Replacement heart valve for transcatheter repair of native valves

Abstract

A replacement heart valve prosthesis for transcatheter repair of a native valve includes a frame having a distal end, a proximal end, and a length between the distal end and the proximal end. The frame further includes an outer surface and an inner surface defining a lumen. The frame is expandable from an unexpanded state to an expanded state. The frame further includes an expandable region near the distal end of the frame and a leaflet region near the proximal region. The leaflet region has a plurality of valve attachment mechanisms. A valve component is mounted on the outer surface of the frame and attached to the frame at least at the valve attachment mechanisms.

Description

Technical Field

[0001] The present disclosure relates to a novel and advantageous expandable frame for use in a transcatheter replacement heart valve prosthesis, and a method of attaching a valve construct to the frame.

Background Art

[0002] The background description provided herein is for the purpose of generally presenting the context of the present disclosure. The research of the present inventors is not admitted as prior art to the present disclosure, either expressly or implicitly, for aspects of this description that may not, at the time of filing, qualify as prior art in another form within the scope described in this background section.

[0003] Transcatheter valve replacement (TVR) is a minimally invasive cardiac procedure for repairing or replacing a heart valve by use of an implantable valve prosthesis (artificial valve) delivered to a patient's native valve via a catheter. The implantable valve prosthesis typically comprises an expandable frame with a plurality of flat prosthetic leaflets attached inside the expandable frame. The prosthetic leaflets are intended to mimic the operation of healthier native leaflets. The expandable frame may be self-expanding using a shape memory alloy, balloon-expandable, or mechanically expandable when placed in the native valve. Transcatheter valve replacement prostheses have been developed for the aortic, mitral, and tricuspid valves. The TVR procedure typically involves the transfemoral introduction of a catheter into the patient's vasculature, with the valve prosthesis loaded onto the catheter and advanced through the patient's vasculature to the native valve.

[0004] Before these minimally invasive transcatheter valve replacement procedures were developed, the options for most patients who needed repair of their heart valves were limited to significantly invasive surgical replacement procedures. However, for many patients who needed heart valve repair, surgical repair carried a relatively high risk or the patient was not a viable candidate for surgery. With respect to the aortic valve, transcatheter aortic valve replacement (TAVR) procedures have been widely adopted by clinicians worldwide as an alternative to surgical replacement for treating these high-risk patients with severe aortic stenosis or similar conditions. Over many procedures spanning several decades, TAVR has been shown to improve the long-term survival of these patients. In addition, in recent years, several studies involving both balloon-expandable TAVR prostheses and self-expanding TAVR prostheses have demonstrated the effectiveness of TAVR procedures for patients with low surgical risk, and in 2019, the US 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 native valve, for positioning or repositioning the prosthesis relative to the native valve structure or surrounding anatomical structures, and for reducing the French size of the catheter to improve delivery via the vasculature. However, this development has not particularly focused on the long-term use of the prosthesis and hemodynamic performance over time. Many of the TAVR prostheses currently used in these procedures exhibit significant calcification of the prosthesis, as well as disintegration or degradation. Over time, typically between 5 and 15 years, many TAVR valve prostheses deteriorate and ultimately cease to function, after which the patient will need to have the valve prosthesis repaired. In recent years, in a procedure called "valve-in-valve" TAVR, a second valve can be provided to patients in whom the TAVR prosthesis has ceased to function. In these procedures, a new transcatheter valve is inserted into the lumen of the non-functional TAVR valve, pushing the artificial valve leaflets aside. Inserting a valve into the lumen of the non-functional TAVR valve necessarily limits or reduces the effective orifice area, and thus the hemodynamic performance of this second valve is limited.

SUMMARY OF THE INVENTION

PROBLEMS TO BE SOLVED BY THE INVENTION

[0006] As younger, lower-risk patients become candidates for TAVR prostheses, there is a need for more durable valves that can effectively withstand prosthesis calcification and degradation. Further, in addition to their long lifespan, there is a need in the art for durable heart valves that also achieve improved hemodynamic performance.

[0007] The following presents a simplified summary of such embodiments in order to provide a basic understanding of one or more embodiments of the present disclosure. This summary is not an extensive overview of all contemplated embodiments, nor is it intended to identify key or critical elements of all embodiments or to delineate the scope of any or all embodiments.

[0008] The present disclosure relates to a novel and advantageous frame for a valve prosthesis that maximizes the effective orifice area of the prosthesis while minimizing wear in a valve assembly attached to the frame. The effective orifice area of a valve is an important metric when measuring the hemodynamic performance of the valve.

Means for Solving the Problems

[0009] In some embodiments, as described in the present disclosure, a valve assembly comprising at least one valve leaflet can be mounted on the outer surface of a frame. Prior art valves typically instead have an artificial valve leaflet mounted on the inner surface of the frame within the lumen of the frame. For these prior art valves, when the valve is implanted in a native valve, the metal alloy frame contacts the patient's native heart tissue, which can contribute to valve prosthesis performance problems such as inflammation in this area, calcification of the prosthesis, and paravalvular leakage. Instead, by mounting the valve assembly outside of the valve, the metal alloy frame no longer contacts the patient's native heart tissue, and inflammation due to the frame can be reduced. The inner surface of the frame can define a lumen, and the frame can be designed such that the cusps or leaflets of the valve assembly can meet in the center of the lumen of the frame to close the valve. Of course, in other embodiments of the invention described herein, the valve assembly may be mounted on the inner surface of the frame of the present disclosure.

[0010] In at least one embodiment, a replacement heart valve prosthesis for the transcatheter repair of a native valve, the replacement heart valve comprising a frame and a valve construct. The frame has a distal end, a proximal end, and a length between the distal end and the proximal end. 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 attachment mechanisms. The valve construct is attached to the outer surface of the frame, and the valve construct is attached to the valve construct at least at the valve attachment mechanisms. In some embodiments, the leaflet region comprises a plurality of posts. In at least one embodiment, the posts are connected by struts to circumferentially adjacent posts, the struts defining leaflet openings. The valve construct may comprise at least two valve leaflets. Each valve leaflet can extend into adjacent leaflet openings and then enter the lumen of the frame across the leaflet openings. In at least one embodiment, the struts are arch-shaped struts.

[0011] In at least one embodiment of the present disclosure, a replacement heart valve prosthesis for transcatheter repair of a native valve comprises a frame and a valve construct attached to the frame, the valve construct 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 construct is externally mounted to the frame such that the inner surface of the valve contacts the outer surface of the frame. In other embodiments, the valve construct is internally mounted to the frame such that the outer surface of the valve construct contacts 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 end and the proximal end. 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 proximally 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 additionally have a plurality of intermediate row cells between the first row of cells and the second row of cells. Each valve post comprises a valve attachment mechanism, and the valve construct may be attached to the frame at least at the valve attachment mechanism.

[0012] In some embodiments, each valve post has a proximal end, a distal end, and a length between the proximal end and the distal end, 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 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] Although multiple embodiments are disclosed, still other embodiments of the present invention will become 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 thought to be better understood from the following description read in conjunction with the accompanying drawings.

Brief Description of the Drawings

[0017]

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[0018] The present disclosure describes a novel and advantageous valve prosthesis having a frame for mounting a valve component, and a method of mounting the valve component to the frame. The embodiments and techniques discussed below may be discussed with respect to aortic valve replacement, but it is within the scope of the present disclosure that the invention of the present disclosure may be suitable for use in other valve replacements such as mitral valve and tricuspid valve. Further, the figures and embodiments discussed below may typically describe an aortic valve having three valve leaflets, but it is within the scope of the present disclosure that the invention of the present disclosure may be suitable for use in a prosthesis for an aortic bicuspid valve.

[0019] In the following detailed description, numerous specific details are set forth in order to provide a thorough understanding of some embodiments. However, it will be understood by those skilled in the art that some embodiments may be practiced without these specific details. In other instances, at least one of well-known methods, procedures, and components has not been described in detail so as not to obscure the discussion.

[0020] In at least some embodiments of the present disclosure, the valve component may be mounted on the outer surface of the expandable frame of the transcatheter valve prosthesis, rather than on the typical inner surface of the frame. In such embodiments, in the expanded state of the valve prosthesis, the valve component may have a diameter larger than the diameter of the frame.

