Heart valve leaflet replacement system and method

Abstract

The present application relates to a heart valve leaflet replacement system and method thereof. A prosthetic heart valve for treating a diseased heart valve having a natural anterior leaflet and a posterior leaflet, the leaflets moving between an open configuration and a closed position to regulate blood flow through the heart valve during the cardiac cycle of the heart. The prosthetic heart valve has a crescent-shaped stent, at least one prosthetic leaflet mounted on the inner surface of the stent, and at least one fork-like structure that couples a portion of the at least one prosthetic leaflet to the lower ventricular portion of the stent frame. The prosthetic heart valve further has a system for anchoring the upper flared portion of the stent to the posterior portion of the natural valve annulus.

Description

[0001] This application is a divisional application of an application with an application date of March 8, 2017, application number 201780028476.8, and invention name “heart valve leaflet replacement system and method thereof”. Technical Field

[0002] The present application relates generally to replacement heart valves, preferably for replacing diseased mitral and / or tricuspid valve leaflets. More specifically, embodiments of the present subject matter relate to tissue-based replacement heart valves and systems and methods for operable delivery of replacement valves. Background of the Invention

[0003] Reference Figure 1 The mitral valve (MV) is located between the left atrium (LA) and the left ventricle (LV) of the human heart and is generally composed of the mitral annulus (MA), two leaflets, chordae tendineae ("chordae"), two papillary muscles, and the left ventricular myocardium. The mitral annulus is subdivided into an anterior and a posterior portion. Typically, the anterior mitral leaflet (AML) is connected to the aortic valve via the aortic-mitral curtain, and the posterior mitral leaflet (PML) is hinged to the posterior mitral annulus. The chordae are derived from the two major papillary muscles (PPM) or from multiple small muscle bundles attached to the ventricular wall and are connected to the free edges of the mitral leaflets. The chordae are mainly composed of collagen bundles, which give the chordae a high stiffness and maintain minimal stretching to prevent the leaflets from flipping into the left atrium during systole. In addition, the normal mitral valve is composed of a right triangle and a left triangle, which are two thickened areas composed of fibrous tissue. The right fibrous triangle is located between the aortic annulus and the right atrioventricular annulus, while the left fibrous triangle is located between the aortic annulus and the left atrioventricular annulus.

[0004] When the mitral valve is closed, the respective anterior and posterior leaflets are in close contact to form a single zone of apposition. As will be appreciated by those skilled in the art, normal mitral valve function involves a proper balance of forces, with each of its components working in harmony during the cardiac cycle. Pathological changes affecting any component of the mitral valve, such as chordae rupture, annular dilatation, papillary muscle displacement, leaflet calcification, and myxomatosis, can lead to altered mitral valve function and cause mitral regurgitation (MR).

[0005] Mitral regurgitation is mitral valve dysfunction, which causes abnormal leakage of blood from the left ventricle back to the left atrium during systole (i.e., the ejection phase of the cardiac cycle, in which blood flows from the left ventricle to the aorta). Mild mitral regurgitation may occur in healthy people, while 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 valvular degeneration. Both ischemic heart disease (mainly due to coronary artery disease) and non-ischemic heart disease (e.g., idiopathic dilated cardiomyopathy) can cause functional or secondary mitral regurgitation through various mechanisms including impaired left ventricular wall motion, left ventricular dilation, and papillary muscle displacement and dysfunction. In functional mitral regurgitation, the mitral valve organ remains normal. Incomplete coaptation of the leaflets is due to enlargement of the mitral annulus secondary to left ventricular dilation and possible left atrial enlargement. Additionally, patients with functional mitral regurgitation may exhibit papillary muscle displacement due to left ventricular enlargement, which results in excessive tethering of the leaflets. In contrast, degenerative (or organic) mitral regurgitation is caused by structural abnormalities of the mitral leaflets and / or the subvalvular apparatus, which may include elongation or rupture of the chordae tendineae.

[0006] Current treatments for mitral valve disease include surgical repair and mitral valve replacement. Thanks to an improved understanding of the mechanism and function of the mitral valve, mitral valve repair may now be superior to complete mitral valve replacement. However, the complex physiology and three-dimensional anatomy of the mitral valve and its surrounding structures pose significant challenges when performing these repair surgeries.

[0007] In an early example of a transcatheter mitral valve replacement device, Endovalve-Herrmann (MicroInterventional Devices, Inc.) developed a mitral valve prosthesis with a foldable nitinol-based valve with a sealing skirt. Similarly, Tendyne Holdings, Inc. produced a prosthetic mitral valve replacement device that includes bovine pericardium with a self-expanding nitinol stent. The device is designed for transapical delivery and has a ventricular anchor. CardiAQ uses bovine pericardium with a nitinol self-expanding stent in its mitral valve replacement device. Finally, Tiara (Neovasc, Inc.) uses a mitral valve replacement system that can be delivered transapically through a 30Fr catheter with an anchoring structure, and bovine pericardium on a self-expanding stent with a D-shaped atrial portion and a ventricular portion with an outer coating. These devices and technologies for delivering mitral valve prostheses to the surgical site are still in the development stage, so although promising, the efficacy of these devices remains a challenge.

[0008] Significant challenges to effective mitral valve replacement devices generally include surgical delivery challenges; positioning and fixation challenges; sealing and paravalvular leak challenges; and hemodynamic function challenges, such as left ventricular outflow tract (LVOT) obstruction. With respect to significant surgical delivery challenges, because conventional mitral valve prostheses are larger than conventional aortic prostheses, it is more difficult to fold and compress the larger mitral valve prosthesis into a catheter for deployment and more difficult to retrieve via conventional transapical or transfemoral delivery techniques.

[0009] For positioning and fixation challenges, instability and movement are the most prominent obstacles because the mitral valve is subjected to highly repetitive loads and high transvalvular pressure gradients during the cardiac cycle, which are close to zero during diastole and may rise to 120 mmHg or higher during systole, and may be above 150 mmHg for patients with aortic stenosis and systemic hypertension. Lack of calcium distribution at the mitral annulus also affects device stability and anchoring. In addition, transcatheter mitral valve replacements may easily dislodge as the heart moves during each beat cycle.

[0010] With regard to sealing and paravalvular leakage, since the mitral annulus is large, a good fit between the native annulus and the prosthesis is desired to minimize paravalvular leakage. Typically, a prosthetic mitral valve may have a large overhanging atrial portion or flaring that can prevent leakage, but problematically, it also requires a large valve size at the ventricular level so that the prosthesis can fit tightly into the native mitral valve. Conventionally, the prosthetic mitral valve is smaller than the diseased native valve, so additional material is added around the prosthetic valve to compensate for the large native mitral annulus. Unfortunately, adding more material to the prosthetic valve increases the size of the delivery system.

[0011] Finally, with respect to preservation of hemodynamic function, surgical positioning of a prosthetic mitral valve of conventional size as described above should not obstruct the LVOT anterior to the mitral annulus and should not interfere with associated structures of the native mitral annulus.

[0012] Therefore, a heart valve leaflet replacement system that is not subject to the shortcomings and deficiencies of conventional valve prostheses is desirable. 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 expansion of the native mitral valve annulus. In addition, other desirable characteristics and features will become apparent from the subsequent detailed description and the appended claims in conjunction with the accompanying drawings and the foregoing technical field and background. Summary of the invention

[0013] Heart valve leaflet replacement systems and methods of fixing heart valve leaflet replacement systems to one of the natural valve annuli are described herein. It is contemplated that the method of fixing a heart valve leaflet replacement system to one of the natural valve annuli is configured to prevent the leaflet replacement system from being displaced from the annulus and to ensure proper engagement between the implanted prosthetic leaflets and the remaining natural leaflets. It is contemplated that the valve leaflet replacement device may be implanted through open surgery or implanted through a catheter transluminal cavity. In one aspect, the heart valve leaflet replacement system may be configured to fix a prosthetic mitral valve to the natural mitral annulus. In a further aspect, the related method may be configured to implant a replacement valve prosthesis and help prevent further expansion of the natural mitral annulus. For the sake of clarity, it should be understood that the present disclosure will focus on the treatment of functional mitral regurgitation, but it is also contemplated that the heart valve leaflet replacement system and related methods may be used or otherwise configured to treat other valve disease conditions and replace other valves of the human heart, or may also be used or otherwise configured for other mammals suffering from valve defects.

[0014] In one aspect, the heart valve leaflet replacement system may include a replacement prosthetic mitral valve that can be configured or otherwise sized to be rolled up to fit within a delivery sheath and then selectively expanded to a surgical size and position once removed from the delivery sheath within the heart. In a further aspect, at least a portion of the prosthetic mitral valve may have a stent shape that may include an upper flared atrial portion and a lower vertical ventricular portion. In one aspect, the upper flared portion may be configured to facilitate anchoring of the stent, which can help prevent paravalvular leakage and displacement of the stent. In addition, the lower ventricular portion can offset the diseased natural leaflet from the blood flow and accommodate at least one prosthetic leaflet. On the other hand, the prosthetic mitral valve may include an inner lining skirt that may be connected to at least a portion of the inner surface and / or outer surface of the stent. In one exemplary aspect, at least one prosthetic leaflet can be mounted on the inner lumen of the stent and / or on at least a portion of the outside of the stent, which can serve to replace at least one natural leaflet to restore normal valve function, for example, to prevent mitral regurgitation.

[0015] In one aspect, at least one leaflet of the prosthetic mitral valve can have at least one fork-like structure that prevents the valve leaflet from turning into the atrium and prolapse. The at least one fork-like structure is also used to reduce prosthetic leaflet stress and promote coaptation with at least one native mitral valve leaflet so as to reconstruct a qualified native mitral valve closed anatomy with sufficient leaflet coaptation length and height and appropriate leaflet angle during systole.

[0016] In one aspect, delivery of the prosthetic mitral valve can be performed using several desired delivery access methods, such as, but not limited to, a surgical approach, a transseptal approach, a transatrial approach, or a transapical approach. In an exemplary aspect, the transseptal approach can include creating an opening in the internal jugular vein or the femoral vein for subsequent minimally invasive delivery of portions of the heart valve leaflet replacement system through the superior vena cava that flows into the right atrium of the heart. In this exemplary aspect, the transseptal approach's access route passes through the atrial septum of the heart, and once reached, the components of the heart valve leaflet replacement system can be operably positioned in the left atrium, the native mitral valve, and the left ventricle. In one aspect, it is contemplated that a main delivery catheter can be placed in the access path to allow the desired components of the heart valve leaflet replacement system to be operably positioned in the left atrium without complications.

[0017] In one aspect, prior to delivery of the replacement prosthetic valve, a plurality of fixation members can be operably positioned and implanted in a desired location in the native annulus. In this regard, the fixation members can improve subsequent positioning and anchoring of the replacement prosthetic valve. In a further aspect, the plurality of fixation members can help prevent blood leakage between the operably positioned prosthesis and the native mitral valve.

[0018] In one exemplary aspect, the fixing member can be an anchor having a proximal portion and a distal portion. In a further aspect, each anchor can be operably inserted and embedded in the annular tissue. In one aspect, the distal portion of the anchor can be completely embedded or partially embedded in the annular tissue. In one aspect, the distal portion can be connected to the proximal portion of the anchor. In this regard, the distal portion of the anchor can be configured to receive a flexible component that serves as a bridge to connect the prosthetic valve to the anchor. In this regard, the flexible component can be used as a device to accurately guide and safely manipulate the prosthetic mitral valve to the natural mitral valve.

[0019] In a further aspect, the flexible component can be a tether configured such that one end of the tether is attached to a proximal portion of the anchor and the other end of the tether can be away from the body. Subsequently, the prosthetic mitral valve can be delivered via the tether and positioned on the anchor such that the upper flared portion of the stent can be proximal to the anchor.

[0020] In one aspect, it is contemplated that multiple locking devices can be delivered via multiple tethers and positioned on the upper flared portion of the stent immediately after delivery of the prosthetic valve. In this regard, a portion of the tether connected to the proximal portion of the anchor will pass through the upper flared portion of the prosthetic valve and enter the locking device, which will engage the tether and secure the stent in a surgical position against the multiple anchors. The tether portion that leaves the locking device can then be removed using a conventional suture-like cutting device.

[0021] Thus, in this regard, a delivery system for the prosthetic valve may include a deflectable main delivery catheter that can accommodate and serve as a delivery path for the valve catheter, an assembly for delivering the multiple anchors, and an assembly for delivering the prosthetic mitral valve and multiple locking devices.

[0022] In one aspect, the locking device can be a different structure than the stent and the fixing member. In one exemplary aspect, the locking device can be configured as a tubular structure that can be clamped to at least one tether using one or more ears that extend radially inward from one side of the tubular structure and form a close contact against the opposite side of the tubular structure. The tether can have an embedded convex protrusion that is configured to increase friction and axial resistance to prevent the tether from sliding. In this regard, a locking delivery system can be used to deliver and release the tubular locking device.

[0023] The locking delivery system may include a locking support catheter and a locking delivery catheter. The locking support catheter may include a rigid portion and a flexible portion. In this regard, the rigid portion may be configured to open one or more tabs, i.e., push the tabs toward the wall of the locking device to allow the tether to pass through, thereby facilitating the sliding of the locking device along the tether. It should be understood that the flexible portion of the locking support catheter allows the catheter to be easily retracted and bent, which can facilitate the delivery of the locking device at different locations around the annulus. In this regard, the locking delivery catheter can be a flexible catheter that can be conventionally operated to push the locking device away from the rigid portion of the locking support catheter so that it can release the tabs and grasp the tether within the tubular structure of the locking device, thereby effectively locking it in place along the tether.

