JP2023521684A - artificial heart valve - Google Patents

Abstract

Prosthetic semi-heart valves for the treatment of diseased heart valves with native anterior and prosthetic posterior leaflets include stingray and crescent-shaped stents with extending tabs configured as safety features. At least one prosthetic leaflet attached to the inner surface of the stent connects the free edge, the two commissural attachment regions, the attachment edge, the junction region, the abdominal region, and a portion of one or more leaflets to the inferior ventricular portion of the stent. at least one leg structure for A seal skirt is coupled to the inner surface of the stent for attaching one or more leaflets and forming a paravalvular seal to the atrial portion of the prosthetic half valve. The prosthetic hemi-heart valve further comprises a plurality of dual-guiding fixation members for securing the atrial flared portion of the stent to the posterior portion of the native annulus. [Selection drawing] Fig. 7

Description

This application relates generally to replacement heart valves, eg, for replacing diseased mitral and/or tricuspid valves. More particularly, the subject embodiments relate to tissue-based, collapsible and expandable replacement heart valves.

Cross-reference to related applications
This application claims the benefit of co-pending U.S. Provisional Application No. 63/007,418, filed April 9, 2020, and No. 15/453,518, which is a continuation-in-part of U.S. Provisional Application No. 62/305,204, filed March 8, 2016, filed October 27, 2016. 62/413,693 filed November 29, 2016, and 62/427,551 filed November 29, 2016, and co-pending filed December 14, 2020. No. 17/121,615, which is a continuation-in-part of International Application No. PCT/US2019/037476, filed June 17, 2019, which is filed on June 17, 2018. Co-Pending Application No. 17/198,097, filed March 10, 2021, which claims the benefit of U.S. Provisional Application No. 62/685,378, filed June 15, 2021 which claims the benefit of U.S. Provisional Application No. 62/988,253, filed March 11, 2020, the disclosure of which, including the specification and drawings, is All are hereby incorporated by reference in their entirety.

The mitral valve (MV) has two distinct large leaflets or leaflets. As shown in FIG. 1A, the MV is on the left side of the heart, located between the left atrium and left ventricle. The mitral valve apparatus consists of the mitral annulus, the two leaflets, the chordae tendineae (“chords”), the two papillary muscles and the left ventricular myocardium. As shown in FIG. 1B, the mitral annulus is subdivided into anterior and posterior portions. Normally, the anterior mitral leaflet (AML) is connected to the aortic valve via the mitral aortic curtain, and the posterior mitral leaflet (PML) is pivotally fixed to the posterior mitral annulus. The chordae arise from the two major papillary muscles, or multiple small muscle fascicles that attach to the ventricular wall and connect to the free end of the mitral valve. The chordae are composed primarily of collagen bundles, which give them high stiffness and maintain minimal stretch to prevent the leaflets from following into the left atrium during systole.

When the mitral valve is closed, the respective anterior and posterior leaflets are brought together to form a single apposed region. As those skilled in the art will appreciate, normal mitral valve function involves a proper balance of forces with each of its components working in unison during the cardiac cycle. Pathological changes affecting any of the components of the mitral valve, such as chordae rupture, annulus dilatation, papillary muscle displacement, leaflet calcification and myxomatous disease, are associated with mitral valve function. can lead to changes in , leading to mitral regurgitation (MR).

Mitral regurgitation is a malfunction of the mitral valve that causes abnormal leakage of blood from the left ventricle back into the left atrium during systole (i.e., the ejection phase of the cardiac cycle when blood moves from the left ventricle to the aorta). . Although minor mitral regurgitation can be seen in healthy patients, moderate to severe mitral regurgitation is one of the most common forms of valvular heart disease. The most common causes of mitral regurgitation include ischemic heart disease, non-ischemic heart disease, and valve degeneration. Both ischemic heart disease (mainly due to coronary artery disease) and non-ischemic heart disease (e.g. idiopathic dilated cardiomyopathy) have various mechanisms such as left ventricular wall motion disturbance, left ventricular dilatation, papillary muscle displacement and dysfunction. may cause functional or secondary mitral regurgitation. In functional mitral regurgitation, the mitral valve apparatus remains normal. Incomplete coaptation of the leaflets results from enlargement of the mitral annulus secondary to left ventricular dilation and possibly left atrial dilation. In addition, patients with functional mitral regurgitation may exhibit papillary muscle displacement due to left ventricular enlargement, resulting in over-constrained leaflets. In contrast, degenerative (or organic) mitral regurgitation is caused by structural abnormalities of the mitral valve leaflets and/or subvalvular organs, including stretching or tearing of the chordae tendineae.

Current treatments for mitral valve disease include surgical repair and replacement of the mitral valve. Mitral valve repair has benefited from an improved understanding of mitral valve mechanism and function and is now considered preferable to complete mitral valve replacement. However, the complex physiology and three-dimensional anatomy of the mitral valve and surrounding structures present significant challenges in performing their repair procedures.

In one early example of a transcatheter mitral valve replacement device, Endovalve-Herrmann (Micro Interventional Devices, Inc.) developed a mitral valve prosthesis with a foldable nitinol-based valve with a sealing skirt. there is Similarly, Tendyne Holdings, Inc. manufactures a prosthetic mitral valve replacement device that includes a pericardial valve with a self-expanding Nitinol stent. The device is designed for transapical delivery and includes a ventricular fixation anchor. CardiAQ uses a pericardial valve with a Nitinol self-expanding stent in a mitral valve replacement device. Finally, Tiara (Neovasc, Inc.) presents a transapically deliverable mitral valve replacement system with a 30 Fr catheter with an anchoring structure and an autologous D-shaped atrial portion and a ventricular portion with an outer coating. A pericardial valve on an expandable stent is used. Although these devices and techniques for delivering mitral valve prostheses into an actuated position are still under development and show promise, challenges to the efficacy of these devices continue to exist.

Highlighted challenges to effective mitral valve replacement devices generally include operational delivery challenges, positioning and fixation challenges, sealing and paravalvular leak challenges, and left ventricular outflow tract (LVOT) occlusion. There are also issues with hemodynamic function. With respect to the operational delivery challenges described above, conventional mitral valve prostheses are larger than conventional aorta prostheses, and therefore require a larger volume for deployment and retrieval by either conventional transapical or transfemoral delivery techniques. Folding and compressing the mitral valve prosthesis into the catheter is more difficult.

Turning to the challenges of positioning and fixation, the mitral valve is nearly zero in diastole and rises to >120 mmHg systolic and >150 mmHg systolic pressure in patients with aortic stenosis and systemic hypertension. Instability and migration are the most prominent obstacles due to high repetitive stresses during the cardiac cycle, with possible high transvalvular pressure gradients. Also, the lack of calcium distribution in the mitral annulus affects the stability and fixation of the device. Additionally, a transcatheter mitral valve replacement can easily dislodge as the heart moves during each beating cycle.

With respect to sealing and paravalvular leakage, a good fit of the native annulus and prosthesis to minimize paravalvular leakage is desired. Due to the large mitral annulus, prosthetic mitral valves usually have a large flared atrial portion or flare to prevent leakage, but the problem is that the prosthesis is tightly attached to the native mitral valve. As such, it requires a large valve size at the ventricular level. Conventionally, prosthetic mitral valves are smaller than the diseased native valve and additional material is added around the prosthetic valve to compensate for the large native mitral annulus. Undesirably, adding more material to the prosthetic valve increases the size of the delivery system.

Finally, with respect to maintaining hemodynamic function, the operating position of the conventionally large mitral valve prosthesis, as described above, should not interfere with the LVOT at the anterior portion of the mitral annulus, rather than the associated native mitral valve. Do not interfere with structure.

Therefore, it would be beneficial to have a heart valve leaflet replacement system that does not suffer from the shortcomings and deficiencies of conventional valve prostheses. It is desirable to secure a prosthetic mitral valve replacement system to the native mitral valve annulus. It is also desirable to improve the positioning of the mitral valve prosthesis and prevent blood leakage between the mitral valve prosthesis and the native mitral valve. Similarly, it is desirable to prevent further dilation of the own mitral annulus. Furthermore, other desirable features and characteristics will become apparent from the subsequent detailed description and the appended claims, taken in conjunction with the accompanying drawings and the foregoing technical field and background.

Described herein are examples of prosthetic heart half valves or prosthetic half valves and methods of securing the prosthetic half valve to one of the native annulus. The method of securing the prosthetic half-valve to one of the native annulus prevents the prosthetic half-valve from dislodging from the annulus and provides a proper separation between the leaflets of the implanted prosthetic half-valve and the remaining native valve leaflets. It is contemplated that it will be configured to ensure a secure bond. It is contemplated that the prosthetic half valve will be implanted by open surgery or percutaneously via a catheter. In one aspect, the prosthetic half-valve comprises a plurality of dual guiding fixation (DGF) members as described elsewhere herein, which are configured to secure the prosthetic half-valve to the native mitral valve. can be In a further aspect, a related method can be configured to implant a replacement valve prosthesis to help prevent further dilation of the native mitral annulus. For clarity, although the present disclosure focuses on treating functional mitral regurgitation, the leaflet replacement system and related methods treat other valve diseases such as degenerative mitral regurgitation. can be used, or otherwise configured to be used, to replace other valves (e.g., the tricuspid valve) of the human heart, or other mammals suffering from valve defects It is contemplated that it may similarly be used in, or otherwise configured to be used in, a

In one aspect, the prosthetic half-valve can be configured or otherwise configured to be collapsed to fit within the delivery sheath and then selectively re-expanded to the working size and position upon removal from the delivery sheath within the heart. The size is adjustable. In a further aspect, at least a portion of the prosthetic half-valve can have a stent shape including an upper atrial portion and a lower ventricular portion. In one aspect, the atrial portion is configured to facilitate anchoring of the stent, which can help prevent paravalvular leakage and stent dislodgement. Additionally, the ventricular portion displaces the diseased native leaflets out of the blood flow path and can accommodate at least one prosthetic leaflet. In another aspect, the prosthetic half valve can comprise a lining skirt that can be bonded to at least a portion of the inner and/or outer surface of the stent. In one exemplary aspect, at least one prosthetic valve leaflet can be attached to the inner lumen of the stent and/or at least a portion of the outer side of the stent, which can be used to restore normal valve function, for example, to a mitral valve. Capable of substituting at least one autologous leaflet to prevent mitral regurgitation.

In one aspect, at least one prosthetic leaflet of the prosthetic half valve can be configured to have at least one leg structure that prevents the leaflet from falling into the atrium and prolapse. The at least one leg structure acts to distribute prosthetic leaflet stress and promote coaptation with at least one of the self mitral valve leaflets, thereby providing sufficient leaflet coaptation length during systole. and proper closing anatomy of the native mitral valve with proper height and leaflet angle can be reproduced.

