Replacement heart valves for transcatheter repair of congenital valves

Abstract

This invention relates to a novel and advantageous frame for a valve prosthesis that maximizes the effective valve orifice area of ​​the prosthesis while minimizing wear on the valve components attached to the frame. [Solution] A replacement heart valve prosthesis for transcatheter repair of a congenital valve, wherein the replacement heart valve comprises a valve component mounted on the outer surface of an expandable frame 200. The frame 200 comprises an expandable region 212 near the distal end 204 of the frame and a leaflet region 214 near the proximal region, the leaflet region 214 including a plurality of valve attachment mechanisms. The valve component can be attached to the valve component at least by the valve attachment mechanisms. The replacement heart valve prosthesis of this disclosure may be a more durable and longer-lasting valve, having additional benefits by positioning the valve tissue between the expandable frame 200 and the congenital heart tissue.

Description

[Technical Field]

[0001] This disclosure relates to a novel, advantageous, expandable frame for use in transcatheter replacement heart valve prosthesis, and a method for attaching valve components to the frame. [Background technology]

[0002] The background information provided herein is for general purposes only. Our research, as with any aspect of this description, may not otherwise qualify as prior art at the time of filing, and therefore is not expressly or implicitly recognized as prior art to this disclosure.

[0003] Transcatheter valve replacement (TVR) is a minimally invasive cardiac procedure to repair or replace a heart valve using an implantable valve prosthesis (artificial valve) delivered to the patient's natural valve via a catheter. The implantable valve prosthesis typically features an expandable frame with multiple flat prosthetic leaflets attached inside. The prosthetic leaflets are intended to mimic the function of a healthier natural valve leaflet. The expandable frame, when implanted in the natural valve, may be self-expanding using a shape-memory alloy, balloon-inflatable, or mechanically expandable. Transcatheter valve replacement prostheses have been developed for the aortic, mitral, and tricuspid valves. A TVR procedure typically involves transfemoral introduction of a catheter into the patient's vascular system, where the valve prosthesis is loaded into the catheter and advanced through the patient's vascular system to the natural valve.

[0004] Before the development of these minimally invasive transcatheter valve replacement procedures, the only option for most patients requiring repair of their own heart valves was significantly invasive surgical replacement. However, for many patients requiring heart valve repair, surgical repair carried relatively high risks, or the patient was not a suitable candidate for surgery. Regarding the aortic valve, transcatheter aortic valve replacement (TAVR) has been widely adopted by clinicians worldwide as an alternative to surgical replacement to treat these high-risk patients with severe aortic stenosis or similar conditions. Many procedures over several decades have shown that TAVR improves the long-term survival of these patients. In addition, several recent studies involving both balloon-inflatable and self-expanding TAVR prostheses have demonstrated the efficacy of TAVR in patients with low surgical risk, and in 2019, the U.S. Food and Drug Administration expanded the indications for TAVR to include these low-risk patients.

[0005] The development of TAVR prostheses and related prior art has focused considerably on mechanisms and methods for delivering the prosthesis to the natural valve, positioning or repositioning the prosthesis relative to the natural valve structure or surrounding anatomical structures, and improving vascular delivery by reducing the French size of the catheter. However, this development has not particularly focused on the long-term use and hemodynamic performance of the prosthesis over time. Many of the TAVR prostheses currently used in these procedures exhibit significant calcification and disintegration or degradation. Over time, typically within 5 to 15 years, many TAVR valve prostheses degrade and eventually fail, after which the patient needs to have the valve prosthesis repaired. In recent years, a procedure called "valve-in-valve" TAVR can provide a second valve to patients whose TAVR prosthesis has failed. In these procedures, a new transcatheter valve is inserted into the lumen of the non-functioning TAVR valve, pushing the artificial valve leaflet aside. Inserting a second valve into the lumen of a non-functioning TAVR valve inevitably limits or reduces the effective orifice area, and therefore the hemodynamic performance of this second valve is limited. [Overview of the project] [Problems that the invention aims to solve]

[0006] As younger, lower-risk patients accept TAVR prostheses, there is a need for more durable valves that can effectively withstand prosthesis calcification and degradation. Furthermore, in addition to their longer lifespan, durable heart valves that also achieve improved hemodynamic performance are needed in this field.

[0007] The following provides a brief overview of one or more embodiments of the present disclosure to give a basic understanding of such embodiments. This overview is not intended to be a comprehensive overview of all possible embodiments, nor to identify key or important elements of all embodiments, nor to describe the scope of any or all embodiments.

[0008] This disclosure relates to a novel and advantageous frame for valve prostheses that maximizes the effective valve orifice area of ​​the prosthesis while minimizing wear on the valve components attached to the frame. The effective valve orifice area of ​​a valve is an important metric when measuring the hemodynamic performance of the valve. [Means for solving the problem]

[0009] In some embodiments, as described herein, a valve component comprising at least one valve leaflet may be mounted on the outer surface of the frame. Prior art valves typically have an artificial valve leaflet mounted on the inner surface of the frame, instead within the lumen of the frame. With these prior art valves, when the valve is implanted in a natural valve, the metal alloy frame comes into contact with the patient's natural heart tissue, which can contribute to inflammation in this area, prosthesis calcification, and performance problems of the valve prosthesis such as perialifoliation. By mounting the valve component on the outside of the valve instead, the metal alloy frame no longer comes into contact with the patient's natural heart tissue, and inflammation caused by the frame can be reduced. The inner surface of the frame can define a lumen, and the frame may be designed so that the valve leaflets (cusps) or valve leaflets of the valve component can join in the center of the frame's lumen to close the valve. Of course, in other embodiments of the invention described herein, the valve component may be mounted on the inner surface of the frame of this disclosure.

[0010] In at least one embodiment, a replacement heart valve prosthesis for transcatheter repair of a natural valve, wherein the replacement heart valve comprises a frame and a valve component. The frame has a distal end, a proximal end, and a length between the distal and proximal ends. The frame further comprises an outer surface and an inner surface defining a lumen. The frame is expandable from a non-expanded state to an expanded state. The frame further comprises an expandable region near the distal end of the frame and a leaflet region near the proximal region, the leaflet region including a plurality of valve mounting mechanisms. The valve component is mounted on the outer surface of the frame, and the valve component is attached to the valve component at least by the valve mounting mechanisms. In some embodiments, the leaflet region comprises a plurality of posts. In at least one embodiment, the posts are connected to adjacent posts in the circumferential direction by struts, the struts defining a leaflet opening. The valve component may comprise at least two leaflets. Each leaflet can extend to an adjacent leaflet opening, and then the leaflet crosses the leaflet opening and enters the lumen of the frame. In at least one embodiment, the support is an arched support.

[0011] In at least one embodiment of the present disclosure, a replacement heart valve prosthesis for transcatheter repair of a natural valve comprises a frame and a valve component attached to the frame, the valve component comprising at least one valve leaflet. The frame may have an outer surface and an inner surface defining a lumen. In some embodiments, the valve component is mounted to the frame from the outside such that the inner surface of the valve is in contact with the outer surface of the frame. In other embodiments, the valve component is mounted to the frame from the inside such that the outer surface of the valve component is in contact with the inner surface of the frame. The frame may be expandable from a non-expanded state to an expanded state. The frame may have a distal end, a proximal end, and a length between the distal and proximal ends. The frame may have an expandable region defining the distal end of the frame and extending toward the proximal end of the frame, and a plurality of valve posts extending proximal from the expandable region. The expandable region may have at least a first row of cells at the distal end of the expandable region and a second row of cells at the proximal end of the expandable region. In some embodiments, the expandable region may have an additional number of intermediate column cells between the first column of cells and the second column of cells. Each valve post is provided with a valve mounting mechanism, and the valve components may be attached to the frame at least by the valve mounting mechanism.

[0012] In some embodiments, each valve post has a proximal end, a distal end, and a length between the proximal and distal ends, and the length of the valve post is 25% to 75% of the length of the frame. In some embodiments, circumferentially adjacent valve posts are arranged equidistant from each other around the frame. In some embodiments, the frame may have two valve posts. In other embodiments, the frame may have three valve posts. In yet another embodiment, the frame may have four or more valve posts.

[0013] In some embodiments, the valve construct can include at least two shaped valve leaflets and an intersection region between the two shaped valve leaflets, and the intersection region of the valve construct is attached to a post. In some embodiments, the valve construct comprises a single piece of biological material. In some embodiments, the valve construct comprises three valve leaflets shaped within a single piece of biological material. In some embodiments, the biological material includes a polymer, bovine tissue, porcine tissue, or pericardium.

[0014] In some embodiments, the post can further comprise an intersection alignment marker. In at least one embodiment, the intersection alignment marker is a radiopaque marker.

[0015] While multiple embodiments are disclosed, still other embodiments of the present invention will be apparent to those of ordinary skill in the art from the following detailed description which illustrates and describes exemplary embodiments of the present invention. As will be understood, the various embodiments of the present disclosure can be modified in various obvious aspects without departing from the spirit and scope of the present disclosure. Accordingly, the drawings and detailed description are to be regarded as illustrative in nature and not restrictive.

[0016] This specification concludes with claims particularly pointing out and distinctly claiming the subject matter regarded as forming various embodiments of the present disclosure, but the present disclosure is considered to be better understood from the following description when read in conjunction with the accompanying drawings.