[0024] Notably, brief rapid ventricular pacing (180-220 times / minute) is often performed during transcatheter heart valve implantation to minimize transvalvular blood flow, thereby reducing the risk of valve embolism during surgery. The amount of time used for rapid pacing is minimal, typically between 14-29 seconds, to minimize risk to the patient. It is contemplated that the prosthetic mitral valve can be deployed and secured to the native mitral valve within 25 seconds of rapid pacing using the delivery system of the present invention. Following transcatheter deployment of multiple anchors attached to a tether, the delivery system provides precise deployment of the replacement prosthetic mitral valve, simultaneous delivery of multiple locking devices, and secure attachment of the locking devices to the replacement prosthetic mitral valve within 25 seconds, and subsequent easy removal of the traction tether.

[0025] In one aspect, a lock shell structure can be used to achieve simultaneous delivery of multiple locking devices. In this regard, the lock shell structure can be configured with multiple lumens to accommodate multiple locks and locking catheters. In this regard, it should be understood that the lock shell structure can also be configured to load the prosthetic mitral valve onto the valve catheter. When the prosthetic mitral valve device is curled to a smaller size and loaded onto the valve delivery catheter, the lock shell structure is loaded at the end of the upper flared portion closest to the replacement prosthetic mitral valve. Multiple locking devices and locking catheters can be loaded into the lock shell structure, located at the end of the upper flared portion adjacent to the replacement prosthetic valve, which will allow the locking device to be deployed immediately after the replacement prosthetic valve.

[0026] In one aspect, in the delivery of the prosthetic mitral valve, after the anchor is deployed to the native annulus attached to one end of the tether, the other end of the tether is still outside the body and can be passed through the upper flared portion of the stent and accommodated in the locking catheter, which is then loaded into the locking shell structure. In one aspect, the tether support catheter can be used to easily accommodate the tether in the upper flared portion of the stent and the locking catheter, and the tether support catheter can eventually be removed from the body before the replacement prosthetic valve is released.

[0027] In an optional aspect, the lock shell structure is coupled to the valve catheter to prevent rotation between the prosthetic valve replacement and the valve catheter. In addition, the valve catheter can be configured so that it does not rotate when it is advanced toward a target implantation location within the native mitral valve during delivery. An advantage of this non-rotational property is that it prevents the tether from becoming entangled within a deflectable main delivery catheter.

[0028] Retracting the valve catheter will release the replacement prosthetic valve. In this regard, release of the distal end of the prosthetic valve replacement can be achieved through the valve annulus. When the distal end of the prosthetic valve replacement is partially released, the entire valve catheter can be positioned across the valve annulus. Complete valve release can be performed during rapid pacing. The locking catheter is released immediately after the replacement prosthetic valve is released.

[0029] The release of the lock and locking catheter can be achieved by manipulating two connecting structures connected to the lock housing structure and the main delivery system handle. In a further aspect, one connecting structure can simultaneously push out the locking catheter and a second connecting structure adjacent to the first connecting structure can release the locking device onto the upper flared portion of the replacement prosthetic mitral valve.

[0030] It is contemplated that any suture-like cutting device may be used to cut the remaining tethers that exit the proximal portion of the locking device.The entire delivery system may be removed, and a septal closure device may be used to close the hole in the atrial septum.

[0031] The various embodiments described in the present disclosure may include additional systems, methods, features and advantages, which are not necessarily explicitly disclosed herein, but are obvious to those of ordinary skill in the art after studying the following detailed description and the accompanying drawings. It is intended that all such systems, methods, features and advantages be included in the present disclosure and protected by the appended claims. BRIEF DESCRIPTION OF THE DRAWINGS

[0032] The features and components of the following figures are illustrated to emphasize the general principles of the present disclosure. For consistency and clarity, corresponding features and components throughout the drawings may be designated by matching reference characters.

[0033] Figure 1 is a perspective view of the anatomy of the native mitral valve, showing the location of the mitral valve (MV) in the heart.

[0034] Figure 2A and Figure 2B is an exemplary aspect of a heart valve leaflet replacement system showing a stent having an upper flared portion and a lower ventricular portion, a prosthetic forked leaflet, wherein a fork couples the prosthetic leaflet to the lower ventricular portion of the stent.

[0035] Figure 3The circumferential dimensions of the device are presented. The anterior mitral leaflet is divided into three sectors: A1, A2, and A3. The posterior mitral leaflet is divided into three sectors: P1, P2, and P3. The flared portion of the device can span two commissures, AC-anterior commissure and PC-posterior commissure, or can cover the entire circumference of the mitral valve when operably positioned. The ventricular portion of the device can span two commissures, covering the entire posterior portion of the mitral valve.

[0036] Figure 4 is a perspective view of a computer-generated model of a prosthetic device showing Figure 2A and Figure 2B The upper flared portion and lower ventricular portion of a stent, without the attached skirt for clarity, are shown in exemplary surgical positions in the native mitral valve annulus in contact with a computer-generated heart model.

[0037] Figure 5A and Figure 5B is a perspective view of an exemplary aspect of a stent comprised of a plurality of unit structures and joints between adjacent units, showing an upper flared portion, a lower ventricular portion, and a portion that accommodates each prosthetic leaflet. In one aspect, it is contemplated that in the upper flared portion, the joint or anchor opening may form a hole configured to facilitate delivery of the stent to the mitral valve location via a tether assembly. In one exemplary aspect, the hole may have a generally circular shape.

[0038] Figure 6A-6E is a perspective view of an exemplary stent design. As exemplarily shown, the height of the lower ventricular portion of the stent, particularly at the two side ends, can vary. Optionally, the cell structure of the lower ventricular portion of the stent can have different shapes and sizes.

[0039] Figure 7A-7C is a perspective view of an exemplary stent design with an additional feature to capture the native leaflets. As exemplarily shown, the distal ventricular portion of the stent can have radially extending hooks, barbs, anchors, etc. to capture the surrounding native leaflets. The capture components can be evenly distributed along the circumference of the lower ventricular portion of the stent, or only along the middle of the lower ventricular portion of the stent, or only at both ends of the lower ventricular portion of the stent.

[0040] Figure 8A-8E A perspective view of an exemplary stent design having variable height and design along the circumference of the stent is shown. Figure 8A-B As shown in FIG. 1 , the bottom ventricular portion of the stent may have a mesh structure, or optionally, Figure 8C-Figure 8E As shown, the bottom ventricular portion of the stent may have a non-mesh structure. Figure 8C-Figure 8E As exemplarily shown, the bottom ventricular portion can be selectively configured for attachment and support of at least one prosthetic leaflet.

[0041] Fig.9A and 9B is a perspective view of an exemplary aspect of a stent in which the upper flared portion covers the entire native mitral valve annulus, and a perspective view of the stent in a surgical position.

[0042] Figure 10A-10C is a top view of an exemplary aspect of a prosthesis leaflet. Fig. 10A A prosthetic leaflet is shown having at least one additional tissue or leaflet coaptation extension configured to extend from the distal free edge of each prosthetic leaflet (lateral leaflet and medial leaflet) and wherein exemplary aspects of a fork-like structure are configured to be operably coupled to the leaflet coaptation extension. Fig. 10B is another exemplary aspect of a prosthetic leaflet wherein the lateral leaflets lack prongs and only the medial leaflet has at least one prong. Fig. 10C is another exemplary aspect of a prosthetic leaflet, wherein the lateral leaflets are configured or tilted such that a portion of the lateral leaflet spaced from the medial leaflet has a lower leaflet height than a portion of the lateral leaflet adjacent to the medial leaflet. In one aspect, the prosthetic leaflet of this example may optionally be free of any fork-like structures.

[0043] Figures 11A-11H are top views of various exemplary aspects of a prosthetic leaflet structure, including the belly region, free edge, and commissure regions. Fig.11A and Fig. 11B An exemplary aspect is shown in which a prosthetic heart valve replacement is composed of two leaflets. Figure 11C-11H An exemplary aspect is shown in which a prosthetic heart valve replacement is composed of three leaflets. Fig. 11C and Fig.11D As shown, the prosthetic leaflets can each have the same design. Optionally, as Figure 11E-11H As shown, the prosthetic leaflets can have different designs. Further, the prosthetic leaflets can have a uniform height, or can be as Fig.11H As shown, they may have an extended free edge to enhance engagement, or they may have a variable height, such as Fig.11G and Fig.11H shown.

[0044] Figures 12A-12F is a top view of exemplary aspects of an engagement and strength enhancing prong structure coupled to a portion of a prosthetic leaflet showing a plurality of prong structures operably coupled to a distal free edge, a portion of a engagement region, and / or a ventral region of a corresponding prosthetic leaflet.

[0045] Figure 13A-13Bis a perspective view of a computer-generated model of a prosthetic heart valve leaflet replacement system showing the prosthetic leaflets coupled to an exemplary stent in which the height of the leaflets and stent are uniform along the circumference of the device.

[0046] Figure 14A-Figure 14C is a perspective view of a computer-generated model of a prosthetic heart valve leaflet replacement system showing a prosthetic leaflet coupled to an exemplary stent with the leaflet and stent shown at a lower height on the side.

[0047] Fig.15 Attachment points of a prosthetic leaflet to a stent in three-dimensional space are illustrated for one exemplary aspect of a heart valve replacement system, wherein solid dots indicate attachment points of edges of the prosthetic leaflets and hollow triangles indicate attachment points of a fork-like structure to the stent.

[0048] Fig.16 Attachment points of a prosthetic leaflet to a stent in two dimensions of an exemplary aspect of a heart valve replacement system are illustrated, wherein solid dots indicate attachment points of edges of the prosthetic leaflets and hollow triangles indicate attachment points of a fork-like structure to the stent.

[0049] Fig.17 A side view of an exemplary aspect of an anchor configured for implantation for a heart valve leaflet replacement system and anchoring specifications showing an atrial side of the anchor having a through slot configured to accommodate a tether, and two L-shaped slots on two opposing sides configured for engagement by an anchor delivery member for delivery, the ventricular side of the anchor configured for implantation.

[0050] Figures 18A-18C is a perspective view of an exemplary anchor delivery system. In this regard, Fig.18A The tip of the anchor delivery catheter can be connected to Fig.18C The distal end of the anchor delivery catheter is shown. Fig.18B As shown, the inner wall of the anchor delivery catheter tip can be configured with two pins for engaging the anchor and holding it in place. In this regard, the tether can be looped through the through slot on the atrial side of the anchor.

[0051] Fig.19 is a side view of an exemplary anchor delivery catheter for delivering an anchor. Fig.19 An anchor delivery tip is shown configured with a pin for grasping an anchor. Fig.19 Also shown is a spatial view of the anchor delivery tip, which is positioned proximal to the anchor, and the tether passing through the anchor and extending out of the tip of the anchor delivery catheter. Fig.19 Also shown is an anchor delivery catheter system having an anchor, an anchor delivery catheter tip, and a tether.

[0052] Fig. 20is a side view of an exemplary anchor configured for implantation for a heart valve leaflet replacement system, showing a means for locking a stent to the anchor coupled to a portion of a tether portion extending from an atrial side thereof, and showing the ventricular side of the anchor configured for implantation.

[0053] Fig.21 is a side view of an exemplary anchor configured for implantation for a heart valve leaflet replacement system, showing a means for locking a stent to the anchor coupled to a portion of a tether portion extending from an atrial side thereof, and showing the ventricular side of the anchor configured for implantation.

[0054] Fig. 22 is a perspective view of an exemplary anchor for a heart valve leaflet replacement system.

[0055] Fig.23 is a perspective view of an exemplary anchor for a heart valve leaflet replacement system.

[0056] Fig.24 is a perspective view of an exemplary anchor for use with a heart valve leaflet replacement system.

[0057] Fig.25 is a cross-sectional view of an exemplary anchor delivery member for a heart valve leaflet replacement system showing a portion of an anchor delivery catheter selectively coupled to a portion of an atrial side of the anchor.

[0058] Fig.26 is a cross-sectional view of an exemplary anchor delivery member for a heart valve leaflet replacement system showing a portion of an anchor delivery catheter selectively coupled to a portion of an atrial side of the anchor.

[0059] Figure 27A-27C is a partial cross-sectional side view of an anchor installed at a desired location on the native mitral valve annulus. Fig.27A The anchor is shown installed in the desired position on the mitral valve annulus. Fig.27B The anchor delivery member is shown rotated in a first direction to secure the anchor into the mitral annulus. Fig.27C The anchor delivery member is shown rotated in opposite directions to separate the implanted anchor from the anchor delivery member.

[0060] Figure 28A-Figure 28D is a schematic diagram of an exemplary locking device. Fig.28A One configuration of a locking device is shown having two tabs that are configured in series and that bend inwardly to push the tether against the inner wall of the locking device, thereby securing the locking device in place and preventing it from sliding along the tether. Fig.28BA tether is shown having an inset male protrusion that facilitates locking of the tether to a locking device. Fig.28C Another configuration of the locking device is shown in which the two side walls are straight and at least one tab is bent inwardly against one side wall. Fig.28D Another configuration of a locking device is shown having two tabs, one on each side wall, with the two tabs meeting in the center of the locking device where the locking device will compress the tether to lock it in place.