[0021] Figures 1A - 1B show a schematic view of the valve prosthesis 100 of the present disclosure from one end of the prosthesis. The valve prosthesis 100 can be designed for either supra - annular (on - valve - ring) placement or intra - annular (within - valve - ring) 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 construct 110, which is attached to the outer surface 106 of the expandable frame 102 as shown in Figures 1A - 1B. The valve construct 110 may comprise a biologic material, as further discussed below. The valve construct 110 has an inner surface 112 and an outer surface 114 with a thickness therebetween. When attached to the expandable frame 102, the inner surface 112 of the valve construct 110 contacts the outer surface 106 of the expandable frame 102. The valve construct 110 may have at least one valve leaflet 120. In a preferred embodiment for an aortic valve, the valve construct 110 may have at least three valve leaflets 120. The valve leaflets 120 are configured to rock or move relative to the expandable frame 102 such that the valve leaflets can join together without back - flow during heart dilation and can open fully during heart contraction to promote at least an appropriate 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 - 3.5 cm 2 2. In at least some embodiments, the average effective valve orifice area of the valve prosthesis 100 is about 2 - 3.5 cm 2 2. In at least some embodiments, the average effective valve orifice area of the valve prosthesis 100 is about 2.2 - 3.5 cm 2 2. In at least some embodiments, the average effective valve orifice area of the valve prosthesis 100 is about 2.5 - 3.5 cm 2 2. In at least one embodiment, the valve prosthesis 100 has an average effective valve orifice area of about 2.5 - 3.5 cm with a Doppler Velocity Index factor of 0.55 - 0.70 2has an average effective valve orifice area and a pressure gradient of about 533 to 933 Pascals (about 4 to 7 mmHg). In at least one embodiment, the valve prosthesis 100 has an average effective valve orifice area of about 2.5 to 3.5 cm with a Doppler velocity index factor of 0.55 to 0.70 2 has an average effective valve orifice area and a pressure gradient of about 533 to 1333 Pascals (about 4 to 10 mmHg). When implanted in a patient's native heart valve, the valve construct with tissue mounted on the outer frame can be in direct contact with the tissue of the native heart valve, whereas a typical valve prosthesis, in contrast, has a valve construct mounted inside an expandable frame that expands outside the valve construct, so that the metal expandable frame contacts the tissue of the native heart valve, which can promote inflammation. By bringing the valve construct 110 into direct contact with the tissue of the native heart valve, inflammation can be reduced. Additionally, by having the tissue outside the expandable frame, the valve prosthesis 100 can have a larger opening area, thereby providing improved hemodynamics. Further, by having the tissue outside the expandable frame, the valve prosthesis 100 can reduce the gradient across the valve during forward flow, thereby providing improved hemodynamics. Depending on the biomaterial used for the valve construct 110, the biomaterial can even be reconstructed with the adjacent native heart valve tissue to attach the valve construct 110 to the native structure, thereby preventing paravalvular leakage and reducing the risk of movement of the valve prosthesis. In such an example where such a material is used, the valve prosthesis of the present disclosure can eliminate the need for an expandable material such as a polymer skirt, a fabric skirt, or a foam typically present in most commercially available valve prostheses to prevent paravalvular leakage. In other examples, a portion of the valve construct 110 may have a coating such as an adhesive to assist in the attachment of the valve construct 110 to the native valve structure. Still other examples of the valve prosthesis of the present disclosure may include a polymer skirt, a fabric skirt, or other paravalvular leakage countermeasures.

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

[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 some other mechanically expandable frame. In yet other embodiments, the expandable frame may have a self-expanding region and a balloon-expandable region. For example, the region of the frame near the valve leaflets may be self-expanding to control the expansion of the valve leaflet region using a shape memory alloy, while the region of the frame closest to the annulus may be balloon-expandable to facilitate control of the placement 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 compared to the distal end, or conversely a larger diameter at the distal end compared to the proximal end, thereby effectively forming a taper of the valve. In some embodiments, the expandable frame 102 may have a shape that flares from the distal end towards the proximal end.

[0024] The expandable frame 102 can be composed of stainless steel, a shape memory alloy, a 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 alloys, tantalum alloys, and the like. Other alloys that can be used to form the frame include, but are not limited to, other cobalt-chromium alloys, titanium-cobalt-chromium-molybdenum alloys, and the like. In addition to these materials, the expandable frame 102 can further be composed of a polymer, a biocompatible material, or a combination thereof. In some embodiments, the expandable frame 102 can have a coating on at least a portion of either the outer surface 106 or the inner surface 104. The coating can include, but is not limited to, polymers including polytetrafluoroethylene (PTFE), silicone, biopolymers, and other suitable polymers. In other embodiments, the coating can include a radiopaque substance. In some embodiments, the coating can include a drug-eluting substance.

[0025] The valve component 110 may include tissue material. In some embodiments, the tissue material may be a biological material. In some embodiments, the tissue material is a crosslinked collagen-based biological material including acellular tissue or cellular tissue selected from the group consisting of cardiovascular tissue, cardiac tissue, heart valve, aortic root, aortic wall, aortic leaflet, pericardial tissue, connective tissue, dura mater, dermal tissue, vascular tissue, cartilage, pericardium, ligament, tendon, blood vessel, umbilical cord tissue, bone tissue, fascia, and submucosal tissue and skin. In some embodiments, the tissue material is an implantable biological material such as the biological material described in the disclosure of U.S. Patent No. 9,205,172 by the present applicant with the title of the invention "Implantable Biomaterial and Method of Producing Same" filed on December 21, 2005, and the entire content of the above patent document is incorporated herein by reference. In some embodiments, the crosslinked collagen-based biological material is treated by the ADAPT® treatment method. The ADAPT® treatment method is an anti-calcification treatment method for biological materials that reduces residual DNA to zero and has more than 10 years of clinical data showing no calcification when used in cardiac surgery. In some embodiments, the tissue material may be an artificial tissue. In some embodiments, the artificial tissue may include a polymer formed or shaped into a single piece. In some embodiments, the artificial tissue may include polytetrafluoroethylene, polyethylene terephthalate, other polymers, and other polymer coatings. The valve component 108 may, in some embodiments, include shaped tissue material. More specifically, at least some or all of the valve leaflets 120 of the valve component 110 may include shaped tissue material.In some embodiments, the valve construct 110, including the valve leaflets 120, is a single-piece three-dimensional valve construct composed of a single piece of tissue material, such as a valve described in the disclosure of U.S. Application No. 16 / 129,235 by the applicant of the present application under the title "Replacement Heart Valve with Reduced Suturing", the entire contents of which are incorporated herein by reference.

[0026] Figures 2-10 show various embodiments of an expandable frame of a valve prosthesis that provides improved hemodynamic performance of the valve prosthesis according to the invention of the present disclosure. Each expandable frame depicted in these figures and further discussed below can be constructed from the frame materials discussed above. Additionally, each expandable frame can be attached to a valve construct configured as discussed above. In some embodiments, the valve construct is mounted outside the frame, and in other embodiments, the valve construct can be mounted inside the frame.

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

[0028] The expandable frame 200 can have a proximal end 202 and a distal end 204 opposite the proximal end 202, and the axial length of the expandable frame extends between the proximal end 202 and the distal end 204. The expandable frame 200 can have an outer surface 206 and an inner surface 208 with a thickness therebetween. The inner surface 208 defines a lumen 210. The expandable frame 200 can have an expandable region 212 and a leaflet tip region 214 proximal to the expandable region 212. The leaflet tip region 214 enables the leaflets of the valve construct to open beyond the outer surface 206, and in some embodiments, more particularly, enables 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 can be considered the ventricular region of the frame. This can effectively produce a taper effect where the area defined by the free edge of the leaflets of the valve construct is larger than the area defined by the outer surface of the frame, resulting in a reduction in the pressure gradient during forward flow and an increase in the effective valve orifice area. Prior art valve prostheses do not allow the leaflets to open beyond the outer surface of the expandable frame due to the cell structure of the frame.

[0029] The expandable region 212 can 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 that define an opening 221. In the embodiments shown in FIGS. 2-3, the openings 221 have different sizes and shapes. In other embodiments, the openings 221 can have the same size and shape.

[0030] The cells 220 can be arranged in at least a first circumferential row of adjacent cells, generally indicated by reference numeral 222, at the proximal end 216 of the expandable region 212, and a second circumferential row of adjacent cells, generally indicated by reference numeral 224, at the distal end 218 of the expandable region 212. In some embodiments, such as the embodiments shown in FIGS. 2-4, at least one intermediate row of circumferentially adjacent cells, generally indicated by reference numeral 226, can extend between the first circumferential row of cells 222 and the second circumferential row of cells 224.