In one aspect, the delivery of the prosthetic half-valve, like the methods disclosed in the applications incorporated herein by reference, are not intended to be limiting, e.g., surgical approaches, transseptal approaches, , a trans-atrial approach or a trans-apical approach using a number of desirable delivery access approaches. In one exemplary aspect, a transseptal approach provides an opening in the internal jugular or femoral vein for subsequent minimally invasive delivery of a portion of the prosthetic half-valve via the superior vena cava that drains into the right atrium of the heart. can include forming a In this exemplary embodiment, a transseptal approach traverses the atrial septum of the heart and, once achieved, the prosthetic half-valve components operate into the left atrium, the native mitral valve, and the left ventricle. can be positioned. In one aspect, it is contemplated that the main delivery catheter is positioned along the access path to allow operable placement in the left atrium without complicating the desired components of the prosthetic half-valve.

In one aspect, the artificial hemi-valve has a unique crescent shape, forming a hemi-valve or hemi-valve. The prosthetic half valve has a ventricular portion that is positioned in the left ventricle and is configured to displace at least one diseased native mitral valve. The atrial portion of the hemivalve is configured to prevent paravalvular leakage and engage the DGF member to secure the entire artificial hemivalve to the mitral annulus. The angled neck region forms the transition between the ventricular and atrial portions of the hemivalve.

In a further aspect, the stent is configured to span at least a portion or all of the circumference of the native mitral valve posterior leaflet via a network of compressible, self-expanding rhomboidal cells, and the surrounding native valve structure. occupy a non-uniform semi-elliptical shape with varying lengths to avoid interference with the In a further aspect, the stent can have an asymmetric, semi-conical or semi-circular cross-sectional profile.

In one aspect, the atrial portion of the stent includes a plurality of cells that assume a shape designed to fit the native mitral valve annulus. The atrial portion of the stent includes an atrial stent tip that is curved so as not to interfere with the atrial wall and a plurality of through holes. It curves downward along its own mitral annulus and connects to the neck region where it transitions into the ventricular portion of the stent.

In a further aspect, a through hole in the atrial portion of the stent is configured to receive a DGF locking member for securing the prosthetic half valve in place on the mitral valve.

In one aspect, the neck region transitions from the atrial portion of the stent to the ventricular portion. The ventricular portion of the stent includes at least one prosthetic leaflet coupled to the inner surface, the prosthetic leaflet forming a C-shape and configured to expand systolic into a D-shape in the operative position. ing.

In one aspect, the ventricular portion of the stent can be configured with a plurality of through holes to facilitate attachment of at least a portion of the prosthetic leaflet.

In one aspect, a plurality of tabs extend from the ventricular portion of the stent, for example, giving the stent a stingray-like shape. The tabs may extend directly from the tip of the stent or may be connected via extending struts. The tab is configured through the housing, positioning and locking process to become a safety mechanism for the prosthetic valve.

In one aspect, a component of the prosthetic half valve is at least one domed prosthetic valve leaflet. At least one prosthetic valve leaflet is attached to the inner surface of the ventricular portion of the stent-frame and is capable of displacing at least one native affected mitral valve posterior leaflet.

In one mode of operation, a prosthetic valve includes a plurality of dome-shaped leaflets that are configured to be flexible and moveable throughout the cardiac cycle. During systole, the at least one prosthetic valve expands radially outward from the stent to form a D-shape and coapt with the healthy autologous anterior leaflet, thereby preventing transvalvular leakage and mitral regurgitation. To prevent. During diastole, the at least one prosthetic leaflet is configured to move toward the stent in a C-shape to allow filling of the ventricle.

It is contemplated that due to the semi-valvular nature of the device, thicker leaflet material may be used to increase the durability of the prosthetic valve. Additionally, a half valve can be shrunk to a smaller profile compared to a full valve, allowing a large proportion of the at-risk population to undergo transcatheter mitral valve replacement.

In one exemplary embodiment, at least one prosthetic leaflet can mimic the configuration of the native mitral valve posterior leaflet, and three adjacent crescent-shaped leaflets extend from the neck portion of the stent into the ventricle. , with the central cusp extending further downward and radially inward than the two smaller side cusps. In further embodiments, each prosthetic leaflet can include a parabolic attachment line, two commissures, an abdominal region, a coaptation region, and optionally at least one leg. .

In one embodiment, the central leaflet attachment line is configured to be symmetrical about the axial midline, with the central prosthetic leaflet spanning ⅓ to ⅔ of the ventricular portion of the stent. The two lateral leaflets are configured to be mirror images of each other on either side of the central leaflet, spanning 1/6 to 1/3 of the ventricular portion of the stent, and are asymmetric about their respective axial midlines. .

In one exemplary aspect, a prosthetic valve includes a plurality of prosthetic valve leaflets configured with arm structures extending from the commissures, the arm structures pointing toward the stent frame during diastole of the cardiac cycle. Stabilize the commissure region of the prosthetic leaflet by limiting the posterior motion of the prosthetic leaflet.

In one aspect, the arm structure can be configured to fold over a portion of the at least one prosthetic leaflet to increase leaflet thickness in the commissure region. Exemplary embodiments contemplate that the arm structures are triangular, rectangular or irregularly shaped.

In a further aspect, the prosthetic leaflet can be provided with at least one dogbone, rectangular, cylindrical or conical leg structure that is attached to the stent frame and radially spaced apart from the stent frame. can be configured to extend Those skilled in the art can appreciate that the leg structure mimics the own aponeurosis in that it can prevent overextension and prolapse of the prosthetic leaflet, which is similar to larger prosthetic leaflets. especially necessary. The leg structure also helps distribute forces across the prosthetic leaflet and frame.

In one embodiment, the prosthetic half valve is configured to occupy approximately half of the mitral orifice in a D-shaped configuration when coapted with the native mitral valve anterior leaflet. The prosthetic half-valve is designed to extend radially inward to the side edges of the stent, but not beyond.

In one aspect, a skirt is coupled to at least a portion of the inner and outer surfaces of the stent. The skirt serves two purposes: to act as a means of mounting the prosthetic leaflets to the ventricular portion of the stent, and to form a paravalvular seal along the atrial portion of the stent.

In one aspect, the material of the skirt can be made of polymer, fabric, biological tissue, or the like. An important feature of the skirt is that it is biaxially oriented, allowing it to stretch both axially and laterally during contraction and expansion of the prosthetic half valve.

In one aspect, the skirt can be a single piece of material, or alternatively the skirt can be made from multiple separate pieces of material coupled to the stent via one or more non-absorbable sutures or strings. can be configured.

In one embodiment, a sealing ring can be bonded to the periphery of the prosthetic half valve to promote tissue growth and protect the native mitral valve peripheral structures from wear by the prosthetic valve.

In one aspect, multiple DGF members can be operatively positioned and implanted at desired locations in the native valve annulus prior to delivery of the replacement prosthetic half valve. In this aspect, the DGF member can improve subsequent positioning and fixation of the replacement prosthetic half valve. In a further aspect, multiple DGF members can help prevent blood leakage between the operably positioned prosthesis and the native mitral valve.

In one exemplary aspect, the DGF member can include permanent head and body portions having removable flexible tail portions. The DGF head member can include a coiled shape that is operatively embedded within valve annulus tissue. The DGF body member can be coupled to a plurality of DGF locking members to secure the prosthetic half-valve device to its own mitral valve annulus. A DGF tail member can be configured as a tether element extending from a proximal portion of the DGF body to connect the DGF member to a crimped prosthetic half valve within a prosthetic half valve delivery implantation system.

In one aspect, a DGF member body is coupled to a plurality of DGF locking members. In one embodiment, the DGF locking member includes a plurality of radially compressible legs forming, for example, a conical shape. In a further embodiment, the tip of the cone is configured to have a smaller diameter than the leg of the cone and smaller diameter than the bore of the atrial portion of the stent, while the leg of the cone is the diameter of the stent. It has a larger diameter than the hole in the atrial portion.

In one embodiment, tension is applied to the DGF tails to pull the DGF locking members through the holes in the atrial portion of the stent, thereby compressing the legs of the DGF locking members inwardly and locking the DGF locking members of the stent. It becomes possible to pass through the hole in the atrium. After passing through the holes in the atrial portion of the stent, the legs of the DGF locking member re-expand to their operative positions, preventing posterior movement of the DGF locking member through the holes in the atrial flared portion of the stent and forming the prosthetic half-valve. effectively locks in the actuated position.

Various embodiments described in the present disclosure may include additional systems, methods, features and advantages, not necessarily expressly disclosed herein, but which are set forth in the following detailed description and accompanying drawings. It will be clear to those skilled in the art from a consideration of . It is intended that all such systems, methods, features and advantages be included within this disclosure and protected by the following claims.

A better understanding of the features and advantages of the present subject matter may be obtained by referring to the following detailed description and accompanying drawings that set forth illustrative embodiments. Features and components in the following drawings are shown to emphasize the general principles of the disclosure. Corresponding features and components throughout the drawings may be designated by corresponding numerals for consistency and clarity.

FIG. 1A is a posterior perspective cross-sectional view of a healthy native mitral valve during systole. FIG. 1A shows that the mitral valve leaflets coapt to form a “fish mouth” coaptation line. FIG. 1B is a perspective view of the native mitral valve after dilatation of the left ventricle to reveal the anatomy of the mitral valve, where the mitral valve leaflets are divided into two parts, anterior and posterior. and each part is subdivided into three sections. The posterior leaflet comprises three adjacent crescents: P1, P2 and P3. The P2 cusp is the largest and extends furthest into the ventricle, while the P1 and P3 cusps are smaller and shorter. The anterior mitral leaflet similarly has regions that systole with P1, P2, and P3, respectively. FIG. 2A shows the native mitral valve viewed from the atrium. It is clear that the self anterior leaflet is larger than the self posterior leaflet. The native posterior leaflet forms a C-shape along the posterior annulus. FIG. 2B is a schematic diagram of an exemplary embodiment of a prosthetic half-valve device including three prosthetic valve leaflets attached to the inner surface of an operating frame in a pressurized deflated state. Prosthesis P1, prosthesis P2 and prosthesis P3 are shown in association with the native mitral valve anterior leaflet. FIG. 3A is a schematic front view of an exemplary embodiment of a prosthetic half-valve frame including a plurality of cells that may be included in a prosthetic half-valve as shown in FIG. 2B. The frame includes an upper atrial portion and a lower ventricular portion separated by a neck region. The atrial portion of the frame has multiple through holes and a curved stent tip. The lower ventricular portion is configured with a plurality of through holes for mounting prosthetic valve leaflets and a variable stent height along its circumference. FIG. 3B shows an alternative embodiment of a stent frame with a central extension member having tabs extending from the tips of the central cells of the ventricular portion of the stent. FIG. 3C shows an alternative embodiment of a stent frame with central and at least one peripheral extension member having tabs extending downward from the ventricular portion of the stent. FIG. 4 is a schematic diagram of an exemplary embodiment of a prosthetic half-valve in a contracted configuration. The free side ends of the stent are configured with bond sites that engage each other during the crimping process, thereby maintaining the valve in a cylindrical shape during crimping. The elongated member is the longest portion of the retracted device and a portion of the delivery system can be configured to engage tabs at the distal end of the elongated member without affecting the rest of the valve. . FIG. 5 is a schematic illustration of an atrial skirt forming a paravalvular seal around the atrial portion of a valve such as the prosthetic half-valve of FIG. 2B. FIG. 6 is a schematic illustration of a frame covered with atrial and ventricular sealing skirts and sealing rings on both sides. FIG. 7 is a schematic diagram of one embodiment of a prosthetic half-valve having three domed prosthetic leaflets attached to the inner surface of a frame. In this aspect, the prosthetic leaflet assembly includes one large central leaflet and two small side leaflets. FIG. 8 shows an exemplary embodiment of a large central prosthetic valve leaflet comprising a domed body, two legs and two arms. Figures 9A and 9B show examples of small side prosthetic leaflets each comprising a domed body and two arms. FIG. 10 is a schematic ventricular diagram of an exemplary embodiment of a prosthetic half-valve device showing the prosthetic valve leaflets in a pressurized contracted state overlaid with the prosthetic valve leaflets in an unpressurized resting state; is. The prosthetic leaflets expand radially away from the frame under systolic pressure. FIG. 11 is a schematic diagram of an exemplary embodiment of a DGF member locking unit; In this aspect, the lock unit comprises a through hole for attachment to the tether and a plurality of legs.