[0061] Fig.29 is a schematic diagram of an exemplary locking device delivery system showing the handle, catheter, and support catheter of the locking device.

[0062] Fig.30 is a side view showing the steerable sheath and handle controller.

[0063] Fig.31 is a side view of a crimped prosthetic device showing the eyelets of the prosthetic device captured by the slots on the locking housing structure.

[0064] Figure 32A-32B is a perspective view of the lock housing structure and its perspective position within the valve conduit. Fig.32A is a perspective view of an exemplary lock housing structure having four holes to accommodate four tethers. Fig.32B is a schematic diagram of a crimped prosthetic device positioned within a delivery catheter with four tethers looped through holes in an upper flared portion of the prosthetic device and a locking structure positioned near the tip of the upper flared portion of the prosthetic device.

[0065] Figure 33A-Figure 33B It is a perspective view of the lock housing structure. Fig.33A is a schematic diagram of the locking shell structure showing the five lumens, the central slot for attaching the main delivery system, and the four side slots at the distal tip for engaging the eyelets of the prosthetic device and pulling it into the valve catheter. Fig.33B It is a cross-sectional view of the end of the lock housing structure.

[0066] Fig.34 is a perspective view of a valve catheter showing the lock housing catheter and the plurality of locks and locking catheters.

[0067] Fig.35 is a cross-sectional view showing a locking housing structure within a delivery catheter, a stent in a compressed delivery position, and a tether portion coupled to the stent.

[0068] Fig.36 is a perspective view of a first connection structure incorporating a locking delivery catheter and a second connection structure incorporating a locking support catheter.

[0069] Fig.37is a perspective view of a valve catheter showing a crimped prosthetic valve, multiple tethers, a lock housing structure, and multiple locks and a locking catheter.

[0070] Fig.38 is a cross-sectional view of a delivery catheter showing a plurality of lumens configured for guiding a tether portion coupled to a stent and showing the stent positioned in a compressed delivery position.

[0071] Fig.39 is an exemplary illustration of a plurality of anchors mounted at spaced apart mounting points on the native mitral valve annulus.

[0072] Fig.40 is a schematic partial cross-sectional view showing a plurality of anchors implanted in the annulus of a mitral valve and showing a tether portion coupled to each anchor extending through a delivery catheter.

[0073] Fig.41 is a schematic partial cross-sectional view showing a delivery catheter positioned within a native mitral valve and a plurality of tethers coupled to respective anchors extending from the delivery catheter.

[0074] Fig.42 is a schematic partial cross-sectional view showing the stent being deployed by pushing the locking housing structure to leave the catheter housing.

[0075] Fig.43 is a schematic partial cross-sectional view showing a stent expanded to a surgical position at the mitral valve annulus (without prosthetic leaflets for ease of illustration).

[0076] Fig.44 is a schematic partial cross-sectional view showing exemplary positions of a deployed stent relative to anchors prior to coupling the stent to a plurality of anchors.

[0077] Figure 45A-Figure 45B is a schematic diagram of a stent that is simultaneously operably coupled to multiple anchors using a locking device delivery catheter. Fig.45B An exemplary aspect of four locking devices is illustrated, delivered by four tethers at four locations on top of the flared portion of the stent.

[0078] Fig.46 is a schematic illustration of a suture thread that is routed circumferentially through a stent structure at the level of the native mitral annulus so that the suture thread can be used to selectively tighten the mitral annulus.

[0079] Fig.47 is a schematic perspective view showing an exemplary occlusion of the atrial septum. In this regard, the septal occluder is introduced through a delivery catheter extending through a hole in the atrial septum. Subsequently, the delivery catheter is withdrawn through the hole in the atrial septum and the septal occluder is pulled toward the atrial septum until the hole is firmly occluded by the septal occluder.

[0080] Figure 48A-48B These are photos taken during in vitro testing of the valve prototype. Fig.48A The valve is photographed open without pressure, with the flared portion of the device positioned atop the mitral annulus and secured by sutures, and the ventricular portion (not shown) within the left ventricle. Fig.48B The images were taken when the valve was closed at a pressure of approximately 120 mmHg. The prosthetic leaflets (P1 , P2, and P3) can provide surfaces for proper coaptation with the native leaflets (ie, visual coaptation lines).

[0081] Figure 49A-Figure 49B This is a photo taken during an in vitro test of a prosthetic mitral valve prototype. Fig.49A The image was taken as the valve was released from the valve catheter with the five anchors pre-attached to the mitral annulus. Fig.49B This image was taken after the valve prototype was released.

[0082] Figure 50A-Figure 50B This is a photo taken during an in vitro test of a prosthetic mitral valve prototype. Fig.50A It is taken while releasing the locking catheter at the same time. Fig.50B This image was taken after the locking device was released and a pressure of 90 mmHg was applied, showing that the valve is firmly anchored to the mitral annulus.

[0083] Figure 51A-Figure 51D is a computed tomography image of a heart valve leaflet replacement system after surgical implantation in the native mitral valve position in a porcine model. The image was taken during the systolic phase of the cardiac cycle. Fig.51A A top view of the valve from the left atrium is shown, showing all three prosthetic leaflets (P1, P2, and P3) coapting with the native anterior leaflet, the dark lines are the coaptation lines, and the light lines represent the stent frame. Fig.51B is another view of the device showing good coaptation of the prosthetic leaflet (P2) with the native anterior leaflet (arrows indicate coaptation). Fig.51C The prosthetic leaflet (P1) is shown to be well coapted with the native anterior leaflet (arrows indicate coaptation). Fig.51D The prosthetic leaflet (P3) is shown to be well coapted with the native anterior leaflet (arrows indicate coaptation).

[0084] Fig.52 It is an echocardiogram of the implanted prosthesis within the native mitral valve during systole. After implantation of the heart valve replacement system, the dynamic motion of the native leaflets remains undisturbed. During systole, the leaflets can coapt well with the prosthetic leaflets.

[0085] Figure 53A-53FA series of angiographic images during the cardiac cycle show the heart valve replacement system after surgical implantation in the position of the native mitral valve in a porcine model. In these images, the prosthetic leaflets of the device coapt well with the native anterior mitral leaflets, without any signs of regurgitation during left ventricular systole. Data were obtained at 30-day follow-up after implantation. Detailed description

[0086] The present invention may be more readily understood by reference to the following detailed description, examples, drawings and claims, as well as the descriptions thereof before and after. However, before disclosing and describing the apparatus, system and / or method of the present invention, it should be understood that, unless otherwise indicated, the present invention is not limited to the specific apparatus, system and / or method disclosed, as these may, of course, vary. It should also be understood that the terminology used herein is for the purpose of describing specific aspects only and is not restrictive.

[0087] The following description of the present invention is provided as a feasible teaching of the present invention in the currently known best embodiment. For this reason, those skilled in the relevant art will recognize and understand that many changes can be made to the various aspects of the present invention described herein, while still obtaining the beneficial results of the present invention. It will also be apparent that some expected benefits of the present invention can be obtained by selecting some features of the present invention without utilizing other features.

[0088] Therefore, those working in this field will recognize that many modifications and adaptations to the present invention are possible, even desirable in certain circumstances, and are a part of the present invention.Therefore, the following description is provided to illustrate the principles of the present invention rather than to limit it.

[0089] For clarity, it should be understood that the present disclosure will focus on the treatment of functional mitral regurgitation, however, it is contemplated that the heart valve leaflet replacement systems and associated methods may be used or otherwise configured to treat other types of mitral regurgitation or to replace other diseased valves of the human heart (such as the tricuspid valve), or may also be used or otherwise configured for use in other mammals suffering from valvular defects.

[0090] 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" may include two or more such leaflets unless the context dictates otherwise.

[0091] Ranges may be expressed herein as from "about" one particular value, and / or to "about" another particular value. When such ranges are expressed, another aspect includes from a particular value and / or to another particular value. Similarly, when a value is expressed as an approximation by using the antecedent "about," it will be understood that the particular value forms another aspect. It will be further understood that the endpoints of each range are significant relative to the other endpoint, and are independent of the other endpoint.

[0092] As used herein, the terms "optional" or "optionally" mean that the subsequently described event or circumstance may or may not occur, and that the description includes instances where said event or circumstance occurs and instances where it does not.

[0093] As used herein, the word "or" means any one member of a particular list, and also includes any combination of members of that list. In addition, it should be noted that conditional language, such as "may," "could," "perhaps," or "might," unless otherwise expressly stated or otherwise understood in the context of use, is generally intended to express that certain aspects include, while other aspects do not include, certain features, elements, and / or steps. Therefore, such conditional language is generally not intended to imply that features, elements, and / or steps are necessarily required for one or more particular aspects, nor is it intended to imply that one or more particular aspects must include logic that determines (with or without user input or prompting) whether these features, elements, and / or steps are included in any particular implementation or are to be performed in any particular implementation.

[0094] Components that can be used to perform the disclosed methods and systems are disclosed. These and other components are disclosed herein, and it should be understood that when combinations, subsets, interactions, groups, etc. of these components are disclosed, although specific references to each different individual and collective combination and arrangement of these components cannot be explicitly disclosed, each is specifically contemplated and described herein for use in all methods and systems. This applies to all aspects of the application, including but not limited to the steps in the disclosed methods. Therefore, if there are various additional steps that can be performed, it should be understood that each of these additional steps can be performed together with any specific embodiment or combination of embodiments of the disclosed methods.

[0095] The present method and system may be understood more readily by reference to the following detailed description of the preferred embodiments and the examples included therein as well as the drawings and the descriptions thereof both before and after.

[0096] Described herein are heart valve leaflet replacement systems and methods of securing a replacement prosthetic heart valve 12 to one of the native valve annuli. In one aspect, it is contemplated that the heart valve leaflet replacement system may be configured to secure a prosthetic mitral valve to the native mitral valve annulus. In a further aspect, the heart valve leaflet replacement system and associated methods may be configured to mitigate mitral regurgitation and / or help prevent further expansion of the native mitral valve annulus during the patient's cardiac cycle. It should be noted that it is contemplated that the heart valve leaflet replacement system 11 described herein may be used to replace any diseased valve within the heart. For purposes of illustration, the description in the present invention will focus on the mitral valve and the naming according to the geometry of the mitral valve. However, the designs described herein may be used accordingly for all other heart valves.

[0097] Reference Figure 1 , the mitral valve 1 is located on the left side of the heart, between the left atrium 9 and the left ventricle 10, and has an anterior leaflet 1 and a posterior leaflet 2 surrounded by the mitral valve ring. In this regard, the mitral valve ring also has a fibrous portion 3 or a fibrous membrane, which extends from the right triangle 6a to the left triangle 6b and is continuous with a part of the aortic valve and the posterior muscle portion 4. Further, the chordae tendineae 7a, 7b originate from the corresponding major papillary muscles 8a, 8b of the left ventricular wall and are connected to the corresponding mitral valve leaflets.

[0098] In one aspect, the heart valve leaflet replacement system 11 may include a replacement prosthetic mitral valve 12 and a transcatheter delivery system. In this regard, and with reference to Figure 2A-2B , an exemplary aspect of a heart valve leaflet replacement system 11 is disclosed herein, showing an assembly and fabricated prosthetic mitral valve 12. In this regard, the prosthetic mitral valve 12 can be configured to be selectively compressed or otherwise constrained to a compressed position and loaded onto a delivery catheter.

[0099] The prosthetic mitral valve 12 may include a crescent-shaped stent 31 , at least one mobile prosthetic leaflet 16 , and at least one fork-like structure 18 that operably couples a portion of the prosthetic leaflet to the infraventricular portion of the stent 14 .

[0100] In one aspect, Figure 2A-2BAs shown, the crescent-shaped stent 31 for replacing the prosthetic mitral valve 12 may include an upper flared portion 13 and a lower ventricular portion 14. At least a portion of the upper flared portion 13 and / or a portion of the lower ventricular portion 14 may be formed to be self-expandable or balloon-expandable to the desired surgical position. In this regard, it is envisioned that the stent 31 may be conventionally laser cut or woven into a desired stent design that is radially collapsible and expandable. Therefore, it is further envisioned that the stent may include a plurality of operably connected components to form an expandable mesh or non-mesh body, which may be made of metal, including but not limited to cobalt chromium, stainless steel; or a metal with inherent shape memory properties, including but not limited to nitinol. Optionally, it is envisioned that the stent may include a plurality of vertical rigid structures, which are connected by soft materials such as biological tissues, synthetic materials such as polymers, and the like. The stent may be configured to allow natural dynamic movement of any remaining natural leaflets engaged with the prosthetic leaflets.

[0101] In one aspect, it is contemplated that in the expanded configuration, the inner surface of the stent 31 can define a generally circular cross-sectional profile. It is further contemplated that the stent 31 can be configured to deform such that the inner surface of the stent defines a non-circular cross-sectional profile, including but not limited to an elliptical cross-sectional profile or an asymmetric cross-sectional profile. As used herein, the term "asymmetric cross-sectional profile" includes any non-circular cross-sectional shape.

