the longitudinal axis. The artificial heart valve according to claim 3, wherein the first length is greater than the second length.

6. The artificial heart valve according to claim 5, wherein, when the artificial heart valve is implanted in the heart, the first length is greater than the second length.

7. The distal atrial segment of the first atrial arm has a first distal end at a first distance from the longitudinal axis, and the distal atrial segment of the second atrial arm has a second distal end at a second distance from the longitudinal axis. The artificial heart valve according to claim 3, wherein the distal atrial segment of the first atrial arm extends with respect to the longitudinal axis such that the first distance is less than the second distance.

8. The artificial heart valve according to claim 3, further comprising an atrial cover including a plurality of distal atrial covers configured to be positioned adjacent to the distal atrial segments of one or more atrial arms.

9. The prosthetic heart valve according to claim 8, wherein the plurality of distal atrial covers include one or more pleats, and as a result, the plurality of distal atrial covers are configured to expand or contract as the length of the corresponding one or more atrial arms increases or decreases.

10. The artificial heart valve according to claim 3, wherein one or more atrial arms are attached to the ventricular end of a cylindrical portion of at least one support structure.

11. Each arm of one or more ventricular arms includes a proximal ventricular segment located proximal to the cylindrical portion and a distal ventricular segment located distal to the cylindrical portion. The artificial heart valve according to claim 5, wherein at least one of the size, shape, or angle of the first ventricular arm is different from the corresponding size, shape, or angle of the second ventricular arm.

12. The artificial heart valve according to claim 11, wherein the size of the first ventricular arm is larger than the size of the second ventricular arm.

13. The first ventricular arm has a first length in a direction parallel to the longitudinal axis, and the second ventricular arm has a second length in a direction parallel to the longitudinal axis. The artificial heart valve according to claim 11, wherein the first length is greater than the second length.

14. The artificial heart valve according to claim 13, wherein, when the artificial heart valve is implanted in the heart, the first length is greater than the second length.

15. In the ported configuration, One or more ventricular arms of the first subset are adjacent to the ventricular side of the first natural leaflet. The artificial heart valve according to claim 11, wherein a second subset of one or more ventricular arms is adjacent to the atrial side of a second natural leaflet.

16. In the ported configuration, The artificial heart valve according to claim 15, wherein at least one arm of a third subset of one or more ventricular arms is adjacent to at least one of the commissures of a natural heart or the atrial side of a first natural leaflet.

17. At least one arm of the third subset has a first length in a direction parallel to the longitudinal axis of the artificial heart valve, and the other arm of the third subset has a second length in a direction parallel to the longitudinal axis. The artificial heart valve according to claim 16, wherein the first length is greater than the second length.

18. The artificial heart valve according to claim 15, wherein each arm of the first subset is configured such that, in the implanted configuration, the arms of the first subset do not come into contact with the natural annulus of the heart, thereby reducing trauma to the heart.

19. The cover is a ventricular cover positioned adjacent to the proximal ventricular segment. This area is on the opposite side of the cylindrical portion, as described in claim 11, for the artificial heart valve.

20. The cover is a ventricular cover positioned adjacent to the proximal ventricular segment of one or more ventricular arms. The artificial heart valve according to claim 11, wherein a portion of the ventricular cover extends to be positioned adjacent to the distal ventricular segment of one or more subsets of ventricular arms.

21. The artificial heart valve according to claim 11, wherein one or more ventricular arms are attached to the atrial end of a cylindrical portion of at least one support structure.

22. The artificial heart valve according to claim 2, wherein at least one cylindrical portion of the support structure is radially foldable for transcatheter implantation.

23. The artificial heart valve according to claim 1, wherein the cover is configured to contact the atrial side of the natural leaflet.

24. The artificial heart valve according to claim 1, wherein the cover is configured to contact the ventricular side of the natural leaflet.

25. The artificial heart valve according to claim 1, wherein the flexed region of the distal segment of the third arm set is configured such that the clamping force acts on the natural leaflet.

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