The present invention can be understood more readily by reference to the following detailed description, examples, drawings and claims, and the discussions that precede and follow them. However, before the devices, systems and/or methods of the present invention are disclosed and described, the present invention is not limited to the particular devices, systems and/or methods disclosed, unless expressly stated otherwise. It should, of course, be understood that this may vary. It is also to be understood that the terminology used herein is for the purpose of describing particular aspects only and is not intended to be limiting.

The following description is provided as an effective teaching of the invention in its best, currently known embodiment. Thus, those skilled in the art will recognize and understand that many modifications can be made to the various aspects of the invention described herein while still achieving the beneficial results of the invention. It will also be apparent that some of the desired advantages of the present invention can be obtained by selecting some of the features of the embodiments described herein without utilizing other features.

Accordingly, those skilled in the art will recognize that many modifications and adaptations are possible, and may even be desirable in certain circumstances, and are part of this invention. Accordingly, the following description is provided as illustrative of the principles of the invention and not as a limitation of the invention.

For clarity, it should be understood that this disclosure focuses on the treatment of functional mitral regurgitation. However, the leaflet replacement system and associated methods can be used to treat other types of mitral regurgitation or to replace other diseased valves of the human heart, such as the tricuspid valve; It is contemplated that it may be otherwise configured for use or may be used or otherwise configured for use in other mammals similarly afflicted with valve defects.

As used throughout, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise. Thus, for example, reference to a "leaflet" can include two or more such leaflets unless the context indicates otherwise.

Ranges can be expressed herein as from "about" one particular value, and/or to "about" another particular value. When such a range is expressed, another aspect includes from the one particular value and/or to the other particular value. Similarly, by use of the antecedent "about," it will be understood that the particular value forms another aspect when the value is expressed as an approximation. Further, it will be understood that the endpoints of each range are important both relative to and independent of the other endpoints.

As used herein, the term "optionally" or "optionally" means that the subsequently described event or circumstance may or may not occur and that the description indicates that It is meant to include cases where an event or situation occurs and cases where it does not.

As used herein, the term "or" means any one member of a particular list and also includes any combination of the members of that list. Further, conditional language, such as specifically "could," "could," "may," or "may," unless otherwise stated or understood within the context in which it is used. Note that in general, it is intended to convey that certain aspects include certain features, elements and/or steps while other aspects do not. Thus, such conditional language implies that the feature, element and/or step is somehow necessary for one or more particular aspects, or that one or more particular aspects require user input or prompting. generally intended to mean necessarily including logic for determining whether or not those features, elements and/or steps are included or performed in any particular embodiment. not

Components are disclosed that can be used to implement the disclosed methods and systems. These and other components are disclosed herein, and each of the various individual and collective combinations and permutations thereof when combinations, subsets, interactions, groups, etc. of those components are disclosed. are not explicitly disclosed, it is to be understood that each is specifically contemplated and described herein for all methods and systems. This applies to all aspects of this application including, but not limited to, steps in disclosed methods. Thus, if there are various additional steps that can be performed, it should be understood that each of those additional steps can be performed with any particular embodiment or combination of embodiments of the disclosed method.

The method and system can be more readily understood by reference to the following detailed description of exemplary embodiments.

Throughout this specification, the terms "prosthetic valve", "prosthesis", "valve stent", "heart valve leaflet replacement device" and "valve device" are used interchangeably and are used interchangeably with the heart valves described herein. Contemplated as a replacement device.

Referring to FIG. 1A, the mitral valve leaflet consists of an anterior leaflet 6 and a posterior leaflet 10 that arise from the annulus and extend into the left ventricle 3 . In healthy patients, the anterior mitral leaflet 6 and the posterior mitral leaflet 10 coapt together during systole to prevent regurgitation through the mitral valve 4 . The posterior mitral valve leaflet 10 forms a "C" shape extending from the posterior annulus, as shown in FIG. 2A. In diseased conditions, the posterior leaflet 10 may not fully coapt with the anterior leaflet 6 due to anchoring of the posterior leaflet 10 and/or dilation of the mitral annulus, thereby causing mitral regurgitation.

Turning to the drawings, mitral regurgitation is treated in a patient with regurgitation and normal anterior mitral leaflet 6 motion by replacing the posterior mitral leaflet 10, for example as shown in FIG. 2B. An exemplary embodiment of a prosthetic half-valve device 1 designed to. The prosthetic half-valve device 1 comprises a crescent-shaped frame or stent 100 fixed to the posterior mitral annulus and, in operation, forms a coaptation region 204 with its anterior mitral leaflet 6 during systole. As such, at least one artificial valve leaflet 200 is positioned on the native posterior leaflet 10 . In this embodiment, one or more artificial valve leaflets 200 extend from the stent 100 to form a C-shape similar to the native posterior leaflet 10, but of note in the dilated heart to the native anterior mitral valve. It can be further radially expanded to join the cusp 10 .

In one exemplary aspect, the prosthetic half-valve device 1 comprises a crescent-shaped stent 100, at least one dome-shaped prosthetic leaflet 200, and a prosthetic leaflet 200 to facilitate sealing and attachment of the prosthetic leaflet 200 to the stent 100. and at least one seal skirt 300 of . The prosthetic half-valve device 1 is configured such that at least one prosthetic valve leaflet 200 coapts with at least one native anterior leaflet 6 during systole of the cardiac cycle during operation, for example as shown in FIG. 2B. there is

In one aspect, it is contemplated that in the expanded configuration, stent 100 defines a substantially semi-circular cross-sectional profile. Additionally, the surface of the stent 100 may have non-circular cross-sections, including but not limited to semi-elliptical cross-sectional profiles or asymmetrical cross-sectional profiles, for example, to at least partially conform to the shape of the native annulus. It is also contemplated that stent 100 is configured to define a profile. As used herein, the term "asymmetric cross-sectional profile" includes any non-circular cross-sectional shape.

In one aspect, as shown in FIG. 3A, stent 100 is configured to have a crescent shape to form a half-valve or hemi-valve. In this aspect, stent 100 can have a semi-conical shape. Half-conical stent 100 lies between upper atrial portion 104, lower ventricular portion 110, and upper atrial portion 104 and lower ventricular portion 110 and defines a longitudinal axis therebetween, i.e., the length of stent 100. and a neck region 109 aligned along the longitudinal direction.

Still referring to FIG. 3A, the semi-valvular stent 100 can be made from a self-expanding or balloon-expandable material formed into a network or mesh of cells. In this aspect, the stent frame 100 is laser cut or made from a deformable biocompatible material, such as stainless steel or cobalt chrome for balloon expandable devices, or nitinol for self-expandable devices with memory shape properties. can be woven. In a further aspect, stent 100 can be configured to be foldable, retractable, and expandable to desired loaded and actuated positions, respectively.

In one aspect, the atrial portion 104 of the stent may be configured to be placed at or over the native mitral valve annulus to facilitate fixation and sealing of the prosthetic half valve 1 .

Additionally or alternatively, the atrial portion 104 of the stent may be configured to span at least a portion or all of the native mitral annulus.

In one aspect, the atrial portion 104 of the stent is configured to radially span a portion or all of the posterior annulus of the native mitral valve. In this aspect, upper atrial portion 104 may be configured to have at least one row of cells. In the illustrated example, the cells include struts oriented in a collapsible diamond configuration extending radially outwardly from neck portion 109 of the stent. In this aspect, the diameter of upper atrial portion 104 is smallest near neck portion 109 and increases outwardly toward atrial crown 117 and the left atrial wall.

Referring to FIG. 3A, the atrial portion 104 of the stent is configured with compressible cells. In one aspect, the atrial portion 104 of the stent includes at least one row of cells. The cells comprise a collapsible network of struts oriented in a diamond configuration extending radially outward from the neck portion 109 of the stent. The cell height can be about six to twelve millimeters (6-12 mm). In the example shown, each cell is formed by four struts, two upper struts and two lower struts. The dimensions of the upper and lower struts can be the same or different. The upper and lower struts are joined together by cell bridges called joints 103 . Bonds 103 can be designed to be compressible or non-compressible throughout stent 100 .

In an exemplary aspect, some of the joints 103 of the atrial portion of the stent can be configured with through holes or holes 108 . In this aspect, through-holes 108 are used to anchor and secure stent 100 on the mitral valve annulus. The holes 108 can be configured to have an inner diameter of about 0.5-3 millimeters (0.5-3 mm), and about 5-15 holes can be configured along the atrial portion 104 of the stent. can. Apertures 108 in atrial portion 104 of the stent are configured to allow passage of locking member 131 in only one direction.

Alternatively, anchoring of stent 100 to the mitral valve annulus may be accomplished by other methods, such as using adhesives and one or more of tissue grasping, capturing and suturing. can.

In optional aspects, the holes 108 can have a circular, rectangular, square or oval shape.

In one aspect, due to the aspect of the prosthetic valve 1 halves, the lateral edges 107 of the lateral cells 106 of the atrial portion 104 of the stent do not share joints 103 with adjacent cells.

In this aspect, the coupling portion 103 of the side cell 106 can be configured to have a coupling site at the side edge 107 . In this aspect, the bond sites on the side edges 107 of the stent can be configured to have matching corresponding shapes so that they fit snugly together and maintain the stent in a cylindrical shape during crimping. In this aspect, the shape of one coupling portion 103 on one side can be configured to match and fit the shape of the other coupling portion on the opposite side.

In one exemplary aspect, the binding sites can be straight, zig-zag, wavy, semi-circular, semi-elliptical, rectangular or irregular shaped struts.