[0102] In one aspect, referring to Figure 3 When implanted, it is contemplated that the upper flared portion 13 of the stent 31 can be configured to be positioned on and / or above the native valve ring. In this regard, the upper flared portion 13 of the stent 31 can be configured to facilitate anchoring, fixation, and sealing of the stent, which can help prevent paravalvular leakage and displacement of the stent after implantation. The mitral valve ring is asymmetrical, such as Figure 3 As shown. The upper flared portion 13 of the prosthetic mitral valve 12 will cover or cap the posterior portion of the mitral valve ring, which is divided into three sectors: namely, P1, P2 and P3. In one aspect, the upper flared portion 13 can span two commissures, namely, AC-anterior commissure and PC-posterior commissure. On the other hand, the upper flared portion 13 can cover the entire circumference of the mitral valve when operably positioned.

[0103] In one aspect, at least a portion of the lower ventricular portion 14 can be positioned within a ventricular chamber of the heart and / or in contact with a portion of at least one native mitral valve leaflet.

[0104] Figure 4 A computer generated stent 31 of a prosthetic mitral valve 12 is shown overlaid with a computer model of a portion of a heart including an aortic annulus 80, a portion of a left ventricle 10, papillary muscles 8, a left atrium 9, and chordae tendineae 7. Those skilled in the art will appreciate that Figure 4As shown, the partial circumferential frame 31 of the present invention can help prevent left ventricular outflow tract obstruction (LVOTO) 81. A potential advantage of the partial circumferential structure of the lower ventricular portion 14 of the stent is that the stent frame does not interfere with the anterior mitral valve leaflet 1 when operably positioned. The native leaflet is not constrained by the stent and can move freely, thereby reducing the risk of LVOTO. The lower ventricular portion 14 of the stent is configured to allow undisturbed movement of the native anterior leaflet.

[0105] In one exemplary aspect, the lower ventricular portion 14 of the stent can have a partial cylindrical or conical shape, and optionally, can have a height range between about 0.5 times and about 1.5 times the radial length of the displaced diseased natural leaflet. The lower ventricular portion 14 of the stent 31 can be configured to cover or cover only a selected portion of the circumference of the natural annulus, and due to the expandable nature of the stent, when expanded to the surgical position, the diseased natural leaflet can be offset from the blood flow path. Since the lower ventricular portion 14 can be configured to cover a selected portion of the circumference of the natural annulus rather than the entire circumference of the natural annulus, this "open" structure allows dynamic movement of the remaining natural leaflets (e.g., the anterior mitral leaflet) and engagement with the prosthetic leaflets. In one aspect, when the stent is expanded to the surgical position, the outer diameter of the upper flared portion can be approximately 5mm to 15mm larger than the inner diameter of the lower ventricular portion.

[0106] In further aspects, such as Figure 3 As shown, the lower ventricular portion 14 of the stent can extend radially from the anterior commissure 5a to the posterior commissure 5b. In a further aspect, as shown Figure 3 As shown, the lower ventricular portion 14 of the stent may have a "C" shaped cross section with one side edge 26b falling at the gap between the anterior leaflet and the anterolateral commissural leaflet and the other side edge 26a falling at the gap between the anterior leaflet and the posteromedial commissural leaflet.

[0107] In one aspect, Figure 5A As shown, the opening 24 defined in the upper flared portion 13 of the bracket 31 may have a circular, square, diamond, triangular or asymmetrical shape. The area of ​​the opening 24 of the upper flared portion 13 may have a diameter of about 0.2 mm. 2 Up to 2mm 2 area range.

[0108] In one aspect, Figure 5B As shown, the angle between the upper flared portion 13 and the lower ventricular portion 14 of the stent can vary between 90 degrees and 150 degrees so that the stent frame can conform to the natural curvature of the left atrium.

[0109] In one aspect, Figure 6A-6E As shown, it is contemplated that the height of the lower ventricular portion 14 of the stent may vary along the circumference of the covered annulus. Figure 5A As shown, the height of the lower ventricular portion 14 of the stent covering the middle portion 14b of the posterior mitral leaflet can be substantially higher than or equal to the height of the lower ventricular portion 14 of the stent covering the two side portions of the posterior mitral leaflets 14a, 14c. It is contemplated that the lower ventricular portion 14 of the stent covering the two side portions of the posterior mitral leaflets 14a, 14c can be shorter in the axial direction so that it does not interfere with the native anterior leaflet, the chordae and the left ventricle when operably positioned.

[0110] In one aspect, Figure 8C As shown, the lower ventricular portion 14 of the stent can be formed with at least one vertical member or elongated strut 85 extending from at least one location on the upper flared portion 13 of the stent 31. Optionally, as Fig.8D As shown, the elongated strut 85 can be a straight segment or a curved segment extending axially. In a further aspect, the elongated strut 85 can branch out to form a secondary strut to facilitate suturing and connecting the skirt or leaflet material. Fig. 8E As shown, it is contemplated that the elongated struts may be shaped to the shape of the leaflet attachment edges.

[0111] like Figure 7A-7C As shown, the bottom 27 of the ventricular portion of the stent can be configured with features 32, such as flanges, hooks, coils, clips, etc., configured to capture the native leaflets when operably positioned. In this regard, the device can also be fixed and anchored to the native valve. The capture mechanism can also further cause the formation of a pannus, which acts as a sealant and prevents paravalvular leakage. In one aspect, as Fig. 7A As shown, at least three hook components 32 can extend radially from the stent struts and grasp the native leaflets and cables when deployed. Figure 7B As shown, when deployed, the hook assembly 32 may extend only from the middle portion of the bracket 14b. Figure 7C As shown, the hook components 32 may extend only from the sides 14a, 14c of the lower ventricular portion 14 of the stent 31 when deployed.

[0112] In the expanded position, e.g. Figures 5A-9B By way of example, the lower ventricular portion 14 of the stent 31 may have an outer diameter of from about 20 mm to about 60 mm, more preferably from about 30 mm to about 50 mm. In a particular exemplary aspect, without limitation, the lower ventricular portion 14 of the stent 31 may have an outer diameter of about 36 mm. However, it is contemplated that the lower ventricular portion 14 of the stent 31 may have any operable outer diameter that allows the stent to be properly positioned within a selected passage of the subject's heart.

[0113] It is contemplated that the diameter of the stent 31, the spacing between parallel struts and / or adjacent openings within the stent mesh pattern, and the mechanical properties of the stent can be selectively changed as needed to achieve the desired positioning and / or desired performance characteristics within a selected chamber of the subject's heart. In an exemplary aspect, the spacing between parallel struts within the mesh pattern of the stent 31 and / or the size of adjacent openings can be uneven across the stent 31. It is also contemplated that the stent 31 can be configured to deform into an elliptical shape. It can also be further contemplated that the mesh configuration of the stent 31 can provide sufficient structural integrity to prevent collapse of the stent when exposed to compressive loads during valve closure (including but not limited to mitral valve closure). In addition, the stent 31 can be configured to adapt to and withstand sufficient radial expansion forces to allow the stent to be securely positioned on the mitral valve annulus within the subject's heart.

[0114] In one aspect, Fig.9A and Fig. 9B As shown, it is contemplated that the lower ventricular portion 14 of the stent 31 may extend circumferentially less than 360 degrees, while the coupled upper flared portion 13 may be formed to extend circumferentially approximately 360 degrees.

[0115] In one aspect, Figure 2A-2B As shown, the replacement prosthetic mitral valve 12 may include a skirt 28 that may be coupled to at least a portion of the inner and outer surfaces of the stent. In one exemplary aspect, it is contemplated that the skirt 28 may be sutured to at least a portion of the inner and outer surfaces of the stent with non-absorbable sutures. In one exemplary aspect, the skirt 28 may be formed of a biocompatible material, such as, but not limited to, a biocompatible fabric, bovine pericardium, or porcine pericardium, and the like.

[0116] In one aspect, at least one prosthetic leaflet 16 can be mounted on an inner surface of the stent. In one aspect, at least one prosthetic leaflet 16 can be mounted on an inner surface of the lower ventricular portion 14 of the stent 31. It is contemplated that the prosthetic mitral valve 12 may include a plurality of prosthetic leaflets 16, wherein all of the leaflets may have the same shape or wherein one or more of the plurality of leaflets may have a different shape. In various aspects, each leaflet may include a free edge 17, two commissural attachment areas 19, an attachment edge 18, and corresponding commissures 21 and ventral regions 20.

[0117] In one aspect, at least one prosthetic leaflet 16 can be configured to move throughout the cardiac cycle so that the prosthetic leaflet 16 can engage with at least one native leaflet during valve closure to prevent blood from flowing back through the valve. In one aspect, the prosthetic leaflet 16 can be flexible and movable enough to contact the native leaflet 1 without damaging the native leaflet, and can fully open during valve opening so that it does not disrupt normal blood flow through the valve or induce stenosis.

[0118] In one aspect, Fig. 10A As shown, each prosthetic leaflet 16 can have additional extension tissue 22 on the free edge 17 that is configured to increase the coaptation area between the prosthetic leaflet and the native anterior leaflet. In this regard, it is contemplated that a plurality of fork-like structures 23 can be configured to couple to the coaptation enhancement extension tissue 22. The additional tissue 22 on the free edge 17 of each prosthetic leaflet 16 can be between about 1 mm and about 10 mm. In this regard, the fork-like structures can be configured to shape the prosthetic leaflet into an optimal coaptation surface of the native anterior mitral leaflet when pressurized to ensure optimal coaptation and prevent prolapse and leakage of blood through the valve.

[0119] In one aspect, Fig. 10B and Fig. 10C As shown, the prosthetic valve replacement may include three prosthetic leaflets 16: a middle leaflet 16b and two lateral leaflets 16a, 16c. The middle prosthetic leaflet 16b may have a plurality of fork-like structures 23, and the two lateral prosthetic leaflets 16a, 16c may not have fork-like structures 23. On the other hand, the heights of the commissure attachment areas 19 of the prosthetic leaflets 16 may be the same or different. In further optional aspects, as Fig. 10C As shown, the commissure attachment regions 19 of the two lateral prosthetic leaflets 16a, 16c may be shortened at the two lateral edges 26a, 26b of the lower ventricular portion 14 of the stent 31.

[0120] exist Figure 2A-2B In one embodiment of the replacement prosthetic heart valve shown, the two commissure leaflets 16a, 16c can span about 30°-60° of the stent circumference. In one exemplary aspect, Fig. 10A The illustrated commissural leaflets 16a, 16c may have a maximum width of 15.0 mm to 30.0 mm and a height of 10.0 mm to 20.0 mm, with the free edge portions extending longer than in FIG. Fig.15 and 16 The tip height of the leaflet-stent attachment shown in FIG. 1 is about 1.0 mm to 6.0 mm. In this regard, the extended free edge can ensure that the prosthesis commissure leaflets 16a, 16c are in contact with the A1 and A3 regions (see FIG. Figure 3 ) and the middle prosthetic leaflet 16b, while maintaining a low overall stent height when operably positioned to prevent the device from interfering with surrounding native structures, i.e., the papillary muscles and myocardium. Further in this regard, the fork-like structure can have a length of 5.0 mm to 15.0 mm and be used to stabilize the extended free edge and facilitate proper engagement between the sides of the native anterior mitral valve leaflet and the prosthetic commissure leaflets, with an engagement height of about 2.0 mm to about 7.0 mm. The tip of the fork-like structure 23 can be configured to have an angle of about 20° to facilitate attachment to the prosthetic commissure leaflets at the lateral aspect of the native anterior mitral valve leaflet. Fig.15 and Fig.16Similar angles of stent struts and forked stent attachment points as shown in . Fig. 10A , the middle prosthetic leaflet 16b can span about 60°-120° of the stent circumference. Preferably, the middle leaflet 16b can be configured to span a larger stent circumference than the two lateral commissure leaflets 16a, 16c, so that the prosthetic leaflet can better engage with the native anterior mitral valve leaflet at the A2 region during valve closure. In an exemplary aspect, the middle prosthetic leaflet 16b can have a maximum width of 20.0 mm to 35.0 mm and a height of 10.0 mm to 20.0 mm, wherein the extended free edge portion is greater than that at Fig.15 and Fig.16 The tip height of the leaflet-stent junction shown in is about 1.0mm to 7.0mm. In this regard, the extended free edge can ensure adequate engagement (engagement height is about 4.0mm to 7.0mm) between the intermediate prosthetic leaflet 16b and the adjacent prosthetic commissure leaflets 16a, 16c and the natural anterior mitral valve leaflet at A2, while keeping the overall stent height low. Further, in this regard, the intermediate prosthetic leaflet 16b can be configured to have two fork-like structures extending from the extended free edge 22 for a length of 5.0mm to 15.0mm and can be used to stabilize the extended free edge and facilitate proper engagement between the intermediate prosthetic leaflet 16b and the natural anterior mitral valve leaflet.

[0121] In one aspect, at least one prosthetic leaflet 16 can be mounted on the inner surface of the upper flared portion 13 of the stent 31. Optionally, selective portions of the prosthetic leaflets 16 can be mounted on the outer surface of the stent 31, for example, the prosthetic leaflets can be wrapped around the sides of the stent 31 to act as a cushion between the stent 31 and the native tissue when operably positioned.