[0031] Each cell 220 includes a plurality of struts 230. Each strut 230 may be a straight strut, or may be a curved strut as shown at least in FIGS. 2-4, or each strut may be a serpentine strut having at least one curved portion or waveform. Each strut 230 may be uniform or may have a varying thickness over the length of the strut 230. Each strut of the cell 220 may be connected to adjacent struts at a node 232. The node 232 can include an end node 234 at the proximal end 216 and the distal end 218 of the expandable region, and the end node 234 connects the circumferentially adjacent struts 230 at each end 216, 218. The node 232 can also include a column node 236, and the column node 236 connects the circumferentially adjacent struts 230 within the columns 222, 224, 226, or connects the axially adjacent struts 230 of one column 222, 224, 226 to an axially adjacent column.

[0032] Next, referring to the valve tip region 214, the valve tip region 214 is intended to facilitate or assist the movement of the valve leaf of the valve assembly attached to the expandable frame 200, and the valve tip region 214 has a proximal end 242 and a distal end 244 adjacent to the expandable region 212. The valve tip region 214 includes a plurality of posts 246 for attaching the valve assembly to the expandable frame 200. In some embodiments, the valve tip region 214 may have two posts 246. In some embodiments, such as the embodiments shown in FIGS. 2-4, the valve tip region 214 may have three posts 246. In still other embodiments, the valve tip region 214 may have any number of posts 246.

[0033] Each post 246 can have a distal end 248 and a proximal end 250, and the proximal end 250 defines the proximal end 242 of the valve tip region 242. In some embodiments, the distal end 248 of the post 246 can be coupled to the end node 234 at the proximal end 216 of the expandable region 212. In other embodiments, the distal end 248 of the post 246 can be coupled to an arcuate strut that extends across the circumferential distance between circumferentially adjacent posts 246, and the arcuate strut can be coupled to the expandable region at one or more end nodes 234. In still other embodiments, such as the embodiments shown in FIGS. 2-4, the distal end 248 of the post 246 can be coupled to one or more valve tip struts 251 of the valve tip region 214, and each valve tip strut can be coupled to the expandable region 212 at one or more end nodes 234. As shown in more detail at least by FIG. 3, each post 246 can be connected to a right valve tip strut 251a and a left valve tip strut 251b. In at least the embodiments shown, the combination of the post 246, the right valve tip strut 251a, and the left valve tip strut 251b forms a wishbone-like structure. In the embodiments shown, the right valve tip strut 251a of the first post 246a and the left valve tip strut 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 valve tip strut has a side surface 253. The side surface 252 of the post 246a, the side surface 252 of the post 246b, the side surface 253 of the right valve tip strut 251a, and the side surface 253 of the left valve tip strut 251b that is circumferentially adjacent to the right valve tip strut 251b define a leaflet opening 254. The leaflet opening 254 enables the leaflets of the valve construct to cross the outer surface 206 of the expandable frame 200. The leaflet opening 254 can also enable improved coronary access.

[0034] Each post 246 can comprise at least one strut 255, which can include at least one mounting mechanism 256 disposed within the strut 255. The strut 255 can have a width greater than the width of at least one strut 230 of the expandable region 214. In at least the embodiment shown in FIG. 3, the mounting mechanism 256 can comprise one or more openings 260. As shown in FIG. 3, the opening 260 can be a hole 260a or one or more slots 260b. In still other embodiments, the mounting mechanism 256 can comprise a plurality of openings 260 that facilitate a particular suturing pattern, the openings being composed of holes, slots, or slits. In other embodiments, the at least one mounting mechanism can comprise a hook, a loop, a tuft, or other mounting mechanism. In some embodiments, at least one of the post 246 and the mounting mechanism 256 can be further utilized to recapture or relocate the frame during or after implantation. In some embodiments, at least one of the post 246, the mounting mechanism 256, and one or more valve tip struts 251 can be utilized in a valve-in-valve procedure to engage a previously implanted valve prosthesis or a valve prosthesis to be implanted.

[0035] The leaflet tip region 214 may further include one or more leaflet tip region cells 270 that may be defined by one or more leaflet tip connector struts 272. The leaflet tip connector struts 272 may provide some additional structure to the posts 246 to address the stresses experienced by the leaflet tip region as the valve pulsates between systole and diastole. The leaflet tip connector struts 272 may have a width greater than the width of at least one strut 230 of the expandable region 214. As shown in FIGS. 2-3, the leaflet tip region cells 270 have an opening 273 that is larger than the opening 221 of the cells 220. Some of the leaflet tip region cells 270a may, in some embodiments, be defined by at least one leaflet tip strut 251, at least one leaflet tip connector strut 272, and one or more struts 230 of the proximal end 216 of the expandable region 212. Other leaflet tip region cells 270b may, in some embodiments, be defined by at least two leaflet tip struts 251 and two leaflet tip connector struts 272. Still other leaflet tip region cells 270c may, in some embodiments, be defined by at least two struts 230 of the proximal end 216 of the expandable region 212 and two leaflet tip connector struts 272. The leaflet tip region cell 270a may define a region that is larger than the leaflet tip region cells 270b, 270c, respectively. The leaflet tip region cell 270a may have a shape that is different from the leaflet tip region cells 270b, 270c, respectively. In other embodiments, the leaflet tip region cell 270a may be smaller than the leaflet tip region cells 270b, 270c, respectively. In one embodiment, the leaflet tip region cell 270b may have a shape that is substantially the same as the leaflet tip region cell 270c. In one embodiment, the leaflet tip region cell 270b may, in some embodiments, be the same size as the leaflet tip region cell 270c or slightly larger than the leaflet tip region cell 270c. In other embodiments, the leaflet tip region cell 270b may have a shape that is substantially different from the leaflet tip region cell 270c. In still other embodiments, the leaflet tip region cell 270b may be smaller than the leaflet tip region cell 270c.

[0036] In some embodiments, the diameter of the valve tip region 214 may be larger than the diameter of the expandable region 212. In some embodiments, the diameter of the valve tip region 214 at the proximal end of the valve tip region 214 may be similar to the diameter of the expandable region 212 at the distal end of the expandable region 212. In some embodiments, the diameter of the valve tip region 214 at the proximal end of the valve tip region 214 may be larger than the diameter of the expandable region 212 at the distal end of the expandable region 212. In at least one embodiment, the diameter of the valve tip region 214 may be larger 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 214 has a tapered outer shape in the expanded state.

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

[0038] FIG. 4 shows the expandable frame 200 in the unexpanded state. As shown in FIG. 4, the end nodes 232 at the distal end 218 of the frame 200 are all radially aligned. As shown in FIG. 4, the column nodes 236 are also all radially aligned, as are the end nodes 232 at the proximal end 216 of the expandable frame 200. Unlike the way the cells 220 of the expandable region 212 shown in FIGS. 2-3 appear in their expanded state, in the unexpanded state the cells 220 are all uniform in shape and size.

[0039] In at least some embodiments, an expandable frame 200 of a design such as the frames shown in FIGS. 2-4 is on the valve annulus. As a result of the valve annulus design of the expandable frame 200, a valve prosthesis utilizing this frame can achieve a reduction in pressure gradient during forward flow and an increase in effective valve orifice area, and thus excellent hemodynamics.

[0040] FIGS. 5-7 represent variations of the expandable frame shown in FIGS. 2-4. FIG. 5 shows a perspective view of an expandable frame 500 in an expanded state. FIG. 6 shows a schematic view of the flat stent pattern of the expandable frame 500 of FIG. 5 in an expanded state, while FIG. 7 shows a schematic view of the flat stent pattern of the expandable frame 500 of FIG. 5 in a non-expanded state. In some embodiments, a valve component (not shown) is mounted outside the expandable frame 500 shown in FIGS. 5-7, and in other embodiments, a valve component (not shown) can be mounted inside the frame 500.