Brief Description of the Drawings

[0017] [Figure 1A] Schematic view of the valve prosthesis of the present invention in which the valve construct is mounted outside the frame during systole and diastole, respectively. [Figure 1B] Schematic view of the valve prosthesis of the present invention in which the valve construct is mounted outside the frame during systole and diastole, respectively. [Figure 2] Perspective view of an expandable frame in an expanded state according to at least one embodiment of the present disclosure. [Figure 3]Schematic plan view of an expandable frame shown in Fig. 2 in an expanded state. [Figure 4] Schematic plan view of an expandable frame shown in Fig. 2 in a non-expanded state. [Figure 5] Perspective view of an expandable frame in an expanded state according to at least one embodiment of the present disclosure. [Figure 6] Schematic plan view of an expandable frame shown in Fig. 5 in an expanded state. [Figure 7] Schematic plan view of an expandable frame shown in Fig. 5 in a non-expanded state. [Figure 8] Perspective view of an expandable frame in an expanded state according to at least one embodiment of the present disclosure. [Figure 9] Schematic plan view of an expandable frame shown in Fig. 8 in an expanded state. [Figure 10] Schematic plan view of an expandable frame shown in Fig. 8 in a non-expanded state. [Figure 11] Perspective view of an expandable frame in an expanded state according to at least one embodiment of the present disclosure. [Figure 12] Schematic plan view of an expandable frame shown in Fig. 11 in an expanded state. [Figure 13] Schematic plan view of an expandable frame shown in Fig. 11 in a non-expanded state. [Figure 14A] Front view of a valve prosthesis in which a valve component is attached to the expandable frame of Fig. 11 according to at least one embodiment of the present disclosure. [Figure 14B] Top view of the valve prosthesis shown in Fig. 14A. [Figure 14C] Perspective view of the valve prosthesis shown in Figs. 14A to 14B. [Figure 15] Perspective view of an expandable frame in an expanded state according to at least one embodiment of the present disclosure. [Figure 16] Schematic plan view of an expandable frame shown in Fig. 15 in an expanded state. [Figure 17] Schematic plan view of an expandable frame shown in Fig. 16 in a non-expanded state. [Figure 18]A perspective view of an expandable frame in an extended state according to at least one embodiment of the present disclosure. [Figure 19] A schematic plan view of the expandable frame shown in Figure 15 in its expanded state. [Figure 20] A schematic plan view of the expandable frame shown in Figure 16 in its non-extended state. [Figure 21] A schematic plan view of an expandable frame in a non-expanded state having at least one radiopaque marker, according to at least one embodiment of the present disclosure. [Figure 22] A schematic plan view of an expandable frame and a suture pattern used to attach tissue to at least a portion of the expandable frame, according to at least one embodiment of the present disclosure. [Figure 23A] A schematic plan view of the commissure posts of the frame and the suture pattern for attaching the valve components to the frame, as seen from the outer surface of the valve prosthesis, according to at least one embodiment of the present disclosure. [Figure 23B] Figure 23A shows a schematic plan view of the commissure posts and suture pattern of the frame as seen from the inner surface of the valve prosthesis. [Figure 24] Perspective views of valve components that can be connected to the frame, as shown in Figures 23A and 23B. [Modes for carrying out the invention]

[0018] This disclosure describes a novel and advantageous valve prosthesis having a frame for mounting valve components, and a method for mounting valve components to the frame. The embodiments and techniques discussed below may be discussed in relation to aortic valve replacement, but it is within the scope of this disclosure that the invention may be suitable for use in other valve replacement procedures, such as mitral valve and tricuspid valve replacement. Furthermore, the figures and embodiments discussed below may describe an aortic valve typically having three lobes, but it is within the scope of this disclosure that the invention may be suitable for use in a bicuspid aortic valve prosthesis.

[0019] The following detailed description includes many specific details to give a complete understanding of some embodiments. However, it will be understood by those skilled in the art that some embodiments can be carried out without these specific details. In other examples, at least one of the well-known methods, procedures, and components is not described in detail so as not to obscure the discussion.

[0020] In at least some embodiments of this disclosure, the valve component may be mounted on the outer surface of the frame rather than on the typical inner surface of the frame to the expandable frame of the transcatheter valve prosthesis. In such embodiments, when the valve prosthesis is expanded, the valve component may have a diameter greater than the diameter of the frame.

[0021] Figures 1A and 1B show schematic diagrams of the valve prosthesis 100 of this disclosure from one end of the prosthesis. The valve prosthesis 100 may be designed for either supraannular or intraannular placement. The valve prosthesis 100 comprises an expandable frame 102 having an inner surface 104 and an outer surface 106. The inner surface 104 of the expandable frame 102 defines a lumen 107. In some embodiments, the expandable frame may comprise a plurality of posts 108. The valve prosthesis 100 further comprises a valve component 110, which is mounted on the outer surface 106 of the expandable frame 102, as shown in Figures 1A and 1B. The valve component 110 may include a biomaterial, as will be discussed further below. The valve component 110 has an inner surface 112 and an outer surface 114 with a thickness in between. When attached to the expandable frame 102, the inner surface 112 of the valve component 110 contacts the outer surface 106 of the expandable frame 102. The valve component 110 may have at least one valve leaflet 120. In a preferred embodiment for an aortic valve, the valve component 110 may have at least three valve leaflets 120. The valve leaflets 120 can oscillate or move relative to the expandable frame 102 so that they can join with each other without regurgitation during cardiac diastole and fully open during cardiac systole to promote at least adequate improvement in blood flow and hemodynamics. In at least some embodiments, the effective valve orifice area of ​​the valve prosthesis 100 is about 1.7 to 3.5 cm². 2 In at least some embodiments, the average effective valve orifice area of ​​the valve prosthesis 100 is approximately 2 to 3.5 cm². 2 In at least some embodiments, the average effective valve orifice area of ​​the valve prosthesis 100 is approximately 2.2 to 3.5 cm². 2 In at least some embodiments, the average effective valve orifice area of ​​the valve prosthesis 100 is approximately 2.5 to 3.5 cm². 2 In at least one embodiment, the valve prosthesis 100 has a Doppler velocity index factor of 0.55 to 0.70 and a length of approximately 2.5 to 3.5 cm. 2It has an average effective valve area and a pressure gradient of approximately 533 to 933 Pascals (approximately 4 to 7 mmHg). In at least one embodiment, the valve prosthesis 100 has a Doppler velocity exponent factor of 0.55 to 0.70 and a pressure gradient of approximately 2.5 to 3.5 cm 2 It has an average effective valve orifice area and a pressure gradient of approximately 533 to 1333 Pascals (approximately 4 to 10 mmHg). When implanted in a patient's natural heart valve, valve components with tissue mounted on an external frame can directly contact the natural heart valve tissue, whereas typical valve prostheses, conversely, have valve components mounted inside an expandable frame outside the valve components, so the expandable metal frame comes into contact with the natural heart valve tissue, which can promote inflammation. By making the valve component 110 directly contact the natural heart valve tissue, inflammation can be reduced. In addition, by having the tissue outside the expandable frame, the valve prosthesis 100 can have a larger opening area, which can lead to improved hemodynamics. Furthermore, by having the tissue outside the expandable frame, the valve prosthesis 100 can reduce the gradient across the valve during forward flow, which can lead to improved hemodynamics. Depending on the biomaterial used for the valve component 110, the biomaterial may even reconstruct together with adjacent innate heart valve tissue to adhere the valve component 110 to the innate structure, thereby preventing paravalvular leakage and reducing the risk of valve prosthesis migration. In such examples where such materials are used, the valve prosthesis of the present disclosure may eliminate the need for expandable materials such as polymer skirts, fabric skirts, or foams to prevent paravalvular leakage, which are typically present in most commercially available valve prostheses. In other examples, a portion of the valve component 110 may have a coating such as an adhesive to assist in the adhesion of the valve component 110 to the innate valve structure. Yet another example of the valve prosthesis of the present disclosure may include a polymer skirt, a fabric skirt, or other paravalvular leakage prevention measures.

[0022] In some embodiments, the valve component may further extend over at least a portion of both the inner and outer surfaces of the post 108. More specifically, a portion of the valve component between the valve leaves, which may be referred to as a commissar region of the valve component, can be aligned with the post 108, and in some embodiments, it may be wrapped around the post 108 such that the inner and outer surfaces of the post 108 are covered by the tissue material of the valve component. In some embodiments, the valve component may also be folded over the distal end (or annular end) of the expandable frame to form a fold, such that the valve component may be present on both the inner and outer surfaces of the expandable frame at the distal end of the expandable frame.

[0023] In some embodiments, the expandable frame 102 may be a self-expanding frame, and in other embodiments, the expandable frame 102 may be a balloon-expandable frame or other mechanically expandable frame. In yet another embodiment, the expandable frame may have a self-expanding region and a balloon-expandable region. For example, the region of the frame near the valve lobe may be self-expanding to control the expansion of the valve lobe region using a shape memory alloy, while the region of the frame closest to the annulus may be balloon-expandable to facilitate control of its position within the annulus. The expandable frame 102 may have a constant diameter from the distal end to the proximal end. The expandable frame 102 may have a larger diameter at the proximal end than at the distal end, or conversely, a larger diameter at the distal end than at the proximal end, thereby effectively forming a valve taper. In some embodiments, the expandable frame 102 may have a shape that widens from the distal end to the proximal end.

[0024] The expandable frame 102 may be composed of stainless steel, shape memory alloy, plastically deformable alloy, or a combination thereof. Examples of such alloy materials include, but are not limited to, nickel-titanium alloys such as Nitinol® alloy, cobalt-chromium alloys such as ELGILOY® alloy, platinum-tungsten alloy, and tantalum alloy. Other alloys that may be used to form the frame include, but are not limited to, other cobalt-chromium alloys and titanium-cobalt-chromium-molybdenum alloys. In addition to these materials, the expandable frame 102 may be further composed of polymers, biomaterials, or a combination thereof. In some embodiments, the expandable frame 102 may have a coating on at least a portion of either the outer surface 106 or the inner surface 104. The coating may include, but is not limited to, polytetrafluoroethylene (PTFE), silicone, biopolymers, and other suitable polymers. In other embodiments, the coating may include radiopaque materials. In some embodiments, the coating may include drug-eluting materials.

[0025] The valve component 110 may include tissue material. In some embodiments, the tissue material may be a biomaterial. In some embodiments, the tissue material may be a cross-linked collagen-based biomaterial including decellularized or cellular tissue selected from the group consisting of cardiovascular tissue, cardiac tissue, cardiac valves, aortic origin, aortic wall, aortic leaflet, pericardial tissue, connective tissue, dura mater, dermal tissue, vascular tissue, cartilage, pericardium, ligaments, tendons, blood vessels, umbilical cord tissue, bone tissue, fascia, and submucosa and skin. In some embodiments, the tissue material is an implantable biomaterial, such as the biomaterial described in the disclosure of U.S. Patent No. 9,205,172, filed December 21, 2005, entitled “Implantable Biomaterial and Method of Producing Same,” which is incorporated herein by reference in its entirety. In some embodiments, the cross-linked collagen-based biomaterial is treated by the ADAPT® treatment method. The ADAPT® treatment method is an anti-calcification treatment method for biomaterials that eliminates residual DNA and has more than 10 years of clinical data demonstrating the absence of calcification when used in cardiac surgery. In some embodiments, the tissue material may be artificial tissue. In some embodiments, the artificial tissue may include polymers molded or formed into single pieces. In some embodiments, the artificial tissue may include polytetrafluoroethylene, polyethylene terephthalate, other polymers, and other polymer coatings. In some embodiments, the valve component 108 may include fabricated tissue material. More specifically, at least some or all of the valve lobes 120 of the valve component 110 may include fabricated tissue material.In some embodiments, the valve component 110, including the valve leaflet 120, is a single-piece three-dimensional valve component composed of a single piece of tissue material, such as the valve described in the disclosure of the present applicant's U.S. Application No. 16 / 129,235, titled “Replacement Heart Valve with Reduced Suturing,” which is incorporated herein by reference.