[0122] Reference Figures 11A-11H , the plurality of prosthetic leaflets 16 can be configured without the fork-like structure 23 extending from the leaflet free edge 17. In one aspect, as Fig.11A and Fig. 11B As shown, a prosthetic valve replacement can be configured with two identical leaflets. Fig. 11C and Fig.11D In another aspect shown, the prosthetic valve can be configured with three identical leaflets 16. Optionally, as Fig.11E and Fig.11F As shown, the commissural lateral leaflets 16a, 16c may be different in shape from the middle leaflet 16b. Fig.11G and Fig.11H As shown, multiple prosthetic leaflets can be configured to vary in leaflet number, size, height, and length to allow for proper coaptation and opening.

[0123] Reference Figures 12A-12F, in one aspect, the fork-like structure 23 can be coupled to the leaflet free edge 17. In another exemplary aspect, the fork-like structure 23 can be coupled to the leaflet ventral portion 20, or optionally to the extended free edge region 22. It is contemplated that the fork-like structure 23 can be configured with a different material than the prosthetic leaflet 16, such as, but not limited to, a biocompatible fabric, suture, or tissue, and can be attached to the prosthetic leaflet 16 in a variety of ways, such as by gluing or suturing to various regions of the prosthetic leaflet 16.

[0124] Reference Figure 13A-13B In one aspect of the prosthetic valve replacement, a plurality of prosthetic leaflets 16 can be attached to the inner surface of the ventricular portion of the stent 14 along the leaflet attachment edges 18 and at attachment tabs on the fork-like structure.

[0125] On the other hand, referring to Figure 14A-Figure 14C , the plurality of prosthetic leaflets 16 can be configured without the fork-like structure 23, and can be attached to the inner surface of the ventricular portion of the stent 14 only along the leaflet attachment edge 18. Optionally, the commissural leaflets 16a, 16c can be shorter on the side away from the central leaflet 16b, corresponding to the aspect that the side of the ventricular portion of the stent 14 is shorter.

[0126] Optionally, at least one prosthetic leaflet 16 may have a shape similar to that of a native diseased valve that the prosthetic valve 12 is intended to replace, or may have a shape similar to that of a native diseased valve that the prosthetic valve 12 is intended to replace. FIG. 10A to FIG. 12F The shapes shown in FIG. 5 are different shapes, including, but not limited to, square, rectangular, triangular, oval, circular or other asymmetrical shapes.

[0127] In one exemplary aspect, the prosthetic leaflets can be configured to be attached to the stent at commissures formed by Figure 15-16 The 2D and 3D leaflet-stent attachment curves shown in FIG. 1 are defined, where the solid dots represent the leaflet edge 18 attachment points and the hollow triangles represent the attachment of the fork-like structure 23 to the stent. This particular leaflet and fork-like stent attachment design and its variations (+ / - 25% derived from the illustrated design curves) are optimal for optimal leaflet coaptation and leaflet stress reduction during the cardiac cycle while having a large effective orifice area without hitting the stent when the valve opens. This design can be scaled or adjusted proportionally or disproportionately for valves of different sizes, as long as these leaflet structures and fork-like structures are used for the purpose of maintaining proper coaptation and reducing leaflet stress and increasing valve durability.

[0128] In one aspect, a device for guiding and anchoring a prosthetic valve 12 to a native annulus may include a plurality of fixing members coupled to a flexible and elongated assembly. In one aspect, the fixing members may be anchors, hooks, or barbs fixed into the annular tissue. The fixing members, for example, anchors 30, may be sequentially delivered and implanted in a desired position via a manipulable catheter. In a further aspect, it is contemplated that a method of implanting anchors 30 may be implemented prior to delivering the prosthetic mitral valve 12. In another aspect, a plurality of anchors 30 may be configured to help prevent blood leakage between an operably positioned prosthetic valve 12 and a native mitral annulus. In another aspect, a plurality of anchors 30 may be configured to facilitate tightening of the diseased annulus in a circumferential direction to reduce the annular size.

[0129] In another aspect, multiple anchors 30 can be directly attached to the stent. In this regard, it is contemplated that the prosthetic valve 12 can be deployed simultaneously with the anchors 30, and once the prosthetic valve 12 is in the surgical position, the anchors 30 can be selectively configured to engage the native annulus to secure the device to the native annulus.

[0130] In one aspect, Figure 17-Figure 21 As shown, each anchor 30 may include a distal portion 39, a proximal portion 40, and a tether portion 44. It is further contemplated that the distal portion 39 of each anchor 30 may be configured to be implanted into native annular tissue and resist separation after implantation. In an exemplary aspect, the distal portion of each anchor 39 may have a spiral, coil, fork, spiral, and barb shape, but is not limited thereto. The anchor 30 may be formed of nitinol, stainless steel, cobalt chromium, a polymer, etc., but is not limited thereto.

[0131] As will be appreciated by those skilled in the art, the anchors of the present invention are specifically configured to securely secure the prosthetic mitral valve 12 to the muscular annular portion of the mitral valve. Fig.17 As shown, anchor 30 is configured to withstand the total forces applied to the prosthetic leaflets without being pulled away from the muscular portion of the annulus. Fig.17 Table 1 shows that the total force applied to the prosthetic leaflets can be estimated by calculating the total area of ​​the prosthetic leaflet surface and the ventricular pressure. Table 1 shows two exemplary prosthetic valve sizes and the calculated forces applied to the prosthetic leaflets. In one aspect, for an average sized 29 mm diameter valve, assuming a ventricular pressure of 140 mmHg, a total force of 12.33 N is required to secure the prosthetic mitral valve 12 in the native valve. Therefore, it is contemplated that the number of anchors to be used should be able to maintain a total force of at least 12.33 N.

[0132] Imagine Figure 17-Figure 24Each anchor configuration of the present invention shown can withstand at least 3N, at least 4N, or at least 5N. In one aspect, one anchor can be placed at the right commissure (right trigone of the mitral valve) and the other anchor can be placed at the left commissure (left trigone of the mitral valve). It is contemplated that the height of the proximal portion 40 of the anchor 30 can be between about 1 mm and about 3 mm, and the length of the distal portion 39 of the anchor can be between about 3 mm and about 6 mm. In one exemplary aspect, as Figures 17 to 21 As shown, the distal portion 39 may have a coil shape of about 3 to 6 coils. In this regard, it is contemplated that the coiled distal portion 39 may have a wire diameter of 0.3 mm to 1 mm, and the outer diameter formed by the coiled distal portion 39 may be about 2 mm to about 5 mm.

[0133] In one aspect, Figures 18A-18C As shown, the tip 43 of the distal portion 39 of the anchor 30 may include a tip that is shaped and configured to facilitate easy penetration into the annular tissue. In one exemplary aspect, the tip 43 of the distal portion 39 of the anchor 30 is curved to the same pitch as the distal portion 39 of the anchor 30. In another exemplary aspect, the tip 43 of the distal portion 39 of the anchor 30 may be straight. Optionally, the tip 43 of the distal portion 39 of the anchor 30 may have an arc length of about 1 mm to 3 mm.

[0134] On the other hand, Figures 18A-18C Combined with Fig.19 As shown, the proximal portion 40 of the anchor 30 can define a slot 47 configured for attachment of a tether. It is contemplated that the tether 44 can be looped through the slot 47 on the proximal portion 40 of the anchor 30. Optionally, as Fig.19 As shown, the proximal portion 40 of the anchor 30 may also define two L-shaped slots 72 configured to receive two pins 50 within the anchor delivery catheter tip 49. In this regard, it is contemplated that the anchor 30 may be operably implanted by rotating the anchor delivery catheter 48 in a first rotational direction. Further, in this exemplary aspect and as will be appreciated by one skilled in the art, the anchor 30 may then be separated from the anchor delivery catheter tip 49 by rotating the anchor delivery catheter 48 in a second rotational direction opposite to the first rotational direction to remove the pins 50 from the slots on the proximal portion of the anchor 30.

[0135] like Figure 20-21As shown, it is contemplated that the means for locking the stent 31 to the anchor 30 may include at least one locking structure 45, including but not limited to ridged engaging teeth, barbs, zippers, flexible barbs or key elements, conical, square, arrow-shaped, circular, triangular, dome-shaped, etc. It is contemplated that the locking structure 45 may be configured to allow a portion of the upper flared portion 13 of the stent 31 to pass downward through the tether portion 44 toward the left ventricle 10, and to resist subsequent movement of the upper flared portion 13 of the stent 31 in the opposite direction. In another aspect, it is contemplated that the locking structure 45 may be configured in series along the tether portion 44 to allow adjustment of the distance between the stent 31 and the anchor 30 and to allow the stent 31 to be operably locked even if there is misalignment between the stent 31 and the anchor 30. In an exemplary aspect, it is contemplated that one or more locking structures 45 may be formed of a polymer, polytetrafluoroethylene (PTFE), a metallic material, or a combination of these materials, but is not limited thereto.

[0136] On the other hand, Figure 22 to Figure 24 As shown, the distal portion 39 of the anchor may include a plurality of barb segments that are bent at an acute angle relative to the longitudinal axis of the anchor. In an exemplary aspect, the acute angle may be between about 45 degrees and about 90 degrees. In a further aspect, the barb segments may have a curved cross-sectional shape. In one aspect, the barb segments may have a length between about 3 mm and 5 mm.

[0137] like Fig. 22 As shown, it is contemplated that the proximal portion 40 of the anchor may include a solid rod structure.

[0138] like Fig.23 and Fig.24 As shown, the proximal portion 40 of the anchor can define one or more openings to allow tissue ingrowth and neovascularization after implantation, thereby helping the implanted anchor to be permanently bonded to the native tissue, thereby preventing the anchor from being detached and dislodged. In this regard, the anchor 30 can be configured to help the upper flared portion 13 of the stent 31 remain in a locked position throughout its use. It is envisioned that the anchor 30 can be delivered to the native mitral annulus in one or more steps using a dilator coupled to a guidewire and an anchor delivery catheter. In this regard, it is envisioned that the anchor 30 can be advanced into a hole formed in the mitral annulus, can be deployed by removing the anchor from the anchor delivery catheter, and finally can be locked in place by pulling back on the tether portion 44.

[0139] Optionally, now refer to Figure 25 to Figure 26 , the proximal portion 40 of the anchor may include a threaded surface 46 configured to be complementarily received within a threaded portion of an anchor delivery catheter 48. In this regard, as shown in FIG. Figure 27A-27CAs shown, it is contemplated that the coiled distal portion 39 of the anchor 30 can be implanted by rotating the anchor delivery catheter 48 in a first rotational direction. As will be appreciated by those skilled in the art, the anchor 30 can then be separated from the threaded portion 46 of the anchor delivery catheter 48 by rotating the anchor delivery catheter in a second rotational direction opposite to the first rotational direction to unscrew the threaded surface of the proximal portion 40 of the anchor from the threaded portion of the anchor delivery catheter 48.

[0140] It is further contemplated that the elongated tether portion 44 can be configured to assist in positioning and securing the prosthetic mitral valve 12 to the implanted anchor 30. Optionally, it is contemplated that the tether portion 44 can be coupled to the proximal portion 40 of the anchor 30 and can be long enough to extend outside the patient's body where it is connected to a locking delivery system. Fig.28B As shown, a portion of the tether adjacent to the proximal portion 40 of the anchor may have at least one convex protrusion configured to facilitate locking the tether within the locking device, thereby locking the stent 31 in the surgical position. In one aspect, each convex protrusion can be formed by a knot in the tether material, or optionally by adding additional material to form a convex protrusion. The tether portion 44 can be formed of a polymer, polytetrafluoroethylene (PTFE), a metallic material, or a combination of these materials, but is not limited thereto.

[0141] Optionally, the tether 44 may include a suture-like portion and a metal portion. In this regard, it is contemplated that the suture-like portion may be pre-attached to the proximal portion 40 of the anchor, and the metal portion may be pre-attached to the suture-like portion. The metal portion may be removed from the body after implantation of the prosthetic mitral valve 12, while the suture-like portion may remain in the body to secure the prosthetic mitral valve 12 to the mitral valve annulus.

[0142] In a further aspect, the method for delivering the prosthetic mitral valve 12 can be based on an optional delivery entry method. In an exemplary aspect and as described in more detail below, the method may require a trans-septal entry method. In this regard, an opening can be created in the internal jugular vein for subsequent minimally invasive delivery of the various parts of the heart valve leaflet replacement system through the superior vena cava flowing into the right atrium of the heart. In this exemplary aspect, the delivery path passes through the atrial septum of the heart, and once completed, the prosthetic mitral valve 12 of the heart valve leaflet replacement system is able to operably enter the left atrium 9, the natural mitral valve, and the left ventricle 10. In this regard, it is envisioned that the delivery path to the natural mitral valve can enter through the septum through an opening formed in the femoral vein, or that the delivery path to the natural mitral valve can be performed through the apex. In one aspect, it is envisioned that the main delivery catheter can be placed along the delivery path to allow all delivery components of the heart valve leaflet replacement system 11 required for the implantation operation to enter the left atrium 9 without complications.

[0143] In one aspect, the delivery catheter 62 can be configured to deliver the prosthetic mitral valve 12 to the pre-implanted anchors 30. Prior to deploying the prosthetic mitral valve 12, the tether portion 44 extending from each anchor 30 can be passed through the opening 24 of the upper flared portion 13 of the prosthetic mitral valve 12.

[0144] In one aspect, Fig.30 As shown, the delivery catheter 62 may include a sheath attached to a selectively deflectable tip 65 configured for selective orientation. The delivery catheter 62 may also include a handle 64 that houses a guidewire 63 and conventional means for manipulating the deflectable tip 65.

