Surgical tricuspid valve prosthesis

Abstract

A tricuspid valve prosthesis is provided for implantation in the heart, the tricuspid valve prosthesis comprising two or more leaflets, each leaflet having an annular length and two free edges forming a tip, the two or more leaflets being adapted to be joined together at commissures to form a ring and to be joined to one another. The tricuspid valve prosthesis may comprise a connector element connected to the tips of the two or more leaflets. The tricuspid valve prosthesis may also comprise two or more sets of cords. The tricuspid valve prosthesis may or may not comprise a stent frame.

Description

[Technical field]

[0001] (CROSS REFERENCE TO RELATED APPLICATIONS) This application claims the benefit of Singapore Application No. 10202110444X, filed September 21, 2021, the disclosure of which is incorporated herein by reference in its entirety.

[0002] The present disclosure relates to prosthetic heart valves. In particular, the present disclosure relates to a tricuspid valve prosthesis for surgical replacement of the tricuspid valve. [Background technology]

[0003] The tricuspid valve is a valve in the heart located between the right atrium (upper chamber) and the right ventricle (lower chamber). The tricuspid valve allows blood to flow from the right atrium to the right ventricle and ensures that blood flows in the correct direction from the right atrium to the right ventricle. The tricuspid valve is located in the right triangle of the heart's fibrous skeleton and consists of the tricuspid annulus, tricuspid valve cusps, chordae tendineae, and papillary muscles.

[0004] The tricuspid valve is generally three-cusp with unequal sized anterior, septal, and posterior leaflets. Similarly, there are three papillary muscles: the septal / medial papillary muscle, the inferior papillary muscle, and the anterior papillary muscle. The anterior papillary muscle is the largest and arises from the accommodative band as it progresses towards the right ventricular free wall. Chordae tendineae connect the papillary muscles to the tricuspid valve leaflets. The tricuspid valve generally spans 7-9 cm. 2 It has an area of ​​10.5 mm and is the largest of the four cardiac valves in the heart.

[0005] The tricuspid valve orifice is made by the tricuspid annulus and averages 11.4 cm in men and 10.8 cm in women. An anterior superior border, an inferior border, and a septal border correspond to each valve leaflet. Connective tissue around the atrioventricular (AV) valve orifice separates the atrium from the ventricle, except for the location of the AV bundle. The normal tricuspid annulus is a saddle-shaped structure with its highest point in an anterior-posterior orientation and its lowest point in a mediolateral orientation. In patients with functional tricuspid regurgitation, the annulus expands along the right ventricular free wall and becomes more circular and flat.

[0006] The tricuspid valve has three thin, membranous leaflets with commissures that look more like depressions than true commissures. The leaflets are named anterior superior, inferior or parietal, and septal, respectively, depending on their corresponding location. The commissures are then named anterior septal, anterior inferior, and inferior. The anterior superior leaflet is the largest leaflet. It attaches to the posterolateral surface of the apex of the superior ventricle and extends from the septal limb to the membranous septum, forming part of the anterior septal commissure. The posterior leaflet is completely attached to the parietal surface and protects the diaphragmatic surface of the AV junction. It can have multiple scallops, the limits of which are the subseptal commissure and the anterior inferior commissure. The septal leaflet is one of the boundaries of the triangle of Koch, an anatomical region in the right atrium, whose location is delimited by the coronary sinus opening, the chordae tendineae of Todaro, and the atrioventricular node at the apex. The septal leaflet is therefore a clinical landmark that helps to identify the location of this conductive tissue during surgery on the right atrioventricular valve.

[0007] The chordae tendineae are thin, strong, inelastic fibrous cords that extend from the free ends of the tricuspid valve cusps to the tips of the papillary muscles in the right ventricle. They transmit the force of the contracting papillary muscles to the leaflets of the valve during ventricular contraction and prevent the valve from prolapsing into the atrium due to the higher pressure generated in the ventricle.

[0008] There are three papillary muscles in the RV: anterior, inferior, and medial or septal, of which the anterior papillary muscle is the largest and the others are smaller muscular tips. Each of these muscles corresponds in both size and position to the leaflet it supports. The anterior papillary muscle arises from the right anterolateral ventricular wall (TV) below the anterior-inferior commissure of the inferior leaflet and blends with the right end of the corpus cavernosum trabeculae (SMT).

[0009] Contrary to its nomenclature, the tricuspid valve (TV) behaves like a bicuspid valve: the anterior and posterior leaflets fan out into the RV during diastole and contract to seal the valve during systole, while the septal leaflets remain fixed between the right and left fibrous trigones and the atrial and ventricular septa. The annulus serves this purpose by expanding and contracting during diastole and systole, respectively.

[0010] Some people say that this valve does not function properly and that they have tricuspid valve disease. Tricuspid valve disease is rare compared to other types of valve disease. The most common form of tricuspid valve disease is tricuspid stenosis, which means that the leaflets are stiff and do not open completely. This causes the valve to narrow and restrict blood flow. Another form of valve disease is tricuspid regurgitation. Patients with this condition have valve leaflets that do not close completely, and instead of blood flowing into the ventricles, it leaks backwards past the valve. This condition reduces the heart's pumping ability and makes it difficult for blood to be pumped through the body.

[0011] There are many surgical treatment options for tricuspid valve disease, one of which is to replace the tricuspid valve with an artificial valve. Tricuspid valve replacement surgery may be performed using traditional open-heart surgery or minimally invasive methods, which involve smaller incisions than those used in open-heart surgery, and may include robotic-assisted techniques. Existing replacement valves are divided into two categories: tissue valves and mechanical valves. Tissue or biological valves are made from animal tissue and valves and have soft, thin leaflets. Biological tissue valves eventually need to be replaced as they degenerate over time. Biological valves require the use of blood-thinning medications for a short period of time, about three to six months. These medications can usually be discontinued at that point unless there is another medical reason for continued use, such as an irregular heartbeat. Mechanical valves made from carbon fiber, on the other hand, have solid leaflets. Patients who undergo valve replacement must follow antibiotic prophylaxis for the rest of their lives. Patients who undergo mechanical valves require lifelong treatment with Coumadin. This drug thins the blood and prevents devastating blood clots from forming on the leaflets themselves. Additionally, current replacement valves connect to the heart only at the tricuspid annulus and do not interact or "crosstalk" with the right ventricle. Lack of this interaction with the right ventricle can lead to heart failure in recipients of replacement valves.

[0012] Thus, there is a need for a tricuspid valve prosthesis that avoids the problems of existing replacement valves, as they are unnaturally shaped, contain bulky foreign material, require strong anticoagulation, are not long lasting, and do not aid in efficient heart recovery. Summary of the Invention

[0013] According to some embodiments of the present disclosure, a tricuspid valve prosthesis for implantation in a heart is provided, the tricuspid valve prosthesis comprising two or more leaflets, each leaflet having an annular length and two free edges forming a tip, configured to be joined together at a commissure to form a ring and to be joined to one another, and a connector element connected to the tips of the two or more leaflets. Optionally, the two or more leaflets may be joined to one another edge-to-edge. Optionally, the two or more leaflets may be joined to one another surface-to-surface.

[0014] According to some embodiments, the connector element may be configured to attach to a papillary muscle of the heart. Optionally, the papillary muscle may be an anterior papillary muscle.

[0015] According to some embodiments, the connector element may be configured to attach to the free wall of the right ventricle.

[0016] According to some embodiments, the tricuspid valve prosthesis may further comprise two or more sets of cords, each set of cords attached at a first end to a connector element.

[0017] According to some embodiments, the tricuspid valve prosthesis may further comprise two or more sets of cords, each set of cords attached at a first end to a tip of one of the two or more valve leaflets, and the two or more sets of cords surrounded by a connector element. Optionally, the connector element may surround the first ends of the two or more sets of cords. Optionally, the connector element spans the length of the two or more sets of cords. Optionally, the two or more sets of cords may be configured to be attached at a second end to one or more papillary muscles of the heart.

[0018] According to some embodiments, the ring may be bean-shaped or saddle-shaped.

[0019] According to some embodiments, the free edge may be shaped along a concave arc of a circle.

[0020] According to some embodiments, the two or more leaflets may further comprise a slot dividing the tips of the two or more leaflets, the slot comprising two circular arcs. Optionally, the two circular arcs may be configured to coapt to one another.

[0021] According to some embodiments of the present disclosure, there is further provided a tricuspid valve prosthesis for implantation in a heart, the tricuspid valve prosthesis comprising two or more leaflets, each leaflet having an annular length and two free edges forming a tip, adapted to be joined together at a commissure to form a ring and to be joined to one another, and two or more sets of cords, each set of cords attached at a first end to the two or more leaflets. Optionally, the two or more sets of cords may be sutured together to form a cap, the cap adapted to be attached to a papillary muscle of the heart. Optionally, the papillary muscle is an anterior papillary muscle.

[0022] According to some embodiments, two or more sets of cords may be sewn together to form a cap, which is configured to be attached to the free wall of the right ventricle.

[0023] According to some embodiments, the ring may be bean-shaped or saddle-shaped.

[0024] According to some embodiments, the free edge may be shaped along a concave arc of a circle.

[0025] According to some embodiments, the two or more leaflets may further comprise a slot dividing the tips of the two or more leaflets, the slot comprising two circular arcs. Optionally, the two circular arcs may be configured to coapt to one another.

[0026] According to some embodiments, the tricuspid valve prostheses disclosed herein further comprise a stent frame, wherein two or more leaflets may be positioned within the stent frame, and the ring may be sized to fit around the periphery of the stent frame.

[0027] According to some embodiments, the stent frame may include one or more slots for inserting two or more leaflets into the stent frame.

[0028] According to some embodiments, the stent frame may include multiple holes for suturing two or more leaflets.

[0029] According to some embodiments, the stent frame may comprise a medical grade material, such as stainless steel, silicon, plastic, graphene oxide, or a mixture thereof.

[0030] According to some embodiments, the tricuspid valve prosthesis disclosed herein may further comprise a cuff attached to the stent frame. Optionally, the cuff may be coated with one or more drugs. [Brief description of the drawings]

[0031] In order to better understand the present disclosure and appreciate its practical applications, the following figures are provided and referenced below. It should be noted that the figures are given by way of example only and are not intended to limit the scope of the invention in any way.