[0026] Figures 2 to 10 illustrate various embodiments of expandable frames for valve prostheses that result in improved hemodynamic performance of valve prostheses according to the invention of the present disclosure. Each expandable frame shown in these figures and further discussed below may be composed of the frame materials discussed above. Furthermore, each expandable frame may be attached to a valve component that may be configured as discussed above. In some embodiments, the valve component may be mounted on the outside of the frame, and in other embodiments, the valve component may be mounted on the inside of the frame.

[0027] Figures 2 to 4 show one embodiment of an expandable frame 200 for the prosthesis of the present disclosure. In some embodiments, valve components (not shown) may be mounted on the outside of the frame 200, and in other embodiments, valve components (not shown) may be mounted on the inside of the frame 200. Figure 2 shows a perspective view of the expandable frame 200 in an expanded state. Figure 3 shows a schematic diagram of the flat stent pattern of the expandable frame 200 of Figure 2 in an expanded state, while Figure 4 shows a schematic diagram of the flat stent pattern of the expandable frame 200 of Figure 8 in an unexpanded state.

[0028] The expandable frame 200 may have a proximal end 202 and a distal end 204 opposite to the proximal end 202, with the axial length of the expandable frame extending between the proximal end 202 and the distal end 204. The expandable frame 200 may have an outer surface 206 and an inner surface 208 with thickness in between. The inner surface 208 defines the lumen 210. The expandable frame 200 may have an expandable region 212 and a leaflet region 214 proximal to the expandable region 212. The leaflet region 214 allows the leaflets of the valve components to open beyond the outer surface 206, and in some embodiments, more specifically, allows the leaflets to open beyond the outer surface 206 of at least the expandable region 212 of the expandable frame, and the expandable region 212 may be considered to be the ventricular segment of the frame. This effectively creates a taper effect in which the area defined by the free edge of the valve leaflets of the valve structure is larger than the area defined by the outer surface of the frame, resulting in a reduction of the pressure gradient during forward flow and an increase in the effective valve opening area. Prior art valve prostheses, due to the cellular structure of the frame, do not allow the valve leaflets to open beyond the expandable outer surface of the frame.

[0029] The expandable region 212 may be involved in the fixation or sealing of the valve prosthesis. The expandable region 212 has a proximal end 216 and a distal end 218. The expandable region 212 comprises a plurality of cells 220 defining an opening 221. In the embodiments shown in Figures 2 and 3, the opening 221 has different sizes and shapes. In other embodiments, the opening 221 may have the same size and shape.

[0030] Cell 220 may be located at least in a first row of circumferentially adjacent cells, indicated overall by reference numeral 222, at the proximal end 216 of the expandable region 212, and in a second row of circumferentially adjacent cells, indicated overall by reference numeral 224, at the distal end 218 of the expandable region 212. In some embodiments, such as those shown in Figures 2 to 4, at least one intermediate row of circumferentially adjacent cells, indicated overall by reference numeral 226, may extend between the circumferential row 222 of the first cell and the circumferential row 224 of the second cell.

[0031] Each cell 220 comprises a plurality of struts 230. Each strut 230 may be a straight strut, or it may be a curved strut as shown in at least Figures 2 to 4, or each strut may be a meandering strut having at least one curved or corrugated section. Each strut 230 may have a thickness that is uniform or varies along its length. Each strut of cell 220 may be connected to an adjacent strut at a nodal point 232. The nodal point 232 may include an end nodal point 234 located at the proximal end 216 and distal end 218 of the expandable region, and the end nodal point 234 connects circumferentially adjacent struts 230 at each end 216, 218. The nodal point 232 may also include a column nodal point 236, which connects circumferentially adjacent struts 230 within columns 222, 224, 226, or connects axially adjacent struts 230 in one column 222, 224, 226 to an axially adjacent column.

[0032] Next, referring to the leaflet region 214, the leaflet region 214 is intended to facilitate or assist the movement of the valve leaf of a valve component mounted on an expandable frame 200, and the leaflet region 214 has a proximal end 242 and a distal end 244 adjacent to the expandable region 212. The leaflet region 214 is provided with a plurality of posts 246 for mounting the valve component to the expandable frame 200. In some embodiments, the leaflet region 214 may have two posts 246. In some embodiments, such as the embodiments shown in Figures 2 to 4, the leaflet region 214 may have three posts 246. In yet other embodiments, the leaflet region 214 may have any number of posts 246.

[0033] Each post 246 may have a distal end 248 and a proximal end 250, the proximal end 250 defining the proximal end 242 of the leaflet region 242. In some embodiments, the distal end 248 of the post 246 may be coupled to an end node 234 at the proximal end 216 of the expandable region 212. In other embodiments, the distal end 248 of the post 246 may be coupled to an arched support extending over a circumferential distance between adjacent posts 246, the arched support may be coupled to an expandable region at one or more end nodes 234. In yet another embodiment, such as the embodiments shown in Figures 2 to 4, the distal end 248 of the post 246 may be coupled to one or more leaflet supports 251 of the leaflet region 214, each leaflet support may be coupled to an expandable region 212 at one or more end nodes 234. As shown in more detail in Figure 3, each post 246 may be connected to a right leaflet support 251a and a left leaflet support 251b. In at least the embodiments shown, the combination of the posts 246, the right leaflet support 251a and the left leaflet support 251b forms a furculate structure. In the embodiments shown, the right leaflet support 251a of the first post 246a and the left leaflet support 251b of the second post 246b (which is circumferentially adjacent to the first post 246a) are connected to the same end node 234 of the expandable region 212. Each post 246 has a side surface 252, and each right leaflet support has a side surface 253. The side surfaces 252 of post 246a, 252 of post 246b, 253 of right leaflet support 251a, and 253 of left leaflet support 251b, which is circumferentially adjacent to right leaflet support 251b, define the leaflet opening 254. The leaflet opening 254 allows the leaflets of the valve components to traverse the outer surface 206 of the expandable frame 200. The leaflet opening 254 may also enable improved coronary artery access.

[0034] Each post 246 may comprise at least one support 255, the support 255 may include at least one mounting mechanism 256 located within the support 255. The support 255 may have a width greater than the width of at least one support 230 of the expandable region 214. In at least the embodiments shown in Figure 3, the mounting mechanism 256 may comprise one or more openings 260. As shown in Figure 3, the openings 260 may be holes 260a or one or more slots 260b. In yet another embodiment, the mounting mechanism 256 may comprise a plurality of openings 260 to facilitate a particular suture pattern, the openings comprising holes, slots, or slits. In yet another embodiment, at least one mounting mechanism may comprise a hook, loop, cotton spool, or other mounting mechanism. In some embodiments, at least one of the posts 246 and mounting mechanism 256 may be further utilized to recapture or reposition the frame during or after implantation. In some embodiments, the post 246, the mounting mechanism 256, and at least one of the one or more valve leaflet supports 251 may be used in a valve-in-valve procedure to engage with a previously implanted valve prosthesis or to engage with a valve prosthesis to be implanted.

[0035] The leaflet region 214 may further comprise one or more leaflet region cells 270 that can be defined by one or more leaflet connector posts 272. The leaflet connector posts 272 may provide some additional structure to the post 246 to accommodate the stresses the leaflet region experiences when the valve rhythmically moves between systole and diastole. The leaflet connector posts 272 may have a width greater than the width of at least one post 230 of the expandable region 214. As shown in Figures 2-3, the leaflet region cells 270 have an opening 273 that is larger than the opening 221 of the cell 220. Some of the leaflet region cells 270a may, in some embodiments, be defined by at least one leaflet post 251, at least one leaflet connector post 272, and one or more posts 230 of the proximal end 216 of the expandable region 212. Other leaflet region cells 270b may, in some embodiments, be defined by at least two leaflet struts 251 and two leaflet connector struts 272. Further other leaflet region cells 270c may, in some embodiments, be defined by at least two struts 230 and two leaflet connector struts 272 at the proximal end 216 of the expandable region 212. Leaflet region cells 270a may define regions larger than leaflet region cells 270b and 270c. Leaflet region cells 270a may have different shapes from leaflet region cells 270b and 270c. In other embodiments, leaflet region cells 270a may be smaller than leaflet region cells 270b and 270c. In one embodiment, the leaflet region cell 270b may have substantially the same shape as the leaflet region cell 270c, and in one embodiment, the leaflet region cell 270b may be the same size as the leaflet region cell 270c in some embodiments, or may be slightly larger than the leaflet region cell 270c. In other embodiments, the leaflet region cell 270b may have substantially a different shape from the leaflet region cell 270c. In yet another embodiment, the leaflet region cell 270b may be smaller than the leaflet region cell 270c.

[0036] In some embodiments, the diameter of the leaflet region 214 may be larger than the diameter of the expandable region 212. In some embodiments, the diameter of the leaflet region 214 at its proximal end may be similar to the diameter of the expandable region 212 at its distal end. In some embodiments, the diameter of the leaflet region 214 at its proximal end may be larger than the diameter of the expandable region 212 at its distal end. In at least one embodiment, the diameter of the leaflet region 214 may be larger at the proximal end of the leaflet region than at the distal end of the leaflet region, such that the leaflet region 214 has a tapered outer shape when expanded.

[0037] In some embodiments, the axial length of the expanded valve leaflet region 214 shown in Figures 2-3 is approximately 25% to 75% of the axial length of the expandable frame 200. In some embodiments, the axial length of the expanded valve leaflet region 214 shown in Figures 2-3 is approximately 45% to 70% of the axial length of the expandable frame 200. In at least one embodiment, the axial length of the expanded valve leaflet region 814 shown in Figures 2-3 is approximately 60% to 75% of the axial length of the expandable frame 200.

[0038] Figure 4 shows the expandable frame 200 in its non-expanded state. As shown in Figure 4, all end nodes 232 at the distal end 218 of the frame 200 are radially aligned. As shown in Figure 4, all row nodes 236 are also radially aligned, as are the end nodes 232 at the proximal end 216 of the expandable frame 200. Unlike the appearance of the cells 220 in the expandable region 212 shown in Figures 2 and 3 in their expanded states, in the non-expanded state, the cells 220 are all uniform in shape and size.

[0039] In at least some embodiments, the expandable frame 200, with a frame-like design as shown in Figures 2 to 4, is mounted on the valve annulus. As a result of the annulus-mounted design of the expandable frame 200, valve prostheses utilizing this frame can achieve reduced pressure gradients and increased effective valve orifice area during forward flow, and therefore superior hemodynamics.