[0041] The expandable frame 500 can have a proximal end 502 and a distal end 504 opposite the proximal end 502, and the axial length of the expandable frame extends between the proximal end 502 and the distal end 504. The expandable frame 500 can have an outer surface 506 and an inner surface 508 having a thickness therebetween. The inner surface 508 defines a lumen 510. The expandable frame 500 can have an expandable region 512 and a valve tip region 514 proximal to the expandable region 512. The valve tip region 514 allows the valve leaflets of the valve component to open beyond the outer surface 506, and in some embodiments, more particularly, allows the valve leaflets to open beyond the outer surface 506 of at least the expandable region 512 of the expandable frame, and the expandable region 512 can be considered the ventricular region of the frame. This can effectively create a taper effect where the area defined by the free edges of the valve leaflets of the valve component is larger than the area defined by the outer surface of the frame, resulting in a reduction in pressure gradient during forward flow and an increase in effective valve orifice area. Prior art valve prostheses do not allow the valve leaflets to open beyond the outer surface of the expandable frame due to the cell structure of the frame.

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

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

[0044] Each cell 520 includes a plurality of struts 530. Each strut 530 can be a straight strut, or at least a curved strut as shown in FIGS. 5-7, or each strut can be a serpentine strut having at least one curved portion or waveform. Each strut 530 can be uniform over the length of the strut 530 or can have a varying thickness. Each strut 530 of the cell 520 can be connected to adjacent struts at a node 532. The nodes 532 can include end nodes 534 at the proximal end 516 and the distal end 518 of the expandable region, and the end nodes 534 connect the struts 530 adjacent in the circumferential direction at each end 516, 518. The nodes 532 can also include column nodes 536 that connect any of the struts 530 adjacent in the circumferential direction in the columns 522, 524.

[0045] Next, referring to the valve tip region 514, the valve tip region 514 is intended to facilitate or assist the movement of the valve leaflets of the valve assembly attached to the expandable frame 500, and the valve tip region 514 has a proximal end 542 and a distal end 544 adjacent to the expandable region 512. The valve tip region 514 includes a plurality of posts 546 for attaching the valve assembly to the expandable frame 500. In some embodiments, the valve tip region 514 may have two posts 546. In some embodiments, such as the embodiments shown in FIGS. 5-7, the valve tip region 514 may have three posts 546. In still other embodiments, the valve tip region 514 may have any number of posts 546.

[0046] Each post 546 can have a distal end 548 and a proximal end 550, and the proximal end 550 defines the proximal end 542 of the valve tip region 542. In the embodiments shown in FIGS. 5-7, the distal end 548 of the post 546 can be coupled to one or more valve tip struts 551 of the valve tip region 514, and each valve tip strut 551 can be coupled to the expandable region 512 at one or more end nodal points 532. As shown in more detail at least by FIG. 6, each post 546 can be connected to a right valve tip strut 551a and a left valve tip strut 551b. In at least the embodiments shown, the combination of the post 546, the right valve tip strut 551a, and the left valve tip strut 551b forms a wishbone-like structure. In the embodiments shown, the right valve tip strut 551a of the first post 548a and the left valve tip strut 551b of the second post 548b (which is circumferentially adjacent to the first post 548a) are connected to the same end nodal point 534 of the expandable region 512. The posts 548 each have a side surface 552, and the right valve tip struts each have a side surface 553. The side surface 552 of the post 546a, the side surface 552 of the post 546b, the side surface 553 of the right valve tip strut 251a, and the side surface 553 of the left valve tip strut 251b circumferentially adjacent to the right valve tip strut 251b define a leaflet opening 554. The leaflet opening 554 enables the valve leaflets of the valve assembly to cross the outer surface of the frame. The leaflet opening 554 may also enable improved coronary access.

[0047] Each post 546 can comprise at least one strut 555, and the strut 555 can include at least one attachment mechanism 556 disposed within the strut 255. The strut 555 can have a width greater than the width of at least one strut 530 of the expandable region 514. In at least the embodiment shown in FIG. 3, the attachment mechanism 556 can comprise a slot 560. In still other embodiments, the attachment mechanism 554 can comprise one opening or a plurality of openings 560 that facilitate a particular stitching pattern, the openings being constituted by holes, slots or slits. In other embodiments, at least one attachment mechanism can comprise a hook, a loop, cotton flocking, or other similar attachment mechanism. In some embodiments, at least one of the post 546 and the attachment mechanism 554 can be further utilized to recapture or reposition the frame during or after implantation. In some embodiments, at least one of the post 546, the attachment mechanism 554, and one or more valve tip struts 551 can be utilized in a valve-in-valve procedure to engage a previously implanted valve prosthesis or to engage a valve prosthesis to be implanted.

[0048] The leaflet region 514 may further include one or more leaflet region cells 570 that may be defined by one or more leaflet connector struts 572. The leaflet connector struts 572 may provide some additional structure to the posts 546 to address the stresses that the leaflet region experiences as the valve pulsates between systole and diastole. As shown in FIGS. 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 be defined in some embodiments by at least one leaflet strut 551, at least one leaflet connector strut 572, and one or more struts 530 of the proximal end 516 of the expandable region 512. Other leaflet region cells 570b may be defined in some embodiments by at least two leaflet struts 551 and two leaflet connector struts 252. Still other leaflet region cells 570c may be defined in some embodiments by at least four struts 5300 of the proximal end 616 of the expandable region 212 and two leaflet connector struts 572. Circumferentially adjacent leaflet connector struts may be further connected to each other by a nodal point or a small strut as indicated by reference numeral 274.

[0049] In some embodiments, the axial length of the leaflet region 514 in the expanded state shown in FIGS. 5-6 is about 25% to 75% of the axial length of the expandable frame 200. In some embodiments, the axial length of the leaflet region 514 in the expanded state shown in FIGS. 5-6 is about 45% to 75% of the axial length of the expandable frame 500. In at least one embodiment, the axial length of the leaflet region 514 in the expanded state shown in FIGS. 5-6 is about 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 of the valve tip region 514 may be similar to the diameter of the expandable region 512 at the distal end of the expandable region 512. In some embodiments, the diameter of the valve tip region 514 at the proximal end of the valve tip region 514 may be greater than the diameter of the expandable region 512 at the distal end of the expandable region 512. 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 knuckle points 532 at the distal end 518 of the frame 500 are radially aligned. As shown in FIG. 7, all of the column knuckle points 536 are also radially aligned, as are the end knuckle points 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 specifically, the cells in the circumferential row 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 row 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 orifice area (EOA) of 2 ~3.76 cm 2 . In some embodiments, the average EOA can be 2 ~3.53 cm 2 . In still other embodiments, the average EOA is 2~3.30 cm 2 It can be. In at least one embodiment, the valve prosthesis 100 has an average EOA of about 2.5 - 3.5 cm and a pressure gradient of about 533 - 1333 Pascals (about 4 - 10 mmHg) along with a Doppler velocity index factor (DVI) of 0.55 - 0.70. 2

[0053] Figures 8 - 10 depict another embodiment of the expandable frame 800 of the present invention. The expandable frame 800, when used with the valve constructs discussed above, can form a shorter supra - annulus valve prosthesis. The junction of the valve construct in this expandable frame can be 45% - 70% of the height of the valve leaflets. Unlike some of the other embodiments described herein, the expandable frame 800 shown in Figures 8 - 10 is designed such that the valve construct is primarily 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 view of the stent pattern of the expandable frame 800 of Figure 8 in an expanded state, while Figure 10 shows a schematic view of the stent pattern of the expandable frame 800 of Figure 8 in a non - expanded state.

[0054] ​The expandable frame 800 can have a proximal end 802 and a distal end 804 opposite 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 can have an outer surface 806 and an inner surface 808 with a thickness therebetween. The inner surface 808 defines a 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 can have an expandable region 812 and a valve tip region 814 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 includes a plurality of cells 820 that define an opening 821. In some embodiments, all of the cells 820 of the expandable region 812 can be substantially the same size and shape. In other embodiments, the cells 820 of the expandable region 812 have different sizes and shapes.

[0056] The cells 820 can be arranged in at least a circumferential row of first cells, generally indicated by reference numeral 822, at the proximal end 816 of the expandable region 812 and a circumferential row of second cells, generally indicated by reference numeral 824, at the distal end 818 of the expandable region 812. In some embodiments, a plurality of circumferential intermediate rows of cells, generally indicated by reference numeral 826, can extend between the circumferential row 822 of first cells and the circumferential row 824 of second cells. As shown in FIG. 9, the expandable frame 800 has two intermediate rows 826 of cells between the circumferential row 822 of first cells and the circumferential row 824 of second cells.