[0145] Reference Fig.44 , multiple anchors 30 can be sequentially implanted in the native mitral valve annulus. Subsequently, the prosthetic valve 12 can be delivered and positioned so that the upper flared portion 13 of the stent 31 can be in close proximity to the anchors 30. Optionally, it is contemplated that a method of retrieving the prosthetic valve 12 back into the delivery catheter 62 can be implemented to ensure optimal delivery and positioning of the prosthetic valve replacement 12 within the native mitral valve annulus.

[0146] In one aspect, it is contemplated that a two-step crimping procedure can be implemented to prepare the crescent-shaped stent 31 into a compressed configuration within a valve catheter. In a first step, the two ends 26a, 26b of the crescent-shaped stent can be joined together to form a complete cylindrical shape by using a locking mechanism incorporated into the stent structure. The two ends 26a, 26b of the stent structure can have locking components, including but not limited to hooks, teeth, and slots. In a second step, one end of the prosthetic valve can be squeezed and inserted into a series of cones and / or tubes until it reaches the desired curling profile, and then the prosthetic valve can be loaded into the delivery catheter 62. A transcatheter valve crimper can be used to compress the prosthetic mitral valve 12.

[0147] The tether portion 44 extending from the proximal portion 40 of the anchor 30 and leaving the body can pass through the opening 24 of the upper flared portion 13 before the curling of the prosthetic mitral valve 12. Then, the tether 44 can be squeezed and curled together with the prosthetic mitral valve 12. In this exemplary aspect and as will be understood by those skilled in the art, the tether portion 44 is located between the stents, and the inner wall of the delivery catheter 75 may be twisted and tangled, thus making it difficult to introduce the prosthetic valve into a natural position. In order to allow the prosthetic valve 12 to slide smoothly along the delivery catheter 62, it is envisioned that each tether portion 44 can be accommodated in a tubular catheter while curling with the prosthetic valve 12. The tubular catheter can be made of stainless steel, nitinol, nylon, polyester, PTFE, EBAX (nylon copolymer), PET, PUR, EVA or a custom blend of materials, etc. It is further envisioned that the tubular catheter can be designed in size to fit in the opening 24 of the upper flared portion 13 of the prosthetic mitral valve 12. The tubular catheter may extend to the distal end of the tether 44 connected to the anchor 30 in the native valve to prevent the tether from becoming tangled within the main delivery sheath 62. In surgery, once the prosthetic mitral valve 12 is positioned at the tip 65 of the deflectable delivery sheath in the native left atrium 9, the tubular catheter may be removed prior to release of the prosthetic mitral valve 12.

[0148] The method of locking the stent 31 to the native valve ring can be achieved by using a locking device 70, such as Figure 28A-Figure 28D As shown, the locking device 70 can be attached to the tether portion 44. It is contemplated that the locking device 70 can be delivered individually, continuously or simultaneously after the prosthetic mitral valve 12 is deployed. It should be understood that by securing the prosthetic valve 12 using the locking device 70, the annulus of the diseased valve can be reshaped into the shape of the prosthetic device 12 by pulling multiple tethers connected to the anchors 30 that have been embedded in the natural tissue. In one example for an expanded annulus, the distance between the anchors 30 on the annulus 4 will be greater than the distance between the hollow structures 24 on the upper flared portion 13 of the stent 31. Therefore, pulling the tether 44 while delivering the locking device can pull or reduce the diameter of the expanded diseased annulus. In this regard, this system of placing the locking device at any preferred position along the tether allows for marginal errors in placing the anchors 30 on the annulus.

[0149] like Figure 32A-32B As shown, the lock housing structure 51 can then be loaded into the delivery sheath 62. In one aspect, the lock housing structure 51 can be configured to operably receive the tether 44 and the locking delivery catheter 57. In one aspect, as shown in FIG. Fig.32AAs shown, the lock shell structure 51 can define a proximal portion 53 and a distal portion 52, wherein the distal portion 52 includes a plurality of lumens 54 for passing the tether. The distal portion 52 is positioned adjacent to the upper flared portion 13 of the stent 31. Optionally, only a portion of the distal end of the lock shell structure 51 can be configured to define a plurality of lumens 54 for passing the tether 44.

[0150] On the other hand, the lock shell structure catheter 51 can have a plurality of lumens 54, and the lumens 54 have Figure 33A-Figure 33B The shape and configuration shown. In this regard, the size of these lumens is configured to accommodate the entire locking device delivery catheter 57. It is contemplated that two or more locking devices 70 can be delivered simultaneously after the prosthetic valve is released when rapid pacing is ready. Therefore, the multiple lumens 54 of the lock housing structure 51 allow for rapid delivery of two or more locking devices.

[0151] Reference Figure 33A-Figure 33B It is envisaged that the outer wall of the distal portion 52 of the lock housing structure 51 has two or more grooves 76 for inserting two or more holes 77 of the bracket. In this regard, as Fig.34 As shown, two or more holes 77 of the stent can be used to load the stent into the stent sheath 75. Fig.31 As shown, the crimping device 74 can then be loaded into the stent sheath 75. A cross-sectional view of the lock housing structure 51, the crimping stent 74 and the tether 44 is shown in FIG. Fig.35 Shown in.

[0152] It is contemplated that the locking device 70 may include a structure having a passageway that allows at least one tether 44 to pass therethrough. In another aspect, the locking device 70 may be manipulated to lock it within a designated portion of the tether 44. In one aspect, as Figure 28A-Figure 28D As shown, the locking device 70 can be, but is not limited to, a tubular structure that can be clamped to at least one tether 44 using one or more tabs 59 that extend radially inward from one sidewall of the tubular structure and form a tight contact against the opposite side of the tubular structure. The tether 44 can have an embedded convex protrusion that is configured to increase friction and axial resistance to prevent the tether from sliding. In this regard, a locking delivery system can be used to deliver and release the tubular locking device 70.

[0153] In one aspect, the locking device 70 can be configured as a non-circular structure having a passage through which at least one tether can pass. In an exemplary locking device, as Fig.28C As shown, at least one tab is cut out from at least one flat side of the locking device and is bent inwardly. In this regard, the tether 44 can form a close contact against the side wall of the locking device. In another aspect of this exemplary locking device, the edge of the tab 59 can be ground (edged) or electro-polished so that it does not cut the tether.

[0154] On the other hand, Fig.28D As shown, the locking device 70 can be configured with two ears 59, one on each side wall. The two ears 59 are configured to bend inward and meet at the center of the locking device 70. In this regard, both ears can squeeze the tether to make the contact between the tether and the locking device closer.

[0155] In one aspect, Fig.34 As shown, the locking delivery assembly includes a plurality of locks 70, a locking delivery catheter 57, a locking support tube 56, and a locking delivery catheter handle 58. In one aspect, the inner diameter of the locking device 70 can be slightly larger than the outer diameter of the support catheter 56, and there is little slippage between the two components. The locking support catheter 56 can include a rigid portion 82 and a flexible portion 83. In this regard, as shown in FIG. Fig.29 As shown, the rigid portion can be configured to open one or more tabs 59, i.e., push the tabs toward the wall of the locking device, thereby allowing the tether 44 to pass through, thereby facilitating the sliding of the locking device 70 along the tether 44. In this regard, it should be understood that the flexible portion 83 of the locking support catheter 56 is configured to allow the catheter to be easily retracted and bent, which will facilitate the delivery of the locking device 70 at different locations around the valve ring. In this regard, the locking delivery catheter 58 is a flexible catheter that can be conventionally operated to push the locking device 70 away from the rigid portion 82 of the locking support catheter 56 so that it can release the tabs 59 and connect to the tether 44 within the tubular structure of the locking device 70 to effectively lock the locking device in place along the tether 44. In a further aspect, the locking delivery catheter 58 can taper to a smaller diameter at the distal portion, adjacent to the locking device 70, to facilitate the pushing and delivery of the locking device 70.

[0156] On the other hand, the locking support conduit 56 can be configured as a single part made of a single material. In this regard, the locking support conduit 56 can be configured to be flexible, such configurations include but are not limited to a laser-cut zigzag pattern or a spiral cut through the wall.

[0157] In an optional aspect, the delivery system can be configured so that all locks 70 are released simultaneously immediately after the stent is released. In this regard, as Fig.36 As shown, it is contemplated that the locks 70 may be coupled together by a coupling mechanism, which may be a solid coupling structure 78 having a hole defined therein, configured to secure and lock in place a plurality of locking support catheters 56. In this regard, since it is also necessary to release the locks 70 simultaneously, a second coupling structure 79 may also be configured to secure a plurality of locking delivery catheters 57. It is contemplated that both the first linkage structure 78 and the second linkage structure 79 may be configured to couple to a catheter system handle to enable simultaneous release with the stent.

[0158] Operably, to help prevent tether 44 from becoming entangled with stent 31 of prosthetic mitral valve 12 , the distal portion of delivery sheath 62 may be configured to have at least four slots 55 formed therein, each slot sized to receive tether portion 44 . Fig.38 is a cross-sectional view of a delivery catheter 62 with a stent of a prosthetic valve 12 contained in a compressed position within the central lumen of the delivery sheath 62 and slots 55 formed in the wall thickness of the delivery sheath 62. It is also contemplated that the slots 55 formed may be evenly spaced or asymmetrically spaced within the sheath to align with the contained stent 12.

[0159] Reference Fig.47 , the prosthetic mitral valve 12 can be delivered from the internal jugular vein via the superior vena cava 66 and through the atrial septum 68 to the native mitral valve. In this exemplary method, a guide wire 63 can be inserted into the body through an incision in the internal jugular vein. The guide wire 63 is advanced along the internal jugular vein via the inferior vena cava 67 to the right atrium of the heart.

[0160] Subsequently, the guidewire 63 is introduced into the left atrium 9 by passing through the septal wall 68, then passed through the native mitral valve and positioned in the left ventricle 10. In this method, in an optional aspect, one or more dilators can then be advanced along the guidewire 63 to open the transseptal puncture to allow the delivery catheter 62 to pass through the septum 63.

[0161] like Fig.39 As shown, once the atrial septum 68 is passed, the tip 65 of the steerable catheter can be bent toward a first desired position within the mitral annulus for deployment of the anchor 30, and the first anchor 30 is implanted at the first desired position. In this regard, the first desired position is preferably located in the left triangle 6b region or the right triangle 6a region. In one aspect, the preferred first desired position embodiment is in the left triangle 6b. The anchors 30 are sequentially delivered and implanted by the steerable catheter 69 until all desired anchors 30 are implanted at the desired positions within the mitral annulus. As shown in FIG. Fig.40 As shown, as each anchor 30 is implanted, the anchor delivery catheter 48 is removed while the tether portion 44 remains within the steerable delivery catheter 69 .

[0162] During a subsequent prosthetic valve replacement deployment procedure, tether portion 44 may be slightly tensioned to guide the corresponding anchor advancement catheter 51 as it is advanced toward prosthetic valve 12 to push prosthetic valve 12 toward anchor 30 . Fig.41 The schematic diagram shows the positioning of the prosthetic valve 12 at the native mitral valve. It is also contemplated that the deployment procedure of the prosthetic valve 12 can be performed while the rapid pacing is in place. In one exemplary view, as shown in FIG. Fig.42As shown, when the steerable tip of the delivery catheter is positioned near the tip of the posterior leaflet or deep into the left ventricle, the stent delivery sheath 75 can be selectively pushed out of the steerable tip 65.

[0163] It is contemplated that the prosthetic mitral valve 12 may be delivered by pushing the locking shell structure catheter 51. Fig.43 and Fig.44 As shown in the different views in , once the stent replacing the prosthetic mitral valve 12 is completely ejected from the delivery sheath, the upper flared portion 13 of the prosthetic mitral valve 12 can be operably positioned on top of the native valve ring.

[0164] In one aspect, it is contemplated that a two-step deployment procedure may be implemented to release the crescent-shaped prosthetic mitral valve 12 into a normal functional configuration. In a first step, the prosthetic mitral valve 12 may be deployed into the left ventricle 10 at the level of the native mitral valve annulus, during which the prosthetic mitral valve 12 may maintain a complete cylindrical shape while the locking mechanisms at both ends 26a, 26b remain in place. The prosthetic mitral valve 12 may be oriented in such a way that the markings on the stent structure may correspond to the two triangles 6a, 6b of the native mitral valve annulus. In a second step, the locking mechanisms at both ends 26a, 26b of the stent may be released, and the prosthetic mitral valve 12 may be deployed into a designed semi-cylindrical shape to replace the native mitral valve leaflet 2.

[0165] Subsequently, the stent of the prosthetic valve 12 can be locked in place relative to the native annulus by locking the anchor 30 to the anchor opening of the upper flared portion 13 of the stent. The native annulus can be reshaped to the shape of the stent by tightening the anchor tether 44 and locking the stent 31 in place by the anchor. It is contemplated that the means for locking the stent to the anchor 30 can provide flexibility so that the stent 31 of the prosthetic valve 12 can be locked in place at the annulus even if the anchors are deployed in a non-optimal configuration (i.e., when the anchors 30 are unevenly spaced or not in the same plane with each other).

[0166] In another aspect, the anchor delivery member can be used to simultaneously lock the stent 31 of the prosthetic valve 12 to the anchor. Pulling the tether while slightly pushing the anchor delivery member can further reduce the annulus and allow the annulus to radially tighten after locking the stent 31 in place.