[0040] Figures 5 to 7 illustrate modified versions of the expandable frame shown in Figures 2 to 4. Figure 5 shows a perspective view of the expandable frame 500 in an expanded state. Figure 6 shows a schematic diagram of the flat stent pattern of the expandable frame 500 of Figure 5 in an expanded state, while Figure 7 shows a schematic diagram of the flat stent pattern of the expandable frame 500 of Figure 5 in an unexpanded state. In some embodiments, valve components (not shown) are mounted on the outside of the expandable frame 500 shown in Figures 5 to 7, while in other embodiments, valve components (not shown) may be mounted on the inside of the frame 500.

[0041] The expandable frame 500 may have a proximal end 502 and a distal end 504 opposite to the proximal end 502, with the axial length of the expandable frame extending between the proximal end 502 and the distal end 504. The expandable frame 500 may have an outer surface 506 and an inner surface 508 with thickness in between. The inner surface 508 defines the lumen 510. The expandable frame 500 may have an expandable region 512 and a leaflet region 514 proximal to the expandable region 512. The leaflet region 514 allows the leaflets of the valve components to open beyond the outer surface 506, and in some embodiments, more specifically, allows the leaflets to open beyond the outer surface 506 of at least the expandable region 512 of the expandable frame, and the expandable region 512 may be considered to be the ventricular segment of the frame. This effectively creates a taper effect where the area defined by the free edge of the valve leaflets is larger than the area defined by the outer surface of the frame, resulting in a reduction of the pressure gradient during forward flow and an increase in the effective valve opening area. Prior art valve prostheses, due to the cellular structure of the frame, do not allow the valve leaflets to open beyond the expandable outer surface of the frame.

[0042] The expandable region 512 has a proximal end 516 and a distal end 518. The expandable region 512 comprises a plurality of cells 520 that define an opening 521. In the embodiments shown in Figures 5 and 6, the opening 521 has different sizes and shapes. In other embodiments, all openings 521 may have the same size and shape.

[0043] Cell 520 may be arranged in at least a first row of circumferentially adjacent cells, generally indicated by reference numeral 522, at the proximal end 516 of the expandable region 512, and a second row of circumferentially adjacent cells, generally indicated by reference numeral 524, at the distal end 518 of the expandable region 512. As shown in Figures 5 to 7, only these two rows of cells 522, 524 are provided, but in other embodiments, intermediate rows of circumferentially adjacent cells may be provided, as described in other embodiments herein.

[0044] Each cell 520 comprises a plurality of struts 530. Each strut 530 may be a straight strut, or it may be a curved strut as shown in at least Figures 5 to 7, or each strut may be a meandering strut having at least one curved or wavy section. Each strut 530 may have a thickness that is uniform or varies along its length. Each strut 530 of cell 520 may be connected to an adjacent strut at a nodal point 532. The nodal point 532 may include an end nodal point 534 located at the proximal end 516 and distal end 518 of the expandable region, and the end nodal point 534 connects circumferentially adjacent struts 530 at each end 516, 518. The nodal point 532 may also include a column nodal point 536 that connects any of the circumferentially adjacent struts 530 in columns 522, 524.

[0045] Next, referring to the leaflet region 514, the leaflet region 514 is intended to facilitate or assist the movement of the valve leaf of a valve component mounted on an expandable frame 500, and the leaflet region 514 has a proximal end 542 and a distal end 544 adjacent to the expandable region 512. The leaflet region 514 is provided with a plurality of posts 546 for mounting the valve component to the expandable frame 500. In some embodiments, the leaflet region 514 may have two posts 546. In some embodiments, such as the embodiments shown in Figures 5-7, the leaflet region 514 may have three posts 546. In yet other embodiments, the leaflet region 514 may have any number of posts 546.

[0046] Each post 546 may have a distal end 548 and a proximal end 550, the proximal end 550 defining the proximal end 542 of the leaflet region 542. In the embodiments shown in Figures 5 to 7, the distal end 548 of the post 546 may be connected to one or more leaflet supports 551 of the leaflet region 514, and each leaflet support 551 may be connected to an expandable region 512 at one or more end nodal points 532. As shown in more detail in Figure 6, each post 546 may be connected to a right leaflet support 551a and a left leaflet support 551b. In the embodiments shown, the combination of the post 546, the right leaflet support 551a and the left leaflet support 551b forms a furculate structure. In the embodiment shown, the right leaflet support 551a of the first post 548a and the left leaflet support 551b of the second post 548b (which is circumferentially adjacent to the first post 548a) are connected to the same end node 534 of the expandable region 512. Each post 548 has a side surface 552, and each right leaflet support has a side surface 553. The side surfaces 552 of post 546a, the side surface 552 of post 546b, the side surface 553 of the right leaflet support 251a, and the side surface 553 of the left leaflet support 251b circumferentially adjacent to the right leaflet support 251b define a leaflet opening 554. The leaflet opening 554 allows the leaflets of the valve components to traverse the outer surface of the frame. The leaflet opening 554 may also allow for improved coronary artery access.

[0047] Each post 546 may comprise at least one support column 555, which may include at least one mounting mechanism 556 located within the support column 255. The support column 555 may have a width greater than the width of at least one support column 530 of the expandable region 514. In at least the embodiment shown in Figure 3, the mounting mechanism 556 may comprise a slot 560. In yet other embodiments, the mounting mechanism 554 may comprise one opening or a plurality of openings 560 that facilitate a particular suture pattern, the openings comprising holes, slots or slits. In other embodiments, at least one mounting mechanism may comprise a hook, loop, cotton spool, or other similar mounting mechanism. In some embodiments, at least one of the posts 546 and the mounting mechanism 554 may be further utilized to recapture or reposition the frame during or after implantation. In some embodiments, the post 546, the mounting mechanism 554, and at least one of the one or more valve leaflet supports 551 may be used in a valve-in-valve procedure to engage with a previously implanted valve prosthesis or to engage with a valve prosthesis to be implanted.

[0048] The leaflet region 514 may further comprise one or more leaflet region cells 570 that can be defined by one or more leaflet connector supports 572. The leaflet connector supports 572 may provide some additional structure to the post 546 to accommodate the stresses the leaflet region experiences when the valve rhythmically moves between systole and diastole. As shown in Figures 5-6, the leaflet region cells 570 have an opening 573 that is larger than the opening 521 of the cell 520. Some of the leaflet region cells 570a may, in some embodiments, be defined by at least one leaflet support 551, at least one leaflet connector support 572, and one or more supports 530 at the proximal end 516 of the expandable region 512. Other leaflet region cells 570b may, in some embodiments, be defined by at least two leaflet supports 551 and two leaflet connector supports 252. Furthermore, other leaflet region cells 570c may, in some embodiments, be defined by at least four struts 5300 of the proximal end 616 of the expandable region 212 and two leaflet connector struts 572. Adjacent leaflet connector struts in the circumferential direction may be further connected to one another by nodal points or smaller struts, as indicated by reference numeral 274.

[0049] In some embodiments, the axial length of the expanded valve leaflet region 514 shown in Figures 5-6 is approximately 25% to 75% of the axial length of the expandable frame 200. In some embodiments, the axial length of the expanded valve leaflet region 514 shown in Figures 5-6 is approximately 45% to 75% of the axial length of the expandable frame 500. In at least one embodiment, the axial length of the expanded valve leaflet region 514 shown in Figures 5-6 is approximately 60% to 75% of the axial length of the expandable frame 500.

[0050] In some embodiments, the diameter of the valve tip region 514 may be greater than the diameter of the expandable region 512. In some embodiments, the diameter of the valve tip region 514 at the proximal end thereof may be similar to the diameter of the expandable region 512 at the distal end thereof. In some embodiments, the diameter of the valve tip region 514 at the proximal end thereof may be greater than the diameter of the expandable region 512 at the distal end thereof. In at least one embodiment, the diameter of the valve tip region 514 may be greater at the proximal end of the valve tip region than at the distal end of the valve tip region such that the valve tip region 514 has a tapered outer profile when in the expanded state.

[0051] In some embodiments, a skirt or other perivalvular leakage reduction mechanism may be attached to the outer surface of the expandable frame 206. FIG. 7 shows an expandable frame 500 in a non-expanded state. As shown in FIG. 4, all of the end nodes 532 at the distal end 518 of the frame 500 are radially aligned. As shown in FIG. 7, all of the column nodes 536 are also radially aligned, as are the end nodes 532 at the proximal end 516 of the expandable frame 500. Unlike the appearance of the cells 520 of the expandable region 212 in their expanded state shown in FIGS. 5-6, in the non-expanded state the cells 520 are all uniform in shape and size. More particularly, the cells in the circumferential column 522 of the first cell all appear to be of the same shape and size in the non-expanded state, whereas, as shown in FIGS. 5-6, the cells 520 vary in shape within the circumferential column 522 of the first cell.

[0052] In some embodiments, a valve prosthesis comprising the expandable frame shown in FIGS. 2-7 has an average effective valve area (EOA) of 2 ~3.76 cm 2 . In some embodiments, the average EOA can be 2 ~3.53 cm 2 . In yet other embodiments, the average EOA is 2~3.30cm 2 This is possible. In at least one embodiment, the valve prosthesis 100 has a Doppler velocity index factor (DVI) of 0.55 to 0.70 and a length of approximately 2.5 to 3.5 cm. 2 It has an average EOA and a pressure gradient of approximately 533 to 1333 Pascals (approximately 4 to 10 mmHg).

[0053] Figures 8 to 10 illustrate another embodiment of the expandable frame 800 of the present invention. When used with the valve components discussed above, the expandable frame 800 can form a shorter suprandial valve prosthesis. The joining of the valve components in this expandable frame may be 45% to 70% of the height of the valve leaf. Unlike some of the other embodiments described herein, the expandable frame 800 shown in Figures 8 to 10 is primarily designed so that the valve components are mounted adjacent to the inner surface of the expandable frame 800. Figure 8 shows a perspective view of the expandable frame 800 in an expanded state. Figure 9 shows a schematic diagram of the stent pattern of the expandable frame 800 of Figure 8 in an expanded state, while Figure 10 shows a schematic diagram of the stent pattern of the expandable frame 800 of Figure 8 in a non-expanded state.

[0054] The expandable frame 800 may have a proximal end 802 and a distal end 804 opposite to the proximal end 802, and the axial length of the expandable frame extends between the proximal end 802 and the distal end 804. In some embodiments, the axial length of the frame from the proximal end 802 to the distal end 804 is about 18 mm to 24 mm. The expandable frame 800 may have an outer surface 806 and an inner surface 808 with thickness in between. The inner surface 808 defines the lumen 810. In at least one embodiment, the diameter of the outer surface 806 of the expandable frame may be greater than the axial length of the frame from the proximal end 802 to the distal end 804. For example, in an embodiment where the outer diameter of the valve is about 25.5 mm to 26.5 mm, the axial length of the valve from the proximal end 802 to the distal end 804 is about 20 mm to 22 mm. The expandable frame 800 may have an expandable region 812 and a valve leaflet region 814 located proximal to the expandable region 812.