In one aspect, the atrial portion 104 of the stent is configured to conform to the valve annulus during operation. The upper struts of the cells of the atrial portion 104 of the stent, also called crowns or free stent tips, are curved tips 117 so as not to interfere with the left atrial wall 2 during operation, for example, as shown in FIG. 3A. can be configured to have In an exemplary embodiment, the angle of curvature of tip 117 can be between about 90° and 145° relative to the remainder of upper flared portion 104 . Such curvature allows the atrial portion 104 of the stent to conform to the wall 2 of the left atrium. In this example, the lower struts of the cells of the atrial portion 104 of the stent curve downward and connect to the neck region 109 and transition relative to the ventricular portion 110 of the stent in an angular range of 65° to 120°.

In an optional aspect, the stent tip 117 of the atrial portion 104 of the stent can be configured to have a curvature such that it is substantially parallel to the mitral valve annulus during operation.

In one exemplary aspect, the atrial portion 104 of the stent can be configured with two rows of cells. In this embodiment, rows of cells near neck region 109 have smaller dimensions than other rows of cells toward stent tip 117 . In this embodiment, additional rows of cells can be made up of bend struts with angles between 90° and 145°.

Alternatively, the two rows of cells in the atrial portion 104 of the stent can have the same dimensions.

In one aspect, neck region 109 joins atrial portion 104 and ventricular portion 110 of the stent. In this embodiment, neck region 109 is continuous with upper atrial portion 104 and lower ventricular portion 110 of the stent. Neck region 109 can be composed of at least one row of cells, for example, having a height of about one to seven millimeters (1.0-7.0 mm). The upper portion of neck 109 is curved or angled to facilitate the transition between atrial portion 104 and neck portion 109 of the stent. Similarly, the lower portion of neck 109 is curved or angled to facilitate the transition between neck portion 109 and ventricular portion 110 of the stent.

In one exemplary aspect, as shown in FIG. 3A, neck region 109 includes a single column of cells. The cells of the neck region 109 are formed by the struts of the atrial portion 104 and the struts of the ventricular portion 110, the lower struts of the atrial portion 104 forming foldable half-cells and connecting to elongated thick straight struts that connect the ventricle. The upper struts of portion 110 form the other half of the collapsible cell. In this example, neck region 109 is configured to bend such that the angle between atrial portion 104 and ventricular portion 110 is in the range of approximately 65° to 120°. In this aspect, the atrial portion 104 of the stent is substantially parallel to the annulus.

In one aspect, shown in FIG. 3A, the ventricular portion 110 of the stent can have an asymmetric semi-conical or semi-circular cross-sectional profile.

In one exemplary aspect, the ventricular portion 110 of the stent is configured to span at least a portion or all of the posterior leaflet 10 of the native mitral valve 4 . Optionally, to ensure that there is at least partial or complete coaptation between the native anterior mitral leaflet 6 and at least one prosthetic leaflet 200 coupled to the inner surface of the ventricular portion 110 of the stent. Additionally, the lateral edges 112 of the stent can extend circumferentially to the native mitral commissures 14 (not shown, see, eg, FIG. 1B).

In one aspect, in the expanded configuration, stent 100 is configured to have an anterior-posterior (AP) dimension. In exemplary embodiments, the AP dimension at the ventricular level is in the range of about ten to forty millimeters (10-40 mm) and/or the AP dimension at the atrial level is in the range of about twenty to sixty millimeters (20-60 mm). be. In further examples, the length of the anterior commissure to the posterior commissure, or intercommissural (CC) length, can range from about twenty to sixty millimeters (20-60 mm) and/or the CC length at the atrial level The height can range from about thirty to ninety millimeters (30-90 mm). The ventricular portion 110 of the stent is configured to form a "C" shape in the actuated position, thereby displacing the native mitral valve posterior leaflet 10 so that at least one prosthetic leaflet 200 is positioned to the side of the stent 100. It expands radially to the edge to allow it to coapt with its own anterior leaflet 6 .

In one aspect, the ventricular portion 110 of the stent is configured to have different heights along its circumference so as not to interfere with the papillary muscles 14 .

In the presently preferred embodiment of the ventricular portion 110 of the stent, the stent height at the center of the valve can be in the range of about ten to forty millimeters (10-40 mm), and the stent height at the sides of the stent 112 is about 5 mm. It can range from ˜15 millimeters (5-15 mm).

In one aspect, the ventricular portion 110 of the stent can include at least one row of cells. The rows of cells can span all or part of the circumference of the ventricular portion 110 of the stent.

In one exemplary aspect, the ventricular portion 110 of the stent is configured with three rows of cells. Rows I 134, II 135, and III rows 136 are configured to be in the upper, middle, and lower portions of the ventricular portion 110 of the stent, respectively. Each row is configured with a plurality of connected struts that take up collapsible diamond-shaped cells with a height of 7-8 mm and a width of 4-6 mm. Each column can contain the same number of cells or a different number of cells.

In one aspect, the row I cells 134 are attached to the neck region 109 at the top of the cell and share the row II cells 135 at the bottom strut 101 . Optionally, one or more of the cells 134 of Row I may be configured to be covered with a sealing skirt 300 to facilitate coupling of the prosthetic valve leaflets 200 and prevent leakage.

In an additional aspect, column II cell 155 shares a top with column I cell 154 and a bottom with column III cell 156 . In one aspect, the plurality of row II cells 155 behind at least one prosthetic valve leaflet 200 can optionally be configured to be open cells without being covered by the skirt 300. is. This configuration facilitates radial expansion of the at least one prosthetic leaflet 200 and prevents blood stagnation behind the leaflet or leaflets 200 . The cells covered by skirt 300 include, for example, leaflet attachment lines for coupling multiple prosthetic leaflets 200 to stent 100 .

In another aspect, column III cells 136 share tops with column II cells 135 and are independent bottoms. Two side edges 112 are configured to be covered with at least one layer of fabric 300 . The portion of the row III cells 136 corresponding to the attachment area for the prosthetic valve leaflet 200 is configured to be covered with a sealing skirt 300, while other areas are optionally left open without the skirt 300. be able to.

In one aspect, the height and width of the cells in each column can be the same. Alternatively, the height and width of the cells in each column may be different.

In one aspect, the ventricular portion 110 of the stent can be configured with a semi-conical shape, the diameter of which is smallest near the neck portion 109 and increases downward toward the ventricle 3 during operation.

In one optional aspect, as shown in FIG. 4, the stent can include bond sites on the side edges 112 of the ventricular portion 110 of the stent to facilitate crimping. In this aspect, the binding site 112 can be configured to include at least one column of ventricular cells and, optionally, at least one column of atrial cells. In this aspect, the side edges 112 of the stent can be configured to have a corresponding shape that fits snugly together and maintains the stent in a cylindrical shape throughout crimping. In one exemplary aspect, the binding sites 112 can be configured as straight, zig-zag, semi-circular, semi-elliptical or rectangular struts.

In one aspect, the joints 103 can be configured as non-straight sections of the side edges 112, with opposite side edges 112 configured to engage each other during retraction 18 of the stent.

In one aspect, one or more cell struts are configured with through holes 113 that provide a mechanism for attaching at least a portion of the prosthetic valve leaflets 200 to the frame without the need for skirt 300 material on the cells. be able to.

In one exemplary embodiment of the prosthetic half-valve device 1, one or more struts of row III 136 of stent ventricular portion 110 have through holes 113 for attaching at least one prosthetic leaflet leg 205 directly to the struts. can be configured to comprise In this aspect, the diameter of the plurality of through-holes 113 can range from approximately 0.1 mm to 1 mm. Optionally, struts containing through holes 113 can be configured to be about 1.1 to 2.5 times wider than other struts to accommodate the presence of through holes 113. can.

In one exemplary embodiment, the stent ventricular portion 110 is configured such that at least one prosthetic leaflet commissure 201 is attached to the frame 100 at one or more of the ventricular stent tips 118 so that the leaflets 200 are The stent tip 118 can flex radially under load.

As shown in FIG. 3A, in one exemplary aspect, the ventricular portion 110 of the stent is configured to have a stingray shape, extending furthest in the center of the ventricle 3 to prevent interference with the autologous papillary muscles 16 during operation. The sides 112 are shorter to prevent squeezing.

As shown in FIGS. 3B and 3C, the stingray design of stent 100 configures at least one stingray tail or extension member 114 to extend vertically downward from the lower strut connection 103 of ventricular section 110 of the stent. be able to. The one or more extension members 114 may extend from the lower central cell of the ventricular section 110 of the stent, or optionally from any other portion of the stent 100 . In an exemplary embodiment, extension member 114 can have a width of approximately 0.3-5.5 mm and a length of approximately 1.0-10.0 mm. The distal end of extension member 114 can be configured with a central tab 115 .

Alternatively, extension members 114 having central tabs 116 can extend from different cells along the circumference of the ventricular portion 110 of the stent. In this embodiment, the extension member 114 can have a length of about 1.0-5.0 mm so as not to interfere with its surrounding structure.

Alternatively, as shown in FIGS. 3B and 3C, at least one peripheral tab 116 is configured to be attached to different cells along the circumference of the ventricle portion 110 of the stent without the use of extension members 114. can do.

In another aspect, at least a portion of ventricle portion 110 is configured such that bottom end 118 curves radially inward. In one example, the bend angle can be configured to be between 10° and 50° with respect to the axial direction of stent 100 .

In one exemplary aspect, tabs 115, 116 can include at least one hole. Tabs 115, 116 may have a variety of shapes for various delivery system engagement mechanisms including, but not limited to, magnetic engagement mechanisms, male-female coupling engagement mechanisms, rotational locks, and the like. configured and the mechanisms can selectively engage at least a portion of the delivery system throughout the valve deployment process, thereby stabilizing the deployment process.

In one aspect, tabs 115, 116 can be made of the same or different material as stent 100 and can be permanently connected to stent 110 via various attachment means such as adhesives, magnetic engagement, and the like. Tabs 115, 116 and their extending structures 114 can be connected to the delivery system in different orientations. In a further aspect, tabs 115, 116 can be removed from stent 100 after stent deployment.

In one aspect, at least one prosthetic leaflet 200 is attached to a skirt 300 that is coupled to the ventricular portion of stent 110 via non-absorbable sutures. Stent 100 can be configured to allow natural dynamic motion of one or more remaining native leaflets to coapt with one or more prosthetic leaflets 200 .

In one aspect, the ventricular portion 110 of the stent is configured to displace the native mitral valve posterior leaflet 10 within the left ventricle 3 of the heart and place at least one prosthetic leaflet 200 in its place.

Seal skirt 300 is coupled to at least a portion of the inner and outer surfaces of stent 100 to prevent leakage between prosthetic half-valve frame 100 and at least one prosthetic leaflet 200 and to seal at least one prosthetic leaflet 200 . Configured to provide a base for mounting.