[0057] Each cell 820 includes a plurality of struts 830. Each strut 830 may be a straight strut, or may be a curved strut as shown at least in FIG. 9, or each strut may be a serpentine strut having at least one curved portion or waveform. Each strut 830 may be uniform over the length of the strut 830 or may have a varying width. Each strut of the cell 820 may be connected to adjacent struts at a node 832. The node 832 can include end nodes 834 at the proximal end 816 and distal end 818 of the expandable region, and the end nodes 834 connect the struts 830 that are circumferentially adjacent at each end 816, 818. The node 832 can also include column nodes 336, and the column nodes 836 connect the struts 830 that are circumferentially adjacent within the columns 822, 824, 826 or connect the struts 830 that are axially adjacent in one column 822, 824, 826 to axially adjacent columns.

[0058] The valve tip region 814 has a proximal end 842 and a distal end 844. The valve tip region 814 includes a plurality of posts 846 for attaching a valve component to the expandable frame 800. In some embodiments, the valve tip region 814 may have two posts 846. In some embodiments, such as the embodiment shown in FIGS. 8-10, the valve tip region 814 may have three posts 846. In still other embodiments, the valve tip region may have any number of posts 846. Each post 846 extending from the proximal end 842 to the distal end 844 of the valve tip 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 strut 830 of the expandable region, and more particularly to a strut of at least one cell 820 in the circumferential row 822 of the first cell. Each post 846 may include at least one strut 852 and at least one attachment mechanism 854 connected to the strut 852. The strut 852 of the post is coupled to the expandable region 812 at one end. The strut 852 may have a width greater than the width of at least one strut 830 of the expandable region 814. The strut 852 may include a neck region 856 at the proximal end of the strut 852 that connects the strut 852 to at least one attachment mechanism 854 of the post 846. The at least one attachment mechanism 854 can include a tab 858, and at least one opening 860 is disposed within the tab 858. As shown in FIG. 8, the tab 858 may have a width greater than the width of the strut 852. In at least the embodiment shown in FIG. 8, the opening 860 can be a slot. In other embodiments, the opening 860 may be a hole. In still other embodiments, the attachment mechanism 854 can have a plurality of openings 860 that facilitate a particular suturing pattern, the openings being composed of holes, slots, or slits. In other embodiments, the at least one attachment mechanism may include a hook. In some embodiments, the post 846 may be further utilized after implantation to recapture or reposition the frame.

[0059] Each post 846 defines at least a part of at least one leaflet region cell 870. As shown in FIGS. 8-9, the leaflet region cell 870 has an opening 872 that is larger than the opening 821 of the cell 820. In some embodiments, the leaflet region cell 870 can enable improvement of the coronary access of the valve prosthesis 800. The leaflet region cell 870 is defined by a strut 830 at the proximal end 816 of the expandable region 812, at least one post 846, and a pair of leaflet struts 874. Each leaflet strut 874 may be a straight strut, or may be a curved strut as shown at least in FIG. 9, or each leaflet strut may be a serpentine strut having at least one curve or waveform. In some embodiments, the leaflet region cell 870 is defined by a strut 852 of the post 846. Each strut 874 forming a pair of leaflet struts is connected to each other at a leaflet node 876. In some embodiments, the leaflet region cell 870 may be further defined by an axial strut 880. As shown in FIG. 9, the axial strut 880 may be circumferentially adjacent to the post 846. The axial strut 880 is connected at a first end 882 to one of the struts of the pair of leaflet struts at a connection node 884 and at a second end 886 to an end node 834. The axial strut 880 may be a straight strut as shown at least in FIG. 9, or the axial strut 880 may be a curved strut, or a serpentine strut having at least one curve or waveform. In at least the embodiments shown in FIGS. 8-9, the leaflet region cell is defined by eight struts, namely, a strut 852 of the post 846, a pair of leaflet struts 874, an axial strut 880, and four adjacent struts 830 of the circumferential row 822 of the first cell at the proximal end 816 of the expandable region 812. As shown at least in FIGS. 8-9, in some embodiments, the opening 872 of the leaflet region cell 870 may form a generally heart-shaped perimeter in the expanded state shown in FIGS. 8-9.

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

[0061] FIG. 10 shows the expandable frame 800 in the unexpanded state. As shown in FIG. 10, all of the end nodes 832 at the distal end 818 of the frame 800 are radially aligned. As shown in FIG. 10, all of the column nodes 836 are also radially aligned, as are the end nodes 832 at the proximal end of the expandable frame 800. Additionally, the column nodes 836 are axially aligned with adjacent column nodes in adjacent columns in the axial direction of the cell. In the expanded state, the valve tip node 876 is distal to the proximal end 850 of the post 846 as shown in FIG. 9, but in the unexpanded state, the valve tip node 876 can be proximal to the proximal end 850 of the post 846. Further, in the unexpanded state shown in FIG. 10, the valve tip node 876 can be proximal to the attachment mechanism 854. In some embodiments, since the valve tip node 876 is positioned relative to the attachment mechanism 854 or the post 846 between the unexpanded and expanded states, the valve tip node 876 can have a retrieval mechanism for re-capturing or re-positioning the expandable frame 800.

[0062] Figures 11 to 13 and Figures 14A to 14C represent another embodiment of the expandable frame 1100 of the present invention. The expandable frame 1100, when used with a valve construct 1200 attached to the expandable frame 1100 and similar to the valve constructs discussed above and shown in Figures 14A to 14C, can form a shorter valved supra-annular prosthesis 1400. Similar to the expandable frames shown in Figures 8 to 10, the expandable frame 1100 is primarily designed such that the valve construct is mounted adjacent to the inner surface of the expandable frame 1100 (particularly shown in Figures 14A to 14C). Figure 11 shows a perspective view of the expandable frame 1100 in an expanded state. Figure 12 shows a schematic view of the stent pattern of the expandable frame 1100 of Figure 11 in an expanded state, while Figure 13 shows a schematic view 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 with the valve construct 1200 attached to the expandable frame 1100 shown in Figures 11 to 13.

[0063] The expandable frame 1100 can have a proximal end 1102 and a distal end 1104 opposite the proximal end 1102, and the axial length of the expandable frame extends between the proximal end 1102 and the distal end 1104. The expandable frame 1100 can have an outer surface 1106 and an inner surface 1108 having a thickness therebetween. The inner surface 1108 defines a lumen 1110. The expandable frame 1100 can have an expandable region 1112 and a valve tip 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 includes a plurality of cells 1120 that define an opening 1121. In some embodiments, all of the cells 1120 of the expandable region 1112 can be of 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 can be arranged as discussed above for the cells 820 of the embodiment shown in Figures 8 to 10.

[0064] The valve tip region 1114 may have a proximal end portion 1142 and a distal end portion 1144. The valve tip region 1114 includes a plurality of posts 1146 for attaching a valve component to the expandable frame 1100. In some embodiments, the valve tip region 1114 may have two posts 1146. In some embodiments, such as the embodiments shown in FIGS. 11-14, the valve tip region 1114 may have three posts 1146. In still other embodiments, the valve tip region may have any number of posts 1146. Each post 1146 extending from the proximal end portion 1142 to the distal end portion 1144 of the valve tip 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 the expandable region 1112 at the proximal end 1116 as discussed above for the post 846 of the embodiments shown in FIGS. 8-10.

[0065] Each post 1146 may include at least one strut 1152 and at least one attachment mechanism 1154 connected to the strut 1152. The strut 1152 of the post is coupled to the expandable region 1112 at one end. The strut 1152 may have a width greater than the width of the strut of the expandable region 1112. The at least one attachment mechanism 1154 can include a tab 1158, and at least one opening 1160 is disposed within the tab 1158. In at least one embodiment, the opening 1160 may be a slot, and in other embodiments, the opening 1160 may be a hole. In still another embodiment, the attachment mechanism 1154 can include a plurality of openings 1160 that facilitate a particular stitching pattern, the openings being composed of holes, slots, or slits. In other embodiments, the at least one attachment mechanism may include a hook. In some embodiments, the strut 1152 may have a retrieval mechanism for recapturing or repositioning the expandable frame 1100.