[0055] The expandable region 812 has a proximal end 816 and a distal end 818. The expandable region 812 comprises a plurality of cells 820 defining an opening 821. In some embodiments, all cells 820 of the expandable region 812 may be substantially the same size and shape. In other embodiments, the cells 820 of the expandable region 812 may be of different sizes and shapes.

[0056] Cell 820 may be located at least in a circumferential row of first cells, shown collectively by reference numeral 822, at the proximal end 816 of the expandable region 812, and in a circumferential row of second cells, shown collectively by reference numeral 824, at the distal end 818 of the expandable region 812. In some embodiments, multiple circumferential intermediate rows of cells, shown collectively by reference numeral 826, may extend between the circumferential row of first cells 822 and the circumferential row of second cells 824. As shown in Figure 9, the expandable frame 800 has two intermediate rows of cells 826 between the circumferential row of first cells 822 and the circumferential row of second cells 824.

[0057] Each cell 820 comprises a plurality of struts 830. Each strut 830 may be a straight strut, or it may be a curved strut as shown in Figure 9, or each strut may be a meandering strut having at least one curved or wavy section. Each strut 830 may have a width that is uniform or varies along its length. Each strut of cell 820 may be connected to an adjacent strut at a nodal point 832. The nodal point 832 may include an end nodal point 834 located at the proximal end 816 and distal end 818 of the expandable region, and the end nodal point 834 connects circumferentially adjacent struts 830 at each end 816,818. The nodal point 832 may also include a column nodal point 336, which connects circumferentially adjacent struts 830 within columns 822, 824, 826, or connects axially adjacent struts 830 in one column 822, 824, 826 to an axially adjacent column.

[0058] The leaflet region 814 has a proximal end 842 and a distal end 844. The leaflet region 814 includes a plurality of posts 846 for attaching the valve components to the expandable frame 800. In some embodiments, the leaflet region 814 may have two posts 846. In some embodiments, such as those shown in Figures 8 to 10, the leaflet region 814 may have three posts 846. In yet other embodiments, the leaflet region may have any number of posts 846. Each post 846 extending from the proximal end 842 to the distal end 844 of the leaflet region 814 may have a proximal end 848 and a distal end 850. In some embodiments, the distal end 850 of the post 846 may be coupled to an end node 834 at the proximal end 816 of the expandable region 812. In other embodiments, the distal end 848 may be coupled to a support 830 of the expandable region, more specifically to a support of at least one cell 820 of the circumferential row 822 of the first cell. Each post 846 may comprise at least one support 852 and at least one mounting mechanism 854 connected to the support 852. The support 852 of the post is coupled at one end to the expandable region 812. The support 852 may have a width greater than the width of at least one support 830 of the expandable region 814. The support 852 may have a neck region 856 at its proximal end that connects the support 852 to at least one mounting mechanism 854 of the post 846. The at least one mounting mechanism 854 may comprise a tab 858, within which at least one opening 860 is located. As shown in Figure 8, the tab 858 may have a width greater than the width of the support 852. In at least the embodiment shown in Figure 8, the opening 860 may be a slot. In other embodiments, the opening 860 may be a hole. In yet another embodiment, the mounting mechanism 854 may have a plurality of openings 860 to facilitate a particular suturing pattern, the openings consisting of holes, slots, or slits. In another embodiment, at least one mounting mechanism may include a hook. In some embodiments, the post 846 may be further utilized to recapture or reposition the frame after implantation.

[0059] Each post 846 defines at least a portion of at least one leaflet region cell 870. As shown in Figures 8-9, the leaflet region cell 870 has an opening 872 that is larger than the opening 821 of the cell 820. The leaflet region cell 870 may, in some embodiments, allow for improved coronary artery access of the valve prosthesis 800. The leaflet region cell 870 is defined by a support 830 at the proximal end 816 of the expandable region 812, at least one post 846, and a pair of leaflet supports 874. Each leaflet support 874 may be a straight support, or a curved support as shown in at least Figure 9, or each leaflet support may be a meandering support having at least one curve or wave-like section. In some embodiments, the leaflet region cell 870 is defined by a support 852 of the post 846. Each support 874 forming the pair of leaflet supports is connected to one another at a leaflet nodule 876. In some embodiments, the leaflet region cell 870 may be further defined by an axial support 880. The axial support 880 may be circumferentially adjacent to the post 846, as shown in Figure 9. The axial support 880 connects at a first end 882 to one of the pair of support posts of the leaflet support at a connecting node 884, and at a second end 886 to an end node 834. The axial support 880 may be a straight support, as shown in Figure 9, or it may be a curved support, or a meandering support having at least one curved or wavy section. In at least the embodiments shown in Figures 8-9, the leaflet region cell is defined by eight struts, namely, struts 852 of post 846, a pair of leaflet struts 874, an axial strut 880, and four adjacent struts 830 of a circumferential row 822 of the first cell at the proximal end 816 of the expandable region 812. As at least as shown in Figures 8-9, the opening 872 of the leaflet region cell 870 may, in some embodiments, form a substantially heart-shaped circumference in the expanded state shown in Figures 8-9.

[0060] In some embodiments, the axial length of the expanded valve leaflet region 814 shown in Figures 8-9 is approximately 25% to 75% of the axial length of the expandable frame 800. In some embodiments, the axial length of the expanded valve leaflet region 814 shown in Figures 8-9 is approximately 30% to 50% of the axial length of the expandable frame 800. In at least one embodiment, the axial length of the expanded valve leaflet region 814 shown in Figures 8-9 is approximately 40% to 45% of the axial length of the expandable frame 800.

[0061] Figure 10 shows the expandable frame 800 in its non-expanded state. As shown in Figure 10, all end nodules 832 at the distal end 818 of the frame 800 are radially aligned. As shown in Figure 10, all column nodules 836 are also radially aligned, as are the end nodules 832 at the proximal end of the expandable frame 800. In addition, the column nodules 836 are axially aligned with adjacent column nodules in adjacent columns along the axial direction of the cell. In the expanded state, the valve leaflet nodule 876 is distal to the proximal end 850 of the post 846, as shown in Figure 9, but in the non-expanded state, the valve leaflet nodule 876 may be proximal to the proximal end 850 of the post 846. Furthermore, in the non-expanded state shown in Figure 10, the valve leaflet nodule 876 may be proximal to the mounting mechanism 854. In some embodiments, the valve leaflet node 876 is positioned relative to the mounting mechanism 854 or post 846 between the non-expanded and expanded states, so the valve leaflet node 876 may have a retrieval mechanism for recapturing or repositioning the expandable frame 800.

[0062] Figures 11-13 and 14A-14C illustrate another embodiment of the expandable frame 1100 of the present invention. The expandable frame 1100, when used with a valve component 1200 similar to the valve component discussed above and shown in Figures 14A-14C, can form a shorter supraannular valve prosthesis 1400. Similar to the expandable frames shown in Figures 8-10, the expandable frame 1100 is primarily designed so that the valve component is mounted adjacent to the inner surface of the expandable frame 1100 (particularly as shown in Figures 14A-14C). Figure 11 shows a perspective view of the expandable frame 1100 in an expanded state. Figure 12 shows a schematic diagram of the stent pattern of the expandable frame 1100 of Figure 11 in an expanded state, while Figure 13 shows a schematic diagram of the stent pattern of the expandable frame 1100 of Figure 11 in a non-expanded state. Figures 14A to 14C show a valve prosthesis 1400 in which the valve components 1200 are attached to an expandable frame 1100 shown in Figures 11 to 13.

[0063] The expandable frame 1100 may have a proximal end 1102 and a distal end 1104 opposite to the proximal end 1102, with the axial length of the expandable frame extending between the proximal end 1102 and the distal end 1104. The expandable frame 1100 may have an outer surface 1106 and an inner surface 1108 with thickness in between. The inner surface 1108 defines the lumen 1110. The expandable frame 1100 may have an expandable region 1112 and a leaflet region 1114 proximal to the expandable region 1112. The expandable region 1112 has a proximal end 1116 and a distal end 1118. The expandable region 1112 comprises a plurality of cells 1120 defining an opening 1121. In some embodiments, all cells 1120 of the expandable region 1112 may be substantially the same size and shape. In other embodiments, the cells 1120 of the expandable region 1112 have different sizes and shapes. The cells 1120 may be arranged as discussed above for the cells 820 of the embodiments shown in Figures 8 to 10.

[0064] The leaflet region 1114 may have a proximal end 1142 and a distal end 1144. The leaflet region 1114 comprises a plurality of posts 1146 for attaching the valve components to an expandable frame 1100. In some embodiments, the leaflet region 1114 may have two posts 1146. In some embodiments, such as those shown in Figures 11 to 14, the leaflet region 1114 may have three posts 1146. In yet other embodiments, the leaflet region may have any number of posts 1146. Each post 1146 extending from the proximal end 1142 to the distal end 1144 of the leaflet region 1114 may have a proximal end 1148 and a distal end 1150. In some embodiments, the distal end 1150 of the post 1146 may be coupled to an expandable region 1112 at the proximal end 1116, as discussed above for post 846 in the embodiments shown in Figures 8 to 10.

[0065] Each post 1146 may comprise at least one support column 1152 and at least one mounting mechanism 1154 connected to the support column 1152. The support column 1152 of the post is coupled at one end to an expandable region 1112. The support column 1152 may have a width greater than the width of the support column in the expandable region 1112. At least one mounting mechanism 1154 may comprise a tab 1158, within which at least one opening 1160 is located. In at least one embodiment, the opening 1160 may be a slot, and in other embodiments, the opening 1160 may be a hole. In yet another embodiment, the mounting mechanism 1154 may comprise a plurality of openings 1160 to facilitate a particular suture pattern, the openings comprising holes, slots, or slits. In other embodiments, at least one mounting mechanism may comprise a hook. In some embodiments, the support column 1152 may have a retrieval mechanism for recapturing or repositioning the expandable frame 1100.