Skirt 300 can be made of synthetic or natural biocompatible impermeable materials including, but not limited to, polymers, fabrics, biological materials, and the like. The skirt 300 can be cut from the same material as the leaflets 200 or a different material to ensure compatibility within the body. Skirt 300 can be laser cut, stamped or hand cut to optimize desired dimensional uniformity and precision. In one exemplary embodiment, the thickness of skirt 300 may range from approximately 0.1 mm to 0.15 mm.

In one aspect, the skirt 300 can be configured to exhibit a biaxial orientation with the fibers aligned circumferentially, thereby allowing the skirt 300 to stretch axially during the crimping and releasing processes. This allows the skirt 300 to conform to the elongated stent shape without tearing or damaging the prosthetic valve leaflets 200 .

Optionally, impermeable sealing skirt 300 further comprises an atrial portion 302 and a ventricular portion 301 . In this option, the atrial portion 302 and ventricular portion 301 can be constructed as a single piece. Alternatively, the atrial 302 portion and the ventricular portion 301 can be configured as two separate pieces/pieces.

In one aspect, skirt 300 is coupled to stent 100 via one or more of sutures, adhesives and/or other biocompatible materials.

In one aspect, ventricular skirt 301 is used as a structure for attaching prosthetic leaflet 200 to stent 100 . In this aspect, a ventricular skirt 301 can be configured to cover at least a portion of the ventricular portion 110 of the stent to facilitate attachment of the prosthetic valve leaflets 200 .

In one aspect, the ventricular portion of the skirt 301 is configured with a plurality of tabs configured to wrap around the struts of the stent at the commissural regions to prevent movement of the skirt during retraction. there is

In one aspect, the ventricular skirt 301 can be configured to conform to the inner surface of the ventricular portion 110 of the stent. The upper edge of the ventricular skirt covers the neck region 109 of the stent and also provides a pathway for a connecting line 303 to attach the ventricular skirt 301 to the atrial skirt 302 . Ventricular skirt 301 is configured to cover selected cells of ventricular portion 110 of the stent.

In one aspect, the prosthetic leaflet 200 is configured to attach to the ventricular skirt 301 along an engineered parabolic leaflet attachment line. Ventricular skirt 301 is configured to cover stent portion 110 along which leaflet attachment lines are to be aligned to facilitate attachment of at least one prosthetic leaflet 200 to stent 100 .

In one embodiment, as seen in FIG. 5, multiple enlarged tabs 312 of the atrial skirt 302 are folded to form multiple pockets for paravalvular seals. In a further embodiment, folding over the enlarged tabs 312 creates a uniform layer of skirt 302 on the dorsal side of the valve 100 in direct contact with the atrial tissue 2 . This layer of folded enlarged tabs 312 prevents paravalvular leakage.

In one aspect, an atrial skirt 302 is used to facilitate a paravalvular seal in the atrium 2 and further secure the valve 1 to the annulus. Atrial skirt 302 is configured to conform to the natural curvature of atrial portion 104 of the stent.

In one aspect, the atrial skirt 302 is made of a material that can be penetrated by the DGF member head so that additional DGF members can be implanted through the atrial skirt 302 to further secure the valve 1 after the valve 1 has been deployed and locked in place. Can be configured.

In the example shown in FIG. 5, the atrial skirt 302 is provided with two side tabs 309 . These tabs 309 are configured to fold back at the lateral edges 106 of the atrial portion of the stent to form side skirts. The lower portion of the side tabs 306 of the atrial skirt 302 engage the large tabs of the ventricular skirt 301 by folding under the corresponding large tabs. The large tabs of the ventricular skirt 301 and the side tabs 309 of the atrial skirt 302 fold over themselves. This feature is notable because this area is in direct contact with the commissures 14 of the own mitral valve 4 . The side skirts thereby serve two functions. First, the side skirts prevent the sharp edges of stent 100 from cutting into its own mitral valve commissure 14 . Second, the side skirts provide mounting for a seal ring 316 to form a paravalvular seal around the rim of valve 1 .

Optionally, as shown in FIG. 6, a sealing ring 316 is attached to the lateral edges 107, 112 of the valve to form a paravalvular seal along the commissures 14 of the native mitral valve 4 and to seal the stent. Cushioning can be provided between the side edges 107, 112 of 100 and the surrounding tissue.

In one embodiment, a sealing ring 316 can be attached to at least a portion of the atrial portion 104 of the frame to form a paravalvular seal along the annulus.

The sealing ring 316 can be made of flexible synthetic or natural biocompatible materials including, but not limited to, polymers, fabrics, biomaterials, and the like. The sealing ring 316 can surround the lateral and superior edges of the valve 1 that may come in contact with the native tissue while avoiding the inferior edge of the valve 1 so as not to impede movement of the leaflets during operation. Sealing ring 316 may be permanently affixed to valve 1 with, for example, one or more sutures, adhesives and/or other biocompatible materials.

In one aspect of the prosthetic half-valve device 1, at least one domed prosthetic valve leaflet 200 can be attached to the inner surface of the frame. In one aspect, at least one prosthetic leaflet 200 can be attached to the inner surface of the lower ventricular portion 110 of the frame. The at least one artificial valve leaflet 200 can have multiple leaflets, and all of the artificial valve leaflets 200 can have the same shape and size, or one or more of the multiple leaflets 200 are different. Contemplated to have a shape and/or size.

In the exemplary embodiment shown in FIGS. 7 and 8, each domed prosthetic leaflet 207 includes two commissures 201, a curved attachment edge 202, an abdominal region 203, a coaptation region 204, and optionally can include at least one arm 215 and at least one leg 205 . In one exemplary aspect, the attachment edge 202 of at least one leaflet 207 can be attached to the inner lumen of the stent 100 or skirt 300 using, for example, non-absorbable sutures. Alternatively, feet 214, ie, the free ends of at least one leg 205, can be attached to the inner lumen of stent 100 or skirt 300 using non-absorbable sutures, for example.

In one aspect, the dome-shaped one or more prosthetic leaflets 207 are configured to be movable throughout the cardiac cycle such that the ventral and coaptation regions expand radially inward from the frame 100 during systole to center the orifice. It prevents reflux or commissural leakage and is adapted to move towards the frame 100 during diastole to allow ventricular filling. The prosthetic leaflet commissures 201 attached to the stent 100 , the attachment edges 202 and the feet 214 of the legs 205 are immobile with respect to the stent 100 .

In one aspect, the at least one prosthetic leaflet 207 can be configured to have at least one arm 215 extending from the leaflet commissure 201 .

In one aspect, the dome-shaped one or more leaflets 207 do not impinge on the frame 100 when the valve is open, and in operation have a limited collapse so that they cannot extend beyond the radius of the frame 100 when the valve is closed. It can be configured to exhibit ease and radial expansion.

In one aspect, the domed one or more artificial valve leaflets 207 may be configured to coapt with the own mitral valve anterior leaflet 6 in systole during operation. Referring to the healthy native mitral valve 4 in systole in FIG. In patients with functional mitral regurgitation, their mitral valves 6, 10 may not extend far enough toward each other to fully coapt. As shown in FIG. 2B, the prosthetic leaflet 200 forms the C-shape of the posterior leaflet 10 of the patient with functional mitral regurgitation, extends beyond this line into a D-shape, It is contemplated that it can be configured to coapt with the anterior leaflet 6 .

The anchoring mechanism of the prosthetic half-valve device 1 may be configured to resist separation from the posterior mitral annulus during systole and device movement during actuation. In one aspect, the prosthetic half-valve device 1 may be configured to cover approximately half or two-thirds of the mitral valve orifice during systole. In this aspect, considering the half-valvular nature of the prosthetic half-valve 1, only about half of the force induced by blood flow during systole is exerted on the prosthetic half-valve device 1, and thus only half of the force is anchored. It will act on the mechanism. The rest of the force induced by blood flow will act on the native mitral valve anterior leaflet 6 and the annulus. Therefore, it is contemplated that the prosthetic half valve 1 can be easily secured to the mitral valve annulus compared to a circumferential prosthetic valve. Those skilled in the art can appreciate that securing a circumferential valve prosthesis device in the mitral valve position continues to be a challenge.

In one aspect of the prosthetic half-valve device 1, with continued reference to FIG. 2B, a plurality of domed prosthetic valve leaflets 200 can be formed from flat pieces of flexible material that are movable throughout the cardiac cycle. The dovetail is sewn or otherwise attached to the frame 100 so that it can resist separation from the frame 100 . In another aspect, multiple dome-shaped prosthetic valve leaflets 200 are preformed into a 3D dome shape by casting, deformation, molding, braiding, thermal or chemical treatment, 3D printing, electrospinning or other manufacturing methods. can be done.

In one aspect, the plurality of prosthetic leaflets 200 can comprise pericardial tissue, or other biological or tissue-engineered materials, polymers, fabrics or flexible metallic materials, or the like. In this manner, the moveable, flexible prosthetic leaflets 200 exhibit resiliency when interacting with their anterior leaflets 6, thus minimizing damage induced to their leaflets 6 by repeated contact. is intended to be reduced to

Due to the semivalve 1 nature of the device, the leaflet prosthesis 200 may be constructed of thicker leaflet material than other mitral valve prostheses intended to be implanted via a catheter, and still remain in place for the procedure. It is contemplated to have a small, reduced device profile, which is desirable for feasibility and patient safety. Those skilled in the art can appreciate that thicker prosthetic valve leaflets 200 are desirable for prosthetic valve 1 durability.

Referring to FIG. 1B, the native posterior mitral valve leaflet 10 includes three adjacent half-moon cusps, the P1 cusp 11, P2 cusp 12 and P3 cusp 13 . The P2 cusp 12 is the largest and extends furthest into the ventricle 3, while the P1 cusps 11 and P3 cusps 13 are smaller and shorter, especially laterally. In one exemplary embodiment of the prosthetic half-valve device 1, as shown in FIG. It can include a larger central leaflet 207 that mimics the natural structure.

Still referring to FIG. 7, in one aspect, prosthetic valve leaflets 200 can be configured as a plurality of dome-like structures extending radially away from and inwardly from stent 100 . In another optional embodiment, the prosthetic P2 (PP2) leaflet 207, similar to the native mitral valve posterior leaflet 10, is laterally wider than the prosthetic P1 (PP1) leaflet 206 and the prosthetic P3 (PP3) leaflet 208. can also extend further downward into the left ventricle 3 during operation.

In the exemplary embodiment shown in FIGS. 9A and 9B, the PP1 leaflet 206 and the PP3 leaflet 208 can be configured as mirror images of each other, with corresponding shorter frame heights at the lateral edges. Central PP1 and PP3 commissures 210 align with PP2 commissures, having a lower height and a higher height of the central margin. Also, having shorter PP1 and PP3 side commissures 209 can desirably reduce the crimped profile of the prosthetic half-valve device 1, as can be appreciated by those skilled in the art. Because the amount of leaflet material is greatest at the leaflet commissures 201, having the lateral commissures 209 at a different height than the central commissures 210 reduces the amount of material at the central commissures 210, thus allowing more This is because it can be reduced to a small diameter.