[0032] [Figure 1] 1 is a schematic diagram of a tricuspid valve prosthesis according to an embodiment of the present disclosure. [Diagram 2] FIG. 1 is a schematic diagram of a tricuspid valve prosthesis implanted in a heart with cords attached to the papillary muscles, according to an embodiment of the present disclosure. [Figure 3A] 2 is a schematic diagram of a tricuspid valve prosthesis that is an alternative embodiment of the tricuspid valve prosthesis of FIG. 1 with a sewn cord, according to an embodiment of the present disclosure. [Figure 3B] 2 is a schematic diagram of a tricuspid valve prosthesis that is an alternative embodiment of the tricuspid valve prosthesis of FIG. 1, with a cord secured to a connector element, according to an embodiment of the present disclosure. [Figure 3C] 2 is a schematic diagram of a tricuspid valve prosthesis, another alternative embodiment of the tricuspid valve prosthesis of FIG. 1, having a connector element, according to an embodiment of the present disclosure. [Figure 4A] 1 is a schematic diagram of a method of implanting a tricuspid valve prosthesis in a heart, according to an embodiment of the present disclosure. [Figure 4B] 1 is a schematic diagram of a method of implanting a tricuspid valve prosthesis in a heart, according to an embodiment of the present disclosure. [Figure 5A] 1 is a schematic diagram of a side perspective view of the leaflets and ring of a first alternative tricuspid valve prosthesis according to an embodiment of the present disclosure; FIG. [Figure 5B] 1 is a schematic diagram of a bottom view of the leaflets of a first alternative tricuspid valve prosthesis, according to an embodiment of the present disclosure; FIG. [Figure 5C] 1 is a schematic diagram of the leaflets and chords of a first alternative tricuspid valve prosthesis according to an embodiment of the present disclosure; [Figure 5D] 1 is a schematic diagram of a top view of the results of a finite element method (FEM) analysis of the leaflets of a first alternative tricuspid valve prosthesis under an external pressure of 23 mmHg, according to an embodiment of the present disclosure. [Figure 5E]1 is a schematic diagram of a side view of the results of a finite element method (FEM) analysis of the leaflets of a first alternative tricuspid valve prosthesis under maximum principal stress (MPa) in accordance with an embodiment of the present disclosure. FIG. [Figure 6A] FIG. 2 is a schematic diagram of a side perspective view of a second alternative tricuspid valve prosthesis, according to an embodiment of the present disclosure. [Figure 6B] 1 is a schematic diagram of a second alternative tricuspid valve prosthesis in an open state according to an embodiment of the present disclosure. [Figure 6C] 1 is a schematic diagram of a second alternative tricuspid valve prosthesis in a closed state according to an embodiment of the present disclosure. [Figure 6D] FIG. 13 is a schematic diagram of an alternative cord connected to the leaflets of a second alternative tricuspid valve prosthesis, according to an embodiment of the present disclosure. [Figure 7A] 1 is a schematic diagram of the leaflets of a third alternative tricuspid valve prosthesis, according to an embodiment of the present disclosure. [Figure 7B] 1 is a schematic diagram of the leaflets of a third alternative tricuspid valve prosthesis, according to an embodiment of the present disclosure. [Figure 7C] 1 is a schematic diagram of a top view of the results of a finite element method (FEM) analysis of the leaflets of a third alternative tricuspid valve prosthesis under an external pressure of 23 mmHg, according to an embodiment of the present disclosure. [Figure 8A] 1 is a schematic diagram of the leaflets of a fourth alternative tricuspid valve prosthesis, according to an embodiment of the present disclosure. [Figure 8B] 1 is a schematic diagram of a top view of the results of a finite element method (FEM) analysis of the leaflets of a fourth alternative tricuspid valve prosthesis under an external pressure of 23 mmHg, according to an embodiment of the present disclosure. FIG. [Figure 9A] FIG. 1 is a schematic diagram of a side perspective view of a fifth alternative tricuspid valve prosthesis designed for a type I tricuspid valve, according to an embodiment of the present disclosure. [Figure 9B] FIG. 1 is a schematic diagram of a top view of the leaflets of a fifth alternative tricuspid valve prosthesis designed for a type I tricuspid valve, according to an embodiment of the present disclosure. [Figure 9C] FIG. 13 is a schematic diagram of the leaflets and chords of a fifth alternative tricuspid valve prosthesis, according to an embodiment of the present disclosure. [Figure 9D]FIG. 13 is a schematic diagram of a top view of the results of a finite element method (FEM) analysis of the leaflets of a fifth alternative tricuspid valve prosthesis under an external pressure of 23 mmHg, according to an embodiment of the present disclosure. [Figure 10A] FIG. 1 is a schematic diagram of a side perspective view of a sixth alternative tricuspid valve prosthesis designed for a type IIIB tricuspid valve, according to an embodiment of the present disclosure. [Figure 10B] FIG. 1 is a schematic diagram of a top view of the leaflets of a sixth alternative tricuspid valve prosthesis designed for a type IIIB tricuspid valve, according to an embodiment of the present disclosure. [Figure 10C] FIG. 13 is a schematic diagram of the leaflets and chords of a sixth alternative tricuspid valve prosthesis, according to an embodiment of the present disclosure. [Figure 10D] FIG. 13 is a schematic diagram of a top view of the results of a finite element method (FEM) analysis of the leaflets of a sixth alternative tricuspid valve prosthesis under an external pressure of 23 mmHg, according to an embodiment of the present disclosure. [Figure 11A] FIG. 13 is a schematic diagram of a side perspective view of a seventh alternative tricuspid valve prosthesis, according to an embodiment of the present disclosure. [Figure 11B] FIG. 13 is a schematic diagram of a top view of the leaflets of a seventh alternative tricuspid valve prosthesis, according to an embodiment of the present disclosure. [Figure 11C] FIG. 13 is a schematic diagram of the leaflets and chords of a seventh alternative tricuspid valve prosthesis, according to an embodiment of the present disclosure. [Figure 11D] 1 is a schematic diagram of a top view of the results of a finite element method (FEM) analysis of the leaflets of a seventh alternative tricuspid valve prosthesis under an external pressure of 23 mmHg, according to an embodiment of the present disclosure. [Figure 12A] 1 is a schematic diagram of a top view of a stent contained within a tricuspid valve prosthesis, according to some embodiments of the present disclosure. [Figure 12B] FIG. 2 is a schematic diagram of a first side perspective view of a stent included within a tricuspid valve prosthesis, according to some embodiments of the present disclosure. [Figure 12C] FIG. 2 is a schematic diagram of a second side perspective view of a stent included within a tricuspid valve prosthesis, according to some embodiments of the present disclosure. [Figure 12D]FIG. 13 is a schematic diagram of a third side perspective view of a stent included within a tricuspid valve prosthesis, according to some embodiments of the present disclosure. [Figure 13A] FIG. 2 is a schematic diagram of a side perspective view of a stented tricuspid valve prosthesis according to some embodiments of the present disclosure. [Figure 13B] FIG. 2 is a schematic diagram of a top view of a stented tricuspid valve prosthesis, according to some embodiments of the present disclosure. [Figure 13C] 1 is a schematic diagram of an anterior leaflet of a stented tricuspid valve prosthesis, according to some embodiments of the present disclosure. [Figure 13D] 1 is a schematic diagram of a posterior leaflet of a stented tricuspid valve prosthesis, according to some embodiments of the present disclosure. [Figure 13E] 1 is a schematic diagram of a septal leaflet of a stented tricuspid valve prosthesis, according to some embodiments of the present disclosure. [Figure 14A] 1 is an image of a top view of a stented tricuspid valve prosthesis according to some embodiments of the present disclosure. [Figure 14B] 1 is an image of a side perspective view of a stented tricuspid valve prosthesis according to some embodiments of the present disclosure. [Figure 15A] 1 is an image of a top view of a stented tricuspid valve prosthesis during valve closure, according to some embodiments of the present disclosure. [Figure 15B] 1 is an image of a top view of a stented tricuspid valve prosthesis during valve opening, according to some embodiments of the present disclosure.

[0033] Identical or overlapping or equivalent or similar structures, elements, or portions that appear in more than one drawing are generally labeled with the same reference number, optionally with the addition of an additional letter to distinguish between similar entities or variations of an entity, but may not be repeatedly labeled and / or described. Reference to previously presented elements is implied without necessarily further citation to the drawing or description in which they appear. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0034] In the following detailed description, numerous specific details are presented to provide a thorough understanding of the present invention. However, it will be understood by those skilled in the art that the present invention may be practiced without these specific details. In other instances, well-known methods, procedures, components, modules, units, and / or circuits have not been described in detail so as not to obscure the present invention.

[0035] Dimensions of components and features shown in the figures are chosen for convenience or clarity of presentation and are not necessarily shown to scale or in true perspective. For convenience or clarity, some elements or structures are not shown, or are shown only in part and / or in a different view or perspective.

[0036] As used herein, the terms "plurality" and "a plurality" may include, for example, "multiple" or "two or more." The term "plurality" may be used throughout this specification to describe two or more components, devices, elements, units, parameters, etc. Unless expressly stated, the method embodiments described herein are not constrained to a particular order or sequence. Furthermore, some of the described method embodiments or elements thereof may occur or be performed simultaneously, at the same time, or together. Unless otherwise indicated, the use of the term "or" as used herein should be understood to be inclusive (any or all of the listed alternatives).

[0037] Referring now specifically to the drawings in detail, it is emphasized that the particulars shown are by way of example and for the purpose of illustrative discussion of embodiments of the present disclosure, and in this regard, the description taken together with the drawings will make apparent to those skilled in the art how embodiments of the present disclosure may be practiced.

[0038] FIG. 1 is a schematic diagram of a tricuspid valve prosthesis 100 according to an embodiment of the present disclosure. The tricuspid valve prosthesis 100 may have features similar to the natural human tricuspid valve. The tricuspid valve prosthesis 100 is intended to closely mirror the function of the natural tricuspid valve, which moves with the natural distortions of the heart muscle. The tricuspid valve prosthesis 100 includes two or more flexible membranous leaflets 104 connected together to form an orifice, annulus, or ring 108 for attaching to the tricuspid annulus in the heart and allowing blood to flow in one direction. The ring 108 mimics the natural tricuspid annulus and may be a flat bean-shaped ring, a flat circular ring, or a saddle-shaped ring. In some embodiments, the ring 108 may be flexible or rigid. In some embodiments, the ring 108 may be formed with an annular length (not shown) of the leaflets 104. In some embodiments, the ring 108 may be formed, for example, from an elastic annuloplasty ring. In some embodiments, the ring 108 may be formed by folding or rolling the leaflets 104 on themselves toward the outside of the tricuspid valve prosthesis 100. In some embodiments, the ring 108 may be further strengthened by adding strips of suitable material, such as biomedical fibers, polymers, or bovine pericardium. Rolling or folding the leaflets 104 on themselves toward the outside of the tricuspid valve prosthesis 100 may advantageously help to avoid blood clot formation inside the tricuspid valve prosthesis 100, and if blood clots are formed, they will only appear on the outside of the tricuspid valve prosthesis 100 in the folded or rolled areas of the ring 108 or ring portion. This reduces the risk of damage to the efficient operation of the tricuspid valve prosthesis 100. In some embodiments, the rolling or folding of the leaflets 104 to form the ring 108 does not include sutures. In some embodiments, the flexible ring 108 is a "stentless ring."

[0039] In some embodiments of the present disclosure, the leaflets 104 mimic the function of the native tricuspid valve leaflets. In some embodiments, each leaflet 104 may mimic the function of one or more native tricuspid valve leaflets. In some embodiments, two or more leaflets 104 may mimic the function of one native tricuspid valve leaflet. In some embodiments, there may be a first leaflet that mimics the function of the patient's native posterior leaflet, a second leaflet that mimics the function of the patient's native septal leaflet, and a third leaflet that mimics the function of the patient's native anterior leaflet (see FIGS. 5A-5E, 6A-6D, 7A-7C, 9A-9D, 10A-10D, and 11A-11D). In some embodiments, there may be a first leaflet and a second leaflet that mimics the function of the patient's native posterior leaflet, a third leaflet and a fourth leaflet that mimics the function of the patient's native septal leaflet, and a fifth leaflet and a sixth leaflet that mimics the function of the patient's native anterior leaflet (not shown). In some embodiments, there may be a first leaflet that mimics the function of the patient's native septal leaflet and a second leaflet that mimics the function of the patient's native posterior and anterior leaflets (see FIGS. 8A-8B). The number, size, shape, and orientation of the leaflets 104 may be customized and adjusted based on the size, shape, and morphology type of the patient's native tricuspid valve and annulus, as well as the location of the patient's native papillary muscles. In some embodiments, the leaflets 104 may be customized and designed based on images of the patient's native tricuspid valve. The images may be acquired through an echocardiography study (or other imaging study). From the imaging study, heart chamber size and motion are measured. Detailed dimensions of the patient's tricuspid annulus, leaflets, and chord are also measured from the acquired images. Three-dimensional echocardiography may be performed, for example, using a transesophageal echocardiography (TEE) probe or a transthoracic echocardiography (TTE) probe. The segments of the tricuspid valve can be modeled and measured in three and four dimensions using software such as eSieValves™ (Siemens Medical Solutions USA, Inc., Malvern, PA). Relevant measurements can include the outer and inner diameters of the annulus, the annular area, the interstriate and intercommissural distances, the lengths along various axes of the anterior, septal, and posterior leaflets, and the positions of the papillary muscles.Additionally or alternatively, three-dimensional studies of the tricuspid valve can be performed using computed tomography (CT) or magnetic resonance imaging (MRI). Segmentation of the tricuspid valve region can be performed using image analysis software and relevant measurements can be obtained. After designing the leaflets 104, the dimensions of the leaflets 104 can be optimized using finite element method (FEM) analysis to examine how the leaflets 104 may coapt, deform, and function under external pressure within the heart.