[0066] Each post 1146 defines at least a portion of at least one leaflet region cell 1170. At least one leaflet region cell 1170 may be defined similarly to the leaflet region cell 870 in the embodiments shown in Figures 8 to 10. In at least the embodiments shown in Figures 11 to 13, the leaflet region cell is defined by eight struts, namely the strut 1152 of post 1146, a pair of leaflet struts 1174, a C-shaped strut 1180 connected at one end to one of the leaflet struts 1174 and also connected to the end node 1134 of the expandable region 1112, and four adjacent struts 1130 of the circumferential row 1122 of the first cell at the proximal end 1116 of the expandable region 1112. Adjacent C-shaped struts 1180a, 1180b may be connected to the same end node 1134 of the expandable region. Adjacent C-shaped supports 1180a, 1180b can be connected to adjacent pairs of supports 1174a, 1174b, respectively. The connection of adjacent C-shaped supports 1180a, 1180b and supports 1174a, 1174b forms a nodal point 1188. Adjacent C-shaped supports 1180a, 1180b of the valve leaflet region cell 1170 form an opening 1192. The opening 1192 can be sized and shaped to allow coronary artery access for secondary procedures (such as atherectomy or angioplasty) without interfering with the movement of the valve leaflets or lobes of the valve components. In some embodiments, the opening 1192 can be sized from 3.3 mm (10 Fr) to 4.6 mm (14 Fr), and in at least one embodiment, the opening 1192 can be sized to 4.0 mm (12 Fr) to allow for subsequent insertion of a catheter.

[0067] Figure 13 shows the expandable frame 1100 in its non-expanded state. In the expanded state, the valve leaflet nodules 1176 are distal to the proximal end 1148 of the post 1146, as shown in Figure 12, but in the non-expanded state, the valve leaflet nodules 1176 may be proximal to the proximal end 1148 of the post 1146. The valve leaflet nodules 1176 may be radially aligned. As shown in Figure 13, the openings 1192 may be radially aligned in the non-expanded state. In some embodiments, adjacent nodules 1188 may be radially aligned in the non-expanded state.

[0068] Figures 14A–14C illustrate the attachment of a valve component 1200 to an expandable frame 1100 according to at least one embodiment of the valve prosthesis 1400. The valve component 1200 may be attached to the frame as described in the disclosure of the present applicant's U.S. Application No. 16 / 129,235, titled “Replacement Heart Valve with Reduced Suturing,” which is incorporated herein by reference. Furthermore, the valve component 1200 may be attached to the expandable frame 1100 by overlapping a portion of the tissue onto the post 1146. In one embodiment, slits 1206 may be formed in the valve component 1200 near each commissure region 1202 of the valve component and near the proximal end 1204 of the valve component. Each post 1146 can be inserted through one slit 1206 of the valve component 1200 such that the commissure region 1202 at least partially overlaps the proximal end of the post 1146. The valve component can then be attached to each post 1146 using a mounting mechanism 1154 with sutures. The valve component can be further connected to the frame using at least one running belly suture circumferentially around the frame with a single suture. In one embodiment, the running belly suture follows the pattern of the valve leaflets of the valve component. In some embodiments of the valve prosthesis 1400, a perivalve leakage skirt 1408 may be provided on the outer surface of the valve. The skirt may be attached circumferentially around the valve with another suture. In at least one embodiment, the valve prosthesis 1400 has fewer than six sutures. In some embodiments, the valve prosthesis has three to six sutures. In other embodiments, the valve prosthesis has 3 to 5 sutures.

[0069] Figures 15 to 17 illustrate another embodiment of the expandable frame 1500 of the present invention. When used with the valve components 1200, which are attached to the expandable frame 1150 and discussed above and shown in Figures 14A to 14C, the expandable frame 1500 can form a shorter supraannular valve prosthesis. Similar to the expandable frames shown in Figures 8 to 13, the expandable frame 1500 is primarily designed so that the valve components are mounted adjacent to the inner surface of the expandable frame 1500.

[0070] The expandable frame 1500 may have a proximal end 1502 and a distal end 1504 opposite to the proximal end 1502, with the axial length of the expandable frame extending between the proximal end 1502 and the distal end 1504. The expandable frame 1500 may have an outer surface 1506 and an inner surface 1508 with thickness in between. The inner surface 1508 defines the lumen 1510. The expandable frame 1500 may have an expandable region 1512 and a leaflet region 1514 proximal to the expandable region 1512. The expandable region 1512 has a proximal end 1516 and a distal end 1518. The expandable region 1512 comprises a plurality of cells 1520 defining an opening 1521. In some embodiments, all cells 1520 of the expandable region 1512 may be substantially the same size and shape. In other embodiments, the cells 1520 of the expandable region 1512 have different sizes and shapes. The cells 1520 may be arranged as discussed above for the cells 820 in the embodiments shown in Figures 8 to 10 and the cells 1120 in the embodiments shown in Figures 11 to 13.

[0071] The leaflet region 1514 may have a proximal end 1542 and a distal end 1544. The leaflet region 1514 includes a plurality of posts 1546 for attaching the valve components to an expandable frame 1500. In some embodiments, the leaflet region 1514 may have two posts 1546. In some embodiments, such as those shown in Figures 15 to 17, the leaflet region 1514 may have three posts 1546. In yet other embodiments, the leaflet region may have any number of posts 1546. Each post 1546 extending from the proximal end 1542 to the distal end 1544 of the leaflet region 1154 may have a proximal end 1548 and a distal end 1550. In some embodiments, the distal end 1550 of post 1546 may be coupled to an expandable region 1512 at the proximal end 1516, as discussed above for post 846 in the embodiments shown in Figures 8 to 10 and post 1146 in the embodiments shown in Figures 11 to 13.

[0072] Each post 1546 may comprise at least one support column 1152 and at least one mounting mechanism 1154 connected to the support column 1152, as discussed above for post 1146 in the embodiments shown in Figures 11 to 13. As shown in Figures 15 to 17, at least one mounting mechanism may differ between one post 1546 and an adjacent post. As shown in Figures 15 to 17, at least one of the posts 1546a may have a mounting mechanism 1548a comprising a plurality of slits 1560 in a certain pattern. As shown in Figures 15 to 17, the plurality of slits 1560 form a lowercase "d" in one of the posts 1146, although the pattern may also form an uppercase "D" or any other suitable or desired shape. The other posts 1546b, 1546c may have the same mounting mechanism 1548b, 1548c, such as holes or slots different from the mounting mechanism 1548. If one post 1546a has a mounting mechanism 1548a that is different from any of the other posts' mounting mechanisms 1548b, 1548c (or the other posts have relatively matching mounting mechanisms), it can help the practitioner identify one of the commissure posts and assist in the alignment and orientation of the valve during delivery. In at least one embodiment, the first post 1546 may have a pattern of slits, the second post 1546 may have at least one hole, and the third post 1546 may have at least one slot, so that each post has a different mounting mechanism from adjacent posts. This configuration can further assist the practitioner in aligning and orienting the valve during delivery.

[0073] Each post 1546 defines at least a portion of at least one leaflet region cell 1570. The at least one leaflet region cell 1570 may be defined similarly to the leaflet region cell 870 in the embodiments shown in Figures 8 to 10 and the leaflet region cell 1170 in the embodiments shown in Figures 11 to 13. In at least the embodiment shown in Figure 16, the leaflet region cell 1570 is defined by eight struts, namely the strut 1552 of post 1546, a pair of leaflet struts 1574, an axial strut 1580 connected at one end to one of the leaflet struts 1574 and also connected to the end node 1534 of the expandable region 1512, and four adjacent struts 1530 of the circumferential row 1522 of the first cell at the proximal end 1516 of the expandable region 1512. In this embodiment, the axial support column 1580 has at least one projection 1593. As shown, the axial support column 1580 has two projections 1593.

[0074] Figure 17 shows the expandable frame 1500 in its non-expanded state. In the expanded state, the valve leaflet nodules 1576 are distal to the proximal end 1550 of the post 1546, as shown in Figure 16, but in the non-expanded state, the valve leaflet nodules 1576 may be proximal to the proximal end 1550 of the post 1546. The valve leaflet nodules 1576 may be radially aligned with each other.

[0075] Figures 18 to 20 illustrate another embodiment of the expandable frame 1800 of the present invention. When the expandable frame 1800 is attached to the valve components discussed above, it can form a shorter supraannular valve prosthesis. Similar to the expandable frames shown in Figures 8 to 17, the expandable frame 1800 is primarily designed so that the valve components are mounted adjacent to the inner surface of the expandable frame 1800. However, the valve components may also be mounted to the outer surface of either this embodiment or any of the embodiments discussed herein.

[0076] The expandable frame 1800 may have a proximal end 1802 and a distal end 1804 opposite to the proximal end 1802, with the axial length of the expandable frame extending between the proximal end 1802 and the distal end 1804. The expandable frame 1800 may have an outer surface 1806 and an inner surface 1808 with thickness in between. The inner surface 1808 defines the lumen 1810. The expandable frame 1800 may have an expandable region 1812 and a leaflet region 1814 proximal to the expandable region 1812. The expandable region 1812 has a proximal end 1816 and a distal end 1818. The expandable region 1812 comprises a plurality of cells 1820 defining an opening 1821. In some embodiments, all cells 1820 of the expandable region 1812 may be substantially the same size and shape. In other embodiments, the cells 1820 of the expandable region 1812 have different sizes and shapes. The cells 1820 may be arranged as discussed above for the cells 820 in the embodiments shown in Figures 8 to 10 and the cells 1120 in the embodiments shown in Figures 11 to 13.

[0077] The leaflet region 1814 may have a proximal end 1842 and a distal end 1844. The leaflet region 1814 comprises a plurality of posts 1846 for attaching the valve components to an expandable frame 1800. In some embodiments, the leaflet region 1814 may have two posts 1846. In some embodiments, such as those shown in Figures 18 to 20, the leaflet region 1814 may have three posts 1846. In yet other embodiments, the leaflet region may have any number of posts 1846. Each post 1846 extending from the proximal end 1842 to the distal end 1844 of the leaflet region 1854 may have a proximal end 1848 and a distal end 1850. In some embodiments, the distal end 1850 of post 1846 may be coupled to an expandable region 1812 at the proximal end 1816, as discussed above for post 846 in the embodiments shown in Figures 8 to 10 and post 1146 in the embodiments shown in Figures 11 to 13.

[0078] Each post 1846 may comprise at least one support column 1852 and at least one mounting mechanism 1854 connected to the support column 1852, as discussed above for the posts 1846 of the embodiments shown in Figures 18 to 20. The at least one mounting mechanism may differ between one post 1846 and an adjacent post. As discussed above for the embodiments shown in Figures 15 to 17, at least one of the posts 1846a may have a mounting mechanism 1848a comprising a plurality of slits 1860 in a certain pattern. In some embodiments, the plurality of slits 1860 form a lowercase "d" in one of the posts 1846, although the pattern may also form an uppercase "D" or any other suitable or desired shape. Other posts 1846b, 1846c may have the same mounting mechanism 1848b, 1848c, such as different holes or slots from the mounting mechanism 1848. In at least one embodiment, the first post 1846 may have a slit pattern, the second post 1846 may have at least one hole, and the third post 1846 may have at least one slot, so that each post has a different mounting mechanism from adjacent posts. This configuration can further assist the operator in aligning and orienting the valve during delivery.