In one embodiment of the prosthetic half-valve device 1 , the prosthetic valve leaflets 200 begin just below the neck region 109 of the frame 100 and extend axially to the tip 118 of the ventricular portion of the frame, extending into the ventricular portion 110 of the frame. It can be configured to be attached to the frame 100 in a circumferential manner. In other optional aspects, the prosthetic leaflets 200 can be configured to wrap around the side edges of the frame 112 or can be configured to cover only a portion of the circumference of the frame 100 . Further, the prosthetic leaflet 200 can be configured to extend axially from the upper flared portion 104 or neck portion 109 of the frame to the ventricular portion 110 of the frame. Optionally, the prosthetic leaflets 200 may be configured to cover only a portion of the ventricular portion 110 of the frame.

In one aspect, the leaflet prosthesis 200 is attached to the frame 100 along a leaflet attachment line 320 , the leaflet attachment line including a plurality of parabolas each outlining the prosthesis 200 .

In one aspect, leaflet attachment line 320 is configured to be symmetrical about the center of skirt 300 . In an optional aspect, the leaflet attachment line 320 is configured to be asymmetrical.

In one exemplary embodiment, the leaflet attachment lines 320 are configured as three parabolas next to each other for attaching three different prosthetic leaflets 200, as shown in FIG. In this aspect, the leaflet attachment lines 206, 207, 208 for PP1, PP2, PP3 can be configured to have the same size and shape, or can be configured to have different sizes and shapes. , can be either symmetrical or asymmetrical.

Optionally, the PP2 leaflet attachment line 320 is configured to span approximately ⅓ to ⅔ of the circumference of the stent 100 and is symmetrical about its axial midline.

Additionally or alternatively, the PP1 and PP3 leaflet attachment lines 320 can be configured as mirror images of each other and configured to span approximately 1/6 to 1/3 of the stent circumference. The PP1 and PP3 leaflet attachment lines 320 are configured to be shorter at the lateral margins and asymmetrical about their respective axial midlines.

In one aspect, the plurality of leaflets 200 may be configured as separate individual pieces of flexible material attached to the frame 100 along each of the parabolic leaflet attachment lines 320 . Each leaflet 206, 207, 208 can be made of the same material or different materials. In another optional aspect, the plurality of leaflets 200 may be formed from a single piece of flexible material by attaching the material to the frame 100 along each of the parabolic leaflet attachment lines 320. can.

In one aspect, the parabolic shape of leaflet attachment line 320 can be configured to distribute flow-induced forces across prosthetic leaflet 200 and frame 100 . Those skilled in the art can appreciate that by distributing the force over the device 1, localized high stress areas that can adversely affect the durability of the device 1 can be prevented.

In one aspect, the leaflet attachment lines 320 can be configured to align with the stent struts so that blood flow forces acting on the leaflets 200 are partially distributed directly to the stent 100, especially in high stress regions. In a further aspect, the prosthetic leaflet commissures 201 are arranged such that the ventricular stent tips 118 can deflect radially inwardly, for example, about 5° to 15° when pressure loads are applied to the prosthetic leaflet 200 . A leaflet attachment line 320 may be configured to align with the ventricular stent tip 118 . In this manner, deflection of the stent tip 118 can cushion the prosthetic leaflet 200 from forces acting on it, which has been shown to be important for the durability of the bioprosthetic valve 1. .

In another optional aspect, the leaflet attachment lines 320 can be configured such that the prosthetic leaflet commissures 201 align with the tabs 116 extending from the lower ventricular portion 110 of the frame, as shown in FIG. 3C. In this aspect, tab 116 may be configured with at least one through hole to facilitate attachment of commissure 201 to frame 100 . Optionally, the ends of the extension members 115 are provided with a tab to allow the tabs to flex radially inward, eg, about 5° to 15°, when a pressure load is applied to the prosthetic valve leaflet 200 . Tab 116 can be configured.

In one aspect, the prosthetic leaflet 200 can be attached to the frame 100 such that the stent cells behind the ventral region 203 of the prosthetic leaflet 200 are open without the skirt 300 material. By keeping these cells open, blood flow can reach the ventral region 203 of the prosthetic valve leaflet 200 more quickly, and the prosthetic valve leaflet 200 covers the mitral orifice during systole. Rapid expansion is contemplated so that backflow can be prevented. Further, it is believed that this aspect may reduce the incidence of thrombus formation due to flow stagnation by increasing blood outflow between the prosthetic leaflets 200 and the frame 100 .

8, in one exemplary embodiment, a larger PP2 leaflet 207 can be configured with multiple leg structures 205, with feet 214 attached to the ventricular portion of frame 110. be done. In this aspect, leaflet legs 205 are configured to limit radial expansion of leaflet abdomen 203 and coaptation region 204 to prevent billowing and prolapse. In addition, leaflet legs 205 can help distribute forces across leaflet 200 and frame 100, which is particularly important for larger leaflets that experience large flow-induced forces.

Those skilled in the art can appreciate that for proper prosthetic valve leaflet 200 function, ie, radial expansion, proper dome shape overall balance must be maintained. For simplicity, consider the height-to-width ratio of a two-dimensional dome. On the other hand, a large height-to-width ratio may limit the radial expansion of the prosthetic valve leaflets 200 and may not expand far enough to cover the regurgitant orifice region. .

Referring to the example shown in FIG. 8, the PP2 leaflet 207 has a small height-to-width ratio of about 0.4-0.7, which allows a large degree of radial expansion, but Deviation is also likely to occur. Thus, the PP2 leaflet 207 has two legs 205 and does not radially extend beyond the length of the legs 205, which is about 70-100% of the anterior-posterior dimension of the frame. The legs are configured to be attached to the frame 100 to limit the . In this aspect, the leg structure 205 is a design feature that prevents prolapse of leaflets with a small height-to-width ratio and a large degree of radial expansion. In this embodiment, the leg structure 205 has a length to width ratio of about 4-7.

With reference to the example shown in FIGS. 9A and 9B, the PP1 and PP3 leaflets 206, 208 have a large maximum height-to-width ratio of about 1-1.5, with a lesser degree of radial expansion. Therefore, the PP1 and PP3 leaflets 206, 208 of this embodiment do not require legs 205. FIG.

The height-to-width ratio that determines leaflet prolapse also depends on the angle of the ventricular portion 110 of the stent relative to the atrial portion 104 of the stent, with an angle of less than 90° for leaflet prolapse for low height-to-width ratios. would help prevent deviations from Furthermore, the height-to-width ratio depends on the opening angle of the leaflets 200, ie, the angle between the two commissures 201 and the center point of the frame 100, with larger angles increasing the valve It may help prevent prolapse of the apex 200. As such, the height-to-width ratio of leaflet 200 shown here is exemplary to illustrate the effect of leg structure 205 and is not intended to be limiting.

Those skilled in the art will appreciate that as a patient's mitral regurgitation progresses, the mitral annulus often expands more and more without requiring a proportional increase in the height of the prosthetic leaflet 200. It can be appreciated that a greater degree of radial expansion of the prosthetic leaflet 200 may be desirable. Thus, in some aspects, the leaflet prosthesis 200 may require one or more additional leg structures 205, including leg structures for the smaller side leaflets 206,208. In some other aspects, the prosthetic leaflet 200 may require one or more additional leaflets to make it 4 or 5 leaflets.

Those skilled in the art will appreciate that the prosthetic half-valve device 1 does not require additional ventricular anchors and has prosthetic valve leaflets 200 with limited radial expansion by design, independent of patient characteristics. can also be understood.

In one aspect, prosthetic leaflet feet 214 at the ends of leaflet feet 205 are attached to stent 100 with through-holes 113 for foot attachments 214 such that no additional skirt material 300 is required in this region. can be attached directly to the

With reference to the example shown in FIG. 10, the prosthetic valve leaflet 200 is a stationary non-stationary leaflet 200 similar to that formed by the native posterior mitral leaflet 10 of a healthy mitral valve 4, for example as shown in FIG. 2A. It can be configured to form a C-shape under pressure. Further, the prosthetic valve leaflets 200 can be configured to form a D-shape to cover about half of the mitral orifice area in the systolic pressurized state, as shown in FIG.

With further reference to FIG. 10, the addition of the leg structure 205 to the PP2 leaflet 207 causes the PP2 207 to be C-shaped so that it radially extends to about the same distance across its width as the native P2 leaflet 12 does. found to be useful in creating It can be seen that without the leg structure 205, the PP2 207 creates a rounded or pointed shape with the longest radial extension in the center and less extension on the sides.

FIG. 10 shows the prosthetic half-valve 1 with the prosthetic leaflet 200 in a pressurized state 211, 212, 213, i.e., in systole, superimposed with the prosthetic leaflet in a resting, unpressurized state 206, 207, 208. 1 shows a ventricular diagram. Each of the prosthetic valve leaflets 200 expands radially away from the stent 100 under pressure, with the degree of expansion being greatest at the center of the prosthetic valve 1 at PP2 207 and at the lateral margins at PP1 206 and PP3 207. can be seen to be minimal. FIG. 10 also shows that the legs 205 extending from the domed bottom of PP2 207 to the frame 100 are both straight with no twist in both states. It can be seen that when fully expanded, the prosthetic leaflets 200 together form a D-shape that covers substantially the entire lumen of the half-valve stent 100 . Thus, in operation, the prosthetic leaflet 200 can cover approximately half of the mitral orifice area. Those skilled in the art can appreciate that this design can prevent mitral valve leakage in patients who have their mitral anterior leaflet 6 covering more than half of the mitral orifice area during systole.

Those skilled in the art can appreciate that the native mitral valve anterior leaflet 6 typically covers approximately two-thirds of the mitral orifice area during systole. Thus, it is expected that the prosthetic valve leaflets 200 of FIG. 2B would not need to expand much, even beyond their resting position, to coapt with their mitral valve anterior leaflets 6 . The extra prosthetic leaflet expansion enabled by this exemplary design sufficiently covers the mitral orifice to provide a large coaptation area 204 for the native mitral valve anterior leaflet 6, even in dilated hearts. It is a preventive measure to prevent

Referring to FIG. 10, in one exemplary embodiment, when the prosthetic valve leaflet 200 is loaded, the leg structure 205 is positioned so that the leg structure 205 is straight radially away from the frame 100 without twisting the leg 205 . can be constructed.

A person skilled in the art can also appreciate that the leg structure 205 acts similarly to the own aponeurosis 15 in that it can prevent overextension and prolapse of the prosthetic leaflet 200 .

In one aspect, the PP1 leaflet 206 and PP3 leaflet 208 can be configured to have a leg structure 205, especially for large prostheses where the PP1 leaflet 206 and PP3 leaflet 208 are large.

Alternatively, the PP1 leaflet 206 and PP3 leaflet 208 can be constructed without the leg structure 205, especially for compact prostheses where the PP1 leaflet 206 and PP3 leaflet 208 are small.