[0040] In some embodiments of the present disclosure, the leaflets 104 may be formed from natural materials or biocompatible composite materials that can resist clotting. In some embodiments, adjacent leaflets 104 may be connected to each other at both ends of the annular length (not shown) to form commissures 112. In some embodiments, the leaflets 104 may be made from separate pieces of material, and adjacent pairs of leaflets 104 may be sutured together at the commissures 112. In other embodiments, the leaflets 104 may be constructed from a single piece of material. In some embodiments, the commissures 112 may be labeled by laser or any other suitable method to aid in orientation of the tricuspid valve prosthesis 100 during implantation.

[0041] In some embodiments of the present disclosure, the leaflets 104 may be generally shaped as a three-sided shape including an annular length at the apex (not shown) and two free edges 116 forming a tip 122. In some embodiments, the free edges 116 may taper toward each other to form the tip 122. The free edges 116 may be shaped in the form of a concave arc. In some embodiments, in the closed state, the free edges 116 of the leaflets 104 may coapt edge to edge, whereby the leaflets free edges 116 may coapt or match with adjacent free edges 116 located in the same leaflet or adjacent leaflets 104 forming coaptation edges (not shown) to seal and close the tricuspid valve prosthesis 100 (see FIGS. 5D, 5E, 7C, 8B, 9D, 10D, and 11D). This differs from the patient's native tricuspid valve, where the leaflets open and close by contacting each other or by coapting surfaces. In some embodiments, in the closed state, coaptation between the leaflets 104 may be increased such that the leaflets 104 may coapt surface-to-surface with adjacent leaflets 104 in addition to the free edges 116 (see FIG. 6C). In the open state, the free edges 116 of the leaflets 104 do not contact one another. In some embodiments, the tricuspid valve prosthesis 100 may be biased in a closed position. In other embodiments, the tricuspid valve prosthesis 100 may be biased in an open position.

[0042] In some embodiments of the present disclosure, the tricuspid valve prosthesis 100 may further comprise cords 120 that mimic the natural chordae tendineae of the heart. Each cord 120 may comprise a first end 121 and a second end 123. Each cord 120 may be connected at the first end 121 to the tip 122 or the body of the leaflet 104. In other embodiments, the tip 122 of the leaflet 104 is connected to a connector element (such as the connector element 132 of FIG. 3B). In this embodiment, the connector element 132 may be connected to the tips 122 of all the leaflets 104. In some embodiments, the connector element 132 is connected at its distal end to the first end 121 of the cord 120. In some embodiments, there may be more than one cord 120 connected to each leaflet 104. In some embodiments, the first end 121 of the cord 120 may be split into branches, with each branch connected to a leaflet 104 (see FIG. 6D). Each cord 120 may be formed from the same piece of material as the leaflets 104, or may be formed from a separate piece of material and then attached to the leaflets 104. In some embodiments, the cords 120 may be connected at the second end 123 to one or more papillary muscles of the right ventricle (see FIGS. 2 and 4A) or to the free wall of the right ventricle (see FIG. 4B). The cords 120 may be connected to the same papillary muscles or to different papillary muscles. In some embodiments, if there are three leaflets 104, each with one cord 120, each of the cords 120 may be connected to one of the three papillary muscles of the right ventricle (see FIG. 2). In other embodiments, the cords 120 may all be connected to one papillary muscle of the right ventricle, preferably the anterior papillary muscle, which is the strongest papillary muscle of the right ventricle. In other embodiments, the second end 123 of the cords 120 may be connected to the free wall of the right ventricle (see FIG. 4B). The cords 120 connecting the leaflets 104 to the papillary muscles of the heart or the free wall of the right ventricle allow the tricuspid valve prosthesis 100 to interact or "crosstalk" with the ventricle, thus reducing the risk of heart failure after implantation.

[0043] In some embodiments of the present disclosure, any or all components of the tricuspid valve prosthesis 100, including the ring 108, leaflets 104, cord 120, and connector element 132 (see FIGS. 3B and 3C), may be produced from natural materials to avoid the introduction of foreign bodies such as pledgets. Allograft materials and / or composite materials, including various combinations of allograft, xenograft, and / or autograft materials, may be used to manufacture the ring 108, leaflets 104, cord 120, and connector element 132 (see FIGS. 3B and 3C). Materials used to form any component of the tricuspid valve prosthesis 100 may include, but are not limited to, human, bovine, or porcine pericardium, decellularized bioprosthetic materials, polymers including natural and synthetic polymers, woven biodegradable polymers incorporated with cells, and extracellular materials. Biodegradable natural polymers may include, but are not limited to, fibrin, collagen, chitosan, gelatin, hyaluronan, and similar materials. Biodegradable synthetic polymer scaffolds that can be infiltrated with cells and extracellular matrix materials can include, but are not limited to, poly(L-lactide), polyglycolide, poly(lactic-co-glycolic acid), poly(caprolactone), polyorthoesters, poly(dioxanone), poly(anhydrides), poly(trimethylene carbonate), polyphosphazenes, and similar materials. The flexible ring 108 may be further customized to provide individualized flexibility or stiffness to the patient. In addition, any component of the tricuspid valve prosthesis 100 may be fabricated intraoperatively with the patient's own pericardium. In some embodiments, the tricuspid valve prosthesis 100 may be fabricated from the patient's own pericardium. Alternatively, the tricuspid valve prosthesis 100 may be fabricated from a xenogeneic material (e.g., animal tissue such as an existing valve) to which a layer of the patient's own cultured cells is applied by tissue engineering. In other embodiments, any or all of the components of the tricuspid valve prosthesis 100, including the ring 108, the leaflets 104, the cord 120, and the connector element 132 (see Figures 3B and 3C), may be made from synthetic or non-biodegradable materials, such as plastic, silicone, or stainless steel.

[0044] Artificial valves are often fixed with glutaraldehyde, a known toxin that promotes regeneration. The tricuspid valve prosthesis of the present invention may be fixed by non-glutaraldehyde-based methods, such as dye-mediated photofixation. The tricuspid valve prosthesis of the present disclosure may also be fixed by using alternative crosslinking agents, such as epoxy compounds, carbodiimides, diglycidyl, reuterin, genipin, diphenylphosphoryl azide, acyl azide, and cyanamide, or by physical methods, such as ultraviolet light and dehydration.

[0045] In some embodiments of the present disclosure, the tricuspid valve prosthesis 100, or some components of the tricuspid valve prosthesis 100, may be directly manufactured using biological materials and with biological three-dimensional (3D) printing. In other embodiments, the tricuspid valve prosthesis 100, or some components of the tricuspid valve prosthesis 100, may be manufactured using a template or mold constructed by three-dimensional printing based on detailed dimensions obtained from preoperative three-dimensional imaging.

[0046] FIG. 2 is a schematic diagram of a tricuspid valve prosthesis 100 implanted in a heart 200 with a cord 120 attached to a papillary muscle 124, according to an embodiment of the present disclosure. The tricuspid valve prosthesis 100 is shown implanted in the position of the native tricuspid valve annulus 204 located between the right atrium 208 and the right ventricle 212. The cord 120 of the tricuspid valve prosthesis 100 is shown connected to the papillary muscle 124. The cord 120, which connects the leaflets 104 (not shown) to the patient's papillary muscle 124, advantageously provides support to the right ventricular wall throughout the cardiac cycle and prevents the leaflets 104 from opening into the right atrium 208. In some embodiments, the cord 120 may be between 5-15 mm in length and between 1-5 mm in width. In some embodiments, the length and width of the cord 120 are adjustable and may be determined based on pre-operative echo and CT scans performed on the patient receiving the tricuspid valve prosthesis 100. In some embodiments, the length of the cord 120 may be determined by measuring the distance from the native tricuspid annulus 204 to the tip of the papillary muscle 124.

[0047] In some embodiments of the present disclosure, the ring 108 may be custom made after an ultrasound examination of the patient's heart. In particular, a three-dimensional echocardiogram may be performed to obtain detailed anatomical measurements and / or to render a three-dimensional model of the patient's heart from which a customized tricuspid valve prosthesis can be manufactured. The leaflets 104 and cord 120 may also be customized based on ultrasound imaging of the subject's native tricuspid valve and surrounding anatomical structures. In some embodiments, a customized tricuspid valve prosthesis may also be produced from data obtained by other imaging modalities that provide three-dimensional information, including cardiac CT and cardiac MRI. Thus, the tricuspid valve prosthesis of the present disclosure may be selected, customized, or designed to match a patient's particular anatomy.

[0048] In some embodiments of the present disclosure, the native commissure locations may be marked with double-armed sutures prior to removal or explantation of the native tricuspid valve. After the native tricuspid valve is removed, the sutures marking the native commissure locations may be passed through corresponding points on the ring 108 of the tricuspid valve prosthesis 100 to guide the tricuspid valve prosthesis 100 into the heart 200 such that the corresponding points on the ring 108 will land on the double-armed sutures marking the native commissure locations. In some embodiments, the corresponding points on the tricuspid valve prosthesis 100 may be the commissures 112. Once the ring 108 is positioned within the native tricuspid valve annulus 204, the commissure sutures may be secured by ties. The cords 120 may then be secured on their corresponding papillary muscles. In some embodiments, the cords 120 may be attached to their corresponding papillary muscles prior to orienting the ring 108 of the tricuspid valve prosthesis 100.

[0049] FIG. 3A is a schematic diagram of a tricuspid valve prosthesis 100-1, an alternative embodiment of the tricuspid valve prosthesis 100 of FIG. 1, with the cords 120 sewn together, according to an embodiment of the present disclosure. The embodiment of FIG. 3A is similar to the embodiment of FIG. 1, with like numbered terms configured similarly, except that the cords 120-1 are sewn together lengthwise to form a cap 128. The cap 128 may then be sutured and secured to the patient's papillary muscles 124, preferably the anterior papillary muscles (see FIG. 4A). In other embodiments, the cap 128 may be secured to the free wall 440 of the right ventricle 212 (see FIG. 4B). The cap 128 ensures a single vector of pull as the heart contracts. The cap 128 also advantageously strengthens the connection between the leaflets 104-1 and the papillary muscles 124 or free wall 440 of the right ventricle 212 because the cap 128 guides the cords 120-1 together to prevent them from tearing as the papillary muscles 124 or free wall 440 of the right ventricle 212 pull on them during cardiac contraction. The cap 128 also ensures uniformity during coaptation of the free edges 116-1 of the tricuspid valve prosthesis 100-1 so that the coaptation is not compromised during cardiac contraction.