[0079] Each post 1846 defines at least a portion of at least one leaflet region cell 1870. At least one leaflet region cell 1870 may be defined similarly to the leaflet region cell 870 in the embodiments shown in Figures 8 to 10. In at least the embodiments shown in Figures 15 to 17, the leaflet region cell 1870 is defined by nine struts, namely the strut 1852 of post 1846, a pair of leaflet struts 1874, a first meandering strut 1880, a second meandering strut 1881, and four adjacent struts 1830 of the circumferential row 1822 of the first cell at the proximal end 1816 of the expandable region 1812. In one embodiment, the first meandering strut 1880 may be connected at a first end to one of the leaflet struts 1874a of the leaflet region cell 1870a and at a second end to an end node 1834 of an expandable region 1812. The second meandering strut 1881 may be connected at a first end to one of the leaflet struts 1874b of the leaflet region cell 1870b adjacent to the leaflet region cell 1870a and at a second end to an end node 1834. In one embodiment, the second meandering strut 1881 may overlap the first meandering strut 1880. The overlapping meandering struts 1880,1881 may form a figure-eight shape with two openings. The overlapping, meandering supports 1880 and 1881 allow for improved rigidity in the valve leaflet region 1814, resisting torsion in this region.

[0080] Figure 20 shows the expandable frame 1800 in its non-expanded state. As with other embodiments discussed herein with respect to Figures 8-13 and 15-17, in the expanded state, the valve leaflet nodules 1876 are distal to the proximal end 1850 of the post 1846, as shown in Figure 19, but in the non-expanded state, the valve leaflet nodules 1876 may be proximal to the proximal end 1850 of the post 1846. The valve leaflet nodules 1876 may be radially aligned with each other.

[0081] In some embodiments, the valve prosthesis with an expandable frame, as shown in Figures 18-20, is 1.33 cm 2 ~3.43cm 2It has an average effective valve area (EOA). In some embodiments, the average EOA is 1.68 cm². 2 ~3.08cm 2 This is possible. In yet another embodiment, the average EOA is 2.03 cm 2 ~2.73cm 2 It is possible.

[0082] The expandable frames discussed herein may further comprise one or more radiopaque markers for positioning the expandable frame and, therefore, the valve components, in a desired position relative to the patient's innate anatomical structure during a delivery procedure. In some embodiments of expandable frames, including but not limited to those shown in Figures 8 to 20, the expandable frame may have radiopaque markers attached to at least one strut. In some embodiments of expandable frames, including but not limited to those shown in Figures 8 to 20, the expandable frame may have radiopaque markers attached to at least one nodal point. In some embodiments, the radiopaque markers may be positioned on at least one strut, or at least one nodal point, or a combination of at least one strut or nodal point. In some embodiments, the radiopaque markers may be a coating on that portion of the expandable frame. The position of the radiopaque marker may be determined by the shortening of the struts from the inserted state (which may or may not correspond to its non-expanded state) to its expanded state within the delivery catheter. In some embodiments, the position of the radiopaque marker may be determined by the shortening of the struts from the non-expanded state to its expanded state. In some embodiments, the radiopaque marker may be positioned in the distal row of the expandable region. In further embodiments, the radiopaque marker may be positioned at at least one of the commissure posts, or at the struts or nodal points of the leaflet region. In at least one embodiment, as shown in Figure 21, the expandable frame 2100 may have an expandable region 2112 of the cell and a leaflet region 2114 of the cell proximal to the expandable region 2112. The leaflet region 2114 can define the outflow end of the expandable frame, and the expandable region 2112 can define the inflow end of the expandable frame.In at least the expandable region 2112, the expandable frame 2100 may have multiple rows 2116 of nodal points 2118 connecting the support columns 2120 of adjacent cells in the expandable region 2112. As shown in Figure 21, the expandable region 2112 has five rows 2116a, 2116b, 2116c, 2116d, and 2116e of nodal points 2118. Row 2116a can define the proximal end 2124 of the expandable region 2112, and row 2116e can define the distal end 2126 of the expandable region 2112. In some embodiments, a radiopaque marker may be placed in one of the end rows 2116a, 2116e. More specifically, radiopaque markers may be positioned at or near the nodal point of row 2116e to help the operator visualize the position of the distal end of the expandable frame during delivery. In other embodiments, radiopaque markers may be positioned at or near the nodal point of row 2116a near the outflow end of the valve prosthesis to help the operator visualize the relative position of the valve cusp of the valve component. In other embodiments, radiopaque markers may be positioned in intermediate rows 2116b, 2116c, and 2116d of the nodal point of the expandable region 2112. More specifically, as shown in Figure 21, radiopaque marker 2128 may be positioned on the support column 2120 between rows 2116c and 2116d. The radiopaque marker 2128 can be moved to a desired position on the patient's innate annulus so that, in some embodiments, the expandable frame can be appropriately positioned supra-annularly with respect to the patient's innate annulus.

[0083] The valve components can be attached to the expandable frame in any of the embodiments shown in Figures 11 to 21 or other similar embodiments with fewer sutures than other commercially available transcatheter aortic valve devices. Figure 22 shows a suture pattern in an expandable frame 2210 similar to the expandable frame shown in Figure 12. The expandable frame 2210 may have a proximal end 2212 and a distal end 2214 opposite to the proximal end 2212. The expandable frame may have a plurality of commissure posts 2246 at or substantially near the proximal end 2212. Each commissure post 2246 may have a proximal end 2248 and a distal end 2250. Each post 2246 may comprise at least one support 2252 and at least one mounting mechanism 2254 connected to or embedded in the support 2252. At least one mounting mechanism 2254 may include a tab 2258, within which at least one opening 2260 is located. The expandable frame further comprises a leaflet support 2274 coupled to both sides of a post 2246. In embodiments where the valve component is a single-piece valve component, the mounting of the valve component to the expandable frame 2210 may include a suture pattern 2200 as shown in Figure 22. The suture pattern 2200 includes three semicircles 2220, each semicircle 2220 corresponding to one leaflet of the valve component. Each semicircle 2220 includes 10 to 45 stitches 2221. In some embodiments, each semicircle includes 20 to 30 stitches 2221. The suture pattern 2200 may include a single suture thread 2222 having a first end 2223 and a second end 2225. In at least one embodiment, the first end 2223 and the second end 2225 are joined together to complete the suture pattern 2200. In some embodiments, the first end 2223 and the second end 2225 may be joined at a frame support. In other embodiments, the first end 2223 and the second end 2225 may be joined around one of the posts 2254. In some embodiments, the suture pattern 2200 consists only of locking stitches.

[0084] The commissure post of the expandable frame shown in Figures 23A and 23B. Figure 23A shows an example of the commissure suture pattern 2320 as seen from the outer surface of the expandable frame 2210, and Figure 23B shows the suture pattern 2320 of Figure 23A as seen from the inner surface of the expandable frame 2210. In at least one embodiment, the suture pattern 2320 includes one suture thread 2322. The commissure post 2346 comprises a proximal end 2348 and a distal end 2350. The commissure post further comprises an inner surface 2349 and an outer surface 2351. The commissure post 2346 further comprises a support column 2352 and a mounting mechanism 2354. The support column 2352 has a first side surface 2356 and a second side surface 2358. The leaflet support column 2374 extends from both side surfaces 2356, 2358 of the support column 2352. The illustrated mounting mechanism includes an opening 2360. In at least one embodiment, the commissural suture pattern 2320 includes a suture thread 2322 having a first end 2380 and a second end 2381. The first end 2380 is positioned within the opening 2360 of the mounting mechanism 2354. The suture thread 2322 then extends from the first end 2380 over the outer surface 2351 of the commissural post 2346 to a first side surface 2356 to a point 2382. At point 2382, the suture thread 2322 crosses over the inner surface 2349 of the commissural post 2346 to a second side surface 2358 to a point 2383. At point 2383, the suture 2322 crosses the outer surface 2351 to the adjacent post 2374 on the side 2356, specifically to the upper part of post 2374, and returns to point 2384. At point 2384, the suture 2322 crosses the inner surface 2349 to the lower part of post 2374 adjacent to side 2358, and reaches point 2385. At point 2385, the suture 2322 crosses the outer surface 2351 toward the distal end of the commissure post 2346 on the first side 2358, and reaches point 2386, then crosses the inner surface 2349, and reaches point 2387. At point 2387, the suture 2322 crosses the outer surface 2351 to the lower part of post 2374 adjacent to side 2356, and reaches point 2388. At point 2388, the suture thread 2322 crosses the inner surface 2349 over the upper part of the adjacent support 2374 on the side 2358 and reaches point 2389.At point 2389, suture 2322 then crosses the outer surface 2351 to point 2389 between points 2382 and 2384. Suture 2322 then crosses the inner surface 2389 and passes through the opening 2360 to the second end 2381. The first end 2380 and the second end 2381 can be connected to each other by a secure knot. In a preferred embodiment, when suturing the valve components to the commissar posts, the valve components are positioned close enough to the frame to ensure there are no gaps between the posts and that the valve components can be properly joined under pressure.

[0085] In some embodiments, to facilitate the attachment of the valve components to the posts as described above with respect to Figures 23A and 23B, the valve components may be modified so that the posts are inserted into a portion of the valve components. An example is shown in Figure 24. The valve component 2400 is a single-piece valve component comprising valve leaves 2402 and commutation regions 2404 integrally molded between adjacent valve leaves. Slits 2406 can be cut into the valve component 2400 in each commutation region 2404, and commutation posts of the expandable frame can then be inserted into the slits such that, when mounted to the frame, a portion of the valve component 2400 is present on the outer surface of the expandable frame (more specifically, the commutation posts).

[0086] As used herein, the terms “substantially” or “generally” mean that the scope or degree of an action, property, characteristic, state, structure, item, or result is complete or nearly complete. For example, an object “substantially” or “generally” encompassed means that the object is either completely encompassed or nearly completely encompassed. The exact degree of permissible deviation from absolute completeness depends in some cases on the specific context. However, generally speaking, being close to completeness means having generally the same overall result as if absolute and overall completeness had been achieved. The use of the terms “substantially” or “generally” is similarly used, when used in a negative sense, to mean the complete or nearly complete absence of an action, characteristic, property, state, structure, item, or result. For example, an element, combination, embodiment, or composition that “actually” lacks or “generally” lacks a certain component or element may still actually contain such item, insofar as its measurable effect is generally absent.