[0167] In one aspect, a method of securing a heart valve replacement system can be achieved by deploying a prosthetic valve 12 within a pre-implanted docking station comprised of a stent or structure, an annuloplasty band or ring, or a ventricular band or ring designed to hold the heart valve replacement system in place. It is contemplated that a heart valve leaflet replacement system that can expand to a larger diameter than the pre-implanted device can be deployed within the pre-implanted device and provide sufficient friction to secure the heart valve leaflet replacement system 12 in place at the surgical site without the need for additional anchors or sutures.

[0168] In one aspect, Fig.46 An optional device for circumferentially tightening the mitral annulus is shown in . Such a device for tightening may require a tightening tether 61, which extends circumferentially along the mitral annulus. In this regard, an additional tightening tether 61 can be pre-attached to the upper flared portion 13 of the stent 31. Optionally, the additional tightening tether 61 can be pre-attached to the anchor 30. In operation, once the stent 31 of the prosthetic mitral valve 12 is locked to the anchor 30, the tightening procedure can be implemented. In one embodiment, the locking device of the tightening tether 61 can have a design similar to the device for locking the stent to the anchor 30.

[0169] In one aspect, Fig.47 As shown, the method of delivering a prosthetic valve replacement may also include occluding, if necessary, the opening formed in the atrial septum 68. Once the septum has been successfully closed, the delivery catheter 62 may be removed from the body and the procedure completed.

[0170] In one aspect, the prosthetic valve 12 can be configured to surgically replace a portion of a natural valve. The upper flared portion 13 of the prosthetic valve 12 can also be configured to be located above the natural valve ring and reinforced by suturing it to the natural mitral valve ring. In this regard, it is envisioned that multiple sutures need to be placed in the valve ring 4, such as, for example but not limited to, at least 4 sutures, at least 6 sutures, at least 8 sutures and / or at least 4 to 10 sutures. All sutures can be symmetrically spaced along the rear valve ring 4. All sutures can extend about 1-3mm from the leaflet-valve ring joint or leaflet hinge. The first suture can be placed in the gap between the front leaflet 1 and the rear medial commissure 5b. The last suture can be placed in the gap between the front leaflet 1 and the front lateral commissure 5a. Then each end of the suture can pass through the upper flared portion 13 of the valve. Once all sutures are placed, the prosthetic valve 12 can be deployed to the appropriate position. Once the prosthetic valve 12 is well positioned, all sutures can be tied.

[0171] To further demonstrate the function of the prosthetic valve replacement device and system, an ex vivo benchtop test was performed using a pig heart. The prototype of the prosthetic valve 12 was implanted into the natural mitral valve 1, 2. The upper flared portion 13 of the stent 31 was sutured to the valve ring in an annuloplasty manner. Fig.48A The prosthetic valve is shown positioned in an inactive heart with no pressure in the left ventricle. The prosthetic leaflet 16 and the native anterior leaflet 1 hang freely. The two side edges 26a, 26b of the prosthetic valve are placed at the anterior commissure 5a and the posterior commissure 5b. The prosthetic valve does not cover the periphery of the anterior mitral leaflet 1. Fig.48BShown is a prosthetic valve 12 positioned in a pressurized heart with a pressure of 100-120 mmHg in the closed left ventricle 10. A static pressure test is used using a high-level water tank to produce maximum pressure, so that a pressure of 100-120 mmHg is reached at the level of the left ventricle. The aorta is cannulated to allow water to flow into the left ventricle. All three prosthetic leaflets 16 and the natural anterior mitral leaflet 1 are visible during pressurization. As shown, the prosthetic valve 12 successfully allows the correct engagement of the leaflets, thereby preventing regurgitant flow. The prosthetic leaflet 16 engages with the natural anterior leaflet. A continuous engagement line 71 (A1 / 16a, A2 / 16b, A3 / 16c) can be seen from the top view. No paravalvular leak is observed during pressurization.

[0172] To demonstrate the functionality of the locking device, an in vitro bench test was performed using a porcine heart. Prior to deployment of the prosthetic valve, five anchors 30 were positioned within the mitral annulus using an anchor delivery catheter 48. The prosthetic valve 12 was then crimped onto the catheter 62 along with the locking assembly. Fig.49A As shown, the prosthetic valve is first released by retracting the valve catheter. Fig.50A As shown, in Fig.49B After the valve is released, the locking catheter 57 is immediately pushed out. Fig.50B Taken after locking device 70 was released and a pressure of 90 mmHg was applied, showing that prosthetic valve 12 is firmly anchored to the mitral annulus.

[0173] like Figure 51A-Figure 51D As shown, the surgical proof of concept of the device was demonstrated by conducting trials in live animals (i.e., pigs). The primary safety endpoints were animal health and freedom from death. Secondary safety endpoints were the absence of device embolization or migration at 7 and 30 days after implantation, and no mitral regurgitation (MR) grade was tracked. All experimental animals met the primary safety endpoint (n=3). Two of the three animals met the secondary safety endpoints. A prosthetic valve failure occurred in one animal, in which an oversized device was used, resulting in 2+ MR (valve regurgitation located in the anterior lateral commissure) at day 30, and the remaining two animals did not track MR and were clinically healthy. On days 7 and 30 after deployment, each animal was hemodynamically evaluated using computed tomography (CT), cardiac fluoroscopy, intracardiac echocardiography (ICE), and transesophageal echocardiography (TEE).

[0174] The CT images consistently show that the prosthetic leaflets 16 of the prosthetic valve 12 are properly coapted 71 with the native anterior mitral valve leaflet 1. The native anterior mitral valve leaflet 1 is divided into three sectors, A1, A2, and A3. A1 is at the anterolateral commissure and A3 is at the posteromedial commissure. Fig.51AIn , a short-axis view of the mitral valve at the level of the mitral annulus shows the native anterior leaflet 1 and posterior leaflet 2, revealing a clear line of coaptation. Figures 51B-51D , good coaptation 71 between all prosthetic leaflets 16 of the prosthetic valve 12 and the native heart valve leaflets 1 is further shown. Fig.51B The natural anterior leaflet 1 is shown to be joined to the prosthetic posterior leaflet 16b at A2. Fig.51C The native anterior leaflet 1 is shown to be joined to the prosthetic anterolateral commissural leaflet 16a at A1, and Fig.51D The native anterior leaflet 1 is shown coapted with the prosthetic posteromedial commissure leaflet 16c at A3. The stent frame 31 of the prosthetic valve 12 is clearly seen in these images, showing the upper flared portion 13 and the lower ventricular portion 14 positioned at the annulus 4 and within the left ventricle 10, respectively. At day 30, there was no evidence of damage to the left ventricle by the stent frame of the prosthetic valve.

[0175] The coaptation 71 of the prosthetic leaflet 16 and the native leaflet 1 can further be shown in an echocardiogram. Fig.52 An echocardiogram of the mitral valve in systole in FIG. 1 shows that the native anterior leaflet 1 at A2 can coapt to the prosthetic leaflet 16b and there is no LVOT obstruction due to the prosthetic valve 12. Figure 53A-53F Cardiac fluoroscopy was performed to detect regurgitant flow across the mitral valve as shown in a series of images captured during left ventricular systole. Almost no regurgitant flow was observed during mitral valve closure.

[0176] Early feasibility studies of the prosthetic valve 12 have shown that it can replicate the function of the natural posterior leaflet 2. The data showed that after implantation of the prosthetic valve, there was virtually no MR in all but one animal in the 30-day study. The prosthetic valve 12 can be used to replace the posterior leaflet of a valve with MR, including but not limited to functional grades of MR: Type I MR with annular dilatation or leaflet perforation / tear (normal leaflet motion), Type II MR with papillary muscle and chordal rupture and / or chordal elongation (excessive leaflet motion), Type III MR with limited leaflet motion in diastole and systole due to thickening and fusion of mitral valve tissue, and Type IIIb MR with limited leaflet motion in systole due to left ventricular enlargement resulting in displacement of the apical lateral papillary muscles and chordal tethering. Other causes of MR for which the prosthetic valve 12 may be used include but are not limited to primary MR or degenerative MR.

[0177] It should be emphasized that the above aspects are only possible implementation examples, which only illustrate a clear understanding of the principles of the present disclosure. Without departing from the spirit and principles of the present disclosure, many changes and modifications can be made to the above embodiments. All such modifications and changes are intended to be included in the scope of the present disclosure, and all possible protections required for the combination of various aspects or elements or steps are intended to be supported by the present disclosure. In addition, although specific terms are used in this article and in the claims thereafter, they are only used in a general and descriptive sense, rather than for the purpose of limiting the invention and the claims thereafter.

[0178] This application also provides the following aspects:

[0179] 1) A prosthetic heart valve for treating a diseased heart valve having natural anterior and posterior leaflets that move between an open configuration and a closed position to regulate blood flow through the heart valve during a cardiac cycle of the heart, the prosthetic heart valve comprising:

[0180] a crescent-shaped stent selectively expandable from a compressed position to an expanded surgical position; wherein the stent has an upper flared portion and a lower ventricular portion, wherein the upper flared portion is configured to cover a posterior portion of a native annulus of the diseased heart valve, wherein at least a portion of the lower ventricular portion extends from the upper flared portion and into a ventricle of the heart, wherein at least a portion of the lower ventricular portion is positioned to contact a portion of at least one native leaflet to displace at least one native leaflet out of the blood flow when expanded to the surgical position;

[0181] at least one prosthetic leaflet mounted on an inner surface of the stent, each leaflet comprising a free edge, two commissure attachment regions, an attachment edge, a coaptation region, and a ventral region, wherein the at least one prosthetic leaflet is configured to move throughout the cardiac cycle such that when the valve is in the closed position, the at least one prosthetic leaflet coapts with at least one native leaflet to prevent regurgitation of blood through the valve, wherein the at least one prosthetic leaflet is mounted to the stent such that in the surgical position, a three-dimensional leaflet-stent attachment curve is formed at the juncture of the at least one prosthetic leaflet and the stent, the curve being configured to promote leaflet coaptation and provide leaflet stress reduction during the cardiac cycle; and

[0182] At least one fork-like structure is configured to couple a portion of the at least one prosthetic leaflet to the subventricular portion of the stent.

[0183] 2) A prosthetic heart valve according to 1), wherein the stent is radially collapsible and expandable.

[0184] 3) The prosthetic heart valve of 2), wherein at least a portion of the upper flared portion and at least a portion of the lower ventricular portion are expandable to a desired surgical position.

[0185] 4) The prosthetic heart valve of 2), wherein at least a portion of the upper flared portion and at least a portion of the lower ventricular portion are configured to selectively reshape the native annulus.

[0186] 5) The prosthetic heart valve according to 3), wherein in the surgical position, the upper flared portion spans the AC-anterior commissure and the PC-posterior commissure of the diseased heart valve.

[0187] 6) The prosthetic heart valve according to 3), wherein in the surgical position, the upper flared portion covers the circumference of the native annulus of the diseased heart valve.

[0188] 7) The prosthetic heart valve according to 3), wherein in the surgical position, the lower ventricular portion spans the AC-anterior commissure and the PC-posterior commissure of the diseased heart valve.

[0189] 8) The prosthetic heart valve of 3) wherein in the surgical position the lower ventricular portion has a partial cylindrical shape.

[0190] 9) The prosthetic heart valve of 3) wherein, in the surgical position, the lower ventricular portion has a partial conical shape.

[0191] 10) A prosthetic heart valve according to 3), wherein in the surgical position, the lower ventricular portion has different heights along its circumferential length.

[0192] 11) The prosthetic heart valve of 3) wherein the height of the lower ventricular portion is between about 0.5 times and about 1.5 times the radial length of the deviated leaflets of the diseased heart valve.

[0193] 12) The prosthetic heart valve of 3) wherein, in the surgical position, an outer diameter of the upper flared portion is approximately 5 mm to 15 mm larger than an inner diameter of the lower ventricular portion.

[0194] 13) The prosthetic heart valve of 2) wherein the crescent-shaped stent allows dynamic movement of the remaining native leaflets and engagement with the prosthetic leaflets.

[0195] 14) A prosthetic heart valve according to 1), wherein the at least one prosthetic leaflet is mounted on the inner surface of the lower ventricular portion of the stent.

[0196] 15) The prosthetic heart valve of 1) wherein the at least one prosthetic leaflet comprises a plurality of prosthetic leaflets.

[0197] 16) The prosthetic heart valve of 15), wherein each of the plurality of prosthetic leaflets has the same shape.

[0198] 17) The prosthetic heart valve of 15) wherein at least one of the plurality of prosthetic leaflets has a different shape.

[0199] 18) The prosthetic heart valve of 1) wherein each prosthetic leaflet is flexible and configured to move between an open configuration and a closed position to regulate blood flow through the heart valve.

[0200] 19) The prosthetic heart valve according to 1), wherein the at least one fork-like structure comprises a plurality of fork-like structures.

[0201] 20) The prosthetic heart valve of 1), wherein the at least one fork-like structure is coupled to the leaflet free edge.

[0202] 21) The prosthetic heart valve of 1), wherein the at least one fork-like structure is connected to the abdominal portion.

[0203] 22) The prosthetic heart valve of 15) wherein each prosthetic leaflet further comprises an extension tissue extending from the free edge, the extension tissue being configured to increase the coaptation area between the at least one prosthetic leaflet and the native leaflet.