[0050] In other embodiments, the cord 120-1 may be sewn lengthwise over the portion of the cord 120-1 connected to the valve leaflet 104-1 at a first end, whereby the cord 120-1 may be free from each other at a second end and attached to a separate papillary muscle (not shown). The suturing ensures that even though the cord 120-1 may be connected to different papillary muscles, there is a single pulling vector when the heart 200 contracts. In some embodiments, the cord 120-1 may be between 2-10 mm in length and may be sewn lengthwise over a length of 2-10 mm. In some embodiments, the length and width of the cord 120-1, as well as the length to which the cord 120-1 is sewn, may be adjustable and may be determined by pre-operative echo and CT scans performed on the patient receiving the tricuspid valve prosthesis 100-1.

[0051] 3B is a schematic diagram of a tricuspid valve prosthesis 100-2, an alternative embodiment of the tricuspid valve prosthesis 100 of FIG. 1, in which the cord 120-2 is secured to a connector element 132, according to an embodiment of the present disclosure. The embodiment of FIG. 3B is similar to the embodiment of FIG. 1, with like numbered terms configured similarly, but differs in that the cord 120-2 is secured to the connector element 132 at a first end of the cord 120-2 joined to the leaflet 104-2, and the connector element 132 spans a portion of the length of the cord 120-2. In some embodiments, the connector element 132 may be a piece of material that surrounds or is wrapped around the cord 120-2 and sutured to the cord 120-2. The connector element 132 may be shorter than the cord 120-2, such that the second ends of the cord 120-2 are free from each other and may be connected to different papillary muscles 124. In some embodiments, the cord 120-2 may be 2-10 mm in length and the connector element 132 may surround the cord 120-2 over a length of 1-5 mm. In some embodiments, the length of the cord 120-2 and the length of the cord 120-2 surrounded by the connector element 132 may be adjustable and may be determined by pre-operative echo and CT scans performed on the patient receiving the tricuspid valve prosthesis 100-2. In some embodiments, the connector element 132 may be connected at one end to the tip 122-2 of the leaflet 104-2 and at a distal end to a first end of the cord 120-2. In some embodiments, the connector element 132 is connected to the leaflet 104-2 in a manner that allows for sufficient coaptation when the edges of the leaflets 104-2 are in contact with each other. In some embodiments, the connector element 132 may be sutured to the tip 122-2 of the leaflet 104-2. In some embodiments, the connector element 132 is molded as a hollow tube (not shown). In other embodiments, connector element 132 is shaped as a solid tube having an oval or circular cross-section that allows tips 122-2 and chords 120-2 of leaflets 104-2 to be connected thereto while minimizing disruption to blood flow through tricuspid valve prosthesis 100-2. In some embodiments, connector element 132 has a length between 1-5 mm.The connector elements 132 ensure that a single pull vector exists as the heart contracts, even though the cords 120-2 may be connected to different papillary muscles 124. The connector elements 132 may advantageously ensure uniformity during coaptation, such that coaptation of the free edges 116-2 of the tricuspid valve prosthesis 100-2 is not compromised by different locations on or distances to the papillary muscles 124.

[0052] 3C is a schematic diagram of a tricuspid valve prosthesis 100-3, another alternative embodiment of the tricuspid valve prosthesis 100 of FIG. 1, having a connector element 132-3, according to an embodiment of the present disclosure. The embodiment of FIG. 3C is similar to the embodiment of FIG. 1, with like numbered terms configured in the same way, except that the cord (not shown) is secured with the connector element 132-3 that spans the entire length of the cord (not shown). The cord (not shown) secured with the connector element 132-3 may then be sutured and secured to the patient's papillary muscles, preferably the anterior papillary muscles, or the wall of the ventricle of the heart. The connector element 132-3 strengthens the connection between the leaflets 104-3 and the papillary muscles or free wall of the right ventricle, because the connector element 132-3 guides the cord 20-3 together to prevent the cord 120-3 from tearing when the anterior papillary muscles pull on the cord 120-3 during heart contraction.

[0053] In other embodiments, the connector element 132-3 may be connected at one end to the tip 122-3 of the leaflet 104-3 and at the other end to the patient's papillary muscle 124, preferably the anterior papillary muscle, or the wall of the ventricle of the heart. In some embodiments, the connector element 132-3 is sutured to the tip 122-3 of the leaflet 104-3. In some embodiments, the connector element 132-3 is shaped as a hollow tube (not shown). In other embodiments, the connector element 132-3 is shaped as a solid tube with an oval or circular cross section that allows the tip of the leaflet 104-3 to be connected to the papillary muscle or the free wall of the right ventricle with minimal obstruction to blood flow through the tricuspid valve prosthesis 100-3. The connector element 132-3 ensures that there is a single vector of pull when the heart contracts. The connector element 132-3 may advantageously ensure uniformity during coaptation such that the coaptation of the free edge 116-3 of the tricuspid valve prosthesis 100-3 is not compromised during cardiac contraction.

[0054] 4A and 4B are schematic diagrams of a method of implanting a tricuspid valve prosthesis 100-3 in a heart 200 according to an embodiment of the present disclosure. In some embodiments, the cords 120-3 secured together with the connector element 132-3 as the cap 128 in the tricuspid valve prosthesis 100-3 may all be connected to the same papillary muscle 124 in the right ventricle (see FIG. 4A). In some embodiments, the cords 120-3 secured together with the connector element 132-3 may be connected to the anterior papillary muscle since it is the strongest papillary muscle. In some embodiments, the cords 120-3 secured together with the connector element 132-3 in the tricuspid valve prosthesis 100-3 may be connected to the free wall 440 of the right ventricle 212 (see FIG. 4B). In some embodiments, the cord 120-3 secured together with the connector element 132-3 in the tricuspid valve prosthesis 100-3 may be connected to the free wall 440 of the right ventricle 212 by passing the cord 120-3 secured together with the connector element 132-3 through an incision (not shown) in the free wall 440 of the right ventricle 212 and suturing the cord 120-3 secured together with the connector element 132-3 to the inner surface 444 of the free wall 440 of the right ventricle 212 and to the outer surface 448 of the free wall 440 of the right ventricle 212. In some embodiments, an apical pad (not shown) may be placed on the outer surface 448 of the free wall 440 of the right ventricle 212, covering the incision in the free wall 440 of the right ventricle 212. The method of implanting the tricuspid valve prosthesis 100-3 into the heart 200 illustrated in Figures 4A and 4B may similarly be employed to implant the tricuspid valve prosthesis 100-1 into the heart 200 with the cord 120-1 sutured together into the cap 128, or to implant the tricuspid valve prosthesis 100-3 with the connector element 132-3 directly joined to the tip 122-3 of the leaflet 104-3. Joining the connector element 132 or the cap 128 together with the secured cord 120, or joining the connector element 132-3 directly to the papillary muscle 124 or the free wall 440 of the right ventricle 212, provides support to the right ventricular wall throughout the cardiac cycle and prevents the leaflet 104 from opening into the right atrium 208. It also allows the tricuspid valve prosthesis 100 to interact or "crosstalk" with the ventricle, thus advantageously reducing the risk of heart failure after implantation.

[0055] FIG. 5A is a schematic diagram of a side perspective view of leaflets 504 and ring 508 of a first alternative tricuspid valve prosthesis 500, and FIG. 5B is a schematic diagram of a bottom view of leaflets 504 of the first alternative tricuspid valve prosthesis 500, according to an embodiment of the present disclosure. The first alternative tricuspid valve prosthesis 500 may be designed for a patient having a circular annulus and papillary muscles located near the center of the circular annulus. Similar to the tricuspid valve prosthesis 100, the first alternative tricuspid valve prosthesis 500 has a ring 508. The ring 508 is circular to fit the circular annulus of the patient. The ring 508 may have a diameter between 20-35 mm to fit within the patient's native tricuspid valve. The ring 408 may have a diameter corresponding to the patient's native tricuspid annulus obtained through imaging of the patient's heart. Similar to tricuspid valve prosthesis 100, the first alternative tricuspid valve prosthesis 500 has leaflets 504 suspended from a ring 508, with the leaflets 504 interconnected at commissures 512. The first alternative tricuspid valve prosthesis 500 may have three leaflets, a first leaflet 504a, a second leaflet 504b, and a third leaflet 504c. The first leaflet 504a may mimic the septal leaflet of the native tricuspid valve, the second leaflet 504b may mimic the posterior leaflet of the native tricuspid valve, and the third leaflet 504c may mimic the anterior leaflet of the native tricuspid valve. The first leaflet 504a may be connected to the second leaflet 504b at a first commissure 512a, the second leaflet 504b may be connected to the third leaflet 504c at a second commissure 512b, and the third leaflet 504c may be connected to the first leaflet 504a at a third commissure 512c. In some embodiments, the first leaflet 504a, the second leaflet 504b, and the third leaflet 504c may be identical and all three leaflets 504 may have the same annular length 532. In other embodiments, the first leaflet 504a, the second leaflet 504b, and the third leaflet 504c may be different and the three leaflets 504 have different annular lengths 532 (see FIG. 5C). In some embodiments, the ring 508 is circular, the first leaflet 504a, the second leaflet 504b, and the third leaflet 504c are identical, and the first alternative tricuspid valve prosthesis 500 is symmetrical, such that the first alternative tricuspid valve prosthesis 500 may be oriented in any manner during implantation.

[0056] 5C is a schematic diagram of leaflets 504 and cords 520 of a first alternative tricuspid valve prosthesis 500 according to an embodiment of the present disclosure. A tip 522 of each leaflet 504 may be connected to a first end 521 of a cord 520. Preferably, all three cords 520 are joined to a single papillary muscle, preferably the anterior papillary muscle. In some embodiments, second ends 523 of all three cords 520 may be secured together through any of the methods previously described, including suturing the cords 520 together to form a cap 128 or wrapping a connector element 132-3 around the cords 520, and then secured to a single papillary muscle 124 (see FIG. 4A) or to the free wall 440 of the right ventricle 212 (see FIG. 4B). In other embodiments, the cord 520 may be sutured together or surrounded by a connector element 132 at a first end 521 that is connected to the valve leaflet 504 and connected to a separate papillary muscle 124 at a second end 523.

[0057] In some embodiments of the present disclosure, the leaflets 504 may have an annular length 532 formed along a 120° convex arc of a circle with a radius of 20-40 mm. In some embodiments, the annular length 532 may be 26.2 mm for a valve of size 25 mm, 28.3 mm for a valve of size 27 mm, 30.4 mm for a valve of size 29 mm, 32.4 mm for a valve of size 31 mm, and 34.5 mm for a valve of size 33 mm. The commissures 512 may have a length between 3-10 mm. In some embodiments, the free edge 516 may be formed along a 20°-30° concave arc of a circle with a radius of between 30-60 mm. In some embodiments, the chord 520 may have a length between 5-15 mm and a width between 2-8 mm. In some embodiments, the dimensions of the leaflets 504 may be determined based on the size of the patient's native tricuspid valve and the vertical distance between the papillary muscle and the annulus (PM height). In some embodiments, a first alternative tricuspid valve prosthesis 500 for a size 36 mm circular tricuspid valve with a PM height of 30 mm or greater may have three identical leaflets 504 with an annular length 532 formed along a 59.07° arc of a circle with a radius of 36.51 mm, commissures 512 with a length of 10 mm, free ends 516 formed along a 28° arc of a circle with a radius of 50 mm, and a chord 520 with a length of 8.62 mm and a width of 1.46 mm. In some embodiments, leaflets 504a, 504b, and 504c may be sized such that tip 522a of leaflet 504a, tip 522b of leaflet 504b, and tip 522c of leaflet 504c converge to a point corresponding to the center of ring 508 (see FIG. 5B). The various dimensions of the leaflets 504 may be optimized and determined using finite element method (FEM) analysis to visualize the opening and closing of the first alternative tricuspid valve prosthesis 500 under pressure.