In one aspect, legs 214 of leg structure 205 can be configured at an angle to facilitate attachment of a stent having through holes 113 to angled struts.

In one aspect, the multiple leg structures 205 may be configured to have a dogbone shape that is wider at the feet 214 that attach to the frame 113 and at the base extending from the dome-shaped bottom, and relatively narrower in the middle region. In this manner, the added width reduces the stress in the leg structure 205 in the areas that experience the highest forces. Those skilled in the art can appreciate that the dogbone shaped design distributes mechanical stress across leg 205, which is important for durability.

In a further aspect, it is desirable to make the multiple leg structures 205 from a single piece of the same material as the rest of the prosthetic leaflet 200 .

In one exemplary embodiment, the PP2 leaflet 207 is the most central part of the leaflet (abdominal region 203 and coaptation region 204) corresponding to the native mitral valve posterior leaflet 12 structure, eg, as shown in FIG. 2B. It can be configured to have a high height and a short height at each of the commissures 201 .

In one example of the prosthetic half valve 1, a plurality of domed prosthetic valve leaflets 200 are constructed as individual flat pieces of flexible material.

In one exemplary aspect, the prosthetic half-valve includes a stent 100 that is coupled to a skirt 300 on the inner surface of the stent 100 and a portion of the outer surface of the stent 100 . Additionally, a plurality of artificial valve leaflets 200 are coupled to the inner surface of skirt 300 . In a further aspect, skirt 300 is attached to stent 100 and prosthetic leaflet 200 is attached to skirt 300 using one or more sutures.

Those skilled in the art can appreciate the advantages of half-valves over full-circumvalves with respect to reduced profiles. Reduced stent 100, cusp 200 and skirt 300 materials allow prosthetic half valves to be crimped onto lower profile catheters, enabling higher risk patient populations to undergo heart valve replacement surgery become.

In one aspect, the prosthetic half-valve device 1 is anchored to the posterior mitral valve leaflet by a plurality of DGF members, which are attached to the prosthesis similar to the systems and methods described in the applications incorporated herein by reference. Prior to delivery of the valve 1, it can be operably positioned and implanted at the desired position in the self-valve annulus. In this manner, the DGF member can guide the subsequent correct positioning and fixation of the prosthesis 1 . In a further aspect, multiple DGF members can help prevent leakage of blood between the operably positioned prosthesis 1 and the native mitral annulus.

In one aspect, each DGF member can be configured to have a removable component and a permanent component, wherein the removable component guides the prosthetic half-valve device 1 to an operable position. and can then be removed from the patient's body after fixation of the prosthesis 1, while the permanent component remains in the patient's body, keeping the prosthetic half-valve device 1 fixed to its own annulus. state can be preserved.

In one exemplary aspect, each DGF member can comprise a head component, a body component and a tail component. In one aspect, each DGF head member can be configured to have a coil shape for operable insertion into and embedment in valve annulus tissue. In one aspect, each DGF body member may be configured with a DGF locking member 131 for securing the prosthetic half-valve device 1 to its own mitral valve annulus, as shown in FIG. In one aspect, the DGF tail member can be configured as a flexible component that extends from the proximal portion of the DGF body and couples the DGF member to the retracted prosthetic half valve 1 within the prosthetic half valve delivery implantation system. . In this manner, the tail portion can be manipulated at the proximal end of the delivery system to guide and securely steer the prosthetic half valve 1 to the native mitral valve. Optionally, the DGF tail can be configured to be selectively removable so that it can be removed from the body upon completion of the heart valve leaflet replacement system implantation procedure.

In one aspect, the prosthetic half-valve can be configured to engage the DGF locking member 131 through a plurality of holes 108 in the atrial flared portion 104 of the stent. In this aspect, each DGF tail member is a tether with one end of the tether attached to the DGF body member and the other end of the tether exiting the body. A tether can then be inserted through the holes 108 in the atrial flared portion 104 of the stent, thereby delivering the prosthetic half-valve device 1 through the DGF tail member and embedding the atrial flared portion 104 of the stent into the annulus. can be accurately delivered to the DGF body member.

In one aspect, the DGF locking member 131 may be configured to pass through the holes 108 of the atrial flared portion 104 of the stent in only one direction.

In one aspect, the DGF locking member 131 is selectively compressed to a diameter less than the diameter of the hole 108 in the atrial flare portion 104 of the stent so that it can pass through the hole 108, after which the DGF locking member 131 passes through the hole 108. It can be configured to be selectively re-expandable to an original size greater than the diameter of the holes 108 in the flared portion 104 of the stent to prevent posterior movement therethrough.

In one exemplary aspect, as shown in FIG. 11, each DGF locking member 131 is configured with a plurality of radially compressible legs 132 forming a conical shape, the proximal end of the conical shape. The tip has a smaller diameter than the holes 108 in the atrial portion 104 of the stent, and the conical distal base has a larger diameter than the holes 108 in the atrial portion 104 of the stent. In operation, the DGF tail can be tensioned to draw the proximal tip of the DGF locking member 131 into the hole 108 of the atrial portion 104 of the stent, and when the locking member leg 132 contacts the edge of the hole 108, The legs are radially compressed to allow the DGF locking member 131 to be fully retracted through the hole 108 . Once the locking member 131 has passed completely through the stent 100, the DGF locking member legs 132 prevent posterior movement of the DGF locking member 131 through the holes 108 in the atrial portion 104 of the stent to bring the prosthetic half valve 1 into the actuated position. It can be re-expanded to full size for effective locking.

In one aspect, referring to FIG. 11, the locking member 131 is selectively compressed from a cross-sectional profile larger than the diameter of the holes 108 in the atrial portion 104 of the stent to a cross-sectional profile smaller than the diameter of the holes 108 in the atrial portion 104 of the stent. so that it can pass through the apertures 108 in the atrial portion 104 of the stent and then re-expand to its original size to prevent the locking member 131 from passing through the apertures 108 in the opposite direction. be able to. In this aspect, the locking member 131 can be configured to have a multi-slit conical, dome, arrow-shaped or wedge-shaped structure using a rigid material, or optionally a conical , dome-shaped, wedge-shaped or spherical deformable rubber cork or stopper structure, or optionally can be configured to have a clamp, clip or snap structure. .

In an alternative aspect, the locking member 131 is configured to be selectively expandable from a cross-sectional profile smaller than the diameter of the aperture 108 to a cross-sectional profile larger than the diameter of the aperture 108, thereby increasing the diameter of the aperture 108 in the atrial portion 104 of the stent. and then can be selectively expanded such that it cannot pass through the hole 108 in the opposite direction. In this aspect, the locking member 131 can be formed, for example, from a shape memory material and a mechanism that selectively retains the locking member 131 in a contracted state so that the locking member 131 can be selectively released and re-expanded. can do.

In one embodiment, referring again to FIG. 11, each locking member 131 includes a conical shape having radially outwardly flared legs 132 . The legs 132 of the locking member 131 radially compress as they pass through the holes 108 in the atrial portion 104 of the stent and expand again once they pass completely through the holes 108 and over the atrial portion 104 of the stent. The extended leg 132 of the locking unit 131 prevents backward movement through the hole 108, thereby locking the prosthetic half valve 1 in place.

It should be emphasized that the above-described aspects are merely possible examples of implementations and merely represent a clear understanding of the principles of the disclosure. Many variations and modifications may be made to the above-described implementations without departing substantially from the spirit and principles of this disclosure. All such modifications and variations are intended to be included within the scope of this disclosure, and all possible claims to individual aspects or combinations of elements or steps are to be supported by this disclosure. is intended. Moreover, although specific terms are employed herein and in the claims that follow, they are used in a generic and descriptive sense only and are used to clarify the invention and claims that follow. is not used for the purpose of limiting

Claims (56)