[0066] Each post 1146 defines at least a part of at least one leaflet tip region cell 1170. At least one leaflet tip region cell 1170 can be defined similarly to the leaflet tip region cell 870 of the embodiment shown in FIGS. 8-10. In at least the embodiment shown in FIGS. 11-13, the leaflet tip region cell is defined by eight struts, namely, the struts 1152 of the post 1146, a pair of leaflet tip struts 1174, a C-shaped strut 1180 connected at one end to one of the leaflet tip struts 1174 and also 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 can be connected to the same end node 1134 of the expandable region. Adjacent C-shaped struts 1180a, 1180b can be coupled to adjacent pairs of struts 1174a, 1174b of the struts, respectively. The connection of adjacent C-shaped struts 1180a, 1180b and struts 1174a, 1174b forms a node 1188. The C-shaped struts 1180a, 1180b of adjacent leaflet tip region cells 1170 form an opening 1192. The opening 1192 can be sized and shaped to allow coronary access for secondary procedures (such as atherectomy or angioplasty procedures) without interfering with the movement of the leaflet tip or leaflets of the valve construct. 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 4.0 mm (12 Fr) to allow insertion after the catheter.

[0067] FIG. 13 shows the expandable frame 1100 in a non-expanded state. In the expanded state, the leaflet tip node 1176 is distal to the proximal end 1148 of the post 1146 as shown in FIG. 12, but in the non-expanded state, the leaflet tip node 1176 can be proximal to the proximal end 1148 of the post 1146. The leaflet tip nodes 1176 can be radially aligned with each other. As shown in FIG. 13, the openings 1192 can be radially aligned with each other in the non-expanded state. In some embodiments, adjacent nodes 1188 can be radially aligned with each other in the non-expanded state.

[0068] Figures 14A - 14C depict the attachment of valve construct 1200 to expandable frame 1100 according to at least one embodiment of valve prosthesis 1400. Valve construct 1200 can be attached to the frame as described in the disclosure of U.S. Application No. 16 / 129,235 by the applicant of the present application having the title of invention "Replacement Heart Valve with Reduced Suturing", which is incorporated herein by reference in its entirety. Further, valve construct 1200 can be attached to expandable frame 1100 by overlaying a portion of the tissue over post 1146. In one embodiment, slits 1206 can be formed in valve construct 1200 near each commissural region 1202 of the valve construct and near the proximal end 1204 of the valve construct. Each post 1146 can be inserted through one slit 1206 of valve construct 1200 such that the commissural region 1202 at least partially overlaps the proximal end of post 1146. Next, a suture can be used to attach the valve construct at each post 1146 using attachment mechanism 1154. At least one continuous running belly suture using a single suture can be used circumferentially around the frame to further connect the valve construct to the frame. In one embodiment, the continuous running belly suture follows the pattern of the valve leaflets of the valve construct. In some embodiments of valve prosthesis 1400, a paravalvular leakage skirt 1408 can be provided on the outer surface of the valve. The skirt can be attached circumferentially around the valve with another suture. In at least one embodiment, valve prosthesis 1400 has less than 6 sutures. In some embodiments, the valve prosthesis has 3 - 6 sutures. In other embodiments, the valve prosthesis has 3 - 5 sutures.

[0069] Figures 15 - 17 illustrate another embodiment of the expandable frame 1500 of the present invention. The expandable frame 1500, when attached to the expandable frame 1150 and used with the valve construct 1200 discussed above and shown in FIGS. 14A - 14C, can form a shorter valve annulus supra - valve prosthesis. Similar to the expandable frames shown in FIGS. 8 - 13, the expandable frame 1500 is primarily designed such that the valve construct is mounted adjacent to the inner surface of the expandable frame 1500.

[0070] The expandable frame 1500 can have a proximal end 1502 and a distal end 1504 opposite the proximal end 1502, and the axial length of the expandable frame extends between the proximal end 1502 and the distal end 1504. The expandable frame 1500 can have an outer surface 1506 and an inner surface 1508 with a thickness therebetween. The inner surface 1508 defines a lumen 1510. The expandable frame 1500 can have an expandable region 1512 and a valve tip 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 that define an opening 1521. In some embodiments, all of the cells 1520 of the expandable region 1512 can be of 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 can be arranged as discussed above for the cells 820 of the embodiments shown in FIGS. 8 - 10 and the cells 1120 of the embodiments shown in FIGS. 11 - 13.

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

[0072] Each post 1546 can include at least one support column 1152 and at least one attachment mechanism 1154 connected to the support column 1152, as discussed above for the post 1146 of the embodiments shown in FIGS. 11-13. As shown in FIGS. 15-17, at least one attachment mechanism can be different for one post 1546 and an adjacent post. As shown in FIGS. 15-17, at least one of the posts 1546a can have an attachment mechanism 1548a with a plurality of slits 1560 in a certain pattern. As shown in FIGS. 15-17, the plurality of slits 1560 form a lowercase "d" in one of the posts 1146, but the pattern can also form an uppercase "D" or any other suitable or desirable shape. The other posts 1546b, 1546c can have the same attachment mechanisms 1548b, 1548c such as holes or slots different from the attachment mechanism 1548. If one post 1546a has an attachment mechanism 1548a different from any of the attachment mechanisms 1548b, 1548c of the other posts (or the other posts have relatively matching attachment mechanisms), it can assist the operator in identifying one of the cross-linked posts and help with the alignment and orientation of the valve during delivery. In at least one embodiment, the first post 1546 can have a pattern of slits, the second post 1546 can have at least one hole, and the third post 1546 can have at least one slot, such that each post has an attachment mechanism different from an adjacent post. This configuration can further assist the operator in performing the alignment and orientation of the valve during delivery.

[0073] Each post 1546 defines at least a part of at least one leaflet region cell 1570. The at least one leaflet region cell 1570 can be defined similarly to the leaflet region cell 870 of the embodiment shown in FIGS. 8 - 10 and the leaflet region cell 1170 of the embodiment shown in FIGS. 11 - 13. In at least the embodiment shown in FIG. 16, the leaflet region cell 1570 is defined by eight struts, namely, the struts 1552 of the 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 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 strut 1580 comprises at least one protrusion 1593. As shown, the axial strut 1580 has two protrusions 1593.

[0074] FIG. 17 shows the expandable frame 1500 in a non - expanded state. In the expanded state, the leaflet node 1576 is distal to the proximal end 1550 of the post 1546 as shown in FIG. 16, but in the non - expanded state, the leaflet node 1576 can be proximal to the proximal end 1550 of the post 1546. The leaflet nodes 1576 can be radially aligned with each other.

[0075] FIGS. 18 - 20 represent another embodiment of the expandable frame 1800 of the present invention. The expandable frame 1800 can form a shorter supra - annulus valve prosthesis when attached to the valve construct discussed above. Similar to the expandable frames shown in FIGS. 8 - 17, the expandable frame 1800 is mainly designed such that the valve construct is mounted adjacent to the inner surface of the expandable frame 1800. However, the valve construct can also be mounted on the outer surface of either this embodiment or any of the embodiments discussed in this specification.

[0076] The expandable frame 1800 can have a proximal end 1802 and a distal end 1804 opposite the proximal end 1802, and the axial length of the expandable frame extends between the proximal end 1802 and the distal end 1804. The expandable frame 1800 can have an outer surface 1806 and an inner surface 1808 having a thickness therebetween. The inner surface 1808 defines a lumen 1810. The expandable frame 1800 can have an expandable region 1812 and a valve tip 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 includes a plurality of cells 1820 that define an opening 1821. In some embodiments, all of the cells 1820 of the expandable region 1812 can 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 can be arranged as discussed above for the cells 820 of the embodiments shown in FIGS. 8-10 and the cells 1120 of the embodiments shown in FIGS. 11-13.

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

[0078] Each post 1846 can include at least one support column 1852 and at least one attachment mechanism 1854 connected to the support column 1852, as discussed above with respect to the post 1846 of the embodiments shown in FIGS. 18-20. The at least one attachment mechanism can be different for one post 1846 and an adjacent post. As discussed above with respect to the embodiments shown in FIGS. 15-17, at least one of the posts 1846a can have an attachment mechanism 1848a with a plurality of slits 1860 in a regular pattern. In some embodiments, the plurality of slits 1860 form a lower case "d" in one of the posts 1846, but the pattern can also form an upper case "D" or any other suitable or desirable shape. The other posts 1846b, 1846c can have the same attachment mechanisms 1848b, 1848c, such as holes or slots, that are different from the attachment mechanism 1848. In at least one embodiment, the first post 1846 can have a pattern of slits, the second post 1846 can have at least one hole, and the third post 1846 can have at least one slot, such that each post has an attachment mechanism different from an adjacent post. This configuration can further assist the operator in aligning and orienting the valve during delivery.