[0058] FIG. 5D is a schematic diagram of a top view of the results of a finite element method (FEM) analysis of the leaflets 504 of the first alternative tricuspid valve prosthesis 500 under an external pressure of 23 mmHg, and FIG. 5E is a schematic diagram of a side view of the results of a finite element method (FEM) analysis of the leaflets 504 of the first alternative tricuspid valve prosthesis 500 under maximum principal stress (MPa), according to an embodiment of the present disclosure. The FEM analysis was performed on the leaflets 504 of the first alternative tricuspid valve prosthesis 500 to visualize the opening and closing of the tricuspid valve prosthesis 500 under pressure and to identify areas of stress. Preferably, the tricuspid valve prosthesis 500 closes at an external pressure of 10-30 mmHg, which is in the range of normal pulmonary artery pressure. The darker an area on the model, the higher the stress the area is experiencing. The material used for the FEM analysis may be bovine pericardium with a thickness of 0.28 mm and a Young's modulus of 30 MPa, although other materials with other properties may be used. In some embodiments, a thin young bovine pericardium with a low Young's modulus may be used. As shown in Figures 5D and 5E, the free edges 516 come together under pressure to form a coaptation edge 536, sealing the tricuspid valve prosthesis 500.

[0059] FIG 6A is a schematic diagram of a side perspective view of a second alternative tricuspid valve prosthesis 600 according to an embodiment of the present disclosure. FIG 6B is a schematic diagram of the second alternative tricuspid valve prosthesis 600 in an open state and FIG 6C is a schematic diagram of the second alternative tricuspid valve prosthesis 600 in a closed state according to an embodiment of the present disclosure. The second alternative tricuspid valve prosthesis 600 is similar to the first alternative tricuspid valve prosthesis 500 in that it has a circular annulus and includes three leaflets, namely, a first leaflet 604a, a second leaflet 604b, and a third leaflet 604c. In some embodiments, the first leaflet 604a may mimic the septal leaflet of the native tricuspid valve, the second leaflet 604b may mimic the posterior leaflet of the native tricuspid valve, and the third leaflet 604c may mimic the anterior leaflet of the native tricuspid valve. The first leaflet 604a may be connected to the second leaflet 604b at a first commissure 612a, the second leaflet 604b may be connected to the third leaflet 604c at a second commissure 612b, and the third leaflet 604c may be connected to the first leaflet 604a at a third commissure 612c. The first leaflet 604a, the second leaflet 604b, and the third leaflet 604c may be identical and all three leaflets 604 may have the same annular length 632. The annular lengths 632 of the second alternative tricuspid valve prosthesis 600 may be sewn together along the commissures 612 to form a ring 608 that is sewn onto the annulus 602 (see FIG. 6B). In some embodiments, the annular length 632 may be 26.2 mm for a 25 mm size valve, 28.3 mm for a 27 mm size valve, 30.4 mm for a 29 mm size valve, 32.4 mm for a 31 mm size valve, and 34.5 mm for a 33 mm size valve. In other embodiments, the first leaflet 604a, the second leaflet 604b, and the third leaflet 604c may be different and all three leaflets 604 may have different annular lengths 632.

[0060] In some embodiments, unlike the first alternative tricuspid valve 500, the second alternative tricuspid valve prosthesis 600 may be designed for surface-to-surface coaptation of the leaflets 604 (see FIG. 6C). In some embodiments, in the open state (see FIG. 6B), the only points of contact between the leaflets 604a, 604b, and 604c are coaptation points 612a, 612b, and 612c, and the free edges 616 of the leaflets 604a, 604b, and 604c do not contact one another. In some embodiments, in the closed state, the leaflets 604 coapt at surfaces proximate the free edges 616, forming coaptation surfaces 614 between the leaflets 604. The first leaflet 604a may interface with the second leaflet 604b to form a coaptation surface 614a, the second leaflet 604b may interface with the third leaflet 604c to form a coaptation surface 614b, and the third leaflet 604c may interface with the first leaflet 604a to form a coaptation surface 614c. Such an embodiment has a higher coaptation surface 614 or area than the edge-to-edge coaptation in the first alternative tricuspid valve 500. The area of ​​the coaptation surface 614 may be adjusted by altering the curvature of the free edge 616.

[0061] In some embodiments, the tip 622 of each leaflet 604 may be connected to a first end 621 of a cord 620. Preferably, all three cords 620 are joined to a single papillary muscle 124, preferably the anterior papillary muscle. In some embodiments, the second ends 623 of all three cords 620 may be secured together through any of the methods previously described, including by suturing the cords 620 together to form a cap 128 or by wrapping a connector element 132-3 around the cords 620, and then secured to a single papillary muscle 124 (see FIG. 4A) or to the free wall 440 of the right ventricle 212 (see FIG. 4B). In other embodiments, the cords 620 may be sewn together or surrounded by a connector element 132 at a first end 621 that is connected to the leaflets 604 and connected to a separate papillary muscle 124 at a second end 523.

[0062] 6D is a schematic diagram of an alternative cord 620-1 connected to a leaflet 604 of a second alternative tricuspid valve prosthesis 600, according to an embodiment of the present disclosure. Similar to cord 620, cord 620-1 may include a first end 621-1 and a second end 623-1. In some embodiments, first end 621-1 of cord 620-1 may split into two or more branches 625, each branch 625 may be connected to a leaflet 604. In some embodiments, by splitting cord 620-1 when connecting to leaflet 604, this may advantageously distribute pressure effects to different walls of the heart's ventricle, aiding in the long-term durability of second alternative tricuspid valve prosthesis 600 and preventing heart failure.

[0063] 7A is a schematic diagram of the leaflets of a third alternative tricuspid valve prosthesis 700 according to an embodiment of the present disclosure. The third alternative tricuspid valve prosthesis 700 may be designed for a patient with a circular annulus and a papillary muscle 124 located near the center of the circular annulus. The third alternative tricuspid valve prosthesis 700 is similar to the first alternative tricuspid valve prosthesis 500 in that it has a circular annulus and includes three leaflets, namely, a first leaflet 704a, a second leaflet 704b, and a third leaflet 704c. In some embodiments, the first leaflet 704a may mimic the septal leaflet of the native tricuspid valve, the second leaflet 704b may mimic the posterior leaflet of the native tricuspid valve, and the third leaflet 704c may mimic the anterior leaflet of the native tricuspid valve. In some embodiments, the first leaflet 704a may be connected to the second leaflet 704b at a first commissure 712a, the second leaflet 704b may be connected to the third leaflet 704c at a second commissure 712b, and the third leaflet 704c may be connected to the first leaflet 704a at a third commissure 712c. The first leaflet 704a, the second leaflet 704b, and the third leaflet 704c may be identical and all three leaflets 704 may have the same annular length 732. In some embodiments, the annular length 732 may be 26.2 mm for a valve of size 25 mm, 28.3 mm for a valve of size 27 mm, 30.4 mm for a valve of size 29 mm, 32.4 mm for a valve of size 31 mm, and 34.5 mm for a valve of size 33 mm. In other embodiments, the first leaflet 704a, the second leaflet 704b, and the third leaflet 704c may be different, and all three leaflets 704 may have different annular lengths 732.

[0064] In some embodiments of the present disclosure, the leaflets 704 of the third alternative tricuspid valve prosthesis 700 may each include two free edges 716 shaped in the form of a concave arc, i.e., a first free edge 716a and a second free edge 716b. The first free edge 716a and the second free edge 716b may have the same dimensions or may have different dimensions. In some embodiments, the first free edge 716a and the second free edge 716b may have the same dimensions and may be shaped along a 120° concave arc of a circle with a radius between 20-35 mm. In some embodiments, the first free edge 716a and the second free edge 716b may be located on either side of the leaflet 704.

[0065] 7B is a schematic diagram of a leaflet 704 of a third alternative tricuspid valve prosthesis 700 according to an embodiment of the present disclosure. Unlike the first alternative tricuspid valve 500, each leaflet 704 of the third alternative tricuspid valve prosthesis 700 is adapted to connect to two cords (not shown). The leaflets 704 may be connected to the two cords by introducing a slot 740 into the leaflet 704 that divides the tip 722 of the leaflet 704 into two separate tips 722a and 722b. The slot 740 is shaped in the general shape of a biconvex lens bounded by two arcs 744a and 744b with an open apex that divides the tip 722 of the leaflet 704. The slot 740 may be adapted such that the arcs 744a and 744b of the slot 740 come together under pressure to form a coaptation edge 736b (see FIG. 7C). In some embodiments, the arcs 744a and 744b of the slots 740 may be shaped along a 20° to 30° arc of a circle having a radius of 30 to 60 mm. As with the first alternative tricuspid valve prosthesis 500, the tips 722a and 722b may each be connected to a first end of a cord (not shown), the second end of which is connected to a papillary muscle in a manner similar to that described in connection with the first alternative tricuspid valve prosthesis 500. The various dimensions of the leaflets 704 may be optimized and determined using finite element method (FEM) analysis to visualize the opening and closing of the tricuspid valve prosthesis under pressure. The third alternative tricuspid valve prosthesis 700 has a larger effective orifice area (EOA) or valve opening area than the first alternative tricuspid valve prosthesis 500 due to the addition of the slots 740 into the leaflets 704, which may advantageously lead to increased hydrodynamic performance. EOA is an important indicator of valve function; the greater the EOA, the lower the pressure gradient across the valve. Lower or reduced pressure gradients may reduce valve wear and tear, increase valve durability, and improve cardiac recovery. Patients may suffer less heart failure and experience better performance.

[0066] FIG. 7C is a schematic diagram of a top view of the results of a finite element method (FEM) analysis of the leaflets 704 of the third alternative tricuspid valve prosthesis 700 under an external pressure of 23 mmHg, according to an embodiment of the present disclosure. The FEM analysis was performed on the leaflets 704 of the third alternative tricuspid valve prosthesis 700 to visualize the opening and closing of the third alternative tricuspid valve prosthesis 700 under pressure and to identify areas of stress. The darker an area on the model, the higher the stress the area is under. The material used for the FEM analysis may be bovine pericardium with a thickness of 0.28 mm and a Young's modulus of 30 MPa, although other materials with other properties may be used. As illustrated in FIG. 7C, the free edges 716 come together under external pressure to form a coming together edge 736a, and the arcs 744a and 744b come together under external pressure to stiffen the coming together edge 736b and seal the third alternative tricuspid valve prosthesis 700.