A prosthetic half valve for replacing the autologous leaflets of a diseased heart valve, comprising:
an upper atrial portion configured to span at least a portion of the native annulus; and a portion that spans only a portion of the native annulus and is configured to allow dynamic movement of at least one other native leaflet in the actuated position. and a neck portion between said upper atrial portion and said lower ventricular portion and defining a longitudinal axis therebetween;
a dampening seal ring attached to at least a portion of the stent frame;
a seal skirt including upper atrial and lower ventricular portions attached to corresponding portions of the stent frame;
at least one dome-shaped prosthetic valve leaflet extending radially inward from the inner surface of the stent frame, the at least one prosthetic valve leaflet configured to be movable from an open position to a closed position over a cardiac cycle in an actuated position; ,
a portion configured to be implanted within self-tissue and configured to selectively engage the stent-frame to guide and secure the stent-frame to the native annulus in an actuated position; and at least one dual guiding fixation member including a curved portion. The prosthetic half valve of claim 1, wherein
A prosthetic half valve, wherein the stent frame comprises a network of cells or wires configured to be radially collapsible and expandable. The prosthetic half valve of claim 2, wherein
wherein the upper atrial portion of the stent frame is configured with at least one row of cells, the cells comprising struts oriented in a collapsible diamond configuration extending radially outwardly from a neck portion of the stent frame; A prosthetic half valve, wherein the diameter of the upper atrial portion is smallest near the neck portion and increases away from the neck portion. The prosthetic half valve of claim 3, wherein
At least a portion of the strut toward the upper free end of the upper atrial portion of the stent frame is adapted to be curved or angled upwardly at an angle of between 90° and 145° relative to the remainder of the upper atrial portion. An artificial hemivalve characterized by: The prosthetic half valve of claim 1, wherein
A prosthetic half valve, wherein the upper atrial portion of the stent frame comprises a plurality of through holes, each through hole having a diameter of about 0.5 to 3 millimeters (0.5-3 mm). The prosthetic half valve of claim 5, wherein
The dual guide fixation member is configured to be secured to the native valve annulus via the plurality of through holes, thereby securing the upper atrial portion to the native valve annulus. valve. The prosthetic half valve of claim 1, wherein
The upper atrial portion of the stent frame includes bonding sites on opposite lateral edges of the stent frame, thereby allowing the lateral edges to come together and engage each other during radial compression. An artificial hemivalve characterized by: The prosthetic half valve of claim 7, wherein
wherein said bond sites are configured to have matching corresponding structures to snugly fit and maintain said stent frame in a generally cylindrical shape during crimping; is linear, zigzag, wavy, semi-circular, semi-elliptical, rectangular or irregularly shaped. The prosthetic half valve of claim 1, wherein
The lower ventricular portion of the stent-frame has a crescent having an anteroposterior (AP) dimension in the range of about ten to forty millimeters (10-40 mm) and an intercommissural (CC) dimension in the range of about twenty to sixty millimeters (20-60 mm). A prosthetic half valve, comprising a shape, wherein said ventricular portion displaces at least one native leaflet in an actuated position. The prosthetic half valve of claim 1, wherein
The axial height of the lower ventricular portion of the stent-frame varies around the circumference of the stent-frame, optionally the axial height is about five to forty millimeters (5-40 mm) around the circumference. An artificial half-valve, characterized in that it is a range. The prosthetic half valve of claim 1, wherein
a lower ventricular portion of the stent-frame having a shorter axial height at the side edges of the stent-frame, optionally having an axial height of about five to fifteen millimeters (5-15 mm); An artificial hemivalve characterized by: The prosthetic half valve of claim 1, wherein
A prosthetic half valve, wherein a lower ventricular portion of said stent frame has a shorter axial height at an intermediate portion along its circumference. The prosthetic half valve of claim 1, wherein
A prosthetic half-valve, wherein the lower ventricular portion of the stent frame comprises free stent tips for attachment of prosthetic leaflet commissures. The prosthetic half valve of claim 1, wherein
A prosthetic half-valve, wherein a lower ventricular portion of said stent-frame includes a semi-conical shape defining a diameter that is smallest near said upper atrial portion and increases away from said upper atrial portion. The prosthetic half valve of claim 1, wherein
A prosthetic half-valve, wherein the lower ventricular portion of the stent frame includes one or more tabs extending from the stent tip. 16. The prosthetic half valve of claim 15, wherein
A prosthetic half valve, wherein the one or more tabs are configured to selectively engage one or more portions of a delivery system. The prosthetic half valve of claim 1, wherein
A prosthetic half-valve, wherein the lower ventricular portion of the stent frame comprises at least one extension member having a tab at its lower tip. 18. The prosthetic half valve of claim 17, wherein
A prosthetic half valve, wherein the tabs are configured to selectively engage one or more portions of a delivery system. The prosthetic half valve of claim 1, wherein
A prosthetic half-valve, wherein at least a portion of a lower ventricle portion of the stent frame is configured such that a tip of the lower end of the stent frame bends radially inwardly with respect to an axis. The prosthetic half valve of claim 1, wherein
A prosthetic half-valve, wherein a lower ventricular portion of the stent-frame comprises a plurality of holes configured to mount one or more portions of the at least one dome-shaped prosthetic valve leaflet. The prosthetic half valve of claim 1, wherein
A prosthetic half-valve, wherein a lower ventricular portion of said stent-frame defines an angle of about 65° to 120° with respect to an axis and an upper atrial portion. The prosthetic half valve of claim 1, wherein
wherein said neck portion comprises at least one row of cells between an atrial portion and a ventricular portion of said frame; optionally said neck portion has an axial height of about 1-7 millimeters (1.0-7 mm); .0 mm). The prosthetic half valve of claim 1, wherein
the at least one dome-shaped prosthetic leaflet comprising a C-shape about an axis, spanning at least a portion of the inner circumference of the stent frame, and radiused to form a D-shape under systolic pressure in an actuated position; A prosthetic half valve, characterized in that it can be expanded in a direction. The prosthetic half valve of claim 1, wherein
A prosthetic half valve, wherein said at least one domed prosthetic leaflet is attached to said stent frame along a parabolic leaflet attachment line. 25. The prosthetic half valve of claim 24, wherein
A prosthetic half-valve, wherein the parabolic leaflet attachment line spans the axial dimension of the ventricular portion of the stent frame from the lower edge of the neck portion to the tip of the ventricular stent. The prosthetic half valve of claim 1, wherein
A prosthetic half valve, wherein said at least one prosthetic domed valve leaflet comprises a central domed valve leaflet and two side domed leaflets that are smaller than said central domed leaflet. 27. The prosthetic half valve of claim 26, wherein
A prosthetic half valve, wherein said central domed leaflet comprises at least one leg structure attached to said stent frame at a leg. 28. The prosthetic half valve of claim 27, wherein
The central domed leaflet spans about 1/3 to 2/3 of the circumference of the stent frame, optionally a body height to width ratio of about 0.4 to 0.7, and a body height to width ratio of about 4 to 4. A prosthetic half valve characterized by having a leg length to width ratio of 7. 29. The prosthetic half valve of claim 27 or 28, wherein
A prosthetic half-valve, wherein the side domed leaflets span about 1/6 to 1/3 of the circumference of the stent frame and have a maximum body height to width ratio of about 1 to 1.5. . The prosthetic half valve of claim 1, wherein
A prosthetic hemivalve, wherein said at least one domed prosthetic valve leaflet includes at least one arm structure. The prosthetic half valve of claim 1, wherein
A prosthetic half valve, wherein said upper atrial portion and said lower ventricular portion comprise separate pieces. The prosthetic half valve of claim 1, wherein
A prosthetic half-valve, wherein the lower ventricular portion of the skirt comprises a plurality of openings that align with ventral regions of the at least one dome-shaped prosthetic valve leaflet during operation. The prosthetic half valve of claim 1, wherein
A prosthetic half valve, wherein tabs extending from a lower ventricular portion of the skirt wrap around struts of the stent frame. The prosthetic half valve of claim 1, wherein
A prosthetic half valve, wherein an upper atrial portion of said skirt comprises a plurality of holes configured to receive passage of tail members and locking members of a plurality of dual guide fixation members. The prosthetic half valve of claim 1, wherein
wherein the upper atrial portion of the skirt is configured to at least partially wrap around the upper atrial portion of the stent frame such that at least a portion of the lower and upper surfaces of the stent frame are covered. Half valve. The prosthetic half valve of claim 1, wherein
A prosthetic half valve, wherein said cushioning seal ring is attached to at least a portion of a side edge of said stent frame. A prosthetic valve for replacing autogenous leaflets of a diseased heart valve, comprising:
A stent frame including a top end, a bottom end, and side edges extending between the top and bottom ends and generally aligned along a longitudinal axis, wherein the stent frame extends between the top and bottom ends. an upper atrial portion and a lower ventricular portion configured to span only a portion of the native annulus and permit movement of at least one native leaflet in an actuated position; and a neck portion between the upper atrial portion and the lower ventricular portion;
a seal skirt covering at least a portion of the stent frame;
at least one prosthetic leaflet extending radially inwardly from the inner surface of the stent frame, movable from an open position to a closed position, and in an actuated position to coapt with at least one native leaflet over a cardiac cycle; and at least one prosthetic valve leaflet configured. 38. The prosthetic valve of claim 37, wherein
A valve prosthesis, wherein the sealing skirt comprises an upper portion attached to the upper atrial portion of the stent frame and a lower portion attached to the lower ventricular portion. 38. The prosthetic valve of claim 37, wherein
A prosthetic valve, further comprising a sealing member attached to at least a portion of said stent frame. 40. The prosthetic valve of claim 39, wherein
A valve prosthesis, wherein said sealing member includes a cushioning sealing member attached to said side edge such that said sealing member extends at least partially between said upper end and said lower end along said side edge of said stent frame. . 38. The prosthetic valve of claim 37, wherein
A valve prosthesis, wherein said neck region has a smaller cross-section than said upper and lower atrial portions. The prosthetic valve according to claim 37 or 41,
A valve prosthesis, wherein said upper atrial portion extends radially outwardly with respect to an axis from said neck portion to said upper end. The prosthetic valve according to claim 41 or 42,
A valve prosthesis, wherein said lower ventricle portion flares outwardly from said neck region to said lower end. In the artificial valve according to any one of claims 37 to 41,
A valve prosthesis, wherein said upper atrial portion comprises a plurality of through-holes for receiving respective fixation members for fixing said upper atrial portion to the native valve annulus. 44. The prosthetic valve of claim 43, wherein
A prosthetic valve, wherein said through-holes are spaced apart from each other between said side edges. 38. The prosthetic valve of claim 37, wherein
A valve prosthesis, further comprising one or more elongated members extending from said lower end, each elongated member including a tip configured to engage an element of a delivery system for delivering said prosthetic valve. . 38. The prosthetic valve of claim 37, wherein
wherein the at least one prosthetic leaflet comprises a domed prosthetic leaflet, comprises a C-shape about an axis, spans at least a portion of the inner circumference of the stent frame, and is D-shaped under systolic pressure in an actuated position; A prosthetic valve, characterized in that it can be radially expanded to form a 47. The prosthetic valve of claim 46, wherein
A valve prosthesis, further comprising lateral prosthetic valve leaflets on either side of said dome-shaped prosthetic valve leaflet. 38. The prosthetic valve of claim 37, wherein
wherein said at least one artificial valve leaflet comprises a central domed leaflet and side domed leaflets on either side of said central domed leaflet and smaller than said central domed leaflet. artificial valve. A prosthetic valve for replacing autogenous leaflets of a diseased heart valve, comprising:
A stent frame including a top end, a bottom end, and side edges extending between the top and bottom ends and generally aligned along a longitudinal axis, wherein the stent frame extends between the top and bottom ends. an upper atrial portion and a lower ventricular portion configured to span only a portion of the native annulus and permit movement of at least one native leaflet in an actuated position; and a neck portion between the upper atrial portion and the lower ventricular portion;
a seal skirt covering at least a portion of the stent frame;
A central prosthetic valve leaflet and two lateral prosthetic valve leaflets extending radially inwardly from an inner surface of the stent frame, the prosthetic valve leaflets being movable from an open position to a closed position and, in an actuated position, at least one self-prosthesis over a cardiac cycle. A prosthetic valve, comprising: a prosthetic valve leaflet configured to coapt with the leaflet. 50. The prosthetic valve of claim 49, wherein
A prosthetic valve, wherein the lateral prosthetic valve leaflets are smaller than the central prosthetic valve leaflets. The prosthetic valve of claim 49 or 50,
A prosthetic valve, wherein the lateral prosthetic valve leaflets are attached to both sides of the central prosthetic valve leaflet. A system for replacing autologous leaflets of a diseased heart valve, comprising:
an artificial valve,
a) a stent frame including a top end, a bottom end, and side edges extending between said top end and said bottom end and generally aligned along a longitudinal axis, said stent frame comprising said top end and said bottom end; and wherein the stent frame spans only a portion of the native annulus and a lower atrial portion configured to allow movement of at least one native leaflet in the actuated position. a stent frame comprising a ventricular portion and a neck portion between the upper and lower ventricular portions;
b) a seal skirt covering at least a portion of the stent frame;
c) at least one prosthetic leaflet extending radially inwardly from the inner surface of said stent frame, movable from an open position to a closed position, and in an actuated position coapting with at least one native leaflet over a cardiac cycle; a prosthetic valve comprising at least one prosthetic valve leaflet configured to
at least one fixation member implanted within autologous tissue and configured to engage the stent-frame to fix the stent-frame relative to the autologous annulus. 53. The system of claim 52, wherein
The at least one fixation member comprises a plurality of fixation members, and the upper atrial portion of the stent frame comprises a plurality of through holes for receiving respective fixation members to fix the upper atrial portion to the native annulus. A system characterized by: 54. The system of claim 53, wherein
A system, wherein said through holes are spaced apart from each other between said side edges. 53. The system of claim 52, wherein
The fixation member comprises an elongate guide member terminating in a fixation portion, the guide member slidably engaging the stent frame to guide the prosthetic valve during delivery to the native annulus. A system characterized by:

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