[0087] In this specification, any mention of “one embodiment” or “embodiment” means that a particular element, feature, structure, or characteristic described in relation to the embodiment is included in at least one embodiment. The phrase “in one embodiment” in this specification does not necessarily refer to the same embodiment.

[0088] As used herein, “equipped,” “having,” “containing,” “having,” “having,” or other variations thereof are intended to cover non-exclusive inclusion. For example, a process, method, article, or apparatus comprising a certain list of elements may also include other elements not expressly enumerated or specific to such process, method, article, or apparatus, but not necessarily limited to those elements. Furthermore, unless the reverse is expressly stated, the term “or” refers to an inclusive “or” and not an exclusive “or.” For example, A or B is satisfied by any of the following: A is true (or exists) and B is false (or does not exist); A is false (or does not exist) and B is true (or exists); and both A and B are true (or exist).

[0089] In addition, the use of "one" or "one" is used to describe elements or components of the embodiments described herein. This is merely for convenience and to give a general meaning to the description. This description should be read as including one or at least one, and includes plural forms unless it is clear that otherwise.

[0090] Furthermore, the drawings illustrate preferred embodiments for illustrative purposes only. Those skilled in the art will be able to understand further alternative structural and functional designs of the apparatus described herein by reading this disclosure.

[0091] Therefore, although specific embodiments and uses are shown and described in the figures, it should be understood that the disclosed embodiments are not limited to the very structures and components disclosed herein. Without departing from the spirit and scope defined in the appended claims, various modifications, changes, and variations are possible with respect to the configuration, operation and details of the methods and apparatus disclosed herein, as will be obvious to those skilled in the art.

[0092] The systems and methods described herein with reference to several exemplary embodiments are not limiting and are not necessarily mutually exclusive. Specific elements of various embodiments can be combined for use within the scope of the invention, either omitted or combined with features of other components. Any feature of any embodiment described herein is available for use in any embodiment and in combination with any feature of another embodiment. The technical concepts included in this disclosure are described below. (Note 1) A replacement heart valve for transcatheter repair of a congenital valve, wherein the replacement heart valve is A frame having a distal end, a proximal end, and a length between the distal end and the proximal end, further comprising an outer surface and an inner surface defining a lumen, and being expandable from a non-expanded state to an expanded state, An expandable region defining the distal end of the frame and extending toward the proximal end of the frame, the expandable region having at least a first row of cells at the distal end of the expandable region, a second row of cells at the proximal end of the expandable region, and a plurality of intermediate row cells between the first row of cells and the second row of cells, A valve leaflet region comprising a plurality of valve posts extending proximal from the expandable region, each of the valve posts comprising a valve mounting mechanism, the valve leaflet region defining a plurality of valve leaflet region cells, each of the valve leaflet region cells being defined by at least (i) one of the valve posts, (ii) a support of the second row of cells at the proximal end of the expandable region, (iii) a first meandering support, (iv) a second meandering support, and (v) a first valve leaflet support. A frame equipped with, A valve component comprising at least one valve leaf, which is attached to the frame in the valve mounting mechanism of at least two valve posts, and Equipped with, The first meandering support and the second meandering support extend between the second row of cells and the first valve leaflet support, The first meandering support and the second meandering support overlap each other to form two openings, A replacement heart valve in which the two openings formed by the first and second meandering struts are not included in the valve leaflet region cell. (Note 2) The valve component is mounted on the frame from the inside such that the outer surface of the valve component is in contact with the inner surface of the frame, as described in Appendix 1, for the replacement heart valve. (Note 3) The valve component comprises a single piece made of biomaterial, as described in Appendix 1, for the replacement heart valve. (Note 4) The replacement heart valve according to Appendix 3, wherein the valve component comprises at least two shaped valve leaves and a commissure region between the two shaped valve leaves. (Note 5) The commissure region of the valve component is attached to the valve post of the frame, the replacement heart valve as described in Appendix 4. (Note 6) The replacement heart valve according to Appendix 5, wherein the valve component further comprises a plurality of slits, each of which is located in the commissure region of the valve component, and each of the valve posts is inserted into a slit before the valve component is attached to the valve post. (Note 7) The replacement heart valve according to Appendix 3, wherein the biomaterial comprises a polymer, bovine tissue, or porcine tissue. (Note 8) The valve post further comprises a commissure alignment marker, as described in Appendix 1, for the replacement heart valve. (Note 9) The valve component is approximately 1.7 to 3.5 cm 2 A replacement heart valve as described in Appendix 1, having an average effective valve orifice area. (Note 10) The replacement heart valve according to Appendix 1, wherein the valve component is attached to the frame at least in the valve mounting mechanism, and the valve mounting mechanism consists of at least three valve posts. (Note 11) The replacement heart valve according to Appendix 1, wherein the first meandering strut has a first end and a second end, the first end of the first meandering strut being connected to the first valve leaflet strut, and the second end of the first meandering strut being connected to the end nodal point of the expandable region. (Note 12) The replacement heart valve described in Appendix 1, wherein one of the valve mounting mechanisms includes a plurality of slits. (Note 13) The replacement heart valve as described in Appendix 12, wherein the valve mounting mechanism on one valve post is different from the valve mounting mechanisms on circumferentially adjacent valve posts. (Note 14) The replacement heart valve as described in Appendix 1, wherein all of the cells in the expandable region are of the same size. (Note 15) The replacement heart valve according to Appendix 1, wherein the valve post includes at least one support column. (Note 16) The replacement heart valve according to Appendix 15, wherein each of the leaflet region cells is defined by nine struts, the nine struts comprising one strut of the valve post, four adjacent struts of the row of the second cell at the proximal end of the expandable region, one first meandering strut, one second meandering strut, and a pair of the first leaflet struts. (Note 17) The valve component is approximately 2.5 to 3.5 cm 2 A replacement heart valve as described in Appendix 1, having an average effective valve orifice area of ​​approximately 533 to 933 Pa (approximately 4 to 7 mmHg), a pressure gradient of approximately 533 to 933 Pa (approximately 4 to 7 mmHg), and a Doppler velocity index factor of 0.55 to 0.70. (Note 18) Each of the valve posts has a proximal end and a distal end, as well as a length between the proximal end and the distal end, and the length of the valve post is 20% to 75% of the length of the frame, as described in Appendix 1. (Note 19) The replacement heart valve according to Appendix 1, wherein adjacent valve posts in the circumferential direction are arranged equidistant from each other around the frame. (Note 20) The replacement heart valve according to Appendix 1, wherein the frame has two valve posts. (Note 21) The replacement heart valve according to Appendix 1, wherein the frame has three valve posts.

Claims

1. An artificial heart valve for transcatheter implantation of a congenital heart valve, wherein the artificial heart valve is A frame that defines a lumen between its distal and proximal ends, comprising a frame that is expandable from a non-expanded state to an expanded state, wherein the frame is An expandable region defining the distal end of the frame and extending toward the proximal end of the frame, the expandable region having (a) a first row of cells at the distal end of the expandable region and (b) a second row of cells at the proximal end of the expandable region, A valve leaflet region defining the proximal end of the frame, comprising a plurality of valve posts extending proximal from the expandable region, wherein the valve leaflet region defines a plurality of rows of valve leaflet region cells in the circumferential direction, and each of the valve leaflet region cells comprises at least (i) a support of the second row of cells located at the proximal end of the expandable region, and (ii) a pair of valve leaflet supports, wherein only one of the pair of valve leaflet supports extends from one of the plurality of valve posts, The artificial heart valve comprises valve components attached to the plurality of valve posts in the lumen.

2. The artificial heart valve according to claim 1, wherein each leaflet region cell is defined by four struts of the second row of cells at the proximal end of the expandable region.

3. The artificial heart valve according to claim 1, wherein the valve component comprises a plurality of valve leaves, and the valve component is further attached around the frame along a semicircular pattern at the distal end of each valve leaf.

4. The artificial heart valve according to claim 1, wherein the valve component comprises a single piece made of the material.

5. The artificial heart valve according to claim 4, wherein the material comprises a polymer, bovine tissue, or porcine tissue.

6. The artificial heart valve according to claim 4, wherein the valve component comprises at least two molded valve leaves and a molded commissure region between the two molded valve leaves.

7. The artificial heart valve according to claim 6, wherein the molded commissure region of the valve component is attached to one of the plurality of valve posts.

8. The artificial heart valve according to claim 7, wherein the outer surface portion of the valve post is covered by the overlapping portion of the molded commissure region of the valve component.

9. The valve components are approximately 1.7 to 3.5 cm ２ An artificial heart valve according to claim 1, having an average effective valve orifice area.

10. The valve component is approximately 2.5 to 3.5 cm ２ The artificial heart valve according to claim 1, having an average effective valve orifice area, a pressure gradient of approximately 533 to 933 Pa (approximately 4 to 7 mmHg), and a Doppler velocity index factor of 0.55 to 0.

70.

11. An expandable frame for an artificial heart, wherein the expandable frame is An expandable region defining the distal end of the expandable frame, wherein the expandable region has at least a first row of cells at the distal end and an expandable region having at least a second row of cells at the proximal end of the expandable region, An expandable frame comprising a leaflet region defining the proximal end of the expandable frame and having a plurality of valve posts extending proximal from the expandable region, wherein the leaflet region has a plurality of leaflet region cells, each of which has a leaflet region cell comprising at least (i) a support of the second row of cells located at the proximal end of the expandable region and (ii) a pair of leaflet supports, wherein only one of the pair of leaflet supports extends from one of the plurality of valve posts to a leaflet region.

12. The expandable frame according to claim 11, wherein each leaflet region cell is defined by four pillars of the second row of cells at the proximal end of the expandable region.

13. Each valve leaflet region cell is further defined by a first meandering strut and a second meandering strut, the first meandering strut overlapping with the second meandering strut, the expandable frame according to claim 12.

14. The expandable frame according to claim 13, wherein the first meandering support has a first end and a second end, the first end of the first meandering support is connected to two valve leaflet supports, and the second end of the first meandering support is connected to an end node of the expandable region.

15. Each of the plurality of valve posts defines an opening, the expandable frame according to claim 11.

16. The expandable frame according to claim 15, wherein each of the valve posts extends proximal to the pair of valve leaflet supports.

17. Each of the valve posts extends proximal between the two sets of the pair of valve leaflet supports, the expandable frame according to claim 11.

18. The expandable frame according to claim 17, wherein each valve leaflet region cell is defined by at least six struts.

19. The expandable frame according to claim 11, wherein each of the valve posts has a proximal end and a distal end, and a length between the proximal end and the distal end, and the length of each of the valve posts is 20% to 75% of the total length of the expandable region of the frame.

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