[0067] 8A is a schematic diagram of the leaflets of a fourth alternative tricuspid valve prosthesis 800 according to an embodiment of the present disclosure. The fourth alternative tricuspid valve prosthesis 800 may be designed for patients with papillary muscles located closer to the tricuspid annular edge than the center of the annulus. The fourth alternative tricuspid valve prosthesis 800 has a bean-shaped annular ring that is a closed elongated curved shape with a concave arcuate recess in a first longitudinal length. The fourth alternative tricuspid valve prosthesis 800 may include two leaflets 804 to achieve good valve closure. The fourth alternative tricuspid valve prosthesis 800 may include a first leaflet 804a and a second leaflet 804b. In some embodiments, the first leaflet 804 may mimic the function of the septal leaflet of the native tricuspid valve, and the second leaflet 804b may mimic the function of the posterior and anterior leaflets of the native tricuspid valve. The first leaflet 804a may be connected to the second leaflet 804b at a first commissure 812a and a second commissure 812b. In some embodiments, the first commissure 812a may correspond to the posterior septal commissure of the native tricuspid valve, and the second commissure 812b may correspond to the anterior septal commissure of the native tricuspid valve. In some embodiments, the first commissure 812a or the second commissure 812b may correspond to the anterior and posterior commissures of the native tricuspid valve, or any other suitable location that may not correspond to a commissure of the native tricuspid valve. In some embodiments, the location of the first commissure 812a and the second commissure 812b may be determined based on the location of the papillary muscles of the heart. The first commissure 812a and the second commissure 812b may have a length of 3-10 mm. The first commissure 812a and the second commissure 812b may have the same length or different lengths. In some embodiments, the annular length 832 of the first leaflet 804a may include a concave arcuate depression in the first longitudinal length. The first leaflet 804a may have a first annular length 832a and the second leaflet 804b may have a second annular length 832b. In some embodiments, a tricuspid valve prosthesis 800 with a standard size of 25 mm may have a first annular length 832a of 39.0 mm and a second annular length 832b of 45.6 mm. In some embodiments, a tricuspid valve prosthesis 800 with a standard size of 27 mm may have a first annular length 832a of 42.2 mm and a second annular length 832b of 49.3 mm.In some embodiments, a tricuspid valve prosthesis 800 with a standard size of 29 mm may have a first annular length 832a of 45.3 mm and a second annular length 832b of 52.9 mm. In some embodiments, a tricuspid valve prosthesis 800 with a standard size of 31 mm may have a first annular length 832a of 48.4 mm and a second annular length 832b of 56.6 mm. In some embodiments, a tricuspid valve prosthesis 800 with a standard size of 33 mm may have a first annular length 832a of 51.5 mm and a second annular length 832b of 60.3 mm.

[0068] In some embodiments of the present disclosure, the first leaflet 804a may comprise a first free edge 816a and a second free edge 816b. The second leaflet 804a may comprise a third free edge 816c and a fourth free edge 816d. In the closed state, the first free edge 816a of the first leaflet 804a may join with the third free edge 816c of the second leaflet 804b to form a first coaptation edge 836a (see FIG. 8B), and the second free edge 816b of the first leaflet 804b may join with the fourth free edge 816d of the second leaflet to form a coaptation edge 836b (see FIG. 8B). The first free edge 816a and the third free edge 816c may have corresponding dimensions, and the second free edge 816b and the fourth free edge 816d may have corresponding dimensions. In some embodiments, the first free edge 816a and the third free edge 816c may be formed along a 50° arc of a circle with a radius of 21 mm, and the second free edge 816b and the fourth free edge 816d may be formed along a 50° arc of a circle with a radius of 28 mm.

[0069] FIG. 8B is a schematic diagram of a top view of the results of a finite element method (FEM) analysis of the leaflets 804 of the fourth alternative tricuspid valve prosthesis 800 under an external pressure of 23 mmHg, according to an embodiment of the present disclosure. The FEM analysis was performed on the leaflets 804 of the fourth alternative tricuspid valve prosthesis 800 to visualize the opening and closing of the tricuspid valve prosthesis 800 under pressure and to identify areas of stress. The darker an area on the model, the higher the stress the area is under. The material used for the FEM analysis may be bovine pericardium with a thickness of 0.28 mm and a Young's modulus of 30 MPa, although other materials with other properties may be used. As illustrated in FIG. 8B, the free edges 816 come together under external pressure to form a coaptation edge 836, sealing the fourth alternative tricuspid valve prosthesis 800.

[0070] 9A is a schematic diagram of a side perspective view of a fifth alternative tricuspid valve prosthesis 900 designed for a type I tricuspid valve, and FIG. 9B is a schematic diagram of a top view of the leaflets of the fifth alternative tricuspid valve prosthesis 900 designed for a type I tricuspid valve, according to an embodiment of the present disclosure. 54% of patients have a type I tricuspid valve morphology, which is the most prevalent tricuspid valve morphology. A type I tricuspid valve has three leaflets, namely, a septal leaflet, a posterior leaflet, and an anterior leaflet. Furthermore, the anterior papillary muscles of a type I tricuspid valve are slightly offset toward the posterior and anterior leaflets. Similar to the type I tricuspid valve, the fifth alternative tricuspid valve prosthesis 900 designed for a type I tricuspid valve has three leaflets 904: a first leaflet 904a that mimics the septal leaflet of the type I native tricuspid valve, a second leaflet 904b that mimics the posterior leaflet of the type I native tricuspid valve, and a third leaflet 904c that mimics the anterior leaflet of the type I native tricuspid valve. The first leaflet 904a may be connected to the second leaflet 904b at a first commissure 912a, the second leaflet 904b may be connected to the third leaflet 904c at a second commissure 912b, and the third leaflet 904c may be connected to the first leaflet 904a at a third commissure 912c. In some embodiments, the first commissure 912a may correspond to the posterior septal commissure of the native tricuspid valve, the second commissure 912b may correspond to the anterior and posterior commissures of the native tricuspid valve, and the third commissure 912c may correspond to the anterior septal commissure of the native tricuspid valve. In some embodiments, the commissures 912 may be labeled by a laser or any other suitable method to assist in orientation of the fifth alternative tricuspid valve prosthesis 900 during implantation.

[0071] 9C is a schematic diagram of the leaflets 904 and chords 920 of a fifth alternative tricuspid valve prosthesis 900 according to an embodiment of the present disclosure. The first leaflet 904a may have a first annular length 932a, the second leaflet 904b may have a second annular length 932b, and the third leaflet 904c may have an annular length 932c. The annular length 932 and the position of the commissure 912 of each leaflet 904 may be adjusted or personalized based on measurements of the patient's native tricuspid valve and annulus. Alternatively, the annular length 932 may be adjusted based on a valve standard size. In some embodiments, a standard size 25 mm valve may have a first annular length 932a of 27.9 mm, a second annular length 932b of 19.4 mm, and a third annular length 932c of 34.5 mm. In some embodiments, a standard size 27 mm valve may have a first annular length 932a of 30.1 mm, a second annular length 932b of 21.0 mm, and a third annular length 932c of 37.2 mm. In some embodiments, a standard size 29 mm valve may have a first annular length 932a of 32.4 mm, a second annular length 932b of 22.5 mm, and a third annular length 932c of 40.0 mm. In some embodiments, a standard size 31 mm valve may have a first annular length 932a of 34.4 mm, a second annular length 932b of 24.1 mm, and a third annular length 932c of 42.8 mm. In some embodiments, a standard size 33 mm valve may have a first annular length 932a of 36.8 mm, a second annular length 932b of 25.6 mm, and a third annular length 932c of 45.5 mm.

[0072] In some embodiments of the present disclosure, the first leaflet 904a may have a first free edge 916a and a second free edge 916b. The second leaflet 904b may have a third free edge 916c and a fourth free edge 916d. The third leaflet 904c may have a fifth free edge 916e and a sixth free edge 916f. Preferably, the first free edge 916a and the third free edge 916c have corresponding dimensions, the fourth free edge 916d and the fifth free edge 916e have corresponding dimensions, and the sixth free edge 916f and the second free edge 916b have corresponding dimensions, such that when the fifth alternative tricuspid valve prosthesis 900 is in a closed state, the first free edge 916a of the first leaflet 904a closes to the second leaflet 916b. The third free edge 916c of the first leaflet 904b may join to form a coaptation edge 936a, the fourth free edge 916d of the second leaflet 904b may join to a fifth free edge 916e of the third leaflet 904c to form a coaptation edge 936b, and the sixth free edge 916f of the third leaflet 604c may join to a second free edge 916b of the first leaflet 904a to form a coaptation edge 936c (see FIG. 9D). In some embodiments, the first free edge 916a and the third free edge 916c may be formed along a concave arc of 50° to 70° of a circle having a radius of 12 to 18 mm. In some embodiments, the fourth free edge 916d and the fifth free edge 916e may be formed along a concave arc of 50° to 70° of a circle having a radius of 10 to 15 mm. In some embodiments, the sixth free edge 916f and the second free edge 916b may be formed along a 30°-50° concave arc of a circle having a radius of 25-35 mm. The various dimensions of the leaflets 904 may be optimized and determined using finite element method (FEM) analysis to visualize the opening and closing of the tricuspid valve prosthesis under pressure. Preferably, the leaflets 904a, 904b, and 904c are sized such that the tips of the leaflets converge to a point above a single papillary muscle 124, preferably the anterior papillary muscle.

[0073] In some embodiments of the present disclosure, the first leaflet 904a may be connected to a first end of a first cord 920a, the second leaflet 904b may be connected to a first end of a second cord 920b, and the third leaflet 904c may be connected to a first end of a third cord 920c. In some embodiments, the first cord 920a may have a length of 5-15 mm and a width of 2-5 mm. In some embodiments, the second cord 920b may have a length of 5-15 mm and a width of 2-5 mm. In some embodiments, the third cord 920c may have a length of 5-15 mm and a width of 2-5 mm. Preferably, the cords 920a, 920b, and 920c have the same length and are connected to a single papillary muscle 124, preferably the anterior papillary muscle or the free wall 440 of the right ventricle 212, by any of the methods disclosed in Figures 3A-3C, 4A, and 4B. The cords 920a, 920b, and 920c may be sewn together to form a cap or may be surrounded by a connector element 924 before suturing to the single papillary muscle or free wall.

[0074] 9D is a schematic diagram of a top view of the results of a finite element method (FEM) analysis of the leaflets 904 of the fifth alternative tricuspid valve prosthesis 900 under an external pressure of 23 mmHg, according to an embodiment of the present disclosure. The material used for the FEM analysis may be bovine pericardium having a thickness of 0.28 mm and a Young's modulus of 30 MPa, although other materials with other properties may be used. As illustrated in FIG. 9D, the free edges 916 come together under the external pressure to form a coaptation edge 936, sealing the fifth alternative tricuspid valve prosthesis 900.

[0075] 10A is a schematic diagram of a side perspective view and FIG. 10B is a schematic diagram of a top view of the leaflets of a sixth alternative tricuspid valve prosthesis 1000 designed for a type IIIB tricuspid valve according to an embodiment of the present disclosure. Thirty-two percent of patients have a type IIIB tricuspid valve morphology, which is the second most prevalent tricuspid valve morphology. A type IIIB tricuspid valve has four leaflets, namely, a septal leaflet, two posterior leaflets, and an anterior leaflet. The anterior papillary muscles of a type IIIB tricuspid valve are slightly offset toward the posterior and anterior leaflets. On the other hand, the sixth alternative tricuspid valve prosthesis 1000 designed for a type IIIB tricuspid valve has three leaflets 1004, namely a first leaflet 1004a that mimics the septal leaflet of a type IIIB native tricuspid valve, a second leaflet 1004b that mimics the two posterior leaflets of a type IIIB native tricuspid valve, and a third leaflet 1004c that mimics the anterior leaflet of a type IIIB native tricuspid valve. The first leaflet 1004a may be connected to the second leaflet 1004b at a first commissure 1012a, the second leaflet 1004b may be connected to the third leaflet 1004c at a second commissure 1012b, and the third leaflet 1004c may be connected to the first leaflet 1004a at a third commissure 1012c. In some embodiments, the first commissure 1012a may correspond to the posterior septal commissure of the native tricuspid valve, the second commissure 1012b may correspond to the anterior and posterior commissures of the native tricuspid valve, and the third commissure 1012c may correspond to the anterior septal commissure of the native tricuspid valve. In some embodiments, the commissures 1012 may be labeled by a laser or any other suitable method to assist in the orientation of the sixth alternative tricuspid valve prosthesis 1000 during implantation.