[0204] 23) The prosthetic heart valve of 22) wherein a plurality of prong-like structures are configured to be operably coupled to the extension tissue.

[0205] 24) A prosthetic heart valve according to 1), wherein the upper flared portion defines a plurality of openings extending through the upper flared portion, and further comprising means for anchoring the upper flared portion to the posterior portion of the native annulus.

[0206] 25) A prosthetic heart valve according to 24), wherein the device for anchoring includes a plurality of anchors configured to be fixed in the natural valve annulus and to fix the upper flared portion relative to the natural valve annulus through the plurality of openings.

[0207] 26) The prosthetic heart valve of 25), wherein each anchor comprises a distal portion and a proximal portion, wherein the distal portion of each anchor is configured to be implanted into native annular tissue and resist detachment after implantation.

[0208] 27) The prosthetic heart valve of 26) wherein the proximal portion of the anchor defines a slot configured for attachment of a tether.

[0209] 28) The prosthetic heart valve of 25) wherein each anchor further comprises an elongated tether portion configured to position and secure the prosthetic heart valve to the anchor.

[0210] 29) A prosthetic heart valve according to 1), wherein the stent has an inner surface and an outer surface, and further comprises a skirt connected to at least a portion of the inner surface and / or outer surface of the stent.

[0211] 30) A prosthetic heart valve according to 24), wherein the attachment edge of at least one prosthetic leaflet is attached to the stent via the skirt, and wherein the at least one fork-like structure is attached to the stent via the skirt.

[0212] 31) A prosthetic heart valve for treating a diseased heart valve having natural anterior and posterior leaflets that move between an open configuration and a closed position to regulate blood flow through the heart valve during a cardiac cycle of the heart, the prosthetic heart valve comprising:

[0213] A crescent-shaped stent selectively expandable from a compressed position to an expanded surgical position; wherein the stent has an upper flared portion and a lower ventricular portion, wherein the upper flared portion is configured to cover a posterior portion of a native annulus of the diseased heart valve, wherein in the surgical position, the upper flared portion spans an AC-anterior commissure and a PC-posterior commissure of the diseased heart valve, wherein at least a portion of the lower ventricular portion extends from the upper flared portion and into a ventricle of the heart, wherein at least a portion of the lower ventricular portion is positioned to contact a portion of at least one native leaflet to displace at least one native leaflet out of the blood flow when expanded to the surgical position;

[0214] means for anchoring said upper flared portion of said stent to said posterior portion of said native annulus;

[0215] at least one flexible prosthetic leaflet mounted on an inner surface of the stent, wherein the at least one flexible prosthetic leaflet is configured to move throughout the cardiac cycle such that when the valve is in a closed position, the at least one flexible prosthetic leaflet engages at least one native valve to prevent regurgitation of blood through the valve; and

[0216] At least one fork-like structure is configured to couple a portion of the at least one flexible prosthetic leaflet to the infraventricular portion of the stent.

[0217] 32) The prosthetic heart valve of 31) wherein the upper flared portion defines a plurality of openings extending through the upper flared portion.

[0218] 33) A prosthetic heart valve according to 32), wherein the means for anchoring comprises a plurality of anchors configured to be fixed in the native valve annulus and extend through the opening in the upper flared portion.

[0219] 34) A prosthetic heart valve according to 33), wherein each anchor comprises a distal portion and a proximal portion, wherein the distal portion of each anchor is configured to be implanted into native annular tissue and resist detachment after implantation.

[0220] 35) The prosthetic heart valve of 34) wherein the proximal portion of the anchor defines a slot configured for attachment of a tether.

[0221] 36) The prosthetic heart valve of 34) wherein each anchor further comprises an elongated tether portion configured to position and secure the prosthetic heart valve to the plurality of anchors.

[0222] 37) A prosthetic heart valve according to 31), wherein in the surgical position, the lower ventricular portion has a partial cylindrical shape.

[0223] 38) A prosthetic heart valve according to 31), wherein in the surgical position the lower ventricular portion has a partial conical shape.

[0224] 39) A prosthetic heart valve according to 31), wherein the crescent-shaped stent allows dynamic movement of the remaining native leaflets and engagement with the prosthetic leaflets.

[0225] 40) A prosthetic heart valve according to 31), wherein the at least one prosthetic leaflet is mounted on the inner surface of the lower ventricular portion of the stent.

[0226] 41) A prosthetic heart valve according to 31), wherein the stent has an inner surface and an outer surface, and further comprises a skirt connected to at least a portion of the inner surface and / or outer surface of the stent.

[0227] 42) A prosthetic heart valve according to 36), wherein the at least one prosthetic leaflet is attached to the stent via the skirt, and wherein the at least one fork-like structure is attached to the stent via the skirt.

[0228] 43) A prosthetic heart valve according to 31), wherein the at least one flexible prosthetic leaflet is mounted to the stent such that, in the surgical position, a three-dimensional leaflet-stent attachment curve is formed at the junction of the at least one flexible prosthetic leaflet and the stent, the curve being configured to promote leaflet coaptation and provide leaflet stress reduction during the cardiac cycle.

[0229] 44) A prosthetic heart valve according to 33), wherein each anchor further comprises an elongated tether portion configured to position and secure a plurality of locking members to secure the prosthetic heart valve at the surgical position at the operably positioned anchor.

[0230] 45) The prosthetic heart valve of claim 31), further comprising a delivery system comprising a locking delivery system configured to simultaneously deploy a plurality of locking members after deployment of the prosthetic heart valve.

[0231] 46) The prosthetic heart valve according to 45), wherein the locking delivery system comprises:

[0232] multiple locking support catheters;

[0233] multiple locking delivery catheters;

[0234] A plurality of lock housing structures; and

[0235] Multiple locking delivery catheter handles.

[0236] 47) The device according to 46), wherein the multiple locking members are simultaneously deployed using a connecting structure, and the connecting structure is configured to combine the corresponding locking support catheter with the corresponding locking delivery catheter; wherein the connecting structure is positioned within the main delivery catheter and is configured to be manipulated using the locking delivery catheter handle.

Claims

1. A prosthetic heart valve for replacing a natural leaflet in a diseased heart valve, comprising: a stent comprising a frame, the frame comprising an upper flared portion configured to span at least a portion of a native annulus of the diseased heart valve at a surgical site and a lower ventricular portion configured to span only a portion of the native annulus at the surgical site and to allow dynamic movement of at least one native leaflet; at least one prosthetic leaflet extending radially inwardly from an inner surface of the frame, wherein the at least one prosthetic leaflet is configured to move from an open position to a closed position at the surgical site during a cardiac cycle; a sealing skirt attached to at least a portion of the frame; as well as a plurality of anchors for guiding and anchoring the prosthetic heart valve to the native annulus, each anchor comprising a distal portion, a proximal portion, and a tether portion attached to the proximal portion, the distal portion being configured to embed in native tissue, the tether portion being configured to engage the frame to guide the frame to the native annulus and to secure the frame relative to the native annulus at the surgical site; Wherein the at least one prosthetic leaflet can be configured to be attached to the stent at a commissure defined by a three-dimensional leaflet-stent attachment curve formed by a plurality of troughs.

2. A prosthetic heart valve for replacing a natural leaflet in a diseased heart valve, comprising: a stent capable of being compressed to a compressed position during delivery and capable of being expanded to a surgical position when deployed within a native annulus of said diseased heart valve, said stent comprising a frame, said frame comprising an upper flared portion and a lower ventricular portion, said upper flared portion being configured to extend completely around a circumference of said native annulus in a surgical position, said lower ventricular portion being configured to extend only partially around said circumference of said native annulus in said surgical position and to allow dynamic movement of at least one native leaflet; at least one prosthetic leaflet extending radially inwardly from an inner surface of the frame, wherein the at least one prosthetic leaflet is configured to move from an open position to a closed position at the surgical site during a cardiac cycle; a sealing skirt attached to at least a portion of the frame; as well as a plurality of anchors for guiding and anchoring the prosthetic heart valve to the native annulus, each anchor comprising a distal portion configured to be embedded in tissue of the native annulus, a proximal portion, a tether portion attached to the proximal portion, and a locking device attached to the tether portion, the distal portion being configured to be embedded in tissue of the native annulus, the tether portion being configured to guide the frame into the native annulus during delivery, the locking device being configured to secure the frame relative to the native annulus; Wherein the at least one prosthetic leaflet can be configured to be attached to the stent at a commissure defined by a three-dimensional leaflet-stent attachment curve formed by a plurality of troughs.

3. A prosthetic heart valve for replacing a natural leaflet in a diseased heart valve, comprising: a stent capable of being compressed to a compressed position during delivery and capable of being expanded to a surgical position when deployed within the native annulus of the diseased heart valve, the stent comprising a frame, the frame comprising an upper flared portion and a lower ventricular portion, the upper flared portion being configured to extend completely around the circumference of the native annulus at the surgical position, the lower ventricular portion being configured to extend only partially around the circumference of the native annulus at the surgical position to cover at least one native leaflet and to allow dynamic movement of at least one additional native leaflet; at least one prosthetic leaflet extending radially inwardly from an inner surface of the frame, wherein the at least one prosthetic leaflet is configured to move from an open position to a closed position at the surgical site during a cardiac cycle; a sealing skirt attached to at least a portion of the frame; as well as a plurality of anchors for guiding and anchoring the prosthetic heart valve to the native annulus, each anchor comprising a distal portion configured to be embedded in tissue of the native annulus, a proximal portion, a tether portion attached to the proximal portion, and a locking device attached to the tether portion, the distal portion being configured to be embedded in tissue of the native annulus, the tether portion being configured to guide the frame into the native annulus during delivery, the locking device being configured to secure the frame relative to the native annulus; Wherein the at least one prosthetic leaflet can be configured to be attached to the stent at a commissure defined by a three-dimensional leaflet-stent attachment curve formed by a plurality of troughs.

4. A prosthetic heart valve according to claim 1 or 2, wherein the stent is capable of selectively expanding from a compressed position to an expanded surgical position.

5. The prosthetic heart valve according to claim 1, wherein: In the surgical position, the upper flared portion covers the entire circumference of the native annulus of the diseased heart valve.

6. The prosthetic heart valve according to claim 1, wherein: The upper flared portion includes a plurality of openings extending therethrough, the plurality of openings being configured to allow at least a portion of a corresponding tether portion of the anchor to pass therethrough to guide the prosthetic heart valve and / or secure the upper flared portion to the native annulus during deployment.

7. The prosthetic heart valve according to claim 2 or 3, wherein: The upper flared portion includes a plurality of openings extending therethrough, the plurality of openings being configured to allow at least a portion of a corresponding tether portion of the anchor to pass therethrough to guide the prosthetic heart valve and / or secure the upper flared portion to the native annulus during deployment.

8. The prosthetic heart valve according to claim 6, wherein: Each of the openings includes one of a circular shape, a square shape, a diamond shape, a triangle shape, or an asymmetrical shape.

9. The prosthetic heart valve according to claim 7, wherein: Each of the openings includes one of a circular shape, a square shape, a diamond shape, a triangle shape, or an asymmetrical shape.

10. The prosthetic heart valve according to claim 6, wherein: Each of the openings has a width of 0.2 mm 2 Up to 2mm 2 opening area.

11. The prosthetic heart valve according to claim 6, wherein: Each of the openings has a width of about 0.2 mm. 2 opening area.

12. The prosthetic heart valve according to claim 6, wherein: Each of the openings has a width of approximately 2 mm. 2 opening area.

13. The prosthetic heart valve according to claim 7, wherein: Each of the openings has a width of 0.2 mm 2 Up to 2mm 2 opening area.

14. The prosthetic heart valve according to claim 7, wherein: Each of the openings has a width of about 0.2 mm. 2 opening area.

15. The prosthetic heart valve according to claim 7, wherein: Each of the openings has a width of approximately 2 mm. 2 opening area.

16. A prosthetic heart valve according to any one of claims 1 to 3, in, When the stent is expanded to the surgical position, the outer diameter of the upper flared portion can be 5 mm to 15 mm larger than the inner diameter of the lower ventricular portion; and / or The three-dimensional leaflet-stent attachment curve is composed of three troughs.

17. The prosthetic heart valve according to any one of claims 1 to 3, wherein: The frame defines a longitudinal axis extending between opposite ends of the frame, and wherein the upper flared portion defines an angle along the longitudinal axis of ninety to one hundred fifty degrees relative to the lower ventricular portion of the stent.

18. The prosthetic heart valve according to any one of claims 1 to 3, wherein: The circumferential region of the lower ventricular portion of the frame has varying heights along its circumferential length.

19. The prosthetic heart valve according to any one of claims 1 to 3, wherein: The subventricular portion of the frame includes features configured to capture native leaflets of the diseased heart valve when the stent is operably positioned relative to the native annulus.

20. The prosthetic heart valve of claim 19, wherein: The features include one or more flanges, hooks, coils, or clips configured to capture native leaflets of the diseased heart valve.

21. The prosthetic heart valve according to any one of claims 1 to 3, wherein: The at least one prosthetic leaflet is configured with at least one fork-like structure.

22. The prosthetic heart valve of claim 21, wherein: The at least one fork-like structure includes a plurality of fork-like structures.

23. The prosthetic heart valve according to any one of claims 1 to 3, wherein: The lower ventricular portion of the frame comprises a part-cylindrical or part-conical shape.

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