[0079] Each post 1846 defines at least a part of at least one tip region cell 1870. The at least one tip region cell 1870 can be defined similarly to the tip region cell 870 of the embodiments shown in FIGS. 8-10. In at least the embodiments shown in FIGS. 15-17, the tip region cell 1870 is defined by nine struts, namely, the struts 1852 of the post 1846, a pair of tip 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 can be connected at a first end to one of the tip struts 1874a of the tip region cell 1870a and at a second end to the end node 1834 of the expandable region 1812. The second meandering strut 1881 can be connected at a first end to one of the tip struts 1874b of the tip region cell 1870b adjacent to the tip region cell 1870a and at a second end to the end node 1834. The second meandering strut 1881 can, in one embodiment, overlap the first meandering strut 1880. The overlapping meandering struts 1880, 1881 can form an "8" shape having two openings. The overlapping meandering struts 1880, 1881 enable an improvement in rigidity in the tip region 1814 and resist torsion in this region.

[0080] FIG. 20 shows the expandable frame 1800 in a non-expanded state. Similar to the other embodiments discussed herein with respect to FIGS. 8-13 and FIGS. 15-17, in the expanded state, the tip node 1876 is distal to the proximal end 1850 of the post 1846 as shown in FIG. 19, but in the non-expanded state, the tip node 1876 can be proximal to the proximal end 1850 of the post 1846. The tip nodes 1876 can be radially aligned with each other.

[0081] In some embodiments, a valve prosthesis comprising the expandable frame shown in FIGS. 18-20 is 1.33 cm 2 ~3.43 cm 2has an average effective orifice area (EOA). In some embodiments, the average EOA can be from 1.68 cm 2 to 3.08 cm 2 . In still other embodiments, the average EOA can be from 2.03 cm 2 to 2.73 cm 2 .

[0082] The expandable frame discussed herein may further comprise one or more radiopaque markers for positioning the expandable frame, and thus the valve construct, at a desired location relative to the patient's native anatomy during the delivery procedure. In some embodiments of the expandable frame, including but not limited to those shown in at least FIGS. 8-20, the expandable frame may have a radiopaque marker attached to at least one strut. In some embodiments of the expandable frame, including but not limited to those shown in at least FIGS. 8-20, the expandable frame may have a radiopaque marker attached to at least one nodal point. In some embodiments, the radiopaque marker may be disposed 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 marker may be attached to 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 marker may be a coating on that portion of the expandable frame. The position of the radiopaque marker may be determined by shortening of the strut from its loaded state (which may or may not correspond to its non-expanded state) within the delivery catheter to its expanded state. In some embodiments, the position of the radiopaque marker may be determined by shortening of the strut from its non-expanded state to its expanded state. In some embodiments, the radiopaque marker may be disposed distally of the expandable region. In further embodiments, the radiopaque marker may be disposed on at least one of the commissural posts, or on a strut or nodal point in the valve tip region. In at least one embodiment, as shown in FIG. 21, the expandable frame 2100 may have an expandable region 2112 of the cell and a valve tip region 2114 of the cell proximal to the expandable region 2112. The valve tip region 2114 may define an outflow end of the expandable frame, and the expandable region 2112 may define an inflow end of the expandable frame.In at least the expandable region 2112, the expandable frame 2100 can have a plurality of columns 2116 of knot points 2118 that connect the struts 2120 of adjacent cells of the expandable region 2112. As shown in FIG. 21, the expandable region 2112 has five columns 2116a, 2116b, 2116c, 2116d, 2116e of knot points 2118. Column 2116a can define the proximal end 2124 of the expandable region 2112, and column 2116e can define the distal end 2126 of the expandable region 2112. In some embodiments, a radiopaque marker can be disposed in one of the end columns 2116a, 2116e. More particularly, the radiopaque marker can be disposed at or near a knot point of column 2116e to assist an operator in visualizing the position of the distal end of the expandable frame during delivery. In other embodiments, the radiopaque marker can be disposed at or near a knot point of column 2116a near the outflow end of the valve prosthesis to assist an operator in visualizing the relative position of the valve cusp of the valve construct. In other embodiments, the radiopaque marker can be disposed in the intermediate columns 2116b, 2116c, 2116d of knot points of the expandable region 2112. More particularly, as shown in FIG. 21, the radiopaque marker 2128 can be disposed on a strut 2120 between column 2116c and column 2116d. The position of the radiopaque marker 2128 can, in some embodiments, be moved to a desired position of the expandable frame relative to the native valve annulus of the patient such that the expandable frame can be properly disposed supra-annularly relative to the native valve annulus of the patient.

[0083] The valve construct may be attached to an expandable frame in any of the embodiments shown in FIGS. 11-21 or other similar embodiments with a fewer number of sutures compared to other commercially available transcatheter aortic valve devices. FIG. 22 shows a suture pattern in an expandable frame 2210 similar to at least the expandable frame shown in FIG. 12. The expandable frame 2210 may have a proximal end 2212 and a distal end 2214 opposite the proximal end 2212. The expandable frame may have a plurality of commissural posts 2246 at or substantially near the proximal end 2212. Each commissural post 2246 may have a proximal end 2248 and a distal end 2250. Each post 2246 may include at least one strut 2252 and at least one attachment mechanism 2254 connected to or embedded in the strut 2252. The at least one attachment mechanism 2254 may include a tab 2258, and at least one opening 2260 may be disposed within the tab 2258. The expandable frame further includes valve leaflet struts 2274 coupled to both sides of the post 2246. In embodiments where the valve construct is a single-piece valve construct, attachment of the valve construct to the expandable frame 2210 may include a suture pattern 2200 as shown in FIG. 22. The suture pattern 2200 includes three semi-circles 2220, each semi-circle 2220 corresponding to one valve leaflet of the valve construct. Each semi-circle 2220 includes 10 to 45 stitches 2221. In some embodiments, each semi-circle includes 20 to 30 stitches 2221. The suture pattern 2200 may include a single suture 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 to complete the suture pattern 2200. In some embodiments, the first end 2223 and the second end 2225 may be tied at a strut of the frame. In other embodiments, the first end 2223 and the second end 2225 may be tied around one of the posts 2254. In some embodiments, the suture pattern 2200 consists of only locking stitches.

[0084] Cross-linking posts of an expandable frame according to FIGS. 23A and 23B. FIG. 23A shows an example of a cross-linking stitching pattern 2320 as seen from the outer surface of an expandable frame 2210, and FIG. 23B shows the stitching pattern 2320 of FIG. 23A as seen from the inner surface of the expandable frame 2210. In at least one embodiment, the stitching pattern 2320 includes a single stitching thread 2322. The cross-linking post 2346 includes a proximal end 2348 and a distal end 2350. The cross-linking post further includes an inner surface 2349 and an outer surface 2351. The cross-linking post 2346 further includes 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 valve tip support columns 2374 extend 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 cross-linking stitching pattern 2320 includes a stitching thread 2322 having a first end 2380 and a second end 2381. The first end 2380 is disposed within the opening 2360 of the mounting mechanism 2354. The stitching thread 2322 then extends from the first end 2380 over the outer surface 2351 of the cross-linking post 2346 to the first side surface 2356 and reaches a point 2382. At the point 2382, the stitching thread 2322 crosses the inner surface 2349 of the cross-linking post 2346 to the second side surface 2358 and reaches a point 2383. At the point 2383, the stitching thread 2322 crosses over the outer surface 2351 to the support column 2374 adjacent to the side surface 2356, specifically to the upper part of the support column 2374, and reaches a point 2384. At the point 2384, the stitching thread 2322 crosses the inner surface 2349 to the lower part of the support column 2374 adjacent to the side surface 2358 and reaches a point 2385. At the point 2385, the stitching thread 2322 crosses over the outer surface 2351 towards the distal end of the cross-linking post 2346 on the first side surface 2358 and reaches a point 2386, and then crosses the inner surface 2349 and reaches a point 2387. At the point 2387, the stitching thread 2322 crosses over the outer surface 2351 to the lower part of the support column 2374 adjacent to the side surface 2356 and reaches a point 2388. At the point 2388, the stitching thread 2322 crosses the inner surface 2349 to the upper part of the support column 2374 adjacent to the side surface 2358 and reaches a point 2389.At point 2389, suture 2322 then crosses outer surface 2351 to point 2389 between point 2382 and point 2384. Suture 2322 then passes through opening 2360 over inner surface 2389 to reach second end 2381. First end 2380 and second end 2381 can be connected to each other with a secure knot. In a preferred embodiment, when suturing the valve construct to the crosslinking posts, the valve construct is arranged in close proximity to the frame sufficient to ensure that there are no post gaps and that the valve construct can be properly joined under pressure.