[0076] 10C is a schematic diagram of the leaflets 1004 and chords 1020 of a sixth alternative tricuspid valve prosthesis 1000 according to an embodiment of the present disclosure. The first leaflet 1004a may have a first annular length 1032a, the second leaflet 1004b may have a second annular length 1032b, and the third leaflet 1004c may have an annular length 1032c. In some embodiments, the annular length 1032 and the position of the commissures 1012 of each leaflet 1004 may be adjusted or personalized based on measurements of the patient's native tricuspid valve and annulus. Alternatively, the annular length 1032 may be adjusted based on a valve standard size. In some embodiments, a standard size 25 mm valve may have a first annular length 1032a of 27.6 mm, a second annular length 832b of 34.4 mm, and a third annular length 1032c of 18.9 mm. In some embodiments, a standard size 27 mm valve may have a first annular length 1032a of 29.8 mm, a second annular length 1032b of 37.1 mm, and a third annular length 1032c of 20.4 mm. In some embodiments, a standard size 29 mm valve may have a first annular length 1032a of 32.0 mm, a second annular length 1032b of 39.9 mm, and a third annular length 1032c of 21.9 mm. In some embodiments, a standard size 31 mm valve may have a first annular length 1032a of 34.2 mm, a second annular length 1032b of 42.6 mm, and a third annular length 1032c of 34.2 mm. In some embodiments, a standard size 33 mm valve may have a first annular length 1032a of 36.4 mm, a second annular length 1032b of 45.3 mm, and a third annular length 1032c of 24.9 mm.

[0077] In some embodiments of the present disclosure, the first leaflet 1004a may have a first free edge 1016a and a second free edge 1016b. In some embodiments, the second leaflet 1004b may have a third free edge 1016c and a fourth free edge 1016d. In some embodiments, the third leaflet 1004c may have a fifth free edge 1016e and a sixth free edge 1016f. Preferably, the first free edge 1016a and the third free edge 1016c have corresponding dimensions, the fourth free edge 1016d and the fifth free edge 1016e have corresponding dimensions, and the sixth free edge 1016f and the second free edge 1016b have corresponding dimensions, such that when the sixth alternative tricuspid valve prosthesis 1000 is in a closed state, the first free edge 1016a of the first leaflet 1004a closes to the second leaflet 1004. The fourth free edge 1016d of the second leaflet 1004b may join with the third free edge 1016c of the third leaflet 1004b to form a coaptation edge 1036a, the fourth free edge 1016d of the second leaflet 1004b may join with the fifth free edge 1016e of the third leaflet 1004c to form a coaptation edge 1036b, and the sixth free edge 1016f of the third leaflet 1004c may join with the second free edge 1016b of the first leaflet 1004a to form a coaptation edge 1036c (see FIG. 10D). In some embodiments, the first free edge 1016a and the third free edge 1016c may be formed along a concave arc of 30° to 50° of a circle having a radius of 25 to 30 mm. The fourth free edge 1016d and the fifth free edge 1016e may be formed along a concave arc of 50° to 70° of a circle having a radius of 10 to 15 mm. The sixth free edge 1016f and the second free edge 1016b may be formed along a 50°-70° concave arc of a circle having a radius of 15-25 mm. In some embodiments, the various dimensions of the leaflets 1004 may be optimized and determined using Finite Element Method (FEM) analysis to visualize the opening and closing of the tricuspid valve prosthesis under pressure. Preferably, the leaflets 1004a, 1004b and 1004c are sized such that the tips of the leaflets converge to a point above a single papillary muscle, preferably the anterior papillary muscle. In other embodiments, the leaflets 1004 may be connected to a single papillary muscle or the free wall through a connector element that is connected to the tip of the leaflet 1004.

[0078] In some embodiments of the present disclosure, the first leaflet 1004a may be connected to a first end of a first cord 1020a, the second leaflet 1004b may be connected to a first end of a second cord 1020b, and the third leaflet 1004c may be connected to a first end of a third cord 1020c. In some embodiments, the first cord 1020a may have a length of 5-15 mm and a width of 2-5 mm. The second cord 1020b may have a length of 5-15 mm and a width of 2-5 mm. The third cord 1020c may have a length of 5-15 mm and a width of 2-5 mm. Preferably, the cords 1020a, 1020b, and 1020c have the same length and are connected to a single papillary muscle 124, preferably an anterior papillary muscle, or the free wall 440 of the right ventricle 212, through any of the methods disclosed in Figures 3A-3C, 4A, and 4B. The cords 1020a, 1020b, and 1020c may be sewn together to form a cap or may be surrounded by a connector element 1024 before suturing to the single papillary muscle or the free wall.

[0079] 10D is a schematic diagram of a top view of the results of a finite element method (FEM) analysis of the leaflets 1004 of the sixth alternative tricuspid valve prosthesis 1000 under an external pressure of 23 mmHg, according to an embodiment of the present disclosure. The material used for the FEM analysis may be bovine pericardium having a thickness of 0.28 mm and a Young's modulus of 30 MPa, although other materials with other properties may be used. As illustrated in FIG. 10D, the free edges 1016 come together under the external pressure to form a coaptation edge 1036, sealing the sixth alternative tricuspid valve prosthesis 1000.

[0080] 11A is a schematic diagram of a side perspective view of a seventh alternative tricuspid valve prosthesis 1100, and FIG. 11B is a schematic diagram of a top view of the leaflets of the seventh alternative tricuspid valve prosthesis 1100, according to an embodiment of the present disclosure. The seventh alternative tricuspid valve prosthesis 1100 is not specifically designed for any native tricuspid valve morphology. The seventh alternative tricuspid valve prosthesis 1100 has three leaflets 1104, a first leaflet 1104a that mimics the septal leaflet of the native tricuspid valve, a second leaflet 1104b that mimics the posterior leaflet of the native tricuspid valve, and a third leaflet 1104c that mimics the anterior leaflet of the native tricuspid valve. The first leaflet 1104a may be connected to the second leaflet 1104b at a first commissure 1112a, the second leaflet 1104b may be connected to the third leaflet 1104c at a second commissure 1112b, and the third leaflet 1104c may be connected to the first leaflet 1104a at a third commissure 1112c. In some embodiments, the first commissure 1112a may correspond to the posterior septal commissure of the native tricuspid valve, the second commissure 1112b may correspond to the anterior and posterior commissures of the native tricuspid valve, and the third commissure 1112c may correspond to the anterior septal commissure of the native tricuspid valve. In some embodiments, the commissures 1112 may be labeled by a laser or any other suitable method to assist in the orientation of the seventh alternative tricuspid valve prosthesis 1100 during implantation.

[0081] 11C is a schematic diagram of the leaflets 1104 and chords 1120 of a seventh alternative tricuspid valve prosthesis 1100 according to an embodiment of the present disclosure. The first leaflet 1104a may have a first annular length 1132a, the second leaflet 1104b may have a second annular length 1132b, and the third leaflet 1104c may have an annular length 1132c. In some embodiments, the annular length 1132 and the position of the commissures 1112 of each leaflet 1104 may be adjusted or personalized based on measurements of the patient's native tricuspid valve and annulus. Alternatively, the annular length 1132 may be adjusted based on a valve standard size. In some embodiments, a standard size 25 mm valve may have a first annular length 1132a of 27.7 mm, a second annular length 832b of 19.7 mm, and a third annular length 1132c of 34.5 mm. In some embodiments, a standard size 27 mm valve may have a first annular length 1132a of 30.0 mm, a second annular length 1132b of 21.3 mm, and a third annular length 1132c of 37.3 mm. In some embodiments, a standard size 29 mm valve may have a first annular length 1132a of 32.2 mm, a second annular length 1132b of 22.8 mm, and a third annular length 1132c of 40.0 mm. In some embodiments, a standard size 31 mm valve may have a first annular length 1132a of 34.4 mm, a second annular length 1132b of 24.4 mm, and a third annular length 1132c of 42.8 mm. In some embodiments, a standard size 33 mm valve may have a first annular length 1132a of 36.6 mm, a second annular length 1132b of 26.0 mm, and a third annular length 1132c of 45.6 mm.

[0082] In some embodiments of the present disclosure, the first leaflet 1104a may have a first free edge 1116a and a second free edge 1116b. The second leaflet 1104b may have a third free edge 1116c and a fourth free edge 1116d. The third leaflet 1104c may have a fifth free edge 1116e and a sixth free edge 1116f. Preferably, the first free edge 1116a and the third free edge 1116c have corresponding dimensions, the fourth free edge 1116d and the fifth free edge 1116e have corresponding dimensions, and the sixth free edge 1116f and the second free edge 1116b have corresponding dimensions, such that when the seventh alternative tricuspid valve prosthesis 1100 is in a closed state, the first free edge 1116a of the first leaflet 1104a closes to the second leaflet 1104. The third free edge 1116c of the second leaflet 1104b may join with the third free edge 1116c of the third leaflet 1104b to form a coaptation edge 1136a, the fourth free edge 1116d of the second leaflet 1104b may join with the fifth free edge 1116e of the third leaflet 1104c to form a coaptation edge 1136b, and the sixth free edge 1116f of the third leaflet 1104c may join with the second free edge 1116b of the first leaflet 1104a to form a coaptation edge 1136c (see FIG. 11D). In some embodiments, the first free edge 1116a and the third free edge 1116c may be formed along a concave arc of 50° to 70° of a circle having a radius of 12 to 20 mm. In some embodiments, the fourth free edge 1116d and the fifth free edge 1116e may be formed along a concave arc of 50° to 70° of a circle having a radius of 12 to 20 mm. In some embodiments, the sixth free edge 1116f and the second free edge 1116d may be formed along a 50°-70° concave arc of a circle having a radius of 12-18 mm. In some embodiments, the various dimensions of the leaflets 1104 may be optimized and determined using finite element method (FEM) analysis to visualize the opening and closing of the tricuspid valve prosthesis under pressure. Preferably, the leaflets 1104a, 1104b, and 1104c are sized such that the tips of the leaflets converge at a point corresponding to the center of the native tricuspid annulus.

[0083] In some embodiments of the present disclosure, the first leaflet 1104a may be connected to a first end of a first cord 1120a, the second leaflet 1104b may be connected to a first end of a second cord 1120b, and the third leaflet 1104c may be connected to a first end of a third cord 1120c. Preferably, the first ends of the cords 1120a, 1120b, and 1120c are connected together by sutures or with a connector element 1124, and the second ends of the cords 1120a, 1120b, and 1120c are free and connected to different papillary muscles. In some embodiments, the second end of the first cord 1120a may be connected to the septal papillary muscle, the second end of the second cord 1120b may be connected to the posterior papillary muscle, and the second end of the third cord 1120c may be connected to the anterior papillary muscle. In some embodiments, the cords 1120a, 1120b, and 1120c may have different lengths and thicknesses from each other since they are connected to different papillary muscles that may have different distances from the tips of the leaflets 1104a, 1104b, and 1100c. In some embodiments, the first cord 1120a may have a length of 5-15 mm and a width of 2-5 mm. The second cord 1120b may have a length of 5-15 mm and a width of 2-5 mm. The third cord 1120c may have a length of 5-15 mm and a width of 2-5 mm.

[0084] 11D is a schematic diagram of a top view of the results of a finite element method (FEM) analysis of the leaflets 1104 of the seventh alternative tricuspid valve prosthesis 1100 under an external pressure of 23 mmHg, according to an embodiment of the present disclosure. The material used for the FEM analysis may be bovine pericardium having a thickness of 0.28 mm and a Young's modulus of 30 MPa, although other materials with other properties may be used. As illustrated in FIG. 11D, the free edges 1116 come together under the external pressure to form a coaptation edge 1136, sealing the seventh alternative tricuspid valve prosthesis 1100.

[0085] In some embodiments, the tricuspid valve prosthesis of the present disclosure may include a stent frame 1200. Thus, unless specifically stated, it should be understood that when the tricuspid valve prosthesis disclosed herein does not include a stent frame, the tricuspid valve prosthesis is considered to be a stentless tricuspid valve prosthesis, such as that described in Figures 1 and 3A-3C. However, it should be understood that, whenever applicable, various embodiments of the tricuspid valve prosthesis, including the first, second, third, fourth, fifth, sixth, and seventh alternative tricuspid valve prostheses described above (see Figures 5A-E, 6A-D, 7A-C, 8A-B, 9A-D, 10A-D, and 11A-D), in addition to the embodiments described below, may also include a stent frame. Figures 12A-12D illustrate a stent 1200 that may be included in the tricuspid valve prosthesis. As used herein, the terms "stent" and "stent frame" may be used interchangeably and have the same meaning. The stent 1200 may be advantageously used as a support for a tricuspid valve prosthesis. In such an embodiment, the tricuspid valve prosthesis may be referred to as a stented tricuspid valve prosthesis. A tricuspid valve prosthesis with a stent frame may advantageously facilitate retrieval of the valve prosthesis. The perimeter of the stent frame 1200 may be adapted to mimic the shape of the native tricuspid valve annulus. In some embodiments, the perimeter may be a circle or an irregular circle (such as a bean-shaped ring). FIG. 12A is an exemplary embodiment of the perimeter of a stent frame 1200 having an irregular circular shape that mimics the shape of the native tricuspid valve annulus. The stent 1200 may be made from stainless steel, silicon, plastic, graphene oxide, or other suitable materials. In some embodiments, the stent 1200 may be made from medical grade materials, such as United States Pharmacopeia (USP) Class VI certified or compliant materials or materials that comply with ISO 10993. In some embodiments, the cuff 1205 may be attached to the stent 1200 (see FIG. 13B). Thus, it should be appreciated that the cuff 1205 may be sized to fit around the circumference of the stent 1200.According to some embodiments of the present disclosure, the cuff 1205 may be a fabric cuff band 1205 attached to the stent 1200 and is advantageously used to reinforce the ring formed by the pericardium and sew the valve with the annular muscle (see FIGS. 14A and 14B). As can be appreciated, in some embodiments, the cuff 1205 may be considered a reinforcement mechanism for the ring. In some embodiments, the cuff band 1205 may comprise silicone and an embedded radiopaque wire. One or more drugs may be coated on the fabric cuff 1205 or wire to prevent or minimize pannus formation, calcification, or a combination thereof.

[0086] In some embodiments, the stent 1200 may be designed according to the location of the papillary muscles. As can be seen from at least FIGS. 12B-12D, in some embodiments, the stent 1200 may include multiple holes 1210 for suturing the pericardium and one or more slots 1230 for the valve leaflets (not shown) to be inserted. In some embodiments, when the stent 1200 is made of silicone or other materials with similar properties, the stent 1200 may be provided without multiple holes. Each hole 1210 of the multiple holes may have a diameter ranging from about 0.5 mm to about 2 mm, preferably 1 mm. In some embodiments, the diameter of the holes within the multiple holes may be uniform. In some embodiments, each hole of the multiple holes may have a different diameter ranging from about 0.5 mm to about 2 mm. In some embodiments, the arrangement or configuration of the multiple holes 1210 may be adjusted accordingly. In an exemplary embodiment, each hole of the multiple holes may be spaced a similar distance from adjacent or neighboring holes. Each slot of the one or more slots 1230 may have a length of about 8 mm to about 16 mm. In some embodiments, if the valve size is 29 mm, the preferred length of the slot may be 12 mm. Thus, the length of the slot 1230 may be adjusted according to the valve size. In some embodiments, the stent frame 1200 may have a thickness of about 0.5 mm to about 2 mm, preferably 1 mm. In some embodiments, for a valve size of 29 mm, the stent 1200 may have a circumference of about 100.81 mm and a height of about 15 mm. It should be understood that such parameters, including circumference and height, may be adjusted according to the valve size. Thus, generally, the stent 1200 may have a circumference in the range of about 80 mm to about 140 mm. In some embodiments, the stent 1200 may have a height in the range of about 12 mm to about 25 mm.

[0087] 13C-13E respectively illustrate the three leaflets of the stented tricuspid valve described in FIGS. 13A and 13B, i.e., the anterior leaflet 1204c (FIG. 13C), the posterior leaflet 1204b (FIG. 13D), and the septal leaflet 1204a (FIG. 13E), before the leaflets are attached to the stent frame 1200. As shown in FIGS. 13C-13E, once the leaflets are attached to the stent frame 1200, each of the leaflets may have a three-sided shape, as previously described. In other words, before assembling the leaflets, the leaflets or the pericardium may include extensions (see the grey areas in FIGS. 13C-13D) that are used to secure the pericardium to the stent frame 1200. When securing the pericardium to the stent frame 1200, the extensions may be folded. As can be seen in FIG. 13A, the leaflet chords 1220 may be sewn together to form a cap or may be surrounded by a connector element 1224 before suturing to a single papillary muscle or free wall. FIG. 13B shows a stented tricuspid valve prosthesis having a stent 1200, a fabric cuff band 1205, and septal leaflets 1204a, posterior leaflets 1204b, and anterior leaflets 1204c. For a stented tricuspid valve prosthesis, the height of each of the leaflets with the chords may range from about 30 mm to 55 mm (see FIGS. 13C-13E). In some embodiments, the measured height may include the aforementioned extensions. In some embodiments, for a valve size of 29 mm, the height of each of the leaflets with the chords may be about 43 mm.

[0088] As illustrated by Figs. 14A and 14B, a tricuspid valve prosthesis with a stent frame may be manufactured by shaping the leaflets by cutting the pericardium (human or bovine pericardium) and then suturing the shaped leaflets onto a stent to form a tricuspid valve prosthesis with a stent frame. Before suturing the leaflets, the shaped leaflets with extensions may be attached to the frame by folding the extensions of the leaflets. The folding may substantially enclose one or more slots of the stent frame. Optionally, the folding may also include attaching a cuff to the frame and then suturing the leaflets. The shaped leaflets may be the anterior leaflet, the posterior leaflet, and the septal leaflet. In such an embodiment, the leaflets (anterior leaflet, posterior leaflet, and septal leaflet) may be positioned within the stent frame.

[0089] 15A and 15B show top views of a stented tricuspid valve prosthesis according to an embodiment of the present disclosure. During hydrodynamic testing, such as in vitro hydrodynamic testing during systole and diastole, the stented tricuspid valve prosthesis may be closed (FIG. 15A) or open (FIG. 15B). Similar to the stentless tricuspid valve prosthesis described above, in a stented tricuspid valve, the leaflets may coapt to form coaptation surfaces or edges to seal the valve prosthesis. Advantageously, such a configuration may minimize leakage during deployment of the tricuspid valve prostheses described herein.

[0090] It should be understood that the above methods and apparatus can be modified in many ways, including omitting or adding steps, changing the order of steps and the types of devices used. It should be understood that different features may be combined in different ways. In particular, not all features described above in a particular embodiment are required in all embodiments of the present disclosure. Further combinations of the above features are also considered to be within the scope of some embodiments of the present disclosure.

[0091] Persons skilled in the art will appreciate that the present invention is not limited to what has been particularly shown and described above, but rather the scope of the present invention is defined only by the following claims.

Claims

1. 1. A tricuspid valve prosthesis for implantation in the heart, comprising: two or more leaflets, each leaflet having an annular length and two free edges forming a tip, the leaflets being adapted to be joined together at commissures to form a ring and to be coapted to one another; a connector element connected to the tips of the two or more leaflets; 1. A tricuspid valve prosthesis comprising:

2. The tricuspid valve prosthesis of claim 1 , wherein the two or more leaflets coapt edge-to-edge.

3. The tricuspid valve prosthesis of claim 1 , wherein the two or more leaflets coapt surface-to-surface.

4. The tricuspid valve prosthesis of claim 1 , wherein the connector element is configured to attach to a papillary muscle of the heart.

5. The tricuspid valve prosthesis of claim 4 , wherein the papillary muscles are anterior papillary muscles.

6. The tricuspid valve prosthesis of claim 1 , wherein the connector element is configured to attach to a free wall of a right ventricle.

7. The tricuspid valve prosthesis of claim 1 , further comprising two or more sets of cords, each set of cords attached at a first end to the connector element.

8. 2. The tricuspid valve prosthesis of claim 1, further comprising two or more sets of cords, each set of cords attached at a first end to the tip of one of the two or more leaflets, and the two or more sets of cords surrounded by the connector element.

9. The tricuspid valve prosthesis of claim 8 , wherein the connector element surrounds first ends of the two or more sets of cords.

10. 9. The tricuspid valve prosthesis of claim 8, wherein the connector elements span the length of the two or more sets of cords.

11. 8. The tricuspid valve prosthesis of claim 7, wherein the two or more sets of cords are configured to be attached at second ends to one or more papillary muscles of the heart.

12. The tricuspid valve prosthesis of claim 1 , wherein the ring is bean-shaped or saddle-shaped.

13. The tricuspid valve prosthesis of claim 1 , wherein the free edge is shaped along a concave arc of a circle.

14. 10. The tricuspid valve prosthesis of claim 1, wherein the two or more leaflets further comprise a slot separating the tips of the two or more leaflets, the slot comprising two arcs.

15. The tricuspid valve prosthesis of claim 14 , wherein the two arcs are configured to coapt.

16. 1. A tricuspid valve prosthesis for implantation in the heart, comprising: two or more leaflets, each leaflet having an annular length and two free edges forming a tip, the leaflets being adapted to be joined together at commissures to form a ring and to be coapted to one another; two or more sets of cords, each set of cords attached at a first end to the two or more leaflets; 1. A tricuspid valve prosthesis comprising:

17. 17. The tricuspid valve prosthesis of claim 16, wherein the two or more sets of cords are sewn together to form a cap, the cap configured to be attached to a papillary muscle of the heart.

18. 18. The tricuspid valve prosthesis of claim 17, wherein the papillary muscles are anterior papillary muscles.

19. 17. The tricuspid valve prosthesis of claim 16, wherein the two or more sets of cords are sewn together to form a cap, the cap configured to be attached to a free wall of the right ventricle.

20. 17. The tricuspid valve prosthesis of claim 16, wherein the ring is bean-shaped or saddle-shaped.

21. 17. The tricuspid valve prosthesis of claim 16, wherein the free edge is shaped along a concave arc of a circle.

22. 17. The tricuspid valve prosthesis of claim 16, wherein the two or more leaflets further comprise a slot separating the tips of the two or more leaflets, the slot comprising two arcs.

23. 23. The tricuspid valve prosthesis of claim 22, wherein the two arcs are configured to coapt.

24. 10. The tricuspid valve prosthesis of claim 1, further comprising a stent frame, wherein the two or more leaflets are positioned within the stent frame, and the ring is sized to fit around the stent frame.

25. 25. The tricuspid valve prosthesis of claim 24, wherein the stent frame comprises one or more slots for inserting the two or more leaflets into the stent frame.

26. 25. The tricuspid valve prosthesis of claim 24, wherein the stent frame comprises a plurality of holes for suturing the two or more leaflets.

27. 25. The tricuspid valve prosthesis of claim 24, wherein the stent frame comprises a medical grade material.

28. 25. The tricuspid valve prosthesis of claim 24, wherein the stent frame is made from stainless steel, silicone, plastic, or graphene oxide.

29. 25. The tricuspid valve prosthesis of claim 24, further comprising a cuff attached to the stent frame.

30. 30. The tricuspid valve prosthesis of claim 29, wherein the cuff is coated with one or more drugs.

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