[0085] In some embodiments, to facilitate attachment of the valve construct to the post as described above with respect to FIGS. 23A and 23B, the valve construct can be modified to insert the post into a portion of the valve construct. An example is shown in FIG. 24. Valve construct 2400 is a single-piece valve construct comprising valve leaflets 2402 and a crosslinking region 2404 integrally formed between adjacent valve leaflets. Slits 2406 can be cut into valve construct 2400 at each crosslinking region 2404, and then the crosslinking struts of the expandable frame can be inserted into the slits such that a portion of valve construct 2400 is present on the outer surface of the expandable frame (more particularly, the crosslinking post) when attached to the frame.

[0086] As used herein, the terms "substantially" or "generally" refer to a range or degree of an action, property, characteristic, state, structure, item, or result that is complete or nearly complete. For example, an object that is "substantially" or "generally" included means that the object is either completely included or nearly completely included. The degree of exact allowable dissociation from absolute completeness depends in some cases on the specific context. However, generally speaking, being close to completeness results in generally the same overall result as if absolute and total completeness had been achieved. The use of the terms "substantially" or "generally" is also used in the same way when it is used in a negative sense to refer to a complete or nearly complete lack of an action, feature, characteristic, state, structure, item, or result. For example, an element or combination, embodiment, or composition that "substantially" lacks or "generally" lacks a certain component may still actually contain such an item, generally as long as there is no measurable effect thereof.

[0087] The description of "an embodiment" or "embodiments" herein means that the specific elements, features, structures, or characteristics described in connection with the embodiments are included in at least one embodiment. The description "in one embodiment" herein does not necessarily refer to all being the same embodiment.

[0088] As used herein, the terms "comprising," "comprises," "including," "includes," "having," "has," or other variations thereof are intended to cover non-exclusive inclusion. For example, a process, method, article, or apparatus that comprises a list of certain elements is not necessarily limited to those elements but may also include other elements not expressly listed or inherent to such process, method, article, or apparatus. Further, unless expressly stated to the contrary, 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 present) and B is false (or absent), A is false (or absent) and B is true (or present), and both A and B are true (or present).

[0089] In addition, the use of "a," "an" is employed to describe elements or components of embodiments herein. This is for convenience only and to give a general sense of the description. This description should be read to include one or at least one and, unless it is clear that it means otherwise, also includes the plural form.

[0090] Furthermore, the drawings illustrate preferred embodiments for purposes of illustration only. Upon reading this disclosure, those skilled in the art will be able to understand additional alternative structural and functional designs of the devices described herein.

[0091] Accordingly, while specific embodiments and uses are shown and described in the figures, it should be understood that the disclosed embodiments are not limited to exactly the structures and components disclosed herein. Various modifications, changes, and variations will be apparent to those skilled in the art without departing from the spirit and scope defined in the appended claims, although such would be apparent to those skilled in the art regarding the construction, operation, and details of the methods and apparatuses disclosed herein.

[0092] The systems and methods described herein with reference to several exemplary embodiments are considered such that these embodiments are not limiting and not necessarily mutually exclusive, and that specific elements of the various embodiments can be omitted or combined for use with the features of another component within the scope of the present invention. Any feature of any embodiment herein can be used in any embodiment and with any feature of another embodiment.

Claims

1. A prosthetic heart valve for transcatheter repair of a native valve, the prosthetic heart valve comprising: a frame having a distal end, a proximal end, and a length between the distal end and the proximal end, the frame further comprising an outer surface and an inner surface defining a lumen, the frame being expandable from a non-expanded state to an expanded state, an expandable region near the distal end of the frame, a leaflet region proximal to the expandable region, at least a first post and a second post, each of the posts having a proximal end, a distal end, and at least one valve attachment mechanism, at least the first post and the second post, a first leaflet strut connected to the first post, a second leaflet strut connected to the first leaflet strut and the second post, a first leaflet opening defined by the first post, the second post, the first leaflet strut, and the second leaflet strut and a leaflet region including the same, an expandable frame further comprising: a valve construct mounted on the outer surface of the frame, the valve construct being attached to the frame and at least to the valve attachment mechanism of the post, the valve construct including at least a first shaped leaflet, the first shaped leaflet extending into the first leaflet opening, a valve construct, comprising: the first shaped leaflet is configured to enter the lumen of the frame across the first leaflet opening, the expandable region further includes cells defined by a plurality of struts, the leaflet region further includes leaflet region cells defined by the first leaflet strut, at least one leaflet connector strut, and one or more of the struts at the proximal end of the expandable region, and further includes leaflet region cells defined by the second leaflet strut, at least one leaflet connector strut, and one or more of the struts at the proximal end of the expandable region, the leaflet connector strut having a width greater than the width of at least one of the struts of the expandable region, a prosthetic heart valve.

2. A prosthetic heart valve for transcatheter repair of a native valve, the prosthetic heart valve comprising: a frame having a distal end, a proximal end, and a length between the distal end and the proximal end, the frame further comprising an outer surface and an inner surface defining a lumen, the frame being expandable from a non-expanded state to an expanded state, An expandable region near the distal end of the frame, and A valve tip region proximal to the expandable region, the valve tip region comprising At least a first post and a second post, each of the posts having a proximal end, a distal end, and at least one valve attachment mechanism; at least a first post and a second post; A first valve tip strut connected to the first post; A second valve tip strut connected to the first valve tip strut and the second post; A first valve tip opening defined by the first post, the second post, the first valve tip strut, and the second valve tip strut; And a valve tip region including the same; An expandable frame further comprising; A valve structure mounted on the outer surface of the frame, the valve structure being attached to the frame and at least to the valve attachment mechanism of the post, the valve structure including at least a first shaped valve leaflet, the first shaped valve leaflet extending into the first valve tip opening; a valve structure; Comprising; The first shaped valve leaflet is configured to enter the lumen of the frame across the first valve tip opening; The expandable region further includes cells defined by a plurality of struts; The valve tip region further includes a valve tip region cell defined by two valve tip connector struts and at least two of the struts at the proximal end of the expandable region; The valve tip connector strut has a width greater than the width of at least one of the struts of the expandable region. A prosthetic heart valve.

3. The prosthetic heart valve according to claim 1 or 2, wherein the valve tip region comprises a third post.

4. The prosthetic heart valve according to claim 1 or 2, wherein the first valve tip strut and the second valve tip strut are arched struts.

5. The prosthetic heart valve according to claim 1 or 2, wherein the valve tip region further comprises a third post, the valve structure further comprises a second shaped valve leaflet, and the second shaped valve leaflet extends into a second valve tip opening defined by at least the second post and the third post.

6. The prosthetic heart valve according to claim 5, wherein the valve structure has an interconnected region shaped between the first shaped valve leaflet and the second shaped valve leaflet.

7. The prosthetic heart valve according to claim 5, further comprising at least a third valve tip opening defined by the third post and the first post, and a third shaped valve leaflet extending into the third valve tip opening.

8. The prosthetic heart valve according to claim 1 or 2, wherein the valve structure is a single-piece valve formed from a biological material.

9. The prosthetic heart valve according to claim 8, wherein the biological material includes a polymer, bovine tissue, or porcine tissue.

10. The prosthetic heart valve according to claim 1 or 2, wherein the expandable region has at least a first row of cells at a distal end of the expandable region and a second row of cells at a proximal end of the expandable region.

11. The prosthetic heart valve according to claim 10, wherein the expandable region has a plurality of intermediate row cells between the first row of cells and the second row of cells.

12. The prosthetic heart valve according to claim 1 or 2, wherein the frame has a longitudinal axis and the posts are axially aligned with the longitudinal axis.

13. The prosthetic heart valve according to claim 1 or 2, wherein the expandable region has a proximal end, a distal end, and a plurality of end nodes at the proximal end of the expandable region, and the first valve tip strut is connected to a first end node of the expandable region.

14. The prosthetic heart valve according to claim 13, wherein the second valve tip strut is connected to the first end node.

15. The prosthetic heart valve according to claim 1 or 2, wherein the valve attachment mechanism is selected from the group consisting of a slot, a hook, a loop, and a suture.

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